New Delhi:In a major regulatory move aimed at tightening compliance and accountability within India's pharmaceutical licensing framework, the Ministry of Health and Family Welfare (MoHFW) has issued draft rules to amend the Drugs Rules, 1945, introducing provisions for debarment of applicants found guilty of submitting fake, fabricated, or misleading documents. The draft notification—G.S.R. 756(E), dated October 16, 2025 — was published by the Department of Health and Family Welfare, exercising powers under the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB). 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