Region/Countries: Asia, India Industry: Biosciences / Medical Devices Date: November 2019

Why this is important to Wisconsin businesses: It is already the fourth-largest medical device market in Asia, and is growing at a rate of 28% annually.

India is among the top 20 markets for medical devices in the world, and is the fourth-largest market for medical devices in Asia, after Japan, China and South Korea. The medical devices industry in India is currently valued at approximately $6 billion, and has the potential to grow at a rate of 28% annually to reach $50 billion by 2025. The industry is largely dependent on imports, with most local manufacturers making products at the lower end of the technology value chain. Thus, the manufacturing space in the medical devices industry is at a nascent stage. Medical device imports increased by 24% percent in 2018-19. The U.S. is the largest source of India’s medical device imports, constituting one-fifth of the pie, followed by Germany, China, Singapore and the Netherlands.

India's highly fragmented medical devices industry is dominated by multinationals such as GE, J&J, Philips, Wipro, Abbott, Siemens, Baxtar and Fresenius, which control about 75% to 80% of the market. India has between 750 and 800 medical device producers, with average investment of ₹170 million to ₹200 million and average turnover of ₹450 million to ₹500 million. However, the list of major domestic manufacturers is very short, comprising Trivitron, Transasia Biomedicals, Hindustan Syringes & Medical Devices and PolyMedicure.

The government of India is encouraging medical device companies to set up manufacturing facilities consistent with the pattern seen in the telecommunications and electronics industries. India allows 100% foreign direct investment in medical devices on the automatic route. The products focused for manufacturing setup include diagnostic devices for heart disease and cancer screening, as well as pacemakers, ventilators, dialysis machines and CT scanners, among others.

The Indian government has introduced policies and regulations that give a boost to the growth of medical device industry to bring it on par with international standards. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. The rules came into force in January 2018.

Recently (on Oct. 18, 2019), the Union Health Ministry came out with a draft notification, making it mandatory for devices to get certified by the Central Drugs Standard Control organization, India’s drug regulatory authority. At present, only 23 medical devices are regulated under the Drugs and Cosmetics Act. Niti Aayog, a government think tank, submitted a draft bill on Oct. 29 proposing that medical devices be governed by a separate regulatory authority that would be an autonomous body under the health ministry.

India’s price control on medical devices has become a sticky issue, with the U.S. advocating to lift the mechanism for coronary stents and knee implants. The government is open to rationalize trade margins to allay concerns of importers, and is weighing a proposal for U.S. companies to reduce prices by producing and/or assembling medical devices in India.

Despite these challenges, the Indian medical device industry represents a huge opportunity for Wisconsin-based medical device companies due to growing demand.