Introduction:

The medical devices industry in India consists of large multinationals, with extensive service networks, as well as small and medium enterprises (SMEs). The Medical Devices Industry (MDI) plays a critical role in the healthcare ecosystem and is crucial to achieve the goal of health for all citizens of the country.  The manufacturing and trade in MDI is growing steadily in double digits. However, it is largely import-driven with imports accounting for over 65 percent of the domestic market. The investigations into faulty hip implants bring out the urgent need for a law to regulate medical devices.

Body:

Importance of Medical Devices in Healthcare:

• Medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease.
• Medical devices also have the capacity to act as “bridges” (as in devices like cardiac assist, pulmonary assist, and renal dialysis) enabling patients desperately in need of a transplant (e.g., heart, lung, kidney, etc.) to survive long enough to receive one.
• Medical devices rarely provide anything approximating “cure”, but can have enormous effect of reducing or even eliminating symptoms and can, on occasion, go so far as to turn a potentially fatal condition (e.g., diabetes, esp. type 1) into a manageable, chronic condition.
• This capacity of devices to enable patients to survive or just improve their quality of life in the absence of a cure will continue to grow as multiple scientific disciplines (biomaterials research, cell biology, information technologies, etc.) individually make advances and complement each other in medical device design.

Laws governing MDI in India:

• Earlier, only 10 notified medical devices were regulated in India later this has since been broadened to 23 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.

Way forward:

• 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.