Needed, medical devices regulator

Equal and timely access to quality health care is a priority for everyone. When ill, it is imperative to visit a doctor for a correct diagnosis. To accurately define the disease, the physician uses certain medical devices, like stethoscope, thermometer and blood pressure monitor.

It also covers a wide range of other products used internally and externally by patients and doctors. They include blood test kits, diagnostic imaging equipment, and heart valves, sticking plasters, contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests. These are intended for use in the scientific and systematic diagnosis of disease, or in the cure, mitigation, treatment and prevention of disease.

Medical devices are ranked from Class I, a low-risk category that would include spectacles, to high-risk Class III items such as hip replacements and pacemakers. Certain devices can be used by patients themselves, like electrocardiography machine (ECG), glucometer and blood pressure monitor, blood test kits and contact lenses but for a majority of others they need to visit a doctor’s clinic or hospital.

Medical devices come in a wide range, offering numerous choices. Consumers may decide on the basis of price, doctor’s advice, quality and brand. Though India remains a price-conscious market, where affordability is the most important factor in decision-making, they believe quality is important too. A majority of them believe a high-quality device would avoid repeated hospitalisation and incurring more costs while others feel that a quick recovery time due to a high quality device is a priority.

However, in India, penetration of medical devices has been low and inadequate due to certain barriers that prevent their usage. The medical sector is largely unregulated. The government has regulated only a few types of medical devices. Of the 14,000 types of devices, only 14 are recognised in India; even these are regulated as pharmaceuticals.
Until recently, there was no medical device-specific legislation. As a result, the country has not been able to tap its potential as a domestic manufacturing base. To address this issue, the government has removed some barriers to the medical devices market. It has effectively allowed 100 per cent FDI. The decision was taken to encourage local manufacturing which would ensure availability, quality and affordability.

For the first time, a Drugs & Cosmetics (Amendment) Bill 2015 (with a separate chapter for devices) has recognised medical devices as a crucial column of the Indian healthcare system. Though the Bill is yet to become law, this is an important development for the medical device industry which, for years, has had no distinct identity and has been clubbed under pharmaceuticals by the Indian regulatory framework. Once it is cleared, import, manufacturing, distribution and sale of all medical devices will come under its purview. This bill is a big leap forward for healthcare delivery and allied sectors in India.
India, an attractive market

India is an attractive market for medical device manufacturers the world over and ranks among the world’s top 20. With increasing population, non-communicable diseases like hypertension, diabetes, heart disease and cancer are surging and resultantly, use of and demand for all kinds of devices has catapulted and will be as crucial as pharmaceuticals to managing and mitigating public health challenges.

Currently, India constitutes only a small segment of the $200 billion medical devices industry. It is valued at four billion dollars—which is 7 to 8 per cent of India’s healthcare sector. But the industry, with 700 medical devices manufacturers, is expected to grow to $50 billion by 2020, according to a CII-BCG report. The new FDI cap will accelerate foreign investment in the domestic industry.

The industry has heartily welcomed the government’s initiative and is of the view that introduction of the legislation would bring uniformity in device standards and certainty of regulation. It would also build confidence in consumers who expect that the medical devices they use, or are exposed to or which are implanted in their bodies have been submitted to a proper risk assessment and are being risk-managed.

To ensure that the medical devices industry continues to remain a sunrise sector and fulfils its potential, a separate space for medical devices will have to be created in the regulatory framework for healthcare in India. The passing of the Drugs and Cosmetics (Amendment) Bill 2015 by parliament will be the first but most important step towards the goal of providing quality healthcare at an affordable cost.

(The writer is Chair, Advanced Medical Technology Association India Working Group)