Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
Cancer has no race, so why do new innovative cancer drugs discriminate based on race and ethnic groups, asks Digonto Chatterjee.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
In contrast with their strong performance in 2020 and 2021, pharmaceutical and healthcare funds experienced a decline in 2022, with returns plummeting by an average 9.8 per cent. This trend has continued in the current year, with year-to-date return remaining in the negative (-4.9 per cent). In the past three months, pharma funds have been hit hard, experiencing a 7.9 per cent decline.
A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
'I got an opportunity to direct him in Baaghi 3.' 'He played a police commissioner's role, and it was so weird directing him.' On the first day of shooting, I asked him, 'What do I call you today?' and he shot back, 'Satish uncle'.'
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
Children who previously had COVID-19 or the inflammatory condition MIS-C are not protected against the Omicron variant of coronavirus, according to a study which found vaccination, however, does afford protection.
Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.
Easy access to this kind of test could help people determine what kind of precautions they should take against COVID-19 infection, such as getting an additional booster shot, the researchers said.
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
Major American food chains, globally known for their chicken and beef offerings, overhaul their menus to go completely vegetarian to grab a larger pie of the predominantly non-meat eating customers in Gujarat.
'We have to do everything in our power to get as many Academy members to watch the film as possible.' 'After that, I am confident, my film will speak for itself.'
The emergency use of the drug will be for adult COVID-19 patients with SpO2 93 percent and who have a high risk of progression of the disease including hospitalisation or death subject to certain conditions
Tears of joy rolled out of the eyes of parents and family members, some of whom distributed sweets and garlanded their children while others welcomed them with bouquets and hugs after their arrival at gate number 4 and 5 of the Indira Gandhi International airport.
Biden got a third Pfizer dose after booster doses were approved by federal health officials.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
"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.
In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
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.
Despite unprecedented levels of uncertainty in Samvat 2077, investors have little to complain about on the returns front. The BSE Sensex delivered returns of 38 per cent in this period, while the Nifty registered a return of over 40 per cent. As is the case in bull markets, companies in the small- and mid-capitalisation basket outperformed the benchmarks, with returns almost twice those of frontliners.
Illustrious international thinkers met at the Milken Institute Global Conference 2021 and many discussions addressed the impact of the COVID-19 pandemic on the world at large.
The results reported from the observational studies, on average, show that vaccination had 95 per cent efficacy against severe disease both from the Delta variant and from the Alpha variant, and over 80 per cent efficacy at protecting against any infection from these variants.
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
There is no evidence that the drug can fight the virus, and regulators warn it may cause heart problems.
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.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
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 recommendation holds true for both indoors and outdoors, the CDC said.
In the next two weeks, the United States will detail plans to equitably distribute about 80 million (8 crore) COVID-19 vaccine doses globally without 'political requirements' of those receiving them, Secretary of State Antony Blinken has said.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
The Covid-19 vaccine demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials, reports Sohini Das
If a retail investor wants exposure to a healthcare ETF, it should be a part of his satellite portfolio, suggests Sanjay Kumar Singh.
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