New Delhi, November 4: The Union Health Ministry has proposed that a drug’s manufacturing licence be suspended immediately once a government laboratory declares the medicine Not of Standard Quality (NSQ) on certain critical tests.
The draft amendments to the Drugs Rules, 1945 cover failures in five parameters: assay, dissolution, related substances, impurities and sterility. The ministry described these as critical to judging the quality of a medicine.
Why the ministry wants the change
Under the present rules, the regulator has to follow the prescribed procedure, including a show-cause notice, before it can suspend or cancel a manufacturing licence. The ministry said this creates a gap between a drug being declared NSQ and action being taken. During that time the drug may stay in circulation, which puts patients at risk and makes a recall harder.
Under the proposal, the Central Licensing Approving Authority or the State Licensing Authority, as the case may be, would suspend the licence for the drug concerned as soon as it receives a Government Analyst’s report declaring the drug NSQ on any of the five parameters.
Suspension to stay until corrective action is verified
The suspension would remain in force until the manufacturer carries out a root cause analysis to find out why the drug failed, and puts in place corrective and preventive action (CAPA) to the satisfaction of the licensing authority.
The licence can be restored only after these measures have been implemented and verified by the authority. The ministry said this is meant to make sure quality failures are fixed and do not happen again.
Test reports to go to more authorities
The ministry has also proposed changes to Form 13, the test report issued by the Government Analyst. The report would be sent to the Drugs Controller General of India (DCGI), to the State or Union Territory licensing authority under whose jurisdiction the manufacturing site falls, and to both the manufacturer and the marketer of the drug.
According to the ministry, this will help the authorities act together on NSQ findings and make manufacturers and marketers more accountable.
How the proposal came about
The amendments follow discussions at the 65th meeting of the Drugs Consultative Committee, held on 20 December 2024, and recommendations of the 92nd meeting of the Drugs Technical Advisory Board, held on 24 April 2025.
The ministry said the changes should strengthen post-marketing surveillance and allow faster action against substandard medicines.
Comments invited within 30 days
The draft rules have been notified for public consultation. Objections and suggestions can be sent within 30 days from the date copies of the Gazette of India carrying the draft are made available to the public. They should be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi 110001.
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