New Delhi: The end-to-end synthesis of Favipiravir, an anti-retroviral drug that has shown promise against Covid-19, has been completed, the Council of Scientific and Industrial Research (CSIR), said on Thursday.
In a conversation with News18.com, Dr Shekhar C Mande, Director General of CSIR, said the synthesis process has been handed over to a private pharmaceutical company and the Drug Controller General of India will now take a call on introducing the drug for testing as Covid-19 treatment.
Favipiravir has demonstrated good results against influenza viruses and is being tested in other countries as a potential treatment against the novel coronavirus, including in China, Japan, Russia and the Middle East.
Dr Mande said the premier research and development organisation, under the Ministry of Science and Technology, is working on repurposing 20 different drugs that could be used as a line of treatment against Covid-19, diagnostic kits, innovation in medical equipment and even vaccine development.
Edited excerpts of the conversation:
Q. Which drugs are being repurposed by CSIR in the fight against Covid-19?
A. As far as repurposing is concerned, CSIR has started generating synthesis processes for almost all drugs that are off-patent. There is a drug called Favipiravir that is already in use in Japan and China. We think if it is made available here, we should have a synthetic route to it and one of our companies can do it. We have handed over the synthesis process to them (a private company), and they have approached DCGI (Drug Controller General of India) for approvals.
It is up to the DCGI whether to introduce the drug as it is - because the drug is already introduced after due clinical trials in other geographies in the world - or they want us to do clinical trials in India.
We will do whatever DCGI tells us along with this (private) company and get the drug to the market as early as possible if everything is successful.
This is one example. Like this, there are 20 different drugs we are looking at for repurposing. For each of them we have generated synthetic routes so that as and when they are required, our pharmaceutical companies can make them. CSIR is the only organization in the country which can do this task.
Q. At what stage is the synthesis process of Favipiravir?
A. It is done. We have generated the entire synthesis process, end-to-end so that not a single chemical needs to be imported and it has been handed over to a pharmaceutical company.
Q. Which company is this?
A. Since approvals are pending at the DCGI, I cannot reveal the name of the company right now at this stage.
Q. As far as Remdesivir is concerned, what is the synthesis status and is there a plan to tie-up with Gilead Sciences, the developer of Remdesivir drug?
A. We believe that the way Remdesivir is produced, it can be improved through the synthetic route. It can be significantly improved. I am not pulling this out of my hat, we have done that. It all depends upon how Gilead enters Indian market because they have obtained a patent for the Indian market in February and in September. Therefore, it all depends on what happens between Gilead and the Indian government. It is not in CSIR's hands. Eventually whatever decision is taken we will go by that. I am not privy to any developments on that front.
Q. Which other drugs is the CSIR looking at as a potential line of treatment against Covid-19?
A. There is good news with regards to a drug called Sepsivac. We got an approval from DCGI to test it on limited patients who are critically ill. Sepsivac is already in the market, it is marketed by Cadila Pharmaceuticals and they have shown that it reduces mortality by 50 per cent in Sepsis patients.
We think that the mechanism for prevention of Sepsis and this infection is similar, and therefore, we got the approval for it two days ago to conduct limited trials. AIIMS Bhopal, AIIMS Delhi and PGIMER, Chandigarh have tied up with us for the trials and they will begin after ethical approvals are in place.
We have also got two more approvals from DCGI to try Mw (Mycobacterium W). We have got approval to conduct trails on Covid-19 affected people. On those who have just been admitted to the hospital and on those who recovered and have antibodies in them. These trials will be done on 600 recovered and recently admitted patients each.
Q. How does CSIR decide on repurposing drugs?
A. There is a list of all the drugs and at what stage of trials they are in in different parts of the world. The WHO publishes this list. We are working based on such literature. We have not done any repurposing work 'de novo'. So we are actually looking closely at what the international agencies are doing. Our emphasis here is to generate entire synthetic routes for particular drugs in India so that we don't have to depend on any single chemical from outside.
Q. What work has CSIR done on HCQ?
A. On HCQ (hydroxychloroquine), CSIR has helped in supply chain logistics. We look at every small, small detail. Today, what happens is that there are 20 odd suppliers for HCQ in the country. On today's date we don't have to worry too much. But hypothetically, if we fall short on HCQ, can we make the drug without relying on any import? That is the question.
We realised that two critical components are imported from China. Therefore, that supply chain model gives a clue that we have to address this issue and now we have generated a new synthetic route based on which we will not have to depend on any imported chemical. All our emphasis is to try to do everything domestically.
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