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New norms for faster drug rollout proposed

By Sohail Khan 15 September 2026, 1:15 am

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Business News›Industry›Healthcare/Biotech›Pharmaceuticals›Centre proposes easier norms for faster drug rollout

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Centre proposes easier norms for faster drug rollout
Synopsis

India's government plans to streamline drug approval processes for domestic use. Applicants can now start studies after intimating the drug regulator. Import license processing timelines for new drugs will be halved to forty-five days. This move aims to improve the ease of doing business in the sector. However, certain high-risk drug categories will retain existing stringent requirements.

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Centre proposes easier norms for faster grug rollout pharma medicines

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.

Also read: New TB vaccines expected from 2029 could prevent 7.3 million deaths by 2050, Gavi says

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.

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