Tuesday, July 22, 2008

Ranbaxy; More Concern over Substandard Medications

This year of 2008 should go down in the history books as the year of drug safety concerns. The latest concerns are over FDA accusations that Ranbaxy Laboratories sold substandard drugs and knowingly concealed the facts.

Ranbaxy is one of India’s largest generic manufacturers and 25% of their sales are in the U.S. They have been accused of using raw materials from unapproved sources in one of their northern India plants and altering in-house testing to meet FDA standards which resulted in sub-potent, super-potent or adulterated products.

"The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products" into the US market, federal prosecutors said.

This coupled with earlier cases this year of adulterated heparin from China, has left consumers doubting the safety of their medications. Most troubling is that the current methods being considered would not be effective in verifying the validity or purity of the drug itself.

Incidents such as this illustrate the need for an authentication of the product as a way to protect all of the members of the Pharmaceutical Supply Chain and most importantly the consumer. Track and Trace technologies (pedigrees and RFID) will not protect the consumer from these types of incidents which we can expect to happen more frequently as we continue to increase our reliance on global sources for our medications. Only XStream Systems’ XT250 has the solution to authenticating the product inside the sealed container. This is the only solution to this clear and present danger.

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