Pharma Firms May Need Prior Approval for Major Drug Changes Under NDCT Draft Amendment

The draft rules have been framed by the Central Government in exercise of the powers conferred under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board (DTAB), and have been published for information of all persons likely to be affected.

As per the notification, the draft rules will be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions received within this period will be considered by the Central Government.

“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 notification stated.

The core proposal introduces a risk-based classification and approval system for post-approval changes made to drugs. It covers changes in manufacturing process, excipients, packaging, shelf life, specifications, testing, or documentation, requiring manufacturers or their authorized agents to inform the licensing authority in writing.

The system categorizes changes into three levels:

Level I (Major quality change): Changes with substantial potential to adversely affect the identity, strength, quality, purity, or potency of a drug product. Prior approval from the licensing authority is mandatory.

Level II (Moderate quality change): Changes with moderate potential impact on product quality. Prior approval is also required.

Level III (Minor quality change): Changes with minimal potential impact. These may be implemented without prior approval, except in cases involving change in shelf life of the drug substance or drug product. Such minor changes must be included in an annual submission to the licensing authority by the first quarter of every calendar year.

The draft rules state:

1. (i) These rules may be called the New Drugs and Clinical Trials (.. Amendment) Rules, 2026.

(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.

2. (i) In the New Drugs and Clinical Trials Rules, 2019, after clause (ix) of rule 77, following clause shall be inserted namely: -

‟(x) 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 or his authorized agent shall inform the licensing authority in writing for such changes.

Provided that;

a) 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.

b) 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.

c) 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.”

3. (ii) In the New Drugs and Clinical Trials Rules, 2019, after clause (viii) of rule 82, following clause shall be inserted namely: -

‟(ix) 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."

Provided that;

a) 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.

b) 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.

c) 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.”

To view the official notice click the link below: