Centre drafts new law to tighten drug and medical device regulation

The Centre has initiated the process of framing a law to strengthen the existing legal framework for drug quality testing and market surveillance, as well as the regulation of medical devices and cosmetics.

The development comes amid increasing demand for stricter compliance with safety and quality control norms for medical products in the wake of the death of several children in Madhya Pradesh and Rajasthan due to the consumption of contaminated cough syrup.

Draft bill presented before Health Ministry

The draft bill titled the 'Drugs, Medical Devices and Cosmetics Act 2025' was presented by the Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi at a high-level meeting of the Union Health Ministry held on Tuesday (October 15), reported PTI, quoting sources.

The report further states that the Centre is planning to introduce the bill in the upcoming Winter session of Parliament.

During the meeting, chaired by Union Health Minister J P Nadda, senior officials from the Drugs Controller General of India (DCGI) and the Central Drugs Standard Control Organisation (CDSCO) outlined the framework of the proposed law.

Also Read: WHO flags three contaminated cough syrups from India; issues global advisory

CDSCO to get statutory power

The new legislation, once passed in the Parliament, will grant the CDSCO statutory power to ensure strict quality checks and surveillance of drugs, medical devices and cosmetics manufactured in India for both domestic use and export, reported PTI.

CDSCO will also be granted, for the first time, statutory powers to take immediate action against fake or substandard medicines. The proposed law will also include provisions for the digitisation of the licensing process, boosting coordination among state-level regulators and upgrading the capacities of testing labs.

The Drugs, Medical Devices and Cosmetics Act 2025 will replace the Drugs and Cosmetics Act of 1940. The legislation is being developed in line with international standards to ensure accountability and transparency at every stage.

Also Read: TN government cancels Sresan Pharma licence over toxic 'Coldrif' cough syrup

The backdrop

The problem of fake and substandard medicines has been a major concern for the authorities.

According to the 2023-24 report by the CDSCO, out of approximately 5,500 drug samples tested, 3.2 per cent were found to be substandard or spurious, reported PTI, quoting sources. The report further stated that in the past two years, over 40 pharmaceutical units have faced action.

(With agency inputs)