New Delhi: With the medical devices industry in the country expected to grow to $50 billion by 2025 as per the ‘Make in India’ sector survey, the centre is set to unveil a draft Medical Device Regulation Bill for comprehensive regulation of the sector.

The medical devices industry in India is at present valued at $5.2 billion and contributes 4-5% to the $96.7 billion Indian healthcare industry. Currently, India has about 750–800 medical device manufacturers, with an average investment of Rs170–200 million and an average turnover of Rs450–500 million. Considering the rapid growth of the industry, the government felt a need to regulate this sector.

“We have already notified the Medical Devices Rules, 2017 and we are in the process of finalizing the draft of Medical Device Regulation Bill for comprehensive regulation of the medical devices in the country," said Anupriya Patel, minister of state for health and family welfare.

The government recently segregated medical devices from drugs. Currently, only 15 categories of medical devices are regulated as drugs.

“The new rules shall enhance ease of doing business and ensure availability of quality medical devices. Also, for the very first time, periodic renewal of licences will not be required. Consequently, manufacturing and import licenses will be valid until they are suspended or cancelled," said the ‘Make in India’ sector survey report released last week.

“The rules also aim to promote a culture of self-compliance by manufacturers of medical devices. In addition, the manufacturing licences for certain medical devices are granted without prior audit of the manufacturing site. In such cases, the manufacturer has to do self-certification of compliance with the essential requirements and, on the basis of such certification, the licence will be issued," the report said.

Currently, India is counted among the top 20 global medical devices markets and is the fourth-largest medical devices market in Asia after Japan, China and South Korea. Equipment and instruments (surgical and non-surgical) form the largest segment (53% of the Indian medical device industry), constituting about $2.7 billion (2017), while the estimated market size of the consumer and durable segment is $1,404 million.

“Industry’s demand is to have a new and separate Act for medical devices as per global best practises, so that medical devices are regulated separately from drugs and pharma. Medical devices are manufactured and sold much differently as compared to drugs and pharma and same yardsticks should not be applied. This will stifle the industry which is at a nascent stage," said Himanshu Baid, chairman, medical technology division, Confederation of Indian Industry (CII).

The Medical Device Regulation Bill was first drafted in 2006.

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