Draft Notification about changes to requirements of Test license under NDCT Rules 2019

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-28082025-265777 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 544] NEW DELHI, THURSDAY, AUGUST 28, 2025/BHADRA 6, 1947 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 27th August, 2025 G.S.R. 588(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, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 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 the New Drugs and Clinical Trials Rules, 2019, the sub-rule (1) of rule 52 shall be substituted, namely:- "(1) No person shall manufacture a new drug or an investigational new drug to conduct clinical trial or bioavailability or bioequivalence study or for examination, test and analysis without obtaining permission or the notification as referred in proviso to sub-rule (2) of rule 52 to the Central Licensing Authority, as the case may be, to manufacture such new drug or investigational new drug." 3. In the New Drugs and Clinical Trials Rules, 2019, after the sub-rule (2) of rule 52, the following proviso shall be inserted, namely: "Provided that in case of manufacture of new drug or Investigational new drug for Analytical and preclinical testing (excluding the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, Biologics with live microorganism and narcotics & psychotropic drugs) an online application shall be submitted as notification and applicant can manufacture such drugs based on the notification." 4. In the New Drugs and Clinical Trials Rules, 2019, in rule 53: (a) under the sub-rule (1), the words "ninety working days" shall be substituted with the words "forty-five working days" wherever occurs. (b) under the clause (ii) of sub-rule (3), the words "ninety working days" shall be substituted with the words "forty-five working days". 5. In the New Drugs and Clinical Trials Rules, 2019, after the sub-rule (1) of rule 59, the following proviso shall be inserted, namely: "Provided that in case of manufacture of new drug or Investigational new drug for Analytical and preclinical testing (excluding the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, Biologics with live microorganism and narcotics & psychotropic drugs) an online application shall be submitted as notification and applicant can manufacture such drugs based on the notification." 6. In the New Drugs and Clinical Trials Rules, 2019, in rule 60: (a) under the clause (i) of sub-rule (1), the words “ninety working days” shall be substituted with the words "forty-five working days". (b) under the clause (ii) of sub-rule (1), the words "ninety working days" shall be substituted with the words "forty-five working days". (c) under the clause (ii) of sub-rule (2), the words “ninety working days” shall be substituted with the words "forty-five working days". [F. No. X.11014/05/2025-DR] NIKHIL GAJRAJ, 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.