The new act empowers CDSCO to ensure safer drugs, medical devices, and cosmetics through stricter regulation and surveillance.
In the wake of child deaths linked to toxic cough syrup in Madhya Pradesh, India's Union Government plans to introduce the 'Drugs, Medical Devices and Cosmetics Act 2025'.
This new legislation will empower the Central Drugs Standard Control Organisation (CDSCO) with statutory powers to enhance regulation, quality checks, and surveillance of drugs, medical devices, and cosmetics.
The proposed 'Drugs, Medical Devices and Cosmetics Act 2025' aims to strengthen the regulatory framework for the testing, approval, and surveillance of pharmaceuticals, medical devices, and cosmetics.
The tragic deaths of over 20 children in Madhya Pradesh due to toxic cough syrup exposed glaring weaknesses in India's drug regulatory system. In response, the Union Government, led by Health Minister J.P. Nadda and senior officials including DCGI Dr Rajeev Raghuvanshi, convened a high-level meeting to finalise the draft of the new legislation.
The aim is to empower the Central Drugs Standard Control Organisation (CDSCO) with statutory authority to enforce quality and safety standards more robustly, ensuring swift action against substandard or counterfeit medicines and medical products.
The newly proposed act is designed to replace the outdated Drugs and Cosmetics Act of 1940. It will introduce a unified regulatory approach covering drugs, medical devices, including implants and diagnostic tools, and cosmetics.
This broadening of scope acknowledges the complex nature of today's healthcare market and the need for updated safety norms.
Crucially, the law seeks to digitise licensing processes, improve coordination among central and state authorities, and upgrade laboratory testing facilities nationwide, aiming for transparency, accountability, and efficiency at every stage from manufacturing to distribution.
The 2023-24 CDSCO report revealed troubling insights, noting that 3.2% of nearly 5,500 drug samples tested were substandard or spurious, prompting action against 40 pharmaceutical units recently.
The new law addresses this systemic issue by strengthening market surveillance mechanisms and providing CDSCO direct powers to act against violators, ranging from immediate product recalls to cancellation of manufacturing licenses.
With the World Health Organization having flagged concerns over India's drug quality on multiple occasions, this stricter framework is vital for restoring public trust, protecting vulnerable populations, and preventing future tragedies like the Madhya Pradesh incident.
The deaths of innocent children from contaminated medicines are a stark reminder of the devastating impact of regulatory failure. The Logical Indian welcomes the proactive measures proposed by the government but underscores that legislation alone is insufficient.
Ethical manufacturing practices, rigorous enforcement, transparent reporting, and public awareness must move in tandem for meaningful change. COVID-19 revealed both strengths and gaps in healthcare systems globally.