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.

(Pl. refer PN. NO. 54/2012, DT. 05/04/2013 for above 2(i) a Earlier the requirement of affixing barcodes on Primary Level packaging was to take effect from 01.07.2013. Now this date has been deferred to 01.07.2014)

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.

(Earlier the requirement of affixing barcodes on Secondary level and Primary level packaging was to come into effect from 01.07.2012 and 01.01.2013 respectively. Now this time limit is being extended by 6 months each vide PN NO. 10/2012, DT. 11/07/2012.

(a) Primary Level packaging - With effect from 1st July, 2013

(b) Secondary Level packaging - With effect from 1st January, 2013)

(Earlier the requirement of affixing barcodes on Secondary level and Primary level packaging was to come into effect from 01.01.2012 and 01.07.2012 respectively. Now more time is being allowed as under vide PN. NO. 87/2010, DT. 22/12/2011.

         (a) Primary Level packaging - With effect from 1st January, 2013

         (b) Secondary Level packaging - With effect from 1st July, 2012 )

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.
 

(Anup K.Pujari)

Director General of Foreign Trade
E-mail: dgft@nic.in

(Issued from F.No. 01/91/180/648/AM 09/Export Cell)