e-Gazette statutory gazette instrument G.S.R. 45(E) · 27 Jan 2026
Official title
Draft Notification Amendment to NDCT Rules 2019 for Waiver of Sub Acute Animal Toxicity Studies
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Check the official recordThe Ministry of Health and Family Welfare proposes an amendment to the New Drugs and Clinical Trials Rules, 2019. The draft introduces an exception for sub-acute animal toxicity studies for intravenous infusions and injectables. This exception applies when the test product contains excipients that are qualitatively and quantitatively identical to the reference product. The government invites public objections and suggestions on these draft rules. Interested persons must submit their feedback within thirty days from the date the Gazette of India copies become available to the public. Submissions may go to the Under Secretary (Drugs) by post or email.
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427 GI/2026 (1)
रजिस्ट्री सं. डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण् ड (i) PART II—Section 3—Sub-section (i) प्राजधकार से प्रकाजित PUBLISHED BY AUTHORITY
स्ट्वास्ट््य और पररवार कल्याण मंत्रालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसूचना नई दिल्ली, 20 िनवरी, 2026 सा.का.जन. 45(अ).—नए औषजध और नैिाजनक परीक्षण जनयम, 2019 में आगे संिोधन करने के जलए कुछ जनयमों का जनम्नजलजखत प्रारूप, जिसे केंद्र सरकार, औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा (1) और धारा 33 की उप-धारा (1) द्वारा प्रित्त िजियों का प्रयोग करते हुए, औषजध तकनीकी सलाहकार बोडड से परामिड के बाि, बनाने का प्रस्ट्ताव करती है, उन सभी व्यजियों की िानकारी के जलए एतद्द्वारा प्रकाजित दकया िाता है जिन पर इसका प्रभाव पड़ने की संभावना है, और एतद्द्वारा सूचना िी िाती है दक उि प्रारूप जनयमों पर उस तारीख से तीस दिनों की अवजध समाप्त होने पर या उसके बाि जवचार दकया िाएगा जिस पर इन प्रारूप जनयमों वाले भारत के रािपत्र की प्रजतयां िनता को उपलब्ध करा ई िाती हैं। उपयुडि जनर्िडष्ट अवजध के भीतर दकसी भी व्यजि से प्राप्त होने वाली आपजत्तयों और सुझावों पर केंद्र सरकार द्वारा जवचार दकया िाएगा। आपजत्तयां और सुझाव, यदि कोई हों, अवर सजचव (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार, यू-6, वकड हॉल सी ववंग, प्रथम तल, कतडव्य भवन-1, नई दिल्ली, 110001 को संबोजधत दकया िा सकता है अथवा ई-मेल के माध्यम से drugsdiv-mohfw@gov.in पर भेिा िा सकता है। सं. 45] नई दिल्ली, मंगलवार, िनवरी 20, 2026/पौष 30, 1947 No. 45] NEW DELHI, TUESDAY, JANUARY 20, 2026/PAUSHA 30, 1947 सी.जी.-डी.एल.-अ.-27012026-269566 CG-DL-E-27012026-269566
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] प्रारूप जनयम
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
(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.
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 Digitally signed by GORAKHA NATH YADAVA Date: 2026.01.27 10:20:54 +05'30'
