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The Union ministry of health and family welfare has notified amendment to certain rules under the Drugs Rules, 1945 to debar those who submit misleading or fake or fabricated documents or information to the licensing authority as part of their application for various regulatory approvals.
The amendment is to add provisions for such debarment of applicants from various activities including manufacturing, sales, clinical trial and testing, among others, along with provisions for the applicant to appeal against such an action.
The draft to the amendments were released in the Official Gazette on October 28, 2025 and the Ministry said that it has considered the objections and suggestions received from the public on the draft rules.
The final notification inserts the definition of debarment under the Rule 2 of the Drugs Rules, elaborating that the term "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 provision for debarment of applicant for various processes has been added as Rules 29B, 66B, 84F, 93A, 122DBA, 122Q, and 150L, with the Sub Rule (1) stating, "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 for such period as may be deemed fit. "
An appeal provision will also be added as Sub Rule (2) to the newly inserted rules, stating, "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."
The draft specifically mentioned central licensing authority in both the sub rules, which has been removed from the final notification.
Rule 29 under the Drugs Rules, 1945, deals with provisions for suspension and cancellation of import license, Rule 66 deals with cancellation and suspension of license for sale of drugs other than homoeopathic medicines, Rule 84 deals with provisions for manufacture of drugs for sale notwithstanding that such drugs are manufactured for sale outside India, Rule 93 deals with cancellation of license for manufacture for examination, test or analysis, while Rule 122 DB deals with suspension or cancellation of permission or approval for import or manufacture of new drug for clinical trials or marketing.
Rule 122Q is related to licensing of blood centres and related manufacturing, processing, testing, storage and other activities, while Rule 150 L is related to institutions carrying out tests on drugs and raw materials.
It may be noted that the Drugs Technical Advisory Board (DTAB) has earlier considered the situation that there is no provision under the Drugs Rules to address the issue of applicants submitting forged or fabricated, misleading data or documents, etc., for obtaining the regulatory approvals.
The Board deliberated a proposal to make provisions in the Drugs Rules for taking action against such applicants, and in a meeting held on August 14, 2024, recommended that in such cases, the applicant may be debarred for submitting forged or fabricated, misleading data or document, etc. to licensing authority in addition to suspension or cancellation of the product as applicable.
While the Board was informed that there is no provision under the Rules to address the issue, according to information available, the drug regulatory authority has been following the method of rejecting the application and debarring the applicant from applying to any of its offices for any purpose for a period of five years.
According to reports, there were several instances in the past where an applicant company was alleged to be submitting forged or fake documents with the drug regulatory authority.
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