After cough syrup deaths, Centre to bring law for strict quality checks, surveillance of drugs and cosmetics

New Delhi: The Centre is preparing a new law to strengthen oversight of drug quality, medical devices, and cosmetics in response to rising global and domestic concerns over safety and compliance. The proposed Drugs, Medical Devices and Cosmetics Act, 2025 aims to overhaul the country’s regulatory framework and replace the existing Drugs and Cosmetics Act of 1940.

The draft legislation was presented by Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi during a high-level meeting chaired by Union Health Minister J P Nadda on Tuesday, according to official sources. Senior officials from the Central Drugs Standard Control Organisation (CDSCO) and the DCGI outlined key provisions of the law during the discussion.

The meeting followed the recent deaths of several children in Madhya Pradesh linked to contaminated cough syrup, which reignited calls for tighter monitoring of pharmaceutical products. “The new law will grant statutory powers to the CDSCO to carry out strict quality checks and surveillance across the supply chain,” a senior official said.

For the first time, the CDSCO will have legal authority to take immediate action against fake or substandard medicines. The legislation also proposes digitising the licensing process, improving coordination between state regulators, and expanding the capacity of testing laboratories.

One of the primary motivations behind the reform, officials noted, has been repeated warnings from international health agencies, including the World Health Organization (WHO), regarding lapses in product quality by certain Indian manufacturers. Data from the CDSCO’s 2023–24 report underscores the scale of the problem. Of nearly 5,500 drug samples tested, about 3.2 per cent were found to be substandard or spurious, and over 40 pharmaceutical units have faced action in the past two years. The government intends the new framework to align India’s regulatory standards with global practices while ensuring accountability from production to market distribution.with agency inputs