Two firms begin production of antibody rapid test kits in India

AAJ KI DELHI/INDIAN NEWS ONLINE

New Delhi Two of the three 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.

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.