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COVID DATA December 5, 2021 INDIA: New Cases: 8,895 Total Cases: 3,46,33,255 New Deaths: 2,796 (including old unreported deaths)Total Deaths: 4,73,326 New Tests: 12,26,064 Total Tests: 64,72,52,850 New Vax: 1,04,18,707 Total Vax: 127,61,83,065 Hot Spot States (daily deaths above 10) Maharashtra: New Deaths: 14 Total Deaths: 1,41,163 Kerala: New Deaths: 52; Old Unreported Deaths: 263 TPR: 7.75% (7-day avg: 8.09%) Total Deaths: 41,439 Bengal: New Deaths: 11 Total Deaths: 19,534 Bihar: Old Unreported Deaths: 2,426 Total Deaths: 12,090 - India Travel Times.Com   [Estd: 1998]       * * *    Travel, More Travel, Travel Means A Million Things     * * *    
Hetero's Tocilizumab to end shortage in supplies for hospitalised covid patients
The DCGI has given Emergency Use Authorisation (EUA) for Tocilizumab for the treatment of covid in hospitalised adults. It is produced by pharma Hetero under brand name ‘Tocira,’a biosimilar version of Roche’s Actemra/RoActemra. Currently there is an acute shortage of the drug in the market.

NEW DELHI, Sept 10: The Drugs Controller General of India (DCGI) has given Emergency Use Authorisation (EUA) for drug firm Hetero’s Tocilizumab for treatment of covid in hospitalised adults, the pharma company said in a statement on Monday.

The drug will have the brand name ‘Tocira’ and will be marketed by Hetero’s associate company Hetero Healthcare in India. It will be available from September-end.

Hetero has not announced the price of their Tocilizumab yet. The price is expected to be lower than Roche’s brand Actemra which sells at Rs 40,600 for a single dose. A patient needs at least two doses.

Apart from the difficulty in procuring, 400 mg of tocilizumab was reportedly selling at Rs 1.5 lakh last year at the peak of covid in the country in some places. This despite the fact that it is not a sure shot for covid, in fact, it is an old medicine for rheumatoid arthritis. There has also been a shortage of remdesivir, another investigational drug that was listed in the clinical management protocol and widely used in India last year for covid.

Swiss pharmaceutical major Roche and its subsidiary Genentech only make this drug. In India, tocilizumab is imported and distributed by Indian company Cipla. There has been a worldwide shortage of the drug.

The medical practitioners can use it to treat adult covid patients, who are hospitalised and require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (EMO), the company said.

Tocilizumab does not directly treat covid but blocks cytokine storm that is resulting from an excessive activation of the body’s immune system.

Hetero’s associate company Hetero Biopharma will manufacture the drug at its facility at Jadcherla in Hyderabad. Tocira 400mg/20ml is the biosimilar version of Roche’s Actemra/RoActemra.

Hetero was also the first company to develop the generic version of covid antiviral drug Remdesivir.

“This approval is extremely crucial for supply security in India considering a global shortage of Tocilizumab. We will be working closely with the Government to ensure equitable distribution,” Hetero Group Chairman B Partha Saradhi Reddy said.

Tocilizumab is one of the drugs approved by the WHO for the treatment of covid in critically ill patients.

The US Food and Drug Administration had also issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalised adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). However, the FDA has not authorized tocilizumab for use in outpatients with covid.

It said, "In clinical trials of hospitalized patients with COVID-19, Actemra in addition to the routine care patients receive for treatment of COVID-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased."

The FDA said Actemra/tocilizumab is not approved as a treatment for covid. It is only authorizing the emergency use of the drug for the treatment of certain hospitalized patients with covid. It is a prescription medication approved for multiple inflammatory diseases, including rheumatoid arthritis. An EUA is different from an approval.

Bharat Biotech International Limited and Dr Reddy’s Labs are other two pharma companies located in Hyderabad dealing with the development and manufacture of chemical and biologic medicines.

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