Government amends drug rules to debar firms submitting fake data for approvals

The Centre has amended the Drugs Rules, 1945, to empower licensing authorities to debar applicants who submit fake or fabricated data in support of applications for regulatory approvals, a move aimed at strengthening the integrity and transparency of India’s drug regulatory system.

The Union Health Ministry said the amendments, notified through GS R 756(E), introduce a new enforcement mechanism in addition to the existing provisions under the Drugs and Cosmetics Act, 1940. Under the amended rules, applicants found to have submitted fabricated data may be barred from filing fresh applications with the concerned licensing authority, either the Centre or the state regulator, as applicable, for a specified period.

“In addition to existing enforcement provisions under the Drugs and Cosmetics Act, 1940, these newly notified provisions empower the Licensing Authority to debar further applications by entities who submit fake or fabricated data in support of their applications.

“This will apply to all applications filed under various provisions of the Drugs Rules 1945,” the ministry said in a statement. Currently, applicants who submit fabricated data face enforcement actions such as rejection of their applications or cancellation of existing licenses.

With this amendment, they will be barred from submitting further applications to the concerned regulatory authority, either the state or the Centre (as applicable), for a specified duration.

Before any punitive action is taken, due process is ensured through the issuance of a show-cause notice. There is also a provision for appeal, according to the statement.

Sound scientific data submitted by applicants forms the basis for regulatory evaluation of the quality, safety and efficacy of drugs, the statement said.

The 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, it said.

“The present amendment is intended to deter such misconduct, strengthen accountability among applicants and ensure that approvals of drugs are backed by reliable and scientifically valid evidence.

“The notification is in line with the Government’s efforts to strengthen India’s regulatory framework in accordance with global best practices, the statement said.

It aims to promote drug manufacturers and distributors who are compliant with the regulatory framework and endeavours to deal with any reported instances of malpractice.

It complements the ongoing regulatory reform in the pharmaceutical domain with renewed focus on enhancing oversight, promoting ethical practices and ensuring that unscrupulous entities are adequately penalised.