Prohibited drugs ... Drugs made at a factory in India are not imported into the US and Canada.
The safety of medicines in Australia are concerned here with lax regulation allowing the sale of drugs that are banned in the US and Canada.
Up to 20 medicines manufactured in India by the Canadian pharmaceutical company Apotex - which supplies a fifth of Australia generics - have been banned overseas because of "significant concerns".
But our medical surveillance is allowing them to Australia.
Checks by the US FDA found the company that makes antibiotics, blood pressure, asthma, pills and generic viagra was manipulating data quality tests.
He moved to prohibit imports from factories in April, Canadian regulators banned the products in September.
The pharmaceutical company that provides medicines make up about 18 percent of the market for generic drugs in Australia.
Questions loom ... FDA inspections of US pig factories Apotexc found deviations from good manufacturing processes. News Corp Australia Image Source: News Corp Australia
Canada regulator said it had "significant concerns" and "serious doubts" about data security and quality of the company's products.
The US FDA said it had "identified deviations from current good manufacturing process.
Our medical surveillance Therapeutic Goods Administration says it is aware of the US and Canadian stocks.
News Corp has learned that inspected the factory in India in late August, but did not ask Apotex suspend imports of medicines from India.
"There is no evidence to suggest that drugs manufactured by Apotex, Ranbaxy or other manufacturers coming to the Australian market, do not meet the quality standards required by the law of therapeutic goods," said TGA.
TGA Teva said inspected while the Candaian regulators in August.
The inspection identified problems with the handling of data quality testing company, said the TGA.
"His nature and the risk it poses to the quality and safety of the product does not justify the forced termination of the offer. The corrective actions were reviewed and found acceptable, pending an ongoing review of its implementation," the regulator said in a statement...
Suppliers tested ... the TGA says it has inspected the factories of India Apotex. Picture: Thinkstock Source: Thinkstock.
"The TGA will continue to rely on their own detailed analysis of information and in doing so, make decisions based on risk acceptability independent manufacturers to continue to provide, or initiate delivery to the Australian market," said TGA .
The TGA says neither the FDA nor Health Canada has begun withdrawing any product from Apotex, as a result of the findings of FDA inspection.
Apotex Corp News contacted but refused to provide an official comment.
The case has highlighted the supreme secrecy surrounding pharmaceutical factory controls by our regulator.
The TGA does not disclose the results of any of the controls. Often based on inspection reports and other regulators to approve a manufacturing plant.
Health Forum Adam Stankevicius Consumer chief said the case was disturbing and showed that it was time for the TGA released the results of its inspections of the factories that make our medicines.
"I hope the information of this type, especially when regulators are relying on overseas." He said.
"We have to have a high level of transparency about the information the TGA is relying in particular if it is out of step with other regulators," he said.
"Consumers should have access so they can see the necessary procedures have been followed to ensure your safety," he said.
The case also highlights the main problems with the new government plans to accept medicines and approved by regulatory agencies in other countries devices.
"If appropriate automatically accept devices and drugs approved abroad, the regulator must also implement security measures that are forbidden Australia would otherwise open to high levels of suspicious devices and it's a concern," he said.
Concerns raised over quality testing of medicines in Indian factories. News Corp Australia Image Source: News Limited
Health Canada says certain necessary medical products made by Apotex may be excluded from the ban on the condition they are tested by an independent third party.
The drugs included in the prohibition of Health Canada include:
Atenolol (angina and chest pain)
Candesartan (high blood pressure)
Irbesartan (high blood pressure)
Losartan (high blood pressure and stroke)
Methylphenidate (attention deficit hyperactivity disorder)
Metoclopramide (reflux)
Valganciclovir (CMV antiviral)
Valsartan (high blood pressure)
Tenormin (angina and chest pain)
The safety of medicines in Australia are concerned here with lax regulation allowing the sale of drugs that are banned in the US and Canada.
Up to 20 medicines manufactured in India by the Canadian pharmaceutical company Apotex - which supplies a fifth of Australia generics - have been banned overseas because of "significant concerns".
But our medical surveillance is allowing them to Australia.
Checks by the US FDA found the company that makes antibiotics, blood pressure, asthma, pills and generic viagra was manipulating data quality tests.
He moved to prohibit imports from factories in April, Canadian regulators banned the products in September.
The pharmaceutical company that provides medicines make up about 18 percent of the market for generic drugs in Australia.
Questions loom ... FDA inspections of US pig factories Apotexc found deviations from good manufacturing processes. News Corp Australia Image Source: News Corp Australia
Canada regulator said it had "significant concerns" and "serious doubts" about data security and quality of the company's products.
The US FDA said it had "identified deviations from current good manufacturing process.
Our medical surveillance Therapeutic Goods Administration says it is aware of the US and Canadian stocks.
News Corp has learned that inspected the factory in India in late August, but did not ask Apotex suspend imports of medicines from India.
"There is no evidence to suggest that drugs manufactured by Apotex, Ranbaxy or other manufacturers coming to the Australian market, do not meet the quality standards required by the law of therapeutic goods," said TGA.
TGA Teva said inspected while the Candaian regulators in August.
The inspection identified problems with the handling of data quality testing company, said the TGA.
"His nature and the risk it poses to the quality and safety of the product does not justify the forced termination of the offer. The corrective actions were reviewed and found acceptable, pending an ongoing review of its implementation," the regulator said in a statement...
Suppliers tested ... the TGA says it has inspected the factories of India Apotex. Picture: Thinkstock Source: Thinkstock.
"The TGA will continue to rely on their own detailed analysis of information and in doing so, make decisions based on risk acceptability independent manufacturers to continue to provide, or initiate delivery to the Australian market," said TGA .
The TGA says neither the FDA nor Health Canada has begun withdrawing any product from Apotex, as a result of the findings of FDA inspection.
Apotex Corp News contacted but refused to provide an official comment.
The case has highlighted the supreme secrecy surrounding pharmaceutical factory controls by our regulator.
The TGA does not disclose the results of any of the controls. Often based on inspection reports and other regulators to approve a manufacturing plant.
Health Forum Adam Stankevicius Consumer chief said the case was disturbing and showed that it was time for the TGA released the results of its inspections of the factories that make our medicines.
"I hope the information of this type, especially when regulators are relying on overseas." He said.
"We have to have a high level of transparency about the information the TGA is relying in particular if it is out of step with other regulators," he said.
"Consumers should have access so they can see the necessary procedures have been followed to ensure your safety," he said.
The case also highlights the main problems with the new government plans to accept medicines and approved by regulatory agencies in other countries devices.
"If appropriate automatically accept devices and drugs approved abroad, the regulator must also implement security measures that are forbidden Australia would otherwise open to high levels of suspicious devices and it's a concern," he said.
Concerns raised over quality testing of medicines in Indian factories. News Corp Australia Image Source: News Limited
Health Canada says certain necessary medical products made by Apotex may be excluded from the ban on the condition they are tested by an independent third party.
The drugs included in the prohibition of Health Canada include:
Atenolol (angina and chest pain)
Candesartan (high blood pressure)
Irbesartan (high blood pressure)
Losartan (high blood pressure and stroke)
Methylphenidate (attention deficit hyperactivity disorder)
Metoclopramide (reflux)
Valganciclovir (CMV antiviral)
Valsartan (high blood pressure)
Tenormin (angina and chest pain)
