Ministry of Health and Family Welfare Department of Health and Family Welfare Not Applicable

Draft Notification Amendment to NDCT Rules 2019 for Waiver of Sub Acute Animal Toxicity Studies

Published: 27 January 2026 Download PDF

Gazette ID: CG-DL-E-27012026-269566

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Core Purpose

The Central Government publishes draft rules to amend the New Drugs and Clinical Trials Rules, 2019, for public information and consideration, exercising powers under sections 12(1) and 33(1) of the Drugs and Cosmetics Act, 1940.

Detailed Summary

This notification, G.S.R. 45(E), issued by the Ministry of Health and Family Welfare (Department of Health and Family Welfare) on January 20, 2026, publishes draft rules to further amend the New Drugs and Clinical Trials Rules, 2019. These draft rules, proposed by the Central Government after consultation with the Drugs Technical Advisory Board, are made under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940). The public is given a period of thirty days from the Gazette's availability to submit objections and suggestions to the Under Secretary (Drugs), Ministry of Health and Family Welfare, New Delhi, or via email at drugsdiv-mohfw@gov.in. The proposed amendment inserts the phrase "except when the test product, in respect of its excipients, is qualitatively and quantitatively same as reference product" after the words "intravenous infusion and injectables" in para 4.2 of 4 of Table 2 of the Second Schedule of the New Drugs and Clinical Trials Rules, 2019. These draft rules are titled the New Drugs and Clinical Trials (...... Amendment) Rules, 2025, and will come into force on a date specified during final publication. The principal rules were initially published via notification No. F.No.X.11014/10/2017- DRS - Part (1), dated 19th March 2019.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-27012026-269566 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 45] NEW DELHI, TUESDAY, JANUARY 20, 2026/PAUSHA 30, 1947 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 20th January, 2026 G.S.R. 45(E). -The following draft of certain rules further to amend the New Drugs and Clinical Trials Rules, 2019, 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 drugsdiv-mohfw@gov.in. DRAFT RULES 1. (i) These rules may be called the New Drugs and Clinical Trials (...... Amendment) Rules, 2025. (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. In New Drugs and Clinical Trials Rules, 2019, under the para 4.2 of 4 of Table 2 of Second Schedule, after the words "intravenous infusion and injectables" the words "except when the test product, in respect of its excipients, is qualitatively and quantitatively same as reference product" shall be inserted. [F. No. X.11014/15/2025-DR] HARSH MANGLA, Jt. Secy. Note: The principal rules were published in the Official Gazette vide notification No. F.No.X.11014/10/2017- DRS - Part (1), dated 19th March 2019 and last amended vide notification number G.S.R......(E), dated....... Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. GORAKHA NATH YADAVA

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