India's Pharma Reforms Target Global Credibility

The Indian government has introduced several measures to simplify drug approvals and support innovation. Key reforms include updating the New Drug and Clinical Trial Rules (2019) and using digital platforms to handle regulatory submissions, with the goal of improving transparency, reducing approval timelines, strengthening pharmacovigilance, and maintaining quality standards. What do these reforms entail, how is the industry responding, and what steps lie ahead to make India's pharmaceutical sector globally competitive? Let's find out.

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On August 28, 2025, in accordance 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 Union Health Ministry published the proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, in the Gazette of India, seeking public comments. The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies.

The key highlights of the proposed amendments include significant changes to the licensing process. For test licence applications, the existing licence system is being transitioned to a simpler notification or intimation mechanism. This means that, except for a limited category of high-risk drugs, applicants will no longer be required to wait for a formal test licence; instead, they can proceed after intimating the Central Licensing Authority. Furthermore, the statutory processing time for test licence applications will be reduced from 90 days to 45 days. Similarly, for bioavailability/bioequivalence (BA/BE) study applications, the current licence requirement will be dispensed with for certain categories of studies.

These may be initiated on the basis of an intimation or notification to the Central Licensing Authority, thereby streamlining the approval process and facilitating faster study initiation.

The reforms are expected to cut application processing times, potentially halving the number of license applications and enabling faster initiation of BA/BE studies, drug testing, and approvals.