Union health and family welfare ministry has notified amendments to the Drugs Rules, 1945, empowering the licensing authority to debar further applications by pharmaceutical manufacturers that submit fake or fabricated data for the evaluation of the quality, safety, and efficacy of drugs.

Sound scientific data are the basis for regulatory evaluation of the quality, safety and efficacy of drugs.

An applicant submitting fabricated data earlier faced actions such as rejection of applications or cancellation of licenses. With the amendments, they would be debarred from filing further applications with the concerned regulatory authority, either in states or at the Centre as applicable, for a specified period.

In a statement issued on Thursday, the ministry called the amendments a significant step towards strengthening the integrity and transparency of the drugs regulatory system. It added that in addition to existing enforcement provisions under the Drugs and Cosmetics Act, 1940, the newly notified provisions empower the licensing authority to debar further applications by entities submitting 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 due process has been prescribed through the issuance of show-cause notices before any punitive action is taken. There is also a provision for appeals.

The ministry said sound scientific data submitted by applicants forms the basis for regulatory evaluation of 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.”

The ministry said the amendments are intended to deter misconduct, strengthen accountability among applicants and ensure that approvals of drugs are backed by reliable and scientifically valid evidence.

The government has amended the Drugs and Cosmetics Act, 1945, to introduce stricter norms to ensure quality and safety of drugs being manufactured in India.

The ministry said the fresh notification is in line with the government’s efforts to strengthen the regulatory framework in accordance with global best practices. “It aims to promote those drug manufacturers and distributors who are compliant with the regulatory framework and endeavours to deal with any reported instances of malpractice,” said the health ministry. “It complements the ongoing regulatory reform in the pharmaceutical domain with a renewed focus on enhancing oversight, promoting ethical practices and ensuring that unscrupulous entities are adequately penalised.”