New Delhi, 06 August (H.S.):

The Union Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945, under which applicants submitting false or fabricated data and documents will face restrictions on filing future applications for a specified period.

The new provisions aim to strengthen transparency, accountability and reliability in the drug regulatory system.

According to information provided by the Ministry of Health and Family Welfare, the amendment was notified through GSR No. 756(E) dated October 16, 2025. In addition to the existing enforcement provisions under the Drugs and Cosmetics Act, 1940, the licensing authority has now been empowered to refuse acceptance of new applications from entities found to have submitted false or fabricated data or documents for a specified period.

The provision will apply to all types of applications submitted under various provisions of the Drugs Rules, 1945. Before taking action, a show-cause notice will be issued to the concerned entity, and an appeal mechanism will also be available.

The Ministry said scientifically validated and reliable data form the foundation for assessing the quality, safety and efficacy of medicines. Fabricated data not only undermine the credibility of the regulatory process but can also pose serious risks to public health.

The amendment aims to discourage such malpractices and ensure that approvals for medicines are based on scientific evidence and robust evaluation.

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Hindusthan Samachar / Jun Sarkar