Medical devices are life saving products like medicines and have to be produced with quality materials and as per good manufacturing practices (GMP). But, most of the units engaged in the manufacture of medical devices in India are small and they do not follow GMP voluntarily. As of now there are no specified standards laid down for the raw materials used for making them. Quality, safety and fair pricing are three factors that determine the growth of any industry and that is not happening in the case of medical devices sector in India. Perhaps profiteering in this sector with the collusion of hospital managements, distributors and doctors is one serious issue that needs to be addressed by the government urgently. A recent report by Pharmabiz brought out the huge margins charged on medical devices when these products are sold to patients. A big part of these margins on devices are shared between the hospital managements and the other intermediaries. Take the case of drug eluting stents (DES) required for the heart patients. The DES manufactured by Medtronic Inc and imported by India Medtronic Pvt Ltd at Rs.30,848 has a MRP of Rs.1,62,000. The huge difference in imported price and MRP is shared by the distributor and the hospital. Another DES manufactured by Abbott Vascular Devices Holland of Netherlands and imported by Abbott Healthcare Pvt Ltd, at Rs.40,710 is sold to the patients at a MRP of Rs.1,50,000 in hospitals. Maharashtra Food and Drug Administration recently came across many such cases of profiteering in medical devices and approached the Drug Controller General of India and National Pharmaceutical Pricing Authority urging these life saving products under the DPCO 2013 to make it affordable to the patients.
The medical devices industry in India is still at a nascent stage with more than 70 per cent of the country’s requirements are being imported as the domestic production is restricted to low technology and disposable items. At the same time, the demand for these life saving products has been steadily growing with a sharp rise in the life style diseases in the country. Quality and prices of medical devices used in India have been a matter of serious concern for some time as this sector has been outside the purview of any regulatory control. Medical devices imported into India also needs to be strictly monitored considering the number of device recalls in the US in recent years. According to a recent Global Business Intelligence report, in 2010 alone, 54 device recalls were effected in the US for their high risks of serious health problems or death. An attempt was made last year to bring medical devices under regulatory control by substantially modifying the Drugs & Cosmetics Act 1940 with a draft bill 2013. The bill also sought to establish a Medical Devices Authority to enable all medical devices and equipments to be regulated under the amended D&C Act. Although the bill was cleared by the Cabinet, it is yet to be passed by the Parliament. It is extremely important that the new government at the Centre should take up this matter with extreme urgency and get it passed in the Parliament.