**Executive Summary**
This document is a notification from the Ministry of Health and Family Welfare regarding proposed amendments to the New Drugs and Clinical Trials Rules, 2019. The notification, dated January 20, 2026, invites objections and suggestions on the draft rules within 30 days from the date of availability of the Gazette copy to the public. The rules come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.
**Key Points / Main Content**
* **Rule Amendment:**
* The document proposes to amend the New Drugs and Clinical Trials Rules, 2019.
* These rules can be called the New Drugs and Clinical Trials (...... Amendment) Rules, 2025.
* **Effective Date:**
* The rules will come into force on a date specified by the government upon final publication in the Official Gazette.
* **Specific Amendment to the Rules:**
* In the New Drugs and Clinical Trials Rules, 2019, in the Second Schedule, Table 2, paragraph 4.2(4), after "intravenous infusion and injectables," insert "except when the test product, in respect of its excipients, is qualitatively and quantitatively same as reference product".
* **Public Consultation:**
* The notification solicits objections and suggestions from individuals potentially affected by the proposed amendments.
* The deadline for submitting objections/suggestions is 30 days from the date the Gazette copies are made available to the public.
* Objections/suggestions should be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, New Delhi, via postal mail or email.
**Impact Analysis**
**Stakeholder**: Manufacturers of Drugs and Clinical Trial Products
* **Impact**: The insertion of the clause "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," potentially affects requirements for clinical trials.
* **Action Required**: Review the proposed amendment to assess the impact on current and future clinical trial protocols for intravenous infusion and injectable drug products.
**Stakeholder**: General Public/Interested Parties
* **Impact**: The notification informs the public about proposed changes to regulations concerning new drugs and clinical trials.
* **Action Required**: Review the proposed amendment and submit any objections or suggestions to the Ministry of Health and Family Welfare within 30 days of the Gazette copy being available.
Key Entities Referenced
New Drugs and Clinical Trials Rules, 2019: The primary legislation being amended by this notification, concerning drug and clinical trial regulations.
Drugs and Cosmetics Act, 1940: The original Act providing the legal framework for drug regulation in India, empowering the government to create and amend rules.
Ministry of Health and Family Welfare: The government ministry responsible for issuing and overseeing the rules and regulations related to drugs and clinical trials.
New Delhi: The location from which the notification is issued, and where objections and suggestions are to be addressed.
Drugs Technical Advisory Board: A board consulted by the central government before making changes to the New Drugs and Clinical Trials Rules, 2019.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-27012026-269566
CG-DxLx-xEG-I2D7H0x1x2x0 26-269566
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.ं 45] नई दिल्ली, मगं लवार, िनवरी 20, 2026/पौष 30, 1947 25/आषाढ़ 3, 1947
No. 45] NEW DELHI, TUESDAY, JANUARY 20, 2026/PAUSHA 30, 1947 SHADHA 3, 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 20 िनवरी, 2026
सा.का.जन. 45(अ).—नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म ें आग े 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 करत े हुए, औषजध तकनीकी
सलाहकार बोड ड स े परामि ड के बाि, बनान े का प्रस्ट्ताव करती ह,ै उन सभी व्यजियों की िानकारी के जलए एतद्द्वारा प्रकाजित
दकया िाता ह ैजिन पर इसका प्रभाव पड़न े की संभावना ह,ै
और एतद्द्वारा सूचना िी िाती ह ैदक उि प्रारूप जनयमों पर उस तारीख स े तीस दिनों की अवजध समाप्त होने पर
या उसके बाि जवचार दकया िाएगा जिस पर इन प्रारूप जनयमों वाले भारत के रािपत्र की प्रजतया ं िनता को उपलब्ध करा
ई िाती ह।ैं
उपयुडि जनर्िष्टड 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 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-मले के
माध्यम से drugsdiv-mohfw@gov.in पर भेिा िा सकता ह।ै
427 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
प्रारूप जनयम
1. (क) इन जनयमों को नए औषजध और निै ाजनक परीक्षण (...... संिोधन) जनयम, 2025 कहा िा सकता ह।ै
(ख) य े जनयम सरकार द्वारा आजधकाररक रािपत्र म ेंजनयमों के अंजतम प्रकािन के समय जनर्िडष्ट तारीख स ेलाग ू होंगे।
2. नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म,ें िसू री अनुसूची की ताजलका 2 के पैरा 4.2 के 4 के तहत,
"अंतःजिरा आसव और इंिेक्िन योग्य" िब्िों के बाि "जसवाय िब परीक्षण उत्पाि, अपन े सहायक पिाथों के संबंध म,ें
संिभड उत्पाि के समान गुणात्मक और मात्रात्मक रूप स े हो" िब्ि सजममजलत दकए िाएंगे।
[फा. स.ं एक्स.11014/15/2025-डीआर]
हष ड मंगला, संयुि सजचव
रिप्पणी: मूल जनयम आजधकाररक रािपत्र म ें अजधसूचना संख्या फा.स.ं एक्स.11014/10/2017-डीआरएस -भाग (1),
दिनांक 19 माच ड 2019 के तहत प्रकाजित दकए गए थ े और अंजतम बार अजधसूचना संख्या सा.का.जन.…..(अ),
दिनांक.…… के तहत संिोजधत दकए गए थे।
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.