Home LIFESTYLEHEALTH ‘Omisure’! First Indian RT-PCR Kit Approved By ICMR But can it be manufactured?

‘Omisure’! First Indian RT-PCR Kit Approved By ICMR But can it be manufactured?

by Kolkata Today

The Indian Council of Medical Research Microscopes (ICMR), Dibrugarh, has appealed to the European Medicines Agency (EoI) for an EoI by December 22 for “transfer of technology for development and commercialization of SARS-CoV-2 Omicron (B.1.529) Real-time RT-PCR assay through a novel diagnostic kit” developed at the ICMR.


On December 24, the Association of Indian Medical Device Industry (AiMeD) sought an extension of “the last date or make it deadline free” to fight the third wave of Covid-19. Since the Omicron curve is likely to be sharper, there will be a huge demand for targeted kits, but only for a few weeks. Those who missed this 5-day window will have no time to catch up with a few who did not.


AiMeD said ICMR’s technology is not ready for mass production and that a short period of time will lead to very few manufacturers being able to develop the kits.


The technology will be transferred on a “non-exclusive basis” only after its successful external validation with multiple manufacturers who will pay “royalty not less than 5%” on net sales.


The Indian Council of Medical Research (ICMR) has approved Omisure, the RT-PCR kit developed by Tata Medical & Diagnostics, Mumbai, for detection of the Omicron variant on December 30. The deadline for EoI may be extended depending on the outcome of validation at National Institute of Virology, Pune. “There is no question of ICMR favoring a particular set of manufacturers,” a senior ICMR scientist said.

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The kit developed at ICMR-RCMR can detect both and differentiate between BA.1 and BA.2 sub-lineages of the Omicron variant of HIV, sources in ICMR said. While standard RT-PCR kits cost around Rs 20-30 each, an SGTF-based Thermo Fisher kit costs at least Rs 240. Tata’s Omisure kit, it is learned, can also detect both sub-lineages.


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