Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments

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....blic Notice No. 4/2015-20 dated 1.04.2015 (as amended), as under, for laying down the procedure for implementation of the Track and Trace system for export consignments of drug formulations: 2.    "2.89 A Procedure for Implementation of the Track and Trace system for export of drug formulations i.  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 details are as follows: a) Primary Level: Incorporation  of two  dimensional  (2D)  barcode  encoding  unique  and universal global product identification code in t....

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....ers (SSI & Non- SSI Manufacturers): As one time exemption all manufacturers are exempted from maintenance of Parent-Child relationship in packaging and its uploading on central portal  (http://dava.gov.in) till 31.03.2016. However, the requirements of printing of  barcoding on the different levels or packaging will be applicable as prescribed.   b) Extended Date of Exemption to SSI Manufacturers: All SSI drug manufacturers are exempted from requirement of maintaining Parent-Child relationship in packaging levels for a further period up to 31.03.2017. However, they are required to upload Tertiary level data on the central portal mandatorily as prescribed in public notice no. 13/2015-2020 dated 22.05.....

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....ing manufacturing date prior to 31.03.2017 are exempted from requirement of data uploading on Central Portal. vii. All drugs manufactured by non SSI units with manufacturing date on or after 01.04.2016 and all drug manufactured by SSI units with manufacturing date on or after 01.04.2017 can be exported only if both tertiary and secondary packaging carry barcoding as applicable and the relevant data as prescribed by DGFT is uploaded on the Central Portal. Explanation: (a) For the purpose of this rule, (i) Drug formulation means a formulation manufactured with a license from Drug Control Authority under the provisions of Drugs & Cosmetics Act and Rules made there under and registered as "Drug" with the FDA of importing....