As India strenuously works towards expanding its testing capacity, there are players on the field developing and supplying COVID-19 test kits to private and government laboratories to inch towards that objective.
What steps does an Indian manufacturer need to go through in order to make, get approval, and commercially produce their RT-PCR test kits? FIT speaks to Dr. Akhilesh Rawat, Head, Research & Development at Kilpest India Ltd (3B BlackBio), the second Indian company to get the permit to manufacture kits for testing for the novel coronavirus. He takes us through the processes, the challenges and what the future looks like.
Here are some excerpts from the interview.
1. Procuring the Test License
Dr Rawat: So around the first week of March, we saw the threat the COVID-19 pandemic was posing in India and decided to do something about it. Generally, when you want to develop a kit, you need to procure a test license from the Central Drugs Standard Control Organisation (CDSC0) the body responsible for controlling drugs and diagnostics in India. Only after getting the license we can work on the development of a product. For this, we need to submit some data and information on our infrastructure and human resources. We started our preparations during the first week of March.
Around 15 March, we applied to CDSCO for the test license. Generally, it takes a month to get the license. But since this was an emergency, CDSCO gave us the test license within 2-3 days.
2. Research and Internal Assessment
Dr Rawat: When you develop a product, you have to check it yourself first. For that, you need both the positive as well as the negative samples of the virus. Because COVID-19 was new at that point of time, India did not have many positive samples. The ones it did have were all with National Institute of Virology (NIV). We didn't have any sample to test if our kits were performing fine. Negative samples we can get from any asymptomatic individual. I don't have any symptoms of the disease. So I can use my own sample as a possible negative sample. But the challenge was with getting the positive samples. For that, we created a synthetic DNA of the novel coronavirus that causes COVID-19. We used this synthetic DNA as a positive sample. We made different dilutions of it.
For instance, patients who have a lot of infection would have a higher quantity of the virus. This is different from other people who are in the initial phases and have just gotten infected. They will have a lesser quantity of the virus. Now the kit that we have to develop should be able to detect both sets of patients. We should not miss people with a low viral load. So the synthetic DNA we used had to be diluted and brought down to a level to ensure that the test could detect even a patient with a low concentration of the virus. Using this synthetic DNA, we modified our kits so that it could successfully detect a low viral load.
3. Kit Evaluation by National Institute of Virology (NIV)
Dr Rawat: For our research, we followed the criteria set by different organisations such as the World Health Organisation (WHO) on how we should develop the test and what our targets should be. We prepared ourselves accordingly and started with the test development. We developed the first version within 4-5 days. Now once this is done you have to send it to a government-authorised centre for performance testing. The product is then tested on known positive and negative samples and a final report is given on whether the kit is giving any false positive or false negative. It should detect the positive as positive and negative as negative.
For this evaluation, the Indian Council of Medical Research (ICMR) had initially approved NIV. So we sent our kits to them. Within two days they did the performance check and sent us the report. Unfortunately, we failed in this first attempt. We got 75% in detecting the positive sample, which means that our kit detected 25% positive samples as negative. In 3-4 days, we launched a second version after making some changes and including guidelines by NIV.
On 30 March, we sent this second version for testing. This time again, NIV was very quick. We got the report on 2 April at 11 in the morning. It said that we had qualified and had been validated. We got 100% in the evaluation.
4. Getting the Manufacturing License
Dr Rawat: Now this is an initial validation process. This data is then submitted to CDSCO by ICMR and NIV. Based on this data CDSCO grants the manufacturing license to the company. We applied for the license the same day. Generally, CDSCO could take 1-2 months to reply. But we got a prompt reply. They said that the next morning their team would visit and check our set-up, qualifications, production capacity and our data. After this, they would decide if we can manufacture the kits commercially or not. Next morning at 9 AM, the team was here. They checked everything, met our employees spoke to them, checked their qualifications, assessed our infrastructure, labs, production capacity and our ISO certification documents.
This went on for the entire day. We were even connected with higher officials in Delhi through video conferencing. They also asked some questions. The CDSCO officials submitted the report at 8 PM the same day. Once this report is submitted it can take up to six months to get the license. But because this was an emergency we were granted the manufacturing license by midnight.
Since then, we have been producing the kits commercially.
For now, we are developing 10,000 tests per day. If the need arises and if the country needs more then we can expand it further. We can scale up to 50,000 tests daily. We have tried keeping the price as low as possible to make it affordable and available for maximum use. So our price is near Rs 1000 for labs and hospitals.
5. How Has the Lockdown Impacted Operations?
Dr Rawat: It has been affecting us immensely. If we think of expanding our capacity then we are concerned about getting the raw material on time because of the lockdown. The material that used to be imported from foreign countries, has also stopped completely for now. Even though the government is trying and sending Air India flights to China for raw materials and other products, but even there, there are many problems because of the lockdown in those countries. So different companies and customs are also not functioning properly there. It is a difficult situation.
Even the companies making the raw materials in India have increased their rates. They say that the raw material that they are getting is high-priced. Sending the material from one city to another within India is also proving to be difficult.
(This story was auto-published from a syndicated feed. No part of the story has been edited by The Quint.)
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