At the current rate of private healthcare spending in the country, three distinct industry segments other than pharmaceutical sector are set for vibrant growth. They are medical equipments, medical devices and diagnostic kits. The government has already made it compulsory for blood banks to test for malaria, HIV, Hepatitis B and C and venereal diseases. Currently, there are 15 widely used diagnostic kits in the Indian market. And the test kits for HIV, hepatitis B and C, pregnancy test kits and thyroid hormones kits are the first five in terms of sales. The demand for all the 15 diagnostic kits, their components and reagents is only expected to expand in the coming years with increasing awareness of health issues among the people. There are just 60 companies manufacturing diagnostic kits in the country today and the annual growth rate is slated at 25 to 30 percent. In the case of medical devices, there are 1,080 products listed by Bureau of Indian Standards such as hearing aids, straps, inhalers, electronic massaging devices, etc. Besides these, there are many other devices in circulation in the market. But so far only 4 types of devices have been notified as drug category for the licensing and quality control purposes. Manufacture and import of high value medical equipments such as X-ray units, scanning machines, etc. is another key segment of healthcare business. A large part of these sophisticated equipment is still being imported for hospitals, as there is no domestic manufacture.
Although signs of growth in these three critical segments were visible sometime ago, adequate regulatory system has not been in place until recently. In case of diagnostic kits, components and reagents, DCGI has recently notified that these products should have special licence for manufacture and sale. An equally important matter in this regard is ensuring required quality standards. The decision of the DCGI to bring these products under the purview of mandatory quality control is, therefore, laudable. Regulatory machinery for medical devices is yet to be set up although DCGI has been working towards it for some time. Currently there are no regulations for the manufacture, import and marketing of these products in the country. With the result, a large number of substandard products manufactured in India as well as imported are circulating in the market. As proposed in the case of diagnostic kits, a minimum quality standard should be made mandatory for this category of products too. In the case of expensive medical equipments, there is no single regulatory authority to monitor their quality and manufacturing standards. The Atomic Energy Regulatory Board is expected to regulate the manufacturing and quality standards for X-ray machines. There are a number of other medical equipments regularly used in hospitals and nursing homes with no designated authority to monitor their manufacturing. It is high time the government took a serious look at all these segments in the healthcare sector and brought under suitable regulatory frameworks.