India seeks anti-fakes tools to preserve reputation

India's major pharmaceutical manufacturers and Pharmexcil, a trade group representing drug exporters, are performing due diligence on drug anti-counterfeiting and security measures to help stem what appears to be a rising tide of fakes made in China but labeled as made in India. It's a big issue for India, which has struggled with its own reputation as a fakes and substandard drugmaker.

In fact, many drug counterfeiting stories include "China" and "India" in the same sentence, early in the article. And Teva Europe CEO Gerald Van Odijk says he wants regulators to conduct dawn raids on pharma plants in India and China because price analyses show that drugmakers there must be cutting corners.

But India has worked to raise its pharma manufacturing standards--if not ethics--and undo that reputation as it begins to enjoy success with the manufacture and export of legitimate generic drugs. The current project to identify anti-counterfeiting technology--which the government may want to mandate for drugs destined for export, reports SecurePharma--is really a continuation of efforts to clean up its drug-making act on a countrywide basis.

The legitimacy of its generics is another sore spot for India. At a World Health Organization meeting in April, India expressed its concerns with use of the terms "counterfeit" and "generic," suggesting that port officials were somehow confusing the two in recent cases of drug shipment seizures at European ports on the basis of intellectual property violations. "The term ‘counterfeit' is more closely aligned with trademark issues rather than the quality, safety and efficacy issues that should drive health officials," India says in a statement.

China, by contrast, may be considered at an earlier stage of its pharma manufacturing reputation rehab. Widespread concerns remain of unchecked counterfeiting and contamination. China waffles between showing commitment to reform and then resistance. An example of the latter is its alleged stonewalling in the FDA's investigation into contaminated heparin [see related story].

But driven by the large and growing market that China represents, some see the country as reformable.  Even Luke Miels, head of Roche's pharmaceuticals unit in the Asia Pacific, says he can see how China may grow into the role of high-quality maker of local generics.

-see the article

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