The Ministry of Health and Family Welfare held a video conference Thursday with top pharmaceutical companies to check the “status” of the drug’s development in India.
According to industry sources, major players like Cipla, Glenmark and Dr Reddy’s are working on the development of the injectable drug, which has been developed by Gilead Sciences in the US, and is under patent protection until 2035. Gilead has given the drug the brand name Veklury.
Representatives of all three aforementioned firms, along with other Indian pharma companies including Jubilant Life Sciences and Hetero Pharma, attended the meeting chaired by health ministry joint secretary Sudhanshu Pant.
“The objective of the meeting was to understand the latest status of remdesivir’s development in India,” a government source told ThePrint.
“The industry was asked if companies have reached out to Gilead Sciences, the maker of remdesivir, to initiate talks about voluntary licencing. The ministry also sought details on the process of production once Gilead gives approval, and in how much time the production can be ramped up,” the source said.
The moves come after a clinical trial showed that the use of remdesivir can reduce the time taken to recover from Covid-19 by a third.
Cipla and Jubilant Life Sciences refused to comment on the meeting or the status of remdesivir development in India, while emails sent to Glenmark, Dr Reddy’s and Hetero did not elicit a response until the publication of this report.
Steps to produce the drug in India
First, Gilead will have to give its approval for Indian companies to manufacture the drug, which will most likely be in the form of a voluntary licencing arrangement, under which it will transfer technology.
An industry insider, who was involved in the technology transfer process when Gilead allowed Indian drug makers to produce the Hepatitis C drug Sovaldi in 2014, explained: “After signing the agreement, Gilead will transfer the technology through which Indian companies will start producing the active pharmaceutical ingredients (APIs). These APIs will then be converted into injectable formulations.”
The insider added: “The first few lots will be produced at a small scale to check the production quality. After that, full scale production can be started.”
Remdesivir has ‘clear-cut’ positive effects
Last month, Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said: “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.”
Patients who were administered the drug, Fauci said, were discharged from the hospital in 11 days, on average, as compared to 15 days for a placebo group, which took dummy or no pills.
“What it has proven is that a drug can block this virus,” Fauci said, referring to data from a study of more than 1,000 patients across the US and around the world. He said the drug would become part of standard Covid-19 care in the US.
However, Fauci’s claims came at a time when another study in medical journal The Lancet suggested the drug had not shown significant clinical benefits in critically-ill Covid-19 patients.