In a significant move to bolster its self-reliance in medical technology, the Indian government has unveiled a comprehensive plan to accelerate the commercialization of homegrown diagnostic innovations. The initiative aims to dismantle regulatory hurdles that have long forced the country to depend heavily on imported medical devices.
Bridging the Innovation-to-Market Gap
The new framework, titled MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook, has been jointly developed by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) under the guidance of NITI Aayog. According to officials and a document reviewed by Mint, the handbook provides a clear, step-by-step pathway for startups and research labs to navigate from prototype development to obtaining a market licence.
"For years, Indian diagnostic innovators have been facing problems where viable scientific breakthroughs failed to reach the market due to regulatory complexities and a lack of clear guidance," stated a government official familiar with the development. "The government has now fixed those gaps to make regulatory procedures simpler and uniform."
A Critical Push for Domestic Manufacturing
This intervention comes at a crucial juncture for India's healthcare sector. The nation currently imports 80–85% of its medical devices by value. While the domestic medical device and diagnostics market presented a $1.72 billion opportunity in FY23, the import bill continues to swell. In FY24 alone, medical device imports surged by 13% to ₹68,885 crore, with high-end equipment like MRI and CT scanners constituting the bulk. Specifically, imports of IVD reagents grew 7% to ₹6,477 crore.
The handbook is designed to reverse this trend by simplifying the often-overwhelming approval process for first-time developers. It breaks down complex procedures into three streamlined stages: prototyping, clinical trials, and market licensing. By integrating approvals with quality management standards, it promises a smoother "first-time-right" approach.
Industry Hails a Move Towards "Controlled Innovation"
Industry leaders have welcomed the initiative as a transformative step. Jatin Mahajan, Managing Director of J Mitra & Co., described it as establishing a single, systematic approach that shifts the sector from disorganized compliance to "controlled innovation."
"This much-needed and timely handbook enables India to transition through market acceleration, audit-readiness improvement, and Make-in-India IVD scale-up capabilities," Mahajan said. He projected that the final product cost reduction for domestically developed diagnostics could range from 30% to 50%, depending on various market and technology factors.
Mahajan cited the example of his company's indigenous dengue rapid test, which slashed diagnostic prices by over 40% at launch. Other leading domestic players like Transasia Bio-Medicals, Trivitron Healthcare, Agappe Diagnostics, Mylab Discovery Solutions, and Molbio Diagnostics are also scaling up manufacturing of advanced analyzers and point-of-care solutions.
Dr. Anand K., MD & CEO of Agilus Diagnostics, termed the handbook a timely intervention for public health. "Faster validation and predictable approvals will not only reduce our dependence on imported kits but also strengthen India’s position as a global hub for high-quality, affordable diagnostics," he said. "For a country with our kind of disease burden, making innovation commercially viable is not just desirable, it is essential."
The handbook introduces three core elements to transform IVD development: early regulatory planning, design traceability, and operational checklists to prevent expensive rework. This structured verification is expected to build the trust necessary for local innovations to replace costly imports and eventually compete in international markets.
