India targets safer, globally accepted medical devices

Indian Pharmacopoeia Commission will create standards for medical devices for the first time

- Priyanka Sharma

The IPC has already started auditing medical device firms and is developing monographs, which will outline standards, specifications for medical equipment.

India is set to overhaul standards for medical devices, strengthening the regulatory framework for the country's $12-billion market and aligning with US, Japanese, and European Union (EU) quality benchmarks.

The Indian Pharmacopoeia Commission (IPC), an autonomous body under the ministry of health and family welfare, will create the standards for medical devices for the first time, in partnership with the Bureau of Indian Standards (BIS), according to documents reviewed by Mint and officials familiar with the matter. Historically, the IPC has focussed on evolving standards for medicines, but has now widened its remit to include medical devices as well.