It takes around 28-days supply chain planning to start manufacturing the RT-PCR kits with all the raw materials in stock
With India deciding to hold Covid-19 testing using the rapid antibody test kits after quality and pricing issues surfaced, the molecular testing method, known as RT-PCR, is in focus. Indigenous real-time reverse transcription polymerase chain reaction (RT-PCR) test kit manufacturers have gone full throttle to expand production.
The Centre had recently asked states to stop using antibody test kits supplied by at least two Chinese firms. So demand for RT-PCR test kits is set tor rise. And, with imports getting more stringent, indigenous players like MyLab and CoSara Diagnostics are witnessing a rise in enquiries from states, Central government and private laboratories.
Both firms are looking to ramp up production of the kits that use nasal or throat swabs to test the virus and gives results in a few hours.
“We started working on inventory building for raw material. We will be able to make 200,000 RT-PCR kits per day by the first week of May. We will dispatch these per day,” said Hasmukh Rawal, managing director, MyLab.
It takes 28-days supply chain planning to start making the RT-PCR kits with all the raw materials in stock. Rawal said cost of raw material had gone up — in some cases by 3.5 to 4 times.
The company has not changed the pricing of its kits (Rs 1,200 for a kit) as they felt it would be opportunistic during a pandemic. So far, it has supplied the RT-PCR kits to ICMR along with the RNA extraction kits at the same price.
CoSara Diagnostics, a joint venture of Synbiotics that is a subsidiary of Ambalal Sarabhai Enterprises (ASE) and CoDiagnostics, is ready to double its 20,000 kits per day capacity, and can meet more demand through a 600,000 kits import shipment. Moreover, with capital infusion, the firm can expand capacity at its Vadodara plant, said the company's chief executive and ASE's managing director Mohal Sarabhai.
While more states and laboratories are enquiring with these companies, ICMR is planning 100,000 tests per day for India, and the ramp up by indigenous players would be critical. “We have also improved our RT-PCR kit that would increase its throughput by three times. With some optimisation in the kit, the lab can test three times more samples in the same time. It would also involve lesser steps, thus enhancing convenience,” said Rawal.
Having already supplied kits to Gujarat, ICMR and to distributors in southern India, Sarabhai said the firm is in talks with more states. “The government has also been supportive to the RT-PCR kit makers by not just buying these kits but also ensuring other infra such as PCR machines and training personnel to operate these kits. Private labs are also reaching out to us,” said Sarabhai.
MyLab also got funding from Adar Poonawallah of Serum Institute who picked up a stake for an undisclosed sum. “Serum's team is helping us to make products according to international standards,” Rawal said.
He said economies of scale will help to keep the prices low. MyLab has also received grants and loans too from several agencies including government and that has helped. Biocon's research arm Syngene too has tied up with MyLab that would help the latter with raw materials.
The Pune-based lab has also received approval from the ICMR for its new RNA extraction kit. Without the extraction kit, a PCR test cannot function.
CoSara has no plans to manufacture RNA extraction kits since it has secured the supply by signing up with relevant suppliers.
"There are only few good manufacturers of RNA extraction kits, which are in short supply globally, but it will not be difficult to source for us due to our partners,” Sarabhai said.