All United Nations member states have agreed to achieve Universal healthcare coverage by 2030, but with 10 years left, can India attain the difficult target?

The statistics are not in India’s favour and require a strong shot... India’s healthcare system has been ranked at a dismal 145 out of 195 countries by the Lancet Study titled “Global Burden of Disease” and NITI Aayog has resembled it to a ‘sinking ship.’ The biggest hurdle in improving the public health is its appalling infrastructure with one doctor for every 1,445 patients and our poor healthcare budget of 1.2 per cent of the GDP adds to the burden, leaving a very minuscule amount in the hand of policymakers to increase accessibility. To cover this gap, India took the first step in the right direction with the launch of a mega healthcare scheme - Ayushman Bharat. It had aimed to put India on a war footing by providing Rs 5 lakh health cover per family to 37 per cent of the population. But in a bid to increase accessibility through affordability, quality seems to have taken a backseat. The Lancet Global Health Commission on High-Quality Health Systems reported that 1.6 million Indians died due to the poor quality of care in 2016, nearly twice as many as due to non-utilisation of healthcare services. This puts a question mark on government strategy. Should the scale tilt in favour of affordable treatment by compromising quality or equally favour both affordability and quality? Considering the state of the medical devices industry, the intent of achieving Universal healthcare will be defeated if India compromises on the quality of medical devices.

One of the biggest challenges in attaining quality healthcare might be the recent directive by the Department of Pharmaceuticals (DoP), where the government has asked states to consider doing away with the requirement of US and European regulatory certification of equipment to be purchased for state-run institutions and hospitals. There have been recommendations that there should be a preference for ‘Make in India’ stents during public procurement. It is important to note how more than 70 per cent of the demand for medical devices is being met by global companies with a large footprint of investment in manufacturing, research and development and training of healthcare workers in India. As a country, we need to re-think if geography alone can be a determining factor to opt for medical devices such as cardiac stents. No FDA approval for the local geographically established stents may mean no standard safety check and doubt over quality. This comes as a double whammy for a market, which has firewalled innovation and halted the entry of innovative premium stents available in the west. So, is the government jeopardising patient safety by undermining the pivotal role played by technology in improving patient outcomes?

The recent directive by the DoP also shifts the focus on the quality standards (BIS) prescribed by the Indian government which are considered outdated compared to the global practices for regulating the quality of medical devices. While globally accepted regulatory frameworks focus on three components: safety, efficacy and standards, the standards of BIS are not considered as robust as USFDA/CE. A key area which BIS does not take into consideration is the clinical evaluation and risk assessment. Without conducting these, the safety and efficacy of the devices cannot be determined domestically.

Health experts are of the opinion that stringent quality control regulations must be put into place before a device is launched in the market to ensure it is safe to use for all. This can only be achieved through extensive clinical trials. However, in India, according to various studies, a device is approved based on only 100 patients’ trial. Taking into account, the diversified demography, complex disease population and burden, clinical trials should be conducted with more than 1000 patients (USFDA standards) so that the device can be evaluated in various verticals to match the global parameters. There is a need for the domestic stent manufacturers to understand that clinical trials are an indispensable aspect of the stent development process to define the safety and efficacy standards of any medical device.

Although several media reports point to an increase in the market share of domestic stent manufacturers, not much emphasis has been laid on the locally manufactured stents matching up to the global standards. Where the primary focus of the government should be on increasing affordability, one must not forget about the aspect of quality and availability of appropriate medical technology that helps yield the desired results. This brings to light the difference in opinion between the government and the industry, also highlighting the rising need for India to look at policies that risk India’s stake in the market with solutions that encourage incremental innovation and boost investment. MTAI in a media statement about the recent directive to states to prefer domestically manufactured medical devices, stated, “this mechanism may end up restricting competition rather than creating a level playing field.”

Even if the central and state governments keep offering universal healthcare services, there will always be an underlying trust deficit in relation to the quality of the locally manufactured stents. What India needs is a strong mechanism that looks at the medical devices from the lens of providing improved quality healthcare access to patients rather than focussing on the geographical aspect. One needs to understand the complexities of the healthcare system in India, exposing patients to higher health risks and unethical practices which might put patient safety at risk. The intent of achieving Universal Healthcare and the vision of a ‘healthy India’ will be defeated if the relevant stakeholders fail to work in coherence with each other to establish a robust healthcare setup.