'We recently launched Yesintek in the immunology space.'
'We are looking at what kind of products, diagnostics or other solutions we can offer to become a well-rounded player in a particular disease area globally.'
Pharma giant AstraZeneca's Covid-19 vaccine is being withdrawn worldwide after the company acknowledged for the first time in court documents that it can cause a rare and dangerous side effect, according to a report in the British newspaper The Telegraph.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
"I realise that a lot of Indians who have taken Covishield are facing issues with travel to the EU, I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries," Poonawalla said in a tweet.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
India has already asked the EU member countries to individually consider allowing Indians who have taken Covishield and Covaxin vaccines and want to travel to Europe.
Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.
We have applied for marketing authorisation to the EMA through AstraZeneca. We will not sell the vaccine in the EU, said a company source.
"We have requested EU member states to individually consider extending similar exemption to those persons who have taken COVID-19 vaccines in India, that is Covishield and Covaxin, and accept the vaccination certificate issued through the CoWIN portal," said a source.
The company did not comply to the 'good manufacturing practice' norms.
Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralising antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
The government may look at areas around Thonnakkal, in Thiruvananthapuram district, for the facility. If successful, this would be one of the few sites of Sputnik V owned by Russian firms outside that country. Shine Jacob and Sohini Das report.
The process is being undertaken in consultation and agreement with the competent authorities.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Over 20 drug companies marketing anti-obesity drug sibutramine under a variety of brand names are likely to soon face a ban on selling the medicine.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
The aim of the exhibition in London is to present evidence relating to the scientific basis of Ayurveda and the potential it holds for global health care.
Guterres reiterated his call for a COVID-19 vaccine to be a global public good available to everywhere and particularly, available in Africa.
The new malaria vaccine (RTS.S/ AS01, tentatively brand-named Mosquirix) is the very first one to offer immunity against a parasite -- specifically the plasmodium falciparum parasite, which is the deadliest of the five parasites that cause malaria.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
The European Medicines Agency's review is the second setback to Alkem Laboratories
Facing accusations of delay in placing orders for vaccines, the government on Thursday defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers.
Exports from Ranbaxy plants at Toansa and Dewas to Europe will remain suspended as probes are continuing even as Indian authorities have withdrawn the certification of manufacturing standards from one of the units, European health regulator EMA said today.
GVK Biosciences is the latest Indian firm to come under international scrutiny over quality issues.
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The British drugmaker said the shot, called RTS,S, is intended exclusively for use outside the European Union but will be evaluated by the European Medicines Agency in collaboration with the World Health Organisation.
Indian pharma firms under European drug regulator's scanner.
Germany's drug regulator has banned the sale of 80 generic medicines with immediate effect on the grounds that their clinical trials conducted by India's pharmaceutical research company GVK Biosciences were "insufficient".
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To focus on molecules at advanced stage of development; move to impact 200 scientists.
Britain's vote to leave the European Union means uncertainty for markets and companies as London initiates at least two years of negotiations with the EU.
Negotiators from were expected to meet in New Delhi on August 28.
Some investors warned of a coming British or even global recession as sterling collapsed to hit its lowest since 1985.
Flight of high-paying banking jobs to other European cities will hurt the prospects of Indian real estate developers and desis in the hospitality business in the UK, says Kunal Bose.
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