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India to Set Up Regulatory Board for Medical Devices

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Published on : Jun 12, 2015

India, the second most populated country in the world, is planning to set up a regulatory board to supervise the nation’s US$ 4 billion medical device industry. A draft policy released this month states that this is India’s first attempt to regulate a sector that comprises every medical device right from a thermometer to a prosthetic.

Despite concerns regarding a dearth of important details, the policy document has been welcomed by a majority of the industry. This document also highlights the plans of the Indian government to empower domestic manufacturing of medical devices and minimize the country’s dependence on imports. 

Even though India is the third largest pharmaceutical market in the world, its contribution towards the global medical device industry is rather small. Over 70 per cent of the medical equipment that is sold in the country is imported and most of the imports come from the United States. 

The central Department of Pharmaceuticals has issued the draft policy which proposes the National Medical Devices Authority – an autonomous body that is responsible for encouraging the local industry and ensuring adherence to standards of safety. 

The policy also proposes medical device price control. Medical devices, in this case, include implants, surgical instruments, and diagnostic equipment. This proposal, however, raised the eyebrows of manufacturers because the pharmaceutical sector in India is already in a legal battle against the government regarding price caps on drugs. 

Local manufacturers have since long pressed the government to curb the import of medical devices and this policy has been welcomed by many industry groups. 

Most medical device manufacturers in India are small and medium cap enterprises who deal in basic, and mostly disposable, medical equipment. High-end devices are left to multinational giants such as Philips, Johnson & Johnson, and Becton Dickinson & Co.