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Govt eases BA-BE study norms

By Sohail Khan 18 September 2026, 11:54 pm

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Business News›Industry›Healthcare/Biotech›Pharmaceuticals›Government to ease BA-BE study norms for domestic generic drug approvals, cut import licence timelines

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Government to ease BA-BE study norms for domestic generic drug approvals, cut import licence timelines
Synopsis

Pharmaceutical companies will soon find it easier to conduct drug studies. Applicants can start eligible trials after intimating the drug regulator. This change aims to speed up the launch of generic drugs locally. Import licence applications for new drugs will also see reduced processing times. These measures are part of efforts to improve ease of doing business.

India's government plans to streamline drug approval processes for domestic use. Applicants can now start studies after intimating the drug regulator. — Govt to ease norms for BA-BE studies

New Delhi: The government will soon make it easier for pharmaceutical companies to conduct bioavailability and bioequivalence (BA-BE) studies for domestic drug approvals, allowing applicants to start eligible trials after intimating the drug regulator instead of seeking its prior permission, people familiar with the matter told ET.

BA-BE studies are critical components of the process to approve generic drugs. They are used to prove that the generic version acts exactly the same way in the body as the original drug.

Also read: Drugs Panel to weigh bringing all sterile drug products under central licensing amid contamination concerns

By giving prior intimation of a study, the drug maker alerts the regulatory agency about its application but doesn't have to wait for the formal clearance, effectively making it faster to launch a copycat drug in the local market. The current system requires drug makers to file an application and wait in queue for clearance, which may take several months.

The Drugs Technical Advisory Board, at its recent meeting, recommended extending the prior-intimation system introduced earlier this year for BA-BE studies conducted for export purposes to domestic approvals as well, to ensure a "level playing field".

The government is also looking to halve the timeline for processing formal import licence applications for new drugs and reference products intended for analytical and non-clinical testing, reducing it from 90 working days to 45 working days, as part of efforts to improve ease of doing business, people familiar with the matter said.

For high-risk categories, however, the existing formal licence requirement will continue to apply, one of the people said.

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