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.