Soon, harsher penalties for submitting false data for drug approval

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.

Also Read: Delhi Police Crack Down On Fake Cancer Drug Racket, 7 Arrested

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.

Also Read: Several pharma, Indian research companies under scanner for faking generic Viagra data for FDA approval: Bloomberg report