The Ministry of Health and Family Welfare has published draft rules proposing stringent penalties, including the debarment of applicants, found guilty of submitting misleading, fake, or fabricated documents and information across various regulatory parts of the Drugs Rules, 1945.
The proposed amendments, titled the Drugs (… Amendment) Rules, 2025, aim to enhance accountability and the integrity of the regulatory process for drugs, cosmetics, and medical devices.
New Debarment Provisions
The draft rules systematically insert new “Debarment of applicant” clauses (Rules 29B, 66B, 84F, 93A, 122DBA, 122Q, and 150L) into several critical parts of the Drugs Rules, 1945. These clauses grant the respective Licensing Authorities the power to bar applicants who commit fraud in their submissions.
Under these proposed rules:
- An applicant, or any person acting on their behalf, found guilty of submitting misleading, fake, or fabricated documents or information may be debarred.
- The debarment order may be made by the Licensing Authority (LA), the Central Licensing Approving Authority (CLAA), or the Central Licensing Authority (CLA), depending on the regulatory part under which the application falls.
- An order for debarment can only be made after giving the applicant an opportunity to show cause as to why such an order should not be made, and the order must be issued in writing, stating the reasons thereof.
- The applicant may be debarred for such period as deemed fit by the Licensing Authority.
Right to Appeal
The draft rules establish a clear appeal mechanism for any applicant aggrieved by a debarment order:
- An aggrieved applicant may make an appeal to the respective Government (Central or State) within thirty days from the receipt of the debarment order.
- The Government, after conducting an inquiry and affording the applicant an opportunity of being heard, may pass appropriate orders.
This comprehensive amendment covers critical areas including the import, manufacturing, sale, and clinical trials of various drugs and devices, significantly strengthening the deterrent against fraudulent documentation within the pharmaceutical regulatory process.
Public Consultation
The draft rules are published for public consultation. The Central Government will consider objections and suggestions received within a period of thirty days from the date the copies of the Gazette (published on October 16, 2025) are made available. Objections and suggestions may be addressed to the Director (Drugs regulation), Ministry of Health and Family Welfare, or emailed to drugsdiv-mohfw@gov.in.