Govt of India, Ministry of Commerce and Industry, Department of Commerce, Directorate General of Foreign Trade, Public Notice No. 56 (RE-2013)/2009-2014 announces Self-certification regarding compliance of bar-coding requirements on secondary and tertiary level packaging on export consignment of pharmaceuticals and drugs.
Director General of Foreign Trade (DGFT) prescribes the procedure for self-certification regarding compliance of bar-coding requirements on secondary and tertiary level packaging on export consignment of pharmaceuticals and drugs.
Requirement at Primary Level Packaging:-
Incorporation of 2D (GS1 DataMatrix) barcodes on medicines at primary level packaging encoding unique product identification code (GTIN) and Unique Serial Number following GS1 global standards.
Barcode Symbology: GS1 DataMatrix
Where product is packed in a mono carton (e.g. ointments, eye/ear drops etc), barcode encoding GTIN and unique serial number should be marked on the mono carton itself.
It is mandatory to print data encoded in barcodes as human readable information as well, as shown above.
Requirements at Secondary Level Packaging :- Incorporation of barcodes (GS1 – 128 i.e 1D or GS1 DataMatrix i.e 2D) encoding unique product identification code (GTIN), Expiry Date, Batch Number and Serial Number of the Secondary package.
Barcode Symbology: GS1-128 or GS1 DataMatrix
Secondary Level Packaging: Is defined as a level of packaging that may contain one or more primary packages or a group of primary packages containing a single item.
At Secondary level packaging, the barcode should encode the following information:
GTIN using application identifier (01)
Expiry Date in YYMMDD format using application identifier (17)
Batch/Lot Number using application identifier (10)
Serial No. of the secondary package using application identifier (21)
Requirements at Shipper/Carton/Tertiary level packaging:- Incorporation of GS1-128 barcode symbology (1D) encoding GTIN of the Shipper/Carton/Tertiary level packaging package, expiry date, batch number of the product and serial number (SSCC) of the Shipper/Carton/Tertiary level packaging .
Barcode Symbology: GS1-128.
As per above the requirement on Shipper/Carton/Tertiary level packaging, barcode symbology to be used is GS1-128. For the same GTIN-14 data structure of GTIN is required to be encoded in the barcode.
Shipper/Carton/Tertiary level packaging: Is defined as a level of packaging that shall contain one or more primary/secondary levels of packaging and can be considered as logistics unit (homogeneous/heterogeneous packages).