Covishield and Covaxin Granted Regular Market Approval For Adults

New Delhi: India’s drug regulator has granted regular market approval for COVID-19 vaccines Covishield and Covaxin for use in the adult population subject to certain conditions, Health Minister Mansukh Mandaviya announced on Thursday (January 25). The minister also said that the government’s vaccination drive will continue to provide first and second doses for all and a precautionary dose for senior citizens. The approval was granted under the New Drugs and Clinical Trials Rules, 2019.

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The regulator has upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions, Mr Mandaviya said.

Soon after the approval, sources said the two vaccines will now be available in private clinics at pre-decided MRP and people can buy those directly. Gradually, the vaccine will be available in the market at a price lower than at what it was being sold earlier at private hospitals, sources added.

The idea is that those who are keen to get a booster dose can now avail it through private clinics as the vaccine available in private clinics can be used for any purpose, whether it’s first dose, second dose or a booster as one wishes, sources said.

Also Read: Dangerous To Assume Omicron Will Be The Last Variant; We Can End The Acute Phase Of COVID-19 This Year: WHO Chief

Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting besides recording all vaccinations done within the country on the CoWIN platform. Adverse events following immunisation will continue to be monitored as part of the conditions, the minister said.

The Drugs Controller General of India’s (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India’s (SII’s) Covishield and Bharat Biotech’s Covaxin for use in adult population subject to certain conditions.

Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.

Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had submitted an application to the DCGI on October 25 seeking regular market authorisation for Covishield.

Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine, he had said.

In an application sent to the DCGI, V Krishna Mohan, whole-time director at the Hyderabad-based Bharat Biotech, submitted complete information regarding chemistry, manufacturing and controls, along with the pre-clinical and clinical data while seeking regular market authorisation for Covaxin.

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Bharat Biotech International Limited (BBIL) took up the challenge to develop, produce and clinically evaluate a vaccine (Covaxin), from the SARS-CoV-2 strains isolated from COVID-19 patients in India, Mr Mohan had said in the application.

Dr Subhash Verma, Pulmonologist at Kailash Hospital, Delhi tells NDTV that the increased availability of the vaccine is definitely something that will further help suppress the ongoing third wave of infections in India.

The fight against COVID-19 just became much stronger with this move. Since there are many reinfections also being reported, it will be useful for people to get their booster doses as and when they please. We have, for a year now, seen the efficacy of COVID-19 vaccines against severe diseases and at a stage where more than 160 crore Indians are immunised, it is the right time for the vaccines to be available in the market. Earlier the thought was for a controlled distribution, where vaccine equity is ensured. Healthcare community has welcomed this move, and hopefully the cost of the vaccine will be affordable for all.

COVID-19 In India

The daily COVID-19 cases in India saw a marginal increase of 0.1 per cent but the positivity rate remained a concern as it jumped to nearly 20 per cent as the country reported under three lakh cases for the third consecutive day today.

India’s COVID-19 vaccination coverage has crossed 163.84 crore dose. At least 72 per cent of India’s adult population is fully vaccinated whereas around 52 per cent of children in the 15-18 years old age group have been inoculated with the first dose. The active cases have decreased to 22,02,472 and now comprises 5.46 per cent of the total infections, while the national COVID-19 recovery rate has decreased to 93.33 per cent.

NDTV – Dettol have been working towards a clean and healthy India since 2014 via the 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, which 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.