On October 30, 2018, the Ministry of Health and Family Welfare (MoHFW) banned the import of Antibody Detecting Rapid Diagnostic Tests (ADRDTs) used for routine diagnosis of Malaria. The Ministry informed this decision of the Central Government, through a gazette notification G.S.R. 1074(E)4, in exercise of the powers conferred by section 10A of the Drugs and Cosmetic Act, 1940 (23 of 1940).
Earlier, the matter was examined by an Expert Committee appointed by the Central Government, which recommended that the said drug was found to have no therapeutic justification. It has been found that there is a rampant use of Antibody Detecting Rapid Diagnostic Tests due to its low cost and free availability. Also this test raises the rate of false positive tests - very high - in the endemic areas, as patients with fever due to other reasons, who test negative by antigen detection, test positive by ADRDTs. Further, the Central Government was satisfied that it is necessary and expedient in public interest, to prohibit the use of the ADRDTs for routine diagnosis of malaria; therefore, earlier it had prohibited the manufacture for sale, sale and distribution of 'Antibody Detecting Rapid Diagnostic Tests' for routine diagnosis of malaria via S.O. 1352(E)5.
Now, the Central Government has banned the import of ADRDTs in exercise of the powers conferred by section 10A of the Drugs and Cosmetic Act, 1940.
Section 10A: Power of Central Government to prohibit import of drugs and cosmetics in public interest - Without prejudice to any other provision contained in this Chapter, if the Central Govern- ment is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.
Conclusion
The government's decision to prohibit the use of Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria is in wider public interest owing to high degree of false positive results and its rampant usage due to its low cost and easy availability. Since other tests like Antigen Detecting Rapid Diagnostic Tests and blood smear examination, are available there would not be any problems faced for malaria diagnosis by banning the Antibody Detecting Rapid Diagnostic Tests.
Footnotes
4. http://www.egazette.nic.in/WriteReadData/2018/191623.pdf
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