News Brief
India's Drug Regulator Issues Guidelines To Clear Way For Import Of Foreign Produced COVID-19 Vaccines
Russian Covid-19 vaccine Sputnik V
Amid the surge in fresh Coronavirus cases, the Indian drug regulator has cleared the way for import of foreign produced Covid-19 vaccine to give a filip to the ongoing vaccination drive in the country.
Earlier last month, the Health Ministry had released the guidelines on liberalised pricing and accelerated national COVID-19 vaccination strategy, under which the ready to use imported COVID vaccine have been allowed to be utilised entirely in the other than Central government channel.
In a bid to pave the way for import of the Covid vaccines, the Central Drugs Standard Control Organisation (CDSCO) has now released the "guidance for import of vaccine by private sector".
According to the CDSCO, any private entity or government sector entity, who wants to import COVID vaccine for vaccination is required to follow the following procedures to procure the foreign produced vaccines.
If the vaccine is not yet approved or licensed in India, the importer or the authorized agent of the manufacturer of the vaccine shall obtain the following permission or license from CDSCO.
New Drug Permission under the New Drugs and Clinical Trials Rules, 2019
Import registration under the Drugs Rules, 1945
Import licence under the Drugs Rules, 1945.
After obtaining the import licence, the importer or authorized agent can import the vaccine and any including private sector entity can procure the vaccine from them as per the National guidelines.
If the vaccine to be imported is already approved and import licence has been obtained from CDSCO, then any entity including private sector entity can procure the vaccine from the importer or licensee for its use as per the National Guidelines.
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