Industry body writes to PM, demands separate Department for Medical Devices

Highlighting the urgent need for a separate department for medical devices, the letter from AiMeD requested the PM to change the name of Department of Pharmaceuticals (DoP) to Department of Pharmaceuticals & Medical Devices or to have a separate Department of Medical Devices so that, the Manufacturers will be assured that the Govt 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 80 % import dependent sector of Medical Devices.

Talking about why this change is necessary, Mr Rajiv Nath, Forum Coordinator, AiMeD said "India still remains 80 percent import dependent in medical devices. The Dept. 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."

The imports of medical devices are up by record 41% at Rs. 63,200 crore in 2021-22 and 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 current Team needs to be supported with required Expertise by at least 4 Persons i.e. one each from Background of Medical, Bio Medical Engineering, Product Development & Marketing with experience from DST / DBT / BIRAC / DHR / MOH&FW / BCIL / NHSRC / EEPC / IBEF may be considered." Said the letter.

"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 Govt. 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," the release stated.

It also aims to create a forum for close working between users, developers, manufacturers & academia with DST, DBT, BIRAC, CSIR, DSIR, Kalam Institute etc.

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 & Make for India Projects for Enterprises with NIL Foreign Equity.

The remodelled dept. will 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.