Remdesivir shortage amid Covid surge: How India plans to deal with the crisis

Remdesivir was one of the first drugs to show relative promise in shortening the recovery time for some Covid-19 patients

India on Sunday banned the export of anti-viral drug Remdesivir and its active pharmaceutical ingredients as demand rocketed due to a record surge in Covid-19 infections, leading to shortages in many parts of the country.

"There is a potential of further increase in this demand in the coming days," the ministry said in a statement, adding that the export ban would be in place "till the situation improves".

Read: India bans export of Remdesivir till Covid-19 situation improves

"India is witnessing a recent surge in Covid cases. This has led to a sudden spike in demand for Remdesivir injection used in treatment of Covid patients," the ministry had said.

India recorded its highest-ever spike of nearly 1,70 lakh new Covid-19 infections on Monday, April 12. The active cases have crossed 12 lakh.

What is Remdesivir?

Remdesivir, made by US pharma giant Gilead, was one of the first drugs to show relative promise in shortening the recovery time for some Covid-19 patients.

In India, the Union Health Ministry in its 'Clinical Management Protocols for Covid-19' last year had recommended the use of Remdesivir in Covid-19 patients in the moderate stages of the illness. The drug was included as an "investigational therapy" and recommended only for restricted emergency use purposes.

However, the World Health Organization in November 2020 had issued a conditional recommendation against the use of Remdesivir in hospitalised patients, saying there was no evidence that the drug improved survival and other outcomes.

What is the crisis that we're staring at?

Several states in India are experiencing shortages of Remdesivir. Additionally India is also seeing an acute scarcity of Covid-19 vaccines with several states having barely enough stocks to last them a few days.

Maharashtra, currently the worst-affected state, is facing multiple issues pertaining to the drug, including demand-supply gap, its hoarding and black-marketing by stockists and pharmacy shops, unaffordable prices and irrational prescription by some doctors, among others.

Read: Maharashtra government sets up Distric-level control rooms for supply of Remdesivir

"Pharmacists and stockists might be doing black marketing and that needs to be checked," Maharashtra Health Minister Rajesh Tope said.

With an alarming spike in cases, Maharashtra now needs needs 40,000-50,000 Remdesivir vials daily, as compared to a peak requirement of 30,000 a day last year, said according to The Indian Express's report.

Several cities in MP have also reported a shortage of Remdesivir injections that are used in the treatment of infected patients.

“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,” Food and Drug Inspector in MP Shobhit Kosta told the publication.

Some other state governments have also raised concerns over hoarding and black marketing of Remdesivir, which in some instances is being sold at over 10 times the maximum retail price, said a Reuters report.

Production slump

A lull in demand from December to February led to low or zero production for three months, The Indian Express cited Remdesivir manufacturers as saying.

“Government had asked us to reduce manufacturing because Covid-19 cases were reducing and there was no demand,” Dr D J Zafar, MD in Kamla Lifesciences told the publication.

Read: Flying squads fanned out to check Remdesivir stock in Mumbai

According to the report, Hetero Healthcare scaled down production to 5-10%. Kamla Lifesciences, which supplies Remdesivir to Cipla, stopped manufacturing from January 31 to March 1.

Currently, Hetero is pushing out 35,000 vials a day while Zydus plans to increase its production to 12 lakh vials a day.

Former Joint Commissioner of Drugs, FDA (Maharashtra), J B Mantri even told the publicaton that a few suppliers had to destroy expired stocks.

What next?

Days before the export ban, Mansukh Mandaviya, Minister of State for Chemical and Fertilizers, had asked drug makers to ramp up Remdesivir production to full capacity.

"I have asked all players to ramp up production to full capacity by next week. The drug's API is manufactured in India so there won't be a problem," Mandaviya had said.

Seven firms in the country — Mylan, Hetero, Jubiliant Life Sciences, Cipla, Dr Reddy's, Zydus Cadila and Sun Pharma — are licensed to manufacture Remdesivir and have a monthly production capacity of 31.60 lakh vials. Of the 31.60 lakh vials, Hetero produces 10.50 lakh vials a month, Cipla makes 6.20 lakh vials, 5 lakh vials are produced by Zydus Cadila and 4 lakh vials are produced by Mylan.

In addition to that, to ensure easy access of the drug to hospitals and patients, all domestic manufacturers of the drug have been advised to display on their website details of their stockists and distributors, the Union Health Ministry had said.

Zydus Cadila had reduced the price of its generic version of Remdesivir to Rs 899 from 2,800 for a 100 mg vial. Jubilant Life Sciences Ltd has priced the drug at Rs 4,700 per 100 mg vial. Mylan sells it at Rs 4,800 per 100 mg vial while Cipla sells it for Rs 4,000. Hetero, the largest producer of the drug in the country, sells it at Rs 5,400 per 100 mg vial.

While Dr Reddy’s said that the company was “preparing to meet additional demand”, Cipla said that it has “have serviced all orders and are in the process to optimise supplies further”.

“We are closely partnering with the government to meet the patient needs in India and ensure access,” a Mylan spokesperson told the publication.

(With Agency inputs)