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Better regulations around diagnostics will ensure availability of quality diagnostics: Dr Kamini Walia


In a big step to address the widespread problem of inadequate access to diagnostic tests, the World Health Organisation (WHO) this May came up with the first ever essential diagnostics list (EDL). Inspired with the same, the Indian government is also putting together an EDL. Dr Kamini Walia, Senior Scientist with the Indian Council of Medical Research, New Delhi, explains the importance of EDL in conversation with Raelene Kambli

What is the main focus of the essential list of diagnostics? How important is this list of diagnostics in the Indian context?
WHO has brought out its first list on Essential list of diagnostics. The main focus of this diagnostic list is on primary healthcare as priority and to suggest tests for all levels of healthcare. It is important and should be implemented by programmes like TB, HIV etc.

Tell us more on the tests this list covers? The list has around 113 products for blood and urine test. Around 55 are priority tests. Can you shed some light of these priority tests?
There are tests and then there are supporting tests. the tests given in WHO list have been divided into two categories: primary health care and the rest.

The first edition of the EDL starts with two categories of in vitro diagnostics (IVDs)—general and disease specific. These recommendations are drawn from existing WHO guidelines, manuals and priority lists of medical devices that have been supported by a review of the evidence. The EDL includes basic information on the test: if it is for general routine assessment or specific to a disease, the purpose of the test, the assay format, type of sample, links to relevant WHO documents, or to any WHO prequalified or endorsed products. The general IVDs include those for clinical chemistry, blood transfusion, serology, microbiology, mycology, parasitology and haematology. These tests form the basic IVDs package to support routine diagnosis and monitoring of many conditions, such as diabetes, cardiovascular, anaemia and liver function. The disease-specific IVDs reflect the existing global priority disease priorities on WHO work programme; HIV, Hepatitis B and C, human papilloma virus,malaria, syphilis and uberculosis.

For each IVD, it was recommended that guidance should be given to member states as to which level of care the test is most suited to; primary care or more specialised facilities, according to level of the facilities and expertise required. Primary healthcare tests can be used in mobile units, emergency situations, at home, community level and includes self-testing products. Other tests are more suited to clinical laboratories.

How is this going to be applied in India? What is your opinion on the same? Why does India need a separate set of EDL?
The government is looking at creating its own set of EDL for India. The WHO EDL is a reference document and all countries are advised to devise a list as per their health priorities. India has its own set of health problems and the Indian list should address those health priorities.

How will this EDL help in bridging the gap of quality access to affordable diagnostics in India?  
By creating an EDL WHO is ensuring that all communities everywhere can benefit from diagnostic technology as a key component for achieving UHC. But implementation in countries will be critical. While some countries already have national lists of medical technologies/devices (57 per cent of 173 countries), others still not.As with the Model List of Essential Medicines, it is expected that India will adapt the EDL to suit our needs and systems, according to their local settings, work force, facilities, epidemiology and budgets. In future this is expected to pave way for more efficient procurement and affordable prices of diagnostics at all levels of health care.

India’s diagnostic sector is fragmented. This is sometimes detrimental to patients as they do not receive good quality diagnostic care. What according to you can help in disciplining this sector and ensuring quality access to diagnostic care to every Indian citizen? 
Having an EDL along with the free diagnostics initiative will ensure availability of diagnostics at all levels of health care. Better regulations around diagnostics will ensure availability of quality diagnostics. Also important is consensus on diagnostic pathways for each syndrome. This will reduce the oportunity/utilisation of wasteful diagnostic tests.

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