The development in science and technology has scaled multiple heights and reached unprecedented levels of sophistication. Advanced methods are being used in all branches of research and technology, including medical diagnosis. Given that diagnosis is done either voluntarily or pursuant to a prescription, the field of medical testing is broad and encompasses a variety of situations. The process of diagnosis depends upon a range of variables, which includes diversified procedures, competent personnel, functional instruments, suitable facility or lab, reagent, etc. Each factor is as important as the other. Further, medical devices include a gamut of instruments ranging from a miniscule syringe used to collect blood samples, to sophisticated CT scanners. Both have the capacity to grossly impact a diagnosis. Hence, arises the need to minimise the variables and ensure uniformity in quality and standards. And, while the monitoring of medical devices, facilities and competent personnel are largely regulated, it is important to ensure that the diagnostic procedures are standardised.
The medical sector has a default level of asymmetry or inequality of information that occurs because one party – the physician possesses far greater information than the other, the patient[1]. This creates a ripple effect and impacts directly the standardisation of quality of these services. Practices such as usage of improper or malfunctioning equipment, underqualified or inexperienced technicians conducting diagnostic tests, as well as distribution of diagnostic reports, in a span of hours, without proper testing or verification are thus common occurrences. Indian diagnostics is one of the fastest growing markets in the world and is expected to grow at a CAGR of 11.53% till 2028. In such a scenario, there is a growing need for strengthening the present regulatory framework for the diagnostics sector.
Present Regulatory Framework
Medical devices are an integral part of the diagnostics framework and are governed by the Medical Devices Rules, 2017[2] (“MD Rules”), in India, focusing primarily on manufacturing, import, sale, distribution, and quality and safety control of medical devices. It provides a comprehensive risk-based categorisation, establish product standards, and set out timelines for obtaining licences. While the supply side is effectively regulated with only quality assured products reaching the market, the demand side endorses a sizeable grey area, as the rules do not extend their coverage to usage or provide any guidance in terms of best practices for medical devices.
Another part of the present framework is the Clinical Establishments Act, 2010 (“CE Act”)[3], which prescribes the minimum standards for registration of facilities. States are allowed to voluntarily adopt the CE Act in their respective jurisdictions. As on date, 10 States and 6 UTs have adopted the CE Act. However, since health is a state subject, several states have their own legislations for the regulation of clinical establishments[4]. From a registration perspective, once a lab submits paperwork and proof of compliance, no checks are conducted after registration. Additionally, the CE Act does not provide for grievance redressal by patients, or even envision fixing the cost of services (while cost of medical devices and drugs is regulated under Drug (Prices Control) Order (“DPCO”), 2013). This leaves room for variance in prices of services charged from consumers.
Laboratories are usually regulated under the provisions of the Shops and Establishments Act, in respect of holidays, standards of cleanliness and hours of work; and some of the laboratories are mandated to obtain registration under the Biomedical Waste Management Rules, 2016 (“BW Rules”). Furthermore, since the reagents and diagnostic kits used by labs are labelled as ‘drugs’ under the Drugs and Cosmetics Act, 1940, approval from the concerned regulatory authority is mandatory. Thus, labs are only regulated by the ancillary regulations for waste disposal (i.e., under BW Rules) or approval for diagnostic kits (i.e. from CDSCO), and there are no exhaustive all-encompassing regulations governing labs in India.
Due to the regulatory vacuum, lab accreditation has stemmed as a legitimate self-regulating mechanism, upon which many now place reliance. While lab accreditation is not a legally mandated requirement, the National Accreditation Board for Testing and Calibration Laboratories (“NABL”), an autonomous institution, prescribes the criteria for accreditation of various labs. This voluntary accreditation aids in providing comfort about quality and standardised services to consumers, as well as the government. However, the compliance norms prescribed by NABL predominantly focusses on quality of equipment more than other aspects of diagnostics. And while bonafide efforts such as voluntary accreditation and self-regulation are being made, there is absence of an over-arching, all-comprehensive framework, which regulates diagnostic labs in India.
In contrast, jurisdictions like the US and the UK have detailed advisories and regulatory standards, which apply to clinical laboratory testing. In the US, the Clinical Laboratory Improvement Amendments (“CLIA”) regulate laboratory examinations and other procedures basis the complexity of the lab tests (i.e. methodology of the procedure, number and type of tests and examinations), and ensure laboratories produce accurate, and timely patient test results, regardless of where the test is performed. Likewise, in the UK, the Public Health Department has issued guidance notes[5], inscribing the standards for microbiology investigations. The guidance aids in the selection of the most appropriate method of testing and accuracy in results through evaluation tests (i.e. comparison against existing method), validation (i.e. evidence-based testing) and verification (i.e. compliance check) of diagnostic methods. This ensures that the variables affecting the results are controlled.
Digital health platforms – the game changers
COVID-19 inspired promising innovation, notably, digital healthcare as an alternative to provision of healthcare services. The new age of healthcare in India is marked by the advent of digital health platforms. Currently, it is possible to access healthcare solutions with the simple click of a button, akin to ordering food online. These platforms have the potential to completely revolutionise and disrupt the industry. We have seen this before with the Unified Payments Interface, which now handles more transactions than credit cards and debit cards in India, both in terms of volume and value[6].
In this vein, the Indian Government, in August 2020, announced the launch of the National Digital Health Mission that aims to create an “open digital health ecosystem”, i.e. digital infrastructure that can be used to provide healthcare solutions. The ecosystem seeks to improve the overall experience by bridging the gaps in allied services, such as storage and use of health records, faster processing of payments and ease of prescription. And while the ecosystem boasts of enabling access to healthcare, and providing benefits in the form of information transparency, interoperability, the road ahead remains unpaved and would require certain challenges to be overcome, regulation being a key one. While waiting for the law to catch up, the industry’s attempt to self-regulate has been codified in the Voluntary Code of Conduct for e-Diagnostics[7]. The Code allows entities in the chain of diagnostics (from sample collection to reporting) to voluntarily adhere to it. It provides guidance relating to the process, from selection of lab to receipt of report, by providing parameters for transparent listing of labs, lab audit mechanism, defined SOPs for sample collection, criteria for sample collection and report preparation as well as consumer grievance mechanism.
While it doesn’t solve the problems highlighted overnight, such an ecosystem has the potential to disrupt market forces and lead to overall improvement in healthcare services, which could lead to India leapfrogging on the healthcare evolution curve. While COVID-19 has largely been a learning experience, the road ahead remains uncharted and while technology may be a possible solution for some of the identified issues, improving the situation on ground would be the real cure. With new-age technologies and varied testing techniques, such as genome testing and mapping for genetic disorders, multi-cancer early detection testing, etc., set to enter the market, it is evident that the landscape of medical diagnostics in India is in a flux and would continue to be so. Against this backdrop of constantly evolving medical technologies and techniques, the laws and regulations cannot be stagnant. When it comes to the medical field, utmost care should always be taken to ensure the safety and wellbeing of patients. It is abundantly clear that we are at the precipice of something novel and disruptive and we must strategise and prepare better for the dawn of new age of healthcare and testing.
