Drug regulator Central Drugs Standard Control Organisation (CDSCO) has cleared the way for the import of COVID-19 vaccines into India. It has released guidance for the import of vaccines by the private sector or state governments.
Importer or agent of the manufacturer will obtain 3 licenses from CDSCO for vaccines not yet approved or licensed in India. These include:
a. New Drug Permission under the New Drugs and Clinical Trials Rules, 2019
b. Import registration under the Drugs Rules, 1945
c. Import license under the Drugs Rules, 1945
With import license, vaccines can be imported to be supplied to state government or private entities. For the import of an already approved vaccine, only an import license from CDSCO is required.
It must be noted that ready-to-use imported COVID-19 vaccines are allowed to be utilized entirely in the other than the government of India channel.
In India, liberalized pricing and accelerated national COVID-19 vaccination strategy started on May 1.
Last month, the government had approved Russia's Sputnik V vaccine against COVID-19 for emergency use. It came after the Subject Expert Committee (SEC) approved Dr Reddy's Sputnik V application. 1.5 lakh initial doses of SputnikV arrived in Hyderabad on May 1.
First Published: IST