Last week the Union health ministry came out with a notification making labelling of medical devices mandatory in the country by amending the Drugs & Cosmetics Rules. Although labels of some of these critical products do contain a few details, many key information is not printed on the packs. With this notification, the labels on the devices should carry proper name of the medical device, the details necessary for the user to identify the device and its use and the name and address of the manufacturer. The label should disclose the net quantity in terms of weight, measure, volume, number of units and the dates of manufacture and expiry. In case of sterile devices the date of sterilisation and details of materials used for the making such devices should be printed on the label. The label should also mention a distinctive batch number or lot number of the product besides the manufacturing license number.
It seems that the key objective of making labelling mandatory for medical devices with all the necessary details is to bring the medical devices sector under the regulatory control of the government. The only regulatory intervention the government did so far was to place 14 medical devices under Drugs & Cosmetics Act. As this sector remained largely outside the purview of any comprehensive law, there has been several unfair practices in producing and marketing of medical devices in the country. The medical devices sector in India is still at a nascent stage with more than 60 per cent of India’s requirement of medical devices and equipments are being imported as the domestic production is restricted to low technology and disposable items. Whereas the demand for these life saving products has been growing over the years with a sharp rise in the life style diseases in the country. Medical devices are life saving products and have to be produced with quality materials as per good manufacturing practices (GMP) and under all the necessary rules. But, 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 for the materials used. Quality, safety and fair pricing are three factors that determine the growth of any industry. What has been done by the government last week is not just enough to have a proper regulatory control on this sector. Apart from laying down standard norms for the materials used for making devices, a system of price control on these products is extremely necessary. Currently huge profits are made on most of the life saving devices by the traders, hospital managements and the doctors. As the patients have no say in deciding whether to use a device and what brand of device to be used, they are subjected to overcharging. This needs to be urgently checked by fixing a system of fair pricing medical devices as in the case of pharmaceutical products.