State health minister Rajesh Tope announced Saturday that Maharashtra will procure 10,000 vials of the investigational drug, Remdesivir. The state government is in price negotiations with various suppliers and is trying to mobilise Corporate Social Responsibility (CSR) funds to buy the expensive medicine.
An anti-viral drug, Remdesivir is being used on moderately ill to severely ill patients to stop the spread of the virus in the body. It was manufactured in 2014 to treat Ebola and has since been used to treat patients of SARS and MERS.
Earlier this week, the Drug Controller General of India approved the use of Remdesivir as a five-day regimen to treat Covid-19 patients. Gilead Sciences, its manufacturer, has signed licence agreements with five generic pharmaceutical manufacturers — with Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan — based in India and Pakistan to expand the supply of the drug in Southeast Asia. So far, Drug Controller General of India VG Somani, who heads the Central Drugs Standard Control Organisation (CDSCO), has only given an approval to Mumbai-based Klinera Global Services to import remdesivir from three manufacturing sites in the US.
The drug has been given emergency authorisation in India, which means that it is being allowed as part of treatment though clinical trials are still ongoing to test its effectiveness. Such an approval means that its use has to be heavily restricted and monitored in India.
While minister Tope initially said a Bangladeshi company may be selected to procure medicines, Dr T P Lahane, director of Directorate of Medical Education and Research, said state government has reached out to the US and some Indian companies to procure Remdesivir.
Meanwhile, state officials said companies were quoting a high price for the drug, which has led to a delay in procurement. ‘We have reached out to a few manufacturers, but nothing has been finalised. We are trying to get CSR funds to procure it,’ Lahane said. Manufacturers are reportedly quoting Rs 20,000 for a single vial, which means for a five-day regimen the cost per patient will go up to Rs 1 lakh and for a 10-day regimen Rs 2 lakh.
According to infectious disease expert, Dr Om Srivastava, the two anti-viral drugs Remdesivir and Favipiravir have shown promise in Covid-19 treatment, so far. ‘But it is too soon to comment on their efficacy,’ he said. Srivastava has used the drug provided by a company on compassionate grounds.
At least two IAS officers in Mumbai have been administered this drug that is otherwise not accessible easily for common public. ‘While there is currently limited global supply of Remdesivir, the company anticipates new supply of the drug to start to become available in July, with supply continuing to increase through the end of this year and into next year,’ a Gilead spokesperson said.
The drug grabbed eyeballs after the National Institute of Allergies and Infectious Diseases (NIAID) trial announced initial trial results that Remdesivir was reducing recovery period to 11 days. The US FDA also approved the drug last month for emergency use.
In India, drug-makers like Cipla are learned to have already sought approval to manufacture and supply Remdesivir as part of a voluntary licence signed with Gilead. However, CDSCO is still performing audits of their facilities and awaiting sufficient data from these companies to ensure that their generic versions of Remdesivir adhere to the quality and safety standards for this medicine, a senior official said.
Another senior official said if Bangladesh provides Remdesivir as donation, India can accept the stock. ‘At the same time, there needs to be a check on how authentic and effective the product manufactured by this company is,’ said an industry executive aware of the development.
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