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.

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