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The Hyderabad-based Indian Institute of Chemical Technology (CSIR-IICT) has synthesized Key Starting Materials (KSM) for Remdesivir, the first step in developing the active pharmaceutical ingredient in a drug.
IICT has also started so-called technology demos for drug makers like Cipla so that manufacturing can start in India if needed. Remdesivir, manufactured by Gilead Sciences, is the first Covid-19 treatment medication approved for emergency use in the US. USA According to clinical data.
Gilead Sciences has a patent on the drug, but patent laws allow the drug to be developed for research purposes only and not for commercial manufacture. Remdesivir, when administered as an intravenous infusion, helped patients recover on an average of 11 days, compared to 15 days for those receiving placebo based on the results of US clinical trials. USA
India is part of the World Health Organization Solidarity Trials for the cure of Covid-19 and has received 1000 doses of the drug for analysis.
Harsh Vardhan, minister of science and technology and health, said in a statement on Monday that CSIR-IICT achieved the synthesis of KSM and that technology demonstrations are taking place for Indian industry. For Favipiravir, another promising drug to treat Covid19, CSIR is working with the private sector for clinical trials and a possible launch in India.
Remdesivir has three KSMs, pyrrole, furan, and a phosphate intermediate. Dr. Srivari Chandrasekhar, director of IICT, said by phone from Hyderabad that KSM synthesis is an important stage in drug development.
“The synthesis of key starting materials (KSM) for any drug is the first step in developing an active pharmaceutical ingredient (API). These key starting materials for Remdesivir are available in India and can be manufactured by chemical companies. Other reagents can be obtained from other countries. We started working at KSM for Remdesivir in late January, when the trials in China started, ”he said.
Gilead Sciences CEO Daniel O ‘Day, in an open letter on April 29, said: “On the supply side, we are working to build a global consortium of pharmaceutical and chemical product manufacturers to expand capacity and global production. It will be essential that countries work together to create a sufficient supply for people around the world and we look forward to these collaborative efforts. “
Experts said the Indian government could apply to Gilead Sciences for voluntary licenses to private Indian companies for a royalty. Otherwise, India could use the compulsory licensing option, under which, or a generic manufacturer can manufacture, patented drugs to protect the health of its citizens. However, the patent owner is paid for this.
“Because it is a proprietary drug, there are two options. One is that manufacturers obtain permission from the patent holder to obtain a manufacturing license. The other option is that the Indian government allows two or three manufacturers to manufacture the drug with either a compulsory license or a government use license. Manufacturers will need regulatory approvals that will become available only when more clinical data is available on the efficacy of the drug, ”said KM Gopakumar, an intellectual property rights expert.
