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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-13082024-256319
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 3124]
NEW DELHI, MONDAY, AUGUST 12, 2024/SHRAVANA 21, 1946
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 12th August, 2024
S.O. 3284(E).— Whereas, the Central Government in exercise of the powers conferred by section 26 A of
the Drugs and Cosmetics Act, 1940 (23 of 1940) prohibited the manufacture for sale, sale and distribution for human
use of drug fixed dose combination of Etodolac + Paracetamol vide notification number S.O. 4706 (E), dated the
7th September, 2018, published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section (ii), dated the
7th September, 2018;
And Whereas, the said notification was challenged by M/s. Emcure Pharmaceuticals Ltd. in W.P. (C)
No. 10098/2018 before the High Court of Delhi, claiming that fixed dose combination of S(+) Etodolac +
Paracetamol is not covered under the notification;
And Whereas, the Hon'ble High Court of Delhi has passed judgement dated 22nd January, 2020, the operative
part of the which is reproduced below:-
"This court is of the view that the Impugned Notification, in so far as it is stated to be applicable to the FDC
of S(+) Etodolac + Paracetamol cannot be sustained. The same is set aside. The matter is remanded back to
DTAB/Sub-committee constituted by it to examine the issue regarding the said FDC in accordance with the directions
issued by the Supreme Court in Pfizer Limited and others (Supra). The DTAB/Sub- Committee shall submit its report
to the Central Government who may act thereon in accordance with law.";
And Whereas, the Drugs Technical Advisory Board in its 88th meeting held on 26th September, 2022
deliberated the issue and recommended for constitution of a DTAB Sub- committee to examine the matter in light of
the judgement passed by the Hon'ble Delhi High Court;
And where as, the DTAB Sub-Committee considered the said fixed dose combination as irrational and
recommended for its prohibition in public interest under section 26A of Drugs and Cosmetics Act, 1940;
And Whereas, based on the recommendation of DTAB Sub- committee, matter was further deliberated in
90th meeting of Drugs Technical Advisory Board held on dated 25th January, 2024 and made recommendation for
prohibiting the manufacture, sale and distribution for human use of fixed dose combination of S(+) Etodolac +
Paracetamol;
Now, therefore, on the basis of the recommendations of the Drugs Technical Advisory Board and in exercise
of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government
hereby prohibits the manufacture for sale, sale and distribution for human use of drug fixed dose combination of S(+)
Etodolac + Paracetamol with immediate effect as the said drug is found to have no therapeutic justification and may
involve risk to the human beings.
[F.No. X.11035/485/2017-DRS]
RAJIV WADHAWAN, Advisor (Cost)
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and Published by the Controller of Publications, Delhi-110054.
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