Centre fast-tracks approval for foreign-produced COVID-19 vaccines cleared in other countries
New Delhi, Apr 13: With an aim to expand the basket of COVID-19 vaccines and enhance the pace of inoculation in India, the central government on Tuesday said it has decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan.
The move is significant as it may make available several vaccines, including those made by Pfizer, Moderna and Johnson & Johnson, in India with certain conditions.
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before they are rolled out for further immunization programme within the country, the Union Health Ministry said.
Terming it a significant development and a liberal regulatory step that will increase the access to vaccines manufactured outside, NITI Aayog member (Health) Dr V K Paul said, "We hope and we invite vaccine makers such as Pfizer, Moderna, Johnson and Johnson and others...to be ready to come to India as early as possible."
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.
They will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of a local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the ministry said.
"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.
The decision came following the recommendations of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
Currently, two vaccines -- Covaxin by Bharat Biotech and Covishield by Serum Institute of India (SII) -- are being used for inoculation in India.
India's drug regulator also granted permission for the restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions on Monday.
At a press conference, Union Health Secretary Rajesh Bhushan said the decision has created a 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 can 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 said.
"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," Bhushan stated.
The matter of augmenting the basket of vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme were discussed in the 23rd meeting of NEGVAC chaired by V K Paul on April 11.
India is following a comprehensive approach to tackle the pandemic in a proactive and pre-emptive manner, the ministry said in a statement.
In this context, as early as May 2020, India constituted a task force headed by the Principal Scientific Advisor to encourage research and development for vaccine manufacture and constituted in August 2020 an expert group headed by Member, NITI Aayog to assist in the rollout of the COVID vaccination programme.
It was because of these strategies that India became the first country to have two "Made in India" vaccines for domestic vaccination drive, it said.
Vaccination is one of the critical pillars of COVID-19 control and management strategy adopted by the Centre, it underlined.
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Post poll TN alliances divided in supporting TVK
Chennai (PTI): In a changed political atmosphere in Tamil Nadu with no single political party having a simple majority to form the government post the Assembly election, opinion is divided among the allies led by the Dravidian majors in extending external support to Vijay-led TVK in government formation.
Both the DMK and AIADMK are at unease as the Congress and also a section in the AIADMK express willingness to extend external support to Vijay-led Tamilaga Vettri Kazhagtam in forming the government.
Post poll, the TVK's political prospects appear to impact alliances led by both the Dravidian majors in a different manner, triggering a speculation of a split.
Leema Rose Martin, who won from Lalgudi on an AIADMK ticket, has stated that talks were underway on extending support to the TVK. Her son-in-law Aadhav Arjuna, who won from Villivakkam is TVK's general secretary.
On May 5, former AIADMK minister O S Manian, emerging from his meeting with party general secretary Edappadi K Palaniswami, stated that AIADMK would not support TVK in forming the government.
The AIADMK, which finished third in the elections with 47 seats has cancelled its meeting of MLAs designate on Wednesday amidst a difference in extending external support to the TVK, which won 108 seats, including two seats by its founder Vijay.
As Vijay is gearing up for his swearing-in on May 7, the police have tightened security at his residence here. The party has lodged its MLA-elect at a resort in Mamallapuram and has simultaneously engaged in talks with the Congress and AIADMK, a source said.
The DMK that won 59 seats on its own, has convened a meeting of its newly elected legislators on May 7 evening and the party is likely to elect the youth wing secretary Udhayanidhi Stalin, who won from Chepauk-Thiruvallikeni as its legislature party leader.
Congress general secretary K C Venugopal admitted that TVK chief Vijay requested the Congress for support to form the government.
"The INC is clear that the mandate in Tamil Nadu is for a secular government, committed to protecting the Constitution in letter and spirit. The INC is determined not to allow the BJP and its proxies to run the government of Tamil Nadu in any manner. Thiru Vijay has also spoken about drawing inspiration from Perunthalaivar Kamaraj," he said.
Accordingly, the Congress leadership has directed the TNCC to take a final decision on Vijay’s request, keeping in view the sentiments of the state as reflected in the electoral verdict, Venugopal said in a statement.
DMK spokesperson Saravanan Annadurai slammed the Congress decision and said the move to ally with TVK, pledging the support of its five MLAs to the party, was tantamount to "backstabbing the DMK and the people of Tamil Nadu."
"They have betrayed the mandate given by the people. Even before the ink on the returning officer’s signature on the victory certificate has dried, they have chosen to go ahead with this alliance," he told PTI.
The most important question was who took this "foolhardy decision, and how is it going to backfire on the Congress?" he asked.
"I don’t think they had any serious deliberation on this. The larger issue is their opposition to the BJP, which is their ideological enemy. We have supported the Congress throughout. It was our leader M K Stalin, who named Rahul Gandhi as the prime ministerial candidate when the BJP and RSS were criticising him. And now, within a day, they say they are supporting TVK. This is not the mandate of the people of Tamil Nadu,” Saravanan said.
The Congress' exit from its long-standing alliance with the DMK will be a significant moment in the political scenario of the state, commentator and political analyst Sumanth Raman said.
The Congress may be betting on the TVK as a long-term partner option, but that comes with risks, as the TVK is as yet an unknown quantity, he said.
"For the DMK, if the TVK+Congress becomes the choice of the minorities as it well could, it is an existential threat. It was the minority vote that gave the DMK alliance a 12%-15% cushion in the polls. If that goes, their chances of winning drops dramatically," Raman said on 'X.'
The Congress won 5 seats. However, DMK's other allies, the IUML, VCK, CPI and CPI (M) and DMDK have categorically stated that they would not support TVK.
As of now, the TVK requires the support of 11 MLAs to attain a simple majority of 118 to form the government.
The PMK, which won 4 seats and AMMK one - both allies of AIADMK - have not announced their decision yet.
"AIADMK’s real post-result drama may not be outside the party, but inside it. Whispers from the west and north suggest that a Coimbatore hand and a Villupuram voice may soon ask the question everyone is avoiding: Is it time to save the party from the leadership, before the cadre are forced to do it themselves? In politics, coups don’t begin with slogans. They begin with silence, phone calls and “review meetings,” Aspire Swaminathan, who is credited with founding the AIADMK IT wing in 2014, said on 'X.'
He has resigned from the AIADMK in 2021 and now acts an as independent political analyst.
