The Union health ministry has proposed amendments to the Drugs Rules, 1945, allowing immediate suspension of manufacturing licenses of drug companies whose products are found to be “not of standard quality” (NSQ).
Under the proposed mechanism, licenses would remain suspended until the manufacturer identifies the cause of the quality failure, implements corrective measures and receives approval from the licensing authority.
The ministry said the amendments aim to prevent the continued manufacture and distribution of substandard medicines and strengthen patient safety.
The proposed suspension would apply when government analysts declare a drug NSQ due to failures in parameters such as assay, dissolution, impurities, related substances or sterility.
Under existing rules, regulatory action generally involves procedures such as issuing a show-cause notice, potentially delaying intervention while substandard medicines remain in circulation.
The proposed amendments also seek to revise Form 13, which contains government analyst test reports. Reports would be shared with the Drugs Controller General of India, the relevant state or Union territory licensing authority, and the drug’s manufacturer and marketer.
The ministry said the changes would improve coordination and accountability across the pharmaceutical supply chain.
The proposals follow discussions at the 65th meeting of the Drugs Consultative Committee in December 2024 and recommendations made at the 92nd meeting of the Drugs Technical Advisory Board in April 2025.
