India plans toolkit to help diagnostics startups commercialize their products

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.

“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," said the first official familiar with the matter. "The government has now fixed those gaps to make regulatory procedures simpler and uniform."

The playbook simplifies the regulatory approval process, which often overwhelmed first-time developers. It breaks down the complex paperwork into three simple stages: prototyping, clinical trials, and market licensing. By integrating these approvals with quality management and safety standards, the guide ensures a smoother, "first-time-right" path to commercial success.

Queries on the development sent to the health ministry spokesperson went unanswered until press time.

Jatin Mahajan, managing director at J Mitra & Co, a major in-vitro diagnostics kit manufacturer, said the plan establishes a single, systematic approach that transitions 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. “The industry benefits from this approach through simplified product authorization, enhanced market competitiveness, and accelerated adoption in healthcare facilities. The final product cost reduction will range from 30% to 50%, depending on market conditions, technology type, disease characteristics, and usage environments."

He added that such efficiency catalyzes affordable testing, citing how the indigenous J Mitra dengue rapid test slashed the diagnostic price by more than 40% upon launch, directly benefiting patients.

Clear roadmap

The handbook introduces three essential elements that transform IVD development through early regulatory planning, design traceability, and operational to-do lists that help avoid expensive rework. This verification is expected to build the trust necessary for local innovations to replace costly imports and access international markets.

In FY24, India's medical device import bill had surged 13% to ₹68,885 crore, with high-end ‘electronics and equipment’ such as MRI and CT scanners comprising the largest share at ₹44,132 crore. Specific to the diagnostics sector, imports of IVD reagents grew 7% to ₹6,477 crore.

While India has achieved self-sufficiency in mass-volume consumables such as syringes and rapid test kits, it continues to depend almost entirely on imports for sophisticated molecular diagnostic machines and analyzers. Leading domestic players in this segment including Transasia Bio-Medicals, Trivitron Healthcare, J Mitra & Co., Agappe Diagnostics, Mylab Discovery Solutions and Molbio Diagnostics are actively scaling up indigenous manufacturing of advanced analyzers and point-of-care solutions.

Dr Anand K., managing director and chief executive officer at Agilus Diagnostics, termed the handbook a timely intervention for public health. “The government is removing a long-standing bottleneck that slowed India’s ability to convert laboratory innovation into patient-ready diagnostic solutions," he said.

“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."