Union Health Ministry Proposes Immediate Suspension of Substandard Drug Licences
· India · The Hindu, Hindustan Times
The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, in New Delhi to immediately suspend manufacturing licences for medicines declared Not of Standard Quality on critical parameters. Under current rules, suspensions require prior show-cause notices, creating a time gap during which substandard drugs can remain in circulation. The proposed changes empower the Central Licensing Approving Authority or State Licensing Authority to act swiftly upon receiving government analyst reports concerning assay, dissolution, related substances, impurities, or sterility. Manufacturers will be required to complete mandatory corrective measures before any suspension can be revoked. The Ministry stated that the move aims to prevent the distribution of faulty medicines and enhance patient safety across public health networks.
Why it matters
The proposed regulatory overhaul directly impacts pharmaceutical manufacturers in India by eliminating procedural delays in penalising makers of substandard drugs, strengthening patient safety safeguards.
Read the original report — The Hindu
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