COVID Crisis: Remdesivir Hits Drug Regulator Hurdle In India

New Delhi: Even as COVID-19 cases are soaring in India, patients in the country are still to get Remdesivir, an experimental drug which has shown promise in treatment of coronavirus in other countries.

This is because the Drugs Controller General of India (DCGI) is yet to give approval for marketing the drug in the country.

“It might take some time before 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,” a pharmaceutical industry insider told The Times of India.

As many as five Indian pharmaceutical companies have signed licensing agreements with American drug maker Gilead Sciences and now sought DCGI’s permission to manufacture and sell Remdesivir in India.

The US drug maker has the authority to manufacture and distribute it to more nearly 127 countries. Re-purposed ebola drug was also originally developed by Gilead Sciences.

However, Gilead has been approved by the drug regulator to import and sell it in India. Sources said that the primary purpose was to support the licencees/Indian firms with whom non-exclusive agreements were signed by Gilead for more supply of the drug.

“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 Central Drugs Standard Control Organisation (CDSCO) official was quoted as saying by TOI.

Also Read: Antiviral Drug Remdesivir Shows Positive Results In COVID-19 Treatment: US Firm