The Hyderabad based Indian Institute of Chemical Technology (CSIR-IICT) has synthesised the key starting materials (KSMs) for Remdesivir, the first step to develop the active pharmaceutical ingredient in a drug.
IICT has also begun so-called technology demonstrations for drug manufacturers such as Cipla so that manufacturing can begin in India, if needed. Remdesivir, manufactured by Gilead Sciences, is the first drug to treat Covid-19 approved for emergency use in the US based on clinical data.
Gilead Sciences has a patent on the drug but patent laws allow for the drug to be developed solely for research purposes and not for commercial manufacturing. Remdesivir, when administered by an intravenous infusion helped patients recover on an average in 11 days, compared to 15 days taken by those on placebo according to US clinical trial results.
India is part of the World Health Organisation’s Solidarity Trials for the cure of Covid-19 and has received 1000 doses of the drug for testing.
Harsh Vardhan, science and technology and health minister said in a statement on Monday that synthesis of KSMs has been achieved by CSIR-IICT and that technology demonstrations to Indian industry are happening. 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 over phone from Hyderabad that synthesis of KSMs is an important stage in drug development.
“The synthesis of key starting materials (KSM) for any drug is the first step to develop an active pharmaceutical ingredient (API). These key starting materials for Remdesivir are available in India and chemical companies can manufacture these. Other reagents can be sourced from other countries. We started working on KSM for Remdesivir in January end, when trials had begun in China,” 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 manufacturers to expand global capacity and production. It will be essential for countries to work together to create enough supply for people all over the world and we look forward to these collaborative efforts.”
Experts said the Indian government could request Gilead Sciences for grant of voluntary licenses to Indian private companies for a royalty. If not, India could use the compulsory licence option, under which it, or a generics manufacturer can manufacture patented drugs so as to protect the health of its citizens. The patent hlder, however, gets paid for this.
“Because it is a patented drug, there are two options. One is that manufacturers obtain permission from the patent holder for a license to manufacture. The other option is that the Indian government allows two to three manufacturers to manufacture the drug on a compulsory license or a government use license. The manufacturers will need regulatory clearances which will be available only when more clinical data is available on the efficacy of the drug,” said KM Gopakumar, an intellectual property rights expert.