Manufacturers question ICMR’s 5-day window to license its Omicron kit

On December 17, the ICMR invited the EoI by December 22 for “transfer of technology for development and commercialisation of SARS-CoV-2 Omicron (B.1.1.529) Real time RT-PCR assay through a novel diagnostic kit” developed at the ICMR-Regional Medical Research Centre (RMRC), Dibrugarh.

On December 24, the Association of Indian Medical Device Industry (AiMeD), in a letter to Balram Bhargava, Secretary, Department of Health Research (DHR), and Director General, ICMR, sought extension of “the last date or make it deadline free… so that the maximum number of manufacturers can take benefit of this to fight the third wave” of Covid-19.

“They (ICMR) mail us (manufacturers) every month for capacity updates. So, they should have informed us directly or generally publicised the call for EoI. Since the Omicron curve is likely to be sharper, there will be a huge demand for targeted kits, but only for a few weeks until other variants are wiped out. Those who missed this 5-day window will have no time to catch up with a few who did not,” a RT-PCR kit manufacturer said.

Pointing out that technologies developed by ICMR in the past never had a deadline, the AiMeD, in its letter, stated: “Since Covid is a global calamity, WHO/CDC also openly offer the assay designs/sequences for fast adoption and widespread development of RT-PCR tests and its manufacturing etc to benefit the society at large.”

“A short restricted EoI will lead to very few manufacturers who can develop the kits, instead of the need of the hour where a large number of manufacturers should be allowed to have access to such technology so that RT-PCR kits are made available in large quantities and reasonable prices,” it said.

Responding to queries from The Indian Express, Bhargava, in an email, said: “The technology has not passed the external validation yet.”

According to the invitation for EoI, the technology will be transferred on “non-exclusive basis” only after its successful external validation with multiple manufacturers who will pay “royalty not less than 5%” on net sales.

Sources in the Council said that 9 EoIs were received by December 22 and the competent authority would take a call on quite a few EoIs received after the deadline.

“There is no question of ICMR favouring a particular set of manufacturers. The technology is undergoing validation at NIV (National Institute of Virology), Pune, and the deadline for EoI may be extended depending on the outcome,” a senior ICMR scientist said.

While ICMR approved Omisure, the RT-PCR kit developed by Tata Medical & Diagnostics, Mumbai, for detection of the Omicron variant on December 30, the multiplex kit marketed by US-based Thermo Fisher is the only one presently being used in India for preliminary confirmation of the Omicron variant with its S-Gene Target Failure (SGTF) strategy.

Since the Omicron variant underwent several mutations in the S-gene, the SGTF strategy indicates it in patients who are detected Covid positive from other target genes of the virus but show a dropout of S-gene. While government agencies procure standard RT-PCR kits for Rs 20-30 each, a SGTF-based Thermo Fisher kit costs them at least Rs 240.

Unlike the SGTF kit that detects only the BA.1 sub-lineage of the Omicron variant, sources in ICMR said, the kit developed at ICMR-RCMR can detect both — and differentiate between — BA.1 and BA.2 sub-lineages. Tata’s Omisure kit, it is learnt, can also detect both sub-lineages.