**Executive Summary**
The Ministry of Health and Family Welfare has issued a draft notification for the New Drugs and Clinical Trial (Amendment) Rules, 2026, to modify reporting timelines for Periodic Safety Update Reports (PSUR). The proposal amends the Fifth Schedule of the 2019 Rules to establish specific frequencies for safety updates post-drug approval. Stakeholders are invited to submit objections or suggestions within 30 days of the draft's publication.
**Key Points / Main Content**
**Proposed Regulatory Framework**
* The draft rules are titled the New Drugs and Clinical Trial Rules, 2019 (…… Amendment) Rules, 2026.
* The rules will come into force on a date specified by the Government upon final publication in the Official Gazette.
* A new proviso is inserted into the Fifth Schedule after paragraph 1 (5) (C) (iii) of the principal rules.
**PSUR Submission Requirements for New Drugs under Rule 2 (1) (w) (iv)**
* **Initial Two Years:** Applicants must submit periodic safety update reports every six months after the drug is granted approval.
* **Subsequent Two Years:** Reports must be submitted annually for the next two years.
* **Long-term Reporting:** Thereafter, reports must be submitted once every three years until the drug product is marketed.
**PSUR Submission Requirements for New Drugs under Rule 2 (1) (w) (v)**
* **Initial Two Years:** Reports are required every six months for the first two years following drug approval.
* **Subsequent Period:** Reports must continue to be submitted annually until the drug product is marketed.
**Public Consultation Process**
* The Central Government will consider objections and suggestions received within 30 days from the date the Gazette copies are made available to the public.
* Feedback can be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or submitted via email to drugsdiv-mohfw@gov.in.
**Impact Analysis**
**Pharmaceutical Applicants and Drug Manufacturers**
**Impact**
Applicants are subject to revised and specific intervals for monitoring and reporting the safety of new drugs. The amendment mandates a structured transition from semi-annual to annual or triennial reporting depending on the drug category and marketing status.
**Action Required**
Must review the updated submission schedules to ensure compliance and submit any objections or suggestions to the Ministry within the 30-day consultation window.
**Regulatory Authorities (Central Government/Drugs Technical Advisory Board)**
**Impact**
The government is responsible for reviewing public feedback and finalizing the implementation date of these safety reporting amendments.
**Action Required**
Must collect, consider, and process all objections and suggestions received within the specified timeframe before final notification.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-25062026-273835
CG-DxLx-xEG-I2D5H0x6x2x0 26-273835
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.ं 453] नई दिल्ली, सोमवार, िनू 22, 2026/आषाढ 1, 1948
No. 453] NEW DELHI, MONDAY, JUNE 22, 2026/ASADHA 1, 1948
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 22 िून, 2026
सा.का.जन. 504(अ).— नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म ेंऔर 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 बोडड स े
परामि डके बाि बनाना प्रस्ट्ताजवत करती ह,ै एतद्द्वारा उन सभी व्यजियों की िानकारी के जलए प्रकाजित दकया िाता ह ैजिनके
इससे प्रभाजवत होन ेकी संभावना ह,ै और एतद्द्वारा नोरिस दिया िाता ह ैदक उि प्रारूप जनयमों पर उस तारीख स ेतीस दिनों
की अवजध की समाजि पर या उसके बाि जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयमों वाल ेभारत के रािपत्र की
प्रजतयां िनता को उपलब्ध कराई िाती ह।ैं
उपयुडि जनर्िष्टड अवजध के भीतर दकसी भी व्यजि स े प्राि होन े 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 ववगं , पहली मंजिल, कतडव्य भवन-1, नई दिल्ली, 110001 को या drugsdiv-mohfw@gov.in पर
ईमेल दकए िा सकते ह।ैं
4611 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 जनयम, 2019 (...... संिोधन) जनयम, 2026 कहा िा सकता ह।ै
(ii) य ेजनयम रािपत्र म ें जनयमों के अंजतम प्रकािन के समय सरकार द्वारा जनर्िडष्ट तारीख स े प्रवृत्त होंगे।
2. नए औषजध और नैिाजनक परीक्षण जनयम, 2019 म,ें परै ा 1 (5) (सी) (iii) के बाि पाचं वीं अनुसूची म ें जनम्नजलजखत
परंतुक अंतःस्ट्थाजपत दकया िाएगा:
परंत ु यह दक:
क. नए औषजधयों के जलए िैसा दक नए औषजध और नैिाजनक परीक्षण जनयम, 2019 के जनयम 2 (1)
(डब्ल्य)ू के खंड (iv) के तहत जवस्ट्तृत ह,ै "आवजधक सुरक्षा अद्यतन ररपोिड औषजध के अनुमोिन के बाि आवेिक को
प्रिान दकए िान े के पहले िो वषों के जलए हर छह महीने म ें प्रस्ट्तुत की िाएगी। अगल े िो वषों के जलए, आवजधक
सुरक्षा अद्यतन ररपोिड वार्षडक रूप स ेप्रस्ट्तुत की िाती रहगे ी और उसके बाि औषजध उत्पाि के जवपणन तक प्रत्यके
तीन वषड म ेंएक बार प्रस्ट्तुत की िाएगी।
ख. नए औषजधयों के जलए िैसा दक नए औषजध और नैिाजनक परीक्षण जनयम, 2019 के जनयम 2 (1)
(डब्ल्य)ू के खडं (v) के तहत जवस्ट्तृत ह,ै "आवजधक सुरक्षा अद्यतन ररपोिड औषजध के अनुमोिन के बाि आवेिक को
प्रिान दकए िाने के पहले िो वषों के जलए हर छह महीने म ें प्रस्ट्तुत की िाएगी। अगले वषों के जलए, आवजधक
सुरक्षा अद्यतन ररपोिड औषजध उत्पाि के जवपणन तक वार्षडक रूप स े प्रस्ट्तुत की िाती रहगे ी।
[फा. सं. एक्स.11014/07/2026-डीआर]
हष ड मंगला, संयुि सजचव
रिप्पणी: मलू जनयम रािपत्र म ें अजधसूचना संख्या ………., दिनांक ………………….. द्वारा प्रकाजित दकए गए थ े और
अंजतम बार अजधसूचना संख्या सा.का.जन.…..(अ), दिनांक.…… द्वारा संिोजधत दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 22nd June, 2026
G.S.R. 504(E).— The following draft of certain rules further to amend the New Drugs and Clinical Trial 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.[भाग II—खण् ड 3(i)] भारत का रािपत्र : असाधारण 3
DRAFT RULES
1. (i)These rules may be called the New Drugs and Clinical Trial Rules, 2019 (...... 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 Trial Rules, 2019, following proviso shall be inserted in Fifth schedule after para 1 (5)
(C) (iii):
Provided that:
a. For new drugs as detailed under (iv) of Rule 2 (1) (w) of the New Drugs and Clinical Trial Rules, 2019, "the
periodic safety update reports shall be submitted every six months for the first two years after approval of the
drug is granted to the applicant. For subsequent two years, the periodic safety update reports shall continue to
be submitted annually and thereafter once every three years until the drug product is marketed.
b. For new drugs as detailed under (v) of Rule 2 (1) (w) of the New Drugs and Clinical Trial Rules, 2019, "the
periodic safety update reports shall be submitted every six months for the first two years after approval of the
drug is granted to the applicant. For subsequent years, the periodic safety update reports shall continue to be
submitted annually until the drug product is marketed.
[F. No. X.11014/07/2026-DR]
HARSH MANGLA, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. ………., dated the
…………………..and last amended vide notification number G.S.R.…..(E), dated the.……
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.