Central Government, after consultation with the Drugs Technical Advisory Board, amended the Drugs Rules, 1945 by inserting a definition of “debarment” and debarment provisions across multiple Parts of the Rules. A draft was published on October 16, 2025, and made available to the public on October 28, 2025. Objections and suggestions received from the public were considered prior to finalisation.

Under Rule 2, the following definition is inserted after sub-rule (b):

‘(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;’

The following debarment rules are inserted after the respective existing rules in each Part:

Rule 29B (after Rule 29A); Rule 66B (after Rule 66A); Rule 84F (after Rule 84E); Rule 93A (after Rule 93); Rule 122 DBA (after Rule 122DB); Rule 122Q (after Rule 122P); Rule 150L (after Rule 150K).

The text of each inserted rule is as follows (sub-rule (1) is common to all; sub-rule (2) applies except where noted):

“(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 [or Central Licensing Approving Authority, where applicable] 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.”

Note: Rule 122 DBA does not contain sub-rule (2).

The authority for debarment is the Licensing Authority in respect of Rules 29B, 66B, and 122 DBA. The Central Licensing Approving Authority or Licensing Authority is the debarring authority for Rules 84F, 93A, 122Q, and 150L.

The Drugs Rules, 1945 were last amended vide G.S.R. 607(E) dated July 8, 2026.