India plans toolkit to help diagnostics startups commercialize their products
Companies have already been notified about the upcoming toolkit, officials said.
The new framework, prepared jointly by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) under the aegis of NITI Aayog, has been developed by MedTech Mitra. Handbook for In-Vitro Diagnostic InnovatorsIt lays out a step-by-step path from prototype to market licence, smoothing over regulatory challenges and complex rules that often delay 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 has reached a $1.72 billion opportunity in FY23.
A stronger domestic industry will not only strengthen the local industry and reduce the import bill, but will 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 phase, including clinical needs assessment, product optimization, analytical validation, clinical performance evaluation and production readiness assessment.
“For years, Indian diagnostic innovators have been facing problems with viable scientific breakthroughs failing to reach the market due to regulatory complexities and lack of clear guidance,” said the first official familiar with the matter. “The government has now fixed these loopholes to make regulatory procedures simpler and more uniform.”
The playbook simplifies the regulatory approval process that often challenges first-time developers. It breaks down the complex paperwork into three simple stages: prototyping, clinical trials, and market licensing. The guide integrates these approvals with quality management and safety standards, providing a smoother, “right first time” path to commercial success.
Questions about the development sent to the Ministry of Health spokesperson remained unanswered until press time.
Jatin Mahajan, managing director of leading in vitro diagnostic kit manufacturer J Mitra & Co, said the plan creates a single, systematic approach that transforms the industry from patchy compliance to “controlled innovation”.
“This much-needed and up-to-date handbook enables India to transition through market acceleration, improved audit readiness, and IVD scaling capabilities in India,” Mahajan said. “The industry benefits from this approach through simplified product authorization, improved market competitiveness, and accelerated adoption in healthcare facilities. End product cost reductions will range from 30% to 50% depending on market conditions, technology type, disease characteristics, and use environments.”
Homegrown J Mitra dengue rapid test has reduced the price of diagnosis by more than 40% upon launch, directly benefiting patients, he said, adding that such efficiency catalyzes affordable testing.
Clear roadmap
The handbook introduces three key elements that transform IVD development through early regulatory planning, design traceability, and operational to-do lists that help avoid expensive rework. This validation is expected to create the confidence necessary for local innovations to replace costly imports and access international markets.
India’s medical device import bill increased by 13% in FY24 ₹68,885 crore, with high-end ‘electronics and equipment’ such as MRI and CT scanners accounting for the largest share ₹44,132 crore. Imports of IVD reagents specifically for the diagnostic sector increased by 7%. ₹6,477 crore.
While India has achieved self-sufficiency in bulk consumables such as syringes and rapid test kits, it remains almost entirely dependent on imports for advanced 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 increasing domestic production of advanced analyzers and point-of-care solutions.
Agilus Diagnostics’ general manager and chief executive officer, Dr. Anand K. described the manual as a timely intervention in public health. “The government is eliminating a long-standing bottleneck that has slowed India’s ability to translate laboratory innovations into patient-ready diagnostic solutions,” he said.
“Faster verification 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 disease-burdened country like ours, making innovation commercially viable is not only desirable but imperative.”
