Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments. - Customs - Public Notice no. 64/2018

OFFICE OF THE COMMISSIONER OF CUSTOMS(EXPORT) AIR CARGO COMPLEX SAHAR ANDHERI MUMBAI-400099. F.No.-S/6-Misc-65/2018-19 ACC(X)Shed. Date: 25.04.2018 Public Notice no. 64/2018 Sub: Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments. - reg. Attention of the Exporters, Custom Brokers and all concerned is invited to the Notice No. 52/2015-2020 dated 05.01.2016 issued by the DGFT on the above subject as amended by Public Notice No. 03/2015-2020 dated 21.04.2016 (copies enclosed). 2. As per the aforesaid notice, all drugs manufactured by Non-SSI units with manufacturing date on or after 01.04.2016 and all drugs manufactured by SSI units with manufacturing date on or after 01.04.2017 can be exported only if all primary, secondary and tertiary packaging carry one or two dimensional (ID 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 secondary or tertiary pack. Further on, the relevant data is also required to be uploaded on the Central Portal. Further the said notification also stated that it will be the responsibility of the drug manufacturer/exporters as the case may be, to satisfy the customs authorities that the export consignment satisfies the condition of the notification. 3. During examination of the export pharmaceutical products, it has been found in some cases that the barcodes present on the packagings could not be successfully verified at the site http://dava.gov.in. It appears that the data was not uploaded successfully on the central portal by Exporter/Manufacturer and therefore resulted in unsuccessful verification of identity by the examining officers. 4. Para 2.89A Of the Hand Book Procedures (as amended) mandates that- (i) Parent - Child Relationship/ Effective dates for SSI and Non-SSI Manufacturers: 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. a) All Manufacturers (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 of 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. (ii). 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. (iii). The responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the manufacturer or exporter. (iv). 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. 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. (v). Export of drugs manufactured by non-SSI units with manufacturing date prior to 31.03.2016 and export of the drugs manufactured by the SSI units and having manufacturing date prior to 3 1.03.2017 arc exempted from requirement of data uploading on Central Portal. (vi). All drugs manufactured by non 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 FDA of importing country. (ii) Primary packaging means the package which is in direct physical contact with the active ingredient. (iii) Secondary packaging means a carton containing one or more primary packs and includes a mono carton containing one primary pack. (iv) The tertiary packaging means a shipper containing one or more secondary packs. b) All relevant guidelines regarding grant of specific exemption (s) if any, procedure or data requirement / maintenance / upload on central portal and clarifications issued under this notification etc. will be available on the central portal i.e. http://dava.gov.in c) It will be the responsibility of the drug manufactures/exporters as the case may be, to satisfy the customs authorities that the export consignment satisfies the conditions of the notification. 5. In view of the foregoing, if the bar-coding is not proper on primary, secondary and tertiary packaging of export consignment, such consignments cannot be allowed to be exported. These consignments may be ordered for back to town by the Proper officer/Competent Authority. Further, in cases of export consignments where coding is proper, but are short of verification of their data on http://dava.gov.in for any reason, the same cannot be allowed to be exported. These consignments are also be ordered to back to town by the Proper officer/Competent Authority. 6. All such exporters of pharmaceuticals/drugs are hereby advised to ensure that the requisite data has been successfully uploaded on the website http://dava.gov.in before dispatch of the export goods from their factories/warehouses. 7. Difficulty, if any may also be brought to the notice of ADC/JC, Export Shed. 8. Action to be taken in terms of decisions taken in this Public Notice should be considered as standing order for the purpose of officers and staff. (S. ANANTHA KRISHNAN) Commissioner of Customs (Export) ACC, Mumbai