NITI Aayog wants drug regulation standards to be on par with global

New Delhi: The NITI Aayog has recommended that Indian standards of drug regulation should be on par with global standards as well as aligned with the International Council for Harmonisation guidelines while promoting ease of doing business. The apex public policy think tank of the central government also suggested creating a separate authority to regulate medical devices in the country which is currently being monitored by the Drugs Controller General of India (DCGI).

The recommendations have been made during the ongoing inter ministerial consultation on the New Drugs, Medical Devices and Cosmetics Bill, 2023. The draft New Drugs, Medical Devices and Cosmetics Bill, 2023, which seeks to replace the existing Drugs and Cosmetics Act of 1940, was put up on public domain in July last year seeking feedback from stakeholders. It has been revised and sent for inter-ministerial consultation.

On clinical trials, the NITI Aayog said the draft bill should reflect the intent of overcoming the hesitancy of the Indian regulation towards global standards viz a viz adoption and alignment with ICH guidelines for clinical trials, timeliness of decisions, promoting access of new therapies/drugs at the earliest to the Indian population and ease of doing business.

"Adopting global standards will further boost export of drugs and assure the quality of drugs supplied domestically and globally. It will also overcome quality related issues which recently appeared in Gambia and Uzbekistan," an official source said. India-made cough syrups were allegedly linked to children deaths in Gambia and Uzbekistan last year. Presently, drugs and cosmetics and medical devices are regulated under the Drugs and Cosmetics Act, 1940. The standards of quality of drugs are prescribed in the Indian Pharmacopoeia and various rules made under the Act.

"However, highly regulated countries such as the USA, Japan and EU have high standards in their regulation to ensure the quality of medical products. In general, many countries do not recognise Indian standards of drug regulations for import of drugs to their countries," the source said.