In a market as complex as the pharmaceutical industry, entry not only requires high initial capital investment but adherence to stringent regulatory controls. In particular, traceability legislation established to stem the threats of counterfeit and gray market drugs are a present market effector, driving rapid growth in the labeling, coding, and decorating machinery market.
Traditionally, drug manufacturers would look to manufacture a drug for global distribution. As requirements have differentiated from various regions and countries, the packaging sector sees more of a trend towards local manufacturing and outsourcing.
In North America, for example, the deadlines imposed for meeting the Drug Quality and Security Act (DQSA) of 2013 come to fruition in 2018 with later deadlines for re-packagers and wholesalers. The regulation requires a transaction document and serialization of all prescription products, enabling the electronic transfer of specified transaction information and complete supply chain history.
Many counterfeit drugs have originated in China, the largest of the ‘pharmerging’ countries. To combat piracy, it initiated a gradual implementation of its Electronic Drug Monitoring Network as part of the China Food and Drug Administration’s (CFDA) plans to enable traceability of all drug products throughout the supply chain.
Serial numbers were to be assigned centrally by the China government, requiring reporting of all transactions, from manufacturing to dispensing. The legislation required all drug manufacturers, both domestic and foreign, to be using the network by the end of 2015. Within a few months, however, the law was shelved, confusing pharmaceutical manufacturers.
In July 2016, the CFDA released an update alluding to future serialization requirements. Possible revisions include alignment with serialization standards in other regions such as 2D barcodes used in the U.S. and Europe and the ability for companies to generate their own codes instead of having them created centrally by the government.
The most considerable legislative uncertainties for the global drug industry lie with President Trump’s pledges to bring down U.S. drug prices. This potential for changing healthcare legislation would have a definite but uncertain impact on the pharmaceuticals market, as it calls for draft legislation allowing the U.S. Department of Health and Human Services to negotiate drug prices for Medicare. The proposed bill is controversial, but its details and the impact it will have are unknown.
Regardless of the outcome, pharmaceutical companies need to have a global labeling approach that addresses the different requirements across the globe. Otherwise, they must decentralize their packaging and labeling or do it in one location that offers flexibility to change label information based on final destination.
Drug companies want to focus on marketing and development of drugs, not on packaging. As technology and requirements change, it becomes more difficult for drug companies to stay on top of the latest innovations. With billions of dollars invested every year into the discovery and development of new medicines that can take over a decade to come to market, drug companies often rely on outside expertise on labeling. By outsourcing, drug companies have access to more up to date technologies and information.
Meeting Compliance
There is no global standard on serialization and information on the label.
There is some discussion within the pharma community to establish standards since it is challenging for packaging and labeling providers because the regulations are broad and drug companies have different ideas about best practices. It becomes difficult for packagers to accommodate different pharmaceutical companies.
Ultimately something will have to give, with the industry assumption being that eventually everyone will get together and establish some sort of standard and a third party would come in to audit. This would come from the industry, not government oversight.
In place of these changes, the options for the drug manufacturer are either to put local information requirements for serialization on their labels or to design their labeling systems so that you can make changes to meet different export requirements. (Labeling a certain way for one region and changing it to meet requirements somewhere else.)
Along with outsourcing, there is more pressure on converters and labeling companies to establish quality management systems that are consistent for drugs. Manufacturing regulations apply to drug companies, not labeling companies. In addition to transparency and information, they want to ensure that packaging and labeling companies are managing themselves with a quality system comparable to drug companies.
The type of information on the label has also been expanding. In 2006, FDA put out a new regulation for label requirements. The purpose was to provide the necessary information to the drug prescriber/doctor, but the regulatory requirements and information didn’t address the consumer.
Now, there is more of an effort to make the information easier for the patient to understand with labels that have more easily understood information for the consumer on the surface while the booklet incorporates information for the doctor.
Regulatory agencies have been focusing on information about potential migrants or leachables in the drug. Suppliers are looking more at what’s in the materials that could seep into drugs. This concern applies to containers, labels, and the substrate that adheres the label to the container.
More sensitive analytical methods enable regulators to see leachables at lower and lower levels. Despite the increase in the oversight of leachables, there are no law changes as of yet. The regulations are written very broadly and put the onus on the drug manufacturer to ensure the suitability of the packaging material and that it will not impact the quality or safety of the drug. This is broad enough not to require any new laws or regulations.
PMMI’s Healthcare Packaging EXPO, co-located with PACK EXPO International 2018, October 14-17, at McCormick Place, Chicago, will provide education on the various ways that current pharmaceutical companies are dealing with labeling challenges, and offer access to a wide range of pharmaceutical and packaging technologies.
About the Author:
Sean Riley is the senior director of media and industry communications at The Association for Packaging and Processing Technologies (PMMI), which represents more than 800 North American manufacturers and suppliers of equipment, components and materials as well as providers of related equipment and services to the packaging and processing industry.