The banned drugs Aussies can buy

Banned drugs ... medicines made at an Indian factory are not being imported into the US and Canada. Picture: AFP Source: AFP

THE safety of Australian medicines is under question with lax regulation here allowing the sale of drugs that are banned in the US and Canada.

Up to 20 medicines made in India for Canadian pharmaceutical company Apotex — which supplies a fifth of Australia's generic medicines — have been banned overseas because of "significant concerns".

But our medicine watchdog is allowing them into Australia.

Checks by the US FDA found the company which makes antibiotics, blood pressure, asthma, pills and a generic viagra was manipulating quality testing data.

It moved to ban imports from the factories in April, Canadian regulators banned the products in September.

The pharmaceutical company supplies medicines that make up around 18 per cent of the Australian generic medicine market.

Questions loom ... US FDA inspections of Apotexc's Indian factories found deviations from good manufacturing processes. Picture News Corp Australia Source: News Corp Australia

Canada's regulator said it had "significant concerns" and "serious doubts" about the company's drug safety and quality data.

The US FDA said it had 'identified deviations from current good manufacturing process'.

Our medicine watchdog the Therapeutic Goods Administration says it is aware of the US and Canadian actions.

News Corp has learned it inspected the Indian factory in late August but did not ask Apotex to suspend imports of medicines from India.

"There is no evidence to suggest that medicines manufactured by Apotex, Ranbaxy or other manufacturers reaching the Australian market, do not meet the quality standards mandated by therapeutic goods legislation," the TGA said.

The TGA says it inspected Apotex at the same time as Candaian regulators in August.

That inspection did identify issues with the company's manipulation of quality testing data, the TGA said.

"Their nature and the risk posed to product quality and safety did not justify an enforced cessation of supply. Corrective actions were reviewed and considered acceptable, pending ongoing review of their implementation," the regulator said in a statement..

Suppliers probed ... the TGA says it has inspected Apotex's India factories. Picture: Thinkstock Source: ThinkStock

"The TGA will continue to rely upon its own detailed analyses of information and, in so doing, make independent risk-based decisions on the acceptability of manufacturers to continue supplying, or commence supply, to the Australian market," the TGA said.

The TGA says neither the FDA nor Health Canada has initiated recalls of any Apotex product as a result of the FDA's inspection findings.

News Corp contacted Apotex but they refused to provide an official comment.

The issue has highlighted the supreme secrecy surrounding pharmaceutical factory checks by our regulator.

The TGA does not make public the results of any of the checks. Often it relies on the reports and inspections of other regulators to approve a manufacturing facility.

Consumer's Health Forum chief Adam Stankevicius said the case was concerning and showed it was time the TGA made public the results of its inspections of the factories that make our medicines.

"We expect information like this, particularly when they are relying on overseas regulators." he said.

"We need to have a high level of transparency about the information the TGA is relying on particularly 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 protect their safety, " he said.

The case also highlighted major problems with the government's new plans to accept medicines and devices approved by other country's regulators.

"If it is appropriate to automatically accept devices and drugs approved overseas, the regulator needs to also apply safeguards when they are banned otherwise it would leave Australia open to high levels of suspect devices and that is a concern," he said.

Concerns raised ... over quality testing of medicines in Indian factories. Picture News Corp Australia Source: News Limited

Health Canada says certain medically necessary products made by Apotex may be excluded from the ban on the condition they are tested by an independent third party.

Drugs included in the health Canada ban 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 (antiviral cytomegalovirus)

Valsartan (high blood pressure)

Tenormin (angina and chest pain)

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