India cuts drug approval timelines and removes pre-clinical approval requirement
Drug approvals must complete within 120–150 days
Change
India reduced clinical trial approval timelines to 120–135 days, capped marketing approvals at 150 days and removed mandatory pre-clinical approval.
Why it matters
Regulatory timelines compress significantly, requiring faster dossier preparation and shifting compliance checks into later stages.
Implications
- — Approval timelines shorten — faster market entry
- — Compliance shifts to later stages — regulatory risk redistributes
Who is affected
- — Pharma companies
- — Regulatory teams
What to watch
- — Impact on drug approval volumes