Pharma Trends

Indian Government introduces self-certification for drug firms by Bar Coding Packages

April 11, 2014: The Government of India has introduced a self-certification mechanism for barcoding of secondary and tertiary level packaging of drugs. The move is expected to further simplify the export orders.  


It may be noted here that a barcode helps in tracking and tracing the origin of drugs which helps in minimising chances of genuine drugs being considered as spurious, substandard or counterfeit.  


"A self-certification process on compliance of bar-coding requirement on secondary and tertiary level packaging of pharmaceuticals and drugs has been introduced. This will be effective from April, 1 2014," the Directorate General of Foreign Trade (DGFT) said in a public notice.  


The government has asked the pharma firms to build trace and track capability for their exported products at three different levels using barcodes – primary, secondary and tertiary. Primary level packaging is the first level of packaging like bottle, can, jar etc that contains the items sold while secondary is the second level like packets and tertiary is the last level like shipper or carton.


The DGFT has also said that in this process, an exporter would be required to furnish a written declaration to custom authorities at the time of export regarding compliance of the relevant provisions of barcoding on secondary and tertiary level of packaging on the consignment.


Industry experts are of a view that maintaining quality is an integral part of Indian pharma companies’ strategy to tap the growth in the global generics market and this move will help in ensuring that.


The huge market for generics in developed countries is expected to increase India’s generics exports by manifold in the coming years.


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