Government proposes immediate suspension of manufacturing licences of substandard drugs

The Union Health Ministry in India has introduced proposed amendments to the Drugs Rules, 1945, aiming to immediately suspend the manufacturing licenses of drugs found to be substandard on specific quality standards. This move was announced on November 4, 2026, with the goal of swiftly intervening in cases of substandard medication, preventing their further production and distribution, and enhancing the regulatory framework for maintaining quality standards, ultimately prioritizing patient safety and public health.

India's issue with substandard drugs has been a concern for some time. The Jan Vishwas Bill, enacted on July 27, 2026, faced criticism over its amendments to the Drugs and Cosmetics Act, 1940. The proposed changes address a regulatory gap where the existing Drugs Rules, 1945, require a notice issuance before suspending or canceling a manufacturing license, potentially leading to a lag in regulatory action and posing risks to public health during this period.

The Ministry aims to rectify this by proposing a provision for immediate suspension of the manufacturing license of the drug by either the Central Licensing Approving Authority or the State Licensing Authority upon receiving a report from a government analyst declaring the drug as Not of Standard Quality (NSQ) based on critical parameters such as assay, dissolution, related substances, impurities, or sterility.

These parameters are crucial in evaluating a medicine's quality. The proposed rule ensures that instances of non-compliance concerning these parameters are addressed promptly, reducing potential patient risks.

To ensure compliance following a suspension, the amendment mandates corrective measures before the suspension can be lifted. Manufacturers must conduct a root cause analysis to identify the reasons for the quality failure and implement Corrective and Preventive Action (CAPA) measures satisfying the licensing authority. The suspension remains in effect until these measures are verified by the licensing authority.

The proposed amendments also include updates to Form 13, which deals with the test report from government analysts. Under the new system, the analyst's report would be submitted to the Drugs Controller General of India (DCGI), the concerned State/UT Licensing Authority overseeing the manufacturing site, and the manufacturer and marketer of the drug in question.

These proposed changes are part of broader discussions following the 65th meeting of the Drugs Consultative Committee and the 92nd meeting of the Drugs Technical Advisory Board. The proposed amendments are currently open for public consultation for 30 days after being published in the Gazette of India, inviting feedback from stakeholders and the public.