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

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.

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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.

The health ministry earlier asked the drug regulatory authority to examine Rules 67, 68, 69 and 70 of the New Drugs and Clinical Trials Rules, 2019, in line with an earlier gazette notification aimed at easing doing business and rationalising the regulatory workforce, according to a government document seen by ET. These rules govern the import of drugs, new or investigational, for clinical trials, BA-BE studies, other tests or analysis.

"At present, licences are required for the import of new drugs for the purpose of test and evaluation, and the prescribed timeline for processing such applications is 90 days," according to the document.