The arrival of rapid antibody kits required for mass testing of Covid-19 in India has been delayed by at least a week, as China has curtailed their exports due to quality-control issues.

This delay has caused the Indian government to push back its strategy of conducting large number of finger-prick blood tests that can yield results within as less as 30 minutes.

Export restriction

On April 2, Beijing had imposed restrictions on export of the kits as Chinese drug watchdog National Medical Product Administration (NMPA) begun a massive exercise to recheck them after previous incidences of bad quality kits flooding the global markets.

Sources told Businessline that even as China had curtailed exports, the Indian Council of Medical Research (ICMR) — which is the nodal body for central procurements — started placing purchase orders from April 3 with four to five firms. ICMR was reviewing firms for this purpose since March. While ICMR has planned to buy 40-50 lakh such kits for ₹300 crore, it has placed purchase orders for at least 31 lakh kits. Most firms are supplying kits in the price range of ₹400-600 per kit. But none of the suppliers which had promised deliveries has been able to honour the contract till date.

A review of three such purchase orders indicates that, for one firm, ICMR had specified that the delivery of kits should start on April 7 and the rest of the consignment should be supplied within two weeks.

In the second purchase order, which ICMR had placed on April 4, to another firm, it stated that 1.25 lakh kits were needed by April 8, while the remaining 8.75 lakh kits could be supplied latest by April 22.

Yet again, in the third purchase order dated April 7 to the same firm, ICMR had asked for one lakh kits and stated that the delivery be made by April 9. “Once received, the kits will be randomly picked up and validated; if the delivered lot are not found to be of good quality, the kits will be returned and the order will stand cancelled,” ICMR has stated in the order.

An official with a firm that has received the purchase order stated, “Almost all the kits arrive from China and are then marketed by firms in India, which had received the purchase orders. We informed ICMR that on April 2, China has imposed restrictions on exports till NMPA clears the products. It was not likely that export clearances from China will happen before two weeks. Ideally, Indian government should directly negotiate with China through its it’s embassy to sort out the issue.”

R Gangakhedkar, head, infectious diseases at ICMR, had earlier stated that antibody kits will be rolled out in hotspots for testing masses and health care workers from April 8. He later mentioned that the supply of kits had been delayed by two to three days, on April 11.

The Centre issued an advisory on starting rapid antibody testing on April 4, and revised the testing guidelines on April 9 to include rapid testing of all symptomatic individuals in hotspot areas.

India’s strategy to employ these new point-of-care immunodiagnostic tests at the field level is contrary to the April 8 recommendation issued by the World Health Organization (WHO) to use this kits only in research settings. “They should not be used in any other setting, including for clinical decision-making, until evidence supporting use for specific indications is available,” WHO has said.