As therapies grow more complex, packaging is evolving beyond protection to enable drug delivery, safety, and adherence. Pharma Industrial India explores emerging technologies and innovations shaping future-ready pharma packaging.

Packaging is no Longer just a Container; It is Becoming an Integral Part of the Therapy: Chandiprasad Ravipati, Head—Packaging Development, Aurobindo Pharma

As conventional solid oral dosage forms and parenterals mature in both regulated and emerging markets, the industry’s focus is steadily shifting toward biologics, inhalation therapies, and advanced drug delivery systems. Many such molecules are already in the development pipeline of leading Indian and multinational pharmaceutical companies. Oncology is another area witnessing significant growth, with the Indian pharmaceutical industry making commendable progress in providing high-quality, affordable therapies through innovative product development.

The rapid emergence of drug-device combination products presents new challenges for pharmaceutical packaging. One of the major constraints in India is the continued dependence on imported medical devices, while regulatory expectations for combination products continue to evolve globally.

To address these challenges, packaging professionals must develop expertise beyond conventional packaging. A sound understanding of global regulatory requirements, pharmacopeial standards, material compatibility, and the intended use of medical devices is essential. Equally important is the establishment of in-house laboratory capabilities to evaluate and validate device performance, functionality, and compatibility throughout the product lifecycle.

Innovation has become indispensable in today’s rapidly evolving pharmaceutical landscape. However, true innovation is often misunderstood. Packaging innovation is not merely about introducing new materials or technologies—it is about creating greater value through improved patient experience, regulatory compliance, operational efficiency, and sustainability.

There is always an opportunity to improve packaging, even for products that have been on the market for years. By rethinking and redesigning existing packs, significant improvements can be achieved without compromising product quality.

From a sustainability perspective, the first principle should always be ‘remove’—eliminating unnecessary packaging wherever scientifically justified. The next is ‘reduce’, achieved through approaches such as material downgauging, optimised blister design, better tablet or capsule orientation, and greater use of digital technologies to minimise printed patient and physician literature where regulations permit.

For every new packaging development, teams should adopt a future-ready mindset instead of relying solely on conventional practices. Innovation should be continuous, practical, and driven by measurable value.

Successful development of drug-device combination products demands close collaboration among all stakeholders from the earliest stages of development.

Device manufacturers establish the safety and functional performance of the materials used in medical devices. However, pharmaceutical manufacturers are responsible for demonstrating formulation compatibility, product protection, stability, and overall system performance before commercialisation. In addition, integrating drug-device combinations into commercial packaging operations requires careful engineering and validation.

These responsibilities cannot be addressed in isolation. Transparent communication, scientific collaboration, and mutual trust between formulation scientists, packaging engineers, device developers, manufacturing teams, and regulatory professionals are essential for developing safe, effective, and commercially successful products.

Advanced drug delivery systems and complex therapeutic molecules continue to evolve rapidly, bringing equally complex packaging requirements.

The primary challenges include demonstrating suitability for the intended use, ensuring compatibility between formulation and packaging components, and complying with the regulatory requirements of multiple global markets.

These challenges can be successfully addressed only through early collaboration between device manufacturers, packaging development teams, analytical laboratories, manufacturing, and quality functions. Scientific evaluation, risk assessment, and well-designed validation studies remain the foundation of successful packaging development.

Today’s pharmaceutical packaging has evolved far beyond its traditional role of protecting the product. Patient-centricity has become a key design objective. Medication adherence remains only around 50 percent globally, with considerable variation across therapeutic areas and patient populations. This presents a significant opportunity for pharmaceutical companies to design packaging that actively supports correct medication use.

Packaging should increasingly be tailored to different patient groups, considering factors such as age, physical ability, therapy complexity, and socio-economic conditions. Digital technologies—including QR codes, instructional videos, dose reminders, refill alerts, and other smart packaging solutions—can substantially improve patient understanding, convenience, and adherence.

Ultimately, packaging should simplify therapy rather than complicate it.

Rather than identifying a single breakthrough technology, it is believed that the greatest impact will come from innovations that improve the overall patient experience while maintaining regulatory compliance and product integrity.

Future packaging should provide simple, intuitive access to information through audio-visual instructions, digital guidance, and patient-friendly interfaces that explain device operation, administration, storage, and disposal. The effectiveness of these innovations will depend on their ability to address the needs of diverse patient populations, considering therapy
complexity, age groups, health literacy, and the socio-economic environment in which products are used.

Further, technology should simplify healthcare—not make it more complicated.

The next generation of pharmaceutical packaging will be shaped by 3 major drivers: smart technologies, sustainability, and advanced drug delivery systems.

Smart packaging will enable digital traceability, condition monitoring, and improved patient compliance. Sustainablesolutions will continue to focus on recyclable materials, PFAS free technologies, optimised package designs, and reduced environmental impact. At the same time, innovations such as large-volume prefilled injection systems, Blow-Fill-Seal (BFS), and Form-Fill-Seal (FFS) technologies will continue to support the growing demand for advanced therapies.

I believe the future of packaging will not be defined simply by sophisticated technologies, it will be defined by how effectively packaging protects the medicine, supports the patient, minimises environmental impact, and remains practical throughout the product lifecycle.

Packaging should be optimal, simple, patient-centric, and wherever possible, fully recyclable or reusable. Above all, packaging professionals must think beyond conventional design approaches and evaluate every solution from the perspective of the patient, healthcare professional, manufacturer, and the entire supply chain.

True packaging innovation is achieved when technology, patient needs, regulatory compliance, and sustainability work together to create better healthcare outcomes.

The Future of Pharmaceutical Packaging will be Defined by Trust, not just Technology: Ankit Gupta, President, Authentication Solution Providers’ Association (ASPA)

Biologics and combination products have changed what packaging is expected to do. It is no longer just a container, it is part of the therapy. Cold chain integrity, tamper evidence, and dose accuracy now sit alongside authentication as non-negotiable requirements. This means packaging teams need people who understand materials science, device engineering, and digital traceability together, not in separate silos. At Authentication Solution Providers’ Association (ASPA), we are seeing more member companies invest in teams that combine anti-counterfeiting expertise with data and serialisation know-how, because a single compromised pack in a biologics supply chain carries far higher risk than a compromised tablet strip. This becomes even more critical as the latest ASPA-CRISIL study found that 80 percent of consumers believe counterfeiting in healthcare products has increased over the last 12 months.

Honestly, it is catching up rather than keeping pace. Formulation science has moved fast, into biologics, sustained release, and drug-device hybrids. Packaging has responded, but often reactively, once a new therapy is already close to market. Where we are seeing real progress is in authentication and traceability, India’s expanding QR code-based traceability framework and the push toward full track and trace are forcing packaging to become smarter and more secure by design.

Our latest ASPA-CRISIL report also found that consumers now perceive nearly 28 percent of healthcare products in the market to be counterfeit, reinforcing the need for secure-by-design packaging. However, on the materials and device integration side, there is still a gap between what formulation scientists are creating and what packaging can support at scale and at cost.

If formulation, packaging, device, and manufacturing teams are not talking from day one, you end up retrofitting security and stability features onto a design that was never built for them. This is something ASPA has consistently pushed with our member companies, authentication cannot be an afterthought bolted on before launch. It has to be designed in alongside the drug and the delivery device, so that safety, compliance, and patient usability are solved together, not in sequence.

Technically, the challenge is balancing complexity with reliability. Advanced delivery systems demand precision engineering, but they still need to be robust enough for real-world handling, transport, and patient use. On the regulatory side, India’s track and trace requirements have expanded well beyond the original top 300 brands to cover entire high-risk therapeutic categories, and companies are still building the systems to comply consistently across manufacturing and export markets. Add to that the lack of harmonisation between India’s requirements and international standards like the US DSCSA or EU FMD, and companies developing for global markets are managing multiple compliance regimes at once.

This is where packaging and patient safety genuinely meet. A biologic or a combination product only works if the patient can use it correctly and consistently. That is pushing packaging design toward simpler dosing cues, clearer authentication markers patients can actually check, and devices that reduce the chance of error.

The ASPA-CRISIL study also found that only 52 percent of consumers actively verify the authenticity of healthcare products before purchase, highlighting why patient-facing authentication features are becoming increasingly important. From an authentication standpoint, we are also seeing demand for verification features that are patient-facing, not just supply chain facing, so a patient can confirm a product is genuine before they use it. That shift, from authentication for regulators to authentication for patients, is one of the more meaningful changes I have seen.

I would point to digital and phygital authentication converging with primary packaging itself, QR codes, invisible taggants, and tamper-evident features that are built into the pack rather than added on. Combined with connected devices for biologics and injectables, this gives the industry real-time visibility into where a product is and whether it is genuine, right up to the point of use. The market for track and trace solutions is already growing fast, and I expect the next 5 years to be about making these systems standard rather than premium, so smaller manufacturers can adopt them too.

The next generation of packaging will be defined by convergence, security, patient safety, and digital traceability will no longer be treated as separate functions. The ASPA-CRISIL report further shows that consumers are willing to pay a premium for guaranteed genuine healthcare products, underlining that trust has become as important as functionality in pharmaceutical packaging.

The biggest opportunity is in making authentication and track and trace genuinely end to end, from raw material to patient, not just from factory to pharmacy. India has an opportunity to lead here, given the scale of our pharma exports and the pace at which our regulatory framework is expanding. ASPA’s focus going forward will be helping the industry build packaging that protects the patient, proves its own authenticity, and does both without adding friction to how medicines are actually used.

Innovation in Packaging is no Longer Optional—it is Essential for the Next Generation of Medicines: Amit Patni, Founder-Director and Dr. Simta Jadhav, Vice President, Raay Neo Pharma

The growth of biologics and drug-device combination products is shifting pharmaceutical packaging from simple containment to an active, precision-engineered component of therapy. It is driving innovation in prefilled syringes, autoinjectors, and smart connected delivery systems.

Biologics are large, complex molecules that require high-concentration formulations, leading to high fluid viscosity and protein aggregation risks. Packaging engineers must design container-closure systems that withstand high injection forces without shedding silicone oil or metal leachable that degrade the drug.

Moving beyond traditional glass, primary packaging increasingly uses specialised Cyclic Olefin Polymers (COP) and plastics that offer extreme inertness, breakage resistance, and tight dimensional tolerances required for automated device assembly.

Packaging teams need advanced technical, regulatory, and human-centric capabilities, specifically sterile barrier expertise, human factors engineering, and dual regulatory compliance, to support biologics and drug-device combination products. They need an understanding of how to design robust primary, secondary, and tertiary packaging systems that ensure product protection and sterility throughout the product’s shelf life. They must also be able to manage temperature-sensitive biologics across global distribution networks and work hand in hand with formulation, device, quality, regulatory, manufacturing, and supply-chain teams. In addition, maintaining the Design History File (DHF) has become an essential competency for packaging professionals involved in drug-device combination products. Maintaining the DHF becomes the mandatory knowhow for packaging expert in drug device products.

Packaging innovation faces challenges to keep pace with rapid drug formulation advances, specifically lagging behind in biologics stability, personalised micro-dosing, and eco-friendly high-barrier needs. While novel therapies evolve quickly, packaging adaptations face strict regulatory and economic hurdles, advance packaging can add cost and complexity. Hence, innovation in packaging is usually not at equal pace as of drug formulations. Many packaging advances or innovations are derived based on formulation feedback such as modification of packaging to control Nitrosamine Drug Substance-Related Impurity (NDSRI) impurities or inclusion of flavors to control the odor in nutraceuticals, etc.

Collaboration is required to ensure product stability, regulatory compliance, cost efficiency, and faster market entry, early cross-functional collaboration shifts product development from a sequential process to an integrated one—resulting in more reliable, safer and patient-friendly products that can reach the market faster.

Many times, it is been observed the lack of collaboration results in delay in timelines such as packaging team not aware of exact formulation criticality such as stability, oxidative or NDSRI impurity or the selected packaging systems does not work on manufacturing lines. Hence, collaboration or communication across cross functional team is very important to avoid market recalls or stoppage of commercial production.

The biggest challenges in developing packaging for advanced drug delivery systems include material-drug interactions, maintaining sterility, managing extractables and leachables, ensuring container-closure integrity, and meeting stringent environmental validation requirements. As products move into scale-up and commercial manufacturing, packaging can no longer be treated as merely a protective container; it becomes a critical component of product quality, process reliability, and regulatory compliance. Another significant challenge is the creation and maintenance of DHFs for legacy products that were developed before these regulatory requirements were introduced.

In addition, packaging design decisions revolves around usually the drug stability or patient convenience. Many examples such as features like child-resistant yet senior-friendly openings (easy open feature), color coding, clear dosage markers, and smart adherence-tracking components, transparent packing material, clear dose instructions even small innovation as tablet keeper for senior citizen for convenience of daily reminder of dosing.

Packaging is becoming part of the patient experience and, in many cases, part of the therapy itself.

The innovation is expected to have the greatest impact like connected smart packaging, large-volume/on-body wearable injectors, and sustainable mono-material designs, RFIF tag cold chain indicator, sustainable packaging, some of the key innovation likes, biodegradable materials, mono-materials, and interactive digital tracking.

The next generation of pharmaceuticals will be defined by key developments like patient-centric design, sustainability, AI-driven technology, expansion of programmable genetic medicines, RNA-based therapies, and gene-editing platforms, advanced mathematical models of human physiology and simulated clinical environments.