From The Economic Times · Teena Thacker · · 1m 10s
India eases drug approval rules for generic manufacturers
New regulations will speed up bioequivalence studies and cut import licence processing times in half.
In brief
New regulations will speed up bioequivalence studies and cut import licence processing times in half. India is streamlining generic drug approvals by allowing companies to start bioequivalence studies with just prior notice instead of waiting for formal clearance. Originally reported by The Economic Times.
Faster approval for generic drugs
India will let pharma companies start bioavailability and bioequivalence studies after notifying regulators, instead of waiting for prior permission.
What BA-BE studies prove
These studies are critical for generic drug approval. They prove the generic version acts exactly the same way in the body as the original drug.
The old system caused delays
Currently, drug makers must file applications and wait in queue for clearance, which can take several months.
Creating a level playing field
The Drugs Technical Advisory Board recommended extending the prior-intimation system already used for export studies to domestic approvals too.
Import licences cut in half
Processing time for import licences for new drugs and reference products will drop from 90 working days to 45 working days.
High-risk drugs still need approval
For high-risk categories, the existing formal licence requirement will continue to apply as before.
The big picture
India is streamlining generic drug approvals by allowing companies to start bioequivalence studies with just prior notice instead of waiting for formal clearance.
