With a view to protect the brand value of Indian pharma and counter the allegations against Indian Pharma Industry as exporter of spurious/counterfeit drugs,bar coding has been made mandatory only for the pharmaceutical exports (Formulations).   Manufacturer or exporter of drug formulations will print the bar code as per GSI Global Standard at different packaging levels to facilitate tracking and tracing of their products as per the procedure prescribed vide DGFT Public Notice No.52/2015-2020 dated 5th January 2016 .

Department of Commerce through Department of Pharmaceuticals had received a representation dated 2.7.2014 addressed to Hon’ble Prime Minister from SME Pharma Industries Confederation (India) highlighting various issues inter-alia the point alleging that barcoding for export of medicine was mandated by Department of Commerce without consulting the AD (Administrative) Ministry or SME Ministry.  It was informed to SME Pharma Industries Confederation (India) that  DGFT Public Notice No.21(RE-2011)/2009-2014 dated 10.1.2011 was issued to implement the bar code on drugs and pharmaceuticals meant for exports only.  Prior to this several stakeholders consultation were held.  It was also informed that Bar code system would be followed in phased manner.  It had also been conveyed that Public Notice was amended  about seven times on the request of the stakeholders vide  (i) Public Notice No. 59(RE-2010)/2009-2014 dated 30.06.2011 ,(ii) Public Notice No. 87(RE-2010)/2009-2014 dated 22.12.2011, (iii) Public Notice No. 10(RE-2012)/2009-2014 dated 11.07.2012 ,(iv) Public Notice No. 54(RE-2012)/2009-2014 dated 05.04.2013, (v) Public Notice No. 31(RE-2013)/2009-2014 dated 17.10.2013 (vi) Public Notice No. 56 (RE-2013)/2009-2014 dated 01.04.2014, (vii) Public Notice No. 58 (RE-2013)/2009-2014 dated 15.04.2014. Bar code system had become effective on Tertiary pack w.e.f. 1.10.2011 and on secondary pack w.e.f. 1.1.2013.

While vide DGFT Public Notice No.52/2015-2020 dated 5.1.2016, one time exemption to all manufacturers (SSI & Non-SSI Manufacturers) was given from maintenance of Parent-Child relationship in packaging and its uploading on central portal upto 31.3.2016, all SSI drug manufacturers were granted further exemption from the requirement of maintaining Parent Child relationship in packaging levels for a period upto 31st March, 2017.

This information was given by the Commerce and Industry Minister Smt. NirmalaSitharaman in a written reply in Rajya Sabha today.

Pharmaceutical export barcoding requirement, with temporary exemption for small scale manufacturers from parent child packaging uploads. Bar coding is mandatory for pharmaceutical exports, with manufacturers required to print GSI standard bar codes at multiple packaging levels for tracking; the regime was phased in after stakeholder consultation. Regulatory relief exempted manufacturers from maintaining and uploading the Parent Child packaging relationship to the central portal for a transitional period, and SSIs received a further extension of that exemption.