CDSCO sets rejection deadline for pending drug applications
Drug applicants must clear CDSCO queries or lose filings and fees
Change
CDSCO set a 30-day rejection deadline for long-pending SUGAM drug applications that have already received three query-response reminders.
Why it matters
Pending drug applications now move to rejection once CDSCO's reminder cycle is exhausted. The mechanism covers Global Clinical Trial, Bioavailability/Bioequivalence, Ethics Committee, and Veterinary divisions. Non-response ends the filing and forfeits the fee, forcing applicants to restart through a fresh application.
Implications
- — Regulatory affairs teams with GCT, BABE, Ethics Committee, or Veterinary applications already through CDSCO's three-reminder cycle must clear pending SUGAM queries by the 30-day cutoff — non-response triggers rejection and fee forfeiture.
- — Clinical trial sponsors and contract research organisations managing CDSCO filings must keep SUGAM query-response ownership current — missed reminders now move inactive applications into final disposal.
- — Generic drug and biosimilar regulatory teams with BA/BE filings must prioritise pending query responses — rejection forfeits the fee and forces a fresh application.
Who is affected
- — Regulatory affairs teams with pending CDSCO applications
- — Clinical trial sponsors and contract research organisations managing CDSCO filings
- — Generic drug and biosimilar regulatory teams with BA/BE filings
What to watch
- — Deadline: 3 June 2026 — applications already through the three-reminder process face rejection and fee forfeiture