Common Packaging Challenges in the Pharmaceutical Sector and How to Overcome Them

Pharmaceutical packaging serves multiple critical functions. It must protect the safety and effectiveness of medicines, comply with detailed regulatory standards and communicate information clearly to patients and healthcare professionals. These demands create a complex environment for businesses operating in the sector. Below, we explore common challenges and practical ways to overcome them.

Regulatory compliance

Regulation sits at the heart of pharmaceutical packaging. In the UK, the Medicines and Healthcare products Regulatory Agency sets the standards, while in Europe, the European Medicines Agency imposes its own strict requirements. Across the Atlantic, the US Food and Drug Administration enforces additional rules, including the Drug Supply Chain Security Act, which requires serialisation and traceability measures.

For businesses trading internationally, keeping pace with multiple regulatory frameworks is one of the biggest hurdles. Flexibility in packaging design – such as adaptable labelling and interchangeable security features – makes it easier to comply with differing regional standards. Partnering with packaging suppliers experienced in international distribution can also reduce the risk of errors and delays.

Counterfeit prevention

Counterfeit medicines remain a major concern worldwide, damaging patient safety and eroding confidence in legitimate products. Packaging represents the first line of defence. The most effective approach is to combine protective measures – tamper-evident seals, serialised barcodes and track-and-trace systems that verify each unit as it moves through the supply chain.

Protecting product integrity

Many medicines are sensitive to environmental conditions such as temperature, light and humidity. Without the right barriers, their quality can deteriorate before reaching patients. Another critical consideration is material compatibility. Packaging materials may release “extractables” or “leachables” into the drug, altering its stability or safety.

Packaging developments such as UV-resistant plastics, moisture-blocking films and desiccant systems are addressing these risks. Compatibility testing also makes sure that materials do not negatively interact with their contents. By working with packaging specialists and validated materials, businesses stand to maintain integrity throughout their product’s lifecycle.

Accessibility and patient-centric design

Safe packaging does not always mean accessible packaging. Patients with limited vision, reduced dexterity or diminished strength can struggle with complex closures or unclear labelling, increasing the chance of medication errors or missed doses.

The industry is placing greater focus on patient-centric design. This includes closures that remain child-resistant but are manageable for older adults, clear large-print labelling and tactile features such as Braille.

Supply chain reliability

Packaging availability has a direct influence on the availability of medicines. Shortages, shipping delays or fluctuations in raw material supply can all disrupt access to essential treatments.
Strong supplier partnerships help address this challenge. Providers with reliable stock levels, scalable production and rapid dispatch give businesses greater resilience against fluctuations in demand. Additional services, such as in-house labelling can also streamline processes and remove unnecessary steps from the supply chain.

Balancing sustainability with safety

While sustainability is a growing priority across all industries, pharmaceutical packaging must continue to meet uncompromising safety and compliance standards. This makes the shift to greener alternatives particularly complex.

Businesses are increasingly turning to recyclable options such as PET plastics, which combine strength, transparency and barrier protection with wide recycling availability. Biodegradable and lightweight designs are also emerging, provided they can meet regulatory and performance requirements. By collaborating with suppliers investing in sustainable innovation, pharmaceutical companies will be ready to implement new technologies as they become viable.

Working towards solutions

Pharmaceutical packaging presents a unique set of challenges, but each comes with achievable solutions. Flexible designs and compliance tools help manage regulatory complexity; layered authentication reduces the risks of counterfeiting and advanced material testing supports product integrity.

For businesses navigating packaging challenges in the pharmaceutical sector, the direction is clear: move beyond minimum standards towards strategies that build resilience, improve patient experience and support international supply. Companies that act now will be better prepared as regulations tighten and patient expectations rise further.