Govt fast-tracks approval for foreign-produced vaccines

Currently, two vaccines -- Covaxin and Covishield -- are being used for inoculation; Russia's Sputnik V gets go-ahead

Govt fast-tracks approval for foreign-produced vaccines

India has fast-tracked emergency use approval for eligible foreign-produced shots against COVID-19, in a move to expand its basket of vaccines amid the "highest" surge in the infections in the country and speed up the inoculation drive that got a boost with a third vaccine Sputnik V from Russia getting clearance.

Maharashtra Chief Minister Uddhav Thackeray, meanwhile, announced on Tuesday a statewide curfew in the worst-hit state for 15 days from April 14. "War against coronavirus has begun once again," he said in his address via social media on a day when the state reported 60,212 new COVID cases and 281 fresh deaths.

The announcement by the Union Health Ministry by which the eligible manufacturers of the foreign vaccines are not required to undertake local clinical trials in India could clear the decks for imports of Pfizer, Moderna and Johnson & Johnson shots with certain conditions.

A statement by the ministry said the government has decided that COVID-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency Use Listing may be granted emergency use approval in India.

The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country, it added.

"We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson and Johnson and be ready to come to India as early as possible," NITI Aayog member (Health) Dr V K Paul said at a media briefing.

He termed the government's move as a significant development and a liberal regulatory step that will increase the access to vaccines that are manufactured outside.

"It also opens up eventually doors for import of bulk or import of finished vaccines in vials or import leading to fill and finish in the country," Union Health Secretary Rajesh Bhushan told the media briefing.

Currently, two vaccines -- Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) -- are being used for inoculation in India.

With India in the grip of the second COVID-19 wave, Finance Minister Nirmala Sitharaman made it very clear that the government would not go for lockdowns in a big way and rather resort to local containment. The minister said this at a virtual meeting with the World Bank Group president David Malpass.

In his address at the 'Raisina Dialogue', Prime Minister Narendra Modi called for united global efforts to deal with the coronavirus crisis, saying mankind will not be able to defeat it unless everyone comes out of it.

"We understand fully, that mankind will not defeat the pandemic unless all of us, everywhere, regardless of the colour of our passports, come out of it. That is why, this year, despite many constraints, we have supplied vaccines to over 80 countries," he said at the conference, held virtually.

The PM also said that during this pandemic, in our own humble way, within our own limited resources, we in India have tried to walk the talk.

Secretary Bhushan said the "previous highest surge" has already been crossed and the trend is going upward and that is a cause for worry and that is something they continuously share with the states and UTs and try to help them tackle the pandemic in a more effective manner.

"The previous highest surge was 94,372 daily cases in September which is now 1,61,736 every day," he added.

The daily deaths are also showing an increasing trend. But the previous surge was 1,104 and it is presently 879 deaths.

He said Maharashtra, Uttar Pradesh, Delhi, Haryana and Gujarat are among the states of concern.

Uttar Pradesh and Delhi recorded 18,021 and 13,468 COVID-19 new cases on Tuesday respectively in the biggest single-day jump so far.

Delhi Chief Minister Arvind Kejriwal appealed to the Centre to cancel the Class 10 and 12 board exams and explore alternative methods, including online exams,

The Russian Direct Investment Fund(RDIF) said more than 850 million doses of Sputnik V are going to be produced annually in India -- the 60th country to approve the vaccine.

RDIF CEO Kirill Dmitriev said the Russian vaccine has an efficacy of 91.6 per cent and provides full protection against severe cases of COVID-19 as demonstrated by the data published in one of the leading medical journals, The Lancet. The approval of Sputnik V is a "major milestone", he added.

"By summer we expect to manufacture 50 million doses or more of Sputnik V a month in India," Dmitriev told a virtual press conference later in the evening.

"We almost think Sputnik V is an Indian-Russian vaccine because lots of production of Sputnik V will be done in India".

The Health Ministry statement said the eligible foreign vaccines will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019.

"This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity, etc., which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic (use)," the ministry said.

Elaborating on the government decision, Secretary Bhushan said it has created an enabling regulatory provision to enable those foreign-made vaccines which have been approved by "credible foreign regulators" to get emergency use nod in India.

"It denotes a very significant streamlining and fast-tracking of the regulatory approval system which means that the pre-condition of having a bridging clinical trial which is phase 2 and 3 trial here for a foreign vaccine before it could be considered for emergency use authorisation has been done away with and has been replaced with a parallel bridging trial. As the approval happens the clinical trial can proceed. So therefore the availability of the vaccine becomes much faster," he added.

The decision came following the recommendations of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).

This decision and the permission for the restricted emergency use of Sputnik V with certain conditions came as India surpassed Brazil to become the second worst-hit country affected by the COVID after the US.

In a regulatory filing, Pharma major Dr Reddy's said it has received permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted use in emergency situations.

The Finance Ministry took to Twitter to give details of Minister Sitharaman's meeting with David Malpass.

"Finance Minister Nirmala Sitharaman shared the measures being taken by India to contain the spread of second wave of pandemic including the five pillared strategy of test-track-treat-vaccination and #COVID19 appropriate behaviour," it said in a tweet.

"Even with the second wave, we are very clear that we are not going in for lockdowns in a big way. We don't want to totally arrest the economy. The local level isolation of patients or households that have people in quarantines are the methods through which the crisis will be handled, the second wave will be handled. There shall not be a lockdown," the minister said.

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