**Executive Summary**
This document is a draft notification from the Ministry of Health and Family Welfare, Government of India, dated February 2, 2026, regarding amendments to the New Drugs and Clinical Trials Rules, 2019. It invites objections and suggestions from the public within 30 days of the gazette's publication. The amendments concern the rules related to the registration of Ethics Committees.
**Key Points / Main Content**
* **Rule Title and Commencement:**
* The proposed rules are called "New Drugs and Clinical Trials (... Amendment) Rules, 2026."
* They will come into force on the date specified by the Government upon final publication in the Official Gazette.
* **Amendments to the New Drugs and Clinical Trials Rules, 2019:**
* Sub-rule (3) of rule 17 is to be omitted.
* Sub-rule (4) of rule 17 is to be replaced with the following:
* The designated authority will scrutinize applications in Form CT-01.
* If requirements are met, the authority will grant final registration to the Ethics Committee in Form CT-03.
* If requirements are not met, the authority will reject the application, providing written reasons.
* **Public Consultation:**
* The notification is published for the information of all persons likely to be affected.
* Objections and suggestions are invited within 30 days of the gazette being made available to the public.
* Submissions should be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, New Delhi, or emailed to drugsdiv-mohfw@gov.in.
**Impact Analysis**
**Ethics Committees:**
* **Impact:** The amendment changes the process by which Ethics Committees are registered under the New Drugs and Clinical Trials Rules.
* **Action Required:** Ethics Committees should familiarise themselves with the new rule and understand the revised process for registration.
**Designated Authorities:**
* **Impact:** They will have to scrutinise applications in Form CT-01 according to the changed procedure.
* **Action Required:** They should follow the procedure detailed in the amendment when evaluating applications for registration.
**Public:**
* **Impact:** Anyone who may be affected by the rules on new drugs and clinical trials.
* **Action Required:** If affected, raise objections and provide suggestions within 30 days of gazette availability.
Key Entities Referenced
New Drugs and Clinical Trials Rules, 2019: The principal rules being amended by this notification related to drug and clinical trial regulation.
Drugs and Cosmetics Act, 1940: The act under which the rules are being amended, granting authority to the government for such changes.
New Delhi: Location where the notification was issued and where objections/suggestions can be addressed.
Ministry of Health and Family Welfare: The ministry responsible for issuing the notification and overseeing the amendment process.
Drugs Technical Advisory Board: The body consulted before proposing amendments to the rules.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-05022026-269847
CG-DxLx-xEG-I0D5H0x2x2x0 26-269847
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 93] नई दिल्ली, मगं लवार, फरवरी 3, 2026/माघ 14, 1947 माघ 13, 1947 26/पौष 17, 1947
No. 93] NEW DELHI, TUESDAY, FEBRUARY 3, 2026/MAGHA 14, 1947 /PAUSHA 17, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 2 फरवरी, 2026
सा.का.जन. 98(अ).—नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म ेंआगे संिोधन करन े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 करत ेहुए, औषजध तकनीकी सलाहकार बोड ड
स े परामि ड के बाि, बनाने का प्रस्ट्ताव करती ह,ै एतद्द्वारा उन सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ै
जिनके प्रभाजवत होन े की संभावना ह,ै और एतद्द्वारा सूजचत दकया िाता ह ै दक उि प्रारूप जनयमों पर भारत के रािपत्र की
प्रजतयां, जिनम ें य े प्रारूप जनयम िाजमल ह,ैं िनता के जलए उपलब्ध कराए िान े की तारीख स े तीस दिनों की अवजध समाप्त
होने पर या उसके बाि जवचार दकया िाएगा।
उपयुडि अवजध के भीतर दकसी भी व्यजि स े 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 मत्रं ालय, भारत सरकार,
यू-6 , वकड हॉल सी ववंग , प्रथम तल , कतडव्य भवन-1 , नई दिल्ली , 110001 को संबोजधत दकया िा सकता ह ै अथवा ई-
मेल के माध्यम स ेdrugsdiv-mohfw@gov.in पर भेिा िा सकता ह।ै
723 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (i) इन जनयमों को नए औषजध और नैिाजनक परीक्षण (...... सिं ोधन) जनयम, 2026 कहा िा सकता ह।ै
(ii) य ेजनयम सरकार द्वारा रािपत्र म ें जनयमों के अंजतम प्रकािन के समय जनर्िडष्ट तारीख स ेलाग ू होंगे।
2. नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म,ें जनयम 17 का उप-जनयम (3) हटा दिया िाएगा।
3. नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म,ें जनयम 17 का उप-जनयम (4) प्रजतस्ट्थाजपत दकया िाएगा,
अथाडत:् ―
“उप-जनयम (1) के तहत प्रपत्र सीटी-01 म ें आवेिन प्राप्त होने पर, उप-जनयम (1) के तहत नाजमत प्राजधकारी
आवेिन के साथ प्रस्ट्तुत दकए गए िस्ट्तावेिों और िानकारी की िांच करेगा, और यदि संतुष्ट हो दक इन जनयमों की
आवश्यकताओं का पालन दकया गया ह,ै तो आचार सजमजत को प्रपत्र सीटी-03 म ें अंजतम पंिीकरण प्रिान करेगा;
या यदि संतुष्ट न हो, तो जलजखत म ें िि ड दकए िाने वाले कारणों के साथ आवेिन को अस्ट्वीकार कर िगे ा”।
[फा.स.ं एक्स. 11014/02/2026-डीआर]
हष ड मंगला, संयुि सजचव
रटप्पणी: मूल जनयम रािपत्र म ेंअजधसूचना संख्या फा.स.ं X.11014/10/2017-डीआर -भाग (1), दिनांक 19 माच ड2019
के तहत प्रकाजित दकए गए थ े और अंजतम बार अजधसूचना संख्या सा.का.जन.…..(ई), दिनांक.…… के तहत
संिोजधत दकए गए थे।
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
1. (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.
2. In the New Drugs and Clinical Trials Rules, 2019, the sub-rule (3) of rule 17 shall be omitted.
3. 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.