India clarifies barcoding requirements for drug exports

India's Directorate General of Foreign Trade has confirmed that mono cartons which contain strips, vials or bottles of medicine are classed as primary packaging under its new barcoding regulations.

The DGFT issued a public notice on October 17 to clear up confusion which has persisted in the marketplace despite informal notices from the Indian authorities.

As primary packaging is defined as the first level of packaging in direct contact with the product there had been concerns that the codes may have had to be placed on the items within the mono carton.

The requirement is to incorporate 2D GS1-compliant datamatrix barcodes on primary packaging that will include a unique product identification code (GTIN), batch number, expiry date and serial number.

Earlier this year India deferred the start date for barcoding the primary packaging of exported pharmaceutical products by 12 months to July 1, 2014, to give Indian drugmakers more time to comply with the requirements.

Requirements for barcodes on the secondary packaging of exports - with either a 1D or 2D code encoding unique product identification code (GTIN), batch number, expiry and serial number - came into effect in India on January 1, despite pleas for an extension from pharma export companies.