Union Health Ministry Bans Antibody Detecting Rapid Diagnostic Tests for Malaria
New Delhi: Through a recent gazette notification, the government has banned the use of Antibody Detecting Rapid Diagnostic Tests for diagnosis of Malaria after finding that the serological testing is not practical for routine diagnosis of acute Malaria due to time required for development of antibody, the persistence of antibodies after clearance of an active infection and the fact that serology does not detect current infection but measures past exposure.
The decision comes after the matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said Antibody Detecting Rapid Diagnostic Tests are found to have no justification for diagnosis of acute malaria. On the basis of the recommendations of the said Expert Committee, the Central Government is satisfied that it is necessary and expedient to prohibit the use of the Antibody Detecting Rapid Diagnostic Tests for diagnosis of malaria in public interest;
Hence in exercise of the powers conferred by section 10A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the Central Government hereby makes the following amendment in the notification of the Government of India in the Ministry of Health and Family Welfare No. G.S.R. 577(E), dated the 23rd July, 1983, namely:-
In the table below to the said notification, after serial number 12 and the entry relating thereto, the following serial number and entry shall be inserted, namely:-
"13. Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria.”.
The decision comes after the matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said Antibody Detecting Rapid Diagnostic Tests are found to have no justification for diagnosis of acute malaria. On the basis of the recommendations of the said Expert Committee, the Central Government is satisfied that it is necessary and expedient to prohibit the use of the Antibody Detecting Rapid Diagnostic Tests for diagnosis of malaria in public interest;
The move comes in light of the following reasons mentioned in the notification:-
- And whereas, 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;
- And whereas, there is a rampant use of Antibody Detecting Rapid Diagnostic Tests due to low cost and free availability of these tests;
- And whereas, the false positive rate in the endemic areas is also high as patients with fever due to other reasons, who test negative by antigen detection, test positive by Antibody Detecting Rapid Diagnostic Tests;
- And whereas, the only tests used in diagnosis are Antigen Detecting Rapid Diagnostic Tests and blood smear examination, and, therefore, there would not be any problems faced for malaria diagnosis by banning the Antibody Detecting Rapid Diagnostic Tests;
Hence in exercise of the powers conferred by section 10A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the Central Government hereby makes the following amendment in the notification of the Government of India in the Ministry of Health and Family Welfare No. G.S.R. 577(E), dated the 23rd July, 1983, namely:-
In the table below to the said notification, after serial number 12 and the entry relating thereto, the following serial number and entry shall be inserted, namely:-
"13. Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of Malaria.”.
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