Although most of the medical devices are lifesaving or critical products, this sector remained largely outside any regulatory and price control in India for all these years. Because of this scenario, there has been several unfair practices in producing and marketing of medical devices in the country. Domestic production of medical devices is hardly 30 per cent of the country’s requirements and most of the units are small and do not follow GMP voluntarily and there are no specified standards for the materials used. Whereas 70 per cent of the medical devices available in the market are imported. As there has been no price control in this sector, the MNCs have been freely importing and selling medical devices through their agents at exorbitant prices and making huge profits with the support of hospital managements and medical professionals. The matter caught the attention of the National Pharmaceutical Pricing Authority only recently and it has issued notices to the companies asking for details of pricing of 14 devices like cardiac stents, drug eluting stents, orthopaedic implants,etc. These 14 devices were classified as drugs by the Health ministry some time ago and placed under the Drugs & Cosmetics Act.
But, only in September last, the first serious move to bring medical devices under some regulatory control was made by issuing a notification making labelling of medical devices with all details mandatory in the country. Although labels of some of these critical products have a few details, many key information is not printed on the packs. With this notification now, the labels on 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. Now, early this month a Task Force, set up by the Department of Pharmaceuticals, recommended framing of a separate price control order for medical devices and placing them under the Essential Commodities Act. The Task Force also proposed to formulate a Medical Device Regulatory Act, treat these products distinctly from drugs and a separate chapter for medical devices in the D&C Act. And for giving a boost to the domestic production of medical devices, Task Force also proposed setting up of one medical devices park in Gujarat and another in Tamil Nadu. These recommendations will serve great public interest if they are accepted and implemented at the earliest. At the same time the Health ministry needs to constantly monitor the quality of materials used for the manufacture of medical devices and their manufacturing processes. For this GMP has to be made mandatory on all the manufacturing units.