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New guidelines by drug regulator CDSCO clears way for import of foreign COVID-19 vaccines like Sputnik V

Dr Reddy's Laboratories, the custodian of the Sputnik V vaccine in India, has already announced the arrival of 1.5 lakh doses as first consignment of the 250 million doses it plans to import from Russia; Pfizer is reportedly negotiating an expedited approval pathway for the use of its vaccine in India

May 05, 2021 / 11:12 AM IST
Representative image of the Russian Sputnik V COVID-19 vaccine being imported by Dr. Reddy's Laboratory for distribution in India

Representative image of the Russian Sputnik V COVID-19 vaccine being imported by Dr. Reddy's Laboratory for distribution in India

The latest guidelines for import of foreign COVID-19 vaccines by the private sector and state governments have been released by the Central Drugs Standards Control Organisation (CDSCO), India's drug regulator.

For vaccines not yet approved or licensed in India, the importer or authorized agents of the foreign manufacturers have to obtain three key permissions or licenses from CDSCO.

These include a New Drug Permission under the New Drugs and Clinical Trials Rules, 2019; import registration permission under the Drugs Rules, 1945 and a basic import license under the Drugs Rules, 1945.

All imports will have to take place based on the guidelines on the Health Ministry's Liberalized Pricing and Accelerated National COVID-19 Vaccination Strategy with effect from May 1, the CDSCO said.

Health Ministry guidelines

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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"After obtaining the import license, the importer/ authorized agent can import the vaccine and any, including private sector entities, can procure the vaccine from them as per the national guidelines," the drug regulator said.

Dr Reddy's Laboratories, the custodian of the Sputnik V vaccine in India, has already announced the arrival of 1.5 lakh doses of Sputnik V to Hyderabad on Saturday. This is the first consignment as part of the 250 million doses that Dr Reddy's plans to import from Russia.

Also in discussions with India to send COVID-19 vaccines, Pfizer is negotiating an expedited approval pathway for Pfizer-BioNTech vaccine for use in India, the company’s chief executive officer, Albert Bourla, reportedly said on May 3.

Expedited approval

On April 15 this year, the Centre announced it would fast-track emergency approvals for foreign-produced COVID-19 vaccines that have already been granted Emergency Use Authorisation (EUA) in other countries.

This allowed all vaccines currently approved by the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA), to be potentially sold in India soon.

The Centre has also allowed foreign vaccines included in the Emergency Use Listing maintained by the World Health Organization (WHO) to be fast-tracked.

NEGVAC decision

The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) took the decision on April 11 as the Second Wave of the Covid-19 pandemic continued to push up the number of daily cases nationwide amidst a severe shortage of vaccines.

The government believes its latest move will facilitate quicker access to foreign vaccines and also lead to more imports of bulk drug material, which can be used to manufacture the vaccines locally.

The Centre said optimal utilisation of domestic fill-and-finish capacity will also be achieved as a result, in turn providing a fillip to vaccine manufacturing capacity and total vaccine availability.
Subhayan Chakraborty

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