The use of medical devices and diagnostics has grown exponentially in India over the last 20 years with the sharp rise in lifestyle diseases among all classes of people. Medical devices or implants are routinely prescribed by doctors for heart patients, kidney patients, people suffering from urological problems, those afflicted by a variety of orthopedic conditions, hearing problems etc. And almost 70 per cent of the medical devices in terms of value are being regularly imported into the country for years as the domestic industry did not register the desired growth rate and the units remained mostly small and medium scale operators. What is disturbing is the fact that the medical devices sector remained largely outside the purview of any regulatory control in India all these years despite the fact that these are life saving products. Taking advantage of this regulatory vacuum, there has been large inflow of not of standard quality products into the country with very high price tags. Patients requiring these devices have no option but go for them at whatever quality and price offered by the suppliers.
Medical devices are life saving products to be produced with quality materials and as per good manufacturing practices as is the case with pharmaceuticals. Quality, safety and fair pricing are three key elements that determine the growth of any industry and that has to be the case with the medical devices also. But, in all these fronts, India’s medical devices industry does not have a reputation at present. Most of the units engaged in the manufacture of medical devices are small and do not follow GMP voluntarily and there are no specified standards laid down by the authorities for the materials used. The decision of the Department of Pharmaceuticals to come out with a draft National Medical Device Policy, 2015 in this context is the first government initiative to give a proper direction to the growth of this sector in the country. The main objective of the policy is to set up National Medical Device Authority, an autonomous body for regulating the manufacture and sales of this sector. Such a national body should be able to strengthen the domestic base of this sector, reduce dependence on import and bring affordability and availability of these critical products. Another move initiated by the health ministry is to come out with a Materio-Vigilance Programme of India (MvPI) intended to ensure safety of medical devices used in the country. There has been several complaints of malfunctioning of medical devices supplied by both Indian companies and MNCs from various parts of the country. Adverse events of even critical medical devices are not being monitored in the country. The basic objective of MvPI is to collect safety data in a systematic manner so that regulatory decisions and actions on the use of medical devices could be taken on time by the health authorities. Both the government initiatives should play a key role in developing this industry and ensure availability of quality medical devices at reasonable prices to the patient community in the country.