FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
The Bombay high court on Wednesday ordered for fresh testing of Johnson & Johnson baby powder samples and permitted the company to manufacture the product but to not sell it, as per the Maharashtra government order. The company had filed a petition challenging two orders of the state government- one dated September 15 cancelling the license and the second dated September 20 ordering to immediately stop manufacturing and sale of the company's baby powder product. The orders were passed by the joint commissioner and licensing authority of the state Food and Drug Administration (FDA).
India consistently ranked among the top three countries whose products were rejected for import by the regulator.
Data also show that several other leading domestic pharma companies have recalled their products from the US
The trouble for Nestle's Maggi started in Uttar Pradesh last month and has now spread nationwide. The Food and Drug Administration has directed all states on Wednesday to get sample of India's most popular instant noodles tested for high content of lead and mono-sodium glutamate, a taste enhancer.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
Aryan, 23, was arrested by the Narcotics Control Bureau (NCB) on October 3 from the cruise ship off the Mumbai coast.
Not much is heard or read about Sun Pharma's media-shy owner.
Top Ramen tested positive for lead in samples taken from Daman.
Apart from Maggi noodles, many other products can be tested for health issues.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
The high court had given the company six weeks for retesting.
The company did not comply to the 'good manufacturing practice' norms.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
There were 52 launches during January-June 2015, compared with 29 in the year-ago period and 32 in 2013.
The Bombay high court on Wednesday permitted Johnson & Johnson to manufacture, sell and distribute its baby powder and quashed three orders of the Maharashtra government revoking the company's license and asking it to stop the product manufacture and sale, terming them as "stringent, unreasonable and unfair". A division bench of Justices Gautam Patel and S G Dige also came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of the company's baby powder seized in December 2018. The bench noted that while maintaining standards of quality and safety are of utmost importance for cosmetic products, at the same time it does not seem reasonable to shut down the whole manufacturing process when there is a slight deviation in one of the products.
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.
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
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.
The Food and Drug Administration said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
Despite the hope that lessons will be learnt, the next accident invariably shows that nothing has been learnt -- or if learnt, they have been ignored, observes Prosenjit Datta.
The company is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra, Hetero Healthcare said in a statement.
The US health authorities registered more than three times as many new cases as in any previous wave of the coronavirus.
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.
If the actress fails to respond to the notice within the stipulated time frame, a case could be registered against her, Food Security Officer Mahimanand Joshi said.
With the threat of COVID-19 pandemic continuing to loom over the world, the Ministry of Ayush has come out with a comprehensive document putting forth the concept of 'holistic health'.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
Serving pilots question the Kozhikode plane crash report findings.
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.
India is currently using two vaccines for COVID-19 -- one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech in collaboration with the Indian Council of Medical Research-National Institute of Virology. Both the vaccines are being manufactured within the country by domestic firms.
Mohabbat Singh was administered a cocktail of Casirivimab and Imdevimab at the Medanta Hospital as part of the "single dose infusion-based treatment" on Tuesday and then kept under observation.
Maharashtra Chief Minister Uddhav Thackeray announced a statewide curfew for 15 days from 8 am on April 14 to contain the rapid spread of the coronavirus in its second wave. With Section 144 being imposed across the state, Thackeray essential services have been exempted from the restrictions. The curfew will be in place till 7 am on May 1.
The matter is now expected to be raised with the PMO.
Sun Pharmaceutical's acquisition of Ranbaxy has received final approvals.
288 first-time offenders have been coaxed to leave the path of crime and lead a normal life.
The guidelines listed several services including government and private offices that will be out of bounds during the period, while exempting establishments such as hospitals, ration shops, dairies, banks, insurance offices, and print and electronic media. Delivery of all essential goods including food, pharmaceuticals, medical equipment through e-commerce has also been exempted from the purview of the lockdown.
The dinner Jill Biden and her husband US President Joe Biden hosted for Indian prime minister Narendra Modi, June 22, at the White House brought together, Indians and Americans from so many firmaments.
In fresh troubles for Nestle over safety standards of its famous Maggi noodle brand, the Uttrakhand Food Safety Department has collected samples of the 'two-minute' noodles from the company's Pantanagar plant and other places in the state.
"When the SHO sir asked me about my interest of area, I told him that I am a dance teacher and want to continue it. The SHO sir said that they will try to find me a suitable job. He sent me to Sandoz to restart earning livelihood till the time I get a job in dancing. I am also thinking to apply in schools for dance teacher," Balaji Sawalkar said.
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