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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-04022026-269818
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 92]
NEW DELHI, TUESDAY, FEBRUARY 3, 2026/MAGHA 14, 1947
722 GI/2026
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd February, 2026
G.S.R. 97(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, 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. (i) In the New Drugs and Clinical Trials Rules, 2019, after clause (ix) of rule 77, following clause
shall be inserted namely: -
"(x) In the event of any change in manufacturing process, or excipients, or packaging, or shelf life,
or specifications, or testing, or documentation etc. as the case may be, the manufacturer or his
authorized agent shall inform the licensing authority in writing for such changes.
Provided that;
a) In case of any major quality change (Level I), the manufacturer shall obtain prior
approval from the licensing authority, where the change has a substantial potential to
have an adverse impact on the identity, strength, quality, purity, or potency of a drug
product.
b) In case of any moderate quality change (Level II), the manufacturer shall obtain prior
approval from the licensing authority, where the change has a moderate potential to
have an adverse impact on the identity, strength, quality, purity, or potency of a drug
product.
c) In case of minor quality changes (Level III), the manufacturer shall implement the
change without prior approval from the licensing authority (except for cases of change
in shelf life of drug substance and drug product), where the change has a minimal
potential to have an adverse impact on the identity, strength, quality, purity, or potency
of a drug product. The annual submission shall be made to licensing authority by 1st
quarter of every calendar year."
3. (ii) In the New Drugs and Clinical Trials Rules, 2019, after clause (viii) of rule 82, following clause
shall be inserted namely: -
"(ix) In the event of any change in manufacturing process, or excipients, or packaging, or shelf life,
or specifications, or testing, or documentation etc. as the case may be, the manufacturer shall
inform the licensing authority in writing for such changes.
Provided that;
a) In case of any major quality change (Level I), the manufacturer shall obtain prior
approval from the licensing authority, where the change has a substantial potential to
have an adverse impact on the identity, strength, quality, purity, or potency of a drug
product.
b) In case of any moderate quality change (Level II), the manufacturer shall obtain prior
approval from the licensing authority, where the change has a moderate potential to
have an adverse impact on the identity, strength, quality, purity, or potency of a drug
product.
c) In case of minor quality changes (Level III), the manufacturer shall implement the
change without prior approval from the licensing authority (except for cases of change
in shelf life of drug substance and drug product), where the change has a minimal
potential to have an adverse impact on the identity, strength, quality, purity, or potency
of a drug product. The annual submission shall be made to licensing authority by
1st quarter of every calendar year."
[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.......