Are your operations compliant with India’s DGFT regulations?
PharmaSecure can help you by extending support 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.
What are India’s DGFT regulations?
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) starting from 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 till 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/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 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.
- Serving pharmaceutical clients for around a decade
- Hundreds of lines at various locations running DGFT solution in the top Pharma companies in India
- Solutions based on non-proprietary and latest technology to deliver maximum value
- Seamless integration using industry standards
- Hassle-free deployments with minimum downtime of production lines
- Modular and easily customisable applications to fit your business process
- Require minimal training/education to end users
For more details, please contact us or mail to: firstname.lastname@example.org or call us on 022-67556011