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Cover Story

Indian Medical Device Industry: Integrating Market, Technology, Innovation And Ecosystem

Dr. Jitendar Kumar Sharma
Head, Division of Healthcare Technology & Director, WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy, National Health Systems Resource Centre, Ministry of Health & Family Welfare, Govt. of India

Highlights of Presentation made by Dr. Jitendar Kumar Sharma during the 13th National Conference and Technology Display Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016, Ahmedabad.

Dr. Jitendar Sharma started his presentation by giving the overview of Medical Devices Sector. He said, “Medical devices Sector are complex knowledge driven field. It is not like producing microwave or transistor or fridge. It is so knowledge dependent that any lapse in knowledge can lead to adverse events.” He expressed happiness for the fact that the conference was jointly participated by Universities and Industries. He appreciated the formation of Orthopaedic Implant Manufacturers Association (OIMA) explaining that unless there is a critical mass of people thinking together in the same way, no job can be done. He also mentioned that all the manufacturers will be benefitted by this.

Introducing Division of Healthcare Technology in National Health System Resource Centre which is at NHSRC under ministry of health, he explained that it is the technical secretariat not for regulation but for service delivery and industry promotion. During the presentation he elaborated on major issues of importance to the Indian Medical Device Industry namely – Quality, Infrastructure, Cost Reduction, Compliance and Reporting.


He introduced the new quality assurance scheme, “Indian Certification of Medical Device Scheme (IC-MED)” - a joint initiative of Association of Indian Medical Device Industry (AIMED), Quality Council of India (QCI) & National Accreditation Board for Certification Bodies (NABCB). Explaining more he said that, “This IC-MED mark is a voluntary certification. It is not the replacement to what the regulators do; it is focused quality improvement strategy to improve medical device manufacturing processes. There are many standards in the IC-MED mark right from product manufacture, realization, process to safety to standardization etc.” He suggested the industry to work together to make “IC-MED mark” a success. He also suggested the industry to have a joint training program so that QCI can offer an orientation program to understand & prepare the company for getting “IC-MED”.


Emphasizing on the importance of Cost Reduction for the industry, Dr. Sharma explained that for both, safety & cost reduction, it is essential to have right quality of infrastructure. Explaining the need for Medical Device Testing Laboratories in India, Dr. Sharma mentioned that two such laboratories are under process of implementation and will be in operation shortly- one in Noida for testing of electrical & electronic devices and second in Vadodara for biomaterials and implants testing.

He explained the quality of such laboratories abroad and emphasized the need for certified Medical Device Testing Labs. In order to guide the industry, Dr. Sharma informed that Division of Healthcare Technology has prepared reports on establishing and operationalising medical devices testing laboratories. The reports have been made available at the WHO website as well.

Medical Device Parks In India

Dr. Sharma informed that two Medical Device Industry parks are announced in India. He explained at length the benefits of such parks and mentioned that it will reduce the cost of manufacturing and make the indigenous products economical and affordable. In particular he informed that Govt. of Andhra Pradesh has decided to establish country’s first Medical Technology Manufacturing Park at Vishakhapatnam. The creation of such as park is based on the fact that medical devices manufacturing requires certain high investment facilities which are too capital intensive for individual manufactures to invest upon. A park with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40%-50%. Currently, due to lack of such centrally located sharable facilities, either manufacturers do not undertake production of technologies requiring them or send their products abroad for process up-gradation and value addition. While the park would have all such facilities in-house to reduce manufacturing process costs, the Andhra Med Tech Zone at Visakhapatnam would be located in an area which is well connected with Railways, Roadways, Waterways and Airways with near presence of Industrial Corridors, Port and Harbor to reduce logistical costs. The park will provide for all capital intensive common manufacturing facilities required by medical device manufacturers and modern state of art 100-150 independent manufacturing units, each of a built-in ready to use area of 1 to 2 acres.

Materiovigilance Program

He explained the materiovigilance program designed on the line of Pharmacovigilance for medical devices. He further mentioned that 10 institutions are identified for reporting of adverse events. He emphasized the need of having a medical device safety officer in each company who can get feedback of adverse events from market so that necessary improvements can be made at product level which would help improve product credibility and profits.


Emphasizing on the need for innovation, Dr. Sharma introduced the National Health Innovation Portal which carries out evaluation of the innovative medical technology innovation and provides report on whether the innovation is suitable to public health needs. The evaluation is carried out by Division of HCT and then approved by a committee appointed by Ministry consisting of distinguished scientists as members which makes recommendation for uptake of innovative technologies. Dr. Sharma also explained the proposed ‘Auction Program’ by government under which patents and prototypes that have been invented at research institutions would be auctioned to the industry thereby leading to transfer of manufacturing rights. Revenue thus generated could be shared with the institutions for carrying out further research and could also be used for supporting medium and small scale manufacturers obtain necessary quality certifications for their products.

Summarizing his presentation, Dr. Sharma strongly suggested the industry to appoint an officer for implementation of “IC-MED” in organization as well as for tracking adverse events. He mentioned that doing this voluntarily will help the industrial progress in a major way. He reiterated that the Govt. will create testing labs as well as Med Tech manufacturing parks which will provide manufacturing space with common facilities at substantially low cost. He also repeated his appeal to the industry to share knowledge on the National Health Innovation Portal.


Dr. Jitendar Kumar Sharma is Head of Healthcare Technology Division and Director of WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy, at National Health Systems Resource Center, the technical support institution under Ministry of Health & Family Welfare, Government of India. He is also Adviser (Health & Medical Technology) to the Hon’ble Chief Minister of Andhra Pradesh and nodal officer for Andhra Med Tech Zone Project. He is a key designer and coordinator of several health technology programs in India and a faculty for courses on health technology policy & assessment in several countries. He is referred as the “Med Tech Man of India” for his contributions to the field of medical technology policy & programs. He earlier served at Sri Sathya Sai Institute of Higher Medical Sciences, later as consultant to World Bank and then as Consultant to the World Health Organization, Geneva. He is Clinical Faculty at University of Adelaide, Australia and program director for Health Technology Assessment (HTA) fellowships in India. He has been an adviser at Health Technology Innovation Centre, IIT Madras and serves as faculty for National Accreditation Board for Hospitals (NABH) in India for Medical Devices. He has contributed through several research papers, seven books on health technologies & assessments, and six compendiums on technical specifications for medical technologies and has been contributor to several reports on health technologies by International agencies including WHO.

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