For a country with the fourth-largest medical devices foothold in Asia, India must aim to increase local investment and production.
The success of India’s aim to be self-reliant will be defined by the regulatory framework in medical devices.
What is the transition?
Japan is paying its companies to shut their manufacturing plants in China.
American companies are planning to shift their base from China.
So, these are times of strategic transitions which India must use wisely.
What is the history?
In 2017, voluntary certifications began in India with the Indian Certification for Medical Devices (ICMED) of Quality Council of India.
The ICMED gave process certification to many medical devices using notified bodies.
The industry couldn’t understand the need for the voluntary certification scheme, and this was opposed by the CII and the FICCI.
Medical device experts see it as a deviation from global practices.
This indicates that the regulatory environment in India is complex.
What kind of reform is needed?
Industry representatives recommended that any new legislation should be aligned with international regulatory best practices.
They also suggested that the industry should be involved and consulted throughout the process.
India aims to transform into a global manufacturing hub.
So, the regulatory mechanism should be harmonised with the global best practices recommended by the International Medical Device Regulators Forum (IMDRF).
What are the global standards?
Essential principles of safety and performance are important.
To demonstrate compliance with essential principles, there are consensus standards developed by global standards bodies such as the ISO, and recognised by stringent regulatory authorities and the IMDRF.
There are two kinds of standards:
Horizontal (ones that describe the process or practice that is applied across a range of devices, like sterilisation, software, etc)
Vertical (specific test methods or performance aspects of a specific grouping of devices).
These standards have been segregated so that a manufacturer can develop a medical device in accordance with key elements of essential principles.
What is the problem?
Procurement agencies have been procuring commodities complying with a specific standard.
In the case of medical devices, they were faced with the challenge in procurement as the same product with different specifications and varying complexities was before them.
This led to complexities in procurement.
Hence, the Bureau of Indian Standards (BIS) was requested to develop standards to procure medical devices.
What could be done?
The BIS must adopt international standards to encourage Indian manufacturers to conquer the global market.
It should also help global players introduce new products and increase investments in India.
The US, the EU, Japan and other IMDRF countries rely on these consensus standards to increase predictability, streamline premarket review and provide clearer regulatory expectations.
