India Publishes Rules For Expediting Approval Of Foreign COVID-19 Vaccines

MOSCOW (UrduPoint News / Sputnik - 16th April, 2021) The Indian government on Thursday published rules for expediting the issuance of emergency use permits for vaccines against the coronavirus authorized abroad.

The national vaccines portfolio currently include three drugs against COVID-19, namely, the locally-produced variant of AstraZeneca vaccine branded Covieshield, India's Covaxin, and recently authorized Russia's Sputnik V. The deliveries of the Russian vaccine are due to begin later in April, and its production is due to start next month.

The country has already allowed the possibility to use vaccines approved by the world's health agencies, such as the US Department of Health and Human Services, the European Medicines Agency, the UK Medicines, and Healthcare products Regulatory Agency, Japan's Pharmaceuticals, and Medical Devices Agency, or included in the WHO list of emergency use.

"An application may be submitted by a foreign manufacturer through its Indian subsidiary or its authorized agent in India.

The Central Drugs Standard Control Organization [of the Government of India] will process such applications ... and the Drugs Controller General of India will review and make a decision within 3 working days from the date of submission of the full application by the applicant," the rules published by Health Ministry states.

According to the ministry, initially, the applicant company is eligible to use its vaccine only on 100 volunteers and is due to submit safety data to the Central Drugs Standard Control Organization. Given the data are satisfactory, the vaccine would be allowed for use in the country.

To date, India ranks second in the world regarding the total number of coronavirus infections, which stands at over 14 million. The mortality rate amounts to more than 173,000, and the number of recoveries has reached over 12 million, according to the latest data provided by the Health Ministry.�