As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
Researchers at McGill University in Canada carried out a survey of 28 experts working in vaccinology in late June 2020. The majority of those surveyed were mostly Canadian or American academics with an average of 25 years of experience working in the field.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
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 been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.
The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.
Nestl India is preparing a blueprint for a possible relaunch.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
'Supplies should start moving to the Serum Institute without any impediments.'
A common antibacterial substance found in toothpaste may combat life-threatening diseases such as cystic fibrosis, or CF, when combined with an already FDA-approved drug.
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.
'Many of them are angry as we could not contest in some seats due to pact with the Sena and lost with a thin margin in some segments'
Both the units were under the scanner of FDA since 2011.
Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n
As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
'As a donor, you may think you are saving one life. But you touch the lives of the entire family and community associated with the person. And it only cost you a few hours of your life.'
Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi
Slapped with Rs 242-crore fine by US authorities for rule violations at Toansa unit, say sources; 2nd such hefty rap in the recent past from US regulators for bending rules.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
Tyson said he wants to spread word of the benefits of psilocybin as widely as possible, which is why he has partnered with Wesana.
The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products
The news that exports to the US will not restart before next year as well as the September quarter performance are sentiment dampeners.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
This time food regulators found excess presence of ash content in Maggi
India's largest drugmaker, Ranbaxy, will have an exclusive six-month marketing opportunity to sell a generic version of Japanese drugmaker Eisai's drug for Alzheimer's in the US.
The US Food and Drug Administration has issued two warning letters to Ranbaxy claiming procedural violations at its plants in Dewas and Paonta Sahib in India. Giuliani, a high-profile Republican leader and former US attorney in Manhattan, would provide advice and review compliance issues. Ranbaxy has been accused of selling generic drugs which did not meet FDA standards.
Should Indian cigarette packs also have photos like these to dissuade smokers? Tell us now!
The Maharashtra Food and Drug Authority has issued notice to Johnson and Johnson, as six products including baby shampoo and baby oil were found to have carcinogenic substances.
Meticulous hand washing is your best bet to get rid of the grime that clings to the hand, that might harbour nasty pathogens, including the coronavirus.
The EUA allows for Remdesivir to be distributed in the US and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe condition.
The Maharashtra Food and Drug Administration seized gutkha worth over Rs 7 lakh from various parts of the state over the last two days in an effort to enforce the ban on gutkha sales.
Speaking at the Conservative Political Action Committee in Orlando, Florida on Sunday, the 74-year-old leader, who left the White House on January 20, stopped short of announcing to run for the president in 2024, although he gave enough indications that he is moving in that direction.
The Maharashtra Food and Drug Administration has issued a show cause notice to a Pune-based diversified group for putting 'objectionable' label in its bottled mineral water and seized water bottles worth Rs 245,000 from Aurangabad.
The labs have been asked to submit their report within six weeks.
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