The Government has paved the way to institute a separate regulatory body for medical devices. It must walk an extra mile to device regulatory provisions, too
According to a recent survey conducted by Anna University, only one in five ventilators used in hospitals across Tamil Nadu has been certified safe for use by biomedical engineers. Further, findings showed that at least 35 per cent of the medical equipment used in hospitals did not pass calibration tests. While we do not have concrete data on complications and deaths caused by malfunctioning equipment, it is not hard to imagine a scenario where treatments are prescribed based on faulty readings, leading to catastrophic consequences. This scenario is all too common in States across the country. The lack of a regulatory framework for medical devices is the main reason behind this laxity. At present, only 23 categories of medical devices are regulated by the Central Drugs Standard Control Organisation. India will not be able to deliver efficient healthcare unless it regulates the rest of the devices.
According to industry associations, the Niti Aayog’s proposal to institute a separate regulatory body for medical devices was long overdue. While the industry awaits a full draft of the 41-page document to be uploaded in the public domain, people in the medical device manufacturing industry have expressed their desire for central regulatory provisions. Any regulatory provision, if implemented correctly, will give the industry a clear idea of the legal requirements that need to be followed in a centrally-regulated market.
Impact of Ayushman Bharat: Even as this healthcare scheme has successfully completed a year, the medical device industry remains at a nascent stage. However, the National Health Protection scheme has led to an increase in patient pool as well as bed capacity. Thus, the medical device industry is all set to become one of the biggest beneficiaries, especially in categories like instruments and equipment and disposables and consumables. A shift in disease burden also means that certain categories like diagnostic equipment will witness greater growth than others. If the scheme is implemented effectively, India can expect a compound annual growth rate of at least 30 per cent over the next three years.
At present, the country imports over 80 per cent of its medical devices and the Government has made its intention clear to make India one of the global hubs for medical devices, both in manufacturing and distribution. This move will attract investors, both Indian and overseas. The lack of predictability has been one of the biggest factors that has been holding back investment in local manufacturing.
Implementation: According to the Ministry of Health and Family Welfare, medical devices are regulated under the Drugs and Cosmetics Act, 1940, and the Medical Device Rules 2017. The industry is awaiting an official announcement to migrate to an independent medical device Act. If the Government is intent on regulating medical devices under a separate regulatory body, it has to fast track its implementation. It must clear the air on this matter. This will give the healthcare sector a clarity on future regulation. Manufacturers will also be able to obtain licences under a streamlined framework. Local manufacturing can be encouraged and, thus, lead to a reduction in the costs incurred due to imports. Further, more hospitals will be able to procure devices and improve infrastructure. Patients, too, will be able to benefit due to better diagnoses and treatments. Overall, it will help India move closer to achieving universal health coverage in line with the UN’s Sustainable Development Goals.
It is equally important to ensure that the regulatory body has competent bio-medical engineers, technocrats, scientists, lab technicians, clinicians and surgeons on its panel. The range of medical devices is quite vast and they must not be seen through the lens of drugs and cosmetics as medical devices do not have any systemic effect/pharmacological actions.
Improper implementation can have adverse consequences. Lack of regulation will lead to unscrupulous manufacturers taking advantage of the loopholes. They may end up manufacturing low-grade equipment, which will worsen the state of healthcare. To play it safe, the Government can start experimenting with just a handful of new devices in the market and see if the transition is smooth. Meanwhile, it can seek expertise of the players in this industry to draft the Bill. Once it is drafted and approved by various stakeholders, it can be passed in Parliament. This will ensure that the regulatory environment is fair and strong, encouraging positive growth in the industry and bolster the Government’s “Make in India” campaign.
(The writer is founder and director of an online medical store)