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More foreign vaccines on cards as govt relaxes rules

The government move to allow import of yet-to-be authorized covid vaccines comes at a time when India is facing an acute shortage of vaccines as both Serum Institute of India and Bharat Biotech International are struggling to quickly scale up production of Covishield and Covaxin, respectively, to meet domestic demand. (REUTERS)Premium
The government move to allow import of yet-to-be authorized covid vaccines comes at a time when India is facing an acute shortage of vaccines as both Serum Institute of India and Bharat Biotech International are struggling to quickly scale up production of Covishield and Covaxin, respectively, to meet domestic demand. (REUTERS)

  • For import of yet-to-be-authorized vaccines, the importer will have to obtain the new drug permission from CDSCO under the New Drugs and Clinical Trials Rules of 2019 and import licence and registration under the Drugs Rule of 1945

NEW DELHI : The government has stepped up efforts to increase the availability of vaccines, allowing private and non-central government entities to import vaccines that are not cleared for mass vaccinations yet.

Any such entity planning to import a vaccine that has not received an emergency use licence in India must obtain the ‘new drug permission’ from the Central Drugs Standards Control Organization (CDSCO) under the New Drugs and Clinical Trials Rules of 2019 and import licence and registration under the Drugs Rule of 1945.

This would mean that the state governments and private entities can import vaccines made by Pfizer, Moderna, and Johnson and Johnson, which have not secured emergency use licence in India yet.

“After obtaining the import licence, the importer/authorized agent can import the vaccine and any, including private sector entity, can procure the vaccine from them as per the national guidelines," CDSCO guidelines issued late on Tuesday said.

Companies and state governments need not follow these processes if the vaccine is already authorized by the Drugs Controller General of India, or DCGI, and any entity, including private companies, can buy it from the importer under the government’s revised guidelines for vaccine procurement.

The government had on 19 April opened up the vaccination drive to all adults beginning 1 May, and also to private companies, besides allowing state governments to directly procure vaccines from foreign companies.

This came five days after the government also allowed fast-track authorizations of vaccines that have already been cleared by one of four drug regulators in the US, the United Kingdom, the European Union and Japan, or the World Health Organization.

If the vaccines are supplied to India post-authorization, then 50% of the vaccines being cleared at the Central Drugs Laboratory at Kasauli will be reserved for the Centre and the remaining can be procured by the state governments and private entities.

The move comes at a time when the country is facing an acute shortage of vaccines as both vaccine makers—Serum Institute of India and Bharat Biotech International—are struggling to quickly scale up production of their vaccines— Covishield and Covaxin, respectively—to meet the domestic demand even as India tops in terms of the daily case counts.

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