India, the largest manufacturer of hydroxychloroquine (HCQ) in the world, is now testing the efficacy of ayurvedic herbs like ashwagandha on its healthcare workers to see if it acts as a preventive medication against the novel coronavirus.
HCQ is being primarily used as prophylaxis, to prevent the frontline healthcare workers like doctors, nurses, ward boys etc from catching the infection. Now two trials have begun in about 10 hospitals across the country (Pune, Mumbai, Lucknow, Varanasi and Delhi) for testing ashwagandha tablets instead of HCQ as a preventive medication and another one on a combination of ayurvedic medicines on coronavirus positive patients.
The Ministry of Ayurveda, Yoga, Unani, Siddha, Homeopathy (AYUSH) task force is taking an inter-disciplinary approach towards use of ayurvedic medicines for coronavirus patients. As such the trials to test an alternate for HCQ are on as the government expects a huge demand surge for preventive medication once the lockdown lifts.
"We are discussing with the Indian Council of Medical Research (ICMR), the Department of Biotechnology (DBT) along with the All India Institute of Medical Sciences (AIIMS) and others to identify potential therapy areas that would help to build immunity against the virus and would act as preventives. As lockdown curbs would ease, there would be a huge demand for such therapies for the larger population and not just healthcare workers, " said a government official on grounds of anonymity. He added that there was no need to panic because at present India had sufficient stock of HCQ.
At present India is roughly making about 300 mn tablets of HCQ per month. "This is currently sufficient to cater to the immediate needs of the country. Exports too are happening, but that is controlled by the government. We are getting demand from all across the world for HCQ. Moreover, a study is underway on the drug's efficacy, and if the outcomes are positive, we expect further demand," said one of the two largest manufacturers of the drug in India. He added that while there are several (over 100) licensed manufacturers of HCQ, none of these smaller units are making the drug in large quantities now as they do not have the active pharmaceutical ingredients (APIs).
Ipca and Cadila Healthcare are the two largest players and they are also backward integrated - which means they make their own API for HCQ.
Trials on alternative therapies gain momentum
Apart from conducting research on ayurvedic alternative to prophylaxis, another trial is also set to start - a combination of ayurvedic drugs (Pippali, Guduchi, Yashtimadhu and some other herbs) on Covid-19 patients. This would be a three month study to be conducted across the country (mostly in private hospitals) and a protocol for the trial has already been drafted.
Meanwhile, the trials on plasma therapy on critically ill Covid19 patients have shown encouraging results. Phase-II clinical trials of convalescent plasma therapy for treatment of COVID-19 at the NHL Medical College centre recognised by the ICMR is underway.
According to reliable sources, two of three patients administered with plasma transfusion have shown recovery from COVID-19, hinting at preliminary success. Plasma therapy is a process under experimentation which involves transfusing blood plasma extracted from the antibody-rich blood from cured COVID-19 patients into infected persons.
"Roughly 3-4 patients have been administered plasma transfusion and two of them have recovered. So far, six patients who had recovered from COVID-19 have donated their plasma for the clinical trial while the process of enrolling more donors is on," said sources.
ICMR had recently begun phase-II multi-centre clinical trials to check the safety and efficacy of convalescent plasma therapy for treatment for COVID-19. The body plans to enroll nearly 500 donors or recovered patients as samples for the randomised controlled trials.
NHL Medical College in Ahmedabad is one of the roughly 28 centres for plasma clinical trials recognised by ICMR out of over 110 such potential institutions in the country.
Favipiravir testing to be complete by August: Glenmark
Glenmark Pharma, the first company in India to initiate phase-3 clinical trials on anti-viral drug favipiravir on Covid-19 patients, said on Tuesday that the study is estimated to be completed by July or August this year. It had recently received nod from the country's drug regulator to start the trials on favipirarvir, the generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd, Japan. Clinical trials have commenced and over 10 leading government and private hospitals in India are being enrolled for the study.
Glenmark has developed the API and the formulations for the product through its in-house R&D team. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. The molecule if commercialized, will be marketed under the brand name ‘FabiFlu’ in India