MoHF&W issues guidelines for COVID-19 vaccine import by private sector

The Ministry of Health and Family Welfare (MoHF&W) has issued new guidelines regarding the import of COVID-19 vaccine by private sector.

In a notification, MoHF&W has said, “As per guidelines on liberalised pricing and accelerated national COVID-19 vaccination strategy published by MoHF&W with effect from 1^st May, 2021, the ready-to-use imported COVID vaccine would be allowed to be utilised entirely in the other-than-the Government of India-channel.”

It also said that any private entity or government-sector entity, who wants to import COVID vaccine for vaccination has to follow some procedures which are as below:

• If the vaccine is not yet approved/licensed in India, the importer/authorised agent of the manufacturer of the vaccine shall obtain the following permission/licence 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/authorised agent can import the vaccine and anyone, including a private sector entity, can procure the vaccine from them, as per the national guidelines.
• If the vaccine to be imported is already approved and an import licence has been obtained from CDSCO, then any entity, including a private-sector entity, can procure the vaccine from the importer/licensee for its use, as per the national guidelines.