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DGFT amends procedure for implementation of Track & Trace system for export of pharma, drug consignments

Updated: Apr 28, 2016 09:50:31am

New Delhi, Apr 28 (KNN) The Directorate General of Foreign Trade (DGFT) has amended the procedure for implementation of the Track and Trace system for export of pharmaceutical and drug consignments.

In a notification dated January 5, 2016, DGFT had amended Para 2.89A of Handbook of Procedure, 2015-20,  for laying down the procedure for implementation of the Track and Trace system for export consignments of drug formulations.

The notification stated that the manufacturer or the exporter of drug formulations will print the barcode as per GS1 Global Standard at different packaging levels to facilitate tracking and tracing of their products. 

The notification further stated that the manufacturer or exporter shall maintain the data in the parent-child relationship for three levels of packaging i.e. Primary, Secondary and Tertiary packaging and their movement in its supply chain.

It said the data mentioned in (ii) i.e.  Parent -Child Relationship/ Effective dates for SSI and Non-SSI Manufacturers shall be uploaded on the central portal of the Government of India by the manufacturer or exporter or its designated agency before release of the drug formulations for sale or distribution.

The responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the manufacturer or exporter, the notification added.

The notification said that the above rules “will not be applicable to those drug formulations manufactured for export purposes, where the government of the importing country has mandated or formally notified its intention to mandate a specific requirement and the exporter intends to avail the option of printing the barcodes in their format after duly obtaining the permission of DCGI or its nominee. However, the tertiary level of packaging will have additional printing of barcode as per (i)(c) above in addition to importing country's requirement, if any.”

Now, the amended para 2 (v) of the notification said, “In case, the Government of the importing country has mandated a specific requirement, the exporter has the option of adhering to the same and in such a case, it would not be necessary to comply with the stipulation under sub para (i) to (iv) of Para 2 of this Public Notice and if an exporter is seeking to avail such exemption from bar coding prescribed by the Government of India as above, the exporter is given the option to move an application to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) for this purpose, clearly specifying the nature of such an exemption in the interest of the exports from the country.

Pharmexcil shall dispose of such applications on case to case basis with prior approval of Government,” it added.

However, the tertiary level of packaging will have additional printing of barcode as per Para 2 (i) (c) of this Public Notice in addition to importing country`s requirement, if any”, said DGFT. (KNN Bureau)


  1. zulkharnine sultana
    zulkharnine sultana 13/05/2016 4:19 PM

    It should not be repacked by Pharma after expiry period to get renewal.

    Reply to this comment


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