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Science

The drug divide: concerns grow in the US over generics produced in India

Several products from Indian drug manufacturers are no longer allowed to enter the US market. Does that mean that drugs from India are of lower quality than those from developed countries?

You could say the US doesn't trust medicines made in India.

There have been growing concerns in recent months, with the US Food and Drug Administration (FDA) banning the importation of products from certain Indian manufacturing plants.

This includes drugs from the companies Ranbaxy Laboratories and Wockhardt.

In January, the FDA banned all products from Ranbaxy's Toansa plant.

"We are taking swift action," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, "to prevent substandard quality products from reaching US consumers."

During an on-site inspection, the FDA had found "significant violations" of drug safety regulations. The FDA says staff retested products after the items had failed initial analytical testing, without reporting or investigating the failures.

And the message has hit home.

Doctors in the US are becoming increasingly concerned about medicines produced in India in general and advising patients to avoid Indian products.

Not every Indian company is the same

Indian drug experts, however, caution against generalizing on the basis of a few singular cases.

vaccine production plant Photo: Novartis Vaccines

International safety regulations are especially strict in the production of drugs and vaccines

"Some instances in a few companies here or there does not mean that all products from India are of low quality," says Suresh Jadhav of the Serum Institute of India.

He adds there are about 300 Indian companies that work successfully to meet US standards without a problem.

Henning Blume of SocraTec R&D, a German service provider for the pharmaceutical industry, agrees there is no specific problem with Indian products - issues can arise anywhere.

"There isn't a significant difference between quality criteria in the different countries," Blume says. "When one company in India does something wrong, you cannot say that another Indian company works just as sloppily."

The process is the product

However, Indian companies have a problem documenting their production processes, says Daara Patal, the secretary general of the Indian Drug Manufacturers' Association.

"They need to be more careful and cautious about it," Patal says.

Manufacturers are required to document every step of the production process of a drug to fulfill the standards of Good Manufacturing Practice (GMP). The system of rules aims to standardize the quality of drugs.

Documentation is just a part of it - albeit a very time-consuming one. If an authority finds any faults in the documentation, it has the power to ban the product from entering the national market - just as in the case between the FDA and Ranbaxy's Toansa plant.

Blume says the rules for documentation exist for a good reason.

"There's a saying: the process is the product. Even if you only make a minor change to the production process, it can change the product, and its effect. And this needs to be monitored closely," says Blume. "So if an authority spots a change in the process, and if they see that the process has not been documented well, they can stop the production to protect consumers - and so they should."

Pharmacy in India Photo: Soeren Stache dpa

A fraction of the drugs licensed for the Indian market are allowed to be imported into Europe

A massive market

Patal, though, accuses the US of harboring a hidden agenda in its criticism of Indian drug manufacturing. A lot of other countries have had problems with FDA bans, he says, but "they highlight India because they're afraid of the Indian companies who are eating into their businesses."

The drug market is an international business, with India and China playing an expanding role.

"Eighty percent of all active pharmaceutical ingredients are manufactured in India and China," says Lembit Rago, head of Regulation of Medicines and other Health Technologies at the World Health Organization. "Europe increasingly depends on the active pharmaceutical ingredients produced in China and India."

And the same is true of the US.

Rago says the US regulators may have realized that these products lie beyond their jurisdiction and so they may be trying to increase their control of the production process in India as a counterbalance.

This may explain why the FDA has recently banned more Indian products than in the past - not necessarily because there are more faults, but because the FDA is taking a closer look.

Good enough for Europe?

A ban in the US does not automatically mean a ban in Europe. The US and the EU do not have an agreement on sharing drug licenses. And a company may even produce the same drug for the US and EU markets at different production sites.

The European Medicines Agency, Europe's version of the FDA, says it is now evaluating the deficiencies identified by the FDA at Ranbaxy's Toansa plant.

This will include an on-site inspection.

Ranbaxy's Toansa site last underwent an EU inspection by German authorities in January 2013. No critical deficiencies were found at the time. But in the light of the FDA's findings, German authorities have withdrawn their GMP certificate. A spokesperson says, however, that "there is at present no evidence suggesting that products currently on the EU market pose a risk to public health."

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