The new draft National Medical Device Policy-2015, issued recently by the Department of Pharmaceuticals (DoP), has mandated a separate price control for medical devices.

As per the new draft policy, the medical devices will be included as separate entry in the list of commodities controlled under the Essential Commodities Act. The government will announce a separate policy enunciating the principles for regulating the prices of identified medical devices and implement the same by notifying a separate Medical Devices Prices Control Order (MDPCO).

Under the new draft policy, a separate division will be created in National Pharmaceuticals Pricing Authority (NPPA) for pricing of the devices by suitably amending the resolution constituting NPPA.

The DoP has recently issued the draft National Medical Device Policy-2015, for strengthening the 'Make in India' drive in medical device sector by reducing the dependence on imports and setting up a strong base for medical devices especially those having critical implications in terms of affordability and availability for patients.


For the implementation of the new policy, in the first phase, the DoP  will within six months, bring a detailed proposal for creation of the National Medical Devices Authority with vision, mission, objectives, constitution, headquarters and likely budgetary allocation for appraisal and approval of the competent authority. The DoP will come up with separate proposals for amending the Essential Commodities Act, amending the scope of functions of NPPA, and the National Medical Devices Pricing Policy.

Medical devices industry is a multi-product industry, producing wide range of products. Manufacturing and trade in medical devices is also growing quite steadily. Double digit growth rates indicate its importance in health care. Medical devices industry mostly depends on imports. Most hi-tech innovative products and technology originate from a well-developed eco-system and innovative cycle which needs to be developed in India to promote indigenous industry and to reduce our dependence on imports.

At present, the Indian medical devices industry is fragmented into small and medium enterprise category and is primarily manufacturing products such as disposables/medical supplies. Requirement for high end medical equipments is met by multinational companies. It is estimated that there are about 800 manufacturers in the country.