Patients wait for Remdesivir as DCGI yet to give clearance

Patients wait for Remdesivir as DCGI yet to give clearance

Sushmi.Dey@timesgroup.com

New Delhi:08.06.2020

Despite rapidly rising Covid-19 deaths and an approval to use Remdesivir for treatment of severe cases, Indian patients are still waiting for the drug to be available in the country as companies are awaiting marketing approval from the Drugs Controller General of India (DCGI).

“It might take some time before the drug (Remdesivir) is available in the Indian market. The regulator has asked companies to submit various sets of data, including stability study, animal toxicity etc. Even if these trials are conducted on a fast-track basis, they will take at least a month’s time,” an official said.

Five Indian pharma companies have applied to the DCGI seeking permission to manufacture and sell Remdesivir — an experimental drug that has shown promise in treating Covid-19 patients — in India.

Companies have signed an agreement with Gilead to make drug in 127 countries

These companies have signed a licensing agreement with US drug maker Gilead Sciences to manufacture and distribute the drug in around 127 countries. Gilead is the original developer of the re-purposed ebola drug.

While the drug regulator has granted approval to Gilead to import and sell the medicine in India, it was primarily with a purpose to support the licencees or Indian firms with whom Gilead signed non-exclusive agreements to further expand supply of Remdesivir, sources said.

However, despite local companies citing Gilead’s data as the reference point, the DCGI has recently written to the five Indian companies to submit data from animal toxicity studies, stability studies and test licences.

“We have asked the companies for this data to ensure quality of these products. Only clinical trials can be waived off based on Gilead’s data,” a senior official in the Central Drugs Standard Control Organisation (CDSCO) said.

When asked how Maharashtra government was procuring 10,000 vials of Remdesivir from Bangladesh, the official said, “We have given permission to only Gilead. Everything else is now from the grey market and unapproved.” Sources said the matter was taken up in a high-level meeting in the government on Sunday.

Local manufacturers said they had everything in place, starting from raw material to capacity, and were only waiting for regulatory approval to start manufacturing the drug. “We are completely backward integrated and can manufacture everything locally, starting from API to finished formulation for Remdesivir. However, the studies can take up to six months’ time and delay launch of the product,” a senior pharma executive said.