The need to bring a set of rules to regulate the manufacture and marketing of medical devices has been under consideration of the government for the last five years. The main concern of the government has been the absence of a monitoring mechanism for these products and their unreasonable pricing. The medical devices are considered to be life saving products like drugs as many of them are implanted into the human body for critical care. These are usually expensive products and have to be recommended by the medical practitioners. Implanting of a poor quality or defective device can cost the very life of the patient and therefore calls for minimum standards and some control on their prices.  And it is with this objective, the government brought ten of these products namely cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, and internal prosthetic replacements under the purview of Drugs & Cosmetics Act in 2005, making it mandatory to get licenses for their manufacture, sale and distribution. There are about 14000 medical devices marketed in India and the country is heavily dependant on imports from countries like the US, Japan, the UK, France, Finland and Germany. Almost 50 percent of the sales of Indian medical devices is met through imports from these countries. And there are 700 domestic medical devices makers but most make low-value products such as needles and catheters, leaving specialist products to multinational firms like GE, Siemens, etc.

As in the case of quality, prices of medical devices are fixed by the manufacturers and trade with no government intervention. There is no transparency in the cost of production of medical devices but it is believed that most of the raw materials used are not very expensive. The profit margins of the trade is the biggest component of the prices of medical devices. The data available with the government indicates that the prices of devices like stents, catheters, orthopaedic implants and heart valves vary wildly in the market. Prices of devices like stents and drug eluting stents ranged from Rs.1 lakh to Rs.1.5 lakhs. This trend indicates that the profitability in these products is not justifiable while their use has been increasing even among poor patients. The government has taken a serious view of this situation and asked the National Pharmaceutical Pricing Authority to collect data on prices, supply and availability of medical devices in the country. It is consoling that at least some action towards controlling prices of medical devices has commenced now after five years of debating the same. NPPA has to speed up the exercise of data collection of medical devices and work out a mechanism to regulate their prices with no delay considering the fact that millions of poor in the country have to buy these products at unreasonable prices.