As trials of anti-viral drugs gain momentum, the government has now turned its focus on ensuring that remdesivir, Gilead's repurposed Ebola drug, is available here for trials.
US Food and Drug Administration (FDA) has already given an emergency approval to the drug for its trials on coronavirus infected patients. This has piqued Indian authorities' interest in conducting 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 discussions with the industry on whether the firms are gearing up for clinical trials on patients. It is also planning to conduct some trials in government hospitals and has held a video-conference with leading pharma players including Dr Reddy's Laboratories, Cipla, Jubilant Lifesciences, Hetero among others. The government is now trying to understand how long it will to start production in India.
About a week ago, 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 quick 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. US government’s top infectious disease expert Anthony Fauci, head of NIAID, said that early results of this trial offered ‘good news’.
The government official added that some of the Indian companies are already in touch with the US-based company for a voluntary license to manufacture the drug here. Gilead’s Chief Executive Officer Daniel O’Day has 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 suggested that Gilead and DRL were on the verge of signing a voluntary licence agreement that will allow DRL to make the drug for the Indian market, the Hyderabad-based firm refused to comment on speculation.
A Gujarat based pharma firm said it expected to study results on remdesivir to be sure. "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. As far as patented drugs are concerned, firms are allowed to import them 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 the technology to make the active pharmaceutical ingredients (APIs) in India, post which the formulation, which is an injectable, can be made.
Meanwhile, the Indian government is also gearing up to start trials on blood poisoning drug sepsivac.