Counterfeit medicines are the bane of pharmaceutical manufacturers. The potential rewards for criminal gangs in smuggling fake drugs into supply chains, or reselling stolen consignments of the real thing, are enormous. Last year, the World Health Organization estimated that 10% of all drugs in low and middle-income countries are fake - in a market worth roughly $30 billion a year.
The problem does not only extend to the developing world. In 2013, the Falsified Medicines Directive came into force in the EU, which is legislation designed to minimise the public's exposure to counterfeit drugs by boosting the traceability of medicines in the manufacturing process.
Pharmaceutical wholesalers were instructed to provide data on the production of medicines to a new body, the National Medicines Verification System (NMVS). Jean-Pierre Allard, chief technology officer at OPTEL Group, states the reason was that companies quickly grew confused as to their obligations under the new law.
"Many of them thought that they only had to send data on a voluntary basis," explains the chief technology officer at OPTEL Group. In reality, says Allard, there are several instances where wholesalers need to send product data, including serial numbers, to the NMVS, including when products are sold outside of the EU. "Another is when a wholesaler buys pharmaceuticals from a manufacturer, or from an official importer. They have an obligation to verify every single product and what they receive."
OPTEL Group caters for this need by providing sophisticated scanning equipment and data management software to pharmaceutical stakeholders, streamlining and automating compliance with existing laws. "We have about 75 different vision tools," explains Allard, including several which analyse the quality of IV bags, vials and tablets, in the latter's case individually and en masse. "One of our great products is TabletProof, which inspects each and every pill using a 360° view. The product uses four cameras to take pictures of tablets in moments of freefall on the production line."
The company's cloud-based solution, Open Site Master (OSM), is also available for manufacturers to operate and back up data on medicines passing down production lines. "It used to be that most packaging lines were not connected with any IT infrastructure, which meant that if there was no internet, production would continue," Allard explains. "Now, the situation is different. If the internet is down for even an hour, there is no way to source new serial numbers, and so on."
What OSM does is act as a single point of entry for several actions, including stocking serial numbers in advance. "It's supposed to be a local buffer," says Allard. In addition to supporting a wide variety of national coding, from Brazilian IUM to Chinese eCode, OSM acts as a temporary Electronic Product Code Information Services (EPCIS) repository. "This way, if there's a shutdown of the internet, the plant will continue to work for weeks ahead. When the numbers are printed and inspected, OSM also records timestamps of what happens."
By providing pharmaceutical manufacturers with sophisticated inspection and data management products, OPTEL Group is giving the weapons to fight against counterfeit drugs. Meanwhile, its participation in cross-industry regulation workshops is helping to narrow the space in which criminal gangs can duplicate or steal vital medicines.
"Since 2009, we've been an active member of several GS1 groups," explains Allard, referring to the non-profit group that seeks to perfect channels of communications between businesses.
OPTEL Group has also co-founded the Open Serialisation Communication Standard Group (OPEN-SCS). "We convinced all of our competitors to join. We also have a few manufacturers, including Roche and Pfizer. The purpose of the group is to enhance standards of communication at the IP level."