India Shifts Stance On Pharma Serialization Compliance, Surprises Industry

India’s government has just thrown domestic drug makers a curve ball, announcing changed pharmaceutical serialization requirements for all drug exports. The country now considers mono cartons as secondary level rather than primary packaging, contradicting its announcement to the industry in October 2013, which indicated that these package types should be considered primary.

This move could put pharmaceutical manufacturers in a panic, as companies in the SME sector are already greatly concerned about regulations due to the costs and complexities involved. And despite admitted confusion amongst India-based drug companies as well as pleas for a deadline extension, the government held to its January 2013 deadline for serializing secondary level packaging for track-and-trace purposes.

India's Directorate General of Foreign Trade (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.

Dr. Avi Chaudhuri, of serialization specialist Kezzler, told SecuringIndustry.com that the DGFT’s latest compliance requirement will be a burden for companies, particularly on small exporters. He expressed concern that drug makers of all sizes will now have to rush to become compliant and serialize mono cartons, which could cause panic and even mistakes.

But despite ever-changing deadlines and compliance requirements, the bottom line is that counterfeiting is not going away.  New reports of fake drugs hit the headlines weekly. Just last week, regulators and police busted a pharmaceutical distributor in the state of Odisha in India and jailed its owner on suspicion of “supplying fake versions of Sanofi Pasteur's Pentaxim, a paediatric vaccine used to prevent diphtheria, tetanus, pertussis, polio and invasive infections caused by Haemophilus influenzae type b (Hib),” according to SecuringIndustry.com. There were also reports of counterfeit operations in Spain and the Dominican Republic.

Navigating pharmaceutical track and trace compliance has been quite a puzzle for the pharma industry globally.  However, serialization could be the key to providing visibility and full traceability within pharma’s supply chain, combatting counterfeiters, and most importantly protecting those who receive the medicines.