Amid an increase in Covid-19 cases, Maharashtra, Delhi, Gujarat, Chhattisgarh and Madhya Pradesh have started reporting a shortage of antiviral remdesivir. On Sunday, the Foreign Trade Directorate of the Ministry of Trade and Industry issued an order banning the export of remdesivir and the active pharmaceutical ingredients (APIs) necessary for its production until further notice.
Remdesivir is an injectable antiviral drug that works to prevent the virus from replicating. It was made in 2014 to treat Ebola and has since been used to treat SARS and MERS. In 2020, it was reused for Covid treatment. Clinical experience has shown that it works best in mildly ill patients and in the early stages of hospitalization; late use has little effect.
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Of India’s 11 active lakh infections are found in Maharashtra, which now needs 40,000 to 50,000 vials of remdesivir per day, up from a peak of 30,000 per day last year. The higher demand is mainly due to the increase in cases, and also manufacturing and supply issues. Madhya Pradesh complained that it was currently getting half of its needs. âAbout 70% of the total production is diverted to Maharashtra. The remaining 30% is distributed to other states. If we need 7,000 vials, we only get 1,500 to 2,000, âsaid MP Shobhit Kosta’s food and drug inspector.
Offer and demand
For two or three months this year, the production of remdesivir has been negligible or zero. Last December, several suppliers and manufacturers were left with huge stocks. They had anticipated sales and increased production, but a drop in Covid cases in November-December reduced demand.
JB Mantri, former co-commissioner of drugs for the FDA (Maharashtra), said a few suppliers need to destroy expired stocks. From January, manufacturers reduced their production. Hetero Healthcare, India’s largest manufacturer of remdesivir, has cut production to 5-10%. Kamla Lifesciences, which supplies remdesivir to Cipla, ceased manufacturing from Jan.31 to March 1. âThe government had asked us to reduce manufacturing as the cases of Covid-19 were declining and there was no demand,â said Dr DJ Zawar, MD of Kamla Lifesciences.
This shutdown has affected supplies now. Cases started to increase from February, but manufacturing picked up to some extent in March. âWe need at least 25 different raw materials for the production of remdesivirâ¦ We had to source a lot of raw materials and our suppliers could not supply quickly,â said Prafulla Khasgiwal, senior vice president, Hetero Healthcare.
The cycle from production to transport of remdesivir can last 20 to 25 days. Production increased last month; it will take another week for fresh stocks to reach the markets.
What is the next
The Department of Pharmaceuticals has asked the seven manufacturers to increase their maximum capacity to 38.80 lakh vials per month. Hetero can produce 10.50 lakh vials, Cipla 6.20 lakh, Zydus Cadila 5 lakh and Mylan 4 lakh. Hetero currently produces 35,000 vials a day or two. Zydus plans to scale up to 12 lakh vials per day. It also reduced the price of a 100 mg vial to Rs 899, from Rs 2,800, the cheapest of all the manufacturers. 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 (API and Services) at Dr Reddy’s, said he was “preparing to meet the additional demand”. Cipla said it “had fulfilled all orders and was in the process of further optimizing its sourcing”. A spokesperson for Mylan said: âWe are working closely with the government to meet the needs of patients in India and ensure accessâ¦â
Remdesivir is over-prescribed even for patients who will not benefit from it. Last year, the DoP reported this. Over-prescription has inflated prices. Worse yet, overuse can make patients resistant to the drug.
Domestic manufacturers were asked to list their distributors on their websites. The Center has ordered states to take action against black marketing and hoarding. He advised hospitals to use remdesivir based on the National Covid Protocol, which lists remdesivir as an investigational drug with contraindications.