The medical device industry in India is witnessing remarkable growth, with revenue in 2023 reaching approximately ₹1,04,760 crore (US$12.8 billion). Forecasts suggest that India could reach US$50 billion by 2030 at a CAGR of 16.4%, underlining immense potential.) Key developments for 2023 include initiatives such as the National Medical Device Policy 2023 (NMDP 2023) and increased investments, along with the establishment of medical device parks across the country. These efforts are expected to have a positive impact on the industry.
India’s position in the global medical devices market
According to the India Brand Equity Foundation (IBEF), India’s share in the global medical devices market is approximately 1.65%, which positions India as the fourth-largest market in Asia, after Japan, China and South Korea, and among the top 20 globally.
The government’s decision to allow import of refurbished medical devices in 2023 runs counter to the National Medical Devices Policy, 2023, and could lead to widespread dumping of obsolete technology and e-waste from abroad. This contradicts the principles of Atma Nirbhar Bharat and Make in India, and poses challenges for Indian companies striving to develop advanced and cost-effective solutions. Such imports should be restricted except in critical situations where no Indian alternatives are available in the near term.
Quality standardisation remains a critical barrier hindering the global expansion of Indian medical device companies. There is an urgent need for rationalisation in this area. The government must ensure that Indian standards such as ICMED and BIS are accorded the same respect, credibility and acceptance as international standards such as ISO, FDA, CE, MDR and AIMD. If they fail to achieve ‘at par’ status, Indian exporters will continue to face hurdles, necessitating the need to obtain multiple region-, country- and product-specific certifications.
Export challenges, with exports valued at Rs 19,803 crore ($2.4 billion) in 2022 and a target of $10 billion by 2025, require attention. Strengthening bodies like the Export Promotion Council for Medical Devices (EPC-MD) and addressing issues of quality standardisation are imperative.
Government policies, including the authorization of imports of refurbished medical devices, raise concerns for self-reliance initiatives such as Atma Nirbhar Bharat and should be carefully regulated.
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Quality standardisation, development of a skilled workforce, implementation of artificial intelligence and addressing the inverted job structure remain critical. Collaborative efforts between the government and industry are essential to overcome these challenges and ensure a prominent global position for Indian medical technology.
Reference:
- Medical Device Industry – (https://www.investindia.gov.in/sector/medical-devices)
Source-Medindia
