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CONTENTS
PHARMA TECHNOLOGY
PRE EVENTS
18 EXPRESS PHARMA TO ORGANISE SECOND EDITION OF AHMEDABAD PHARMASUMMIT IN APRIL
20 FDD CONCLAVE 2025 TO BE HELD IN HYDERABAD THIS JUNE
INTERVIEW
P21: SANTHOSH AF VP,ASIAPACIFIC SOUTH & INDIA,MEDIDATA
Regd.With RNI No.MAHENG/2005/21398.Postal
P24: INTERVIEW
SEBASTIEN DANNAUD GLOBALCEO,COTECNA
LOGISTICS
50 EMPOWERING STOCKISTS: THE KEYTO UNLEASHING PHARMAGROWTH AND MEDICINE ACCESS
P26: INTERVIEW
SARVESH MUTHA MD,INTEGRIMEDICAL
Express Pharma®
Regd.No.MCS/164/2025 - 27.Printed and Published byVaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press,Plot No.EL-208,TTC Industrial Area,Mahape,Navi Mumbai-400710 and Published at Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021)
On April 2, US President Trump is expected to follow through on his threats to impose 25 per cent tariffs on drug imports from India. And even if the tariff announcements are deferred or lower than expected, the US Trade Representative (US TR)'s latest report gives some clues that the re-calibration indicated by President Trump will continue. On March 3, the US TR Jamieson Greer delivered President Trump’s 2025 Trade Policy Agenda and the 2024 annual report to the US Congress. Titled, A Trade Policy for the Next Great American Century, the document lays out why President Trump's trade policy favours a "Production Economy" and how such a policy will help the President Make America Great Again. While major Indian pharma companies have a US-based manufacturing footprint, there are other non-tariff barriers in play as well. For instance, the report has once again included India in the “priority watch list” for IP violations along with China, Russia, Argentina, Chile, Indonesia and Venezuela.
On the IP front, the ongoing legal proceedings to allow the manufacture of generic risdiplam, a drug for spinal muscular atrophy (SMA) is being seen as a test case for interpreting India's IP laws. The judgements could impact petitions from patients suffering from other rare diseases, who are dependent on medicines still under patent protection. These patients are therefore dependent on compassionate use programmes, government or NGO funding, all of which run out after a certain number of doses. A more permanent solution would be to legally challenge these patents, as Natco has done for Roche's brand of risdiplam Evrysdi.
AN MSF statement on February 28, Rare Disease Day, highlighted that since early 2021, the High Courts have been addressing petitions related to SMA, calling for local production and generic competition to address challenges like the high cost of medications caused by patent monopolies. While effective therapies, such as risdiplam, have proven to be lifesaving, they continue to remain out of reach for many patients due to their prohibitive cost.
As mentioned above, present policies do not go the entire distance. The MSF release further indicates that despite the availability of funding under India's National Policy for Rare Diseases, the high price of risdiplam –priced at Rs 6.2 lakh per bottle by Roche – continues to limit access. For patients weighing under 20 kg, one bottle is required each month, and those above 20 kg may need up to three bottles per month, making the treatment unaffordable.
Seba P A, an SMA patient, submitted that under Roche’s Patient Support Programme in India, patients pay Rs. 12.5 lakhs for two bottles and get three bottles free. Thus, patients get five bottles for Rs. 12.5 lakhs, and for a patient weighing 20 kgs or more, needing 30 bottles a year, will still pay over Rs.30 lakhs, pointing out that this was
The judgements on the RocheNatco case for SMAmedicine risdiplam could impact petitions from patients suffering from other rare diseases,who are dependent on medicines still under patent protection
still unaffordable for patients like her.
Leena Meghaney, a lawyer focusing on public health, pharmaceuticals & access issues, and global IP advisor, MSF emphasises that, "Seba’s challenge of treatment interruption highlights that SMA patients cannot afford delays given the price disparity between the Roche’s price for the patented drug risdiplam and the anticipated low cost of generic versions due to Roche’s long drawn patent dispute in courts. The question before the courts is not just about patent validity, but whether a generic can be allowed in the public interest while the patent is testedroyalties can be paid if the patent is upheld. Although the Indian government has increased funding for rare disease patients under the National Policy for Rare Diseases, providing up to Rs 50 lakh per patient, this amount remains insufficient due to Roche’s exorbitant monopoly pricing - Rs 203,840 per bottle - creating significant barriers to continued therapy, as the government is unwilling to raise the funding limit.”
If the courts do not provide legal relief, this situation could continue till Roche's patent runs out in May 2035. The Delhi High Court’s judgment decision of March 24 2025 drew comparisons between the cost of Roche’s imported drug and the potentially lower cost of Natco’s generic version, which is still under development but the company claims could eventually be 80-90 per cent cheaper than Roche’s Evrysdi. The two other alternative treatments for SMA, Zolgensma and Spinraza, are also too expensive and not registered in India.
The court also referred to statements made by senior counsel Anand Grover who represented the Cure SMA Foundation in a 2017 case, when he stated that while Roche made the drug available at Rs 72 lakhs annually for the first two years and Rs 56 lakhs annually for the third year via their patient support programme, the same medicine was available at much lower costs in countries such as China and Pakistan. He thus contended that the Union of India has a responsibility to negotiate better prices with the company to ensure that a larger number of patients can access these medicinal products at an affordable price.
But these deliberations could earn India more censure from the US. Will the courts stand by the March 24 decision to not grant any injunction to Roche, reasoning that Natco can compensate them in damages should they win the case at a later stage? Or will they back down under tariff threats?
Express Pharma to organise second edition of Ahmedabad Pharma Summit in April
The summit will bring together industry leaders,policymakers,R&D experts,and regulatory professionals to explore strategies for fostering pharma innovation,tackling regulatory challenges,and strengthening the supply chain ecosystem
Express Pharma is organising the Ahmedabad Pharma Summit 2025 on April 16, 2025 at Novotel Ahmedabad. The summit will bring together industry leaders, policymakers, R&D experts, and regulatory professionals to explore strategies for fostering pharma innovation, tackling regulatory challenges, and strengthening the supply chain ecosystem.
WhyAhmedabad?
Ahmedabad has emerged as a powerhouse of pharma innovation, manufacturing and re-
Ahmedabad has a critical role in shaping the next phase of India’s pharma and biopharma growth story
search. The city is home to a thriving pharma ecosystem, including global and homegrown giants like Zydus Lifesciences, Intas Pharmaceuticals, Cadila
Pharmaceuticals, and Torrent Pharma.
The Gujarat government, through initiatives like Gujarat State Biotechnology Mission
(GSBTM) and Gujarat Industrial Development Corporation (GIDC), have also aided in fostering growth in biotech and pharma.
With its world-class R&D and manufacturing capabilities, growing regulatory expertise and expanding global market reach, Ahmedabad has a critical role in shaping the next phase of India’s pharma and biopharma growth story.
Keytopics to be covered
Advancing R&D for next-gen pharma innovation
Scaling biosimilars and bio-
pharma for global markets
PLI scheme: Unlocking growth opportunities in pharma manufacturing
Regulatory roadmap for India’s pharma exports
Digital transformation in pharma: AI, automation and smart manufacturing
Future of drug development: Trends, challenges and opportunities
Building strategic partnerships: Academia, CDMOs and global collaborations
Leadership playbook for scaling pharma businesses from local to global
Supplychain leaders to congregate at Pharma and Med Devices SupplyChain Conclave 2025 this May
They will address the unprecedented shifts occurring in pharma and med devices supply chains driven by patient-centric care models,advanced therapies,and sustainable practices
The second edition of Pharma and Med Devices Supply Chain Conclave 2025 organised by Express Pharma, will be held on May 9,2025 at the Holiday Inn, Mumbai. The event will bring together supply chain leaders to address the unprecedented shifts occurring in pharma and healthcare supply chains driven by patient-centric care models, advanced therapies, and sustainable practices.
It will also examine how pharma and med device supply chains are moving from rigid, efficiency-focused systems to adaptive, resilient networks capable of thriving in uncertainty.
This conference seeks to be a crucial platform for knowl-
The event will bring together supply chain leaders to address the unprecedented shifts occurring in pharma and healthcare supply chains driven by patient-centric care models,advanced therapies, and sustainable practices
edge sharing, networking, and strategic planning among key stakeholders. It aims to Foster cross-industry dialogue on emerging supply chain challenges and opportunities in pharma and medical devices
Showcase innovative technologies and solutions transforming healthcare logistics
Facilitate strategic partnerships and collaboration within the pharma and healthcare supply chain ecosystem
Share best practices in regulatory compliance, sustainabil-
ity, and patient-centric supply chain management
Some topics to be covered: From factory to patient Advanced therapy logistics
Digital transformation in pharma and med devices
Sustainable supply chain
strategies
Supply chain resilience
Whyattend ?
Enhance understanding of emerging trends and challenges in healthcare supply chains
Form of new strategic partnerships and collaborations
Identify of practical solutions for common industry challenges
Knowledge sharing on best practices and innovative approaches
Development of actionable strategies for supply chain transformation
To attend, stay tuned on our website for the registerations to openexpresspharma.in/events/
FDD Conclave 2025 to be held in Hyderabad this June
This year,it will focus on formulation and drug delivery strategies which can ensure that innovations translate into tangible benefits for healthcare systems and patients worldwide
The Formulation Development & Drug Delivery (FDD) Conclave 2025, now in its eighth edition, is set to bring together experts and leaders from the formulation R&D (FR&D) community to explore csutting-edge advancements and growth strategies in pharma formulation and drug delivery. Organised by Express Pharma, the two-day event will be on June 13 & 14, 2025, in Hyderabad.
Advancements in pharmaceutical sciences and novel technologies are reshaping how drugs are formulated and delivered. Be it artificial intelligence, precision medicine, advanced materials science or digital health technologies, their intervention is creating unprecedented opportunities for therapeutic innovation. However, true innovation is not just scientific advancement but meaningful improvement in patient outcomes and experiences.
Therefore, FDD Conclave 2025, now in its eight edition, aims to highlight the need to reimagine formulation and drug delivery through the lens of patient needs, experiences and outcomes. This year, it will focus on formulation and drug delivery strategies which can ensure that innovations translate into tangible benefits for healthcare systems and patients worldwide.
With the theme 'From Lab to Life: Bridging science and care', FR&D experts and leaders will explore how India can leverage its unique strengths— skilled talent, manufacturing excellence and market understanding—to develop therapeutic solutions that enhance efficacy, compliance, and quality of life across diverse patient populations.
The conclave, through thought-provoking discussions and interactive sessions, will
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also explore and examine the role of supportive regulatory frameworks, sustainable funding models, talent development and collaborative ecosystems in enabling innovation.
Building on the momentum of previous conclaves, the 2025 edition aims to create a blueprint for India's pharma industry as a global leader in patientcentric therapeutic innovation. This year's conclave will spotlight how novel technologies are revolutionising drug formulation and delivery. However, the focus will be on scientific breakthroughs that lead to meaningful improvements in patient outcomes and experiences.
Experts in FR&D will discuss how India’s skilled talent, manufacturing excellence, and market insights can drive the development of therapies that enhance efficacy, compliance, and quality of life for diverse patient populations. The event
will also emphasise the role of regulatory frameworks, sustainable funding models, and collaborative ecosystems in enabling and accelerating innovation.
Keyfocus areas at the conclave will include
Integrating patient insights into formulation and drug delivery design
The convergence of digital technologies with advanced formulation sciences
Overcoming long-standing formulation and drug delivery challenges
Scaling lab innovations into commercially viable products
Fostering cross-disciplinary partnerships to accelerate therapeutic innovation
Regulatory support for novel drug delivery approaches
Topics to be covered
Accelerating OSD innovation: From R&D to market
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Biologics and biosimilars: The next leap in patient-centric drug development
Injectable therapies 2.0: Enhancing patient-friendly parenteral drug delivery
Non-invasive treatments: The rise of topical and transdermal drug delivery
Painless drug delivery innovations: Moving beyond traditional injections
Future-ready formulations: Addressing challenges for special populations
For the 100+ pharma professionals attending, FDD Conclave 2025 will present a unique opportunity to engage with industry pioneers, showcase innovative solutions, and gain insights into the latest trends shaping the future of pharma formulation and drug delivery.
Stay tuned for further updates and speaker announcements on our websiteexpresspharma.in/events/
Email your contribution to: The Editor, Express Pharma, Business Publications Division,The Indian Express (P) Ltd, Mafatlal Centre,7th floor,Ramnath Goenka Marg, Nariman Point,Mumbai 400021 viveka.r@expressindia.com viveka.roy3@gmail.com
INTERVIEW
INTERVIEW
AI does not just make clinical trials faster; it makes them smarter
Santhosh AF, VP,Asia Pacific South & India,Medidata highlights how AI is improving the efficiency and speed of the clinical trial process from early drug discovery to data analysis and decision-making.He also explains Medidata’s contributions towards a digital transformation of the clinical research landscape,in an interview with Kavita Jani
What are the major advancements in drug development research? What are the opportunities for India in the current landscape?
Drug development research has made remarkable progress globally, with India emerging as a key contributor. According to Deloitte, India’s pharmaceutical research and development (R&D) market is estimated to expand to $130 billion by 2030, and the country is considered the third-largest global producer of drugs by volume (1)
The biggest shift we are seeing in drug development is the introduction and increasing adoption of advanced technologies, such as artificial intelligence (AI), data analytics, telemedicine, and wearables and sensor technologies. While still relatively in the early stages in India compared to other markets, we are already seeing great appetite on the ground and tremendous opportunities to revolutionise drug development research. Benefits of AI include accelerating insights by processing colossal amounts of data within seconds, a number that would take humans years to process, while telemedicine and wearables enable hybrid and decentralised trials which make them more accessible to participants.
What are the challenges in the current clinical trial landscape in India? How can they be tackled?
While the talent pool has grown, the industry still grapples with skill gaps and high attrition rates of around 30
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INTERVIEW
per cent, higher than the global average of 12 per cent (1). One way to tackle attrition is through the incorporation of technology that will enable talent to do their work more efficiently, thereby helping to mitigate stress and burnout. For example, AI can help automate time-consuming and traditionally manual tasks such as the collection, organisation, and analysis of data, minimising human error and providing real-time insights.
Another challenge is patient diversity, locally in India and globally. Despite its large population, India contributed about 4 per cent to global clinical trials annually from 2010 to 2022, with just 3 per cent of global trial participants coming from the country, compared to 30 per cent in the US (2). There is also a significant patient population in tier 2 and tier 3 cities in India (1) which remains untapped when it comes to clinical research.
The reason patient recruitment has been challenging is because of barriers such as limited awareness of clinical trials, fear of side effects, and concerns about exploitation and trust in the healthcare system (3). This must be addressed, as participants in clinical trials should ideally be representative of the groups of people who will use the therapy, as drugs can react differently to genetics and biological factors.
To help overcome some of these barriers, sponsors and contract research organisations (CROs), including hospitals, should prioritise trial designs that create more welcoming experiences for all patients by selecting study sites trusted by underrepresented communities. Local doctors should also play a role in helping to raise awareness of clinical trials to their patients, as well as educating them and alleviating any fears, concerns or misconceptions they might have.
Technology and AI can also be part of the solution. On one hand, they empower researchers to identify and select sites that are more likely
We believe that transformation through AI,once embraced, takes clinical trials to a whole new level.Beyond developing innovations,we also provide training courses and certifications to upskill and empower customers and partners to keep up with industry and technology advancements
to enroll diverse patients, including those from underserved communities, while on the other, they allow patients to join trials remotely, improving convenience and accessibility, especially for those in the smaller cities.
How can AI help accelerate drug development? And at which stages of a clinical trial can it be particularly useful?
How can AI integration bring improved efficiencies into the whole process?
Drug development has
traditionally been a long, complex, and costly process, often taking over a decade to bring a new therapy to market. However, AI is reshaping this landscape by boosting efficiency and accelerating every stage of the clinical trial process from early drug discovery to data analysis and decision-making. The integration of AI and machine learning could lead to the discovery of 50 novel treatments within the next decade, according to Morgan Stanley Research, and AI could
potentially reduce the time required for identifying viable drug candidates to just one to two years.
One of the most timeconsuming aspects of clinical trials is patient recruitment. AI holds transformative potential in clinical trial recruitment by utilising Real-World Data (RWD) to identify qualified participants (4). By analysing huge datasets, including historical clinical trial data and electronic health records, AI can significantly shorten recruitment timelines by uncovering patterns that are difficult to detect manually and through targeted outreach. Often seen as a virtual assistant, it can also analyse site-specific recruitment rates from past trials to predict which sites are most likely to recruit effectively for future studies.
There are multiple areas where AI is used during clinical trials to improve efficiencies and outcomes, from remote patient monitoring to accelerating insights, and predictive modelling. In the context of clinical trial imaging, for instance – with over 50 per cent of trials using medical imaging and 95 per cent of all oncology trials using it – AI has proven essential in efficiently handling large volumes of data and managing high levels of complexity. AI does not just make clinical trials faster; it makes them smarter, enabling more targeted therapies and improving patient outcomes.
Medidata has entered into strategic partnerships such as the tie-up with Cognizant, and the collaboration with NIHR. How will these tie-ups translate into added value for its partners?
We have strong collaborations with partners around the world to enhance clinical trial efficiency and quality at every stage, ultimately helping to bring new treatments to the market faster. For instance, in January 2025, we expanded our agreement with Cognizant to enhance responsiveness and improve user satisfaction for life sciences organisations that rely on Medidata's technology
services for clinical trial development. This month, we also announced that we have integrated data from the UK interactive Costing Tool (iCT), hosted by the National Institute for Health and Care Research (NIHR), into Medidata Grants Manager, creating a first-of-itskind offering in the life sciences space. This will consolidate study budgeting with consistent costs, coding, and processes.
Such collaboration with stakeholders is crucial for India clinical trials as they grow larger, more complex, and globally distributed. To help our partners and customers keep up with the evolving landscape, we provide comprehensive solutions that break down silos and provide real-time, data-driven insights.
As emerging technologies transform the clinical research landscape, how should professionals in this sphere keep pace with these advancements? How can Medidata help create a pool of skilled professionals for clinical research?
Emerging technologies, such as AI, are transforming clinical trials. However, it also comes with uncertainties and fears, including around data privacy and security, which can be a barrier to adoption.
Our recommendation to help professionals keep pace with such advancements is to build a foundation of clarity and understanding through a fourpillar upskilling approach. When it comes to AI, it could include the following:
Increase literacy: To increase literacy in and understanding of AI, provide teams with learning programs and a knowledge base infrastructure, interactive learning with examples, an understanding of the iterative nature of AI, and a way to identify new business cases and support evolution.
Put clinical data managers in the loop: To make sure that clinical data management teams feel like they’re in control of how AI is used, ensure that feedback expectations are clear, that the impact of the AI
INTERVIEW
feedback loop is understood, and that advantages and shortcomings are understood (e.g., insufficient or low quality of data and bias).
Manage change: To achieve the successful adoption of AI, focus on changing mindsets, eliminating fears of the unknown and job losses, increasing comfort levels through training, and building confidence by selecting champions.
Validation: To reduce the potential bias in AI, emphasise the need for human-in-the-loop adjudication, test across multiple subsets of data, perform sensitivity tests, use real-world evidence for validation, and work with regulators.
We believe that transformation through AI, once embraced, takes clinical trials to a whole new level. Beyond developing innovations,
we also provide training courses and certifications to upskill and empower customers and partners to keep up with industry and technology advancements.
What are Medidata’s business growth plans for India? Are there any plans for collaborations on the horizon?
In India, we have tailored our strategy to capitalise on unique local opportunities, such as growing investments in R&D and the increased adoption of advanced technologies such as AI-enabled healthcare solutions and tools (5) To support our local customers, we are committed to offering comprehensive and integrated solutions across every step of a trial, from start to finish. For instance, our cloud-based Medidata Platform enables
timely and informed decisionmaking, improving trial outcomes, while our AI solutions and advanced wearable and sensor technologies meet the increasing need to go digital, patient centricity and personalised study designs. Our culture of innovation also enables us to quickly adapt to a rapidly evolving healthcare environment, while still focusing on digitalising and accelerating clinical trials.
While India's technologypowered drug discovery and development market is growing, it also faces challenges that must be addressed. This includes building trust in technology and AI, and addressing data privacy and cybersecurity concerns, which requires a whole-of-industry approach. We work with customers and partners to move towards a patient-centric
approach and to find creative new ways to develop trust so that patients are increasingly willing to share their healthcare data with researchers to create an ecosystem of new discovery that is mutually beneficial to both.
References
1. Deloitte (2024), Positioning India as a Pharmaceutical Innovation Hub, https://www2.deloitte.com/conte nt/dam/Deloitte/in/Documents/li fe-sciences-health-care/in-lshcpositioning-india-as-apharmaceutical-innovation-hubnoexp.pdf
2. PwC (2023), Clinical Trial Opportunities in India https://www.pwc.in/assets/pdfs/c onsulting/managementconsulting/clinical-trialopportunities-in-india.pdf
3. Journal of Clinical and Diagnostic Research (2024), Bridging the Divide: Tackling
Recruitment Challenges in Indian Clinical Trials: A Narrative Review
4. Forbes (2024), How The Healthcare Industry Can Use AI In Clinical Trial Recruitment https://www.forbes.com/councils/ forbesbusinesscouncil/2024/09/3 0/how-the-healthcare-industrycan-use-ai-in-clinical-trialrecruitment/
5. Deloitte (2024), Positioning India as a Pharmaceutical Innovation Hub https://www2.deloitte.com/conte nt/dam/Deloitte/in/Documents/li fe-sciences-health-care/in-lshcpositioning-india-as-apharmaceutical-innovation-hubnoexp.pdf
We are expanding our footprint in high-growth markets,particularlyin Europe and
Asia
Cotecna Group is a leading provider of testing,inspection,and certification services,providing regulatory compliance solutions across various industries,including pharma. Sebastien Dannaud, Global CEO,Cotecna shares insights on the company's expansion plans,innovation,and growth strategies for the pharma sector,in an exclusive interview with Lakshmipriya Nair
Can you elaborate on the Cotecna Group's offerings and how they support pharma companies in meeting global regulatory standards, especially in highly regulated markets?
At Cotecna, we understand the critical importance of regulatory compliance in the pharma industry, particularly in highly regulated markets such as Europe and Asia. Our expertise spans across Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Distribution Practices (GDP), as well as regulatory requirements set by major bodies such as the EMA and WHO.
To support pharma companies in navigating these complex regulations, we offer comprehensive testing and auditing services conducted onsite. Our specialised facilities, such as SHIVA Lab and Cotecna Life Sciences in India, provide advanced pharma testing and regulatory support, ensuring that products meet stringent safety and quality standards. Similarly, Neotron Food Pharma Lab in Europe offers specialised pharma and nutra testing, with a particular focus on biopharma solutions.
By fostering strong synergies between India and Neotron, we ensure a harmonised global service offering that provides consistency, reliability, and compliance assurance to pharma clients worldwide.
How does Cotecna differentiate itself from competitors in the pharma
In the coming decade,we envision significant expansion of Cotecna's pharma division through the addition of new laboratories and strategic acquisitions across Europe and Asia
testing and certification space? Are there specific strategies or expansion plans targeting high-growth regions like the US, Europe, and emerging markets?
Cotecna stands out due to its strong technical and scientific expertise, combined with its agility, responsiveness, and commitment to tailored solutions. We often describe our approach as "smart, agile, and highly responsive." This mindset allows us to deliver faster turnaround times, customised services, and a client-centric approach that ensures we meet the specific needs of our partners. Our global presence, combined with specialised local expertise, allows us to cater to diverse regulatory environments effectively. Additionally, we are investing in cutting-edge technologies such as artificial intelligence, digital compliance systems, and blockchain to enhance transparency and efficiency in our testing and certification processes. As part of our strategic growth plan, we are expanding our footprint in high-growth markets, particularly in Europe and Asia. We are also increasing our focus on biopharma and biotech sectors, ensuring that our analytical offerings remain at the forefront of industry advancements.
What are the biggest quality control challenges in pharma manufacturing today, and how does Cotecna help companies navigate these complexities?
Pharma manufacturing faces
numerous quality control challenges, including contamination risks, counterfeit drugs, and the everevolving complexity of regulatory frameworks. Additionally, vulnerabilities in global supply chains necessitate robust risk assessment strategies to ensure product safety and integrity. Cotecna addresses these challenges by deploying advanced analytical methods to assesspharma products for safety, efficacy, and compliance. Our comprehensive quality assurance and risk management solutions enable companies to proactively identify and mitigate potential issues, ensuring uninterrupted market access and consumer trust.
With the growing focus on Extractable & Leachable (E&L) studies, how is Cotecna positioning itself to meet industry demands, and what potential business opportunities do you foresee in this segment?
Regulatory agencies are increasingly emphasising the importance of Extractable & Leachable (E&L) studies to ensure the safety of pharma packaging and drug delivery systems. At Cotecna, we are proactively expanding our E&L testing capabilities to meet this growing demand, offering thorough risk assessments that comply with global standards such as USP, EMA, ICH, and ISO. This segment presents significant business opportunities, particularly in biopharma, medical devices
and combination products. By investing in state-of-the-art testing methodologies, we are well-positioned to support clients in achieving compliance while driving innovation in drug packaging safety.
Pharma trends such as biologics, specialty drugs, and increasing regulatory scrutiny are reshaping industry needs. How is Cotecna adapting to these shifts with specialised testing and compliance solutions?
As the pharma landscape evolves, Cotecna is continuously strengthening its expertise in biologics, biosimilars, and specialty drugs. We actively collaborate with industry startups and consultants to stay ahead of emerging trends and regulatory changes.
By enhancing our analytical capabilities and expanding our services in niche areas, we
ensure that pharma companies receive the specialised support they need to navigate complex regulatory frameworks and maintain product quality.
Where do you see Cotecna Group's pharma division in the next 5-10 years? Are there plans for strategic partnerships, acquisitions, or service diversification to strengthen your global footprint?
In the coming decade, we envision significant expansion of Cotecna's pharma division through the addition of new laboratories and strategic acquisitions across Europe and Asia. Our goal is to establish a robust laboratory network that enhances our global reach and service capabilities.
Additionally, we are actively exploring partnerships with key industry players to foster innovation and service diversification. These
initiatives will further solidify our position as a trusted partner in pharma testing, certification, and compliance solutions.
As the pharma industry evolves with advanced modalities like biologics, and precision medicine, how is Cotecna enhancing its inspection, testing, and certification capabilities?
To support the rapid advancements in biologics and precision medicine, we are strengthening our capabilities in microbiological testing, sterility assurance, and highsensitivity assays. Our focus remains on delivering cuttingedge solutions that ensure the safety, efficacy, and compliance of these advanced therapeutic modalities.
By integrating state-of-theart technologies and continuously refining our testing methodologies, Cotecna
remains at the forefront of regulatory compliance and quality assurance in the evolving pharma landscape.
What recent investments in technology have driven growth for Cotecna's pharma services, and how do you plan to stay ahead of emerging trends in testing and regulatory compliance?
Cotecna is committed to continuous investment in technology and infrastructure to keep pace with the dynamic regulatory landscape. Our ongoing facility upgrades ensure compliance with evolving global standards, while our investment in AIdriven analytics, digital compliance tools, and blockchain technology enhances efficiency and transparency in testing processes.
Looking ahead, we will continue leveraging
technological advancements to maintain our leadership position in pharma testing and regulatory compliance, empowering our clients with innovative solutions that drive success in the global market.
Cotecna remains dedicated to ensuring the highest standards of pharma quality, safety, and compliance. Through our global expertise, advanced analytical capabilities, and strategic expansion plans, we are committed to supporting pharmal companies in navigating regulatory complexities and achieving excellence in product safety and efficacy. As the industry continues to evolve, we will remain a trusted partner, delivering innovative solutions that meet the ever-evolving needs of the pharma sector.
N-FIS was developed to address a critical challenge in healthcare—needle phobia
Integri Medical has launched a needle-free injection system (N-FIS) to address needle phobia and enhance patient convenience.In this interview, Sarvesh Mutha, MD,IntegriMedical discusses the technology behind the device and plans for scaling this innovation worldwide,in an interaction with Viveka Roychowdhury
Give a short background of the founders IntegriMedical is led by a team of experienced professionals with a strong background in medical technology, business development and healthcare innovation. The key leadership team includes myself, Ankur Naik, MD, Scott McFarland, CEO and Mark Timm, COO. With over two decades of entrepreneurial experience, I have been at the forefront of medtech innovations, strategic partnerships, and business expansion. As Managing Director of IntegriMedical, I oversee the company’s strategic vision, spearheading efforts to drive business growth, expand market reach, and accelerate the adoption of needle-free injection technology.
How did the founders decide to venture into the needlefree injection system (N-FIS) and what is its USP compared to existing systems? How does it fare on the cost front? What does it mean for patients?
N-FIS was developed to address a critical challenge in healthcare—needle phobia. Research has reported that fear of needles constitutes about 20-50 per cent among children and 20-30 per cent among adults globally; often leading to missed vaccinations and delayed treatments. In addition, conventional needles expose patients to risk of crosscontamination and potential needle stick injuries to healthcare professionals. Recognising the need for a safer, more patient-friendly
alternative, we set out to find a better solution—and that’s how N-FIS was born.
N-FIS stands out by completely eliminating the need for needles, delivering medication through a highpressure jet stream that is both highly effective and almost painless. Unlike some existing needle-free devices, N-FIS is compact, lightweight, and ergonomically designed, and the only eco-friendly, needlefree injection with a stainlesssteel body for ease of use. Compared to the old-fashioned syringes, it significantly reduces pain, anxiety, and the risk of injuries—making it a game-changer, especially for children and individuals with needle phobia. While the initial investment may seem higher, N-FIS can be cost-effective over time by minimising medical waste and improving patient compliance. Ultimately, it offers a safer, more comfortable, and stress-free healthcare experience.
How does the technology work? Has it been validated via clinical trials etc? Have any such systems and N-FIS been approved by regulators for use? Kindly give details. The needle-free vaccination by N-FIS uses a high-pressured, spring-driven stainless-steel piston to dispense medication in a consistent, predictable pattern and is completely needle-free. Upon injection, a jet stream is produced which penetrates the skin, delivering the drug to a specific depth without the need for a needle. This process occurs in under 1/10th of a second, making N-
FIS both efficient and almost painless. Unlike traditional syringes, which can cause medication pooling and tissue damage, the N-FIS ensures precise drug delivery, reducing pain and needle-related hazards. Key parameters, such as pressure and orifice size, are carefully calibrated to achieve accurate drug delivery at the desired depth and dosage, making it a safe and efficient alternative to traditional needle injections.
Additionally, clinical trials have been conducted to validate the safety and performance of N-FIS. Needle Free Injection System (N-FIS) was proven to be safe, tolerable, and acceptable, with nearly 80 per cent participants reporting zero pain while taking needlefree vaccination through N-FIS. Additionally, no significant differences were observed in terms of tenderness, redness,
induration, vital signs, or systemic examination parameters, further establishing the system's clinical reliability.
N-FIS is a US-patented device with certifications such as CDSCO (India), CE, MDSAP, and ISO 13485, and has its presence in multiple markets across the US, Europe, and Asia.
What has been the global experience with N-FIS?
N-FIS has garnered widespread recognition globally, with over 45,000 successful administrations across India and Europe. The technology is rapidly gaining traction among doctors in India, while internationally, institutions like Hungary’s Heim Pál National Paediatric Institute, one of the largest paediatric hospitals has adopted N-FIS to enhance patient care. By integrating NFIS, the institute has significantly reduced pain and anxiety for over 4,000 haematology-oncology patients.
Aligned with the World Health Organisation’s (WHO) recommendation for safe injection technologies and its advocacy for government adoption of such advancements, needle-free injections have the potential to revolutionise healthcare worldwide. By prioritising patient comfort and safety, NFIS is setting a new standard in medical practices.
What were the initial challenges, like funding etc for a healthtech/drug
delivery system like N-FIS?
What's been the funding journey, who are the current investors, collaborators, etc? Introducing a new drug delivery system and establishing an entirely new category came with several challenges, including raising awareness about a needle-free alternative to syringes, navigating R&D complexities, securing regulatory approvals, and driving market adoption.
IntegriMedical was initially funded by the founder’s capital and early investors who shared the same vision. We bootstrapped the venture with approximately $4 million, backed by support from family and friends. Last year, we formed a strategic partnership with the world’s largest vaccine manufacturer, Serum Institute of India, which acquired a 20 per cent stake in the company. The collaboration between SII and IntegriMedical leverages the strengths of both companies. While SII brings its extensive expertise in vaccine manufacturing and global distribution, we at IntegriMedical contribute our innovative drug delivery technology and research capabilities. Together, the companies aim to expand access to care and improve efficiencies in the global healthcare industry.
How does the company work with doctors to use the system? What's been their feedback in India? How many healthcare facilities are currently using this system? IntegriMedical operates on a direct-to-doctor model, where
PHARMA TECHNOLOGY
healthcare professionals are met and introduced to the device through workshops, training sessions, and hands-on demonstrations. Currently, NFIS is used in multiple healthcare facilities, with adoption steadily increasing in hospitals and paediatric clinics. The response from Indian doctors has been highly positive, with nearly 1000 practitioners across Tier 1 and Tier 2 cities actively using the device, praising its ease of use and the enhanced comfort it provides to patients.
How does the company collaborate with pharma and vaccine companies to optimise efficacy of medicines with this delivery system?
We are in the early phases of collaboration with pharma companies, with our initial focus on adoption by
paediatricians and physicians treating children who require frequent injections. Currently, we are actively working on co-packaging collaborations with pharma companies to drive adoption across various medical sectors, including paediatrics, infertility treatments, and broader healthcare applications. Additionally, we are expanding our regulatory approvals to enter international markets and are engaging with global health organisations to integrate needle-free technology into immunization programs, making injections safer and more accessible worldwide.
Have needle-free injection systems made inroads into the existing injection market? What are the projections? Will this be a niche or mass market?
Needle-free injection technology is steadily gaining traction in the traditional injection market. The global market for needle-free injectors is estimated to be valued at $27.65 billion in 2028, growing at a compound annual growth rate (CAGR) of 14.16 per cent. While initially considered a niche, the system has the potential to become more mainstream as regulatory approvals, cost efficiencies and large-scale manufacturing continue to advance.
How does the company plan to scale up this venture, across India and globally?
We are taking significant steps toward expansion and scaling our operations, including our partnership with the world’s largest vaccine manufacturer. Additionally, the adoption of our technology by one of the largest paediatric hospitals in
Hungary and its growing use among doctors in clinics, private and corporate hospitals like Cloudnine, KEM, Apollo Cradle, Hiranandani etc. across India are driving a deeper market penetration, reinforcing the shift toward needle-free drug delivery.
The company is focused on increasing adoption across hospitals and clinics while securing regulatory approvals in additional global markets. Efforts are also underway to enhance manufacturing capabilities, strengthen distribution networks worldwide, and establish partnerships with pharmaceutical companies for co-packaging opportunities. Additionally, we aim to collaborate with governments and healthcare agencies to integrate N-FIS into mass vaccination programs, driving broader
accessibility and impact.
How do collaborations like the recent partnership with the Serum Institute of India play into the future plans of IntegriMedical?
Our collaboration with the Serum Institute of India is a pivotal step in our growth strategy, both validating our technology and a catalyst for its widespread acceptance. Beyond vaccine delivery programs, this partnership enables us to leverage SII’s global expertise and distribution network to fasttrack the development and commercialisation of N-FIS. Together, we aim to enhance accessibility, ensuring that patients in India and worldwide benefit from this advanced needle-free injection system.
viveka.r@expressindia.com vivekaroy.3@gmail.com
Viscometers
Industry leaders,innovators,and experts came together to explore cutting-edge packaging solutions,regulatory trends and sustainability strategies shaping the future of pharma packaging
The Pharma Packaging and Labelling (PPL) Conclave 2025, hosted by Express Pharma, presented by West Pharma and powered by CILICANT, brought together industry stalwarts, innovators and decision-makers to explore advancements shaping the future of packaging and labelling.
The event started with a welcome address by Viveka Roychowdhury, Editor, Express Pharma & Express Healthcare. She informed about Express Pharma's legacy of more than three decades since its first print edition and seven years of impactful conferences. She also highlighted the pharma sector's rapid evolution, driven by techno-
The PPLConclave 2025 seeks to be a crucial platform with engaging panel discussions,technical deep dives and networking sessions,to shape the future of pharma packaging under the theme, "Powering Innovation,Sustainability,and Leadership"
logical advancements, sustainability imperatives, and shifting patient needs.
She informed that the PPL Conclave 2025 seeks to be a crucial platform with
engaging panel discussions, technical deep dives and networking sessions, to shape the future of pharma packaging under the theme, "Powering Innovation, Sustainability, and Leadership".
Her session was followed by the lamp lighting ceremony to kickstart the event on a postive and auspicious note. Viveka Roychowdhury, Editor, Express Pharma; Sheetal Arora, CEO, Mankind; Chakravarthi AVPS, Global Ambassador, WPO; Dr Ranjana Pathak, Chief Quality Officer, Lupin; Alok Chandorkar, National Sales Manager, West Pharmaceutical Services India and Manish Jain, MD, Cilicant participated in this ceremony.
Leadership Lens
PPL Conclave 2025 comprised several power packed discussions on leadership, innovation, and the future of the pharma packaging industry. Leadership Lens was one of the key discussions that featured influential leaders who shared their perspectives on navigating challenges, fostering innovation and driving industry progress.
Moderated by Chakravarthi AVPS, Global Ambassador, World Packaging Organisation, the session brought together two eminent industry leaders: D. Ranjana Pathak, Chief Quality Officer, Lupin, and Sheetal Arora, CEO, Mankind Pharma. Their valuable insights into leadership, quality and innovation were very interesting and compelling.
In a wide-ranging discussion, the panelists addressed several areas rele-
vant to the industry and its continued progress. They explored crucial strategies for expanding India's pharma footprint on the global stage, addressing both opportunities and challenges. Experts emphasised the importance of aligning with evolving international regulatory standards to make India a global leader in pharma. They also highlighted how AI, data analytics, and advanced manufacturing technologies are transforming efficiency and innovation in the sector. Sustainability was another key theme, panelists shared insights on ecofriendly manufacturing and sustainable practices. They also spoke on the delicate balance between making medicines accessible and ensuring long-term business viability.
It has several key takeaways for pres-
ent and future leaders such as: Innovation and leadership go hand in hand. The panelists emphasised that an innovative mindset is critical for India Pharma Inc to achieve global leadership. They highlighted the importance of fostering a culture of innovation that supports new technologies and progressive business strategies.
Quality should be the cornerstone of all phama operations. Experts on the panel stressed that quality must be felt and experienced in every aspect of the industry.
Practicality, proactiveness, preparedness, and planning were described as key attributes for pharma leaders to stay ahead of challenges and drive sustainable growth.
Integrity in leadership was highlighted during the session time and
again.The leaders on the panel emphasised on doing things right, even in the face of adversity, leads to long-term success. Leaders must uphold ethical standards and maintain transparency to build trust within their organisations and the industry.
Effective leaders should 'walk the talk' and demonstrate honesty and transparency, emphasised the panelists. They stressed that only by by aligning words with actions, can leaders build a strong foundation of trust, be it in their team or with industry stakeholders.
The session reinforced the need for continuous innovation, strategic leadership, and a strong commitment to quality to shape the future of Indian pharma. Thus, this session set the stage for thought-provoking discussions that followed during the two-day conference.
PPL Conclave 2025 witnessed several compelling panel discussions. One of them was on 'Patient-centric packaging: Safe, Smart, Secure.' The session underscored the importance of putting patients at the core of pharma packaging innovations to enhance safety, adherence and healthcare outcomes.
Moderated by Avinashkumar Talwar, VP & Head of Strategic Procurement, Packaging - Global Procurement, Dr. Reddy's Laboratories, the panel consisted of other leading experts in packaging development - Chandi Prasad Ravipati, Head - Packaging Development, Aurobindo Pharma; Sekhar Babu
Puli, Head - Packaging Development, MSN Laboratories; Ganesh Valluri, Associate VP - Packaging Development, Hetero Labs; Mallikarjun Patil, Director of Quality Assurance, Azurity Pharmaceuticals; and Alok Chandorkar, National Sales Manager, West Pharmaceutical Services India.
The panel addressed several important topics in a free-wheeling discussion. One of the points they emphasised was that packaging must be designed with the diverse needs of patients in mind, ensuring ease of use, safety and accessibility. The panelists also spoke on chellenges that the issues are faced with such as inaccessibility, labelling errors,
dosage mistakes, and counterfeit drugs. Highlighting that a 'one-size-fits-all' approach does not work; the experts on the panel stressed that packaging solutions should be tailored for different patient populations, including geriatric and pediatric patients.
The panel also looked at the advent of technology and the impact of emerging technologies like smart packaging, RFID tracking, and digital solutions in packaging. They discussed the role of these technologies in enhancing security, compliance and user experience. The experts on the panel advised companies to adopt a design-thinking approach, and prioritise patient convenience while en-
suring regulatory adherence and sustainability.
Sharing statistics from various studies, the panel informed that innovative packaging can improve patient adherence from 35 per cent to 50 per cent globally, significantly impacting treatment success rates.
The discussion reinforced the vital role of packaging in improving patient outcomes, ensuring regulatory compliance and driving sustainability. It concluded that as pharma packaging continues to evolve, the industry must integrate technology and patientfriendly designs for a safer, smarter, and more secure future.
Changing landscape of injectable packaging regulations
Dynamic changes in packaging regulations signify a crucial evolution, demanding industry adaptation for enhanced safety and compliance. Therefore, Prabhaharan Sankaran, Sr Technical Account Specialist, India, West Pharmaceutical Services India elaborated on how the evolving regulations affect the injectables packaging landscape.
Revised USP <660> chapter made official on October 01, 2023. Valor Glass Vials by West Pharma meet global pharmacopeia standards. Glass passing the test for Type I can be used for drugs that require Type I glass. Its technical advantages include the elimination of glass contamination, exhibiting a low and consistent extractables profile, resisting damage and increasing throughout on filling lines.
Other regulatory lookouts include the new chapter, USP <382> Elas-
Prabhaharan Sankaran,Sr Technical Account Specialist,India,West Pharmaceutical Services India
Enhancing shelf life with innovative active packaging solutions
At the recently concluded PPL Conclave 2025, Komal Bhavsar, AGM - Business Development, Cilicant, presented a session titled ‘Enhancing Shelf Life with Innovative Active Packaging Solutions.’ The session focused on the impact of moisture and oxygen on product degradation and the role of active packaging in addressing these challenges.
Bhavsar began by outlining the primary factors affecting product stability— moisture and oxygen exposure. She explained that these elements contribute to oxidation, mould and fungus growth, protein degradation, and changes in odour, colour, and texture. Addressing these challenges, she introduced Cilicant’s specialised active packaging solutions, which include desiccants and oxygen absorbers.
She further detailed how combining these two components enhances product protection. Desiccants, she noted, reduce the rate of oxygen absorption while simultaneously managing moisture levels, ensuring improved stability for sensitive for-
Komal Bhavsar,AGM- Business Development,Cilicant
mulations.
Moving on to product specifics, Bhavsar introduced Cilicant’s Oxabide canisters, highlighting their design for high-potency compressed tablets. She de-
scribed them as self-activated, leakproof, and non-perforated, offering controlled absorption without the risk of leakage or contamination.
Concluding the session, Bhavsar
tomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025.
Sankaran also highlighted how a Notified Body Opinion will need to be included within the Marketing Authorisation Application becoming a critical part of the approval pathway as per EU MDR.
Additionally, the revised EU GMP Annex 1 has been effective since August 25, 2023, which requires a more stringent contamination control strategy and the recommendation for use of RABS and Isolators.
The regulatory requirements need to keep up with the latest global trends and technology to further ensure patient safety. Therefore, it is in the best interest of the pharma packaging stakeholders to stay abreast and monitor major developments.
Cilicant’s Oxabide canisters are self-activated, leakproof,and non-perforated, offering controlled absorption without the risk of leakage or contamination
stressed the importance of selecting the right active packaging solutions to extend shelf life and maintain product stability. She noted that Cilicant’s offerings align with the pharma industry’s evolving needs.
From shelf to strategy: Operational strategies for smarter pharma packaging
Pharmaceutical packaging is developing from a functional necessity to a strategic enabler.
Sandeep Raktate, President - India & Ireland Operations, Amneal Pharmaceuticals shared his expertise on the operational strategies for smarter packaging at the PPL Conclave 2025.
Packaging is a strategic priority, not just an operational task. It impacts brand perception and enhances patient experience and regulatory compliance. However, there are several challenges such as compliance, cost, and data security that must be mitigated to make packaging smarter. Companies must identify key trends, assess areas of improvement, strategise to implement these trends and execute the plan.
Key trends include digitalisation,
automation and the use of AI. Additionally, implementing sustainable practices by reducing waste and opting for eco-friendly materials. Initiatives to reduce packaging waste are not only beneficial for the environment but also enhance brand loyalty among increasingly eco-conscious consumers. Another trend that requires attention is personalised medicine which necessitates packaging solutions that are flexible and can quickly adapt to changing market needs.
Implementing these changing trends can lead to a future where pharma packaging plants are AI-powered and fully automated, and personalised packaging that prioritises the use of eco-friendly, bio-degradable smart labels.
Ready-to-use container solutions can drive operational efficiency and total cost of ownership (TCO) reduction. Vinayak S Joshi, Country Manager – India, Stevanato Group highlighted the recent development that supports pharma operations efficiency and TCO reduction.
Industry trends driving RTU vials configuration are growing in biologics and pharma innovation with an increased focus on quality in drug product development, outsourcing of noncore activities and faster time to market.
Stevanato Group presents the Z-fill Platform: A fully integrated pre-sterilised containment solution for aseptic manufacturing. The platform de-risks operations and reduces complexity while preserving quality, increasing flexibility, reducing TCO, standardisation and a faster market time.
EZ-fill configuration in aseptic filling process guarantees a reduction of costs of upstream operations, reduction of quality issues (hidden costs) as-
VinayakS Joshi,CountryManager – India,Stevanato Group
sociated with non-core activities and improvement of operations efficiency.
Stevanato Group offers integrated solutions for scientific, analytical and technical support, drug delivery systems, visual inspection systems, and,
Stevanato Group offers integrated solutions for scientific, analytical and technical support, drug delivery systems,visual inspection systems,and, assembly and packaging systems
assembly and packaging systems. Customer benefits include flexible assembly solutions for multiple formats on the same line, scalable assembly and packaging equipment to accompany drug development programs and end-to-end offerings from visual inspection to end-of-line process reducing overall TCO.
Sandeep Raktate,President - India & Ireland Operations,Amneal Pharmaceuticals
The science and value of sustainable packaging
Sustainability is no longer just an industry buzzword—it’s an essential business strategy in the 21st century. As regulatory pressures increase and consumer awareness grows, pharma companies must embrace packaging solutions that are both sustainable and compliant. To explore the science and value of sustainable packaging,, Ashley Reynolds, Sales Director, Körber Pharma Packaging AG, took the stage.
He began by explaining how leaders in pharma packaging will win with sustainability through ecodesign, value through mono-material cartons and adherence through top-loading. The PCC 2021 urges the reduction of plastics due to high fossil fuel dependency,
among other reasons and recommends renewable energy adoption in manufacturing.
Körber’s innovative and sustainable packaging solutions are environmentally friendly due to the raw materials used and the reduction in the use of materials.. The pack BOM material cost analysis findings indicate that Körber’s NeoTOP costs 58 per cent less than a regular blister pack. The packaging logistics cost analysis findings indicate that NeoTOP also provides a cost effective solution. Therefore, there are compelling efficiency and effectiveness advantages of sustainable packaging, as they significanty reduce carbon footprint
Cutting-edge advancements in traceabilitytechnology for enhanced tracking and transparenc
At the PPL Conclave 2025 in Hyderabad, a session titled ‘Cutting-edge Advancements in Traceability Technology for Enhanced Tracking and Transparency’ was conducted by Hiren Rathod, Regional Account Director – West, North & Madhya Pradesh, Optel Group. Rathod began by highlighting Optel’s all-in-one solution, which integrates printing, checking, tamper-evident labelling, and checkweighing into a single process. He also introduced Optel’s CountSafe tablet inspection solution, designed to be compatible with all tablet counting systems. This solution detects incorrect products, broken or defective tablets, and colour variations, ensuring accuracy in pharmaceutical manufacturing. Additionally, Optel’s L4 solution supports multiple regulatory markets and facilitates seamless connectivity across various contract manufacturing organisations (CMOs).
Expanding on traceability solutions, Rathod discussed how Optel offers end-to-end tracking systems that enhance regulatory compliance and optimise supply chain performance. The Optchain platform provides supply
Hiren Rathod,Regional Account Director – West,North & Madhya Pradesh,Optel Group
chain visibility, supporting ESG compliance and transparent product life cycles. Meanwhile, TrackSafe integrates serialisation, aggregation, and AI vision systems for manufacturing solutions, while VerifyBrand focuses on downstream traceability, regulatory
compliance, and c ounterfeit p revention.
With billions of products tracked annually for global brands, Optel’s production data solutions ensure seamless data extraction using the Op300 and Line Master. Through a secure indus-
trial communication protocol (OPCUA), manufacturers can access critical production information, including machine state availability, alarm status, product counters, and active production ID.
To further enhance quality control, Optel has developed an inspection system for detecting defective tablets on bottle counting machines. This system integrates with existing counting machines and features ejector units that remove defective tablets in real time based on camera inspection. It identifies incorrect products, broken or oversized tablets, and colour inconsistencies without disrupting the production line. The solution is compatible with 12, 16, 24, and 48-track systems. Addressing regulatory compliance, Rathod noted that manufacturers of the Top 300 drug formulations under Schedule H2 must incorporate barcodes or QR codes on packaging labels. These codes contain critical product data, including product identification codes, drug names, brand names, manufacturer details, batch numbers, and manufacturing and expiry dates, ensuring greater transparency and traceability in the pharmaceutical industry.
AshleyReynolds,Sales Director,Körber Pharma Packaging AG
Panel Discussion: Aligning packaging strategies with R&D
L-R: Dr Sandhya Shenoy,AVP- Formulation R&D,MSN Laboratories (MODERATOR); Dr VaibhavDubey,GM,KashivBiosciences; Mohit Mittal,Senior Manager – Packaging & Medical Devices,R&D Gurgaon,Sun Pharmaceutical Industries; DhananjayM Chaudhari,DGM – Packaging Development (Formulations),Indoco Remedies; Raviteja Reddy,Team Lead – Medical Devices & Packaging Development,Hetero Labs; Dr Srikanth Reddy,Head & DGM,Jodas Expoim; VinayKumar A,DGM,Aurobindo Pharma
At the recently held PPL Conclave 2025 in Hyderabad, a panel discussion titled "Aligning Packaging Strategies with R&D" brought together industry leaders to explore the integration of pharmaceutical packaging into drug development. The session emphasised the need for packaging strategies to be cost-effective, safe, scalable, sustainable, and aligned with evolving regulatory and patient needs to ensure effective drug delivery.
Moderated by Dr Sandhya Shenoy, AVP - Formulation R&D, MSN Laboratories, the discussion featured Dr Vaibhav Dubey, Senior General Manager –R&D, Kashiv Biosciences; Mohit Mittal, Senior General Manager – Packaging Development, Sun Pharmaceutical Industries; Dhananjay M. Chaudhari, Senior General Manager – Packaging Development, Indoco Remedies; Raviteja
Reddy, Associate General Manager –Packaging Development, Hetero Labs; Dr Srikanth Reddy, Vice President –R&D, Jodas Expoim; and Vinay Kumar A, General Manager – Packaging Development, Aurobindo Pharma.
The discussion opened with insights into the critical attributes of drug products that influence packaging decisions. Experts emphasised the importance of selecting the right primary packaging material to ensure drug stability and efficacy. Panellists stressed that effective collaboration between packaging and R&D teams is essential for successful drug development. Integrating packaging considerations at an early stage allows for the selection of appropriate materials and technologies that protect the drug while ensuring cost and scalability requirements are met.
As the conversation progressed,
panelists addressed the role of packaging vendors in drug development. They highlighted the need for vendors to be agile and adaptable, capable of adjusting to new component requirements that may emerge as formulations evolve. However, they also warned that changing vendors midway through development can have significant repercussions, especially in an industry where regulatory landscapes are evolving. Ensuring vendor continuity and flexibility is vital for maintaining smooth development timelines and regulatory compliance.
Another key focus area was the need for packaging to evolve in line with stringent regulatory requirements and patient needs. As compliance standards become increasingly rigorous, the panelists highlighted the importance of pharma companies adopting advanced packaging solu-
tions that not only meet safety and efficacy requirements but also enhance usability.
The discussion concluded with a unanimous agreement that aligning packaging strategies with R&D is no longer an afterthought but a strategic necessity. With pharma formulations and regulatory frameworks continuously evolving, packaging must be designed proactively to support longterm safety, efficiency, and sustainability. The session reinforced the importance of cross-functional collaboration, strategic vendor partnerships, and continuous innovation to ensure that pharma packaging not only meets industry demands but also improves patient outcomes.
Designing packaging that is cost-effective, safe, scalable, sustainable and effective is necessary to align packaging and R&D.
Pharma Packaging 2.0: Innovations for a safer,smarter future
At the PPL Conclave 2025 in Hyderabad, a session titled “Pharma Packaging 2.0: Innovations for a Safer, Smarter Future” was conducted by Shreyans Bhandari, Managing Director, Bilcare.
Bhandari highlighted the role of high-barrier packaging solutions in ensuring product integrity and patient safety. He stated that such solutions contribute to safe and effective medicine, enhanced adherence and trust, strong market differentiation, accelerated brand growth, and cost-efficient products.
Further discussing, he emphasised the importance of child-resistant packaging in preventing accidental ingestion and meeting global safety standards. He also addressed the need for authentication technologies to strengthen the pharma supply chain, enhancing resilience and agility
Desiccant
Shreyans Bhandari,MD,Bilcare Research
against counterfeit threats.
Sustainability remained a key focus, with Bhandari stressing the industry's responsibility to minimise resource consumption and ensure recyclability. He noted that ecofriendly packaging solutions—recyclable, biodegradable, and resource-efficient—are critical to reducing environmental impact.
He stated that Bilcare Research is positioned to collaborate with global pharmaceutical companies and contract manufacturing organisations (CMOs) for seamless adoption of these advancements.
The session concluded with a discussion on future strategies, with Bhandari reiterating the significance of high-barrier packaging, sustainable materials, and advanced security technologies in shaping a more secure and efficient pharmaceutical supply chain.
foil/Anti-counterfeit solution and sustainable packagin
At the recently concluded PPL Conclave 2025 in Hyderabad, a session titled ‘Desiccant Foil/Anti-Counterfeit Solution and Sustainable Packaging’ was presented by Anil H Mittal, Managing Director of Alutech Packaging.
Mittal stated that Alutech offers 3L CLFF, 4L CFF, strip packs, sachet packs, and effervescent packs. He highlighted that the company’s desiccant foil is designed to address moisture-related challenges by absorbing moisture, increasing drug shelf life, preventing drug degradation, and ensuring patient safety.
Discussing moisture as a significant concern in pharma packaging, he noted that a 2 per cent increase in moisture can reduce shelf life by 30 per cent. Approximately 30 per cent of pharma products are moisture-sensitive, contributing to $35-50 billion in annual losses. Moisture exposure leads to active phar-
Anil H Mittal,MD,Alutech Packaging
maceutical ingredient (API) breakdown, tablet disintegration, and caking or
clumping in powder formulations. To mitigate these challenges, he
stated that Alutech’s desiccant foil provides an effective solution by absorbing moisture, increasing shelf life by 1.5 times, and preventing drug degradation. It also reduces product rejection rates by up to 40 per cent and contributes to cost optimisation.
Beyond moisture protection, Mittal highlighted Alutech’s focus on combating counterfeit medicines through anticounterfeit packaging solutions, including holographic PVC, holographic alu-alu foil, and holographic blister and strip foil. He noted that counterfeit medicines account for 10-15 per cent of the global market, causing $200 billion in annual revenue losses and one million deaths per year.
He further stated that Alutech is also working towards sustainable packaging solutions, developing 100 per cent recyclable blister packs and PVC-free barrier films as part of its sustainability initiatives.
Panel Discussion: Balancing cost and innovation in pharma packaging
L-R: Prasad Satam,VP– Packaging Research Development,Aurobindo Pharma (MODERATOR); Loganathan S,AVP,Onesource Biopharma; Avinash Ballal,Head – Packaging Development, Serum Institute of India; Shivaji Chakraborty,Head – Packaging Development,Fresenius Kabi Oncology; Manjunath Nadella,Assistant VP& Head Packaging Development,Strides Pharma; Shantanu Shome,Former GM – Procurement,Pfizer Healthcare
Express Pharma recently hosted the PPL Conclave 2025 in Hyderabad, where the final panel discussion on Day one, titled ‘Balancing Cost and Innovation in Pharma Packaging,’ brought together industry experts to discuss key challenges and advancements in pharma packaging.
The session was moderated by Prasad Satam, Vice President - Packaging Research Development, Aurobindo Pharma, and included insights from Loganathan S, Associate Vice President, Onesource Biopharma; Avinash Ballal, Head - Packaging Development, Serum Institute of India; Shivaji Chakraborty, Head - Packaging Development, Fresenius Kabi Oncology; Manjunath Nadella, Assistant Vice President & Head - Packaging Development, Strides Pharma; and Shantanu Shome, Former General Manager - Procurement, Pfizer Healthcare.
The discussion highlighted the role
of innovative packaging solutions in improving production efficiency within the pharma industry. Panellists noted that adopting advanced packaging technologies can streamline manufacturing processes and enhance supply chain efficiency. This approach supports operational excellence while maintaining product integrity and regulatory compliance.
The panel examined the importance of a strategic design approach in minimising overall packaging costs. Speakers emphasised that cost reduction must not compromise quality or compliance. Instead, a well-planned strategy should focus on material selection, process optimisation, and technological advancements to achieve cost efficiency without sacrificing performance.
The increasing threat of counterfeit drugs was identified as a significant challenge for the industry. The panel underscored the importance of innovation
in packaging as a primary defence mechanism against counterfeit products. Tamper-evident seals, serialisation, and advanced tracking technologies were discussed as critical tools in ensuring authenticity and supply chain security.
Modern pharma packaging must prioritise patient-centricity, inclusivity, and technological advancements. The panellists highlighted the need for packaging solutions that enhance accessibility for diverse patient demographics. Features such as easy-to-open designs, clear labelling, and smart packaging technologies were cited as essential for improving patient adherence and overall treatment effectiveness.
The ecological impact of packaging processes was also a focal point. The discussion stressed the need for sustainable packaging solutions that align with environmental goals without compromising product stability. Reducing
waste, optimising resource use, and exploring biodegradable and recyclable materials were identified as key strategies for minimising environmental impact.
The panel concluded by addressing the long-term cost benefits of strategic investment in packaging innovation. Speakers agreed that while initial investments in advanced packaging solutions may be high, they offer substantial cost savings in the long run. Enhanced efficiency, reduced waste, improved patient compliance, and better counterfeit prevention were cited as factors contributing to long-term value.
The discussion underscored the importance of balancing cost considerations with innovation in pharmaceutical packaging. The insights shared reinforced the need for a strategic approach that ensures efficiency, security, sustainability and compliance in packaging solutions across the industry.
PPLAwards 2025 lauds excellence and innovation in pharma packaging
Held alongside the PPLConclave,PPLAwards 2025,hosted by ExpressPharma,celebrated visionary leaders and groundbreaking innovations in pharma packaging and labeling
PPL Awards 2025, organised by Express Pharma, presented by West Pharmaceutical Services, and powered by Cilicant, celebrated the leaders, game-changers and rising stars in pharma packaging and labelling. It was held in Hyderbad on March 7, 2025 in Hyderabad, co-located with PPL Conclave 2025.
The evening commenced with a welcome address by Viveka Roychowdhury, Editor, Express Pharma and Express Healthcare. She empha-
Chakravarthi AVPS urged packaging professionals and pharma companies to nominate themselves for these awards so that their work get recognised and lauded
sised the vision and mission of the PPL Awards -- to recognise outstanding
contributions in pharma packaging and labelling.
Following her address, Chakravarthi AVPS, Global Ambassador, World Packaging Organisation, took the stage to explain the methodology behind the selection process for the PPL Awards. He also urged packaging professionals and pharma companies to nominate themselves for these awards so that their work get recognised and lauded.
Next, the winners of this year's edition of PPL Awards were felicitated.
All winners of PPLLeadership Awards with the Jury
Winners of the PPLInnovation Awards 2025 with the Jury
PPLLEADERSHIPAWARDS 2025
PPLLeadership Awards 2025,continuing its tradition for the eighth year, honoured 10 pharma packaging professionals who are contributing to the progress of this sphere across three keycategories:
CATEGORY: ACHIEVERS (INDIVIDUALS WITH IMPACTFULCONTRIBUTIONS)
KAMLESH CHIMALAKONDA
KAUSTUBH KULKARNI
RAJESH SINGH
VINAYKUMAR A
CATEGORY: RISING STARS (EMERGING LEADERS IN PACKAGING)
NARESH MOTOORI
SAJJASIVAKUMAR
SRINIVASARAO D.CH
SURESH KUMAR PATTI
The awards were presented to the winners byViveka Roychowdhury,Editor,Express Pharma; Alok Chandorkar,National Sales Manager,West Pharmaceutical Services India: Manish Jain,Founder & MD,Cilicant; and members of the jurypresent at the event -- Chakravarthi AVPS,Global Ambassador,World Packaging Organisation and AjayBapat,Pharma Consultant.
Honoring the jury
PPLINNOVATION AWARDS 2025
The PPLInnovation Awards 2025 celebrated promising and trailblazing solutions/innovations that are redefining the pharma packaging landscape, pushing boundaries,and shaping the future. The winners were as follows:
CATEGORY: SUSTAINABLE PACKAGING
Serum Institute of Packaging
CATEGORY: PATIENT-CENTRIC PACKAGING
Biological E
Inventia Healthcare
The success of the PPLAwards was made possible by an esteemed panel of jurymembers,who dedicated their expertise to selecting the most deserving winners.Therefore,Roychowdhurypresented
Certificates of Appreciation to the jurymembers, acknowledging their integral role in PPLAwards. The evening concluded with cocktails and dinner, allowing attendees to networkand celebrate. After each award presentation,winners shared brief remarks on their journeyand contributions to the industry.
She Leads
Laboratories
The first session on day two of the PPL Conclave 2025 was chaired by an all-women panel, to commemorate the occasion of Women’s Day. Moderated by Viveka Roychowdhury, Editor, Express Pharma; She Leads was a free-flowing conversation with women leaders who are driving inn ovation and transformation in the pharma packaging industry.
Leaders on the dias included Dr Swati Mukherjee, AVP & Head Formulation & Packaging R&D, Kusum Pharma; Preeti Thukral, Associate VP, Biocon Biologics; Rajshri Pardeshi, Team Leader-Packaging Development, Glenmark Pharmaceuticals; Leena Padala, Head - Packaging Development & Opex (R&D), Eugia Pharma Research Centre; and Mamta Rani, Team Lead Packaging Development, Dr. Reddy's Laboratories.
The discussion began with a unanimous agreement over women encouraging and uplifting other women in the industry to create a supportive environment. As the pharma industry is predominantly male-dominated, the women who have made it into these workplaces must create a safe and conducive environment that allows mutual growth and encourages younger women to pursue a career in pharma.
This also helps women build a network of strength and solidarity, and, promotes knowledge sharing that is essential for both personal and professional growth. Practical ways of implementing such a culture would involve supporting a colleague’s career progression, ensuring women are given opportunities for leadership roles, or helping to remove barriers that might otherwise hinder their success.
The panelists stressed that success is independent of gender. Therefore, workplaces must reward each em-
Padala,Head – Packaging Development & Opex(R&D),Eugia Pharma Research
ployee based on their merit, devoid of any gender biases. They also emphasised that this does not mean that women should be offered token positions, but rather creating an environment where merit is the sole determining factor for growth and advancement.
Women are instinctivey creative and empathic, and are known to have a better emotional intelligence quotient that can reflect in their work and office place, also making them good leaders. More inclusive and dynamic workplaces bring different perspectives to-
gether which can result in a flourishing workplace.
The panellists also advised women to not let any labels define who they are, their worth or their potential. Women must work to push past their selfdoubts and trust in their abilities. They emphasised that self-doubt can be paralysing and that the most successful women are those who find their inner strength and affirm their value. Therefore agreeing that self-confidence is the key to growing, both internally as well as in career.
Women’s Day,which coincided with Day2 of PPLConclave 2025 this year,was also celebrated with gusto.Sheroes of pharma packaging were lauded for their invaluable contributions towards the industry’s progress
L-R: Viveka Roychowdhury,Editor,Express Pharma (MODERATOR); Dr Swati Mukherjee,AVP& Head Formulation & Packaging R&D,Kusum Pharma; Preeti Thukral,Associate VP,Biocon Biologics; Rajshri Pardeshi,Team Leader – Packaging Development,GlenmarkPharmaceuticals; Leena
Centre; Mamta Rani,Team Lead – Packaging Development,Dr.Reddy's
Panel Discussion: Business innovation through sustainability: From obligation to opportunit
Express Pharma recently hosted the PPL Conclave 2025 in Hyderabad, where the last day’s panel discussion focused on business innovation through sustainability in pharmaceutical packaging.
The session was moderated by Ajay Bapat, Pharma Consultant, and included industry experts Manoj Kumar, Cluster Lead – Packaging, Sun Pharma; Prafull V Deshpande, Team LeaderPackaging Development, Lupin; Kumar Suman, AGM & Head Packaging Development Injectables and Medical Devices, Macleods Pharmaceuticals; and Iranna SB, VP – MSAT, Maiva Pharma.
In today’s business landscape, sustainability is often seen as a compliance requirement—an obligation to be met. However, companies are increasingly
recognising sustainability not as a burden but as a driver of innovation and long-term success. The discussion examined how businesses can shift their approach to sustainability, integrating it as a key factor for growth and competitive advantage.
The panellists emphasised that innovation in pharma packaging is successful only when it generates business value or is cost-efficient. While sustainability is a priority, its adoption must align with business objectives to ensure practical implementation. The discussion focused on the need for packaging innovations to be both environmentally responsible and economically viable.
Reusability was identified as a key factor in sustainable packaging. The panellists highlighted that the industry
must actively promote and prioritise reusable packaging solutions to reduce environmental impact. Collaboration between manufacturers, regulators, and stakeholders was discussed as a necessary step to establish effective and scalable sustainable packaging strategies.
The panel noted that sustainability in packaging is no longer an option but a necessity. Packaging materials need to be developed and innovated with sustainability as a core consideration. Businesses must integrate these principles into their long-term strategies to comply with evolving environmental regulations and reduce their carbon footprint.
Regulatory frameworks were discussed as a crucial driver of sustainability efforts. The panellists suggested that clear mandates should be established to
enforce the use of sustainable materials in pharma packaging. Without regulatory enforcement, they noted, the transition to environmentally friendly materials may face delays due to cost concerns and industry resistance.
The discussion also addressed the rapid expansion of the e-pharmacy sector and its impact on packaging sustainability. While e-pharmacies have improved accessibility for consumers, their reliance on nonbiodegradable packaging materials presents environmental challenges. The panellists highlighted the need for solutions that balance convenience and sustainability, urging the industry to explore alternative packaging materials that minimise waste while ensuring product integrity.
L-R: AjayBapat,Pharma Consultant (MODERATOR); Manoj Kumar,Cluster Lead – Packaging,Sun Pharma; Prafull VDeshpande,Team leader – Packaging Development,Lupin; Kumar Suman,AGM & Head – Packaging Development (Injectables and Medical Devices),Macleods Pharmaceuticals; Iranna SB,VP– MSAT,Maiva Pharma
Panel Discussion: Packaging for the connected age
L-R: Rahul Bhargava,Director – R&D Packaging,Packaging Prescriptions (MODERATOR); Srinivas Sukasi,AGM,Packaging Development,MSN Laboratories; G VSrinivas,Associate Director – Packaging Research & Development,DifGen Pharmaceuticals; Bhupesh Mittal,Technical Packaging Program Lead – APAC,Bayer Consumer Healthcare; Bangarayya Mathamsetti,Senior Manager – Packaging and Development,Lyrus Life Sciences; Rajendra Shetty,Senior Manager – Packaging Innovation,Abbott Healthcare; B Ganesh,DGMPackaging Development,Inventia Healthcare; Rajendra Prasad,Head,Senior Manager – Packaging Development,Maiva Pharma
For the concluding session of the PPL Conclave 2025, the panel on packaging for the connected age delved into an increasingly relevant topic. Technology is transforming the way we think about packaging. Today, Packaging isn’t just about protecting products; it’s about making them smarter, safer, and more interactive. The panel, moderated by Rahul Bhargava, Director- R&D Packaging, Packaging Prescriptions delved into how digital tools, track-and-trace systems, and evolving regulations are shaping the future of pharma packaging.
The set of panellists included Srinivas Sukasi, AGM, Packaging Development, MSN Laboratories; G V Srinivas, Associate Director – Packaging Research & Development, DifGen Pharmaceuticals; Bhupesh Mittal, Technical Packaging Program Lead - APAC, Bayer Consumer Healthcare; Mr Bangarayya
Mathamsetti, Senior Manager- Packaging and Development, Lyrus Life Sciences; Rajendra Shetty, Senior Manager Packaging Innovation, Abbott Healthcare; B Ganesh, DGM- Packaging Development, Inventia Healthcare and; Rajendra Prasad, Head Senior Manager Packaging Development, Maiva Pharma.
The discussion began by explaining how smart packaging can provide realtime monitoring, track and trace, and tamper-proof features that ensure the safety, efficiency and efficacy of the product. Monitoring features ensure that the products are not only delivered safely but can be tracked throughout their lifecycle. Additionally, these smart systems offer continuous data that can improve the overall efficiency and efficacy of the product.
The panellists highlighted that as the focus on sustainability grows, the
pharma packaging industry is under increasing pressure to minimise waste and adopt more responsible practices. The industry must also focus on optimising the use of materials in packaging. This includes utilising lightweight materials, reducing material thickness, or exploring new eco-friendly materials that can perform the same function while using fewer resources. They also agreed that making packaging accessible and ensuring that it’s user-friendly to a diverse range of consumers is important. Implementing the rule: reduce, reuse, recover and recycle must be practised for sustainable packaging.
The transition to smart and connected packaging in pharma depends on strengthening digital infrastructure. This includes adopting technologies to collect, store, and analyse data from packaging to improve the effectiveness
of its design and ensure better patient experiences. Therefore, they unanimously agreed that, digitisation has the potential to expedite packaging R&D. In turn, it enhances patient engagement and experience at optimal cost
In India, smart pharma packaging has made progress, but there is still a long way to go. Challenges like adapting to new technology, data security, and standardising packaging features across markets remain, however, the industry is steadily advancing in this sphere.
For pharma companies, it is essential to recognise the areas within their operations where digitisation can have the maximum impact. By integrating technology in the right area, these innovations can help the company reach its best potential enhance sustainability, improve patient safety, and stay ahead in a competitive market.
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GLIMPSES OFPPLCONCLAVE 2025
LOGISTICS
Empowering stockists: The keyto unleashing pharma growth and medicine access
Chandrachur Datta, Partner,Vector Consulting Group explains why it's crucial to rethink and optimise the pharma distribution model in order to create a system that benefits stockists, companies,and patients alike
Stockists play a critical role in pharmaceutical supply chains, ensuring medicines reach chemists efficiently. Whether they operate in wholesale markets (Dawa Bazaars) or as distributiondriven stockists delivering directly to chemists, their ability to maintain stock availability is essential for ensuring a steady supply of medicines to chemists and, ultimately, patients. However, despite their importance, stockists' ability to serve their market and grow is often constrained—primarily due to inventory management challenges. These inefficiencies impact stockists' profitability and limit pharmaceutical companies' market reach and sales potential. To create a system that benefits stockists, companies, and patients alike, it's crucial to rethink and optimise the pharma distribution model.
The stockist-company equation: Why profitabilitymatters
For pharmaceutical companies, stockists are more than just intermediaries—they are key partners in ensuring product visibility and accessibility at the chemist level. A profitable stockist can expand their reach, offer a broader range of medicines, and invest in better service levels. Conversely, when stockists struggle financially, they restrict their product offerings and limit their market presence, ultimately hurting pharmaceutical companies' sales. This makes stockist return on investment (ROI) a critical factor in a company’s success.
The inventorychallenge and its impact on sales
A stockist’s profitability is directly tied to inventory turns—how quickly they can sell and replenish stock. Higher inventory improves capital efficiency and cash flow. However, current inventory management practices hinder this efficiency significantly. Pharmaceutical companies structure their distribution by therapeutic divisions, each operating almost as an independent business unit with its stockist network. To maximise their sales, these divisions push significant inventory onto stockists, requiring them to hold 2-7 weeks' worth of stock across a mix of fastand slow-moving products for each division they handle.
This creates significant challenges:
1. High working capital lockin: Stockists must allocate substantial capital to inventory, limiting their ability to invest in other divisions and increase the range offered to chemists. With working capital locked in inventory, stockists also lack the financial flexibility to extend their services to more chemists, reducing overall market penetration
2. Limited portfolio offering: Since stockists work with only specific therapeutic divisions of a firm, this also limits them
from providing the full range of products chemists’ need from a company - Missed opportunities to increase sales without additional operating costs.
This situation poses challenges for both chemists and pharmaceutical companies, as well. Since stockists typically handle only a few divisions, chemists often need to work with multiple stockists to source all the medicines they
sure reliable product availability at chemists.
Asmarter approach:
Helping stockists reduce inventoryburden
Pharmaceutical companies can tackle these challenges by rethinking their inventory management strategy. Instead of burdening stockists with high inventory levels within a single therapeutic division, they
sell more to existing chemists and reach new ones, boosting both availability and revenue. This approach improves stockist profitability while ensuring better product availability at chemists, ultimately driving higher sales and sustainable growth for pharmaceutical companies. However, reducing inventory levels comes with the risk of stockouts. To counter this and maintain excellent
require from a single company. This fragmented supply increases the risk of stock gaps, making it harder for chemists to maintain a complete inventory.
For pharmaceutical companies, the issue is just as pressing. Despite holding high inventory levels throughout the supply chain and absorbing significant losses from stock expiry and obsolescence—often leading to write-offs of 4-10 per cent—they still struggle to en-
should:
1. Reduce inventory requirements per SKU – Lowering stockholding obligations allows stockists to manage their working capital more efficiently.
2. Enable multi-division stocking – With freed-up capital; stockists can offer a wider range of medicines across multiple therapeutic divisions.
3. Expand market coverage and sales – By reducing capital constraints, and enhancing range availability; stockists can
availability, companies must take additional steps.
Mitigating stockout risks while reducing inventory levels
This involves:
◆ Enhance supply frequency: Companies should aim to supply stockists with the same SKUs more frequently—ideally at least once a week or 2-3 times a week in some markets. More frequent deliveries allow stockists to reduce their maximum stockholding from 2-7 weeks to 1-2 weeks, minimising overstocking and freeing up working capital.
◆ Set inventory limits: Deliveries should not only be in smaller quantities, but companies must establish a maximum inventory level for each SKU at the stockist level and ensure it is not exceeded.
◆ Adapt inventory limits to market signals: Demand for
LOGISTICS
certain products fluctuates seasonally. A system should be in place to regularly assess and adjust inventory levels to align with changing market conditions.
◆ Implement an Automatic Replenishment System (ARS): The replenishment process should be automated, prioritising SKUs based on stockout risk while dynamically adjusting inventory limits using real-time data.
◆ Ensure warehouse availability: For this model to be effective, companies must maintain near 100 per cent availability of all relevant SKUs in their warehouses, which requires a highly responsive supply chain.
◆ Adopt a demand-driven supply chain: Shifting away from fixed monthly forecasts,
companies should move toward demand-driven inventory management. Lead times can be reduced, and supply chain variability can be managed using strategic buffers of finished goods and raw materials. Finished goods buffers enable efficient production scheduling, while raw material buffers provide flexibility to manufacture high-demand products as needed.
The path forward: A smarter,more sustainable pharma distribution model
The pharmaceutical industry stands at a pivotal moment— one where optimising distribution is not just a competitive advantage but a necessity. The current model, burdened by inefficiencies
and rigid inventory structures, limits stockists growth opportunities, reduces companies market reach, and compromises availability for chemists and patients. However, by transitioning to a demand-driven supply chain, pharmaceutical companies can create a win-win-win scenario:
◆ Stockists gain improved
profitability, reduced working capital burdens, and the ability to serve more chemists.
◆ Pharma companies see stronger market penetration, higher sales, and reduced stock write-offs.
◆ Chemists and patients benefit from the consistent availability of essential medicines. Companies proactively implementing this transforma-
tion will strengthen their market position, enhance operational efficiency, and ensure a more resilient healthcare ecosystem. The time to act is now—those who embrace this change will lead the future of pharma distribution, while those who hesitate risk falling behind in an increasingly competitive landscape.
IBM Combination Ink Printing and Laser Writer
tionInk Printingan d LaserWriter
The IBM Combination, Roto-Gravure Printing Machine with Class 1 Safety CO2 Laser system or Class 1 Safety UV Laser marking system gives you the ability to mark all your products with different marking systems. Our high-speed production machine designed to mark soft gelatin capsules between the sizes of 1.3 Ovals through 22 Oblongs and various sized tablets and caplets. The high output laser marking required by our customers can be reached with 2 of our Class 1 Safety CO2 Laser systems.
This machine has an average output of 300,000 PPH
Hartnett offers this machine with Allen Bradley or Siemens controls, all servo driven motors for the most accurate print registration, and recipe selection that holds over 200 programs for repeat jobs. All our machines are 21 CFR Part 11 compliant and UL, CSA & CE approved.
From set up to production in 3 hours or less, the IBM machine will satisfy your printing needs for the highest outputs.
One sided printing system
Quick release tooling set
Adjustable incline hopper assembly
Solid Aluminum base unit that includes the electrical
Mobile unit with wheels and locking pad
Dual channel inter-locking safety system
Upper feed hopper
15-inch HMI with swing arm
Wi-Fi or hardwired connectivity for remote customer
The SCHOTTFIOLAX® Scholarship Program has been widely appreciated by academic institutions and faculty members for its emphasis on fostering independent thinking and vision among students
The SCHOTT FIOLAX® Scholarship Program, organised annually by SCHOTT Glass India, is a prestigious initiative aimed at supporting and nurturing the academic and professional growth of pharmacy students in India. Launched in 2014, the program has been instrumental in providing financial assistance to meritorious students pursuing Bachelor's (B. Pharmacy) and Master's (M. Pharmacy) degrees in pharmacy.
The selection process is rigorous, involving multiple stages of evaluation, including aca-
demic performance, written submissions, and personal interviews conducted by a panel of experts from SCHOTT.
The scholarship not only offers financial support but also provides recipients with unique opportunities to gain industry insights and exposure.
Awardees are given exclusive tours of SCHOTT Glass India's state-of-the-art facilities, where they can observe cutting-edge pharmaceutical glass tubing production processes and interact with industry professionals.
“We are proud to help in fa-
cilitating a sound studying environment for these deserving candidates who have really shown their dedication in the field of pharmacy,” said Sundeep Prabhu, Senior Vice President, SCHOTT Glass India.
The SCHOTT FIOLAX® Scholarship Program has been widely appreciated by academic institutions and faculty members for its comprehensive evaluation criteria and its emphasis on fostering independent thinking and vision among students. By recognising and supporting the next generation of pharmacists,
SCHOTT Glass India is contributing to the advancement of pharmaceutical education and research in the country.
Rishab Driver, a recipient of the scholarship said, “SCHOTT should continue with this program as it’s a great motivation to students. Winning this scholarship was a very special moment for me. It has encouraged me, and I look forward to working in a pharmaceutical MNC.”
“It was a huge boost to my confidence. This scholarship provides an environment of growth, and positivity, it’s a
wonderful opportunity to have”, said another scholarship holder, Pooja Patel. With its commitment to sustainability and innovation, SCHOTT Glass India continues to play a pivotal role in shaping the future of the pharmaceutical industry, ensuring that deserving students have the resources and opportunities they need to excel in their careers.
For more details, please reach out to mansi.shelke@schott.com, Phone: 022 40947014
Ensuring clean room integritywith prime clean reset high-speed doors: Minimising air permeabilityand leakages
These doors enhance hygiene by providing an airtight seal that effectively isolates clean room environments,preventing the ingress of dust and other contaminants
High-speed doors for clean rooms are specialised industrial doors essential for maintaining controlled environments. These doors are engineered to be airtight, creating a reliable barrier between different areas of a facility. Their design ensures durability and minimal maintenance, reducing the frequency of repairs and replacements.
High-speed clean room doors offer a range of critical benefits essential for maintaining stringent environmental control. These doors enhance hygiene by providing an airtight seal that effectively isolates clean room environments, preventing the ingress of dust and other contaminants. This capability is especially crucial in sectors such as pharmaceuticals, biotechnology, and food production, where maintaining sterility is non-negotiable.
In the pharmaceutical and life sciences industries, compliance with rigorous regulatory standards necessitates the manufacture of products within controlled clean room environments. A high-performance clean room door is an integral component in ensuring the integrity of these spaces, safeguarding product quality and patient safety.
Beyond contamination control, these doors are engineered with advanced safety mechanisms, including automated sensors and emergency stop functions, which mitigate the risk of operational hazards. Moreover, high-speed clean room doors are designed to maintain precise overpressure or under pressure conditions within the environment. This is vital for
preventing cross-contamination and ensuring that the clean room remains in a state of controlled integrity, even under varying operational demands.
Given the critical role these doors play in maintaining the purity and safety of highly specialised environments, selecting the appropriate door system is a decision of strategic importance.
Prime Clean Reset, our highspeed door is designed specifically for clean rooms. This innovative solution is engineered to meet the stringent requirements of controlled environments, ensuring exceptional performance and reliability. Designed with precision to meet the stringent requirements of controlled environments, Prime Clean Reset is the epitome of performance and reliability, ensuring that your clean room operations consistently meet the highest standards of regulatory compliance and product integrity.
Prime Clean Reset is suitable for clean rooms up to ISO Class 5, offering an unparalleled air permeability rate of less than 12 m³/m² h at ? 50 Pa. This en-
sures that even in the most sensitive environments, the door effectively maintains the critical pressure differentials required to prevent contamination, thereby safeguarding your processes and products.
Engineered with cuttingedge European technology and innovative design principles, Prime Clean Reset offers rapid cycle times for both opening and closing, making it the optimal solution for medium to large entrances in clean room applications. The door's construction is specifically tailored to minimise air leakage and particulate infiltration, ensuring that it supports the rigorous cleanliness standards necessary for applications such as pharmaceutical manufacturing, semiconductor fabrication, food processing, and other highly specialised sectors. With its robust design and reliable performance, Prime Clean Reset seamlessly integrates into your clean room infrastructure, providing a critical barrier that preserves the integrity of controlled environments. Whether you are operating in a pharmaceutical, biotechnology, electronics, or
defence industry, Prime Clean Reset offers the precision, durability, and compliance needed to maintain your competitive edge in highly regulated markets.
Key features of Gandhi Automations' High-Speed Clean Room Doors include: Low air permeability: Designed to maintain low air permeability in pressurised rooms with both positive and negative air pressure.
Compact design: The doors are designed to fit inside the columns, with a self-supporting construction that minimises air leakage.
Customisable transparency: They can be equipped with transparent PVC horizontal sections or vision windows for visibility.
Specialised side guides: The special side guides ensure a tight integration of the curtain,
providing high leak tightness. Efficient operation: The doors offer high efficiency and low permeability values, compliant with EN 12426 and EN 12427 standards, ensuring < 12 m³/m² h ∇ 50 PA.
Durable control device enclosure: The control device enclosure is made of Stainless-Steel SS 316, ensuring durability and resistance to corrosion.
These high-speed doors are meticulously engineered to minimise air leakage and maintain strict environmental control, making them indispensable for clean room operations. Their rapid opening and closing operation ensure that the internal facility remains isolated from external conditions, effectively upholding the cleanliness and controlled environment essential for maintaining the integrity of clean rooms.
PHARMA PULSE
The future of mRNAvaccines beyond COVID-19
While a dramatic increase in mRNAresearch related to COVID-19 vaccines emerged,we see that other non-COVID-19 research and development technology now dominates preclinical and clinical trials,especially for infectious diseases and cancers
Development and deployment of messenger RNA (mRNA) vaccines for SARS-CoV-2 was a tremendous public health achievement in the face of a global health crisis. That success generated immense excitement around mRNA technology, significantly accelerating its development and application to a wide range of diseases.
About 70 per cent of active mRNA vaccine preclinical and clinical trials worldwide are now focused on diseases beyond COVID-19, comprising 31 per cent of mRNA vaccine trials on cancer and 69 per cent on other infectious, genetic, and immune diseases (see Figure 1). The surge of research into these vaccines since 2020 is surpassing COVID-19, proving they’ll be a long-term avenue for research and development.
The state of mRNA vaccine research
Although it may appear that mRNA vaccines were invented recently, research into these types of vaccines has been ongoing for over 30 years. As indicated in the CAS Content Collection, the largest human-curated repository of scientific information, the output of journal publications in the mRNA vaccine field followed a slow upward trend from 1965 to 2019, with slight annual growth. The number of journal publications on mRNA vaccines was only 571 until 2019 (see Figure 2B).
Significant growth began in 2020, and by 2024, there were more than 8,000 journal publications relating to mRNA vaccines. Patents also reflect this trend, with mRNA vaccine patent publications increasing from around 30 in 2020 to several hundred in
Figure 1:(A) Line graph shows active mRNAvaccine preclinical and clinical trials over the years and the pie chart shows the global status of mRNAvaccine development.(B) Number of preclinical and clinical trials of mRNAvaccines on COVID-19 and beyond COVID-19.(C) Distribution of mRNAvaccine trials among cancer and other diseases.Source: Pharmaproject Citeline Clinical Intelligence updated on December 28,2024.
Figure 2:(A) Total number of journal,patent and preprint publications on mRNAvaccines (B) Journal and preprint publications and (C) patent publications through the years in the field of mRNAvaccines.Inside bar charts showpublications before 2019.Pie charts showthe distribution of publications before and after 2020. Source: CAS Content Collection
2024 (see Figure 2C). The notable rise in preprint publications from 2020 to 2024 can be attributed to the urgent need to disseminate research findings on mRNA vaccines during the pandemic.
While COVID-19 understandably dominated the research landscape in the early years of this decade, the infrastructure and inn ovations established during the pandemic are now being applied to other diseases, including cancer, HIV, and rare diseases. As shown in Figure 1A, by December 2024, there were 280 vaccines in developmental stages, with 55 per cent in the preclinical stage and 45 per cent in various clinical stages.
COVID-19 was the catalyst for large-scale mRNA vaccine development, but this technology is now on a long-term path of research and development to address a range of challenging diseases.
What is mRNA?
mRNA is a single-stranded macromolecule comprised of nucleotide subunits, which can carry the genetic sequence of corresponding DNA and be read by ribosomes for the translation of protein in the cytoplasm. At the core of mRNA vaccine technology is the use of synthetic mRNA, designed to encode specific antigens (see Figure 3A).
Untranslated regions (UTRs), a 5’ cap, and a 3’ poly(A) tail flank the coding region and nucleosides within the mRNA are modified (Figure 3D) to delay degradation in the cytoplasm, decrease immunogenicity, and enhance translation. Oncedelivered into cells, these vaccines must be translated into antigens using the host cell’s translation machinery to trigger antigenspecific immune responses.
PHARMA PULSE
The translated antigens can be secreted and absorbed by cells as exogenous antigens, stimulating MHC class II-mediated immunity. Additionally, when mRNA vaccines are delivered to antigen-presenting cells (APCs), the translated antigens are perceived by the host as endogenous antigens, primarily activating MHC class I immune responses. The mRNA strand gets broken down by nucleases and has a short half-life.
This method is highly promising, but mRNA can be degraded by extracellular RNases, which may lead to failed translation and internalisation by APCs. It can also struggle to cross the anionic cellular membrane. However, two key breakthroughs made mRNA vaccines possible: using lipid nanoparticles (LNPs) as mRNA delivery materials and chemically modifying mRNA to avoid unwanted immune responses.
LNPs for mRNA vaccine deliveryare the only drug delivery system that has demonstrated clinical effectiveness and received approval for human use. In 2023, two scientists at the University of Pennsylvania, Dr Katalin Karikó and Dr Drew Weissman,won the Nobel Prize in Physiology or Medicinefor their breakthroughs in chemically modifying mRNA bases that have significantly impacted mRNA stability, translation efficiency, and immune evasion.
Types of mRNAvaccines
There are three types of mRNA vaccines currently: non-replicating mRNA, selfamplifying RNA (saRNA), and circular RNA (circRNA).
Figure 3: (A) An overviewof mRNAtranscript for mRNAvaccine.In addition to conventional mRNA,different mRNAtypes include (B) self-amplifying mRNA(saRNA) and (C) trans-amplifying mRNA(taRNA).(D) Chemical modifications in the bases.The illustration was created using BioRender.com.
tion efficiency.
◆ Circular mRNAs (circRNAs): This type of mRNA vaccine contains a closed-loop structure with no 5’ and 3’ UTR. CircRNA is produced from mRNA precursors through back-splicing. The initiation of circRNA translation is independent of the 5’ cap structure. It translates proteins by rolling circle amplification (RCA). The closedloop structure protects circRNAs from exonuclease degradation, and these vaccines with LNP carriers are highly stable. However, more safety testing is needed before being approved for clinical usage.
mRNAvaccines for conditions beyond COVID-19
The advancement of mRNA vaccines for infectious diseases beyond COVID-19 has shown consistent progress over the years (see Figure 4). Influenza represents half of the clinical trials in this area of study, followed by RSV, HIV, and the varicella zoster virus. Before 2020, research primarily focused on diseases like influenza, HIV, and HPV, with early clinical trials demonstrating the potential of mRNA technology. The success of mRNA COVID-19 vaccines in 2020 spurred expanded efforts targeting chlamydia, CMV, EpsteinBarr virus, hepatitis B, hepatitis C, malaria, inflammatory bowel disease, and Zika virus by 2021.
◆ Conventional/non-replicating/non-amplifying mRNA: This type of mRNA vaccine consists of an ORF encoding for the proteins of interest, a 5’ cap structure, a 5’ UTR, a 3’ UTR, and a poly(A) tail that can be transcribed to one copy of immunogenic protein (Figure 3A). The immune response is directly proportional to the number of transcribed mRNAs. While these vaccines can be produced quickly and cost-effectively, they must be administered repeatedly because of the mRNA’s short half-life.
Figure 4:(A) Disease-wise distribution of mRNAvaccine documents.(B) Time trends for mRNAvaccine documents for (B) COVID-19 (C) infectious diseases beyond COVID-19 and (D) cancer.Source: CAS Content Collection
◆ Self-amplifying (saRNAs) and trans saRNAs: In addition to the conventional elements of linear mRNA, saRNA contains a long ORF sequence that encodes a viral
replicase (nonstructural proteins; nsP1–nsP4), derived from alphaviruses, to amplify mRNA in the host cells (Figure 3 B). These vaccines are also easy to produce at scale and produce more antigens at lower doses than conventional mRNAs. However, synthesis
can be difficult, and the large replicon size (~10 kb) limits cell internalisation. saRNAs may be divided into a set of two taRNAs (Figure 3C), the mRNA without nsP1–nsP4 and the mRNA that encodes nsP1–nsP4 genes, to avoid large size and low encapsula-
Multivalent vaccines for influenza (quadrivalent influenza mRNA vaccine MRT5413, NCT05650554) and RSV progressed to late-stage trials in 2022, while early-phase studies began for diseases such as chikungunya, Nipah, HSV, rabies, yellow fever, varicella zoster, and multi-component vaccines (e.g., influenza and RSV; influenza, RSV, and SARS-CoV-2).
Emphasis centres on expanding mRNA vaccine platforms to tackle unmet needs in the future, including dengue, Ebola, heartland virus, gonorrhoea, Japanese encephalitis, Lassa virus,
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Marburg virus, mpox, human metapneumovirus, phlebovirus, and tuberculosis, highlighting significant growth in this field. Moderna recently secured substantial funding from the U.S. government todevelopmRNAbased vaccines for bird flu, aiming to prepare for potential human outbreaks.
Another exciting development is using mRNA vaccines to induce a robust T-cell response anderadicatecancer cells. In the 2010s, advancements in mRNA technology and delivery systems led to the initiation of early-phase clinical trials for personalised cancer vaccines targeting melanoma and other cancers. Efforts in mRNA vaccine research increased substantially after the successful deployment of COVID-19 vaccines.
More than 60 trials on mRNA cancer vaccines are currently listed for a range of cancers, including breast, ovarian, prostate, colon, metastatic renal cell, glioblastoma, melanoma, and solid tumours. Most are preclinical, but some have progressed to phase II (see Figure 5).
As pioneers in developing mRNA therapeutics, CureVac, Moderna, and BioNTech have designed a series of mRNA vaccines based on tumour-associated antigens (TAAs) and tumor-specific antigens (TSAs). Recently, Merck and Moderna initiated a phase III study (NCT05933577) evaluating V940 (mRNA-4157), which uses mRNA, encoding up to 34 neoantigens, in combination with KEYTRUDA (pembrolizumab) for adjuvant treatment of patients with resected high-risk (stage IIBIV) melanoma.
Recent advances in mRNAvaccine delivery
Choosing the right carrier is crucial for vaccine success and influences the immune response’s strength and precision. Advances innanotechnologyhave enabled diverse carrier systems to improve mRNA delivery and expression in target cells. Table 1 presents themain delivery
Synthesis materials
Lipid-based
Polymer-based
Lipid-polymer hybrid
Naturally-derived materials
Peptide/ protein
Bio-membrane
Good biocompatibility,high loading efficiency,high ransfection efficiency
Good biocompatibilityand stability,stimulation of drug release,easymodification
Both the advantages of lipids and polymers
Lowimmunogenicity,easilyto metabolise,rich functional groups
Good transfection efficiency,long circulation,high biocompatibility
tations and proteoglycanshielding that conceals critical epitopes. An mRNA vaccine would need to produce broadly neutralising antibodies to be effective against HIV. Any mRNA vaccine would need to be thermostable to tackle a disease like Ebola. The only current FDA-approved vaccine requires -80? storage, and there are no mRNA vaccines in clinical development currently. Rabies, RSV, and malaria are also targets for potential mRNA vaccines, but each needs to demonstrate success in clinical trials.
Despite these challenges, the future of this technology is extremely promising. Decades of advancements in mRNA design and nucleic acid delivery technology, along with the identification of novel antigen targets, have positioned mRNA vaccines at the forefront of disease pre-
Nondegradable for responsive polymers,dose-dependent toxicity,purification concern
Dose-dependent toxicityconcern
Lowloading efficiency,short circulation in vivo,instability
High cost of manufacturing, immunogenicityconcern
Table 1:Summaryof nanoparticle-based platforms for mRNAdeliveryin mRNAvaccine technology.Adapted from Meng-Zhen Yu et al 2023.The clinical progress and challenges of mRNAvaccines - PubMed
carriersfocused on mRNA vaccine development, includingLNPs,polymer-based nanostructures, and naturally-derived materials. These nanoparticle-based delivery systems protect administered mRNA from nuclease degradation, self-hydrolysis, and immune system threats. They also provide a versatile and targeted system for the safe delivery of mRNA to the target cells.
Current limitations of mRNAvaccines and how to overcome them
Recent breakthroughs in mRNA vaccines prove that this is an effective technology that could be leveraged against many other diseases. However, challenges remain for future development, including issues related to the immunogenicity and stability of mRNA, biosafety concerns, targeting problems in deliv-
ery systems, and quality control for large-scale production of mRNA vaccines. For example, coronaviruses like SARS-CoV-2 and influenza continually present new variants and strains, which require new vaccines. Therefore, researchers are working on multivariant boosters and universal vaccines for these types of viruses. The HIV virus also exhibits rapid mu-
vention and treatment. While a dramatic increase in mRNA research related to COVID-19 vaccines emerged, we see that other non-COVID-19 research and development technology now dominates preclinical and clinical trials, especially for infectious diseases and cancers. As research progresses, we can anticipate more innovative applications of mRNA technology.
Figure 5:Year-wise distribution of mRNAcancer vaccines in various phases of development.Source: Pharmaproject Citeline Clinical Intelligence updated on December 28,2024.
TRUTH – PLS calibrated glass syringes with individual calibration certificate (Class Aas per ISO 4788)
The syringes offer a jerk-free experience while collecting and dispensing accurate liquid doses through a 100 per cent inert liquid path of borosilicate glass that also withstands higher pressures
TRÜTH Calibrated Glass Syringes (PLS) are Certified Volumetric measuring Instruments as per Class A ISO 4788. The syringes offer a jerk-free experience while collecting and dispensing accurate liquid doses through a 100 per cent inert liquid path of borosilicate glass that also withstands higher pressures. Ideal for laboratory liquid handling of various liquids including Plastic Sensitive Materials, hazardous chemicals, Adjuvant solutions, petroleum derivatives, glues, synthetic dyes, perfumes, essential oils and organic chemicals. Recommended for your Good Laboratory Practices (GLP) /
GMP Certified facility at quality control, quality assurance etc.
Features
◆ Class of accuracy is Class A as per ISO 4788
◆ Permissible error of + /- 1 per cent
◆ Autoclavable at 121°C, can withstand up to 200°C. Out-
standing Chemical Resistance is made of 3.3 Borosilicate Glass
◆ Extremely air-tightness and can hold a particular pressure. 100 per cent jerk-free movement
◆ Fine graduation markings (up to 0.01ml)
◆ Glass Barrels & Pistons are made from borosilicate Glass.
◆ Graduation marks are perma-
nently fused into a glass barrel
◆ Inert Liquid Path, No ‘O’ Ring, Calibration Certificate with Each Syringe
◆ Suitable for all types of needles as per ISO594/1;595/2
◆ Luer locks are Nickel-chrome plated brass or Stainless Steel (SS316) as per ISO 594/1; 595/2
Top Syringe exports its prod-
ucts to over 40 countries worldwide and counting, keeping a single quality standard for local and export products. The PLS syringe is manufactured 100 per cent in India by Top Syringe Mfg Co (P) Ltd. We are fully committed to supporting you with our full product range, spares, and technical assistance.
Lonza Capsules & Health Ingredients establishes center of applied sustainability
The dedicated team at the center will work alongside partners,suppliers and customers to achieve collective environmental goals
Lonza Capsules & Health Ingredients announced it has established a Center of Applied Sustainability. Comprised of a dedicated team of experts, the Center will drive forward Lonza CHI’s sustainability strategy by implementing solutions to reduce its footprint in line with Lonza’s near-term science-based emissions reduction targets, validated by the Science Based Targets initiative (SBTi). It will also contribute to reducing Lonza CHI’s environmental impact through energy efficiency, waste reduction and resource optimisation initiatives.
sive assistance to help address emissions, adopt sustainable practices, and contribute to a greener future.
The Center will also provide end-to-end support for customers seeking to reduce their emissions, from upstream supply chain emissions to downstream low environmental impact products. By partnering and co-innovating with customers, it will offer comprehen-
As a core service, the Center will conduct carbon footprint assessments for CHI products to support customers in assessing their own emissions and identify further reduction opportunities. The Center will also drive innovation, aiming to achieve the lowest possible environmental im-
pacts for CHI product portfolio.
Christine Lebeault, Head of Applied Sustainability, Lonza Capsules & Health Ingredients, commented, “As environmental concerns in the pharmaceutical and nutraceutical industries continue to grow, developers and manufacturers face increased pressure to reduce environmental impact, particularly in final dosage forms. We believe that sustainability and innovation go hand
in hand, strengthening competitive advantage and contributing to a more sustainable future. With our newly established Center of Applied Sustainability, we will integrate sustainability into the early stages of product development and co-inn ovate with our customers to help them meet their environmental goals through responsible sourcing, manufacturing and innovation.”
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Understanding the importance of sterilityin biopharmaceutical applications
Khushi Gandhi, Senior Executive – International Marketing,Ami Polymer,introduces the company’s overmoulded assemblies – ImaLINK™ that are designed to meet the stringent requirements of biopharma applications,engineered for precision and built for sterility
When I learned that 70 per cent of product recalls in the biopharma industry are caused by contamination risks, it became clear how critical sterility is in biopharmaceutical applications. This insight propelled me to explore solutions that could prevent such costly setbacks. It was during this exploration that I came across the term “Aseptic Fluid Transfer" This process involves the movement of sterile liquids between systems or containers without introducing contaminants, a method gaining significant attention as minimising contamination has become a primary goal across the industry.
Introducing overmoulded assemblies
The first product that technically and commercially fulfills this crucial need is the Overmoulded assembly. Overmoulded assemblies are innovative components created by molding a secondary material over a base substrate, such as tubing or connectors. The most commonly used materials are Silicone and Thermo-Plastic Elastomers (TPE), which are selected for their flexibility, durability, and exceptional biocompatibility. These assemblies provide a seamless and integrated solution that minimises the risk of leakage and contamination, making them ideal for aseptic fluid transfer in biopharma applications.
Any breach in sterility can lead to contamination, which may result in costly product recalls, regulatory non-compliance, or even serious health risks to patients. Contaminated products might need to be discarded, causing significant financial losses and production
delays. In severe cases, contaminated biopharmaceuticals can lead to adverse patient reactions, resulting in legal liabilities and reputational damage.
Whysilicone and TPE and silicone are optimal for overmoulding
Traditionally, fluid transfer systems utilised plastic connectors and nylon clamps. However, these have often been prone to leaks and contamination if not properly sealed. Overmoulded assemblies, utilising a single material composition like silicone or TPE, offer a significant advantage. The homogeneity of these materials significantly re-
duces the risk of extractables and leachables, substances that can leach into the product from the materials used in the fluid transfer system. Silicone and TPE have been extensively studied and are known for their minimal interaction with biopharmaceutical products, ensuring they do not introduce unwanted impurities into the system.
The
seamless construction and validation process of overmoulded assemblies
Overmoulded assemblies provide a seamless construction without joints, which are potential points of failure in tradi-
tional connectors. This design ensures that fluids are transferred without exposure to external contaminants, maintaining the integrity of the internal environment and providing a smooth and consistent flow. Moreover, the use of a single material streamlines the validation process, reducing the time and resources required for extensive testing on multiple materials. This efficiency not only accelerates the development timeline but also reduces costs.
Aseptic
connectors in modern biopharma applications
While overmoulded assemblies offer numerous advantages, it is also important to consider the role of aseptic connectors in biopharma applications. Aseptic connectors facilitate sterile connections between fluid pathways without compromising the system's sterility. These connectors are particularly valuable in processes requiring frequent changeovers or handling multiple fluids. Sterile aseptic connectors are engineered to maintain a sterile barrier during connection and disconnection, making them ideal for applications such as media preparation, cell culture, and final fill/finish operations.
Aseptic connectors are equipped with features like protective caps and sterile barriers that prevent contaminants from entering during the connection process. These connectors have become a modern standard in biopharma manufacturing.
Discover the
future
of
semblies – ImaLINK™ are designed to meet the stringent requirements of biopharma applications, engineered for precision and built for sterility.
We are proud to introduce our innovative T, Y, & Cross overmoulded connection technology, designed to revolutionise the bioprocess industry. ImaLINK™ offers a leak-free connection with tubing engineered for precision across various diameters, providing an efficient and reliable solution for single-use bag assembly systems. ImaLINK™ adheres to the highest standards, including FDA 21 CFR 177.2600 and USP Class VI certifications, ensuring compliance and safety in all applications.
From sterile filling and peristaltic pumps to vaccine production and closed collection systems, our connections are built to enhance your operations, minimise setup times, and maintain the integrity of your bioprocessing needs. Discover the future of connection technology with Ami Polymer and streamline your processes with our trusted solutions.
with Ami Polymer
biopharma
At Ami Polymer, we are dedicated to upholding the highest standards in biopharma manufacturing. Our Overmoulded as-
Ready to elevate your operations? Visit our website at www.amipolymer.com or contact us to learn more at Khushi.g@amipolymer.com
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Newtesto 174 mini dataloggers: Revolutionising indoor climate monitoring
The range offers smart,intuitive features that save time,reduce costs and provide hassle-free digital documentation for a wide range of industries,including food production,pharmaceuticals, and industrial sectors
Testo, a leader in measurement technology, introduces the new testo 174 BT (BT is Bluetooth enabled) series mini data loggers, designed to optimize indoor climate monitoring and ensure precise temperature and humidity control. The range offers smart, intuitive features that save time, reduce costs and provide hassle-free digital documentation for a wide range of industries, including food production, pharmaceuticals, and industrial sectors.
Innovative features for enhanced efficiency
The new testo 174 mini data loggers come in multiple models: testo 174 H BT, testo 174 T BT, testo 174 H, and testo 174 T. These loggers support Bluetooth and USB-C connectivity, providing seamless integration with mobile devices or PC software for easy data access and management. These loggers are designed to meet stringent quality assurance requirements and simplify compliance with regulatory standards.
Bluetooth-enabled data loggers: convenient and efficient
The testo 174 H BT (for temperature and humidity) and testo 174 T BT (temperature only) are equipped with Bluetooth, allowing for convenient wireless monitoring. Users can easily configure, record and evaluate measurement data using the free Testo Smart App. The app connects directly to the loggers from up to 30 meters away, enabling real-time data retrieval without the need to remove the device from its monitoring location. This wireless functionality ensures more efficient operations and signifi-
cant time savings. With automatic data backup, even if the battery is replaced, all previously recorded data remains intact.
The Testo Smart App allows for seamless excel exports, as well as the generation of professional PDF reports with signature and comment functionality. These features eliminate the need for manual recordkeeping, reducing the risk of human error and ensuring paperless documentation.
Both Bluetooth models are HACCP certified, ensuring they meet food safety standards, and the testo 174 T BT also holds NSF certification and complies with EN 12830, making them ideal for indus-
tries that require stringent monitoring, such as food production and pharmaceuticals.
USB-C data loggers: Simplified data acquisition
For users who prefer traditional PC-based data management, the testo 174 H (temperature and humidity) and testo 174 T (temperature only) models with USB-C offer an intuitive solution. These loggers feature a large measurement range, from -30 °C to +70 °C for the Testo 174 T and -20 °C to +70 °C for the Testo 174 H, ensuring precise readings for a wide variety of applications. With a data storage capac-
ity of up to 16,000 readings, these devices can operate for extended periods, ensuring continuous monitoring. The data can be easily accessed and analysed using the ComSoft Basic software, included with the devices, for fast configuration and readout. ComSoft Professional offers advanced features for batch programming, data analysis, and report generation, making it easier to handle complex quality assurance tasks.
Like the Bluetooth models, these USB-C loggers also meet HACCP standards and EN 12830 requirements, and the testo 174 T is NSF certified, ensuring reliable product safety in sensitive industries.
Whychoose testo 174 Mini Data Loggers?
◆ Time & cost efficiency: Digital documentation and easy data retrieval reduce manual labour and the risk of human error, saving time and costs.
◆ Wireless connectivity: Bluetooth-enabled models offer convenient data readout via the Testo Smart App, streamlining processes.
◆ Large data storage: With up to 16,000 readings, these loggers support extended measurement periods without the need for constant monitoring.
◆ HACCP and NSF certification: Compliance with international standards ensures reliable product safety in food, pharmaceutical and industrial environments.
◆ User-friendly software: The free Testo Smart App and ComSoft software make data management simple and efficient.
Whether you're ensuring the quality of temperature-sensitive goods or maintaining optimal indoor climates, the testo 174 series mini data loggers provide a reliable, efficient, and intuitive solution for all your measurement needs.
◆ Service & Calibration: Located at our Head Office in Pune, Testo India has a highquality NABL accredited service and calibration lab. Instruments of any brand/make can be calibrated and serviced locally, maintaining international standards. All calibrations are traceable to highly accurate international standards of the PTB Germany.
We undertake calibration jobs for temperature: contact as well as non-contact, humidity, pressure, air velocity, RPM, sound, flue gas & dew point instruments of any brand/make.
