The NITI Aayog, a government think tank in India, has suggested that the country’s drug regulation standards should meet global standards and align with International Council for Harmonisation guidelines. The think tank also recommended creating a new agency to regulate medical devices, which is currently overseen by the Drugs Controller General of India. These suggestions were made during the consultation on the New Drugs, Medical Devices and Cosmetics Bill, which aims to replace the existing Drugs and Cosmetics Act of 1940. The bill has been revised and sent for inter-ministerial consultation.
The NITI Aayog also emphasized the importance of adopting global standards for clinical trials in order to overcome hesitancy towards global standards and promote timely access to new therapies for the Indian population. It is believed that adopting global standards will boost the export of drugs and ensure the quality of drugs supplied domestically and globally.
Presently, drugs and cosmetics and medical devices in India are regulated under the Drugs and Cosmetics Act, 1940. However, highly regulated countries such as the USA, Japan and EU have high standards in their regulation to ensure medical product quality. Many countries do not recognize Indian standards of drug regulations for importing drugs. Last year, India-made cough syrups were allegedly linked to children’s deaths in Gambia and Uzbekistan.
