The Centre is considering a new legislation to overhaul India’s drug regulatory framework and replace the decades-old Drugs and Cosmetics Act, 1940. The proposed law seeks to regulate drugs, medical devices and cosmetics under a more comprehensive legal framework.
The move aims to strengthen oversight of these products while addressing changes in the healthcare and pharmaceutical sectors.
DCGI May Get a New Identity
One of the key proposals involves renaming the Drugs Controller General of India (DCGI), who currently heads the Central Drugs Standard Control Organisation (CDSCO). The proposed changes are intended to reflect the regulator’s wider responsibilities beyond medicines.
According to a News18 report, the new legislation could formally expand the regulatory framework to cover medical devices as well, marking a significant change from the existing law.
Medical Devices to Come Under the Law
For the first time, medical devices are proposed to receive explicit and comprehensive coverage under the new legislation. The framework would include provisions governing their safety, quality and performance, along with requirements related to manufacturing, import, distribution and sale.
The proposed approach could therefore bring greater regulatory clarity to India’s growing medical device sector. At present, medical devices are regulated through provisions under the Drugs and Cosmetics Act and related rules.
Focus on Safety and Quality
The proposed legislation is expected to cover the import, manufacture, distribution and sale of drugs, medical devices and cosmetics. It would also provide a framework for clinical trials of new drugs and investigations involving medical devices.
Furthermore, the government aims to create a regulatory system that keeps pace with developments in pharmaceuticals, medical technology and healthcare delivery.
A Wider Regulatory Framework
Overall, the proposed Bill represents an attempt to modernise India’s drug and medical product regulations. By bringing medical devices more explicitly within the legal framework and redefining the role of the country’s drug regulator, the government seeks to create a more comprehensive system focused on safety, quality and regulatory oversight.