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CDSCO nod to import of COVID-19 vaccines; to be used by private entities, states

As per CDSCO guidelines, ready to use imported Covid-19 vaccines can be utilised entirely in "other than the government of India channel". After obtaining an import licence, importer or authorised agent can import vaccine and any including private sector entity can procure vaccine from them

twitter-logoBusinessToday.In | May 5, 2021 | Updated 08:54 IST
CDSCO nod to import of COVID-19 vaccines; to be used by private entities, states
Private entity or government sector entity, which wants to import Covid vaccine, is required to follow certain procedures

The drug regulator Central Drugs Standard Control Organisation (CDSCO) has cleared the way for the import of Covid-19 vaccines from other countries into India. As per the latest CDSCO guidelines, the ready to use imported Covid-19 vaccines would be utilised entirely in the "other than the government of India channel". This means these vaccines can be used by private companies and state governments only. Any private entity or government sector entity, which wants to import the Covid vaccine for vaccination as per the above-mentioned guidelines is required to follow certain procedures.

"If the vaccine is not yet approved or licensed in India, the importer/authorised agency of the manufacturer of the vaccine shall obtain three permission licences," says the new guidelines.

  • New Drug Permission under the New Drugs and Clinical Trials Rules, 2019
  • Import registration under the Drugs Rules, 1945
  • Import license under the Drugs Rules, 1945

After obtaining an import licence, the importer or authorised 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 an import licence has been obtained from the CDSCO, then any entity, including a private sector entity, can procure the vaccine from the importer or licencee for its use as per the national guidelines.

In India, 'liberalised pricing and accelerated national Covid-19 vaccination strategy' started on May 1.

In April, India also gave a go-ahead to Russia's Sputnik V vaccine against Covid-19. It's the first foreign vaccine that has been approved in India. Sputnik V was approved after the subject expert committee (SEC) gave a nod to Dr Redddy's application for Sputnik V rollout in India. The first batch of 1.5 lakh Sputnik V vaccines arrived in Hyderabad on May 1.

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