As trials on anti-viral drugs pick up, the Centre has now turned its focus on ensuring that remdesivir, Gilead's repurposed Ebola drug, is available for trials here. The USFDA has recently given an emergency approval to the drug for use on coronavirus patients.
This has generated interest among the authorities, who want to conduct trials on patients here. “Our clinicians can use remdesivir on patients here on compassionate grounds. However, the drug needs to be available. It is a patented drug and we understand it is complex to make as well,” said a senior government official.
He added that the government is in discussion with the industry on whether the firms are gearing up for clinical trials on patients. It is also considering conducting some trials in government hospitals. It has held a video-conference with leading pharma players, including Dr Reddy's Laboratories, Cipla, Jubilant Lifesciences and Hetero, among others. The government is now trying to understand how long it will take before production can start in India.
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About a week earlier, India had decided to adopt a wait-and-watch approach on remdesivir as initial reports from Chinese trials were not encouraging. It had decided to focus on drugs like favipiravir and had given fast approvals to firms like Glenmark to start trials.
However, last week, Gilead announced that the National Institute of Allergy and Infectious Diseases (NIAID) trial had shown that remdesivir helped patients recover quicker than standard care. The US government’s top infectious disease expert Anthony Fauci, head of NIAID, said the early results of this trial offered ‘good news’.
The government official added that some Indian companies are already in touch with the US-based company for voluntary licence to manufacture the drug here. Gilead's chief executive officer (CEO) Daniel O'Day said the company will ensure access is not an issue with this medicine. This is positive news for countries like India, as remdesivir is patent protected till 2035.
While multiple industry sources said Gilead and DRL were close to signing a voluntary licence agreement that will allow DRL to make the drug for the Indian market, the Hyderabad-based firm did not comment on speculation.
A Gujarat-based pharma firm said it expected the study results on remdesivir to be positive. "We would wait until some Indian studies offer positive results too. We can make remdesivir, but are not rushing to do so. We also do not have the raw material ready with us at the moment," said a senior official of the firm. For patented drugs, firms are allowed to import it in small quantities for research purposes. Firms thus try their hands at understanding the process involved in making complex drugs.
As for remdesivir, Gilead will have to transfer technology to make the active pharmaceutical ingredients (APIs) here after which the formulation, which is an injectable, can be made.
Meanwhile, the Centre is also gearing up to start trials on blood poisoning drug Sepsivac.