Pharmexcil
Bar Code Tracking
 
All about Barcoding for Drugs exported from India
 

On 10 January 2011, Directorate General of Foreign Trade (DGFT), issued a public notice announcing the implementation of a track and trace system incorporating barcode technology as per GS1 standards for all drugs and pharmaceutical products exported from India. Under this notice, all export pharmaceutical consignments should be marked and coded at various packaging levels using GS1 barcode standards. DGFT issued this mandate as a step towards implementing a traceability system to address counterfeit and ineffective product recall challenges, which effects the entire healthcare supply chain, from manufacturers all the way to patients, wholesalers, distributors, exporters and healthcare providers. Adopting globally harmonized standards for product identification and data exchange, is a critical step in addressing these issues. The traceability solution implemented by the DGFT requires the use of product serialization at the secondary level packaging. Serialization enables to build a comprehensive system to track and trace the movement of drugs through the entire supply chain. By identifying every product with a globally unique product number (Global Trade Item Number [GTIN]), and by capturing information on its expiry date, batch/lot number, and unique serial number (where applicable) allows the product’s lifecycle to be tracked from production to distribution across borders, all the way to its dispensation to patients at the drugstore or hospital. In addition to the coding and marking guidelines of products outlined in the specifications, Manufacturers/Brand Owners/Responsible Entities/Exporters/Merchant Exporters will submit additional information to a central track and trace portal. Manufactures need to maintain records of serial numbers assigned to drugs and pharmaceuticals exported for a minimum period of six months after their expiry date.

Various agencies involved in implementation of track and trace system
   

Monitors implementation of system
http://commerce.gov.in

Issues Public Notices from time to time
http://dgft.gov.in
   

Prescribes standards for barcoding
http://www.gs1india.org
plexconcil
Maintains Central Server "DAVA"
http://dava.gov.in
   

Catalyst between Exporters & implementing agencies; issues exemption
http://pharmexcil.org