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Centre to amend Drugs Rules to tackle submission of forged data or documents
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Gireesh Babu, New Delhi
October 09 , 2024
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The drug regulatory authority may tighten the provisions against those who submit misleading or fake documents to the licensing authority as part of their application for regulatory approvals through an amendment of the existing Drug Rules.
At present, 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 Drugs Technical Advisory Board (DTAB), the body that advises the Central and state governments on technical matters related to drugs in the country, has lately considered this situation and deliberated a proposal to make provisions in the Drugs Rules for taking action against such applicants.
DTAB, following its latest meeting held on August 14, 2024, said that it has deliberated the matter and "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.
It may be noted that there were several instances where an applicant company was alleged to be submitting forged or fake documents with the drug regulatory authority. According to reports, the drug regulator has also questioned some of the multinationals in 2014, in connection with filing documents which are "fraudulent" in nature.
The Union health ministry, in 2015, also initiated efforts to tighten the provisions under the Schedule Y of Drugs Rules, 1945, as a measure to confirm the authenticity of the data or documents submitted by the applicant.
Pharmabiz has reported during the time that the Note under Schedule Y provides that only authentic data should be submitted for the application for permission to import and/or manufacture new drugs for sale or to undertake clinical trials. The data is required to be self certified. It also provides that the licensing authority reserves the right to reject any data or any document(s) if such data or content of such document are found to be of doubtful integrity.
However, the above provision does not explicitly provide for the administrative action which could be taken in case any data on documents submitted is found to be of doubtful integrity. This was discussed in the DTAB during the time and the Board has agreed to the proposed amendment.
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