I was more than a little disappointed when I saw that SecuringIndustry.com had beaten me in a race to publish an essay/article about the new crazy serialization and traceability requirements published last week by the government of India. That was to be my topic for next Monday. But after reading their excellent coverage—received just as I was sitting down to begin writing—I felt better. At least I had not yet started writing! Don’t miss Phil Taylor’s excellent coverage and his link to the source regulation. See if you agree how crazy it is. The deadlines are now impossible to meet. What is the point of that? The new requirements will either result in the shutdown of the country’s entire drug export business, or they will force the Directorate General of Foreign Trade (DGFT) to push out the deadlines to avoid that business calamity. (See my earlier commentary on the pharma export serialization regulation and the work of the DGFT: Ranbaxy, FDA, FDASIA and Indian Pharma Credibility.)
While I was moping around over taking too long to write my essay on the slow train-wreck triggered by the DGFT in India, I received my near-daily article notification email from Newsweek (I’m a life-long subscriber/reader). That notice contained a link to the lead article that recounts the alarming story of the criminal quality negligence of the New England Compounding Center (NECC) in 2012. That negligence led to the deaths of 64 people, and led directly and swiftly to Congress passing the Drug Quality and Security Act (DQSA). That Act contains the Drug Compounding Quality Act (DCQA) that provides the FDA with new regulatory tools to monitor and guide compounding pharmacies. Readers of RxTrace know that the DQSA was the legislative vehicle that also contained the Drug Supply Chain Security Act (DSCSA). The nationwide catastrophe that resulted from the NECC’s negligence is what swept the DQSA, and thus the DSCSA, toward certain passage. Don’t miss this excellent piece by Kurt Eichenwald called, “Killer Pharmacy: Inside a Medical Mass Murder Case”.
It is a chilling reminder that quality is a life or death matter in our industry.