mPRiDE can boost ‘Make in India’ medical devices, reduce import dependence

The Indian Council of Medical Research (ICMR), in what certainly was a timely move in its bid to accelerate commercialisation of medical devices, launched the Product Ignition and Development Enabler (mPRiDE) programme. This will spur medical device product development and scale-up commercialization by supporting medical device companies having extensive experience and demonstrated capabilities by providing them handholding support with enabling ecosystem to accelerate product deployment for societal impact. The launch of this program is of great significance as India is dependent on imports, up to 80 per cent, for its medical device requirements. Given this situation and the long technology development cycle of medical devices, the necessity of holistic support across the medical device development and commercialisation cycle including R&D, scale-up, validation, regulatory compliance and market access was always felt.

To address the challenges, ICMR had earlier established Medical Device and Diagnostics Mission Secretariat (MDMS) that was envisioned to support and catalyse research, development and indigenous manufacturing of cost-effective medical devices to strengthen healthcare sector in India and reduce import dependence through a mission mode consortia approach. Also launched was a landscape study to identify various medical devices based on unmet healthcare needs and their contribution to import dependence. The study will prioritize devices for extending funding support thus accelerating development of unmet need driven devices and diagnostics products. It is also endeavoured to strategize, categorize, prioritize, and plan devices, sub-sectors and verticals for extending funding support in a phased manner by initially focusing on low-end devices, which can deliver volumes and then graduating to high-end devices as the program progresses, for accelerating unmet need driven devices and diagnostics product development for wide societal impact. The study was launched under the mPRiDE programme of Medical Device and Diagnostics Mission Secretariat, ICMR.

The country’s apex body for formulation, coordination and promotion of biomedical research, has urged medical professionals in government and private hospitals, who are key opinion leaders and the end users of the products, to participate in the landscape study for medical devices and diagnostics.

More recently, ICMR shortlisted three companies-Udyog Yantra Technologies Pvt Ltd, LVP Eye Innovations, Hyderabad and Evelabs Technologies Pvt Ltd, Kollam, under the Accelerating Medical Device and Diagnostics Product Development and Scale-up as a mPRiDE program to accelerate commercialisation of medical devices for public use. Subject to the terms and conditions of an agreement, ICMR-MDMS will support indigenous development, scale-up and pilots of Make-in-India manufacturing of critical medical devices and diagnostic products. Based on the recommendations of the expert committee, applications for manufacturing Make-in-India products areas have been duly considered for extending support for Chronic Obstructive Pulmonary Disorders (COPD), maternal, child healthcare and nutrition and remote monitoring devices.

The Indian medical device market is currently valued at $ 11.2 billion and is experiencing a growth rate of 15% CAGR in order to touch $ 50 billion by 2025.

During the financial year 2021-22 compared to the previous years, imports of medical devices grew at an alarming 41 per cent as India imported medical devices was worth Rs. 63,200 crore in 2021-22, up 41% from Rs. 44,708 crore in 2020-21. China remained at the top of import source for India as medical device imports from China grew 48% from Rs 9,112 crore in 2020-21 to Rs 13,538 crore in 2021-22. Imports from the USA also increased steeply by 48% to Rs 10,245 crore in 2021-22 from Rs 6,919 crore in 2020-21. The value of medical devices from China was nearly the same as the combined value of imports from Germany, Singapore and the Netherlands in 2021-22.

The gravity of the situation can be gauged from the fact that the increase of import of medical devices has been five-fold over a six-year period as India imported Rs12,866 crore worth of medical devices in 2016-17. Among the six major categories of medical devices like consumables, disposables, electronics and equipment, implants, IVD reagent & surgical instruments that are imported, the growth has been the highest in the ‘electronics and equipment’ category.

India imported Rs 40,649 crore worth of medical devices that come under this category in 2021-22 against an import worth Rs 4,569 crore in 2016-17. The import of surgical instruments went up to Rs 1,260 crore from Rs 243 crore during this period. The other categories included IVD reagent (from Rs 361 crore in 2016-17 to Rs 6,564 crore in 2021-22), consumables (from Rs 5,249 crore in 2016-17 to Rs 8,488 crore in 2021-22), implants (from Rs 384 crore to Rs 3,155 crore) and disposables (from Rs 2,061 crore to Rs 3,084 crore).

In such a background, the launch of the mPRiDE program holds considerable significance.

(The author is freelance

journalist with varied experience in different fields)