Smart packaging emerges as key to tackle the complexities and challenges facing the pharma industry
‘Smart’ is the buzzword in the fast transforming landscape of pharmaceutical packaging which has metamorphosed from an afterthought to a crucial differentiator. Going beyond the traditional functions of containment and protection, smart packaging solutions offer significant value-additions and tremendous impact as the life sciences sector moves towards sustainability, value-based care and patient-centric medicine. They have also become a valuable tool as the industry grapples with growing complexities and mammoth challenges like cost reduction, regulatory compliance, altering demographics, varying treatment patterns, and threat of counterfeiting.
But, what does ‘smart packaging’ actually entail?
It is an umbrella term that involves the transformation of conventional packaging into intelligent systems that are multi-functional by nature. The market for smart packaging is broadly classified as: active and intelligent packaging. The former interacts with the product and improves it while the latter encompasses electronic devices and sensors to communicate data to users.
The market for smart packaging is growing at a rapid pace. Research and Markets, a global market intelligence firm, in its ‘Global Smart Packaging Market Analysis & Trends – Industry Forecast to 2025’ predicts that the global smart packaging market is poised to grow at a CAGR of around 5.4 per cent over the next decade to reach approximately $52 billion by 2025.
Debarati Sengupta, Senior Analyst, Transformational Health Practice, Tech Vision, Frost & Sullivan, explains, “Traditionally, the primary function of pharma packaging was to ensure protection to the drugs/ biologics, ease the handling, and to provide relevant product information to the caregivers and patients. However, with the growing challenges of counterfeiting, prescription drug abuse, patient non-compliance, and requirements of an increasingly-sophisticated, digitally-connected supply chain, these packaging features have been proven to be insufficient. Smart packaging is being used to address these challenges.”
Let’s examine some major applications of smart packaging in detail.
Regulatory compliance: Changing regulations in different markets have been instrumental in the pharma sector moving away from conventional packaging to more intelligent packaging. As Sengupta states, “There is a greater emphasis on supply chain streamlining, digital connectedness, and increased attention from regulatory agencies to ensure standard of drugs.”
To cite recent examples, the US FDA recently issued a draft guidance for industry, instructing the manufacturers and other supply chain stakeholders to include a product identifier on prescription drug packages and cases before November 2018, under the US Drug Supply Chain Security Act. The European Union has also released the Falsified Medicines Directive (FMD) Safety Features Delegated Regulation, which mandates serialisation of licensed drug products for companies operating in the EU from early 2019. Such measures have led to the rise of radio frequency identification (RFID) systems and innovations in serialisation technologies to aid compliance.
Countering counterfeiting: Counterfeiting is another major challenge in the pharma sector. As per World Health Organisation (WHO) estimates, around ten per cent of pharma products in the world are counterfeits, with far higher rates in developing countries. Thus, the need for more sophisticated packaging options in the war against counterfeit medicines has become evident.
To elaborate this point, Anand Khare, GM Innovations, ACG Pharmapack, gives the example of smart blister packaging and says, “To deter counterfeiters, pharma manufacturers are increasingly resorting to adding a feature in blister packaging that would be hard to copy. A variety of overt and covert solutions are incorporated directly into the barrier packaging film used for thermoforming, either as part of the film or at the time of thermoforming. These features, if incorporated at the time of manufacturing barrier films, becomes very difficult for counterfeiters to copy the packaging. Various overt features such as holography are also available and are in use presently. ACG Pharmapack manufactures one such type of film where distinct and unique differentially-grated holographic images are embedded into the film. This technology has not only given pharma companies the ability to protect their products but also the opportunity to enhance their brand image and shelf presence. Since this is an overt feature, the end consumer can very well recognise the genuine brand just by looking at the blister pack.”
He also elaborates on some covert features that include taggants of various kinds. He says, “These taggants are embedded in the packaging material and are not visible to the naked eye. Specialised detectors are required to find out whether the pack is genuine or fake. While these methods are more robust in nature, they are a little cumbersome too, as the end consumer cannot really find out whether the product is genuine unless he has these hand held detectors. This type of protection is usually used by field representatives to check whether the product is genuine in the supply chain before it reaches the patients’ hands. The third and the most intricate level of anti-counterfeit packaging is where a forensic type of investigation needs to be done in designated labs to detect taggants built into the packs. Normally, the first two are used combinedly while the third is yet to gain favour with the pharma companies.”
Preserve and extend shelf life and quality of drugs: Another major advantage of smart pharma packaging is its ability to extend the shelf life of medicines, thereby providing more value to the patients and helping pharma companies reduce costs.
Sengupta elucidates, “It is possible for pharma manufacturers and the participants along the supply chain to monitor crucial parameters such as temperature and pressure. These data points can help the companies monitor the quality and integrity of their products during transportation. The importance of tracking these parameters becomes apparent when dealing with vaccines, and biologics, and when transporting drugs to places without appropriate storage facilities.”
Laxmikant Khaitan, GM, Multisorb Technologies highlights, “With reducing product pipelines or promising pipelines that are in early clinical studies stage, pharma companies have returned to promising older drug products. Products that could not be stabilised with prior packaging systems have new found potential with advances in smart packaging. Other products that have had limited success due to shelf life and distribution challenges can now reach new customers and new markets.” To elaborate this point, he highlights the foray of smart packaging technology into segments of the pharma industry such as parenteral drugs. He points out that whether administered in large dosage bags for infusion or in ready-to-administer pre-filled syringes, these drugs could be sensitive to oxygen degradation and can now be protected by a range of smart packaging approaches.
Similarly, Khare also refers to various types of specialised inks used in packaging that ‘intelligently’ change colours at certain temperature. For e.g. a pack can show whether the medicine has been preserved in refrigerated condition just by the colour of the ink which changes to a certain hue under cold conditions. This, in turn, gives clear indications about the safety and efficacy of the product.
Sengupta informs, “Smart packaging may not be able to solve all the problems related to drug quality, but certainly issues relating to shelf-life and tampering can be monitored. In three to five years, we expect greater use of information and communication technology in pharma packaging.”
Patient adherence: This has always been one of the major factors in favour of smart packaging as it benefits the most significant stakeholder in the healthcare chain, the patient.
Sengupta explains various ways in which smart packaging can ensure patient adherence and points out, “Alarms and reminders in smart packaging ensure patients take their medication on time. This is particularly useful for patients suffering from neurological illness like Alzheimer’s, which requires caregivers and family members to give timely medication to the patient. While this helps the patient considerably, the pharma company benefits in terms of better consumer acceptance and enhanced brand loyalty, significant advantages in the long run.
He gives the example of embedded sensors in packaging and explains, “At the patient’s end, added sensor features can further improve patient care. For instance, sensors can be added to dispensing bottles to remind patients to take medications, and to prevent them from having them out-of-turn. In hospitals and clinical trials, smart packaging can ensure timely medications and avoid missing any dosage.”
Khare cites blisters with dates marked at the back of individual blister pockets with the amount of dosage built into a single pocket as a simple example of compliance packaging. So, for instance, if the doctor has prescribed that the patient take two different types of medicines at the same time, these two medicines are then packed into the same pocket. Or, if the patient needs to consume the same on a particular date or time, the message can be printed on the back end. Usually when multiple dosages are packed together, deep draw blisters with adequate protection against moisture and oxygen are needed.”
Obstacles to growth
Thus, the advantages offered by smart packaging are very crucial for the pharma industry. Some technologies are finding rapid adoption, but many others with considerable potential haven’t taken off as expected. So, what is hindering the growth of smart packaging technologies? In Sengupta’s opinion, “In India, there is greater use of RFID on pharma supply chain. However, technology adoption is still in nascent stage, and hasn’t penetrated the supply chain completely.” This has been a major hurdle in the adoption of smart packaging.
Moreover, smart packaging material and production is expensive compared to conventional packaging which can hinder its widespread adoption. With R&D costs already being quite high, and the time-to-market extending into decades, pharma companies may be loath to invest more in what may be viewed at this time as an extravagance.”
Growth drivers of smart pharma packaging
- Evolving regulations, e.g. serialisation, tamper evidence requirements
- Changing demogaphics (geriatric, paediatric)
- Self medication
- Evolving therapeutic areas
- The growth of biological medicines
- Growing malpractice suits
- Growing deployment of intellingent technology
- Growing importance of data
He further states, “Scaling up the smart packages is another major challenge. Consumer education about the innovative packaging designs and functionality is essential for its proper usage.”
Khare believes that the biggest deterrent in adoption of smart packaging, especially for covert technology, is that the end consumer does not have direct access to its benefits and the cost of these technologies is still high for mass adoption. That said, he also believes that in the next few years prices would come down as demand increases. In the meanwhile, he feels that overt and easily executable technologies such as differentially grated images and track and trace will find traction with pharma companies.
Tsuyoshi (Zach) Yamazaki, Director, PharmaPackaging Division, Nipro Corporation, also asserts, “The problem isn’t the lack of acceptance for the concept of smart packaging; it’s bringing it to scale affordably. Unless the figures add up concepts will stay as concepts.”
He also feels that scepticism about the return on investment and aversion to taking a huge risk is deterring adoption of smart electronic technologies for packaging. Yamazaki also has an alternative to this problem. He says that companies should look at simpler and less technology-intensive, but effective and smart ways of packaging to be smart yet affordable. He gives the examples of a few products offered by his company. One of them is a new bag-type combination product combining powdered drug and dissolving solution. Its design and packaging prevents risks of medical malpractice by preventing administration before mixing medication. (See pic 2)
Similarly, he explained how information printed in Braille, makes patient adherence easier in the case of blind patients. (See Pic 1) He also gave the example of how they have enabled a tamper-proof packaging solution which has a pink strip and is visible only if the packaging has been opened. Thus, he recommended that alongwith high-tech solutions, smart packaging also means using effective means of packaging which need not be driven by electronic technology only.
In times to come
All said and done, the need and potential of smart packaging cannot be denied. However, pharma companies would need to make a major shift in their strategy and structure to integrate newer systems and processes. Though leading pharma companies have already embarked on this journey, it is time the rest of them to go down this route to address unmet needs, get a competitive advantage in industry, and leverage the growth opportunities in the market.