Red tapes license have been stuck for 5 firms and now a part in the covid treatment protocol
Health activists and industry sources allege “not a single” vial of the drug has been brought into India since its approval for emergency use by Drug Controller General of India (DCGI) on June 1.
Most generic pharma companies hoping to produce and supply the drug in India are still awaiting approval from the Central Drugs Standard Control Organisation (CDSCO), which is learnt to be performing stringent checks on their manufacturing sites and testing their samples.
The government on Saturday released guidelines for doctors to use investigational antiviral medication remdesivir in treating India’s Covid-19 patients, but there is still little clarity on how patients can access the drug.
It is unclear though how many firms with voluntary licences from Gilead have received the drug regulator’s go-ahead to manufacture and supply remdesivir in India. Only Jubilant Life Sciences confirmed it received “conditional approval” for its generic version “subject to certain criterion being met”. It plans to launch its remdesivir in July 2020.
As on Friday, the regulator had finished inspection of BDR Pharmaceuticals International’s active pharmaceutical ingredient facility “on account of Cipla”, said CMD Dharmesh Shah. BDR had tied up with Cipla following controversy over its move to manufacture its own generic of remdesivir, which Gilead has patented in India.
“They have asked for samples of our product, which will be tested at their Central Drug Testing Laboratory. We will be submitting those samples (on Saturday),” Shah told The Indian Express. “While we await approvals, we have received calls from a huge number of patients trying to access the drug. We can’t do anything,” he said.
There is a dilemma over whether approvals should be fast-tracked further, even skipping certain procedures, to ensure that patients get early access to the product.
However, some feel this might risk patient safety. “The real test of any of these procedures is during a crisis. If you say that, during a crisis, you will not follow the procedure, it undermines the authority of the regulator,” said Neelakantan.