NEW DELHI: The Centre is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, to simplify requirements and procedures for obtaining test licenses and for submitting applications related to Bioavailability (BA) and Bioequivalence (BE) studies.
The amendment will help reduce delays in drug development and approval timelines in the future in the country.
According to the Union Health Ministry, in accordance with the directions of Prime Minister Narendra Modi towards reducing the regulatory compliance and towards promoting ease of doing business in the pharmaceutical and clinical research sectors, the 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 August 28, 2025 seeking public comments. Under the proposed amendment, the present license system for test licenses has been converted to a notification 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. Now, 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.
These proposed amendments will reduce the number of license applications being submitted by approximately 50%. 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 Organisation (CDSCO) to optimise the deployment of its human resources, thereby enhancing the efficiency and effectiveness of regulatory oversight.
“This initiative 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,” a statement from the health ministry said.
Amendments to reduce licence applications
These proposed amendments will reduce the number of licence applications being submitted by approximately 50%. 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. The proposed amendments were published in the Gazette of India on August 28, 2025.