NITI Aayog proposes Indian drug regulating standards to be on par with international standards

NITI Aayog gate

In order to promote ease of doing business, the NITI Aayog has proposed that Indian standards for drug regulation be on par with international norms and coordinated with ICH recommendations.

The country’s top public policy think tank also recommended setting up a new agency to oversee medical devices, which are now under the control of the Drugs Controller General of India (DCGI).

The suggestions were provided as part of the continuing inter-ministerial consultation on the New Drugs, Medical Devices, and Cosmetics Bill, 2023.

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 interministerial 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.

“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.

The Central Drugs Standard Control Organisation (CDSCO) has been given the authority to grant manufacturing licences for drugs and cosmetics in place of state regulators, and NITI Aayog has endorsed this new provision, saying it will ensure uniform and effective application of the law and signal a significant shift towards placing all manufacturing responsibilities with the central licencing authority.

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