Private labs start Covid-19 testing amid stringent regulations

New Delhi: With the Central government allowing 51 private laboratories to conduct Covid-19 tests across the country, stringent regulations have been put in place to make sure that only those who need it take the test. Sources in the Ministry of Health and Family Welfare (MoHFW) said that one of the primary challenges that it had to tackle before giving private laboratories the permission to do Covid-19 tests was to make sure that people did not go for the tests just because they had the resources, but no symptoms or travel history. One of the main reasons behind this is to make sure that Covid-19 test kits are not spent on those who do not need it.

“We have made it very stringent for anyone who wants to take the test at these private laboratories. First, he/she has to submit a duly signed Form 44 along with the signed and stamped doctor’s medical advice in which it has to be clearly mentioned that symptoms of Covid-19 are present in the patient. Then only the laboratories, after taking a photocopy of the identification card of the patient, can do the test. These details, including the doctor’s name and prescription, along with the test result, will then be sent to the ICMR for collating the data at the Central level,” an official source in MoHFW said.

Form 44 is a form to undertake clinical trials given out by the Central Drugs Standard Control Organisation under the Directorate General of Health Services of Ministry of Health and Family Welfare.
In Delhi, eight private laboratories have been given the permission to do these tests.
The Sunday Guardian spoke to officials at all these laboratories and all of these laboratories said that a valid, signed and stamped doctor’s prescription was needed along with the ID card for the Covid-19 test.
Officials at Thyrocare, one of the private diagnostic laboratories that have been given the permission, said that they are carrying out tests in Maharashtra for now and that for Delhi, the testing would possibly start after 14 April when the lockdown ends.

Asked for reasons on why they have not started testing in Delhi, an official from Thyrocare said that they have a tie-up with the Maharashtra government and as far as Delhi is concerned, they have not received the testing kits yet and hence their Covid-19 operations in Delhi were taking time.

Dr Lal Pathlabs, one the largest private diagnostic chains in the country, has already begun testing across India. Dr Lal Pathlabs has formed a team of dedicated Covid-19 sample collectors who would visit the patient’s home to collect samples. According to the diagnostic laboratory, after the sample is collected, the results would be sent via SMS and email within the next 24-48 hours to the patient.

Even Max Hospital, which has received approval for privately testing for Covid-19, confirmed to The Sunday Guardian that they have also started testing. However, Max Hospital, which is currently testing samples at two centres—Max Hospital Saket and Max Hospital Patparganj in Delhi—said that they are not doing home collection for the samples and that the patient will have to come to these two centres to get their tests done.

LABS CHARGING RS 4,500
All these laboratories stated that the price for the test was Rs 4,500. MoHFW has capped the diagnostic test for Covid-19 on 22 March at Rs 4,500. However, ICMR had encouraged private laboratories to go for free or subsidised testing in this hour of “national public health emergency”. The steep price has kept off most of the people, who might have Covid-19 symptoms, from going to the private laboratories. “We are getting two-three calls every hour (seeking process and cost of Covid-19 tests), but after learning about the price, people don’t enquire further,” an official at one of the private laboratories told The Sunday Guardian.

According to manufacturers of the kits, they were selling the kits to vendors (hospitals, laboratories) at the minimum price they could afford while keeping a very low margin for themselves, but it was up to the hospitals and laboratories to pass the benefits of the low price to the patients. “We have decided to keep the price of the kit as low as we can so that the benefit of this low price can be forwarded to the patients by the laboratories and hospitals, but if the laboratories are charging Rs 4,500, then it is their call, we cannot force them to pass on the benefits of the low price that they are buying it from us, to the patients. This is in the hands of the government bodies,” a director of one of the companies, which has got the permission to manufacture the testing kits, told The Sunday Guardian.
On 24 March, ICMR had stated that it had given commercial approval to Covid-19 testing kits made by three companies—Mylab, Altona Diagnostics and a South Korea based company, Seegene.

On 2 April, Bhopal-based Kilpest India Limited became the second Indian company, after Mylab, to get the commercial approval.

The BSE-listed Kilpest was incorporated in 1972 and the commercial approval was given to its subsidiary 3B BlackBio Biotec on Thursday. Speaking to The Sunday Guardian, Prateek Goyal, Director, Commercial, said that the first lot of the kits would be dispatched very soon as they had started working on the kits more than a month ago. “The day the WHO listed the DNA sequencing, we started to work on it; we sent the kits for approval to the ICMR, which was received on Thursday.”

“We will be producing 100 kits per day as of now (each kit can check 100 samples). The price of our kits will be within Rs 1,000 as we want to make sure that it is affordable enough for the entire country. We have received demands from outside India too, but right now, we will be focusing on selling it to India-based clients,” Goyal said.
Speaking to The Sunday Guardian, Hasmukh Rawal, managing director of Mylab, said that the company has started distribution of the kits to both private and government laboratories. “I do not want to go into the pricing of the kits, but it is one fourth of the rate of what the present kits are being sold for. We are not selling the kits to the laboratories for Rs 4,500. We are also scaling up the manufacturing operation and we will be able to manufacture 20,000 kits per week in the next few 10 days,” he said. Each Mylab test kit can test 100 samples.

Tarun Jain, General Manager, India, Altona Diagnostics, told The Sunday Guardian that they, too, have started manufacturing and distributing the kits to private laboratories across India.

He said, “We are a Germany-based company; so we have been manufacturing this test kit and supplying in Germany since February. We also have expertise in this as we have already done so during the Sars-Cov and the MERS-Cov. So these kits which we are selling are all imported from Germany and being distributed to the laboratories that are our clients and have the necessary permissions across India.”

Asked at what price are these kids being sold in India, Jain said, “I would not like to give out the prices of these kits, but what I can say is that since they are being imported from Germany, we are paying import duties and we are maintaining competitive pricing.”