Govt to amend NDCT rules to ease drug testing procedures

The Union Health Ministry on Wednesday said it 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, seeking public comments. The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies.

Under the proposed amendment, applicants will not be required to wait for test licences—except for a small category of high-risk drugs—but will only need to intimate the Central Licensing Authority.

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

The proposed amendment also states that the existing licence requirement will be dispensed with for certain categories of BA/BE study applications.

BA/BE studies are applied in the pharmaceutical industry to demonstrate that a generic drug is therapeutically equivalent to a brand-name drug, or that a new drug formulation performs comparably to a standard dose.

“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%. 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,” an official statement said.

The Ministry said the proposed amendments are in line with Prime Minister Narendra Modi's direction towards reducing regulatory compliance and promoting ease of doing business in the pharmaceutical and clinical research sectors.

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.