India has drafted the first national essential diagnostics list (NEDL), a country-specific set of tests for detecting common morbid conditions and priority diseases, along the lines of the National List of Essential Medicines. The draft catalogue, created by the Indian Council of Medical Research (ICMR), is expected to improve the availability of quality diagnostics at all healthcare facility levels and drive down cost of disease detection and treatment.
The apex medical research body has held several rounds of consultations with clinicians, diagnosticians, medical device manufacturers and innovators to formulate the comprehensive 40-page document, which also spotlights regulatory requirements and implementation challenges. It is based on the global EDL unveiled by the World Health Organisation (WHO) earlier this year.
The government has come out with the national diagnostics list to build upon the initiatives of the health ministry to provide an expanded basket of tests at different levels of the public health system. According to experts, its immediate implementation would lead to reduction in out-of-pocket expenditure and better disease surveillance.
Though India has had its NLEM for more than four decades, the same importance was not given to diagnostics. Since the new NEDL is developed for different tiers of healthcare — to address needs of villages, primary, secondary and tertiary care centres — diagnostic tests are chosen on the basis of the country’s disease burden. For instance, tests for malaria, dengue, chikungunya, leptospirosis, brucellosis, tuberculosis, hepatitis B and C, HIV and syphilis are given priority on the draft list. Blood sugar test to detect diabetes using glucometer should be available from village level itself. Detection tests for diseases such as filariasis and Japanese encephalitis have been put as ‘desirable’, which have to be available in regions with high prevalence of that illness.
“To create the new list, the WHO list was taken as a model and additional tests were added to address India-specific infection patterns,” said Dr Kamini Walia, a senior scientist with the ICMR who was on the WHO expert panel that drafted the global list.
Walia emphasised the need to develop diagnostics infrastructure to achieve the country’s healthcare goals. “The NEDL will complement the NLEM, which has been successful in promoting affordable drug prices,” she added.
Once approved and adopted by the health ministry, the national diagnostics list is expected to influence the government’s price control policies. It will help streamline procurement of essential diagnostics required at primary healthcare centres and encourage local companies to manufacture these products to ensure uninterrupted supply.
The ICMR will accept comments and suggestions on the draft document till the end of January 2019. It would be updated on a regular basis since the global list issued by the WHO could expand over the next few years. The UN health agency is currently incorporating other crucial areas such as antimicrobial resistance, emerging pathogens, neglected tropical diseases and additional noncommunicable diseases into its catalogue.