The Union Health Ministry is planning to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, to reduce the delays in the drug development and approval processes in India. The amendments are intended to facilitate the quicker initiation of bioavailability and bioequivalence (BA/BE) studies, which test and examine drugs for research purposes in the country.

As part of simplifying the requirements and procedures for obtaining test licences, the proposed amendment seeks to convert the present system for issuing test licences into a notification/intimation system. It is expected that the change will permit applicants to avoid the wait to obtain test licenses from the drug regulatory authority, allowing them to proceed with their plans after notifying the Central Licensing Authority. A small category of high-risk category drugs will still need to obtain this approval, though the amendment will see the overall statutory processing time for test licence applications reduced from 90 days to 45 days.

Similarly, the amendment will also see the existing licence requirement getting dispensed with for certain categories of BA/BE studies, which may instead be initiated upon submission of an intimation or notification to the Central Licensing Authority.

These regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications. According to the ministry, the proposed amendments will reduce the number of license applications submitted by approximately 50% and facilitate the quicker initiation of BA/BE studies, testing, and examination of drugs for research, thereby reducing delays in the drug development and approval processes.

The amendments will also enable the central drug regulator—Central Drugs Standard Control Organisation (CDSCO)—to optimise the deployment of its human resources, thereby enhancing the efficiency and effectiveness of regulatory oversight.

The ministry showcases the proposed amendment as the Government’s commitment to ongoing regulatory reforms in the pharmaceutical sector.

“It forms a part of the broader efforts toward Ease of Doing Business to promote the growth of the Indian pharma industry and align domestic regulations with global best practices. These steps are expected to increase the attractiveness of India for clinical research, thereby strengthening India’s position as a global hub for pharmaceutical research and development”, a health ministry statement said.