Soon, harsher penalties for submitting false data for drug approval
New Delhi: Soon, there will be a stringent action against pharma companies who submit forged or false data for drug approval for sales in the country.
The Drug Technical Advisory Board (DTAB) has proposed stringent action against pharmaceutical companies and individuals submitting misleading or forged data to gain drug approval. As per the proposal, those found guilty will be prohibited from submitting future drug applications in addition to having existing product licenses suspended or revoked.
In its 91st meeting held on August 14, 2024, the board deliberated on proposals to amend the Drugs Rules, 1945, to address the rising issue of false or fabricated documentation during the drug approval process.
During the meeting, members of the DTAB, led by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), including officials from the Central Drugs Standard Control Organization (CDSCO) and other prominent health bodies, stressed the importance of maintaining data integrity in drug submissions.
At present, the Drugs Rules, 1945, do not have specific provisions to punish those submitting false data or fabricated documents to licensing authorities. Recognizing the serious implications of such actions on public health and safety, the board has recommended incorporating a framework to take action against applicants involved in such fraudulent activities.
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The DTAB has recommended that offenders should face significant consequences, including being debarred from submitting future applications, along with the potential suspension or cancellation of the product licenses. The recommendation read;
"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."
Medical Dialogues team had reported that in July this year several pharma and Indian research companies were under scanner for fake generic Viagra data for FDA approval.
