COVID-19 vaccine: Pfizer withdraws Emergency Use Authorisation application in India
New Delhi: Pharma major Pfizer on Friday said it has decided to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India.
Pfizer was the first pharmaceutical firm to seek an emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country, after it secured such clearance in the UK and Bahrain.
"In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time," a company spokesperson said in a statement.
Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement said.
"Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," the spokesperson said.
Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources had said.
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Threatens existence of Muslim community: Kerala-based Hindu body moves SC against Waqf Amendment Act
New Delhi: Sree Narayana Manava Dharmam Trust, a Kerala-based Hindu organisation, moved the Supreme Court on Monday against Waqf Amendment Act, arguing that the law threatens the existence of the Muslim community in India.
"Given the teaching of Sree Narayana Guru about the inter-dependent nature of the well-being of all persons and communities, the ‘Sree Narayana Manava Dharmam Trust’ cannot be an idle spectator to the devastating impact of the impugned Act taken as a whole on the Muslim community of India and to social justice in our country," Bar and Bench quoted the organisation as saying to the top court.
The Waqf matter will be heard at 2:00 p.m. on Monday by a bench comprising of Chief Justice of India (CJI) Sanjiv Khanna, Justice PV Sanjay Kumar and Justice KV Viswanathan, the report added.
Meanwhile, the Supreme Court has prohibited the filing of more petitions on the issue and stated that those seeking to challenge the law can file intervention applications to add to the arguments of the existing petitioners.
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