Hetero Pharma announced today that its biologics arm ‘Hetero Biopharma’ has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture for sale, Sputnik Light, with restricted emergency use in India.

Hetero is the the first biopharmaceutical company in India to receive Manufacturing and Marketing (M&M) approval for the product manufactured locally for the prevention of C-19 in adults aged over 18 years, administered in single dose of 0.5ml.

Click for more articles on CDSCO

All other currently approved vaccines in India require two doses of administration.

In a statement, Hetero said that Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world’s first registered vaccine against coronavirus disease, C-19. In February 2022, the Drugs Controller General of India (DCGI) had granted emergency use permission to the Single-dose Sputnik Light C-19 vaccine in India.

Click for more articles on hetero Pharma

“Clinical data of Sputnik Light (Component I of Sputnik V) had shown significantly high titers of antibodies against C-19, both glycoprotein-specific and virus-neutralising antibodies along with CD4 & IFN-γ levels.

Sputnik Light has also shown its neutralising activity against Omicron variant of SARS CoV-2 virus.

Earlier, Sputnik V clinical trials globally had shown significant protection against C-19, including other subtypes,” said Dr Shubhadeep Sinha, Senior VP and Head – Clinical Development and Medical Affairs (CDMA), Hetero, in the statement.

Must read

Covishield

Covaxin

Sputnik V

Modenra

Other approvals by CDSCO

CDSCO gives nod to Sun Pharma to conduct Phase 4 clinical trial of Cyclosporine...

CDSCO gives nod to Cipla to conduct study on Paxlovid

CDSCO gives nod to Wockhardt to export Sputnik vaccines 

CDSCO gives nod to Sun Pharma for phase III clinical trial for antipsychotic drug...

CDSCO panel gives nod to Takeda Pharma for Vadolizumab

CDSCO approves Corbevax, Covovax and Molnupiravir for restricted use

Pharma firm Director and 4 others held for illegal export of Tramadol

CDSCO penal asked for more data on Tildrakizumab

USFDA approves drug for treatment of Seizures associated with rare disease

Drug alert: 40 out of 1221 samples declared as NSQ in February 2022

Govt releases draft Uniform Code for Medical Devices Marketing Practices

USFDA approves new Bristol Myers cancer Immunotherapy

US Pharmacopeia report finds high reliance on Indian manufacturers for APIs

19 Indian Pharma Companies get licence to make Pfizer’s oral generic

USFDA approves first generic of Symbicort to treat Asthma and COPD

Latest Notifications regarding Pharmaceuticals
https://thehealthmaster.com/2022/03/22/cdsco-approves-sputnik-light-vaccine-for-manufacture-for-sale-in-india/