Local manufacturers of antibody based rapid testing kits (RTKs) for the coronavirus disease (Covid-19), whose kits were validated by the Indian Council of Medical Research (ICMR) and approved by the Central Drugs Standard Organisation (CDSCO), seem to be grappling with a sense of uncertainty as they are yet to receive any orders from the ICMR.

To make matters worse, on Monday, ICMR asked states to return RTKs sourced from China after its field assessment found them to be showing too much variation in results — and while doing so, did not say anything at all about its future plans regarding RTKs. To be sure, some states had been directly trying to source RTKs, including from some domestic manufacturers.

CDSCO has approved RTKs made by six local companies.

Antibody tests are done using a person’s blood, and results are available in 30 minutes to an hour as opposed to the RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) tests that take about five hours. Still, the latter are the gold standard for diagnosis of Covid-19; the antibody tests are largely used to measure prevalence of a disease, according to experts.

ICMR , on April 11, invited a techno-commercial offer for procurement of 4.5 million RTKs, with a tight deadline. However, even those who were not rejected by the council are yet to hear from it. “We applied for the tender, and even though our bid wasn’t rejected, we are yet to hear from them. It is a little confusing. They haven’t placed orders yet. The states somehow seem more proactive in their approach, and we are also getting several export queries,” says Prateek Mittal, director, marketing, Medsource Ozone Biomedicals Pvt Ltd.

“This uncertainty will be counterproductive to cost efficiency. The cost can come down at even half the volumes given to the Chinese,” he added.

ICMR placed an order for 550,000 RTKs with two Chinese companies; these are the kits it has now asked states to return.

Medsource is approved by both ICMR and CDSCO to manufacture rapid tests kits, and has started production; its peak capacity is 115,000 kits in a day.

“We can ramp up but since there is no clarity on procurement right now we don’t want to do that just yet. In these difficult times we are making investments but this uncertainty is quite challenging,” said Mittal.

Gurugram-based SD Bio Sensor, another company with requisite approvals, is also waiting to hear from the research body as the manufacturers say their first priority is to produce for ICMR.

“ ICMR has taken samples of our kits for further testing, and we are waiting to hear from them. We are sure though that our sample will pass the test as our company has already been exporting kits to US/UK etc. About 80% of the manufacturing already happens in South Korea and we just finish the product here,” said Punit Kumar, deputy manager, regulatory affairs.

The company can make 100,000 RTKs a day and can scale it up to double the quantity. “We have about 300,000 kits already in our warehouse, and even Haryana procured about 25,000 of our rapid testing kits. Let’s see what ICMR says,” he added.

Even the government-owned HLL Lifecare is yet to receive an order from ICMR. “We have 2 lakh rapid test kits ready, and can produce one lakh kits in a week,” said an official at the company who asked not to be identified.

Surat (Gujarat) based Voxtur Bio Ltd, another approved company, has begun production with a capacity of manufacturing 10 million kits in a month. Two of the six companies, Vanguard Diagnostics and ImmunoScience India, are still in the process of beginning production. “We did not apply for the ICMR tender because of the strict timeline for deliver,” said Atul Tarde, CEO, ImmunoScience India.

“The tender is open for all, and those who qualify will get an equal opportunity,” said Dr Rajnikant Srivastava, the spokesperson for ICMR. Experts believe it makes sense to encourage local manufacturing. “Stop relying on China; we should encourage Indian manufacturers,” said Dr T Jacob John, former head of the department of virology at Christian Medical College, Vellore.