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All About Roche s COVID Antibody Cocktail That India Approved As Treatment For Mild Cases
A Switzerland based drug maker, Roche has received approval from India s Central Drugs Standards Control Organisation (CDSCO) for COVID-19 emergency use .
Image: PTI
Widening the arsenal of drugs to combat COVID-19, a Switzerland-based drug maker, Roche has received approval from India s Central Drugs Standards Control Organisation (CDSCO) for use in emergency situations for treatment of COVID-19. The said experimental antibody cocktail was consumed by former US President Donald Trump when he contracted COVID-19 infection last year during his tenure at the White House.
The antibody cocktail is to be administered for the treatment of mild to moderate coronavirus disease in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease.
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New Delhi, February 5
Pfizer on Friday withdrew its application seeking grant of Emergency Use Authorisation (EUA) of its Covid vaccine in India after the regulators sought additional data.
Pfizer was the first to apply for EUA in India but has been repeatedly asked to update its data as the company never applied for any bridging studies here.
Under the Indian clinical trial rules, any company with a new drug or vaccine should apply for bridging studies in India to produce domestic safety data involving Indians.
Russia had very early on tied up with Dr Reddy’s Lab in Hyderabad to conduct bridging studies in India for Sputnik V vaccine.
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By Krishna N. Das NEW DELHI (Reuters) - India on Sunday granted emergency approval to Bharat Biotech's COVAXIN but faced questions after taking the st.