India Plans For Bar Codes

The country looks to protect its brands with a requirement for serialized coding on exported packaging.
Although Indian government deadlines were recently deferred for meeting a bar coding mandate, drug manufacturers in the country still have only months to implement serialization solutions.
“Because the regulation just came out in June, companies have been in a mad rush to evaluate technology and make a decision. These decisions have to be made by the end of August or they won’t meet the deadline for secondary packaging,” David DeJean, VP, Business Development, Systech International (www.systech-tips.com) said last month.
“Some of these manufacturers have large foot prints, with hundreds of lines,” DeJean added.
The ruling from the Indian Department of Commerce requires drug exporters to build track and trace capability using bar code technology following GS1 standards. The department’s Directorate General of Foreign Trade published revised deadlines in June for applying unique product ID codes to primary, secondary, and tertiary packaging.
Effective dates are:
• October 2011. 1-D codes with GTINs, batch number, expiry, and unique serial number for shipper cartons.
• January 2012. 1-D or 2-D codes with GTIN, batch, expiry, and unique serial number on secondary packaging.
• July 2012. Unique serial numbers in the GTIN schema in 2-D codes for primary packaging.
The regulation does not apply to product exported to a country with an existing serialization requirement.
Issued in June, Public Notice No. 59 adds requirements to an initial rule released in January. Manufacturers must maintain the data for a minimum of six months after the expiry date of the product. Also, authentication features will be required in due course and will be integrated with the track and trace system.
India will set up a central portal for tracking and tracing the exported products.
“The government will take ownership responsibility for putting a central portal under one of their regulatory agencies. (But) it is too early to say what it will look like and when it will be available. No technical decisions have been made. There are a lot of meetings underway between solution vendors and the Indian government,” DeJean says.
The regulation doesn’t address associating the levels of packaging, or aggregation. “If importing countries require aggregation, eventually they will have to deal with it. As the regulation now stands, it is more like three levels of item level serialization,” DeJean observes.
Most domestic and multi-national manufacturers believe they can meet the tertiary and secondary deadlines. The primary level coding is the biggest concern.
“Putting a serialized bar code on a shipper label is not that overly complicated. There may be some resource constraints, but generally they feel the secondary packaging—for the most part printing on unit cartons or bottles—can get done by January.
For primary packs, the requirement is not coding the unit-of-sale, but a lower level of packaging, such as a blister card.
“This is the first time this has been done any where in the world outside of a few pilots. Companies therefore cannot leverage technology that has been used and proven before. They may be facing significant packaging changes to accommodate the serial numbers on blister cards, small pre-filled syringes, and vial labels that are already highly congested with art work,” De Jean says.
“This is where most of the push back is. But the sense from the government is, we have already moved this back once, we’re not going to do it again,” he adds.
As a requirement on exports, the mandate is aimed at protecting the overall image and brand of India’s pharma products. The coded product can be authenticated against bogus product with “Made In India” labels that has been found in markets such as China, DeJean says.
“India’s booming pharma industry includes many multi-nationals using Indian manufacturing not only for APIs but also for finishing. The government does not want to lose this emerging market,” DeJean says.
There are separate initiatives going on for the domestic market focused on the India consumer, and internally distributed drugs will also be serialized at some point, he adds.
Systech, with Mumbai-based partner Techind Engineers and Consultants, has developed a network of “certified” select solution providers to support companies’ serialization deployments.
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