The Drugs Controller General of India (DCGI) has granted permission to Cipla to import the vaccine for restricted emergency use in India as per the provisions of the New Drugs and Clinical Trial Rules, 2019 under Drugs and Cosmetics Act, 1940, PTI reported.
Moderna’s vaccine, developed in the United States, will be the fourth Covid-19 jab to be available in India after Covishield, Covaxin and Sputnik.
Speaking at a media briefing, Niti Aayog member Dr VK Paul said that Moderna, the first international vaccine, will be administered in two doses.
He indicated that the approval for Pfizer‘s vaccine will likely come through soon.
“There are four vaccines now: Covaxin, Covishield, SputnikV and Moderna. We will soon close the deal on Pfizer as well,” he told reporters.
Currently, Covishield and Covaxin are the two main vaccines being administered across the country.
Covisheild is developed by AstraZeneca and is being producted locally by the Serum Institute of India. Covaxin is an indigenous vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Russia’s Sputnik V was approved in May this year and is being administered in limited capacity.
On June 1, in a bid to expedite the rollout of Covid vaccines, the DCGI decided to waive testing of batches at Central Drugs Laboratory (CDL) for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK’s MHRA or the WHO.
The central government in April issued detailed guidelines and proactively eased entry of foreign made Covid-19 vaccines approved by US FDA, EMA, UK’s MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India.
According to the guidelines, these vaccines will not need to undergo prior bridging trials.
The provision was further amended to waive the trial requirement altogether for the well-established vaccines manufactured in other countries.
The government is planning to inoculate India’s entire adult population by the end of this year and has set an ambitious target of vaccinating 1 crore people every day starting end of July or early August.
(With inputs from PTI)
Watch Moderna secures approval for emergency use of Covid-19 vaccine in India