Government proposes immediate suspension of manufacturing licences of substandard drugs
Proposed amendment provides for mandatory corrective measures before revocation of the suspension; suspension shall continue until the manufacturer undertakes corrective action
The Union Health Ministry in India has suggested amendments to the Drugs Rules of 1945, aiming to swiftly suspend the manufacturing licenses of substandard drugs. This proposal was announced on November 4, 2026. The government's aim is to swiftly intervene in cases of substandard medicines, prevent their further manufacturing and distribution, and ensure compliance with quality standards.
The Jan Vishwas Bill, which was passed on July 27, 2026, has sparked debates regarding its amendments to the Drugs and Cosmetics Act, 1940.
Presently, under the existing rules, suspension or cancellation of a manufacturing license requires a prescribed procedure, including a show-cause notice, which might cause a delay between declaring a drug as Not of Standard Quality (NSQ) and initiating regulatory action. During this time, the drug might still be in circulation, potentially posing health risks and complicating the recall process.
In response to this, the Ministry has proposed a provision for immediate suspension of a manufacturing license by the Central or State Licensing Authority when a government analyst's report declares a drug NSQ regarding quality parameters like assay, dissolution, related substances, impurities, or sterility. These parameters are crucial for assessing medicine quality. The proposal intends to ensure prompt regulatory action, minimizing patient risks.
The amendment also mandates corrective actions before a suspension is revoked. Initially, the suspension remains until the manufacturer carries out a root cause analysis and implements CAPA as per the licensing authority's satisfaction. Once these measures are in place and verified by the authority, the suspension can be lifted. This system guarantees that quality deficiencies are rectified and safeguards are in place to avoid future recurrence.
The amendments also include revisions to Form 13, the government analyst's test report submission process. The report will now be endorsed to the Drugs Controller General of India (DCGI), the State/UT licensing authority, the manufacturer, and the marketer of the drug. The draft amendments are now open for public consultation for 30 days from the date of their publication in the Gazette of India.
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