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Drafts Rules for Debarment for submitting misleading, fake fabricated Information

Drafts Drugs Rules for Debarment for submitting misleading, fake fabricated Information

 

The Ministry of Health and Family Welfare has issued notification of Draft Rules to Drugs Rules, 1945 vide GSR 756 (E) dated 16.10.2025. Accordingly, it is proposed to insert Rules 29B, 66B, 84F, 93A, 122DBA, 122Q, 150L in the Drugs Rules, 1945.

 

Thereby, it is proposed to authorise Licensing Authority for debarment of applicant or any person on his behalf, is found to be guilty of submitting misleading or fake or fabricated documents or information.

 

The Licensing Authority is required to give an opportunity to show cause as to why such order of debarment should not be made. The period of debarment shall be as deemed fit by the Licensing Authority.

 

The provision for appeal on such order of the Licensing Authority is also proposed. The appeal can be filed, by the aggrieved, before the Government to be submitted within 30 days from receipt of the order.

 

Objections and suggestions on the said draft rules may be sent within thirty days of publication (i.e. till 27.11.2025) to Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.