WHAT IS THE MEANING OF “ADULTERATED”?
Pharma Evolution just released an “abridged” Blog, “WHO, TGA & MHRA: Just What Does the Word ‘Adulterated’ Mean?” (see below).(http://www.pharmaevolution.com/author.asp?section_id=3055&doc_id=560475)
Should you wish to read and comment on this abridged version, please go to the location listed above. To view the total Blog, continue reading below.
As many of my readers know and appreciate, the FDA releases regulatory information to include Warning Letters and periodically Form FDA 483s and various other miscellaneous Regulatory documents on a frequent basis. When one begins to seek this documentation from other countries’ Regulatory Agencies, this information is often difficult to obtain unless the Regulatory Agency within that country wants to share their findings, e.g., MHRA Press Release June 13, 2013 Ranbaxy Laboratories.
Over the past several years I have “blogged” about Ranbaxy (see February 1, 2012; http://barryafriedmanphdllc.wordpress.com/) and the various issues that they have encountered with various Regulatory authorities within India and other countries where they manufacture their products. With the pharmaceutical industry essentially becoming a single world-wide market for procurement of drugs, it has become more important for the educated user to know who is manufacturing the drugs they are using and learning about Regulatory issues within each of these manufacturing Companies.
Thus, it was of great interest when I recently noticed several reports from India, MHRA, TGA and WHO where they recently indicated that each of these Regulatory organizations had provided a “clean bill of Regulatory Health” to Ranbaxy – even after the FDA levied a $500 million dollar fine against this Company.
What made these reports even more interesting is that the various Regulatory Agencies within several countries had removed the “veil of silence” and were permitting the public to learn that, in fact, they had also either individually or in concert with other countries’ Regulatory groups audited Ranbaxy and also had obtained various samples that were tested within their laboratories and found each sample to meet specifications. Of course, when one witnesses the numerous quantities of tablets and capsules manufactured, one must recognize that these samples hardly represent an AQL. Yet, these Regulatory organizations had to further justify their findings by advising their local population as well as the world’s population of drug users that by obtaining and testing these samples that Ranbaxy was manufacturing safe product.
Interestingly, in a recent WHO document entitled “Participation of Ranbaxy Laboratories Limited in WHO Medicines Prequalification” (May 2013), WHO wrote “On 13 May 2013, the US Justice Department announced that Ranbaxy USA Inc., a subsidiary of Ranbaxy Laboratories Limited, had pleaded guilty to felony charges relating to the manufacture and distribution of adulterated drugs (including Sotret, gabapentin, and ciprofloxacin) made at two Ranbaxy facilities in India. Ranbaxy agreed to pay a US$ 150 million penalty and to settle civil claims under the False Claims Act and related State laws for US$350 million.1, 2”
Footnote 2 at the bottom of the page provides a very interesting commentary on WHO’s overall thinking when it states “In the USA, the term “adulterated” has a specific legal meaning. If a company is not complying with Current Good Manufacturing Practice Regulations (cGMP), any medicines that it manufactures are considered to be “adulterated” under the law. In other words, its medicines are not manufactured under conditions that comply with cGMP. It does not mean that the medicine is necessarily substandard.”
Based on this footnote, it would be very interesting to engage the FDA and WHO in a dialogue regarding the meaning of “adulterated”. Is this the method by which WHO “gets around” cGMPs and justifies the selling of not only Ranbaxy’s products, but other products manufactured by other Companies that do not meet cGMPs? Let’s learn of your interpretation of this.