The study examines the regulatory framework and use of fixed-dose combination (FDC) medications, specifically metformin FDCs, for diabetes in India, compared to England and Australia. In India, between 1961 and 2012, the Central Drugs Standard Control Organisation (CDSCO) approved 1,098 FDC formulations, with 45 for diabetes, 41 of which were metformin-based. Despite metformin FDCs making up a significant portion of the oral diabetes drug market in India (56% by volume and 61% by value in 2011-2012), only 19 of 23 formulations had CDSCO approval, with several launched before or without regulatory approval. In contrast, in England and Australia, metformin FDCs made up less than 4% of the market. The study also highlights that multinational companies (MNCs) produced 11 formulations available in India, but only four were sold in England and/or Australia.
The findings underscore concerns over regulatory rigor and the commercial interests driving the widespread use of metformin FDCs in India, despite discrepancies with national guidelines and international standards. The research aims to inform regulatory improvements and ensure better alignment between medicine approval processes and treatment guidelines, contributing to global discussions on medicine accessibility and safety.