The Central Drug Research Institute (CDRI), Lucknow, has received permission from Drug Controller General of India (DCGI) for carrying out Phase III clinical trials to test the efficacy, safety and tolerability of the antiviral drug Umifenovir. The Phase III activities will be carried out at King George's Medical University (KGMU), Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and ERA's Lucknow Medical College and Hospital, Lucknow.
Umifenovir is mainly used for treatment of influenza and is available in China and Russia, with the brand name of Arbidol and has recently come into prominence due to its potential use for COVID-19 patients. To evaluate its efficacy in Indian patients, CDRI has taken up the clinical trial.
These will be randomised, which means the drug would be tested in random manner, double blind, placebo-controlled trials. “This drug has a good safety profile and acts by preventing entry of virus into human cells and also by priming the immune system. Hopefully we will complete the trials in the next two months,” said Dr Ravishankar Ramachandran, Nodal Scientist, CDRI, while speaking with India Science Wire.
“This drug has a good safety profile and acts by preventing entry of virus into human cells and also by priming the immune system. Hopefully we will complete the trials in the next two months,”
Prof. Tapas Kundu, Director, CSIR-CDRI, said that all the raw materials for the drug are indigenously available and if the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against COVID-19 and can be part of the national programme against COVID-19. Prof. Kundu also added that this drug has the potential for prophylactic use.
Dr Shekhar Mande, Director General, Council of Scientific and Industrial Research (CSIR), told that this clinical trial is an integral part of the CSIR strategy of repurposing drugs for COVID-19.
The clinical trial application was processed on high priority as per the Drug Controller General of India (DCGI) initiative against COVID-19. The next steps of the trial are being fast-tracked to enable the availability of the drug to Indian patients as soon as possible
The Institute has developed the process technology for Umifenovir in record time and licensed the economical process technology for manufacturing and marketing the drug to Medizest Pharmaceuticals Pvt. Ltd, Goa, which has already received the test license from DCGI.
- India Science Wire