Mounting global concerns over the quality of Indian pharmaceuticals have prompted the Centre to frame a stringent new law aimed at tightening drug surveillance and regulating medical devices and cosmetics. The proposed legislation seeks to plug loopholes in the country’s existing framework and bring India’s regulatory standards in line with global benchmarks.
The move follows recurring complaints by international health regulators, including the World Health Organization (WHO), about lapses in the quality of Indian-manufactured medicines. The issue gained renewed urgency after the recent deaths of several children in Madhya Pradesh linked to a contaminated cough syrup, exposing serious gaps in quality control mechanisms.
The draft ‘Drugs, Medical Devices and Cosmetics Act, 2025’, prepared by the Union Health Ministry, was unveiled during a high-level review meeting chaired by Health Minister J P Nadda in New Delhi on Tuesday. Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi presented the framework of the proposed law at the meeting, which was attended by senior officials from the Central Drugs Standard Control Organisation (CDSCO).
Sources in the ministry said the government plans to introduce the Bill in the upcoming Winter Session of Parliament. Once enacted, the law will empower the CDSCO with statutory authority to carry out strict quality checks and surveillance of all drugs, medical devices and cosmetics produced for both domestic consumption and export.
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Under the new framework, for the first time, the CDSCO will be vested with direct powers to take immediate punitive action against fake or substandard medicines found in circulation. Officials said the law also envisages a fully digitised licensing system, better coordination among state-level regulators, and a significant upgrade of the country’s network of drug testing laboratories.
The proposed law will replace the existing Drugs and Cosmetics Act of 1940, which has long been criticised for being outdated and inadequate to handle the scale and sophistication of India’s pharmaceutical sector, the third largest in the world by volume.
Sources said the government’s objective is to ensure accountability and transparency at every stage, from manufacturing to market distribution, while safeguarding the reputation of Indian medicines globally.
According to the CDSCO’s 2023–24 report, nearly 3.2 per cent of the 5,500 drug samples tested across India were found to be substandard or spurious. Over the past two years, regulatory authorities have initiated action against more than 40 pharmaceutical manufacturing units.
Health officials believe the upcoming legislation will help rebuild confidence in India’s drug exports, which have come under scrutiny following repeated red flags from foreign regulators. By mandating stricter surveillance, improved testing protocols and digital transparency, the government aims to protect consumers and ensure that “Made in India” continues to stand for quality and trust in the global pharmaceutical market.
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