India shifts goalposts on pharma serialization

India has suddenly changed the serialisation requirements for exported drugs in a move that could wrong-foot pharmaceutical manufacturers in the country.

An announcement from the Directorate General of Foreign Trade (DGFT) - which regulates drug exports in India - issued a public notice towards the end of last month that reverses its position on mono cartons containing strips, vials or bottles of pharmaceutical products.

The latest notice indicates mono cartons should be treated as secondary level rather than primary packaging, countermanding an earlier pronouncement issued last October. The change is important because the deadline for serialising secondary level packaging for track-and-trace purposes has already passed, becoming mandatory on January 1, 2013.

Dr Avi Chaudhuri, who runs the Indian operations of serialization specialist Kezzler, told SecuringIndustry.com that the exporters "now have to rush to serialize mono cartons [and] panic is likely setting in."

The DGFT requires secondary level packaging to carry a barcode (1D or 2D) encoding unique product identification code (GTIN), batch number, expiry date and a unique serial number. Manufacturers are required to maintain records of serialized products for a minimum of six months after their expiry date.

Chaudhuri said that the new DGFT notice "will require immediate compliance by Indian pharma exporters, placing a particular burden on small exporters," who number in the hundreds and possibly thousands.

Kezzler created an online service a couple of years ago - called the Indian Pharmaceutical Export Serialization (IPES) programme - to make it easier for companies to meet the DGFT's requirements. IPES allows companies to buy small batches of serial number codes that can be printed using a desktop printer.

The serialized barcode requirement has been of great concern to the Indian SME sector because of the costs and complexities involved according to Kezzler.

The IPES programme is "specifically designed to help SMEs and microindustries comply with the mono carton ruling in the fastest and most cost-effective way possible," said Chaudhuri.

Last 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. In April it introduced a self-certification mechanism - via a written notification to customs - in order to simplify the export process.

In time, the DGFT will also mandate the addition of authentication features that will integrate with the track-and-trace system.