Local diagnostics to reach patients faster and cheaper

Govt plans to cut regulatory delays that have kept Indian diagnostics dependent on imports

- Priyanka Sharma

India is moving to reduce its heavy reliance on imported diagnostic technology by fast-tracking commercialization of homegrown solutions.

The government has drawn up a detailed plan to help startup and research-lab innovations reach hospitals faster, reducing regulatory delays that have long kept Indian diagnostics dependent on foreign suppliers, according to two officials and a document reviewed by Mint. Companies have already been informed about the upcoming toolkit, the officials said.

Jointly prepared by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) under the aegis of NITI Aayog, the new framework, MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook, sets a step-by-step pathway from prototype to market licence by fixing regulatory challenges and complex rules that often stall commercialization.

The move comes at a crucial time: India imports 80-85% of its medical devices by value, and the domestic device and diagnostics sector had grown to a $1.72 billion opportunity in FY23.