“GS1 India has been actively providing technical guidance and implementation support for the DAVA portal”
Ravi Mathur, CEO, GS1 India talks about GS1’s initiatives for the pharma sector and the impact its aims to create, in an exclusive interview with Sanjiv Das
Can you elaborate on how GS1 can help the pharma industry create safe drug distribution systems?
One essential element in safe drug distribution relates to its tracking in the supply chain from its source/ point of manufacture till its sale/dispensation across multiple supply chain stakeholders. This enables near real-time visibility in movement and storage of pharma drugs, which in turn, deters entry of counterfeits and hence enables safe drug distribution.
GS1 standards enable unique and universal identification of pharma drugs, medical devices, etc., and sharing of information amongst trading partners unambiguously. Product track & trace, recalls, expiration management, stocks’ visibility, and product authentication become possible through the use of these global standards.
GS1 is working towards a globally harmonised approach to serialisation. What are the critical steps that you have taken to identify and trace drugs across the supply chain?
GS1 has developed open, global standards, which enable unique and universal identification of each item (drug unit) through serialisation. This was done with active collaboration of pharma manufacturers, and has been successfully deployed by them worldwide in their supply chains.
Through standardised capture of information related to product code (GTIN), batch number, serial number, and expiry date at point of manufacture, encoded within barcodes at the item level and on the cartons, and its scanning during transit, a robust track & trace system can be implemented.
The DGFT has launched the Drug Authentication and Verification Application (DAVA) portal which is based upon GS1 standards. So, how has this portal enabled the pharma sector to identify, capture and share important information about exported consignments?
Pharma exporters are required to upload their daily production data with product codes (GTINs), batch numbers, serial numbers, and expiry dates into the DAVA portal. On scanning of barcodes on drugs, using DAVA mobile app, consumers can verify/validate product label information, populated directly by the manufacturers, and thus, be confident of accessing reliable and trusted information.
Today, more than 380 large and medium sized pharma companies have registered and are uploading their daily production data into the DAVA portal.
DGFT Notification link:
http://dava.gov.in/davahq/files/PublicNotice_04_july_2019.pdf
What are the other initiatives that GS1 is collaborating with regulatory agencies in India to bring in better efficiency, transparency and safety in the pharma sector?
GS1 India is working with various state health departments and medicine procurement agencies for State/Central governments to bring in better efficiency, transparency and safety in the pharma sector.
Tell us about your initiatives with the pharma sector to improve their readiness and preparation for compliance with global regulations?
GS1 India continually shares global developments with the Indian pharma industry and various regulatory bodies related to prevalent and emerging regulations, policies and best practices across the world. It also provides technical guidance on implementation of regulatory requirements on track & trace, product recalls, and counterfeit detection through the use of open, global supply chain standards.
The Director-General of Foreign Trade (DGFT) outlines the requirements for a track and trace system that enables traceability of exported pharmaceutical consignments in order to prevent counterfeits. What role does GS1 India play in this regard?
GS1 India has been actively providing technical guidance and implementation support for the DAVA portal, and to pharma exporters in complying with DGFT’s requirements.
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