Several home in vitro diagnostic (IVD) check package producers have questioned the brief deadline of 5 days set by the Indian Council of Medical Research (ICMR) to submit an expression of curiosity (EoI) for commercialization of a diagnostic package. . Detecting the omicron kind of coronavirus.
His reasoning: Since the anticipated Omicron surge will set off an unprecedented however comparatively short-term demand focused check package, Any head begin on those that missed the 5 day window can be of nice profit to some who didn’t.
On 17 December, the ICMR prolonged by 22 December for “Real-time RT-PCR Assay through a Novel Diagnostic Kit for Transfer of Technology for Development and Commercialization of SARS-CoV-2 Omicron (B.1.1.529)”. EOI invited. ICMR-Regional Medical Research Center (RMRC), Dibrugarh.
On 24 December, the Association of Indian Medical Device Industry (AIMED) in a letter to Balram Bhargava, secretary of the Department of Health Research (DHR) and director normal of ICMR, sought “extension of the last date or making it the deadline so that as many as possible.” Number of producers can benefit from this to struggle the third wave of Kovid-19.
“They (ICMR) mail us (manufacturers) every month for capacity updates. So, they should have publicized the call to us directly or generally for EOI. Since the Omicron curve is likely to be steep, there will be a huge demand for targeted kits, but only for a few weeks until the other variants are wiped out. Those who missed this 5-day window will not have time to catch up with some of the people,” mentioned an RT-PCR package producer.
Stating that the applied sciences developed by ICMR up to now by no means had a time restrict, AiMeD mentioned in its letter: “Since COVID is a worldwide catastrophe, WHO/CDC additionally overtly referred to as for fast adoption and widespread improvement of assay designs. / provide sequence. RT-PCR check and its formulation and so on. to learn the society at giant.
“A small restricted EOI will lead to very few manufacturers who can develop kits, instead of the need of the hour where large number of manufacturers should be allowed access to such technology so that RT-PCR kits are made available on a large scale Can you quantity and reasonable price,” it mentioned.
Responding to questions from The Indian Express, Bhargava mentioned in an e-mail: “The technology has not yet passed external verification.”
As per the invitation from the EoI, the expertise might be transferred on a “non-exclusive basis”, adopted by its profitable exterior verification with a number of producers, who can pay “royalty not less than 5%” on web gross sales.
Council sources mentioned 9 EOIs had been acquired until December 22 and the competent authority would take a choice on some EOIs acquired after the deadline.
“There is no question of ICMR favoring a particular group of manufacturers. Verification of the technology is underway at NIV (National Institute of Virology), Pune, and depending on the result the deadline for EOI may be extended,” mentioned a senior ICMR scientist.
While the ICMR on December 30 permitted Omisure, an RT-PCR package developed by Tata Medical and Diagnostics, Mumbai, for Omicron variant detection, the multiplex package marketed by US-based Thermo Fisher is presently in India for preliminary is getting used. Confirmation of the Omicron variant with its S-gene goal failure (SGTF) technique.
Since the omicron variant has undergone a number of mutations within the S-gene, the SGTF technique is indicated in sufferers who’re discovered to be COVID constructive with different goal genes of the virus, however present a dropout of the S-gene. While authorities businesses purchase normal RT-PCR kits for Rs 20-30, SGTF-based Thermo Fisher kits price as little as Rs 240.
Unlike the SGTF package which detects solely the Ba.1 sub-lineage of the omicron variant, ICMR sources mentioned, the package developed at ICMR-RCMR can detect each – and Ba.1 and Ba.2 sub-lineages. can differentiate between It is realized that Tata’s Omisure package also can hint each the sub-lineages.
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With inputs from TheIndianEXPRESS
