COVID19 Vaccine: Serum Institute readies 30 million bottles, awaiting emergency license

Pune : The Serum Institute of India (SII) has produced 30 million Covishield vaccine bottles, informed S B Patil, Joint Commissioner (Drugs) of Pune Division of the Food and Drug Administration (FDA).

Abhimanyu Kale, FDA Commissioner visited the Serum Institute of India on Friday to inspect the production quality and safety measures of other officials.

It was told that the Serum Institute of India (SII) is waiting for an emergency license for the vaccine from the central government based on the guidelines of the World Health Organization (WHO).

A statement issued by the Food and Drug Administration (FDA) said, “Adar Poonawala said that there is a possibility of a safe and effective ‘coronavirus vaccine in India by January 2021. Serum Institute of India (SII) officials requested that the government should provide an emergency license based on WHO guidelines.”

Kale said, “The purpose of his visit was to know how ready the institute is in terms of the government approved vaccine.”

He said that “we also want to ensure that there should not be any misunderstanding or lack of coordination between the government and the institute in relation to the permission and license.”

Kale said that “We told the Serum Institute of India (SII) officials that we are ready to provide them with a regular license, but for an emergency license we will need to get more information.”

Patil said, “More than 30 million doses of Covid are ready and the quality level is satisfactory. The company has asked for permission for an emergency license for which at present there is no provision in our law.

However, the institute has sought permission from us under the guidelines of WHO, which grants such licenses in exceptional circumstances as before in the case of Ebola. ”

He said that the institute will send us an official letter and then we will send it to the Drugs Controller General of India who will take the final decision. The institute has received such licenses from other countries, on the basis of which they have made similar requests for health workers of the Indian population. ‘

Currently, Phase III trials of the vaccine are underway in many cities of the country and the results are expected by the end of this year.