Centre to bring law for strict quality checks, surveillance of drugs and cosmetics

Amid growing demand for stricter compliance with safety and quality control norms for medical products, the Centre is framing a law to strengthen the legal framework for drug quality testing and market surveillance, along with regulation of medical devices and cosmetics.

One of the major reasons behind the drafting of the law is the repeated complaints and concerns flagged by health regulators across the globe, including the WHO, over serious quality lapses by Indian drug manufacturers.

The draft of the ‘Drugs, Medical Devices and Cosmetics Act 2025’ was presented by Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi at a high-level meeting of the Union health ministry held on Tuesday, the sources said.

The meeting was chaired by Union Health Minister J P Nadda.

During the meeting, 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.

The meeting comes days after several children died in Madhya Pradesh due to a contaminated cough syrup.

Once approved, the new legislation will grant the CDSCO authorities statutory power to ensure strict quality checks and surveillance of drugs, medical devices and cosmetics manufactured in India for both domestic use and export, the sources said.

Under the new law, they said, the CDSCO will be granted statutory powers for the first time to take immediate action against fake or substandard medicines.

It will also include provisions to digitise the licensing process, enhance coordination among state-level regulators and upgrade testing lab capacities.

The new law will replace the Drugs and Cosmetics Act of 1940, and it is being developed in line with international standards. The aim is to ensure accountability and transparency at every stage—from manufacturing to market distribution.

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, a source said, adding that in the past two years, over 40 pharmaceutical units have faced action.

India