Govt Proposes Easier Norms to Speed Up Drug Rollout
What Happened
The Centre has proposed easing regulatory requirements for drug approvals by allowing eligible bioavailability and bioequivalence (BA/BE) studies to begin after merely informing the regulator, instead of obtaining prior approval. It has also proposed reducing the processing time for certain import licences used in drug testing from 90 days to 45 days. The proposals will be considered by the Drugs Technical Advisory Board (DTAB).
Key Takeaways
The move is aimed at improving ease of doing business and helping generic medicines reach patients faster. However, stricter rules will continue for high-risk categories such as vaccines, cell and gene therapies, narcotic and psychotropic drugs, and certain biologics.