Govt proposes immediate licence suspension for substandard drug makers
New Delhi: India has proposed the immediate suspension of manufacturing licences for medicines that fail critical quality tests, the Union health and family welfare ministry said on Wednesday.
The government has proposed amendments to the Drugs Rules, 1945, through a draft gazette notification.
Under the draft rules, manufacturing licences will be suspended at once when a government analyst declares a drug “Not of Standard Quality” (NSQ) on parameters including assay, dissolution, related substances, impurities, or sterility.
The proposal is significant for India’s $60-billion pharmaceutical industry, which supplies generic medicines globally. It 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 children in Rajasthan and Madhya Pradesh.
Under existing norms, suspending or cancelling a licence requires formal administrative procedures, including issuing a show-cause notice.
“Under the existing provisions of the Drugs Rules, 1945, suspension or cancellation of a manufacturing licence is preceded by the prescribed regulatory procedure, including issuance of a show-cause notice,” the government said in a statement. “This may result in a time gap between the declaration of a drug as NSQ and 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.”
To close this gap, the ministry proposed that the Central Licensing Approving Authority or the State Licensing Authority will act immediately upon receiving an adverse lab report.
The ministry stated that the prompt action was designed “in the interest of patient safety and public health” to “enable prompt regulatory intervention upon detection of substandard medicines, prevent their continued manufacture and distribution, and strengthen the mechanism for ensuring compliance with prescribed quality standards”.
The draft rules also mandate strict conditions before any suspension can be revoked. A suspension will continue until the manufacturer completes an effective root-cause investigation and executes corrective and preventive action (CAPA) satisfactory to regulators.
The health ministry statement said: “Revocation of the suspension shall be permitted only after implementation of the requisite corrective and preventive measures and their due verification by the Licensing Authority”.
Manufacturing norms
Consequential amendments have also been proposed to Form 13 for Government Analyst test reports, ensuring they are endorsed simultaneously to the Drugs Controller General of India (DCGI), the concerned State or Union Territory licensing authority, and the manufacturer and marketer. The ministry noted that this reporting mechanism is intended to “ensure 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 meeting on December 20, 2024, and recommendations of the 92nd Drugs Technical Advisory Board meeting on April 24, 2025. Both draft rules have been opened for public feedback for 30 days.
In a separate draft notification, the ministry has proposed amendments to Schedule M of the Drugs Rules, 1945, to align domestic sterile manufacturing standards with World Health Organization norms.
According to the draft rules, the government has revised the permissible microbial contamination limits in Grade A clean areas—the critical zones where exposed drug formulations, containers, and sterilised components are processed.
The amendment mandates that any detection of microbial growth in these ultra-clean environments will automatically trigger a regulatory investigation, harmonising India’s Good Manufacturing Practices with global requirements under WHO Technical Report. The ministry has invited feedback from stakeholders and the public within 30 days.
