WHO, TGA & MHRA: Just What Does the Word 'Adulterated' Mean?
The FDA publishes Warning Letters, 483s, and other regulatory documents on a regular basis. However, even in this age of "regulatory harmonization," it can be difficult to get the same information from other global regulatory authorities, unless they want to share it. Different global agencies also seem to interpret the word "adulterated" differently. Recent communications they’ve sent suggest that they may view a company’s products as not being adulterated, even when the FDA has cited the manufacturer for failing to follow current good manufacturing practices (cGMPs). This disconnect is a problem, since the pharma industry has essentially become one single world-wide market. Educated consumers need to know who is making the medicines they take, and whether there have been any quality or other issues with those drugs. So I was very interested to note several reports from India, MHRA, TGA, and the WHO indicating that each of these regulatory organizations had provided a “clean bill of Regulatory Health” to Ranbaxy -- even after the FDA levied a $500-million dollar fine against this company.
What made these reports even more interesting is the fact that the three agencies allowed the public to learn that they had also audited Ranbaxy, obtained various product samples and tested them, and found each sample to meet specifications.
Of course, when one considers the vast quantities of tablets and capsules manufactured, one must recognize that these samples hardly represent an acceptable quality level (AQL). Yet, these regulatory agencies seemed to need to justify their findings, by advising the public that their findings suggested that Ranbaxy was manufacturing safe product.
Interestingly, in a May 2013 report entitled "Participation of Ranbaxy Laboratories Limited in WHO Medicines Prequalification," WHO wrote: “On 13 May 2013, the US Justice Department announced that Ranbaxy USA Inc., a subsidiary of Ranbaxy Laboratories Limited, had pleaded guilty to felony charges relating to the manufacture and distribution of adulterated drugs (including Sotret, gabapentin, and ciprofloxacin) made at two Ranbaxy facilities in India. Ranbaxy agreed to pay a US$ 150 million penalty and to settle civil claims under the False Claims Act and related State laws for US$350 million.”
Footnote 2 of the report provides some interesting insight into 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? What are your thoughts? Please let me know in a comment. You'll find more of my analysis of Ranbaxy on my blog.
source link:
WHO, TGA & MHRA: Just What Does the Word 'Adulterated' Mean? - Barry A. Friedman | Pharma Evolution
What made these reports even more interesting is the fact that the three agencies allowed the public to learn that they had also audited Ranbaxy, obtained various product samples and tested them, and found each sample to meet specifications.
Of course, when one considers the vast quantities of tablets and capsules manufactured, one must recognize that these samples hardly represent an acceptable quality level (AQL). Yet, these regulatory agencies seemed to need to justify their findings, by advising the public that their findings suggested that Ranbaxy was manufacturing safe product.
Interestingly, in a May 2013 report entitled "Participation of Ranbaxy Laboratories Limited in WHO Medicines Prequalification," 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.”
Footnote 2 of the report provides some interesting insight into 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? What are your thoughts? Please let me know in a comment. You'll find more of my analysis of Ranbaxy on my blog.
source link:
WHO, TGA & MHRA: Just What Does the Word 'Adulterated' Mean? - Barry A. Friedman | Pharma Evolution
