The union commerce ministry has deferred the implementation of barcoding on export consignment of pharmaceuticals and drugs on primary level packaging till further notification from the ministry. The requirement of affixing barcodes on primary level packaging was to be effective from 01.07.2014. Now this date has been deferred till a new date is notified by the ministry.

In another significant decision, the ministry has notified that the mono cartons will be treated as secondary level packaging. “Earlier through Public Notice No. 31 dated 17.10.2013, mono cartons were to be treated as part of Primary Level Packaging.  Now this has been modified to treat mono cartons as Secondary Level Packaging”, the Directorate General of Foreign Trade (DGFT) Pravir Kumar in a notification dated June 26, 2014 said.

According to the new notification, every exporter of drugs & pharmaceuticals at the time of shipment shall submit, along with other required documents, a copy of certificate of analysis issued by the manufacturer for the subject products; or a copy of certificate of analysis issued by approved laboratory of the importing country/ FDA; or a copy of certificate of analysis issued by a laboratory approved by Drugs Controller under Drugs & Cosmetics Act, 1940 and the rules made thereunder.

The exporters of pharmaceutical products should adopt a track and trace system and incorporate its features for exported medicines using barcode technology as per GS 1 global standards. In this regard, for the secondary level packaging, which is already in force from January 1, 2013, there is a requirement of incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), batch number, expiry date and unique serial number of the secondary pack. Mono cartons shall be treated as secondary level packaging in line with prevalent global packaging nomenclature.

For the tertiary level packaging, which has already been implemented in the country from October 1, 2011, there is a requirement of incorporation of barcodes (1 D) encoding unique product identification code (GTIN), batch number, expiry date and unique serial number of the tertiary pack (shipper/carton).

For the primary level packaging, for which the effective date will be notified later, there is a requirement of incorporation of 2D (GS1 data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding unique product identification code (GTIN) and unique serial number of the primary pack.

In case, the government of the importing country has mandated a specific requirement, the exporter has the option of adhering to the same and in such a case, it would not be necessary to comply with the stipulations at serial number a, b & c of para 3(i) above and if an exporter is seeking to avail exemption from bar coding prescribed by the government of India as above, the exporter is given the option to move an application to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) for this purpose, clearly specifying the nature of such an exemption in the interest of the exports from the country. Pharmexcil shall dispose of such applications on case to case basis with prior approval of government, the notification said.

Under the track and trace system, manufacturers would be required to maintain serialized record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product.  Authentication features will be added in due course and integrated with the track and trace system and government will set up a central portal for tracking and tracing exported pharmaceutical products, the notification further said.