New Delhi: In a move aimed at ensuring stricter safety and quality standards for pharmaceutical products, the Central government is drafting a new legislation titled the Drugs, Medical Devices and Cosmetics Act, 2025, to overhaul the country’s existing regulatory framework.
The proposed law seeks to strengthen drug quality testing, market surveillance, and regulation of medical devices and cosmetics, officials said on Tuesday. The draft legislation is expected to be tabled during the upcoming Winter session of Parliament.
Global concerns prompt stronger regulation
According to senior officials, one of the key motivations behind the new law is the growing number of complaints from international health regulators, including the World Health Organization (WHO), regarding serious quality lapses in Indian-manufactured drugs.
In recent years, multiple incidents involving substandard or contaminated medicines exported from India have drawn global criticism, prompting calls for a more robust regulatory system to safeguard both domestic and international consumers.
A senior government source said, “The aim is to create a law that ensures Indian drugs and medical devices meet the highest quality and safety standards, in line with global benchmarks.”
Draft presented at health ministry meeting
The draft of the Drugs, Medical Devices and Cosmetics Act, 2025 was presented by Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), during a high-level meeting convened by the Union Health Ministry on Tuesday.
Officials familiar with the discussions said the draft focuses on strengthening post-market surveillance, enhancing penalties for non-compliance, and bringing medical devices under a unified legal framework for the first time.
The legislation is also expected to grant greater enforcement powers to drug inspectors and regulatory bodies, allowing faster response to quality violations and product recalls.
Addressing gaps in the current system
Currently, India’s drug and cosmetic regulation is governed by the Drugs and Cosmetics Act, 1940, a law widely seen as outdated given the advances in pharmaceutical technology and the emergence of the global medical devices market.
Health experts have long called for modernisation of drug laws, citing the need to regulate biologics, gene therapies, diagnostic kits, and complex medical devices, which were not envisaged when the 1940 Act was framed.
Industry observers believe that a comprehensive, modern law will not only enhance domestic consumer safety but also help restore global confidence in Indian pharmaceutical exports, which form a crucial part of the country’s healthcare economy.
Conclusion
The Drugs, Medical Devices and Cosmetics Act, 2025 marks a major policy shift towards a more accountable, transparent, and globally compliant drug regulatory regime. Once passed, it is expected to usher in a new era of pharmaceutical governance and patient safety in India.