We’ve seen this sequence of events before in China, Brazil, and India, and now they may be happening in the Russian Federation. The government issues regulatory requirements mandating pharma serialization and tracing with crazy-aggressive deadlines and with confusing, sometimes illogical requirements. Amendments are issued, sometimes helping, sometimes making things worse. Then just before (or just after) the deadline, when confusion reigns, someone else in the government issues calls for rationality, and the government quickly folds their requirements, rethinks and retrenches. In China and Brazil it resulted in a full withdrawal and total redesign of their entire approach…and much more reasonable deadlines. So far in India it has mostly just resulted in pushing the deadline out, again and again, but even there, there are signs that some are proposing a complete withdrawal and redesign. So far in the Russian Federation, all we have is the posting of a set of very rational recommendations by a group of participants in parliamentary hearings of the State Duma Committee on Health Protection. Their hearings were apparently related to the spotty readiness of the government and industry and their report comes less than 3 months from the deadline for serialization and tracing of all drugs.Continue reading Russia: Rationality Makes An Appearance at the 11th Hour. Will It Matter?
What is a counterfeiter to do today? Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line. It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities. Or is it? Let’s take a closer look.Continue reading Pharma Counterfeiter Strategies In a Track & Trace World
Earlier this month the Russian Federation finally amended Decree #1556 to cut the length of the Signature portion of the crypto-code element of their pharmaceutical unique identifier in half. Will that solve the problems the industry uncovered, like the barcode taking up so much space and slow read performance? Let’s take a closer look at it, but first, a review.Continue reading Russia Officially Cuts Length of Crypto-code in Half
CRPT, the company authorized to conduct the development, piloting and operation of the Russian government pharmaceutical serialization and tracing system, posted an important document last week. The document is intended “…to unify the process of testing printing on the packaging of medicinal products of identification features using the verification code and electronic signature with the content in it of a different number of characters and the aggregation process of drug manufacturers to obtain comparable test results and their applicability in the framework of industrial implementation.” Will it help you?Continue reading Russia: CRPT Posts Test Methodology For Crypto Code
I’m not talking about the mixed signals from Russia in your daily political newsfeed, I’m talking about the mixed signals we see between the Russian Federation decrees for their pharma serialization and traceability mandate, and the announcements of the government’s designated technology contractor to develop that system: CRPT, LLC. Considering how short the deadlines are, these mixed signals are counterproductive because they cause companies to pause while they figure out what they should do. Let me explain.Continue reading Mixed Signals From Russia
Since my last essay about the Russia Crypto-Code (a.k.a., Crypto-Tail) (see “New Direction For Pharma Serialization In The Russian Federation”), Russia has published little of value in document form about the requirements or the technology. I have heard rumors that the pilots conducted with the Crypto-Code have failed. Interestingly, according to the Center for Research in Perspective Technologies (CRPT), the Russian 50-50 public-private company now under contract with the government there to define and implement the technology, those same pilots were a smashing success. I am skeptical of that reported success, but let’s take a look at some of the details they have provided. Continue reading More Details On The Russian Crypto-Code
Over the last 18 months or so, the Ministry of Health in the Russian Federation has been conducting a pilot to learn what works and what doesn’t work for pharma serialization and tracing (see “Russia Begins Its Pharma Supply Chain Pilot” and “The Russia Serialization Pilot Guideline”). They were due to publish a report on their findings in February of this year, but we are still watching for that. As we’ve learned over the years, it’s not uncommon for governments to miss their deadlines, at the same time, making tough statements about the industry needing to meet theirs, followed by caving on those deadlines too (See US, China, Brazil, US, India, Pakistan…). That pattern is repeating in Russia. Continue reading New Direction For Pharma Serialization In The Russian Federation
The Russia Ministry of Health (MoH) is conducting a serialization and tracing pilot with a number of supply chain members between February 1, 2017 and December 31, 2017 (see “Russia Begins Its Pharma Supply Chain Pilot”). The MoH is due to publish an assessment of the pilot by next February 1st.
Two weeks ago the Russian Minister of Health, Veroníka Skvortsova, signed the guidelines document for the pilot. The 42-page document appears to be written as a pilot setup document, as opposed to Continue reading The Russia Serialization Pilot Guideline