Showing posts with label DRUGS. Show all posts
Showing posts with label DRUGS. Show all posts
Friday, August 30, 2013
Regulatory Actions against 4 Indian Drug Companies
New Delhi, India, August 30, 2013 - US Food and Drug Administration (FDA) has taken certain regulatory actions in respect of violations or deviations of US FDA regulations applicable in that country in the cases of the following Indian Pharmaceutical companies:-
1. M/s Ranbaxy Laboratories Ltd.,
2. M/s Wockhardt Ltd.,
3. M/s Hospira Healthcare India Pvt. Ltd.,
4. M/s RPG Life Sciences Ltd.,
The Drugs Controller General (India) [DCG(I)] has taken appropriate measures to ensure that the said firms manufacture drugs in compliance with the standards and Good Manufacturing Practices prescribed for them under the Drugs and Cosmetics Rules, 1945 through the system of inspections and testing of drugs.
This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the LokSabha today.
Friday, March 23, 2012
Israeli drug-lord Atala gets bail from Indian court
Panaji, (India), March 22, 2012 - Israeli national Yaniv Benaim alias Atala, a key accused in police-drug dealers nexus case in Goa, was given bail by a local court today.
Atala was arrested by CBI in Lima, Peru, after Interpol nabbed him there. The drug-lord had earlier jumped the bail here, and escaped to Israel before heading for Peru.
Narcotic Drugs and Psychotropic Substances (NDPS) court today granted Atala bail on personal bond of Rs 50,000, and also reprimanded from interfering with the investigations.
He has been asked to make himself available to CBI as and when required in the course of probe.
Seven Goa policemen have been arrested and suspended in the case. The investigation also put spotlight on Roy, the son of former Home Minister Ravi Naik, for alleged involvement in running a drug cartel.
Atala was exposed through a sting operation by his former girlfriend, Lucky Farmhouse, a Swedish model. The video clips of Atala boasting about his links to the policemen were uploaded on social networking websites in 2008, which caught attention of the media only two years later.
He was arrested in March 2010 by local police, but got bail, and escaped, only to be arrested in Peru. The case was later handed over to CBI after National Students Union of India (NSUI) moved the Bombay High Court.
Atala was arrested by CBI in Lima, Peru, after Interpol nabbed him there. The drug-lord had earlier jumped the bail here, and escaped to Israel before heading for Peru.
Narcotic Drugs and Psychotropic Substances (NDPS) court today granted Atala bail on personal bond of Rs 50,000, and also reprimanded from interfering with the investigations.
He has been asked to make himself available to CBI as and when required in the course of probe.
Seven Goa policemen have been arrested and suspended in the case. The investigation also put spotlight on Roy, the son of former Home Minister Ravi Naik, for alleged involvement in running a drug cartel.
Atala was exposed through a sting operation by his former girlfriend, Lucky Farmhouse, a Swedish model. The video clips of Atala boasting about his links to the policemen were uploaded on social networking websites in 2008, which caught attention of the media only two years later.
He was arrested in March 2010 by local police, but got bail, and escaped, only to be arrested in Peru. The case was later handed over to CBI after National Students Union of India (NSUI) moved the Bombay High Court.
Wednesday, September 28, 2011
Increased Risk of Blood Clots with Certain Birth Control Pills
PHILADELPHIA, Sept. 28, 2011 - On Monday, the United States Food and Drug
Administration ("FDA") said its primary results of an agency funded
study suggest a 1.5 fold increase risk of blood clots for women who use
drospirenone-containing birth control products, such as Yaz and Yasmin.
The safety of Yaz and Yasmin is the subject of approximately 2,000 lawsuits filed in Pennsylvania before Philadelphia Court of Common Pleas Judge Sandra Mazer Moss, Coordinating Judge of the Complex Litigation Center. Another 7,110 lawsuits are pending in federal court before the Honorable Judge David R. Herndon, who oversees the federal multidistrict litigation (MDL).
The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills and that Bayer over-promoted the drug without disclosing the higher risks. Bayer was warned by the Food and Drug Administration (FDA), in the fall of 2008, that its television advertisements were misleading and did not disclose the additional risks.
The FDA announced through its website that, "initial data from an FDA-funded epidemiologic study exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with results from the 2009 and 2011 published studies. Although FDA's review is ongoing, the preliminary data from the FDA-funded study are consistent with an approximately 1.5-fold increase in the risk of blood clots for users of drospirenone-containing contraceptives compared to users of other hormonal contraceptives."
Judge Moss appointed three Pennsylvania lawyers as Liaison Counsel for the plaintiffs, including Michael M. Weinkowitz of Levin, Fishbein, Sedran & Berman, Philadelphia; Daniel N. Gallucci of RodaNast, P.C., Lancaster, and Rosemary Pinto of Feldman & Pinto, Philadelphia. Dianne M. Nast, RodaNast, P.C. was appointed Pennsylvania Federal-State Liaison Counsel by the Honorable David R. Herndon.
The safety of Yaz and Yasmin is the subject of approximately 2,000 lawsuits filed in Pennsylvania before Philadelphia Court of Common Pleas Judge Sandra Mazer Moss, Coordinating Judge of the Complex Litigation Center. Another 7,110 lawsuits are pending in federal court before the Honorable Judge David R. Herndon, who oversees the federal multidistrict litigation (MDL).
The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills and that Bayer over-promoted the drug without disclosing the higher risks. Bayer was warned by the Food and Drug Administration (FDA), in the fall of 2008, that its television advertisements were misleading and did not disclose the additional risks.
The FDA announced through its website that, "initial data from an FDA-funded epidemiologic study exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with results from the 2009 and 2011 published studies. Although FDA's review is ongoing, the preliminary data from the FDA-funded study are consistent with an approximately 1.5-fold increase in the risk of blood clots for users of drospirenone-containing contraceptives compared to users of other hormonal contraceptives."
Judge Moss appointed three Pennsylvania lawyers as Liaison Counsel for the plaintiffs, including Michael M. Weinkowitz of Levin, Fishbein, Sedran & Berman, Philadelphia; Daniel N. Gallucci of RodaNast, P.C., Lancaster, and Rosemary Pinto of Feldman & Pinto, Philadelphia. Dianne M. Nast, RodaNast, P.C. was appointed Pennsylvania Federal-State Liaison Counsel by the Honorable David R. Herndon.
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