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
'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.'
This time food regulators found excess presence of ash content in Maggi
Accenture -- considered as one of the top-most employers in India among the global technology services companies -- is believed to have over 150,000 workers in India, next to IBM.
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.
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.
Sun Pharma and Dr Reddy's top list in terms of those who face most class-action litigation
An International Policy Network report in 2010 found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredient whatsoever.
A key lesson for the pharmaceutical sector in this case is to not downplay the significant impact that regulatory non-compliance can have on operations.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
As states grapple with a shortage of coronavirus vaccines, the Centre on Thursday said that over two billion doses will be made available in the country in five months between August and December, enough to vaccinate the entire population.
Reduction in customs duty on certain bulk drugs used in making life saving drugs to 5% is a positive for companies having product pipeline catering to these segments.
'We lost our place in being first in the epidemic, when it hit India so hard, but we were actually the epicentre of the epidemic from essentially April 2020, for almost an entire year. We had such high cases. We were the country that had the most mixed response.'
'The government had a vaccine from January.' 'The government should have given the vaccine to all population above the age of 45, right from the start.' 'Each state has its own problems, but as far as vaccine coverage in India is concerned, there have been mistakes.'
These vaccines have not yet been approved by the World Health Organization
The labs have been asked to submit their report within six weeks.
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.
The news that exports to the US will not restart before next year as well as the September quarter performance are sentiment dampeners.
While Reliance Retail did not comment, sources said the company will have to follow order, at least in Delhi.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
Data also show that several other leading domestic pharma companies have recalled their products from the US
Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
Some US doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.
As the global debate on booster shots gathers momentum, several scientists in New Delhi said the priority must be to ensure that more people are inoculated with at least their first jab.
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
The pain relieving balm is made available at more than 1,000 retail stores in 75 different cities in 12 states in India
The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
Sun Pharma's acquisition of Ranbaxy has once again revived evaluation of the troubled past of the latter, which had changed hands from the promoters merely five years ago.
For Sun Pharma, it is an astute purchase that it hopes will not only boost its position in India but also globally.
Maggi noodles was recalled in June because some states had found presence of MSG and excessive lead content in the samples.
This may include Rs 1,500 as a screening test for suspect cases and an additional Rs 3,000 for confirmation test, the guidelines said.
The Ranbaxy experience has made multinational corporations more cautious about Indian acquisitions in general
After Maggi, the sample of macroni pasta was taken from Mau and sent to National Food Analysis Laboratory.
Work to begin after that on corrective measures to meet US regulator's requirements.
Only 11 antibiotics in clinical trials have received qualified infectious disease product status from the US FDA, of which five are Wockhardt's drugs.
'Nobody is attacking the company or the vaccine.' 'The concerns are about the process and the lack of transparency.'
The outcome reaffirms the company's own testing and the long-standing assurance it gave that its baby shampoo does not contain formaldehyde or any formaldehyde-releasing ingredients, J&J said.
In 2013, Daiichi had launched the arbitration proceedings in Singapore.
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