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Centre to amend 2019 rules to simplify drug testing process
The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability and Bioequivalence (BA/BE) studies
The Union ministry of health and family welfare on Wednesday announced its plans to amend New Drugs and Clinical Trials (NDCT) Rules, 2019, to promote ease of doing business and to accelerate drug development and clinical research in the country.
“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 Union Health Ministry is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019,” said the health ministry in a statement.
The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability and Bioequivalence (BA/BE) studies, it added.
Bioavailability (BA) refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.
Bioequivalence (BE) of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
Under the proposed test licence amendment, the present license system for test licenses has been converted to a notification or intimation system except for certain high-risk drugs categories.
“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,” read the health ministry statement.
Under the proposed BA and BE study application 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, it said.
“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.”
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, added the health ministry.
“This initiative underscores the Government of India’s commitment to ongoing regulatory reforms in the pharmaceutical sector. 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,” read the statement.
It added that these steps are expected to increase the attractiveness of India for clinical research thereby strengthening India’s position as a global hub for pharmaceutical research and development.
The proposed amendments were published in the Gazette of India on August 28, seeking public comments within 30 days.
Dinesh Thakur, co-author of The Truth Pill: The Myth of Drug Regulation in India, described the changes as a “bad idea”, saying, “On what basis was the overall statutory processing time halved? Does the CDSCO plan to allocate twice the staff who currently do this work? Even if they do, are they saying that the additional staff will be functional (without adequate training and experience) on Day 1 of this notification?”
The second issue he found more concerning centered around the BA/BE application amendment. “BA/BE studies were made mandatory for new drug approvals going forward. We know that a majority of the drug formulations on the market today have no evidence of therapeutic equivalence to the innovator drug. We see this time and time again with narrow therapeutic dosage drugs. The fact that the regulator has caved to industry pressure is a grave risk to public health,” he added.
