It’s been a week since a nationwide lockdown was imposed to contain the spread of coronavirus in India. And although the Centre and state governments have emphasised that essential services will not be disrupted during the 21-day lockdown, private laboratories testing for COVID-19 say that they are still facing a number of bottlenecks. The biggest issue remains the supply of testing kits, and this they attribute to disruption in logistics.
The Indian Council of Medical Research (ICMR) has approved 51 private labs and 126 government labs for testing. The polymerase chain reaction tests or RT-PCR is the only one that can determine whether a person has tested positive SARS-CoV-2. While ICMR procures the RT-PCR test from the USA and distributes it to state governments, private labs are required to procure the kits on their own. As per ICMR’s guidelines, only kits approved by the US FDA (Food and Drug Administration) and European CE certified are allowed for COVID-19 diagnosis. ICMR together with the National Institute of Virology, Pune have evaluated 17 non-US FDA/EU CE kits, and approved four.
Speaking to TNM, Aishwarya Vasudevan, Group COO of Neuberg Diagnostics, a private lab, says, “Supply of testing kits is a universal problem.” Neuberg Diagnostics has four ICMR approved labs for testing COVID-19 in Bengaluru, Chennai, Pune and Ahmedabad, and procures its kits from companies such as Altona Diagnostics, and My Labs, which have been approved by ICMR.
“There is immense pressure on diagnostic firms to get the kits to various parts of the state and to get enough in time has been a challenge not just for Neuberg but for everyone across. Our mother company Trivitron is making their own kits and that will come out soon. But I don’t think even then we will have an abundance of kits, because then the question becomes how am I going to get my kits from Chennai to Pune," she explains.
Pointing out that it’s not just kits, but safety materials such as personal protective equipment (PPE) and masks that are also in short supply, Aishwarya says, “One of the biggest reasons for this is the courier companies and the logistics. So even if I have enough kits in my Ahmedabad lab, and need to send it across to Pune, I am stuck. Even between Bengaluru and Chennai, I can’t drive by and give it to them. The biggest challenge is that courier or logistics companies are not functioning as per our requirement currently.”
The Neuberg Diagnostics COO notes, “We have the capacity to do 3000 tests per day easily. But the point is, even if we are able to do the same amount of tests, we need the same number of kits. But we are not able to get them in time from different states. If the border eases up, if the couriers are running normal again, much of the problem will get taken care of.”
A Velumani, Chairman and MD of Thyrocare, a private laboratory chain headquartered in Mumbai, told TNM that the reason there has been a short supply is because organised diagnostics players are not supplying these COVID-19 testing kits.
“The machinery of diagnostics was wonderfully running, with some 10 organised players contributing to 95% of supplies in this country. They were organised, importing logically, distributing logically, and the supply chain was in place. But none of them have RT-PCR kits," he says.
He notes that foreign manufacturers of RT-PCR kits do not have a supply chain or distribution system in place in India. “In the lockdown environment, their distribution and supply chain is not in place. So this is why for the last 10 days, there is chaos. Now Siemens has come in. Soon Roche will be in. Once they are in, the raw material issue will be sorted out. Within one week’s time I expect everything to be in place.”
And while logistics is one part of the challenge, Aishwarya of Neuberg Diagnostics says the lockdown has also made it difficult for laboratory staff to get to their workplaces. “We are essential services, it is very important to motivate our staff. But it is very difficult and challenging for us to replace the fear in their heart with motivation. With all that is happening -- bikes are being seized, people are being stopped even after we give passes -- how are we going to run this country without people? Even all of this stuff we are doing depends on people testing for you. I am very worried about that. Kits ayega, logistics ayega (kits will come, logistics will come). If people are not there means what are we going to do?” she says.