Exporting to India’s Healthcare Sector

The Indian healthcare sector is experiencing change due to rapid economic growth, rising middle class incomes, and a surge in lifestyle diseases. Today, there is a renewed interest in the growing market for healthcare services and products.

The Indian healthcare industry comprised of hospitals, medical infrastructure, medical devices, clinical trials, outsourcing telemedicine, health insurance, and medical equipment is expected to reach $280 billion in U.S dollars by 2020.

The industry is rapidly developing since receiving large investments from existing corporate hospital chains along with new entrants backed by private equity investors. This growth is driven by healthcare facilities, private-public projects, medical diagnostic and pathological labs, and the health insurance sector.

E-healthcare and telemedicine is in its infancy in India but is starting to take root. Most public hospitals are funded by state governments but private single and multi-super specialty hospitals have gone in for customized hospital management systems and other medical based IT products.

Since there are few quality healthcare facilities outside the large and second tier cities, telemedicine is expected to become a viable business proposition. Several major private players like Apollo, AIIMS, and Narayan Hrudalaya have adopted telemedicine services.

The best sales prospects in the medical equipment market include medical and surgical instruments, medical imaging electro medical equipment, orthopedic and prosthetic appliances, cancer diagnostics, orthodontic and dental implants equipment and appliances, and diagnostic kits.

In addition, imports constitute 50 percent of the market with a need for hand-held portable diagnostic equipment to use for blood sugar, blood pressure testing, since India now has around 46 million diabetics which is expected to continue to grow.

The Indian medical device market is worth an estimated $3.2 billion and expected to reach $5 billion this year. India imports nearly 80 percent of its medical devices as barriers to entry are low compared to other industries. The country is highly dependent on imports for many types of medical devices, particularly higher end products that include devices for cancer diagnostics, medical imaging, ultrasonic scans, and PCR technologies.

However, the Central Drugs Standard Control Organization is the key regulatory organization in India. Import of medical devices still remains largely unregulated although the government has adopted some measures in recent years to help solve the problem. Final procedures and guidelines are not yet ready and regulatory issues are still pretty confusing at this state.

Go to http://cdso.nic.in/Medical_div/list%20of%20notified%20medical%20device.0001.pdf for more information on the current list of regulated medical devices. For further information on medical device import regulations and registration requirements, email Dr. G.N Singh, Drug Controller General India for CDSCO dci@nb.nic.in or call +91-11-2323 6965. For additional help on exporting, go to http://export.gov.