Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation). But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”. These details are for drugs made in India but exported to other markets. Continue reading India Posts New Deadlines (Again) For Serialization Of Drug Exports
Last month India’s Central Government published a proposal for comment that, if enacted, would cause all drugs entering the Indian domestic supply to contain unique serial numbers encoded within 2D barcodes, and including aggregation and data reporting–all 180 days after publication of the final rule.
If you download the PDF, don’t be disappointed when you find that the first couple of pages are in Hindi. The full text is also included in English, starting on page 3.
RxTrace readers will recall that India Continue reading India Proposes Serialization of Domestic Drug Supply
On May 22nd, 2015, India’s Directorate General of Foreign Trade (DGFT) quietly published Public Notice #13 with the subject “Implementation of the Track and Trace system export of drug formulations”. It was an amended version of Public Notice #4, dated April 1, 2015 with a similar subject. Get it? April Fools!
I have to admit, I fell for it. Did you? Continue reading India’s Pharma Export Serialization Deadlines: April Fools!
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 Continue reading India’s Pharma Export Regulations Update And The NECC Story