NEW DELHI: Drug manufacturers found submitting fake or fabricated data to obtain regulatory approval can now be debarred from filing future applications, following stricter rules notified by the Union Health Ministry to strengthen the integrity and transparency of India's drug regulatory system.
Officials said the amendment aims to deter malpractice, strengthen accountability and ensure that drug approvals are based on reliable and scientifically valid evidence.
The ministry has notified amendments to the Drugs Rules, 1945 through G.S.R. No. 756(E), dated October 16, 2025. Besides the existing enforcement provisions under the Drugs and Cosmetics Act, 1940, the amended rules empower the licensing authority to debar entities that submit fake or fabricated data in support of their applications.
The provision will apply to all applications filed under various provisions of the Drugs Rules, 1945.
At present, applicants submitting fabricated data face action such as rejection of applications or cancellation of existing licences. Under the amended rules, they can also be barred from filing further applications before the concerned state or central regulatory authority for a specified period.
The rules provide for the issuance of a show-cause notice before any such action is taken and also include a provision for appeal.
Officials said sound scientific data submitted by applicants forms the basis for evaluating the quality, safety and efficacy of drugs.
“Submission of fake or fabricated data compromises the integrity of the regulatory process, casts aspersions over the quality of drugs and may pose serious risks to public health,” officials added.
Officials said the notification is in line with the government's efforts to strengthen India's regulatory framework in accordance with global best practices.
It aims to promote drug manufacturers and distributors who comply with the country's regulatory framework and deal with reported instances of malpractice.
They added that the amendment complements ongoing regulatory reforms in the pharmaceutical sector with a renewed focus on enhancing oversight, promoting ethical practices and ensuring that unscrupulous entities are adequately penalised.
