COVID-19 update: India to grant emergency authorisation to vaccines approved by foreign regulators

No pre-approval bridging study will be required, said the Union health ministry

By DTE Staff
Published: Tuesday 13 April 2021

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).

  • In the last two days, India recorded over 160,000 cases in a day, the highest since the beginning of the outbreak and over 60 per cent more than the peak in September last year.
  • With this, India now has a COVID-19 tally of 13,689,453 cases, according to the Union health ministry.
  • The country’s COVID-19 daily death count grew three times in the last fortnight. In the last 24 hours, India recorded 880 deaths due to COVID-19.
  • India also currently has the highest burden of active cases — over 1,250,000.
  • The country has tested 259,207,108 samples as on April 12, 2021, according to ICMR.
  • As many as seven states have introduced night curfew for all the districts: Maharastra, Karnataka, Delhi, Madhya Pradesh, Punjab, Haryana and Rajasthan.
  • Uttar Pradesh, Odisha and Jammu & Kashmir introduced night curfews for some of their districts to curb the spread of infections.

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