Impact of Medical Devices Bill on the Indian Medical Devices Industry: Vishnu Bhat, Founder & Chairman, Blue Neem Medical Devices

Talks about how the new Medical Devices Rules is a great step in establishing the fundamental framework for medical devices

According to a recent report, the growth rate of India’s medical-device industry is around 15 per cent, which is more than double of the global industry growth rate of 4-6 per cent, and is expected to become a $25-30 billion industry in India by 2025.

With the introduction of the New Medical Devices Bill, due to the maturity and process driven DNA of some of the companies in the medical devices manufacturing space, it will bring stronger credibility to Indian companies on the global platform. Consequently, the medical devices industry will take centre stage, as several start-ups and SMEs selling specialty surgical devices such as stents, catheter to high-end devices and equipment like the ones used in Intervention Radiology, are gearing up to meet this pent-up demand.

Though the medical devices industry has been on the uptick since 2012, regulatory framework was not well articulated and was governed under the drugs and cosmetics act. While India’s regulatory framework was evolving, there were a lot of grey/ambiguous areas leaving a lot to interpretation. India’s new Medical Device Rules 2017 will introduce more formalised registration requirements compared to the country’s current system. This will in the long term result in a robust local manufacturing capability, attracting more foreign investment and reduce prices of medical devices.

With the Indian medical devices sector growing at a rapid rate and with the current dynamics in play, there is a significant opportunity and rationale for manufacturing medical devices in India. The new bill is aimed to bring in collaborative efforts and key policy initiatives, will bring in increased focus on fostering local innovation and set the stage for making India a global hub for medical device manufacturing in the near future.

The manufacturing space in the medical devices sector is virgin territory and with the government’s push, there is a real opportunity for Indian companies. Apart from the cost, the government’s move to separate manufacturing of medical devices and drugs from the regulatory perspective could usher in better transparency and a level playing field for medical devices makers.

As part of this initiative, there seems to be strong focus on ease of doing business. With expected availability of digital platforms to apply for licenses and accreditations, the speed of approvals and transparencies are likely to match global standards and also be convenient.

Earlier, only about 15 categories of medical devices were regulated. This left a large category of devices unregulated or ambiguous. The new bill covers all categories of devices with clear classification of low risk and high risk devices. Regulations for manufacturing, imports, marketing and distribution are now based on these classification and risk profiles. This brings significant clarity and ensures accountability of all parties involved.

In the earlier scenario, the clinical trial process of new devices or designs was subject to the same process as that of drugs/ pharmaceuticals. They were either unsuitable or too complex for medical devices. With the new regulation, they have been appropriately streamlined based on the classification of the device. This should encourage the manufacturers to innovate with new designs to cater to needs of the local practitioners and patients.

These initiatives and a strong regulatory framework will help the Indian manufacturer grow and meet the needs of healthcare in the country and furthermore allows them to be globally credible and competitive as well.

In the last decade, the Indian Healthcare industry is on a high growth trajectory. In India, changing demographics, rising life expectancy, and growing public awareness have contributed to a higher demand for quality and yet affordable medical care. However, in large parts of the country, challenges in access to quality, affordable healthcare persists.

Despite the medical devices sector also having grown considerably during this period and having played an instrumental role in providing access to affordable health care services, the policy loopholes has led to high dependency on imports for addressing the high local demand.

Today, in excess of 75 per cent of medical devices are imported which has been mainly due to lack of a thriving local manufacturing ecosystem. The new regulations will no doubt strengthen and boost the domestic manufacturing industry.

At the same time, it will ensure that the quality of locally made devices meet global standards and are safe for use. With all the categories of medical devices being brought under the ambit of regulations, it thereby ensures basic safeguards for quality. This will greatly enhance the credibility of locally made medical devices. A good range of quality devices manufactured locally ensures availablity at the right price points. This should benefit the healthcare industry and patients in the long run.

The new Medical Devices Rules is a great step in establishing the fundamental framework for medical devices in India. This will go a long way in building a strong standards ecosystem for the industry. It will boost domestic production as well as boost exports, usher in greater foreign investment in the sector and bring in more investments into infrastructure and processes, design and manufacturing of medical devices in India, thereby reducing dependence on imports. A strong regulatory framework brings immense credibility and strength to the industry and thereby ensuring that the industry caters towards providing high quality products with low pricing benefits to the end-user – The patients.

In conclusion, it is a welcome move by the government to usher in the processes, quality standards and regulation framework that are required to structure the medical devices industry.