Foreign COVID-19 vaccines: Decision on EUA applications within three days
India's drug regulator will make a decision on applications seeking approval for restricted emergency use of foreign-produced vaccines within three working days from the date of submission, the government said on Thursday. The Central Drug Authority, CDSCO, will process applications for registration certificates and import licenses within three working days from the date of approval of restricted use in an emergency situation.
Detailed guidelines specifying regulatory pathways issued
The CDSCO issued detailed guidelines specifying regulatory pathways for approval of foreign approved COVID-19 vaccines. This happened after the central government on Tuesday decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the World Health Organization (WHO) or regulators in the United States, Europe, Britain, or Japan.
Decision was taken to facilitate quicker access to foreign vaccines
The government had on April 13 approved streamlining and fast-tracking of the regulatory system for COVID-19 vaccines approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports.
Russia's Sputnik V is the third vaccine to be approved
Notably, the Health Ministry had earlier announced that the Drugs Controller General of India (DCGI) approved Russia's COVID-19 vaccine Sputnik V for restricted use in emergency situations. Hyderabad-based Dr. Reddy's Laboratories—which has partnered with the Russian Direct Investment Fund (RDIF)—had applied for Sputnik V's EUA in India. Limited doses of the vaccine—which is 91.6% effective—are going to be available by the end of April.
India has reported 14.1 million COVID-19 cases
The import of bulk drug material, optimal utilization of domestic fill, and finish capacity would be encouraged, which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country, the ministry said. India has, until yesterday, reported 14.1 million coronavirus-positive cases. The number of deaths due to the infection reached 173K with 1,038 deaths registered yesterday.
