Biocon Limited has launched its GLP-1 peptide, liraglutide, for the treatment of diabetes and obesity in the Netherlands, as the biopharmaceutical firm positions itself as a global player in the fast-growing diabetes and obesity market currently dominated by the likes of Novo Nordisk and Eli Lilly.
In 2009, Ranbaxy had to recall about 4,000 cartons of Sotret Isotretinoin through its US-based subsidiary.
Domestic majors, such as Himalaya and Baidyanath, are in a dilemma after the UK Medicines and Healthcare products Regulatory Agency made traditional herbal registration mandatory for herbal medicines.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant
The UK's medicines regulator on Thursday approved a new antibody treatment against COVID-19, which it believes will also be effective against new variants such as Omicron.
"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.
This means fully vaccinated Indian passengers will no longer be subjected to a compulsory 10-day hotel quarantine on their arrival in Britain.
The UK government is under increasing pressure on Monday to review its COVID-19 vaccine protocol in place for travellers from India, after its updated rules effective from next month failed to recognise Indian vaccines under an expanded list of countries.
The UK's National Health Service was already lining up thousands of medics and volunteers to be ready to deliver jabs up and down the country.
Its Waluj manufacturing facility in Maharashtra failed to meet the good manufacturing norms prescribed by the UK drug regulator.
Despite these rare occurrences, the pharmaceutical company maintains that extensive clinical trial data and real-world evidence consistently support the vaccine's safety and efficacy.
The Medicines and Healthcare Regulatory Agency, which had been formally tasked by the UK government last month with the process of clearance after the jab emerged "safe and effective" against the novel coronavirus in human trials, is expected to authorise the vaccine by December 28 or 29 after the final data is provided on Monday, 'The Daily Telegraph' quoted senior government sources as indicating.
The Indian Council of Medical Research's national task force for COVID-19 has decided against including antiviral drug Molnupiravir in the clinical management protocol for COVID-19 as of now, official sources said on Tuesday.
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The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.
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.
The UK's medicines regulator on Friday approved the Pfizer/BioNTech coronavirus vaccine for 12 to 15 year olds.
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.
The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom, whereby the agency has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at Kadaiya, Nani Daman, Wockhardt said in a filing to the Bombay Stock Exchange.
The British-Swedish pharmaceutical major and the UK's medicines regulator said that the vaccines produced by Oxford University in collaboration with AstraZeneca to protect against COVID-19 are safe.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
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.
The warning comes after two National Health Service (NHS) workers experienced 'anaphylactoid reaction' symptoms shortly after being injected, but are now said to be recovering well.
Frontline healthcare staff, people over the age of 80 and care home workers will be among the first to get the vaccine as part of Phase 1 of the programme from Tuesday, which was approved for rollout by the UK's independent regulator earlier this week.
Hari Shukla from Tyne and Wear said he feels it is his duty to receive his first of the two-dose vaccine, a moment UK Prime Minister Boris Johnson hailed as a "huge step forward" as Tuesday was dubbed "V-Day" or Vaccine Day in the UK.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
But no extra risk after second dose, shows study led and funded by drug maker, reports Sohini Das.
The United Kingdom on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, paving the way for mass vaccinations against the deadly novel coronavirus.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
The Oxford vaccine, which also has a tie-up with the Serum Institute of India, is expected to win approval in the UK before Thursday, speeding up the provision of the jab to the most vulnerable groups.
The Medicines and Healthcare Products Regulatory Agency said in its latest Yellow Card monitoring of the coronavirus vaccine programme this week that of the 18.1 million people who had the Oxford vaccine in the UK, 30 people developed blood clots and seven had died as of March 24.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
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 European Medicines Agency's review is the second setback to Alkem Laboratories
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
If the company manages to get a go-ahead from the regulator for this plant, it might result in resumption of supplies of several of their products, barred from the US last year.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
Working round-the-clock over the past few days, an Indian Institute of Science team is buildingan indigenous ventilator prototype for Covid-19 victims, and it is expected to be ready in the current month itself. A ventilator can be a life-saver for patients whose lungs are damaged by the Covid-19 infection. But India, like all countries grappling with this pandemic, is likely to face a large shortage of ventilators.
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