Two New Delhi based Indian manufacturers of antibody-based Rapid Test Kits (RTKs) for Covid-19 have begun production after the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for pharmaceuticals and medical devices, issued manufacturing licenses.
The move comes at a time when the RTKs that the Indian government ordered from China and which were supposed to arrive first by April 5, then April 9 and finally by Wednesday, have still not reached, reported Hindustan Times.
Earlier this month, the Indian Council of Medical Research (ICMR) validated samples of RTKs manufactured by three companies, Vanguard Diagnostics in New Delhi, the state-owned HLL Lifecare Limited in Kerala and Voxtur Bio Limited in Gujarat, following which they applied for, and received, their manufacturing licenses.
While HLL and Voxtur have begun production — the former expects to deliver its first batch of 100,000 RTKs by April 20 — Vanguard aims to start production within three weeks.
These kits are in great demand because unlike the RT-PCR (reverse transcription polymerase chain reaction) tests currently in use, which take up to five hours to throw up a result, RTKs provide results in 30 minutes. However, ICMR's protocol requires a confirmatory RT-PCR test to back up a negative RTK result.
Public sector company HLL Lifecare Limited, known for its production of popular condom brand Nirodh, began producing RTKs in its Manesar, Haryana plant on April 14. It aims to ready its first batch of 100,000 kits by April 20.
"We have just started [manufacturing the kits] after receiving the approval from CDSCO on Monday [April 13]. We have the capacity to produce 100,000 testing kits in a week. We will be supplying directly to the ICMR," a senior executive at the company said on condition of anonymity. .
The executive added that some of the material needed to manufacture the RTKs is imported from the US. "As of now we are comfortably placed in terms of stock… We are trying to scale up but there are several logistical issues. We import our raw material, but not from China. We import raw material from a US company."
"We have started production. We are planning to make 25,000 kits a day," E A Subramanian, director of technical operations of the HLL Lifecare added.
Surat-based Voxtur Bio Ltd is using indigenously manufactured raw material to develop the kits. "We have got nothing to do with China or any other country; we are manufacturing the kits and the raw material required to develop the kits indigenously. We have the capacity to produce 10 million kits a month, and we can double it if required. But we have to look for vendors, distributors and manage other logistics, so it takes about 10-12 days to start the production from the day you get the licence," said Khushroo Pastakia, CEO and managing director, Voxtur.
He did not specify the quantities of kits currently under production.
Vanguard is putting processes in place to produce RTKs in large numbers. "We haven't started manufacturing yet as we are internally getting ready for production. If all goes well then we should be able to start production in the next two to three weeks. There's a lot of demand for rapid test kits, and everyone is working hard to ensure that the kits are produced in India. In my opinion, during the next few weeks many other manufacturers will also be ready," said Veena Kohli, CEO of Vanguard Diagnostics Limited said.
The list of manufacturers is a dynamic one: the CDSCO provides licenses as and when the ICMR validates sample kits. In all, ICMR has validated 13 RTKs, of which four are made by Indian manufacturers. This includes antibody test kits of Indian vendors with Chinese suppliers.
Chennai-based CPC Diagnostics received the go ahead from both ICMR and CDSCO to import Chemi Luminescence Immuno Assay or CLIA-based antibody detection kits, which are not the same as RTKs, but close — the CLIA kit also requires a specific instrument to conduct the antibody test. These kits, which CPC has been sourcing from YHLO, a Shenzen, China based company, are also used to perform other kinds of tests, including fertility and thyroid tests , and thus several accredited labs in the country already possess them, a company spokesperson said. "By using this system a laboratory can test 100 samples per hour," he added.
The company expects to receive the supply of the CLIA-based antibody test kits this week. The order was placed at least two weeks ago, and the delay is due to a number of factors the spokesperson said. "The government of India has been following due process in validating and approving kits. This process takes time. The restriction on air traffic has been a major reason for delay of receiving test kits and sending them for approval. This factor will continue to delay supplies. Currently the world demand being large it will be difficult for us to obtain the entire quantity of kits we require in a short period."
China recently restricted export of its supplies of antibody test kits to a few companies following quality control concerns raised by different European countries.
Mumbai-based Lab Care, which has a manufacturing facility in Gujarat also received ICMR approval for its RTK, but it is yet to receive its manufacturing license. "We have applied for a manufacturing license, and expect to receive it within 10 days," said Ravi Chadha, director, Lab Care.
Chadha said the company can make between 125,000 to 150,000 kits every day. Lab Care imports its raw material from China, and finding new suppliers would involve new ICMR approvals. What's more, it cannot stock raw material till it receives its manufacturing license.
"For the Chinese to dispatch raw material is a task given the current situation. And even once the raw material is sent from China to Delhi , transporting that to the manufacturing unit will be a challenge," he said.