Health Ministry Drafts Rule to Debar Pharma Applicants Submitting Fake or Misleading Documents

The draft is published for the information of all persons likely to be affected thereby, and notice is 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.

According to the proposal, new provisions titled “Debarment of applicant under this part” will be inserted across multiple sections of the Drugs Rules, including Rules 29B, 66B, 84F, 93A, 122DBA, 122Q, and 150L, empowering both Licensing Authorities and the Central Licensing Approving Authority to debar individuals or firms for a period deemed appropriate if found guilty of furnishing false or misleading information in connection with licensing, manufacturing, or related approvals.

The draft rules mandate that before issuing such an order, the concerned authority must give the applicant an opportunity to show cause and communicate the reasons in writing. Aggrieved applicants may appeal within thirty days to the respective government, which will conduct an inquiry and provide a hearing before passing a final order.

The Ministry has invited objections and suggestions from stakeholders within thirty days of the Gazette publication. Submissions may be sent to the Director (Drugs Regulation), MoHFW, at Room No. 407, A Wing, Nirman Bhavan, New Delhi – 110011, or emailed to drugsdiv-mohfw@gov.in

Following is the 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 subsection (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board.

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 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 the 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 Licensing Authority for such period as deemed fit.

(2) Where an applicant is aggrieved by an order made by the Central Licensing Approving Authority or 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 inquiry as it considers necessary and after affording an opportunity of being heard, pass such orders as are 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 the 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 Licensing Authority for such period as deemed fit.

(2) Where an applicant is aggrieved by an order made by the Central Licensing Approving Authority or 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 inquiry as it considers necessary and after affording an opportunity of being heard, pass such orders as are considered appropriate.