New Delhi: The Union ministry of health and family welfare has come out with a draft of amendment to certain rules under the Drugs and Cosmetics 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, dated October 16, was released in the Official Gazette on October 28 and the Ministry said that it shall be taken into consideration on or after the expiry of a period of 30 days from the date on which the copies of the Gazette of India containing the draft rules are made available to the public.
Objections and suggestions which may be received from any person within this period will be considered by the Central government, it added.
The provision for debarment of applicant will be 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/information, 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 Central Licensing Approving Authority or Licencing Authority for such period as deemed fit.”
However, an appeal provision will also be added as sub Rule (2), which states, “Where an applicant is aggrieved by an order made by the Central Licensing Approving Authority or Licencing 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 considered appropriate.”
Rule 29 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 would be related to licensing of blood centres and related manufacturing, processing, testing, storage and other activities, while Rule 150 L would be related to institutions carrying out tests on drugs and raw materials.
It may be noted that the Drugs Technical Advisory Board (DTAB), the body that advises the Central and state governments on technical matters related to drugs in the country, has earlier considered the situation that there is no provision under the Drugs Rules, 1945 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/fabricated, misleading data/document, etc. to licensing authority in addition to suspension/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.
An order from the fixed dose combination (FDC) division of the Drug Controller General (India) (DCGI) office in the year 2015, shows that it has declared such a decision after issuing a show cause notice.
“In view of facts and circumstances, it is ample clear that you have submitted forged and fabricated data in connivance with your consultant and QA manager. Therefore, your all applications pending in the FDC division are hereby rejected and you are also debarred for applying to any of the offices of CDSCO (Central Drugs Standard Control Organisation) for any purpose for a period of 5 years,” said the order.
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.
