New Delhi: The Ministry of Health and Family Welfare has proposed changes to the Drugs Rules, 1945, to immediately suspend the manufacturing licence for a drug if a government analyst finds specified quality defects under Rule 85 or declares it not of standard quality under Rule 122O.
The suspension would continue until the manufacturer conducts an effective root cause analysis and implements corrective and preventive action (CAPA) to the licensing authority’s satisfaction, with revocation permitted only after verification.
The draft also proposes wider circulation of Government Analyst reports and invites objections and suggestions within 30 days of the Gazette copies being made available to the public.
The proposal has been issued by the Department of Health and Family Welfare through G.S.R. 956(E), dated October 28, 2026, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i). The Gazette issue is dated October 29, 2026.
Also Read:NSQ Alert: 42 Drug, Surgical Product Samples Fail CDSCO Quality Tests in September
The Central Government has proposed the amendments in exercise of the powers conferred by Section 12(1) and Section 33(1) of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board.
Under the proposed new sub-rule 85(2A), the Central Licensing Approving Authority or State Licensing Authority, as applicable, would be required to immediately suspend the manufacturing licence granted to manufacture the drug upon receiving a Government Analyst’s certificate of test or analysis under the Act stating that the drug is not of standard quality in respect of assay, dissolution, related substance, impurity or sterility.
This requirement would apply notwithstanding the provisions of sub-rules (1) and (2) of Rule 85.

The licence would remain suspended until the licence holder carries out an effective root cause analysis and implements CAPA to the satisfaction of the licensing authority.

Proposed sub-rule 85(2AA) provides that the licensing authority could revoke the suspension only after CAPA has been implemented and duly verified by that authority.

The Central Licensing Approving Authority could also seek details of the root cause analysis, CAPA, investigation report and final action taken by the State Licensing Authority, wherever required, to ensure compliance.

A consequential amendment would insert the words “or sub-rule (2A)” after “sub-rule (2)” in Rule 85(3).

The draft also proposes inserting sub-rules (1A) and (1AA) after Rule 122O(1).

Under proposed sub-rule (1A), notwithstanding sub-rule (1), the Central Licensing Approving Authority or State Licensing Authority, as applicable, would immediately suspend the manufacturing licence granted for a drug upon receiving a Government Analyst’s certificate stating that it is not of standard quality.

Unlike the proposed provision under Rule 85, this clause does not enumerate particular quality parameters.

The suspension would continue until effective root cause analysis and CAPA are completed to the licensing authority’s satisfaction. Its revocation would require implementation of CAPA and due verification by the authority.

The Central Licensing Approving Authority could similarly seek the root cause analysis, CAPA details, investigation report and final action taken by the State Licensing Authority to ensure compliance.

Rule 122O(2) would also be amended to insert “or sub-rule (1A)” after “sub-rule (1)”.

Also Read:State Drug Alert: Azithromycin, Cefixime Among 191 Drug Samples Flagged by CDSCO for Quality Failures in August

The proposed amendment to Form 13 would add a “Copy to” provision after the Government Analyst’s signature designation, requiring copies to be sent to:

  1. The Drugs Controller General of India;

  2. The State or Union Territory Drugs Controlling Authority having jurisdiction over the manufacturing site; and

  3. The manufacturer and marketer mentioned on the label.

The notification states that the draft rules would be considered on or after the expiry of 30 days from the date on which copies of the Gazette containing them are made available to the public. The Central Government would consider objections and suggestions received within that period.

Submissions may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi–110001, or emailed to drugsdiv-mohfw@gov.in.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/2026/11/09/28102026-gsr-956edraft-proposal-for-suspension-of-product-permission-for-nsq-drug-till-capa-is-implemented-482883.pdf
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Susmita Roy

Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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