As the number of cases increases in the country, companies await marketing approval from Drugs Controller General of India (DCGI) to roll out the experimental coronavirus drug Remdesivir in the country. However, it might be a while as the regulator has sought various sets of data from the companies. Five companies have applied for permission to manufacture Remdesivir in India after signing a licencing deal with original developer and drug maker Gilead.
According to a report in Times of India, an official said that it might take some time before Remdesivir is available in the Indian market. DCGI has asked the companies concerned to furnish various sets of data including animal toxicity, stability study etc. "Even if these trials are conducted on a fast-track basis, they will take at least a month's time," an official told the daily.
The five companies have signed licencing agreement with Gilead Sciences to manufacture and distribute Remdesivir in 127 countries. The regulator has however granted approval to Gilead to import and sell Remdesivir in India.
A Central Drugs Standard Control Organisation (CDSCO) official told the daily that they have asked for this data to ensure quality of the drug. The data furnished by Gilead can only waive off clinical trials, the official told the daily.
India had recently approved the use of drug Remdesivir for emergency use, as mentioned by Health Ministry Joint Secretary Lav Agarwal at a press conference. This approval was given after the emergency use authorisation by the US Food and Drug Administration. "Remdesivir approved on June 1 under emergency use with condition for five dose administration," the regulator had said.