Maharashtra government has put on hold its decision to purchase investigational drug Remdesivir from Bangladeshi company Eskayef Pharmaceuticals Ltd, that has neither got a licensed agreement with manufacturer Gilead Sciences nor got an approval to sell the drug to any company in India. Senior state officials said they plan to wait for DCGI to approve Indian and foreign companies before initiating procurement procedure for 10,000 vials.
Eskayef Pharma has also quoted a single vial at 2.5 times the retail price announced in Bangladesh. The pharma’s marketing and sales directorDr Mujahidul Islam had informed media in Bangladesh that the retail price of the drug, marketed as Remivir, would be kept at 5,500 Takas per vial (Rs 4,894 INR), however, when they mailed their quotation to Maharashtra government they priced onevial at $160 (Rs 12,090).
Eskayef has so far not signed a licensed agreement with Gilead to market the drug. In an e-mail response, Gilead Sciences spokesperson told The Indian Express, “Gilead has not provided a licence to Eskayef Pharmaceuticals or any other company in Bangladesh to manufacture Remdesivir. Gilead cannot comment on or verify the authenticity or effectiveness of this product as it is not manufactured by Gilead or one of our licensed partners.”
A senior health ministry official told The Indian Express that no application has been made as yet to import Remdesivir from Bangladesh. Any approvals for imports would be granted only after a proper study of the clinical data. Batches of the products would also have to be submitted to central drug testing laboratories for stability tests, the official added.
In Bangladesh, Eskayef along with few other manufacturers is allowed to manufacture Remdesivir under World Trade Organisation’s drug patent waiver. Senior officials in Mantralaya said since the pharma company’s drug efficacy has not been gauged by India’s regulatory authority, Maharashtra is not going to perform a stability test to gauge the efficacy of the drug, and will follow procurement procedure only from companies approved by Drug Controller General of India (DCGI).
“We are not going to buy Remdesivir from Eskayef if they do not have necessary approvals,” state Health Minister Rajesh Tope said on Sunday.
So far, DCGI’s V G Somani, who heads the Central Drugs Standard Control Organisaiton (CDSCO), has only given an approval to Mumbai-based Klinera Global Services to import Remdesivir from three manufacturing sites in the US. Applications submitted by companies like Cipla and Hetero are still under process.
Remdesivir is an anti-viral manufactured in 2014 to treat Ebola. It remains under clinical trials and no conclusive evidence has been found to confirm whether it is able to help in faster recovery of Covid-19 patients. Maharashtra, with over 83,000 cases, accounts for 33 per cent of India’s Covid-19 burden. The state has used Remdesivir, so far available on donation, on selected severely ill patients, but even in them a cocktail of other drugs have been used to treat Covid-19. So far National Institute of Allergies and Infectious Diseases (NIAID) trial announced initial results that the drug was reducing recovery period to 11 days. The drug has been given emergency authorisation in India in June, which means that it is being allowed as part of treatment despite clinical trials still ongoing to test its effectiveness.
“There are certain sections, like 47 and 100 of the Patents Act that allow the government in a national emergency situation to import and use a product despite it being patented in the country. These provisions are TRIPS compliant,” said Murali Neelakantan, former global general counsel of Cipla and Glenmark Pharmaceuticals. “These approvals can be granted by the central government in a matter of hours.” If the Maharashtra government were to import Remdesivir from Bangladesh, its procurement entity would have to apply to the Central Drugs Standard Control Organisation (CDSCO) for a licence.
“They’ll have to give CDSCO the manufacturing and test data which includes production and supply chain records and samples for testing by CDSCO, in order for them to understand the tests done and the process followed by the company to manufacture the drug and to ensure its quality,” Neelakantan toldThe Indian Express. Eskayef has not responded to an email query from The Indian Express.
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