Diagnostics plays a very important role in health improvement and quality of life. This includes equitable access, affordability, and appropriate use of good quality diagnostics as the backbone of high quality care in healthcare. Accurate diagnostics are indispensable for effective management of diseases for better patient care and improved clinical outcomes; enhance affordability by reducing the overall cost of medicine; and also by reducing antimicrobial resistance. This will also ensure proper application of EML by adopting quality diagnostic products. Even though diagnostics has not received equal importance as EML for the last 40 years since EML exists in India, it all falls under universal health coverage. Some of the declared goals that must be achieved under SDG 3.8 by 2030 are financial risk protection, access to essential health care services of satisfactory quality, and access to safe, effective, quality, and affordable essential medicines and vaccines for all. Today, India seeks to realize universal coverage of health—which means eliminating the following out-of-pocket barriers to accessing and receiving essential care: out-of-pocket expenses, time to reach a healthcare facility, and inadequately equipped facilities and poor providers. It also calls for access to diagnostic tests to be a part of this process. And on the horizon will be the critical need for an essential diagnostics list or EDL in India, which would be in line with the list of essential medicines to ensure healthy living and ultimately achieve the goal of universal health.
During the process of implementation of the National Health Mission itself, the Ministry of Health and Family Welfare, Government of India, felt a definite need to increase access to quality diagnostics in public health facilities and in July 2015 launched the Free Diagnostics Services Initiative (FDI), under which the NHM supports all states to enable them to provide essential diagnostics—laboratory and radiology—free of cost in their public health facilities. Apart from strengthening the rural public health system, the NRHM has been launched under which the IPHS is tasked with achieving and maintaining a certain level of quality of care besides providing high quality specialized medical services to the community. All these standards have been updated recently with a view to moving forward in providing quality health care in the country. WHO published the first version of the National List of Essential Diagnostics in May 2018. The National List of Essential Diagnostics, in essence, is an extension of the Free Diagnostic Service initiative of the Ministry of Health and Family Welfare and other diagnostics initiatives under IPHS and Health and Wellness Centres etc. and needs to be added to the about 10,000 free diagnostic facilities already established at all levels of the public health system.
This will lead to improved delivery of healthcare in NEDL and evidence of this is better patient outcomes and lower out-of-pocket expenditure. Quality diagnostics will provide holistic care but also increase rationality of care. Effective public health facilities are achieved through effective assessment of disease burden, disease trends, surveillance and identification of outbreaks and tackling the crisis of antimicrobial resistance. With these, technology/diagnostic services will be standardized and research and development efforts for new appropriate and effective diagnostics will be facilitated. This will reduce costs. Better regulation in procurement will begin with accreditation of better laboratories, national control systems and laboratory capacity. The EDL will complement the national EML which has so far proven successful in opening up access to treatment and reinforcing affordable prices of medicines. For the first time, it is the Indian Council of Medical Research that has designed a standardized treatment flow in case of over 100 diseases. The treatment flow will guide the physician about the best way to treat the patient with respect to the specific disease and provide secondary and tertiary care hospitalization services in line with the vision of the newly-launched Pradhan Mantri Jan Arogya Yojana. This will be a very practical approach from ICMR that can outline how diseases can be managed and monitored better with proper and early diagnosis. In the past there was no regulatory process on diagnosis, and hence it flooded the Indian market with poor quality substandard diagnosis. In a country like India which is classified as a low middle income country, it will be quite difficult to emphasize on price over quality diagnosis; cheap mispriced diagnosis has no role in a quality healthcare system.
The Central Drugs Standard Control Organization, Ministry of Health and Family Welfare has recently further strengthened the national regulatory capacity for diagnostics in a set of Medical Devices Rules, 2017. Therefore, the process of prequalification has demanded very stringent requirements for national prequalification specifications and procedures, in order to provide safe, effective, affordable tests of good quality and increase access to new diagnostics in resource-constrained settings.
