The move aims to streamline test licence and bioavailability/bioequivalence study applications.
The Union Health Ministry is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019. The proposed amendments were published in the Gazette of India on 28 August, 2025 seeking public comments.
According to the ministry, the amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to bioavailability/bioequivalence (BA/BE) studies.
A press release issued by the Public Information Bureau (PIB) says that this is being done to reduce the regulatory compliance for drug companies, which, in turn promotes ease of doing business in the pharmaceutical and clinical research sectors.
Key highlights of the proposed amendments are as under:
- Test Licence Applications: Under the proposed amendment, the present license system for test licenses has been converted to a notification/intimation system. Through this, the applicants need not wait for test licenses (except a small category of high risk category drugs) but will need to just intimate the Central Licensing Authority. Additionally, the overall statutory processing time for test licence applications will be reduced from 90 days to 45 days.
- Bioavailability/Bioequivalence (BA/BE) Study Applications: Under the proposed amendment, the existing licence requirement will be 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.
Promote Growth of Indian ,harma Industry
The press release says that these regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications. These proposed amendments will 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.
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.
This initiative underscores the Government of India’s commitment to ongoing regulatory reforms in the pharmaceutical sector, the PIB said.
“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.”
It further added, “these steps are expected to increase attractiveness of India for clinical research thereby strengthening India’s position as a global hub for pharmaceutical research and development.”
