Govt halts exports of Remdesivir: All you need to know about the Covid treatment drug

NEW DELHI: Amid an unprecedented surge in fresh

Covid-19

infections, multiple states, including Maharashtra, Gujarat and Delhi, have flagged a shortage of anti-viral drug Remdesivir. The shortage prompted the government to halt the export of the drug and Remdesivir active pharmaceutical ingredients (APIs) till the Covid spread is contained.

As the country witnesses a ferocious resurgence of the virus, so has the demand for this medicine. Here are a few questions answered on the use of Remdesivir for Covid treatment and problems in the supply chain management.

How did Remdesivir come into use?

Remdesivir is an investigational antiviral drug to fight Sars-Cov 2, the virus that causes Covid-19. The US Food and Drug Administration (FDA) approved

Gilead Sciences

Inc’s antiviral therapy Remdesivir in October 2020, making it the first drug to obtain formal clearance for treating the coronavirus disease.

How is Remdesivir given to Covid-19 patients?

Remdesivir, which is administered by an injection, was one of the first drugs to show relative promise in shortening the time to recovery in some coronavirus patients. The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on it to ensure it's safe for them and to monitor for any possible side effects.


How does Remdesivir help Covid-19 patients?

The drug works by inhibiting a substance the virus uses to make copies of itself. Once this happens, the virus is no longer able to spread within the body. Certain kidney and liver tests are required before starting patients on it to ensure it's safe for them and to monitor for any possible side effects.

According to research, the drug is known to cut the time to recovery by five days - from 15 days to 10 on average - in a large study led by the US National Institutes of Health.

What WHO says about Remdesivir

The World Health Organization (WHO) had earlier said its global trial of Covid therapies found that Remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. That study has not been reviewed by outside experts. Gilead has questioned the potential for bias in the WHO study. Gilead has questioned the potential for bias in the WHO study.

India's stand on the use of Remdesivir for Covid treatment

India has approved Remdesivir under the National Clinical Management Protocol for Covid-19 which was developed after many interactions by a committee of experts. The protocol acts as the guiding document for the treatment of Covid-19 patients in India. In the protocol, Remdesivir is listed as an investigational therapy, ie where informed and shared decision making is essential, besides taking note of contraindications mentioned in the detailed guidelines.

Refuting WHO's claims last year, the core Covid-19 treatment group at Sawai Man Singh Medical College in Jaipur had said that the drug has been effective in preventing mortalities.
How is the medicine priced in India?

Zydus has priced it at Rs 2,800 ($37.44) per 100mg vial India. It is being sold under the brand name Remdac to government and private hospitals treating Covid-19 patients.

Recently, the Maharashtra government on Thursday decided to cap the price of Remdesivir between Rs 1,100 and Rs 1,400 per vial with state health minister Rajesh Tope calling for slashing the MRP of the key Covid-19 drug.

What has led to the shortage of the drug?

• Scaling down or stoppage of production amid low caseload

One of the key reasons behind the current shortfall in supply is the scaling down or stoppage of production of the drug in January and February due to the low Covid-19 caseload since December 2020 and the resultant low demand, pharma industry sources said. Manufacturers have said they are unlikely to get the numbers immediately. “Manufacturers can’t take the risk of being saddled with huge inventories as Remdesivir has a short shelf-life of six to eight months,” said a pharma industry source, confirming that there was low production.

• Skyrocketing demand due to surge in cases

The other reason for the crunch is the rapid surge in cases which seems to be more widespread.

"As of April 11, India has over 11.08 lakh active cases and they are steadily increasing. This has led to a sudden spike in demand for Remdesivir injection used in the treatment of Covid patients," the Union health ministry said.

“In the first wave, the impact of Covid and demand for Remdesivir was restricted to only the metros and Tier-1 cities. But in this second wave, there is a surge in cases even in Tier-2, 3 and 4 cities and towns due to which the distribution network is struggling to keep pace with the demand and stocks of Remdesivir have been spread thin,” said a top official at one of the manufacturers of the drug.

“It is not a question of just shortage. The surge in the second wave has been so rapid that it has resulted in a mismatch in the production curve and the demand curve,” added an official with another pharma company.

Pharma industry officials insisted that this is just a temporary situation and in the next week to 10 days about a couple of million doses should hit the market.

What firms in India manufacture Remdesivir?

At present, seven Indian companies are producing Injection Remdesivir under a voluntary licensing agreement with the American pharmaceutical company Gilead Sciences that holds the patent for the product. The companies are:

Cipla

, Dr Reddy's Laboratories, Hetero Labs,

Jubilant Life Sciences

, Biocon's Syngene, Zydus Cadila Healthcare and the Indian unit of Mylan.

What is the production capacity?

Union Minister of State (Chemicals and Fertilizers) Mansukh Mandavia said on 7 April that these companies have been asked to increase production. Currently, their production capacity is 31.60 lakh vials monthly. Out of 31.60 lakh vials, Hetero produces 10.50 lakh vials a month, Cipla produces 6.20 lakhs, and Zydus Cadila 5 lakhs.

What is the government doing about its acute shortage?

• Govt prohibits exports of Remdesivir

In the wake of rising demand for Remdesivir for treatment of Covid-19 amid surge in severe cases, the Centre has prohibited exports of Remdesivir injection and Remdesivir Active Pharmaceutical Ingredients (API) till the Covid-19 situation in the country improves.

• 'Display stocklists and distributors'

Besides, companies have been asked to ramp up production of the drug and all local manufactures of Remdesivir have been advised to display on their website, details of their stockists or distributors to facilitate access to the drug.

• Drug shortage gave way to black marketing

Some state governments have in recent days raised concerns over hoarding and black marketing of Remdesivir, which in some instances is being sold at over 10 times the maximum retail price. Drugs inspectors and other officers have also been directed to verify stocks and check their malpractices and also take other effective actions to curb hoarding and black marketing.


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