Centre proposes easier norms for faster drug rollout
The government proposed simplifying the regulatory process for bioavailability and bioequivalence (BA/BE) studies for domestic drug approvals, letting applicants begin eligible studies after merely intimating the drug regulator instead of seeking prior permission. The proposal goes before the Drugs Technical Advisory Board (DTAB). The Centre also plans to halve the processing timeline for Form CT-17 import licences from 90 to 45 working days.
Nabka Insight
Regulatory easing for BA/BE studies aims to speed drug approvals and improve ease of doing business.
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- Eligible BA/BE studies can start after intimation, not prior permission
- Proposal placed before the Drugs Technical Advisory Board (DTAB)
- Form CT-17 import licence timeline to be cut from 90 to 45 working days
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