The Centre has strengthened India's drug regulatory framework by empowering licensing authorities to debar companies and applicants that submit fake or fabricated data in support of applications filed under the Drugs Rules, 1945
NEW DELHI — The Centre has strengthened India's drug regulatory framework by empowering licensing authorities to debar companies and applicants that submit fake or fabricated data in support of applications filed under the Drugs Rules, 1945, an official statement said on Thursday.
The Ministry of Health and Family Welfare (MoHFW) said the new provisions have been notified through amendments to the Drugs Rules, 1945, and are aimed at improving transparency, accountability and integrity in the country's drug approval process.
Under the revised rules, applicants found submitting fabricated or misleading data may not only face rejection of applications or cancellation of existing licences but can also be barred from filing fresh applications with the concerned regulatory authority for a specified period.
According to the government, due process has been prescribed before any such action is taken, including the issuance of a show-cause notice. However, a provision for appeal has also been incorporated.
The ministry further said that 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," it added.
The amendment seeks to deter malpractice, strengthen accountability among applicants and ensure that regulatory approvals are supported by reliable and scientifically valid evidence.
The government said the move is in line with ongoing efforts to strengthen the country's pharmaceutical regulatory framework in accordance with global best practices.
It added that the new provisions are intended to promote compliance among drug manufacturers and distributors while providing stronger deterrence against entities involved in regulatory misconduct.
The amendments complement broader reforms being undertaken in the pharmaceutical sector with a focus on enhancing oversight, encouraging ethical practices and ensuring appropriate penalties for violations, according to the government.