The Central government is planning to introduce a new law to ensure strict quality checks for drugs, medical devices, and cosmetics. The move comes amid growing concerns over the safety and quality of medical products manufactured in India. The proposed legislation, called the ‘Drugs, Medical Devices and Cosmetics Act 2025’, aims to replace the existing Drugs and Cosmetics Act of 1940 and bring India’s regulatory framework in line with international standards.
The government’s decision has been influenced by repeated complaints from global health regulators, including the World Health Organization (WHO), regarding lapses in quality control by Indian drug manufacturers. Over the years, concerns have been raised about substandard medicines and unsafe medical devices entering both domestic and international markets. The draft legislation is expected to strengthen legal oversight and accountability, ensuring that all products meet strict safety and quality standards.
One of the major reasons behind drafting this law is the increasing number of quality lapses reported by regulators worldwide. Serious incidents, such as the recent deaths of several children in Madhya Pradesh due to a contaminated cough syrup, have highlighted the urgent need for stronger measures. The government wants to ensure that incidents like these do not happen again.
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 of the Union Health Ministry. The meeting was chaired by Union Health Minister J P Nadda and included senior officials from the Central Drugs Standard Control Organisation (CDSCO). The officials outlined the framework of the proposed law, which aims to bring accountability, transparency, and stricter enforcement at every stage of production and distribution.
Once approved, the new legislation will give CDSCO statutory powers to carry out inspections, conduct rigorous quality checks, and take immediate action against fake or substandard medicines. For the first time, the authorities will be legally empowered to monitor medical devices and cosmetics, in addition to drugs, ensuring compliance with high safety standards.
The new law will also introduce several modern measures, including:
Digitisation of the licensing process to make approvals faster and more transparent.
Enhanced coordination between central and state regulators for effective supervision.
Upgradation of testing laboratories to ensure more reliable results and quicker response times.
The law aims to ensure that all medical products, whether for domestic consumption or export, meet international safety standards. The government is also looking to make regulatory processes more efficient while holding manufacturers accountable for any lapses.
The proposed legislation will replace the Drugs and Cosmetics Act of 1940, which has been in place for more than 80 years. While the old law has provided a basic framework for regulating drugs, it is considered outdated and insufficient for addressing modern challenges in pharmaceuticals and healthcare products. The new law will adopt global best practices and standards to make India’s medical product industry safer and more reliable.
The problem of fake and substandard medicines has been a major concern for regulators. According to the 2023-24 CDSCO report, out of approximately 5,500 drug samples tested, 3.2 per cent were found to be substandard or spurious. Over the past two years, authorities have taken action against more than 40 pharmaceutical units for quality violations. The new law will help prevent such cases and ensure stricter monitoring of manufacturing practices.
Experts believe that introducing this law will also boost India’s reputation in the global pharmaceutical market, which is a significant exporter of generic medicines and medical devices. By adhering to international standards, India can ensure that its products are trusted worldwide, protecting public health and supporting the growth of the healthcare industry.
ALSO READ: Shoe strike at Constitution: tensions rise amid hate speech
ALSO READ: AIIMS Delhi performs India’s first robotic kidney transplant on patient with renal failure
The legislation will also include provisions to improve market surveillance, enabling regulators to detect and address issues early. It will encourage manufacturers to follow best practices in production, storage, and distribution. This holistic approach aims to reduce risks associated with unsafe or substandard products and improve confidence among consumers and healthcare professionals.
The introduction of the Drugs, Medical Devices and Cosmetics Act 2025 is expected to have a significant impact on India’s healthcare system. It will provide a stronger legal framework for regulators to act swiftly against violations, enhance the safety of medicines and devices, and ensure accountability across the supply chain.
With the new law, patients can expect higher quality medical products and fewer instances of harmful or ineffective drugs. Medical professionals and hospitals will also benefit from clearer standards and guidelines for prescribing and using drugs and devices. The law will create a more transparent, efficient, and globally compliant regulatory environment, benefiting manufacturers, healthcare providers, and consumers alike.
The government plans to introduce the legislation in the upcoming Winter session of Parliament, signaling its commitment to strengthening India’s healthcare regulations. Once implemented, the law will be a major step toward safe, reliable, and high-quality medical products in India, protecting public health and reinforcing global trust in Indian pharmaceuticals.
In conclusion, the new law for strict quality checks of drugs, medical devices, and cosmetics is a crucial reform for India’s healthcare system. It aims to prevent lapses, modernize regulatory practices, and ensure that all medical products meet high safety and quality standards. By giving statutory powers to regulators and adopting international best practices, the government hopes to protect consumers, improve public health, and strengthen India’s position as a trusted global supplier of medical products.
Copyright © © 2022 Copyright. All Rights Reserved with Arth Parkash