Government bans export of Remdesivir, Active Pharmaceutical Ingredients

JNS: In view of the huge spurt in COVID-19 cases across the country, the central government put an indefinite ban on the export of Ramdesivir and its Active Pharmaceutical Ingredients (API).

The export of the antiviral injection and its API has been banned till the situation improves, the Center said on Sunday.

Seven Indian companies are producing injection Remdesivir under a voluntary licensing agreement with Gilead Sciences, USA. They have an installed capacity of about 38 lakh 80 thousand units per month.

All domestic manufactures of Remdesivir have been advised to display their stockists and distributors on their website details to facilitate access to the drug. Drugs inspectors and other officers have been directed to verify stocks, check their malpractices, and take other practical actions to curb hoarding and black marketing, it said.

“The State Health Secretaries will review this with the Drug Inspectors of the respective States and Union Territories. The Department of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the production of Remdesivir,” it said.

The Central Government has also advised the States that the extant National Clinical Management Protocol for COVID-19 has been developed after many interactions by the Committee of Experts and is the guiding document for treating Covid-19 patients.

Besides taking note of the counter-indications listed in the comprehensive guidelines, the Protocol lists Remdesivir as an investigatory therapy, where informed and mutual decision-making is necessary.

It was notified to States and UTs that these measures should be communicated and enforcement monitored to all hospitals, both public and private.

Remdesivir is an investigational antiviral drug to combat Sars-cov 2 (Covid-19 virus). In October 2020, Gilead Sciences Inc.’s Remdesivir antiviral therapy was approved by the US Food and Drug Administration (FDA) to become the first medicine to receive formal approval for coronavirus.

In order to allow doctors access to medicines outside a research context, the FDA had to issue an emergency use authorisation for Remdesivir. Starting in May of last year, the doctors offered Remdesivir instead of restricting its use to those involved in clinical trials to patients hospitable with serious Covid-19.

Following Remdesivir in hospitalised Covid 19 patients across the country, the FDA assessed new data on the medicinal product’s efficacy. IN AUGUST, the FDA extended its emergency authorisation to allow all Covid-19 hospitalised patients, including those with severe and moderate conditions, to receive this medication. In October, the FDA changed the status of Remdesivir from an authorised medicine for emergency use to an approved medicine.

The drug is administered to Covid-19 patients intravenously. People usually get an injection for 5 to 10 days once a day, depending on their illness’s seriousness.

Remdesivir inhibits the development of a specific enzyme that the virus needs to replicate itself. The virus will no longer spread inside the body until this occurs.

Research indicates that when patients receive Remdesivir with mild Covid-19, their symptoms increase faster. Duration of patient hospital stays has also been shown to decrease. Remdesivir was associated with fewer deaths in critically ill patients with Covid-19, it reported.

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