New Delhi, Sep 3 (UNI) The union Health Ministry today said that it is in the process of amending the New Drugs and Clinical Trials (NDCT) Rules, 2019, aiming to streamline regulatory procedures and reduce approval timelines for clinical trials and new drug manufacturing.
In this regard, it has issued a draft notification proposing significant amendments to the New Drugs and Clinical Trials Rules (NDCTR), 2019.
The draft has proposed to reduce the approval timelines for clinical trials and related permissions from ninety working days to forty-five working days to accelerate the regulatory review process.
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, the present licence system for test licences has been converted to a notification/intimation system. Through this, the applicants need not wait for test licences (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.
Also, 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.
“These regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing 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,” said the statement here.
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, it said.
The ministry has invited all stakeholders, including pharmaceutical companies, academic researchers, and members of the public, to submit their views on the proposed changes within 30 days of the draft being published.
