2.90A
Track and Trace system for export of drug formulations
Procedure for Implementation of the Track and Trace system for export of drug formulations will be as under :
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 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 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, 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 for SSI and Non-SSI Manufacturers:
The manufacturer or exporter shall maintain the data in the parentchild relationship for three levels of packaging i.e. Primary, Secondary and Tertiary packaging and their movement in its supply chain.
iii. Maintenance of data of Parent-Child relationship:
The data mentioned in (ii) above shall be uploaded on the central portal of the Government of India (http://dava.gov.in) 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) above 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 Pharmaceutical 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) in addition to importing country’s requirement, if any.
vi. Export of drugs manufactured by SSI and non-SSI units and having manufacturing date on or before 01.04.2021 [OLD- 01.10.2020 [OLD- 01.04.2020 [OLD- 01.07.2019 [OLD- 15.11.2018 ] are exempted from maintenance of data in the Parent-Child relationship for three levels of packaging and its uploading on Central Portal(http://dava.gov.in).
vii. All drugs manufactured by SSI or non SSI units and having manufacturing date after 01.04.2021 [OLD- 01.10.2020 [OLD- 01.04.2020 [OLD- 01.07.2019 [OLD- 15.11.2018 ] 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.
(In above vi. & vii "01.04.2021" has been substituted vide PUBLIC NOTICE NO. 16/2020, DT. 22/09/2020)
(In above vi. & vii "01.10.2020" has been substituted vide PUBLIC NOTICE NO. 66/2019, DT. 30/03/2020)
(In above vi. & vii "01.04.2020" has been substituted vide PUBLIC NOTICE NO. 16/2019, DT. 04/07/2019)
(In above vi. & vii "01.07.2019" has been substituted vide PUBLIC NOTICE NO.43/2018, DT. 01/11/2018)
(Above vi. & vii has been substituted vide PUBLIC NOTICE NO.05/2018, DT. 09/05/2018)
[OLD- 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.
(iii) Secondary packaging means a carton containing one or more primary packs and includes a mono carton containing one primary pack.
(iv) 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.