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.