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. 

5 Common errors in pharmaceutical labeling 

Pharmaceutical labels contain a lot of information such as ingredients, expiry dates, warnings and more. 

In the artwork development process, human errors can creep into label management. 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 label management issues and necessitate product recalls.

Let’s understand in detail, 5 commonly occurring errors in pharmaceutical labeling and how to overcome them.

1. Compliance risks 

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 pharmaceutical packaging can creep in if it’s not accurately reviewed in the artwork approval process.

Download now: The Essential Guide to AI-powered Label Compliance

2. Incorrect information

An incorrect pharmaceutical label can put patient safety at risk, whether it's a translation mistake, typos, missing information, or incorrect claims. For instance, if a dosage information is incorrectly labeled or a caution statement is missing, it could lead to serious health ramifications.

Such recalls are not only expensive but damaging to the manufacturer’s reputation.

3. Quality issues

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.

4. Translation errors

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.

5. Improper inspection

Manual proofing of pharmaceutical labeling is a time-consuming job. Sometimes, developing labeling 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 labeling errors.

Avoid errors in pharmaceutical labeling

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, a labeling error can significantly impact a brand's bottom line and reputation.

So, how can you avoid making these errors in pharmaceutical labeling?

Automate compliance

Instead of manual compliance checks, look for a software that automates the regulatory compliance process for your brand. Artwork Flow's ComplyAI allows users to create custom checklists for various labels and run compliance checks with the help of AI to catch any labeling errors before it goes to print.

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Automate artwork proofing

Look for an artwork management software that has annotation and commenting features for a seamless feedback process. Collaborators such as translators and legal teams can offer feedback right on the file for refined labels. Without a proofing process, it can be easy to overlook these errors in the artwork. Tools such as font finder, color extractor, braille reader, and version comparison can help to review files with greater rate of accuracy.

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Faster reviews

Don't miss out on any details with checklist-oriented tasks. Building checklists for your teams will help them systematically review labels and not miss out on any label requirements, simplifying the review and approval process.

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Cloud storage and version control

AI-led asset library makes it easy to store and share latest label with teams anywhere. Users can find any label using smart tags, custom metadata, and filers. Version control eliminates version confusion and helps retrieve any artwork version instantly.

Pharmaceutical labeling done right

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 happen 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.
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What are the challenges that you face when managing pharmaceutical packaging and labels? Do you use any tools to automate the process? Book a demo with us to analyze and learn what suits your label management needs for a better labeling process.