The Central Drugs Standard Control Organization (CDSCO) has granted manufacturing approval for three indigenously developed kits designed to detect Mpox (formerly known as monkeypox).

The kits, developed by Siemens Healthcare, Transasia Diagnostics, and JITM C Genes, met the approval criteria with a sensitivity and specificity of over 95%, according to the drug regulator.  These RT-PCR kits, which utilise fluid samples from pox rashes to detect the virus, were validated by the Indian Council of Medical Research (ICMR). However, a Health Ministry official noted that there has been no commercial manufacturing of these kits as they are not currently required.  

Out of six kits validated by the ICMR for detecting the viral infection, these three have received approval. The ICMR initially called for companies to develop diagnostics and vaccines in 2022, following the first reported Mpox cases in India.

The approval process for these detection kits gained momentum after the World Health Organization (WHO) declared Mpox a Public Health Emergency of International Concern (PHEIC) earlier this month for the second time in two years. India has reported 30 Mpox cases since 2022, with the most recent case recorded in March 2024. Initially, the infection was observed in individuals with a history of international travel, but it later spread among others as well.  

(IE)