Frequently Asked Questions
What is the size of the industry in India?
Medical devices form a more than $200-billion global industry, which develops and manufactures essential healthcare equipment. The Indian industry is currently valued at US$ 4.4 billion. With about 700 medical device makers, India’s medical device market is currently the fourth-largest in Asia (after Japan, China and South Korea) and ranks among the world’s top 20.
What are the predictions for the future of the Indian medical device market?
The medical device industry which forms a critical segment of the healthcare industry is going through rapid growth in India and is projected to grow even faster as health insurance becomes more widely available and the country’s consumers continue to demand better healthcare services. According to a CII-BCG report in 2014, in a facilitating environment, the industry has the potential to grow to US$ 50 billion by 2025.
How much of India’s demand for medical devices is met by imports?
Imports constitute a substantial part of the medical device market in India. An estimated 80% of India’s demand for medical devices is currently met by imports, nearly 30% of which are supplied by the United States. Imported medical devices are often those that are critical, innovative and high-risk in nature - either life-saving or life-enabling - and therefore undergo rigorous testing. These complex, innovative devices are designed to address the growing expectations of India’s population in the country’s rapidly evolving healthcare system.
The government has identified medical devices as a key area for its ‘Make in India’ campaign. What role can the medical technology sector play here?
The medical device industry has been very encouraged by the Prime Minister’s recognition of the critical role of medical devices in addressing India’s healthcare challenges. In general, we have a received a strong message from the government that they are interested in promoting the medical devices sector and creating an environment that fosters innovation.. This is great news not only for manufacturers of medical devices but more importantly for patients who desperately need access to high quality yet affordable lifesaving and life enhancing medical technologies.
The PM’s call to medical device manufacturers is a welcome recognition of this separate and important part of the healthcare system. Several of AdvaMed’s member companies have already established manufacturing units in India, and India is being increasingly viewed as an R&D base.
What are the major regulatory challenges faced by the medical device industry in India?
The medical device industry in India has grappled with challenges for several years around recognition and regulation. While the Global Medical Device Nomenclature (GMDN) lists more than 14,000 different product types, the current regime only regulates a relatively modest portion of these products. Moreover, these devices/products are regulated as “drugs” under the Drugs and Cosmetics Act of 1940. This is problematic because medical devices are very different from drugs in terms of diversity, product development, patent structures, types of failures, scientific disciplines involved in assessing performance/efficacy.
In addition to the arbitrary application of the rules for drugs to medical devices, which hinders the development, quality of and access to medical devices, there is also a lack of predictability in the regulatory system. The industry is also concerned about the lack of standardization in line with global best practices.
 Grant Thornton
 Indian Semiconductor Association data reported in Grant Thornton ‘Healthcare Pulse’ report