The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to enable the immediate suspension of manufacturing licences for drugs declared Not of Standard Quality (NSQ) on specified critical quality parameters.
Under the existing provisions of the Drugs Rules, suspension or cancellation of a manufacturing licence is preceded by the prescribed regulatory procedure, including the issuance of a show-cause notice. This may create a time gap between the declaration of a drug as NSQ and the initiation of regulatory action, during which the concerned medicine may remain in circulation, potentially posing risks to public health and complicating recall efforts.
To address this concern, the Ministry has proposed a provision empowering the Central Licensing Approving Authority or the State Licensing Authority, as applicable, to immediately suspend the manufacturing licence for the concerned drug upon receipt of a Government Analyst’s report declaring it NSQ with respect to assay, dissolution, related substances, impurities or sterility.
According to the Ministry, these parameters are critical to determining the quality and safety of medicines, and the proposed provision aims to ensure that instances of non-compliance involving these parameters are met with prompt regulatory action, thereby minimising potential risks to patients.
Corrective measures required before revocation of suspension
The proposed amendments also include mandatory corrective measures before a suspension can be revoked.
The suspension would remain in force until the manufacturer conducts an effective root cause analysis to identify the reasons for the quality failure and implements appropriate Corrective and Preventive Action (CAPA) to the satisfaction of the concerned Licensing Authority.
Revocation would be permitted only after the required corrective and preventive measures have been implemented and verified by the Licensing Authority.
“This mechanism is intended to ensure that identified quality deficiencies are adequately addressed and necessary safeguards are put in place to prevent their recurrence,” the Ministry said.
Strengthening regulatory coordination
To facilitate timely regulatory action and improve coordination, consequential amendments have also been proposed to Form 13, which relates to the Government Analyst’s test report.
Under the proposed mechanism, the report would be endorsed to the Drugs Controller General of India (DCGI), the concerned State or Union Territory Licensing Authority having jurisdiction over the manufacturing site, and the manufacturer and marketer of the drug.
“The proposed arrangement is aimed 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 Ministry said.
Public consultation on draft amendments
The proposed amendments follow deliberations at the 65th meeting of the Drugs Consultative Committee (DCC), held on 20 December 2024, and recommendations made at the 92nd meeting of the Drugs Technical Advisory Board (DTAB), held on 24 April 2025.
The draft amendments have been notified for public consultation. Stakeholders and members of the public have been invited to submit objections and suggestions within 30 days from the date the relevant Gazette of India notification is made available to the public.
The proposed changes are expected to strengthen post-marketing regulatory surveillance, enable timely action against substandard medicines, promote accountability among manufacturers and marketers, and reinforce public confidence in the quality of medicines available in India.
