BDR Pharmaceuticals move on Remdesivir clone irks Gilead | Economic Times

New Delhi: BDR Pharmaceuticals, a Mumbai-based company, has sought the drug controller’s approval to manufacture and sell the generic version of Remdesivir without entering into a licensing pact with Gilead Sciences, prompting the patent-holder for the medicine to flag its concerns with the government.The Indian company had submitted its application for manufacturing the Covid-19 drug to the Drug Controller General of India (DCGI) last week. The subject expert committee looking into the matter has asked BDR Pharma to submit details such as the chemistry manufacturing control (CMC) data, people familiar with the matter said. Gilead has approached the government and questioned the application, said these persons.Government officials said the US company has written to the Prime Minister’s Office, Niti Aayog, Department of Pharmaceuticals, Department for Promotion of Industry & Internal Trade (DPIIT), health ministry and the drug controller’s office. Remdesivir Only Approved Drug for Covid"Gilead has sought to understand the plans of an Indian player for manufacturing its patented products without entering into a voluntary licensing agreement with it,” said a government official. Gilead did not respond to emailed queries from ET.BDR Pharmaceuticals chairman Dharmesh Shah told ET that discussions were on with the DCGI, and given the sensitivity of the matter, he would not like to comment.The company generated revenues of Rs 584 crore and net profit of Rs 100 crore in 2019, according to records available with the Registrar of Companies. It focuses on four specialised therapeutic segments — oncology, critical care, gynaecology and neurology.76055058Gilead has signed voluntary licensing agreements with Cipla, Hetero Labs and Jubilant Life Sciences for the manufacture and sale of Remdesivir in 127 poor and middle income nations, including India. Remdesivir is currently the only drug approved to treat Covid-19 patients.The US granted emergency approval to Remdesivir after trials showed that it reduced recovery time for patients on oxygen support. Japan, too, has granted similar approval to the drug that was originally developed to treat Ebola.‘LEGALLY VALID’The entry of another Indian pharma player is valid and does not defy the patent laws, said Leena Menghaney, head, South Asia, MSF Access Campaign. “Under international laws (Trade-Related Aspects of Intellectual Property Rights or TRIPS agreement), Indian patent law and the Drugs & Cosmetics Act, a company that has the capacity to register and manufacture the product cannot be denied approval solely on the grounds that the product is patented,” she said.“There is no linkage between patent status and drug approval. Therefore, if a company has the capacity to manufacture, it can’t be denied approval,” Menghaney said.Health activists said commercial interests of Gilead cannot be put before India’s humanitarian commitments and the interest of the Indian generics industry to be free to supply Remdesivir at an affordable cost.