The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to allow immediate suspension of manufacturing licences for drugs found to be Not of Standard Quality (NSQ) on specified critical quality parameters.
The proposed changes aim to strengthen regulatory oversight, ensure prompt action against substandard medicines and prevent their continued manufacture and distribution to safeguard public health.
Under the existing provisions, suspension or cancellation of a drug manufacturing licence requires a prescribed regulatory procedure, including the issuance of a show-cause notice. According to the Ministry, this process can create a gap between the identification of a substandard drug and the initiation of regulatory action, potentially allowing the medicine to remain in circulation.
To address this concern, the Ministry has proposed empowering the Central Licensing Approving Authority or the concerned State Licensing Authority to immediately suspend the manufacturing licence in respect of a drug upon receiving a Government Analyst’s report declaring it NSQ on specified critical parameters.
These parameters include assay, dissolution, related substances, impurities and sterility, which are essential for assessing the quality, safety and performance of medicines.
The proposed provision seeks to minimise potential risks to patients by enabling timely regulatory intervention when drugs fail to meet prescribed quality standards.
Mandatory Corrective Action Before Licence Restoration
The draft amendments also propose that suspended licences may be restored only after manufacturers identify the underlying causes of quality failures and implement appropriate corrective measures.
Manufacturers will be required to conduct a Root Cause Analysis and undertake Corrective and Preventive Action (CAPA) to address identified deficiencies and prevent their recurrence.
The suspension will remain in force until the concerned Licensing Authority verifies the corrective measures and is satisfied that the necessary quality safeguards have been implemented.
Stronger Reporting and Regulatory Coordination
The Ministry has also proposed amendments to Form 13, which relates to the Government Analyst’s test report, to improve communication and coordination among regulatory authorities.
Under the proposed mechanism, reports identifying drugs as NSQ will be shared with the Drugs Controller General of India (DCGI), the concerned State or Union Territory Licensing Authority, and the manufacturer and marketer of the drug.
The Ministry said the enhanced reporting system would facilitate timely regulatory action, improve accountability and strengthen coordination across the pharmaceutical manufacturing and marketing chain.
The proposed amendments follow discussions at the 65th meeting of the Drugs Consultative Committee (DCC) held on December 20, 2024, and recommendations made at the 92nd meeting of the Drugs Technical Advisory Board (DTAB) on April 24, 2025.
The government expects the proposed changes to strengthen post-marketing surveillance, ensure quicker action against substandard medicines and reinforce public confidence in the quality of drugs available in the country.
Public Consultation Invited
The draft amendments have been notified for public consultation, with stakeholders and members of the public invited to submit objections and suggestions within 30 days from the date on which copies of the Gazette notification are made available.
Suggestions may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Kartavya Bhawan-1, New Delhi, or emailed to drugsdiv-mohfw@gov.in.
The proposed amendments form part of the government’s efforts to strengthen India’s drug regulatory framework and ensure the availability of safe, effective and quality medicines.
-PIB
