Daily Intelligence for Industry Leaders

A curated stream of the latest news and regulatory updates across drugs, pharma, medical devices, and cosmetics for industry leaders.

Showing 337 news updates.

5 November 2026

Healthcare & Wellness

National Dental Commission directs dentists to restrict practice to their qualifications and training

The National Dental Commission (NDC) has clarified that registered dentists must perform dental procedures only within the scope of their qualifications and clinical training. In an advisory dated June 9, 2026, the Commission emphasised that dentists must adhere to these professional boundaries and should not undertake procedures beyond their training. It has asked State Dental Councils and Tribunals to issue advisories or guidelines to registered dentists, ensuring that their clinical services remain aligned with their formal qualifications and training.

5 November 2026

Food & Beverages (F&B)

Use of 'Energy Drink' label on caffeinated beverages challenged by FSSAI over alleged misbranding

The Food Safety and Standards Authority of India (FSSAI) directed manufacturers to remove the description 'Energy Drink' from certain beverage products, citing concerns of misbranding and misleading claims. The directions were challenged before the Delhi High Court on the grounds that FSSAI had previously permitted the use of the description. The manufacturers also questioned the directions for having been issued without a show-cause notice or an opportunity of hearing.

On October 6, 2026, the Court stayed the impugned directions and permitted the sale of existing stock, while prohibiting further manufacture using the disputed description. By an order dated October 30, 2026, the Court clarified that cans manufactured before October 6 could also be filled and utilised. The interim arrangement will continue pending disposal of the petition.

5 November 2026

Pharmaceuticals

Training programme advances non animal testing methods for pharmaceutical evaluation

The National Institute of Biologicals, PETA Science Consortium International and Institute for In Vitro Sciences has reportedly conducted practical training on non animal toxicity testing. The programme trained regulatory, research and pharmaceutical professionals in approaches using human cells, tissue models and computational tools to support biomedical research and pharmaceutical quality evaluation.

Open

5 November 2026

Healthcare & Wellness

Reliance on Apnea test for brain-stem death certification questioned over need for additional medical tests

The Supreme Court has reserved its judgment in a petition questioning the procedure followed to declare patients brain-stem dead, particularly the reliance on the Apnea test. The petition alleges that patients may be incorrectly declared brain-stem dead to facilitate organ transplantation. He has argued that the Apnea test should not be the sole or primary basis for such a determination and that additional tests, including electroencephalography (EEG) and cerebral angiography, to assess the condition. The Supreme Court directed AIIMS, New Delhi, to constitute a three-member expert committee to review the protocols and recommend appropriate procedures.

4 November 2026

Pharmaceuticals

Downward revision in oxaliplatin injection ceiling price by NPPA following a review order

The National Pharmaceutical Pricing Authority (NPPA) has announced a downward revision in the ceiling price of oxaliplatin injection (5 mg/ml, 10 ml vial) under the Drugs (Prices Control) Order, 2013, incorporating the applicable Wholesale Price Index (WPI) adjustment for 2026.

The revision reduces the regulated ceiling price for the scheduled formulation. Manufacturers and importers must issue revised price lists in Form V through IPDMS and provide copies to the concerned authorities and dealers, while complying with applicable reporting and discontinuation requirements.

4 November 2026

Food & Beverages (F&B)

Draft rules propose use of recycled polymers in food contact packaging

The Food Safety and Standards Authority of India has issued draft rules proposing to permit chemically recycled polyethylene and polypropylene in food contact materials where equivalent to virgin material. Food grade recycled polymers may also be used in the outermost layer of multilayer packaging, subject to adequate barriers and prescribed migration limits. Comments are invited within 60 days.

4 November 2026

Pharmaceuticals

Government proposes enhanced batch-release controls under the Drugs Rules, 1

India's Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, requiring manufacturers of drugs to authorise qualified personnel for batch release as per the GMP requirements. The proposal also introduces a prescribed Batch Release Certificate and batch-wise documentation covering manufacturing, testing and quality checks. Loan licensees and manufacturer of blood products would also be required to maintain batch-release records for every batch manufactured under their licences strengthening accountability for quality oversight even where manufacturing is undertaken at another licensee’s premises.

Open

3 November 2026

Pharmaceuticals

US removes Black Box Warnings from three estrogen patch products

The US regulator has approved the removal of broad black box warnings from three estrogen patch products used to treat menopause symptoms. The decision follows a review of existing safety labelling and aims to ensure warnings appropriately reflect risks while improving access to hormone replacement therapies amid rising demand.

3 November 2026

Hospitals

Hospital drug price disclosure circular on hold in Karnataka

Karnataka High Court has recorded that the State government has undertaken not to insist on compliance with its October 1, 2026 circular requiring hospitals to disclose the purchase price, maximum retail price (MRP) and price charged to patients for medicines, medical devices and consumables. The circular, issued by the Karnataka Food Safety and Drugs Administration, also required hospitals to display this pricing information at billing and pharmacy counters.

Private hospitals had challenged the circular, reportedly arguing that the authorities lacked the legal power to compel disclosure of their procurement prices. The State informed the Court that the circular is under review and its implementation would not be insisted on until the next hearing on November 12, 2026. The Court has not yet decided the legality of the circular.

3 November 2026

Hospitals

PPP model for MRI services in government hospitals to be introduced in Telangana

Telangana plans to introduce MRI services under the Public-Private Partnership (PPP) model across government hospitals within two years. Under the proposed arrangement, private operators will be responsible for installing, operating and maintaining MRI equipment.

The move aims to minimise service disruptions arising from equipment breakdowns and maintenance issues, while ensuring that patients referred by government doctors continue to receive MRI scans free of cost.

3 November 2026

Hospitals

Andhra Pradesh sets ICU upgrade deadlines in compliance with Supreme Court directions on critical care infrastructure

The Supreme Court in September 2026 had directed the Centre, States and Union Territories to implement the 2026 Guidelines for Organisation and Delivery of Intensive Care Services, formulated by the Directorate General of Health Services (DGHS). 

Pursuant to these directions, Andhra Pradesh's Director of Medical Education has reportedly directed all government general hospitals to upgrade their ICUs. Hospitals must complete structural modifications, including ICU location, size and nursing stations within nine months. Bedside facilities, non-emergency equipment and laboratory services must be provided within three months. Emergency equipment and imaging procurement orders must be issued within three months, with up to another three months for delivery and installation. Additional services must be introduced within one month. Level-I ICU standards are mandatory across these hospitals.

3 November 2026

Pharmaceuticals

IPC flags adverse reactions linked to levetiracetam and nasal decongestants

The Indian Pharmacopoeia Commission has identified suspected links between levetiracetam and gingival hypertrophy, and between xylometazoline or oxymetazoline and rebound nasal congestion. Healthcare professionals and patients are advised to monitor for these adverse reactions and report suspected cases to the Pharmacovigilance Programme of India through its prescribed reporting channels.

Open

3 November 2026

Pharmaceuticals

Delhi High Court restrains NPPA from taking coercive action over ₹151 crore drug pricing demand

The Delhi High Court has directed the National Pharmaceutical Pricing Authority (NPPA), India's drug price regulator not to take coercive steps against a Pharma company over a ₹151.19 crore demand for alleged overcharging and interest on asthma medication. NPPA alleges that the company sold the drug above its applicable ceiling price under the Drugs (Prices Control) Order, 2013 (DPCO), which regulates prices of specified essential medicines. This was challenged by the company stating that its inhaler contains different drug strengths from those listed in the DPCO and therefore cannot be subjected to the same price ceiling. It also disputed recovery from 2016, as the comparable formulation's ceiling price was fixed only in 2019. The Court granted interim protection until January 11, 2027, finding a prima facie case in the company's favour.

2 November 2026

Food & Beverages (F&B)

CCPA cracks down on misleading '100% Whole Wheat Bread' claims

The Central Consumer Protection Authority (CCPA) has penalised two bread manufacturers for misleading consumers with 100% whole wheat claims, as their products contained less than the prescribed 75% whole wheat threshold required for the “Whole Wheat Bread” declaration. The authority has also directed them to discontinue the misleading advertisements across print, electronic and social media and submit compliance reports within 15 days.

2 November 2026

Animal Health & Wildlife

Animal disease control: Centre notifies new rules on reporting, vaccination and carcass disposal

The Central Government has replaced the Prevention and Control of Infectious and Contagious Diseases in Animals Rules, 2010 with the new 2026 Rules, notified in October, 2026. Earlier, the Rules prescribed vaccination certificate formats, post-mortem procedures and methods for carcass disposal. The new 2026 Rules retain these requirements of the old Rules, while introducing portal based reporting of disease outbreaks by Village Officers and veterinarians, along with reporting of vaccination details and issuance of vaccination certificates through the Bharat Pashudhan portal. They also prescribe more detailed procedures for post mortem examinations, including submission of reports to the Central and State Governments within 12 hours. The Rules expand carcass disposal requirements to cover animals suspected of infection and introduce detailed record keeping obligations. They further establish a formal mechanism for complaints, adjudication and appeals, including procedures for imposing and recovering penalties for contraventions of the Act.

2 November 2026

Pharmaceuticals

Karnataka Government pauses enforcement of hospital medicine price disclosure circular

The Karnataka Government has reportedly informed the Karnataka High Court that it would not enforce the circular requiring hospitals to disclose the landing or procurement price, MRP, patient charge and applicable taxes for medicines, medical devices and consumables on itemised bills. The circular is being re-examined following a legal challenge concerning its statutory basis, confidentiality of commercial arrangements and absence of adequate stakeholder consultation. Its implementation remains suspended until further court orders.

Open

2 November 2026

MedTech

US FDA revises draft guidance on drug delivery devices

The US Food and Drug Administration (FDA) has issued revised draft guidance on how manufacturers should show that devices used to deliver medicines work properly. It covers devices such as syringes, autoinjectors, infusion pumps, inhalers and nasal sprays. The revised draft replaces the 2024 version and changes the term “Essential Drug Delivery Outputs” to “Essential Drug Delivery Device Performance Characteristics” (EDDCs). The guidance refers to the key features that ensure a device delivers the correct drug dose to the intended site and explains how manufacturers should test device performance, maintain quality during manufacturing and assess changes made after a product enters the market. The draft is non-binding. Comments may be submitted until January 28, 2027.

2 November 2026

Alcohol & Tobacco

Surrogate advertising: Show-cause notice to brand endorser challenged before Bombay High Court

The Maharashtra Food and Drug Administration (FDA) had issued show-cause notices to three celebrity endorsers over advertisements for a mouth freshener, alleging that the campaign indirectly promoted a prohibited tobacco product. One of the endorsers has now reportedly approached the Bombay High Court, challenging the notice on grounds of arbitrariness, predetermination and violation of principles of natural justice and Article 14 of the Constitution. The petition also questions the legal provisions invoked and the regulator’s decision to proceed against the endorser rather than the manufacturer.

2 November 2026

Pharmaceuticals

Price list of 1,024 non-scheduled anti-cancer medicines released by NPPA

The National Pharmaceutical Pricing Authority (NPPA) has published the Maximum Retail Prices (MRPs) for 1,024 brands of non-scheduled anti-cancer medicines, effective November 9, 2026. The move aims to improve the affordability and accessibility of cancer treatment by rationalising trade margins. Manufacturers must ensure that the specified MRPs are implemented from the effective date.

2 November 2026

Environment & Waste Management

Pharmaceutical waste disposal: Karnataka pharmacies seek better medicine collection systems

Pharmacy associations across Karnataka have raised concerns over the improper disposal of expired, unused and unsold medicines, citing inadequate collection facilities and difficulties in returning expired stock. When discarded with household waste or poured down drains, these medicines can release harmful chemical residues, contaminate water, pose poisoning risks to people and animals, and contribute to antimicrobial resistance.

In May 2025, the Central Drugs Standard Control Organisation (CDSCO) had issued a guidance document which places responsibility on retailers to return expired stock to suppliers or manufacturers within 30 days of expiry, and calls on manufacturers to ensure its disposal within six months of expiry. The guidance also recommends collection facilities for unused medicines from the public.

Open

2 November 2026

Hospitals, MedTech

Karnataka experts flag gaps in monitoring reuse of single-use medical devices

Experts in Karnataka have raised concerns over inadequate monitoring of private hospitals for compliance with restrictions on reusing single-use medical devices, citing staff shortages, limited inspections and weak enforcement. The concerns arise against the backdrop of a national DGHS direction reiterating the prohibition on such reuse. The direction also highlights concerns over hospitals charging patients or claiming reimbursements for devices that may have been reused. Experts have called for dedicated regulatory officers, regular inspections and medical audits to strengthen oversight and protect patient safety.

2 November 2026

Pharmaceuticals

Pharmaceutical manufacturer recalls 11 eye medicines amid quality concerns

A pharmaceutical manufacturer has voluntarily recalled 11 ophthalmic products and temporarily halted their production following quality concerns at its Assam manufacturing facility. The action follows reported regulatory findings of deficiencies in quality management systems, with the company undertaking corrective measures before resuming manufacturing and supplies.

30 October 2026

Controlled Substances

MDMB-FUBINACA included in the schedule of psychotropic substances

The Central Government has added MDMB-FUBINACA, a synthetic cannabinoid to the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985. The decision follows concerns regarding the substance’s nature, effects and potential for abuse,  taking into account amendments to the United Nations Convention on Psychotropic Substances, 1971.

30 October 2026

Pharmaceuticals

Bombay High Court emphasises strict scrutiny of pharmaceutical trademarks to prevent medication errors

The Bombay High Court has directed the removal of a pharmaceutical trademark from the Trade Marks Register after finding it deceptively similar to an existing mark used for a medicine treating a different medical condition. The Court held that differences in active pharmaceutical ingredients, therapeutic indications and prescription requirements do not eliminate the risk of confusion between medicinal products. It further clarified that manufacturing medicines in India exclusively for export constitutes use of the trademark in India under the Trade Marks Act, 1999. The removal has been deferred until 31 December 2026 to allow the manufacturer to rebrand and obtain necessary regulatory approvals. The judgment reinforces the heightened standard of scrutiny applicable to pharmaceutical trademarks, given the potentially serious consequences of medication errors





30 October 2026

Pharmaceuticals

One year minimum residual shelf-life mandated for imported drugs in India

The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, mandating a minimum residual shelf-life of one year for imported drugs at the time of import, with biological drugs and radiopharmaceuticals permitted at 60% of their labelled shelf-life. The amendment aims to reduce the risk of importing medicines nearing expiry and ensure adequate shelf-life in the Indian supply chain.

30 October 2026

Diagnostic Labs

ICMR funds genomic study on autoimmune diseases

The Indian Council of Medical Research has reportedly funded a four-year study examining genetic and immunological mechanisms underlying autoimmune diseases. Researchers will enrol families with multiple affected members, including at least one lupus patient, to identify shared disease pathways and potential therapeutic targets through genomic profiling and biological assessments.

29 October 2026

Pharmaceuticals

Anti-cancer drug pricing: NPPA clarifies identification of government sales

The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing regulator, has clarified how pharmaceutical supplies qualify as “Government sales” under its trade margin rationalisation framework. According to the FAQs issued on October 23, 2026, a sale qualifies where either the Maximum Retail Price (MRP) is not printed on the product package or the package carries the label “For supply to Government; not for sale”.

The clarification follows NPPA’s October 17, 2026 order under the Drugs (Prices Control) Order, 2013, which rationalises trade margins for 137 identified non-scheduled anti-cancer medicines, with revised prices effective November 9, 2026. 

29 October 2026

Pharmaceuticals

Indian Patent Office rejects patent for fixed-dose combination of tuberculosis medicines

India’s Patent Office has reportedly rejected a patent application for a fixed-dose combination of three medicines used to treat drug-resistant tuberculosis. The applicant failed to establish patentability, while opponents argued that combining existing medicines into one pill lacked sufficient evidence of improved clinical outcomes, product stability and additional therapeutic benefits.

29 October 2026

Pharmaceuticals

Price list of 543 non-scheduled anti-cancer medicines released by NPPA

The National Pharmaceutical Pricing Authority (NPPA) has published revised maximum retail prices (MRPs) for 543 brands of non-scheduled anti-cancer medicines, effective 9 November 2026. The revision aims to improve the affordability and accessibility of cancer treatment by rationalising trade margins. Manufacturers must ensure that the revised MRPs are implemented from the effective date.

29 October 2026

Hospitals

Maharashtra standardises PET-CT and CT/MRI contrast charges at government hospitals

Maharashtra government has standardised charges for PET-CT scans and CT/MRI contrast agents at government hospitals, particularly those operating under the public-private partnership (PPP) model, to address inconsistent pricing and improve affordability. The prescribed rates include ₹10,250 for a whole-body PET-CT scan, ₹420–830 for CT contrast and ₹950 for MRI contrast. Patients are classified into three categories: eligible beneficiaries receiving free services, paying patients and patients sponsored or referred by other hospitals. Payments must be made through hospital billing desks, not directly to private operators. Hospitals must display rates and payment procedures in Marathi and English, while PPP operators must follow the prescribed pricing and contractual arrangements.

29 October 2026

Pharmaceuticals

Anti-cancer drug pricing: Newspaper advertisements must disclose pre-revised and revised prices

The National Pharmaceutical Pricing Authority (NPPA), the government body responsible for regulating medicine prices in India, has clarified that pharmaceutical companies must publish newspaper advertisements for all products whose prices are reduced under its trade margin rationalisation (TMR) exercise. The advertisements must state both the pre-revised and revised Maximum Retail Prices (MRPs). Companies may choose whether to include products whose prices remain unchanged.

The clarification forms part of the FAQs issued on October 23, 2026, following NPPA’s October 17 order rationalising trade margins for 137 identified non-scheduled anti-cancer medicines under the Drugs (Prices Control) Order, 2013. The revised prices take effect on November 9, 2026. By requiring both prices to be disclosed, NPPA seeks to make price reductions transparent and help consumers identify the change. Pharmaceutical companies should ensure that their newspaper advertisements accurately reflect the revised MRPs.

29 October 2026

Food & Beverages (F&B)

Nutraceutical advertising: Advertising Standards Council of India flags unsupported health claims in 60 advertisements

The Advertising Standards Council of India (ASCI), in its July–September 2026 review, examined 61 nutraceutical advertisements and found 31 in violation of its Code. Another 29 advertisements were modified or withdrawn by advertisers without contesting the complaints, while one case remains under process. The review covered claims relating to weight management, skincare, respiratory health and disease management, including claims that could suggest therapeutic benefits.

The key concern is whether advertisers can substantiate the claims made for their finished products. ASCI identified instances where ingredient-level research was relied upon without adequate product-specific evidence, alongside exaggerated efficacy claims and promises of disease-related benefits. From a compliance perspective, businesses should ensure that claims are supported by reliable evidence relevant to the product itself and do not imply treatment or reversal of medical conditions without appropriate substantiation.

29 October 2026

General Universal All

Supreme Court seeks Centre’s response on transgender law’s impact on women’s safeguards

The petitioner has reportedly raised concerns before the Supreme Court of India regarding the amended transgender rights law’s impact on women’s reservations, prison accommodation, sports participation and criminal procedure safeguards. The Court sought the respondents’ response and tagged the matter with pending petitions challenging the validity of the 2026 amendment.

29 October 2026

Environment & Waste Management

Air quality standards: Revision remains pending after five-year review process

India’s National Ambient Air Quality Standards (NAAQS), last revised in 2009, remain unchanged as the Central Pollution Control Board (CPCB) continues to review recommendations for updated pollution thresholds. Reportedly, according to a response to an RTI query dated October 26, 2026, a revised report submitted by IIT Kanpur on December 16, 2025, remains under consideration by a steering committee constituted in May 2020. The review is intended to assess existing pollutant limits and consider additional parameters in light of evolving scientific evidence.

28 October 2026

Pharmaceuticals

Handheld devices deployed to screen medicines for suspected quality defects

The Maharashtra Government has reportedly deployed handheld devices to screen medicines supplied through government health facilities for suspected spurious or substandard products. Flying squads will conduct random monthly checks using the devices, which provide preliminary results within minutes. Flagged samples must undergo confirmatory testing at NABL-accredited laboratories before regulatory or enforcement action is initiated.

28 October 2026

Pharmaceuticals

Pre-existing stocks need not be recalled under anti-cancer drug trade margin rationalisation: National Pharmaceutical Pricing Authority

The National Pharmaceutical Pricing Authority (NPPA), the government body responsible for regulating drug prices in India, has clarified that manufacturers are not required to recall, re-label or re-sticker anti-cancer drug stocks released in the market before implementation of revised maximum retail prices (MRPs), provided they can ensure price compliance at the retailer level.

The clarification forms part of the FAQs issued in connection with the trade margin rationalisation (TMR) exercise for identified non-scheduled anti-cancer medicines. It provides operational relief to manufacturers dealing with pre-existing market inventory, while making clear that the relaxation is conditional on compliance with the revised prices at the retail level.

28 October 2026

Pharmaceuticals

Health ministry proposes revised microbial contamination limits for sterile drug manufacturing

The Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, introducing revised microbial contamination limits under Schedule M of the Drugs Rules, 1945, for sterile drug manufacturing. The amendment seeks to strengthen environmental monitoring standards across manufacturing areas, including air, surface and personnel testing, supporting improved contamination control and product quality.

Open

28 October 2026

Pharmaceuticals

Karnataka pharma trade body seeks halt to direct supplies and preferential schemes

Karnataka’s pharmaceutical trade body has reportedly urged a drug manufacturer to halt direct supplies to pharmacies, hospitals and medical shops at preferential rates, alleging that such practices disadvantage authorised stockists. It has called for uniform trade schemes, transparent verification procedures and stronger supply-chain traceability to ensure fair competition.

Open

28 October 2026

Pharmaceuticals

Recalling or relabeling existing anti-cancer medicine stocks not mandatory after MRP revision

The National Pharmaceutical Pricing Authority (NPPA) has clarified that recalling, relabeling or re-sticking existing stocks of anti-cancer medicines to reflect revised maximum retail prices (MRPs) is not mandatory, provided manufacturers and importers ensure price compliance at the retailer level. This clarification reduces the operational burden and costs associated with recalling and relabeling existing stocks for manufacturers and importers.

28 October 2026

General Universal All

Bill to protect senior citizens’ rights passed by Keralam Assembly

The Keralam Legislative Assembly has unanimously passed the Keralam Senior Citizens’ (Care and Protection of Rights) Bill, 2026, proposing a comprehensive framework for senior citizens aged 60 and above. The Bill mandates registration of care centres, introduces caregiver training and certification, and extends regulatory oversight to home-care agencies and digital platforms. It also requires medical practitioners and care centres to report suspected abuse, neglect or exploitation, with specified cases reportable within 48 hours. Abuse, abandonment and illegal possession of residents’ property may attract imprisonment and fines. 

28 October 2026

Pharmaceuticals

Supreme Court criticises centre and DCGI over expired COVID-era approvals for antifungal drug

The Supreme Court has reportedly criticised the Centre and the Drug Controller General of India (DCGI) for delays in taking action against pharmaceutical companies allegedly continuing to manufacture and sell Liposomal Amphotericin B under expired emergency permissions granted during the COVID-19 pandemic. The permissions were introduced in 2021 to address shortages of the drug, used to treat mucormycosis or black fungus. The case raises questions about the DCGI’s enforcement of licence conditions and the consequences of continued manufacturing after emergency permissions expire. The Court has not yet ordered a ban or recall; the final directions are awaited.

28 October 2026

General Universal All

Women’s safety advisory calls for stronger workplace protections, safer public spaces and improved survivor support

The National Human Rights Commission (NHRC) has issued an advisory recommending measures to improve women’s safety at workplaces and public spaces. The recommendations cover sexual harassment awareness, infrastructure, bystander intervention, police response, survivor support, cybercrime and long-term reforms.

The advisory calls for functional Internal and Local Committees under the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013, and annual submission of inquiry reports to District Officers by enterprises covered under the Act. It also recommends security and safe transport for women working night shifts, alongside gender audits of workplaces and public spaces. The NHRC has requested concerned authorities to submit action-taken reports within two months.

28 October 2026

Pharmaceuticals

Courier services to report medicine consignments to drug authorities: Drugs Control Administration of Nagaland

Nagaland’s Drugs Control Administration has reportedly directed courier operators to disclose medicine consignments to district drug control authorities. However, the original order has not been independently located in the public domain, leaving key aspects of the directive unverified.

 The directive can help authorities track medicine shipments and identify potentially illegal online sales. From a regulatory standpoint, the effectiveness of such a reporting mechanism will depend on the scope of consignments covered, the frequency and format of disclosures, and the consequences of non-compliance.

Open

27 October 2026

Pharmaceuticals

CDSCO reiterates strict batch-wise testing of raw materials and finished formulations

India's central drug licensing authority, CDSCO has directed State and UT Drug Controllers to strictly enforce the testing requirements under the Drugs Rules, 1945. The manufacturers are required to test every batch of raw materials, including active pharmaceutical ingredients and excipients, in their own laboratory or a laboratory approved by the Licensing Authority. This includes critical excipients such as propylene glycol, glycerol and sorbitol. Every batch of finished formulation must also be tested, with records maintained as prescribed under Schedule U. The latest direction reinforces inspections, vendor qualification and sourcing from reliable, approved suppliers. Manufacturers should ensure documented batch-wise testing and compliance before releasing products into the market.

27 October 2026

Pharmaceuticals

NPPA clarifies annual price hike eligibility for anti-cancer drugs under trade margin rationalisation

The National Pharmaceutical Pricing Authority (NPPA) has clarified that manufacturers of anti-cancer drugs covered by trade margin rationalisation can avail annual price increases under Paragraph 20(1) of DPCO, 2013, from implementation of revised MRP by November 9, 2026, or 12 months after the last MRP revision if unchanged. The clarification provides manufacturers with greater certainty on price revision timelines following trade margin rationalisation.

27 October 2026

Pharmaceuticals

CDSCO strengthens digital tracking of high-risk pharmaceutical solvents through ONDLS

The Central Drugs Standard Control Organisation (CDSCO), through a communication dated 27 October 2026, has directed State and UT Drug Controllers to ensure compliance with the Digital Monitoring System on the Online National Drugs Licensing System (ONDLS) portal for specified high-risk pharmaceutical-grade solvents. Manufacturers and relevant vendors/suppliers are required to register on the portal and upload batch-wise information, including quantities manufactured and supplied, Certificates of Analysis (CoAs), vendor details and onward distribution records. A system-generated No Objection Certificate (NOC) must be obtained before distribution of covered batches. The materials include glycerin, propylene glycol, sorbitol and other specified solvents and excipients. The measure strengthens end-to-end traceability of pharmaceutical-grade raw materials, particularly in light of concerns over contamination of cough syrups with diethylene glycol (DEG).

27 October 2026

Hospitals

Keralam proposes legislation to regulate private hospital charges and improve billing transparency

The Keralam Government reportedly plans to introduce legislation to regulate charges levied by private hospitals, with a proposed committee tasked with preparing a draft Bill for consideration by the State Legislative Assembly. The proposed framework is intended to improve transparency in hospital billing and address the cost of medicines, diagnostic tests, room rent and medical procedures. 

 The proposal remains at the preparatory stage; the reported announcement does not establish any new binding price controls on private hospitals. If enacted, the legislation could introduce additional obligations concerning pricing transparency and patient billing.

27 October 2026

Cosmetics

CDSCO cancels cosmetic import registration over misleading fat-dissolving claims

The Central Drugs Standard Control Organisation has cancelled a cosmetic registration after finding claims that the product “dissolves fat cells” and “reduces their size.” The authority considered these claims beyond the scope of cosmetics and found the importer’s response to the show-cause notice unsatisfactory, resulting in cancellation of the registration certificate.

Open

26 October 2026

Healthcare & Wellness, Hospitals

Karnataka to frame policy against hospitals withholding bodies over unpaid medical bills

Karnataka’s Health Minister reportedly announced plans to formulate a policy preventing hospitals from withholding deceased patients’ bodies over unpaid bills, following a meeting with private hospital representatives. Discussions also covered excessive billing, essential medicine costs, unauthorised price increases and insurance claim simplification to strengthen patient protection and healthcare affordability.

26 October 2026

Pharmaceuticals

Committee formed to review UCPMP and recommend stronger oversight mechanisms

The Department of Pharmaceuticals (DoP), through an order dated 22 October 2026, has constituted a committee to review the effectiveness of the existing framework of the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), governing pharmaceutical marketing practices and recommend measures to strengthen its implementation and enforcement. 

The committee will examine the existing monitoring and enforcement mechanisms, identify gaps and recommend measures to improve compliance. It will also consider whether additional statutory, regulatory or other legal measures are necessary. The committee’s recommendations may inform future changes to the regulation and enforcement of pharmaceutical marketing in India.

26 October 2026

Hospitals

Emergency patients cannot be required to verify hospital empanelment, Kerala High Court

The Kerala High Court has ruled that patients facing grave medical emergencies cannot be expected to verify hospital empanelment before seeking life-saving treatment, dismissing an appeal against medical reimbursement under a post-retirement scheme. This is important because strict empanelment requirements may impede timely emergency care. The ruling reinforces that the urgency of treatment and nature of the illness must be considered when deciding reimbursement claims.

26 October 2026

Food & Beverages (F&B)

Maharashtra FDA challenges FSSAI’s licensing and enforcement powers before Bombay High Court

The Government of Maharashtra, through its Food Safety Commissioner, has approached the Bombay High Court, alleging that the Central Government and FSSAI created a parallel enforcement regime that encroaches upon State powers. The petition specifically contests the May 2023 circular barring State FDA officers from inspecting or taking enforcement action against establishments holding Central licenses. It argues that the restriction curtails State oversight of major food businesses and seeks a stay on the circular and restoration of inspection and enforcement authority.

26 October 2026

Pharmaceuticals, MedTech

CDSCO alerts reporting of falsified Defitelio drug if identified in India

India's central drug authority, CDSCO, has issued a public notice following a WHO alert concerning falsified DEFITELIO (defibrotide) 80 mg/ml concentrate for infusion, batch No. 24GC01A, expiring April 2027. Although this batch was never supplied to India and it has no marketing authorisation in India, healthcare professionals, hospitals, pharmacies and distributors should remain vigilant, verify product authenticity and immediately report any suspected stock found for sale or distribution to the relevant State/District Drugs Control Authority and CDSCO.

Open

26 October 2026

Pharmaceuticals

Centre directs states to enforce ban on reuse of single-use medical devices

The Directorate General of Health Services (DGHS) has directed states and Union Territories to enforce a prohibition on reusing medical devices and disposable surgical items meant for one-time use. The directive follows reports of hospitals sterilising and reusing such items, particularly in cardiology, oncology, nephrology and neurosurgery. The DGHS has warned that this practice can expose patients to infections, device malfunction and other complications.

The DGHS has also raised concerns that, in some instances, patients and government authorities were charged the full cost of these items even when they had been reused. The letter states that the practice may violate applicable provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, the Clinical Establishments Act, 2010, and relevant infection-control and biomedical-waste management requirements. The DGHS has directed health authorities to maintain strict vigilance, monitor healthcare establishments and take necessary action against non-compliance. 

26 October 2026

General Universal All

Kerala High Court seeks government responses on blocking of digital news platform's social media page

The Kerala High Court has reportedly sought responses from the Centre and the Kerala Government on whether an order was issued to a social media company to block the Facebook page of an independent Malayalam digital news platform. The petition alleges that the page was restricted under Section 79(3)(b) of the Information Technology Act, 2000, without disclosing the underlying order, identifying the specific unlawful content or providing an opportunity to challenge the action. The case raises questions about transparency and procedural safeguards in content-blocking actions under the IT Act and the IT Rules, 2021. The key issue is whether affected users must be informed of the underlying order and its basis to enable an effective legal challenge. 

26 October 2026

General Universal All

CDSCO cancels registration of Ethics Committee for non-compliance with clinical trial rules

The Central Drugs Standard Control Organisation (CDSCO), India’s national drug regulatory authority has cancelled the registration of a Gujrat based Ethics Committee, for non-compliance with the New Drugs and Clinical Trials Rules, 2019. The action takes the total number of Ethics Committees whose registrations have been cancelled by the regulator to eight. Ethics Committees review and approve clinical trial protocols and oversee trials to protect participants’ rights, safety and well-being.

25 October 2026

Healthcare & Wellness, MedTech

Experts urge mandatory BIS standard for hospital bills

The Bureau of Indian Standards introduced voluntary standard IS 19493:2025 for hospital billing to improve transparency through itemised charges, package inclusions and patient details. Civil society experts have reportedly urged the government to make it mandatory, as adoption remains limited. The Clinical Establishments (Central Government) Rules, 2012, requires establishments to display service rates and charge within Central Government-prescribed ranges, determined in consultation with States. However, these ranges remain unfinalized till today. Mandatory implementation could improve patient understanding of healthcare costs, reduce billing disputes and support more informed financial decisions, although it may not directly prevent overcharging.

Open

23 October 2026

Pharmaceuticals

IDMA seeks industry feedback on draft pharmaceutical patent examination guidelines

The Indian Drug Manufacturers’ Association has reportedly invited pharmaceutical and biotechnology companies, researchers and intellectual property professionals to participate in the consultation on the draft 2026 pharmaceutical patent examination guidelines. Stakeholders are encouraged to submit feedback to help improve clarity and consistency in patent examination practices in India.

Open

23 October 2026

Hospitals

Centre flags hurdles in regulating hospital mark-ups on medicines and consumables

The Supreme Court is examining concerns over the high prices patients pay for medicines and medical consumables supplied by hospitals. The concern is whether hospitals are charging excessive mark-ups over their purchase costs and whether stronger price controls are needed.

In its latest response, the Centre has reportedly told the Court that reliable data on hospitals’ purchase costs and patient charges is lacking, making it difficult to determine the extent of these mark-ups. It has also flagged a legal hurdle: existing price-control rules do not cover every product sold by hospitals. Any wider controls would therefore require both evidence of the problem and clear legal authority to regulate the products concerned.

23 October 2026

Food & Beverages (F&B)

FSSAI flags fruit-content disclosure, reconstitution and sugar claims on packaged pomegranate juice

The Food Safety and Standards Authority of India (FSSAI) has initiated proceedings over misleading labelling on a packaged pomegranate juice product. The product contains 4% pomegranate juice concentrate and 12% apple juice concentrate. 

The regulator has initiated adjudication proceedings after finding the label claim “Equivalent to 100% Fruit Juice (Reconstituted)” non-compliant. Under its 3 June 2024 advisory, FSSAI directed food businesses to remove “100% fruit juice” claims from reconstituted juices because adding water to fruit concentrate does not justify presenting the product as 100% fruit juice.

Open

23 October 2026

Food & Beverages (F&B)

FSSAI flags unapproved health claims and labelling violations on cranberry supplement

The Food Safety and Standards Authority of India (FSSAI) has issued a show-cause notice regarding a cranberry extract supplement over unapproved disease-risk claims and misleading advertising.

The regulator identified claims like “Supports Urinary Tract Health” as Disease Risk Reduction (DRR) and health claims. Under the Food Safety and Standards (Advertising and Claims) Regulations, 2018, reduction of disease risk claims require prior FSSAI approval. The "100% Natural" claim directly violates FSSAI's advisory dated 28 May 2025 prohibiting "100%" claims on food products.

23 October 2026

Hospitals

Bulk-Transferred blood stocks may face mandatory re-testing

Uttar Pradesh Food Safety and Drug Administration has reportedly sought re-testing of blood stocks transferred in bulk between blood banks, signalling tighter regulatory scrutiny of blood handling and distribution. The move is important because existing screening may not adequately address risks arising during storage and transportation, highlighting the need for stronger quality control across the blood supply chain.

23 October 2026

Pharmaceuticals

NPPA mandates Form V and Annexure-I filing for anti-cancer drugs irrespective of MRP changes

The National Pharmaceutical Pricing Authority (NPPA) has clarified that manufacturers of anti-cancer drugs covered by trade margin rationalisation must submit Form V and Annexure-I (Format for submission of revised MRP by the manufacturer) through the Integrated Pharmaceutical Database Management System (IPDMS) within seven days of publication of the Order, even if the maximum retail price (MRP) remains unchanged. The revised prices for the identified non-scheduled anti-cancer drugs will take effect from 9 November 2026. The clarification reinforces manufacturers’ reporting obligations under the Drugs (Prices Control) Order, 2013

23 October 2026

Pharmaceuticals

Punjab intensifies crackdown on unauthorised pregabalin sales amid tighter regulatory controls

Punjab’s Health Department reportedly plans to intensify inspections of chemist shops to curb the unauthorised sale of pregabalin amid concerns over its misuse and dependence. In September 2024, the state had restricted the sale and stocking of pregabalin formulations exceeding 75 mg. Subsequent enforcement action between April 2025 and August 2026 included seizures and the suspension and cancellation of licences. Separately, the Centre has notified pregabalin under Schedule H1, effective 12 November 2026, introducing stricter prescription, recordkeeping and labelling requirements. Pharmaceutical distributors and pharmacies should review their compliance processes and prepare for enhanced regulatory scrutiny.

23 October 2026

Artificial Intelligence, MedTech

Tech-giant develops AI tool that mimics doctors’ step-by-step diagnostic process

Researchers of a tech-giant have reportedly developed an AI system that progressively gathers patient history, evaluates examination findings, recommends investigations and updates diagnostic hypotheses.  The entity plans to test the tool for triage in emergency department waiting rooms. In India, AI software intended for medical diagnosis may qualify as a medical device under the Medical Devices Rules, 2017, depending on its intended purpose and functionality. Commercial deployment may therefore require applicable licensing and evidence of safety and performance, including software validation and clinical evidence.

22 October 2026

Food & Beverages (F&B)

FSSAI flags growth and immunity claims under food advertising regulations

The Food Safety and Standards Authority of India (FSSAI) has issued a notice to a food and wellness company over claims on Complan’s packaging and online listings, including “2X Faster Growth”, “Supports Concentration and Memory” and “Pro Immunity + 34 Vital Nutrients”. Under the Food Safety and Standards (Advertising and Claims) Regulations, 2018, food claims must be scientifically substantiated. FSSAI sought evidence for the “clinically proven 2X growth” and immunity claims and flagged “Growth Comes in 4 Flavors” as non-compliant.

22 October 2026

Agriculture

Sealed substandard fertilizer: Karnataka High Court quashes case against dealer for lack of specific allegations

The Karnataka High Court has quashed criminal proceedings against a fertilizer dealer accused in a case involving fertilizer samples that failed to meet prescribed quality standards. The case arose after a Fertilizer Inspector collected samples from the dealer’s shop and sent them for laboratory testing. Although the report found the samples to be substandard, the Court noted that the complaint did not explain how the dealer was responsible for their production or quality, particularly since they had been collected from sealed bags. Holding that the dealer could not be held criminally liable merely by virtue of his role, the Court quashed the proceedings against him.

22 October 2026

General Universal All

Fake ISI Mark on Roller Insufficient to Prove Offence: Kerala High Court Upholds Acquittal

The Kerala High Court has dismissed an appeal by the Bureau of Indian Standards (BIS) against the acquittal of a veneer manufacturing firm and its partners accused of possessing a spurious ISI mark. The prosecution alleged that officials found a roller bearing a fake ISI mark and a similar mark on the factory wall. However, no manufactured product bearing the mark was seized or produced before the court. The Court held that the Bureau of Indian Standards Act, 1986, penalise the "use" of a spurious standard mark, not "mere possession" of an object capable of affixing it. It upheld the acquittal, finding no evidence that the mark had been used on manufactured goods.

22 October 2026

Food & Beverages (F&B)

Infant formula promotion on Instagram draws FSSAI notices to influencer and four companies

The Food Safety and Standards Authority of India (FSSAI) has issued notices to an influencer and four international food and healthcare companies over an Instagram Reel ranking five infant formula products and promoting their purported benefits. The Reel featured NAN-Pro 1, Aptamil Premium 1, Similac Advance 1, Enfamil A+ Stage 1 and Dexolac 1, attributing benefits such as stronger immunity, brain development and easier digestion to the products.

FSSAI has alleged violations of the Infant Milk Substitutes Act, 1992, and the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020. The Infant Milk Substitutes Act, 1992 restricts the advertising and promotion of infant milk substitutes. Even if a product claim may be scientifically supported, that does not automatically make its promotion lawful.

22 October 2026

Food & Beverages (F&B)

FSSAI seeks scientific evidence for whey protein digestibility claim

The Food Safety and Standards Authority of India (FSSAI) has issued a notice to a food company seeking scientific substantiation for the claim that whey protein in Lactogen Pro 1 Powder is “easy to digest”.  The infant formula is intended for babies from birth to six months when breastfeeding is not possible or the product is used for top-feeding. Under the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, and Regulation 4 of the Food Safety and Standards (Labelling and Display) Regulations, 2020, infant food claims must meet relevant regulatory standards. FSSAI has sought supporting evidence and asked why action should not be initiated under the Food Safety and Standards Act, 2006. The notice is not a final finding of non-compliance.

The notice only initiates regulatory scrutiny; it does not establish that the claim is false.

22 October 2026

Food & Beverages (F&B)

FSSAI questions immunity and digestibility claims for infant formula

The Food Safety and Standards Authority of India (FSSAI) has issued a notice to a global food company over claims made for its NAN Excella Pro Stage 1 infant formula, which is an infant starter milk formula designed for babies from birth up to 6 months of age when they are not breastfed. FSSAI considered the claim “5 HMOs helps support normal immune system” potentially contrary to Regulation 10(1) of the Food Safety and Standards (Advertising and Claims) Regulations, 2018, which prohibits claims linking food suitability to preventing, alleviating, treating or curing a disease, disorder or particular physiological condition unless specifically permitted.

22 October 2026

General Universal All

Karnataka government allows third-party agencies to assist with regulatory inspections

The Karnataka Government has reportedly directed departments facing staff shortages to engage authorised third-party agencies to conduct inspections, audits and certifications within prescribed timelines. The initiative covers Legal Metrology, Food Safety and Drugs Administration, and the Department of Factories and Boilers.

However, outsourcing does not transfer statutory enforcement powers to private agencies. Powers to collect food and drug samples, seize goods and initiate prosecutions will remain with government officials. Departments will use agency reports to identify high-risk establishments for targeted enforcement.

22 October 2026

General Universal All

Health ministry invalidates pharmacist service rules over lack of government approval

The Union Health Ministry has reportedly issued a circular declaring the Pharmacy Council of India’s regulations on government pharmacists’ recruitment, promotions and service conditions invalid, citing the absence of prior government approval. The Ministry states that the Council can regulate pharmacy education but cannot independently decide how government pharmacists are recruited, promoted or paid.

22 October 2026

Pharmaceuticals

Supreme Court quashes drug supplier’s blacklisting over denial of retesting

The Supreme Court of India quashed the blacklisting and product debarment imposed on a drug supplier after authorities failed to follow the mandatory procedure for confirmatory testing by a second laboratory. The Court held that delays attributable to the State caused the disputed batches to expire, depriving the supplier of an effective opportunity to challenge the adverse quality reports through retesting.

22 October 2026

Animal Health & Wildlife

Government formally notifies 16 indigenous livestock and dog breeds

India's Ministry of Agriculture and Farmers’ Welfare has formally notified 16 livestock and dog breeds for specified States and nationwide purposes, for animal husbandry, breeding, conservation, production and trade. Building on ICAR’s breed-registration process, the notification strengthens official breed recognition. For livestock businesses, breeders and traders, this can improve breed identification, support targeted breeding and conservation programmes, and help establish clearer breed-specific market positioning.

22 October 2026

Pharmaceuticals

GLP-1 users drive supplement boom, prompting safety concerns and calls for tighter oversight

Rising use of GLP-1 weight-loss drugs is reportedly driving demand for dietary supplements such as fibre, collagen, probiotics and electrolytes, as users seek to manage side effects including nausea, fatigue and constipation. The trend, amplified by social media influencers, has raised concerns over product safety, unverified health claims and limited pre-market scrutiny in the US. Regulators are considering tighter oversight of dietary ingredients. The trend highlights the need for stronger scrutiny of influencer-led health marketing, particularly for products targeting GLP-1 users.

22 October 2026

General Universal All

Import restrictions cannot apply to goods shipped before notification: Bombay High Court

The Bombay High Court has held that import restrictions under the Foreign Trade Policy must be assessed with reference to the shipment date, rather than customs clearance or bill-of-entry filing dates. The ruling protects importers from subsequent policy changes affecting goods already dispatched, ensuring that newly notified restrictions are not applied retrospectively to consignments shipped before publication.

21 October 2026

Food & Beverages (F&B)

Indian food safety violations prompt foreign regulators to restrict product sales

The Food Safety and Standards Authority of India (FSSAI) has sanctioned prosecution against an Indian biscuit manufacturer after an inspection found that cattle-feed bran was being used as a fibre source in biscuit manufacturing, alongside hygiene and storage deficiencies. The company’s FSSAI licence had been suspended.

Separately, Nepal has banned the import, sale and distribution of the manufacturer’s biscuits and ordered a recall of existing stocks over food safety concerns. The case highlights how domestic food safety enforcement can have cross-border consequences, prompting foreign regulators to take independent action to protect consumers.

Open

21 October 2026

Food & Beverages (F&B)

FSSAI proposes ban on adding sucrose and fructose in foods for infants up to six months

The Food Safety and Standards Authority of India (FSSAI) has proposed amending the Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2020, to prohibit adding sucrose and fructose to foods intended for infants up to six months of age. Under the existing regulation, sucrose and fructose are permitted when needed as a carbohydrate source, provided their combined amount does not exceed 20% of total carbohydrates.

The proposed amendment would remove this exception for the specified age group. The draft has been issued for public consultation, allowing stakeholders to submit objections or suggestions before the amendment is finalised.

Open

21 October 2026

Pharmaceuticals

Telangana warns against prescribing unapproved weight-loss drugs and experimental peptides

The Telangana Standards Authority for Food and Essential Drugs (TG SAFE) has warned that unapproved weight-loss drugs and experimental peptides sold through online platforms and social media may pose serious health risks. Products named in the advisory include retatrutide, orforglipron, tesamorelin, BPC-157 and GHK-Cu. These products have not undergone the required regulatory review by the Central Drugs Standard Control Organization (CDSCO) and TG SAFE to establish their safety, efficacy and quality for the intended use.

TG SAFE has cautioned that such products may be fraudulent. counterfeit, mislabelled or contaminated, particularly when sold by unregulated suppliers. It has advised doctors not to procure, prescribe or administer these products in violation of applicable requirements and warned that violations may invite action under the Drugs and Cosmetics Act, 1940, and its rules. 

Open

21 October 2026

General Universal All

National Medical Commission withdraws medical education standards regulations, retains annual disclosure requirement

The National Medical Commission (NMC) has withdrawn the Maintenance of Standards of Medical Education Regulations, 2023, with immediate effect, removing the specific framework that prescribed penalties for non-compliance by medical colleges.

Introduced in September 2023, the regulations required colleges to disclose information on infrastructure, faculty strength and clinical training facilities. They also allowed penalties of up to ₹1 crore per violation for medical institutions and ₹5 lakh for faculty members or administrators submitting false declarations, alongside measures such as admission restrictions and withdrawal of accreditation. 

However, colleges must continue submitting Annual Disclosure Reports (ADR) under the National Medical Commission Act, 2019. The ADR allows the NMC’s undergraduate and postgraduate medical education boards to assess whether a college meets prescribed standards by reviewing its infrastructure, qualified faculty, clinical training facilities, teaching methods, student assessment systems and student feedback.

Open

21 October 2026

Pharmaceuticals

Prepared culture media exports remain free, subject to destination-country certificate requirements

The Directorate General of Foreign Trade (DGFT) has amended the export policy for prepared culture media. Prepared culture media are nutrient-rich formulations designed to grow, isolate, and study microorganisms like bacteria and fungi in laboratories and industrial settings. These products are used to grow or maintain microorganisms, including viruses, and plant, human or animal cells. Export for these remains freely permitted. However, if the importing country requires certificates, exporters must follow the prescribed process.

The Chemicals and Allied Products Export Promotion Council (CAPEXIL) will issue a Shipment Clearance Certificate for each consignment. It must include details such as the exporter, product, invoice number, quantity, port of loading and destination. After shipment, the exporter must provide a Health Certificate to the buyer, containing details of the product, its packaging, origin, destination, vessel, departure date and applicable health requirements. The amendment takes immediate effect.

Open

21 October 2026

Pharmaceuticals

Medicine freebies raise questions over trade margins and patient affordability

The Karnataka State Registered Pharmacists Association (KSRPA) has reportedly urged the State Food and Drug Administration to examine pharmaceutical companies’ “Buy 1, Get 1 Free” schemes and clarify how free units should be accounted for when calculating the actual purchase cost of medicines. It was questioned whether the cost of free units should be spread across the total quantity purchased to calculate a lower per-unit cost, or whether the additional medicines should be supplied to patients free of charge. Hospitals and bulk purchasers may retain the financial benefit instead of passing the savings on to patients. The association also flagged large gaps between retailers’ purchase prices and printed MRPs, calling for stricter scrutiny of medicine pricing under the Drugs (Prices Control) Order, 2013.

Open

21 October 2026

Food & Beverages (F&B)

Botanical ingredient products: FSSAI's advisory on mandatory labelling and caution statements

The Food Safety and Standards Authority of India (FSSAI) has issued an advisory for businesses dealing health supplements and nutraceuticals to comply with mandatory labelling requirements for products containing plant and botanical ingredients or their extracts.

Under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, labels must identify the plant part used and carry the applicable cautionary statements. For example, neem leaf products must carry the prescribed warning against use by men and women planning to conceive.

Open

21 October 2026

Healthcare & Wellness

PET-CT scans added to Maharashtra’s public health schemes for cancer patients

The Maharashtra government has reportedly expanded coverage for PET-CT scans under the Mahatma Jyotirao Phule Jan Arogya Yojana (MJPJAY) and Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), following demands from patients and empanelled hospitals. ET-CT scans have been added as an additional diagnostic procedure to 63 cancer treatment packages, up from 44 earlier. The scan has also been approved as a standalone or primary diagnostic procedure for 13 selected cancer categories.

21 October 2026

Pharmaceuticals

US FDA sets up board to review drug exclusivity decisions

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has established an Exclusivity Board to improve the clarity and consistency of decisions granting drug market exclusivity. The Board will review selected cases involving five-year new chemical entity exclusivity, three-year clinical investigation exclusivity and biological products, including disputes over eligibility and the scope of protection. Exclusivity can delay competing products from entering the market. More consistent decisions can help drug developers understand the scope of their protection and help generic manufacturers assess when competition may be possible.

21 October 2026

Alcohol & Tobacco

Andhra Pradesh allows tobacco growers to sell extra crop, with higher contributions for larger excess quantities

The Central Government has allowed registered tobacco growers in Andhra Pradesh to sell excess flue-cured Virginia (FCV) tobacco during the 2026–27 crop season. The extra tobacco can be sold to registered traders through auctions authorised by the Tobacco Board.

The amount growers must contribute to the Tobacco Fund depends on how much they exceed their quota (the Tobacco Fund is the Tobacco Boards’ Growers’ Welfare Scheme, for the educational, social and health welfare of the registered FCV tobacco growers and their dependent family members):

  • Up to 5% above quota: 1% service charge on sale proceeds.

  • More than 5% and up to 10% above quota: ₹2 per kg plus 5% of sale proceeds.

  • More than 10% and up to 20% above quota: ₹2 per kg plus 10% of sale proceeds.

  • More than 20% above quota: ₹2 per kg plus 15% of sale proceeds.

The service charge of 1% applies separately in all cases. In simple terms, growers can sell their extra tobacco, but the more they produce beyond their quota, the higher their contribution to the Tobacco Fund.

Open

21 October 2026

Pharmaceuticals

NPPA Excludes Eligible Patient Assistance Supplies from Cancer Drug Price Calculations

The National Pharmaceutical Pricing Authority has allowed qualifying anti-cancer drugs supplied free under manufacturer-run Patient Assistance Programmes to be excluded from trade margin calculations, subject to record-keeping and undertaking requirements. Government sales are also excluded from price-to-stockist calculations. The framework clarifies how manufacturers must determine regulated retail prices across different sales channels.

Open

21 October 2026

Pharmaceuticals

NPPA Extends Trade Margin Cap to Patented Anti-Cancer Drugs

The National Pharmaceutical Pricing Authority has extended a 30% trade margin cap to 137 non-scheduled anti-cancer drugs, including patented formulations and combination products, irrespective of strength, dosage form or route of administration. The move brings patented cancer medicines within the scope of exceptional price intervention in public interest, expanding regulatory oversight of anti-cancer drug pricing.

Open

21 October 2026

Pharmaceuticals

Mandatory CCTV proposal for pharmacies faces opposition from chemists’ body

The All India Chemists and Distributors Federation (AICDF) has opposed the Centre’s draft proposal to make CCTV cameras mandatory at licensed retail pharmacies, citing additional costs for small shop owners including cameras, storage equipment and maintenance. In semi-urban and rural areas, frequent power outages could also force pharmacies to invest in generators or other backup power systems.

The Ministry of Health and Family Welfare had issued a draft notification proposing an amendment to Rule 65 of the Drugs Rules, 1945 requiring non-wholesale supply of medicines against prescriptions from registered medical practitioners to take place under CCTV surveillance, with recordings retained for at least three months.

The federation contends that CCTV cameras cannot verify handwritten prescriptions or authenticate doctors. It has urged the Health Ministry to withdraw the draft and introduce a mandatory e-prescription framework instead.

Open

21 October 2026

MedTech

US FDA clarifies labelling and review requirements for prescription drug apps

The US Food and Drug Administration (FDA) issued final guidance clarifying how pharmaceutical companies should label and submit apps used with prescription medicines. Apps linked to medical devices, such as asthma inhalers, should generally be described in the medicine’s prescribing information. Standalone apps, such as dose reminders and symptom trackers, need to be included if essential for safe and effective use or supported by evidence of clinical benefit. 

21 October 2026

Pharmaceuticals

NPPA caps trade margins at 30% for 137 non-scheduled anti-cancer drugs

The National Pharmaceutical Pricing Authority (NPPA) has capped trade margins at 30% for 137 non-scheduled anti-cancer drugs under Paragraph 19 of the Drugs (Prices Control) Order, 2013. The revised prices will take effect from 9 November 2026.

Manufacturers must calculate revised maximum retail prices (MRPs) using the prescribed formula based on the March 2026 price to stockists or distributors.  Manufacturers must submit revised price details to NPPA and the relevant State Drug Controller within seven days of publication. They must also maintain existing production levels and notify NPPA before reducing production or discontinuing a product. Non-compliance may lead to recovery of overcharged amounts with interest.

Open

19 October 2026

Food & Beverages (F&B)

FSSAI proposes tea-specific residue limits for Acetamiprid and Imidacloprid

The Food Safety and Standards Authority of India (FSSAI) has proposed amendments to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, prescribing maximum residue limits (MRLs) in tea of 20 mg/kg for acetamiprid and 50 mg/kg for imidacloprid. Stakeholders may submit objections or suggestions within 60 days of the draft notification’s publication. The proposed limits would establish tea-specific pesticide residue standards, with implications for tea producers, processors and testing laboratories’ residue monitoring and compliance practices.

19 October 2026

Food & Beverages (F&B)

Maharashtra FDA tightens spice industry oversight with ban on loose sales and harmful additives

Maharashtra FDA has issued a comprehensive compliance order for spice manufacturers, processors, packers, wholesalers, retailers, e-commerce operators and food service establishments. It requires spice powders and blended spices to be packed and sealed at the place of production, restricting loose sales. The order prohibits ethylene oxide sterilisation and unauthorised colours, including metanil yellow, rhodamine B, Sudan dyes and lead chromate. It also strengthens requirements for hygiene, labelling, traceability, laboratory testing and food safety licensing across the supply chain.   

19 October 2026

Food & Beverages (F&B)

FSSAI Tightens Storage and Transport Requirements for Perishable Foods

The Food Safety and Standards Authority of India (FSSAI) has reportedly issued an advisory directing food businesses to maintain prescribed temperature and hygiene conditions while storing and transporting khoa, paneer, meat and fish. This is important because improper handling can promote microbial growth, spoilage and food contamination, posing risks to public health. The advisory requires businesses to follow prescribed food safety practices during storage and transportation to minimise contamination risks.

19 October 2026

Hospitals

Category-wise display of ICU bed availability mandated in hospitals

The West Bengal Health Department has reportedly directed government and private hospitals to classify and display ICU bed availability at prominent locations. Beds must be categorised into three levels, with Level 1 distinguishing ventilator and non-ventilator beds. This classification will consider equipment, monitoring facilities, patient space, staffing ratios and round-the-clock doctor availability.

19 October 2026

Pharmaceuticals

India proposes stricter pharmaceutical patent examination guidelines

India has issued draft pharmaceutical patent examination guidelines aimed at curbing evergreening and facilitating timely access to generic medicines. The guidelines clarify standards for assessing novelty, inventive step and incremental innovations, reinforcing scrutiny of patent applications. The proposals seek to balance pharmaceutical innovation with competition and public health interests.

Open

16 October 2026

General Universal All

Social media platforms must report child abuse material directly to police, Supreme Court reiterates

The Supreme Court has reportedly urged the Centre to ensure that social media platforms comply with their legal duty to report child sexual abuse material directly to Indian police authorities. The proceedings concern alleged failures to implement the Court’s 2024 ruling, which held that reporting such material to a foreign organisation alone does not meet the requirements of Indian law.

16 October 2026

Healthcare & Wellness

Maharashtra FDA suspends three Mumbai blood banks over donor gifts

The Maharashtra Food and Drug Administration (FDA) has suspended the licences of three Mumbai blood banks after wristwatches were allegedly offered to blood donors at a donation camp. The practice violates guidelines requiring blood donation to remain voluntary and non-remunerative. Blood banks and camp organisers must ensure that donor engagement initiatives do not constitute gifts or inducements, potentially attracting regulatory action.

16 October 2026

Healthcare & Wellness

Menstrual health upheld as a fundamental right under Article 21

The Supreme Court has warned States of possible contempt proceedings for failing to implement its directions on menstrual hygiene in schools. The Court has recognised menstrual health as a fundamental right under Article 21 and has sought accountability from States for delays in implementing the required measures.

The directions require access to free sanitary napkins, functional toilets, washing facilities and menstrual hygiene management corners in schools. The proceedings highlight the need for authorities responsible for school infrastructure and education services to ensure these requirements are implemented.

15 October 2026

Artificial Intelligence

Delhi High Court protects doctor’s personality rights against misleading artificial intelligence videos

The Delhi High Court permanently restrained social media pages from misusing a doctor’s identity and a hospital’s trademarks in fabricated videos promoting medical treatment, including artificial intelligence-generated content. It directed Meta and Google to remove or block identified videos and allowed the plaintiffs to report similar content through affidavits for independent assessment by the platforms, addressing personality rights and public health risks.

15 October 2026

Pharmaceuticals

National Formulary of India 2026 clarified as non-binding prescribing guidance

The Indian Pharmacopoeia Commission (IPC), which sets out the official quality standards for all drugs manufactured, imported, and consumed in India, has clarified that the National Formulary of India (NFI) 2026 is a guidance document, not a legally binding regulatory instrument or a substitute for statutory approvals. This clarification comes after the Drugs Controller General of India (DCGI) asked for an explanation following reports that the 7th edition of the formulary listed certain drugs and formulations that lacked CDSCO approval. 

The IPC reaffirmed that the NFI (which was last updated in 2021) does not override existing drug laws, and healthcare professionals must continue following statutory regulations and their own professional judgment when prescribing medicines.

15 October 2026

Pharmaceuticals

Export NOC exemption clarified for already-approved r-DNA products

India’s central drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has clarified that a manufacturer who wishes to export an already-approved recombinant DNA (r-DNA) product need not approach CDSCO for a Export No Objection Certificate (NOC). Previously, such a manufacturer would have had to amend its existing manufacturing license if it wanted to manufacture r-DNA product for export purposes, and as a pre-requisite to making the manufacturing license application, it would have had to approach the CDSCO for Export NOC. This particular requirement, of approaching CDSCO for export NOC prior to applying for manufacturing license, has been relaxed in cases where the r-DNA product is already approved and the manufacturer is seeking export NOC only to export same product under a different marketing name. This development is expected to expedite the timeline for manufacturers of r-DNA products to procure manufacturing license for export purposes for already approved products.

15 October 2026

Hospitals

NMC restricts use of HCP images and promotional claims in hospital advertising

The National Medical Commission’s Guidelines on Ethical Advertising and Public Communication, effective October 6, 2026, permit hospitals to publish factual, objective and verifiable information about their facilities, services and charges. However, hospital communications must not solicit patients, make unverifiable claims or use promotional portrayals of individual doctor. The guidelines further specify that using an RMP’s photograph or image in a manner constituting self-advertisement, solicitation or promotional publicity is prohibited. Hospital’s  will therefore now be required to reassess use of HCP images in advertising materials.

Open

15 October 2026

Food & Beverages (F&B)

Alcohol packaging and age verification at liquor outlets under Supreme Court scrutiny

The Supreme Court has reportedly sought responses from the Centre and States on pleas seeking mandatory age verification at liquor outlets and a ban on alcohol sold in inconspicuous packaging, including tetra packs and sachets. The pleas raise concerns that fruit-like packaging may mislead minors and facilitate underage drinking.

15 October 2026

Pharmaceuticals

Pharmacovigilance surveillance identifies new adverse drug-reaction signals

The Pharmacovigilance Programme of India has identified adverse-reaction signals associated with nine reported drug-safety findings across multiple therapeutic categories. The update links commonly prescribed medicines with visual, electrolyte, cardiovascular, dermatological and neurological reactions, reinforcing the need for continued post-marketing surveillance and clinical vigilance among healthcare professionals.

Open

15 October 2026

Food & Beverages (F&B)

Delhi High court seeks Food Safety Authority’s response on non-dairy products sold as paneer

The Delhi High Court has reportedly sought responses within six weeks from food safety authorities on a petition seeking action against non-dairy substitutes sold or served as paneer without adequate disclosure. The issue highlights potential gaps in food labelling compliance, consumer awareness and enforcement of prescribed product standards. If stricter action follows, it could lead to enhanced inspections, product sampling and greater scrutiny of restaurants and food businesses, reinforcing the need for transparent disclosure of dairy substitutes.

15 October 2026

MedTech

Coronary stent safety to be reviewed in India following quality concerns in Sri Lanka

India’s Cabinet Secretariat has reportedly asked the Health Ministry to examine coronary stent safety concerns following reports of quality-related withdrawals in Sri Lanka. The reported risks include stent dislodgement, thrombosis and improper expansion, potentially causing serious risks to patients undergoing coronary interventions. The review may lead to closer scrutiny of stent safety, traceability and post-market surveillance in India.

15 October 2026

Pharmaceuticals

Extension in minimum import price condition for glufosinate and its salts imports until April 2027

India's Directorate General of Foreign Trade has extended the existing Minimum Import Price (MIP) condition on imports of glufosinate and its salts until 12 April 2027. Glufosinate and its salts are an active ingredient used in herbicides. Under this condition, imports with a combined CIF value (cost, insurance and freight) and applicable anti-dumping duty below ₹1,154 per kg remain restricted, while imports meeting or exceeding this threshold remain free, subject to conditions. The measure continues the import restriction introduced in April 2026 and aims to protect Indian agrochemical manufacturers from lower-priced imports for fairer competition and stability in the domestic market.  

14 October 2026

Pharmaceuticals

Trustees cannot be held criminally liable under Drugs and Cosmetics Act, solely because of their designation

The Bombay High Court discharged a hospital trust’s managing trustee from prosecution over a substandard ophthalmic drug. It held that a trust is not a “company” under the Drugs and Cosmetics Act, 1940, and designation alone cannot establish criminal liability without specific allegations of involvement.

Open

14 October 2026

Pharmaceuticals

Focused inspections of cough syrup manufacturing units to commence

The Drugs Controller General of India reportedly announced coordinated inspections of cough syrup manufacturing units by central and state drug authorities. Non-compliant facilities may face stringent action, including licence cancellation. The regulator also plans response timelines for corrective-action notices, with manufacturing licence suspension for delays.

14 October 2026

Artificial Intelligence

Data Protection Board may become functional within eight weeks, says Kerala High Court

The Kerala High Court has reportedly directed the Union of India to make the Data Protection Board of India to become functional within eight weeks, while addressing privacy concerns over passenger data collected through digital airport systems. The Court observed that citizens’ privacy was being compromised and suggested that Voter ID may also be accepted as proof of identity for air travel, alongside Aadhaar and Driving Licence.

14 October 2026

Food & Beverages (F&B)

FSSAI plans stricter disclosure rules for online food platforms

The Food Safety and Standards Authority of India (FSSAI) is reportedly considering regulatory changes requiring e-commerce and quick-commerce platforms to display manufacturing dates, expiry dates and batch numbers on food product listings. The proposed measures aim to improve consumer transparency, product traceability and food safety across online food supply chains. However, implementation may be challenging due to real-time inventory changes, data integration across sellers and warehouses, and increased technology and compliance costs.

14 October 2026

Pharmaceuticals

Input tax credit restrictions proposed to be eased for pharma samples and expired goods

The GST Council has recommended amending Section 17(5) of the CGST Act, 2017, to allow input tax credit on free samples and goods destroyed or written off due to expiry as required by law.

The change if allowed could reduce tax costs for pharmaceutical manufacturers and ease the financial burden of mandatory write-offs.

Open

14 October 2026

Pharmaceuticals

Delhi Drugs Control Department issues advisory for hospitals on record maintenance and safe disposal of empty anti-cancer drug vials

The Delhi Drugs Control Department has issued an advisory directing oncology hospitals to maintain strict records of anti-cancer drugs and ensure the safe disposal of empty vials to prevent their misuse, diversion, illegal resale, and counterfeiting. Under the advisory, hospitals must procure drugs exclusively from authorized and licensed sources, maintain detailed documentation, including batch numbers, invoices, and patient administration records, and verify authenticity via barcodes and manufacturer verification systems. Furthermore, used empty vials and ampoules must be rendered unusable immediately by crushing, mutilating, or defacing labels before disposal under Bio-Medical Waste Management Rules, 2016, while internal controls, audits, and surveillance must be strengthened to report any suspicious activities to regulatory authorities promptly.

14 October 2026

Healthcare & Wellness

Third-party endorsements prohibited for promoting doctors’ professional services

The National Medical Commission (NMC) has clarified that doctors cannot use celebrities, influencers, patients or other third parties to promote professional services through testimonials or endorsements. The restriction aims to prevent patient solicitation and commercialisation of medical practice. Doctors and medical institutions remain responsible for promotional content they authorise or knowingly permit, including digital communications.

The restriction aims to prevent indirect advertising and preserve ethical standards in medical practice.

Open

14 October 2026

Healthcare & Wellness

Doctors must sign using approved E-signatures or Digital signatures on medical records such as diagnostic test reports

The National Medical Commission (NMC) has clarified that registered medical practitioners must electronically sign laboratory, pathology and radiology reports remotely using means approved under Information Technology Act, 2000 (IT Act, 2000). Scan of a hand signature, or authentication using email-driven commercially available means such as DocuSign, do not qualify as Electronic Signature or Digital Signature under IT Act, 2000. Aadhar based OTP authentication is recognized as valid e-signature. Digital Signature Certificates are also recognized as valid means of authentication under IT Act, 200. Healthcare establishments must secure records and maintain audit logs.

Open

14 October 2026

Animal Health & Wildlife

BIS certification mandatory for manufacturers and importers of specified animal feed and animal feed ingredients from 2027

The Ministry of Fisheries, Animal Husbandry and Dairying has notified The Animal Feeds and Feed Ingredients (Quality Control) Order, 2026 on October 7, 2026. The manufacturers and importers of common salt and cattle licks for animal consumption, mineral mixtures for supplementing and Dicalcium Phosphate will have to obtain BIS registration under compulsory registration scheme before manufacturing and importing in India. General implementation (other than micro and small enterprises) begins on 1 April 2027, with phased deadlines for small enterprises from1 July 2027 and micro enterprises from 1 October 2027.

14 October 2026

Healthcare & Wellness

Remote authentication of medical records clarified by National Medical Commission

The National Medical Commission (NMC) clarified that registered medical practitioners may electronically sign laboratory, pathology and radiology reports remotely. This addresses uncertainty over remote authentication. Doctors must review sufficient clinical information and remain responsible for what they sign. Healthcare establishments must secure records and maintain audit logs.

Open

14 October 2026

Animal Health & Wildlife

Animal experimentation approvals proposed to shift to severity-based framework

The draft Prevention of Cruelty to Animals Rules, 2026 proposes institutional approval for mild and moderate experiments, while requiring central approval for severe and non-recovery experiments involving animals other than rodents and lagomorphs. It also permits conditional exceptions for using certain protected, wild-caught and stray animals.

12 October 2026

MedTech

Medical device industry reportedly seeks caps on trade markups

After India's drug price regulator capped markups on cancer medicines, news show that an Indian medical device industry body has sought a similar cap for medical devices. Earlier caps on prices left importers' margins out, so imported devices could carry a much higher retail price than Indian-made ones. The body pushed for making import the first point of sale, providing parity between Indian and foreign manufacturers. To this effect, the body has said that it is ready to work with the Government authorities.

12 October 2026

Pharmaceuticals

30% trade margin cap approved for non-scheduled anti-cancer drugs

National Pharmaceutical Pricing Authority (NPPA), the authority responsible for controlling the prices of medicines in India has approved a cap on sale margins for non-scheduled anti-cancer drugs. Non-scheduled anti-cancer drugs are cancer medicines whose prices are not fixed directly by the government, allowing companies to set their own retail rates. This measure is intended to reduce medicine prices and improve affordability. Directorate General of Health Services, the technical advisory body under India's Ministry of Health will finalise the medicines covered, following which NPPA will decide and issue the notification.

Open

12 October 2026

Healthcare & Wellness

Tamil Nadu consumer commission holds wellness clinic liable for deficiency in service

A Tamil Nadu consumer commission has reportedly held a wellness clinic liable for deficiency in service for failing to justify retaining payment for an incomplete cryotherapy package. The Commission emphasised the need for proper treatment records and found the clinic unable to establish satisfactory service delivery or justify retaining fees for unused sessions.

Open

12 October 2026

Traditional Medicines

Ayurveda, Siddha, Sowa-Rigpa and Unani Medicines used in specified traditional preparations exempted from Schedule E(1)

The government has amended Schedule E(1) of the Drugs Rules, 1945, exempting listed drugs of plant origin when used to prepare specified traditional formulations, including Bhasma, Parpam, Kushta, Thalsman, Sindhuram and Chendooram. The exemption is limited to these specified preparations and does not automatically extend to all formulations containing these ingredients.

12 October 2026

MedTech

CDSCO invites stakeholder comments on draft guidance for manufacturers of in-vitro diagnostic medical devices

India's central medical device authority, CDSCO has published a draft guidance document for manufacturers of in-vitro diagnostic medical devices and invited stakeholder comments within 15 days from the date of this guidance document. The draft aims to clarify regulatory requirements and support manufacturers in navigating India’s medical device framework. 

Open

12 October 2026

Pharmaceuticals

DCGI seeks explanation from IPC over unapproved drugs listed in National Formulary

The Drugs Controller General of India (DCGI) has reportedly sought an explanation from the Indian Pharmacopoeia Commission (IPC) after the seventh edition of the National Formulary of India (NFI 2026) listed drugs or formulations not approved by CDSCO. The discrepancy involves at least five drugs or variants, including methylene blue, flumazenil, folinic acid, pyridostigmine and alteplase. The issue raises concerns about regulatory verification and the reliability of an authoritative reference used by healthcare professionals for prescribing and administering medicines.

12 October 2026

Agriculture

Government prohibits Paraquat Dichloride registration over human and animal health risks

The Ministry of Agriculture and Farmers Welfare has prohibited the registration of Paraquat Dichloride, a herbicide used to control weeds, citing risks to human health and animals. Effective September 22, 2026, all existing registration certificates stand cancelled. The Registration Committee must recover these certificates, while state governments are responsible for implementing the prohibition.

12 October 2026

Controlled Substances

Ayurvedic medicines prepared from the separated leaves of cannabis plant may require label changes

The government has amended Schedule E(1) of the Drugs Rules, 1945, retaining cannabis under the poisonous substances list for traditional medicines. The revised entry removes “Linn.” from the botanical name Cannabis sativa, potentially requiring label revisions for Ayurvedic medicines containing cannabis leaves.

9 October 2026

Pharmaceuticals

India revises list of poisonous substances under Drugs Rules

The government has amended Schedule E(1) of the Drugs Rules, 1945, revising the list of poisonous substances used in Ayurveda, Siddha, Sowa-Rigpa and Unani medicines. The revised schedule expands the list of substances of plant, animal and mineral origin and specifies that any ingredient not listed but containing arsenic or mercury as a chemical constituent shall also be treated as a Schedule E(1) drug.

9 October 2026

Food & Beverages (F&B)

India's Food Regulator pulls up protein supplement marketed to users of weight-loss drugs

Food Safety and Standards Authority of India (FSSAI) has issued notices to nutraceutical manufacturers over their protein supplement which claims to protect muscle in people on GLP-1 weight-loss and diabetes drugs. The Regulator questioned the claims of the product's multiple benefits & purity. The Regulator found the name of the product implying a link to these drugs, potentially misleading buyers. Online platforms selling the product also received notices.

9 October 2026

Pharmaceuticals

NAB-CCM Releases White Paper on Strengthening Pharmaceutical Cold Chain Accountability

The National Accreditation Body for Cold Chain Management (NAB-CCM) has released a White Paper proposing stronger implementation of Good Storage and Distribution Practices (GSDP) across India's pharmaceutical supply chain. The White paper among other things recommend establishing a multi-stakeholder Cold Chain Community Committee and Advisory Board, evaluating a standardised temperature-sensitive product indicator, and introducing documented end-to-end accountability across the distribution chain. The central objective is to ensure that medicines retain their quality in transit until they reach the patient.

9 October 2026

Pharmaceuticals

Non-scheduled anti-cancer medicines to face 30% trade-margin cap

The government has approved a 30%-of-MRP trade-margin cap on non-scheduled anti-cancer medicines, projecting price reductions of up to 70% and annual patient savings of ₹2,500 crore. A DGHS committee will finalise coverage before NPPA notification.

9 October 2026

Pharmaceuticals

Supreme Court directs Centre to recommend statutory framework to curb unethical pharmaceutical marketing practices

The Supreme Court has directed the Union Government to constitute a committee to recommend statutory regulations to curb unethical marketing practices by pharmaceutical companies, including the offering of gifts, hospitality, sponsored travel and other inducements to doctors. The committee must examine the adequacy of the existing regulatory framework, including the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024, and assess the effectiveness of existing monitoring and enforcement mechanisms.

9 October 2026

Pharmaceuticals

Prior government sanction proposed for advertising specified prescription drugs

The Central Government has proposed requiring prior sanction for advertising drugs specified under Schedules H, H1 and X. The draft amendment seeks to regulate advertisements of these prescription medicines and will be considered after the 30-day stakeholder consultation period.

8 October 2026

Pharmaceuticals

US drug industry body sues to block rule tying medicine prices to overseas prices

The Pharmaceutical Research and Manufacturers of America (PhRMA), a US drug industry body has sued to cancel a government rule making drugmakers pay rebates on some medicines priced higher in America than abroad. The legal challenge here is whether the government can tie medicine prices to overseas prices, using a pilot program, without new legislation bypassing the US Congress. The rule takes effect starting January 2027. 

8 October 2026

Cosmetics

CDSCO cancels import registration for cosmetic products of international haircare brand

The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration certificate held by an Indian agent for cosmetic products of an international haircare brand, with immediate effect. The cancellation follows a request by the agent after the brand decided to discontinue the registration for business and administrative reasons and confirmed that the products covered under the certificate would no longer be imported into India.

7 October 2026

Pharmaceuticals

NMC tightens rules on digital advertising and public communication by doctors

The National Medical Commission has issued new guidelines regulating advertising, publicity and digital communications by registered medical practitioners and hospitals, effective immediately. The guidelines prohibit misleading or exaggerated claims, patient solicitation, paid or misleading testimonials, promotional endorsements of medical devices and diagnostic products, and certain influencer-led or AI-assisted promotions. They also require compliance with applicable data-protection requirements for digital personal data. 

7 October 2026

Pharmaceuticals

GST Council may consider IGST relief for imported rare disease treatments

The GST Council may reportedly consider exempting imported medicines and specialised foods used to treat additional rare diseases from IGST, potentially lowering the final cost of high-priced therapies. The move could also have implications for medicines covered by the Drugs (Prices Control) Order, 2013: while an IGST exemption would not by itself change an NPPA-fixed ceiling price or retail price under the DPCO, it could reduce the MRP payable by patients by removing the tax component.

7 October 2026

Pharmaceuticals

Proposed US nuclear safety rules could create barriers to Pluvicto patient access

The US Nuclear Regulatory Commission has proposed new guidance on the release of patients treated with radioactive materials that could create additional compliance hurdles for radioligand therapies such as Novartis’ Pluvicto. Under the draft methodology, a full six-dose course of Pluvicto would exceed the proposed release threshold, potentially requiring longer hospital stays or patient-specific radiation calculations. Industry and medical groups have raised concerns that the changes could particularly affect community treatment centres and limit access to the therapy.

7 October 2026

Hospitals

AI-generated testimonials and misleading medical promotions prohibited

India’s National Medical Commission has prohibited doctors and hospitals from using AI-generated patient testimonials, clinical outcomes or endorsements for advertising through a Public Notice dated October 06, 2026, and have come into effect immediately. The guidelines also restrict unverifiable claims, paid manipulation of online rankings and payment-linked patient referrals. The requirements have come into effect immediately, with graded disciplinary action for violations.

7 October 2026

Food & Beverages (F&B)

Odisha’s ban on tobacco- and nicotine-containing food products challenged before HC

The Orissa High Court has reportedly sought the Odisha government’s response to a writ appeal challenging the state’s ban on food products containing tobacco or nicotine. The appeal follows an August 21 judgment upholding the January 2026 notification prohibiting the manufacture, processing, packaging, storage, transportation, distribution and sale of such products, including gutkha and pan masala. The appellant has primarily challenged the classification of chewing tobacco as “food” under the Food Safety and Standards Act, 2006.

6 October 2026

Pharmaceuticals

Maharashtra FDA cancels drug distribution licences over packaging and storage violations

The Maharashtra FDA has reportedly cancelled the drug sale and distribution licences of a major pharmaceutical manufacturer’s Pune warehouse over violations involving packaging, storage, documentation and recall requirements. The action highlights increased scrutiny of supply-chain compliance and reinforces that regulatory obligations extend beyond manufacturing to warehousing and distribution.

6 October 2026

Pharmaceuticals

DCC recommends cough syrups to include red colored warning against use in children below four years

The Drugs Consultative Committee of India (DCC) has agreed that cough syrups should have warning labels against use in children below the age of four years, indicated in red. The Committee found that cough syrups are still given to young children despite an advisory, and opined that the pictures of infants, toddlers and similar suggestive depictions should not appear on labels. Cough syrup manufacturing businesses should monitor the enforcement of this recommendation to adhere to timely compliance.

6 October 2026

Pharmaceuticals

DCC considers bringing all sterile drugs under central licensing

The DCC deliberated on bringing all sterile drug products under the Central Licence Approving Authority (CLAA) scheme, recognising the high-risk nature of sterile products and the need for specialised regulatory scrutiny. The Committee recommended constituting a sub-committee to examine the proposal's feasibility, including the legal implications of changing the existing division of licensing responsibilities and joint inspections. The proposal could expand central oversight of sterile drug licensing, potentially standardising scrutiny and inspections across States, subject to further review and a final decision.

6 October 2026

Pharmaceuticals

DCC recommends streamlining retention of drug licences through ONDLS

The Drugs Consultative Committee (DCC) has recommended integrating drug licence retention fee payments with the Online National Drugs Licensing System (ONDLS), enabling automatic electronic acknowledgements and a searchable database. Separate retention certificates and repeated submission of documents should generally not be required unless specifically prescribed under the Drugs Rules, 1945. This could reduce regulatory paperwork and administrative burdens for drug licence holders and improve standardisation of licence retention processes across States.

6 October 2026

Pharmaceuticals

DCC recommends monthly State reporting to curb illegal diversion of narcotic and psychotropic medicines

The Drugs Consultative Committee has recommended a comprehensive action plan to prevent diversion of pharmaceutical preparations containing narcotic drugs and psychotropic substances. A reliable national database on their manufacture, sale, stocking and enforcement is needed. States and Union Territories would submit monthly data in a uniform format, followed by a common digital platform.

5 October 2026

Food & Beverages (F&B)

“Energy drink” labelling restriction challenged before Delhi court

Beverage manufacturers have reportedly challenged FSSAI’s restriction on using “energy drink” and similar descriptions for high-caffeine beverages before the Delhi court. They contend that the direction was issued without prior notice and would have serious commercial consequences. The petitioners have sought to have the restriction set aside.

5 October 2026

Pharmaceuticals

CDSCO seeks DGHS view on exemptions for mercury-based topical antiseptics

CDSCO is seeking the DGHS’s opinion and data on the manufacture and use of mercury-based topical antiseptics, including Merbromin, before deciding whether to continue their exemption under Schedule K of the Drugs Rules, 1945. The review considers patient safety and clinical need, alongside India’s obligations under the Minamata Convention on Mercury. The outcome could affect the regulatory status and continued availability of mercury-containing topical antiseptics in India.

5 October 2026

MedTech

Indian Council of Medical Research seeks proposals for centres to develop priority medical devices

ICMR has invited proposals to establish Centres for Advanced Research focused on developing priority medical devices and diagnostic technologies addressing identified healthcare needs. The initiative aims to accelerate indigenous development of affordable, accessible and clinically relevant technologies while strengthening India’s medical device ecosystem. Eligible institutions can now submit proposals covering multiple priority technologies, with applications open until November 15, 2026.

5 October 2026

Hospitals

The Kerala Government plans to legislate for reduced treatments costs in private hospital sector

The Health Minister of Kerala has reportedly planned to introduce legislation to regulate treatment costs in private hospitals, with a four-member committee preparing the draft. The move aims to improve affordability and transparency amid concerns over hospital bills. The proposed framework may cover medicines, diagnostics, room rent and procedures, alongside upfront cost information and itemised billing.

3 October 2026

Pharmaceuticals

Supreme Court considers whether patent terms should be calculated from grant date during examination delays

The Supreme Court of India issued notice on a legal challenge concerning whether a patent's 20-year term should be calculated from the grant date rather than the filing date. Under current statutory provisions, the 20-year clock begins at filing, which patentees argue reduces their commercial exclusivity window when regulatory decisions are delayed.

3 October 2026

Immediate drug license suspension without prior hearing ruled invalid

The High Court of Karnataka ruled that drug control authorities cannot suspend a pharmaceutical distribution license simultaneously while issuing a show-cause notice. Due process requires giving the licensee a fair opportunity to respond before imposing any suspension. Pharmaceutical businesses can challenge immediate license suspensions if regulatory authorities fail to provide a preliminary hearing prior to enforcement action.

3 October 2026

Minimum import price floor extended on key pharmaceutical raw materials

The Directorate General of Foreign Trade (DGFT) has extended Minimum Import Price (MIP) restrictions on two active pharmaceutical ingredients, ATS-8 and Sulfadiazine API. The price floor prevents foreign dumping, curbs under-invoicing, and protects domestic bulk drug manufacturing capacity.

3 October 2026

US Waives Import Tariffs on Essential Specialty Drugs From India and Other Nations

The United States government issued tariff waivers on specific specialty and lifesaving pharmaceutical products imported from 20 partner nations, prominently including India. The waiver addresses growing domestic drug shortages and rising healthcare costs in the US market. The policy reinforces India's position as a reliable supplier of cost effective, high quality specialty medicines to Western healthcare systems.

3 October 2026

Fake medicine PIL sent to Centre for consideration by the Supreme Court

The Supreme Court of India declined to entertain a petition seeking measures to tackle the manufacture and sale of fake medicines, including time-bound investigations, standard procedures for search and seizure, and faster forensic reports. Without examining the merits, the Court directed that a copy of the petition be forwarded to the regulatory authorities for consideration.

3 October 2026

Central Drugs Standard Control Organisation directs Fludrocortisone manufacturers to add Hypokalaemia as adverse drug reaction

The Central Drugs Standard Control Organisation has directed manufacturers of Fludrocortisone formulations to add hypokalaemia, or low blood potassium levels, as an adverse drug reaction in the prescribing information leaflet and promotional literature. The direction follows safety signal assessment by the Pharmacovigilance Programme of India and expert review.

3 October 2026

Pharmaceuticals

Supreme Court Questions Exorbitant Drug Markups, Proposes Capping MRP at 16% Above Trade Price

The Supreme Court of India reportedly raised critical questions regarding the wide disparity between the procurement/trade price of non-scheduled medicines and the Maximum Retail Price (MRP) charged to consumers. While essential drugs are regulated under the National Pharmaceutical Pricing Authority (NPPA), non-scheduled drugs often carry significant profit markups. The bench inquired why the government cannot impose a mandatory ceiling capping the MRP of non-scheduled drugs at a fixed margin, specifically suggesting 16% above the price at which the retailer purchases the product.

30 September 2026

MedTech

Pharmaceutical distributor arrested over alleged government hospital procurement fraud

Delhi anti-curreption authorities have reportedly arrested a pharmaceutical distributor over allegations of manipulating medical procurement for government hospitals. Investigators allege that he established companies through associates, coordinated with suppliers and officials, and helped secure contracts without following prescribed procedures. The case involves procurement of medical equipment, medicines and surgical consumables.
Has reported.

30 September 2026

Pharmaceuticals

Delhi High court allows well-known trademark protection without prior formal declaration

The Delhi High Court has ruled that a formal declaration under Rule 124 is not mandatory to invoke Section 11(2) of the Trade Marks Act, 1999, which protects well-known trademarks from similar marks even for unrelated goods or services. Proprietors may establish well-known status through evidence in individual proceedings.

30 September 2026

Pharmaceuticals

Probe into spurious blood-pressure drug expands to manufacturing network

The Haryana Food and Drugs Administration’s investigation into suspected spurious blood-pressure tablets has reportedly expanded to the manufacturing and supply network, resulting in further arrests. A joint search with the Delhi Drugs Control Department also uncovered an unlicensed stockist and recovered additional suspected spurious tablets.

30 September 2026

Agriculture

Government prohibits registration of Paraquat Dichloride

India's Central Government has prohibited the registration of Paraquat Dichloride under the Insecticides Act, 1968, effective from publication of the Order in the Official Gazette. Existing registration certificates are cancelled, and registrants must return their certificates. State Governments are directed to implement the prohibition under applicable laws and rules.

30 September 2026

Pharmaceuticals

Kerala HC permits government intervention over exorbitant prices of patented medicines

The Kerala High Court has held that the Centre may invoke provisions of patents act to manufacture patented medicines and supply them to patients on a non-commercial basis where government intervention is warranted, including cases of exorbitant pricing. The Court directed the Centre to collect data and assess the affordability of patented life-saving medicines before deciding whether to invoke the provision. The ruling could have wider implications for access to high-cost patented medicines.

29 September 2026

Healthcare & Wellness

Surrogacy eligibility age limit challenged before Bombay High Court

The Bombay High Court has sought responses from the Centre and Maharashtra authorities on a challenge to the 50-year upper age limit for intending mothers under the surrogacy framework. The petition was filed after a 54-year-old woman was denied an eligibility and essentiality certificate for surrogacy following unsuccessful IVF and embryo-transfer attempts.

29 September 2026

Food & Beverages (F&B)

Madras HC dismisses FSSAI review plea on micro/nanoplastic warning labels

The Madras High Court has dismissed FSSAI’s review petition seeking recall of its earlier order requiring warnings regarding possible micro/nanoplastic contamination in PET water bottles and packets of sugar and salt. The Court has therefore retained its earlier direction concerning warning labels.

29 September 2026

General Universal All

Attorney-client privilege faces fresh scrutiny in GST searches

The Supreme Court has stayed the Delhi High Court’s directions permitting Goods and Services Tax authorities to examine data seized from an advocate’s office. The Court questioned how investigators could themselves identify and segregate material protected by attorney-client privilege, and issued notice to the Union Government and GST authorities.

29 September 2026

MedTech

Surgical robot manufacturers face new US FDA premarket guidance

The United States Food and Drug Administration has issued draft guidance setting out recommendations for premarket submissions for robotically assisted surgical devices. It covers non-clinical testing, clinical data and labelling, with the aim of creating a more consistent review framework for devices that combine robotic technology with surgical instruments. Comments are invited until 24 November 2026.

29 September 2026

Food & Beverages (F&B)

Supreme Court reserves order on front-of-pack warning labels for packaged foods

The Supreme Court has reserved its order on a plea seeking mandatory front-of-pack warning labels for packaged foods high in sugar, salt and fat. The Court questioned FSSAI’s proposed 365-day voluntary compliance period and raised concerns regarding the need for another stakeholder consultation.

28 September 2026

Healthcare & Wellness

Choice of a recognised medical procedure alone cannot establish negligence

The Bombay High Court has quashed an order removing two doctors from the medical register after finding that the choice of one recognised surgical procedure over another could not, by itself, establish medical negligence. The Court relied on Supreme Court precedent that a doctor acting with reasonable skill and competence cannot be held negligent merely because another treatment option may have been preferred. The ruling reinforces that professional disagreement over treatment choice does not, by itself, justify disciplinary action where the chosen procedure was recognised and performed with reasonable competence.

28 September 2026

Food & Beverages (F&B)

FSSAI seeks four months to finalise front-of-pack warning label rules

The Food Safety and Standards Authority of India has proposed a single-phase rollout of front-of-pack warning labels for packaged foods high in sugar, fat or salt, with a red hexagonal warning identifying the nutrient of concern. FSSAI has sought approximately four months to issue and finalise the draft regulations, including a 60-day consultation process.

28 September 2026

General Universal All

New rules tighten medical preparedness requirements for Indian ships

The Merchant Shipping (Medicines, Medical Stores, Appliances and Medical Officers) Rules, 2026 have come into force, replacing the earlier framework governing medicines and medical supplies on Indian ships. The rules prescribe requirements for medicine chests, medical equipment, medical kits, records and periodic inspection, and apply to specified Indian ships undertaking international voyages and coasting trade.

28 September 2026

Pharmaceuticals

NPPA cannot impose blanket drug price ceilings without following DPCO mechanism

The Bombay High Court has held that the National Pharmaceutical Pricing Authority cannot impose a blanket price ceiling on a drug formulation without following the price-fixation mechanism prescribed under the Drugs (Prices Control) Order, 1995. The ruling limits regulatory pricing action where the prescribed statutory mechanism for calculating and notifying a formulation-specific ceiling price has not been followed.

25 September 2026

Pharmaceuticals

Timely challenge displaces conclusiveness of drug analyst report if sample expires un-tested

The High Court of Jammu and Kashmir and Ladakh held that communicating an intention to controvert a Government Analyst report within the statutory 28-day period displaces its conclusive evidence value under the Drugs and Cosmetics Act, 1940. Failing to re-analyze the sample at the Central Drugs Laboratory before shelf-life expiration deprives the accused of statutory safeguards, invalidating the prosecution. 

25 September 2026

Pharmaceuticals

Non-animal testing methods formally recognized for preclinical drug safety by regulator

The United States Food and Drug Administration (US FDA) has issued a direct final rule clarifying that validated non-animal testing methods can be used for preclinical drug safety evaluations. The rule updates regulatory terminology from animal tests to nonclinical tests, supporting the adoption of cell based assays, organ on chips, and computer models in human drug development applications.

25 September 2026

Food & Beverages (F&B)

Prohibition proposed on using paneer terminology for non-dairy analogue food products.

The Food Safety and Standards Authority of India (FSSAI) has proposed draft regulations prohibiting the manufacture and sale of non-dairy analogue products under the name "paneer". Under the proposed draft, businesses licensed under the analogue dairy category must discontinue using the term paneer in product nomenclature, labelling, menu cards, and marketing materials to prevent consumer deception.

25 September 2026

General Universal All

Policy tagging, public mis-selling records, and commission clawbacks proposed for insurance salespersons under new IRDAI proposed guidelines

The Insurance Regulatory and Development Authority of India (IRDAI) has issued a draft consultation paper. The proposal suggests commission clawbacks by insurers and aims to establish public accountability, inform prospective buyers, and alert future employers about an agent's mis-selling history.

Public disclosure of mis-selling records and mandatory clawbacks will require insurers and corporate intermediaries to overhaul agent recruitment background checks and strengthen compliance.

25 September 2026

General Universal All

Hard commission caps proposed to curb insurer distribution costs and eliminate regulatory arbitrage

The Insurance Regulatory and Development Authority of India (IRDAI) has issued a draft consultation paper. The proposal seeks to set strict commission caps for insurance agents and intermediaries. As flexible spending limits failed to curb high sales costs, the regulator plans to enforce fixed, effort-based commission ceilings and tighter supervision to lower distribution expenses across all sales channels. 

25 September 2026

Pharmaceuticals

Formal court application unnecessary to invoke Central Drugs Laboratory re-testing safeguard

The High Court of Jammu and Kashmir and Ladakh held that accused drug manufacturers are not required to make a formal request before a Magistrate to invoke sample re-analysis safeguards under the Drugs and Cosmetics Act, 1940. Written notification to the drug inspector controverting the analyst report within 28 days sufficiently obligates authorities to send samples to the Central Drugs Laboratory.

25 September 2026

MedTech

Medical device mark-up debate prompts industry calls for trade margin rationalisation

Medical technology associations and hospital bodies have reportedly supported Trade Margin Rationalisation (TMR) following a Maharashtra Food and Drug Administration (FDA) survey revealing large price mark-ups on medical consumables. Industry representatives backed establishing clear guidelines on permissible gaps between procurement costs and printed maximum retail prices, while distinguishing complex technologies from commoditised consumables.

24 September 2026

Pharmaceuticals

Drugs Technical Advisory Board recommends prohibition of Lindane in India

The Drugs Technical Advisory Board has recommended prohibiting the manufacture, sale and import of Lindane in India. The recommendation follows its review of international regulatory status and the availability of alternative treatments in India.

24 September 2026

MedTech

Exemption from sale licensing proposed for glucometers, BP monitors, pregnancy kits, and self test medical devices

The Drugs Technical Advisory Board (DTAB) has recommended amending the Eighth Schedule of the Medical Devices Rules, 2017 to grant sale exemptions for specific medical devices. The proposed change covers medicated dressings in first-aid kits, self-test devices such as glucometers, pulse oximeters, and pregnancy kits, and small device quantities brought for trade exhibition displays.

24 September 2026

Hospitals

Blood donor authentication, E-RaktKosh registration proposed as an amendments to Drugs Rules, 1945

India’s Drugs Technical Advisory Board has recommended amending the Drugs Rules, 1945 to mandate blood-centre registration on the e-RaktKosh portal and authenticate donors through ABHA/Ayushman Bharat Digital Mission ID or Aadhaar-linked OTP. The move aims to strengthen donor traceability, enable post-donation follow-up and help identify high-risk or deferred donors.

24 September 2026

MedTech

Medical Devices Rules may introduce fee and documentation requirements for post-marketing clinical investigations

The Drugs Technical Advisory Board has recommended to formally require applications for post-marketing clinical investigations to be submitted in Form MD-22, accompanied by the prescribed fee and information specified in the Seventh Schedule. The proposal also recommends a INR 1 lakh fee for permission to conduct such investigations. The amendment would provide a defined regulatory and fee framework for post-marketing clinical investigations of medical devices.

24 September 2026

Food & Beverages (F&B)

Manufacture and sale of non-milk products as paneer proposed to be prohibited

India’s FSSAI has issued a draft Notification which has proposed prohibiting the manufacture and sale of products made from non-milk constituents as paneer. Existing products licensed or registered as dairy analogues must discontinue using “paneer” in their nomenclature, labelling and marketing. Stakeholders may submit objections or suggestions within 60 days of the Gazette’s public availability.

21 September 2026

MedTech

DTAB considers exemption for imported first-aid kits used for captive consumption

The Drugs Technical Advisory Board (DTAB) considered a proposal to exempt imported first-aid kits for captive consumption by industries including automobile and hospitality sectors from import and sale licensing requirements under the Medical Devices Rules, 2017. The proposal contemplates exemption from import licensing requirements under Chapter V and sale licensing under Chapter XI, subject to conditions including a minimum residual shelf life of 60% and compliance with applicable standards. The kits would also be restricted from resale.

21 September 2026

MedTech

Exemption from Test Licence proposed for certain medical devices

India’s Drugs Technical Advisory Board has recommended amending Rule 31 of the Medical Devices Rules, 2017, to exempt manufacturers from obtaining a Test Licence for devices made solely for testing, examination, evaluation, demonstration or training. The proposal could ease regulatory requirements for limited-purpose medical device manufacturing. 

21 September 2026

Pharmaceuticals

Drugs Technical Advisory Board recommends exemption from wholesale sale licence for liquid antiseptics

The Drugs Technical Advisory Board has recommended amending the Drugs Rules, 1945, to exempt liquid antiseptics from sale licence requirements, subject to conditions. The exemption would apply where products are manufactured by licensed manufacturers, contain no substances specified in Schedules G, H, H1 or X, and are sold in the original, unopened containers of the licensed manufacturer.

21 September 2026

In Vitro Diagnostics

India's Drugs Technical Advisory Board recommends a separate, clearer definition for IVD Medical Devices

The Drugs Technical Advisory Board (DTAB) has recommended amending the Medical Devices Rules, 2017 to introduce a separate definition for in vitro diagnostic (IVD) medical devices, aligned with global regulatory standards. The change is important because IVDs currently lack a distinct definition, creating greater clarity on their regulatory scope.

21 September 2026

Pharmaceuticals

DTAB weighs central licensing for all sterile drugs

The Drugs Consultative Committee is set to consider a proposal to bring all sterile drug products, including small-volume parenterals, under central licensing. Currently, only specified categories of sterile medicines are centrally licensed, while others fall under state authorities. The proposal cites contamination risks, variations in state-level scrutiny and inspections. If adopted, the proposal could significantly expand central regulatory oversight and standardise licensing, inspection and compliance requirements for manufacturers of sterile medicines.

18 September 2026

Healthcare & Wellness

Public health reform gets ₹4,250 crore five-year push

The Government of Maharashtra has reportedly approved a ₹4,250-crore health reform programme for 2026-2031, focused on strengthening primary, secondary and tertiary care, digital health systems, disease prevention and early screening.

18 September 2026

Pharmaceuticals

Wholesale drug licences may require registered pharmacists as competent persons

The Drugs Technical Advisory Board has recommended restricting the qualification of the “competent person” for wholesale licences to registered pharmacists. The proposal would tighten eligibility for wholesale drug licences and could affect existing businesses that rely on non-pharmacist competent persons. 

18 September 2026

MedTech

Hospital consumable mark-ups trigger proposal for price regulation

Maharashtra Food and Drug Administration reportedly found large gaps between procurement prices and printed Maximum Retail Prices in hospitals and sought National Pharmaceutical Pricing Authority and Department of Pharmaceuticals intervention to consider price regulation under the Drugs Price Control Order, 2013. The action seeks to extend price regulation beyond scheduled medicines to commonly used hospital consumables. Whether these products can be brought within the DPCO framework, and what pricing mechanism may apply, will depend on action by the competent central authorities. 

18 September 2026

Food & Beverages (F&B)

Food sample analysis gets fixed timelines and testing methods

India's Food Safety and Standards (Laboratory and Sample Analysis) Regulations, 2011 have been amended to prescribe a 14 day timeline for regulatory sample reports and five days for import samples. Laboratories must use FSSAI-prescribed methods, and where none exists, may use validated methods recognised by specified international bodies. The amendment takes effect on 1 April 2027. The amendment makes both the testing methodology and timelines more structured, giving food businesses a clearer framework for challenging delays or departures from prescribed analytical methods.

18 September 2026

Food & Beverages (F&B)

Food licence suspension must be challenged before the Commissioner before going to court

The Bombay High Court has directed that a challenge to suspension of food licence should be first pursued as per the statutory appeal before the FDA Commissioner before seeking writ relief from the High Court. The decision reinforces the requirement to exhaust the available remedy as per the law before directly approaching the courts.

18 September 2026

Pharmaceuticals

Retailers to procure medicines only from authorised distribution channels only

The Bangalore District Chemists and Druggists Association has reportedly urged retailers to procure medicines only from authorised stockists and legitimate distribution channels amid an ongoing investigation into alleged counterfeit, relabelled and repackaged medicines. Retailers have also been advised to verify invoices, batch numbers, expiry dates and manufacturer details. The association’s advisory is not itself a new statutory requirement. 

Open

18 September 2026

Controlled Substances

Limited opium poppy cultivation does not attract stringent NDPS bail restrictions

The Jammu & Kashmir and Ladakh High Court held that stringent bail restrictions under the NDPS Act were not attracted in a case involving alleged cultivation of opium poppy, as no small or commercial quantity is prescribed for such cultivation. The conveys that if businesses are cultivating opium within the prescribed limits, they cannot be called up under the provision of NDPA Act.

17 September 2026

Food & Beverages (F&B)

Jaipur Consumer Commission holds manufacturer liable for short-weight packaged food

The District Consumer Disputes Redressal Commission-II, Jaipur held a food manufacturer liable after a packaged snack was found to contain substantially less than its declared net weight. The Commission treated the shortfall as deficiency in service and an unfair trade practice, ordered a refund and compensation, and dismissed the complaint against the retailer.

16 September 2026

Pharmaceuticals

Counterfeit and unregulated medicines put online pharmacies under scrutiny

A roundtable convened by the General Pharmaceutical Council in the United Kingdon on fake online pharmacies and unregulated medicines has highlighted the need for stronger coordination between regulators, technology platforms and other stakeholders to tackle websites selling counterfeit or unauthorised medicines. The discussion focuses on improving detection, information-sharing, enforcement and consumer protection across the online medicines supply chain.

16 September 2026

General Universal All

Ride-hailing apps cannot pressure riders to pay more through booking prompts

The Central Consumer Protection Authority (CCPA) has found a ride hailing app in it’s booking interface was using prompts which encouraged users to increase payments to have a better chance of the ride getting confirmed. CCPA has flagged this practice as dark pattern and has directed discontinuation of such prompts and practices, following a sector-wide examination of advance tipping and dynamic pricing.

16 September 2026

MedTech

Medical devices cannot be prosecuted as drugs without statutory Gazette notification

The Punjab and Haryana High Court has held that an administrative clarification bringing a device under ambit of a notified medical device is not tenable in law. The judgment raises a broader regulatory concern around products that remain outside statutory notification, including spectacles and toothbrushes, despite being regulated as medical devices in other jurisdictions, and the role of administrative convenience in such exclusions.

16 September 2026

General Universal All

Social media platforms face scrutiny due to allowance of Child Sexual Abuse Material

The National Commission for Protection of Child Rights has again summoned the India head of a social media platform as part of its formal inquiry into allegations involving advertisements linked to Child Sexual Exploitative and Abuse Material.  The proceedings underscore increasing regulatory scrutiny of platform systems for detecting, reporting and responding to child sexual exploitation content. 

16 September 2026

Food & Beverages (F&B)

Food-safety inspections in Madhya Pradesh to be triggered by food-app data and customer ratings

Madhya Pradesh’s Food and Drug Administration (MP FDA) is using food-delivery platform data, customer ratings and order activity to identify high-footfall restaurants and hotels for priority inspections. FSSAI’s inspection framework does not identify customer ratings, online popularity or order volumes as food-safety risk parameters. The concern is whether the MP FDA can treat commercial visibility indicators, such as customer ratings and order volumes, as a basis for prioritising food-safety inspections.

16 September 2026

Healthcare & Wellness

Medical practitioner registration may move to online renewal and time-bound appeals

The National Medical Commission has proposed amendments to the Registration of Medical Practitioners & Licence to Practice Medicine Regulations, 2023. The proposed amendments introduce changes to National Medical Register registration, licence renewal and appeals, including online processes and time-bound consideration of challenges to registration or licensing decisions. Stakeholders have sought an automated online renewal system and a transparent, time-bound online mechanism for challenging rejection of registration or licence applications.

15 September 2026

Food & Beverages (F&B)

Food application for higher capacity does not entitle applicant to start operations on strength of existing registration

The Allahabad High Court has held that large-scale slaughterhouses require a FSSA licence and cannot rely only on a registration certificate. A registration certificate, GST or Udyam registration, laboratory reports, municipal NOC or even a pending licence application cannot substitute the statutory licence required under the Food Safety and Standards Act, 2006. 

For slaughterhouse operators, registration is sufficient only within the prescribed petty-business limits; larger operations must obtain and maintain the appropriate FSSAI licence before commencing or restarting operations.

14 September 2026

General Universal All

Search results on e-commerce platforms to be fair

Under the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, effective from 1 January 2027, platforms cannot manipulate search results in a manner that misleads consumers or reduces the relevance of results to their searches. The provision brings greater scrutiny to how products are ranked and displayed on online marketplaces. Businesses may need to review ranking algorithms and commercial arrangements where payments or other business interests influence product visibility.

How a platform ranks and displays products is now a compliance issue, particularly where commercial interests or payments may affect search visibility.

14 September 2026

General Universal All

Patent Office proposes new practice and procedure manual

The office of the Controller General of Patents, Designs and Trademarks (CGPDTM) has invited comments and suggestions from stakeholders on the Draft Manual of Patent Office (Practice & Procedure), 2026. The Draft Manual incorporates provisions introduced through the Patents (Amendment) Rules, 2024, the Jan Vishwas Act, 2023 and the SHANTI Act, 2025. It also reflects the 2025 CRI Guidelines and recent case law, while continuing the focus on automation, IT-enabled processes and electronic handling of patent applications.

14 September 2026

General Universal All

E-commerce platforms have to mandatory conduct annual checks for dark patterns

The Consumer Protection (E-Commerce) (Amendment) Rules, 2026 require e-commerce entities to comply with the existing Guidelines for Prevention and Regulation of Dark Patterns, 2023, conduct an annual self-audit and display a compliance certificate. The amendment therefore adds a recurring compliance requirement for practices such as false urgency, basket sneaking, subscription traps and drip pricing. 

 

14 September 2026

Artificial Intelligence

Guidelines for Computer-related inventions revised by Patent Office

The Patent Office has published the Guidelines for Examination of Computer Related Inventions (CRIs), 2025, providing updated guidance on how patent examiners should assess computer-related inventions. The guidelines aim to improve consistency and clarity in examination of CRI applications.

14 September 2026

General Universal All

Product listings on e-commece platforms to carry additional information from January 1, 2027

The Consumer Protection (E-Commerce) (Amendment) Rules, 2026 expand the information marketplaces must display about goods and sellers, including country of origin, best-before or use-before dates, return shipping costs and government-issued identification numbers such as GSTIN or MSME registration numbers. The amended requirements will apply from 1 January 2027.

14 September 2026

General Universal All

Trade Marks Office invites comments on revised manual for examination and procedure

The office of the Controller General of Patents, Designs and Trademarks (CGPDTM) has invited comments and suggestions from stakeholders on the Draft Manual of Trademark Office (Practice & Procedure), 2026.

The Trade Marks Office has released a revised draft Manual of Trade Marks Practice and Procedure for stakeholder comments. The Draft Manual of Trade Marks incorporates the Trade Mark Rules, 2017; modernises the trademark filing workflow by formally digitising several of the protocols; includes references to recent case laws; expands on the procedure related to oppositions; and adds a new chapter 7 on ‘concept of claiming prior user and well-known marks’.

14 September 2026

General Universal All

Sponsored listings on E-Commerce platforms to be clearly identified as paid promotions

Under the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, effective from 1 January 2027, e-commerce platforms must clearly disclose when products or services are sponsored. Platforms now will not be able to make paid visibility look like organic search results. Their advertising and ranking interfaces will need clearer separation between sponsored and ordinary listings.

14 September 2026

General Universal All

E-commerce rules amended, to take effect on 1 January 2027

The Indian Government has amended the Consumer Protection (E-Commerce) Rules, 2020 through the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, covering pricing, sponsored listings, search results, dark patterns, product disclosures, consumer information and grievances. The amended rules have been notified and will apply from 1 January 2027.

E-commerce businesses have a transition period to review pricing practices, sponsored listings, search algorithms, grievance processes and consumer disclosures and align their systems with the amended Rules before they take effect.

14 September 2026

General Universal All

Online discounts on e-commerce platforms will have to reference the lowest price offered in last 30 days

Under the Consumer Protection (E-Commerce) (Amendment) Rules, 2026, taking effect from 1 January 2027, e-commerce platforms advertising a discount must show the current price and the lowest price offered in the previous 30 days. This could make promotional pricing more difficult where businesses frequently change prices across sales periods. Platforms will need reliable systems to track historical prices and substantiate discount claims.

Businesses will no longer have complete flexibility in how they present “discounts”. They will need to substantiate the reference price with actual 30-day pricing data.

11 September 2026

Pharmaceuticals

20 scheduled drug formulations cleared for discontinuation amid weak demand and competition

The National Pharmaceutical Pricing Authority has approved 20 Form-IV intimations for discontinuation of scheduled formulations for FY 2025-26. The reasons cited include low or no market demand, declining market share, availability of competing products, portfolio optimisation and difficulties in sourcing APIs.

11 September 2026

Agriculture

New Seed Bill still in consultation with no fixed date for Parliament

The Government is continuing consultations with farmer organisations before finalising the proposed new Seed Bill, aimed at tightening controls over fake and substandard seeds. No fixed date has yet been announced for introducing the Bill in Parliament.

Open

11 September 2026

Hospitals

Hospital defamation case puts limits on doctors’ social media posts

Bombay High Court passed an interim direction restraining a trainee doctor from publishing further social media posts concerning a hospital after the hospital approached the Court with a defamation claim over allegations of harassment and excessive working hours. The Court has issued notice, and the underlying allegations remain to be decided in the proceedings.

11 September 2026

Food & Beverages (F&B)

FSSAI open to warning labels for foods high in even one nutrient

The Food Safety and Standards Authority of India has told the Supreme Court that it will consider requiring front-of-pack warning labels where a packaged food is high in even one nutrient of concern, such as sugar, salt or fat, moving away from its earlier two-nutrient trigger. The Court has sought further information before deciding the framework. The proposal is not final yet, but food businesses should factor in the possibility of a wider labelling requirement. 

9 September 2026

Food & Beverages (F&B)

Bombay High Court directs Maharashtra FDA to revoke food licence suspension after rectification of deficiencies

The Bombay High Court directed the Maharashtra FDA to promptly revoke suspension or cancellation of a food business licence once identified deficiencies are rectified and compliance is confirmed. The Court held that compliant establishments should not be forced into litigation and cannot suffer further business losses due to regulatory inaction. 

9 September 2026

Pharmaceuticals

Supreme Court allows criminal proceedings against companies without arraigning individual employees

The Supreme Court of India has held that criminal proceedings against a company cannot be quashed merely because the individual employee or officer involved has not been identified or made an accused. The Court clarified that the allegations must still show, at least prima facie, that someone acted for the company and that the circumstances support the required mens rea. The ruling raises the compliance stakes for companies because criminal exposure cannot be avoided simply by showing that no particular employee has been named. 

9 September 2026

Pharmaceuticals

Government panel recommends retaining doorstep delivery of medicines

A government sub-committee has recommended retaining the 2020 notification permitting doorstep delivery of medicines, instead of withdrawing it as sought by chemists. The panel has instead suggested stricter enforcement to prevent online sale without valid prescriptions and ensure compliance with the notification. The recommendation would preserve the existing legal route for doorstep delivery while increasing compliance expectations for pharmacies and digital platforms, particularly around prescription verification and sale procedures.

9 September 2026

Food & Beverages (F&B)

Food licence should be restored after rectification

The Bombay High Court has restored a hotel’s FSSAI licence after a re-inspection found it 97% compliant with food safety requirements, despite an earlier suspension for deficiencies. The Court held that once the deficiencies are rectified, the suspension should be revoked, while continued monitoring can ensure compliance with food safety requirements. The ruling makes clear that licence suspension is not meant to continue as a penalty after a food business has corrected the identified deficiencies and achieved compliance.

9 September 2026

Pharmaceuticals

Supreme Court reserves order on regulation of pharmaceutical marketing practices

The Supreme Court has reserved its order on a plea seeking statutory regulation of pharmaceutical marketing practices and freebies to doctors. The Centre informed the Court that it will constitute a three-member committee to examine whether a statutory framework is necessary to address unethical practices by pharmaceutical companies. Until then, the UCPMP 2024 will continue to govern the sector.

The proceedings could determine whether India moves from the existing UCPMP framework towards a legally enforceable statutory regime governing pharma-doctor interactions and promotional practices.

9 September 2026

General Universal All

Meta's child safety policy under scrutiny for gaps in handling sexual abuse material

The National Commission for Protection of Child Rights has decided to initiate a formal inquiry into alleged gaps in Meta’s child safety policies and its handling of child sexual abuse material. The move follows the Commission finding Meta’s response inadequate, with the company’s India head also summoned for questioning. The inquiry can increase compliance scrutiny for social media platforms around child protection, content moderation and the handling of child sexual abuse material in India.

9 September 2026

Food & Beverages (F&B)

Calcutta high court sets higher evidentiary standard for food adulteration

The Calcutta High Court has set aside a longstanding conviction, observing that only low fat content alone does not establish that curd is adulterated. Adulteration must be supported by evidence demonstrating harm, unfitness for consumption, or satisfaction of the statutory definition. The Court also cited shortcomings in sample handling and evidentiary proof.

9 September 2026

Hospitals

Hospitals cannot recover damages from doctors who leave without serving notice period

The Bombay High Court has dismissed a private hospital’s claim for damages after a senior doctor resigned with seven days’ notice instead of the three months required under his contract. The Court held that damages under Section 73 of the Indian Contract Act require proof of actual loss, and the hospital had not shown that the doctor’s departure caused the claimed business loss. The judgment reinforces that a contractual breach does not automatically justify damages. Hospitals and other employers seeking compensation for premature departures will need to show actual, provable loss and evidence of reasonable steps taken to reduce that loss.

9 September 2026

Pharmaceuticals

Supreme Court lays down three-stage test for corporate criminal liability

The Supreme Court has laid down a three-stage framework to determine when an individual’s conduct and mens rea can be attributed to a company. Courts must first examine the company’s constitutional documents to identify the authority for the relevant act, then consider whether that authority was delegated, and finally, if neither answers the question, whether the purpose of the law requires the employee’s actions to be attributed to the company. The framework gives courts a structured way to assess corporate criminal liability. Merely holding a particular position is not, by itself, enough for attribution, although the person’s status may still be relevant depending on the circumstances and the purpose of the statute.

9 September 2026

Healthcare & Wellness

India’s Bihar Consumer Commission holds Doctor liable for reliance solely on ultrasound report

The State Consumer Disputes Redressal Commission, Bihar passed an Order that held gynaecologist liable and to monetarily compensate the patient’s husband after a patient died due to her unborn baby's death in the womb due to medical negligence. The Commission ruled that relying purely on ultrasound reports and ignoring the patient’s symptoms is against the established norm of medical practise and not relied upon alone. The gynaecologist must pay a lumpsum compensation and the cost of litigation with an interest to the patient’s husband.

9 September 2026

Pharmaceuticals

Open API facilities introduced for digital certificate of origin applications by DGFT

The Directorate General of Foreign Trade has reportedly introduced an Open API facility for Certificates of Origin, allowing pharmaceutical exporters to integrate ERP and accounting systems with the online certification platform. The initiative can reduce manual data entry, streamline certificate applications, minimize repetitive tasks and improve overall processing efficiency for exporters.

Open

9 September 2026

Environment & Waste Management

Land possession not required before environmental clearance application for biomedical waste facilities

The Supreme Court has ruled that prior land possession is not mandatory to apply for environmental clearance for common biomedical waste treatment facilities. This is important because requiring land possession upfront could delay the clearance process and project development. Applicants can now seek environmental clearance while progressing toward securing the required land.

8 September 2026

Pharmaceuticals, MedTech, Cosmetics

CBIC introduces mandatory compliance checklists for drugs, cosmetics, medical devices and IVDs imports

CBIC has prescribed seven mandatory checklists for Customs verification of imported cosmetics, drugs, medical devices and IVDs before granting Out-of-Charge in PGA facilitated bills of entry.  Pending integration of regulatory documents with SWIFT 2.0, Customs officers must verify applicable licences, registrations, permissions and supporting documents. Importers are advised to upload required records on e-SANCHIT. 

8 September 2026

Food & Beverages (F&B)

Bombay High court denies interim relief against FSSAI order over rum labelling

The Bombay High Court has reportedly denied interim relief against an food regulator's order restricting sales of a rum product in Maharashtra after regulators found external rum flavouring was used without declaring it as flavoured rum. The manufacturer submitted three revised labels proposing compliance changes, while the court deferred further consideration.

8 September 2026

Pharmaceuticals

Karnataka FDA raids unlicensed e-commerce storage units, seizes unauthorised medicines

Karnataka's Food Safety and Drug Administration reportedly conducted simultaneous raids at two unlicensed e-commerce storage facilities in Anekal and Devanahalli, acting on intelligence about illegal pharmaceutical storage and distribution. Officials seized unauthorised medicines stored without valid drug licences worth lakhs.

8 September 2026

Pharmaceuticals

NMC warns doctors against unauthorised use and promotion of stem cell therapy

The National Medical Commission has reiterated that stem cell therapy may be offered as routine clinical care only for approved indications under applicable ICMR/DHR/MoHFW guidelines. Any unauthorised administration, prescription, promotion or advertisement beyond these indications may constitute professional misconduct and attract disciplinary action following due process. The advisory strengthens regulatory oversight of stem cell therapies and reinforces that uses beyond approved indications must remain within an appropriately approved clinical research framework.

7 September 2026

Pharmaceuticals

Gujarat’s FDA intensifies action against counterfeit medicines

Gujarat’s Food and Drug Control Administration has cancelled pharmaceutical licences following intensive investigations into the sale and manufacture of counterfeit and illegal medicines. The action forms part of the state’s zero-tolerance approach to activities that compromise public health and strengthens regulatory oversight of pharmaceutical operations.

7 September 2026

Hospitals

India’s Parliamentary Standing Committee seeks abolition of prior-consent requirement for emergency neonatal, paediatric referrals

Parliamentary Standing Committee has flagged the shortage of specialised neonatal and paediatric care in district hospitals, calling the mandatory prior-consent letter for transferring critical patients to empanelled facilities flawed and life-threatening. The neonatal and paediatric care means the care of infants and children respectively. Committee has recommended abolishing this requirement and setting up self-sufficient paediatric care units in all district hospitals.

7 September 2026

Pharmaceuticals

Rabies vaccine batch flagged as substandard amid suspected counterfeit concerns

India’s drug regulator has flagged a batch of a widely used rabies vaccine as “Not of Standard Quality” after a field sample failed potency testing. The seized vials also showed discrepancies in labelling, packaging, QR-code verification and licence details, prompting an investigation into whether the product is spurious. The incident highlights the public-health risks posed by counterfeit vaccines and the need for stronger supply-chain traceability, batch verification and regulatory surveillance

7 September 2026

Food & Beverages (F&B)

FSSAI seeks review of micro/nanoplastics warning labels

India's central food authority, FSSAI has reportedly urged the Madras High Court to review its direction requiring drinking water, sugar and salt sold in plastic packaging to carry a prominent warning that they may contain micro/nanoplastics. The regulator has sought reconsideration of the labelling requirement, which could significantly affect food and beverage packaging practices.

7 September 2026

Controlled Substances

Unaccounted Psychotropic Stock lead to Drug Licence Cancellation: P&H High Court

The Punjab and Haryana High Court has upheld cancellation of a drug licence over excess, unaccounted psychotropic medicines, holding that the absence of evidence of sale does not excuse stock discrepancies. The ruling reinforces the need for pharmacies to maintain complete, verifiable records of controlled medicines. It signals that unexplained inventory mismatches can independently invite regulatory action, making robust stock reconciliation and documentation critical for continued licensing.

4 September 2026

Pharmaceuticals

Allopathic Drugs Manufactured Under Ayurvedic Licence: Illegal Drug Manufacturing Unit Exposed in Ujjain

The Uttar Pradesh Food Safety and Drug Administration, Madhya Pradesh’s regional drug administration, Ayush officials and police have reportedly jointly uncovered an illegal drug manufacturing operation in Ujjain, involving production of an allopathic medicine under an Ayurvedic licence. The case highlights patient risks from unlicensed manufacturing and cross-state distribution. Authorities are tracing the wider supply network.   

4 September 2026

General Universal All

CCPA acts against misleading claims and service lapses by water purifier company

India's Central Consumer Protection Authority (CCPA) has found misleading or inadequate disclosures in claims relating to annual maintenance contracts, warranty benefits and refund policies, following complaints about water purifier after-sales service. The CCPA has directed stronger consumer disclosures, better grievance handling and availability of genuine spare parts. The order reinforces that consumer facing claims must clearly disclose material conditions, while companies must have effective systems for handling warranties, repairs and complaints.

4 September 2026

Pharmaceuticals

Telangana HC seeks report on alleged unregulated sale of MTP kits

The Telangana High Court has directed the State Health and Medical Department to file a detailed affidavit on action taken against the alleged sale of MTP kits without prescriptions or supervision by registered medical practitioners. The PIL raises concerns over unrestricted access to medical abortion medicines and compliance with statutory safeguards governing their sale and use. The matter highlights increased judicial and regulatory scrutiny of the distribution of MTP kits and enforcement of prescription and medical-supervision requirement

4 September 2026

Pharmaceuticals

Indian drug manufacturer recalls clobetasol propionate cream in the US over quality concerns

Major Indian drug manufacturer has voluntarily recalled 5,082 tubes of clobetasol propionate cream in the US after the product failed to meet content uniformity specifications. Manufactured at its Pithampur facility in India, the recall is classified as Class II by the US FDA, indicating potential temporary or medically reversible adverse health consequences.

4 September 2026

Pharmaceuticals

NPPA to revise guidelines for drug overcharging cases

The National Pharmaceutical Pricing Authority is reportedly revising its internal guidelines for pharmaceutical overcharging cases following amendments to the Drugs (Prices Control) Order, 2013. The proposed framework would limit manufacturers’ liability to stock actually overcharged through identified distributors or retailers, where manufacturers have complied with previous price revisions.

Open

3 September 2026

Pharmaceuticals

Delhi high court upholds rights over “REDDY” trademark

The Delhi High Court has rejected a plea challenging rights associated with the “REDDY” trademark. The Court’s decision provides relief to the existing trademark holder and reinforces the importance of established trademark rights, particularly where a mark has acquired significant recognition in the pharmaceutical sector.

3 September 2026

Pharmaceuticals

Recall of clobetasol propionate cream over content uniformity failure in the United States

Several tubes of clobetasol propionate cream have been voluntarily recalled in the US after the product failed to meet content uniformity specifications. The affected batch was manufactured in India, and the recall has been classified as Class II, indicating potential but generally temporary or reversible health risks. The recall highlights the importance of robust quality-control systems and content uniformity testing for pharmaceutical products manufactured in India for export markets.

3 September 2026

Cosmetics

CDSCO cancels cosmetic registrations over sale of unregistered products

India's central cosmetics authority has cancelled cosmetic registration certificates for a cosmetic company after an investigation found unregistered products sold through e-commerce platforms, incorrect registration numbers on labels, and an unauthorised warehouse relocation. The firm acknowledged the violations, leading to cancellation under the Drugs and Cosmetics Act, 1940 and Cosmetics Rules, 2020.

3 September 2026

General Universal All

India’s Central Consumer Protection Authority directs removal of non-compliant explosive substance listings

The Central Consumer Protection Authority (CCPA) has directed the immediate removal of online listings for facilitating the online listing, hosting, advertising and sale of Ammonium Nitrate that do not comply with substance classified as an explosive under the Explosives Act, 1884 and heavily fined the company. The Authority reiterated that consumers rely on product listings and descriptions when making online purchasing decisions, and that e-commerce platforms must exercise appropriate due diligence in relation to regulated products.

3 September 2026

Pharmaceuticals

Rajasthan drug control department seizes medicines worth ₹4 crore from unlicensed warehouse

The Rajasthan Drug Control Department seized medicines and pharmaceutical raw materials worth nearly ₹4 crore from an unlicensed warehouse in Bhiwadi. Around 1,500 cartons were recovered, including medicines, packing material and sensitive raw materials. Nine medicine samples were collected for testing, highlighting serious violations involving unlicensed storage and distribution.

Open

2 September 2026

Pharmaceuticals

India’s Delhi High Court orders forensic audit into share dissipation amid arbitral award enforcement

The Delhi High Court has directed a six-month forensic audit into alleged dissipation of listed company shares during enforcement of a long-pending foreign arbitral award, upheld earlier by the Supreme Court. A chartered accountancy firm has been appointed to reconstruct transaction records, including share pledges, transfers and fund flows involving banks and related entities, to determine whether assets were deliberately moved to evade enforcement, or genuinely lender-driven.

2 September 2026

Pharmaceuticals

India seeks predictable regulatory framework to strengthen pharma trade with Brazil

India has reportedly urged Brazil to establish more predictable and transparent regulatory processes to facilitate pharmaceutical trade and improve market access for Indian drug manufacturers. Discussions focused on reducing regulatory barriers and strengthening cooperation between the two countries, with greater regulatory certainty expected to support exports of quality and affordable medicines.

2 September 2026

MedTech

Adverse event reporting manual for medical devices issued by Indian Pharmacopoeia Commission

The Indian Pharmacopoeia Commission has issued a user manual for reporting medical device adverse events through the Adverse Drug Reactions Monitoring System under the Materiovigilance Programme of India. The manual standardises reporting and supports systematic collection, assessment and monitoring of medical device safety information, strengthening India’s post-market surveillance framework.

2 September 2026

MedTech

Government introduces Ninth Schedule setting fees for medical device testing and evaluation

The Government has introduced the Ninth Schedule through the Medical Devices (Second Amendment) Rules, 2026, establishing prescribed fees for specified medical device tests and evaluations. Charges for unspecified tests will be determined by laboratories, with an annual five percent increase.

1 September 2026

MedTech

Government plans domestic ecosystem for advanced medical device manufacturing

The Government of India is reportedly developing an ecosystem to support domestic manufacturing of advanced medical devices, including magnetic resonance imaging machines, by 2028. The initiative aims to reduce import dependence, strengthen domestic supply chains, promote research and innovation, attract investment, and position India as a competitive global medical device manufacturing hub.

1 September 2026

Pharmaceuticals

FDA withdraws pharma licence cancellation after High Court raps it for going 'overboard'

Maharashtra's FDA cancellation of a pharma company's wholesale distribution licence due to irregularities related to packaging, storage and recall of Schedule H drug was withdrawn. The Bombay High Court withdrew a pharma firm's licence cancellation, ruling it unfair and against "principles of natural justice" since the company was summoned on a public holiday and its licence was cancelled when no representative appeared. The Court shall pass an order upon the FDA issuing a fresh show-cause notice to the Company.

1 September 2026

Healthcare & Wellness

MoHFW issues national guidelines to standardise brainstem death certification

The Ministry of Health and Family Welfare, through NOTTO, has issued national guidelines aimed at standardising the diagnosis and certification of brainstem death across hospitals. The guidelines provide a uniform framework for certification, including clinical assessment and special circumstances, with the objective of improving consistency and supporting deceased-organ donation.

1 September 2026

Environment & Waste Management

Common EPR portal registration made mandatory for plastic packaging producers, importers and brand owners

The Central Pollution Control Board has directed producers, importers, brand owners, manufacturers, sellers and plastic waste processors covered under the Plastic Waste Management Rules, 2016, to register on the Common EPR Portal. The move is important as covered entities cannot conduct business without registration. Stakeholders must now complete portal registration before carrying out operations.

Open

1 September 2026

MedTech

QMS requirements clarified for Class A NSNM medical devices

Indian central Health ministry has amended the Medical Devices Rules, 2017 to expressly require manufacturers and importers of Class A non-sterile and non-measuring medical devices to self-certify compliance with applicable standards and Quality Management System (QMS) requirement. The amendment strengthens quality controls for these devices under the registration framework.

31 August 2026

Food & Beverages (F&B)

Maharashtra drug regulator withdraws licence cancellation order after High Court intervention

The Maharashtra Food and Drug Administration has reportedly withdrawn its order cancelling a pharmaceutical company’s drug licence after the Bombay High Court criticised the regulator for denying a fair hearing. The regulator will now issue a fresh notice and reconsider the matter through due process before deciding on further action.

31 August 2026

Hospitals

India’s Orissa High Court: No bar on Radiologists from conducting ultrasonography at clinics in two different districts

The Orissa High Court held that a qualified cannot be barred from conducting ultrasonography at clinics located in two different districts, especially when a no-objection certificate has been issued by his employer. The Court granted relief to Radiologist and set aside the District Advisory Committee's order, which prevented the Radiologist from conducting ultrasonography at a private clinic.

31 August 2026

Pharmaceuticals

NPPA proposes making manufacturers solely responsible for essential medicine overpricing

The National Pharmaceutical Pricing Authority has proposed making manufacturers solely responsible for overpricing essential medicines, while removing prosecution risks for retailers, chemists and hospitals. The move is important as medicines may continue to be sold above revised prices, affecting affordability. The draft would remove action against downstream sellers for such violations.

31 August 2026

Pharmaceuticals

Government plans incentives to diversify India’s chemical exports

The government is considering policy support and financial incentives to help chemical exporters reduce dependence on the US market and expand into Europe, Southeast Asia, Africa and Latin America. The proposed product-region strategy would also encourage a shift towards higher-value specialty, green and pharmaceutical chemicals. The move could strengthen the resilience of India’s chemical sector by reducing export concentration and supporting Indian manufacturers.

31 August 2026

Food & Beverages (F&B)

India allows free export of wheat and wheat flour products

The Directorate General of Foreign Trade (DGFT) has revised the export policy for specified wheat and wheat flour products from “Prohibited” to “Free” with immediate effect. The change covers wheat under HS Codes 10011900 and 10019910, and wheat flour, atta, maida and related products under HS Code 11010000.

26 August 2026

Food & Beverages (F&B)

India’s Delhi High Court restrains FSSAI from cancelling FMCG major's licence over "100%" labelling claim

The Delhi High Court granted interim protection to a packaged food company against licence cancellation by the FSSAI, which had objected to "100 per cent" claims on its atta product. The High Court held no cancellation decision would be taken pending resolution of jurisdictional questions, listing the matter for further hearing on September 9.

26 August 2026

Pharmaceuticals

Indian Pharmacopoeia Commission proposes revisions to drug monographs

The Indian Pharmacopoeia Commission has proposed revisions to several drug monographs for inclusion in the Indian Pharmacopoeia, including additional requirements for bacterial endotoxins, sterility and related quality tests. The revisions are important as they seek to strengthen quality standards and testing requirements for pharmaceutical products covered under the pharmacopoeia.

26 August 2026

MedTech

EU-approved medical devices get easier regulatory pathway in India

India's health ministry has included the European Union ("EU")among recognised regulatory jurisdictions under Medical devices rules, 2017. Now, EU-approved medical devices without predicate devices may qualify for a waiver from clinical investigation requirements in India, potentially facilitating faster regulatory approvals and market access.

26 August 2026

Pharmaceuticals

CBN ties with Pharmexcil to regulate controlled substances exports

The Central Bureau of Narcotics (CBN) has signed a Memorandum of Understanding (MoU) with the Pharmaceutical Export Promotion Council for preventing the diversion of controlled substances, particularly Narcotics and Psychotropic Drugs. Under the agreement, the CBN will develop a non-binding voluntary code of Conduct, setting out recommended practices. The two sides will identify and recommend measures to streamline export procedures for compliant exporters.

26 August 2026

Food & Beverages (F&B)

Delhi High court restrains use of ‘SMOOTH’ over similarity with ‘SMOODH’

The Delhi High Court has restrained the use of ‘SMOOTH’ for a dairy-based yogurt drink, finding it prima facie deceptively similar to the registered ‘SMOODH’ trademark. The Court noted potential consumer confusion and prominence of ‘SMOOTH’ on packaging, and granted an interim injunction against its use pending further proceedings.

Open

25 August 2026

Healthcare & Wellness

NMC proposes changes to the National Medical Register

In the recent Draft Registration of Medical Practitioners and License to Practice Medicine (Amendment), Regulations 2026,  the Apex Medical Commission has proposed to include other information, including the active or inactive status of the doctor's license to practice medicine and the details of disciplinary action taken against the doctor (if any) in the NMR. The Commission has invited objections and suggestions from stakeholders within 30 days of the Gazette notification.

25 August 2026

MedTech

Parliamentary panel recommends greater licensing powers for state authorities

A Parliamentary Standing Committee has reportedly recommended decentralising licensing of Class A and B medical devices to State Licensing Authorities (SLAs), with greater autonomy based on quality assessments by QCI-approved notified laboratories. The move aims to strengthen state-level regulation, attract global manufacturers, expand testing infrastructure and improve access to safe medical devices.

Open

25 August 2026

MedTech

Sterilisation licence number made mandatory on medical device labels

The Indian Government has amended the Medical Devices Rules, mandating manufacturers outsourcing sterilisation to mention the sterilisation facility’s licence number on product labels, preceded by “Sterilization Sites Manufacturing License Number”, “Ster. Mfg. Lic. No.” or “S.M.L.” The move strengthens traceability while removing the need for a separate loan licence. Manufacturers get six months to update labels.

25 August 2026

Healthcare & Wellness

Bengaluru authorities penalise Private Medical Facilities Over KPME Violations

Bengaluru authorities have reportedly fined seven private medical establishments for violations of the Karnataka Private Medical Establishments Act, with registration licences of three facilities cancelled. Authorities have also ordered inquiries, warnings and undertakings to strengthen compliance among private healthcare establishments.

25 August 2026

Food & Beverages (F&B)

India’s FSSAI issues over 150 notices to food companies for misleading advertisements

The FSSAI has reportedly issued over 150 notices to major food business operators over misleading advertisements, false claims and labelling non-compliances of its laws and regulations in recent months. Twelve notices were issued to e-commerce companies, with one warehouse licence cancelled, while over 30 notices targeted food service establishments, with five licences suspended. FSSAI has stated that many companies have started taking corrective actions, following notice issued to these companies.

24 August 2026

Pharmaceuticals

Four drugs proposed for inclusion under Schedule H1

India's Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to include Flupentixol, Zopiclone, Gabapentin and Carisoprodol under Schedule H1. Stakeholders may submit objections within 30 days. If finalised, the proposed amendments will take effect within 180 days after publication of the final rules.   

24 August 2026

MedTech

Centre eases medical device rules for sterilisation

The Centre has amended the Medical Devices Rules, 2017 to ease requirements for manufacturers that outsource sterilisation, removing the need for a separate loan licence where the sterilisation facility already holds a valid licence. 

24 August 2026

Pharmaceuticals

Government tightens restrictions on two-drug combinations for children

The Government has restricted the manufacture, sale and distribution of fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, requiring a warning against their use in children below four years. The restriction now covers all formulations containing the two ingredients and follows recommendations from the expert committee and Drugs Technical Advisory Board

24 August 2026

Food & Beverages (F&B)

India extends transition period for mandatory Halal Certification of meat exports to Egypt

The Government has extended the transition period for mandatory India Conformity Assessment Scheme-Halal certification for specified meat and meat products exported to Egypt from six to nine months. The extension provides additional time for Egyptian Halal certification bodies to complete onboarding and accreditation requirements.

19 August 2026

MedTech

Parliamentary Panel seeks better drug pricing data capture in rural and remote regions

A Parliamentary panel has recommended a strategy to improve drug pricing data capture in remote regions through digital initiatives. Better coverage is important to ensure data and strengthen medicine price monitoring, particularly in areas affected by poor connectivity. Authorities may also explore real-time inventory tracking across the supply chain.

Open

19 August 2026

Healthcare & Wellness

National Medical Commission proposes unique identification number for doctors, single licence to practise across India

The National Medical Commission has proposed a unique identification number for every registered doctor, linking state and national records. The proposed system would allow doctors to practise across India without fresh state registration, while centrally tracking licence status, suspensions, cancellations and disciplinary proceedings through an electronically synchronised national register.

19 August 2026

Food & Beverages (F&B)

India’s FSSAI says six food firms fix misleading claims and trademarks after crackdown

FSSAI has reportedly announced that six food business operators took corrective action after receiving regulatory notices for violations. The measures taken included withdrawing misleading "vegan" and "healthy" label claims, halting production of non-standardised products, delisting items from their websites, and changing misleading trademarks. These charges were aimed at ensuring consumer safety and regulatory compliance.

19 August 2026

Traditional Medicines

NCH clarifies limits on cross-practice by homoeopathic practitioners

The Indian National Commission for Homoeopathy has clarified that homoeopathic practitioners cannot practice other systems of medicine, but may participate in government health programmes after completing training recognised by the competent government authority. The clarification comes amid ongoing controversy in Maharashtra over allowing BHMS doctors with additional pharmacology training to practise modern medicine.

Open

19 August 2026

Healthcare & Wellness

NMC proposes centralised tracking of doctors’ disciplinary records

The National Medical Commission has proposed linking the National Medical Register with State Medical Registers to centrally track doctors’ licence status, suspensions, removals and other disciplinary actions pursuant to draft Registration of Medical Practitioners and Licence to Practice Medicine (Amendment) Regulations, 2026,. The proposed system aims to ensure that disciplinary action taken in one State is visible nationally and cannot be circumvented by practising elsewhere. 

18 August 2026

Healthcare & Wellness

Government tightens standards for India’s cosmetology sector

India’s Health Ministry has reportedly issued binding standards for the cosmetology clinics requiring them to be operated by registered dermatologists or plastic surgeons. Botox, fillers and chemical peels are classified as Level 1 procedures, while ablative lasers and surgeries face stricter infrastructure requirements.

18 August 2026

Food & Beverages (F&B)

Government weighs new incentive framework for India's nutraceuticals sector

Government is developing a new incentive framework for India's nutraceuticals sector, consulting the food processing ministry, health ministry and Food Safety and Standards Authority of India (FSSAI). Government  may instead of a separate production-linked incentive (PLI) scheme, the government is reviewing lessons from the existing food-processing PLI before finalizing the framework.

18 August 2026

Food & Beverages (F&B)

CAG flags failure to penalise food businesses for annual return defaults

A Comptroller and Auditor General audit reportedly found that the Food Safety and Standards Authority of India failed to impose crores of penalties on thousands of food businesses for non-filing or delayed filing of mandatory annual returns between 2017–18 and 2022–23. None had their licences suspended or cancelled as of August 2023.

18 August 2026

Animal Health & Wildlife

Digital record, penalties in new rules for contagious diseases in animals

The Government of India has proposed new regulations, The Prevention and Control of Infectious and Contagious Diseases in Animals Rules, 2026, for the prevention and control of infectious and contagious diseases in animals. The new draft expands on the rules established previously and emphasizes enhanced surveillance, timely reporting, and penalties for individuals who fail to report a contagious disease in cattle within a specified time frame.

18 August 2026

Controlled Substances

Supreme Court tightens bail verifications for foreign nationals in NDPS cases

The Supreme Court has issued 13 binding directions to strengthen bail and surety verification for foreign nationals accused in commercial quantity NDPS cases. The directions follow concerns over fake sureties and accused persons absconding after bail. Courts must now verify sureties, addresses and financial details more strictly before releasing such accused.

17 August 2026

Healthcare & Wellness

NHAI tightens service standards for ambulances on national highways

India National Highway Authority, NHAI has reportedly introduced stricter service standards for ambulances on national highways, requiring arrival at accident sites within 10 minutes for incidents within 10 km and hospital transport within one hour. The ambulances must also maintain prescribed medical equipment, medicines and trained personnel, with performance monitored through GPS and NHAI’s dashboard. 

17 August 2026

MedTech

Parliamentary Panel recommends statutory price capping for unregulated medical devices

A parliamentary committee has proposed a new framework to bring unregulated medical devices under statutory price capping. This step is critical to reduce exorbitant out-of-pocket patient expenses and control wide price variations in essential medical implants. Under the proposed system, high-priority devices will face immediate maximum retail price ceilings or restricted trade margins.

17 August 2026

Cosmetics

Delhi high court allows limited sale of existing stock amid packaging dispute

The Delhi High Court has allowed a leading consumer goods company to sell existing stock of a cooling hair oil until September 30 amid a trade dress dispute with a competing personal care company. The Court retained the injunction, restricting sales to physical outlets, requiring e-commerce listings removal and recalling unsold stock. 

17 August 2026

Healthcare & Wellness

NCH clarifies rules on Homoeopathic practitioners practising other systems of medicine

The National Commission for Homoeopathy has clarified that Homoeopathic practitioners cannot practise other systems of medicine under Regulation 36(y) of the 2022 Code of Ethics. However, they may do so under National Health Programmes or government programmes where they have completed training or courses recognised by the competent authority. The clarification provides greater regulatory certainty on the circumstances in which Homoeopathic practitioners may participate in government health programmes involving other systems of medicine.

Open

14 August 2026

MedTech

ICMR and CDSCO propose standard evaluation protocols for Scrub Typhus IgM Rapid Diagnostic Tests and Enzyme-Linked Immunosorbent Assays

The Indian Council of Medical Research and Central Drugs Standard Control Organization have proposed standard protocols for evaluating Scrub Typhus IgM rapid diagnostic tests and enzyme-linked immunosorbent assays. The protocols aim to establish consistent requirements for assessing diagnostic accuracy, reliability and performance in India.

14 August 2026

Healthcare & Wellness

Parliamentary panel calls for comprehensive national strategy on chronic kidney disease

A parliamentary standing committee has urged the Health Ministry to develop a comprehensive national strategy for chronic kidney disease, focusing on prevention, early detection, treatment and long-term care. It flagged severe shortages of nephrologists, urologists and trained dialysis technicians, recommending stronger primary healthcare and trained physicians to supervise dialysis units.  

14 August 2026

Food & Beverages (F&B)

India’s FSSAI warns content creators against endorsing unverified food claims

FSSAI has cautioned influencers and celebrities against promoting food products with unverified or misleading health claims, such as "boosts immunity." The Regulator stressed that the products to be endorsed must have claims that are truthful, verified and comply with laws must be verified by the content creators else these violations could invite action under the Food Safety and Standards Act, 2006, and the Advertising and Claims Regulations, 2018.

14 August 2026

Environment & Waste Management

FSSAI seizes liquor boxes over recycled plastic labelling violations

The Food Safety and Standards Authority of India has reportedly seized around 18,000 boxes of liquor bottles in Bengaluru after finding that PET bottles lacked mandatory markings indicating that the recycled plastic was suitable for food contact. The action highlights increased regulatory scrutiny of recycled plastic packaging and labelling compliance.

14 August 2026

MedTech

Medical device industry opposes draft Drugs, Medical Devices and Cosmetics Bill, 2026

Medical device companies, patient safety groups and healthcare providers have opposed the draft Bill, arguing that medical devices are fundamentally different from pharmaceuticals and require a distinct regulatory framework. Stakeholders have warned that treating devices like medicines could increase compliance burdens and adversely affect manufacturing, innovation and access to advanced technologies.

13 August 2026

Pharmaceuticals

CDSCO flags unauthorised manufacture and marketing of enclomiphene products

India's central drug authority, CDSCO, has directed State and Union Territory drug regulators to identify and take action against manufacturers and marketers of unapproved drug products containing Enclomiphene and its combinations. The regulator has reiterated that such products cannot be manufactured or marketed without the required regulatory approval, reinforcing compliance under India’s drug regulatory framework.

13 August 2026

Food & Beverages (F&B)

India's High Court upholds cancellation of factory zone over processing unit delay

The Telangana High Court dismissed an appeal against cancellation of an oil palm factory zone allotment, holding that the allottee had failed to establish a processing unit within the stipulated 24-month period despite repeated opportunities. Observing unsatisfactory plantation performance and rejecting reliance on belated compliance steps, the Court ruled that continued non-compliance meant the Company could not expect the allotment to carry on indefinitely.

13 August 2026

Hospitals

Consumer Commission holds hospital liable for deficient maternity care package

A District Consumer Commission has held a hospital liable for deficiency in service after finding unhygienic amenities and contaminated food were provided to patient recovering from a Caesarean delivery under a maternity care package. The ruling underscores that hospitals must maintain promised standards of hygiene and patient care.

13 August 2026

Healthcare & Wellness

Supreme Court to issue guidelines for hospitals on providing medical care to crime victims

The Supreme Court will reportedly frame comprehensive guidelines for hospitals on providing medical assistance to crime victims. The proposed guidelines are expected to ensure timely treatment, protect victims’ rights, and clarify hospitals’ responsibilities, with the Court likely to issue detailed directions following further consideration.

13 August 2026

Pharmaceuticals

Pharmacy trade bodies push action against misleading discount hoardings

Following a Kerala High Court ruling upholding regulatory action against deceptive discount displays at medical shops, pharmacy trade bodies in several states are advocating stricter enforcement against misleading price hoardings. The Delhi-based RDCA has advised retailers to remove exaggerated discount claims, ensure authorised sourcing and maintain transparency in retail pricing and invoices.

Open

12 August 2026

Hospitals

Centre defends Clinical Establishments framework before Supreme Court

The Minister of Health & Family Welfare has defended the Clinical Establishments framework before the Supreme Court, stating that regulation of clinical establishments and standardisation of treatment charges are necessary to curb excessive pricing of medical services and protect patients. The matter raises important questions on the extent of government authority to regulate pricing in private healthcare establishments.

12 August 2026

Hospitals

Centre defends constitutional validity of uniform healthcare rate rule

The Centre has informed the Supreme Court that the rule requiring private hospitals to charge within government-determined rate ranges is constitutionally valid, although the rates have not yet been finalised due to a lack of consensus among States. The framework could reduce variations in hospital charges and improve transparency for patients.

12 August 2026

Pharmaceuticals

CDSCO clarifies processing of applications for unapproved new drugs undergoing global clinical trials with Indian subjects

CDSCO has clarified that applications for permission to import and market new drugs not approved anywhere in the world, where Phase III Global Clinical Trials (GCTs) are ongoing or completed with Indian subjects, must be processed by its Investigational New Drug (IND) Division. Applicants are required to submit such applications to CDSCO Headquarters, New Delhi, under the NDCT Rules, 2019.

12 August 2026

Healthcare & Wellness

Parliamentary panel recommends national framework for healthcare public-private partnerships

A parliamentary committee has reportedly endorsed Punjab’s public-private partnership model for subsidised diagnostic services, citing its potential to reduce healthcare costs. It recommended a standardised national framework enabling states to outsource high-cost diagnostic and dialysis services at capped rates, improving affordability and access to quality healthcare.

12 August 2026

MedTech

India’s ICMR-CDSCO invite public comments on scrub typhus IVD evaluation protocols

ICMR and CDSCO have jointly drafted performance evaluation protocols for Scrub Typhus IgM ELISA and RDT kits under the Medical Devices Rules, 2017. Stakeholders can submit comments to ivdevaluation@gmail.com until 25th August 2026, after which the protocols will be finalized with minimal scope for further changes.

11 August 2026

Food & Beverages (F&B)

FSSAI tightens packaging rules for pan masala, bans plastic and aluminium-based materials

The Food Safety and Standards Authority of India has amended the Food Safety and Standards (Packaging) Regulations, 2018, prescribing specific packaging requirements for pan masala. Permitted materials include plastic-free paper, paper board and naturally derived materials, as well as tin or glass containers. Aluminium foil, metallised layers and synthetic polymers are prohibited.

11 August 2026

Pharmaceuticals

Medical device industry opposes proposed legislation treating devices on par with pharmaceuticals

Medical device companies are raising concerns over a proposed bill that could bring medical devices within a regulatory framework similar to pharmaceutical products. Industry stakeholders argue that devices differ fundamentally from medicines in terms of technology, manufacturing, risk classification and lifecycle, and therefore require a distinct regulatory approach. The development could have significant implications for India’s medical-device regulatory framework and compliance requirements.

11 August 2026

Food & Beverages (F&B)

FSSAI proposes stricter thresholds to define high fat, sugar and salt foods in schools

The Food Safety and Standards Authority of India (FSSAI) has issued draft amendments to the Food Safety and Standards (Safe Food and Balanced Diets for Children in School) Regulations, 2020. The proposal introduces ICMR Dietary Guidelines 2024 thresholds for identifying foods high in added fat, added sugar and salt in school settings.

11 August 2026

Pharmaceuticals

CBI probes alleged bribery linked to CDSCO regulatory clearances

The Central Bureau of Investigation has registered a case involving a CDSCO official and a pharma executive over alleged bribery linked to regulatory clearances. The investigation may lead to increased scrutiny of interactions between regulatory officials and applicants during the processing of drug-related clearances.

11 August 2026

Pharmaceuticals

CDSCO widens the applicability of Form 29 test licence for drugs

CDSCO under the Drugs Rules, 1945 issues an amendment for the requirement for obtaining a Form 29 licence for manufacturing drugs for examination, test or analysis. The proposed amendment expands the existing reference to manufacturing licences to cover specified categories under Forms 25A, 25F, 28A, 28B, 28D, 28DA, 28E and 28F, bringing greater clarity to Form 29 requirements for these licence holders.  

10 August 2026

Food & Beverages (F&B)

FSSAI weighs nutrition table over front-of-pack warning labels

India's central food authority, FSSAI is reportedly considering a nutrition-table approach instead of mandatory front-of-pack warning labels for packaged foods high in sugar, salt and fat. The proposal has drawn concern from public-health experts, who argue that consumers may struggle to interpret detailed nutritional information. The issue remains under consideration following Supreme Court intervention.

10 August 2026

Environment & Waste Management

CPCB to Act against biomedical waste deep-burial violations across 17 States, UTs

The Central Pollution Control Board (CPCB) has informed the National Green Tribunal that it will take action against States and Union Territories failing to comply with biomedical waste deep-burial requirements. The CPCB has issued communications to concerned authorities, with further enforcement action proposed if compliance is not achieved within eight weeks.

10 August 2026

Pharmaceuticals

India’s Maharashtra FDA issues compliance order for blood centres to ensure safety standards

Maharashtra FDA has issued a comprehensive compliance order for all licensed blood centres, mandating strict adherence to the Drugs & Cosmetics Act, 1940 and Rules, 1945, including Schedule F Part XII-B norms. It covers testing, storage, donor criteria, e-RaktKosh reporting, and warns of strict legal action against non-compliant centres.

Open

10 August 2026

Clinical Trials

CDSCO seeks stakeholder inputs on single Ethics Committee review for multi-centre research

CDSCO has invited stakeholder comments on proposed operational guidelines for a single Ethics Committee review of multi-centre research in India. The initiative seeks to streamline ethics review across multiple research sites while maintaining appropriate ethical oversight and participant protection, potentially reducing duplication and delays in multi-centre studies.

10 August 2026

Food & Beverages (F&B)

Delhi High Court gives temporary relief over ‘100 Per Cent’ food claims

The Delhi High Court has reportedly temporarily stayed the food regulator’s order stopping a major Indian consumer goods company from selling food products carrying “100 per cent” claims. The company argued that it was not given prior notice or an opportunity to present its case.

7 August 2026

Healthcare & Wellness

West Bengal health department bars 11 blood banks from organising donation camps amid regulatory probe

West Bengal health department has reportedly barred 11 blood banks from organising blood donation camps pending an investigation into alleged regulatory violations, including unauthorised camps and suspected illegal transfer of blood components. The affected facilities may continue accepting voluntary walk-in donations but require prior approval for large intra-state blood transfers.

7 August 2026

Food & Beverages (F&B)

India’s Maharashtra bans analogue paneer for a year, citing health risk

Maharashtra's FDA Commissioner has banned manufacture, storage, distribution and sale of analogue/non-dairy paneer statewide for one year under Section 30(2)(a) of the Food Safety and Standards Act, 2006. Food service establishments must not use, prepare, serve, store, sell, or present analogue/non-dairy paneer as genuine paneer, as doing so is misleading to consumers and constitutes an unfair trade practice. Any contravention of this Order shall be punishable under the applicable penal provisions of the FSS Act, 2006.

7 August 2026

Pharmaceuticals

Review of cost-based drug pricing framework recommended by Parliamentary Panel

A Parliamentary Committee has reportedly recommended examining the feasibility of reintroducing a cost-based pricing mechanism for medicines through statutory amendments where significant price disparities or excessive mark-ups are observed. The recommendation seeks to address pricing distortions that may not be captured under the existing market-based pricing framework.

Open

7 August 2026

Pharmaceuticals

Sterile injectable antibiotic recalled following particulate contamination

A lot of a sterile injectable antibiotic has been voluntarily recalled after particulate matter, identified as cardboard, was detected in the infusion solution. The contamination poses risks including vascular occlusion, immune reactions and organ damage if administered intravenously, underscoring the importance of stringent manufacturing quality controls and post-market surveillance.

7 August 2026

Healthcare & Wellness

NITI Aayog proposes national caregiving policy and regulatory council

NITI Aayog has proposed a National Policy on Caregiving, including a National Caregiver Council to accredit caregivers, standardise training and regulate the sector. It also recommended a dedicated caregiver cadre and digital portal. The move aims to professionalise care services, create skilled employment, boost women’s workforce participation and support India’s growing elderly population.

4 August 2026

Food & Beverages (F&B)

Bombay High Court to review FSSAI's action on labelling practices

A manufacturer has reportedly challenged the Food Safety and Standards Authority of India before the Bombay High Court against its order restricting sales of a rum product over alleged labelling violations. The company maintains its labels comply with regulations and industry practice, while describing the dispute as an industry-wide regulatory issue.

4 August 2026

Food & Beverages (F&B)

Bombay High Court questions Maharashtra FDA over closure of four star hotel

The Bombay High Court criticised the Maharashtra FDA for suspending the food business licence of a four star hotel over the discovery of two insects, observing that the action appeared disproportionate in light of an otherwise satisfactory inspection report. The Court emphasised that regulatory enforcement must be fair, consistent and proportionate, and set aside the suspension order.

4 August 2026

MedTech

India proposes to build national patient safety framework for dental implants

India's central government is reportedly considering a comprehensive national regulatory and patient safety framework for dental implants, implant biomaterials, artificial teeth and related implant systems. The proposed framework aims to strengthen regulatory oversight, improve quality and safety standards, and ensure greater accountability across the dental implant ecosystem amid rising adoption in India.

4 August 2026

Controlled Substances

Delhi Court orders framing of charges in codeine syrup seizure case

A Delhi court has ordered that charges be framed in a case involving the alleged illegal possession and seizure of codeine-based cough syrup under narcotics law, finding sufficient grounds to proceed to trial. The order clears the way for formal prosecution and further judicial proceedings in the matter.

4 August 2026

Electronics

India proposes first regulatory framework for two-wheeled road ambulances

The Ministry of Road Transport and Highways has proposed additions of two-wheeled road ambulances Central Motor Vehicles Rules, 1989 to provide emergency response in rural, remote and hilly terrain. The draft introduces uniform safety, construction, registration, and fitness standards to strengthen last-mile emergency medical response. The draft has been opened for a 30-day public consultation period, after which the rules will be finalized.

3 August 2026

Pharmaceuticals

Indian major drug manufacturer recalls eye drops in India following contamination concerns

India's major manufacturer of eye drops has reportedly voluntarily recalled a batch of eye drops in India after contamination concerns were identified during quality checks. The company initiated the recall as a precautionary measure, informed the concerned authorities, and advised distributors to withdraw the affected batch while reiterating its commitment to patient safety and product quality.

3 August 2026

Pharmaceuticals

Parliamentary Panel asks Department of Pharmaceuticals to regulate price of trade generics medicines

A parliamentary panel has recommended that the Department of Pharmaceuticals regulate prices of trade generic medicines distributed through separate marketing channels, citing concerns over excessive markups and affordability in rural and remote markets. If implemented, the proposal could improve access to reasonably priced medicines through greater pricing oversight.

Open

3 August 2026

Food & Beverages (F&B)

India’s FSSAI takes action against three firms for major food safety violations

FSSAI has reportedly intensified enforcement against three food businesses and has ordered recall of raisins for excessive pesticide residues; suspended Pharmaceuticals’ manufacturing licence over critical compliance failures and prohibition order for marketing as a food supplement with misleading claims of folic acid syrup and non-compliance of FSSAI Regulations, 2016. These actions were taken to protect consumers and warned of strict consequences for violations.

3 August 2026

Pharmaceuticals

Centre to launch Integrated Digital Drug Regulatory System within eighteen months

The Central Drugs Standard Control Organisation will launch the first phase of the Digital Drug Regulatory System within eighteen months. The integrated online platform will simplify regulatory approvals, improve transparency, strengthen medicine traceability, use artificial intelligence for faster processing, and help pharmaceutical companies meet compliance requirements through a single digital window.

3 August 2026

Pharmaceuticals

Maharashtra FDA to seek NPPA action against overpriced medicines

The Maharashtra Food and Drug Administration (FDA) has identified several medicines allegedly being sold at excessive prices and plans to refer these cases to the National Pharmaceutical Pricing Authority (NPPA) for regulatory action. The FDA has also indicated that it will intensify surveillance of drug pricing and investigate instances of unreasonable mark-ups to strengthen compliance with pricing regulations.

3 July 2026

Pharmaceuticals

Drugs Rules amended to include cell therapies, gene therapeutics and xenografts

The Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945, expanding their scope to expressly cover cell or stem cell-derived products, gene therapeutic products, and xenografts alongside recombinant DNA (r-DNA) derived drugs. The amendments take effect from the date of publication in the Official Gazette. 

3 July 2026

Pharmaceuticals

Department of Pharmaceuticals Enhances DPCO Record-Keeping Requirements

The Department of Pharmaceuticals has strengthened record-keeping requirements under the Drugs (Prices Control) Order, 2013. Manufacturers must maintain records relating to APIs, bulk drugs, formulations, and other prescribed information for at least seven financial years, with records retained until the conclusion of any pending proceedings, if any.

3 July 2026

Pharmaceuticals

Government Plans Comprehensive Audit of Drug Approvals to Strengthen Regulatory Oversight

India's Central Drugs Standard Control Organisation (CDSCO) is undertaking a nationwide reconciliation exercise to identify and authenticate missing drug approvals from 1945, including legacy products approved by State Licensing Authorities (SLA) before 1988. Manufacturers will be required to submit historical approval records to help create a comprehensive national repository, address gaps in the CDSCO approval database, improve regulatory oversight, and verify that older formulations comply with current safety and efficacy standards. 

3 July 2026

Food & Beverages (F&B)

FSSAI issues notices over misleading energy drink claims

The Food Safety and Standards Authority of India (FSSAI) has issued notices to six beverage manufacturers over the use of the term "energy drink" and related misbranding and misleading claims. The regulator observed that there is currently no notified standard for products classified as "energy drinks" under the Food Safety and Standards framework, and objected to promotional claims suggesting functional or therapeutic benefits, such as boosting energy or enhancing focus. The action reinforces FSSAI's ongoing efforts to ensure compliance with food labelling and advertising regulations and to prevent misleading claims that may deceive consumers. 

3 July 2026

Pharmaceuticals

Overcharging liability under DPCO revised under The Drugs Prices Control Order, 2013

The Department of Pharmaceuticals has clarified the framework governing overcharging liability under the Drugs (Prices Control) Order, 2013. Manufacturers demonstrating compliance with prescribed price communication requirements will have their liability restricted to the quantity of stock actually overcharged by distributors or retailers, providing greater regulatory certainty.

3 July 2026

Pharmaceuticals

Separate pricing for Drug variants permitted by Department of Pharmaceuticals

The Department of Pharmaceuticals has amended the Drugs (Prices Control) Order, 2013 to permit separate ceiling or retail prices for therapeutically justified variants of the same drug. The amendment recognizes differences in packaging, pack size, dosage compliance, and dosage form while determining regulated prices.

 

3 July 2026

Hospitals

Alleged ₹600 crore procurement irregularities surface in Delhi health department

India's Delhi Anti-Corruption Branch (ACB) reports have alleged ₹600 crore procurement scam involving the directorate general of health services (DGHS) and the central procurement agency (CPA). The scam includes claims of changing tender rules, using fake companies, and raising prices for medical supplies. Items like X-ray machines, bedsheets, and ORS sachets were bought at much higher prices than usual. Three officials have been arrested, and the investigation continues to uncover more information. 

3 July 2026

Pharmaceuticals

Form IA for New Drug launches introduced by Department of Pharmaceuticals

The Department of Pharmaceuticals has amended the Drugs (Prices Control) Order, 2013 to introduce Form IA for intimating new drug launches. The amendment simplifies the launch process for existing manufacturers by replacing the requirement for fresh retail price approval with a post-launch intimation within one month.

Join our 1500+ subscribers to get our daily Health Laws and Policy Updates.