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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-28102025-267196
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 672]
NEW DELHI, THURSDAY, OCTOBER 16, 2025/ASVINA 24, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 16th October, 2025
G.S.R. 756(E). -The following draft of certain rules further to amend the Drugs Rules, 1945, 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 Director (Drugs regulation), Ministry of
Health and Family Welfare, Government of India, Room No. 407, A Wing, Nirman Bhavan, New Delhi - 110011
or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.
(ii) These rules shall come into force at the time of final publication of the rules in the Official Gazette.
2. In the Drugs Rules, 1945, after the rule 29A following rule shall be inserted:
29B. Debarment of applicant under this part:
(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting
misleading, or fake, or fabricated documents/ information, may, after giving him an opportunity to show
cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
Licensing Authority for such period as deemed fit.
(2) Where an applicant is aggrieved by an order made by the Licensing Authority under sub-rule (1), such
applicant may, within thirty days from the receipt of the order, make an appeal to that Government and that
Government, may, after such enquiry as it considers necessary, and after affording an opportunity of being
heard, pass such orders as considered appropriate.
3. In the Drugs Rules, 1945, after the rule 66A following rule shall be inserted:
66B. Debarment of applicant under this part:
(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting
misleading, or fake, or fabricated documents/ information, may, after giving him an opportunity to show
cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
Licensing Authority for such period as deemed fit.
(2) Where an applicant is aggrieved by an order made by the Licensing Authority under sub-rule (1), such
applicant may, within thirty days from the receipt of the order, make an appeal to that Government and that
Government, may, after such enquiry as it considers necessary, and after affording an opportunity of being
heard, pass such orders as considered appropriate.
4. In the Drugs Rules, 1945, after the rule 84E following rule shall be inserted:
84F. Debarment of applicant under this part:
(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting
misleading, or fake, or fabricated documents/ information, may, after giving him an opportunity to show
cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
Central Licensing Approving Authority or Licencing Authority for such period as deemed fit.
(2) Where an applicant is aggrieved by an order made by the Central Licensing Approving Authority or
Licencing Authority under sub-rule (1), such applicant may, within thirty days from the receipt of the order,
make an appeal to that Government and that Government, may, after such enquiry as it considers necessary,
and after affording an opportunity of being heard, pass such orders as considered appropriate.
5. In the Drugs Rules, 1945, after the rule 93 following rule shall be inserted:
93A. Debarment of applicant under this part:
(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting
misleading, or fake, or fabricated documents/ information, may, after giving him an opportunity to show
cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
Central Licensing Approving Authority or Licencing Authority for such period as deemed fit.
(2) Where an applicant is aggrieved by an order made by the Central Licensing Approving Authority or
Licencing Authority under sub-rule (1), such applicant may, within thirty days from the receipt of the order,
make an appeal to that Government and that Government, may, after such enquiry as it considers necessary,
and after affording an opportunity of being heard, pass such orders as considered appropriate.
6. In the Drugs Rules, 1945, after the rule 122DB following rule shall be inserted:
122 DBA. Debarment of applicant under this part: Whoever himself or, any other person on his behalf,
or applicant is found to be guilty of submitting misleading, or fake, or fabricated documents/ information,
may, after giving him an opportunity to show cause as to why such an order should not be made, in writing,
stating the reasons thereof, be debarred by the Licencing Authority for such period as deemed fit.
7. In the Drugs Rules, 1945, after the rule 122P following rule shall be inserted:
122Q. Debarment of applicant under this part:
(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting
misleading, or fake, or fabricated documents/ information, may, after giving him an opportunity to show
cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
Central Licensing Approving Authority or Licencing Authority for such period as deemed fit.
(2) Where an applicant is aggrieved by an order made by the Central Licensing Approving Authority or
Licencing Authority under sub-rule (1), such applicant may, within thirty days from the receipt of the order,
make an appeal to that Government and that Government, may, after such enquiry as it considers necessary,
and after affording an opportunity of being heard, pass such orders as considered appropriate.
8. In the Drugs Rules, 1945, after the rule 150K following rule shall be inserted:
150L. Debarment of applicant under this part:
(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting
misleading, or fake, or fabricated documents/ information, may, after giving him an opportunity to show
cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
Central Licensing Approving Authority or Licencing Authority for such period as deemed fit.
(2) Where an applicant is aggrieved by an order made by the Central Licensing Approving Authority or
Licencing Authority under sub-rule (1), such applicant may, within thirty days from the receipt of the order,
make an appeal to that Government and that Government, may, after such enquiry as it considers necessary,
and after affording an opportunity of being heard, pass such orders as considered appropriate.
[F.No. X.11014/07/2025-DR]
NIKHIL GAJRAJ, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated
21st the December, 1945 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.
GORAKHA NATH
YADAVA
Digitally signed by GORAKHA
NATH YADAVA
Date: 2025.10.28 14:50:57 +05'30'