BDR Pharmaceuticals seeks drug controller’s nod to manufacture generic version of Remdesivir, irks Gilead: Report

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Mumbai-based BDR Pharmaceuticals has sought the Drug Controller General of India (DCGI)’s approval to manufacture and sell Remdesivir’s generic version without entering into a licensing pact with Gilead Sciences, according to an Economic Times report.

This has led Gilead Sciences, the patent-holder for the medicine to raise concerns with the government.

BDR Pharmaceuticals had reportedly submitted its application for manufacturing the drug — which is under consideration for treatment of COVID-19 patients — to the Indian drug controller last week.

Gilead has approached the government and questioned the application. It has reportedly written to the Prime Minister’s Office (PMO), the Union Health Ministry, the government policy think tank NITI Aayog, Department of Pharmaceuticals, Department for Promotion of Industry & Internal Trade (DPIIT) and the drug controller’s office.

The report suggested the subject expert committee which is looking into the matter asked the Mumbai-based company to submit details such as the chemistry manufacturing control (CMC) data.

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BDR Pharmaceuticals’ Chairman Dharmesh Shah told the newspaper that discussions were on with the DCGI. However, Shah did not comment further citing the sensitivity of the matter.

Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.

United States-based Gilead has signed a pact with Cipla, Hetero Labs, Jubilant LifeSciences and Dutch firm Mylan for manufacturing of the drug.

Under the licensing agreements, the companies have the right to receive a technology transfer of the Gilead manufacturing process for Remdesivir to enable them to scale up production more quickly.