Hetero's Tocilizumab to end shortage in supplies for hospitalised
covid patients
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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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SELECTIONS FROM OUR ARCHIVES |
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Top Govt officer thrashed, kicked inside Bhubaneswar office: Incident sparks a debate
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The incident has triggered a debate on social media whether the officer refused to take orders from a party leader or he was accused of any corruption, some netizens justifying the handling in either case, that Ratnakar was blocking public welfare work! It is true the Govt machinery has been the enemy Number One of the people of this country, existing for itself and for these politicians, for well over seven decades. India will never make an inch of progress - real progress, not make-believe-progress - unless and until this machinery is eliminated.
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UK's House of Commons votes to legalise assisted dying: What it means | |
ANALYSIS: There have been cases of Britons going to Switzerland to get rid of a miserable life. Now once the House of Lords also passes the Terminally Ill Adults (End of Life) Bill, terminally ill Britons can call it quits with the help of a medical practitioner here itself. But the measure when comes into practice, will have very serious social consequences, it is feared. There won't be comparisons, even as tropes in Latin American folklores. The worst case scenario is of those who are not terminally ill also trying to misuse the provision to leave this world early when life with dignity is not available. But that is, in fact, a political question and not a moral imbroglio!
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What caused Air India Boeing 787 crash? Some questions, some answers | |
The CCTV footage and the video circulating on social media do not indicate any serious abnormalities in takeoff or descent, it has been confirmed. The disaster is becoming curiouser and curiouser. The flight path was not curvy. And the aircraft maintained a steady, gliding descent with its nose straight and the wings perfectly level. The pilot's distress call does not specify what prevented lift and climb-out. Here are some expert opinions. The sole purpose is to raise travellers' awareness about air travel.
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Udhampur-Srinagar-Baramulla line brings Kashmir Valley on India's rail map |
- The Udhampur-Srinagar-Baramulla line provides Kashmir with all-weather connectivity and integrates the Valley with the rest of India.
- The saying 'Kashmir to Kanyakumari' is now a dream come true.
- The Chenab bridge on the line, an engineering marvel, is the world's highest
railway bridge, taller than the Eiffel Tower. (Video: File)
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Work done, Elon Musk steps down from DOGE, leaves White House | |
Musk wrote: "My scheduled time as a Special Government Employee comes to an end... The @DOGE mission will only strengthen over time as it becomes a way of life throughout the government." Now on it will be on auto-pilot.
PROGNOSIS: DOGE was prematurely born to protect the country by aborting an impending socio-economic disaster which very few people could see coming.
Although its immediate job was to save American taxpayers billions by slashing waste, eliminating fraud, cutting Government bloat and ensuring utmost efficiency in administration for the good of the people.
(Today's headlines )
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Ailing Asiatic lion Pataudi too dies of bird flu at Kanpur zoo
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Originally from Junagadh, Gujarat, Pataudi was relocated to Etawah Lion Safari in September 2019 before being transferred to Gorakhpur Zoo in 2021. Recently it was receiving treatment for pancreatic and liver infections. After tigress Shakti died in the zoo on May 7 due to bird flu, Pataudi was shifted to Kanpur. Some birds are also reported to have died mysteriously around Gorakhpur. All zoos in UP are closed for fear of a bird flu outbreak.
Three other animals too had died - a tiger, a leopardess and a female wolf. Wolf Bhairavi died last Saturday, leopardess Mona died the Thursday before that and tiger Kesari died on March 30. Some of them had Shakti's symptoms but the cause of death has not been confirmed yet.
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48 tourist destinations closed in Kashmir following Pahalgam terror attack
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As tourist inflow is an indicator of normalcy returning to an erstwhile terrorist infested Valley, the Government has been trying hard to make everything travel-friendly, launching lot many projects and bringing Kashmir on the national rail map that physically completes the process of Kashmir's integration with the rest of India. And that defeats the designs of Pakistan eyeing Kashmir and simply explains a recrudescence of terrorism in J&K.
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Trump slaps ‘kind’, ‘reciprocal’ tariffs on trading partners; a 'lenient' 26% on India!
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ANALYSIS: There is a lot of hue and cry around the world over Trump's tariffs. But tariff, simply put, is a tax. But unlike tax, it affects the exporting country too. Domestic prices will go up for some time. Nothing more will happen, good or bad!
What motivated Trump's newfound policy, apart from being a stunt to justify his existence in the White House, is a false realisation that increased tariff will make foreign goods prohibitive, thereby boosting local production, and create more jobs, and more prosperity will ring in! If that is true, India would have been shining by now: Producing own Rolls-Royce La Rose Noire Droptail and Scotch Whiskies! And what about coconut and palm oil by America!
(Today's headlines )
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Trump signs order to shut Education Dept - And the contrast with India
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PROGNOSIS: It looks a Real New Trump is emerging - courageous, balanced, powerful and disinterested. Determined to save his country from the cliff, he has done quite a few draconian things that will reduce the burden of debts of the Federal entity, like the golden handshake, stopping senseless funding, pulling out of a worthless WHO. Shutting the Education Department is another. On the other hand, running it is also not the Centre's job either (We will convincingly elaborate it in the next chapter).
In India the scene is just the opposite. Centralisation is the core agenda and identity of the ruling dispensation without which it has no existence, or in other words, it exists for that set of schemes only. A realisation of this never dawned upon any Opposition party in 2014 or any time thereafter, what to talk of being able to see it coming 70 years ago! The consequence of all this violation of basic natural law of the universe we cannot predict.
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Sunita, Wilmore's Dragon splashes down in Gulf: What delayed their return? |
THE AMERICAN CONUNDRUM: Political venom has migrated to top echelons in the US. It was reported last year NASA has become politicised, vitiated. But NASA refuted the charge. How Boeing developed a glitch but its unmanned return was smooth. When Suni-Wilmore were stranded last June, why the return was set for February? Because that comes only after January 20! SpaceX called the shots, for itself and for Trump. Then the mission was manipulated for March for a better bargain! In between, what made Elon Musk 'predict' during campaign if Kamala Harris wins he would be in jail. In politics, it is said, "the only rule is there are no rules." Difficult times for Americans too.
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All 80k health workers in US offered $25,000 voluntary buyout: Administering wrong prescriptions!
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The terminations are part of a large-scale exercise going on all across Fed departments and organisations to reduce wasteful Government expenditure as decided by a Trump in a mess gone berserk, and improve administrative efficiency following the whims of billionaire and his associate Elon MusK and his DOGE. It has not been shared how terminations are going to raise the efficiency bar! It looks like Trump has stolen some of the prescriptions meant for India. But the American problems are quite different.
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Neighbours Calling
Bhutan
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Visit Indian Travel Sites
Goa,
Kerala,
Tamil Nadu,
Andhra Pradesh,
Delhi,
Rajasthan,
Uttar Pradesh,
Himachal Pradesh,
Assam,
Sikkim,
Karnataka,
Madhya Pradesh,
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Gujarat
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