Gilead Sciences, an American biopharmaceutical company, has recently engaged in talks with some leading chemical & pharmaceutical companies in countries including India. The discussion has been held on remdesivir, the company’s patented antiviral drug, and its production. The drug has recently been authorized by the U.S. FDA for emergency use in COVID-19 patients.
Gilead is considering allowing companies to produce the drug under voluntary licenses, throughout at least 2022, for Asia, Europe and other developing regions. A voluntary license is given by the patent holder to the generics drug manufacturers to develop a drug. India is a top generics hub across the globe.
The company has reportedly stated that it is negotiating with various drug manufacturers in Pakistan and India for long-term voluntary licenses to make the drug available in developing countries. It will transfer the technology to initiate this production. Additionally, it is also having active discussions with its partner, Medicines Patent Pool, to license the drug for the developing countries.
As per the ICMR (Indian Council of Medical Research), local drug manufacturers can initiate the patented drug production during the coronavirus pandemic under certain regulations. According to Dr. Raman R Gangakhedkar, ICMR’s department of epidemiology & communicable disease H ead, such drugs can be developed generically by making a royalty payment to the patent holder. Certain provisions can be used to manufacture the drug during the pandemic.
India is a part of the WHO’s (World Health Organization) Solidarity Trials for treating COVID-19 disease. The country has received 1000 doses of the drug to get tested. The Hyderabad-based CSIR-IICT (Indian Institute of Chemical Technology) has also synthesized the main starting materials for the drug, which is the 1st step of developing its active pharmaceutical ingredient.
The company is also having discussions with UNICEF to leverage the extensive experience for delivering medicines to both low- and middle-income countries during the crisis. This will help deliver remdesivir by adopting its distribution networks as well as further facilitating access in the developing countries.
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