The cause for the new deadline was not revealed by the DGFT, which did not respond to a request for comment. Industry in the past called for extensions to adding bar codes to secondary packages due to cost concerns and confusion over GS1 standards. Pharmexcil (Pharmaceutical Export Promotion Council of India) and the Indian Drug Manufacturers’ Association previously called for an extension on secondary packages that was denied by the High Court of Chennai.
But the DGFT did clarify that mono cartons - which Pharmexcil previously told us would not require barcodes, and previously fell under primary packaging rules - should be considered secondary level packaging, which is in line with standards group GS1, according to the DGFT.
“Mono cartons are to be treated as part of Secondary Level Packaging and accordingly the requirement of affixing bar-codes on Mono-carton as Secondary Level Packaging became effective from 26.06.2014,” the DGFT said in its notice. “Now the effective date of affixing bar-codes on Mono-carton as Secondary Level Packaging has been deferred to 1st April, 2015.”
Manufacturers using GS1-compliant 2D data matrix barcodes previously saw the deadline for primary packages pushed back to July 1, 2014, from July 2011.
Exporters are still allowed to adhere to the stipulations of an importing country if that country has its own serialization requirements.
Track and Trace System
In addition to the bar coding system, India is creating a system to track and trace drug products through its supply chain, which few other countries in the world have established. Serialization and track and trace systems, however, may become the norm as opposed to the exception – China, Argentina, South Korea and the US are all looking at various systems to deploy, while Turkey .
Under India’s system, manufacturers would be required to maintain a serialized record of exported pharma products for a minimum of six months after the expiry date of the product.
The secondary and tertiary packaging requirements call on companies to include a unique product identification code (GTIN), batch number, expiry date and unique serial number.
Authentication features will be added over time and integrated with the track and trace system, according to the government, which also says it will set up a central portal for tracking and tracing exported pharmaceutical products.
The track and trace system comes as India is still grappling with reports of counterfeit medicines, as well as some companies looking to skirt the new barcoding laws.