Indian pharmaceutical companies are yet to receive an approval to market remdesivir - the COVID-19 drug, the Business Standard has reported. It is the only drug so far that has shown significant effect on patients infected with novel coronavirus.
This comes despite the Indian drug regulator — the Central Drugs Standard Control Organisation (CSDSCO) — having granted conditional approval to Gilead Sciences to market the investigational drug.
Moneycontrol could not independently verify the report.
The conditional marketing authorisation for remdesivir was granted under an accelerated review process, considering the emergency situation and unmet medical needs in light of the novel coronavirus pandemic, Moneycontrol reported earlier.
Gilead Sciences' experimental drug Remdesivir has been found to aid in the recovery of COVID-19 patients.
In India, the US-based company has licensing agreements for Remdesivir with four pharmaceutical companies — Cipla, Hetero Drugs, Jubilant Life Sciences and Mylan.
The newspaper report further suggests that firms have not yet approached the National Pharmaceutical Pricing Regulator (NPPA) formally to discuss pricing of the drug, which will be used on hospitalised patients.
Additionally, the Indian Council of Medical Research (ICMR), which will decide the dosage, it is yet to come up with an advisory.
It was also reported earlier that companies licensed to manufacture Remdesivir might have to sell it only to government institutions for now as the drug was still under trial.
Gilead Sciences is reportedly developing easier-to-administer versions of Remdesivir for COVID-19 that could be used outside of hospitals, including ones that can be inhaled, after trials showed moderate effectiveness for the drug given by infusion.
For critically-ill patients, Roche and Eli Lilly and Co are testing drugs in combination with remdesivir.