India’s Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, that would require licensing authorities to immediately suspend the manufacturing licence for a drug declared Not of Standard Quality (NSQ) under specified circumstances. The draft also proposes mandatory root cause analysis (RCA), corrective and preventive action (CAPA), and changes to the distribution of Government Analyst test reports.

Two proposed routes for immediate licence suspension

The draft notification, G.S.R. 956(E), dated 28 October 2026, proposes amendments to Rules 85 and 122O of the Drugs Rules, 1945. Both provisions would enable the Central Licensing Approving Authority or the relevant State Licensing Authority, as applicable, to immediately suspend the manufacturing licence granted for the affected drug after receiving a Government Analyst’s certificate of test or analysis declaring the drug to be not of standard quality.

The proposed amendment to Rule 85 specifies five critical quality parameters: assay, dissolution, related substances, impurities and sterility. Under proposed sub-rule 85(2A), an NSQ finding in respect of any of these parameters would trigger immediate suspension.

The proposed amendment to Rule 122O is broader in its wording. It would provide for immediate suspension when a Government Analyst’s certificate declares a drug NSQ, without repeating the five-parameter list set out in Rule 85. The distinction between the two provisions is material and should not be interpreted as limiting the proposed Rule 122O mechanism to the five parameters listed under Rule 85.

Suspension would remain in place pending RCA and CAPA

Under the proposed provisions, the licence would remain suspended until the licence holder has carried out an effective root cause analysis and implemented corrective and preventive action to the satisfaction of the licensing authority.

The draft further provides that suspension may be revoked only after CAPA has been implemented and duly verified by the licensing authority. The Central Licensing Approving Authority would also be able to request details of the root cause analysis, CAPA, investigation report and final action taken by the State Licensing Authority, where required.

The proposal therefore links reinstatement to both implementation and regulatory verification. It does not describe RCA and CAPA as interchangeable steps: the investigation is intended to identify the cause of the failure, while CAPA addresses the identified deficiencies and helps prevent recurrence.

Government Analyst reports would be circulated to additional recipients

The draft proposes a consequential amendment to Form 13, the Government Analyst’s test report. A new “Copy to” section would provide for the report to be sent to the Drugs Controller General of India (DCGI), the State or Union Territory Drugs Controlling Authority with jurisdiction over the manufacturing site, and the manufacturer and marketer named on the product label.

The proposed reporting arrangement is intended to improve the flow of analytical information between central and state authorities and ensure that both the manufacturer and marketer receive the relevant findings.

Implications for manufacturers

If adopted, the amendments would make the handling of critical quality failures more time-sensitive for manufacturers. Companies would need to be able to initiate documented investigations promptly, establish the scope and root cause of an affected batch failure, implement effective CAPA and provide evidence that the measures have been completed. The proposed verification requirement also makes the quality and traceability of investigation records relevant to any request to revoke a suspension.

The proposal also increases the importance of coordination between quality control, quality assurance, regulatory affairs and supply-chain functions when a Government Analyst reports an NSQ result. These are practical implications of the proposed mechanism, not additional obligations that are already in force.

Regulatory background and consultation

The Ministry’s announcement states that the proposal follows discussions 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 rules were published for public consultation through Gazette notification G.S.R. 956(E), dated 28 October 2026. Objections and suggestions may be submitted within 30 days of the date on which copies of the Gazette containing the draft rules are made available to the public. The notification states that the draft rules would be considered after expiry of that period.

The proposed amendments are not yet in force. They would take effect only upon final publication in the Official Gazette.

Primary sources

Ministry of Health and Family Welfare / Press Information Bureau, 4 November 2026: Union Health Ministry proposes immediate suspension of manufacturing licences for drugs found not of standard quality on specified critical parameters.

Draft notification: G.S.R. 956(E), 28 October 2026, draft amendments to the Drugs Rules, 1945. Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i). Official e-Gazette portal: https://egazette.gov.in/