India’s action plan to reduce imports of medical devices from 80% to 50%

Indian exports of medical devices have been growing continuously for the last 20-30 years. However, there is a significant disproportion between imports and exports. India aims to reduce imports of medical devices from 80% to 50% over the next two decades.

We are actively developing a strategy and implementing measures to reduce imports. This will boost the country’s medical device industry and increase India’s self-reliance in healthcare, paving the way for a more robust and sustainable future.

Industry overview

The Indian medical device market has grown steadily over the last decade and this growth trajectory is expected to continue. This is due to increasing health care spending, growing awareness about health care, technological advancements and government initiatives. The Indian MedTech industry, valued at around $10 billion in 2020, is expected to reach $50 billion by 2025, demonstrating its enormous potential.

Medical device products in India include diagnostic imaging equipment, surgical instruments, consumables, implants, etc. However, we are still highly dependent on foreign manufacturers, mainly from countries like the US, Germany and China, for high-end equipment for imaging and advanced surgical tools.

Current ground realities

Our overwhelming dependence on imported medical devices poses a direct challenge to health care delivery and economic stability. This vulnerability has been clearly visible during the Covid-19 pandemic, underscoring the urgent need to reduce this dependence and strengthen our domestic production capacity.

The exorbitant costs of imported medical devices burden patients’ health care costs and hamper access to essential therapies, especially for people from low-income backgrounds. This stark reality underscores the urgent need for India to strengthen its domestic medical device manufacturing capabilities and reduce its dependence on imports. However, a suboptimal supply chain, inadequate infrastructure, financial constraints and limited access to modern technologies hamper the development and scalability of domestic manufacturing, making it difficult for Indian companies to compete with foreign manufacturers on both quality and price.

Action plan

Policy reforms: The Government of India is crucial to creating an enabling environment for growth. This includes implementing policy reforms to ease regulatory hurdles, encourage domestic production and promote innovation. Recent reforms, such as the National Medical Devices Policy 2023, have aimed to align with international standards. We need to ensure that Indian standards are harmonized with internationally recognized standards. This will improve the acceptance process of our products in other countries.

Streamlining approval processes, financial incentives in the form of tax breaks and subsidies, and supporting research and development initiatives will encourage domestic companies to invest in the production of high-quality medical devices.

Investments in infrastructure and technology: Developing a robust manufacturing infrastructure and adopting advanced technologies are important steps towards increasing the competitiveness of Indian players.

The government is investing in specialized medical device parks and industrial clusters with state-of-the-art research, production and testing facilities. Collaboration between industry, academia and research institutions will facilitate technology transfer and skills development in the sector.

Capacity building and skills development: To meet the ever-increasing demand, India needs a skilled workforce trained in manufacturing, quality control and regulatory compliance.

The government should prioritize skills development and job training initiatives tailored to the needs of the medical device industry. Collaborating with industry associations and academic institutions to develop specialized training and certification programs can help build a talent pool capable of driving innovation and growth in the sector.

Promotion of domestic orders: Increasing domestic procurement of medical devices by government healthcare institutions could significantly boost the domestic industry.

The government must mandate that a certain percentage of medical devices be domesticated for public healthcare facilities, and encourage purchases from domestic manufacturers through preferential pricing and public procurement policies.

Domestic production of raw materials: To become more self-reliant, India must try to meet its raw material needs. The government must facilitate local production of key raw materials.

The Association of Diagnostics Manufacturers of India (ADMI) has extended its support to the Department of Pharmaceuticals to collaborate with institutes such as NIPER, AIIMS, IIT and CCMB for local production of essential raw materials.

International cooperation and market access: Government-to-government (G2G) collaboration and international partners can facilitate technology transfer, knowledge exchange and market access for Indian medical device manufacturers.

The government should focus on forging strategic partnerships with leading global players in the medical device industry to leverage their expertise, access new markets and enhance the competitiveness of Indian products. Additionally, participation in international trade fairs, exhibitions and regulatory harmonization efforts can showcase India’s capabilities and attract investment and cooperation abroad.

Research and development: Local manufacturers need to invest significantly in research and development to innovate and improve the quality of their products. Collaboration with international technology providers and academic institutions can help transfer knowledge and adapt advanced technologies to local production.

Through BIRAC, the government has launched incentive programs to support start-ups in the fields of telemedicine, digital health and artificial intelligence. Implementing the Health Care Digital Information Security Act and other data privacy laws is a step toward using data to drive innovation while ensuring the security of sensitive information. NMDP 2023 also encourages investment in technologies such as 5G and IoT to spur innovation.

Institutes such as NIPER, AIIMS and IIT engage in research and development, including early-stage prototypes, innovative testing methodologies and collaborative projects with industry partners. Their expertise and capabilities should continue to be exploited.

Clinical Sample Availability: This is a key issue for the IVD medical device industry. The government must create regulatory guidelines to ensure access to clinical samples for licensed IVD manufacturers.

Improving quality: Emphasizing quality assurance and obtaining international certifications can help local products compete better in domestic and international markets. This includes compliance with global standards such as ISO 13485 for medical devices.
Market expansion and diversification: Indian manufacturers should not only focus on the domestic market but also look for export opportunities. By expanding their market presence, they can achieve economies of scale and reduce unit costs, increasing the competitiveness of their products.

Reducing India’s dependence on imported medical devices is essential to increase access to healthcare, promote economic self-reliance and strengthen the country’s position in the global medical device market. The Government of India and medical device manufacturers can work together to achieve the ambitious goal of reducing imports from 80% to 50% and pave the way for a self-sufficient and resilient healthcare ecosystem.

IVD Kit Manufacturer in India| Medical Devices | J. Mitra