NITI Aayog advises Indian standards of drug regulation be on par with international standards

In order to promote ease of doing business, the NITI Aayog has recommended that Indian standards for drug regulation be on par with international standards and coordinated with ICH recommendations. The country’s top public policy think tank also recommended setting up a separate agency to oversee medical devices, which are currently under the control of the Drugs Controller General of India (DCGI). During the ongoing inter-ministerial consultation on the New Drugs, Medical Devices, and Cosmetics Bill of 2023, recommendations were made. In July of last year, the draught New Drugs, Medical Devices and Cosmetics Bill, 2023—which would replace the current Drugs and Cosmetics Act of 1940—was made available for public comment. It has been updated and distributed for inter-ministerial review. Regarding clinical trials, the NITI Aayog stated that the draught bill should reflect the intention to overcome the Indian regulatory system’s reluctance to adopt and align with ICH guidelines for clinical trials, timeliness of decisions, and promoting access to new therapies and medications for the Indian population as soon as possible. It should also reflect ease of doing business.