Council for Scientific & Industrial Research (CSIR) - Institute of Chemical Technology (IICT) has completed the process of making two more Active Pharma Ingredients (APIs) for anti-viral drugs - Umifenovir and Remdesivir. It had already handed over anti-viral Favipiravir API to a large pharmaceutical firm for approvals of Drug Controller General of India (DCGI) to conduct animal/human trials before releasing it into the market.
“We are in the process of transferring two APIs to select pharmaceutical organisations for them to approach the drug control authorities for conducting necessary trials and approvals before manufacturing them,” said Director S. Chandrasekhar on Tuesday.
CSIR had identified about 25 drugs for ‘repurposing’ for quick deployment in treatment for COVID-19 since new drugs take at least 10-15 years to reach the market. IICT had taken up development of synthetic ‘process expertise’ for molecules, which are showing promising data in various trials across the globe of five drugs including - Favipiravir, Umifenovir, Remdesivir, Baloxavir and Chloroquine/Hydroxycloroquine.
“We have zeroed in on a few molecules for repurposing based on World Health Organisation (WHO) recommendations. Using molecular modelling, which includes theoretical and computational techniques to study the structures and reactions of molecules, we made rapid progress,” said IICT senior principle scientists Dr Raji Reddy and Dr. Prathama S. Mainkar.
IICT develops processes for APIs required to make the drug providing alternate cost-effective solutions and transfers it to interested pharmaceutical firms for commercialisation. Favipiravir, is a promising generic drug for treatment of COVID 19 developed in Japan and used for treatment of flu. Clinical trials of Favipiravir have begun in China, Japan and Italy and trials have so far had generated positive results, they said.
Yet, Favipiravir entry into market depends on the result of clinical trials and recommendations of DCGI. “If the results are positive, we believe it will be launched within a month or two. Umifenovir may take more time to generate additional data,” explained Dr. Reddy and Dr. Prathama.
The institute top brass kept a watch on virus situation in China and studied the available literature on drugs developed for treating influenza, Ebola and other virus-related infections from February. “The plan was to develop processes with available local chemicals as it reduces the cost and it is also difficult to source raw materials for APIs from other countries,” said Dr. Reddy.
The Director formed a team of scientists, research scholars and technicians to work in three shifts during lockdown to develop APIs for these identified drugs and also into works pertaining to RT-PCR kits, PPE material, masks, etc., to handle COVID-19 cases with all safety protocols.
“We are working on tight schedules to help in containment and treatment of the virus. It is a challenge as a new drug discovery can take take 10-15 years to reach the market, and currently there is an immediate necessity for drugs against the virus,” added Dr. Chandrasekhar.