Regulatory Blindspot and Contradictions: Sale, Manufacturing and Price Regulation of India’s Medical Devices market

The medical devices sector in India is growing in size and in importance. It’s evolving regulatory regime is one to watch.

While medical devices long fell into a regulatory blindspot, recent innovations, technological developments, and the COVID-19 pandemic have emphasized the sector’s prominence and potential. However, new regulatory developments in the medical devices sector have presented some contradictions. On the one hand, initiatives such as the Production Linked Incentives Scheme for Medical Devices and the National Medical Devices Policy 2023 aim to encourage medical device manufacturing and research within the country. On the other hand, the NPPA’s price caps and increased regulatory authority over medical devices may discourage domestic innovation and manufacturing.

Against this backdrop, Ashish Rao, Partner, and Ashna Contractor, Senior Associate, Economic Laws Practice (ELP) have co-authored an article titled Regulatory Blindspot and Contradictions: Sale, Manufacturing and Price Regulation of India’s Medical Devices market published by Mondaq. The article examines these latest developments and provides an introductory overview of the medical devices regulatory regime.

For further details, read the article here: Click here