Vaccines, drugs and medical devices are the three vital pillars of the modern healthcare industry. The current market size of the medical devices sector in India is estimated to be USD 11 billion and its share in the global medical device market is estimated to be 1.5%. India is the 4th largest market for medical devices in Asia after Japan, China and South Korea and is amongst the top 20 markets in the world. Medical Device Industry has been recognized as a key industry under the Make in India initiative and accorded the status of ―Sunshine Sector. Indian medical devices industry has potential to reach 50 billion dollars by 2030.
- Sunrise industry is a colloquial term for a burgeoning sector or business in its infancy stage showing promise of a rapid boom. Sunrise industries are typically characterized by high growth rates, numerous start-ups, and an abundance of venture capital funding.
- Sunrise industry is a new business or business sector showing potential for substantial and rapid growth.
- Notable characteristics of sunrise industries include high-growth rates and a lot of start-ups and venture capital funding.
- As a sunrise industry develops, it may transition to the maturity stage and then to the sunset stage.
- To remain relevant and on an upward trajectory, sunrise industries must prove their viability and sustainability.
- Earlier, only 10 notified medical devices were regulated in India later this has since been broadened to many categories of devices.
- These mainly include syringes, needles, perfusion sets, in-vitro devices for HIV treatment, catheters, intra-ocular lenses, cannulas, bone cements, heart valves, orthopedic implants, coronary stents, IUDs and condoms.
- The important segments of medical devices in India are consumables and disposables that are mostly manufactured by Indian player, patients aids like hearing aids and pacemakers, various implants, and stents.
- In India, medical devices continue to be regulated as “drugs” via the Drugs and Cosmetics Act, 1940, and that newly introduced Medical Device Rules, 2017, which came into effect on January 1, 2018.
- New rules classify medical devices based on risk, as is done by the Global Harmonization Task Force.
Issues in Indian medical device regulation:
- In India a device such as a pacemaker cost less in the market and much more when implanted in a hospital.
- For instance, a US-based company buys an ‘X’ pacemaker for Rs 25,000.
- The Indian subsidiary then increases the price, fixes the MRP at Rs 50,000, and then sells it to a distributor at a “discounted price”, say Rs 46,000.
- The distributor then sells it to a hospital at a price that is still discounted compared to the MRP, say at Rs 48,000.
- Finally, the patient buys the device from the hospital at Rs 50,000, so within the chain all three make a profit.
- Additionally, the patient pays the cost of the surgery, which varies from hospital to hospital.
- Currently, there are no specific rules or a law that allows the government to direct a medical device company to give compensation to a victim after the device has been found faulty.
- The medical device industry is a unique blend of engineering and medicine.
- It involves the creation of machines that are then used to support life within the human body.
- Given this, it needs not only careful regulation but also the highest ethical standards.
- Certainly, major changes are needed in the sector.
- It is up to the government to reinvigorate both the IPC and the CDSCO, and to give them more resources and a clearer mandate.
- The issue of the trustworthiness of the private sector to be relied for the tertiary health care system also needs attention.
- A large and vibrant public sector in tertiary health care is essential.
- This is possibly the way to counteract the hurtful consequences of information asymmetries and poor regulation.
- The government should re-examine its plan for universal health care, at this juncture.