Centre proposes easier norms for faster drug rollout

New Delhi: The government is looking to simplify the regulatory process for bioavailability and bioequivalence (BA/BE) studies for domestic drug approvals, allowing applicants to start eligible studies after intimating the drug regulator instead of requiring its prior permission.

The proposal has been placed for deliberation before the Drugs Technical Advisory Board (DTAB) slated to happen this month, people familiar with the matter told ET.

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A similar prior intimation mechanism was earlier introduced for specified BA/BE studies conducted for export purposes.

The government is also moving to halve the timeline for processing formal import licence applications under Form CT-17 for new drugs and reference products for analytical and non-clinical testing from 90 working days to 45 working days, as part of the efforts to improve the ease of doing business, the people said.

The health ministry had 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 earlier gazette notification to ease of doing business and rationalise the workforce, a government document said.

"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," it said.

ET has seen a copy of the document.

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Bioequivalence studies are a critical step in the generic drug approval process in India. Any reduction in the time will have a direct impact on how quickly affordable generic versions of medicines can reach patients.

Sex hormones, psychotropic drugs left out. The prior intimation system will not be available for all drug categories though.

The proposal excludes sex hormones, cytotoxic drugs, beta-lactam antibiotics, vaccines, cell and gene therapy products, biologics with live microorganisms, and narcotics and psychotropic drugs.

"For these high-risk categories, the existing formal licence requirement will continue to apply reflecting the higher regulatory scrutiny these products demand before they can be imported and tested," one of the persons cited above said.