Regular Market Approval Granted for Covishield, Covaxin for use in Adult Population

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 said on Thursday.

The minister also said that the government's vaccination drive will continue as it is to provide first and second doses for all and a precautionary dose for senior citizens.

"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," Mandaviya said.

Soon after the approval, highly-placed sources said the two vaccines will now be available in private clinics at pre-decided MRP and people can buy those.

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," a source said.

The approval was granted under the New Drugs and Clinical Trials Rules, 2019.

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 event following immunisation will continue to be monitored as part of the conditions.

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.

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.

The DCGI had sought more data and documents from the Pune-based company following which Singh recently had submitted a response along with more data and information.

"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.

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, Mohan had said in the application.

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

The health ministry later said in a statement that the proactive and agile approach followed by the government has been a hallmark of its strategy of management of COVID-19.

The latest approval accorded by DCGI for conditional market authorisation to two vaccines in the country indicates the promptness and timeliness with which the public response strategy and decision-making apparatus of the country has responded to the emerging needs during the pandemic, it added.

Among major regulators globally, only the US Food and Drug Administration (USFDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK have granted 'conditional market authorization' to Pfizer and AstraZeneca, respectively,for their COVID-19 Vaccines.

The 'Conditional Market Authorisation' is a new category of market authorisation that has emerged during the current global pandemic of COVID-19.

The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

India's nation-wide COVID-19 vaccination programme was launched on January 16, 2021 and as of today, more than 160 crore doses have been administered.

"The Union Government is committed to accelerating the pace and expanding the scope of COVID-19 vaccination throughout the country. New categories of the population have been added to the national COVID-19 vaccination drive starting from January 3, 2022," the ministry said.