Finalization of draft notification GSR 756 E regarding debarment for applicants who submit fake data

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-05082026-275233 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 642] NEW DELHI, WEDNESDAY, AUGUST 5, 2026/SHRAVAN 14, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 30th July, 2026 G.S.R. 706(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 756 (E), dated the 16th October, 2025, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; Whereas, copies of the said Gazette were made available to the public on the 28th October, 2025; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely: 1. (i) These rules may be called the Drugs (Eleventh Amendment) Rules, 2026. (ii) These rules shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules, 1945, (a) under rule 2, after sub-rule (b), the following sub-rule shall be inserted, namely: '(bb) "debarment" means the prohibition, exclusion, or disqualification of any person, firm, or entity from engaging in the import of drugs, manufacture for sale or for distribution, sell, stock or exhibit or offer for sale, or distribute, for a specified period or permanently as a consequence to the violation of statutory provisions;'; (b) after rule 29A, the following rule shall be inserted, namely: "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 or information under this part, 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 may be 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 may be considered appropriate."; (c) after rule 66A, the following rule shall be inserted, namely: "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 or information under this part, 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 may be 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 may be considered appropriate."; (d) after rule 84E, the following rule shall be inserted, namely: "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 or information under this part, 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 may be 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 may be considered appropriate."; (e) after rule 93, the following rule shall be inserted, namely: "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 or information under this part, 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 may be 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 may be considered appropriate."; (f) after rule 122DB, the following rule shall be inserted, namely: "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 or information under this part, 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 may be deemed fit."; (g) after rule 122P, the following rule shall be inserted, namely: "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 or information under this part, 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 may be 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 may be considered appropriate."; (h) after rule 150K, the following rule shall be inserted, namely: - "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 or information under this part, 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 may be 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 may be considered appropriate.". [F. No. X.11014/07/2025-DR] HARSH MANGLA, Jt. Secy. Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H(1), dated the 21st December, 1945 and last amended vide notification number G.S.R. 607(E), dated the 8th July, 2026.