Government Bans Antibody Rapid Diagnostic Test Kits For Malaria

New Delhi, 4 APRIL 2018: Malaria antibody detection is performed using the indirect fluorescent antibody test for a patient who is infected with plasmodium and because of the time required for development of antibody and also the persistence of antibodies, serologic testing is not practical for routine diagnosis of acute malaria.

There is a rampant use of antibody detecting rapid diagnostic test due to its low cost and free availability.

The false positive rate in endemic areas is also high as patients with fever due to other reasons, who test positive by antibody detecting rapid diagnostic tests.

And as the only tests used in diagnosis are antibody detecting rapid diagnostic test and blood smear examination, there would not be any problems faced for malaria diagnosis by banning the antibody detecting rapid diagnostic test.

The matter has been examined by an expert committee appointed by the central government and the committee has recommended to the central government that the said drug is found to have no therapeutic identification.

On the basis of the recommendations of the expert committee, the central government is satisfied that it is necessary and expedient to prohibit the use of the antibody detecting rapid diagnostic test for routine diagnosis of malaria in public interest.

Hence, in exercise of the powers conferred by section 26 A of the Drugs and Cosmetic Act 1940, the central government hereby prohibits the manufacture for sale, sale and distribution of the test kits used in of antibody detecting rapid diagnostic tests for routine diagnosis of malaria with immediate effect.

Dr Sandeep Yadav, President of Maharashtra Association of Pathologist and Microbiologist said, “This is a welcome move that government has decided to ban antigen rapid detection test. This test was misused a number of times. Many a times, patients were made to undergo the test without any valid reason.”

M/s Pinakin Pharmaceuticals Private Limited, Nizampura, Vadodara, Gujarat and several other companies are manufacturing these kits under various brands names.My Medical Mantra