Drug Firm Hetero Gets Approval To Produce, Sell Sputnik Light Vaccine

New Delhi: Drug firm Hetero on Monday (March 21) said its biologics arm has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell Sputnik Light for restricted emergency use in India. Hetero is the first biopharmaceutical company in India to receive Manufacturing and Marketing (M&M) approval for the product manufactured locally for the prevention of COVID-19 in adults aged over 18 years, administered in a single dose of 0.5 ml, the company said in a statement.

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

Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world’s first registered vaccine against COVID-19.

In February 2022, the Drugs Controller General of India (DCGI) granted emergency use permission to single-dose Sputnik Light COVID-19 vaccine in India.

Clinical data of Sputnik Light (Component I of Sputnik V) had shown significantly high titers of antibodies against COVID-19, both glycoprotein specific and virus-neutralising antibodies. Sputnik Light has also shown its neutralising activity against Omicron variant of SARS CoV-2 virus, Hetero Senior VP & Head – Clinical Development & Medical Affairs (CDMA) – Shubhadeep Sinha said.

Earlier, Sputnik V clinical trials globally showed significant protection against COVID-19, including other subtypes, he added.

Also Read: Covishield Dose Gap Reduced To 8-16 Weeks From 12-16

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol have been working towards a clean and healthy India since 2014 via Banega Swachh India initiative, which is helmed by Campaign Ambassador Amitabh Bachchan. The campaign aims to highlight the inter-dependency of humans and the environment, and of humans on one another with the focus on One Health, One Planet, One Future – Leaving No One Behind. It stresses on the need to take care of, and consider, everyone’s health in India – especially vulnerable communities – the LGBTQ population, indigenous people, India’s different tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically remote populations, gender and sexual minorities. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign will continue to raise awareness on the same along with focussing on the importance of nutrition and healthcare for women and children, fight malnutrition, mental wellbeing, self care, science and health, adolescent health & gender awareness. Along with the health of people, the campaign has realised the need to also take care of the health of the eco-system. Our environment is fragile due to human activity,  that is not only over-exploiting available resources, but also generating immense pollution as a result of using and extracting those resources. The imbalance has also led to immense biodiversity loss that has caused one of the biggest threats to human survival – climate change. It has now been described as a “code red for humanity.” The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene. Banega Swasth India will also be taking forward the dream of Swasth Bharat, the campaign feels that only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and the country can become a Swasth or healthy India.