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Thursday, May 06, 2021

Explained: Behind the shortage of Remdesivir, and what is being done about it

Remdesivir uses, effects: Remdesivir is an injectable anti-viral that aims to prevent replication of the virus. It was manufactured in 2014 to treat Ebola, and has since been used to treat SARS and MERS. In 2020, it was repurposed for Covid-19 treatment.

Written by Tabassum Barnagarwala | Mumbai |
Updated: May 6, 2021 9:13:26 am
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Amid a surge in Covid-19 cases, Maharashtra, Delhi, Gujarat, Chhattisgarh and Madhya Pradesh have started reporting a shortage of the anti-viral remdesivir. On Sunday, the Directorate of Foreign Trade in Ministry of Commerce and Industry issued an order prohibiting export of remdesivir and active pharmaceutical ingredients (APIs) required in its production until further notice.

Remdesivir is an injectable anti-viral that aims to prevent replication of the virus. It was manufactured in 2014 to treat Ebola, and has since been used to treat SARS and MERS. In 2020, it was repurposed for Covid treatment. Clinical experience has shown it works best in mildly ill patients, and in early stages of hospitalisation; late use has little effect.

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The crisis

Of India’s 11 lakh active infections are in Maharashtra, which now needs 40,000-50,000 remdesivir vials daily, as compared to a peak requirement of 30,000 a day last year. The higher demand is primarily due to rising cases, and also manufacturing and supply issues. Madhya Pradesh has complained it is currently getting half its requirement. “Around 70% of total production is diverted towards Maharashtra. The remaining 30% is distributed to other states. If we need 7,000 vials, we get only 1,500-2,000,” said Food and Drug Inspector in MP Shobhit Kosta.

Demand and supply

For two or three months this year, remdesivir production was negligible or nil. Last December, several suppliers and manufacturers were left with huge stockpiles. They had anticipated sales and scaled up production, but a drop in Covid cases in November-December reduced demand.

Former Joint Commissioner of Drugs, FDA (Maharashtra), J B Mantri said a few suppliers had to destroy expired stocks. From January, manufacturers scaled down production. Hetero Healthcare, India’s largest manufacturer of remdesivir, scaled down production to 5-10%. Kamla Lifesciences, which supplies remdesivir to Cipla, stopped manufacturing from January 31 to March 1. “Government had asked us to reduce manufacturing because Covid-19 cases were reducing and there was no demand,” said Dr DJ Zawar, MD in Kamla Lifesciences.

That halt has affected supplies now. Cases began rising from February, but manufacturing resumed to an extent in March. “We need at least 25 different raw materials in production of remdesivir… We had to procure a lot of raw material and our suppliers could not supply quickly,” said Prafulla Khasgiwal, senior VP, Hetero Healthcare.

The cycle from production to transportation of remdesivir can take 20-25 days. Production scaled up last month; it will take another week for fresh stocks to hit markets.

What next

The Department of Pharmaceuticals has asked all seven manufacturers to scale up to their maximum capacity of 38.80 lakh vials per month. Hetero can produce 10.50 lakh, Cipla 6.20 lakh, Zydus Cadila 5 lakh and Mylan 4 lakh vials. Hetero is producing 35,000 vials a day or two currently. Zydus plans to scale up to 12 lakh vials a day. It has also slashed the price of a 100 mg vial to Rs 899, from Rs 2,800, the cheapest from any manufacturer. The MRP for others is: Cipla Rs 4,000, Hetero Rs 5,400, Dr Reddy’s Lab Rs 5,400, Mylan Rs 4,800 and Jubilant Rs 4,700.

Deepak Sapra, CEO (APIs and Services) in Dr Reddy’s, said it is “preparing to meet the additional demand”. Cipla said it has “have serviced all orders and are in the process to optimise supplies further”. A Mylan spokesperson said, “We are closely partnering with the government to meet the patient needs in India and ensure access…”

Remdesivir is being over-prescribed even for patients who won’t benefit from it. Last year, the DoP had red-flagged this. Over-prescription has inflated prices. Worse, over-use can make patients resistant to the drug.

Domestic manufacturers have been directed to list their distributors on their websites. The Centre has directed states to take action against black marketing and hoarding. It has advised hospitals to use remdesivir based on the national Covid protocol, which lists remdesivir as an investigational drug with contraindications.

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