Health Ministry Proposes New Rules for Post-Approval Drug Manufacturing, Quality Changes

The proposed rules require drug manufacturers to inform licensing authorities about changes in manufacturing processes, excipients, packaging, shelf life, specifications, testing, or documentation, and in certain cases obtain prior approval.

The draft notification, published in the Gazette of India on March 9, 2026, states that the Central Government of India proposes to further amend the Drugs Rules, 1945 in exercise of the powers conferred under subsection (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board.

The draft rules have been published for the information of all persons likely to be affected, and the government has stated that they will be taken into consideration after the expiry of thirty days from the date on which copies of the Gazette containing the draft rules are made available to the public.

According to the draft rules, manufacturers will be required to notify regulators whenever significant changes occur in product manufacturing or quality control systems.

The notification states that

“In the Drugs Rules, 1945, after sub rule (g) of rule 74, following sub rule shall be inserted namely: ―

‟(g) (i) In the event of any change in manufacturing process, or excipients, or packaging, or shelf life, or specifications, or testing, or documentation, etc. as the case may be, the manufacturer shall inform the licensing authority in writing for such changes.

The proposal further classifies manufacturing and quality changes into three levels depending on their potential impact on drug quality.

“In case of any major quality change (Level I), the manufacturer shall obtain prior approval from the licensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.”

Similarly, the draft mandates regulatory approval for moderate-risk changes. It states that

“in case of any moderate quality change (Level II), the manufacturer shall obtain prior approval from the licensing authority, where the change has a moderate potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.”

For lower-risk modifications, the draft allows manufacturers to proceed without prior approval but with mandatory reporting requirements. The notification notes that

"In case of minor quality changes (Level III), the manufacturer shall implement the change without prior approval from the licensing authority (except for cases of change in shelf life of drug substance and drug product), where the change has a minimal potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product. The annual submission shall be made to licensing authority by 1st quarter of every calendar year.”

The notification further states that similar provisions are proposed to be inserted in other rules governing drug manufacturing licenses.

“In the Drugs Rules, 1945, after sub rule (i) of rule 74A, following sub rule shall be inserted namely: ―

‟(j) In the event of any change in manufacturing process, or excipients, or packaging, or shelf life, or specifications, or testing, or documentation as the case may be, the manufacturer shall inform the licensing authority in writing within 30 days from such change.

Provided that in case of any major change, the manufacturer shall obtain prior approval from the licensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product.”

The draft also proposes insertion of similar provisions after sub rule (3) of rule 74B, after sub rule (f) of rule 78, after sub rule (3) of rule 78A, and after sub rule (iv) of rule 122P of the Drugs Rules, 1945.

Further, the notification proposes additional conditions under manufacturing license forms, including Form 25, Form 25A, Form 25B, Form 25C, Form 25D, Form 25E, Form 25F, Form 28, Form 28A, Form 28B, Form 28C, Form 28D, Form 28DA and Form 28E. The notification states that:

"In the event of any change in manufacturing process, or excipients, or packaging, or shelf life, or specifications, or testing, or documentation etc. as the case may be, the manufacturer shall inform the licensing authority in writing of such changes. Provided that in case of any major or moderate quality change, the manufacturer shall obtain prior approval from the licensing authority, where the change has a substantial potential to have an adverse impact on the identity, strength, quality, purity, or potency of a drug product."

The ministry has invited feedback from stakeholders before finalizing the amendments. According to the notification, “objections and suggestions that may be received from any person within the period specified above will be considered by the Central Government.” Stakeholders have been given 30 days from the date of publication of the draft rules to submit their comments.

"Objections and suggestions, if any, 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 at drugsdiv-mohfw@gov.in." the notice added.

To view the official notice, click the link below: