The Union Health Ministry is weighing the immediate suspension of manufacturing licences for medicines that fail critical quality tests to curtail the distribution of unsafe drugs through market channels while regulatory proceedings are underway against non-compliant drugmakers.
Under this proposal, the ministry will amend India’s Drugs Rules, 1945, with licences being suspended as soon as any government-accredited laboratory declares a drug as Not of Standard Quality (NSQ).
The testing parameters would include assay, dissolution, related substances, impurities or sterility, according to a draft notification detailing the amendment.
Until now, such suspensions or cancellations of manufacturing licences were preceded by the prescribed regulatory procedure, such as the issuance of a show-cause notice. However, people aware of the matter noted that this sometimes resulted in a time gap between the declaration of a drug as NSQ and the initiation of regulatory action.
“During this period, the concerned drug may continue to remain in circulation, posing potential risks to public health and making effective recall more challenging,” the ministry said on Wednesday.
The proposal comes amid recurrent domestic crackdowns on substandard drugs and international scrutiny of contaminated syrups manufactured in India that were linked to the deaths of dozens of children in The Gambia and Uzbekistan in 2022 and 2023.
Last year, contaminated cough syrups manufactured in India caused the deaths of at least 22 children in Madhya Pradesh and Rajasthan.
The draft rules also mandate strict conditions before any suspension can be revoked. “The suspension shall continue until the manufacturer completes an effective root-cause investigation and executes corrective and preventive action (CAPA) satisfactory to regulators,” the ministry said.
The notification added that revocation of the suspension shall be permitted only after the implementation of the requisite corrective and preventive measures and their due verification by the licensing authority.
Amendments have also been proposed to Form 13, which relates to the test report of the government analyst conducting the tests.
Under the proposed mechanism, the government analyst’s report would be endorsed to the Drugs Controller General of India (DCGI), the concerned state licensing authority under whose jurisdiction the manufacturing site is located, as well as the manufacturer and marketer of the concerned drug.
The ministry stated that the proposed arrangement aims at ensuring timely communication of NSQ findings to the relevant authorities and stakeholders, thereby facilitating coordinated regulatory action and strengthening accountability across the drug manufacturing and marketing chain.
The proposals follow deliberations at the 65th Drugs Consultative Committee (DCC) meeting on December 20, 2024, and recommendations of the 92nd Drugs Technical Advisory Board (DTAB) meeting on April 24, 2025.
The draft rules have been opened for feedback from stakeholders for 30 days.
