The Union Ministry of Health and Family Welfare has notified major amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. The main purpose of these changes is to reduce regulatory burden and improve the Ease of Doing Business in India’s pharmaceutical sector. The move follows the government’s trust-based reform approach to support faster drug research and development while protecting public health.

The amendments simplify approvals, shorten timelines, and make clinical research easier nationwide. Experts expect these steps will help India become a global hub for pharmaceutical research.

Test Licence Rules Simplified for Faster Drug Research

Earlier, companies needed a test licence from the Central Drugs Standard Control Organisation (CDSCO) to manufacture small quantities of drugs for research or testing. The amended NDCT Rules replace this licence with a prior-intimation system for non-commercial drug manufacture.

Under this system, companies can begin work after submitting an online intimation to CDSCO. Only high-risk drugs such as cytotoxic drugs, narcotic drugs, and psychotropic substances still require approval. This change alone can save at least 90 days in the drug development process.

For cases where a test licence remains mandatory, the statutory processing time has been reduced from 90 days to 45 days, cutting delays and paperwork.

Low-Risk BA/BE Studies Get Faster Clearance

The amendments also remove the need for prior permission for selected low-risk Bioavailability and Bioequivalence (BA/BE) studies. These studies help confirm that generic drugs work the same as branded ones.

Now, companies can start such studies by submitting a simple online intimation to CDSCO. This change will primarily benefit the generic pharmaceutical industry, which relies heavily on BA/BE studies. CDSCO handles approximately 4,000 to 4,500 BA/BE applications each year, and the new system will significantly reduce waiting times.

Online Systems to Support Transparent Implementation

To ensure smooth execution, the government will introduce dedicated online modules on the National Single Window System (NSWS) and the SUGAM portal. These platforms will enable transparent, hassle-free submission of intimations.

The reforms will also help CDSCO use its manpower more efficiently, improve regulatory oversight, and speed up drug approvals. Overall, these changes strengthen India’s pharmaceutical R&D ecosystem, align rules with global best practices, and support innovation-led growth.

The amendments reflect the government’s long-term commitment to Ease of Doing Business, Jan Vishwas Siddhant, and India’s vision to become a preferred global destination for pharmaceutical research and development.