Are your operations compliant with India’s DGFT regulations?
PharmaSecure can help you by extending supports and services to make your organization compliant with DGFT India. Need more information? Get in touch with us today and request a quote for our DGFT compliance solutions.
Latest Update – Requirements as of January, 2016
- The DGFT barcoding requirement has till recently talked about putting a 2D Data matrix encoded with the required information and in human readable form on the Secondary packaging level (including mono cartons) and a 1D linear barcode on the Tertiary packaging level. However, the recent Public Notice No. 52/2015-2020 dated the 05 January, 2016 specifies specific dates of implementation of parent-child relationship for SSI and Non-SSI manufacturers as below:
- All Non-SSI Manufacturers must maintain parent-child relationship in packaging and upload this information onto the central portal (http://dava.gov.in) beginning 31.03.2016. In addition, manufacturers are required to continue barcoding on the different levels or packaging as prescribed.
- 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 as prescribed in public notice no. 13/2015-2020 dated 22.05.2015.
- 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 under the DGFT mandate
- The data mentioned 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.
How PharmaSecure can help
PharmaSecure is one of the leading providers of regulatory serialization solutions to pharmaceutical companies operating in India and around the world.
Our solutions are backed by an experienced team that understands the criticality of plant operations and the complexities of Printers and Vision systems. Our teams support your during the entire lifecycle of your DGFT journey and ensure you maintain compliance with regulations moving forward.
- Hassle-free deployments with minimum downtime of production lines
- Seamless integration with almost all the branded printers and vision system
- Over 100 lines at 30 locations running DGFT solution in the top 10 Pharma companies in India
For more details, please request a quote below or contact firstname.lastname@example.org or call us on 022-67556011
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India Serialization Regulations Overview
The DGFT Barcoding requirements call for pharmaceutical manufacturers to affix GS1 standard barcodes as well as information in human readable form on the packages. The following is summary
Tertiary Level – 1D linear barcode encoding (GTIN) along with batch number, expiry date and a unique serial number [Serial Shipping Container Code (SSCC)] on the Tertiary pack.
Secondary Level – 1D or 2D GS1 barcode encodingGTIN along with batch number, expiry date and a unique ID of the secondary pack.
Primary Level – GTIN along with batch number, expiry date and a unique ID of the primary pack. It is to be noted that the barcoding is exempted for the moment however information in human readable form is required.
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, however maintenance of parent-child relationship between Primary and Secondary packaging is optional till further notification.
The data mentioned in the aggregation section 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.