NEW DELHI: Approval for restricted, emergency use of Covid-19 vaccines may be granted under the new clinical trial rules, top government officials said on Tuesday.
“India’s regulatory framework has a specific provision for grant of emergency use authorisation (EAU), although this phrase is not used,” Union health secretary Rajesh Bhushan said at a press briefing, citing the New Drugs and Clinical Trial Rules, 2019.
The statement came a day after Hyderabad-based Bharat Biotech, following US pharma major Pfizer and Pune based Serum Institute of India, applied for restricted use permissions for their respective vaccines.
In response to a query on what rule will be followed by the drug regulator in the absence of a watertight EUA law for granting licence to vaccine makers, Bhushan said not all countries’ regulatory frameworks or rules and Acts mention EUA.
“So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that specific country does not have an enabling provision to accord an approval which is early and which is distinct from a regular market approval,” he said.
The government is ready to launch a massive production of Covid-19 vaccine once the scientists and researchers give a nod, Bhushan added.
“We have made all the preparations and drawn an outline to ramp up production of vaccines and to make it available to each and every person in the shortest possible time.”
The Drugs Controller General of India could grant a licence to some Covid-19 vaccine developers in the next few weeks, Bhushan said.
As per the details shared at the briefing, the current cold chain supply is capable of storing the first lot of 3 crore vaccines for healthcare and frontline workers.
This will be augmented in the coming weeks. NITI Aayog member (health) V K Paul said the Covid situation in India has stabilised with active cases showing a “clear-cut declining trend”.
Foreign heads will be taken to biotech companies, says MEA
NEW DELHI: The Ministry of External Affairs has organised a visit of foreign heads of missions in India to leading biotech companies in Hyderabad for Covid briefing on Wednesday.
More than 60 head of missions will be taken to Bharat Biotech and Biological E in Hyderabad, according to sources. This is the first such visit and it will be followed by visits to facilities in other cities, they said.
“We have been contributing significantly to global efforts against COVID 19 pandemic. There is a lot of interest in India’s vaccine development efforts. India is the world’s largest vaccine manufacturer. As PM said India’s vaccine production and delivery capacity will be used to help all humanity in fighting this crisis,” according to the MEA.
Foreign secretary Harsh Shringla had recently held a briefing with foreign heads of mission on COVID-19 preparedness.