Health Ministry proposes key amendments to ease drug trials rules

The Union Health Ministry on Wednesday announced that the government plans to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, calling it a significant step towards reducing regulatory compliance and promoting ease of doing business in the pharmaceutical and clinical research sectors.

The proposed amendments were published in the Gazette of India on August 28, 2025, seeking public comments, health officials said. The reforms aim to simplify and expedite the process of obtaining testing licences for specific scientific studies.

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According to an official document, under the suggested changes, applicants seeking to test any drug—except those in high-risk categories—may simply notify the Central Licensing Authority before commencing trials. They will not be required to wait for prior approval, effectively reducing the processing time for test licence applications from 90 days to 45 days, the ministry highlighted.

A similar reform is directed at improving the processing of Bioavailability and Bioequivalence (BA/BE) studies, which are typically conducted to assess whether a new version of a drug (such as a generic medicine) performs in the same way as an already approved drug.

These changes would make the process less bureaucratic and more efficient for certain types of drug trials, shifting from a “permission first” model to a “notify and proceed” framework.

The ministry underscored that the reforms will facilitate quicker initiation of BA/BE studies, drug testing, and scientific examinations, thereby reducing delays in drug development and approval processes.

It further noted that the amendments would also enable the Central Drugs Standard Control Organization (CDSCO) to optimise deployment of its human resources, enhancing both efficiency and regulatory oversight.

According to the official statement, these steps are expected to increase India’s attractiveness as a destination for clinical research, strengthening the country’s position as a global hub for pharmaceutical research and development.

ENDS