Indian regulators will be notified when the Food and Drug Administration U.S. is inspecting plants that produce generic drugs in the country, and join to observe the standards of the FDA.
The agreement between government officials in India and FDA Commissioner Margaret Hamburg came during his visit to India this week, the FDA said yesterday. Hamburg, who told Bloomberg News, last week that expanded inspections of overseas plants, also met in a closed session with 16 pharmaceutical companies and affiliated groups in India to discuss the quality of manufacture.
U.S. lawmakers are scheduled to listen to the doctors, researchers and patient advocates at a conference of 26 February on whether generics inferior leaks in the U.S. medical system abroad. Harry Lever, a cardiologist at the Cleveland Clinic, said he will tell them that generic drugs manufactured by companies based in India for heart failure often do not work as they should, opening questions about the FDA's ability to track growth of generics business of India.
"It's like taking a squad to fight a huge army," Lever said in a telephone interview, referring to the efforts of the FDA to inspect drug plants in India.
Lever said he is awaiting test results of samples sent to questionable drugs Preston Mason, a researcher at Brigham and Women's Hospital in Boston. Mason previously reviewed the generic versions of Pfizer Inc. (PFE)’s Lipitor 15 countries and factory waste sometimes rendered ineffective drugs were found.
Pills produced by U.S. generic manufacturer Mylan Inc. (MYL) and Actavis Plc (ACT) were not contaminated, as reported by Mason in his research published in the June issue of the Journal of Clinical Lipidology.
Charges collected
in 2012, the FDA gave it the power to collect fees from manufacturers of generic drugs, in part, to pay for increased inspections of facilities outside the U.S. While the Indian government has cleared the way for the FDA to increase the number of staff members at December 19, it is unclear how many are based today. The agency has refused to provide a number.
Congressional aides are watching how well the FDA ramps up inspections abroad and may raise the issue of the quality of medicines as part of an oversight hearing of the FDA in the Senate in the coming months, according to a staff member on the Senate Health, Education, Labor and pension Committee was not authorized to speak publicly about it.
Generic drug makers Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL), whose executives were among those attending the meeting with Hamburg, has banned the sale of drugs in the U.S. plants from India due to quality problems. In the latest incident last month, a fourth installation Ranbaxy was banned from U.S. exports after FDA inspectors found drugs were re-evaluated to obtain favorable results after the initial analysis failed.
The agreement between government officials in India and FDA Commissioner Margaret Hamburg came during his visit to India this week, the FDA said yesterday. Hamburg, who told Bloomberg News, last week that expanded inspections of overseas plants, also met in a closed session with 16 pharmaceutical companies and affiliated groups in India to discuss the quality of manufacture.
U.S. lawmakers are scheduled to listen to the doctors, researchers and patient advocates at a conference of 26 February on whether generics inferior leaks in the U.S. medical system abroad. Harry Lever, a cardiologist at the Cleveland Clinic, said he will tell them that generic drugs manufactured by companies based in India for heart failure often do not work as they should, opening questions about the FDA's ability to track growth of generics business of India.
"It's like taking a squad to fight a huge army," Lever said in a telephone interview, referring to the efforts of the FDA to inspect drug plants in India.
Lever said he is awaiting test results of samples sent to questionable drugs Preston Mason, a researcher at Brigham and Women's Hospital in Boston. Mason previously reviewed the generic versions of Pfizer Inc. (PFE)’s Lipitor 15 countries and factory waste sometimes rendered ineffective drugs were found.
Pills produced by U.S. generic manufacturer Mylan Inc. (MYL) and Actavis Plc (ACT) were not contaminated, as reported by Mason in his research published in the June issue of the Journal of Clinical Lipidology.
Charges collected
in 2012, the FDA gave it the power to collect fees from manufacturers of generic drugs, in part, to pay for increased inspections of facilities outside the U.S. While the Indian government has cleared the way for the FDA to increase the number of staff members at December 19, it is unclear how many are based today. The agency has refused to provide a number.
Congressional aides are watching how well the FDA ramps up inspections abroad and may raise the issue of the quality of medicines as part of an oversight hearing of the FDA in the Senate in the coming months, according to a staff member on the Senate Health, Education, Labor and pension Committee was not authorized to speak publicly about it.
Generic drug makers Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL), whose executives were among those attending the meeting with Hamburg, has banned the sale of drugs in the U.S. plants from India due to quality problems. In the latest incident last month, a fourth installation Ranbaxy was banned from U.S. exports after FDA inspectors found drugs were re-evaluated to obtain favorable results after the initial analysis failed.
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