ENTERPRISE RISK MANAGEMENT (ERM): ACRITICAL IMPERATIVE FOR INDIA'S PHARMACEUTICALSECTOR
P23: DR ABDELAZIZTOUMI CEO,LUPIN MANUFACTURING SOLUTIONS (LMS)
LOGISTICS
27 SUPPLYCHAIN LEADERSHIP: STEPPING INTO THE SPOTLIGHT
Nihar Medh Pramod Pandit
Bharat Bhushan Rathi DeepakKhurana
PHARMA TECHNOLOGY
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COLIFORM BACTERIAAND E.COLI IN PHARMAWATER SYSTEMS: AHIDDEN THREATTO PRODUCTINTEGRITY
47 INDIAIS ASTRATEGICALLYIMPORTANTMARKETFOR OPTIMAAND THIS IS WHYWE ARE INCREASING OUR FOOTPRINTHERE
49 NEWTECHNOLOGIES TO COMBAT COUNTERFEIT DRUGS
Regd.With RNI No.MAHENG/2005/21398.Postal Regd.No.MCS/164/2025 - 27.Printed and Published byVaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press,Plot No.EL-208,TTC Industrial Area,Mahape,Navi Mumbai-400710 and Published at Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021.
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How counterfeiters are breaching India’s QR code system
There is growing concern that a sizable proportion of medicines in India could be unsafe for patients. For example, on April 19, 2025, CDSCO published three lists of Not of Standard Quality (NSQ) drug alerts for March 2025, spanning 131 product batches. The most common reason cited is failing the dissolution test as per IP 2022.
In the recent past, pharma associations as well as many individual pharma companies have clarified the differences between various terms: spurious, NSQ and counterfeits, seeking to distance themselves from products emanating from the ‘grey market’.
More recently, news has filtered out that four batches of Sun Pharma's Levipil 500, an antiepileptic medication, have fake QR codes.
Writing for Express Pharma in two successive blog posts, Dr Avi Chaudhuri, a global expert on anticounterfeiting, gives details of how Sun Pharma seems to be the victim of digital leakage of QR codes, either from the code generating source (the vendor supplying the codes) or the code application site (Sun Pharma’s plant in Assam).
And, this is one of the early companies to comply with the Ministry of Health and Family Welfare’s QR code mandate for the top 300 drugs, “in ways that security specialists view as a best-practices approach”. As he argues, the QR code has turned out to be a “gift to the counterfeiter.”(Ref: https://www.expresspharma.in/atroubling-new-development-in-indias-qr-code-saga/, https://www.expresspharma.in/sun-pharma-mustimmediately-declare-a-voluntary-recall-of-levipil-500/)
As Dr Chaudhuri narrates, counterfeiters succeeded in placing a unique active code on every fake package, and that each counterfeit variant will therefore be successfully authenticated in the hands of a consumer.
His findings were subsequently supported by further investigation by Dr Hemant G Koshia, Commissioner, Food & Drugs Control Administration (FDCA), Gujarat. The FDCA investigation concluded that “the incident represents a first-of-its-kind operation involving interstate trade of counterfeit drugs with active QR codes encompassing at least six states as of now (Delhi-NCR, Gujarat, Madhya Pradesh, Maharashtra, Uttar Pradesh and West Bengal)” and involved 8-10 distributors in Gujarat alone.
We have approached Sun Pharma for a response to this news, and will feature an update when we do get a response. The company, like a few of its peers, has acted proactively in the recent past, issuing an advisory to its distributors on the escalating threat of counterfeit medicines. The advisory dated March 18, 2025 reportedly urged its CFAs and distributors to purchase only from authorised sources to prevent counterfeit and substandard drugs from entering the supply chain.
If the QR code system is not all that it was promised to be, what are the next steps to safeguard our medicines?
If the QR code system is not all that it was promised to be, what are the next steps to safeguard our medicines? As it primarily seems to be a case of a compromise of the serial number bank, what can companies do to prevent such digital theft? How can they respond faster, with recalls and increased consumer awareness campaigns, when counterfeiters manage to outsmart the system?
Dr Chaudhuri has suggested three steps in his second blog post: inactivating all serial numbers associated with the four batches of Levipil 500 known to have been compromised so far — (GTF0885A, GTF1456A, GTF1540A and GTF3432A), ordering a voluntary recall of all Levipil 500 products belonging to these four identified batches thus far and thirdly, understanding how this happened and disclosing it so that the whole industry can take preventive steps.
It’s clear that we need changes at the policy level too. India’s pharma sector has invested precious resources and time to deploy track and trace (TnT) infrastructure in roder to comply with the QR code mandate. Such incidents beg the question: were they the wrong choice of TnT systems, given the complexity of India’s pharma supply chain? Could these failures be due to faulty implementation? And more importantly, where do we go from here?
Commenting on Dr Chaudhari’s investigations and conclusions, Bejon Misra, founder of Patient Safety and Access Initiative of India Foundation and a consumer policy expert, says,“Both the blogs talk about what we already know and had shared with the Government regarding the risks connected with QR Code.
Unfortunately the Government never takes us seriously. We had at length proposed the technology that will enable a robust tracing and tracking system to protect the consumers from spurious and NSQ medicines. World over the accepted technology is being implemented and it is high time India harmonises with the world. We must go for serialisation and data security in a robust manner. Jan Aushadhi has constituted a Committee to look at Blockchain Technology as an option.”
While we wait for more clarity and action from the various stakeholders, it is clear that counterfeiters will always outsmart technology. It is time policy makers and pharma companies enlist India’s patients and caregivers in this war against counterfeiters. After all, they stand to lose the most.
19th edition of PharmaTech Expo & LabTech Expo 2025 held in Chandigarh
Three-day event organised by PharmaTechnologyIndex.Com,featured over 300 exhibitors,drew 5,000 industry professionals,and hosted seminars and panel discussions on regulatory updates, innovation,and industry challenges
The 19th edition of PharmaTech Expo & LabTech Expo 2025, Chandigarh was successfully held from April 10th to 12th, 2025, at the Parade Ground, Sector 17, Chandigarh was organised by PharmaTechnologyIndex.Com. The expo's success was marked by its ability to foster meaningful connections and spark innovative ideas. Through its comprehensive showcase of pharmaceutical technology and laboratory equipment, the event provided a platform for industry professionals to explore new trends, share knowledge, and drive growth. With its strong focus on collaboration and inn ovation, PharmaTech Expo & LabTech Expo 2025 cemented its position as a leading event in the pharmaceutical industry, setting the stage for future advancements and breakthroughs.
The expo covered an area of 15,000 square meters, featuring over 300 exhibitors
from across the industry. The event attracted approximately 5,000 visitors, including industry professionals, entrepreneurs, regulatory authorities, and delegates.
Inauguration of PharmaTech Expo and LabTech Expo
The event was inaugurated on 10th April 2025 by Chief Guest Harshwardhan Chauhan, Hon-
ourable Minister for Industries, Himachal Pradesh.
The Minister further shared that, “in an era where the pharmaceutical and pharma machinery industries are growing
at an unprecedented pace, platforms like PharmaTech Expo are vital. They enable knowledge exchange, showcase innovation, and ensure that Indian industry stakeholders maintain
POST EVENTS
a competitive edge on the global stage”
The Inauguration Ceremony was attended by several dignitaries, including:
Dr H G Koshia, Commissioner FDCA, Gujarat, Raja Bhanu, Director General, PHARMEXCIL, Dr Pradeep Mattu, Former Joint Commissioner Drugs, Punjab, Dr Manish Kapoor, State Drugs Controller, Himachal Pradesh, Sushant Sharma, Deputy Drugs Controller (India) CDSCO, Himachal Pradesh, Manmohan Taneja, State Drugs Controller, Haryana, Sanjeev Kumar, Joint Commissioner Drugs, Punjab, Dr Rajesh Gupta, President, Himachal Drugs Manufacturers Association (HDMA), Harish Jain, President, Federation of Pharmaceutical Entrepreneurs (FOPE), Arun Goyal, Director, Tirupati Group, Sanjay Singla, Director, MMG Healthcare, Ramesh Arora, Managing Director, Kwality Pharmaceuticals Ltd., Jawaid Imam, Sr. Vice President, Aristo Pharmaceuticals, and Arun Shukla, CEO, Vishwakarma Industries.
Many Exhibitors launched New Machines & Technologies In PharmaTech Expo & LabTech Expo Chandigarh. Some of them are as follows: Falcon Machineries, N.K.P. Pharma, Pharmachine India, Ambica Pharma Machines, Indu Ionpure India, Brothers Pharmamach (India), Saimach Pharmatech, Radiant Industries, Aureole Pharma, Limra Integrated Project Work, Agilent Technologies India etc.
The expo included a series of seminars and panel discussions on topics
1. Panel Discussions on: Revised Schedule M on 10th April - Gap Analysis: Aarjav Shah, CEO, PharmaTechchnologyIndex.Com Pvt Ltd given the welcome Address. Dr Rajesh Gupta, President, Himachal Drugs Manufacturers Association (HDMA) lodged the Opening remarks followed by the Keynote Address by Dr H G Koshia, Commissioner FDCA, Gujarat.
Harish Jain, President, Federation of Pharmaceutical Entrepreneurs (FOPE) Set the
Address by Money khannaashrae chandigarh chapter president elect and ishrae chandigarh chapter treasurer.
S. Balkar singh Ashrae chandigarh chapter presidential & Mukul grover Ishrae chandigarh chapter presidential also given the address Manpreet singh spoke on topic - energy conservation opportunities in pharma utilities through energy audits. Pradeep singh spoke on topicsmart air handling in pharmaimproving indoor air quality and energy efficiency. Ravinder singh spoke on topic - the critical role of refrigeration in pharmaceutical manufacturing and storage. Bhupinder singh Parmar spoke on topic - optimising pharma facility programme- effective testing and commissioning strategies.
3. Panel discussion on China Plus One (C+1): Possibilities and Challenges in Pharmaceutical & Medical Devices Sector happened on 11th April where Dr Anil Kumar Angrish Associate Professor, NIPER S.A.S. Nagar, spoke about Need for China Plus One (C+1) due to de-
Context for Panel discussion.
Dignitaries who were the part of Panel discussion are Raja Bhanu, Director General, PHARMEXCIL, Dr Pradeep Mattu, Former Joint Commissioner Drugs, Punjab, Dr Manish Kapoor, State Drugs Controller, Himachal Pradesh, Sushant Sharma, Deputy Drugs Controller (India), CD-
SCO, Himachal Pradesh, Manmohan Taneja, State Drugs Controller, Haryana, Amit Duggal, Assistant Commissioner of Food and Drugs Administration in Punjab
2. Seminar on SAMATA - Balancing Act: Quality, Energy, and Innovation in Pharma on 11th April by Ashrae & Ishrae Chandigarh chapter. Welcome
pendence on China for APIs and Opportunities for India. Prof. Anand Sharma, NIPER S.A.S. Nagar, talked about Existing Initiatives to become selfreliant in APIs and Medical Devices, e.g., PLI in Bulk Drugs, Bulk Drug Parks, and PLI for Medical Devices and other dignitaries who were talked there Supreet Singh, Founder &
CEO, Psychocare Health, Punit Bansal, Director & Promoter, Theon Pharmaceuticals, Dr G. S. Pandey, Director, GAMP Technologies, Dr D. N. Dikshit, Director, Aqex Pharma Solutions (opc).
The expo sawsignificant support from industry associations,including Himachal Drug Manufacturers Association (HDMA), Federation of Pharma Entrepreneurs (FOPE), Laghu Udyog Bharati (LUB), Drug Marketing & Manufacturers Association (DMMA), Ambala Scientific Instruments Manufacturers’ Association (ASIMA), The Indian Society of Heating, Refrigerating and Air Conditioning Engineers (ISHRAE), The American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE), Fire and Security Association of India (FSAI), Fire Awareness and Safety Association (FASA) & Bhagwanpur Industries Association.
Conclusion
Future events should continue to focus on showcasing the latest technologies and innovations in the pharmaceutical sector. More emphasis should be placed on attracting international exhibitors and visitors to further enhance the event's global reputation. The event should continue to provide a platform for industry professionals to connect, share knowledge, and drive growth.
The PharmaTech Expo & LabTech Expo 2025, Chandigarh was a resounding success, providing a platform for industry professionals to connect, innovate, and grow. The event's impact is expected to be felt across the pharmaceutical industry, driving advancements and innovation in the years to come.
The success of the PharmaTech Expo & LabTech Expo 2025 would not have been possible without the support of our sponsors, exhibitors, visitors, and partners. We would like to extend our gratitude to all those who contributed to the event's success, including the dignitaries who graced the occasion with their presence.
Leading experts converge to explore advances in excipient technologies for next-generation oral formulations
In a landmark seminar held on April 22, 2025, TransChem Corporation Pharma Pvt Ltd., in collaboration with BASF Pharma Solutions, hosted an insightful and knowledge-rich event at the prestigious ITC Narmada, Ahmedabad. Titled “Formulator’s Forum: Focusing on Your Oral Formulation Needs with Kollidon and Beyond”, the event delved deep into innovative excipient solutions driving
next-generation oral dosage forms.
Dr Krishna Bhavanasi the distinguished guest speaker from Torrent Pharmaceuticals set the tone with a compelling presentation on Advancements in 505(b)(2) regulatory pathways. The international spotlight continued with Kai Zhuang and Umakanth Kanna from BASF Pharma Solutions, who shared cutting-edge perspectives on Push-Pull
Technology for Controlled Release and Nitrosamine Control Strategies, respectively.
Adding further value, Dr Aditi Poddar and Dr Rajkiran Narkhede, from BASF Pharma Solutions, Mumbai, addressed the multifaceted applications of Kollidon Grades and innovations in Solid Dispersions.
A standout session by Anna Kanios from Elementis showcased the versatile and essential role of Talc as a pharma-
ceutical excipient, sparking dynamic discussion and curiosity among participants.
With 125+ formulation scientists, R&D experts, and industry professionals in attendance, the seminar was widely praised for its practical insights and technical depth. The event's success was driven by the strategic vision and leadership of Zubin Zaveri, Managing Director and Shivang Zaveri, Managing Director
of TransChem Corporation Pharma.
This collaboration between BASF Pharma Solutions and TransChem Corporation Pharma exemplifies a shared commitment to innovation and excellence in pharmaceutical formulation science. As the industry advances, such forums will continue to act as vital platforms for knowledge exchange and collaborative progress.
IT Enterprise RiskManagement (ERM): Acritical imperative for India's pharma sector
Gurmeet Singh, Procurement Director at Alfa Pharma,
highlights how risk-resilient practices can strengthen the Indian pharma sector’s global standing
The Indian pharmaceutical industry is one of the largest globally, known for its significant role in the production of generic drugs, contributing around 20 per cent of the global supply by volume. The industry is crucial in meeting global healthcare needs, especially in producing affordable medicines. However, the sector faces several supply chain challenges, affecting both domestic and international operations. However, the sector faces numerous risks and disruptions, including geopolitical tensions, pandemics, supply chain failures, and regulatory challenges. To address these challenges, there is an emergent need for the sector to develop and embrace a comprehensive Enterprise Risk Management (ERM) framework tailored to the unique needs of Indian pharma companies. Some of the key challenges faced by Indian Pharma are the following:
1. Dependence on China for imports of basic chemicals and input raw materials.
2. Regulatory hurdles and need to comply with USFDA and European Medicine Agency regulations.
3. Logistical bottlenecks, the complex transport net-
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work, port congestion, road conditions and inadequate cold chain infrastructure.
4. Quality control issues arising from deviation from the Standard Operating Procedures resulting in product failures and product recalls impacting the company’s reputation and revenues.
5. Supply chain disruptions arising out of unforeseen pandemics, further getting compounded by sudden price increase, contract cancellations and non-availability of critical raw materials.
6. Inadequate technology integration, lower focus on innovation and minimal R&D spend. Indian companies lag in adoption of advanced technologies like block chain, AI in drug discovery and use of robotics.
7. Environmental impact due to pollution from pharmaceutical waste. Many units face a sudden stoppage due to non-compliance and risks thereof.
8. Product recalls and adverse FDA 483 observations resulting is revenue impact
ERM – The purpose
The purpose of Enterprise Risk Management (ERM) policy framework in an organisation is to establish a structured and systematic approach to identifying, assessing, managing, and monitoring risks that may impact the achievement of the organisation’s strategic and operational objectives. The ERM policy framework once tailored to the organisations requirement will ensure alignment with regulatory requirements and industry best practices to enhance resilience and long-term sustainability. This policy applies to all business units, functions, and subsidiaries of the organisation. It covers strategic, financial, operational, regulatory, reputational, IT/cybersecurity, ESG, and compliance risks.
The competitive advantage of ERM Companies that implement comprehensive ERM strategies don’t just manage risk -
they create opportunities. By embedding ERM into business strategy, decision-making, and operations, pharma companies can drive:
◆ Stronger investor confidence
◆ Enhanced operational efficiency
◆ Better regulatory preparedness
◆ Sustainable long-term growth
Keycomponents of the ERM framework
◆ Risk identification
- Categorise risks into Strategic, Financial, Operational, Compliance, Cyber, and Reputational risks.
- Use Risk Registers, SWOT analysis and others
◆ Risk assessment & prioritisation
- Use a Risk Matrix -Likelihood vs. Impact, to classify risks as High, Medium, or Low.
- Conduct Scenario Analysis and Stress Testing for critical risks
◆ Risk mitigation strategies
- Develop a Risk Response Plan - Avoid, Mitigate, Transfer, Accept
- Implement a Risk Dashboard for real-time tracking.
- Conduct regular risk audits and quarterly risk committee meetings.
Introducing ERM in a pharma organisation
In a highly complex and regulated pharma industry, there are risks at every step. From evolving regulatory landscapes to global supply chain disruptions, from clinical trial uncertainties to reputational vulnerabilities, the need for a structured and proactive approach to risk management is most important and a strategic imperative. It becomes a value-adding discipline that supports compliance, safeguards innova tion, and protects every aspect of all the stakeholder. A roadmap to effectively implement ERM in a pharma setting.
1. Importance of executive sponsorship and board alignment
In a pharma organisation, the link between ERM and regulatory compliance (FDA, EMA), product quality, and patient safety makes it a natural fit for a board-level oversight.
The first step is to define the ERM mandate, gain approval for an ERM charter, and establish the function as a critical part of corporate gov-
ernance. ERM is to be seen as a strategic enabler.
2. Assess current state and compliance gaps
It is important to understand the baseline as to where the Organisation currently stands. Conduct a thorough risk maturity assessment and gap analysis with respect to industry standards like ICH, ISO 31000, and COSO ERM. In pharma, the assessment must include - cGMP adherence, clinical trial risk, Pharmacovigilance and patient safety, data integrity, Supply chain traceability etc
3. Define the ERM framework and governance structure
With a clear view of current gaps, establish an ERM framework tailored to pharma operations. The framework should define risk principles, reporting structures, and escalation protocols. This may include a CFT - Cross Functional ERM team having participants from Regulatory, Quality, Medical, Supply Chain, and Legal. This should be followed by a defined risk ownership across business units, a Board approved risk appetite statement which will be different for different organisation. However, this may be guided by the following:
◆ Regulatory and compliance risks e.g., FDA 483s, consent decrees
◆ Supply chain risks e.g., API shortages, Logistical disruptions
◆ Market and IP risks e.g., patent cliffs etc
Once these risks are compiled into Risk Register, thereafter take steps to prioritise them for further analysis.
4. Facilitate risk assessments across departments Risk cannot be managed in silos. A collaborative process ensures a 360-degree view of enterprise risk and builds ownership across the organisation.
5. Integrate ERM with strategic planning
The true value lies in enabling better business decisions - especially in portfolio strategy, market launches, and clinical development.
6. Develop mitigation plans and risk indicators
For each top-priority risk, assign owners, define mitigation actions, and track progress. Use Key Risk Indicators (KRIs) that are specific to pharmaceutical operations, such as: Overdue CAPAs, recurring deviations, Compliance Audit scores and internal ratings, batch rejection incidences
7. Risk awareness culture and implement technology to support ERM
Align regulatory expectations, quality culture and leverage digital tools to improve visibility, traceability, and scalability. Risk platforms must meet pharma’s validation and audit requirements.
8. Review, report, andcontinuously improve
ERM is a project in perpetuity, it is a journey and it must evolve with the business, regulatory shifts, and product portfolio changes. There should be a regular review of risks in various units in the organisation and it is important to have a Board level reporting to ensure that a right tone is set-up from the top to make the entire process of ERM effective and efficient.
A well-run ERM program not only ensures resilience but also creates competitive advantage through smarter, riskinformed decisions
Are you future-ready?
In a highly competitive market, risk-resilient companies thrive while others struggle. It’s time to move beyond reactive risk management and adopt an integrated, forwardlooking ERM approach to safeguard the company’s future.
The need of the times is to invest in ERM today in order to build a risk-proof tomorrow.
INTERVIEW
We are well-aligned to capitalise on the CDMO opportunity
India may today account for less than 2–3 per cent of the pharma CDMO market today but has the potential to grow from $3.5 billion to $25 billion. DrAbdelaziz Toumi, CEO,Lupin Manufacturing Solutions (LMS) explains to Viveka Roychowdhury how LMS is aligning longterm strategies,repositioning key assets,lining up investments in new modalities and leveraging India’s API ecosystem to capitalise on this opportunity.He also believes that while global policy shifts,such as the US Biosecure Act present an important tailwind,Lupin has always taken a long-term view,investing for the long haul,to build resilient,future-ready systems that align with global trends and customer needs
In the light of the US Biosecure Act and the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act, aimed at reducing dependencies on other countries and incentivising manufacturing of pharma
products in the US, how is Lupin Manufacturing Solutions (LMS) adjusting to the policy changes?
The pharmaceutical industry is inherently dynamic — constantly evolving and adapting to scientific breakthroughs, market needs, and policy shifts. Change has
become a norm in our business, driven by compelling reasons such as supply chain security, access to innovation, and the need for resilient healthcare systems.
The COVID-19 pandemic was a wake-up call that exposed vulnerabilities in global supply chains,
especially in the life sciences sector. It emphasised the urgent need to build robust, future-ready systems — not just for potential pandemics, but to support the increasing complexity of a globally interconnected pharma landscape. Pharmaceuticals are developed, manufactured,
and distributed across borders, making supply chain reliability and quality control more critical than ever.
At the same time, we are witnessing major demographic and economic shifts. Populations around the world are aging — India included — and healthcare
INTERVIEW
access is expanding. These trends are accompanied by rapid medical innovation and rising expectations from patients. However, with longer life expectancy and access to advanced therapies comes increased pressure on healthcare budgets. The challenge lies in delivering broader access to cutting-edge treatments while maintaining cost-efficiency. This requires innovative solutions that can serve more patients sustainably.
Geopolitical shifts are also shaping our strategy. For instance, the US Biosecure Act aims to safeguard sensitive health data and bolster domestic manufacturing capacity. It is not a protectionist measure, but rather a response to legitimate concerns around data privacy and national resilience. The PILLS Act similarly promotes US-based manufacturing — an understandable move given its economic implications.
We’re closely monitoring these developments and aligning our long-term strategies accordingly. As a global organisation, we must be close to our customers. The US remains the largest pharma market, and proximity — geographic and operational — is key to delivering best-inclass service. That’s why colocating select activities closer to our clients makes strategic sense, especially when considering time zones, logistics, and regulatory expectations.
We have always taken a long-term view. Our commitment to quality, compliance, and ESG principles reflects our ambition to build a top-tier, globally respected organisation. In our role as a Contract Development and Manufacturing Organisations (CDMO) partner, our goal is to be known for deep expertise and unwavering quality. While regulatory changes like the Biosecure Act may trigger shifts, our broader objective is to build resilient, future-ready systems that allow us to serve our customers — whether in the US, Europe, Japan, China,
or India — with excellence. Innovation is no longer limited to the West. China is fast emerging as a powerhouse in pharmaceutical R&D, and India is poised to follow. At LMS, we’re not here for shortterm gains — we are investing for the long haul, building capabilities that align with global trends and customer needs.
Where does India fit in the global API CDMO space as compared to other countries like China, Korea, etc?
India has long held the reputation of being the “pharmacy of the world,” especially in the generic pharma segment — where it leads in volume and costefficiency. However, when it comes to CDMO — the service-driven side of the pharma industry — India still plays a relatively small role on the global stage, accounting for less than 2–3 per cent of the market today.
At LMS, we see this as a major opportunity. The global CDMO space is expanding rapidly, particularly as it supports not just large pharma
companies, but a growing base of innovative biotech firms and academic entrepreneurs. In fact, more than 70 per cent of drug discovery today originates from small to midsized enterprises. These innovators often rely on CDMO partners to help advance their molecules from early-stage development to commercial production.
India’s current CDMO market is valued at around $3.5 billion and has the potential to grow to $25 billion, according to the Boston Consulting Group — an impressive CAGR of over 21 per cent. Despite India’s current underrepresentation, we believe the country is wellpositioned to take on a far more significant role in this space, thanks to its robust manufacturing foundation, world-class scientific talent, and evolving infrastructure.
At LMS, we are capitalising on this opportunity with purpose. We are building on Lupin’s five decades of expertise in small molecule manufacturing. We are carefully selecting and repositioning key assets within
our network. We’ve begun with two strategic manufacturing sites — at Vizag and Dabhasa — supported by our centralised R&D hub in Pune focusing on all API research under LMS.
Furthermore, global policy shifts, such as the US Biosecure Act, which calls for more secure and diversified supply chains, present an important tailwind. The Act is not just about domestic production — it reflects a broader push for supply chain resilience and data protection, both of which play to India’s strengths in scale, reliability, and compliance.
Sustainability is also at the heart of our strategy. Across Europe and the U.S., regulatory frameworks are increasingly focused on ESG compliance — not only environmental factors like renewable energy and waste management, but also social and governance standards. Modern manufacturing must be green, automated, and AIenabled. We are investing significantly in these areas to meet the evolving expectations of our global customers.
India’s API ecosystem is another strength we’re leveraging — from raw materials and intermediates to a strong supplier base and toptier universities. Our ecosystem is vast and interconnected, supported by an exceptional talent pool and an increasingly innovationdriven outlook.
While profitability in the CDMO space can be nuanced, India undoubtedly enjoys a structural cost advantage compared to Western markets and several of its Asian peers. This positions us competitively — especially when paired with Lupin’s global scale, robust quality systems, and long standing customer trust.
In a market as competitive as CDMO, we welcome the challenge. Competition drives excellence — and our differentiation lies in a combination of deep expertise, global outlook, and a culture of quality and transparency. We are committed to building a
sustainable, innovationaligned business that serves the future needs of our international client base with consistency and purpose.
Tell us more about Lupin Manufacturing Solutions. Lupin Manufacturing Solutions (LMS) was officially incorporated in November 2023. We moved swiftly to define our core purpose and positioning within the global CDMO landscape. In the months that followed, Lupin carved out manufacturing assets at Vizag and Dabhasa, marking the operational start of LMS. These facilities are integral to LMS’ ambitions and were carefully selected for their proven track record and future scalability.
As with any strategic initiative, having the right leadership in place was the critical first step in setting the direction and building the foundation for long-term success. I joined as the CEO of this company around midJune 2024. Over the past nine months, our primary focus has been on building a world-class team and operational structure. I’m proud to share that we at LMS have successfully assembled our full leadership team, collectively bringing decades of CDMO experience with Indian and international world-class CDMOs. Given the global nature of this business, we have also established dedicated business development capabilities across the US and Europe, ensuring proximity to our clients and agility in our response.
A key strategic milestone was our recent integration of API R&D under LMS. We have consolidated more than 200 scientists and over 20 labs into a dedicated R&D centre in Pune. This move significantly enhances our development capabilities and gives us the flexibility to offer tailored, high-quality solutions to our CDMO partners. We have also moved into LMS’ new headquarters in Mumbai, further consolidating our operations and enhancing
INTERVIEW
connectivity with clients and partners.
This has been an exciting start. We are growing rapidly, attracting exceptional talent, and building the capabilities that will define the future of LMS as a trusted, innovationled CDMO on the global stage.
How does LMS differentiate its offerings in the CDMO space? And, since most of the future growth will come from biologics and biosimilars, how will India make its mark as a global biosimilar CDMO market? At LMS, we can fully leverage the world-class capabilities of our parent company Lupin, while building a focused CDMO platform that caters to the evolving needs of global innovators. Our facilities in Vizag and Dabhasa represent strong
foundations — proven sites with more than five decades of operational experience. These sites are already approved by all major global regulatory authorities, including the US FDA, EMA, WHO, TGA, and ANVISA.
Recently, we hosted a WHO audit at our Vizag facility, which went exceptionally well — another affirmation of our compliance and quality-first mindset.
Today, LMS has a portfolio of over 25 APIs being supplied to various pharma companies in more than 50 countries. Our track record in delivering high-quality APIs at scale gives us a strong foundation for our CDMO journey.
At LMS, while our core focus is on small molecules, we bring deep technical expertise across a broad technology spectrum. This includes
complex chemical synthesis, high-potency manufacturing, and specialised platforms like peptides, iron-based formulations, and both nonrecombinant and recombinant fermentation. In Vizag, we already operate a high-potency facility, positioning us to support oncology, the largest therapeutic category globally with over 3,000 active drug candidates.
We are lining up investments in the new modalities – antibody-drug conjugates (ADCs), peptides –as these will be driving the industry growth. Importantly, we approach CDMO partnerships as platformagnostic. Our clients don’t define themselves by modality — they define their mission by therapeutic need. Whether that involves small molecules, biologics, mRNA, or a
combination like ADCs, we aim to be the agile partner that enables them to succeed.
ADCs, for example, represent a highly complex and growing category where we already have the foundational capabilities — protein development, linkers, toxins.
Being a part of Lupin, LMS has access to adjacent capabilities beyond small molecules, including biologics and injectables, which we can extend to our clients depending on their needs. This flexibility allows us to act as a true solutions partner — whether the client is a large pharma company or an emerging biotech driving early-stage innovation. For biologics, our group capabilities extend to CDMO services for large molecules, including monoclonal
antibodies and proteins. Additionally, our advanced chemistry portfolio includes capabilities like highpressure hydrogenation and low-temperature transformations — critical for solving complex development challenges. Furthermore, our regulatory expertise is a critical asset. Many of the biotech clients are sciencedriven organisations that rely on strong partners to navigate the complex, global regulatory landscape. Our ability to combine scientific understanding with compliance rigor is what sets us apart.
We’re not just building a CDMO — we’re building a trusted, globally relevant manufacturing platform designed for the future of pharmaceutical innovation.
INTERVIEW
You mentioned sustainability as part of the manufacturing processes. However, following sustainable and environmentally responsible practices add to CapEx and operational cost, and pharma companies are constantly on the lookout to lower the cost of medicines. So how does LMS approach this challenge of adhering to sustainability guidelines while keeping the costs and budget in check?
At LMS, sustainability isn’t a project or a box to check — it’s deeply embedded into the way we operate. It is not viewed as a cost element, but rather as an essential investment in the future of our business, our communities, and the planet.
This is not a discussion point — it’s a non-negotiable principle. It is how we think, how we plan, and how we act. We’ve adopted a wide range of green manufacturing practices aimed at minimising environmental impact — not just in terms of global sustainability, but also in how we operate within local ecosystems and communities. Our processes are designed to reduce and recycle waste, including solvent recovery systems, minimal-waste chemical reactions, and innovative packaging design. We continuously assess and re-engineer our operations to ensure minimal resource usage without compromising quality.
We're particularly proud to
be pioneering enzymatic processes and biotransformation for the synthesis of some of our APIs. These are routes that reduce the use of chemicals and dramatically improve the environmental footprint of manufacturing operations. In parallel, we're actively transitioning select processes to aqueous fermentation, replacing conventional solvent-based approaches where possible. And when solvents are essential, we ensure maximum recovery and reuse to maintain circularity.
LMS’s efforts are fully aligned with Lupin’s broader sustainability goals, including the carbon neutrality targets for 2030. As of now, more than
40 per cent of our energy consumption in Dabhasa for instance is sourced from renewable sources like solar and wind — putting us ahead of many global benchmarks, including in several developed markets. Additionally, we are embedding clean chemistry principles into our R&D workflows, while investing in advanced technologies like continuous flow reactors to reduce both energy use and waste.
Sustainability also extends to diversity and inclusion, which we view as vital to longterm success. We're actively working to promote more women in leadership roles and ensuring that our teams reflect the global nature of the CDMO business. This is not
just an ESG imperative — it’s about unlocking the full potential of talent across regions and backgrounds.
And the numbers speak for themselves — Lupin’s ESG score has jumped from 17 to 76 over just four years, making us one of the leading organisations in India and beyond on several critical ESG parameters.
We don’t just see sustainability as a responsibility — we see it as a competitive advantage and a driver of innovation, job creation, and long-term resilience. Simply put, if a business isn’t sustainable, it isn’t built to last.
viveka.r@expressindia.com viveka.roy3@gmail.com
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Supplychain leadership: Stepping into the spotlight
As pharma supply chains rise in strategic importance,its leaders must sharpen their business acumen and competencies to keep pace and gain a seat in pharma boardrooms
By Lakshmipriya Nair
‘The line between disorder and order lies in logistics’, says Sun Tzu, the Chinese warrior, philosopher and author in his renowned war treatise. He points out that even the strongest army or best plan will fail without proper management, transportation, and resource coordination.
Modern businesses face the same reality—even the strongest business strategy will fail without a robust supply chain.
Traditionally a cost and operations management function, supply chain has evolved into a
critical and strategic imperative that directly impacts customer satisfaction, revenue generation, and market differentiation. Today's business landscapes are conquered through supply chain excellence.
Industry experts reiterate these views.
"The role of supply chain has evolved from tactical indenting and purchasing to a team that drives growth by directly impacting profitability and customer metrics. The supply chain builds a bridge between demand and revenue, inculcating both agility and efficiency in the organisation to improve on customer metrics
and serving them at an optimal cost. This influences success and growth of business and drives shareholder value creating long term gains for all stakeholders," notes Nihar Medh, Sr VP and Global Head of Supply Chain, Piramal Pharma.
And, in this scenario, supply chain leaders have to be strategic thinkers, risk managers, and innovation drivers. Their expertise directly impacts revenue, risk mitigation, innovation, and brand reputation— making them indispensable to corporate strategy and governance, points out Pramod Pandit, Sr VP & Head Commercial, Ajanta Pharma.
As Deepak Khurana, VPProcurement & Supply Chain Management, Suven Pharma, elaborates, "The role of supply chain leaders has transformed from a back-office, cost-focused function into a critical strategic position that drives business resilience, customer satisfaction, and competitive advantage."
Bharat Bhushan Rathi, Head Distribution and Logistics, Mankind Pharma points out that the role of supply chain professionals has undergone a significant transformation over time. He points out that the COVID pandemic underscored their critical importance, repositioning them as central to busi-
ness continuity and the backbone of operations.
Yet, several factors still keep supply chain leaders from gaining their rightful place in the boardroom: For instance; an outdated mindset that sees supply chain work as just day-to-day operations. And, supply chain leaders have contributed to this perception with their tendency to communicate in operational terms rather than in strategic and financial terms.
The road to recognition So, how can supply chain leaders get their due in boardrooms? How do they reposition themselves as strategic business
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leaders rather than functional experts?
Well, this journey requires a mindset shift that extends far beyond traditional supply chain expertise. Let’s understand this shift better from the experts themselves.
Elevate the conversation
Khurana explains that "supply chain leaders can play a pivotal role in shaping discussions on revenue growth, risk management, and corporate strategy by aligning their operations with business objectives."
Medh also emphasises that supply chain leaders need "a strong executive presence and the ability to explain to the board about complex supply/ demand scenarios and seek consensus for right decision making."
So, this means that supply chain leaders need to articulate their strategic value. They need to present clear, data-driven and distinctive perspectives to boardroom discussions on core business priorities, offering insights that complement those of other C-suite executives.
Connect supplychain to revenue growth
Pandit explains, “Supply chain decisions directly impact profitability, working capital, and return on investment. Boards need leaders who can optimise these financial outcomes.”
So, supply chain leaders with C-suite ambitions need to clearly demonstrate how their intiatives have a direct impact on top-line performance through faster time-to-market, improved product availability, and enhanced customer experience.
Rathi also advises, "Now supply chain leaders should understand their competition, changing market needs and curate design which will outperform in the market." He adds that while cost management and efficiency are pivotal to a supply chain professional, it is equally important for them to understand the business needs.
Align with corporate strategy
Supply chain leaders should foster a mindset that blends strong business acuity with supply chain goals to contribute to-
Supply chain leaders need to have a sharp business and financial acumen with a strategic mindset
Nihar Medh
Sr VPand Global Head of Supply Chain, Piramal Pharma
Supply chain decisions directly impact profitability, working capital, and return on investment.Boards need leaders who can optimise these financial outcomes
Pramod Pandit
Sr VP& Head Commercial, Ajanta Pharma
Asupply chain leader must understand market dynamics,change in customer consumption behavior and the current needs of business
Bharat Bhushan Rathi
Head Distribution and Logistics, Mankind Pharma
ROADMAPTO BUILD C-SUITE READINESS
1.Assess current capabilities: Supplychain leaders must honestlyevaluate their strengths and development needs across each competency.Seekfeedbackfrom mentors,colleagues,and direct reports to identifyblind spots.
2.Create learning opportunities: Seekcross-functional projects,crisis management roles,digital transformation initiatives,and other assignments to build relevant capabilities.Consider executive education programmes,certifications,or advanced degrees that fill knowledge gaps.Build relationships with C-suite executives,board members,and other leaders who can provide mentorship and training
3.Clearlycommunicate contributions: Start communicating supplychain contributions in strategic business terms rather than functional language.Focus on outcomes that matter to business goals,such as revenue growth,market share,customer experience,and riskmitigation.
4.Build personal brand: Develop internal and external visibilityas a strategic business leader rather than a supplychain specialist:
◆ Publish thought leadership content in business publications
◆ Speakat industryconferences on strategic topics
◆ Participate in cross-functional leadership forums within the organisation
◆ Contribute to industryassociations and professional networks
5.Seekfeedbackand adapt: Regularlysolicit input on your executive presence,communication effectiveness,and strategic thinking.Use this feedbackto refine your approach and close development gaps
wards corporate strategy. This requires them to develop a deeper understanding of financial metrics, market dynamics, and consumer behaviour.
"Supply chain leaders need
to have a sharp business and financial acumen with a strategic mindset. They also need to have an eye to read evolving global geopolitical scenarios and their impact on business and carve
out strategies for risk mitigation," advises Medh. Rathi emphasises that "A supply chain leader must understand market dynamics, change in customer consumption behav-
The role of supply chain leaders has transformed from a back-office,costfocused function into a critical strategic position that drives business resilience, customer satisfaction,and competitive advantage
ior and the current needs of business." This market intelligence, combined with their expertise, will enable supply chain leaders to contribute meaningfully to strategic discussions and decision-making.
Lead strategic initiatives
Khurana states that supply chain leaders need "expertise in risk management, digital transformation, and sustainability" as they are "expected to navigate global risks, drive technological advancements, and meet ESG compliance requirements." These competencies position supply chain leaders as strategic assets in boardroom discussions about business resilience, innovation, and sustainable growth.
For instance, supply chain operations have a tremendous impact on an organisation's environmental footprint and social impact. Supply chain leaders to demonstrate strategic leadership in this critical area.
Khurana emphasises that supply chain leaders can drive
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"sustainability initiatives by reducing carbon footprints, ensuring ethical sourcing, and meeting ESG compliance requirements, thereby strengthening brand reputation."
Similarly, supply chain leaders have unique opportunities to lead digital transformation initiatives too. As Khurana notes, "By leveraging advanced technologies like AI, IoT, and blockchain, they can enhance visibility, optimise decision-making, and unlock new revenue opportunities."
Medh agrees, “A digital mindset and the ability to drive cross business collaborations are highly needed”, in supply chain leaders looking to become a C-suite leader.
Thus, collaborating with cross-functional leaders on strategic projects and driving business transformation and innovation will help supply chain leaders to ascend in the corporate hierarchy. Leading strategic initiatives increases
DRIVERS OFSUPPLYCHAIN TRANSFORMATION
◆ Global disruptions: Events like the COVID-19 pandemic,geopolitical tensions,and regulatory changes exposed vulnerabilities in global supplychains,making resilience and business continuity critical boardroom concerns
◆ Digital transformation: Technologies like AI,blockchain,and IoTare reshaping supplychain operations,and leaders must drive adoption to enhance agility,transparency,and predictive capabilities.
◆ Sustainabilityand ESG Compliance: The growing emphasis on ethical sourcing,reducing carbon footprints,and compliance with environmental and social governance norms has pushed supply chain leadership into strategic sustainabilityinitiatives.
◆ Riskmanagement: Supplychain disruptions nowhave direct financial and reputational consequences,making proactive riskidentification and mitigation essential at the leadership table
visibility with senior leadership while demonstrating strategic capabilities.
Master riskmanagement
Leaders who can navigate uncertainty and build resilience within the organisation are highly sought after in this volatile business climate. And, supply chain leaders are uniquely positioned to identify, assess, and mitigate risks. They
must hone and leverage this ability effectively to take their rightful place in pharma boardrooms. By positioning themselves as experts in business resilience and risk management, supply chain leaders can become attractive candidates for C-suite positions.
Giving more insights about this aspect, Khurana explains that supply chain leaders can offer valuable insights into "iden-
tifying vulnerabilities, such as disruptions caused by geopolitical tensions or natural disasters.
He further explains, “Through tools like scenario planning, real-time monitoring, and contingency strategies, they can proactively address risks to ensure business continuity," This expertise is particularly valuable in today's volatile business environment.
Pandit also recommends
supply chain leaders to gain the ability to implement new systems, and processes, and to lead teams through periods of change.
An opportunityin waiting Thus, by developing some key competencies outlined in this article supply chain leaders can position themselves as valuable candidates for C-suite roles. This journey requires intentional development, but the opportunity has never been greater.
And, as organisations recognise the importance of the supply chain in driving competitive advantage, the voice of supply chain leadership in the boardroom will only grow stronger and more indispensable.
However, business lea ders too must recognise and harness the expertise of their supply chain leaders to navigate the volatile landscape effectively.
The Ahmedabad Pharma Summit 2025 successfully convened over 100 pharma leaders, policymakers and experts to discuss the future of India’s pharma sector under the theme ‘Pathways for Global Excellence’. As the first Pharma Summit in FY25 organised by Express Pharma, the event spotlighted Ahmedabad’s vital role as a hub of innovation, manufacturing, and global expansion in pharma and biopharma.
The summit featured thought-provoking sessions on advancing R&D, leveraging the PLI scheme, digital transformation, and regulatory strategies to spur progress in the pharma sector. Eminent speakers shared insights on building global competitiveness through innovation, sustainability, and strategic partnerships.
The Ahmedabad Pharma Summit reinforced the city’s position as a strategic launchpad for the next decade of pharma innovation and growth. The event kickstarted with a Welcome Address and an auspicious lamplighting ceremony
L-R: GauravKaushik,Managing Director & CEO,Meteoric Biopharmaceuticals; Naresh Gaur,EVPOperations,Stallion Laboratories; Dr H G Koshia,Commissioner,Food & Drugs Control Administration; Parag Swadia,CEO & Executive Director, Otsuka Pharmaceutical; Dr Kiran Marthak,Director - Medical Affairs,Phase-1 and RegulatoryAffairs,Veeda Lifesciences
Keynote Address: Building global trust through science,speed,and transparency
At the recently held Ahmedabad Pharma Summit 2025, Dr HG Koshia, Commissioner, Food & Drugs Control Administration (FDCA), Gujarat, delivered an inspiring keynote address, emphasising Gujarat’s pivotal role in India's pharma growth story.
He lauded the summit’s theme and noted its timely relevance. Dr Koshia shared that Gujarat is home to over 5,000 licensed manufacturers across pharmaceuticals, cosmetics, and medical devices, contributing significantly to India’s pharma production and to its exports.
Highlighting Gujarat's technological leadership, he detailed how the FDCA pioneered online licensing systems and fully digitalised product databases, enhancing transparency and efficiency. Today, the state boasts more than 56,000 licensed pharmacies operating through a centralised online platform, enabling real-time verification and monitoring.
Dr Koshia also reflected on Gujarat’s strong educational foundation,
Dr H G Koshia,Commissioner,Food & Drugs Control Administration
citing LM College of Pharmacy’s historic role in nurturing entrepreneurs who later founded globally recognised
pharma companies. Today, Gujarat hosts over 65 pharmacy institutions, further strengthening the talent pool
and inn ovat ion ecosystem.
Underscoring the state’s commitment to quality, he shared that Gujarat’s FDCA runs India’s first NABLaccredited government lab, enhancing credibility in pharmaceutical testing.
Dr. Koshia also narrated how Gujarat’s regulatory systems have won international acclaim. Foreign health officials visiting Gujarat's FDA offices expressed heightened trust in medicines sourced from the state after witnessing its transparent and techdriven operations.
Concluding, Dr Koshia emphasised that Gujarat’s blend of science, technology, regulatory excellence, and entrepreneurial spirit positions it as a true global hub for quality pharma products. He reiterated the FDCA’s commitment to ensuring patient safety, fostering innovation, and strengthening Gujarat’s contribution to global healthcare.
The session set an optimistic tone for the summit, reinforcing the message that Gujarat will continue to lead India’s pharma advancement.
Panel Discussion: Next-gen Pharma Innovation
Dr Kiran Marthak,Director - Medical Affairs,Phase-1 and RegulatoryAffairs,Veeda Lifesciences; Hiren
The first panel discussion at Ahmedabad Pharma Summit 2025 was on ‘Next-gen Pharma Innovation.’ The session delved into the cutting-edge trends and technologies shaping the future of the pharma landscape.
Moderated by Naresh Gaur, EVPOperations at Stallion Laboratories, the panel featured a distinguished lineup of experts: Dr Vaibhav Dubey, General Manager, Kashiv Biosciences; Yogesh Joshi, Head - Formulation Development CDMO and Head - Clinical Manufacturing Operations, Piramal Pharma Solutions; Dr Kiran Marthak, Director - Medical Affairs, Phase-1 and Regulatory Affairs, Veeda Lifesciences; Hiren Shah, General Manager – Packaging Development, Cadila Pharmaceuticals; and Ashwani Verma,
Senior General Manager - Operations, Intas Pharmaceuticals
The panelists stated that strategic investments in innovation, particularly in areas like drug discovery and development is key for the growth of India’s pharma sector. They agreed that holistic pharma inn ovation, encompassing R&D, manufacturing, packaging, clinical operations, and regulatory processes, will be vital.
The conversation veered towards technology transformation. Panelists highlighted how digitalisation, automation, and artificial intelligence (AI) are redefining pharma operations. These technologies are enhancing product quality and ensuring compliance with stringent regulatory standards. They also speed up the drug development process, thus bring-
ing critical therapies to market faster.
The discussion also spotlighted biologics as a major area of innovation. Panelists pointed out the need for costeffective biologic therapies that can improve patient outcomes. They stressed that innovation in biologics manufacturing and delivery technologies can enhance accessibility and affordability, particularly in emerging markets.
An important takeaway was the role of incremental innova tion. Panelists observed that simple, thoughtful changes—such as digitising medical leaflets to reduce paper usage and packaging costs—can lead to significant operational efficiencies and sustainability benefits.
Panelists underlined the necessity for pharma companies to embrace digital tools that enhance transparency,
traceability, and agility in a VUCA world. Investing in robust digital compliance solutions will be crucial to stay competitive and navigate complex regulatory challenges.
Throughout the session, a recurring theme was the importance of patient-centric inn ovation. Enhancing accessibility, affordability, and patient experience was identified as the key goal. The experts accentuated that innovations must align with patient needs to truly transform healthcare delivery.
The panel concluded that the future of pharma innovation lies in a balanced approach: embracing advanced technologies, investing in biologics, encouraging incremental changes, and keeping the patient at the center of every innovation.
L-R: Naresh Gaur,EVPOperations,Stallion Laboratories (Moderator); Dr VaibhavDubey,GM,KashivBiosciences; Yogesh Joshi,Head- Formulation Development CDMO,Head Clinical Manufacturing Operation,Piramal Pharma Solutions;
Shah,GM – Packaging
Polymeric solutions for the pharma industry
At the Ahmedabad Pharma Summit 2025, Prabhat Balyan, Manager – Business Development at Ami Polymer, delivered a presentation on the critical role of polymer solutions in the pharma and biopharma sectors. His session highlighted the growing importance of choosing the right materials to ensure product safety, process efficiency, and regulatory compliance.
He underlined how the pharma industry's evolving needs demand specialised polymer solutions. He emphasized that the selection of appropriate tubing and hoses is vital to maintain product integrity and meet stringent quality standards across various stages of pharma manufacturing.
Explaining the diverse applications of tubing solutions, Balyan noted that different pharma processes—such as sterile fluid transfer, drug formulation, and final
product filling—require specific types of materials. Each application demands tailored solutions to address unique challenges like chemical compatibility, temperature resistance, flexibility, and durability.
The presentation also provided a detailed overview of Ami Polymer’s extensive product portfolio. A significant part of Balyan’s talk focused on the company's ongoing efforts to broaden their product range. He shared that Ami Polymer is continuously investing in R&D to develop advanced materials that can support the pharma industry’s dynamic needs, including the growing demand for singleuse systems and bioprocessing solutions.
Balyan concluded by affirming that Ami Polymer can offer customised, compliant, and high-performance products to enable safer, more efficient pharma manufacturing.
Supplychain and procurement transformation for pharma companies
Bharat Gakhar, Director, Moglix, delivered a session on “Supply Chain and Procurement Transformation for Pharma Companies at the Ahmedabad Pharma Summit 2025.
Gakhar highlighted that the pharma supply chain must evolve from a cost-centric to a value-centric approach, driven by faster time-to-market expectations, growing demand volatility, and external disruptions. He pointed out that traditional procurement processes are often manual, fragmented and reactive—leading to inefficiencies and missed opportunities.
He also explained that Moglix’s transformative framework can streamline procurement by improving demand forecasting, automating PR-to-PO workflows, enhancing vendor management, and ensuring clean master data.
His presentation compared the current scenario to a future-ready model powered by Moglix’s digital platform. This includes enhanced governance, improved visibility and inventory optimisation.
Gakhar underlined that Moglix, a B2B commerce platform with operations in
over 40 locations and a presence in key global markets, is positioned to partner with pharma companies in their supply chain transformation journey. He con-
cluded by urging pharma stakeholders to reimagine their supply chain and procurement ecosystems with a digital-first mindset.
Pharma supply chain and procurement should move from cost-centric to value-centric, adopt a data and technology-first approach,and focus on ESG and governance
This session underscored the critical need for pharma companies to move beyond tactical sourcing to strategic procurement—enabling agility, compliance, and long-term value creation in a competitive global landscape.
Bharat Gakhar,Director,Moglix
From standardisation to customisation: Rethinking single-use technologies in modern bioprocessing
Vasudevan M, Technical Leader –Fluid Handling Solutions, IMEA, Avantor Biosciences, delivered an insightful presentation on “From Standardisation to Customisation: Rethinking Single-Use Technologies in Modern Bioprocessing.” His session shed light on how the biopharma industry's evolving needs demand a paradigm shift from standardised to customised single-use solutions (SUTs).
Vasudevan began by tracing the evolution of single-use technologies—from their early days of standardisation to today’s pressing need for customisation. He pointed out that as biopharma pipelines diversify and facilities juggle multiple products, platforms, and batch types, standard SUTs often fall short in addressing the unique requirements of modern manufacturing environments. Vasudevan highlighted common constraints such as non-standard ceiling heights, complex cleanroom layouts, and localised utility limitations.
At the Ahmedabad Pharma Summit 2025, Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries, delivered an informative session on the role of excipients in ensuring pharma quality and regulatory compliance.
Dr Gothoskar began by addressing the growing global concern around impurities such as nitrosamines that can pose serious health risks. As regulatory authorities worldwide tighten scrutiny on nitrosamine levels in pharma products, he highlighted the urgent need for manufacturers to proactively mitigate these risks. He pointed out excipients, particularly in tablet formulations, play a significant role in either exacerbating or controlling impurity levels.
A key focus of the session was the importance of intelligent excipient selection. Dr Gothoskar stressed that excipient choice should not be driven merely by cost or availability. Instead, manufacturers must consider factors like chemical stability, reactivity, and purity to minimise the risk of nitrosamine formation.
This approach ensures safer products, regulatory compliance, and enhanced patient trust.
The presentation placed special em-
phasis on Microcrystalline Cellulose (MCC), a critical excipient in tablet manufacturing. Dr Gothoskar described MCC as a highly versatile material val-
In contrast, custom SUTs—designed to fit exact facility layouts and process needs—enhance operational efficiency, reduce downtime, and support compliance and safety.
A key message from the session was that customisation, when executed correctly, doesn’t slow down manufacturing—it removes the barriers that do. Purpose-built assemblies minimise validation steps, streamline training, and enable seamless process transfers, particularly critical for CDMOs and facilities handling high-potency APIs, gene therapies, or running parallel product lines.
Vasudevan also explained how Avantor’s portfolio is designed for flexibility, scalability, and compliance with modern bioprocessing demands.
The session ended with a call to industry stakeholders to rethink their approach to SUTs, not just as a plug-andplay option, but as an enabler of speed, safety, and success in the competitive biopharma landscape.
ued for its excellent compressibility, binding properties, and contribution to tablet integrity and stability. He shared practical examples of how MCC improves manufacturing efficiency and enhances batch-to-batch consistency, leading to higher-quality pharma products.
He also highlighted Sigachi Industries' contribution in supplying premium-grade MCC and other excipients, backed by strong technical expertise. He explained how Sigachi supports pharma manufacturers in optimising their formulations, meeting stringent regulatory standards, and addressing emerging challenges like nitrosamine contamination.
In his concluding remarks, Dr Gothoskar reiterated that in today's regulatory environment, quality by design must extend to excipient selection. By partnering with excipient suppliers like Sigachi Industries, pharma companies can safeguard their products, protect patient safety, and build greater resilience in their operations.
Dr Abhijit Gothoskar,Technical Expert,Sigachi Industries
Fixed-dose combinations in India – Addressing approval challenges
At the Ahmedabad Pharma Summit 2025, Ganesh Boddu, GMRegulatory Affairs & Clinical Research, Eris Life Sciences delivered a session titled "Regulatory pathway for fixed-dose combinations (FDCs) in India – Addressing approval challenges." His presentation shed light on the complex regulatory landscape surrounding FDC approvals and provided strategic insights for navigating this domain.
Boddu outlined the role of key regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO), Drugs Technical Advisory Board (DTAB), and Drugs Consultative Committee (DCC) in governing FDC approvals in India. He explained how FDCs are classified into four categories based on historical use, requirement of clinical trials, safety concerns, and irrationality — using real-world examples like Paracetamol + Ibuprofen and Ofloxacin + Ornidazole + Racecadotril
RegulatoryAffairs & Clinical Research,Eris Life Sciences
to illustrate each category.
A major highlight of the session was his detailed explanation of the regulatory pathway for FDC approvals. He outlined the data requirements, which include CMC (Chemistry, Manufactur-
ing, and Controls) data, preclinical studies, Phase III clinical trials, and bioequivalence or bioavailability studies. He stressed that the lack of robust scientific justification often leads to rejections by regulatory authorities.
Boddu shared several case studies where FDC proposals were rejected by the CDSCO due to reasons such as undefined dosing schedules, lack of clear therapeutic justification, insufficient published literature, and stability concerns.
He also touched upon the recent Supreme Court interventions concerning irrational FDCs, citing the 2024 ban on combinations like Nimesulide + Paracetamol + Phenylephrine + Cetirizine. This highlighted the ongoing regulatory scrutiny and the judiciary's growing role in ensuring patient safety.
In conclusion, Boddu emphasised industry best practices for FDC approval, including the need for strong scientific rationale, clear alignment with CDSCO expectations, and robust post-marketing surveillance plans. He urged companies to build dossiers that preemptively address regulatory concerns to smoothen the approval process.
Cutting-edge advancements in traceabilitytechnology
for
Henhanced tracking and transparency
iren Rathod, Regional Account Director – West, North & Madhya Pradesh, Optel Group, delivered an insightful presentation at Ahmedabad Pharma Summit 2025, highlighting the company's traceability solutions for the pharma sector.
Tracing Optel’s journey since its inception as a vision inspection system provider, Rathod outlined the company's evolution into a comprehensive traceability solutions provider for pharma. He elaborated on Optel’s three key verticals: Op-Chain (carbon traceability and ESG intelligence), TracSev (track and trace solutions for L1-L3), and Verify Brand (L4 enterprise-level solutions).
Rathod discussed Optel’s global footprint, with operations across Canada, Europe, South America, and India.
The session provided an in-depth look at Optel’s integrated solutions, including hardware integration, line con-
trol, plant servers, and enterprise-level serial number generation and reporting. Notably, Optel’s L4 solution enables
seamless reporting to government portals globally without per-serial number charges, offering pharma companies
transparency and cost efficiency.
Highlighting rece nt inn ovations, Rathod showcased solutions for carton and bottle packaging lines, emphasising tamper-evident packaging, serialisation, aggregation, and the introduction of a combo system that integrates tamper-evident, printing, and checkweighing in a single unit.
A key highlight was Optel’s new Vial Mislabeling Prevention and Seal Defect Inspection Solution, aimed at enhancing patient safety by preventing labeling errors in injectable products. Through innovative printing and inspection technologies, the system ensures product integrity even at high operational speeds.
The session concluded with Rathod reinforcing that Optel can help pharma firms to advance quality assurance through tablet inspection systems and help them to flexible integrate into existing production lines.
Ganesh Boddu,GM-
Hiren Rathod,Regional Account Director – West,North & Madhya Pradesh,Optel Group
Secure your pharma QC results bysecondarystandards
At the Ahmedabad Pharma Summit 2025, Dr Shankar Varaganti, Commercial Marketing Manager, Merck, delivered a presentation on advancing pharma quality control (QC) through robust reference material solutions. His session, titled ‘Secure Your Pharma QC,’ began by outlining the complexities of pharma drug development. He stressed that accurate analytical testing is a vital pillar of this process. He highlighted key challenges in pharma QC analysis, including the detection of impurities, extractables, leachables, nitrosamines, heavy metals, and residual solvents.
He explained the essential role of reference standards in every stage of the analytical workflow, from sample collection to quantification and reporting. Drawing attention to the resource investment required for companies to develop in-house working standards, he presented Merck’s Pharma Secondary Certified Reference Materials (CRMs) as an efficient and globally recognised alternative.
He informed that these CRMs offer full traceability, regulatory compliance, and consistent performance, reducing the burden on pharma companies.
A significant focus of his session was the concept of metrological traceability, emphasising the importance of standards that are linked to internationally accepted measurements, such
AI-based smart inspection systems
At the recently concluded Ahmedabad Pharma Summit 2025, Manish Agarwal, President Global Sales, Jekson Vision gave an insightful presentation on how artificial intelligence (AI) is revolutionising pharma inspection systems. He also gave an overview on Jekson Vision’s offerings for AI-driven quality control in pharma manufacturing.
The presentation, titled "Elevating Inspection with Intelligence", focused on the transformative potential of AI in machine vision inspection. Highlighting statistics from global research, Agarwal emphasised that AI could enhance productivity in manufacturing by over 40 per cent and reduce unplanned downtime by 45 per cent, significantly optimizing operational efficiency.
He introduced Jekson Vision’s BiSMART architecture, a comprehensive AI-powered inspection solution equipped with image capture, inspection, reporting, and plant management capabilities.
The company also demonstrated the
Manish Agarwal,President Global Sales,Jekson Vision
capabilities of its AI-based inspection systems for various pharmaceutical formats such as tablets, capsules and softgels.
He also spoke about CODEQUEST and BPO Clarity systems and their features for AI-based vision inspection of packaging materials, including barcode,
pharmacode, label, and vial inspection.
His presentation gave detailed insights into pharma quality control through intelligent automation. He also reassured the audience that Jekson Vision’s solutions aim to reduce human error, enhance accuracy, and boost overall manufacturing excellence.
as those maintained by National Metrology Institutes (NMIs) and pharmacopeial bodies like USP and EP. Dr Varaganti explained the traceability pyramid, which ensures the highest levels of accuracy and confidence in QC results.
He also elaborated on Merck’s innovative approach of providing dual traceability — linking both to pharmacopeial primary standards and SI units via mass balance or quantitative NMR methods. This dual validation gives companies a powerful assurance of quality and compliance during audits and regulatory reviews.
Additionally, Dr Varaganti showcased Merck’s expanding portfolio of over 3,000 secondary pharma standards, covering a wide range of APIs and related compounds.
In conclusion, he highlighted that Merck’s Pharma Secondary Standards not only save time and resources but also help pharma companies achieve excellence in their QC practices, paving the way for safer, more effective medicines.
AI in the manufacturing industry offers 40 per cent productivity boost, saves costs by 30 per cent,reduces downtime by 45 per cent ,limits resource shortage and develops durable,repetitive competitive advantages
Dr Shankar Varaganti,Commercial Marketing Manager,Merck
Qualitymanagement maturityas a driver for achieving pharmaceutical global excellence
Vipul Doshi, Chief Quality and Compliance Officer, Zydus Life Sciences delivered a session on "Quality Management Maturity (QMM): A driver for achieving pharmaceutical global excellence." His presentation emphasised how QMM can transform pharma operations beyond mere regulatory compliance, paving the way for sustained excellence, supply chain resilience, and business success.
Doshi described QMM as the integration of business operations, manufacturing processes, and advanced quality practices to optimise product quality and drive improvement. He emphasised that a mature quality management system is proactive, datadriven, and continuously improving.
He explained how adopting mature quality management practices not only enhances regulatory readiness but also aligns with key business objectives, including supply chain reliability, business continuity, and customer satisfaction.
Doshi outlined the five pillars of QMM assessment, covering areas such as management review, resource management, CAPA activities, patient
CONTRIBUTOR’S CHECKLIST
Vipul Doshi,Chief Qualityand Compliance Officer,Zydus Life Sciences
impact understanding, and supply planning. He stressed that QMM promotes robust pharma quality systems (PQS), technical excellence, empowered employee engagement, proactive
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risk management, and a resilient business strategy.
A significant part of his talk focused on building a strong quality culture, characterised by leadership com-
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mitment, effective communication, continuous learning, and proactive risk management. He emphasised that employee engagement and a qualityfirst mindset across all organisational levels are vital for achieving higher levels of QMM.
The session also explored the challenges associated with QMM implementation, such as defining clear scope, integrating quality principles into decision-making processes, understanding supply chain maturity, and ensuring that investments translate into tangible quality improvements.
Doshi provided insights into the proposed QMM assessment protocols being piloted by the FDA, including on-site or hybrid evaluations and benchmark reports to help establishments identify areas for continuous improvement.
Concluding his session, he reiterated that ‘Quality is not a destination; it’s a journey of continuous excellence.’ He urged pharma companies to view QMM not merely as a compliance exercise but as a strategic enabler for global leadership, patient trust, and long-term sustainability.
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The final panel discussion of the day, titled ‘Leadership playbook for scaling pharma businesses,’ brought together a lineup of industry veterans who are actively shaping India's pharma growth story. Moderated by Prashant Sharma, CTO, Zydus Lifesciences, the session offered a deep dive into the strategies, mindsets, and practices required to scale pharma businesses sustainably and successfully.
Joining him on the panel were Sandeep Raktate, President, Operations, Amneal Pharmaceuticals, Naresh Gaur, EVP- Operations, Stallion Laboratories, Gaurav Kaushik, MD & CEO, Meteoric Biopharmaceuticals and Rahul Songire, VP- Central Quality, Zydus Lifesciences. Together, they mapped out a compelling playbook for Indian pharma’s next phase of growth.
The panelists discussed how scaling in pharma is not just about expanding footprints or numbers but also about building resilient, compliant, digitally
enabled organisations that can thrive in a volatile world driven by global competition and regulatory scrutiny. The conversation addressed crucial aspects including technology adoption, talent development, operational excellence, and leadership ethos.
The experts underlined that forecasting and demand planning in pharma, must evolve into a more evidence-based, strategic function. They highlighted how advanced analytics, artificial intelligence, and machine learning are playing a critical role in improving forecasting accuracy, and helping companies better align their production, supply chain, and market launch strategies.
The panelists also recommended that companies must invest in building strong data foundations and predictive capabilities to meet market demands.
Another important point discussed was the importance of a strong User Requirements Specification (URS).
The panelists agreed that a well-defined URS is crucial for operational efficiency, and to ensure regulatory compliance, reduce risks, and guide the overall design and validation processes.
They also advised that leadership involvement in the creation of robust URS frameworks is vital since it drives clarity, accountability, and long-term value.
The panelists emphasised that effective leadership in pharma means leading by example. They stressed that leaders must thoroughly review all documents, guidance, and processes themselves, rather than delegating important aspects blindly.
This in turn, will foster informed decision-making, strengthen compliance, and drive accountability in teams.
A key takeaway from the session was the urgent need to invest in developing talent. The leaders urged pharma professionals to continuously upgrade their competencies, embrace cross-
functional learning, and strengthen quality systems.
They noted that organisations that prioritise employee development alongside process innovation to drive continuous improvement.
While digitalisation is often touted as a game changer, the panelists stressed that pharma organisations must honestly assess their digital maturity, identify existing gaps, and make targeted investments in digital transformation initiatives.
Strategic digitalisation, they said, can unlock horizontal growth, drive operational efficiencies, enhance decisionmaking, and create long-term enterprise value.
The session concluded with a message: scaling pharma businesses in today’s world requires more than operational scaling — it demands visionary leadership, a strong foundation in compliance and quality, investment in people, and smart adoption of technology.
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Coliform bacteria and E.coli in pharma water systems: Ahidden threat to product integrity
Water quality is critical in pharma manufacturing,and contamination by coliforms or E.coli can threaten product safety and compliance. Dr Girish B Mahajan, Sr VP- Microbiology,HiMedia Laboratories examines the risks,regulatory focus,and new technologies for real-time microbial monitoring in this article
The COVID-19 pandemic brought microbiology to the public eye, making terms like RT-PCR, antigen, and PPE kit part of everyday discussions. In the pharmaceutical world, another set of terms-coliforms and E. coli -carry immense importance, especially where water quality is concerned. Water is a critical utility in pharma manufacturing processes and is used in various stages including formulation, cleaning, and even as raw material in some products. Any microbial contamination in the water supply chain can have cascading effects on product integrity, batch sterility, and ultimately patient safety.
Pharma-grade water systems like Purified Water (PW), Water for Injection (WFI), and Clean-in-Place (CIP) are designed with rigorous microbial quality parameters. However, coliform bacteria-especially E. coli-serve as early indicators of water system failures and contamination by fecal matter or biofilm development. A recent E. coli outbreak in 2024 due to contaminated food illustrated how lapses in microbial control can spiral into public health emergencies. For the pharma industry, the implications are even more severe, with potential regulatory actions, product recalls, and brand damage.
Understanding coliforms and their relevance in pharma Coliform bacteria, comprising genera such as Escherichia, Citrobacter, Enterobacter, and Klebsiella, are Gram-negative, rod-shaped microorganisms commonly found in the envi-
ronment, including soil, surface water, and the gastrointestinal tracts of warm-blooded animals. Though most are not pathogenic, their presence in pharma water systems-especially Escherichia coli , which indicates faecal origin-raises serious red flags regarding the integrity of production processes. In pharma manufacturing, water serves not only as a raw material but also as a cleaning agent and solvent, particularly in sterile and parenteral preparations. This necessitates strict control of microbiological quality. Coliforms and E. coli function as key indicator organisms, signaling potential failures in system sanitisation, biofilm control, or mechanical issues such as faulty valves and dead legs. Regulatory authorities treat their detec-
tion with urgency, often triggering investigations and corrective actions.
Globally harmonised standards reflect this concern. The United States Pharmacopeia (USP), in Chapter <1231>, outlines microbial specifications for pharma-grade water. Both Purified Water (PW) and Water for Injection (WFI) must be free from objectionable organisms including E. coli , Pseudomonas aeruginosa, Salmonella spp, and Staphylococcus aureus. Specifically, WFI must not exceed 10 CFU per 100 mL, with an absolute absence of coliforms. Similarly, USP <645> and <1231> provide detailed test procedures and acceptance criteria for microbial monitoring. These guidelines are echoed in the European Pharmacopoeia and the Indian Pharmacopoeia (2022), as well
as the Bureau of Indian Standards (BIS), all of which mandate coliform-free status in pharma waters.
Advanced testing platforms, including chromogenic media [e.g., HiCrome Chromogenic Coliform agar (CCA Agar), Chromogenic Coliform Medium (without membrane filter)] and enzyme-based methods (e.g., Rapid HiColiform Agar, Colisure), have been validated for pharma applications. These tools detect coliforms via β -D-galactosidase and E. coli via β -D-glucuronidase activity, allowing rapid, specific, and regulatorycompliant detection. Their adoption supports the pharma industry's move toward realtime microbial risk control, aligning with GMP expectations and ensuring product safety throughout the production life cycle.
Keyregulatoryupdates and guidelines
The regulatory landscape surrounding the detection of coliforms and E. coli has undergone considerable refinement in response to technological progress and public health needs. Agencies worldwide are embracing more sensitive, enzyme-driven detection methods while upholding rigorous safety benchmarks.
One significant update is the revision of the ISO 9308-1 standard, which replaced older lactose-based media with chromogenic coliform agar. This transition highlights a methodological shift: targeting enzymes such as β -D-galactosidase and β -D-glucuronidase has proven more reliable for differentiating between gen-
eral coliforms and E. coli, especially in low-contamination matrices like potable water. The method offers improved specificity and has been validated for both repeatability and accuracy.
In the US, the Environmental Protection Agency (EPA) has approved a suite of enzyme-substrate methods. These tests employ defined substrate reactions to produce visible color changes or fluorescence, allowing quick detection. However, their performance can vary depending on the water chemistry and microbial background, such as the presence of Aeromonas species, which may interfere with accuracy.
Globally, regulatory expectations are adapting as well. WHO guidelines, USP <1231>, and EU GMP Annex 1 all recognise the relevance of rapid microbial testing. In the pharma industry, real-time microbial monitoring is increasingly being explored for critical control points, including WFI and surface hygiene checks.
The direction is clear: regulatory bodies are not only supporting faster technologies but are also encouraging localised validation to ensure reliability. This evolution is opening the door to broader use of rapid diagnostics across sectors, creating a more agile framework for microbial safety and compliance.
Emerging technologies in coliform detection
Recent advancements in coliform detection are reshaping microbial monitoring practices, offering faster, more
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sensitive, and field-deployable solutions that are highly relevant to the pharma industry. Traditional methods such as membrane filtration and the MPN (most probable number) technique, while widely accepted, are time-intensive and often unsuitable for rapid decision-making in pharma cleanroom environments. However, the creative advancements in these classic techniques still p revail in the market. Example HiSelective E. coli Test Kit, HiE.coli Test Kit, and HiFast Coli-nella Water Testing Kit.
Innovative platforms, such as graphene-based electrochemical sensors integrated with polyacrylamide gels, enable real-time detection of coliforms via β -D-galactosidase activity. These sensors deliver quantifiable signals within 30 minutes with detection limits as low as 0.1 log 1 0 CFU/cm². Such tools are valuable for rapid hygiene assessments of equipment surfaces and production areas, supporting stringent microbial limits mandated in pharma-grade manufacturing.
In water system validationa critical component of pharma quality control-automated fiber-optic devices using EPA-approved Colilert reagents and Raspberry Pi imaging can detect coliforms and E. coli down to 1 CFU/100 mL within 16 hours. These compact, automated systems reduce reliance on central labs, allowing quicker release decisions for WFI and purified water systems.
Moreover, advanced molecular methods such as qPCR, FISH, and laser-based detection are gaining traction in the pharma sector due to their ability to detect viable but nonculturable organisms, offering faster and more precise microbial risk assessments compared to traditional culturebased techniques.
Together, these emerging technologies offer significant advantages for pharma environments-ensuring rapid microbial detection, supporting regulatory compliance, and enhancing contamination control strategies.
Rapid detection of coliforms: The need for speed Time is a critical factor in quality control. Traditional methods such as the Multiple Tube Fermentation Technique or membrane filtration take 24-48 hours for results. Rapid detection systems now enable real-time or near real-time microbial quality checks. Enzyme substrate tests (e.g., Rapid Hicoliform Test Kit, ColiBlue24, Colilert), when combined with fluorescence or chromogenic response, help detect total coliforms and E. coli in less than a day.
HiMedia has introduced several chromogenic culture media that not only cut down on turnaround time but also improve specificity and reduce false positives. These systems are being validated for use in both in-process monitoring and finished water testing.
To further accelerate detection, compact technologies like lab-on-chip systems and fiber-optic sensors are gaining attention. These tools automate the analysis process by combining optical signals with digital imaging to identify microbial contaminants at very low levelssometimes as low as 1 CFU per 100 mL-within 16 hours. Their ease of use and portability make them especially suitable for pharma settings, where rapid water quality assurance is essential.
Emerging tools such as laser scanning cytometers and im-
munoassay-based magnetic separation are also enabling precise identification of stressed or non-culturable organisms-offering an edge over traditional plate-based techniques. For pharma manufacturers aiming for faster batch release and realtime decision-making, integrating these rapid methods into QC protocols is not just beneficial, it's becoming the new standard.
Market trends and Indian scenario
The global market for E. coli and coliform diagnostics is expected to grow at a CAGR of 6.5 per cent, reaching $3.2 billion by 2027. This growth is driven by the pharma sector's increasing reliance on highpurity water and regulatory pressure to adopt rapid, reliable testing tools.
In India, the push for GMP compliance, digitalisation, and real-time monitoring has fueled demand for automated microbiology solutions. Pharma hubs in states like Maharashtra, Gujarat, and Telangana are investing in water purification and testing infrastructure. In February 2025, CPCB published reports indicating fecal coliform presence in surface waters near industrial zones, raising compliance flags for nearby pharma units.
HiMedia, in collaboration with Indian pharma manufacturers, is pioneering cost-effective detection workflows that
comply with WHO and BIS norms. Training and capacity building for lab technicians to handle new-age diagnostics is also gaining traction.
The future of Coliform and E. coli diagnosis
Coliform and E. coli diagnostics are entering a transformative era, driven by the need for faster, more accurate, and field-deployable methods.
Conventional culture-based techniques, though dependable, often fall short in timesensitive environments such as pharma manufacturing and food safety assurance.
In recent years, several groundbreaking tools have emerged. Compact biosensor systems, particularly those enhanced with graphene and enzyme-specific substrates, have shown the ability to detect coliform contamination on contact surfaces within half an hour. These sensors rely on the activity of β -D-galactosidase-an enzyme characteristic of coliforms-to generate measurable electrochemical signals. Their minimal detection threshold and portability make them particularly suited for on-site contamination checks in cleanrooms and production zones.
Another notable advancement involves low-cost, fiberoptic platforms integrated with microcontrollers and cameras. By combining colorimetric and fluorescent readings using EPA-approved reagents, these systems can automatically detect even a single bacterial cell in 100 mL of water in under 16 hours. Their digital architecture reduces reliance on manual inspection, supporting objective and scalable analysis.
Meanwhile, updates to global testing protocols reflect a broader shift toward enzyme-targeted diagnostics. The adoption of chromogenic and fluorogenic substrates, now recognised in international standards, aligns with a growing preference for biochemical specificity over traditional fermentation-based detection.
With developments in AI and digital imaging further en-
hancing sensitivity and interpretation speed, the future points toward smarter diagnostics. These tools are not just faster-they're evolving into platforms that integrate seamlessly with quality management systems, offering realtime insights. The result is a new generation of coliform detection that's more responsive, robust, and adaptable to industry demands.
Acall for vigilance
Water is more than a raw material in pharma manufacturing-it is the lifeblood of operations. Ensuring microbiological safety is critical not only for compliance but also for safeguarding public health. Detecting coliforms and E. coli is no longer just about identifying a contaminant but it's about identifying a systemic gap in quality assurance.
With evolving detection technologies, clearer regulations, and growing market demand, pharma companies must adopt a proactive and integrated approach to water quality monitoring. The future belongs to those who invest in precision, speed, and preparedness.
India is a strategicallyimportant market for Optima and this is whywe are increasing our footprint here
Optima recently acquired the Global Competence Centre (GCC) of Pune-based Eckstein Engineering — a strategic move to significantly enhance Optima India's engineering, manufacturing and service capabilities.In an exclusive interaction, Stefan König, CEO, Optima,and Christoph Müller, Managing Director,Optima,share details about the company's three-decade journey in the pharma sector and its expanding footprint in India. They also delve into Optima’s focus on delivering end-to-end turnkey solutions,advancing sustainability goals,and leveraging India’s distinct market dynamics,with Lakshmipriya Nair
Can you take us through Optima's evolution? And, what are the major transformations that the pharma and biotech industries have seen since Optima's inception?
Stefan König: The Optima story in pharma started about 30 years ago. At that time, it was mainly about syringe filling with high quality results. Then there was rapid development in requirements - regulations emerged, quality standards increased, and 100% IPC weight control became essential.
The next major shift was the growing importance of isolators. We addressed this by acquiring a company specialised in both filling machines and isolators. Various containers gained prominence, like cartridges, which have become significant in recent years, while ampoules have declined in usage. Now we're in a phase with many new therapies emergingbiobased pharmaceuticals, weight reduction medications, cell and gene therapies, etc.
For us, this means delivering complete turnkey lines is the best way to support our customers.
Can you share more about Optima's journey in India?
Christoph Müller: We entered the Indian market with our own setup in 2011, so we've been operating here for quite some time. We started
with a classical sales approach with just one person. This person, Akshay Chikodi, is now the Managing Director of Optima Machinery India. Over the years, both fortunately and through the hard work of our teams in India and Germany, we've managed to sell equipment to the rapidly growing Indian market. We've also been able to grow alongside the company. Beyond pure sales activities, we've expanded to offer comprehensive aftersales services to our customers.
So, who are your major clients at Optima?
Müller: We have a broad base of clients here in India and I think one big milestone is that we just recently sold our first turnkey line to the Indian market.
So as Stephan König said before, we are really covering the full set of technology. It is a big milestone for us and for the team here in India.
So what are the major trends that we are going to witness in the pharma filling and packaging
industry in the next 5 to 10 years?
König: Globally, we do a lot of business with major pharmaceutical and biotech companies. We are the go-to partner for pharma products with extremely high requirements, as clients need a reliable partner to make it happen. We support all local customers and are open to working with companies, whether foreign companies or emerging local heroes who aim to grow and supply pharma products to the global market.
How huge is your focus in India? What are your plans for the Indian market in the next three to five years?
König: We don't have fixed plans yet, instead, we're actively exploring possibilities. To support this, we've already strengthened our set up in India by expanding our sales team and, even more importantly, by growing our service base. We've also built up more engineering capabilities locally, so we can help our customers directly with application questions, project management
Stefan König
Christoph Müller
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concerns, and issues related to installed lines, such as how to rebuild or adapt them to new requirements. Our focus will increasingly be on building a knowledge base here in India, with local staff and a local share of things we can do. While we'll likely continue to mainly import our equipment, we'll have an increased local contribution of expertise, particularly in after-sales services.
So today's acquisition is part of your expansion strategy. Are there any more partnerships, collaborations in the pipeline, within the Indian market and globally?
Müller: I think we should start by looking at the current situation. This began as a partnership - we worked together with Eckstein Engineering Solutions as an outside partner providing services for us.
Now we've been able to acquire their team and integrate them into Optima India. Certainly, when similar opportunities arise in the future, we might take this approach again.
This is exactly how we've grown - by incorporating new technologies and expertise. It’s definitely a strategy we could continue pursuing in the future, though we don't have any specific plans at the moment.
König: But the requirements are also changing. There are increasingly more software requirements now - greater automation, more SCADA systems. Digital twins are becoming essential as customers want to simulate any software changes or modifications before implementing them on the production line.
This requires significant resources and new competencies, and it’s crucial for us to accelerate our development in this area. If mergers and acquisitions could help us in this regard, we would certainly consider that option.
All these emerging requirements around small
batch lines and specialised filling lines are important considerations. So when we see solutions which would take too long for us, we are always open to integrate that into our business.
So how are emerging technologies being deployed at Optima? How are you utilising it to meet customers' expectations?
Because as I said, we're seeing a lot of emerging technologies being used these days.
König: Optima is one of the few machine builders conducting its own research and development, creating platforms both in collaboration with customers and independently based on our vision of the future. For e.g. What kind of automation systems will be required? What will the lines for scaling up cell and gene therapy look like?
These platform developments take place at our headquarters in Schwäbisch Hall, Germany, partly in collaboration with leading customers. From there, we scale these innovations to serve the global market.
But India is also a very cost-sensitive market. So how do you balance cost and innovation when it comes to India?
Müller: I think one of Optima's big successes is our technology-driven approach. However, we've learned over time that cost sensitivity is a reality in the market. That said, we believe that shouldn't mean compromising on quality.
This is why we've focused on scaling up and ramped up the local know-how and strengthening the local team. We are confident we can offer premium technology that is also more accessible to Indian customers.
König: A lot of the value comes from the expertise of our people, especially those with extensive experience. We won't cut corners there, but of course, we're always
working to make our operations more efficient.
We've implemented many initiatives to reduce costs, particularly when it comes to sourcing parts and modules that we don't need to manufacture ourselves. We are also significantly increasing local shares in countries like India, ensuring that services, continuous customer support, line operations, rebuilding, and modifications can be handled with a high proportion of local resources.
This approach will also lead to an attractive cost position for our customers.
So what's next for Optima in terms of product expansion and market expansion when it comes to India?
Müller: India is strategically important for us. That's why we're expanding our footprint here - it's a clear commitment to the market. With the resources we have in place, we want to support both our global engineering and our international customers. We see this as an important next step in Optima's development in India.
So how huge is Optima India today in terms of your team strength and your facilities?
Müller: Optima’s base is currently in Bengaluru, where we started with our sales and service activities. We have resident engineers based on customer locations and, we are now expanding with a dedicated service hub in Ahmedabad.
One key focus is to improve service by offering spare parts directly from India to Indian customers. This reduces lead time, and is more cost effective for them.
Additionally, with the acquisition of Eckstein Engineering, we have this base here in Pune as well with an engineering team that is supporting the global engineering activities, but also further expanding our footprint here in India.
How will today's acquisition actually ramp up your capabilities in India?
König: The team we acquired from Eckstein has been built up over several years. We started with basic mechanical engineering and design tasks, gradually moving to more complex projects and innovations across all Optima businesses - not just pharma, but others as well. This approach allowed us to quickly build a strong team.
Most of the team members have received training in Germany, so they know the machines. They can then do engineering work here, and from time to time they will return to our headquarter plants to see the machines they are working on. We are continuously increasing the services this engineering hub can provide. In the last year, we added automation technology in particular.
Now we are expanding to support our service parts, also for spare parts. We now have a critical base of people. Most of them have extensive experience in the packaging industry, process and packaging industry, many with 6-8 years of experience.
So they are well prepared now to take on additional tasks and work together with our sales and service hub, which we have here as Optima India.
So any other new developments that you would like to share?
König: We have a lot of initiatives currently in sustainability. We focus on sustainability not only as acompany, but also by offering sustainable solutions.
This means, especially in the consumer area, we are supporting fiber-based packaging. These are compostable solutions that help reduce plastics in the environment. We are significantly increasing our activities in this field and will announce many initiatives this year.
Secondly, we look for products which are used long-
term. For example, we provide machines for special components used for fuel cells and electrolyzers for the hydrogen business. Then we develop new solutions together with our customers for hygienic consumer products.
Because in the past, it was always about baby care. Now it is becoming more and more about caring for older people. So hygienic products for older people and the packages for that in high volume at low costs.
The pharma side is already discussing some topics. We are especially supporting our customers, as I said, with turnkey projects, because we are one of the few providers who really can bring a full solution of filling line, isolator and freeze-dryer from one source to the customer. So we can take on the full responsibility.
We can do the qualification of the whole line, reducing risks, reducing the lead time. So these are typical new offerings which we provide to the world and of course also to India.
What are the opportunities and challenges which are very specific to India in your space?
König: India presents a clear challenge: delivering highquality drug products in large volumes at low costs. Solving this will not only meet India's needs but also set a standard for many other emerging countries. It's a major opportunity to develop scalable solutions with global relevance.
Müller: Beyond the technical demands, it's impressive how fast India is growing - in infrastructure, company size, and general wealth. I recently read that India adds about one million new employees to the labour market. In contrast to ageing societies elsewhere, this demographic strength is a huge opportunity for the Indian market and for us.
Preeti Jain, Information Scientist,ACSI India,highlights that the global counterfeit drug trade poses a serious public health threat.Emerging technologies and collaborative regulatory efforts are key to combating this evolving and lucrative illicit industry
The illicit trade of counterfeit drugs is a lucrative, widespread business, and it has a severe impact on developing countries. According to the U.S. Food & Drug Administration,up to 30 per centof medicines in Asia, Latin America, and Sub-Saharan Africa are counterfeit or substandard.
However, this problem doesn’t just affect low- and middleincome countries. With the rise of online pharmacies,estimatedat nearly 40,000, counterfeit drugs are more common in developed countries as well.
The risks from counterfeit pharmaceuticals are numerous — there are the obvious risks of medications failing to treat a given condition, and severe reactions or even death from a dangerous substance, improper dosage, or a drug interaction. Counterfeit drugs also undermine the public’s trust in healthcare systems, which leads to major health issues (see Figure 1). At a time when misinformation is rampant, it’s vital to provide patients with safe and effective treatments, and that includes combating counterfeit medication and harmful medical products.
Fortunately, researchers are making progress in the development of technologies to stop counterfeiting. Many tactics are being explored to verify that medications are legitimate, from the packaging that protects drugs to the surface and structure of the pills themselves. Some can be observed with the naked eye, and others use advanced technologies to scan and validate drugs or packaging. All could provide important breakthroughs in combating fake drugs.
Which drugs are most often counterfeit?
Different therapeutic categories of drugs are counter-
economy.Source:
Recent research notes that counterfeiters are moving from drugs for non-fatal conditions such as baldness or erectile dysfunction into treatments for life-threatening conditions
feited across the world, but recent researchnotesthat counterfeiters are moving from drugs for non-fatal conditions such as baldness or erectile dysfunction into treatments for life-threatening conditions. For example, drugs like Viagra and Cialis arecommonlycounter-
feited, but now, fraudulent antidepressants and medications for thecentral nervous system are also increasing. In 2023, the Pharmaceutical Security Institute reported the five major therapeutic categories targeted for counterfeiting ( see Figure 2):
The anti-infective category includesantibacterials, antivirals, antifungals, and antimalarials. Counterfeit drugs in this category can harm patients with HIV or malaria, and they can lead to antibioticresistancefrom inadequate dosages, among other risks.
Technological advances to stop counterfeit drugs
To combat this growing threat, pharmaceutical companies and regulatory authorities are turning to advanced technologies to authenticate medications and deter counterfeiters. One approach is advanced package labeling technologies, such as blockchain, radio frequency identification (RFID), holograms, QR codes, and 2D barcodes.
Several patents have been filed for advanced labeling, such as a process for adding hidden security features to packaging that can be revealed with a laser pointer (US20150183257A1), and Nuceria Adesivi S.r.l. patenting the indelible printing of the traceability code for pharmaceutical stickers (EP3130474 A2[2017]). Companies like Authentix, Inc. and Alp Vision are also working on numerous forms of encrypted printing, holograms, and packaging identifiers.
However, package labeling can be ineffective if drugs are repackaged at any point along the supply chain. As a result, “on-drug labeling” is also being explored to prevent counterfeits from reaching patients. Here are five emerging technologies to stop counterfeits: ◆ DNA tagging incorporates uniqueDNA markersinto drug formulations. This method is difficult to replicate and easy to verify, making it effective against counterfeiting. However, this technology has drawbacks like requiring costly, specialised equipment. An example of this technology was patented by the University of Southern California, using RFID and DNA taggant authentication systems and methods to prevent counterfeit, gray, and black-market pharma, medical, and other products (US7710269 B2 [2010]). The companyApplied
Figure 1:Impact of counterfeit drugs on patients,pharmaceuticals,and the
JAMA
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DNA Sciences, Inc., provides molecular tagging and DNA markers for similar operations.
◆ Blind watermarkingembedsbinary digits (bits)onto the surface of Fused Deposition Modelling (FDM) 3D-printed tablets. The benefit of this process is that it doesn’t impact the appearance, weight, or API content of medications, nor the printing time needed to make the tablets. Further, a computer, FDM 3D printer, and a paper scanner are all that are needed for detection. However, this process only works on straight, flat tablets, and only certain polymers can be used.
◆ CandyCodesareedible identifiersunique to each pill, tablet, or capsule to which they’re applied. These identifiers are just what their name suggests — they’re nonpareils, the same tiny candy spheres used as decorations on desserts. When applied at random to legitimate drugs during manufacturing, the patterns can then be photographed and stored in a database. A patient would only have to upload a picture from their phone’s camera to the manufacturer’s database to verify that their medications are real. Since the chances of a random pattern of candy sprinkles being reproduced at random again by a counterfeiter are miniscule, this is a simple, scalable, and relatively inexpensive method to protect drug supplies. The main roadblock to implementing this technology is creating and maintaining a global database of these identifiers and keeping it secure from hacks and data breaches. The firm McNeill-PPC, Inc., explored a similar approach in an earlier patent filing(US20060088585 A1 [2006]) using a microrelief surface, which demonstrates that physical surface modification of individual doses may be a viable technique if data management issues can be addressed.
◆ Edible Physical Unclonable Functions (ePUFs)also use surface modifications on drugs. In this method,electrospray depositionuses strong electric fields to atomise a liquid suspension onto the surface of drug tablets. For ePUF authen-
tication, researchers used a machine vision approach with the open-source SIFT pattern matching algorithm. The Purdue Research Foundation has also explored this process in a recent patent (WO2021076217 A1[2021]). These surface depositions have the benefit of being extremely secure because they can’t be altered or removed. Patients can see them with the naked eye, and a simple phone camera picture can be used to verify that they’re
not counterfeit. The main drawback is that automated manufacturing processes are required to achieve higher throughputs, and like CandyCodes, any manufacturer’s database would require management and security.
◆ Hidden imaging with peptide nanodotsembedsthese nanoparticles in polymer films. By selectively photo-bleaching the nanodots with a focused light source, hidden images or patterns can be created within
the films. This approach has several benefits. First, the patterns remain stable, making his technique suitable for longterm storage of information. Peptide nanodots are also biocompatible. However, this method has some limitations in that the polymer films can eventually degrade over time. The limited color palette for nanodots could restrict the complexity of images that can be created, thereby limiting this method’s efficacy. Reading
the hidden images also requires specialised equipment that would need to be scaled up and made easier to obtain.
What’s at stake
Implementing these and other emerging technologies is more important as the threat from counterfeit pharma products increases. With the growth in online and mail-order pharmacies, more fake drugs are being sold, sometimesup to 50 per centof the medicines purchased from these pharmacies. Often operated in regions with lax oversight or regulation, these pill mills are mostly illegal.
Yet, the value of the global counterfeit drug trade is estimated at over $4 billion a year. According to the not-for-profit Pharmaceutical Security Institute, in 2023, there were 6,987 reported counterfeit drug incidents in 142 countries, an increase of 4% from 2022 (see Figure 3). These threats to public health will continue as long as financial incentives exist to sell counterfeit drugs and the internet provides the means to do so, which makes it vital for researchers and pharma companies to implement innovative ways to thwart counterfeiters.
Amulti-faceted approach to prevent counterfeiting
The problem of counterfeit drugs is complex, geographically dispersed, and constantly changing. To meet this threat, the global community needs multiple technologies as well as robust regulatory measures and partnerships. The World Health Organization (WHO) firstpublishedguidelines on combating counterfeit drugs over 25 years ago, and efforts between the WHO, the United States, and other countries are continuing to refine new regulations.
Technologies from advanced package labeling to 3D printing to nanoparticles can make a difference in the fight against counterfeit drugs. With researchers leveraging AI, machine learning, and nanotechnologies, to name only a few, it’s possible that significant progress against the growing counterfeit drug trade is near.
Figure 2:Counterfeiting incidents according to the different therapeutic categories,including the top five categories in the year 2023.Data source: Pharmaceutical SecurityInstitute
Figure 3:Year-wise distribution of global counterfeit drug incidence along with trends over time.Source: Pharmaceutical SecurityInstitute
opportunities to strengthen our presence in European,Southeast Asian,Middle East,and LATAM markets
Jaynil Doshi, Head - Techno Commercial,Pioma shares insights into Pioma'a growth strategy,investments in technology,global expansion plans,and long-term vision for the next decade,in an exclusive interview with Express Pharma
How do you envision the role of M/s Pioma evolving in response to advancements in the pharmaceutical and cosmeceutical industries?
At M/s Pioma, we are committed to aligning our offerings with the dynamic advancements of both the pharmaceutical and cosmeceutical sectors. As these industries increasingly embrace personalised medicine, clean beauty trends, and high-performance active ingredients, we see our role expanding from a traditional ingredient supplier to a strategic innovation partner. By staying attuned to emerging technologies and scientific breakthroughs, we aim to co-create value with our clients through customised solutions, cutting-edge ingredients, and robust regulatory support.
What are the primary growth drivers for M/s Pioma in the current market, and how do you plan to leverage them over the next few years?
Domestically,we plan to further penetrate tier-2 and tier-3 cities in India by partnering with the R&D as well as the F&D teams to offer tailored technical support and assist where possible with product development and trouble shooting
Key growth drivers include increasing demand for highquality, differentiated excipients, rising awareness around specialty ingredients, and a growing preference for customised formulation support among pharma and personal care brands. Our strategy involves deepening R&D collaborations, enhancing our technical service capabilities, and expanding our global distribution network to stay ahead of market demands. Do you have plans for geographical expansion, either within India or
internationally? What markets are you considering, and why?
Yes, we are actively exploring opportunities to strengthen our presence in European, Southeast Asian, Middle East, and LATAM markets. These regions offer robust demand for high-performance and compliant pharma and cosmetic ingredients, and our portfolio is well-positioned to address their stringent regulatory and quality expectations. Domestically, we plan to further penetrate tier-2 and tier-3 cities in India by partnering with the R&D as well as the F&D teams to offer tailored technical support and assist where possible with product development and trouble shooting.
Any planned investments in technology or infrastructure that will significantly shape the future of M/s Pioma?
We are investing in expanding our technical knowhow of our products by upgrading our lab facilities and implementing advanced digital tools for simulation and customer interaction. Additionally, we're enhancing our infrastructure and our team to support the marketing team. These upgrades will not only boost our capabilities but also ensure our compliance with international regulatory frameworks and customer requirements from time to time.
How does M/s Pioma assess and respond to evolving
customer needs, especially in the highly specialised pharma ingredients segment?
Customer-centricity is at the core of our operations. We maintain a proactive feedback loop with clients through our technical service teams and engage in regular co-creation workshops and webinars. This helps us stay aligned with specific therapeutic needs, regulatory changes, and evolving market preferences. Our agile product development framework allows us to quickly adapt and innovate based on real-time insights.
What is your vision for M/s Pioma in the next five to ten years? Are there specific milestones or achievements you're aiming for?
Over the next decade, we envision M/s Pioma as a globally recognised partner for innovation and development in functional excipients and specialty ingredients. Our goals include establishing regional teams, expanding our global footprint, and achieving recognition as a top-tier solution provider in addition to our existing supply chain benefits and service, in both pharma and personal care segments. Milestones include expanding our product portfolio, attaining certifications where necessary and required to upgrade our existing systems, and fostering strategic alliances with global formulators and brands.
INTERVIEW
Mettler-Toledo provides flexible rental options with fast support to help manufacturers get the most out of their equipment
For manufacturers facing production challenges,renting product inspection systems can be a cost-effective,flexible solution. Christine Gottschalk, Head of PI Test and Demo Center at Mettler-Toledo,discusses the benefits of rental technologies,including bridging delivery gaps,scaling up without CAPEXand how to achieve the best product quality with advanced inspection solutions,in an interaction with Express Pharma
Why should manufacturers consider renting product inspection systems instead of purchasing them outright?
Renting our systems i.e. checkweighing, metal detection, x-ray and/or vision inspection, offers a flexible and cost-effective solution for manufacturers facing immediate product inspection needs. This can be due to increased demand, equipment breakdown or quality control requirements. With rental solutions from MettlerToledo, for example, manufacturers can scale up production without significant capital expenditure or test inspection technologies before making a purchase decision.
What types of businesses benefit most from renting inspection systems?
Our rental solutions are particularly beneficial for all sizes of food and pharmaceutical manufacturers, but we also see demand from other industries such as building supplies. Any business that needs to achieve the utmost in product safety and compliance while managing costs and operational flexibility can benefit from renting one of our product inspection systems.
One of the key advantages of rental systems is bridging delivery gaps. How does this work?
Due to the nature of how product inspection systems are made, there can be significant lead times for delivery and installation when manufacturers order new equipment. Rental systems provide an immediate solution to inspection needs while waiting for permanent
equipment. This means that companies don't face costly downtime or disruptions in meeting customer demand.
How does renting help businesses with seasonal production fluctuations?
Many industries experience seasonal demand peaks where they need to temporarily increase production capacity. Instead of investing in expensive equipment that may sit idle
during quieter months, renting allows businesses to scale up as and when needed. This is particularly useful for food and pharma manufacturers during peak holiday seasons or promotional periods.
What role does renting play in the 'Test Before You Invest' approach?
Investing in inspection technology is a big decision, and manufacturers need to be sure they're selecting the right solution for their specific needs. Renting provides the opportunity to trial the Mettler-Toledo equipment in real factory conditions, to be sure of compatibility with production processes before committing to a purchase. It removes any uncertainty and gives businesses the relevant information to make informed decisions.
Can rental systems be used for re-inspection of products?
Absolutely. There are instances where manufacturers need to reinspect products due to a recall or to be sure of quality before distribution. For example, a manufacturer that initially used metal detection technology to inspect for ferrous, nonferrous metals plus stainless steel, may need to re-inspect with x-ray technology to
detect additional contaminants including plastics, glass and calcified bone. Renting provides a fast and efficient way to complete this process without disrupting standard production.
What types of inspection technologies are available for rent?
At Mettler-Toledo, we offer a comprehensive range of rental product inspection systems designed to help manufacturers maintain high standards of quality and safety while adapting to changing production needs. Our rental solutions include:
◆ Checkweighing: Helps facilitate product weight compliance, preventing under- or overfilling while optimising efficiency. Our systems range from entrylevel checkweighers to advanced high-precision models and are available as standalone units or in combination with metal detection, x-ray or vision inspection.
◆ Metal detection: Our metal detection systems are designed to identify ferrous, non-ferrous metals and stainless-steel contaminants. Systems are available for conveyorised, pipeline, free-falling and pharmaceutical applications.
◆ X-ray inspection: Ideal for detecting a wide range of contaminants, including
PHARMA PULSE
metal, glass, stone and dense plastics, even in packaged or foil-wrapped products. This technology also completes several product and pack quality assurance checks for example, fill level, mass component counts and packaging defects.
◆ Vision inspection:
Designed for label inspection, print verification and quality control, vision systems help manufacturers detect incorrect labelling, poor print quality and missing information, helping with compliance with industry standards.
◆ Combination systems:
Our rental fleet includes integrated inspection solutions that combine checkweighing with metal detection, x-ray or vision
inspection, offering a spacesaving and highly efficient way to achieve product quality.
All rental systems are available with professional installation and fast service support for seamless integration into production lines.
How quickly can a business access rental equipment?
Our rental machines are available immediately and, if needed, can be installed onsite by our experienced service team. We also offer edemos and the opportunity to test systems in a controlled environment before deployment. Our goal is to provide fast, hassle-free solutions that keep businesses running
efficiently.
What support do companies receive when they rent equipment?
Mettler-Toledo provides flexible rental options with fast support to help manufacturers get the most out of their equipment. From expert installation and training to ongoing technical support, we help manufacturers maintain optimal performance throughout the rental period.
To learn more, visit the Mettler-Toledo Test Before You Invest page or our Rental Machines page to explore available options and request a consultation.
www.mt.com/pi-testbeforeinvest-pr
ARBOCEL® - Plantderivedfunctionalfiller
ARBOCEL®,powdered
Cellulose, a natural polymer found abundantly in plant cell walls, has found diverse applications across various industries. In pharmaceuticals, powdered cellulose has emerged as a versatile and essential ingredient, revolutionising drug formulations and manufacturing processes. This article explores the various properties of ARBOCEL® (Powdered cellulose, Ph Eur / NF / JP/ E460 (ii) / FCC), offered by JRS Pharma in the pharmaceutical industry and highlights its key benefits and applications.
Manufacturing process
ARBOCEL® is manufactured by the purification and mechanical size reduction of acellulose obtained as a pulp from fibrous plant materials. [3]
Typical properties and benefits
Natural
◆ Extracted from wood source / No animal origin / Vegan
◆ During manufacturing process, no organic solvent is used
◆ No allergens
◆ Biodegradable
◆ Clean label-friendly
◆ Recognized as GRAS [1][3]
Biocompatibility
ARBOCEL® is considered as safe and biocompatible, making it an ideal choice for pharmaceutical applications. It is non-toxic and does not interact with the body's physiological processes, ensuring patient safety. Powdered cellulose is widely used in oral pharmaceutical formulations and food products and is regarded as a nontoxic and nonirritant material. It is not absorbed systemically following oral administration and thus has little toxic potential. [3]
Chemically inert
ARBOCEL® is chemically inert and hence is not metabolized by the human body. As ARBOCEL® is not digested, it has no functional caloric value.[3]
Low moisture absorption
In the dry form, it absorbs lesser amount of moisture, when compared to other diluents. This low moisture absorption assures better shelf life, especially with moisture sensitive active ingredients in pharmaceuticals. [3]
Versatility
ARBOCEL® fibers come in different forms, including fine powders and granules, making them versatile for use in diverse manufacturing processes and products. It finds applications in a wide array of industries, including food, pharmaceuticals, cosmetics, and industrial manufacturing. [3]
Eco-friendly and sustainable
One of the appealing aspects of ARBOCEL® is its eco-friendliness. Being sourced from renewable plant-based materials, it reduces the carbon footprint and contributes to a more sustainable future. Moreover, its biodegradability ensures that it will not linger in the environment for extended periods, fur-
Swelling properties
Another notable feature of ARBOCEL® is its impressive absorbent capabilities. In the food and cosmetic sectors, it can be used in products like animal feed and facial masks, thanks to its ability to absorb liquids effectively. This property makes it an asset in various personal care and food applications.
ther reducing its impact on the planet.
Physical parameters
ARBOCEL® is available in various grades, bifurcated based on PSD and other physical attributes [3]
Applications
◆ Filler/Diluent: Because of their fibrous structure and
good binding properties, ARBOCEL® grades are used as fillers in oral formulations like tablets and capsules. Due to finer particle size, ARBOCEL® M80 and ARBOCEL® P290 are suitable for wet / dry granulations, while ARBOCEL® P290 and ARBOCEL® A300 can be used in dry mixing and extragranular applications because of improved flow characteristics. Excellent flow and low dusting improves handling and weight uniformity in capsule formulations. It can also be used as a filler in sachet formulations and dry syrups. It is commonly used as an alternative to lactose, when the target population is lactose-intolerant patients. [1][3]
◆ Oily suspension: Due to its fine PSD and higher surface area, ARBOCEL® M80 may be used to reduce the sedimentation rate of oily suspension. This property can be explored to decrease the sedimentation in oily fills in soft-gel capsules and in oil based oral suspensions as well. It may also be used as suspending agent during the processing of suppositories. [1]
◆ Aqueous suspension: It is also used as a suspending agent in aqueous suspensions for oral delivery. It helps to form flocculated suspension which is easily re-dispersed upon shaking. [1] Amongst the grades, ARBOCEL® M80 is most suitable due to its fine PSD and higher surface area.
Famotidine dry suspension is one of such formulation.[6]
◆ Food applications: Powdered cellulose is also widely used in food products in various applications. Its ability to absorb moisture and coat ingredients in a fine powder makes it the perfect additive for anti-caking applications. Shredded and grated cheeses, powdered drink mixes and spice mixes are some of the examples.
Because cellulose binds and mixes easily with water, it is often added to increase the fibre content of drinks and other liquid items when the gritty texture of regular fibre would be undesirable.
Cellulose has become a popular bulking agent in diet foods. Because it is indigestible to humans, it has no caloric value. Eating foods with high cellulose content allows dieters to feel full without consuming too many calories.[2]
◆ Animal food: ARBOCEL® is used as a part of food for livestock and other pet animals to improve digestion and gut health.
Summary
ARBOCEL® is a highly versatile and eco-friendly material that offers numerous benefits across various industries. Its sustainable nature, coupled with its ability to enhance product quality and safety, makes it an attractive choice for manufacturers and
PHARMA PULSE
consumers alike. As a renewable resource, ARBOCEL® presents a promising solution to reduce environmental impact and promote a more sustainable future.
[4] JRS Pharma Media Library (https://www.jrspharma.com/ph arma_en/media-library/)
[5] United States Pharmacopoeia, USP 43-NF 38 (2019).
[6] DailyMed (nih.gov)
(https://dailymed.nlm.nih.gov/d ailymed/)
Nipro India unveils glass cartridge expansion at Pune plant
Author Krishnakumar Patel
Technical Services – Pharma
JRS Pharma, India Krishna.Patel@jrsindia.com
Nipro India expands glass cartridge production to meet growing demand in dental and pen applications
Nipro, a global leader in healthcare and drug delivery systems, has announced the start of highquality glass cartridge production for dental and pen applications at its manufacturing site in India, starting in July 2025. This strategic capacity expansion aims to support the growing market demand for glass cartridges in the Asia region.
The Nipro Pune plant is an experienced manufacturing site that has been producing premium-quality glass containers for leading Indian and global pharmaceutical companies for years. The state-ofthe-art production site, highquality standards, and customer-centric service make Nipro India an ideal partner for supplying highquality glass cartridges that meet the requirements of dental and highly sensitive drug products administered with
pen systems.
Benefits of working with Nipro India:
◆ Premium product and service quality
◆ State-of-the-art manufacturing site
◆ Long-standing experience in glass container production
◆ Part of a global manufacturing network with four cartridge production sites
◆ Fast and flexible supply times
◆ Dental and pen cartridges made in India
“The new lines will enable us to serve our customers even better, with high-quality
dental and pen cartridges made right here in India, resulting in more flexible and faster delivery times,” said Ashish Moghe, Managing Director NPH.
Ultimately, the capacity expansion aims to contribute to faster and more reliable delivery of life-saving drugs and
treatments packed in glass cartridges to patients.
About Nipro Nipro PharmaPackaging specialises in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or the enhancement of packaging solutions for existing drugs.
Nipro PharmaPackaging is part of Nipro Corporation Japan, established in 1954. As a leading global healthcare company with over 38,000+ employees worldwide, Nipro serves the Medical Device, Pharmaceutical, Regenerative Medicine and Pharmaceutical Packaging industries.
Truth gas tight syringes are ideal for transferring liquids and gases in lab settings and are suitable for samples with complex matrices or those containing chlorinated solvents
Truth gas tight syringes are ideal for dispensing both liquids and gases. They have a precision-machined PTFE plunger tip which creates a leak-free seal. With the tight fit, the tip essentially wipes the interior of the syringe barrel free of sample. Barrels made of 3.3 expansion glass. All syringes are precision within 1 per cent
Individual Calibration Certificate available on request.
Applications:
◆ Manual gas-tight syringes are crucial for introducing samples into GC instruments for analysis.
◆ They are ideal for transferring liquids and gases in various laboratory settings where precise volume control is needed.
◆ These syringes are wellsuited for handling volatile or gaseous samples that require a tight seal to prevent leakage or sample loss.
◆ Their resistance to chemical degradation makes them suitable for samples with complex matrices or those containing chlorinated solvents.
Top Syringe exports its products to over 40 countries worldwide and counting, keeping a single quality standard for local and export products. The Manual Gas Tight
Top Syringe exports its products to over 40 countries worldwide and counting,keeping a single quality standard for local and export products.The Manual Gas Tight syringe is manufactured 100 per cent in India by Top Syringe
We are fully committed to supporting you with our full product range, spares, and technical assistance.
Address - Top Syringe
Compound, W.E. Highway, Pandurangwadi, Mira road (East), Thane 401107 India Mob: 81046 82560 Email: sales@topsyringe.com Website: www.topsyringe.com
syringe is manufactured 100 per cent in India by Top Syringe.
Manual Gas Tight Luer Tip(LT)
Manual Gas Tight Fixed Needle Beveled (LTFN)
Manual Gas Tight PTFE Luer Lock(TLL-X)
PHARMA PULSE
Gandhi Automations presents the multi-composites,high-performance door
PRIME NEO for clean environments
PRIME NEO High Speed Doors are designed to provide superior sealing,resistance to pressure differences for clean rooms,and are completely washable
When it comes to pharmaceutical facilities and laboratories, clean rooms’ hygiene and protection from environmental contamination are the most important factors to consider.
PRIME NEO high-speed doors assures:
Minimised contamination:
Gandhi Automation's PRIME NEO High Speed Doors are designed to provide superior sealing, resistance to pressure differences for clean rooms, and are completely washable.
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.
Multi-composite structure:
Safety: PRIME NEO reduces the risk of accidents and damage. The free, flexible, and soft bottom edge minimises hitting impact. The radar detector and inbuilt photocells reopen the door at the slightest impact. Windows: The transparent material allows people to see oncoming traffic. Long-term transparency is assured, as the material is anti-fatigue PVC fabric.
The toughness of the side guides and their ability to absorb an impact avoids 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.
To know more about PRIME NEO, write to us at sales@geapl.com or call 022 6672 0200/0300
Sampling manifolds in single-use systems for bioprocessing
Sampling Manifolds in Single-Use Systems for bioprocessing:
In modern biopharmaceutical manufacturing, maintaining sterility and process integrity
multiple samples at different intervals without interrupting the process or compromising the sterility of the system.
Typically, the setup includes five or more sampling bags
various stages of the production process.
3.Conduct in-process testing without breaching aseptic boundaries.
4. Reduce risk of cross-con-
◆ The operator can direct the sample to a specific bag by rotating the valve, enabling timeseparated sampling.
3. Sampling bags (2D Bags):
◆ Made from pharmaceutical-
vaccine or biologics development. One critical aspect of this is sample collecting process fluids at various time intervals for analysis, without risking contamination. This is where a Sampling Manifold in a Single-Use System (SUS) plays a vital role.What is a sampling manifold?
A sampling manifold in a single-use system is a preassembled, gamma-irradiated, sterile, and disposable setup designed specifically for aseptic sample collection from bioreactors or process containers. It allows users to collect
valves that control the flow between them. A sampling needle at the inlet is inserted into the bioreactor or container, while a needleless sampling port at each bag’s outlet allows secure sample withdrawal for analysis.
Whyto use a sampling manifold?
The need for a sampling manifold arises from the requirement to:
cleaning validation compared to traditional stainless-steel systems.
Keycomponents of a sampling manifold
1. Sampling needle:
◆ Typically made from SS316L, this is the initial point of contact with the bioprocess fluid.
◆ It’s inserted aseptically into the bioreactor or container to draw samples.
2. Three Way Stopcock valves:
◆ These valves act as flow controllers between the sampling needle and each sampling bag.
◆ Its volume usually ranges from 100 mL to 1 liter, depending on the total sampling capacity.
Additional Features and Benefits
Presterilised and ready-touse:
Every sampling manifold is preassembled in an ISO Class 7 cleanroom and sterilised via gamma irradiation. This eliminates the need for on-site cleaning or autoclaving.
Customisable design: Manifolds can be tailored with different numbers of sam-
pling bags, varied tubing lengths and types (e.g., TPE, Silicone etc.), and specific connectors (e.g., MPC, MPX, Luer, etc.) based on the customer’s process requirements. Compatible with single-use bioprocess equipment:
These manifolds integrate seamlessly with single-use bioreactors, mixer bags, and media bags, making them ideal for upstream and downstream processing.
Reduced Risk and downtime:
Being disposable, these systems drastically reduce downtime related to cleaning, validation, and maintenance— making them a cost-effective and efficient solution.
Conclusion
The sampling manifold is a simple yet critical component in ensuring product quality and process reliability in biopharma manufacturing. With a focus on sterility, ease of use, and flexibility, these systems are now a standard in facilities that use single-use technologies for vaccine production, biologics development, and other high-purity applications. Their adoption not only enhances product safety but also aligns with the growing trend toward disposable, scalable, and contamination-free bioprocessing solutions.
Written By : Chinmaya Ranjan ParidaSenior Executive
