Five Commonplace Mistakes in Pharmaceutical Labelling (and How To Keep away from Them)

In February 2019, Dr Reddy’s recalled 2,770 bags of an epilepsy drug because of a pharmaceutical labelling error.

We all understand the consequences of errors in pharmaceutical labelling. And that’s why such news makes global headlines. 

In India, the Central Drugs Standard Control Organization (CDSCO) and the Drug and Cosmetics Act (DCA) strictly regulate pharmaceutical products, their packaging, and labelling. The organization handles everything from distributing a manufacturer’s license to enforcing quality control. 

If you manage packaging artwork for pharma products, you need to be careful to avoid mistakes that often happen. Even the slightest slip-up, such as an incorrectly placed decimal point, can cause problems.

Let’s understand in detail 5 commonly occurring errors in pharmaceutical labelling and ways to overcome them. 

5 Common Errors in Pharmaceutical Labelling 

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, especially when it comes to proofing the text, colours, or translation. 

These errors could lead to delays in launch or product recalls.

1. Compliance Mistakes

Pharmaceutical brands are under constant scrutiny. Hence, it’s important to adhere to safety regulations at all costs. The DCA has mandatory pharmaceutical labelling requirements:

• Name of the product
• Brand name and logo
• Manufacturing license number
• Manufacturing date and expiry date
• Warnings of side-effects
• Instructions (Eg., For external use only)
• Dosage information
• Batch number of the production
• List of active ingredients and their amounts
• Barcode
• Contact details of the manufacturer

Certain categories of medicines might accompany additional regulations. But as the number of regulations increases, it can be difficult to maintain compliance. Errors on packaging can creep in if it’s not accurately reviewed in the artwork approval process.

The Solution

Online Artwork Proofing Tools are a great way to reduce compliance risks. Proofing is generally the task of multiple teams. Online tools such as a PDF comparison tool, can be used to identify minor changes in the artwork easily.

2. Incorrect Information 

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 labelled as being for children. 

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

The Solution

Labelling errors are common. Without proper proofing tools, it can be easy to overlook these errors in the artwork. An online artwork comparison tool can be a great way to see changes in a revised label. It can find and highlight even the smallest changes in the labelling text. 

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 colours 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 colour codes.

The Solution

Review tools, such as a Font Finder, or Colour Extractor can simplify the process of identifying and checking such inconsistencies in the artwork. You could compare two versions of the product artwork to identify discrepancies.

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. 

The Solution

Translation errors can happen due to manual proofing. Local translators might review the pharmaceutical labelling by eye. Instead, an online proofing tool can be used to easily track the changes in the revised labelling artwork and share feedback.  

5. Improper Inspection

Manual proofing of pharmaceutical labelling 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.

The Solution

Automating the proofing process makes it faster and error-free. Online tools can help to accurately review labelling artwork in a short span of time. 

Pharmaceutical Labelling 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 happening due to errors in labelling. 

Pharmaceutical brands need a reliable way of checking labelling artwork. And Artwork Proofing Tools help them 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.