MUMBAI: Lasa SuperGenericsNSE -3.92 %, a manufacturer of active pharmaceutical ingredients (APIs), said it will team up with the Institute of Chemical Technology to start development of the anti-viral drug Favipiravir, which is being tested as a treatment for Covid-19.
The Mumbai-based company said it is the first in India to have started working on this molecule, and if it gets all the necessary regulatory approvals, it can start manufacturing the drug in a few months.
Favipiravir, an off-patent drug originally owned by Japanese drug maker Fuji, holds potential against RNA viruses, one of which is Covid-19. The World Health Organisation has listed this drug as part of its experimental protocol for treating the disease.
“Since it is a generic drug, all we need to do is BE (bioequivalence) studies to prove its efficacy. With the help of researchers of ICT we can do this,” said Omkar Herlekar, chairman of Lasa Supergenerics. Bioequivalence means comparin .
The Covid-19 pandemic, which so far has infected over 100,000 people across the world, remains a mystery for researchers. In the absence of any new drugs or vaccines, physicans have been looking at combination of anti-virals to treat the infection. One of the treatment protocols that has emerged is the administration of combination of anti-retrovirals (ARVs) like Lopinavir, Ritonavir, Darunavir, Ripavarin, Favipiravir, and Remidasvir.
Remidasvir and Favipiravir are the two drugs that have not got official approval. In India, other ARVs are manufactured by several generic makers. The leading ones are Cipla, Aurobindo Pharma and Mylan. The Indian Council of Medical Research had approved the combination of Lopinavir and Ritonavir in their treatment protocol for Covid-19. Data on Remidasvir and Favipiravir is still under consideration globally.
“Once the Favipiravir therapy is approved by global regulatory authorities, we would approach DCGI for conducting required bioequivalence clinical trials in India and also seek strategic private investments and/or government aid to commercialise this product, subject to all regulatory approvals and trials,” Herlekar said.