India eyes single regulatory framework for local and foreign medical devices

All imported devices are currently subject to US FDA approval for registration.

India’s plan to consolidate imported and locally-made medical devices under a single regulatory framework can help boost its credibility, according to a report by analytics firm GlobalData.

The firm expects that the Indian medical devices market, which comprised more than 13% of the Asia Pacific market in 2018, will grow at a compound annual growth rate (CAGR) of 7.4% until 2025.

The Indian Ministry of Health and Family Welfare (MoHFW) has recently proposed that all medical devices being manufactured in or imported by the country will get a regulatory certification from the Central Drugs Standard Control Organisation (CDSCO).

Currently, all imported devices are subject to US Food and Drug Administration (FDA) approval for registration, says GlobalData analyst Rohit Anand.

In addition, the Central Expert Committee of the Drugs Technical Advisory Board (DTAB) has submitted a compensation policy for regulated medical devices to MoHFW. Under this policy, makers and importers will have to pay compensation to patients in case of an injury or death caused by a faulty device.