Local manufacturers of rapid antibody-based test kits (RTK) for coronavirus (Covid-19), whose kits have been approved by the Indian Council for Medical Research (ICMR) and the Central Drug Standards Organisation (CDSCO), seem to be struggling with a sense of uncertainty as they have not yet received orders from the ICMR.
Worse, on Monday, the ICMR called on states to return BTIs retrieved from China after the field assessment showed the results were too different – and said nothing about their future BTI projects. Certainly, some states have tried to obtain TRCs directly, including from some domestic producers.
CDSCO has approved the BTI of six local companies.
Antibody tests are performed with human blood and the results are available after 30 minutes to an hour, unlike RT-PCR (reverse transcriptase polymerase chain reaction) tests, which take about five hours. However, the latter is the reference for the diagnosis of covid-19, and antibody tests are mainly used to measure the prevalence of the disease, according to experts.
The ICRM demanded the 11th. April: a technical-commercial offer of 4.5 million. RTK in no time. But even those who have not been rejected by the Council have not heard about it. We have applied to participate in the call for proposals and although our application has not been rejected, we have not yet heard about it. It’s a little confusing. They haven’t given the orders yet. Somehow the states seem to be more active and we also receive several export requests, says Pratek Mittal, marketing manager of Medsource Ozone Biomedicals Pvt Ltd.
This uncertainty will have a counterproductive effect on profitability. The cost can even be halved compared to what the Chinese give, he added.
ICMR placed an order for 550,000 RTK with two Chinese companies and the kits have now been returned by the government.
Medsource has been approved by ICMR and CDSCO to produce and put into production rapid test kits with a maximum capacity of 115,000 kits per day.
We can give an impulse, but since there is currently no clarity on public procurement, we do not want to do so yet. We are investing in these difficult times, but this uncertainty is quite complex, according to Mittal.
Another company with the necessary permits, SD Bio Sensor, based in Gurugram, is also waiting for an answer from the research institute, as their main concern, according to the manufacturers, is the production for the ICMR.
The CIRM has taken samples from our kits for further testing, and we’re waiting to hear from them. However, we are confident that our sample will pass the test, as our company has already exported the kits to the United States, Great Britain, etc. About 80 percent of production already takes place in South Korea and we have just completed production here, says Punit Kumar, deputy director of Regulatory Affairs.
The company can produce 100,000 RTK per day and can double that number. We already have about 300,000 kits in our warehouse, and even Haryana has bought about 25,000 kits for quick tests. Let’s see what the ICRM has to say, he added.
The state-owned company HLL Lifecare has not yet received an order from the ICRM either. We have two quick test kits ready, and we can produce one a week, said an employee who asked not to be identified.
Another licensed company, Voxtur Bio Ltd. based in Surat, Gujarat, has started production with a capacity of 10 million units per month. Two of the six companies, Vanguard Diagnostics and ImmunoScience India, are still in production. We did not apply for the ICMR RFP because of the short delivery time, says Atul Tardet, CEO of ImmunoScience India.
The tender is open to all, and those who qualify have an equal chance, according to Dr. Rajnikant Srivastava, spokesman for ICRM. Experts find it useful to promote local production. Stop relying on China; we should encourage Indian manufacturers, said Dr. T. Jacob John, former director of virology at Christian Medical College in Wellora.