Pharma packaging is an ever evolving yet challenging segment of the pharma industry. Business insights from the last decade will help the industry in visualising the need of the sector with high reliability and sustainability solutions with low-cost methods. Express Pharma presents the industry’s views, understanding and preparedness for the next decade. By USHA SHARMA
Serialisation is the buzz word transforming pharma packaging industry
-Shivaji Chakraborty, Assistant General Manager-Packaging Development, Fresenius Kabi Oncology
Pharma packaging is one such pillar for business development which has evolved and is still evolving in an accelerated pace. The motive has been defined differently from time to time from containment and protection, to branding to user-friendliness.
Now is the era where the business perspectives are driven through regulatory compliance, customer focus and environmental sustainability. So maintaining the same packaging should also be designed with a purpose to meet the mentioned perspective as
Regulatory compliance
Regulatory changes are driving packaging innovation globally. Track and trace of the products throughout the supply chain to address the counterfeit issues. Serialisation is the buzz word transforming pharmaceutical packaging industry.
Evolving Product Composition – Rethinking Primary Packaging
These days the focus is on biologic drugs. Most biologic drugs being injectables; glass is the logical choice for primary packaging. However, some biologic drugs are found to interact with glass, delaminate it, causing flaking. So, it is necessary to keep this in mind while developing the primary packaging.
Customer focus and intelligent packaging
An ageing population and increasing life expectancy provides room for packaging innovation. While digital medicine with in-built sensors is making inroads in compliance monitoring and connected care, features such as daily dose markings on the pack are common, advanced features such as digital timers and alarms on packaging reminding patients of the time for next dose are the need of the hour.
Accurate dosing and dose monitoring: Dose monitoring features in packaging are increasingly playing an important role in abuse deterrence as well as patient adherence. Simple metered dosing systems to calendar-enabled closure technologies tracking and counting pills as they are dispensed and send the data to a smartphone. Unit-dose packaging with key drug details incorporated in every dose is gaining popularity in hospitals and clinics as a convenient and safe option, driving allied trends in packaging.
Tamper protection and Child Lock: With a high contribution of pharmaceuticals unintentional childhood poisoning, need for child locking mechanisms is critical. Packaging industries continue to incrementally innovate in striking the right balance between making it inaccessible to children but not too difficult for elderly patients. Several innovative packaging mechanisms are evolving in pharmaceutical packaging, including braille printing for blind people
Sustainability: Lot of packaging waste generated gets dumped into ocean, destroying marine life. In the process, it is destroying the ecological balance.
Business will sustain with its people and mankind will sustain only with a safe and healthy environment. Packaging shall be designed in a way to meet the three main mantras Reduce, reuse and recycle.
Packaging has a profound impact across the entire supply chain
– Soumyanath Mishra, General Manager- Packaging and Development, Mankind Pharma
The Indian pharmaceutical industry is undergoing significant growth. Even at current rates of seven to eight per cent CAGR, the industry’s annual revenues can grow to about USD 80 to 90 billion by 2030. As we enter in the new decade, pharma will continue to face the challenges from the past. Particularly, the globalisation of drug supply, delivering new product types, meeting demand from emerging countries, the rise of chronic lifestyle conditions such as obesity and diabetes, and the growing threat of counterfeit and falsified medicine.
To fulfill these requirements, the demand for pharma packaging products will rapidly evolve in the next three to seven years as portfolio diversification strategies translate to revenue realisation milestones. This will drive expanded demand in several products categories across primary and secondary packaging.
In the coming decade, there will be numerous changes within the pharma industry:
1. Increasing in the number of complex formulations
2. More active engagement in biopharmaceuticals
3. Increasing price pressure and competition within generics, regulatory changes and critical emphasis on the product safety and integrity
4. Increasing the focus on patient-centricity etc.
ANDA Filled by Indian generic companies – (December 2019)
A- Solidoral doses
B- Injectable
C- Ophthalmic
D- Others (Inhalation, topical, Transdermal etc.)
The above chart shows that about 85-90 per cent of the ANDAs held by Indian pharma companies are comprised of oral solids but there is a planned shift towards more complex molecules whose packaging is not only complex but also should be based on patient safety, patient compliance and patient convenience as well as patient-centric, intelligent and smart packaging for coming decade.
So, in the face of such disruption, we can expect some leading developments from Pharma packaging in the coming decade.
A) Focus on patient safety, compliance and convenience
The patient today has progressed from being the passive recipient of drugs to an active partner in the entire drug development process, right from the formulation type to the type of packaging. Digitalisation and awareness through social media have been the key driver of this change and the industry has been proactive in recognising the importance of ‘patient-centricity’, better to put as ‘customer-centricity’.
Some examples of patient safety, compliance and convenience pack:
- Child-resistant packaging and Senior Friendly packaging
- Wallet pack
- Unit dose packaging with CR features. Unit dose packaging to avoid contamination of the drug product
- Child-resistant medication with timer or alarm caps
B) Smart Packaging and intelligent packaging
Embedding advanced features into packaging such as sensing or wireless communication makes packaging ‘smart’ which can provide significant functionality. The packaging then becomes not only a way to protect and provide information on medicines but can add a whole host of extra functionality. The smart packaging can reduce supply chain losses through enhanced environmental monitoring and support improved patient adherence through smart adherence packaging.
For an example – Smart Bottle uses Biometric (fingerprint) authorisation to ensure that patients—and only patients—receive their prescribed doses of liquid opioid medications. If an unauthorised user tries to tamper with or force-dispense medication from the Smart Bottle, the device immediately neutralises the opioid.
C) Device and self-administration
Changing in hospital administration to self-administration process is increasing rapidly in the market. So, the medical devices are taking the leading role for the coming decade.
D) Connecting device
A connected medical device can collect and store data about patient use and trace the effectiveness of a particular device and treatment to help them to do so.
Utilising connectivity in drug delivery devices such as injectors and inhalers, connected health solutions help pharmaceutical companies, healthcare professionals and patients, improve how people take their medication. In addition to medication tracking, these systems support patients through reminders, incentives and peer communities to improve disease management, medication adherence and, ideally, outcomes. Additionally to this, we hope the connecting device will be used for the emergency treatment of the patient in the coming decade with a secure channel.
E) Blow fill seal(BFS) for unit dose stérile product
The inherent safety of the process, packaging sterile products under aseptic conditions without human intervention, has led the FDA to characterise Blow/Fill/Seal technology as an “advanced aseptic process”, indicating its use as a preferred technology going forward for thecoming decade.
G) IoT (Internet of Things)
Internet of Things (IoT) is gradually becoming an everyday reality in pharma, inventory and supply chain management being the biggest adopters. Amalgamation of IoT in drug delivery devices is a recent trend supplementing adherence packaging.
H) Anti-counterfeit packaging
The global anti-counterfeit packaging is having significant demand due to strong growth in the pharmaceutical & healthcare sectors. The growing pharmaceutical and healthcare industry and an increasing number of counterfeit products in the market are the major drivers of the anti-counterfeit packaging market. The upcoming decade would be more dedicated to overt counterfeit options as the patient is the one who will demand genuine products.
I) Serialisation and digitisation of the supply chain.
Serialisation is forcing businesses to move towards a more digital approach to data management as well as Anti-Counterfeit of drug products.
J) Optimisation of the cost and reducing the carbon footprint
Packaging, while easy to overlook, has a profound impact across the entire supply chain. It touches almost every aspect of the organisation. Most of the time it is never considered how packaging affects cost, handling, shipping, and more. Even the smallest of changes can save a manufacturer thousands of crores money per year while simultaneously reducing negative environmental effects. By taking a holistic approach to optimization through innovations that drive cost reduction and sustainability while
maintaining the desired functionality.
In the era of globalisation, it would be a challenge for the Indian packaging industry to match the international standards, safety, patient compliance and quality. So the packaging industry has to upgrade more in research to have a holistic approach towards packaging that would go beyond the functional aspect of packaging.
Smart packaging which can communicate – an interesting avenue
-Chandiprasad Ravipati, Head – Packaging Development, Aurobindo Pharma
The past decade from 2010 to 2019 was phenomenal for the Indian pharma industry, which came out of regulatory and statutory challenges namely – increased and more stringent inspections by US FDA, issuing of warning letters and imposing import alerts. Products-recalls due to quality issues mainly due to packaging errors. Serialisation requirements to start with DGFT followed by DSCSA, EUFMD and few other countries proposed. This is a massive project for any organisation exporting to USA, Europe and Emerging Markets.
Head – Packaging Development, Aurobindo Pharma
The Indian pharma industry triumphed from all these challenges and continued its reputation as ‘Pharmacy of World’. The quantum of role played in the implementation of serialisation by packaging technologists is commendable.
In the last decade, challenges gave ample experience and confidence to face the bigger challenges in the decade ahead. Some of the factors that will be influencing innovation in pharma packaging are:
- Diminishing patent expiry, especially in solid oral and liquid oral dosage forms, but some bright scope in oncology therapeutic segment.
- Shift of focus to formulations of parenterals and other novel drug delivery systems where primary packaging and dose delivery packaging is big challenge.
- Sustainable packaging in its entire life cycle of package journey from initial designing, establishing safety, efficacy and cost-effectiveness.
- Followed by supply chain management, which includes secondary and tertiary packaging meeting transportation until the final saleable pack is disposed.
- Catching the speed of IoT and using the technology for better information of the medicine, dosage, precautions.
- Instituting connectivity to each patient, retail and hospital pharmacists, understanding their needs and fulfilling them will play a pivotal role in making brand establishment by getting the patient loyalty.
- It’s a necessity to the pharmaceutical industry to dispel the bad propaganda done on the quality of drugs by Indian firms and infuse the confidence by practising of integrity and world-class cGMP.
The challenges for the packaging industry will continue in the coming years as well and due to various demands. Reduction in manual interference and installation of more and more automation with corrected validation to completely eliminate packing and labelling errors. Increasing the speed of packing lines for better productivity will be addressed which needs accurate packaging materials.
Meeting of US Pharmacopoeial standards <661> Plastic Packaging Systems and their Material of Construction effective from May 1, 2020 for packaging materials to meet overall perspective and establish with documented evidence that “The packaging system has been established to be safe by means of the appropriate chemical testing, such as extractables or leachables profiling, and toxicological assessment of the test data. This combination of chemical testing and toxicological assessment is termed “chemical safety assessment”.
It is one of the important responsibilities of pharma packaging technologists to facilitate 100 per cent transparency with packaging material vendors in translating the regulatory requirements and innovation.
They should play a role in participating in discussions with premier packaging academies who are nurturing future packaging professionals. The institutes should be aware of the needs and trends of pharmaceutical packaging. Another important task is to develop pharmaceutical packaging engineering expertise in line with leading FMCG, as more and more automation with proven efficacy is the need of the future.
Another avenue is smart packaging which can speak to the patient and even able to listen. It will induce a level of psychological impact, wherein the same drug product can do wonders especially in a critical and prolonged illness. The current form of patient information or medication guides can be replaced by easy ways of audio-visual communication with advantage of smart phones. Packaging can play a commendable part in e-pharmacy that is gaining popularity in India.
It’s going to be tough with so many geographical factors, millennials ruling world, technological advancement and ever-increasing regulatory demands, but there lays the beauty of the profession. Only those with heritable traits better suited to the environment will survive and not the strongest.
Use of AI and IOT concepts for smart packaging will be on the rise
-Tripti Nakhare, Sr. General Manager-Regulatory Affairs & PDD, FDC
Pharma Packaging is likely to go through a major transformation in this decade.
On the domestic front (Indian market), the shift is majorly towards affordable medicines for the masses in India. With such a large population below the poverty line, the government’s efforts will be towards providing medicines at minimal costs to the masses. This will call for cost-effective, simpler packaging.
The shift will be towards Janaushadhi supplies, Government tenders, and institution supplies. These would also require some levels of traceability hence barcoding may be expected.
At the same time with India growing to be a major economy, there is a growing elite, educated patient population. Hence smart packaging concepts, use of AI and IOT concepts for packaging machines will be on the rise! Packaging that will help in patient compliance – a combination of digital solutions and smart packaging solutions will be essential to fulfil the needs of such customers.
Moreover Hospital tourism is a fast-growing area in India and hence doctors would need to communicate with patients across the world! This would call for the use of digital technology for patient compliance.
With the government becoming conscious of counterfeit and spurious medicine and wanting to curb the menace, the serialisation and traceability of domestic Pharma products also seems to be in the pipeline. This increases the challenges for the Pharma industry. The service providers are however ready ad many vendors are now available for the same.
In the global scenario, serialisation and traceability are fast becoming the norm! Most countries are wanting this serialisation and traceability so having multiple software to fulfil each country requirement on each line is going to be a challenge and at some point will have limitations!
There will certainly be a shift towards automation and robotic controls. The continuous regulatory changes and demands of the inspecting authorities are leading to the growing need for lesser human interventions and increased automation. The regulatory requirements on packaging materials are increasing with the requirements like elemental impurities, recent USP chapter on plastics in packaging need to be attended to. The vendors need to upgrade themselves to meet the growing regulatory requirements for packaging.
With the awareness to nurture the environment and reduce the damage already done due to the industrialisation, the reduction in the use of plastics will require the development of environment-friendly biodegradable packaging materials. With growing digitisation, need for Good Distribution Practices, the pharma supply chains will undergo a major transformation and hence will impact the packaging community.
Next decade – an era of eco-friendly, cost-effective, innovative Pharma packaging with an increased use of AI in the equipments!
Markets have started accepting newer packages
-Ajay Bapat, Pharma Packaging consultant
Pharmaceutical packaging is going to be a breadwinner next year. The Indian pharma industry has stedaliy grown year after year. The average growth of drug industry could also have been maintained due to certain factors like molecules going off patent, new markets opening up for manufacturers or some time it is addition or extension of product pipeline with genomics, cell therapy or biologics etc.
As the pharma industry is growing with a rapid pace, the packaging industry which is an integral part of this pharma business worldwide has to make a fortune. In most of the cases, the product goes with packaging and gives equal opportunity for growth, however, people/ manufacturers associated with hardcore packaging material, find this industry a challenge but at the same time, it is very interesting as well. As the world is coming closer, newer technologies worldwide are available to everyone. Still we find there are preferred packaging styles and requirements in each market. For example, in the US they prefer to have bottle packs whereas typical commonwealth nations including the EU prefers blisters. It depends on habits, distribution system and even the weather conditions prevailing there. However, as compared to the last decade, markets have started accepting newer packages, thereby reducing the cost and number of SKUs for the manufacturer.
In the coming decade, there is every possibility that the manufacturer can offer a single type of SKU for all markets depending on volumes and market penetration. Hospitals have started preferring unit dose blisters and this can be one of the areas where smaller or emerging markets, including Asian markets, adapt to this type of packaging with small batch manufacturing concept. For example, Myanmar does not specifically ask for unit dose blisters or with cross perforations, however, they ask to print a batch detail with every tablet or capsule in blister.
In India, we already have a concept, as the chemist cuts a strip, even to single unit, as required by the customer and do not bother if remaining the part has the batch number printed on it. This concept of having batch identity on each pocket should pick up here as well. In my opinion, the coming decade may be the decade of compliances as regulators across the world are coming with newer guidance and complying to them will be a challenging job for packaging engineers, be it related to primary packing materials or labelling.
One of the major compliance is going to be related to serialisation or a job related to anti-counterfeit issues. The supply chain needs to be made more secure and packaging plays the most important role in making it more difficult for counterfeiters to eat in our product share. As such in major markets, serialisation, in one or other format is being worked out and in a regulated market, it is already been implemented.
The coming decade will have a major say in the aspect of how to make it more secure and whether the digital identity that is recognised as of today is enough or to have a combination of technologies of physical identity along with existing digital technology will make it perfect security. Making use of big data from serialisation with blockchain technology should be helping in a secured supply chain.
The coming decade is going to be dominated by devices; a packaging suitable and complimentary to these new devices will be a challenging job.
All of us have already started working on patient-centric packaging and as a medium of communication; it is packaging, which is going to play a major role.
With customer-centric features of the new decade and pharma companies as customers, even the packing material manufacturers will have to work on very attractive, sustainable and at the same time a cost-effective options. With the growing availability of information and awareness of intellectual property, the new material being developed in this decade will surely be covered under IP.
Worldwide, next decade, the buzz word is going to be sustainability, and what else other than pharma packaging is going to make it happen.
Of course, FMCG or retail markets with e-commerce will attract most volumes but pharma is not going to be lagging behind.
More and more companies have started working on automation and increase in productivity. The material that is being used also has to support these functions. So a chalta hai attitude will have to be kept aside and all of us will have to work with most precise and perfect material development.
With all these aspects in mind, a pharma packaging engineer or personnel involved in material development will have the most interesting, challenging and a decade demanding them to use the best of the skills, knowledge and aptitude.
u.sharma@expressindia.com
Thanks, your write up is really insightful nice and helpful content. Thanks for sharing a helpful article with us.