<br>Saldanha said a single global protocol is insufficient to tackle every nation's situation; we also need to rely on our own statistics and measures for control. “The same goes for treatment options, and that is why we are exclusively studying Favipiravir on the Indian population before adopting its widespread use in market”, he added.
Q: Glenmark has initiated Phase 3 clinical trials on anti-viral Favipiravir for COVID-19 patients in India. What will be the next step on this?
A: With the DCGI's go ahead for phase 3 clinical trials, Glenmark will now be testing the efficacy and safety of Favipiravir in Indian patients. The data we receive at this stage of the trial will tell us if the antiviral can become a suitable and effective COVID-19 treatment in India. Following this, Glenmark will submit the clinical trial data to the DCGI and seek marketing approval for Favipiravir in the Indian market.
Q2. Which hospitals in India are being enrolled for the study?
A: We have a good representation of leading public and private hospitals enrolled for the study. These are SSG Hospital & Medical College, Vadodara, Deenanath Mangeshkar Hospital & Research Centre, Pune, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai, Government Medical College and Hospital, Nagpur, Government Medical College and Hospital, Aurangabad, AIIMS in Raipur, HCG Hospital, Ahmedabad, Dr Balabhai Nanavati Hospital, Mumbai, and Kasturba Hospital, Mumbai.
Q: Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical of Japan. What has been the use of Avigan and has it been used for COVID?
A: Avigan has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Recently in the past few months and according to reports, post the outbreak of COVID-19, multiple clinical trials involving this drug have been initiated on COVID-19 patients in China, Japan, Italy, Egypt, a few Asian countries and in the US.
Q: What is the potential of the drug being tested?
A: Globally, as per reports COVID-19 patients treated with Favipiravir have shown positive outcomes, such as reduced symptoms and quicker disease recovery. Having internally developed the API and the formulations for the product, Glenmark hopes to see similar positive outcomes in Indian patients during these clinical trials.
Q: How do you view the coronavirus situation in India?
A: I believe India's response to the health crisis has been prompt from the beginning, and is reflective of collective action by the center and state authorities, frontline health workers, private health sector and non-profit organizations. No doubt, there have been setbacks and loss of lives and livelihoods, and the country will take a while to recover from the effects of this damage. However, given the magnitude of our population and scale of the crisis, I think India's timely and stringent response has helped a great degree in controlling the devastating impact of the disease.
Q: Different countries have shown varying infection and mortality rates with COVID-19. What are your thoughts?
A: There are several factors at play that determine a country's infection and mortality rate. For instance, we have seen higher rates of COVID-19 in countries with a higher proportion of elderly population, or in countries that initiated their containment lockdowns at a later stage of the disease. This is why a single global protocol is insufficient to tackle every nation's situation; we also need to rely on our own statistics and measures for control. The same goes for treatment options, and that is why we are exclusively studying Favipiravir in the Indian population before adopting its widespread use in market.
Q: How long do you think the lockdown should continue?
A: As you know, the central and state governments are closely monitoring the evolving situation, and we look forward to any updates from them on lockdown directives.
(Sanjeev Sharma can be contacted at email@example.com)