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

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....s 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 the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the primary pack. The bar ....

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....ill 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 22.05.2015. iii. The data mentioned in (ii) above 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. iv. The re....

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....n 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 country. (ii) Primary packaging means the package which is in direct physical contact with the active ingredient. Secondary packaging means a carton containing one or more primary packs and includes a mono carton containing one primary pack. The tertiary packaging me....