The All Food And Drug Licence Holders Foundation (AFDLH), a pan-India body of distributors of Food and Drugs, has urged the Union Health Ministry to conduct investigation on illegal supply of malaria rapid diagnostic tests (RDT) samples to the manufacturers in the country. This is in view of the fact that National Institute of Biologicals (NIB) is the only sole authorised body in the country to supply the same in the interest of patient safety.
The Foundation has questioned the quality and performance of malaria RDTs in view of the fact that data from NIB clearly reveals that samples are not sourced from NIB and hence is detrimental to patient safety.
According to AFDLH, NIB list of buyers of the last three years of malaria positive samples clearly proves that companies that manufacture 90 per cent of malaria antigen kits are not the positive samples from NIB.
“Submission have been made to the medical devices and diagnostics division of Central Drugs Standard Control Organization (CDSCO) and the same have been acknowledged. We have urged CDSCO to scrutinise claims made by manufacturers of malaria RDTs for accuracy in test results,” according to Abhay Pandey, national president, AFDLHF.
While malaria RDT is a user friendly screening test done by any individual in rural and urban settings to facilitate malaria control programmes and health services, microscope based test is a confirmatory test followed by the screening test recommended for actual treatment.
According to experts, only a microscope based test can validate and confirm the parasite load in human blood for confirmation of having malaria based on WHO specified standards. WHO standards stipulate parasite load of 50 to 100 per micron of blood which can be confirmed by a microscope based test successfully.
Moreover, what is more of grave concern is that many doctors rely on the malaria RDT because it saves on time which otherwise takes 3 to 4 days to confirm through a microscope based test.
Some of the major players of malaria antibody IVD kits in the country are Tulip, Accurex, Oscar, Selio Healthcare and Oscar Medicare Pvt Ltd.
Drug license holders have therefore urged CDSCO to review claims made by manufacturers of malaria antibody IVD kits of giving 100 per cent sensitivity.
Blood for the malaria antibody IVD test is commonly obtained from a finger-prick and results are available within 15 to 30 minutes. Though there are variations among the RDT products in the market, the principles of the tests are similar.
Since there are no WHO standards prescribed on parasite load with reference to malaria RDT available in the market, manufacturers have stooped to the level of even manufacturing RDT at low cost by using less antibodies in the kit leading to improper screening.
A malaria RDT cost today ranges between Rs.200 to Rs.350 in the retail market.