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Fresh Attempt to Regulate Medical Devices Independently in India by CDSCO

Fresh Attempt to Regulate Medical Devices Independently in India by CDSCO

With the new government in place, policies to encourage local manufacturing is being stressed on. Additionally, with the growth of the medical device market in India, steps to ensure fair play in the market is being taken. After the draft policy for regulating medical devices has been released earlier this month, the government of India takes its first step to regulate the medical device which is worth $4 billion in the country. The policy got a good response from the industry with plans to boost local manufacturing. India being the world’s third-largest pharmaceutical market, the medical device market is behind with 70 percent imports, primarily from the US.

The draft policy by the CDSCO also proposes price control on medical devices. Rajiv Nath of the Association of Indian Medical Device Industry (AIMED) said “We are importing Audis and Mercedes, but the consumer also needs Maruti Suzukis and Tata Nanos as well.” Johnson and Johnson and Becton Dickinson has manufacturing plants already while Philips, General Electric and Siemens AG are ramping-up their India operations. Indian medical device could be $50 billion by 2015 says the analysts.

Currently several medical devices are regulated by the CDSCO. They include spinal implants, dental implants, stents, surgical sealants, orthopedic products, catheters, syringes, cannula etc. A complete list of notified medical devices can be found here. Suitable strategies for medical device manufacturers to enter the Indian market can be found here.

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