Pharmaceutical labeling errors have generated many global headlines. They are the leading cause of product recalls in the pharmaceutical industry. In November 2020, Aurobindo Pharma USA had to recall 7,440 bottles of Ibuprofen oral suspension drug due to a labeling error. Similarly, Dr. Reddy's made the following headline as well:
There are many such similar cases across the pharmaceutical industry. The pharmaceutical industry is strictly regulated all over the world. Inaccurate pharmaceutical labeling leads to spreads the wrong information. Sometimes, consuming an incorrect dosage might make patients ill. In a few drastic cases, the consequences might also lead to deaths.
In India, the Central Drugs Standard Control Organization (CDSCO) and the Drug and Cosmetics Act (DCA) regulates pharmaceutical products.
Brands like Cipla, GlaxoSmithKline, Biocon, Sun Pharmaceuticals and more fall under this category. CDSCO also has an elaborate set of rules for pharmaceutical packaging and labelling. The organization handles everything from distributing the manufacturer’s license to enforcing quality control.
Pharmaceutical labels contain a lot of information such as ingredients, expiry dates, warnings and more.
In the artwork development process, human errors can creep in. Even an incorrectly placed decimal point on the product label can cause problems. Other instances such as mistakes in language translation or inconsistency in colors may result in product recalls.
Let’s understand in detail, 5 commonly occurring errors in pharmaceutical labeling and how to overcome them.
As mentioned before, pharmaceutical brands are under constant scrutiny. It's important they adhere to safety regulations for all their products. Local regulations are often complex and brands need to be fluent in the requirements.
Depending on the category of medicines, pharmaceutical brands have to follow other mandatory regulations. As the number of regulations increase, so does the difficulty to stay in compliance. Errors on packaging can creep in if it’s not accurately reviewed in the artwork approval process.
An incorrect pharmaceutical label can put patient safety at risk.
For example, Endo Pharmaceuticals in Ireland had to recall two batches of Robaxin® 750mg Tablets 100, owing to an error in the amount of dosage. In UAE, JulpharGulf Pharmaceutical Industries had to recall Laxocodyl because of a certain medicine for adults that was instead labeled as being for children.
Such recalls are not only expensive but damaging to the manufacturer’s reputation.
Quality issues may persist throughout the entire artwork development and proofing process. Furthermore, they can lead to inconsistencies in product packaging. These problems are not extreme enough to result in a recall but affect branding.
Misplaced or distorted graphics, inconsistency in colors and fonts, are common issues. This can make a product look unauthentic, and in certain pharmaceutical products, give out the wrong information due to the use of incorrect color codes.
Pharmaceutical industries have limited time to get a product out in the market and in the hands of those who need it. Often medicines are imported from other countries. In such cases, translation comes into play.
Proofing translated labels are a major task undertaken by professional translators. Any errors in the language can make the content unclear, delaying the product’s launch.
Manual proofing of pharmaceutical labeling is a time-consuming job. Sometimes, developing labelling artwork involves many teams from different locations. Often, the volume of the artwork is also quite large. Orchestrating all the activities and integrating different processes creates more difficulties.
First, pharmaceutical labeling is not a one time job. For every SKU, for every country, for every new product, the rules are different. Second, it involves many collaborators and cross-functional teams. And third, pharmaceutical labeling above all needs to offer assurance and instruction.
Therefore, an error can significantly impact a brand's bottom line and reputation.
So, how can you avoid making these errors in pharmaceutical labeling?
It’s no surprise that the pharmaceutical industry is stringent. It has to be. What’s shocking, however, is that over 50% of product recalls happening due to errors in labeling.
Pharmaceutical brands need a reliable way of checking labeling artwork. And Artwork Flow can help curb these errors by simplifying the review process.
What are the challenges that you face when managing pharmaceutical packaging and labels? Do you use any tools to automate the process? We’d like to know your thoughts.