Antiviral drug gets regulatory approval
nNEW DELHI: Glenmark Pharmaceuticals on Thursday announced that it received approval from India’s drug regulator, the drugs controller general of India (DCGI), to manufacture and market the oral antiviral drug Favipiravir to treat mild to moderate Covid-19 cases in India.
The drug will be marketed under the brand name ‘Fabiflu’.
The drug is known to inhibit virus replication and in April, the company was the first to receive approval from the regulator to conduct clinical trials in the country.
“This approval has been granted based on evaluation of data and in consultation with the Subject Expert Committee, as part of accelerated approval process, considering the emergency situation and unmet medical need of the Covid-19 outbreak. It is for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation,” said company in a statement.
Favipiravir, sold under the brand name Avigan in Japan, is used to treat influenza in that country. What Glenmark is producing is a generic version of Avigan, the company had said in an earlier statement.
In the past few months, post the outbreak of Covid-19, multiple clinical trials have been initiated on Covid-19 patients in China, Japan and in the US.
“Having internally developed the Active Pharmaceutical Ingredient (API), and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients,” the company had said.
The treatment duration is a maximum of 14 days.
nNEW DELHI: The Supreme Court told the government Friday that it expected all stranded migrants to be sent home free of cost by the June 24, the deadline set by it.
Organisations helping migrants had complained to the court over the alleged lack of publicity about the schedule of Shramik Special trains launched in May to ferry migrant workers home. Also, there were allegations that migrants had to pay for their journey home.
“We issued appropriate directions to all states (on June 9). All migrant workers have to be transported in 15 days,” the bench of justices Ashok Bhushan, SK Kaul and MR Shah said, reiterating its order through video conferencing. “Our order is very clear that no migrant worker has to pay for the ticket.”
Senior advocate Gopal Shankaranaraynan, who appeared for the National Law Universities Alumni Association, told the court that members of his group were helping migrants stuck in Maharashtra to reach destinations in Bihar, Uttar Pradesh and Uttarakhand. He alleged that there was lack of information on the trains.he complained that migrants were being asked to pay for tickets.
Solicitor general Tushar Mehta said the Centre will make available trains within 24 hours of receiving a request.
The court posted the matter on July 8 to monitor implementation of its directions.
States and Union territories received a mandate on June 9 from the court to ensure the return of all workers stranded by the lockdown to their home states and to inform it about welfare programmes, including job opportunities, they plan to offer the returnees.the court also asked states and Union territories to identify migrant workers who have returned and prepare an inventory of the vocational skills they possess and their employment history.