US President Trump's fresh salvo of 100 per cent tariffs on branded or patented pharmaceutical products not ‘Made in America’ finally ends months of suspense. For now, there’s a sense of cautious relief among India Pharma that off patent generics, the bulk of our exports to the US, have been exempted.
The devil lies in the definitions, especially as products like generic biologics are generally considered as brands themselves. Follow on clarifications have already started coming in, adding more nuance to the September 26 Truth Social announcement. On September 27, a Bloomberg report quoted a White House official clarifying that countries with negotiated agreements with the US, like the EU and Japan among other countries, are exempted from the 100 per cent tariffs on imported branded or patented pharmaceutical products.
The true danger lies in resting on our “Pharmacy of the World’ blindspot. India Pharma Inc has excelled at turning a tight spot into a sweet spot. And this could be one such turning point.
As India Pharma Inc mulls adding more manufacturing muscle in the US, there are quite a few takers for their investments. For example, New Jersey governor Phil Murphy was on a week long, four city India tour. In a closed door meeting hosted by international law firm Nishith Desai Associates on September 24 during the Mumbai leg of his India trip, Governor Murphy pitched his state as an ideal life sciences innovation destination. Choose New Jersey officials spoke about strategic innovation centers like the lifesciences-focused HELIX innovation district, as well as “try before you buy” real estate options as part of a “soft landing ecosystem” designed to ease potential investors into settling into NJ.
Aurobindo Pharma, Glenmark Pharma, Dr Reddy’s Laboratories, Sun Pharma, Enzene Biosciences were familiar logos in the Partner with New Jersey booklet, which also mentioned Biocon’s $20 million investment, announced this month, its first manufacturing site in the US.
A sector-wise analysis of Indian companies based out of New Jersey, shows that life sciences companies are the second largest (32 per cent) sector, a close second to tech firms (38 per cent). As per a New Jersey Economic Development Authority (NJEDA) factsheet, Aurobindo Pharma USA is the second largest Indian investing company in NJ by capex ($396 million), followed by Glenmark Pharma ($88.1 million). Dr Reddy’s Laboratories is fifth on the list ($70 million).
Many more states could follow New Jersey, hoping to attract more investments and create more jobs in their states.
All pharma companies need to evaluate such offers with renewed urgency. While short term revenues might not be impacted, this is no time to be complacent. (https://www.expresspharma.in/trump-imposes-100-per-cent-tariffon-patented-drugs-impact-on-india-to-be-limited/)
The ongoing investigation under Section 232 of the Trade Expansion Act of 1962 examining whether pharma imports are a “national security risk” to the US needs to be carefully monitored. While the US Supreme Court might rule that President Trump does not have the authority to impose these trade tariffs, no one is holding their breath for this verdict.
As India Pharma Inc mulls adding more manufacturing muscle in the US, states like New Jersey position themselves as ideal life sciences innovation destinations
The September 25 announcement is yet another warning bell, a wake up call for India’s pharma companies to move up the value chain beyond vanilla generics. India Pharma Inc will need to work with renewed vigour, on replicating its cost effectiveness in emerging areas like complex generics, biosimilars, cell and gene therapy, etc if it wants to remain in the race. This will take time and the clock is already tickling. It's a given that pharma companies will also have to diversify beyond the US market.
While we await the next announcement on Truth Social, it's clear that a slew of pharma companies already anticipated this move and increased investments in the US. A White House tally puts such pharma manufacturing expansion pledges at $ 325 billion. The latest is Eli Lilly’s plan to build a new $6.5 billion manufacturing facility at Generation Park in Houston, Texas. Over the past year, companies like Novo Nordisk, Merck, Roche, Sanofi and Novartis have announced similar plans to build up their manufacturing presence in the US.
But as pharma companies reassign investments into manufacturing, will R&D budgets shrink even further? Will we see stalled research projects and delayed launches a few quarters down the line?
Most India-based pharma companies already have manufacturing and repackaging facilities in the US but will have to double down on similar fresh investments. President Trump’s message on Truth Social specifies that “building” means “breaking ground” and/or “under construction”. This makes it very clear that mere announcements will not do. Syngene picked up its first US biologics facility in March this year, and we should see more such deals as India Pharma Inc re-draws its risk mitigation strategies.
For example, an HSBC analysis points out that only Sun Pharma has sizable sales from patented drugs in the US (c17 per cent of FY25 revenue). HSBC analysts Damayanti Kerai and Gaurang Sakare suggest that Sun can work around this issue by shifting manufacturing of key products (like Ilumya, which accounts for 56 per cent of its total patented product sales in FY25) from its current CDMO partners (a South Korean CDMO for the drug substance and a European-based CDMO for the finished dose) to US-based CDMO partners, or to its own three plants in the US, or buy existing manufacturing plants. The HSBC analysts estimate that moving supply chains, tech-transfer, plant repurposing etc. would take considerable time (anywhere from 6-24 months) and resources.
From a patient point of view, generics in the US will remain affordable. For now. A few pharma companies might be impacted by the 100 per cent tariffs while they put in place onshore manufacturing to the US. Sooner or later, these extra costs will be passed on to patients, who will have no choice but to pay up. So will India advocate for affordability and access, over politics and tariffs? Or will it continue to fall in line? India Pharma Inc cannot rest on our “Pharmacy of the World’ blindspot; we have to focus on finding and maximising the next sweet spot.
Research misconduct …can delay meaningful and reliable discoveries
Dr Gráinne McNamara, Research Integrity /Publication Ethics Manager,S.Karger AG explores how research misconduct,peer review fraud slow down pharma research.Of particular concern to India is the fact that India-based researchers constitute 5 per cent of articles in life sciences retracted between 1976-2023.India-based researchers also have one of the highest rates of retraction relative to the overall publication output.Over an email exchange with Viveka Roychowdhury, she details how publishers are now deploying AI tools,some of which contributed to the problem in the first place,to detect and avert fraudulent research submissions
In terms of peer review fraud, research misconduct, how large is the problem, globally and specifically for pharma/life science research papers being published out of India? In recent years, we have seen increased reporting in scholarly and traditional news on instances of suspected research misconduct and publication integrity violations. This has ranged from investigations into individual authors or researcher groups to largescale retraction of many thousands of articles. The observed increase in the number of articles being retracted can be attributed, in part, to improvements in detection systems by publishers; however, it may also reflect a change in the rate of research or publication misconduct.
There are no completely accurate rates of research misconduct or peer review fraud available, in part because of the existence of as yet undiscovered misconduct and the high professional cost of admitting to misconduct. Some attempts to quantify this exist, for example, a 2016 study found that just under 4 per cent of screened published papers contained problematic images [1]
Another study looking at nucleotide sequences found that 713 out of >3400 screened articles contained incorrectly
described nucleotide sequences [2]. Even less certain is the prevalence of misconduct in unpublished works. An analysis on paper mills from the Committee on Publication Ethics (COPE) and the STM Association [3] found that publishers reported that between 2-46 per cent of the submissions to a journal can be suspected of having paper mill involvement. This question is also addressed outside the scope of scholarly publishing. A survey of researchers in the Netherlands on Questionable
Research Practices estimated a self-reported prevalence of fabrication or falsification as just over 8 per cent [4]. This study also found that ‘life and medical sciences’ had the highest self-reported prevalence of falsification or fabrication of the disciplines analysed.
It is clear that concerns about research integrity and trust in research are a global issue, also impacting India. Publications by India-based researchers constitute 5 per cent of the articles in the life sciences retracted between
1976-2023 [5], and India-based researchers have one of the highest rates of retraction relative to the overall publication output (1996-2023) [6]. This overrepresentation of publications from India has contributed to the recent announcement from India’s National Institutional Ranking Framework that retracted articles will negatively contribute to an institution’s score [7]
Incentive structures, such as perceived publication requirements for career progression, have been cited as drivers to engage in questionable practices [4] What is clear from research in this area is that the phenomenon of research and publication misconduct is a global one which requires collaboration across the research ecosystem to tackle.
What is the impact of gen AI tools on research integrity in the pharmaceutical sector?
The pharmaceutical sector requires up-to-date, trustworthy information to make responsible and informed decisions. Generative AI tools have challenged research integrity since their widespread availability in the last three years, though these tools are also understood to have potentially beneficial applications for research integrity, both of which could significantly impact the sector.
There are clear concerns related to the relative ease of fabrication of data or articles with Generative AI. Fabricated data and figures pose a substantial risk of misleading investigators and research directions and are becoming increasingly challenging to detect. Beyond data fabrication or falsification of research using generative AI, legitimate uses of Generative AI can impact research integrity in the pharmaceutical industry in negative ways. Uncritical use of the output of Generative AI technology, regardless of the user’s intent, can result in ‘nonsensical’ inclusions in articles and ultimately retraction of the work [8, 9] Good faith use of Generative AI tools is undermined by the known bias and inaccuracies, which are features of ChatGPT outputs [10, 11]. Significant for making informed decisions about research in the pharmaceutical sector is the observation that ChatGPT does not acknowledge retractions of articles [12] Transparency, or lack thereof, around the datasets used to train Generative AI tools can mean that users ‘don’t know what they don’t know’, which is unstable ground for decision making in the pharmaceutical sector. Though new software to detect research misconduct is being developed using machine learning, for now, it remains more important than
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ever for the sector to be vigilant and validate information sources.
How does research misconduct impact society, from the pharma industry, doctors and patients?
The most infamous example in recent decades of societal impact of a retracted article is the now retracted article linking the MMR vaccine to the development of autism in children [13]. Though the original article was discredited and retracted in 2010, vaccine hesitancy continues to contribute to new measles outbreaks across the globe to this day [14, 15]. On a smaller scale, the recent example of disappointing clinical trial results for the treatment of cognitive decline in
Alzheimer’s Disease with simufilam, following research misconduct investigations into the earlier work on the small molecule, demonstrates the financial impact on the pharmaceutical industry if high standards of research integrity are not upheld [16]. A 2014 study based on records from the US estimated that papers retracted due to misconduct accounted for approximately $58 million in direct funding between 1992 and 2012 [17]. Research misconduct, whether it involves misleading or biased information in published articles, can delay meaningful and reliable discoveries by diverting attention from more dependable research streams. Such misconduct can lead to the misallocation of
substantial resources towards faulty research, impacting the pharmaceutical industry, doctors, and patients in significant ways every day.
What are the tools available to detect fraudulent research submissions?
There are several existing and new tools available to assist journal teams in identifying potentially problematic submissions. These include iThenticate, paper mill alarm from ClearSkies, Signals, imagetwin, Proofig, reviewerzero, Paperpal Preflight from Cactus, among many, many more. However, as outlined by the Committee on Publication Ethics (COPE) in relation to AI in decision making [18], all tools require human oversight to interpret
the reports, understand the context of any identified concerns and be accountable for the decision making. Editors and reviewers play an invaluable role, as they always have, manually identifying methods and data that are not logical, poorly executed or simply too good to be true. This is not likely to change substantially in the future.
Are there SOPs that life sciences researchers, from industry as well as academia, can follow to ensure that their research submissions meet the authenticity criteria?
Researchers can build trust in their research, as well as grow its visibility and impact, by following the principles of Open Science. This can take
many forms, beginning before the research starts, for example, by pre-registering their study and analysis plans or engaging patient groups or affected communities in their research study design. Open Science practices are relevant throughout the research cycle, for example, using open digital lab notebooks. These principles can strengthen research all the way to publication by using reporting checklists when writing a paper or making the data and code used or generated publicly available. In particular, the importance of data sharing was recognised by India’s recent National Data Sharing and Accessibility Policy, which emphasises the importance of making nonsensitive data available for
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others to use to enable “breakthroughs in scientific understanding as well as to economic and public good” [19] Overall, the most important advice researchers can follow, or give to their students, is to be as transparent as possible from the research design to publication.
References
1. Bik EM, Casadevall A, Fang FC. The Prevalence of Inappropriate Image Duplication in Biomedical Research Publications. mBio. 2016;7:10.1128/mbio.0080916.https://doi.org/10.1128/ mbio.00809-16.
2. Park Y, West RA, Pathmendra P, Favier B, Stoeger T, Capes-Davis A, Cabanac G, Labbé C, Byrne JA. Identification of human gene research articles with wrongly identified nucleotide sequences. Life Science Alliance. 2022 Apr 1;5(4). https://doi.org/10.26508/ lsa.202101203.
3. COPE & STM. Paper Mills — Research report from COPE & STM — English. https://doi.org/10.24318/jtbG8IHL.
4. Gopalakrishna G, ter Riet G, Vink G, Stoop I, Wicherts JM, et al. Prevalence of questionable research practices, research misconduct and their potential explanatory factors: A survey among academic researchers in The Netherlands. PLOS ONE. 2022;17(2):e0263023. https://doi.org/10.1371/journal.pone .0263023.
5. Bhattacharyya S, Chatterjee N, Ramanathan A. Understanding the patterns and magnitude of life science publication Retractions in the last four decades. Int J Educ Integr. 2025;21:17. https://doi.org/10.1007/s40979025-00193-8.
6. Sebo P, Sebo M. Geographical Disparities in Research Misconduct: Analyzing Retraction Patterns by Country. J Med Internet Res.
2025;27:e65775. https://doi.org/10.2196/65775.
7. https://www.thehindu.com/ sci-tech/science/nirf-to-award-mildpenalty-to-institutions-forretractions-this-year-harshpenalty-next-year/article69831849. ece#goog_rewarded. Accessed 19/8/2025. Archived from the original.
8. https://retractionwatch.com/ 2025/08/04/springer-natureretracts-book-fake-citations-helpus-find-more/. Accessed 19/8/2025. Archived from the original.
9. https://theconversation.com/ problematic-paper-screenertrawling-for-fraud-in-the-scientificliterature-246317. Accessed 19/8/2025. Archived from the original.
10. https://help.openai.com/en/ articles/8313428-does-chatgpttell-the-truth. Accessed 19/8/2025. Archived from
the original.
11. https://help.openai.com/en/ articles/8313359-is-chatgpt-biased. Accessed 19/8/2025. Archived from the original.
12. Thelwall M, Lehtisaari M, Katsirea I, Holmberg K, Zheng E-T. Does ChatGPT Ignore Article Retractions and Other Reliability Concerns? Learned Publishing. 2025;38(4):e2018. https://doi.org/10.1002/leap.2018.
13. Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ. 2011;342.
14. Do LAH, Mulholland K. Measles 2025. N Engl J Med. 2025 June 25; http://dx.doi.org/10.1056/NEJMra2 504516.
15. 1. Larson HJ, Gakidou E, Murray CJL. The Vaccine-Hesitant Moment. Longo DL, editor. N Engl J Med. 2022 July 7;387(1):58–65.
http://dx.doi.org/10.1056/NEJMra2 106441.
16. https://www.science.org/ content/blog-post/cassava-sagafinally-ends. Accessed 19/8/2025. Archived from the original.
17. tern AM, Casadevall A, Steen RG, Fang FC. Research: Financial costs and personal consequences of research misconduct resulting in retracted publications. eLife. 2014;3:e02956. https://doi.org/10.7554/eLife.02956.
18. COPE Council. COPE Discussion document: Artificial intelligence (AI) in decision making — English. https://doi.org/10.24318/9kvAgrnJ.
19. https://dst.gov.in/national-datasharing-and-accessibility-policy-0. Accessed 19/8/2025. Archived from the original.
viveka.r@expressindia.com viveka.roy3@gmail.com
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With India
soon to be three times the population of the EU,it makes perfect sense
to have manufacturing here
As part of Sweden’s Focus Asia programme,a high-level SME delegation recently visited India to strengthen bilateral ties and explore collaborations across sectors including pharma, biotech and others.Building on the momentum of the “Time for Sweden”event,the visit underscored Sweden’s commitment to innovation,sustainability,and co-creation with India. Among the delegation was Emil Alexander Byström, CEO of SpinChem AB,who in an interaction with Kalyani Sharma shared his insights on how advanced Swedish technologies like biocatalysis and the company’s patented Rotating Bed Reactor (RBR) can accelerate India’s pharma and biotech innovation journey while supporting sustainable growth.
Could you share a brief introduction about your company and its current work in India?
SpinChem AB is a Swedish process technology company transforming industrial liquid processing through its patented Rotating Bed Reactor (RBR) technology. The RBR enhances solid–liquid mass transfer, enabling faster catalysis, extraction, and contaminant removal while reducing waste. Our scalable systems are applied across pharmaceuticals, biotech, food & beverage, and environmental industries. In India, we are actively engaging with leading biotech and pharmaceutical partners to demonstrate how RBR can support sustainable manufacturing and accelerate the country’s innovation-driven growth.
How can Swedish SMEs contribute to advancing India’s pharma and biotech innovation journey?
Swedish SMEs can contribute with technology, knowledge, and strong networks across Europe and the world. Out of the 1.2 million companies in Sweden, 99.9 per cent are SMEs. This is quite different from the situation in India, as the absolute majority in Sweden are small companies. For small companies, networks are critical. We focus on innovation and creativity inhouse — taking an idea all the way to a finished product with development, testing, and more. But when it comes to manufacturing, we work with
multiple subcontractors and suppliers across the globe, while ensuring quality by keeping things as close as possible to ourselves.
Once the right routes are established, we can extend this
to other countries. With India soon to be three times the population of the European Union, it makes perfect sense to have manufacturing here rather than shipping components across continents.
For instance, within biocatalysis, which is our specific target, we are in an alliance with six SMEs in the Netherlands, Germany, and Singapore. Together, we can provide the same strength as large corporations by focusing on our individual areas of expertise and then collaborating. We usually start by selling a small product or renting it out for proof of concept. By asking a few questions, I can usually determine if it will work or not. Then, once collaboration begins, customers often return. In fact, 90 per cent of our revenue comes from repeat customers.
That’s why we put so much emphasis on customer satisfaction. When you buy our product, you don’t just get the hardware, you get knowledge and a way of using it. Even though we don’t provide a warranty that it will work in all cases, if there is a problem, we help solve it.
What role can Swedish technologies like yours play in improving efficiency, scalability, and sustainability in India’s pharma and biotech manufacturing?
The biggest role is in enabling the use of new technology not just mechanical but also chemical. Take biocatalysis, for
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example. It’s been around for over 20 years, but the real breakthrough will come with AI, like Google DeepMind’s AlphaFold, which predicts protein folding. A few years ago, only about 12,000 proteins were characterised; today, that number exceeds 200 million.
With this understanding, we can now use AI to design proteins for specific technologies or APIs. That’s where the power lies. I’m happy to note that several Indian companies I met recently have started biocatalysis groups, some as recently as six months ago. This is an emerging, gamechanging technology for pharma.
It also extends to other areas, such as carbon capture using CO2 as a building block, water purification, or reducing industrial waste. The key is to stop pollution at the source and then solve problems.
Swedish SMEs can contribute with technology, knowledge,and strong networks across Europe and the world.Out of the 1.2 million companies in Sweden,99.9 per cent are SMEs.This is quite different from the situation in India,as the absolute majority in Sweden are small companies
Biocatalysis can also be used in textiles and plastic recycling, where enzymes break down plastics like PET bottles or polyester fabrics into their building blocks. This makes it possible to recycle clothes endlessly instead of relying on fossil fuels to create new materials.
How do you see India’s growing life sciences sector creating opportunities for collaboration with Swedish
companies?
The opportunities are endless. There are so many applications and such a wide variety of companies here. India’s growth in life sciences offers tremendous potential for collaborations across multiple areas.
Sweden is known for its sustainability-first approach. How can this be integrated into India’s biotech growth story?
Sweden’s sustainability-first approach shows that environmental responsibility can go hand in hand with growth. For India’s biotech sector, this means adopting technologies that reduce waste, energy use, and reliance on harmful chemicals. One clear example is biocatalysis: by controlling stereochemistry and synthesising single enantiomers in fewer steps, it minimises solvents and purification, making
production both greener and more efficient. Integrating such technologies early in India’s biotech growth story ensures scalability without sacrificing sustainability.
What kinds of partnerships are you exploring with Indian pharma and biotech players? We primarily see pharma companies as customers, but in our approach, every customer is also a collaboration partner. We aim to work with them from lab scale all the way to full-scale production. That’s how we ensure sustainability both financially and environmentally. For us, sustainability goes beyond environmental aspects. It includes financial viability and the well-being of the people working in the system.
From compliance to commitment: HowPiramal Pharma is reimagining sustainabilityin pharma
In its fourth annual Sustainability Report,Piramal Pharma charts an evolution from foundational ESG reporting to embedding sustainability in its business strategy.According to the report,the company reports strong progress on emissions reduction,zero hazardous waste to landfill,digital transformation,and employee engagement — all while successfully navigating 36 regulatory inspections,including USFDAaudits in FY25.In an exclusive interview, Ganesh Tripathy, SVPand Global Head,Sustainability & EHS,Piramal Pharma discusses with Swati Rana on achieving sustainability goals and the next big sustainability challenge faced by the pharma industry
This is Piramal Pharma’s fourth annual Sustainability Report under the theme “Innovating Responsibly. Growing Sustainably.” How has your sustainability vision evolved since the first report? When we published our first sustainability report four years ago, our primary focus was on building the foundational blocks of ESG, establishing baselines, formalising disclosures, and creating a unified governance framework across Piramal Pharma globally.
Over time, our vision has matured from compliancedriven reporting to embedding sustainability into the very core of our business model. For example, today we operate with targets approved by SBTi, aiming to cut absolute Scope 1 and 2 emissions by 42 per cent and Scope 3 emissions by 25 per cent by 2030, from base line year nos of FY2022.
Operationally, we conserved over 2.10 lakh KL of freshwater in FY25, achieving zero hazardous waste to landfill, or steadily increasing the share of renewable energy and biofuels in our energy mix. At the same time, our people’s agenda has become more inclusive, with 63 per cent women among campus hires this year and ESG training extended to 100 per cent of employees.
In short, our journey has been one of evolution from measuring and disclosing, to driving measurable impact, and now to shaping a resilient, inclusive, and low-carbon growth model. where patient well-being, environmental
stewardship, and long-term value creation reinforce each other.
Pharma is often seen as a high-impact sector in terms of energy, compliance, and supply chain complexity. What unique challenges does the industry face on its sustainability journey?
The pharmaceutical industry operates at the intersection of science, regulation, and patient safety,which makes its sustainability journey uniquely complex. Our processes are energy-intensive and highly regulated – every change whether in solvents, processes, or packaging must meet the highest standards of quality, efficacy, and compliance standards. Transitioning continuous operations to renewable energy or biofuels is far more challenging than in any other sectors, yet, we have steadily increased our renewable and bioenergy share, which today accounts for almost nearly one fifth of our total energy consumption. Global supply chains add further complexity. Ensuring responsible sourcing, reducing Scope 3emissions, and building resilience while maintaining uninterrupted supply of essential medicines is a task that requires both collaboration and innovation.
At Piramal Pharma, we assess critical suppliers on sustainability parameters and build their capacity to move collectively towards greener operations.
Finally, transparency expectations are rising.
Sustainability reporting today must show measurable impact, backed by global frameworks and independent assurance. For pharma, the biggest challenge and opportunity is proving that strong ESG performance can coexist with uncompromised patient care.
Regulatory compliance is critical in pharma. What measures helped the company achieve 36 successful regulatory inspections globally, including USFDA audits?
For a pharmaceutical company, regulatory compliance is not just an operational requirement it is the very foundation of patient trust. At Piramal Pharma, our approach has always been to treat compliance as a culture rather than a checklist. The fact that we successfully completed 36 global inspections in FY25, including two by the USFDA, with zero observations of concern, reflects this deeply embedded mindset.
Several measures have helped us achieve this
consistency. We go beyond statutory norms with aQuality by Design framework that integrates risk assessment at every stage, from sourcing to batch release. Digital tools strengthen monitoring, documentation, and traceability across sites, ensuring consistency and accuracy.
Second, we focus heavily on people. All employees undergo regular training on cGMP and evolving regulatory standards, with 100 per cent coverage on Code of Conduct and compliance training in FY25. Alongside this, we run proactive internal audits and encourage customer audits— 165 in FY25 as an additional assurance layer. This approach has enabled us to maintain an unbroken record of “no OAI” from the USFDA since 2011. For Piramal Pharma, regulatory compliance is a strategic enabler of trust, reinforcing our ability to deliver safe, highquality medicines worldwide.
Over the past four years of sustainability reporting, what has been the biggest learning curve for Piramal Pharma that could serve as a blueprint? What is PPL’s top three sustainability priorities for the next five years?
Our biggest learning over the past four years has been that sustainability cannot remain a parallelfunction. Early efforts focused on building baselines and strengthening governance, but real impact came once ESG goals were embedded into decision-making across capital
allocation, operations, and supply chains. Independent assurance and alignment with global frameworks like GRI, S&P Global, and UNGC have further strengthened accountability and credibility.
Looking ahead, our top three sustainability priorities for the next five years are clear.
1. Climate action – delivering on SBTi-approved targets to cut Scope 1 and; 2 emissions by 42 per cent and Scope 3 by 25 per cent by 2030.2. Water stewardship and; circularity –reducing freshwater dependence, expanding zeroliquid-discharge practices, and minimizing waste. In FY25, we conserved over 2.1 lakh KL of water and achieved zero hazardous waste to landfill.
2. Inclusive growth & people development – enhancing diversity, equity, and safety while building future-ready talent.
Women already form 63 per cent of campus hires, and ESG training has reached 100 per cent of employees. In essence, our learning has been that sustainability is a journey of integration and accountability linking ESG priorities directly to resilience, growth and stakeholder trust.
Can you share how digital transformation initiatives like Catalyst NxGen (S/4HANA) are shaping quality, agility, and scalability at Piramal Pharma and how it can set new benchmarks for quality excellence across the industry?
Digital transformation has become a critical lever in
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reimagining how pharma companies deliver on quality, agility, and scalability and at Piramal Pharma, Catalyst NxGen (our SAP S/4HANA initiative) is central to this journey. For us, it is not just an IT upgrade; it is an enterprisewide transformation that is embedding digital intelligence across operations, supply chains, and quality systems.
On quality, advanced analytics and real-time visibility allow predictive assurance by tracking deviations, monitoring batch performance, and strengthening traceability. This ensures patient safety and compliance with global standards.
On agility, the platform integrates procurement, manufacturing, and logistics, enabling fasterdecisionmaking and responsiveness to
fluctuating demand cycles, including during public health emergencies.
On scalability, Catalyst NxGen creates an unified digital backbone across geographies and business lines, harmonising reporting and standardizing quality practices as we expand our global CDMO and critical care presence. As Piramal Pharma expands its global CDMO presence and critical care portfolio, the system ensures consistent processes, harmonised reporting, and standardised quality practices across sites. We believe this sets an industry benchmark, showing how digital transformation can hardwire quality, resilience, and sustainability into pharma operations. It reflects our ethos of innovating responsibly while building an agile, future-ready organisation.
With a 6 per cent reduction in Scope 1 & 2 emissions achieved and increased renewable energy use by nearly 8per cent, what enabled these achievements and what are the next milestones on your decarbonisation glidepath?
Achieving a 6 per cent reduction in Scope 1 and 2 emissions in FY25 and scaling up renewable energy contribution by nearly 8 per cent is the outcome of a deliberate, multi-pronged approach to decarbonisation. For us, these are not isolated initiatives but part of a structured glidepath aligned to our science-based targets approved by SBTi.
The key enablers were:
◆ Energy transition: Expanding renewables (solar, wind, biofuels) to nearly 20 per cent of our energy mix,
supported by energy-efficiency initiatives like process optimization and equipment upgrades.
◆ Culture and discipline: Embedding energy efficiency into daily operations and training 100 per cent of employees on ESG awareness and accountability.
◆ Partnerships: Collaborating with suppliers, technology providers, and renewable energy partners to adopt cleaner solutions and prepare for long-term Scope 3 reductions.
Looking ahead, we aim to reduce Scope 1 & 2 emissions by 42 per cent and Scope 3 by 25 per cent by FY30 (baseline FY22). This includes accelerating renewable procurement, piloting green hydrogen and advanced biofuels, and expanding circularity initiatives to lower
process-related emissions.
The fourth annual Sustainability Report for FY2025 mentioned achieving zero hazardous waste to landfill and a 90 per cent recycling target for nonhazardous waste. Could you detail the systems or innovations you implemented?
Achieving zero hazardous waste to landfill using coprocessing of waste in cement Kilns, and recycling nearly 90 per cent of our non-hazardous waste in FY25 was not the result of a single initiative, but of building a circular mindset into our operations.
The first enabler has been robust segregation and tracking at all sites, with hazardous waste directed only to authorised recyclers or for co-processing in cement kilns—
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ensuring no landfill disposal. Non-hazardous waste like paper, plastics, and packaging is segregated at source and routed to certified recycling channels. The second is investment in technology and partnerships. Advanced effluent treatment and zeroliquid-discharge systems enable water recovery and minimise sludge.
Collaborations with certified vendors allow innovative reuse of by-products, such as using hazardous residues in cement kilns.
Third, we have embedded a culture of waste minimization.
Cross-functional “Green Teams” identify opportunities to reduce material intensity, redesign packaging, and cut down single-use plastics. Going forward, our goal is not only to maintain zero hazardous waste to landfill, but to push towards closed-loop systems that maximize recovery and reuse.
By doing so, we are creating a blueprint where pharma manufacturing can be both world-class in quality and exemplary in environmental stewardship.
Can you brief us on the role of cross-industry collaboration in achieving shared sustainability goals?
Sustainability challenges such as climate change, water scarcity, and circularity cannot be solved in silos they demand cross-industry collaboration.
For the pharmaceutical sector in particular, value chain is deeply linked with chemicals, energy, packaging, and logistics—making partnerships essential for systemic change.
At Piramal Pharma, we collaborate with renewable energy providers and innovators to pilot advanced biofuels and green hydrogen. In supply chains, we assess critical suppliers on
sustainability parameters— 26.5 per cent already covered— and aim to reach 30 per cent by value by FY26. This builds capacity for Scope 3 reductions collectively.
We are active members of platforms like ICC and IPA and align with global frameworks such as GRI, CDP, S&P Global, and UNGC, which drive benchmarking and shared learning. Collaborations with regulators, audit agencies, and academic institutions also help raise common standards.
Through the Piramal Foundation, we extend this approach to communities by partnering withgovernments and NGOs in health, education, and skilling. In essence, collaboration turns ESG from a competitive agenda into a shared mission. The sectors that succeed will be those that move together to safeguard the planet, strengthen communities, and build long-
term resilience.
Looking ahead, where do you see the next big sustainability challenges for the pharma sector?
The next wave of sustainability challenges for the pharmaceutical sector will be shaped by both global megatrends and sector-specific realities. At the top of the list is climate resilience. Pharma manufacturing depends heavily on energy, water, and complex global supply chains all of which are increasingly vulnerable to climate risks. Transitioning to low-carbon, resource-efficient operations while maintaining affordability and access will be critical.
Scope 3 emissions remain another major hurdle, as most emissions come from purchased goods,chemicals, packaging, and logistics. Building supplier capacity, ensuring traceability, and
driving circular partnerships will be essential but complex. Responsible innovation will also come under greater scrutiny. As biologics, digital health, and new therapies expand, lifecycle emissions, ethical clinical practices, and equitable access must be addressed upfront in R&D and product strategies.
Finally, embedding ESG into organizational culture will be crucial. Reskilling talent, fosteringdiverse leadership, and ensuring sustainability is lived across functions will determine credibilitywith regulators, investors, and patients.
In short, the sector must move from incremental improvements to system-level transformation—balancing patient well-being with planetary well-being.
Pharma leaders come together to highlight Bengaluru's R&D strength,tech ecosystem,and talent pool to power India Pharma Inc’s shift from generics to innovation and global leadership
Inaugural Session
The Bengaluru Pharma Summit 2025 began with a warm welcome to leaders, experts, and innovators from across India’s pharma and biopharma ecosystem.
Lakshmipriya Nair, Assistant Editor, Express Pharma, Express Healthcare, and Express Nutra, introduced the summit theme, “Pathways for Global Excellence”, and emphasised that the responsibility of India Pharma Inc is not just to respond to global healthcare needs, but to actively shape the future of healthcare.
A major theme of the inaugural session was that growth must go hand in hand with excellence in inn ovation, quality, and global impact.
The session highlighted that Bengaluru, known as the hub of ideas and innovation, brings together research, technology, and entrepreneurship. It is home to leading Indian players such as Biocon, Syngene, Strides, and Shilpa Biologics, alongside global giants like AstraZeneca, Novo Nordisk,
L-R: Rajesh Bhatkal,GM – Express Pharma,Express Healthcare & Express Nutra; Murali Ramachandra,CEO,Aurigene Oncology; Dr Mahesh Bhalgat,Group CEO & MD,Veeda Lifesciences; Dr Anand Anandkumar,Co-founder and CEO,Bugworks; Kavitha Iyer Rodrigues,Founder & CEO,Zumutor Biologics; Dr Taslimarif Saiyed,CEO and Director, CCMP; and Dr Jogin Desai,Founder and CEO,Eyestem Research
and GSK. This unique blend positions the city to drive the next wave of pharma and biopharma growth.
The Welcome Address was followed by the lamp-lighting ceremony. Distinguished dignitaries and members of the first panel discussion, Dr Mahesh Bhalgat, Group CEO & MD, Veeda Lifesciences; Murali Ramachandra, CEO, Aurigene Oncology; Kavitha Iyer Rodrigues, Founder & CEO, Zumutor Biologics; Dr Anand Anandkumar, Co-founder and CEO, Bugworks; Dr Taslimarif Saiyed, CEO and Director, Centre for Cellular and Molecular Platforms (CCMP); and Dr Jogin Desai, Founder and CEO, Eyestem Research, joined Rajesh Bhatkal, GM –Express Pharma, Express Healthcare & Express Nutra, on stage for the ceremony.
With this auspicious start, the summit kickstarted a day of rich dialogues on manufacturing, quality, technology, and building the pharma workforce of the future.
Sustainable packaging solutions in pharma industry
The session on 'Sustainable packaging solutions in pharma' addressed a challenge that is increasingly critical, how to reduce environmental footprint while ensuring compliance, safety, and cost-effectiveness. Manjunath Nadella, Assistant VP & Head – Packaging Development, Strides Pharma Science began by pointing out that packaging is no longer just about protecting medicines; it is about responding to global sustainability imperatives, regulatory demands and patient expectations.
He gave examples of sustainable design approaches and showcased how significant improvements can be achieved through simple interventions. For e.g. by reducing bottle sizes from 100cc to 60cc, companies can cut plastic use by 40 per cent, lower logistics costs by 30 percent, and achieve similar reductions in carbon footprint. Similarly, the move from standard to perforated blister packs reduces material use by 30 per cent, while improving efficiency in transportation and storage.
These changes support sustainability goals and bring tangible economic benefits. Nadella also explored innovative
packaging concepts that go beyond material reduction. One such example was integrating patient literature directly into printed cartons, eliminating the
need for separate leaflets. This reduces both material costs and man-hours in packaging operations. Another example was the introduction of press-fit closures as an alternative to child-resistant closures. With 50 per cent less polymer use, cost advantages, and easier patient handling, these closures demonstrate how sustainability and convenience can go hand in hand while still complying with CRSF guidance.
He also highlighted technology as a major enabler of sustainable packaging. The shift from paper-based medication guides and printed literature to digital alternatives such as QR codes and electronic patient information leaflets can significantly cut paper usage.
The session concluded with a clear message, sustainable packaging is no longer optional, it is essential. By adopting smarter designs, leveraging technology and integrating sustainability, pharma companies can meet regulatory expectations, reduce costs and play their part in addressing global environmental challenges.
Manjunath Nadella,Assistant VP& Head – Packaging Development,Strides Pharma Science
Panel Discussion: Overcoming barriers in drug discoveryand development
L-R: Dr Mahesh Bhalgat,Group CEO & MD,Veeda Lifesciences (MODERATOR); Murali Ramachandra,CEO,Aurigene Oncology; Kavitha Iyer Rodrigues,Founder & CEO,Zumutor Biologics; Dr Anand Anandkumar,Co-founder and CEO,Bugworks; Dr Taslimarif Saiyed,CEO and Director,Centre for Cellular and Molecular Platforms (CCMP); Dr Jogin Desai,Founder and CEO, Eyestem Research
Drug discovery, from molecule to patient, is long, risky, and expensive. India has world-class scientific talent and a rapidly growing biopharma ecosystem, yet barriers remain. For instance, how to fund and sustain early discovery, how to accelerate clinical validation, and how to take Indian science global. These critical issues were explored in the panel discussion at Bengaluru Pharma Summit 2025.
This discussion had a stellar panel which included Dr Mahesh Bhalgat, Group Chief Executive Officer & Managing Director, Veeda Lifesciences (Moderator); Murali Ramachandra, Chief Executive Officer, Aurigene Oncology; Kavitha Iyer Rodrigues, Founder & Chief Executive Officer, Zumutor Biologics; Dr Anand Anandkumar, Cofounder & Chief Executive Officer, Bugworks Research; Dr Taslimarif Saiyed, Chief Executive Officer & Director, Centre for Cellular and Molecular Platforms (C-CAMP); and Dr Jogin Desai, Founder & Chief Executive Officer, Eyestem Research
The session highlighted a pressing
challenge — antimicrobial resistance (AMR). India loses nearly 400,000 lives every year to AMR, yet funding for this critical area remains extremely low. The panelists stressed that wWhile programmes such as the Research, Development and Innovation S cheme have been positive steps, they require faster and more efficient execution to create a real impact on biopharma research and development.
Financing was a central theme throughout the discussion. The panel highlighted that traditional funding models are inadequate for drug discovery, where high costs and long timelines discourage investment. To overcome this, there is a pressing need for blended financing models, larger grant pools, and stronger public–private partnerships. These models are essential to derisk innovation, sustain early-stage research, and encourage risk-taking in high-potential areas.
India’s innovation advantage was also underlined. The experts pointed out that solutions developed here can address the dual challenge of affordability and accessibility, making them rele-
vant both for domestic needs and for global markets. However, the panel emphasised that achieving this requires sustained investments, bold funding strategies, and a willingness to embrace risk.
Another focus was the role of clinical data. India generates vast amounts of clinical information, but its true potential lies in building stronger partnerships to analyse and apply this data effectively. The shift from being suggestive to being predictive was identified as a major step forward. Predictive models, supported by clinical and real-world evidence, can transform drug discovery by improving clinical validation, reducing costs, and delivering better patient outcomes.
Technology was seen as the engine that can accelerate progress. Artificial intelligence, machine learning, and digital platforms are reshaping the way drug discovery is carried out. Integrating these tools with traditional science can shorten timelines, improve efficiency, and expand the scope of discovery.
The panel also emphasised the critical role of talent. India has an exceptional scientific workforce, but the
future demands professionals who are not just skilled but also driven by purpose, nimble in their approach, and quick to adapt. Developing pathways for young researchers, strengthening academia–industry collaborations, and fostering a culture of innovation were seen as essential steps to power India’s next wave of R&D leadership.
Bengaluru was highlighted as an important hub for discovery. The city is becoming a hotspot for innovation in areas ranging from oncology to infectious diseases. With its strong mix of start-ups, global pharma players, and academic institutions, Bengaluru provides a model of how ecosystems can drive discovery momentum across the country.
The key takeaway from the session was clear. India’s future in biopharma innovation lies in moving from incremental progress to transformative breakthroughs. By combining its talent pool, technological strengths, and innovative financing with sustained collaboration, India can not only address its own healthcare needs but also create solutions for the world.
Overcoming challenges in serialisation and aggregation implementation
At the recent Bengaluru Pharma Summit 2025, Hiren Rathod, Regional Account Director –West, Madhya Pradesh & Karnataka, Optel Group presented about his company's latest solutions designed to strengthen pharma supply chains and regulatory compliance. The session highlighted Optel’s expanding role in ensuring transparency, safety, and efficiency in pharma operations worldwide.
Rathod started off with an overview of his company and its operations. He went on to funderlined the importance of end-to-end traceability in meeting global regulations and safeguarding patient safety. His preseantation showcased Optchain, Optel’s supply chain visibility platform, which helps companies improve ESG compliance while offering real-time insights into product life cycles.
The presentation also informed about Optel's acquisition of Vanguard
Robotics, a Canadian firm specialising in collaborative robotic (cobot) solutions for pharma packaging. This acquisition will accelerate innovation in pharma automation, improve productivity, and reduce reliance on manual labor in highly regulated environments, informed Rathod.
He also spoke about other solutions such as TrackSafe serialisation and aggregation systems, VerifyBrand downstream compliance technologies, and Optel’s L1–L4 integration framework for serialisation, inspection, and regulatory
reporting. The highlight was OPTEL’s Verify L4 Platform, which enables pharma manufacturers to connect seamlessly with global regulatory hubs.
The presentation also featured innovations in vial mis-labelling detection at high speeds, integrated inspection systems for tablets, and versatile packaging line solutions for cartons and bottles. According to the company, these innovations not only ensure compliance but also offer business benefits such as cost savings, simplified validation, and enhanced data-driven insights.
The company positioned its solutions as essential for Indian manufacturers navigating heightened global scrutiny, export market requirements, and patient safety imperatives.
Concluding his session, Rathod asserted that in an era of increasing regulatory demands and complex supply chains, traceability is not just compliance—it is a strategic advantage.
Audit-proof pharma: Creating a culture of compliance
Alok Mehrotra, Chief Quality Officer, Syngene International presented a session on 'Audit-proof pharma: Creating a culture of compliance' on creating a culture of compliance that goes beyond simply meeting regulatory requirements. He began by emphasising that compliance is the true foundation of patient safety, product quality, and trust. With regulators worldwide raising expectations and audits becoming more rigorous, organisations cannot afford to treat compliance as a checkbox exercise. Instead, it must be seen as a strategic differentiator that ensures efficiency, market continuity and long-term competitiveness.
He underscored that compliance is not just the responsibility of quality assurance teams or senior management. It has to be embedded across the organisation, with every employee taking ownership of doing things right the first time. This cultural mindset helps companies remain resilient not only during regulatory audits but also in times of
external disruptions such as supply chain crises or product recalls.
He introduced a three-pillar framework that integrates self-inspections, corporate audits, and Gemba walks.
Mehrotra described self-inspections as powerful tools when conducted objectively, documented thoroughly, and followed by corrective actions that lead to real improvements. Corporate audits,
on the other hand, bring independence and alignment with best practices. Gemba walks were presented as a key practice to bridge management and operations, allowing leaders to observe processes first-hand and promote a culture of accountability.
By weaving these three practices into an integrated system, companies can embed audit readiness into daily operations rather than scrambling to prepare only when an inspection is due. The result is a resilient quality ecosystem where transparency, proactive problem-solving, and continuous improvement are the norm. The speaker also pointed out that such an approach reduces stress on teams, builds regulator confidence, and safeguards reputations in a highly competitive market.
In conclusion, the session underscored that audit-proofing is not about eliminating audits, but about creating organisations that are always ready for them.
Hiren Rathod,Regional Account Director – West,Madhya Pradesh & Karnataka,Optel Group
AlokMehrotra,Chief QualityOfficer,Syngene International
Sun Teknovation Pvt Ltd: Made in India for the World
The Bangalore Summit 2025 featured a session led by Sunteknovation. Titled, 'Sun Teknovation Pvt Ltd: Made in India for the World', the session examined how innovation in inspection and serialisation is reshaping pharma manufacturing. The speakers for this session, Drashti Vyas, Marketing Manager, Sun Tekn ovation; and Vijay Kumar, Regional Manager-South, Sun Teknovation, highlighted how cutting-edge technologies can improve accuracy, reduce risks, and strengthen trust across the pharma value chain.
They also showcased Sunteknovation's suite of solutions that are “Made in India for the World,” emphasising indigenous inn ovation, cost-effectiveness, and adaptability for both domestic and global markets.
A highlight of the session was the introduction of the world’s thinnest PHD system, capable of detecting pin holes as small as 10 microns in packaging. The speakers also highlighted applications across blisters, sachets, pouches, and flexible packs, making it a
Drashti Vyas,Marketing Manager,Sun Teknovation; and VijayKumar,Regional ManagerSouth,Sun Teknovation
versatile and export-ready innovation.
They also demonstrated their AIpowered Blister Inspection System, which uses AutoTeach technology to generate inspection recipes in just one minute.
Another solution they focused on was the Error-Free Coding Inspection System, which ensures batch codes, barcodes, QR codes, and pharmacodes are verified at speeds up to 600 codes per minute.
The session also spotlighted a 360° tablet inspection system, capable of full-surface inspection for both coated and uncoated tablets.
The speakers also spoke about their Track & Trace serialisation and aggregation solutions, which enable end-to-end compliance with global mandates such as DSCSA (US), EU FMD, DGFT (India), and CRPT. T
The session concluded by reinforcing how inspection and serialisation are no longer optional investments but core to building resilience, trust and global competitiveness in the pharma industry.
Challenges in assemblyof deliverydevices
Bengaluru Pharma Summit 2025 had some really informative sessions that offered actionable insights critical for the pharma industry. One of them was the session on 'Challenges in assembly of delivery devices' that gave an overview on the evolving landscape of drug delivery systems, with a focus on pen and autoinjector devices. Loganathan S, Associate VP, Onesource Biopharma, the speaker, began by highlighting the expertise and infrastructure of their specialty pharma CDMO, OneSource. This set the context for a detailed overview of how complex devices are assembled and the kinds of challenges that manufacturers encounter.
Loganathan explained that the assembly of pen devices is a multi-step process involving three core device components along with a filled cartridge. He pointed out how key aspects such as stopper depth, plunger position, and assembly force as parameters that directly affect both process efficiency and
S,Associate VP,Onesource Biopharma
product safety.
A major part of the session revolved around the challenges faced during assembly. High rejection rates, lower operational efficiency, limited flexibility in changeovers, and difficulties in scaling up were identified as recurring issues. The speaker also highlighted high development costs, qualification delays due to weak technology transfer, and regulatory complications when pilot and commercial processes differ. Each of these issues can lead to significant project delays and cost escalations.
The session also explored how such problems can be mitigated through strategies such as modular equipment design, strong ownership of validation, and closer collaboration between development teams, operations, and equipment manufacturers.
In conclusion, Loganathan made a strong case for treating device assembly as a critical enabler of speed, quality, and regulatory success.
Loganathan
Panel Discussion: Bengaluru: An emerging global innovation gateway?
L-R: Elayaraja Natarajan,VP- R&D,Lyrus Life Sciences (MODERATOR); Ishwar Bajaj,Fermentation R&D Head,Biocon; Dr Sachin Mundade, VP- R&D,Micro Labs; MayankGarg,Group MSATHead,Biocon Biologics; Dr Goutam Pujari,Board of Directors; Head BE and Clinical Research,ApotexResearch; Dr MaloyGhosh,CSO,Zumutor Biologics; Loganathan S,Associate VP,Onesource Biopharma; Dr Shailendra Gaur,Director-Process Sciences,Cipla
Bengaluru, known globally as India’s IT capital, is now fast emerging as a powerful hub for pharma and life sciences. With its combination of global capability centers (GCCs), world-class institutions, startups, and scientific talent, the city is well positioned to drive the next wave of healthcare innovation. This was the central theme of a panel discussion titled, 'Bengaluru – An emerging global innovation gateway?' at the Bengaluru Pharma Summit, organised by Express Pharma.
Moderated by Elayaraja Natarajan, Vice President – R&D, Lyrus Life Sciences, the panel also comprised leaders like Ishwar Bajaj, Fermentation R&D Head, Biocon; Dr Sachin Mundade, Vice President – R&D, Micro Labs; Mayank Garg, Group MSAT Head, Biocon Biologics; Dr Goutam Pujari, Member –Board of Directors; Head – Bioequivalence and Clinical Research, Apotex
Research; Dr Maloy Ghosh, Chief Scientific Officer, Zumutor Biologics; and Loganathan S, Associate Vice President, Onesource Biopharma.
The session highlighted Bengaluru’s strong base for capability-building, research, and innovation. The Government of Karnataka’s GCC policy, with its focus on monitoring, incentives for smaller centers, and support for apprenticeships, has further strengthened the city’s innovation ecosystem and enabled its rapid rise in pharma and life sciences.
Panelists underlined that Bengaluru’s increasing concentration of R&D centers is transforming it into a life sciences hub of global relevance. The city has the right ecosystem to help India move beyond its traditional strength in generics and focus on complex biologics, biosimilars, and specialty medicines.
Another key theme was the risk-averse nature of the life sciences
industry. The discussion emphasised that collaboration can help break this barrier. Stronger industry–academia partnerships, incubation centers, and start-up ecosystems can create win–win opportunities where innovation is nurtured, and solutions are designed for real-world problems.
The importance of continuous learning and process improvement was also highlighted. The pharma industry faces critical challenges that require ongoing inn ovation, and Bengaluru’s talent pool and digital fluency provide the right foundation to address these needs.
The panel pointed out that the city’s combination of global pharma companies, leading academic institutions, and a vibrant start-up culture creates a fertile ground for new innovation models. This convergence is helping develop solutions that combine research excellence with global scalability.
The role of start-ups was particularly noted. Bengaluru’s biotech ventures are experimenting with novel platforms and attracting international recognition. However, to scale effectively, they need greater support in terms of funding, mentorship, and regulatory clarity.
The experts emphasised the role of digital transformation in shaping the future of pharma. Integrating advanced technologies into research, manufacturing, and compliance processes will help ensure efficiency, quality and competitiveness on the global stage.
The session closed with a strong message. Bengaluru's ability to integrate technology with talent, foster collaboration, and embrace continuous learning will be crucial to help India move from being the pharmacy of the world to a global leader in innovationdriven healthcare.
The R&D playbookfor complexgenerics
Dr Rakesh Bhasin, Head R&D (Formulations), Biocon, gave a presentation on 'The R&D playbook for complex generics'. He offered an in-depth perspective on how pharma companies can approach the development of complex generics, a space that is rapidly gaining importance as the industry looks to expand access to advanced therapies at affordable costs. Dr Bhasin began by underlining the complexities in these products ranging from challenging active ingredients to sophisticated formulations, advanced delivery mechanisms and intricate drug-device combinations. Each of these categories presents unique technical, regulatory and commercial challenges, making the development pathway very different from that of conventional generics.
He outlined the importance of strategic product selection. Here, the focus was on mapping patent expiries, analysing competitive landscapes and assessing value through market dynamics such as price erosion, reimbursement potential and patient vol-
ume. He also highlighted the role of market intelligence and early planning.
Dr Bhasin spoke about complexity assessment where the scientific chal-
lenges of formulation, device integration, and analytical characterisation were explored. He stressed that analytical comparability is often the biggest
hurdle, with no single test being sufficient to prove sameness between a reference and a proposed complex generic. He spoke on device-related issues as well, including the need to carefully evaluate pens, auto-injectors, and other platforms for functionality and user interface similarities with reference products.
He also focussed on patent and regulatory pathways. Freedom to Operate (FTO) analyses and patent landscaping were described as essential steps in shaping development strategy, with design-around solutions offering a way to overcome intellectual property barriers. The presentation also covered regulatory expectations in both the US and Europe, particularly the role of design controls, human factor studies and threshold analyses in demonstrating device equivalence.
The session reinforced that developing complex generics requires far more than scientific expertise. It demands a holistic playbook that integrates market intelligence, IP strategy, analytical rigour and regulatory foresight.
Secure your Pharma QC-reference standards
The Bengaluru Pharma Event 2025 also featured a detailed session by Dr Markus Obkircher, Director, Head of Customer Solutions R&D, Chemistry, Merck KgaA. He presented on the theme “Secure Your Pharma QC – Reference Standards.”
Dr Obkircher began by explaining the critical role of reference standards in drug discovery, development, and quality testing. He distinguished between primary standards and secondary standards, which serve as cost-effective, traceable alternatives for routine QC applications.
Merck introduced its portfolio of Pharma Secondary Certified Reference Materials (CRMs), which are fully traceable to both national metrology institutes (such as NIST and PTB) and compendial standards. These materials provide laboratories with reliable, ready-to-use solutions, reducing the significant time and resources often spent on developing in-house working standards.
Highlighting the regulatory frame-
Dr Markus Obkircher,Director,Head of Customer Solutions R&D,Chemistry,MerckKgaA
work, Dr Obkircher noted that both the US FDA and Pharmacopoeias allow the use of secondary standards as long as they are qualified against primary standards.
This, he emphasised, makes Merck’s offering unique, as it combines dual traceability with global availability across a wide range of APIs and impurities.
He informed that Merck’s product portfolio spans over 2,500 catalog items, including APIs such as ibuprofen, acetaminophen, metformin, amlodipine, and amoxicillin. Each product is developed with metrological traceability through advanced methods like quantitative NMR (qNMR) and mass balance characterisation, ensuring accuracy and comparability across labs worldwide.
The session also introduced ChemisTwin, Merck’s digital innovation for QC laboratories. This online platform enables automated analytical spectra interpretation using a comprehensive database of digital reference materials (dRMs).
According to Dr Obkircher, the adoption of secondary standards and digital tools can help scientists focus more on innovation rather than administrative and compliance burdens. He stressed that as regulatory scrutiny increases globally, metrological traceability and digitalisation will become essential for maintaining quality and competitiveness in pharma manufacturing.
Dr Rakesh Bhasin,Head R&D (Formulations),Biocon
Next-gen CDMOs: What will theylooklike
Dr Huzaifa S Choonia, Director & Head, Drug Substance-MSAT, OneSource, spoke on how nextgeneration contract development and manufacturing organisations (CDMOs) are reshaping global drug development and supply, at the Bengaluru Pharma Summit 2025.
He began by noting that the global pharma market is at an inflection point. Biologics are set to double in market size by 2034, while small molecules will continue to lead in volume. In this dynamic landscape, CDMOs are moving from being outsourcing vendors to becoming strategic partners.
According to him, next-gen CDMOs differentiate themselves through end-toend integration, covering the full cycle from cell bank vial to finished product. Digital and data-driven operations, enabled by tools like digital twins and predictive modeling, ensure faster devel-
opment cycles and seamless tech transfer. Advanced modalities, including cell and gene therapies, antibody-drug conjugates, and mRNA platforms, are also
becoming a core part of the service portfolio.
He also stressed the growing importance of sustainability and ESG commit-
ments. With energy-efficient operations and modular facility designs, CDMOs are aligning with global expectations while ensuring agility and speed. Another shift is towards customer-centric partnerships, where risk and reward are shared, reducing capital burden for pharma companies.
Drawing from OneSource’s experience, Dr Choonia highlighted innovations in drug substance and drug product manufacturing, from process intensification and modular single-use facilities to advanced delivery systems and global serialisation. These, he noted, can deliver tangible benefits: 30-40 per cent faster IND-to-commercial timelines, 20-25 per cent lower costs, and reduced compliance risks.
Dr Choonia concluded by emphasising that next-gen CDMOs will be critical accelerators of innovation and resilience in the global healthcare supply chain.
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Dr Huzaifa Shabbir Choonia,Director and Head,Drug Substance-MSAT,OneSource
Panel Discussion: Moving up the value chain without losing volume advantage
L-R: Himanshu Saxena,Head-Biopharmaceutical Manufacturing Operations,Syngene International (MODERATOR); Dr Sanjib Banerjee,COO (Biopharma),Veeda Lifesciences; Saroj Kumar Jena,QualityHead,VJ Biosciences; Mohan Pandey,Head,Global Program Office and Operational Excellence,Syngene International; SiddalingaswamyC.A,VPOperations & Plant Head, Zuventus Healthcare; Dr Manoj Kumar Singh,Sr VP- Analytical Development,Micro Labs; Prof Somnath Dutta,Associate Professor- Molecular Biophysics Unit,Division of Biological Sciences,Indian Institute of Science
India has earned global recognition for making affordable medicines available at scale. But the big question now is: can India move into highvalue areas like biologics, complex medicines, and innovation without losing its volume advantage? This was the theme of the third panel at the Bengaluru Pharma Summit, organised by Express Pharma. The panel discussion, featuring industry leaders and experts, was moderated by Himanshu Saxena, Head – Biopharmaceutical Manufacturing Operations, Syngene International, and included Dr Sanjib Banerjee, Chief Operating Officer (Biopharma), Veeda Lifesciences; Saroj Kumar Jena, Quality Head, VJ Biosciences; Mohan Pandey, Head – Global Program Office and Operational Excellence, Syngene International; Siddalingaswamy CA,
Vice President – Operations & Plant Head, Zuventus Healthcare; Dr Manoj Kumar Singh, Senior Vice President –Analytical Development, Micro Labs; and Prof. Somnath Dutta, Associate Professor – Molecular Biophysics Unit, Division of Biological Sciences, Indian Institute of Science.
The discussion began with a reminder that the future will demand value-driven growth through complex generics, biosimilars, specialty drugs, and innovation. The panelists stressed the importance of targeted R&D investments on unmet needs where India can leverage scale and scientific skills. They highlighted the role of stronger industry–academia collaboration to boost discovery and innovation.
The panel also underlined the need for trust and integrity. They empha-
sised that integrity is not optional. Quality and patient safety are the foundation of our industry. Return on integrity must match return on investment.
The experts also spoke about building digital fluency, process excellence and talent pipelines as key enablers of the value shift. The panelists stressed that new-age talent, with fresh perspectives and scientific depth, will drive innovation. They added that future leaders must balance profit with purpose and inspire teams to take on new challenges.
From a technical lens, the panel highlighted that moving into complex generics and biosimilars will require deep analytical expertise and worldclass laboratories. Without this, India risks losing ground to global competitors.
The panel also discussed the strategy of expanding into new markets. This way, companies can continue to retain their scale advantage while also diversifying into higher-value products. The message was clear. Sustainable growth will come from combining volume and value, not choosing between them.
The panelists reminded the audience that India Pharma Inc must protect its strengths in scale while building new capabilities in value creation. India has the talent, capacity and ambition to climb higher in the pharma value chain. By balancing inn ovation with a ccess, and profit with purpose, India can remain the pharmacy of the world while becoming a true hub for advanced therapies.
PARTNERS IN PROGRESS
PARTNERS IN PROGRESS
PARTNERS IN PROGRESS
PARTNERS IN PROGRESS
RESEARCH
Cell therapy’s next chapter: Industryembraces in-vivo innovation
Nikhil C Bhanumathi, Principal Clinical Lead,Thermo Fisher Scientific highlights that cell therapy is entering a bold new phase in 2025 as the industry shifts from complex,lab-based ex vivo CAR-Tto faster,more accessible in vivo CAR-Tinnovations.This approach promises to expand access,lower costs,and potentially tackle solid tumors and autoimmune diseases
The world of cancer treatment is entering a new chapter in 2025. For more than a decade, CAR-T therapy transformed life for those fighting blood cancers. However, traditional CAR-T (called ex vivo CAR-T) is expensive, complex and available in limited centers. Patients wait for weeks for their cells to be processed and returned. For fast moving cancers such delays can sometime be deadly. A new approach to tackling these challenges is now rapidly emerging. With the introduction of in-vivo CAR T method, the engineering of T Cells happens inside the patient’s body, not in a laboratory. This could make the treatment faster, safer, and more widely accessible. Now this idea is no longer just talk. Multi-billion-dollar investments are being made for development and capacity building of this new method. Fast progress seen in 2025 is not just hype. Major deals and clinical programs show rising confidence.
◆ AbbVie acquires Capstan Therapeutics for $2.1 billion: AbbVie’s acquisition of Capstan signals intent to lead in mRNA-LNP technology, the same technique behind COVID-19 vaccines, now adapted for cancer.
◆ AstraZeneca buys EsoBiotec for $425 million: AstraZeneca expands its oncology pipeline and in vivo capabilities by acquiring a major player in non-viral gene delivery
◆ Kite Pharma (Gilead) acquires Interius BioTherapeutics for $350 million: Kite, a legacy ex vivo CAR-T leader, now positions itself toward vivo lentiviral vector platforms to stay competitive
What is CAR-Ttherapy?
Traditional CAR-T therapy uses a patient’s own immune
cells. Doctors collect T-cells, take them to a lab, equip them with new “antennae” (chimeric antigen receptors, CARs) and infuse them back[nature].
These engineered CAR-T cells then find and destroy cancerous cells. While this strategy has saved lives, especially in leukemia and lymphoma, it comes with several serious challenges:
◆ Patients’ T-cells are extracted, shipped, modified, and returned; a process often takes weeks.
◆ It can cost hundreds of thousands of dollars per patient (not including hospital bills)
◆ Many eligible patients are never able to receive it due to limited facilities and logistical hurdles
In Vivo CAR-T: The new approach
In Vivo CAR-T therapy solves these problems by delivering genetic instructions into the body, turning ordinary T-cells into cancer fighters inside the patient. This can be done by injecting the necessary genes or mRNA, packaged in viral vectors (like lentivirus or adenoassociated virus) or non-viral systems (such as lipid nanoparticles). No apheresis, no complex manufacturing: just a simple injection or infusion.
The science behind in Vivo CAR-T
◆ Viral Vectors: Modified viruses (lentivirus, AAV) are used to deliver the CAR genes. These can provide stable, longterm CAR expression but raise safety questions due to potential gene integration risks.
◆ Non-Viral Systems: Lipid nanoparticles (LNPs) with mRNA, inspired by COVID-19 vaccines, can deliver transient CAR expression. This approach is scalable, may carry fewer long-term risks, and al-
lows precise control over CAR presence, lowering the risk of side effects.
Keyadvantages over ex vivo therapy
◆ Manufacturing simplicity: Skipping lab manipulation means lower costs and fewer logistics failures. Instead of custom therapies for each person, off-the-shelf solutions become possible.
◆ Speed: Patients can be treated without long waits, crucial for aggressive cancer.
◆ Access: More hospitals will be able to administer treatment, even in low-resource settings.
◆ Potential for solid tumors: Re-engineering T-cells inside the patient—potentially many times—not only helps in blood cancers but might pierce the defenses of solid tumors, historically a challenge
◆ Wider applications: Expanding use into autoimmune and fibrotic diseases is already being explored in 2025 trials
Points of friction
In-Vivo CAR-T therapy holds considerable promise, but several challenges and limitations remain. One major concern is safety, particularly the need to
ensure that genetic engineering tools precisely target Tcells without modifying other cell types, as off-target effects could lead to serious complications. The durability of response is another issue, since transient approaches such as mRNA-based delivery may require repeated administration, while viral vectors like AAV, although capable of longer persistence, carry risks of insertional mutagenesis and uncontrolled expression. Immune reactions also pose a barrier, as the patient’s immune system may recognise and neutralise viral vectors or even attack the engineered Tcells themselves, thereby diminishing therapeutic efficacy. Furthermore, solid tumors present unique hurdles, including dense stromal barriers, immunosuppressive signaling within the tumor microenvironment, and poor trafficking of engineered T-cells, all of which significantly hamper the effectiveness of CD19-like CAR-T strategies traditionally used in blood cancers.
Clinical trials and real-world momentum
Recent studies and trials in 2025 show that in-vivo CAR-T can deplete tumor cells or wipe out pathogenic B-cells in animal models and early human tests. For solid tumors, sequential and multi-antigen strategies enabled by mRNA show promise. Autoimmune “immune reset” therapies are being evaluated in monkeys and humanised mice. First-inhuman trials for in vivo CAR-T are underway with patient enrollment documented across the US, Europe, and Asia-Pacific.
Industryimpact and the future
Pharmaceutical leaders made multi-billion-dollar invest-
ments in in-vivo CAR-T platforms throughout 2025, driven by robust venture capital infusion and strategic partnerships between major corporations and inn ovative biotech startups. This surge in funding has accelerated clinical development and resulted in forecasts of over 100 publicly disclosed in vivo CAR-T assets by year-end. If current progress continues, these therapies could transform CAR-T into a truly “drug-like” modality—administered easily in standard hospital settings, bypassing the need for complex cell engineering labs.
Transformative potential
The advent of in-vivo CAR-T platforms could finally unlock the technology’s efficacy against solid tumors, a major challenge for traditional exvivo CAR-T approaches. Developers are also exploring CAR-T for autoimmune diseases, extending their reach far beyond oncology. As delivery techniques such as lipid nanoparticles or viral vectors become more refined, treatment costs are set to decline, making these advanced therapies affordable and accessible globally, not solely in wealthy regions.
Market and partnerships
With global investment exceeding $2 billion, pharma companies like AbbVie and Novartis, together with partners such as Capstan and Vyriad, are spearheading this next-generation therapeutics revolution. These partnerships reflect a dynamic pipeline, as well as a shift toward scalable, off-the-shelf treatments promising shorter timelines and more consistent patient access worldwide
The views and opinions are the author’s personal views
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AI compass: Transforming pharma commercialisation
As the world evolves at a rapid pace,pharma companies are embracing smarter approaches, leveraging AI across nearly every aspect of commercialisation,from market forecasting and personalised marketing to dynamic pricing and beyond.In this article, Neha Aathavale takes the pulse of the industry to explore who is taking note and how companies are beginning to put AI into action in their commercial operations
While much of the spotlight has been on AI’s role in drug discovery, its influence is no longer confined to the laboratory. Discovery has often been described as the beating heart of any pharma company, where AI strengthens and accelerates critical breakthroughs. But if discovery is the heart, commercialisation is the network of nerves and veins. It is here that AI is fast becoming the compass, guiding companies in India and across the world toward more efficient, responsive, and innovative ways of bringing medicines to market and smoothing the business part of it.
As global healthcare landscapes become increasingly competitive and patient expectations evolve, the ability to leverage AI across commercial functions is no longer optional. From demand forecasting and inventory optimisation to personalised marketing and dynamic pricing, pharma companies are beginning to use AI to make decisions faster, anticipate market shifts, and tailor outreach to diverse stakeholders.
By bridging the gap between scientific innova tion and business execution, AI is reshaping operations and enabling smarter, more agile, and scalable commercial strategies. The key question now is which companies are taking note and actively turning this potential into action?
Shifting gears with AI
Early signs suggest the momentum is building. An EYOPPI survey shows that 79 per cent of pharma CXOs view AI and machine learning as central to growth. Indian organisations expect genera-
Artificial Intelligence (AI) is set to revolutionise pharmaceutical commercialisation in India over the next five years
Antony Prashant Partner, Deloitte India
By integrating predictive analytics, intelligent supply chains,and responsive marketing,Indian pharma can move beyond cost leadership to value-driven innovation
Sushant Rabra Partner and Head, Digital Strategy, Solutions and Insights, KPMG in India
Data is the bedrock of AI adoption in pharma,and regulatory guidance will be key to enabling responsible use
Suresh Subramanian Partner and National Lifesciences Leader, EYParthenon India
tive AI to transform their business within the next three years, driven by pressure from both internal and external stakeholders to accelerate adoption.
Affirming this trend, Sushant Rabra, Partner and Head, Digital Strategy, Solutions and Insights, KPMG in India, states, “Indian pharma companies are increasingly adopting AI and running GenAI applications in production, forecasting, supply chain and channel targeting and rep productivity, signalling a shift from experimentation to scaled deployment.”
Demand forecasting and inventory optimisation are proving to be early winners. According to KPMG, 60 per cent of life sciences leaders are using AI-driven predictive analytics and real-time data feeds to cut stock-outs and reduce excess inventory. Nearly half of the companies are also investing in AI for pricing simulations, payer insight analytics, and market access modelling. On the supply chain front, half of leading Indian pharma companies have implemented GenAI-enabled orchestration platforms, cutting logistics costs by 20 to 25 per cent while improving on-time delivery rates by 15 per cent.
Within this evolving landscape, Suresh Subramanian, Partner and National Lifesciences Leader, EY Parthenon India, points out that branded generics dominate the Indian market and AI adoption has advanced in highly targeted areas. “Medical rep engagement, coaching, and upskilling, generating sharper customer insights, and providing rep nudges to improve in-clinic time for demand generation are key focus
points. Doctor real-time support services are also gaining traction.” He adds that emerging use cases include, microsegment campaigns, virtual MSLs, and trade generics experimenting with AI-led pricing and discount management.
The AI compliance equation
While AI offers tremendous potential, pharma companies must balance innovation with regulatory compliance. The Uniform Code of Pharmaceutical Marketing Practices restricts direct-to-consumer promotions and mandates ethical engagement. Hypersegmented, AI-driven marketing campaigns remain an attractive possibility, but they must operate within these strictures.
Prashant explains, “AI can support compliant marketing by automating MLR reviews, generating modular content, and enabling real-time engagement strategies. Rather than pushing boundaries, companies are using AI to streamline regulatory workflows, personalise within approved frameworks, and ensure traceability.”
Rabra notes that, given the stricter MLR and audit-trail mandates, only about 20 to 25 per cent of companies currently run fully automated persona segmentation without manual review. He adds, “Scaled hyper-segmentation across half of pharma’s digital marketing spend will only materialise in the next couple of years, once industry-wide AI governance and automated MLR workflows are fully harmonised.”
Subramanian provides additional context on how AI can improve both compliance and effectiveness. “Personalised campaigns tailored to specific customer personas are critical in a heterogeneous market. AI can improve both transparency and effectiveness, creating a win-win for policymakers and pharma companies,” he says, while noting that safeguards around data privacy, patient consent, and responsible data use are essential.
It (Gen AI) allows us to move beyond one-size-fits-all campaigns toward dynamic,real-time communication that is economical,adaptable,and compliant ensuring consistency in messaging while meeting the unique needs of each stakeholder with greater speed and relevance
Rabra adds, “Multinationals use India as a strategic testbed, deploying global CRM platforms, predictive-analytics engines, and GenAI content tools. The various global players allocate around 20 to 25 per cent of their commercial budgets to AI and cloud infrastructure, versus just around 10 to 15 per cent for domestic firms.”
Pharma
Joy Chatterjee Vice President,Sales and Marketing Head, Consumer Business Unit,Mankind
At Mankind Pharma,we believe AI is not just the future of technology but the future of healthcare
Indian-origin firms, however, are no less ambitious. Subramanian observes that they are “leveraging data and analytics to create multiple market segments, generate deeper insights, and enhance their ability to serve both doctors and patients, ultimately improving outcomes.” While cautious and cost-sensitive, they are actively exploring modular AI tools, often co-developed with health-tech startups, to boost operational efficiency.
The next AI frontier Industry consensus suggests that the next five years will see mainstream adoption of AI in commercialisation. It is expected to focus on supply chain, forecasting, and
According to the official website of GoML, an AI development company andAWS Gen AI partner, pharma giants like Sun Pharma have long relied on manual processes to retrieve data from relational databases. Extracting insights on sales performance, stock levels, and field agent effectiveness required SQL expertise and time-consuming workflows. To address this, GoML built a solution for Sun Pharma using Microsoft Autogen, OpenAI’s GPT-4, and a modular multi-agent framework.
The result: an AI sales assistant that enables conversational queries for complex sales data in plain English, instantly visualised and contextualised. Prashanna Rao, Head of Engineering at GoML, explained on the company’s official website that the initiative aimed not merely to replace dashboards but to speed up decision-making by simplifying access to data for users.
The impact: faster sales decisions with AI sales analytics agents Sun Pharma’s sales and operations teams can now ask questions in natural language and receive answers instantly, without requiring SQL knowledge or analyst intervention. “With GoML’s GenAI system, we’ve made our data truly self-service. Sales leaders now act on insights in seconds, not days,” said a senior leader from Sun Pharma.
The AI sales assistant has not only saved time but also transformed how Sun Pharma’s sales force engages with performance metrics and operational data:
◆ 70% reduction in manual effort: Automated analysis and visualisation replace spreadsheet-based workflows.
◆ 80% simplified data consumption: Lightweight charting and smart summaries reduce the need for full BI dashboards. Overall, the deployment of this Generative AI sales assistant, which allows conversational queries for complex sales data, has resulted in a 70 per cent reduction in manual effort and 85 per cent faster data retrieval for sales teams.
Source: https://www.goml.io/case-study
The global-local divide
Another interesting dimension lies in the pace of adoption between global pharma
subsidiaries and Indian-origin companies. According to KPMG, 60–70 per cent of AI commercialisation initiatives
in India are driven by global pharma subsidiaries, with Indian-origin firms accounting for 30–35 per cent.
marketing, followed by pricing optimisation and HR. Prashant highlights the tangible benefits, noting that
Sun Pharma’s AI-driven shift in sales and operations
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AI-driven supply chain management has demonstrated “increase in demand prediction accuracy, operational cost reduction, and decrease in drug shortages.”
Rabra adds that virtual digital twins, powered by GenAI, are enabling end-to-end supply chain simulations and dynamic rerouting in case of disruptions. He cites a case where a diagnostic player reconfigured monsoon-affected routes in real time, cutting transit delays by approximately 20 per cent.
In HR, Subramanian notes, “AI adoption in pharma HR is already underway, with GenAI and Agentic AI being tested for improved employee engagement, upskilling, and enterprise performance management. This is reshaping how
Cipla’s push into patient-facing AI diagnostics
According to Cipla’s official press release, Cipla launched CipAir, a mobile application designed to provide timely and convenient first-line screening for asthma in India. Clinically validated through a multi-centric pan-India study, the technology aims to empower people by helping them understand their likelihood of having asthma, enabling timely intervention and management. Available on Android, with plans to roll out on iOS devices, CipAir is a free, innovative tool accessible via Cipla’s Breathefree mobile application, the company’s existing patient support ecosystem for respiratory care.
Using a proprietary algorithm and software, the tool turns a mobile phone into an asthma screening device. It guides users through a simple, interactive process: in a quiet setting, users perform three exhalations while focusing on extinguishing a virtual candle displayed on the screen. During this process, CipAir provides real-time feedback on the user’s effort, test quality, and steps needed to ensure accurate results. The exhalation sounds are analysed in the backend to detect unique acoustic patterns indicative of asthma.
According to the company’s press release, Umang Vohra, Managing Director & Global CEO of Cipla, emphasised that the company’s focus on innovation and patient-centric solutions is driving the development of next-generation healthcare technologies. He highlighted that CipAir’s AI-led approach makes personalised asthma screening more accessible, user-friendly, and enables patients to take timely action for better health outcomes.
HR teams are structured and creating value through the three Es: efficiency, expense
reduction, and employee experience.”
Prashant further observes
that emerging applications include micro-segment campaigns, virtual MSLs, and
pricing and discount management in trade generics, showing that AI is increasingly
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embedded across multiple layers of commercial operations.
Building the ecosystem
For these gains to scale, the pharma ecosystem in India requires a series of strategic shifts. Prashant highlights that India’s pharmaceutical sector is poised for a transformative leap, but full-scale adoption will require strengthened infrastructure, clear regulatory guardrails, and talent development.
The government’s ?5,000 crore PRIP scheme offers up to 50 percent funding support for pharma and MedTech innovation, targeting areas such as biosimilars, precision medicine, and AI-enabled commercialisation. Public-private partnerships are also gaining traction. The ?330 crore AI Centre of Excellence by IIT Delhi and AIIMS Delhi, for example, is developing indigenous AI tools for national health programmes.
Subramanian emphasises the importance of data and governance frameworks. “Data is the bedrock of AI adoption in pharma, and regulatory guidance will be key to enabling responsible use. Policies must facilitate secure sharing of real-world data such as prescription records, electronic health records, and patient adherence information, while ensuring compliance with HIPAA, GDPR, and country-specific laws on privacy, security, and consent management,” he says. He adds that platforms like the Ayushman Bharat Digital Mission can enhance efficiency, reduce costs, and expand access to patients in underserved regions.
Talent development is also critical. AIIMS and PGIMER have been designated as Centres of Excellence for AI, supporting training and deployment of AI tools in diagnostics and commercial operations. Strong cybersecurity measures, robust risk and governance frameworks, and clearly defined policies on AI explainability, bias detection, and accountability are all essential to build trust and enable scaling. With these ecosystem ele-
Novo Nordisk’s global leap in data management through AI
NovoNordisk’s Bengaluru centre is leveraging AI, in collaboration with Indian startups, to dramatically reduce document summarisation times in global safety processes from 40 hours to just 40 minutes. This initiative is part of the Danish drugmaker’s expansion in Bengaluru, where it has operated for 17 years. The centre manages vast amounts of data on the safety and efficacy of its medicines, including information from clinical trials and reports of potential side effects.
The company has partnered with ten Indian startups to use AI for tasks such as summarising documents, extracting insights, and checking for editing errors. Some of these AI tools are now deployed across Novo Nordisk’s global operations. Medical writers at the Bengaluru centre are using AI to streamline quality checks on documents, many of which are intended for submission to drug regulators in formats required in countries ranging from the U.S. to Japan.
According to Dawber, speaking in Bengaluru, AI has reduced the time needed for document processing from 40 hours to around 40 minutes per document. He added that he expects the India centre to become “an almost perfect mirror image” of the company’s headquarters in Bagsvaerd, Denmark, within three years, particularly in handling research and development data.
While collaboration with the Denmark headquarters will continue, Dawber noted that Bengaluru is taking on increasing responsibility for both current and future products, reflecting a strategic shift in the company’s global operations.
Source: Reuters.
Dr Reddy’s Laboratories exploring AI for patient engagement
According to Dr Reddy's Digitalisation, Dr. Reddy's Laboratories (DRL) is driving a comprehensive digital transformation, leveraging Artificial Intelligence (AI) across its entire value chain, from manufacturing quality to the patient experience. In manufacturing, the company has incorporated AI-driven capabilities, including elements of computer vision for packaging validation and defect detection—to ensure stringent product quality. This is part of its acclaimed "Digital Lighthouse" factory in Hyderabad, recognised by the World Economic Forum (WEF) for leadership in Industry 4.0.
The deployment of advanced analytics and IIoT at the site has yielded significant operational results, including a 40 per cent reduction in quality-related costs and a significant dip in quality deviations.
The company is piloting chatbots and other digital solutions designed to improve patient compliance with long-term medication regimens. These AI-powered tools enhance patient engagement, provide personalised reminders, and help manage adherence obstacles, supporting DRL’s strategy to improve access and outcomes for chronic conditions.
ments in place, India is positioned to become a global leader in AI-powered pharma innovation, moving beyond cost leadership to value-driven, digitally advanced solutions.
Case study: Mankind Pharma
Several Indian pharma companies have begun taking concrete steps toward integrating AI into their operations. A detailed example comes from Mankind Pharma. In September, the company announced a collaboration with OpenAI to institutionalise AI across its value chain. Mankind plans to deploy OpenAI Enterprise across multiple functions, including field force enablement, digital marketing, re-
search and development, manufacturing, and medical affairs.
Asked about the impact specifically on digital marketing, the company highlighted the limitations of traditional engagement models. Before adopting AI, campaigns relied heavily on celebrity ambassadors and conventional formats. Joy Chatterjee, Vice President, Sales and Marketing Head, Consumer Business Unit, explains, “Celebrity-led activations, while impactful, often came with restrictions around availability, contractual boundaries, and limited adaptability across diverse campaign requirements—offline, online and digital.”
Chatterjee adds that main-
taining a consistent presence across multiple touchpoints was challenging, especially in direct engagement contexts where continuous, personalised communication is critical. Ensuring participation across multiple activations or securing quick turnarounds was not always feasible, sometimes hindering campaign agility and continuity.
The adoption of their AI brand ambassador, Myra Kapoor, has addressed these challenges. “Unlike human ambassadors, an AI model offers consistent availability, quick turnaround times for content creation, and seamless adaptability across platforms and formats. It ensures uniform messaging, removes
scheduling dependencies, and allows cost-effective scalability,” says Chatterjee.
Mankind Pharma is piloting several GenAI approaches for content creation and personalisation:
◆ AI-generated visuals: Using ComfyUI with Flux to create original images for social media and marketing campaigns.
◆ Personalised AI influencer content: Using DeepFaceLab to swap faces onto AI-generated images, creating a consistent branded persona.
◆ High-quality output and customisation: Using Flux upscale workflow and Photoshop tweaks to ensure professional, polished visuals.
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◆ Targeted personalisation: Content can be adapted for different audience segments or campaigns, aligning with hyper-segmentation and personalised outreach.
The company has already seen tangible benefits. Chatterjee notes, “Myra Kapoor— Manforce’s new brand ambassador—allows us to overcome time and availability constraints by offering scalability, 24/7 availability, and the flexibility to adapt messaging seamlessly across campaigns.”
GenAI has also reshaped the company’s broader engagement philosophy. Chatterjee explains, “It allows us to move beyond one-size-fits-all campaigns toward dynamic, real-time communication that is economical, adaptable, and
Mankind Pharma is using AI to transform marketing and operations,with its AI brand ambassador,enabling scalable,personalised campaigns.The company is also leveraging AI for content creation,outreach,and field force training,aiming for greater efficiency and real-time engagement across its value chain
compliant, ensuring consistency in messaging while meeting the unique needs of each stakeholder with greater speed and relevance.”
Arjun Juneja, Chief Operating Officer, adds, “At Mankind Pharma, we believe AI is not just the future of technology but the future of
healthcare. Our vision is to harness its power to make our organisation smarter, more agile, and deeply human in how we serve. We are piloting personalised AI-driven video nudges for our 18,000-strong field force to enhance learning and engagement at scale. We have introduced an AI-pow-
ered chatbot that ensures every representative has instant, science-backed answers, whether to refresh their knowledge or respond with confidence in the field.
And we have reimagined the packaging of more than 1,000 products through AI, demonstrating how innova tion can
touch every corner of our value chain. For us, this collaboration with OpenAI is not just about adopting new tools, it is about setting a new benchmark for how Indian pharma can lead globally with innovat ion, efficiency, and a relentless focus on improving patient lives.”
Conclusion
As more players adopt AI across commercial and operational functions, India is moving closer to redefining its role in global pharma not just as the pharmacy of the world, but as an AI-enabled hub capable of delivering smarter, faster, and more responsive healthcare solutions.
Jan Vishwas Act 2025: Decriminalisation and penalisation of drug offences through compounding
Dr Suresh R Saravdekar, Former Assistant Director,Ministry of Medical Education & Research, Maharashtra & Honorary Consultant,Institute of Medical Sciences,Banaras Hindu University, Varanasi informs that with limited resources and overburdened courts,governments are increasingly outsourcing regulation to private or semi-private bodies.In India,this trend is visible in healthcare and pharma,where weak quasi-judicial systems often protect businesses more than the public
Around the world, one thing that is prominent in the current functioning of democracies is that if the government system cannot control and regulate professional businesses due to inadequate manpower and insufficient resources available in the judiciary and regulatory system, the regulatory system is either fully or partially privatised. This is the overall policy of governments seen globally and locally too.
The best example of this can be seen from the constant hike in healthcare charges in private hospital services and other medical expenses. Now it has reached the sky and has become unaffordable for the common people. The Clinical Establishments Act was enacted in 2010 to standardise and regulate private healthcare services in India. But because of high pressure from the private hospital lobby, the Government of India has failed to make the Clinical Establishments Act, 2010 mandatory for private hospitals in all states.
Under such a situation, to fill up this gap, the procedure of ‘Accreditation’ is adopted in many developed countries. The Joint Commission is one of the most widely used accreditation organisations. The International Society for Quality in Healthcare (ISQua) is the umbrella organisation responsible for accrediting the Joint Commission accreditation scheme in the US and Accreditation Canada International, as well as accreditation organisations in the UK and Australia. These bodies ensure the quality of health services and issue certification based on international standards which are continuously updated to accommodate needless new technological developments. This results in continuously hiking the
charges to the patient by subjecting them to over-drugging and over-diagnosis.
The Government of India too has adopted and established this Accreditation Policy to partially fill up the gap of regulation on private healthcare services and developed a quasi-government organisation called the Quality Council of India (QCI) at the national level. The QCI has designed and transferred this regulatory system to a private external organisation called the National Accreditation Board for Hospitals (NABH). In other words, the government has directly outsourced regulatory and standardisation work to this semi-private organisation. NABH is only empowered to design the quality standards based on the standards prescribed by an international agency named Joint Commission International (JCI).
However, the most interesting part is – this system is voluntary and not mandatory and does not cover important regulatory aspects and completely lacks the strength of government enactments and the judiciary system. Therefore, if any serious lapses are found in hospital standards, the hospital administration gets only a warning and there is no provision for prosecution or punishment. In a way, this has given minimum protection to the patients but maximum to the private hospitals. Moreover, as there is no scope for prosecution, there is no deterrent or regulatory fear of the charges levied. That’s how all doors are kept open only for making maximum profits by putting patients at a heavy financial burden.
Now, going further, one step forward, the government’s policy of helping private pharma
businesses is being legalised. This is clear from the recent amendment made by the government in the Food and Drug Administration’s (CDSCO) Drugs and Cosmetics (Compounding of Offences) Rules, 2025, under the Jan Vishwas Act. In this amendment, the punishment that would have been imposed on the drug manufacturer/trader by law has been reduced and converted into a fine.
The government argues that after registering a case against drug companies as per the existing statutes, due to inadequate management in the judiciary, results do not come for years and finally, the accused is not punished suitably. Therefore, this simple ‘’quasi-judicial’’ method is now being established by the government.
Purpose of the amendment –The Central Government has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025, with effect from 25th April 2025 by amending the Drugs and Cosmetics Rules, 1945. Under this new enactment, the government aims to reduce prosecution cases and encourage compliance by allowing offenders to pay a ‘’compounded amount’’ for minor violations in-
stead of facing the Court of Law. In this process, the authority has been empowered to adjudicate quasi-judicially by applying to the designated authority, either an administrative officer or a drugs inspector, for minor offenses. Instead of going through the judicial process, the offender will be asked to pay a fine in cash and from now on, after enforcing these rules, a report will be filed in the court for adjudicating only major offenses.
The government claims that this transformation will reduce the number of offences, especially for minor violations like labelling errors, packaging misprints or logistical issues that the government considers minor and not compromising the quality or safety of the product. But for that, regulatory authorities need to first establish transparent guidelines on minor offences and the consequences of repeated violations. Otherwise, there are concerns that the newly revised amalgamation of offences in the Drugs and Cosmetics Act could be misused by the industry, particularly in the following cases:
For example, currently there are:
1. Lack of clear definitions – the revised rules do not clearly define what constitutes a minor offence, leaving room for interpretation and potential exploitation by the industry machinery.
2. Insufficient deterrence –Penalties for minor offences may be too lenient, which may not deter companies from committing repeated violations.
3. Potential for repeat offenders – The rules state that only first-time offenders will be considered for a fine, while repeated offenders may be subject to fines or imprisonment. However, the
effectiveness of this provision will depend on the implementation and monitoring by the regulatory authorities.
4. Risk of concealment of material details – If companies provide false evidence or conceal material details during compounding proceedings, the immunity granted may be withdrawn. However, detecting such instances can be challenging.
5. Potential abuse scenarios –Companies may neglect proper record-keeping and rely on the compounding provision to solve problems without adequate results.
6. Repeated violations – Companies may repeatedly commit minor offences and easily escape the law by paying only a fine without making the necessary changes in their practices.
This change has already been implemented for food/food processing, manufacturing, and distribution. So, processed food manufacturers and hoteliers have no reason to panic even if minor laws are violated due to negligence. They are allowed to pay some amount as a fine and go free.
The government under the ‘Jan Vishwas’ Act will certainly succeed in gaining the trust of traders by replacing the strong judicial institution and creating an alternative, simple, but weak quasi-judicial institution. However, in the absence of clear guiding principles regarding effective implementation, transparency and the honesty, integrity and responsibility of the authorised officer, this quasi-judicial parallel system seems to be untrustworthy for the public in the present context. This will be the major challenge faced by the Government during practical implementation of the amendment.
AYUSH
Unani Medicine: At crossroads of tradition and modernity
Manufacturers,academic institutions and research councils are working together to elevate Unani medicine through clinical validation and policy alignment with international standards,finds Swati Rana
Unani medicine has been practiced in India for centuries but in recent years, the global health and wellness trend has brought renewed attention to Unani and other traditional systems. Once viewed largely as a heritage stream of healthcare, it is now repositioning itself as a modern, evidence-driven system with aspirations for global recognition. The sector is proactively investing in analytical technologies, pharmacological studies, and clinical evaluations to build a body of data that strengthens both credibility and consumer confidence.
The industry is witnessing a significant change to further strengthen and boost the growth of Unani medicine not only in India but across globe. The three major stakeholders of the industry – manufacturers, academia and CCRUM are collaborating and exploring various initiative that would help in gaining credibility and accessibility of Unani medicine.
From traditional to modern,evidence-based products
Today, Unani stands at a transformative moment where its future is shaped not only by the weight of its tradition but also by the demands of modern science, global regulation, and discerning consumers. “Unani medicine today stands at a unique crossroads where tradition and modern science can enrich one another,” reflects Abdul Majeed, Chairman & Trustee, Hamdard. “The journey ahead is about harmonising timeless wisdom with rigorous evidence to earn both trust and global acceptance,” he adds.
Unlike earlier decades, where classical formulations were reproduced with little alteration, today’s Unani manufacturers are increasingly turning to evidence-based validation.
“This shift is not cosmetic—it is strategic,” said Majeed. He
further elaborated that the industry is currently focusing on credibility and accessibility to ensure Unani is scientifically validated at the same time making it affordable for wider acceptance, especially among younger, wellness-driven consumers.
To achieve this, the industry is placing greater emphasis on
The industry is currently focusing on credibility and accessibility to ensure Unani is scientifically validated at the same time making it affordable for wider acceptance,especially among younger,wellness-driven consumers
Abdul Majeed Chairman & Trustee,Hamdard
Today’s students are learning not just Nabz (pulse diagnosis) and Mizaj (temperament analysis),but also biomedical sciences,pharmacology,and evidence based medicine.Labs for pharmacognosy and phytochemistry are ensuring that classical formulations meet global quality standards
Prof.Khan Mohammad Qaiser
HOD,Tahaffuzi waSamaji Tib (PSM),Anjuman Islam's Dr.M.I.J.Tibbia Unani Medical College & H.A.R.KHospital, Mumbai
Our focus is on aligning Unani with global benchmarks of quality,safety, and efficacy.From patents to clinical trials,we are building a robust scientific foundation for international acceptance
Dr Ghazala Javed
Assistant Director at CCRUM
investment in R&D, state-ofthe-art quality systems, and sustainable sourcing. Majeed opines, “The next generation of consumers is not only healthconscious but also value-driven and exceptionally well-informed, seeking authentic knowledge about products and their ingredients—they expect transparency, authenticity, and
ecological responsibility. By integrating GMP practices, digitised supply chains, and environmentally responsible cultivation, Unani medicine can demonstrate its relevance in a modern, wellness-driven world. The vision is clear: preserve its heritage while innovating boldly to create a global future for Unani.”
Sharing his thoughts on how academic institutions are integrating modern scientific methods in Unani research and teaching, Prof Khan Mohammad Qaiser, HOD, Tahaffuzi wa Samaji Tib (PSM), Anjuman Islam's Dr.M.I.J.Tibbia Unani Medical College & H.A.R.K Hospital, Mumbai said, “Today’s students are learning not just Nabz (pulse diagnosis) and Mizaj (temperament analysis), but also biomedical sciences, pharmacology, and evidencebased medicine. Labs for pharmacognosy and phytochemistry are ensuring that classical formulations meet global quality standards.”
The Unani institutes are focusing on curriculum modernisation. It is integrating biomedical sciences, pathology, and pharmacology into Unani education while embedding Evidence-Based Medicine (EBM) modules to train students in critical appraisal, clinical reasoning, and research methodology. Establishing pharmacognosy, phytochemistry, and quality-control laboratories within Unani colleges to ensure safety, reproducibility, and scientific validation of classical formulations. Conducting ethics committee–approved clinical trials with robust study designs, while combining modern diagnostic tools (imaging, biomarkers, lab investigations) with traditional diagnostic methods like Nabz (pulse), Mizaj (temperament), and Baul-Baraz (urine–stool examination).
Current market scenario and challenges
As of 2024, the Indian traditional medicine market was valued at approximately $416 million, with a projected growth to $707 million by 2030, according to a study published by Precedence Research. The Ministry of AYUSH actively supports this growth by funding research, infrastructure, and public awareness programmes. Initiatives like the construc-
tion of new Unani colleges and hospitals, such as the 200-bed Unani Medical College & Hospital in Bihar last year, signal strong government commitment. In addition, schemes promoting herbal cultivation and AYUSH integration into public healthcare have boosted the credibility and reach of Unani treatments.
Despite all these positive trends, several challenges persist in the domestic market. These include a lack of standardisation in formulations, limited clinical validation, inadequate awareness among the public, and weak supply chains for medicinal plants. Regulatory compliance for exports also remains a hurdle, with many products struggling to meet international quality and safety standards.
On the global front, Unani medicine, though lesser-known than ayurveda or other tradition medicine, is gradually gaining recognition. It is practiced in parts of the Middle East, Southeast Asia, and among South Asian diaspora communities worldwide. The global herbal medicine market is booming and expected to surpass $580 billion by 2034, offering a large potential market for Unani products.
Global expansion faces hurdles such as varying regulatory frameworks, limited international awareness, and skepticism about traditional medicine. Intellectual property issues and the lack of standard pharmacopoeia for Unani products also restrict global adoption.
Majeed explained that these hurdles can be overcome if international expansion navigates stringent quality standards, proving safety through clinical substantiation, and overcoming the perception gap that often sidelines traditional systems of medicine. However, he views these challenges as opportunities: “Every regulatory barrier is a chance to showcase Unani’s credibility. If Ayurveda and Yoga have earned global recognition, Unani too will claim its rightful space.”
The modern consumer is both health-conscious and value-driven—demanding transparency, sustainability, and au-
thenticity. To meet these expectations, the Unani industry is investing in state-of-the-art R&D, digitised supply chains, GMPcertified production, and sustainable sourcing of medicinal plants. This evolution is not just about product quality, but also about ecological responsibility—ensuring Unani’s growth aligns with environmental stewardship. Majeed emphasises, “We must innovate boldly, but with the wisdom to preserve nature’s balance. Only then can Unani remain relevant in a wellness-driven world.”
On the academic side, the sector is facing challenges like:
◆ Curriculum–practice gap –Overemphasis on theoretical teaching with limited hands-on clinical exposure in both Unani and integrative settings.
◆ Balancing tradition and modernity – Preserving the integrity of Unani’s classical principles while equipping graduates with contemporary skills in diagnostics, pharmacovigilance, and digital health.
◆ Regulatory and standardisation issues – Variability in enforcement of Good Manufacturing Practices (GMP), drug quality, and clinical trial standards creates hurdles for credibility.
◆ Professional identity and career pathways – Ambiguity around the role of Unani practitioners in modern healthcare, limited career opportunities, and low global visibility affect student motivation and longterm prospects.
Contribution of CCRUM
The Central Council for Research in Unani Medicine (CCRUM) is playing a pivotal role in shaping Unani’s future. Under the Ministry of Ayush, CCRUM has established NABLaccredited labs, introduced high-end testing technologies like HPTLC and HPLC, and rolled out a structured pharmacovigilance programme with peripheral centers across India.
Dr Ghazala Javed, Assistant Director at CCRUM, explains: “Our focus is on aligning Unani with global benchmarks of quality, safety, and efficacy. From patents to clinical trials, we are
building a robust scientific foundation for international acceptance.”
She added, “In recent years, the Government of India has taken several important steps to globalise the Ayush streams of medicine, positioning them as credible and evidence-based healthcare options. Ministry of Ayush has actively entered into MoUs with many foreign countries for cooperation in the field of traditional medicine. The creation of Ayush Information Cells in Indian embassies, as well as the inclusion of Ayush systems in bilateral dialogues concerning health, has further strengthened the international visibility and accessibility of Ayush practices.”
CCRUM has signed MoUs with Hamdard University, Bangladesh, and University of Western Cape, South Africa for establishment of academic chairs in Unani medicine. Various academic activities were undertaken by the Unani chairs at these Universities. CCRUM has also signed MOUs with Avicenna Tajik State Medical University, Tajikistan for cooperation in Unani medicine and with Tehran University of Medical Sciences, Iran for cooperation in the field of Unani and Persian medicine.
The International Cooperation Scheme of the Ministry of Ayush provides financial assistance for a wide range of activities aimed at the global promotion of Ayush streams of medicine. These include deputation of experts to foreign institutions, organisation of international conferences and seminars, translation and publication of Ayush literature in foreign languages, provision of scholarships to foreign students for pursuing Ayush courses in India and participation in health fairs and exhibitions abroad. The scheme also supports market access for Ayush products by addressing regulatory challenges.
A landmark initiative by the Government in the globalisation of Ayush is the establishment of the WHO Global Centre for Traditional Medicine (GCTM) in Jamnagar, Gujarat, developed in collaboration between the Government of India and the World
Health Organisation. The GCTM serves as a knowledge hub for global traditional medicine, fostering research, policy development, innovation, and cross-country learning in Ayush and other traditional systems. It is the first and only global centre of its kind, and its presence in India highlights the country’s leadership role in shaping the future of traditional medicine worldwide.
Alongside these efforts, the government has also worked with WHO to develop global benchmarks for practice and training in Ayush systems including Unani medicine. Dr Javed, highlighted that these benchmarks define the minimum requirement/criteria for establishing training and practice of Unani medicine in WHO Member States and the documents shall serve as a reference to national authorities to establish/strengthen regulatory standards to ensure qualified training and practice of Unani medicine.
Another important milestone is the publication of International Standard Unani Terminologies comprising 4,028 terms. CCRUM has also successfully incorporated Unani morbidity codes into the ICD-11 ASU TM 2 Chapter, a crucial step toward global recognition of the Unani medcine. This initiative not only enhances the credibility of Unani Medicine but also integrates it with mainstream healthcare systems.
Power of PPAPs
Public–Private–Academic Partnerships (PPAPs) hold tremendous potential in shaping the future of Unani healthcare delivery. Such collaborations create a robust ecosystem where public sector institutions provide validated knowledge and infrastructure, academia contributes research and innovation and the private sector brings expertise in scale-up, commercialisation, and outreach.
For CCRUM, which has developed a large repository of research data, pharmacopoeial standards, and formulations, these partnerships are an avenue to translate publicly funded research into commer-
cially viable products. By opening up publicly available resources for responsible commercialisation, the impact of Unani research can move beyond laboratories and reach communities in the form of accessible, standardised, and evidence-based healthcare solutions.
Academia can play a pivotal role by strengthening research infrastructure through the establishment of multi-disciplinary research centers and biostatistics units to support rigorous clinical trials and metaanalyses. Collaborations with international universities, the WHO, and global integrative medicine networks can help codevelop standardised research protocols and conduct comparative effectiveness studies. Developing teaching hospitals and clinical partnerships with allopathic institutions would facilitate integrative patient care and enable outcomes-based research. In addition, there is a pressing need for faculty development—training Unani educators in clinical research methods, modern diagnostics, and regulatory science to enhance both academic and clinical standards. Increased public and professional outreach, through publication in peer-reviewed journals, participation in global conferences, and community engagement, can raise awareness and build patient trust. Finally, sustained research investment—via dedicated AYUSH funding, industry partnerships, and international grants—will be essential to accelerate the innovation, validation, and global positioning of Unani therapies.
Looking ahead, public–private–academic partnerships are emerging as the catalyst for Unani’s growth. By translating publicly funded research into commercially viable products, involving academia in rigorous validation, and leveraging private sector expertise in scale-up and distribution, these partnerships can accelerate Unani’s integration into global healthcare.
Sustainable packaging with Romaco and Liveo Research
Recycable blister packs
The field of pharmaceutical packaging is one of many in which sustainability is rising to the top of the agenda. Together with Liveo Research, Romaco is taking another step ahead as a sustainability enabler and manufactures blister packs from PET mono-material with its Noack N 760 blister packaging machine. The PVC-free PET/PET blisters reduce the carbon footprint of the end product. What’s more, they offer equivalent barrier properties to PVC/aluminium blisters when used as an alternative for products currently packaged in this way.
Around the world, packaging and film manufacturers are carrying out research into alternatives to the standard PVC and aluminium blister packaging commonly used across the globe. These are made of laminate comprising several layers of plastic and aluminium – a complex mix of materials that cannot be sorted or recycled after use and which is therefore incompatible with the circular economy. Blister packs with a forming and lidding film of PET (polyethylene terephthalate) offer a more sustainable solution. This mono-material is approved for use in the primary packaging of pharmaceuticals and nutraceuticals, and can also be recycled.
Romaco has recently demonstrated the machinability of the innovative One-Material Blister film (OMB™) from Liveo Research on its Noack N 760 blister packaging machine. The PET One-Material Blister film has been certified recyclable by the TCEP (Tray Circularity Evaluation Platform). Moreover, when used for products currently packaged in PVC/aluminium blisters, the PET/PET blisters boast equivalent barrier properties to their PVC/aluminium counterparts, facilitating the switch to this eco-friendlier alternative. And when it comes to pushing the tablets through the lidding film, the PET/PET blisters are entirely as user-friendly as the
conventional blister packs. Additionally, the significantly lower weight of the PET/PET blisters also puts them ahead environmentally. In four-lane operation, the Noack N 760 platen sealing machine achieves a maximum output of 150 sustainable PET/PET blisters per minute. An international pharmaceutical group is already marketing painkillers in primary packaging made of PET OMB™ from Liveo Research.
N 760 blister packaging machine byRomaco Noack
The N 760 by Romaco Noack is an intermittent motion blister
packaging machine in balcony design for universal use. It is perfect for packaging a very broad range of products from solid dosage forms, ampoules and medical devices to semisolids. Blisters with a maximum forming area of 155 x 138 mm and a maximum forming depth of 25 mm can be produced in this way. Product changes can be carried out quickly and easily, because only a very few compact and lightweight format parts need to be replaced and all parameters are electronically stored. The N 760 has an exceptionally space-saving layout and is easy to operate, fulfilling all of the requirements of the contract
packaging sector, which needs to respond quickly and flexibly at any time to dynamic market situations. With a maximum output of up to 200 blisters per minute, the technology is mainly deployed to produce smaller batch sizes in the low to medium speed segment. The product feeding unit is available in different configurations and is either manual or fully automatic, for example when used with high-tech systems for demanding products or multi-dose blisters. The electrical cabinet can be swung out, meaning the N 760 is readily accessible for maintenance work. Furthermore, the extremely short foil web from the forming station to the die-cutter restricts the amount of waste while running in and retooling the machine to a minimum. Users have the option of connecting the N 760 blister packaging machine to a cartoner and a case packer. Last but not least, the N 760 blister packaging machine from Romaco is compatible with all the format parts of its predecessor, the Noack DPN 760.
Romaco Group
Romaco is a leading international supplier of processing and packaging equipment specialising in engineering technologies for pharmaceutical products. The Group provides individual machines, lines and turnkey solutions for manufacturing, filling and packing powders, granulates, pellets, tablets, capsules, syringes, liquids and medical devices. The company also serves the food and chemical industries. Through its various technologies, Romaco is committed to sustainable production and to systematically reducing CO2 emissions.
The Romaco Group has its headquarters in Karlsruhe (Germany) and is part of the Truking Group, a globally operating high-tech enterprise based in Changsha (China). Truking’s core competency is handling and filling pharmaceutical liquids.
Romaco operates from six production sites worldwide, with a broad portfolio comprised of seven established product brands. Noack and Siebler (Karlsruhe, Germany) supply blister, heat-sealing and rigid tube filling machines. Macofar (Bologna, Italy) markets technologies for filling sterile and non-sterile powders and liquids. Promatic (also Bologna, Italy) specialises in cartoners, track & trace systems and case packers. Kilian (Cologne, Germany) is a leading manufacturer of tablet presses. Innojet (Steinen, Germany) is in the business of granulating and coating fine solid particles. Tecpharm (Barcelona, Spain) offers tablet coating technologies.
More than 930 highly skilled and committed Romaco employees are dedicated to the development of future product technologies and to the continuous implementation of internal improvement processes. The Romaco Group’s multibrand system solutions are sold worldwide through eight Sales & Service Centres and a dense network of local agent organisations. Over 12,000 installations delivered by Romaco are currently in use in more than 180 different countries.
For more information on Romaco, visit our website and social media channels: www.romaco.com –Showroom – LinkedIn – YouTube
Company contact
Susanne Silva
Market Communications
Romaco Group Am Heegwald 11 76227 Karlsruhe
Germany
T +49 (0)721 4804 0 E susanne.silva@romaco.com
Press contact
Micha L. Harris
Senior PR Consultant
Carta GmbH
Iggelheimer Str. 26
67346 Speyer
Germany
T +49 (0)6232 100 111 20 E harris@carta.eu
N 760 blister packaging machine byRomaco Noack
Recyclable blister packaging byRomaco Noackin collaboration with Liveo Research
PETOne-Material Blister (OMB™) from Liveo Research
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PRIME NEO: Newage doors from Gandhi Automation
Gandhi Automations presents the multi-composites, high-performance door PRIME NEO for clean environments.
Complete Washable, Greater Sealing and Pressure Resistant.
When it comes to pharmaceutical facilities and laboratories, clean rooms’ hygiene and protection from environmental contamination are the most important factors to consider.
Gandhi Automation's PRIME NEO High Speed Doors are designed to provide superior sealing and resistance to pressure differences for clean rooms. And the added advantage is that it is absolutely washable.
PRIME NEO High Speed Doors assures Minimized Contamination:
The reinforced polymer material is smooth-surfaced and joint-free. The door structure has been designed with full accessibility for water cleaning. Contamination risks are very minimal, making it fully compliant with the requirements of clean environments.
Just-in-time Opening Cycle: Its smart design and German technology cause no delay in operation. Opening and closing in time reduces exposure time to a minimum, resulting in a reduction in energy costs and the risk of airborne contamination.
Sealing and Resistance to Pressure Differences: The door has a flexible curtain with horizontal FRP stiffeners guided by vertical guides. Pressure is evenly distributed over the whole curtain, pushing it against the guides, giving a perfect seal. This design allows the door to operate even under pressure differences up to 50 Pa in a controlled room environment.
Safety: PRIME NEO reduces the risk of accidents and damage. The free, flexible, and soft bottom edge minimizes hitting impact. The radar detector and inbuilt photocells reopen the door at the slightest impact.
Windows: The transparent material allows people to see
Gandhi Automation's PRIME NEO High Speed Doors are designed to provide superior sealing and resistance to pressure differences for clean rooms.And the added advantage is that it is absolutely washable
coming traffic. Long-term transparency is assured, as the material is anti-fatigue PVC fabric.
Multi-Composite Structure:
The toughness of the side guides and their ability to absorb an impact avoid high repair costs. PRIME NEO is anticorrosion and paint-free, which ensures durability in corrosive and aggressive environments.
Auto-reset: The door is equipped with auto-reset technology. In the event of an accidental crash, the curtain sets
itself again. This unique system avoids time loss and reduces the risk of high repair costs.
For further information on our high-speed doors offering, contact: Gandhi Automations Pvt LtdChawda Commercial CentreLink Road, Malad (W), Mumbai-400064, India. Off : +91 22 66720200 / 66720300 (200 lines) Fax : +91 22 66720201
Email : sales@geapl.com Website : www.geapl.com
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The latest trends in drug discovery
Can gene editing be used as a life-saving treatment? Could antiviral drugs that target human proteins be more effective than those than target the viruses themselves? The constant evo-
publications in less than 10 years, which demonstrates their therapeutic potential. Cancer is the leading disease in PROTAC-related literature, but neurodegenerative, infectious, and autoimmune dis-
lution of drug discovery is one of the most exciting aspects of modern medicine, and new research is leading to breakthroughs in precision medicine, cancer immunotherapy, neurodegenerative disease detection, and much more. Let’s take a closer look at eight key trends happening in drug discovery today.
Chimeras (PROTACs) are small molecules that drive protein degradation by bringing together the target protein with an E3 ligase. To date, ??more than80 PROTAC
eases are represented as well. Despite the diversity of E3 ubiquitin ligases, however, most designed PROTACs act via one of four E3 ligases: cereblon, VHL, MDM2 and IAP. Efforts are now underway to identifynew ligases andutilizeothers already known beyond the main four. These include DCAF16, DCAF15, DCAF11, KEAP1, and FEM1B.
New insights into the structure and functionality of different ligases could enable targeting of various proteins that were previously inaccessible, and it may lead to fewer offtarget effects. Expect to see new PROTAC drug designs entering the preclinical pipeline as researchers continue expanding the E3 ligase
toolbox.
Expanding probiotic use beyond gut health for systemic diseases
The human microbiome — the vast community of bacteria, viruses, fungi, and other microbes living in and on our bodies — plays a crucial role in maintaining health.Far from being passive bystanders, these microbial ecosystems influence digestion, immunity, mental health, and even chronic disease risk. Researchers are harnessing the power of gut bacteria to treat antibiotic-resistant infections, metabolic disorders, and mental health conditions.
For example, fecal microbiota transplants (FMT) have beenapprovedby the FDA to treat recurrentClostridioides difficileinfections. As of 2025,over 180microbiome-targeted therapies were in development for many conditions. A greater understanding of the microbiome’s role in chronic diseases may also result in early-life interventions and dietary recommendations that are low-cost,
long-term improvements to many aspects of human health.
Drug conjugates are innovative molecules that combine a targeting moiety (such as an antibody, peptide, or small molecule) with a potent therapeutic payload (e.g., chemotherapy agents, toxins, or radionuclides), enabling selective delivery to diseased cells while sparing healthy tissues. There are several types in existence, such asantibody-drug conjugates, and now researchers are making progress with radiopharmaceutical conjugates.
This form of nuclear medicine combines targeting molecules with radioactive isotopes for imaging or therapy. These
specific cells. These drugs can also improve efficacy through better targeting of tumors with a lethal payload. We expect to see increased use of these theranostic approaches as several radiopharmaceuticals have entered late-stage clinical trials or received regulatory designations.
Scaling CAR-Ttherapy
for solid tumors with next-generation platforms
Immunotherapy has become a pillar of cancer treatment, along with surgery, chemotherapy, and radiation. The number of immunotherapy drugs is constantly growing, andCAR-T therapies, which use a patient’s own genetically engineered cells to attack and kill cancer cells, have been found particularly effective. Yet their cost and thedevelopment time from an
drugs are in the development pipeline, and over 100 commercial organizationsare involved in this field of research. We’ve seen in theCAS Content CollectionTM, the largest human-curated repository of scientific information, a sharp increase in PROTAC-related
conjugates offer dual benefits — real-time imaging of drug distribution and highly localized radiation therapy. For cancer treatments, radiopharmaceutical conjugates can reduce off-target effects and toxicity by directing drugs to
individual’s cells make them prohibitive for most cancer patients. Advances in allogeneic and armored CAR-T cells are overcoming problems of cost and scale as well as drug efficacy, and they may hold the key to expanding the use of these cancer treatment options to more patients:
◆ Allogeneic CAR-T: These are donor-derived or gene-edited cells that are faster and more affordable to develop than autologous (patient-derived) CAR-T cells. By providing an off-the-shelf option, these treatments could be-
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come more accessible to a larger pool of patients.
◆ Dual-target and armored CAR-T: Dual-target CAR-T cells recognize two antigens, while armored CAR-Ts are engineered to secrete cytokines or resist immunosuppression, which enhances efficacy and durability. Several dual-target CAR-Ts (e.g., AUTO1/22, CD19/CD22) are in clinical trials (CAR-T for pancreatic cancer;CAR-T for solid tumors), and armored CAR-Ts like ATA3271 are being developed to overcome tumor escape and exhaustion. These innovations aim to reduce relapse rates and improve outcomes in cancers with high antigen variability or immunosuppressive environments.
Enabling earlydiagnosis of neurodegenerative diseases with biomarkers
Biomarkers are measurable biologicalindicatorsin blood, tissue, or bodily fluids that reflect normal or pathological processes, and they play a pivotal role in detecting diseases at their earliest, most treatable stages. In cancer treatment, for example, BRCA1/2 genetic mutations are an important component of preventive care for breast and ovarian cancers.
Now, blood-based and imaging biomarkers are being developed to detect early signs of neurodegenerative diseases like Alzheimer’s and Parkinson’s before clinical symptoms appear. Recentstudieshave
By demonstrating the feasibility of rapid, individualized gene editing, even for lifethreatening conditions, this breakthrough could lead to new options for rare diseases that have no existing treatments. Beyond this type of personalized medicine,in vivo CRISPR therapies may be the next evolution in treating cardiovascular and metabolic diseases. For example, CRISPR Therapeutics’ CTX310reducedLDL by 86% in Phase 1 trials, and Intellia’s NTLA2002 for hereditary angioedema hasenteredPhase 3 with strong early efficacy.
also validated plasma biomarkers (e.g., phosphorylated tau) that correlate with early Alzheimer’s pathology, enabling earlier diagnosis and trial enrollment. Early detection could allow for timely intervention, improve clinical trial design, and shift the focus from symptom management to disease prevention.
Transforming drug development with AI-powered trial simulations
AI in healthcare is pushing all sorts of newboundaries, and the technology is constantly improving. Not only are AI models and platforms capable of designing novel drug candidates and predicting protein structures, but they’re now accelerating the clinical trial process. Quantitative systems pharmacology (QSP) models and “virtual patient” platforms simulatethousands of individual disease trajectories, allowing teams to test dosing regimens and refine inclusion criteria before a single patient is dosed. AI-powered digital twins are also transforming clinical development and translational research. For ex-
ample, Unlearn.ai has validated digital twin-based control arms inAlzheimer’s trials, demonstrating that AI-augmented virtual cohorts can reduce placebo group sizes considerably, thereby ensuring faster timelines and more confident data without losing statistical power.
Launching rapidresponse gene editing with personalized CRISPR therapy
In 2025, a seven-month-old infant with CPS1 deficiencyreceivedpersonalized CRISPR base-editing therapy developed in just six months. This treatment was delivered via lipid nanoparticlesto correct a life-threatening mutation and marked the first use of CRISPR tailored to a single patient.
Accelerating antiviral discoverywith AI to fight future pandemics
Antiviral drugs work by disrupting a virus’s ability to infect and replicate, targeting stages like cell entry, replication, or release. Traditionally tailored to specific viruses, these treatments are now evolving into broad-spectrum antivirals and host-directed therapies — approaches that target shared viral mechanisms or the human cellular pathways that viruses exploit. To accelerate development, researchers are leveraging AI and machine learning to identify and design promising compounds, often before a new virus even appears.
◆ Broad-spectrum antivirals(BSAs) are designed to target conserved viral elements or host pathways shared across multiple virus
families, enabling a single drug to work against diverse pathogens. These could serve as a first line of defense in future outbreaks by buying time until pathogen-specific treatments are developed.
◆ Host-derived antivirals (HDAs) target human proteins or pathways that viruses require, rather than the virus itself. They mayprovide more durable antiviral protection from rapidly mutating viruses.
◆ Machine learning is screening compound libraries, predicting viral protein structures, and identifying hostvirus interaction networks before new pathogens emerge. Global initiatives likePANVIPREPin the EU and the U.S. Antiviral Program for Pandemics are investing in AIdriven platforms to preemptively identify antiviral candidates. These inn ovations can enable a proactive rather than reactive response to a new outbreak or pathogen.
Additionally, last month (August 2025), researchers at MITreportedthe invention of antibiotics using generative AI against drug-resistant strains of gonorrhea and Staphylococcus aureus. While still in the early stages, this breakthrough is likely to be a beacon of hope for antibiotic research.Drug discovery is always in motion, and with AIdriven tools and the rise of personalized medicine, we can expect to see more breakthroughs in 2025 and beyond.
At CAS, we’re keeping our finger on the pulse of new innovations in drug discovery, and you can stay up-to-date on the latest research here. Visit https://www.cas.org/resources/ cas-insights for more information
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Flexotherm Heating Tapes & Cords
Typical Applications of Heating Tapes and Cords in Industrial Solvent Handling
Handling and processing solvents in industrial environments requires precise temperature management. Many
Tempo heating cords and tapes are thin, robust, and easy to wrap around drums, pipes, valves, or vessels. They deliver uniform heating, reduce the risk of cold spots, and can be paired with Tempo’s digital or
2. Pipeline and Transfer Line Heat Tracing Solvent transfer lines are prone to cooling and blockages. Flexotherm™ heat tracing cords maintain consistent flow and prevent condensation or freezing.
5. Laboratory Solvent Applications
◆ Energy Efficiency: Localized heating ensures minimal energy loss.
solvents are sensitive to fluctuations—too cold, and they may thicken or crystallize; too hot, and they may degrade or evaporate. Tempo’s Flexotherm™ heating tapes and cords provide a safe, flexible, and efficient solution for maintaining solvent temperature across a wide range of industrial processes.
WhyTempo Heating Tapes and Cords?
Unlike bulky heating systems,
thermostatic controllers for precise monitoring and safe operation.
Typical Applications in Solvent Handling
1. Drum and Container Heating
Solvents stored in poly or metal drums can become viscous at low temperatures. Tempo drum heating jackets and tapes keep contents at the right viscosity for safe pumping, mixing, or decanting.
3. Valve and Flange Heating
Critical fittings often act as cold spots. Tempo heating tapes eliminate these risks, ensuring solvents move smoothly through the system.
4. Reactor and Vessel Heating
In chemical processing, Tempo customized heating solutions wrap neatly around reactors, tanks, or vessels to deliver controlled, uniform heating.
From Soxhlet extractors to heating mantles, Tempo lab heating products support safe solvent extraction, distillation, and analysis.
◆ Safety: Avoids leaks and blockages from cold solvent lines.
◆ Flexibility: Easy to install on pipelines, drums, reactors, or valves.
6. Gas Cylinder Warming
For solvent-related gases such as SF6, propane, or nitrogen, Tempo cylinder warmers improve pressure stability and minimize losses due to condensation.
Advantages with Tempo Solutions
◆ Viscosity Control: Prevents thickening, crystallization, or freezing of solvents.
For further information: Tempo Instruments Pvt. Ltd.
Top Syringe Compound, 126, Western Exp. Highway, Behind Samrat Hotel, Near Lodha Aqua, Pandurang Wadi, Mira Road (East), Dist. Thane - 401104. Web: www.tempoinstruments.com E-mail : Sanjiv.Gupta@ shandilyagroup.com
Single-Use Technologies in Biologics Manufacturing: Benefits,Challenges,and Growing Demand
Abstract
The biopharmaceutical industry is increasingly adopting single-use technology (SUT) to achieve flexibility, cost efficiency, and faster time-to-market. Compared with stainless steel systems, SUT reduces capital investment, eliminates cleaning and sterilization steps, lowers contamination risk, and shortens production timelines.
This paper reviews the benefits, challenges, and growing demand for SUT in biomanufacturing.
Introduction
Single-use technologies (SUT) are disposable components such as bioreactors, tubing, filters, and storage bags, designed for one-time use before disposal. Introduced in the
Benefits of Single-Use Technologies
early 2000s, SUT has expanded from simple buffer preparation to complex upstream and downstream bioprocessing.
The demand for biologics, vaccines, and personalized medicines has accelerated adoption, with SUT now dominating small- and mid-scale facilities and expanding into large-scale operations. Unlike stainless steel, which requires costly infrastructure and lengthy cleaning, SUT enables rapid product changeovers,
Reduced water/energyuse; potential for recyclable/ biodegradable materials
Shorter setup and validation; quicker responses to healthcare demands
Riskof production delays; need for diversified suppliers
Time-consuming approvals and additional testing
Recurring disposable costs may exceed stainless steel
reducing downtime and enhancing flexibility.
SUT’s benefits have made it a cornerstone of biomanufacturing, especially during urgent healthcare needs such as the COVID-19 pandemic.
Conclusion
Single-use technologies have reshaped biologics manufacturing by lowering costs, enhancing flexibility, and accelerating production. While waste management, supply reliability, and regulatory hurdles remain challenges, ongoing advances in material science, hybrid systems, and recycling initiatives are expected to improve adoption. As the industry shifts toward agile and personalized medicine, SUT will continue to
play a vital role in the future of biomanufacturing.
Written by: Suresh Rathod Assistant manager, Bioprocess marketing & sales
Suresh.r@amipolymer.com
Contact No - 6357077083
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PROSOLV® SMCC 50 - Ahigh-functional excipient from JRS Pharma
The development of coprocessed, multi-functional excipients has enabled formulators to address multiple challenges with a single excipient, resulting in enhanced production and better finished product quality.
WhyPROSOLV® SMCC?
Attaining good hardness at low compaction forces is quite essential while considering suitability of excipient for tablet formulation. Microcrystalline cellulose is one of the widely used and accepted excipients in tablet dosage form. Compactability of microcrystalline cellulose (MCC) is of prime importance during compression.PROSOLV® SMCC is a novel high-functionality tableting excipient. The material is manufactured by co-processing MCC with colloidal silicon dioxide (CSD) and can be used to improve flow, lubricant sensitivity and tablet strength. The addition of CSD in MCC helps to improve compactability [1][2]
It has been reported that silicification appears to have no apparent effect on the primary chemical and polymorphic characteristics of MCC. This suggests that bulk modification of MCC does not occur during silicification and that the CSD, either by providing surface modification or by modifying strengthening interactions, is primarily responsible for the improvements in functionality, in particular tablet strength. This may be solely due to a morphological property or some other silicon dioxide MCC interfacial interaction. Based on scanning electron microscopy studies together with electron microprobe analysis, it was stated that silicon dioxide is primarily located at the surface of the SMCC particles. While certain amounts of silicon dioxide were detected in the internal regions of some particles, the colloidal silicon dioxide particles present
PROSOLV® SMCC is available in following grades[3]
PROSOLV® SMCC 50 LDBest in class binder (improves tabletability)
PROSOLV® SMCC 50Formulas in which optimal compaction and decent flow are required
PROSOLV® SMCC 90Formulas in which a balance of flow and compaction are required
PROSOLV® SMCC HD 90Formulas in which optimal flow and consolidation are required
PROSOLV® SMCC 90 LMEquivalent to PROSOLV® SMCC 90, with lower moisture content
at the surfaces of the SMCC particles are shown to be uniformly distributed[2][4]
PROSOLV® SMCC provides solutions to the problems often encountered by formulation scientists while using conventional diluents having low bulk density (BD), poor flow, low compactability or loss of compactability during processing, sticking and sensitivity to lubricant(s). This article will focus on physico-chemical properties, applications and advantages of PROSOLV® SMCC 50 & PROSOLV® SMCC 50 LD.
SMCC grade, it is having benefits like it improves the tablet hardness and re-compactability issues after roller compaction.
PROSOLV® SMCC 50 LD can be first choice.
PROSOLV® SMCC 50 can be useful when both tablet hardness and powder flow are required.
Following are the case studies to evaluate the effect of physiochemical properties of PROSOLV® SMCC 50 and PROSOLV® SMCC 50 LD on tablet dosage form.
Roll compaction is necessary
PROSOLV® SMCC 50 LD is the Lowdensitygrade from PROSOLV® familyof excipients having belowcharacteristics –
Particlesize(d50)Bulkdensity
Around 50 μm0.20-0.30 g/cc
PROSOLV® SMCC 50 is the grade from PROSOLV® familyof excipients having belowcharacteristics –
Particlesize(d50)Bulkdensity
Around 65 μm0.25-0.37 g/cc
These grades offers several benefits to formulation development scientist(s) during development and production at later stage. These benefits along with a few case studies will be elaborated in next section of this article –
Benefits of PROSOLV® SMCC 50 and PROSOLV® SMCC 50 LD in Roller Compaction Applications [3][4]: As stated above,Silicification of Microcrystalline cellulose results in an increase in surface area. This increase in surface area increases binding interaction between the individual particles by reducing the interparticulate cohesion. As a result, silicification improves both the flowability and re-compaction properties of compacts.
PROSOLV® SMCC 50 LD is a low-density PROSOLV®
to improve bulk density, flowability, compactability & to improve content uniformity in the tablet dosage form.
In this study the comparison of MCC 101, PROSOLV SMCC 50 & PROSOLV SMCC 50 LD was studied & evaluated in roller compaction. The Powder blends used consisted of 75% of the Cellulosic compound (either MCC or SMCC) and 25% Dicalcium phosphate dihydrate.Material were blended for 10 mins.Different roller compaction forces were adjusted and the compacts were milled. The resulting powder was tested for particle size distribution and flowability. Furthermore, placebo tablets containing 0.5% of the lubricant, Sodium Stearyl fumarate (PRUV®), were compressed (Tablet weight- 400 mg, round,
Ingredients Percentage
PROSOLV® SMCC or MCC 75 %
DCP (EMCOMPRESS®) 25 %
PRUV® (Extra granular) 0.5 %
ated. After roller compaction compacts density plays an important role to get desired Granules: Fines ratio. This is important step for the flow & content uniformity point of view.
Conclusion:
The silicification of MCC has
MCC 101 PROSOLV® SMCC 50 PROSOLV® SMCC 50 LD
Observation: MCC 101,PROSOLV® SMCC 50 and PROSOLV® SMCC 50 LD yield nicelyshaped hard compacts at 25kN compaction force. From above picture we can conclude that PROSOLV® SMCC 50 LD yields dense compacts compare to Microcrystalline cellulose.
Flowability
In this studythe flowof milled compacts was evaluated.
Observation: Compacts were milled.It was found that PROSOLV® SMCC 50 exhibit best flowabilityfollowed byPROSOLV® SMCC 50 LD and MCC 101.
13mm diameter) and hardness as well as disintegration time of compressed tablets was analyzed.
Compacts comparison:
In this study, the comparison of compacts at 25 KN was evalu-
been shown to significantly influence the hardness and the flowability of compacts in roll compaction process, as well as the hardness of tablets made from granules obtained from the milled compacts. If the overall target in tablet production is
PHARMA PULSE
Tablet Hardness
In this studythe effect on Tablet harness of roller compacted granules was evaluated.
Observation: Tablets were manufactured byusing lubricant sodium stearyl fumarate (PRUV®) & compressed in to tablets. Compacts based on PROSOLV® SMCC 50LD yield 30% harder tablets.Compacts based on MCC 101 and PROSOLV® SMCC 50 have nearlyidentical tablet hardness profiles over the entire range of compression forces.
the highest possible tablet hardness, the use of PROSOLV® SMCC 50 LD recommended [3][5][6].
If both, the particle flow and the tablet hardness is the target PROSOLV® SMCC 50 is the best choice [3] .
REFERENCES
[1] Tobyn, M.J., McCarthy, G.P., Staniforth, J.N., Edge, S. (1998) Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose. Int. J.Pharm. 169, 183-194.
[4] Sherwood, B.E., Becker, J.W. (1998) A new class of high functionality excipients: silicified microcrystalline cellulose. Pharm. Tech. 22, 78-88.
[5] Staniforth, J. N., Tobyn, M. J. (1996) towards a new class of high functionality tablet binders. III: Physical characteristics and particle morphology of silicified microcrystalline cellulose (SMCC). Proc. AAPS Conf. PT6162
[6] Sherwood, B. E., Hunter, E. A., Staniforth J. N. (1996) Silicified microcrystalline cellulose (SMCC): a new class of high functionality binders for direct tableting. Proc. AAPS Conf. PT 6164
AUTHOR Prashant Bhangdiya Business Development Manager –Pharma Rettenmaier India Private Limited Prashant.bhangdiya@jrsindia.com
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