Centre proposes immediate suspension of licences for substandard drugs

NewsIndia NewsCentre proposes immediate suspension of licences for substandard drugs Centre proposes immediate suspension of licences for substandard drugs The Health Ministry has introduced new regulations aimed at suspending manufacturing licenses for medicines that do not meet quality criteria.

(Pic Credit: Magnific.com) NEW DELHI: A medicine that fails critical quality tests could soon trigger immediate suspension of the manufacturer’s licence, under proposed rules aimed at preventing substandard drugs from reaching patients.

Health ministry has proposed changes to the drugs rules, 1945, to allow regulators to act without waiting for the existing show-cause notice process.Currently, authorities follow a procedure that includes issuing a show-cause notice before suspending or cancelling a manufacturing licence.

This can create a gap during which medicines declared ‘Not of standard quality (NSQ)’ may continue to circulate.Under the proposed amendments, central or state drug licensing authority can immediately suspend manufacturing licence for a drug if a govt analyst’s report finds it deficient in any of five critical parameters: assay, dissolution, related substances, impurities or sterility.

Watch Govt Tightens Grip On GLP-1 Weight Loss Drugs Amid Rising Concerns Over Unauthorised Sales These tests determine whether a medicine contains the required amount of active ingredient, releases it properly in the body and is free from harmful impurities or microbial contamination.The suspension will continue until the manufacturer identifies the reason for the quality failure and takes corrective and preventive action.

The licence can be restored only after the regulatory authority verifies that the required measures have been implemented.Join conversation InsightfulAgreeDisagreeSkepticalConcerningPromisingWorth ReadingBig Development The ministry has also proposed a system to ensure that reports of substandard drugs reach the drugs controller general of India (DCGI), the state or UT drug licensing authority concerned, and the manufacturer and marketer.

This is intended to speed up regulatory action and fix accountability across the supply chain.The draft amendments have been opened for public consultation. Get the latest India News and Live updates. Download the TOI app.

Anuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers.

Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.

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