Proposal regarding submission of Periodic Safety Update Reports annually for subsequent years till the drug product is marketed
The Gazette of India
CG-DL-E-25062026-273835
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 453] NEW DELHI, MONDAY, JUNE 22, 2026/ASADHA 1, 1948
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.
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.……
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