Only 23 categories of medical devices are currently regulated in India under the Drugs and Cosmetics Act. We cannot deliver efficient healthcare unless we regulate the rest of the devices.
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 from the survey showed that at least 35% 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, and 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 Organization. We are not going to be able to deliver efficient healthcare unless we regulate the rest of the devices.
NitiAayog’s proposal to institute a separate regulatory body for medical devices was long overdue as per many industry associations. While the industry awaits the full draft of the 41-page document to be uploaded in the public domain, people in the medical device manufacturing industry have been expressing their desire for central regulatory provisions for quite some time now. Any regulatory provision, if implemented correctly, will give the industry a clear idea of the legal requirements they have to follow in a centrally regulated market.
The impact of Ayushman Bharat
Even as Ayushman Bharat successfully completes a year, the medical devices industry is still at a nascent stage. However, the National Health Protection Scheme has led to an increase in the patient pool as well as bed capacity, and the medical devices industry is set to be one of the biggest beneficiaries, especially categories like instruments and equipments, and disposables and consumables. The shift in disease burden also means that certain categories, like diagnostic equipment, will witness a greater growth than others. If the scheme is implemented effectively, we can expect a compound annual growth rate of at least 30% over the next three years.
At present, India imports over 80% of its medical devices and the government has stated its intention to make India one of the global hubs for medical devices manufacturing and distribution. This move will attract investors, both Indian and overseas, as the lack of predictability has been one of the biggest factors holding back investment in local manufacturing. It will also help patients who suffer from health problems caused by faulty medical devices and implants get the compensation they deserve.
According to the Ministry of Health and Family Welfare, medical devices are regulated under the Drugs and Cosmetics Act of 1940 and Medical Device Rules 2017. If the government is intent on regulating medical devices under a separate regulatory body, then it has to fast track implementation. It should quickly announce so and remove the confusion in this matter. It will be beneficial for everybody in the healthcare ecosystem to have clarity on the future regulation. Manufacturers will be able to obtain licenses under a streamlined framework encouraging local manufacturing and by reducing the costs incurred on imports more hospitals will be able to procure them and improve their infrastructure, and patients will be able to benefit from better diagnoses and treatments, helping us move closer to achieving universal health coverage in line with the United Nations’ 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 & Cosmetics asmedical devices do not have any systemic effect/pharmacological actions. Improper implementation can have adverse consequences. Lack of regulation allows unscrupulous manufacturers to take advantage of the loopholes and end up manufacturing low grade equipment, which will end up worsening the state of healthcare. To play it safe, the government can start with experimenting with just a handful of new devices in the market and see if the transition is smooth. Meanwhile it can go about seeking the expertise of the players in the industry to draft the bill. Once the bill is drafted and approved by the stakeholders in the ecosystem, it can be passed in parliament. This will ensure that the regulatory environment is fair and strong, encouraging positive growth in the industry bolstering the government’s Make in India campaign.
The author is founder and director, ColMed