AiMeD urges Prime Minister to set up a separate Department for medical devices

The Association of Indian Medical Device Industry (AiMeD) has urged Prime Minister Narendra Modi to either change the name of Department of Pharmaceuticals to Department of Pharmaceuticals & Medical Devices or set up a Separate Department of Medical Devices.

In a letter, AiMeD on behalf of the Indian Medical Devices industry urged the PM to set up a Department of Medical Devices or change the name of Department of Pharmaceuticals to Department of Pharmaceuticals and Medical Devices and at some point house it under a Ministry of Life Sciences/Healthcare Products in order to recognise the importance of the sector and reduce import dependence.

In the letter, Rajiv Nath, forum coordinator of AiMeD, said, “We will highly appreciate if the name of Department of Pharmaceuticals is changed to Department of Pharmaceuticals & Medical Devices or there is a separate department of medical devices so that the manufacturers will be assured that the government is taking this sector seriously as medical devices are not pharmaceuticals, though both may be medical products. The current name reflects the focus on the mature sector of pharmaceuticals and the ignored import dependent sector of medical devices”.

He added that India still remains 80 per cent import dependent on medical devices with imports crossing Rs. 63,200 crore in 2021-22 and an estimated market of Rs. 160,000 crore at retail and institutional level but with a huge investment opportunity of over Rs. 80,000 crore.

“The Department of Pharmaceuticals and the ministry of chemicals & fertilizers have so far had limited success to carry out the mandate given to them to boost manufacturing of medical devices and address the 70 to 80% import dependency and have limited expertise of this Industry as the high precision device industry has very little synergy with chemical & fertilizers industry,” he added.

The current team (of officials) needs to be supported with required expertise by at least four persons, that is one each with a background of medical, bio medical engineering, product development and marketing with experience from Department of Science and Technology/Department of Biotechnology/Biotechnology Industry Research Assistance Council/Department of Health Research/Ministry of Health & Family Welfare/Biotech Consortium India Ltd/National Health Systems Resource Centre / Engineering Exports Promotion Council or IBEF may be considered, added the Association.

The vision ahead for a separate department for medical devices is to make India one of top 5 manufacturing hubs for medical devices worldwide and be nodal interface of manufacturing industry with all Central Government Dept’s to catalyze the growth of the Indian Medical Device Sector – Make in India, Made by India & Made for India.

The separate department would define priority devices to fight priority diseases. Implement strategy to shift India’s import dependency from over 70-80% to less than 30% in next 5 years for priority devices and next 10 years for all devices. It also aims to create a forum for close working between users, developers, manufacturers & academia with DST, DBT, BIRAC, CSIR, DSIR, Kalam Institute etc.

A two per cent custom duty surcharge on imports of the 151 of Eight Digit HS Code that constitute medical devices may be used to create a corpus to finance the Dept and provide outlay for supporting creation of infrastructure of existing clusters and proposed Med Tech Parks.

The goal is also to create and manage a Special Purpose Vehicle Fund for Govt. to Jointly Own Patents/IP’s Shareholding and infuse $75 million or Rs. 500 crore as equity for long gestation R&D projects under Made by India and Make for India Projects for Enterprises without any Foreign Equity. The remodelled department can facilitate creation & development of clusters for medical devices, creation of laboratories & service centres under PPP & skill development of personnel in field of manufacturing, sales, service & regulations.

The letter suggested that this Dept. could be placed in the ministry of health as its extension with a ministry of health care products or ministry of life sciences.

“We had been proposing that the ministry of health as the key stakeholder needs to appoint a coordinating officer or a department within the ministry of health to help establish the medical device industry in India. In the past this was arbitrarily and inadequately handled by the regulatory wing of MOH&FW who passed the buck to CDSCO most of the time which is a meaningless exercise as CDSCO is a regulator and not policy maker,” it added.

It has also proposed that the division of healthcare technology at NHSRC may formally be given the task of being the Nodal Coordinating Centre for all health technology related issues related to medical devices not only for ministry of health but for all stakeholder departments, that is the Department of Pharmaceuticals, Department of Commerce, Department of Electronics, Department of Science & Technology, Department of Industrial Policy & Promotion etc.

“We would not recommend shifting CDSCO (Central Drugs Standard Control Organisation) to the Department of Pharmaceuticals under ministry of chemicals & fertilizers as the international credibility of a free sales certificate by a manufacturer will be only if the regulator is under the ministry of health,” added the Association.

Source : 1