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Pfizer becomes first to seek permission from India to release vaccine

Days after the UK announced its approval for emergency use authorization of the Pfizer vaccine in the country, the drugmaker has stepped up to seek the permission of India for the release of its Covid-19 vaccine, which it says is 95% effective, in the Indian market.

The American pharmaceutical company that has collaborated with German partner BioNTech for developing the vaccine is the first to furnish such a request to the regulatory body of India, the DCGI (Drugs Controller General of India).

The UK and Bahrain are set to receive the vaccine after the nations gave the EUA to the drugmaker.

According to sources, the DCGI might accept the request for release in India, if it witnesses promising results from the clinical trials conducted abroad as according to the latest drugs-related law, trials for vaccines/medicines can be waived off in India.

The United Kingdom created history on Wednesday by becoming the first country to approve Pfizer to administer its vaccine to British citizens.

The drugmaker on Friday presented an application asking India its permission to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.”

NDTV reported official sources connected to the regulatory body, DCGI as saying, “Pfizer’s CT-18 application for grant of permission to import new drug (Covid vaccine) for sale in India is under process. As per New Drugs and Clinical trials Rules 2019, the application has to be decided within 90 days.”

According to the new law, the body has the power to “waive localized clinical trials for a vaccine”. However, since 2019, the discretionary power hasn’t been utilized for giving permission to any drugmaker.

Following its success in seeking the license from the United Kingdom, Pfizer expressed its goals of providing the vaccine to Indians as well because it remains “committed to engaging with the Government of India and explore opportunities”.

The problem, however, still persists as experts are concerned about the delivery means of the vaccine, also related to its storage in a developing country like India.

The vaccine needs an ideal storage temperature of -70 degrees Celsius, which is very difficult to be attained in the country as the majority of the vaccine the nation possesses needs to be kept at temperatures ranging from 2-8 degrees Celsius.

This not only creates logistic issues but also decreases the number of doses that be brought in the country at once, leaving many without the shot.

Previously, a vaccine expert, Dr. Gagandeep Kang, a vaccine expert, stated on Twitter, “This RNA vaccine needs ultracold storage. Not sure of BioNTech price, but Moderna is 37$ a dose. Which makes these vaccines a stretch for less-resourced countries that will find them hard to deliver and expensive. (SIC)”

NITI Aayog member of Health department and the head of National Task Force for Covid-19, Dr. VK Paul told in November that even though India approves the vaccine, Pzifer-developed shot will not be available in enough doses to cover the entire population. Nevertheless, he had said that the government is hunting ways and designing strategies to allow all citizens to get administered with the vaccine that is extremely crucial to stay protected from the deadly virus, which has killed millions across the globe until now.

After an all-party conference on Friday, Prime Minister Narendra Modi took the initiative to speak about the Indian vaccines that are currently inching towards completion. He said, “Three indigenous vaccines are already in the final stages of the trial. Vaccines for COVID are likely to be ready within a few weeks. Indian health agencies and manufacturers are working in tandem with global agencies. We are fully prepared for the rollout.”