Several domestic In Vitro Diagnostic test kit manufacturers have questioned the Indian Council of Medical Research’s (ICMR) five-day deadline to submit Expressions of Interest to commercialise its diagnostic kit, developed to detect the coronavirus’ Omicron variant.
The manufacturers claim that while the anticipated Omicron surge would trigger an unprecedented demand for targeted test kits, it would be relatively short-lived and any head start over those missing the five-day window would benefit the few who did not.
The ICMR on December 17 invited Expressions of Interest by December 22 for the transfer of technology to develop and commercialise the SARS-CoV-2 Omicron (B.1.1.529) RT-PCR assay through a novel diagnostic kit it developed at the Regional Medical Research Centre in Dibrugarh.
The Association of Indian Medical Device Industry, in a letter to ICMR Director General Balram Bhargava on December 24, sought an extension of the deadline so that the maximum number of manufacturers could benefit to fight the third Covid-19 wave.
An RT-PCR test kit manufacturer told The Indian Express that the ICMR mailed manufacturers every month for updates on capacity. As a result, they should have directly informed the manufacturers or generally publicised the call for Expressions of Interest.
There will be huge demand for targeted kits since the Omicron curve is likely to be sharper, the manufacturer said. However, it would only be for a few weeks until the other variants are wiped out. Those who missed the window will have no time to catch up with the few who did not.
Pointing out that ICMR-developed technologies never had a deadline in the past, the Association of Indian Medical Device Industry said in its letter that since Covid-19 was a global calamity, the World Health Organization/US Centers for Disease Control and Prevention also openly offered the assay designs/sequences for widespread development of test kits and manufacturing to benefit the society at large.
The industry body added that the short and restricted Expression of Interest would lead to very few manufacturers developing the kits, instead of a large number of manufacturers that should be allowed to access the technology so that RT-PCR kits could be made available in large quantities and at a reasonable price, as was the need of the hour.
Bhargava, in his response, told The Indian Express that the technology had not passed external validation yet.
According to the Expression of Interest invitation, the technology would be transferred on a non-exclusive basis after successful external validation with multiple manufacturers who would pay royalty not less than 5% on their net sales.
ICMR sources said it had received nine Expressions of Interest by December 22, adding that the competent authority would decide on several others it received after the deadline.
An ICMR scientist told The Indian Express that there was no question of the council favouring particular manufacturers. The technology is undergoing validation at the National Institute of Virology in Pune and the Expression of Interest deadline might be extended depending on its outcome.
On December 30, the ICMR approved Mumbai-based Tata Medical & Diagnostics-developed Omisure test kits for detection of the Omicron variant. However, US-based Thermo Fisher Scientific’s multiplex kit is the only one being used in India at present for preliminary confirmation of the variant using its S-Gene Target Failure strategy.
Government agencies procure standard RT-PCR test kits for Rs 20-30 each. However, the S-Gene Target Failure-based Thermo Fisher Scientific kit costs at least Rs 240.
Unlike the S-Gene Target Failure kit, which detects only the BA.1 sub-lineage, the ICMR kit can detect and differentiate between the BA.1 and the BA.2 sub-lineages, ICMR sources told The Indian Express. The Omisure kit can also detect both the sub-lineages.