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Poor quality control for some generic drugs [ClearOnMoney]
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Poor quality control for some generic drugs

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Commentary

Poor quality control for some generic drugs

20 May 2013 by Jim Fickett.

Not all generics are quite what they seem, and it is worth learning something about the reputation of the company before accepting a product at the drugstore. That is the practical takeaway from a fascinating case history on Ranbaxy, a large Indian generics manufacturer, in a recent long article in Fortune.

Attempts to control healthcare costs have resulted in booming business for generics companies (84% of the US drug supply) and overseas factories (80% of all active pharmaceutical ingredients dispensed in the US).

Although 80% of drug manufacturing is overseas, little regulatory oversight is directed to overseas plants:

A report by the Government Accountability Office found that in 2009, regulators inspected only 11% of foreign drug manufacturing plants, while they inspected 40% of domestic ones.

The FDA has increased its inspections of foreign plants in recent years with a goal of reaching parity with the frequency of domestic inspections. It now has agents based in India and other countries. But even if the frequency were equal, the inspections themselves are not. Due to complex logistics, foreign inspections can last less than a week and allow companies weeks of advance notice, while domestic ones can last up to six weeks and are unannounced. “The reality is that we simply don't know what we're dealing with,” says Dr. Roger Bate, an international pharmaceutical expert. “No one has actually gone into these sites to expose what's going on.”

Fortune goes into considerable detail for one case where more regulation was/is clearly needed. It would seem that at Ranbaxy wholesale fabrication of results, fraudulent regulatory filings, and substandard products were all standard operating procedure:

Lying to regulators and backdating and forgery were commonplace, [Thakur, a whistelblower] says. The company even forged its own standard operating procedures, which FDA inspectors rely on to assess whether a company is following its own policies. Thakur's team was told of one instance in which company officials forged and backdated a standard operating procedure related to how patient data are stored, then aged the document in a “steam room” overnight to fool regulators.

Company scientists told Thakur's staff that they were directed to substitute cheaper, lower-quality ingredients in place of better ingredients, to manipulate test parameters to accommodate higher impurities, and even to substitute brand-name drugs in lieu of their own generics in bioequivalence tests to produce better results. …

[According to an internal report based on data from the whistleblower] “the majority of products filed in Brazil, Mexico, Middle East, Russia, Romania, Myanmar, Thailand, Vietnam, Malaysia, African Nations, have data submitted which did not exist or data from different products and from different countries …” The company not only invented data but also fraudulently mixed and matched data, taking the best results from manufacturing in one market and presenting it to regulators elsewhere as data unique to the drugs in their markets. …

In September 2008, [the US FDA] announced it was restricting the import of 30 drug products made by Ranbaxy (11 of which had been approved after Thakur's first contact with the FDA three years earlier) … finding that Ranbaxy had committed fraud on a massive scale.

Those at the FDA and within Ranbaxy who know the facts are reluctant to use the company's drugs.

congressional … investigators interviewed the FDA inspectors who went to Paonta Sahib and asked them a simple question: Would they feel comfortable taking Ranbaxy drugs? “Every single inspector that went to India said they would never take a Ranbaxy drug,” says Nelson, “like eight out of eight.”

They were not alone. One by one, each of the former Ranbaxy executives Fortune interviewed had determined, while still at the company, to stop taking Ranbaxy drugs.”