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Coronavirus pandemic: DCGI to expedite approvals of COVID-19 drugs, vaccines

The drug regulator said in case of emergency, they are would granting import license without registration certificate subject to approval of government.

March 27, 2020 / 09:48 AM IST
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In an effort to provide quick access to vaccines and drugs to treat COVID-19, the Drug Controller General of India (DCGI) has announced several measures including expediting reviews and approvals for drugs and vaccines already approved in other countries. The Indian drug regulator will also grant speedy permissions for clinical trials, waiver of data requirement for animal studies and approval of manufacturing licenses within seven days.

The drug regulator said, in case of emergency, it is granting import license without registration certificate subject to approval of the government.

At least three Indian vaccine Serum Institute of India, Zydus Cadila and Bharat Biotech are developing vaccine for COVID-19, other drug companies like Cipla are working on developing antiviral drugs that are considered to work against COVID-19. Many public research laboratories and pharma companies are developing vaccines, antibody therapies and repurposing existing drugs for COVID-19.

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"Any firm or research institute having protocol for repurposing of existing drugs/vaccines for treatment of COVID-19 will also be given priority for review and approval," VG Somani, Drug Controller General of India (DCGI) said in a notification.

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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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Applications for clinical trial permission and application to import or manufacture drug or vaccine for sales and distribution would be processed on priority through expedited review and accelerated approval, the notification said.

"Any firm having a drug or vaccine already approved for COVID-19 in any other country can directly approach DCGI for expedited review and accelerated approval," DCGI said.

Data requirement for animal toxicity study, clinical study, stability study etc. may be abbreviated, deferred or waived on case to case basis depending upon the type of vaccine, nature of drug, plant from which the drug is extracted and its experience in case of phyto-pharmaceuticals, the notification added.

Application to manufacture or import drugs or vaccines for test, analysis or clinical trial may be processed within seven days.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Mar 27, 2020 09:48 am

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