# India eases drug approval rules for generic manufacturers

> New regulations will speed up bioequivalence studies and cut import licence processing times in half.
- Title: India eases drug approval rules for generic manufacturers
- Summary: New regulations will speed up bioequivalence studies and cut import licence processing times in half. India is streamlining generic drug approvals by…
- Keywords: india, generic drugs, pharmaceutical regulations, ba-be studies, bioavailability, bioequivalence, drug approvals, drugs technical advisory board, import licences, clinical trials, eases, drug
- Source: The Economic Times — https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/government-to-ease-ba-be-study-norms-for-domestic-generic-drug-approvals-cut-import-licence-timelines/articleshow/134342263.cms
- Author: Teena Thacker
- Published: 2026-09-18T18:24:00+00:00
- Read time: 1 min
- Topics: india, generic drugs, pharmaceutical regulations, ba-be studies, bioavailability, bioequivalence, drug approvals, drugs technical advisory board, import licences, clinical trials
## 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.
## Key takeaway

India is streamlining generic drug approvals by allowing companies to start bioequivalence studies with just prior notice instead of waiting for formal clearance.