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Implementation of the Track and Trace system for export of drug formulations

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....: Implementation of the Track and Trace system for export of drug formulations. In exercise of the powers conferred under Paragraph 2.04 of the Foreign Trade Policy, 2015-20, as amended from time to time, the Director General of Foreign Trade hereby amends Para 2.89 A of Handbook of Procedure, 2015-20, as notified vide Public Notice No. 4/2015-20 dated 01.04.2015, as under, for laying down the pr....

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....ove mentioned details are required to be printed in human readable form on optional basis till further notification. (b) Secondary Level: Incorporation of one or two dimensional (1D or 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 seco....

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....r notification. (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 responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the manufacturer or expor....

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....e exported only if both the 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. (ii) P....