By Nethra Sailesh
The Union Health Ministry has announced that the government is set to make reforms to the New Drugs and Clinical Trials Rules, 2019. According to health officials, all the proposed changes were published in the Gazette of India on August 28 and are seeking public comments.
The amendments are in place to reduce red tape in drug testing and clinical research. This includes simplifying the requirements and procedures for obtaining test licenses and for submitting applications related to studies on bioavailability (BA) and bioequivalence (BE).
The first proposed amendment includes applicants who will be able to intimate the Central Licensing Authority rather than having to wait to be issued a test license. Along with this, the overall statutory processing time for these applications will be reduced from 90 days to 45 days.
For BA and BE studies, for certain categories, the need for a licence will be replaced with a simple intimation or notification system. This is expected to cut licence applications by about 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.
These reforms are expected to benefit drug developers by reducing delays, speeding up research, and cutting paperwork. They will also help the Central Drugs Standard Control Organization (CDSCO) optimise its resources and strengthen oversight.
According to the official press release, these new reforms will make India a priority when it comes to clinical research on a global scale. It will also promote the growth of the Indian pharma industry and align domestic regulations with global best practices.