e-Gazette statutory gazette instrument G.S.R. 98(E) · 05 Feb 2026
Official title
Draft amendment in NDCT Rules, 2019 for Omit the requirements of granting of Provisional Certificate for registration of ethics committee
Official record
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The Central Government proposes to amend the New Drugs and Clinical Trials Rules, 2019. The amendment removes the requirement for a provisional certificate for the registration of an ethics committee. The designated authority will now directly grant final registration in Form CT-03 upon successful scrutiny of the application in Form CT-01. If the authority is not satisfied, it will reject the application and record the reasons in writing. The public may submit objections or suggestions to the Under Secretary (Drugs), Ministry of Health and Family Welfare, within thirty days from the date the Gazette notification is available to the public.
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Key dates
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723 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, 2 फरवरी, 2026 सा.का.जन. 98(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, एतद्द्वारा उन सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता है जिनके प्रभाजवत होने की संभावना है, और एतद्द्वारा सूजचत दकया िाता है दक उि प्रारूप जनयमों पर भारत के रािपत्र की प्रजतयां, जिनमें ये प्रारूप जनयम िाजमल हैं, िनता के जलए उपलब्ध कराए िाने की तारीख से तीस दिनों की अवजध समाप्त होने पर या उसके बाि जवचार दकया िाएगा। उपयुडि 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. 93] नई दिल्ली, मंगलवार, फरवरी 3, 2026/माघ 14, 1947 No. 93] NEW DELHI, TUESDAY, FEBRUARY 3, 2026/MAGHA 14, 1947 सी.जी.-डी.एल.-अ.-05022026-269847 CG-DL-E-05022026-269847
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 2nd February, 2026
G.S.R. 98(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. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
(i) These rules may be called the New Drugs and Clinical Trials (.. 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.
In the New Drugs and Clinical Trials Rules, 2019, the sub-rule (3) of rule 17 shall be omitted.
In the New Drugs and Clinical Trials Rules, 2019, the sub-rule (4) of rule 17 shall be substituted, namely: ― “On receipt of application in Form CT-01 under sub-rule (1), the authority designated under sub-rule (1) shall scrutinise the documents and information furnished with the application, and if satisfied that the requirements of these rules have been complied with, grant final registration to Ethics Committee in Form CT-03; or if not satisfied, reject the application, for reasons to be recorded in writing”.
[F.No. X.11014/02/2026-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: 2026.02.05 16:14:12 +05'30'
