The following is a guest posting to the Supply Chain Matters blog.

Bob called my attention to a June 25 ProcurementLeaders.Com article, Analysis: The Battle for pharma supply chain security, which notes that a recent UPS 2010 ‘Pain in the (Supply) Chain Survey’ of healthcare and pharmaceutical executives “showed a marked degree of concern around product safety”.  These same executives noted in the survey reported “that they are planning to expand into emerging countries.”

What does that mean for consumers such as myself ?

I recently went to a national chain pharmacy and picked up a generic prescription.  I was informed that this time there was a new pharma company from which this vendor was purchasing this generic, so I should not to be alarmed if I noticed a slight difference in color, size, or markings on the pill.  Well, since I had not ever really thought about from where my generic came, having the attention called out to me, I did get concerned.  The bottle did have a nice sounding American style pharma company name under the generic title, so I felt a bit relieved, but decided to check it all out on-line to see just what this company was all about.  Now I was interested.  Where was my generic made?

To my surprise, the American pharma company acquires, licenses, develops, markets, sells and distributes  generic products for the global prescription market and uses “strategic outsourcing” from Asia and North America.  The company clearly states that it uses sources that are U.S.  FDA qualified manufacturing and development.  The issue, however, is that I still don’t know from where my generic drug comes- China, India, Mexico, Russia, Japan???   So, I must trust that this particular pharma company cares about my well being more than it cares about its profit margin.

Given that my experience is not unusual, I worry, especially since, as the above article notes that “studies have shown that hundreds of thousands of people die each year because of dubious medicine” and “concerns about product safety are fuelled by a disturbingly high volume of counterfeit products…and pirated goods” that find their way into the supply chain.  This is a consumer’s nightmare.

Now, let’s add the movement toward expanding into emerging markets.  India is the third largest pharmaceutical industry in the world, by volume, has over 20,000 registered drug manufacturers, and defined manufacturing and production standards.  At least 74 of these manufacturing facilities are U.S.  FDA approved. (Pharmaceuticals in India – Wikipedia)   If this is indeed the case, then what is the case in an emerging market with limited experience and few or non-existent standards?

ProcurmentLeaders.Com notes that companies need to put a “track-and-trace system” in place to identify the source of tainted or counterfeit drugs that may enter their supply chains and need to put supply security measures in place to limit the possibilities. Supply chain risk strategies reduce problems, increase quality control, and allay consumer fears. These may be expensive, but they are good for business.

We, the consumers, are subject to the business practices and standards of big pharma.  We must be vigilant and give scrutiny to our generic drug prescriptions and demand that all pharma companies utilize only U.S. FDA approved organizations.  It’s not perfect, but, for now, it is the best we have.

If readers need more information about U.S. FDA Compliance and Quality Systems you can go to:

Guidance for Industry- Quality Systems Approach to Pharmaceutical CGMP Regulations

US Food and Drug Administration Compliance Program Guidance Manual- Chapter 56 Drug Quality Assurance: API Process Inspection Guidance

Marie Ferrari