Notification regarding inclusion of additional items under the Centrally Licensed Approval Authority (CLAA) provisions in the Drugs Rules, 1945

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-02072026-274000 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 477] NEW DELHI, TUESDAY, JUNE 30, 2026/ ASHADHA 9, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 29th June 2026 G.S.R. 530(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 758 (E), dated the 16th October, 2025, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas, copies of the said Gazette were made available to the public on the 18th October, 2025; And whereas, no objections and suggestions received from the public on the said draft rules; Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:— 1. 2. (a) (1) These rules may be called the Drugs (Eighth Amendment) Rules, 2026. (2) These rules shall come into force on the date of their publication in the Official Gazette. In the Drugs Rules, 1945, — (i). in rule 75, in sub-rule (3), after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words "Cell or Stem Cell derived products, Gene therapeutic products or Xenografts," shall be inserted; (ii). in rule 75A, in sub-rule (1A), after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs", the words ""Cell or Stem Cell derived products', 'Gene therapeutic products or Xenografts'" shall be inserted; (iii). in rule 76, for the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs” wherever may occur, the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be substituted; (iv). in rule 76A, for the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs”, the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived products, Gene therapeutic products or Xenografts," shall be substituted; (v). in SCHEDULE A, — in Form 27D, – (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS," shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words "Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted; (b) (c) in Form 27DA, — (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS," shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts," shall be inserted; in Form 28D, – (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets "RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS," shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts," shall be inserted; (d) in Form 28DA, - (A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”, the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS," shall be substituted; (B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts," shall be inserted; [F. No. X.11014/07/2025-DR-Part(2)] HARSH MANGLA, Jt. Secy. Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H(1), dated the 21st December, 1945 and last amended vide notification number G.S.R. 506(E), dated 22nd June, 2026