India To Ease Clinical Trial Rules To Attract Global Pharma, Cut Red Tape, And Speed Up Drug Approvals

The Union Health Ministry has proposed key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 to simplify licensing procedures and accelerate the pace of pharmaceutical research in India.

Published in the Gazette of India on 28 August , the draft amendments are open for public comments.

The reforms are aligned with the directions of Prime Minister Narendra Modi towards reducing the regulatory compliance and towards promoting ease of doing business in the pharmaceutical and clinical research sectors, the Health Ministry said in a statement on Wednesday (3 September).

Major Changes Proposed

• Test Licence Applications: The current licensing system will be replaced with a notification/intimation model. Except for high-risk drugs, companies will no longer need to wait for formal test licences. The statutory processing period will also be halved from 90 days to 45 days.

• BA/BE Study Applications: For certain categories of Bioavailability/Bioequivalence (BA/BE) studies, the licence requirement will be scrapped. Instead, researchers will be able to initiate studies by simply notifying the Central Licensing Authority

Expected Benefits

According to the ministry, these regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications.

The changes could cut licence applications by nearly 50 per cent, enabling faster drug testing, research, and approval.

The move will also help the Central Drugs Standard Control Organisation (CDSCO) optimise manpower and improve regulatory efficiency.

Industry Impact

The ministry expects these reforms to strengthen India’s appeal as a global hub for clinical trials and pharmaceutical development.

By aligning domestic rules with global best practices, the government aims to boost growth in the Indian pharma industry and attract more international research investments.

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