Health Ministry to amend rules for new drug, clinical trials to promote ease of doing business
The Union Health Ministry on Wednesday announced plans to amend rules for the pharmaceutical and clinical research sectors to promote ease of doing business.
New Delhi: The Union Health Ministry on Wednesday announced plans to amend rules for the pharmaceutical and clinical research sectors to promote ease of doing business.
“The proposed amendments in the New Drugs and Clinical Trials (NDCT) Rules, 2019, aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies,” the Ministry said, noting that it has also published this in the Gazette of India on August 28 to seek public comments.
The initiative underscores the government’s commitment to ongoing regulatory reforms in the pharmaceutical sector.
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“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 India’s position as a global hub for pharmaceutical research and development,” it added.
The amendment proposes that the current license system for test licenses be converted to a notification/intimation system.
“Through this, the applicants need not wait for test licenses (except a small section in the high-risk category drugs) but will need to just intimate the Central Licensing Authority,” the Ministry said.
In addition, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days.
The proposed amendment also seeks 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”.
These regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications, the Ministry said.
It will not only “reduce the number of license applications being submitted by approximately 50 per cent, but also facilitate quicker initiation of BA/BE studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes”, the Ministry added.
Moreover, the amendments will enable the Central Drugs Standard Control Organization (CDSCO) to optimise the deployment of its human resources, thereby enhancing the efficiency and effectiveness of regulatory oversight.
