WHO’s first diagnostics list to quicken India’s efforts to create national EDL, consultative meeting set for August
The World Health Organisation’s (WHO) first essential diagnostics list, a catalogue of tests for detecting common morbid conditions and priority diseases, would provide a strong impetus to India’s endeavour to chart out its own national list of diagnostic procedures, say experts associated with the initiative.
The essential diagnostics list (EDL), unveiled by the United Nations agency on April 15, concentrates on in vitro tests. It contains 113 items - 58 tests are listed for detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening and management of patients. The remaining 55 tests are designed for the detection, diagnosis and monitoring of ‘priority’ diseases such as HIV, TB, malaria, hepatitis B & C, human papillomavirus and syphilis.
India’s move to craft the EDL is spearheaded by the Indian Council of Medical Research (ICMR), the research body of the health ministry. Experts from the WHO India and the McGill University are also playing an active role. “The EDL will be prepared along the lines of the National List of Essential Medicines. Our first consultative meeting, held in March this year, was attended by health ministry officials, pharma industry representatives and other stakeholders. We are glad that the WHO list is now ready. It will act as a guidance document for us when we go for our next meeting in August. It has made our task a lot easier,” Dr Kamini Walia, a senior scientist with ICMR, told Pharmabiz.
The proposed EDL is significant as it is expected to influence the government’s price control policies. It will also help streamline procurement of essential diagnostics required at primary healthcare centres and encourage local companies to manufacture these products to ensure adequate and uninterrupted supply.
While emphasising that affordable diagnostics is the cornerstone of treatment, Walia has said the country needs to develop its diagnostics infrastructure to achieve its healthcare goals. “It is a massive task. The policymakers have to weigh up issues of accuracy, affordability, human resources and regulatory challenges,” she pointed out.
By launching the EDL, the WHO aims at providing a tool for all countries. It would help governments utilise health funds efficiently by concentrating on the truly essential tests. “An accurate diagnosis is the first step to getting effective treatment. No one should suffer or die because of lack of diagnostic services, or because the right tests were not available,” Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said in a statement.
Some of the tests listed are particularly suitable for primary healthcare facilities, where laboratory services are often poorly resourced and sometimes non-existent, for instance, tests that can rapidly diagnose a child for acute malaria or glucometers to test diabetes. These tests do not require electricity or trained personnel. Other tests are more sophisticated and therefore intended for larger medical facilities.
For each category of test, the EDL specifies the type of test and intended use, format and whether it is appropriate for primary healthcare or for health facilities with labs. The list also provides links to WHO guidelines and, when available, to prequalified products.
The list will be updated on a regular basis and in the coming months, WHO will issue a call for applications to add categories to the next edition. It is expected to expand significantly by incorporating important areas such as antimicrobial resistance, emerging pathogens, neglected tropical diseases and additional non-communicable diseases.