In response to allegations India is a source of counterfeits, stemming, in part, from discovery of “Made in India” labels on fakes produced in China, has prompted the country to take action. The Directorate General of Foreign Trade (DGFT) issued the following change in export regulations.
“Exporters of pharmaceutical products will be required to affix barcodes on their export products to facilitate tracing and tracking of their products. In order to enable exporters of pharmaceutical products for incorporation of this technology, adequate time is being given”, said DGFT.
Manufacturers have until July 1 2011 to comply with the regulation. After this date exports must have track and trace capabilities “using barcode technology as per GS1 global standards”.
Primary packaging, such as vials and bottles, will be modified to incorporate 2D barcodes encoding a unique product identification code, batch number, expiry date and serial number.
Secondary packaging will be encoded with the same information using either 2D or 1D barcodes. Finally, tertiary packaging must use 1D barcodes to encode the same information.
Documentation
The DGTF also changed export documentation requirements. Exporters must, at the time of shipment, show a copy of Certificate of Analysis issued by: the manufacturer; or an approved laboratory of the importing country; or a laboratory approved by the Indian Drugs Controller.
Furthermore, officials of the Drug Control Department can, when required, retain a sample of a shipment for reference and tracking purposes.