India’s medical device industry has huge untapped potential and can be a potent force globally if regulated and pushed in the right direction, stated a report released by the National Health Systems Resource Centre (NHSRC) at the National Symposium of Safety of Medical Devices, organised in association with UL (Underwriters Laboratories) in Bengaluru recently. The report reinforces the need for bringing in a systematic and harmonized approach towards testing for safety and efficacy of medical devices.

UL is a premier global independent safety science company and NHSRC has been set up under the National Health Mission (NHM) of Government of India to serve as an apex body for technical assistance.

Medical devices manufacturing is a $350 billion global industry, with India accounting for just over $5 billion. With a population of one billion, ensuring that citizens of the country have access to affordable, quality healthcare remains a challenge.

The national symposium witnessed the launch of two reports on setting up medical device testing laboratories for electrical and electronic medical devices as well as for biomaterials and medical implants. The reports developed by the National Health Systems Resource Centre, in technical collaboration with the WHO Country Office for India and with technical inputs from UL in India and Sree Chitra Tirunal Institute of Medical Sciences and Technology, highlight the basic requirements, work flow, infrastructure and human resources required for establishing medical devices testing laboratories.  

Speaking on the sidelines of the symposium, Ravi Capoor, joint secretary, Ministry of Commerce said, “Medical devices have a huge potential in India. However, 70 to 75% of the market continues to be import based. To grow the industry and achieve the 25 billion USD target, we need to lay greater emphasis on developing industry standards and making regulatory amendments to the existing Drug and Cosmetics Act. Technology can be a great enabler to these efforts and we need to set up R&D incubation centers across the country that foster innovation and thereby help in designing and manufacturing devices locally”.

Speaking at the symposium, Suresh Sugavanam, vice president and managing director, UL South Asia, said, “The government approving 100 percent foreign direct investment (FDI) in the medical devices sector is a positive step towards developing the overall healthcare infrastructure, thereby reducing our dependency on imports. The expected inflow of investment should target research, testing and infrastructure strengthening to promote domestic manufacturing. UL has made significant investments in terms of resources and laboratories to support the industry. The current landscape is highly fragmented and calls for a restructuring of regulatory framework to boost the industry.”

“The medical devices industry in India needs to be governed by new laws which will facilitate the creation of a separate identity for the sector. As a first step, the ministry is trying to establish a one-stop shop to address all kinds of grievances in health sciences. To ensure the success of the Make in India campaign, quality enhancement is crucial along with the setting up of regulatory standards”, added KL Sharma, Joint Secretary, Ministry of Health and Family Welfare.

 “Access to safe, good quality and effective medical devices is an important component of health services. With the increasing commitment of the government towards achieving health for the people, proportionate effort is required towards developing systems such as testing laboratories to support the medical devices sector. Only with comprehensive and collaborative effort can the nation progress towards self-dependency and bring cost-effective and safe medical technologies within the reach of masses,” said Dr Sanjiv Kumar, executive director, NHSRC.

The symposium was attended by a diverse set of stakeholders who debated on key issues facing the industry like the importance of patient and user safety in medical technology, the role of third-party testing and notified bodies towards the growth of the MedTech industry, general requirements for basic safety and essential performance of medical electrical equipment.