India plans toolkit to help diagnostics startups commercialize their products

Subscribe to enjoy similar stories. New Delhi: 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 medical device and diagnostics sector had grown to a $1.72 billion opportunity in FY23.

A stronger domestic industry will not just boost the local industry and reduce the import bill but also ensure that cutting-edge diagnostic solutions reach patients faster and at more affordable prices. In line with the Medical Device Rules (MDR) 2017 regulatory framework, the document outlines each development stage, including clinical need evaluation, product optimization, analytical validation, clinical performance assessment, and manufacturing readiness assessment.