The cause for the pushback was not revealed by the DGFT, though 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.
Manufacturers affixing the GS1-compliant 2D data matrix barcodes previously saw the deadline for primary packages pushed back to July 1, 2014, from July 2011, and now will have to wait for more information from the DGFT, which did not respond to a request for comment by press time.
According to Pharmasecure, a company helping manufacturers adhere to the new rules, there is difficulty achieving 100% read rates of codes on primary packaging using standard processes.
In addition to the delay, mono cartons -- which Pharmexcil previously told us would not require barcodes, and previously fell under primary packaging rules -- are now to be treated as secondary level packaging, which is in line with standards group GS1, according to the DGFT.
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
India is taking the lead on creating a track and trace system, which few other countries in the world have established. Under the system, Indian manufacturers would be required to maintain a serialized record of exported pharma products for a minimum period of six months after the expiry date of the product.
Under the secondary and tertiary packaging requirements established in 2011 and 2013, respectively, and which both include a unique product identification code (GTIN), batch number, expiry date and unique serial number.
Authentication features will be added in due course and integrated with the track and trace system and the government will set up a central portal for tracking and tracing exported pharmaceutical products.
But 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.
But serialization and track and trace systems may become the norm as opposed to the exception – China, Argentina, South Korea and the US are all looking at various systems to deploy.