Towards a consistent regulatory framework in India’s medical device industry

A large chunk of the Indian medical device market is serviced by imports, which currently stand at 70 – 75 percent of total demand.

Towards a consistent regulatory framework in India’s medical device industry
While Text neck is yet to be defined as a medical diagnosis, the term is commonly used for a repetitive stress injury. (File)

By Ashok Patel

A holistic healthcare delivery framework is one that caters to all aspects of the healthcare value chain. From the health centres, clinics and hospitals to the pharmaceutical industry, there’s a long chain of activities that needs to be properly managed and regulated for the best possible deliverables. However, there is a part of the mix that is not getting as much regulatory attention in India; the medical device industry.

Valued at $10.36 Billion in 2020, the Indian medical and surgical devices market is projected to rise at a CAGR of 37 percent to $50 Billion by 2025. The growing expansion of medical facilities and the numerous initiatives by government and partner agencies are two key factors responsible for this growth, thereby reemphasizing the need for a proper regulatory framework to ensure quality standards and professional conduct, especially in the areas of design, development, manufacturing, and servicing.

Medical devices include those used for screening and diagnosis, management, treatment and care, monitoring and restoration, among others. From the Pulse oximeter and digital thermometer to the stethoscope and blood pressure monitor to larger and more advanced dialysis and surgical equipment, every bit of medical device requires the highest quality standardization, like those ratified by the International Organisation for Standardisation (ISO) and spearheaded by institutions like the US Device Good Manufacturing Practice Advisory Committee and many others in the EU.

Current outlook and regulatory framework

A large chunk of the Indian medical device market is serviced by imports, which currently stand at 70 – 75 percent of total demand. At the far end of the spectrum is an export portfolio of $2.51 Billion, with the potential to increase to $10 Billion by 2025, according to the the Indian Brand Equity Foundation. The United States, China, and Germany currently serve as the global hubs for medical equipment and devices and these three nations account for almost all of India’s imports.

To break free from such dependency, the Union needs to develop a properly financed and ambitious program with a comprehensive approach towards encouraging local manufacturing and instilling consistent regulation to compete favorably with the big players. The Indian medical device market is among the top 20 in the world and presents a very viable market for local players and foreign direct investments (FDI). Only in May 2020, the government announced a series of incentivization plans totaling $4.9 Billion (Rs 3,240 Crores) available to manufacturers who invest in medical device set-ups over a five-year period.

With such initiatives, it is important to strengthen regulations to meet up with expected proliferation in the country. Until 2017, the only available regulatory framework for specific medical devices was captured in the Drugs and Cosmetics Act, 1940. Obviously flawed and not comprehensive enough for the evolving medical devices industry, the Indian Medical Device Rules (2017) were released by the Central Drug Standard Control Organisation (CDSCO), providing new regulations for India’s medical device ecosystem.

Amended in 2020, the reviewed Medical Device Rules came into force in April 2020, covering areas like registration, classification, manufacturing, sales, labeling, import, and other post-market requirements, etc. While these rules are a step in the right direction – spelling out many requirements for the safety and functionality of medical devices – a lot of revamping and clarity are needed if India is to match the standards and advancement of key regulations in more advanced climes like the European Union and the US.

The way forward

The Indian healthcare sector is currently undergoing tremendous growth and the medical device subsection is one of its fastest growing components. The fact that more than 70 percent of these medical devices are imported is worrisome, but it also presents massive opportunities for local manufacturers and investors as well as foreign manufacturers to take advantage of the FDI space. The surge in the acquisition of ventilators and the attendant scarcity that followed during the peak of COVID-19 in India is a good example of reasons why local manufacturing and standardisation should be ramped up.

Although there are a number of players already blazing the trail in ventilator manufacturing, among other devices, a lot more needs to be done to make India a choice hub for medical devices among the comity of nations. For this to happen, the country’s regulatory process must be unbundled to become less complex and faster. Impediments and discouraging procedures should be made seamless for investors without compromising standards; that’s where regulation begins.

The Indian Medical Device Rules (2017) as amended in 2020 must also follow in the footsteps of the EU’s Medical Device Regulations which focus on quality and functionality by reassessing medical devices for compliance and subsequent certification, as well as conducting a clinical evaluation for demonstrating the efficacy and safety of those devices. India must, therefore, be stringent in its approval processes, but such processes must be clear and free of complexities while ensuring that only the top-quality devices are approved for use in the country.

(The author is Founder & CEO, Max Ventilators. Views expressed are personal and do not reflect the official position or policy of

Get live Share Market updates and latest India News and business news on Financial Express. Download Financial Express App for latest business news.