Amid rising global scrutiny and repeated concerns over drug safety and manufacturing standards, the Government of India is formulating a new law to reinforce the legal framework for drug quality testing, market surveillance, and regulation of medical devices and cosmetics.
The proposed legislation, titled the ‘Drugs, Medical Devices and Cosmetics Act, 2025’, aims to ensure stricter compliance with safety and quality norms while aligning India’s regulatory system with international standards.
The draft law was presented by Drugs Controller General of India (DCGI) Dr. Rajeev Raghuvanshi during a high-level meeting of the Union Health Ministry, chaired by Union Health Minister J. P. Nadda, on Tuesday. Senior officials from the Central Drugs Standard Control Organisation (CDSCO) and the DCGI office detailed the proposed framework and implementation roadmap.
Strengthening Oversight and Enforcement
The new legislation comes in the wake of several incidents, including the recent deaths of children in Madhya Pradesh linked to contaminated cough syrup, underscoring the urgent need for a more robust regulatory system.
Once enacted, the law will grant statutory powers to the CDSCO to conduct stringent quality checks and market surveillance for drugs, medical devices, and cosmetics manufactured in India—both for domestic consumption and export.
For the first time, the CDSCO will have legal authority to take immediate action against manufacturers producing fake or substandard medicines.
Key Provisions of the Draft Act
Digitisation of Licensing Processes: Streamlining and modernising regulatory workflows to improve transparency and traceability.
Enhanced Coordination: Strengthening collaboration between central and state drug regulators for more uniform enforcement.
Testing Infrastructure Upgrades: Expanding and modernising laboratory capacities to improve drug testing accuracy and turnaround times.
Accountability and Transparency: Establishing clear accountability mechanisms throughout the drug lifecycle—from manufacturing to market distribution.
Addressing Quality Concerns
Health regulators worldwide, including the World Health Organization (WHO), have repeatedly raised concerns over quality lapses in Indian pharmaceutical exports, prompting the Centre to take corrective action.
According to the 2023–24 report by the CDSCO, of approximately 5,500 drug samples tested, 3.2% were found to be substandard or spurious. Over the past two years, more than 40 pharmaceutical units have faced regulatory action for non-compliance.
The proposed Drugs, Medical Devices and Cosmetics Act, 2025 will replace the existing Drugs and Cosmetics Act of 1940, providing a more comprehensive, modern, and globally aligned regulatory structure to ensure the safety, efficacy, and quality of medical products manufactured in India.
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