India Pharma Outlook Team | Monday, 08 December 2025
India is exploring options to enhance the World Health Organisation (WHO) global benchmarking standards for medicines, aimed at standardizing and reinforcing the drug regulatory system for the safety, quality, and effectiveness of medications available in the nation.
A proposal aligned with this was talked about in the latest meeting of the Drugs Consultative Committee (DCC), where the drug regulatory experts also suggested forming a sub-committee focused on executing plans for the WHO National Regulation Authority (NRA) assessment preparation.
Also Read: Merck wins FDA conditional nod for Exzolt Cattle-CA1 therapy
During its meeting on November 17, the DCC was informed about the evaluation of a proposal to also broaden the WHO global benchmarking for medicines. It was suggested that states with an already established regulatory system for medicines might voluntarily engage in self-assessment and prepare for further benchmarking (evaluation) of their regulatory system by WHO.
Following the discussion, the Committee suggested "holding a consultation meeting for manufacturing states/UTs in conjunction with WHO officials for enhanced understanding and a more significant result," as stated in the meeting minutes.
The WHO's evaluation of the regulatory framework serves as a tool to recognize and rectify deficiencies in the regulatory system, aiming to attain a standard of oversight that ensures a stable, effective, and cohesive regulatory system.
The WHO employs a global benchmarking tool to evaluate the regulatory framework for medical product oversight, utilizing a benchmarking approach that allows the organization and regulatory bodies to pinpoint both strengths and opportunities for enhancement, and assist in the development of an IDP to leverage strengths and tackle recognized shortcomings.This will assist in prioritizing investments in IDP execution and aid in tracking the advancement.
