Draft Notification reg PAC for amendment in Drugs Rules

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-11032026-270856 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 167] NEW DELHI, WEDNESDAY, MARCH 11, 2026/PHALGUNA 20, 1947 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 9th March, 2026 G.S.R. 173(E).—The following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by 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 is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions which may be received from any person within the period specified above 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 [email protected]. DRAFT RULES 1. (i) These rules may be called the Drugs (...... 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 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. 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." (ii) 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 etc. 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." (iii) In the Drugs Rules, 1945, after sub rule (3) of rule 74B, following sub rule shall be inserted namely: "(3) (a) 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." (iv) In the Drugs Rules, 1945, after sub rule (f) of rule 78, following sub rule shall be inserted namely: "(f) (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. 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." (v) In the Drugs Rules, 1945, after sub rule (3) of rule 78A, following sub rule shall be inserted namely: "(3) (a) 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." (vi) In the Drugs Rules, 1945, after sub rule (iv) of rule 122P, following sub rule shall be inserted namely: "(iv) (a) 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." (vii) In the Drugs Rules, 1945, under the Condition of License in the 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 after the last condition in each Form, the following condition shall be inserted namely: "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 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." [F. No. X.11014/01/2026-DR] HARSH MANGLA, Jt. Secy. Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st the December, 1945 and last amended vide notification number G.S.R......(E), dated.......