2.89A
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 GSI 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 code labeling at primary level is exempted till further notification; however, the above mentioned details are required to be printed in human readable form on optional basis till fuither 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(GTN) along with batch number, expiry date and a unique serial number of the secondary pack. However, incase of monocartons manufacturer or exporter shall affix bar code on mono carton containing one primary pack on optional basis till further notification.
c) Tertiary Level:
Incorporation of one dimensional (1D) 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 tertiary pack i.e. Serial Shipping Container Code (SSCC).
ii) 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 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 responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the manufacturer or exporter.
v. 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.
(Above sub-para v. has been amended vide PUBLIC NOTICE NO.03/2016, DT. 21/04/2016)
[OLD- v. The above rules (i) to (iv) will not be applicable to those drug formulations manufactured for export purposes, where the government of the importing country has mandated or formally notified its intention to mandate a specific requirement and the exporter intends to avail the option of printing the barcodes in their format after duly obtaining the permission of DCGI or its nominee. However, the tertiary level of packaging will have additional printing of barcode as per (i)(c) above in addition to importing country's requirement, if any. ]
vi. Export of drugs manufactured by non-SSI units and having manufacturing date prior to 31.03.2016 and export of the drugs manufactured by SSI units and having 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 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 means a shipper containing one or more secondary packs.
(b) All relevant guidelines regarding grant of specific exemption (s) if any, procedure of 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.
(Above para 2.89A has been amended vide PN. NO.52/2015, DT. 05/01/2016 )
[OLD-
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 code labelling at primary level is exempted till further notification; however, the above 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 secondary pack. However, manufacturer or exporter shall affix bar code on mono carton containing one primary pack on optional basis till further notification.
(c) Tertiary Level:
Incorporation of one dimensional (1D) 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 tertiary pack i.e. Serial Shipping Container Code (SSCC).
(ii) 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. However, maintenance of parent-child relationship between primary and secondary packaging is optional till further 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 exporter.
(v) The above rules (i) to (iv) will not be applicable to those drug formulations manufactured for export purposes, where the government of the importing country has mandated or formally notified its intention to mandate a specific requirement and the exporter intends to avail the option of printing the barcodes in their format after duly obtaining the permission of DCGI or its nominee. However, the tertiary level of packaging will have additional printing of barcode as per (i)(c) above in addition to importing country’s requirement, if any.
(vi) The exports of the drugs having manufacturing date prior to 01.10.2015 will be exempted from requirement of data uploading on central portal.
(vii) With effect from 01.10.2015, all drugs with manufacturing date on or after 01.10.2015 can be 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) 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 means a shipper containing one or more secondary packs.
(b) Separate guidelines shall be issued for grant of exemption (s), data requirement, maintenance and upload on central portal.]
(Above para 2.89A has been amended vide PN. NO.13/2015, DT. 22/05/2015)
[OLD- 2.89A
Procedure for Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments
(i) The manufacturer of drug for 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 code labelling at primary level is exempted till further notification, however the above mentioned details are required to be printed in human readable form.
(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 secondary pack.
(c) Tertiary Level:
Incorporation of one dimensional (1D) 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 [Serial Shipping Container Code (SSCC)] of the Tertiary pack.
(ii) The manufacturer shall maintain the data in the parent-child relationship for all three level of packaging i.e. Primary, Secondary and Tertiary and their movement in its supply chain.
(iii) The data mentioned in (ii) above, shall be uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of the drugs 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.
The above rules will not be applicable to those drug formulation manufactured for export purposes, where the government of the importing country has mandated a specific requirement and the exporter intends to avail the option of printing the barcodes in their format with the permission of licensing authority appointed under rule 21. However, the tertiary level of packaging will have additional printing of barcode as per (i)(c) above in addition to importing country’s requirement, if any.
(v) The exports of the drugs having manufacturing date prior to 01.04.2015 will be exempted for requirement of barcode labelling and data uploading on central portal.
(vi) The drugs with manufacturing date on or after 01.04.2015 will compulsorily carry barcode on tertiary and secondary packages as per the Notification No. 68 dated 06.08.2014. However the requirement of data uploading on central portal will be exempted till 30.06.2015.
(vii) With effect from 01.07.2015, all drugs with manufacturing date on or after 01.04.2015 can be 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, primary packaging means the package which is in direct physical contact with the drug, secondary packaging means the carton containing multiple primary packs including a mono carton and tertiary packaging means a shipper containing multiple secondary packs.
(b) Separate guidelines shall be issued for data requirement, maintenance and upload on central portal.]
(Above para 2.89A has been inserted vide PN. NO.04/2015, DT. 01/04/2015)