Cipla has approached the Indian Council of Medical Research (ICMR) after initially rejecting the government’s offer for non-exclusive licenses to produce critical enzyme-linked immunosorbent assay (ELISA) antibody testing kit developed by the National Institute of Virology(NIV) in Pune.
ELISA measures the antibodies IgG present in the blood against the novel coronavirus SARS-CoV2 with sensitivity and specificity of 98.7% and 100% respectively and was used to detect HIV. These antibody tests will help to understand the proportion of the population exposed to the infection. There was a controversy around faulty rapid antibody test kits imported from China’s Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics. So the government focused to indigenously produce these antibody test kits.
Previously, the government announced it had signed a Zydus Cadila for mass production of the country’s first indigenous ELISA test kit for antibody detection of covid-19 and was in a controversy that the government had not floated a tender for selecting the maker of the test kits.
On Thursday, ICMR clarified, “After development in the lab at ICMR-NIV, Pune, based on the potential of companies, namely SPAN, J MITRA, Zydus Cadila and Cipla were offered to take up the production. Except for Zydus Cadila, three others refused to take the offer.”
ICMR then signed a ‘non-exclusive agreement’ with Zydus Cadila and NIV validated a batch of ELISA test kits produced by Zydus and plans to conduct a surveillance study of 24,000 individuals.