Why is there a shortage of Remdesivir? – Business News
The reduction in production due to lower demand after the first wave of coronavirus and the lack of vigilance on the part of the government to ensure storage has led to the current Remdesivir crisis, sources say.
Gilead Life Sciences, the innovator of the reused drug, had authorized six manufacturers in India to produce the drug. Most of them depended on contract manufacturers and their subsidiaries to make the product. Demand fell to almost zero in January after the first wave of the pandemic in the country. Since there was no demand, most manufacturers stopped giving new orders for manufacturing. Neither manufacturers nor policymakers predicted a second wave and failed to stockpile the life-saving drug, sources said.
While the active pharmaceutical ingredient (API) and the main raw materials of the drug may be of national origin, only a few intermediates need to come from countries like China or Egypt. However, his availability was not a problem. If raw materials are available, the drug can be produced within 1-2 weeks. But, black marketing, supply chain issues and the surge in Covid-19 cases in Delhi, Maharashtra, Karnataka have led to a shortage, sources say.
Remdesivir was produced at full capacity in March-April with 25-30 lakh vials produced per month. As of April, India was making 38.8 lakh vials of Remedesivir per month, with the government allowing producers to increase their capacity. Among them, Hetero Drugs was the largest manufacturer with a capacity of 33% (13 lakh vials per month). Cipla represented 20%, or 7.6 lakh vials, Zydus Cadila 16% or 6.1 lakh vials. Mylan Labs manufactured 5 lakh vials representing 13% of total capacity. Dr Reddy’s Labs, Syngene and Jubilant Ingrevia each accounted for 6% of the 2.4 lakh vial production per month. With cases increasing, the government last week approved 25 manufacturing sites for remdesivir. This will increase production to over 90 lakh vials per month, they said.
“Today, around ten new manufacturing sites have sprung up and production has increased by 20%,” said Daara B Patel, secretary general of the Indian Drug Manufacturers Association. “We have doubled the production of Remdesivir since the last wave of the pandemic. Given the unprecedented demand for the drug, we have now further increased our capacities through our network, to meet the demand,” Cipla said. .
According to an affidavit filed by the government in the Supreme Court on April 21, the current production of Remdesivir is around 74 lakh vials per month and once the additional manufacturing sites are commissioned by May, production will increase to over 90 lakh vials per month. .
A health ministry statement said that the production capacity of the seven licensed domestic manufacturers had increased from 38 lakh vials per month to 1.03 crore vials per month and a total of 13.73 lakh vials had was delivered across the country between April 21 and 28. Daily supply increased from 67,900 vials on April 11 to 2.09 lakh vials on April 28. HLL Lifecare, a government-owned Indian government procurement company, has also ordered 4,50,000 vials of Remdesivir from Gilead Sciences USA and Egyptian company Eva Pharma. The first shipment of 75,000 bottles arrived a few days ago.
In addition, on April 20, the Department of Revenue exempted tariffs on the injection of remdesivir, its API and the beta cyclodextrin used in the manufacture of remdesivir, until October 31. On April 17, the National Pharmaceutical Pricing Authority capped its prices at 3,500 rupees.
Meanwhile, the Supreme Court asked on April 30 whether the Center had considered invoking section 92 of the patent law to increase the availability of COVID-19 drugs. A petition filed by Jan Swastya Abhyan asks the Supreme Court to grant permission to use patents for government purposes under section 100 of the Patent Law. “The provisions of the patent law allow the compulsory license to be invoked because it is a pandemic and a national emergency,” said Gopakumar G Nair, founder and CEO of GNA Patent Gurukul, a specialist company in patents.
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