In the wake of reports of faulty test kits and protective gear purchased by India from China, India’s medical device industry has been in limelight again which can hamper India’s fight against COVID -19. In the past too, India has faced such failures over patient safety, quality control and efficacy of the medical devices and equipments, be it Johnson’s and Johnson’s faulty hip transplants leading to disabilities in patients or use of unapproved drug eluting cardiac stents threatening heart care in India. At the time when India has been looking at scaling up testing and surveillance due to increased diseases burden, significance of regulation, monitoring and increased domestic manufacturing of medical devices cannot be overemphasized.
Medical Devices in general means any instrument, apparatus, implement, machine, implant or other to be used for the specific medical purposes of diagnosis, prevention. monitoring, treatment or alleviation of diseases or injuries, supporting or sustaining lives control of conception , replacement, modification , support or providing information of a physiological processes. Ranging from simple thermometers, stethoscopes and tongue depressors to complex devices like pacemakers with micro chip technology, ultrasound etc., medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease.
Until recently, the healthcare stakeholders, i.e., doctor’s patients, physicians, employers, insurance companies, pharmaceutical firms and government were focused on the drugs and other pharmaceuticals. There was a limited awareness which led to free hands on the medical devices regulation. Now, India attaches great significance to medical devices as they are quintessential to healthcare. The industry is expected to grow drastically over the next several years amidst the rising demands, high incomes and growing middle class, speed innovation and technology changes, increased public health awareness and spending and government health initiatives.
Despite such widespread significance, there were fundamental and systematic issues persisting in this industry .The most common concern is the device safety and efficacy. Lack of regulatory systems with global standards has put the patient›s life at stake. Poor device safety and functionality has been crucially related to legislative loopholes which makes it easy for device makers to get their products in the market before proper testing. Lack of quality product testing in India is another hurdle which results in sub standard devices in the market. Rampant imports at low cost not only leads to poor quality equipment but a big impediment to the domestic manufacturers and the government revenue. Absence of regulatory oversight and under reporting of failure of medical devices has added to the issues surrounding this sector. Other combinations of issues include failure to work as intended/malfunction, instructions/labeling/packaging issues and use errors.
As we’ve seen, though, each of these major problems with the health care device market has captured the attention of regulators and concerned citizens, government is yet to attain a safer and more transparent industry. In such scenario, proper manufacturing, regulation, planning, assessment, acquisition, management and use of medical devices which are of good quality, safe and compatible with the settings in which they are used has become quintessential. The Indian medical devices and equipments sector with the majority of medical devices sold in India imported from other countries (Currently 75%) went unregulated so far until the notification of Medical Devices Rule, 2017. The CDSCO under the Health Ministry regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics act, 1940 and the Rules made there under. The Indian Government stepped up and initiated some reforms for improving the quality of the medical device sector.
In January 2017, India’s Ministry of Health and Family Welfare released the longawaited Medical Device Rules of 2017, which took effect on Jan. 1, 2018. Upon implementation, this regulation replaced the existing Drugs and Cosmetics Act (DCA). Prior to implementation of the Act, the medical device industry in India was largely unregulated, except for a few devices covered specifically by the DCA. The list of covered devices was limited (only 15 medical devices were included), and the DCA treated these devices as drugs rather than establishing regulations tailored to the medical device industry. The implementation of MDR 2017 attempted to establish a uniform regime for Indian medical device manufacturing and marketing, at par with the global standards. It laid down a risk based classification of medical devices. The rules notified increased number of medical devices to be regulated and separate provisions for clinical trial of medical devices to access safety, performance and effectiveness. Certifying bodies for third party assessment were also notified. Strict Registration and licensing norms and post market surveillance to ensure safety, performance and adaptability of the device were the key highlights.
The 2017 rules were a good step in right direction. However, there still existed some gaps and ambiguities. Bringing into domain larger no of medical devices was the ultimate aim with opportunities to domestic manufacturers to penetrate into the market. The pricing of the devices still remained under the market forces of demand and supply resulting into out of pocket expenditures and poverty shocks. The country still witnessed scandals, the biggest of which was the hip implants which resulted into patient disabilities. Still, outside of these “notified” device categories, manufacturers with unproven designs, little or no quality control, limited defect traceability, and inconsistent reliability could operate with relative abandon in India.
Taking cue from the above, on February 11, 2020, the Ministry of Health and Family Welfare (Mo H&FW) issued two notifications in the Indian Gazette – a new definition of medical devices and The Medical Devices (Amendment) Rules, 2020, the latter amends the Medical Devices Rules, 2017, and has been effective from April 1, 2020. This will bring all medical devices under single regulatory framework. Under the new Medical Devices (Safety, Effectiveness and Innovation) Bill, the government has also proposed an improved regulatory framework which is said to improve the ease of doing business by providing a sound environment for innovation and approval of medical devices in the country. The new proposed regulatory framework is said to focus on safety, efficiency and quality of medical devices, and will be operating under Central Drugs Standard Control Organization (CDSCO), which will be enhancing its expertise to regulate safety and efficacy of medical devices. The ministry of health and family welfare (Mo H&FW) in partnership with Niti Aayog has established a separate regulatory body for medical devices sold in the Indian markets. Also, the government plans to include the country’s top technical institutes such as the Indian Institute of Technology (IIT), Indian Institute of Science (IISc) and others, thereby utilising their worldclass laboratories, to help set benchmarks and safety guidelines for providing certifications to medical devices
The Medical Device Rules, 2017 and the amendment Rules of 2020 have many attractive features that encourage the medical device sector in India. By introducing a single online portal, the registration process has been streamlined. An audit by the notified bodies will further increase the manufacturing quality of devices. A change in clinical trial requirements will encourage the innovation of new medical devices. The regulations will thus encourage domestic manufacturing and increased scrutiny of import license documents. However, there still remains certain grey areas with changes in the industry dynamics. They include looking for regional prospects and providing market opportunities, increasing competition, bringing down costs and reducing imports, separate FDI Framework for medical device industry that is independent of regulations governing the pharmaceutical sector, penalising frauds exclusively for medical devices. Mere control through licensing, testing and certification lead to red-tapism, bureaucratic hurdles and delays.
With the shifting market dynamics caused by Covid-19, pretty much everything is in overhaul mode. Within the burgeoning health technology ecosystem, the medical devices market is also witnessing a dramatic shift as policies are being changed to accommodate the high demand. The Covid-19 pandemic has just highlighted the importance of medical devices more than ever. A lot of startups, researchers and medical device manufacturers are currently focusing on improving the quality of care and also developing affordable devices, including ventilators, contactless wearable devices, UV sterilising chambers, testing kits, PPE among others. At the same time, the Indian government has been supportive in this context and is easing the regulatory process for mass testing and production, where they are pushing startups and SMEs to develop medical devices that help India tackle the pandemic and other lifestyle and chronic diseases.
Financial incentives are also underway to boost local manufacturing of medical devices over five years through a comprehensive production linked incentive (PLI). Central government through Department of Pharmaceuticals notification (DoP) lays out plan to incentivise Indian players with at least Rs.3,420 crore, over a period of five years. This incentive would be provided if they were to invest in their set-ups to produce key medical devices. According to a data compiled by DoP, India’s medical device market stood at Rs.50,026 crore for 2018-19 and is skewed in the favour imports which were to the tune of Rs.43,365 crore, while exports were Rs.16,300 crore. While both exports and imports grew at 25. 2 and 23.8 per cent as compared to 2017-19, and it is expected to touch Rs.86,840 crore in 2021-22, officials said that there is a lack of level playing field in India versus the competing economies. Lack of adequate infrastructure, domestic supply chains, logistics, high cost of finance, limited availability of quality power supply, limited design capabilities, low focus on R&D, and skill development are the main roadblocks.
Today the India’s medical device industry market is still in the nascent stage and many companies are facing closures since they cannot compete with China and imports from other countries, including the US, Singapore and Germany and others. The industry is surviving a regulatory vacuum & regular patient safety concerns. The recent J&J hip implant frauds and most recent ban on Trans-vaginal Pelvic Mesh by USFDA made the Indian regulators seriously think to look medical devices as a different sector altogether. It has become imperative to have a separate law as devices are engineering items and not medicine, continued attempts to regulate them as drugs is irrational. A separate legislation for the same would be a welcome step.
Neha Gyamlani is an Advocate at Rajasthan High Court and Partner at J&G Advocates. Aditya Jain is an Advocate on Record at Supreme Court of India and Partner at J&G Advocates.