India has decided to grant emergency approval to all vaccines against the novel coronavirus disease (COVID-19) approved by foreign drug regulators, said the Union Ministry of Health and Family Welfare in a statement April 13, 2021. Pre-approval bridging studies that were required for Covishield and Sputnik vaccines will not be mandatory.
A post-approval parallel bridging study will be conducted, the ministry said. “The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programmes within the country.”
Vaccine candidates approved by regulators such as the United States Food and Drug Administration, European Medicines Agency, Medicines and healthcare products Regulatory Agency of the United Kingdom, Pharmaceuticals and Medical Devices Agency of Japan, or, those in the emergency use list of the World Health Organization, will be authorised for emergency use in the country, the ministry said.
The Drugs Controller General of India approved Russia’s Sputnik V vaccine for ‘emergency use’ amid a second and more severe surge of COVID-19 cases in the country, reported Reuters. The news was announced by the Russian Direct Investment Fund on Monday.
Sputnik V becomes the third vaccine candidate available in India and India is the latest among the 60 countries to have subscribed to the vaccine.
Till now, the country’s immunisation drive against COVID-19 was being carried out with Covishield, developed by Oxford-AstraZeneca, and Covaxin, developed by Indian biotechnology company Bharat Biotech and Indian Council of Medical Research (ICMR).
Support Ethical Journalism. Support The Dispatch
The Dispatch is a sincere effort in ethical journalism. Truth, Accuracy, Independence, Fairness, Impartiality, Humanity and Accountability are key elements of our editorial policy. But we are still not able to generate great stories, because we don’t have adequate resources. As more and more media falls into corporate and political control, informed citizens across the world are funding independent journalism initiatives. Here is your chance to support your local media startup and help independent journalism survive. Click the link below to make a payment of your choice and be a stakeholder in public spirited journalism