The Ministry of Health and Family Welfare (MoHFW) on October 29, 2026, issued the Draft Drugs (...... Amendment) Rules, 2026 to further amend the Drugs Rules, 1945.
The Ministry has invited objections and suggestions from stakeholders and other affected persons within 30 days from the date of publication of the draft rules in the Official Gazette. The submissions will be considered by the Central Government before finalisation and may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, through the prescribed postal address or email at [email protected].
The following amendments have been stated:
• In the Drugs Rules, 1945, after sub rule (2) of rule 85, following shall be inserted, namely: ―
“(2A) Notwithstanding anything contained in sub-rule (1) and (2), the Central Licensing Approving Authority or State Licensing Authority, as the case may be, on receipt of a certificate of test or analysis under the Act from Government Analyst for any drug with opinion that the drug is not of standard quality with respect to Assay/Dissolution/Related Substance/Impurity/Sterility, shall immediately suspend the manufacturing licence granted to manufacture the said drug and the licence shall remain suspended till the licencee carry out the effective route cause analysis and implement the Corrective Action and Preventive Action (CAPA) to the satisfaction of the licensing authority.
(2AA) The suspension of the manufacturing licence referred in sub-rule (2A) may be revoked by the licensing authority only after the implementation of the Corrective Action and Preventive Action (CAPA) after its due verification by the said authority
Provided that the Central Licensing Approving Authority may also seek details of root cause analysis, Corrective Action and Preventive Action (CAPA), investigational report as well as final action taken by State Licensing Authority to ensure compliance with the requirements under the rule in such cases as may be required.”
• In the Drugs Rules, 1945, after sub rule (1) of rule 122O, following sub rule shall be inserted namely: ―
“(1A) Notwithstanding anything contained in sub-rule (1), the Central Licensing Approving Authority or State Licensing Authority, as the case may be, on receipt of a certificate of test or analysis under the Act from Government Analyst for any drug with opinion that the drug is not of standard quality, shall immediately suspend the manufacturing licence granted to manufacture the said drug and the licence shall remain suspended till the licencee carry out the effective route cause analysis and implement the Corrective Action and Preventive Action (CAPA) to the satisfaction of the licensing authority.
(1AA) The suspension of the manufacturing licence referred in sub-rule (2A) may be revoked by the licensing authority only after the implementation of the Corrective Action and Preventive Action (CAPA) after its due verification by the said authority.
Provided that the Central Licensing Approving Authority may also seek details of root cause analysis, Corrective Action and Preventive Action (CAPA), investigational report as well as final action taken by State Licensing Authority to ensure compliance with the requirements under the rule in such cases as may be required.”
[Notification No. G.S.R. 956(E)]
