Tag: Remdesivir

To enhance availability of Remdesivir production capacity of the drug increased to nearly 119 lakh vials per month from 38 lakh vials per month: Ministry of Chemicals and Fertilizers

May 17, 2021.Reading time 2 minutes.

Department of Pharmaceuticals intensified monitoring of availability, production and supply of drugs used for Covid-19 Treatment in early April, 2021 as number of cases of Covid-19 started increasing steeply.

Remdesivir is a patented drug, manufactured in India under voluntary licenses granted by Gilead Life Sciences USA, the patent holder, to 7 Indian pharmaceutical companies (Cipla, Dr Reddy’s Lab., Hetero, Jubilant Pharma, Mylan, Syngene and Zydus Cadila).

To augment the domestic production capacity, all the seven domestic licensed manufacturers of Remdesivir were asked to ramp up production quickly.

With combined efforts of the central government and the manufacturing companies, the production capacity of the licensed manufacturers has increased unprecedentedly from 38 lakh vials per month to nearly 119 lakh vials per month.

With accelerated approval of 38 additional manufacturing sites, the number of  approved manufacturing sites of Remdesivir in country has increased from 22 sites to  60 sites. 

With the help of Ministry of External Affairs, the manufacturers of Remdesivir are being facilitated for getting supplies of requisite raw materials and equipments from foreign countries.

All efforts are being made to enhance the availability of the drug both through imports as well as augmented domestic production.  

Exports of Remdesiver has been prohibited since 11th April, 2021. Customs duty has been exempted on Remdesivir injection, Remdesivir API and Beta Cyclodextrin (SBEBCD) used in the manufacture of Remdesivir with effect from 20th  April 2021.

Looking to the suddenly increased demand in the country, in order to ensure equitable distribution of Remdesivir among different regions of the country, central government has been making allocations to States and UTs since third week of April.  

All the seven Indian manufacturers have been making supplies to States as per the allocation both against government purchase orders and also through their private distribution channels in States.

Total 54.15 lakh vials of Remdesivir have been supplied across the country by the Drug companies during 21st April-15th May, 2021 period.

In addition to allocation mentioned above, as on 16.05.2021, a total of 5.26 lakh vials of Remdesivir, which have been received through donation from other countries/organizations and 40000 vials which have been commercially imported, have also been allocated to States and UTs.

Customs duty on Remdesivir waived: Sadananda Gowda

April 21, 2021.Reading time less than 1 minute.

Considering the immediate requirement on the recommendation of the Department of Pharmaceuticals, the Department of Revenue has waived customs duty on Remdesivir and its API/KSM.

This step will further augment domestic availability of Remdesivir injection.

DV Sadananda Gowda – union minister

Remdesivir production to be doubled in coming weeks: Sadananda Gowda

April 19, 2021.Reading time less than 1 minute.

DV Sadananda Gowda – Union Minister:

Took a meeting with Secretary (Pharma) to review availability of Remdesivir.

Government is in regular touch with manufacturers regarding this. Weekly production plans have been prepared in consultation with the manufacturers.

Manufacturers have agreed to ramp up production of Remdesivir. Additional sites for production have been approved. Production to be doubled in coming weeks.

Black marketing/hoarding is being strictly monitored and State Governments have been advised to take strict action against those indulging in such malpractices.

In a huge relief to people in this crucial time, after Govt’s intervention, the price of Remdesivir is now reduced! : DV Sadananda Gowda – Union Minister

April 17, 2021.Reading time less than 1 minute.

In a huge relief to people in this crucial time, after Govt’s intervention, the price of Remdesivir is now reduced!

I am grateful to Pharma companies for standing along with PM Narendra Modi’s fight againt Covid.

Revised prices of major brands of Remdesivir 100 mg/vial are …

DV Sadananda Gowda – Union Minister

Government approves stepping up of production of Remdesivir

April 14, 2021.Reading time 2 minutes.

Ministry of Chemicals and Fertilizers:

The issue of availability of Remdesivir was reviewed by Shri Mansukh Mandaviya, Minister of State for Chemicals& Fertilizers, Government of India in meetings with the all-existing manufacturers of the Remdesivir drug and other stakeholders on 12th and 13th April 2021, where decisions have been taken to increase production/supply and reduce prices of Remdesivir.

The current total installed capacity of the seven manufacturers of Remdesivir is 38.80 lakh vials per month.

Fast-track approval has been given for seven additional sites having the production capacity of 10 Lakh vials /month to six manufacturers.

Another 30 lakh vials/month production is lined up. This would ramp up the production capacity for manufacturing to around 78 lakh vials/month.

As an additional measure, Remdesivir, API and formulation were placed under Export ban on 11.04.2021 by DGFT to increase the supply of Remdesivir in the Domestic Market.

On Government intervention, Remdesivir supplies of approximately 4 lakh vials meant for Export is being diverted by manufacturers to fulfil domestic requirement. EOU/SEZ units are also being enabled to supply to the domestic market.

Manufacturers of Remdesivir have volunteered to reduce the price to less than Rs 3500 by the end of this week, to support the efforts of  Prime Minister Shri Narendra Modi, to Fight against COVID,

Manufactures of Remdesivir have been directed to give priority to fulfil hospital/institutional level supplies.

Enforcement Authorities of States and Central Govt. have been directed by DCGI to take immediate action on incidence of black-marketing, hoarding and overcharging of Remdesivir.

National Pharmaceutical Pricing Authority (NPPA) is continuously monitoring the availability of  Remdesivir.

Centre Prohibits Exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients till the COVID situation in the country improves

April 11, 2021.Reading time 2 minutes.

Ministry of Health via PIB India:

India is witnessing a recent surge in COVID cases. As on 11.04.2021, there are 11.08 lakh active COVID cases and they are steadily increasing. This has led to a sudden spike in demand for Injection Remdesivir used in treatment of COVID patients. There is a potential of further increase in this demand in the coming days.

Seven Indian companies are producing Injection Remdesivir under voluntary licensing agreement with M/s. Gilead Sciences, USA. They have an installed capacity of about 38.80 lakh units per month.

In light of the above, Government of India has prohibited the exports of Injection Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API) till the situation improves.

In addition, Government of India has taken the following steps to ensure easy access of hospital and patients to Remdesivir:

All domestic manufactures of Remdesivir have been advised to display on their website, details of their stockists/ distributors to facilitate access to the drug.

Drugs inspectors and other officers have been directed to verify stocks and check their malpractices and also take other effective actions to curb hoarding and black marketing.

The State Health Secretaries will review this with the Drug Inspectors of the respective States/UTs.

The Department of Pharmaceuticals has been in contact with the domestic manufacturers to ramp up the production of Remdesivir.

The Government of India has also advised the States that the extant  “National Clinical Management Protocol for COVID-19″, which is based on evidence, has been developed after many interactions by Committee of Experts, and is the guiding document for treatment of Covid-19 patients. 

In the Protocol, Remdesivir is listed as an Investigational Therapy, i.e. where informed and shared decision making is essential, besides taking note of contra indications  mentioned  in the  detailed guidelines.

The States and UTs have been advised that these steps should again be communicated to all hospitals, both in public and private sector, and compliance monitored.