Implementation of Barcoding of Drugs and
Pharmaceuticals Export Consignments
[Ref:
DGFT Public Notice No. 59(RE)/dated 30 June 2011]
Sub: Deferment
in the date of effect for implementation of bar-coding on export consignment of
pharmaceuticals and drugs for tracing and tracking purpose.
In exercise of the powers conferred under Paragraph
2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time,
Director General of Foreign Trade hereby amends Public Notice No. 21 dated 10th
January, 2011 and prescribes the following procedure for tracing and tracking
of export consignments of pharmaceutical products.
2. (i) Exporters of pharmaceutical
products will adopt a trace and track system and incorporate its features for
exported medicines using barcode technology as per GS 1 global standards as
detailed below:
a. Primary Level packaging requirement:
Incorporation
of 2D (GS1 Data matrix) barcodes on medicines at strip/vial/bottle, etc.
encoding unique product identification code (GTIN) and Unique Serial Number of
the Primary pack.
b. Secondary Level packaging requirement:
Incorporation
of barcodes (1D or 2 D) encoding unique product identification code (GTIN),
Batch Number, Expiry Date and Unique Serial Number of the Secondary pack.
c. Tertiary Level packaging requirement:
Incorporation
of barcodes (1 D) encoding unique product identification code (GTIN), Batch
Number, Expiry Date and Unique Serial Number of the Tertiary pack
(shipper/carton).
(ii) The trace and track technology as per serial number 2(i) above will come into effect as follows:
(a) Primary Level packaging - With effect from 1st
July, 2012
(b) Secondary Level packaging - With effect from
1st January, 2012
(c) Tertiary Level packaging - With effect from 1st
October, 2011
3. In case the importing country has mandated a specific requirement,
the exporter can adhere to the same and it would not be necessary to comply
with the stipulations at serial number a, b & c of para
2 above.
4. Under the track and trace system, manufacturers would be required
to maintain serialized record of exported pharmaceutical products for a minimum
period of six months after the expiry date of the product.
5. Authentication features will be added in due course and integrated
with the trace and track system.
6. Government will set up a Central Portal for tracing and tracking
exported pharmaceutical products.
7. Effect of this Public Notice:
Earlier the requirement of
affixing barcodes was to come into effect from 01.07.2011. Now more time is
being allowed.