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Maharashtra clears import of Remdesivir, an antiviral drug with a proven record of efficacy against Covid-19
Maharashtra clears import of Remdesivir, an antiviral drug with a proven record of efficacy against Covid-19
The state government on Saturday announced it had initiated the process to procure , a day after Mumbai Mirror reported the state was dilly-dallying despite the city running out of the crucial drug and a Bangladeshi manufacturer offering 10,000 vials.
Remdesivir, an antiviral drug with a proven record of efficacy against Covid-19, has been widely used across the world. In Mumbai, it has been made available to some critical patients -- mostly people with deep pockets and influence -- on compassionate grounds, though the drug regulator cleared it only for “restricted emergency use” on Monday.
“GoM to procure 10k vials of Remdesivir. Based on evidence from laboratory, animal and clinical studies, it has generated promising results in MERS-CoV and SARS which are also caused by Corona Virus. WHO suggests it may have some positive effects in Covid19 treatment. This expensive medicine is being made available for poor and needy patients,” Health Minister Rajesh Tope tweeted on Saturday.
Tope, however, didn’t mention where the drug would be procured from.
State government officials, however, said that the order was being placed with the Bangladesh-based Pharma company Eskayef Pharmaceuticals Ltd, which made its first offer on May 28 at $ 160 (Rs 12,000) a piece.
The company had offered to fly the drug over from Dhaka provided the government paid the full amount upfront.
A state government official said Indian companies are also ready with their own versions of Remdesivir and are waiting for the controller’s approval to start manufacturing. Four companies in India are licensed to sell Gilead’s drugs, but none have permission from the drug controller.
Dr Sanjay Oak, who heads the state’s Covid-19 Task Force, said, “I have repeatedly requested at all levels to decide drug protocols. We have told them that we need this drug along with three others. Trials should be sped up or multiple centres should be allowed to conduct them. So far there are only promises from the Indian Council of Medical Research and Drug Controller of India.”
Suraj Samant, a representative of Eskayef Pharmaceuticals, said: “As stated earlier, we have given our proposal to the Maharashtra government. We are awaiting the procurement order for the same.”
When asked if Eskayef Pharmaceuticals has the license from the patent holder to manufacture the drug in Bangladesh, Samant said: “Eskayef Pharmaceuticals Limited is the one of the leading drug manufacturing company in the world. Bangladesh, as a UN Least Developed Country, is allowed to produce any patented medicine without obtaining prior permission under World Trade Organisation agreements.”
Last month, the state’s Covid-19 task force had urged Chief Minister Uddhav Thackeray to find a way to circumvent bureaucratic paperwork and give Mumbaikars immediate access to Remdesivir and another drug, Favipirevir.
In a letter to the chief minister, the Task Force had said lives are at stake and that a few clinical trials or permissions should not be allowed to come in the way of doctors using a medicine they know will work.
https://mumbaimirror.indiatimes.com...import-of-remdesivir/articleshow/76239550.cms
Maharashtra clears import of Remdesivir, an antiviral drug with a proven record of efficacy against Covid-19
The state government on Saturday announced it had initiated the process to procure , a day after Mumbai Mirror reported the state was dilly-dallying despite the city running out of the crucial drug and a Bangladeshi manufacturer offering 10,000 vials.
Remdesivir, an antiviral drug with a proven record of efficacy against Covid-19, has been widely used across the world. In Mumbai, it has been made available to some critical patients -- mostly people with deep pockets and influence -- on compassionate grounds, though the drug regulator cleared it only for “restricted emergency use” on Monday.
“GoM to procure 10k vials of Remdesivir. Based on evidence from laboratory, animal and clinical studies, it has generated promising results in MERS-CoV and SARS which are also caused by Corona Virus. WHO suggests it may have some positive effects in Covid19 treatment. This expensive medicine is being made available for poor and needy patients,” Health Minister Rajesh Tope tweeted on Saturday.
Tope, however, didn’t mention where the drug would be procured from.
State government officials, however, said that the order was being placed with the Bangladesh-based Pharma company Eskayef Pharmaceuticals Ltd, which made its first offer on May 28 at $ 160 (Rs 12,000) a piece.
The company had offered to fly the drug over from Dhaka provided the government paid the full amount upfront.
A state government official said Indian companies are also ready with their own versions of Remdesivir and are waiting for the controller’s approval to start manufacturing. Four companies in India are licensed to sell Gilead’s drugs, but none have permission from the drug controller.
Dr Sanjay Oak, who heads the state’s Covid-19 Task Force, said, “I have repeatedly requested at all levels to decide drug protocols. We have told them that we need this drug along with three others. Trials should be sped up or multiple centres should be allowed to conduct them. So far there are only promises from the Indian Council of Medical Research and Drug Controller of India.”
Suraj Samant, a representative of Eskayef Pharmaceuticals, said: “As stated earlier, we have given our proposal to the Maharashtra government. We are awaiting the procurement order for the same.”
When asked if Eskayef Pharmaceuticals has the license from the patent holder to manufacture the drug in Bangladesh, Samant said: “Eskayef Pharmaceuticals Limited is the one of the leading drug manufacturing company in the world. Bangladesh, as a UN Least Developed Country, is allowed to produce any patented medicine without obtaining prior permission under World Trade Organisation agreements.”
Last month, the state’s Covid-19 task force had urged Chief Minister Uddhav Thackeray to find a way to circumvent bureaucratic paperwork and give Mumbaikars immediate access to Remdesivir and another drug, Favipirevir.
In a letter to the chief minister, the Task Force had said lives are at stake and that a few clinical trials or permissions should not be allowed to come in the way of doctors using a medicine they know will work.
https://mumbaimirror.indiatimes.com...import-of-remdesivir/articleshow/76239550.cms
