No human trials at CDRI even 2 months after nod
LUCKNOW: The Central Drug Research Institute (CDRI), Lucknow is yet to begin human trials of influenza drug Umifenovir even two months after it got a go-ahead from the Drugs Controller General of India (DCGI).
The trials aimed at checking the efficiency of the drug in management of Covid-19 got clearance from DCGI in mid-June. The institute was to conduct human trials on over 130 patients, but the project remains in a limbo. This is when CDRI was one of the few institutes to have got the nod from DGCI for human trials.
Meanwhile, CDRI officials maintained that the trials were on time. “The project is not delayed. There are many processes, which need to be completed before starting the trials. Our experts were focusing on manufacturing the repurposed drug for trials. This part is almost completed,” said Tapas Kumar Kundu, director, CDRI.
Experts at CDRI selected Umifenovir drug for the trials, saying it has a good safety profile and acts by preventing entry of virus into human cells and also by priming the immune system. The drug has been in use to cure influenza in countries like China and Russia for over two decades.
The CDRI has partnered with a Goa-based private drug manufacturing firm, which has been tasked to manufacture the drug that will be used in the trials.
“Our preliminary research shows that it could be a suitable candidate in Covid-19 management. The clinical trials will be aimed to gauge its efficacy,” said Kundu.
The CDRI has tied up with e King George’s Medical University (KGMU), Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and a private medical college for the trials.
The director asserted that the human trials will begin by August 18 and the results can be expected within two months. “If everything goes well, we can expect results within two months and possible drug by November,” said Kundu.
The CDRI will conduct a randomised, placebo controlled trial of efficacy, safety and tolerability of the antiviral drug, he added. “This basically means that the candidates will be divided into several groups. Some group will be administered Umifenovir while the rest will be given placebo. None of the candidates will know if they are getting the drug or a placebo,” he said.
The institute has also developed technology to make Umifenovir in record time and licenced a manufacturing unit for the same. Kundu said all the raw materials for the drug were indigenously available and if the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against Covid-19 and can be part of national program against Covid-19.