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Medical Devices Industry Looks For Consultative Process And A Transition Roadmap For New Regulations

The medical devices industry was taken by surprise when earlier this month the government notified medical devices as drugs. Although the move is based on the recommendations from the Drug Technical Advisory Board, there were months of industry consultations and submissions on designing new regulations for the sector that deals from syringes to implants.

The ministry of health and family welfare notified changes in the Medical Devices Rules, 2017 to regulate medical devices on the same lines as drugs under the Drugs and Cosmetics Act, 1940. The order will come into effect on April 1, 2020. The consumables/devices will be brought under regulation in a phased manner up till April 1, 2021.

The industry is now looking forward to the consultative process and a transition roadmap for new regulations. The regulation now means every medical device, either manufactured in India or imported, will have to have the name and address of the company along with name and address of manufacturing site and certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

Speaking with CNBC-TV18 on the sidelines of BioAsia 2020 in Hyderabad, Madan Krishnan, vice president and managing director, Medtronic India said, “Industry wants consistency in approach and awareness of timelines on regulations, considering we need to make changes in labelling, etc.”

The medical devices is a $5.2 billion industry in India and need to be proactive on how to regulate devices. Bhargav Kotadia, managing director, Shajanand Medical Technologies said, “We had good consultation with the government. Will continue to push in that direction.”

The biggest concern that the medical devices industry has is on the price control of medical devices. Currently, the government regulates only 24 medical devices under drug-pricing laws.

Kotadia, whose company was one of a large beneficiary of stent price caps, says India is well within India’s right to do price control of medical devices. However, a broader view needs to be adopted and international examples need to be studied before formalising price control rules.

While Krishnan of Medtronics said unilateral price controls can damage the whole balance of the industry and players, capping trade margins is a transparent way for price control.

The industry is in desperate need of gaining traction in manufacturing. Despite governments flagship programs of Make in India, medical devices have not seen a much larger investment from MNCs.

The problem is in the focus of the program. Kotadia says the Make in India program should talk about servicing global markets from India and not only focus on the local market, “When China looks at setting up manufacturing it sees how it can export those products.”

Krishnan added, “We have to play in India for India and in Indian for the world and that way even the cost of production will come down. There will be economies of scale.”

The industry also stresses on the need for the government to take a larger role by investing more in healthcare. A larger local market is conductive even for foreign players to come and invest in manufacturing, “Besides some fiscal incentive for R&D and tax breaks for export units if provided can help the industry reach a critical mass in manufacturing.-CNBC18

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