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Draft Rules mandating manufacturers to notify every product update will boost transparency & responsibility: Expert
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Nandita Vijayasimha, Bengaluru
March 17 , 2026
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The Union health ministry has recently issued draft amendments to the Drugs and Cosmetics Rules, extending mandatory provisions for submission and approval of changes beyond new drugs to cover all drug formulations. This will boost transparency and accountability, said Dr Premnath Shenoy, former director - regulatory affairs & patient safety, AstraZeneca, and pharmaceutical policy expert & chairman, advisory board - IPA Kerala Consortium on Innovation and Entrepreneurship in Healthcare.
Pharmaceutical manufacturers are required to notify the licensing authority in writing of any changes to their products. This includes modifications in the manufacturing process, excipients, packaging, shelf life, specifications, testing methods, or documentation. The move aims to enhance regulatory oversight, ensure drug quality and safety, and maintain transparency in the pharmaceutical sector, he added.
"This amendment ensures that every significant change is backed by proper validation and regulatory oversight. Extending the requirement to all drugs is a landmark move that strengthens accountability, transparency, and patient trust,” Dr Shenoy told Pharmabiz.
In fact Dr Shenoy had earlier urged that quality assurance and patient safety demand uniform oversight across the entire spectrum of medicines in an earlier published version in Pharmabiz on February 10 when the Union government mandated reporting clause in the New Drugs and Clinical Trials (NDCT) Rules, 2019 issued in early February.
"We view this amendment as a progressive step toward global alignment, robust quality assurance, and enhanced patient safety. The framework introduces a three-tier classification of changes. The Level I calls for major quality change. Here prior approval is required for changes with substantial potential to adversely impact identity, strength, quality, purity, or potency.
The Level II deals with moderate quality change, where prior approval is required for changes with moderate potential impact. Under Level III which is on minor quality change, the changes may be implemented without prior approval, except shelf life changes, but must be reported annually to the licensing authority.
According to Dr Shenoy, the draft rules also specify timelines, requiring manufacturers to inform the licensing authority within 30 days of any change in certain cases. By embedding these provisions into multiple sections of the Drugs Rules, 1945 including Rule 74, Rule 74A, Rule 74B, Rule 78, Rule 78A, and Rule 122P, the Union government has signalled its intent to harmonize regulatory practice across the industry.
There will be multiple benefits with this draft amendment as it will enhance drug safety. By notifying authorities of any changes in manufacturing, ingredients, or testing, regulators can ensure that only safe and effective products reach patients. There will be improved quality control as continuous oversight of processes and specifications helps prevent substandard or adulterated medicines from entering the market.
We also see mandatory reporting promotes accountability and strengthens trust between manufacturers, regulators, and consumers. The faster regulatory response will allow companies to assess risks and take corrective actions before issues escalate, said Dr Shenoy.
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