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Draft of India’s First Essential Diagnostics List Out, to Ensure Quality at all Levels of Healthcare Facilities

The Indian Council of Medical Research (ICMR) has formulated a new list of essential diagnostics on the lines of the essential medicines list, to ensure that quality diagnosis is provided at all levels of healthcare facilities. “The list is on the lines of the drug list. It is a scientifically designed list, which has been based on the World Health Organization’s list of essential diagnostics for key areas like HIV and hepatitis, but it also takes into account the priority areas of non-communicable diseases and diseases prone to outbreaks such as dengue,” said Dr Kamini Walia, senior scientist at ICMR. ICMR, the apex body in India for the formulation, coordination and promotion of biomedical research, however, is not the implementing authority and cannot fix prices of the test. “The list prepared by ICMR may be considered by the committee that is in the process of developing the new national medicine list for 2018. If the diagnostic list is included, the prices will be regulated under the Drug Price Control Order, 2013,” said a senior official from the country’s apex drug regulator Central Drugs Standard Control Organisation (CDSCO). The current committee formed for routine update of the medicine list, which is done every three years, has been given a wider mandate to include certain devices and products, like sanitary napkins.

The essential diagnostics draft list, which has been put out for public consultation, contains 130 general laboratory tests and 26 disease-specific tests, which includes tests for HIV, hepatitis, dengue, and malaria. The diagnostics list was prepared after two national consultation of stakeholder and a consultation with device manufacturers this year. The WHO also released its essential drugs list earlier this year focusing on priority areas like tuberculosis, malaria, HIV, and Hepatitis B and C. The village-level diagnostics done by an Asha volunteer (village health worker), ANM (auxiliary nurse midwife) or other health workers includes tests for pregnancy, blood-sugar monitoring, malaria, urine albumin to detect kidney disease, blood sugar tests for diabetes and test for filaria, a parasitic disease that causes swelling of lymph nodes. At the primary healthcare (PHC) level, the list includes electrocardiography (ECG) for diagnosing heart disease and X-ray. Tests to measure cholesterol levels and thyroid, along with a pap smear to detect cervical cancer, have also been included at the PHC level. The list also includes specialized tests like fine-needle aspiration cytology for detecting cancerous lumps would be available at community health centers.

Pulmonary function test to diagnose respiratory diseases has also been included as an essential test at district level hospitals. The draft does not list essential diagnostics for tertiary care and medical college hospitals. “We were formulating a list of specialized tests for tertiary care hospitals, but it is extensive and it was believed that these hospitals generally do have the facilities in place. Looking at the essentiality, we have focused on the primary and secondary level care, in line with the government’s other policies,” said Dr Walia. Tests for eye disease have also been included at the district hospital level. “It is an interesting document, but a lot depends on the implementation. The government has to focus on the availability of good quality tests at its own facilities, which will discourage people from seeking it from private labs that may or may not be up to the mark or regulated. It is a good starting point but the government will have to ramp up its capacity to perform these tests so that the list gets implemented,” said Malini Aisola, co-convenor of All India Drug and Action Network (AIDAN). – Hindustan Times