The Directorate General of Civil Aviation (DGCA) has released a draft procedure that calls for testing pilots, other aviation personnel and crew members for psychoactive substances before they take to the skies. The Indian civil aviation regulator has sought comments from stakeholders over the next 30 days before issuing a regulation to this effect. Asking airlines and airports to do random checks on crew and air traffic controllers, DGCA proposed that violators be suspended for a minimum of three years or their licence be permanently cancelled as maximum punishment.
After discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, the statement said.
GlaxoSmithKline has filed a lawsuit in a United States court against Dr Reddy's Laboratories alleging infringement of patent rights of a generic version of 'Imitrex' drug, used for the treatment of migraine.
The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
With an increasing number of people from the Indian-American community playing a significant role in US elections, Congressman Raja Krishnamoorthi said there is a realisation among them that "if you don't have a seat at the table, you're on the menu -- that is why they are voting and running for office in large numbers".
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.
United States' Food and Drug Administration has granted approval to Ranbaxy Laboratories Ltd to manufacture and market 40 mg capsules of Fluoxetine, a drug used in treatment of obsessive-compulsive disorders.\n\n
Global pharma firm AstraZeneca on Tuesday said it had filed a lawsuit in the United States District Court of New Jersey
A Russian court on Tuesday dismissed US WNBA basketball star Brittney Griner's appeal against a nine-year sentence for possessing and smuggling vape cartridges containing cannabis oil, paving the way for her to be sent to a penal colony, in a court case that Washington has called "sham".
Biden got a third Pfizer dose after booster doses were approved by federal health officials.
Most of the Kuki MLAs irrespective of their party affiliations are unlikely to attend the Manipur assembly session slated to be called from August 21 in view of the continued ethnic violence, according to leaders from the community.
The US arm of Ranbaxy pleaded guilty to seven felonies relating to the manufacture and distribution of certain adulterated drugs
Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of
US drug regulator's fiat on Mohali factory, after strictures on the two other major Indian units, has numerous negative implications.
The United States Food and Drugs Administration has granted Ranbaxy Laboratories a tentative approval to market a generic form of Bristol-Myers' anti-depressant Serzone, US FDA's web site said.
This generic Doxorubicin HCl Liposome injection USP, 2 mg/ml is therapeutically equivalent to Doxil Liposome Injection, 2 mg/ml of Janssen Research and Development, LLC.
The Japanese company alleges the earlier Ranbaxy promoters withheld crucial information when they sold the company in 2008.
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.
After recovering from issues such as defaults on foreign currency convertible bonds and piling debts, pharmaceutical major Wockhardt has been on the slow lane through the last six months, following warnings from global regulators such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency.
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.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities.
According to the TMZ website, the multi-millionaire hotel owner was arrested on April 2 at the Fort Lauderdale/Hollywood International Airport after Transportation Security Administration (TSA) officials found an "arsenal of drugs", including cocaine, weed, heroin and various prescription pills hidden on his person and in his bag.
The number of dollar billionaires in India has risen to 55 this year from 46 last year.
If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US Food and Drug Administration, it may face ban on many of its products in the US market, made from the facility at Ontorio, Canada. If Taro fails to address the issues raised by the US FDA, it may face ban on many of its products.
Teva Women's Health filed a suit this week in the US District Court for New Jersey, claiming that Lupin had filed an abbreviated new drug application with the US Food and Drug Administration, which infringes the patents of Seasonale, its oral contraceptive that limits the number of menstrual periods women have in a year.
Pharmaceutical giant Ranbaxy on Monday said that it has received tentative approval from the US Food and Drug Administration to manufacture and market carvedilol tablets for treatment of cardiac disorders including hypertension.\n\n\n\n
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
The popular anti-impotence drug will be available in about 2,000 drugstores in major cities.
A slight variation of lactoferrin, known as talactoferrin alfa, helps fight lung cancer, according to research by Dr Atul Varadhachary, president and chief operating officer of the Houston-based Agennix.
The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi -- a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. 'The purpose of the appointment is to help develop food and medical product regulations and agencies improve product safety and conduct inspections in a more timely manner,' said Christopher Kelly, press officer, USFDA.
Indian drugmaker Dr Reddy's Laboratories Ltd said on Wednesday it has filed with the US Food and Drug Administration to market a generic version of Aventis Pharmaceuticals' anti-allergy drug Allegra.
Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.
These brands belong to about 320 drugs of leading Indian pharmaceutical companies. The Drug Controller General of India's (DCGI's) office feels that these have been launched without its approval.
Ranbaxy Pharmaceuticals Inc said on Tuesday it has received US Food and Drug Administration's approval for manufacturing and marketing cardiovascular drug -- Atenolol tablets in the US.
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