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Pharma experts scouring the joint statement issued at the end of the talks between Prime Minister Modi and President Trump seized on para 18 of the 33-point statement which expands on the US-India TRUST (Transforming the Relationship Utilising Strategic Technology) initiative.
The joint statement released by the Prime Minister's Office, stated that the leaders also committed, as part of the TRUST initiative, to build trusted and resilient supply chains, including for semiconductors, critical minerals, advanced materials and pharmaceuticals. As part of this effort, the leaders plan to encourage public and private investments to expand Indian manufacturing capacity, including in the US, for active pharmaceutical ingredients (APIs) for critical medicines. These investments will create good jobs, diversify vital supply chains, and reduce the risk of life-saving drug shortages in both the US and India, as per the statement.
US President Trump is also threatening to levy 25 per cent tariffs on pharma imports (as well as automobiles and semiconductors) from April 2, clearly pushing India’s pharma companies to subscribe to his Make America Great Again (MAGA) policy rather than Prime Minister Modi’s Make India Great Again (MIGA).
US legislators are planning to further sweeten the deal for generics pharma companies. On February 20, Congresswoman Claudia Tenney reintroduced the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act to promote the domestic production of generic medicines, offering pharma companies various tax incentives to enable them to shift all aspects of the manufacturing process for generic medicines, including materials and testing, to the US.
Sounds familiar? That’s because the PILLS Act seeks to do exactly what India’s Production Linked Incentive (PLI) Scheme proposed: incentivise manufacturers, across sectors, with financial incentives to invest and Make in India, aiming to boost domestic manufacturing, reduce imports, and increase employment.
According to a media release, the generic drug industry is ‘centralising production in India and China due to their significantly lower costs and looser manufacturing standards’ which is raising ‘serious concerns about potential supply chain disturbances and inadequate drug safety measures.’
Justifying the PILLS Act, the release quoted Congresswoman Tenney as saying, "Drug manufacturing has moved overseas, putting American jobs and the security of our essential medical supply chains at risk. To address this, I reintroduced the PILLS Act, which incentivises businesses to produce critical generic medications and antibiotics here in the US. By strengthening tax incentives for domestic drug production, this legislation will help prevent dangerous supply chain disruptions, reinforce our pharmaceutical security, and will create American jobs."
The reintroduction of the PILLS Act has predictably garnered support from lobby groups like the Coalition for a Prosperous America (CPA) and Securing America’s Medicines and Supply.
While the PILLS Act,aims for “strategically incentivising reshoring of essential medicines”to the US,India Pharma Inc cannot do this at the expense of other geographies, including their home market, India
Hailing the PILLS Act as “a critical step toward reshoring America’s generic drug production and reducing our dangerous dependence on foreign suppliers,” Zach Mottl, Chairman of the Coalition for a Prosperous America (CPA) pointed out that since 2002, imports from India have increased 35 times, while imports from China have surged 165 times over that same period. According to him, “Passing the PILLS Act is a necessary first step to reverse this trend, restore American pharmaceutical production, create high-quality jobs, and protect national security by ensuring a safe, reliable domestic supply of high-quality generic medicines, antibiotics, and other essential drugs."
David Sanders, Founder and Board Member, Securing America’s Medicines and Supply and Vice President of Coherus BioSciences, commented that the PILLS Act, aims for “strategically incentivising reshoring of essential medicines including generic drugs, biologics, and biosimilars through tax credits proposed in the legislation. Equally important, the PILLS Act will create more American jobs, reduce our nation’s overreliance on foreign production, and improve patient access to essential medicines.”
The facts speak for themselves. McKinsey & Company’s latest report, ‘Shaping the future of India’s pharmaceutical operations’, shows that stronger investments in world-class infrastructure has led India to surpass the US in the number of FDA-registered generic manufacturing sites, having grown at 2.6 per cent CAGR. India now has a network of 752 FDA-approved, 2,050 WHO GMP-certified, 286 EDQM-approved plants in 2024.
As per data from the Pharmaceuticals Export Promotion Council of India (Pharmexcil), the US made up nearly 31 per cent of India’s pharma exports, a sizeable $8.73 billion in FY2024. Ironically, tariffs on imported generics will trigger shortages, just the situation that President Trump seeks to avoid. Moving API manufacturing to the US will take time. The hope is that bilateral trade talks will find a middle path. As a statement from Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA) indicates, “The proposal regarding reciprocal tariffs is currently under talks and is being examined. This matter will be discussed through bilateral engagements between the two countries, and further steps will be determined accordingly.” The IPA statement also pointed out that ensuring the continued availability of affordable medicines remains a shared priority for both nations.
India’s pharma companies with huge exposure to the US market will need to re-strategise future investments in the US in sync with these policy changes. At the same time, they cannot do this at the expense of other geographies, including their home market, India. Clearly, India Pharma Inc will have to find an optimal balance between MAGA and MIGA, as both markets are important growth drivers.
Hyderabad to host the seventh edition of PPLConclave 2025
With the theme ‘Powering Innovation,Sustainability,Leadership,’PPLConclave 2025 will serve as a critical platform for thought leadership,knowledge exchange,and strategic networking
Pharma Packaging and Labelling (PPL) Conclave 2025, organised by Express Pharma, is scheduled to take place at Le Meridien on March 7-8, 2025. The conclave will bring together over 100 industry leaders, innovators, and decision-makers to explore the latest advancements, challenges, and opportunities in the sector.
Keythemes and topics
The event will feature keynote addresses, expert panels, and interactive sessions covering a
With the theme ‘Powering Innovation, Sustainability, Leadership,’ PPL Conclave 2025 will serve as a critical platform for thought leadership, knowledge exchange, and strategic networking.
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range of pivotal topics:
◆ Smart packaging for the connected age
◆ Packaging for global markets: Navigating diverse regulatory landscapes
◆ Next-gen labelling solutions: eLabelling and more
◆ Balancing cost and innovation in pharma packaging
◆ Anti-counterfeit packaging: Protecting patients and products
◆ Role of packaging in supply chain security
◆ Patient-centric packaging: Safe, Smart, Secure
◆ Strategies to speed up serialisation
PPL Conclave 2025 will offer attendees a valuable opportunity to:
◆ Gain firsthand insights from leading experts in pharma, biotech, and packaging industries
◆ Explore innovative packaging solutions from top solution providers
◆ Engage in discussions on regulatory trends, market dynamics, and sustainability in pharma packaging
◆ Network with key stakeholders, fostering collaborations and business partnerships
◆ Demonstrate and discover cutting-edge packaging capa-
bilities and technologies
The conclave will bring together a diverse set of stakeholders, including:
◆ Pharma packaging professionals – from R&D, quality assurance, and supply chain management.
◆ Regulatory and compliance experts – to discuss evolving guidelines and best practices.
◆ Technology providers –showcasing the latest innovations in smart and sustainable packaging.
◆ Industry leaders and decision-makers – sharing strategic perspectives on market growth.
◆ Investors and policy makers – exploring new opportunities in the pharma packaging ecosystem.
With an impressive lineup of speakers, interactive discussions, and state-ofthe-art solutions on display, the conclave is poised to set new benchmarks in innovation, sustainability, and leadership within the industry.
Stay tuned for updates as we count down to PPL Conclave 2025 – the platform for the future of pharma packaging and labelling.
Leadership evolution in India's pharma sector in 2025
As the sector adapts to technological advancements,regulatory requirements,and increasing competition,several leadership role trends are emerging to drive global growth and innovation, highlights Tarunesh
Madan, Co-Managing Partner,Amrop India
The Indian pharma industry is evolving rapidly, leading to the emergence of new leadership roles that address the sector's dynamic global challenges and opportunities. As the sector adapts to technological advancements, regulatory requirements, and increasing competition, several leadership role trends are emerging. These roles are designed to strengthen the companies' operational efficiency, expand their market presence, and foster innovation. The US market also continues to present a significant growth opportunity, driving many companies to evolve their leadership roles to stay competitive and compliant with stringent regulations. As Indian pharma companies continue to expand their footprint in the US and other international markets, leadership role trends are emerging that focus on regulatory expertise, market access, R&D innovations, and operational excellence.
Integrated roles of manufacturing,supplychain and technical operations
Given the large scale of operations and growth aspirations, leading companies have brought together manufacturing, supply chain, procurement
and technical operations under an integrated role. This allows to streamline operations, improve efficiency, and meet both regulatory and market demands. These roles are increasingly interconnected to ensure smooth production processes, cost efficiency, product quality, and timely delivery to global markets. While manufacturing and supply chain have often been integrated, the coming years will also see the trend of technical operations getting integrated. This role focuses on process development, technology transfer, and ensuring that manufacturing processes are efficient and compliant with global standards. Integration with both manufacturing and supply chain unlocks efficiency in production and manage scale-up activities. Key benefits through this role are regulatory compliance, faster time to market, quality control and enhanced flexibility.
Transition of talent from consulting to operating roles in pharma
The interesting trend of talent in consulting firms (McKinsey etc) transitioning to wider operating roles has been prevalent for long across various consumer, consumer services and industrial sectors. However, this has now started to play out in Indian pharma companies where Consulting Partners are taking on interesting roles including R&D Project Management of generics, leading integrated product development
organisations, Supply Chain transformation, BD support for certain therapeutic segments, M&A, Digital Transformation and above all CEO roles. This trend is likely to continue given the ecosystem complexity, pace of change and the context of spotting opportunities and creating scalable business models out of those.
Continued strategic focus on North America
US market accounts for anywhere between 30 per cent to 60 per cent of annual revenues for leading pharma companies in India. Companies will continue to acquire leadership capabilities with focus on these markets. Two approaches are being pursued: Bring top executives on the board as Independent Directors from global pharma landscape with deep understanding of the US Markets; and create integrated leadership roles for North America and elevate the roles as part of the Management or Executive Committees.
◆ Pharma companies also building CDMO capabilities: Several large pharma companies have established or acquired Contract Development and Manufacturing Organisations (CDMOs) to enhance their manufacturing capabilities and expand their service offerings. This has got accelerated in recent years, thanks to India’s emergence as a pharma R&D hub. Many companies will continue to strategically integrate CDMO services to leverage
their manufacturing expertise, expand their market reach, and provide comprehensive solutions to the pharma industry. While CDMO players like Divi’s, Laurus Labs and Jubilant Pharmova will continue to invest aggressively, established API and formulation companies are developing CDMO capabilities. Subsidiary companies are getting established, led by expert professionals as CEO’s. There will be continued Private equity interest in this space. In the last few years, Goldman Sachs acquired 33 per cent in Aragen, Piramal invested in CDMO’s Hemmo Pharmaceuticals and Yapan Bio, Advent International acquired Suven Pharma which was subsequently merged with Cohance Lifesciences.
◆ Digital transformation: Digital will continue to be the backbone of transformation. Historically, pharma has been something of a laggard in the digital space. However, the rate of adoption has gathered speed in recent years and the momentum will continue going forward. To remain competitive, companies will need to demonstrate agility in responding to changes and investing in building new age capabilities. Digital transformation leadership roles are being created in parallel to conventional CIO roles to drive business impact on the ground by adoption of AI, machine learning, and data analytics while leading implementation of digital initiatives. Industry players are also focussing on devel-
oping new products and solutions by integrating science and innovation with data insights.
◆ Regulatory affairs: Appointing global regulatory affairs leaders is a strategic move to enhance international market access and ensure compliance with diverse regulatory standards. Indian pharma companies over the recent years have demonstrated significant leadership in securing approvals from the US FDA. More global leaders are expected to be appointed in these key roles to help in securing marketing authorisations in various markets. These are global experts who understand the complex issues associated with regulatory agencies and help in the approval of each complex API by analysing the latest regulatory trends and quality. Large pharma companies in India have already been appointing North America-focused Regulatory Affairs leadership roles, responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings. This talent has deep understanding of global drug development and filing requirements, including focus on successful biologics, biosimilars and other specialty product approvals. They also drive cross-border compliance with focus on understanding US regulations, including Good Manufacturing Practices (GMP) and
Good Clinical Practices (GCP), as well as managing interactions with FDA representatives.
R&D and innovation leadership
R&D leadership plays a crucial role in driving innovation, particularly with respect to complex generics and biosimilars, two growing segments.
◆ Complex generics development: Leadership focuses on the development of complex generics, which have increased demand in the US, as these are difficult to replicate but offer significant market potential.
◆ Biosimilars and biologics: There’s a growing trend towards investing in leadership that focuses on the R&D of biosimilars and biologics, which are particularly important for the US market given the ageing population and increasing demand for biologic therapies. The market opportunity demands robust leadership across multiple facets of the pharma business, particularly in regulatory affairs, R&D, market access, supply chain, and digital transformation. Indian pharma companies are adjusting their leadership structures accordingly to stay competitive and ensure their products meet the stringent standards of the US market. These emerging leadership roles reflect the industry's commitment to innovation, digital advancement and global expansion, positioning Indian pharma companies for sustained growth and competitiveness on the global stage.
STRATEGY
Being complacent in pharma quality: Five minutes to midnight
Dr Sumedha Nadkar, Pharma Consultant and Visiting Faculty,shares a hard hitting article which highlights that complacency in pharma quality can have devastating consequences,eroding hardearned trust and endangering lives.She urges that urgent action is needed to safeguard its reputation and reinforce ethical responsibility
Irecently had the honour of listening to the talk of Dr Yusuf Hamied, Non-Executive Chairman of Cipla who inaugurated the upgraded chemistry department at the Ramnarayan Ruia Autonomous College, Mumbai. It has been renamed as 'Dr Yusuf Hamied, Dept of Chemistry'. He quoted the teaching of Swami Vivekananda, “While knowledge is important its ap-
plication is even more important”. Looking at the recent incidents in the Indian pharma industry, are we applying our knowledge ethically? Where is the goodwill we earned when the Father of Generics, our own Dr Yusuf Hamied paved the way for generics way back in the year 2001? Nobody can forget how Dr Hamied led efforts to eradicate in the developing world and to give patients
life-saving medicines regardless of their ability to pay, The cocktail of AIDS drugs offered low-cost generic versions of antiretroviral drugs (ARVs) at around $1 per day—a groundbreaking move that disrupted traditional pharma pricing. This strategy showcased CIPLA’s corporate responsibility and prioritisation of public health over profit by giving access to essential medicines to
one and all.
Dr Hamied had stated then, "I don't want to make money off these diseases which cause the whole fabric of society to crumble."
What would be the reaction of the same Africans who had benefited through our antiretroviral drugs and praised Cipla?
While the recent government initiatives are laudable,
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e.g. incentives such as exemption of basic customs duty on 36 life-saving drugs and concessional for cancer, rare diseases, and chronic illnesses, have we considered proactively instituting additional resources for enforcement to prevent their misuse? True, we are not moral policemen to prevent offlabel or illegitimate use, but indulging or encouraging such activities is unpardonable.
Even more shameful is that a BBC World Service sting operation had to reveal the recent incident of the concoction of Narcotics to African nations, by Aveo Pharmaceuticals. Worse, one of the directors, Vinod Sharma was filmed showing off the same dangerous products the BBC found for sale across West Africa. This video is going viral.
The US FDA publishes a list of debarred individuals on their website. It is time for the ministry to introspect the regulatory oversight and take strict
While we talk about digital era and mechanisms to reduce personnel,can digital leaders help in finding such criminal drug activities and nip them at the root? If yes,it is time to ACTNOW
measures to prevent recurrence. We make multi-bagger Bollywood movies accusing our neighbours. Have we looked in the mirror ourselves or are we turning a blind eye to this incident? How many times are we going to only react: The Gambia cough syrup incident is not very old.
As we know, after this incident was brought to light, The Central Drugs Standard Control Organisation (CDSCO) and the State FDA banned the production and export of combination drugs containing Tapentadol and Carisoprodol, which were found to be misused in West African nations. The Centre and State regulators are
still pointing fingers at each other stating their limits of jurisdiction, for this apparent 'miss'.
Where were our enforcement officers? Do we need more human resources or do we need to build efficiency or do we need 'Musks' to challenge their efficiency? Out of the box thinking is required ASAP now.
Can we deploy defence forces to support the raids? Can we hire experienced independent auditors and deploy them to conduct surprise audits?
Another big issue is already gazing at us: the recent re-introduction of the PILLS Act by
Congresswoman Tenney. This bill offers tax incentives to pharma companies to shift manufacturing processes, including materials and testing, to the United States. So, what is the effect on our 'Make in India' scheme?
It is time for CDSCO to pull up their sleeves, engage pharma leaders on deputation or projects and just conduct random surprise inspections. We have to wake up. We have once again showcased to the world something that we should be ashamed of.
While we talk about digital era and mechanisms to reduce personnel, can digital leaders help in finding such criminal
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drug activities and nip them at the root? If yes, it is time to ACT NOW.
We all talk about quality culture, technology advancements, and patient-centric approach. Advanced data analytics and skilled talent will drive the next phase of growth in India’s pharma industry. We preach that quality is everybody’s responsibility; unfortunately, we have proven by example that it is nobody’s.
It is now past a wake-up call for leaders - Both regulators and industry to start thinking about how to improve our severely tarnished image in the pharma sector.
“The key to everything is patience. You get the chicken by hatching the egg, not by smashing it.” – Arnold H. Glasow
The above proverb will not work for us. It has to be exactly the opposite.
It takes years to build an image and seconds to break it!
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STRATEGY
Shaping the future of India’s pharmaceutical operations
Over the past decade and more, India’s pharmaceutical sector has become the world’s largest supplier of generic medicines, with exports growing faster than the global average. The industry is at a tipping point, however: the Indian and global landscapes are shifting. While emerging trends could disrupt the current environment, they could also lead to the next horizon of opportunities for the industry.
Against this backdrop, what will it take for the industry to achieve its full potential and
unlock the next S-curve of performance as a global leader?
To answer the question, this report looks at Indian pharma’s journey so far, highlights the potential disruptions and opportunities likely ahead, and proposes strategic, thematic priorities for pharma companies as they pursue accelerated and sustained global leadership.
The evolution of India’s pharma operations: Triumphs and trials
With a thrust on strong operations over the past decade, In-
dian pharma production has outpaced global growth by over two times, and Indian exports (at 9 per cent) have outpaced global growth (5 percent).1
Five factors have contributed to this performance:
1. Increased investments in infrastructure: India now has a manufacturing infrastructure of 752 Food and Drug Administration (FDA)-app roved sites, 2,050 World Health Organization (WHO) Good Manufacturing Practice (GMP)certified plants, and 286 European Directorate for the
Quality of Medicines and Healthcare (EDQM)-approved plants as of 2024 (2).
2. Enhancing quality to meet global standards: Global compliance outcomes have improved over the past decade, and the industry achieved a step change in its quality excellence trajectory.
3. Leadership in cost and operational efficiencies: Manufacturing costs in India have stayed 30 to 35 per cent lower than in the United States and Europe, because of structurally low-cost labor, collective efforts toward industry-
leading cost and productivity performance, and accelerated digital adoption.
4. Expanded capabilities across the value chain: India has also enhanced its position in the operations value chain by demonstrating broader capabilities across more complex dosages and large molecules.
5. Sustained reliability and structural resilience: The Indian pharma industry has worked toward fostering selfreliance and building strong supply-chain networks. This supported the industry to consistently and reliably maintain
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essential supplies in critical times such as the COVID-19 pandemic between 2020 and 2022.
Trends likelyto impact the operations landscape
The industry now stands at a crossroads, with internal and external disruptions poised to create a shifting landscape (Exhibit 1). Within the industry, performance has started plateauing while the bar for quality excellence continues to rise. Disruptions such as the next generation of digital technologies, smart automation, and new modalities or therapies could reshape traditional plant operations.
In the external environment, an even more complex set of forces is shaping the landscape.
Geopolitical uncertainties and nearshoring could challenge current operations strategies. Sustainability in operations is fast becoming a critical business enabler for companies. New opportunities could arise and scale up, such as pharma services or contract development and manufacturing organisations (CDMOs) and emerging markets.
Purposeful moves that build on the tailwinds and address the headwinds could help companies to remain ahead in this ever-evolving global market.
Themes for the future of Indian pharma operations
Over the next decade, companies will need to fundamentally redefine their operational strategies. With a focus on eight core priorities, the pharma industry could build agile, efficient, reliable, and sustainable operations for the future (Exhibit 2).
1. Zero-error operations enabled by future-shaping smart quality systems: These could effect a fundamental shift from reactively resolving issues to proactively preventing defects, and from merely reducing errors to structurally eliminating them. This could unlock industry-best outcomes such as over 99.9 per cent right-first-time performance, less than 0.01 per cent batch failures and deviations, eight -
Exhibit 1
McKinsey& Company
Various trends are likelyto impact the operations landscape.
Trends shaping internal operations networks in India Evolution and disruptions in the external environment
A Plateauingperformance improvements
B Evolvingbaronquality excellenceinplantoperations
C Disruptionsindigital technologiesand acceleratingadoptionrates
D Evolutionofcore manufacturinginfrastructure andsmartautomation
E Shifttowardthenext generationoftherapies
Exhibit 2
Company
Eight prioritythemes could shape the next decade of pharma operations.
Plant level focus areas
A Zero-error operations enabled byfuture-shaping smartqualitysystems
B Low-touch,sentient plantoperations driving high-performance manufacturing
C Miniaturizationof manufacturing throughadvanced technologies
D Customer-centric operations tosupport thegrowthofservices
E Nexthorizonof expandedenterprise widecostleadership
Networkwide priorities
F Distributedpharma operations for networksofthefuture
G All-timeautonomous planning acrossthe supplynetwork,or planningbyexception
H Greennetwork tounlockanetzero visionforoperations
McKinsey&
McKinsey&
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sigma process capability, and zero repeat errors, among others.
2. Low-touch, sentient plant operations driving high-performance manufacturing: Intelligent systems could autonomously manage and optimise manufacturing operations to eliminate human error and enhance overall quality, over and above a potential, repeatable step-change in efficiency (such as more than 40 per cent lower manufacturing costs, consistently more than 70 per cent OEE levels, doubled productivity, and over 70 per cent reduction in plant downtimes).
3. Miniaturisation of manufacturing footprint through advanced technologies: New possibilities of continuous manufacturing, modular “plant-in-plant” setups, and small-scale operation/ microreactors for higher reliability especially in biopharma manufacturing could all contribute to modular but highperformance delivery.
4. Customer-centric operations to support the growth of services: With purposeful shifts, emerging companies could fully unlock the CDMO opportunity, such as by broadening portfolio and capabilities, cultivating a customercentric operations excellence model, streamlining operations for cost efficiency, attracting and retaining top operations talent, and continuing a focus on capacity expansion.
As part of the network strategy, companies could think about establishing centres of excellence (CoEs) and distributing their manufacturing footprint
5. The next horizon of expanded enterprise-wide cost leadership: In the face of operational plateaus, companies could target the next S-curve of cost leadership through a focus on four themes: attaining the same level of cost leadership in large molecules as in small molecules, exploring deep de novo scientific optimisation for active pharmaceutical ingredient/ key starting material (API/KSM) manufacturing, attaining a last-man standing position in their hero product, and unlocking the next wave of procurement excellence.
6. Distributed pharma networks of the future: As part of their network strategy, companies could think about establishing centres of excellence (or CoEs) and distributing their manufacturing footprint. These COEs could help to navigate both the increasing complexity of global pipelines and emerging pockets of regionalisation.
7. All-time autonomous planning across the supply network: “Planning by exception”, where companies will need to embed artificial intelligence/machine learning (API/KSM) or digital principles in day-to-day supply chains to unlock new levels of performance, such as more than 30 per cent lower costs on planning and inventory, service levels above 98 percent across the network, and lead times shortened by around 25
ACOPOS6D
to 40 per cent.
8. Green network to unlock a net zero vision for operations: Organisations could start adopting an integrated dual mission approach, to drive cost optimisation across spend items while optimising their Scope 3 footprint. They could target win-win approaches to cut costs and carbon dioxide emissions, such as raw material value chain decarbonisation, process and energy efficiency, recycling and circulating, package/product redesign, and sustainable supply collaboration.
India’s pharma industry stands strong today because of what it has built over the last decade.
It can further accelerate its global leadership even with significant disruptions on the horizon. On the brink of a pathbreaking S-curve, it could boost growth and profitability, achieve industry-leading quality and sustainability, and drive greater innovation. The priorities outlined here could serve as a guide for pharma companies as they pursue taking this potential to reality.
BMI, a Fitch solutions company, 2024.
2 United States Food and Drug Administration. “Generic Drug Facilities, Sites, and Organization Lists”; Department of Science and Technology. Indian Pharmaceutical Sectorial System of Innovation (IPSSI) Report.
Industry visionaries came together to shape the future of Indian pharma under the theme 'Leadership for the Next Leap' at Pharma Leadership and Innovation (PLI) Conclave 2025.The event explored strategies to drive innovation, sustainability and global leadership
Inaugural Session
The Pharma Leadership and Innovation Conclave 2025, recently held in Mumbai, marked the launch of new platform by Express Pharma to support innovation and leadership in the pharma industry. The event, themed ‘Leadership for the Next Leap’, brought together key industry stalwarts to navigate the evolving landscape of Indian pharma. The session began with a welcome address by Viveka Roychowdhury, Editor, Express Pharma.
She said, “The PLI Conclave is conceptualised to empower pharma leaders, across organisations and functions, with the vision and tools needed to drive meaningful change. Under the theme, “Leadership for the next leap”, today’s inaugural edition has a series of panel discussions, showcasing how the pharma industry's leaders are forging strategies that put the patient at the centre of every strategy and conversation.”
Setting the tone for engaging discussions ahead, she added, “The speakers will give real world examples of how their organisations balance innovation with responsibility, growth with sustainability, and profit with purpose.”
A lamp lighting ceremony followed, symbolising the industry’s collective commitment to progress and innovation. The inaugural session laid a strong foundation for thought-provoking discussions and collaborations.
Innovations in active packaging
Active packaging plays a crucial role in securing the safety and efficacy of medicines. As the pharma industry grows and diversifies, the sphere of active packaging has too witnessed several advancements.
During the PLI Conference 2025, Dhairy Sharma, Senior ExecutiveBusiness Development, Cilicant, delivered an informative presentation on the latest inn ovations in active packaging technology and their significance for the pharma sector.
Sharma highlighted the growing importance of intelligent active packaging and how Cilicant is addressing the industry's evolving needs with cutting-edge solutions. He explained that active packaging goes beyond protec-
tion, interacting with its contents to preserve both efficacy and safety.
Cilicant presented Frexil, an innovative canister featuring patented technology that not only protects pharmaceutical products from potential contamination but also eliminates the dusting problem, ensuring the cleanliness and safety of the packaging. The product comes in two different forms to meet the packaging needs, resolving the issues of both odour control and moisture.
With its line of products, Cilicant aims to aid the pharma industry by providing effective active packaging solutions that eliminate packaging and storage issues of the medicine and ensure its shelf-life, safety and efficacy.
The Pharma Leadership and Innovation Conclave 2024 hosted a thought-provoking panel discussion on ‘The Patient of the Future: Shaping Pharma’s Next Big Opportunity’. It focused on how the pharma industry must evolve in response to shifting patient expectations and advancements in healthcare.
Moderated by Viveka Roychowdhury, Editor, Express Pharma, the panel brought together key industry experts. Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA); Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI); Daara Patel, Secretary General, Indian Drug Manufacturers' Association (IDMA);
Chakravarthi AVPS, Sr VP (National) & Chairman (TG & AP), FOPE South and Pramod John George, Joint Secretary & Trustee, Friends of Max, Mumbai.
The discussion highlighted the transformation of patients from passive recipients of care to informed, engaged, and empowered stakeholders in their health. The discussion highlighted that this shift presents a significant opportunity for pharma companies to rethink their strategies, not just in drug development but in overall patient engagement.
Panelists emphasised the need for pharma companies to set up and support more programmes to expand access to essential medicines. Public-
private collaborations and policydriven initiatives were identified as crucial for ensuring equitable access to life-saving treatments.
The discussion also addressed the need for incentivising innova tion to drive more investment in R&D. The panelists stressed that while regulatory frameworks must ensure patient safety, they should also encourage innovation and breakthrough therapies.
A key takeaway from the discussion was that the future of healthcare is not just about selling medicines but ab out providing integrated healthcare solutions.
The panelists highlighted five crucial elements for holistic healthcare: Drugs, Diagnosis, Devices, Delivery
and Digital. These pillars represent a shift towards a patient-centric, technology-driven ecosystem to enhance patient outcomes.
The panel underscored that only companies that proactively embrace technological advancements will be able to deliver on the promise of integrated healthcare. The convergence of pharma, diagnostics, and digital technology will drive value-based care.
The discussion reinforced that patient empowerment, sustainable innovation, and a holistic approach to healthcare will define the future of the pharma industry. Companies that focus on value-based care, digital transformation, and access-driven strategies will lead the next phase of growth.
Global excellence in sourcing and distribution of high
qualityingredients
At the Pharma Leadership & Innovation (PLI) Conclave 2025, Vijay Doshi, MD of Pioma Chemicals, discussed sourcing and distribution practices in the excipients and speciality ingredients sector. He outlined the company’s approach to raw material supply, adherence to industry standards, and cost considerations in international markets.
He also informed that Pioma Chemicals supplies functional excipients and speciality ingredients to the pharmaceutical, nutraceutical, personal care, and allied industries. The company has established partnerships with over 20 international firms, offering a portfolio of more than 2,000 products catering to various industry applications.
Headquartered in Mumbai, Pioma Chemicals operates in domestic and international markets. Its business model
VijayDoshi,MD,Pioma Chemicals
incorporates product development, technical support, and regulatory documentation. The company has expanded its manufacturing and supply chain capabilities through collaborations with external partners, ensuring compliance with global standards.
Pioma Chemicals has invested in science and technology to develop new products and manufacturing processes. Its sourcing and distribution networks are structured to meet industry demand while maintaining cost efficiency and regulatory compliance.
The company continues to focus on supply chain optimisation and strengthening global partnerships. Its product portfolio supports pharmaceutical and personal care industries, reinforcing its position as a supplier of excipients and speciality ingredients in multiple markets.
Nurturing talent & leadership for the future
At the Pharma Leadership & Innovation (PLI) Conclave 2025 in Mumbai, Dr Pratibha Pilgaonkar, Founder and MD of Rubicon Research, discussed the significance of talent development and leadership in driving industry growth. She outlined the need for a structured approach that integrates education, mentorship, experience, and continuous learning.
Building on this, she highlighted how Rubicon Research has consistently prioritised identifying and nurturing future leaders while maintaining a strong focus on quality and patient care. The company’s growth, both in India and globally, has been driven by sustained investment in talent development. From its inception, the organisation has actively worked towards creating a pipeline of skilled professionals.
Expanding on the company’s approach, she emphasised the importance of engaging professionals from diverse backgrounds. Rubicon Research has incorporated experienced retired profes-
Dr Pratibha Pilgaonkar,Founder and MD,Rubicon Research
sionals into its workforce, recognising the value of their expertise, while also creating opportunities for fresh graduates through experiential learning initiatives. The Rubicon Academy has played a central role in offering structured training programmes for both students and employees, ensuring continuous skill enhancement. To further support workforce development, the company has implemented a strong performance appraisal system. This includes regular feedback, mentorship opportunities, and skill development exercises designed to encourage continuous learning. Additionally, collaboration with external agencies has strengthened its workforce capabilities, providing access to global best practices.
Dr Pilgaonkar also underscored that leadership in the pharma sector requires adaptability, resilience, and a proactive approach to fostering a growth mindset. She stressed that sustained investment in leadership development is essential for securing the industry’s future.
Panel Discussion: Rewriting the pharma playbook: Safer,Smarter,Sustainable
L-R: Venkatanarayan V,VP& Digital Transformation Leader,GMO,Dr Reddy's Laboratories (MODERATOR); Rajesh Mishra,Director - Packaging Development,Abbott Healthcare; Satya Chandrasekhar,Head-Corporate QualityAssurance,Reliance Life Sciences; Pramod S Pandit,Sr VP& Head Commercial,Ajanta Pharma; Kaifeel Shaikh,VP-Domestic Distribution & Global Logistics – EXIM,Indoco Remedies; Mannan Khambati,VP,Bharat Serums and Vaccines
At the recently held Pharma Leadership & Innovation (PLI) Conclave 2025, in Mumbai, a panel discussion titled "Rewriting the Pharma Playbook: Safer, Smarter, Sustainable" brought togetherindustry leaders to discuss how technology, sustainability, and strategic collaboration are reshaping the Indian pharma landscape.
Moderated by Venkatanarayan V, VP & Digital Transformation Leader, GMO, Dr Reddy's Laboratories, the panel featured key figures from across the sector. The panellists included; Rajesh Mishra, Director of Packaging Development, Abbott Healthcare; Satya Chandrasekhar, Head of Corporate Quality Assurance at Reliance Life Sciences; Pramod S Pandit, Senior VP & Head of Commercial, Ajanta Pharma; Kaifeel Shaikh, VP, Domestic Distribution and Global Logistics – EXIM, Indoco Remedies; and Mannan Khambati, VP, Bharat Serums and Vaccines.
The discussion opened by highlighting the need for the Indian pharma industry to adopt safer, smarter, and more sustainable practices to stay competitive and future-ready. Panellists emphasised that embracing automation could help eliminate repetitive tasks, allowing professionals to focus on higher-value activ-
ities, thereby boosting both engagement and productivity.
Building on this foundation, the conversation moved to the benefits of digital transformation. The panel pointed out how other industries have successfully leveraged digital technologies to enhance productivity, urging the pharma sector to adopt similar strategies to stay relevant in an increasingly dynamic global market.
The focus then shifted to packaging innovations, with panellists noting how technology is simplifying traditionally product-centric processes. This shift is helping to reduce operational layers while improving product stability and safety.
From packaging, the conversation moved to quality control. The panel discussed how digitalisation is reshaping Quality Assurance (QA), with digital parametric testing seen as a potential replacement for conventional methods in the future. However, they also highlighted the ongoing importance of human insights in both QA and QC, to maintain productivity and accuracy.
Logistics transformation was another key area of focus. The panellists discussed the shift toward larger, smarter warehouses, noting that despite
technological advances, the core challenge remains ensuring timely and accurate product delivery while meeting strict regulatory standards.
The panel also highlighted how the industry is beginning to adopt a distribution model similar to that of Fast-Moving Consumer Goods (FMCG), aiming to streamline processes without compromising patient-centric care.
When discussing the complexities of biotech manufacturing, industry leaders acknowledged challenges such as high costs, lengthy processes, and stringent regulatory requirements. However, they noted that integrating artificial intelligence (AI) and digital technologies could enhance efficiency and promote sustainability within the sector.
Expanding the discussion to global competitiveness, experts recognised India’s technological capabilities and cost advantages. However, they stressed that maintaining world-class quality standards is essential for the country to secure a leadership position on the global stage.
Balancing affordability, safety, and quality emerged as another central theme. The panel underscored that affordability should never come at the expense of patient safety or product quality.
This perspective aligns with the Triple P framework—pharma, patient, and planet—which seeks to balance commercial success with patient welfare and environmental responsibility.
The conversation also explored the role of digitalisation in improving visibility across manufacturing processes. Panellists highlighted benefits such as enhanced tracking, simplified management, and stronger supplier relationships through more efficient vendor inventory systems.
Collaboration across different functions was identified as a key driver for the future growth of the industry. The panel agreed that fostering interdepartmental cooperation will be essential to shaping the next phase of evolution in the pharmaceutical sector.
The discussion concluded with a focus on profitability through innovation. The panellists stressed that financial success should be a natural outcome of advancements in technology and research, rather than reliance on material gains. The session underscored that the future of the Indian pharma industry lies in embracing digital transformation, fostering innovation, and maintaining a focus on sustainability while ensuring patient safety and affordability.
Nitrosamines & MCC
At the Pharma Leadership & Innovation (PLI) Conclave 2025, held in Mumbai, Dr Abhijit Gothoskar, Technical Expert at Sigachi Industries, delivered an individual session titled 'Nitrosamines and MCC'. His presentation addressed the critical role excipients play in maintaining pharma product quality while adhering to regulatory standards.
Dr Gothoskar focused on the increasing global concern around nitrosamines—impurities that present potential health risks. As regulatory authorities worldwide intensify scrutiny on nitrosamine levels, he stressed the need for manufacturers to proactively manage these contaminants to meet compliance requirements.
A key point of discussion was the importance of excipients, particularly in tablet formulations, in reducing the risk of nitrosamine contamination. Dr Gothoskar emphasised that excipient selection should prioritise chemical stability and purity, rather than focusing solely on cost and availability. The session also highlighted Micro-
Dr
crystalline Cellulose (MCC) as a versatile excipient essential for the pharma
WhyOPTELis the ideal choice for your L4 traceabilitysolution
Increasing global regulations demanding compliance and traceability and the risk of counterfeits, recalls, and supply chain disruptions are some of the reasons why the pharma landscape requires a global compliance solution. Offering solutions to these problems, Sagar Narvekar, Delivery Leader - OPTEL| L4 Verify Solutions presented OPTEL’s traceability solutions.
He informed that the L4 software ensures efficient, compliant, and cost-effective operations in the highly regulated and complex pharma industry. It helps manage and optimise production operations at the corporate level by integrating and coordinating business systems with operational processes. It ensures data integrity, traceability, and audit readiness to achieve full regulatory compliance. OPTEL offers data migration with minimal downtime and uses a two-server methodology. The
Sagar Narvekar,DeliveryLeader - OPTEL| L4
VerifySolutions
MCC plays a significant role in enhancing tablet integrity and stability
industry. Known for its compressibility and binding properties, MCC plays a significant role in enhancing tablet integrity and stability. Dr Gothoskar illustrated how MCC has contributed to improved production efficiency and consistent tablet quality across batches.
Concluding the session, Dr Gothoskar positioned Sigachi Industries as a reliable partner for pharma manufacturers, offering both high-quality excipients and technical expertise to navigate regulatory challenges and ensure product consistency.
The
L4 software
ensures
efficient,
compliant,and costeffective operations in the highly regulated and complex pharma industry
company delivers real-time, insightful data analytics to support decision-making. Verify by Optel ensures regulatory compliance, data integrity, and operational efficiency, informed Narvekar.
At the recently held PLI Conference 2025, an insightful discussion on the significance of quality in the pharma industry was held. The panel titled “From compliance to competitive edge: Making quality the cornerstone to success,” was moderated by Dr Ranjit Barshikar, CEO- QbD International, United Nations Advisor, QbD/CGMP Consulting and included quality leaders like Gopi Reddy, VP-Corporate Quality, Sun Pharma; Dr Madhu Raju Saghee, VP - VP-Corporate Quality (Global Injectables), Lupin; Minoo Biju, Head-Regulatory Affairs, Piramal Pharma; Manoj Chitnis, VP-Corporate Quality, JB Pharma; and Tripti Nakhre, VP-Regulatory Affairs & Packaging Development, FDC.
The discussion began by highlighting the importance of the right leadership inorder to imbibe the right qual-
ity culture within a company. The panellists agreed that leadership should be forward-thinking, embrace innovation while ensuring decisions are free from bias and driven by objective analysis to build a culture of quality. they also highlighted that a responsible leader advocates a culture of accountability across teams, not only upholding high standards but also embedding a culture of continuous improvement and excellence within the organisation.
The panellists stressed quality must be a core-value for pharma companies. They also underscored that quality is an inter-dependent system, so it is pertinent to all the departments of a pharma firm.
The role of AI in implementing a robust quality management system and driving inn ovation within the industry was the next point of discus-
sion. All pharma companies are becoming digital factories. So the pharma workforce must also upskill and reskill to keep pace with the transformations.
Implementing smart and new technologies that can ease daily tasks or monitor crucial areas such as reading software that aids in understanding new guidelines/compliances, ChatGPT based SOP, STP software making information accessible, camera-based AI model that monitors cleanrooms were also discussed during the session.
The quality experts also discussed various automation techniques and technologies that can ensure quality to be held in the highest regard from R&D to commercialisation. They accentuated that implementing a quality by design approach from the development stage of a product can result in creating a procedure that is designed
to uphold regulatory guidelines and maintain quality standards while simultaneously simplifying the process throughout a production cycle. They also discussed the importance of training the workforce to empower them with skills needed to keep pace with the transformations in the industry.
They also discussed on several types of monitoring technologies for track and trace to protect the product from tampering or counterfeiting and softwares that can monitor and process data of the efficacy of the product once launched to encourage pharmacovigilance practices can aid quality control overall.
Thus, it was a comprehensive discussion on quality and the strategies to achieve and uphold it across teams and functions in pharma organisations.
IPstrategyfor creating innovations in pharma domain
At the PLI Conference 2025, in yet another insightful session, Swati Veera, Head-IPM, Alivus Life Sciences (Formerly Glenmark Life Sciences) highlighted the role of IP in the pharma industry. She began by explaining the types of innovations - pioneering innovations, incremental innovations, products developed and improved over time and re-innovations that are prominently observed in the generics industry in re-formulations.
Veera explained how IP facilitates the commercialisation of the product from the lab to the market. The number of patents is an indicator of a company’s progress, capacity for R&D and scope of inn ovation. It helps a company to gain and retain its innovationbased advantage. Additionally, IP protection allows the developer company
Future trends in excipients with lownitrite
Managing nitrosamine impurities is a major challenge in the industry as nitrosamines can form during manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. Highlighting this issue in a presentation, Santosh Kakad, AGM - Sales and Marketing, Nitika Pharmaceutical Specialities discussed the impact of excipient selection on nitrosamine formation in drug products.
Nitrosamine formation is highly influenced by nitrite levels in excipients like microcrystalline cellulose (MCC), lactose, and superdisintegrants. High nitrite levels can increase nitrosamine formation by up to 151 per cent. Therefore, changing the supplier of MCC or such critical excipients can reduce nitrosamine levels by up to 89 per cent.
Kakad emphasised the importance of selecting low-nitrite excipients to reduce the risk of nitrosamine formation and improve product safety. He also informed that Nitika offers products like MCC, magnesium stearate, and sodium stearyl fumarate with low nitrite levels. These excipients are part of a strategy
Santhosh Kakad,AGM - Sales and Marketing,Nitika Pharmaceutical Specialities
the opportunity to recoup the heavy investment made in R&D, allowing it exclusive rights to develop the product for a certain duration of time.
Veera further explained offensive and defensive patent application strategies. The objective of the offensive patent strategy is to dominate the market by preventing competitors from entering the technology area. The defensive patent strategy is generally followed by smaller companies here patents are filed for creating prior art thereby prev enting others from patenting similar inventions.
The essence of the pharma industry lies in inventing novel drugs that address unmet medical needs, and enhance quality of life. Therefore, innovation vis-a-vis IP protection is crucial for the industry, was a key takeaway from her session.
Nitika offers products like MCC, magnesium stearate,and sodium stearyl fumarate with low nitrite levels. These excipients are part of a strategy to mitigate nitrosamine risk and enhance patient safety
to mitigate nitrosamine risk and enhance patient safety. This approach can be vital for high-risk formulations and aligns with regulatory guidelines to validate the safety and efficacy of pharma products.
Swati Veera,Head-IPM,Alivus Life Sciences (FormerlyGlenmarkLife Sciences)
Polymeric solutions for pharmaceutical industries
At the inaugural event of Pharma Leadership & Innovation (PLI) Conclave 2025, held in Mumbai, Rupesh Patil, Senior Manager – Business Development, Ami Polymer, held an individual session focused on the role of polymeric solutions in pharma industry.
Patil outlined how Ami Polymer supports pharma processes through a diverse range of polymeric products designed to meet specific industry needs. The company offers customisation, competitive pricing, and shorter delivery times, ensuring adaptability and efficiency for its clients.
The company’s expertise in advanced engineering techniques enhances its capability to deliver tailored solutions. It specialises in various moulding methods, including overmoulding, Liquid Silicone Rubber (LSR) moulding, insert moulding, and Thermoplastic Elastomer (TPE) injection moulding. These techniques enable the development of high-quality, customised assemblies designed to meet specific client requirements.
Patil also highlighted the company’s commitment to precision and customisation, stating that their polymeric so-
CONTRIBUTOR’S CHECKLIST
Rupesh Patil,Senior Manager – Business Development,Ami Polymer
lutions are developed with a clear focus on client-specific needs. This ap-
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Email your contribution to:
By offering flexible solutions,Ami Polymer positions itself as a reliable partner for pharma manufacturers aiming to enhance operational efficiency
port their operational and manufacturing processes effectively.
By offering flexible solutions, Ami Polymer positions itself as a reliable partner for pharma manufacturers aiming to enhance operational efficiency.
The Editor, Express Pharma, Business Publications Division, The Indian Express (P) Ltd, Mafatlal Centre,7th floor, Ramnath Goenka Marg, Nariman Point,Mumbai 400021 viveka.r@expressindia.com viveka.roy3@gmail.com
Panel discussion: Leadership for the next leap
Panelists: Viveka Roychowdhury,Editor,Express Pharma (MODERATOR); Dr C Naveen Kumar Reddy,AVP,Head- Project Management-API division; MSN Laboratories; Parag Sancheti,CEO, Rubicon Research; Prakash Agarwal,President-Strategy,Mankind; Dr Mahesh Bhalgat,Group CEO and MD,Veeda Lifesciences; Mr BG Barve,Joint MD,Bluecross Laboratories; Divya Sharma,Sr GM - Strategic Manufacturing Projects,Lupin; Dr PratikShah,VP-Medical Affairs,Bharat Serums and Vaccines
The panel discussion on "Leadership for the Next Leap" brought together prominent leaders from India's pharma sector. Moderated by Viveka Roychowdhury, Editor, Express Pharma, the panel featured insightful contributions from Parag Sancheti, CEO, Rubicon Research; Dr. Mahesh Bhalgat, Group CEO and MD, Veeda Lifesciences; B.G. Barve, Joint MD, Bluecross Laboratories; Prakash Agarwal, President-Strategy, Mankind Pharma; Dr. Pratik Shah, VP-Medical Affairs, Bharat Serums and Vaccines; Dr. C. Naveen Kumar Reddy, AVP and Head of Project Management-API Division, MSN Laboratories; and Divya Sharma, Senior GM of Strategic Manufacturing Projects, Lupin.
The panel highlighted the urgent need for India to transition from being a high-volume producer to a global leader in value-driven pharma inn ovation. This transformation requires a holistic approach, emphasising collaboration
Akey takeaway from the discussion was the increasing importance of streamlined regulatory processes.The panelists noted that with regulatory frameworks becoming more efficient,India is poised to witness a significant rise in clinical trials
across research and development (R&D), manufacturing, distribution, and healthcare systems to drive sustainable growth and innovation.
A key takeaway from the discussion was the increasing importance of streamlined regulatory processes. The panelists noted that with regulatory frameworks becoming more efficient, India is poised to witness a significant rise in clinical trials. This acceleration
will not only speed up drug development but also make a broader range of medicines available to the Indian market, ultimately improving patient outcomes.
The panel underscored the necessity of fostering stronger synergies between industry and academic institutions to advance high-quality pharma innovations. Encouraging young minds to pursue careers in science and re-
search was highlighted as a critical factor in sustaining long-term innovation and ensuring a robust talent pipeline for the future.
The discussion also emphasised the role of integrating advanced data analytics, cutting-edge technology, and skilled talent in driving the next phase of growth for India's pharmaceutical industry. The panelists agreed that these elements are essential to maintaining a competitive edge in the global market.
Throughout the session, quality and execution were repeatedly cited as foundational pillars of the pharma value chain. The leaders emphasised that maintaining the highest standards in these areas is vital to ensuring longterm success and global leadership.
The panel concluded with a collective call to action: for the industry to embrace innovation, invest in talent, and foster cross-sector collaboration to propel India to the forefront of the global pharma landscape.
Express Pharma Excellence Awards 2025 celebrates industrytrailblazers and export powerhouses in pharma
Recognises pharma companies driving innovation,market leadership, and global expansion
The Express Pharma Excellence Awards 2025, an initiative by Express Pharma, held along with the Pharma Leadership and Innovation Conclave, recognised the trailblazers and powerhouses that have propelled the Indian pharma industry to new heights. The event honored companies that have demonstrated exceptional financial performance, market leadership, and global expansion.
The evening commenced with a Welcome Address by Viveka Roychowdhury, Editor of Express Pharma and Express Healthcare. She said, “On behalf of The Indian Express Group and the Express Pharma team, it gives me immense pleasure to welcome you to the inaugural edition of the Express Pharma Excellence Awards. This endeavour aims to recognise and celebrate organisations driving growth, in-
KRaja Bhanu,DG,Pharmexcil
MARKETTRAILBLAZERS
The first category,Market Trailblazers,recognised companies that have set benchmarks in financial performance and market dominance.
SUN PHARMA
DIVI’S LABORATORIES
CIPLA
TORRENTPHARMACEUTICALS
MANKIND PHARMA
DR REDDY’S LABORATORIES
ZYDUS LIFESCIENCES
LUPIN
AUROBINDO PHARMA
ALKEM LABORATORIES
EXPORTPOWERHOUSES
The second categoryof awards were Export Powerhouse (FY24).These awards honored companies that have made significant contributions to India's global footprint.The awards were presented in two subcategories:
APIS & INTERMEDIATES
DIVI'S LABORATORIES
DR.REDDY'S LABORATORIES
MSN LABORATORIES
PIRAMALPHARMA
SUN PHARMAINDUSTRIES
FINISHED FORMULATIONS
DR.REDDY'S LABORATORIES
SUN PHARMAINDUSTRIES
LUPIN
AUROBINDO PHARMA CIPLA
LIFETIME ACHIEVEMENTAWARD
ALifetime Achievement Award was also announced for DILIPSHANGHVI,Founder and Managing Director of Sun Pharmaceutical Industries,at the PLI Awards 2024.The award is in recognition of his outstanding contributions to the Indian pharma industryand visionaryleadership
Winners of PLI Conclave 2025
novation, and excellence within India and globally.”
She also elaborated on the vision and mission of the awards, highlighting the crucial role of industry leaders in driving the future of pharma.
Her session was followed by an address by the Chief Guest of the event,
K Raja Bhanu, Director General, Pharmexcil. He emphasised on the global impact of Indian pharma companies and the need for continued innovation and regulatory excellence.
Drawing from his extensive experience in drug control and regulation, he provided valuable insights into the
evolving landscape of the pharma industry.
The awards ceremony followed next. Roychowdhury, along with Manish Jain, MD, Cilicant; Vijay Doshi, MD, Pioma Chemicals and Raja Bhanu, DG, Pharmexcil, presented the awards to the winners.
The event concluded on a high note, follwed by cocktails and a etworking dinner. Thus, the first edition of Express Pharma Excellence Awards 2025 was a resounding success.
The evening came to close on a celebratory note followed by a networking gala dinner.
TeamSun Pharma
Team Piramal Pharma
Team Mankind
Team Dr Reddy’s Laboratories
TeamLupin
Team Aurobindo
Team Alkem
TeamCipla
Team MSN Laboratories
PLI PPLI CONCLAVE 2025
PLI PPLI CONCLAVE 2025
PLI PPLI CONCLAVE 2025
INFRASTRUCTURE
Integrated research campuses: Future of Hyderabad’s life sciences industry
Vishal Goel, MD,RXPropellant outlines how transitioning from isolated industrial clusters to integrated research campuses can drive collaboration,accelerate commercialisation,reduce infrastructure costs,and enhance sustainability
Hyderabad leads in bulk drug manufacturing, advanced biopharma research, and vaccine innovation, serving as the base for renowned international players. The life sciences ecosystem in the city has expanded significantly to include contract research organisations (CROs), contract development and manufacturing organisations (CDMOs), and medical device manufacturing. However, this growth is still fragmented. Specialised clusters like the Genome Valley and the Medical Devices Park have attracted investment and strengthened supply chains, but they function primarily as co-located industrial zones rather than fully integrated ecosystems where academia, startups, and industry interact seamlessly. Only 12 per cent of Genome Valley’s operations, 18 per cent in Patancheruvu, and 23 per cent in Uppal-Nacharam integrate both R&D and manufacturing, highlighting the need for more connected research environments. The lack of shared R&D infrastructure, real-time industry-academia collaboration, and integrated regulatory pathways lead to inefficiencies in translating research into commercial applications. Additionally, entrepreneurs face challenges in accessing capital while global competition for life sciences investments continues to intensify, making it imperative for Hyderabad to create a more cohesive and innovation- driven ecosystem.
Transitioning from clusterbased models to integrated research campuses could bridge these gaps. Unlike industrial clusters, which focus on sectorspecific co-location, integrated campuses create a collaborative environment where research
institutions, academia, and industry converge. These campuses foster a multi-disciplinary ecosystem where pharma and biotech firms engage with universities, leveraging shared research infrastructure, joint innovation programs, and industry-driven training to accelerate commercialisation and scientific breakthroughs.
Examples of integrated research ecosystems include Brown University’s Danoff Laboratories, planned in Providence, and the University of Idaho’s Integrated Research and Innovation Center (IRIC).
As Hyderabad aims to expand its life sciences sector from $100 billion to $250 billion by 2030, adopting an integrated research campus model could be the key to achieving this growth.
The academic and research advantage
Hyderabad’s academic and scientific ecosystem is one of its greatest strengths, supporting its rise as a biopharma, biosimilars, regenerative medicine, and vaccine research leader. With over 50 premier research institutions, including CCMB, IICT,
NIPER, and the University of Hyderabad, the city produces over 100,000 graduates annually in biotechnology, pharma, and biomedical sciences. However, limited industry-academia integration often slows the commercialisation of research advances.
Despite over 300 biotech startups and 20+ incubators, such as Aspire BioNEST and IKP Knowledge Park, many ventures lack access to high-end R&D infrastructure, industry mentorship, and regulatory guidance. Existing skill development programs, including the Vaccine Skill Development Program, attempt to address workforce challenges but lack cohesion. The current model of isolated clusters does not provide the structured industry exposure necessary for students and researchers to transition seamlessly into the workforce. Given this scenario, integrated research campuses would provide AI-driven research training, hands-on industry exposure, and direct hiring pipelines, ensuring that Hyderabad produces a job-ready workforce with cutting-edge pharma R&D, bioinformatics, and person-
alised medicine expertise.
Economic and industrial impact
Hyderabad’s life sciences industry is on a high-growth trajectory, attracting major global investments. Companies such as Bristol Myers Squibb ($97M), Syngene International ($96M), and Eurofins Scientific ($121M) have expanded their R&D and drug development centers in the city, reinforcing Hyderabad’s reputation as a premier location for life sciences innovation. However, Hyderabad must enhance its capacity for cost-effective R&D and streamlined commercialisation to sustain this momentum.
The disparate nature of its industrial clusters sometimes results in inefficiencies, particularly for startups and mid-sized firms that struggle with high infrastructure costs. Integrated research campuses will address these challenges by reducing infrastructure costs, optimising production efficiency, and providing startups access to shared world-class R&D facilities. Instead of setting up expensive, independent research labs and pilot production units, emerging firms can leverage shared infrastructure, lowering capital expenditures while accelerating innovation cycles.
Push to sustainability through integrated infrastructure
The pharma and biotech sectors require extensive resources, making sustainability a critical concern. Generally, environmental efforts are largely company-driven rather than integrated at a systemic level. Waste treatment, solvent recovery, and energy adoption are managed separately, increasing compliance costs and opera-
tional inefficiencies.
Integrated research campuses offer a more sustainable model by embedding centralised effluent treatment, solvent recycling, and AI-driven biomedical waste management into their infrastructure. Renewable energy solutions like solar and green hydrogen lower carbon footprints while ensuring long-term cost stability. The Institute of Integrated Research in Japan exemplifies how research campuses can align sustainability with scientific advancements, creating environmentally responsible R&D ecosystems. Integrated campuses can take the city’s sustainability initiatives beyond isolated corporate efforts, promoting a collaborative ecosystem around green infrastructure.
Conclusion
Given the low R&D investment from both public and private sectors (0.65 per cent of GDP), weak corporate participation in research (41 per cent of Gross Expenditure on Research and Development), and underdeveloped research infrastructure, Hyderabad’s continued leadership in life sciences depends on creating a research ecosystem that prioritises integration over isolated growth. Integrated Research Campuses provide the necessary structural shift, breaking down silos between academia, industry, and regulatory bodies to accelerate commercialisation, optimise research costs, and attract global investment. As competition grows, Hyderabad has an opportunity to be a frontrunner in manufacturing and innovation, contributing to the global competitiveness and future readiness of India's life sciences sector.
TECHNOLOGY
Highlyflexible blister production at Remedica
The blister machines and cartoners at Remedica’s manufacturing site in Limassol,Cyprus,are arranged in-line in a so-called Z-layout.Romaco tailored the configuration to meet Remedica’s needs exactly
Aportfolio comprising several hundred products, an enormous range of batch sizes and customers with rapidly changing requirements: day-to-day production at Remedica, the Cypriot pharma manufacturer and contract packager, holds plenty of challenges. Short changeover times, reliable processes and maximum flexibility are therefore high on the company’s list of priorities. When it comes to packing solid pharma dosage forms, Remedica trusts in blister machines and cartoners made by Romaco, a leading international supplier of packaging and processing technologies for the pharma industry.
Remedica – Cyprus’s biggest pharma manufacturer – specialises in the development, production and sale of a broad spectrum of medicines, including cardiovascular agents and anticancer drugs, which are its flagship products. The company is committed to corporate social responsibility and environmentally friendly practices and has received numerous awards in the past for its sustainability initiatives.
Today, Remedica’s product portfolio comprises more than 300 generic, branded generic and over-the-counter (OTC) medicines in a variety of dosage forms such as tablets, capsules, oblongs, gels, creams, ointments, suppositories and topical aerosols. Remedica is also active in the market as a contract packager, meaning an enormous range of batch sizes, often very small, have to be processed – for instance as few as 500 blister packs with pharma solids.
Frequent format changes
In view of this huge repertoire of products and the extreme variations in batch size, flexibility,
reliable processes and high availability are key in day-to-day production at Remedica. This is particularly true with regard to the format parts, because format changes are necessary on the company’s blister machines every one and a half to two days
on average.
For more than ten years now, Remedica has trusted in Romaco technologies when it comes to blisters as primary packaging for tablets, capsules and oblongs or cartons as secondary packaging. The pharma
manufacturer presently has eleven Romaco Noack 921 rotary sealing machines at its disposal. Eight of these blister machines are used as modules of fully automated lines in conjunction with Romaco Promatic cartoners while the other three are
standalone units.
This standardisation of the solids packaging technology provides multiple benefits for Remedica in everyday production, especially where small batches are concerned, “Diminishing batch sizes are a growing trend in the contract packaging sector,” reports Dimitar Vasilev, Production Engineer at Remedica.
“Against that background, using several machines of the same type enables far more flexible production planning because we can use the same format parts on all our rotary sealing machines. On top of that, standardised solutions make life easier for our operators and they need less training to become familiar.”
More than 50 Romaco blister format sets in use
All parts belonging to a format set – such as feeding formats, deflection rollers or sealing, coding, perforating and die-cutting tools – are tested by Romaco before they leave the factory on machines specially reserved for this purpose together with the specific customer product and the relevant packaging.
“Our stock of format sets has been regularly expanded ever since we first started working with Romaco. We currently have more than 50 blister format sets in total, and we liaise closely and constantly with Romaco’s PacTech format competence center,” Vasilev continues.
He adds, “We can rely on Romaco to supply us with precisely fitting format parts that let us resume production again without delay whenever we change the format. The light weight of the individual components is another important advantage here. Every format part can be lifted and fitted by a single person.”
Remedica manufactures more than 300 generic,branded generic and OTC products
Remedica,the Cypriot pharmaceutical manufacturer,has its headquarters in Limassol
Romaco blister machines and cartoners have an ergonomic design with easy access to all components. The plug and play principle of the format parts guarantees fail-safe installation. Over the last few years, Romaco has systematically reduced the number of format parts for its machines and thus also the times for retooling. Romaco Noack’s blister packaging lines permit reproducible, toolless format changes in under 30 minutes. Furthermore, the hygienic design of these machines means less downtime and optimal availability because with their smooth surfaces and their rounded corners and edges, all blister machines and cartoners built by Romaco Noack and Promatic are quick and easy to clean.
Individual,space-saving line layout
The blister machines and cartoners at Remedica’s manufacturing site in Limassol, Cyprus, are arranged in-line in a socalled Z-layout. Romaco tailored the configuration to meet Remedica’s needs exactly. The blisters are discharged at the front and the cartoner is positioned in front of the blister machine and slightly to one side of it. This individual layout and the compact design of the machines helped Romaco achieve a very small footprint overall and fit the blister packaging lines optimally into the limited space available.
Production expanded with a Romaco Noack623 platen sealing machine
The products on Romaco Noack’s blister machines can be fed using different systems. Remedica relies on dedicated feeders for making aluminiumaluminium blisters and universal brush-box feeders for PVC blisters. The pharma manufacturer is now planning to expand its production capacity in the near future and also to introduce a platen sealing machine – a Romaco Noack 623, which is capa-
ble of processing all common thermoformable and sealable foils with an output of up to 480 blisters per minute and a maximum forming depth of 25 mm.
Dimitar Vasilev, Production Engineer at Remedica, is confident, “By expanding our existing production capacity, which is based on rotary sealing, with a blister machine featuring platen technology, we’ll be in a position to manufacture even more flexi-
bly and give the market what it wants better than ever, because we’ll additionally be able to process very large or thick tablets and oblongs with the Romaco Noack 623. Apart from the technical aspects, we were convinced, too, by Romaco’s commitment to take back the machines free of charge at the end of their service life in the interests of a circular economy.”
Company contact Sanjeev Nimkar
Managing Director, Romaco India, Unit No. 1005, 1006, 1007, Fenkin 9, Plot no. C5, Road No. 9, Behind Satkar Grande Hotel, Wagle Industrial Estate, Thane (W) 400604
Maharashtra, India
T +91 22 69207600
E india@romaco.com
The blisters are packed in cartons on a Romaco Promatic cartoner
Thanks to the light weight of the individual components,Romaco Noack’s blister packaging lines permit format changes in under 30 minutes
Chandrachur Datta, Partner,Vector Consulting Group explores how revamping the multi-tier distribution system with a demand-driven approach can optimise inventory,improve stockist efficiency,and ensure seamless access to medicines,benefiting pharma companies,stockists, and patients alike
India's pharma market is on a rapid growth trajectory, projected to reach $130 billion by 2030, driven by increasing affluence, improved healthcare access and rising income levels. However, despite this significant opportunity, pharma companies struggle to ensure consistent product availability at chemists across the country.
The cost of inconsistent quality
A survey by Vector Consulting Group (n=934 chemists) revealed that even top pharma firms have only 60-85 per cent brand reach at chemists, leading to frequent prescription substitutions.
and substitutions. This is despite companies carrying high
The study also found that one in four prescriptions go unfulfilled, resulting in substantial financial leakage for pharma firms due to stockouts
inventory in supply chain to prevent this.
To address these issues, it's crucial to grasp the root cause, which create these inefficien-
and tailored marketing strategies. Products from each division reach chemists through a network that includes company central/regional warehouses,
cies. Understanding the intricacies of the multi-tier distribution system is the first step towards identifying and solving the problem.
Understanding the multitier distribution system
Pharma companies in India are typically structured into distinct therapeutic areas, each managed as a quasi-business unit with dedicated sales teams
carrying & forwarding agents (C&F), and stockists/substockists. While central and regional warehouses and C&Fs may serve multiple divisions, the further distribution chan-
nels are customised to meet the specific needs and dynamics of each therapeutic segment. Additionally, each therapeutic division works with a unique set of stockists across the country. There may be some overlap, but not all stockists handle all therapeutic divisions, and not all divisions engage with every stockist. There are two kinds of stockists in India:
1. Stockists in wholesale (Mandi) markets (e.g., Dawa Bazaars) - Chemists order from these stockists, who are primarily counter-sellers, by visiting or on phone call, to purchase medicines and arrange for delivery.
2. Distribution-driven stock-
ists – Stockists actively take order from chemists and then provide door delivery to them.
Medicines move through this distribution chain—from pharma plants to stockists and chemists—based on sales forecasts and targets. However, when stock faces expiration or obsolescence in the channel, it is typically returned up the supply chain and destroyed by the company, resulting in significant losses.
In spite of this risk, companies maintain high inventory levels across the entire distribution chain, including with stockists, to mitigate the cost of unavailability, particularly the loss of sales as doctors stop prescribing unavailable brands.
However, despite these precautions, availability issues persist, as observed in the study.
Whyis ensuring availabilitya challenge
Ensuring 100 per cent availability of all medicines at chemists remains a challenge, even if pharma companies hold high inventory in the distribution system, due to the very design of this multi-tier distribution system.
Pharma companies that proactively shift to a demand-driven distribution model will achieve higher prescription fulfilment rates,motivated stockists with increased ROI with optimised inventory,improved cash flow by reducing expired stock losses.These companies will unlock the untapped potential of India's rapidly growing pharma market
ments). Expanding their product portfolio can help boost sales and offset these expenses. Therefore, ideally, stockists would want to offer a broader range of products across multiple therapeutic areas. However, doing so requires them to maintain substantial inventory, which is challenging due to their limited working capital. As a result, stockists are forced to focus on specific divisions, restricting their ability to provide a full product range and limiting chemists' access to a wider variety of medicines. Additionally, logistical and credit constraints make it difficult for stockists to serve all chemist customers, further reducing product avail-
stockists benefit from better returns on inventory investments and improved cost recovery, while companies enjoy a broader product presence at stockists, enhancing their market reach at chemists.
However, lowering inventory levels comes with the risk of stockouts. To prevent this, companies should adopt a demand driven distribution system which involves the following steps:
1. Build frequent supply capability: Companies should aim to supply stockists same SKUs more frequently, ideally at least once a week or two to three times a week in some markets. With frequent deliveries of
Chemists, whether sourcing medicines from wholesale or distribution-focused stockists, typically work with a limited number of stockists, which restricts their product availability to what these stockists can supply.
Stockists themselves, however, are not able to offer the full range of products from all the companies they represent as they are limited by the therapeutic areas they handle.
Stockists face significant costs related to manpower, transportation, handling, and frequent deliveries (such as same-day or multiple ship-
ability in the market.
What should companies do?
Pharma companies can address this issue by allowing stockists to maintain a full range of products across various therapeutic divisions without requiring additional working capital. This can be achieved by reducing the amount of inventory stockists need to hold for each SKU, enabling them to carry a broader product range without increasing their overall inventory investment. This creates a mutually beneficial situation, where
same SKUs, the maximum stockholding could be reduced from two to seven weeks to one to two weeks, thus minimising overstocking and capital tied up in inventory.
2. Ensure inventory limits: Not only should deliveries be in small quantities, companies should set a maximum inventory level for each SKU at the stockist level and prevent exceeding this limit.
3. Enable inventory limits that are adaptive to market signals: Demand for some products fluctuates seasonally. System should be in place to regularly assess and adjust the
inventory levels accordingly.
4. Implement Automatic Replenishment System (ARS):
The amount delivered prioritising SKUs as per risk of stockouts based priority and the dynamic limit adjustment based on real-time data can be automated.
5. Ensure warehouse availability: However for this to work companies must ensure near 100 per cent availability of all relevant SKUs in their warehouses. For this they have to build a highly responsive supply chain.
6. Demand driven supply chain: Ensuring warehouse availability involves abandoning fixed monthly forecasts and adopting demand driven inventory movement. Lead times can be reduced and the supply chain protected from variability by using strategic buffers of finished goods and raw materials. Finished goods buffers help schedule production efficiently, while raw material buffers provide flexibility to produce needed products.
Proven results: Awin-winwin model
By implementing these demand-driven strategies, companies can address availability issues effectively. The following results demonstrate the benefits of adopting such an approach:
◆ For chemists: Consistent product availability ensures higher prescription fulfilment rates, driving sales growth. As stockists broaden their product range, chemists benefit from a wider selection, further boosting fulfilment rates and sales.
◆ For stockists: With increased sales at the same service cost, stockists enjoy improved returns on investment. Additionally, freed-up capital enables stockists to expand market coverage, reaching more chemists, including those in remote areas, thus increasing sales further.
◆ For the company: The company can maintain near 100 per cent product availability at CWH, RWH, and C&FA depots. Frequent, smaller deliveries reduce inventory levels, mitigating month-end stock build-ups and sales skew. This allows for faster market feedback and quicker responses to demand shifts. A responsive supply chain reduces lead times and lowers working capital requirements, potentially reducing inventory holding costs by up to 30 per cent. Additionally, minimising excess stock reduces the risk of obsolescence. Broader coverage and increased sales lead to higher company profits, with minimal added logistics costs due to increased delivery frequency.
Whypharma companies must act now
Revamping the current multitier distribution system is no longer optional, it is essential for maximising sales, improving market reach, and eliminating inefficiencies and unlocking the full potential of the market. Pharma companies that proactively shift to a demand-driven distribution model will achieve:
◆ Higher prescription fulfilment rates
◆ Motivated stockists with increased ROI with optimised inventory
◆ Improved cash flow by reducing expired stock losses These companies will unlock the untapped potential of India's rapidly growing pharma market. And companies that fail to address these challenges risk losing market share to competitors that can guarantee consistent product availability.
However, this is not just a business challenge. Ultimately, a smarter multi-tier distribution system is also key ensuring a more reliable healthcare experience for millions of Indians.
Report states that India’s CRDMO sector is poised for rapid growth with strong fundamentals and global realignments,focusing on leading-edge science and technology,Excerpts from the report
The Indian Contract Research, Development, and Manufacturing Organization (CRDMO) sector is at an inflection point, with the potential to grow to $22 - $25 billion by 2035, as revealed in a new report, Unleashing the Tiger: Indian CRDMO Sector 2025, published by Boston Consulting Group (BCG) and Innovative Pharmaceutical Services Organisation (IPSO). The report highlights India's strong foundation in small molecule capabilities, sustainable cost advantages and emerging biologics expertise, positioning the country as a global leader in pharmaceutical innovation.
Keyfindings from the report
India’s CRDMO market is growing at a 15 per cent CAGR, outpacing global industry growth, fueled by its cost advantage over the West and 90 per cent faster project startup times.
Global supply chain realignments are unlocking a $10 billion opportunity for Indian CRDMOs, with Western pharma companies looking for alternative hubs.
New modalities such as Antibody Drug Conjugates (ADCs), DNA and RNA therapeutics are witnessing a 25-35 per cent annual growth, providing India with an opportunity to leapfrog in innovation.
Indian biotech and pharma innovation is accelerating, backed by over Rs 25,000 crore in government funding to foster a self-sufficient, local innovation-driven ecosystem.
India holds a two to three per cent share of the $140-145 billion global CRDMO market but has the potential to become a global leader. Four key tailwinds are driving this growth: the push to de-risk supply
India is currently2–3% of the ~145Bn global CRDMO market with huge headroom,India advantage reflected in its fast growth vs.industry
India’sShareinGlobalCRDMO Market—FY2024
India’sCRDMOsectorhasgrown atCAGR15%from2019–2024
Note: CRDMO market includes EarlyBiology,Drug Discovery,DiscoveryBiology,DMPK& Toxicology, Bioanalytics/Biomarkers,and CDMO for Small Molecules,Biologics & NewModalities.Excludes GxCDMO, Drug Product CDMO,Clinical Trials,Disease models and Clinical Toxicology
Strong & sustained competitive advantage has fueled the growth
chains is making India a preferred outsourcing destination; pricing pressures and policies like the Inflation Reduction Act (IRA) are accelerating offshoring; rising demand for advanced modalities like ADCs, gene therapy, and RNA therapeutics is boosting specialised CRDMO services; and growing investments in R&D and infrastructure are strengthening India’s innovation ecosystem.
India’s CRDMO sector must overcome five key challenges to sustain growth. It needs a 6-7x talent expansion by 2035, faster regulatory approvals and a stronger tier 1 supplier base to reduce import reliance. Limited funding and high capital costs hinder the 4-5x investment needed, while ESG compliance still lags behind Western peers.
90% fasterprojectstarttimevs.West Established Capabilitiesin SmallMolecules
In a step toward advancing India’s CRDMO sector, eleven of the country’s leading CRDMO companies have come together to launch a dedicated industry body called IPSO, bringing together diverse expertise in discovery, development, biomanufacturing, and other specialised areas. This collective initiative aims to advance India’s CRDMO sector and is dedicated to fostering pharmaceutical and healthcare innovation in India, that supports research, policy advocacy and industry collaboration to drive the next wave of biotech and pharma growth.
Peter Bains, CEO Designate, Syngene International, emphasised the importance of such collaborations among all stakeholders to realise growth. "The Indian CRDMO sector is positioned for major transformation, with the potential to become a leader in serving the global biopharma and wider life sciences outsourcing market models. Realising this opportu-
nity will require change and collaboration among all stakeholders in the Indian CRDMO ecosystem. As leading industry players, we must express vision, ambition and intent to move beyond our recognised strengths in small molecules development and manufacturing and into new technologies and modalities, in order to realize the inherent potential. We will also need to work with and collaborate with the Government to foster a more competitive regulatory and financial ecosystem in India to compete with other geographies. We will need to work with India’s academic ecosystem to ensure a strong flow of highly talented scientists, engineers and technology leaders to ensure we are capability competitive. Only by working together, can we unlock new opportunities in drug discovery, process innovation, and advanced manufacturing, that can strengthen India’s position in the global pharmaceutical value chain. This is where IPSO serves as a catalyst, bringing together leading CRDMOs to drive advocacy, build an ecosystem of innovation, and address critical challenges such as supply chain resilience and regulatory efficiencies. But no single organisation can do this alone—it is the collective effort of the entire ecosystem that will enable India to move beyond being a cost-efficient outsourcing hub to a strategic global partner for cutting-edge R&D and biopharmaceutical manufacturing.”
Manni Kantipudi, CEO and Whole time Director, Aragen Life Sciences, adds, "India’s CRDMO sector has all the right ingredients to scale from its current $3-3.5 billion market to $22-25 billion by 2035. The shift in global pharma outsourcing, the rapid rise of biologics, and India’s expertise in chemistry and process innovation create a once-in-a-generation opportunity. However, to compete at a global level, Indian CRDMOs must not only scale capabilities in new modalities like ADCs, cell & gene therapies, and RNA therapeutics but also work together to build a resilient supply chain and streamline regula-
Looking ahead,four keytailwinds which will propel the sector forward
CRDMO market. However, unlocking this full potential will require collective push from both industry and policymakers. With the right investments in infrastructure, talent, and policy simplifications, we can truly emerge as the innovation and manufacturing hub for the global pharma industry.”
Smruthi Suryaprakash, Partner, BCG, adds, “The global pharmaceutical landscape is evolving, and India has the potential to play a transformative role in shaping the future of drug discovery and advanced manufacturing. As the industry moves up the tech curve to biologics, gene therapies, and next-generation modalities, Indian CRDMOs must aggressively expand capabilities in these high-growth areas. By addressing regulatory bottlenecks, fostering cutting-edge R&D collaborations, and scaling talent development, India can emerge as a leader not just in small molecules but in next gen technologies. The time to act is nowbuilding a world-class CRDMO ecosystem will be crucial to India’s ambition of becoming a global life sciences hub."
To unlock India's CRDMO potential, the report highlights five key imperatives:
◆ Accelerating talent development through industry-ready curricula and upskilling initiatives
◆ Streamlining policies with a CRDMO-focused regulatory framework
◆ Strengthening the supplier ecosystem by incentivising local manufacturers and establishing Innovation Parks
1.Includes biotechnologyin mAbs,protein/peptide therapeutics,recombinant abs,bio-engineered vaccines, and small-molecule chemistry,in addition to newmodalities Note: Sales data based on EvaluatePharma,does not include generics market,not representative of total Pharma industryrevenue
tory pathways. IPSO is committed to driving this change by working closely with stakeholders to improve access to capital, accelerate talent development, and champion policy initiatives that make India an even more attractive destination for pharmaceutical R&D and manufacturing. As an in-
dustry, we must come together to shape the future of Indian life sciences and secure our place at the forefront of global innovation”
Commenting on the potential of India’s CRDMO sector, Vikash Agarwalla, Managing Director and Partner at BCG, says, “India’s CRDMO industry
is at the beginning of its “Amritkaal”, with many strong tailwinds. Our report highlights how India’s inherent strengths—small molecule expertise, cost competitiveness, and a rapidly growing innovation ecosystem—provides the springboard to becoming a dominant player in the global
◆ Expanding capital access by designating CRDMO as a sunrise sector, and
◆ Enhancing sustainability through green practices and adherence to global ESG benchmarks With strategic investments, policy interventions, and global partnerships, India’s CRDMO sector can drive economic growth, job creation, and global pharmaceutical leadership. The next decade presents an unparalleled opportunity to solidify India's position as the world’s leading CRDMO hub.
In the biopharmaceutical industry, it's important to have flexible, sterile, and efficient systems for moving fluids. One key part of single-use bioprocessing systems is the PUP SIT Assembly. While it may not be a common term, this assembly is crucial in keeping fluid transfers sterile and safe during processing.
What is PUPSIT Assembly?
The PUP SIT is a Pre Used Post Sterilised Integrity Testing assembly, used in single-use systems to transfer fluids, especially in the early and later stages of bioprocessing. It includes various parts designed to keep the process sterile and allow easy transfer of liquids without contamination.
Components of a PUPSIT Assembly
A PUP SIT Assembly consists of several main parts:
1. Hoses and Tubing: Made from materials like silicone or special plastics, these hoses need to resist chemicals and meet biopharmaceutical standards. They come in different sizes based on how much fluid is being transferred. Tubing often has quick connectors to make the process easier and reduce contamination risk.
2. Connectors: These are quick-connect systems like AQG, STC, or HFCD, which ensure a leak-proof and sterile connection. They are designed to easily connect or disconnect without needing welding or complicated fittings.
3. Clamps: Stepless ear clamps are used to seal hoses or tubes securely, giving even pressure around the hose to avoid gaps and contamination.
4. Filters (Optional): Some assemblies have filters to sterilize the fluids passing through.
5. Overmolded Manifolds: These are included to reduce the number of joints, which minimizes leaks and contamination. They also have a smooth surface inside for easy cleaning.
Applications in Bioprocessing
The PUP SIT Assembly is used throughout different stages of processing, such as transferring media for cell culture or in the final steps of filtration and filling. Its main functions include:
◆ Sterile Transfer: Ensures safe and sterile movement of liquids without needing cleaning processes, saving time and reducing contamination risks.
◆ Modularity: The pre-assembled nature allows for quick connections, making processes more flexible.
◆ Scalability: These assemblies can be customized for both small-scale and large scale production.
Benefits of Using PUPSIT Assembly
1. Sterility Assurance: Using pre-sterilized parts greatly reduces contamination risk, keeping the system sterile throughout fluid transfers.
2. Efficiency: Single-use systems like the PUP SIT Assembly remove the need for cleaning between batches, making the process faster.
3. Time-Saving: Pre-assembled components reduce setup time, important in high-production settings.
4. Cost-Effective: By cutting down on cleaning, sterilization, and validation steps, single-use assemblies lower production costs.
5. Process Flexibility: These assemblies can be tailored to
different process needs, providing more design options.
WhyChoose Ami Polymer's for PUPSIT Assembly?
At Ami Polymer, we proudly offer ISO Class VII and ISO Class VIII cleanroom facilities, certified to ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, and ISO 13485:2016 standards. Our products are supported by a comprehensive BPOG extractables program to meet regulatory requirements worldwide.
Founded in 1998, we are a leading manufacturer and supplier of single-use systems, specializing in bioprocessing bags produced in an ISO Class 7 cleanroom. Our manufacturing technology ensures world-class quality and end-to-end process capabilities to meet diverse customer needs.
As we continue to advance in the field of single use system, we invite you to join us on this exciting journey. Discover how Ami Polymer Pvt. Ltd. Can support your innovations and contribute to the future of bioprocessing. For more information, reach out to us via email at chandan.s@amipolymer.com. We look forward to partnering with you and driving progress together.
Industries that rely on temperature control for their processes benefit greatly from Flexotherm Heating Tape, manufactured by Tempo Instruments. This advanced heating solution ensures uniform and reliable heat distribution, reducing downtime and preventing temperature-related disruptions. Its durable and adaptable design makes it an ideal choice for multiple industries, including agriculture, food processing, gas handling, oil and gas, and laboratory medical science.Enhancing industrial efficiency with flexotherm heating tape
Flexotherm Heating Tape offers high-temperature resistance, ensuring reliable performance even in extreme conditions. Its flexible and robust design allows it to conform to various surfaces, making it suitable for complex heating applications. The tape is energy-efficient, reducing power consumption while maintaining effective heating. Additionally, its resistance to moisture and chemicals ensures longevity in harsh industrial environments.
Customisation options in terms of length and wattage provide industries with tailored solutions that meet their specific
Flexotherm Heating Tape ensures uniform and reliable heat distribution,reducing downtime and preventing temperature-related disruptions
heating equirements. Industrial applications and benefits In agriculture, maintaining optimal temperatures is crucial for improving productivity.
Flexotherm Heating Tape supports greenhouse temperature regulation, seed germination, and soil heating. By preventing temperature fluctuations, it enhances crop growth and protects delicate seedlings from cold weather. Additionally, it plays an essential role in livestock care by providing warmth in animal enclosures, ensuring healthier livestock and increased farm efficiency.
The food processing industry relies on strict temperature
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Gas handling industries depend on precise temperature control to prevent condensation and pipeline blockages.
Flexotherm Heating Tape ensures seamless gas transportation by maintaining stable temperatures in gas cylinders and pipelines. By preventing gas from liquefying in cold conditions, the tape enhances efficiency in handling gases like oxygen, nitrogen, and carbon dioxide. This prevents costly downtime and operational disruptions.
In the oil and gas industry, the flow properties of crude oil and petroleum-based fluids are critical for operational success. Flexotherm Heating Tape supports pipeline heating and ensures that stored materials in drums and barrels remain at
Adaptive safetyfor the smart factory
B&R's innovative solutions make it possible to seamlessly integrate safety processes into production processes without compromising efficiency
In today's industry, safety is a key factor. Hard-wired safety systems immediately shut down machines in the event of safety-critical events, making maintenance work more difficult for service personnel. With integrated safety technology from B&R, companies can make their machines safer and more pro-
ductive. B&R's innovative solutions make it possible to seamlessly integrate safety processes into production processes without compromising efficiency. This allows you to protect your employees while optimising your production output. No longer limited to a single machine, today's safety
solutions span entire production lines.
Source: B&R Industrial Automation (A member of the ABB Group) | Pune Email: marketing.in@br-automation.com | Tel: 020 41478999 Website: www.brautomation.com
the desired temperature. Offshore platforms, where extreme environmental conditions pose challenges, also benefit from this heating solution. By preventing blockages and maintaining optimal fluid viscosity, the tape improves overall efficiency and reduces maintenance costs.
Laboratories and medical facilities require precise temperature control for sensitive research and diagnostic applications. Flexotherm Heating Tape ensures uniform heating in incubators, laboratory reactors, and diagnostic equipment. It aids in fluid heating and sample preservation, ensuring consistent experimental conditions and reliable test results. The tape plays a vital role in medical science by maintaining stable temperatures for biological samples, reducing variability in experimental outcomes.
PHARMA PULSE
TRUTH interchangeable glass syringe
Top Syringe exports its products to over 40 countries worldwide and counting,keeping a single quality standard for local and export products
Top Syringe is a leading manufacturer of glass syringe and glass tube engineering products for decades.
Ideal for laboratory liquid handling of various liquids including Plastic Sensitive Materials, hazardous chemicals, Adjuvant solutions, petroleum derivatives, glues, synthetic dyes, perfumes, essential oils and organic chemicals.
Features-
◆ Glass Barrels and pistons are made from borosilicate glass that provide protection against thermal shock
◆ Graduation marks are permanently fused into a glass barrel
◆ Luer locks are NickelChrome plated brass or stainless steel (SS316) as per ISO 594/1
◆ Outstanding chemical resistance being of 3.3 borosilicate glass
◆ Colored fiducial line at the tip of plunger facilitates dosage measurements
◆ Inert liquid path – Glass and Nickel-chrome plated brass
◆ Autoclavable at 121oC at 15 PSI (1.05 kg/cm2) pressure
◆ Reinforced truncated flange prevent syringe rolling
◆ Interchangeable part of the syringe provide instant assembly without any sorting during bulk sterilisation and hence improves operational efficiency
◆ We supply in private label terms as well (OEM), special graduation on request Top Syringe exports its products to over 40 countries worldwide and counting, keeping a single quality standard for local and export products.
The Blissfill syringe is manufactured 100 per cent in India by Top Syringe. The company is fully committed to supporting you with its full product range, spares, and technical assistance.
Contact
Top Syringe Compound
W.E. Highway, Pandurangwadi, Mira road (East), Thane 401107
India
Mob: 81046 82560
Email : sales@topsyringe.com
Website: www.topsyringe.com
PHARMA PULSE
Ensuring clean room integritywith Prime Clean Reset high-speed doors
These high-speed doors are meticulously engineered to minimise air leakage and maintain strict environmental control,making them indispensable for clean room operations
High-speed doors for clean rooms are specialised industrial doors essential for maintaining controlled environments. These doors are engineered to be airtight, creating a reliable barrier between different areas of a facility. Their design ensures durability and minimal maintenance, reducing the frequency of repairs and replacements.
High-speed clean room doors offer a range of critical
and patient safety.
Beyond contamination control, these doors are engineered with advanced safety mechanisms, including automated sensors and emergency stop functions, which mitigate the risk of operational hazards. Moreover, high-speed clean room doors are designed to maintain precise overpressure or under pressure conditions within the environment. This is vital for preventing cross-contamination and ensuring that
benefits essential for maintaining stringent environmental control. These doors enhance hygiene by providing an airtight seal that effectively isolates clean room environments, preventing the ingress of dust and other contaminants. This capability is especially crucial in sectors such as pharmaceuticals, biotechnology, and food production, where maintaining sterility is non-negotiable.
In the pharma and life sciences industries, compliance with rigorous regulatory standards necessitates the manufacture of products within controlled clean room environments. A high-performance clean room door is an integral component in ensuring the integrity of these spaces, safeguarding product quality
and reliability, ensuring that your clean room operations consistently meet the highest standards of regulatory compliance and product integrity.
Prime Clean Reset is suitable for clean rooms up to ISO Class 5, offering an unparalleled air permeability rate of less than 12 m³/m² h at ? 50 Pa. This ensures that even in the most sensitive environments, the door effectively maintains the critical pressure differentials required to prevent con-
reliable performance, Prime Clean Reset seamlessly integrates into your clean room infrastructure, providing a critical barrier that preserves the integrity of controlled environments. Whether you are operating in a pharmaceutical, biotechnology, electronics, or defence industry, Prime Clean Reset offers the precision, durability, and compliance needed to maintain your competitive edge in highly regulated markets.
the clean room remains in a state of controlled integrity, even under varying operational demands.
Given the critical role these doors play in maintaining the purity and safety of highly specialised environments, selecting the appropriate door system is a decision of strategic importance.
Prime Clean Reset, our high-speed door is designed specifically for clean rooms. This innovative solution is engineered to meet the stringent requirements of controlled environments, ensuring exceptional performance and reliability. Designed with precision to meet the stringent requirements of controlled environments, Prime Clean Reset is the epitome of performance
tamination, thereby safeguarding your processes and products.
Engineered with cuttingedge European technology and innovative design principles, Prime Clean Reset offers rapid cycle times for both opening and closing, making it the optimal solution for medium to large entrances in clean room applications. The door's construction is specifically tailored to minimise air leakage and particulate infiltration, ensuring that it supports the rigorous cleanliness standards necessary for applications such as pharma manufacturing, semiconductor fabrication, food processing, and other highly specialised sectors.
With its robust design and
doors offer high efficiency and low permeability values, compliant with EN 12426 and EN 12427 standards, ensuring < 12 m³/m² h ? 50 PA.
◆ Durable Control Device
Enclosure: The control device enclosure is made of StainlessSteel SS 316, ensuring durability and resistance to corrosion. These high-speed doors are meticulously engineered to minimise air leakage and maintain strict environmental control, making them indispensa-
Key features of Gandhi Automations' High-Speed Clean Room Doors include:
◆ Low air permeability: Designed to maintain low air permeability in pressurised rooms with both positive and negative air pressure.
◆ Compact design: The doors are designed to fit inside the columns, with a self-supporting constructtion that minimises air leakage.
◆ Customisable ransparency: They can be equipped with transparent PVC horizontal sections or vision windows for visibility.
◆ Specialised side guides: The special side guides ensure a tight integration of the curtain, providing high leak tightness.
◆ Efficient operation: The
ble for clean room operations. Their rapid opening and closing operation ensure that the internal facility remains isolated from external conditions, effectively upholding the cleanliness and controlled environment essential for maintaining the integrity of clean rooms.
For further information on our high-speed doors offering, contact:
Gandhi AutomationsChawda Commercial CentreLink Road, Malad (W), Mumbai-400064, India.
Off : +91 22 66720200 / 66720300 (200 lines)
Fax : +91 22 66720201
Email : sales@geapl.com
Website : www.geapl.com
PHARMA PULSE
COMPACTROL®: Anewage diluent for pharma and nutra industries
COMPACTROL®,specially processed calcium sulfate dihydrate powder,is suitable as a filler in tablets manufactured by direct compression.It is also an effective diluent for two-piece hard capsule filling application
COMPACTROL® is calcium sulfate dihydrate, an inorganic material, which is naturally derived. It is roller compacted and size classified to obtain a median particle size and size distribution ideal for pharmaceutical and nutraceutical applications.
COMPACTROL® - Calcium Sulfate as a diluent has an advantages of possessing low con-
temperature of approximately 80oC is reached.
Such bound water is usually unavailable for chemical reaction. Such excipients containing tightly bound water and having a low remaining moisture demand may be vastly superior to an anhydrous diluent, which has moderate to high moisture demand[1][4]
Table 1. Solubility of COMPACTROL® Solvent Solubility at 20°C Unless otherwise stated
Ethanol (95%) Water Practically insoluble 375 mg/l 485 mg/l at 100°C
centration of unbound moisture as well as having a low affinity for atmospheric moisture. These are required features for any excipient material to be combined with a water sensitive drug.
The bound water of calcium sulfate is not released until a
Types of calcium Sulfate [3]:
There are three types of calcium sulfate -
A) Calcium sulfate Dihydrate is used in the formulation of tablets and capsules. In granular form, it has good compaction properties and moder-
Table 2. Physical properties of COMPACTROL® Bulk density Max 1.1 g/ml Median particle size 120 μm
ate disintegration properties.
B) Calcium sulfate hemihydrate is used in the preparation of plaster of Paris bandage, which is used for the immobilization of limbs and fractures; it should not be used in the formulation of tablets or capsules.
C) Anhydrous calcium sulfate is hygroscopic and is used as a desiccant. Uptake of water can cause the tablets to become very hard and to fail to disintegrate on storage. Therefore, anhydrous calcium sulfate is not recommended for the formulation of tablets, capsules, or powders for oral administration. Therapeutically, calcium sulfate is used in dental and craniofacial surgical procedures.
COMPACTROL® is 23.3% calcium and can be used in dietary supplements as a calcium source [2]
Benefits of COMPACTROL® [2]:
Wet granulation
COMPACTROL® is a calcium sulfate dihydrate material meeting Ph.Eur., NF and FCC monograph requirements. It is mainly used in wet granulation to improve the binding properties of classical granulation bases such as starch or powdered cellulose. When COMPACTROL® is wetted during the granulation process and dried afterwards, it acts like a glue in powder mixtures.
Direct compression
COMPACTROL®, specially processed calcium sulfate dihydrate powder, is also suitable as a filler in tablets manufactured
by direct compression. It is also an effective diluent for twopiece hard capsule filling application.
It is a non-hygroscopic and free-flowing powder which is relatively inert offering excellent long-term stability and provides required flow characteristics necessary for highspeed compaction and capsule filling.
TABLE 3.Formulation Example
API 10.0% ARBOCEL® (Powdered cellulose) 70.0% COMPACTROL® 20.0% Water q.s.
API, ARBOCEL® and COMPACTROL® were wet granulated in a fluid bed processor. After drying and sieving, the granules were compressed using a mixture of VIVAPUR® 102, VIVASTAR®P and magnesium stearate.
Incompatibilities [3]:
In the presence of moisture, calcium salts may be incompatible with amines, amino acids, peptides, and proteins, which may form complexes. Calcium salts will interfere with the bioavailability of tetracycline antibiotics. It is also anticipated that calcium sulfate would be incompatible with indomethacin, aspirin, aspartame, ampicillin, cephalexin, and erythromycin since these materials are incompatible with other calcium salts. Calcium sulfate may react violently, at high temperatures, with phosphorus and aluminum powder; it can react vio-
lently with diazomethane.
Applications:
◆ As a binder in wet granulation.
◆ Filler & Diluent for tablets.
◆ High Bulk density filler suitable for capsule filling.
◆ For water sensitive drugs as it absorbs very less moisture.
References:
1. Eerika¨ inen S et al. The behavior of the sodium salt of indomethacin in the cores of filmcoated granules containing various fillers. Int J Pharm1991; 71: 201–211.
4. Leon Lachman, Herbert A. Lieberman, Joseph L. Kanig. The theory and Practice of Industrial Pharmacy, Varghese publication house, 3rd edition, 1990, 326-327.
Author: Mr. Prashant Bhangdiya Technical Manager-Pharma Rettenmaier India Pvt Ltd Prashant.bhangdiya@jrsindia.com
