Centre to amend NDCT rules to simplify drug testing process, promote ease of doing business

New Delhi, Sep 3 (PTI) The Centre is set to amend the New Drugs and Clinical Trials Rules, 2019, that would halve the statutory time to process applications for test licenses to manufacture or use a new drug in clinical trials, promoting ease of doing business in the pharmaceutical sector.

The Union health ministry sought public comments on the proposed amendments to the rules through a gazette notification on August 28.

It said the proposed changes aim to simplify the requirements and procedures for obtaining test licences and for submitting applications for bioavailability/bioequivalence (BA/BE) studies.

The amendments look to dispense with the existing licence requirement for certain categories of BA/BE studies, which may instead be initiated upon submission of an intimation or notification to the Central Licensing Authority.

Moreover, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days.

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

"It would also reduce the number of license applications being submitted by approximately 50 per cent. This will facilitate quicker initiation of BA/BE studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes," it stated.

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

This initiative underscores the Government of India's commitment to ongoing regulatory reforms in the pharmaceutical sector, the ministry added.

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.

The ministry said these steps are expected to increase the attractiveness of India for clinical research, thereby strengthening the country's position as a global hub for pharmaceutical research and development. PTI PLB NSD NSD