India has recently made moves to impose a new barcoding requirement for all drugs procured by state and federal governments for domestic public consumption. The new requirements are part of the preference to “Make In India” program that is intended to “…promote manufacturing and production of goods and services in India with a view to enhancing income and employment.”Continue reading Barcoding Regulation For India’s Domestic Drug Supply
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!