P20: HARI KIRAN CHEREDDI MD,HRVGLOBALLIFE SCIENCES
24 ACCESS TO DIABETES CARE FOR CHILDREN AND YOUNG PEOPLE: PHARMA COMPANIES' CURRENTACTIONS AND OPPORTUNITIES AHEAD
STRATEGY
29 SMALLBENEFITS, BIG IMPACT: UNDERSTANDING THE VALUE OF NOVELDRUGS IN METASTATIC CANCER
RESEARCH
31 ROLE OFNITRIC OXIDE IN CONTROLLING GENETIC REGULATORS TO MAINTAIN CELLULAR HEALTH
PRE EVENT
45 FDD CONCLAVE 2025 TO BE HELD IN HYDERABAD THIS JUNE
TECHNOLOGY
46
DRIVING CHANGE: DIGITALINNOVATION AND THE FUTURE OFDRUG DISCOVERYIN INDIA
50 MULTIPURPOSE FLUID BED PROCESSORS FROM ROMACO INNOJETIN USE AT KLOCKE PHARMASERVICE GMBH
53 DATACLEANING AND HARMONISATION: ACATALYST FOR INNOVATION
What US FDA's new surprise foreign inspections plan means for India
On May 06, 2025, the US Food and Drug Administration announced the expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.
The release mentions that this change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot programme in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.
The revival of unannounced inspections of overseas manufacturing plants will need considerable planning at the US FDA. But any hopes of lower oversights due to the recent staff cuts at the US FDA, as part of the Trump Administration's reduction in force (RIF) efforts, were dashed by recent reports that the agency plans to rehire some staff providing logistics support for the inspections programme.
This should be taken as a signal of the agency’s intention to revive overseas inspections as soon as possible. Pharma companies exporting to the US should now rightly be on guard and start preparing for the inevitable “knock on the factory-gate.”
The release also notes that the FDA is authorised to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.
This policy move seems to be aimed at addressing a key grouse of US-based manufacturers: that their foreign counterparts get advance notice of inspections, allowing them an undue advantage to set the stage. This is evident in DA Commissioner Martin A. Makary’s statement that, “For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.”
As per the FDA release, the agency conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. The May 6 announcement evidently seeks to rebalance this skew in the number of inspections across jurisdictions.
The release further points out that while US manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections, as per the release.
The US FDA does make exceptions allowing preannounced domestic inspections “in specific programmes and cases”, “to assure that appropriate records and
Pharma companies exporting to the US should now rightly be on guard and start preparing for the inevitable “knock on the factorygate.”
personnel will be available during the inspection. But regulated companies do not have the authority to negotiate the day or time of the inspection— nor should foreign companies have the capability to do so either.”
Besides expanding overseas inspection programme, the US FDA seems to be revamping certain processes. The release notes that “the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for-hire vehicle transit), to maintain the integrity of the oversight process.” Thus the agency’s intention to tighten the loopholes is very evident.
The release ends almost on a warning note, that this expanded approach “marks a new era in FDA enforcement—stronger, smarter, and unapologetically in support of the public health and safety of Americans.”
Many larger Indian pharma companies seem to have read the writing on the wall and have initiated collaborations with US-based counterparts or indicated increased investments in their own US presence. For instance, in March, Syngene International acquired its first biologics manufacturing site in the US. In the same month, Sun Pharma acquired New York City-based Checkpoint Therapeutics, an immuno-oncology biopharmaceutical company focussing on solid tumors.
Companies with a manufacturing presence in the US are buying assets to leverage this presence. For instance, in May, Senores Pharmaceuticals acquired USFDA-approved Abbreviated New Drug Application (ANDA) for Enalapril Maleate Tablets 2.5mg, 5mg, 10mg, and 20mg from Wockhardt, a move aimed at expanding Senores' portfolio in the US market.
While business strategies could help in the short term, it is clear that companies seeking a slice of the US market will need to comply with higher US FDA benchmarks. Being inspection ready at all times will need to be the default protocol.
This policy change comes against the backdrop of President Trump’s tariff regime. Various countries, including India are currently negotiating bilateral trade deals to limit the impact of tariffs. While heightened regulatory scrutiny might well be an intended entry barrier and a bargaining chip in ongoing trade negotiations, pharma companies would do well to buckle down and toe the line.
India needs to step up more as a strategic innovator in the global supplychain
In a free wheeling conversation,US-based Hari Kiran Chereddi, MD,HRVGlobal Life Sciences explains to Viveka Roychowdhury that “where biotech meets geopolitics, compliance is a currency”and therefore the future of pharma supply chains is a “distributed orchestration,rather than centralised ownership”
HRV Global Life Sciences specialises in ‘virtual Active Pharmaceutical Ingredient (API) manufacturing’, what does the term entail? Is it like a super CDMO, which contracts out manufacturing to mid-sized pharma companies in India and then meets the sourcing requirements of global MNC pharma?
We're just not transforming typical pharma manufacturing. I do not want to put ourselves in a box of saying we're a CDMO or a CMO or all those terms that are out there today. We're basically reimagining the whole manufacturing setup. Unlike traditional companies that rely on owning and operating factories, we've activated a big network of underutilised globally compliant, be it USFDA, EU GMP or the likes, API production facilities across the country. The average utilisation of USFDA approved manufacturers in the country is about 50–70 per cent, as per an AT Kearney-OPPI report.
We pull all together into a single tech enabled platform, allowing us to deliver regulatory grade APIs across countries without the need to invest in a physical infrastructure. The model is not outsourcing, more an orchestration, where we have led with compliance, filing our own US Drug Master Files (DMFs), Certificates of Suitability (CEPs) and managing global regulatory audits as well.
As a case in point, in the last nine months alone, we
have filed about 10 or 11 US DMFs and three CEPs at a pace rarely matched by even large legacy manufacturers. What sets us apart is that we sponsor the regulatory journey and the product journey of some of what we offer, owning the quality and compliance from dossier creation to delivery. Where others have attempted to do an aggregation of APIs in a very fragmented manner, we've built a scalable regulatory first platform, where we've consolidated multiple Indian manufacturers under one umbrella. And today, our portfolio that we sell, make, distribute close to about 450470 different products, whereby global buyers have access to Indian manufacturers with speed, reliability and trust.
Our growth actually has been powered by this very unique approach. We've been
able to achieve about 75 per cent revenue CAGR over the last seven years, and have been consistently profitable, entirely debt free from day one. We have a greater than 35 per cent return on capital employed. Probably this year, I think we are targeting 40 per cent internally. So, our model ensures that we go to market very, very quickly. It also reduces costs and enhances compliance assurance and also creates these long-term partnerships.
This is the first time India's fragmented GMP certified capacity has been aggregated. We have also extended our model beyond human APIs by now actively entering veterinary APIs with about 10 products in the pipeline for 2025. We are exploring forward integration into finished dosage forms, and we have been focusing on underserved therapeutic care categories like rare diseases,
women's health and oncology.
A case in point is our recent shipment to Mendoza, Argentina, of anti-diabetic medications (USFDA qualified Metformin (1000mg)) the first ever Indian formulation after 31 years to Argentina.
And in fact, that got made in an extremely well reputed manufacturing site here in India. This was applauded by the President of Argentina. We are working with them to create local partnerships.
To sum up, HRV Global Life Sciences is about smarter, faster, more compliant ways to scale companies. We are currently at consolidated annual revenues of Rs 419 crores as of March 2025, with a seven year CAGR of 75 per cent.
We have not just disrupted the game, we're changing the board the game is played on. People say that we have seen some of these things come up, but not at the size and scale that we have done in about five and a half years as a bootstrapped company.
HRV Global was started five and a half years ago?
HRV as a company was officially incorporated in 2016, but I started spending significant time on it from January 2019. Previously, I led the intermediates division and sales at Sriam Labs, a wholly owned subsidiary of Laurus Labs. While technically associated with the company for six and a half years, the real hockey stick growth began when we reimagined our model during COVID—when
most were pausing, we were building. As a fun fact, I took 291 RT-PCR tests during that period—that’s the number of days I was on the road during this time.
Does the company have its own manufacturing sites?
We do not have any manufacturing sites at all. We only underwrite capacities. Wherever there is free capacity, with an existing product that matches our interest, we go ahead and underwrite that capacity.
That's one way. The second thing that we do is we also have a big portfolio team that brings in new products. For example, more than 60 USDMFs filed for Pantoprazole. Everybody is playing in exactly the same field and wants to continue to get a share of this business across the world. And the only two logical points that people come to a table is that the quality is better, or the price is cheaper.
It's like, going and buying a car and saying, I expect the car to have steering and a brake. And that typically is what has become of generics manufacturing.
We've moved ahead of that and said that we will pick products which have not more than two regulated players in the market. For example, there are only three buyers for some of the products we make in the world, with only one maker in India.
Their problem is that their finished dose is no longer viable because the only
INTERVIEW
manufacturer of API does not want to drop prices. When we went back and looked at it, we were able to offer close to about 45 or 48 per cent saving on the first pass. All three manufacturers who had decided to pull out or reduce their overall sales size in the market, have now decided to come back because suddenly this whole thing becomes very meaningful and profitable for them. We've seen a lot of people do this, especially in petrochemicals, and agriculture where regulations are as limited as required. In spite of this, we've still been able to post about 10 per cent EBITDA, without a bank loan to worry about. At five years, we're just getting warmed up, with the volumes and places that are getting added. We haven't even broken a sweat. Companies now come to us and say we want to invest, but we say we don't need money. So, it's a very beautiful spot to be in personally, as a promoter. Opportunities are coming in, from various parts of the world, where we put a lot of underutilised manufacturers who've actually not been exposed to some of these markets, and to the product portfolio that we're bringing into the game. The only way that I'm looking at it is that we want to quickly scale and expand to more countries. My only largest challenge is how to make more of myself in the company!
You mentioned sponsoring the regulatory journey and not just aggregating contract manufacturing. I would assume that you are aggregating or sponsoring the regulatory journey of much smaller companies, of mid-size companies and not the big pharma companies in India. Quality has been an issue. So when you sponsor the regulatory pathway, their quality benchmarks and GMPs to the companies that you're selling to, which would be in regulated markets, how do you do that and what kind of safeguards are there?
For one, we are not talking to any of the big boys. And incidentally, one thing I can tell you is that as early as last month, one of them approached and said, how can we work together? So, it was a good feeling for us, but we just left it there because we strongly believe that right now, we want to choose people who we can actually work with, instead of a big system that they want to change.
We have two-three sets of manufacturing partners. One set who already have approvals (for example from the US FDA) and second set who have built FDA class facilities and don't know how to get approved.
The third type is those who have built a facility, but don't know how to talk or think about a regulatory standpoint. The good part is we have ROW and regulated market players. So if I underwrite a capacity, for example, a pantoprazole’s capacity, I'm able to not only sell to the US, but I also have these semi-regulated markets that we're able to play with. And what we have kept at the bottom of this whole model is that we should be the last man standing, even if it means to go ahead if the big players change the price points in any market.
Those are the key tenets we've laid out. Some of these things as a model are evolving extremely well for us because we are realising more new things together. I'm not looking at it in a myopic view.
And the other thing that has worked very well is that if one unit runs into a regulatory problem, we have a blend of such facilities. So, we tell customers that we are going to make sure that even if we are not your primary source, we have to be your source number two and three. Here is where we are going to give you both options , and how we are helping people. In fact, this started during the COVID pandemic.
We are asking how we can sustain and secure the supply chain as part of this process. Supply chain is already very crucial. We have a great
product. It has to reach the patient in the form that it's supposed to reach the patient and benefit the patient rather than harm the patient.
What is the impact of certain policies like the US BioSecure Act, the reciprocal tariffs being levied by US President Trump and the intention to move manufacturing back to the US? How do these policies affect initiatives like yours, which is primarily built on the premise that you manufacture in a lower cost economy like India and semiregulated markets.
You asked about the BioSecure Act. Today in my world, where biotech meets geopolitics, compliance is a currency. We're not a stopgap arrangement to the US or in a trade war. It is more a scalable long-term answer to showing how we can help in reducing dependence on China, and also redefine the trust in life sciences, especially from an India standpoint.
The new tariffs, like the ones you brought up, are more than just that. It's a very clear indication of changing global patterns. We have talked about China plus one for three years. India Pharma needs to see it not as an interruption, but more as an opportunity for recalibration, with higher duties on certain imports and particularly APIs.
In fact, we were trying to buy something from China for a US customer. When we said that the API is being tariffed at 20 per cent, the manufacturer in China replied back the next morning, saying that they would absorb the duty. And that was very surprising.
So it's not just about the cost or volume. The future obviously belongs to countries that can offer speed with compliance and scale with trust.
I'm no expert in politics but looking at how things have evolved from a Biosecure Act to reducing manpower at the US FDA. Now they are talking about how to double down on regulatory precision and digital supply chain
transparency whereby partners in the US and beyond have access to consistent and de-risked ingredients. The BioSecure Act will talk about finished dose formulations but to actually become an API powerhouse or actually make them in the US, It will probably take the US at least two decades before they even come to a situation where they can go head on with these people.
So, in the long term these tariffs may have the potential to speed up and decouple some of these tendencies. India needs to step up more not only as a manufacturer but a strategic innovator in the global supply chain.
I think we're waiting for the US market to open up. I don't know what this morning is going to look like. But that is anyone's guess and anyone's best effort at it.
There are wars/conflicts in major geographies, including the latest one at India’s border, which could cause major disruptions to life science supply chains. How will life science supply chains need to change to become more agile and resilient, while meeting growth targets?
Geopolitical shocks—from tensions at the borders to allout wars—are no longer exceptional occurrences but the new normal of operations. The life sciences industry needs to cease viewing supply chain resilience as a back-up and begin viewing it as core strategy.
At HRV, we see the future of pharma supply chains in terms of distributed orchestration, rather than centralised ownership. That's what our virtual model allows us to do—we de-risk through diversification. Rather than being dependent on one facility or one geography, we orchestrate capacity from a network of federated GMPcompliant partners placed across India. This enables us to quickly reroute, scale or replace production without any compromise on compliance or delivery
timelines.
To remain nimble and yet achieve growth goals, firms require:
◆ Multi-sourcing of key APIs from regions with varying risk profiles
◆ Real-time visibility on production and logistics through AI and digital twins
◆ Regulatory redundancy, with duplicate facilities already audited and approved for business continuity
◆ Disputes will rise and fall. But those who invest in robust ecosystems—not linear chains—will succeed.
What’s your take on addressing the reputational impact of unfavorable regulatory decisions regarding pharma GMP that come up from time to time? Reputation in life sciences is not ternary—you're either trusted or you're not. And one regulatory misstep, even in isolation, can have a long shadow.
Our method is straightforward:We insure compliance before we insure capacity. We don't merely plug in manufacturing partners— we elevate them. We conduct pre-audit mock inspections, facilitate DMFs readiness, and assume ownership of regulatory filings in our name.
If there's a red flag—a warning letter—we directly deploy standby capacity across our network so that customers experience zero disruption. This is only made possible because our architecture is designed on regulatory elasticity—having vetted substitutes ready.
Even more significant, we communicate actively with customers. Transparency, documentation, and ownership are powerful tools for turning an anticipated reputational risk into an evidence point of resilience.
The takeaway for the industry? GMP is not a check box. It's a mentality. And in a world where perception creates value, trust is the new molecule.
viveka.r@expressindia.com viveka.roy3@gmail.com
Access to diabetes care for children and young people: Pharma companies' current actions and opportunities ahead
Arecently released report from Access to Medicine Foundation highlights that children and young people living in low-and middle-income countries face gross inequities when it comes to the diagnosis and treatment of type 1 diabetes.Without sustainable access to diabetes care,they are unable to manage this chronic condition,leading to severe outcomes that are entirely preventable.Excerpts from this report that sheds light on current efforts to address access challenges and practical solutions to ensure children and young people get the care they need
Children living with type 1 diabetes (T1D) can survive and go on to lead long, healthy lives with the right care. Yet, in low- and middle-income countries (LMICs), far too many children and young people (CYP) are still dying from this manageable disease because they lack access to timely diagnosis and treatment.
In 2024 alone, an estimated 30,113 preventable deaths occurred in people under 19 years of age due to T1D, with nearly 40 per cent (11,352) in sub-Saharan Africa - the highest burden of any region. As T1D cases continue to rise among CYP, so does the urgency to make lifesaving insulin and other essential diabetes care products available where they are needed most.
In response to this pressing issue, dedicated initiatives have been established to provide diabetes care specifically for CYP. This report examines how Lilly, Novo Nordisk and Sanofi –three companies that are key players in global insulin production, including in LMICs – along with leading biosimilar insulin manufacturer, Biocon, back 11 such initiatives providing support to
CYP living with T1D in LMICs. Collectively, these 11 initiatives operate in 71 LMICs in scope. However, they are largely sustained by
donations and are reaching a limited number of CYP living with T1D in these countries through the provision of diabetes-related products.
FIGURE 1: The 11 initiatives targeting children and young people currentlycover 71 low- and middle-income countries in scope
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What does the report find?
Companies are backing initiatives that supply essential diabetes care products and commodities, strengthen local healthcare systems or combine both to improve diabetes care for CYP in LMICs. Five main findings help chart the current landscape of these initiatives, highlighting what progress is being made, where challenges persist, and what still needs to be done to scale access for CYP living with T1D.
Main findings
1. While over 50 per cent of LMICs in scope are being covered by company-supported initiatives, only a limited number of CYP are being reached across these countries.
2. Three companies are taking steps to broaden the types of products they provide to initiatives, including the provision of insulin analogues and pens in certain LMICs.
3. All four companies contribute to capacity building initiatives – including educational efforts – within the CYP-focused initiatives they support.
4. All four companies provide donations to at least one of the 11 initiatives, which can pose risks to the long-term certainty of an initiative.
5. CYP's access to long-term, affordable diabetes care remains a critical challenge
Safeguarding and scaling access to diabetes care for CYPamid successes like Glp-1 receptor agonist blockbusters
We are in an era of unprecedented demand for diabetes care products, with the number of people living with T1D projected to nearly double in the next 16 years, reaching 16.4 million globally by 2040. At the epicentre of this crisis are LMICs, where the burden is expected to grow disproportionately.
At the same time, recent decades have ushered in a number of breakthroughs in diabetes care. From new insulin formulations and delivery devices to groundbreaking treatments like GLP-1
receptor agonists for obesity and diabetes, these innovations hold the potential to dramatically improve care and the quality of life for millions. Yet, as companies race to capitalise on these advancements – driven by high profits and demand from high-income markets – they must not neglect the most vulnerable. Today, insulin remains out of reach for half of those who need it, meaning that for many CYP living with T1D in low-resource settings, diabetes care is not about effective management but mere survival. Even when they do gain access to treatment, it often falls below the standard of care offered elsewhere, highlighting stark disparities.
But companies have the power to change this. By making their products more accessible and ensuring that the diabetes treatments and technologies best suited to CYP are available where they are needed most, they can not only save countless lives but also enhance them. This way, no child will be left behind in the evolving landscape of diabetes care.
Recommendations to improve diabetes care
◆ How to scale and sustain access: As outlined in this report, children and young people (CYP) living with type 1 diabetes (T1D) are receiving vital support through company-backed initiatives that bridge gaps in access to treatment, monitoring devices, essential supplies and diabetes education, while also strengthening local healthcare systems in LMICs. However, despite their meaningful impact, the reality is that these programmes alone cannot support of CYP who remain in desperate need of diabetes care.
While companies are collaborating with partners to enhance initiatives and strengthen their sustainability, a fundamental shift is required to truly scale up access and reach CYP with unmet needs. Companies must move beyond the donation-based
models that largely define diabetes care access efforts focused on CYP in LMICs. By taking actions to address affordability and product availability, companies can help facilitate the successful transition to government owned T1D care in LMICs. This way, all CYP, regardless of where they live, can have access to lifesaving diabetes care products.
◆ Scale existing initiatives strategically to reach more cyp in need: Companies should work closely with partners to scale up initiatives for CYP beyond the eight per cent currently reached and expand access to underserved regions. Companies can prioritise countries where CYP initiatives are currently absent, access to care is severely limited and the burden of T1D is high. Engaging local governments, diabetes organisations and people living with T1D in LMICs is essential for identifying priority communities and directing resources where they are needed most. Furthermore, companies should enhance the sustainability of their efforts by aligning with broader initiatives like PENPlus, which integrates care for non-communicable diseases (NCDs), including T1D, in rural LMIC settings. By strategically combining partnership-driven expansion, local insights and alignment with existing CYPfocused initiatives, companies can maximise both reach and long-term impact.
◆ Ensure choice and access to a broader range of products: Companies should broaden the range of insulin products and delivery devices supplied in LMICs to meet the diverse needs of CYP living with T1D and ensure they receive the same standard of care as those in high-income countries.
Companies must engage with local stakeholders and PLWD to underst and local needs, preferences and resources and tailor their product supplies accordingly. This could involve scaling access to analogue insulins and pens
TABLE 1: The 11 initiatives are all partnerships and focus on making essential diabetes products available,building capacityor a combination.
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within initiatives, providing more CYP with more treatment options. Additionally, companies can engage in cross-sector partnerships to improve access to a wider range of diabetes care products for CYP in LMICs. For example, partnering with glucose monitoring device companies could improve the accessibility of glucose monitoring devices and their related commodities, including continuous glucose monitors, alongside insulin. Such partnerships can also be leveraged to bundle various diabetes products including insulin, delivery devices, glucose monitoring tools, and educational materials together in national public healthcare packages, which would provide CYP
with broader access to the full continuum of diabetes care.
◆ Improve the sustainability of t1d care for CYP: To improve the sustainability and continuity of diabetes care for CYP living with T1D, companies should be clear about how long their support will last, setting clear commitments, to help governments plan and allocate resources effectively. In parallel, companies can support governments as they prepare to transition to sustainable national diabetes programmes. This involves aligning initiatives with national health priorities, sharing relevant data and insights, supporting local capacity building and helping develop exit strategies for donation-
based programmes. Ultimately, to ensure long-term access, companies must make their products affordable and available through commercial operations and access strategies, enabling CYP and governments to access care independently of donations.
◆ Address the availability and affordability gap beyond cyp-focused initiatives: Many CYP living with T1D still lack access to basic diabetes care. To improve the availability of lifesaving products, insulin manufacturing companies, including biosimilar manufacturers, should expand product registration with national regulatory authorities and engage with frameworks like World Health Organisa-
tion (WHO) prequalification for eligible products to speed up this process. Investing in technology transfers and local production could also help improve availability and reach. Just as importantly, these approaches can contribute to greater affordability, which should go hand in hand with product availability to ensure CYP living with T1D can access the care they need. To further improve affordability, companies can implement pricing strategies that account for the ability to pay of all local stakeholders and apply them across a broader range of diabetes care products.
◆ Strengthen data-driven approaches for t1d access and policy: Many company-
supported initiatives collect on-the-ground data on the number of CYP reached and the outcomes of their efforts. This helps identify gaps in access and generate missing evidence on the burden of T1D in LMICs, including key metrics such as the number of undiagnosed CYP living with T1D. Companies should continue to make this a priority, working with local partners who play a crucial role in capturing, collating and reporting this information. By doing so, companies can support the enhancement of key data sources, like national registries and the T1D Index, which provide governments and organisations with a clearer understanding of T1D’s impact.
Small benefits,big impact: Understanding the value of novel drugs in metastatic cancer
Dr Jahnavi Pedireddy, Medical Oncology Trainee,Apollo Hospitals,Bengaluru; Dr Narendhar Gokulanathan, Medical Oncology Trainee,Apollo Hospitals,Bengaluru; Dr Muthulingesh Kumar, Medical Oncology Trainee,Apollo Hospitals,Bengaluru; and Dr Vishwanath Sathyanarayanan, Professor and Head,Department of Medical Oncology,Apollo Hospitals, Bengaluru; delve into the clinical,economic,and emotional complexities of adopting novel cancer drugs,especially in lower-middle income countries
Metastatic cancer refers to malignancies that originate in one organ and spread to adjacent or distant organs via the blood or lymphatic systems. tumour cells continuously shed into the circulation, and while many are cleared by the immune system, some manage to evade immune defences and travel to distant sites in the body. Interestingly, different cancers tend to metastasise preferentially to specific organs. For example, breast cancer commonly spreads to the bones, brain, liver, and lungs, while lung cancer often metastasises to the adrenal glands, bones, brain, and liver. Prostate cancer tends to spread to bones, liver, lungs, and adrenal glands, and col-
orectal cancer typically involves the liver, lungs, and peritoneum.Clinically, metastatic cancer is categorised based on its relationship to the primary tumour site:
◆ Regional metastasis refers to spread to adjacent organs or areas.
◆ Distant metastasis is cancer that has travelled to far-off organs, often through the blood-
◆ Locally advanced cancer involves nearby tissues or lymph nodes.
STRATEGY
stream or lymphatics.Historically, the management of metastatic cancer has relied on four primary therapeutic modalities: surgery, radiation therapy, chemotherapy, and, more recently, immunotherapy , The 2018 Nobel Prize in Physiology or Medicine was awarded to Tasuku Honjo and James Allison for their discoveries in cancer immunology. Professor Honjo was awarded due to his discovery of the pro-
Assessing value: The clinical benefit vs. cost debateAs novel cancer therapies emerge, discussions around their value — the clinical benefits they offer in relation to their often-high costs — have aggrandised. This debate is especially relevant in lowermiddle income countries (LMICs), where the cancer burden is increasing, but access to these new therapies remains limited due to finan-
grammed death molecule-1 (PD-1) on T cells.
Localised treatments like surgery and radiation are directed at specific tumour sites, while systemic treatments such as chemotherapy and immunotherapy target cancer cells throughout the body.
For decades, chemotherapy using cytotoxic drugs to kill rapidly dividing cells remained the cornerstone for treating metastatic disease. However, recent advances have introduced targeted therapies and immunotherapy into treatment algorithms for several metastatic cancers with reasonable benefit. Targeted therapies or magic bullets focus on specific genetic mutations or molecular pathways essential for tumour growth, while immunotherapy harneses the body’s immune system to recognise and attack cancer cells.
to understand how oncologists in these settings perceive the value of new drugs and the financial implications for their patients.The patient perspective: Small benefits, significant impactWhile clinicians and drug manufacturers may debate the magnitude of clinical benefit required to justify a drug’s cost, for many patients living with metastatic cancer, even modest gains are meaningful. A small ex-
are modest. Others may be willing to endure aggressive treatments for the chance of extending life by even a few months.In LMICs, social and financial considerations play a significant role in these decisions. The cost of novel targeted therapies and immunotherapies, travel expenses, and loss of income often add to the burden. In many families, treatment decisions are influenced not only
systemic chemotherapy or novel targeted therapies offer limited survival benefits, they often alleviate symptoms, reduce tumour burden, and improve overall well-being. For many patients and families, this symptomatic relief alone justifies the continuation of therapy.Bridging the gap between evidence and experienceIn the context of metastatic cancer management in lowermiddle income countries, un-
Even if systemic chemotherapy or novel targeted therapies offer limited survival benefits,they often alleviate symptoms,reduce tumour burden,and improve overall well-being.For many patients and families,this symptomatic relief alone justifies the continuation of therapy
cial constraints and out of pocket expenditure to the tune of 50 per cent.Physician opinions about the approval of new cancer drugs, particularly those based on surrogate endpoints (such as progression-free survival or response rates rather than overall survival), vary widely. In LMICs, where healthcare resources are limited, prioritising the use of expensive therapies becomes a difficult decisionmaking process. It is crucial
tension in progression-free survival (PFS) or improvement in quality OF LIFE (QOL) can translate into renewed hope, and precious time with loved ones. However, in some, the pricing is beyond their reach. Importantly, patient preferences in metastatic cancer care are deeply personal and varied. Some patients prioritise quality of life and opt for treatments with milder side effects, even if survival gains
by the patient but also by caregivers and relatives. Some patients continue treatment for the mental reassurance it provides, while others experience treatment fatigue or feel societal pressure to keep fighting, despite uncertain benefits.
With novel therapies like immunotherapy, the average time to response is four to six months which is a major test to their patience and financial resources. Moreover, even if
derstanding both the clinical and personal value of novel therapies is essential. While oncologists must navigate the complexities of clinical evidence, surrogate endpoints, and cost-effectiveness, they must also remain aligned to the perspectives of their patients — for whom small benefits can hold profound meaning or also a financial turmoil. As the cancer burden grows and drug prices continue to rise, healthcare systems in resource-limited settings must engage in evidence-based prioritisation of therapies. At the same time, having an open conversations between oncologists, patients, and families about realistic goals of care, potential benefits, and the financial implications of treatment can help ensure that decisions align with both medical evidence and patient values. Shared decision making is the key.
Dr Narendhar Gokulanathan
Dr Jahnavi Pedireddy
Dr Vishwanath Sathyanarayanan
Dr Muthulingesh Kumar
Role of nitric oxide in controlling genetic regulators to maintain cellular health
Prof Syamantak Majumder,Prof Sandeep Sundriyal,
and Prof Shibasish Chowdhury, researchers at BITS Pilani,reveal how nitric oxide regulates the EZH2 protein through S-nitrosylation in blood vessel cells.This discovery sheds light on vascular stability and opens new avenues for treating conditions like heart attacks and strokes
When you think of gases involved in your health, oxygen probably tops the list. But there’s another gas, nitric oxide, that quietly plays a crucial role in keeping your body running smoothly. Though it might sound like something from a chemistry lab, nitric oxide is made right inside your body. In fact, the discovery of this gaseous molecule led to the No-
bel Prize in Physiology or Medicine in 1998 to Dr Robert F Furchgott, Dr Louis J Ignarro, and Dr Ferid Murad for their discoveries concerning nitric oxide as a signaling molecule in the cardiovascular system. However, we are still far from understanding the complex set of regulations this gaseous molecule governs, and Scientists are still uncovering how deeply it’s involved in cellular health.
In our recent study published in Nature Communications (1), we explored how this tiny, simple molecule interacts with proteins inside endothelial cells, the cells that line your blood vessels. What we found opens a new window into how nitric oxide helps regulate key proteins that maintain the health and balance of your vascular system. At the heart of this discovery is a protein
called EZH2, and a chemical process called S-nitrosylation.
The central player: Nitric oxide
Nitric oxide is a short-lived gas that your body naturally produces. It plays an essential role in many bodily functions—from helping your blood vessels relax and widen, to controlling how cells communicate, move, and even defend themselves.
One of nitric oxide’s lesserknown talents is its ability to chemically modify proteins. It does this through a process known as S-nitrosylation, where it attaches to specific parts of a protein, namely, to a sulfur-containing amino acid called cysteine. Think of it as adding a tiny “tag” to the protein, which can change the protein’s function, stability, or location in the cell.
RESEARCH
Meet EZH2: The genetic regulator
One of the proteins affected by S-nitrosylation is Enhancer of Zeste Homolog 2 (EZH2).
EZH2 is a gene regulator. It’s part of a group of proteins called the Polycomb Repressive Complex 2 (PRC2 complex), which works like a dim-
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mer switch to turn down the activity of certain genes.
EZH2’s main job is to add a chemical marker, known as H3K27me3 to histones, the spool-like proteins around which DNA is wrapped. This mark tells the cell to keep that section of DNA quiet, preventing the genes in that area from being expressed. Proper con-
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trol of these genes is essential for normal cell function and health, particularly in endothelial cells, which constantly respond to changing blood flow, pressure, and chemical signals.
Anewlayer of control: S-Nitrosylation of EZH2
Our research shows that nitric oxide can attach to specific cys-
teine sites on EZH2, changing how it behaves inside the cell.
We found two important sites where this happens:
◆ Cysteine 329: When nitric oxide modifies this residue through S-nitrosylation, EZH2 becomes unstable. It no longer functions properly and starts to break down.
◆ Cysteine 700: In contrast,
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when this residue is S-nitrosylated by nitric oxide, EZH2 loses its ability to add the H3K27me3 mark, essentially shutting down its gene-silencing function.
This is a big deal because it means nitric oxide can turn off EZH2 in two different ways— by making it unstable or by diminishing its function.
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Several important things happen when EZH2 gets modified by nitric oxide:
◆ The PRC2 complex falls apart. Normally, EZH2 works with its partner protein, SUZ12, to form PRC2. But when EZH2 is S-nitrosylated, it can’t hold on to SUZ12 properly. This causes the complex to break apart early, which reduces the gene-silencing H3K27me3 marker.
◆ EZH2 is kicked out of the nucleus. After losing its function, EZH2 moves out of the nucleus (where DNA lives) into the cell’s cytoplasm.
◆ EZH2 gets destroyed. Once in the cytoplasm, EZH2 is marked for degradation. It’s tagged with ubiquitin, a small molecule that tells the cell’s waste-disposal system to break it down. In short, nitric oxide effectively shuts down EZH2, making it unable to silence genes and triggering its removal from the cell.
One of nitric oxide's lesser-known talents is its ability to chemically modify proteins.It does this through a process known as S-nitrosylation, where it attaches to specific parts of a protein, namely,to a sulfur-containing amino acid called cysteine.Think of it as adding a tiny "tag" to the protein,which can change the protein's function, stability,or location in the cell
Whydoes this matter?
This whole process turns out to be very important for endothelial homeostasis—a term that means the overall balance and healthy functioning of the cells lining our blood vessels. These cells need to adapt constantly to mechanical stress, inflammation, and signals from other parts of the body. EZH2 helps keep certain genes turned off so the cells don’t overreact or go haywire. But under certain conditions such as oxidative stress or inflammation, it’s helpful to
reduce EZH2 activity. That’s where nitric oxide steps in, offering a smart way for the cell to fine-tune its genetic control systems in real time. Our study shows that this nitric oxide driven mechanism works not just under healthy conditions, but also during pathological (disease-related) states.
Molecular simulations add insight
To better understand why SUZ12 and EZH2 break up when EZH2 is S-nitrosylated,
we used molecular dynamics simulations—computer models that mimic how molecules move and interact. These simulations revealed that S-nitrosylation alters the shape of EZH2’s SAL domain, a region critical for binding SUZ12. When this domain is modified, SUZ12 simply can’t latch on properly anymore, leading to the breakdown of the PRC2 complex.
Looking ahead
This study brings new clarity to how nitric oxide regulates
cell behavior through precise protein modifications. We now understand that NO doesn’t just relax blood vessels, it actively rewires how genes are controlled in endothelial cells by modifying a key player like EZH2. The implications of this are wide-ranging. These findings are important because problems with blood vessel stability can lead to many diseases, including heart attacks and strokes. By understanding these mechanisms better, future therapies could be developed to keep blood vessels healthier for longer.
Reference 1. Sakhuja A, Bhattacharyya R, Katakia YT, Ramakrishnan SK, Chakraborty S, Jayakumar H, Tripathi SM, Pandya Thakkar N, Thakar S, Sundriyal S, Chowdhury S, Majumder S. Snitrosylation of EZH2 alters PRC2 assembly, methyltransferase activity, and EZH2 stability to maintain endothelial homeostasis. Nat Commun. 2025 Apr 27;16(1):3953.
Industry leaders come together to explore strategies and innovations shaping the next generation of pharma and medtech supply networks
Welcome Address
The second edition of the Pharma and Med Devices Supply Chain Conclave 2025, organised by Express Pharma, brought together key stakeholders across pharma and healthcare logistics to discuss supply chain excellence under the theme: Adaptability, Agility, Accessibility.
The conclave served as a pivotal platform forindustry leaders, supply chain experts, and policy influencers to deliberate on how the sector is shifting from traditional efficiency-focused models to intelligent, interconnected networks that are not only crisis-ready but also crisis-resilient.
Key sessions explored a wide range of critical issues such as patient-centric delivery models, direct-to-patient logistics and complexities of managing cold chains for cell and gene therapies. Discussions also delved deep into the role of digital transformation, showcasing blockchain, IoT, and predictive analytics as enablers of visibility and agility across the supply chain.
Sustainability emerged as a central theme, with actionable insights on carbon-neutral warehousing, green
Special Address
Archana Jatkar, Associate Secretary General, IPA began her address by highlighting the dynamic challenges confronting the global pharma industry, from pandemics and geopolitical issues to climate change and rising protectionism. She underscored that in these volatile environment; smarter, more agile supply chains are an imperative.
She also emphasised the need to shift from “just-in-time” to “just-incase” supply chain models. She also called for preparedness through distributed manufacturing, buffer inventory, and enhanced visibility across the supply chain.
She stressed on the urgency for India to de-risk by accelerating the PLI Scheme’s implementation, easing regulatory bottlenecks, and forging strategies to develop alternate sourcing hubs.
Jatkar advocated for a shift from reactive to predictive supply chains. She said that the industry must leverag
packaging, and eco-friendly transportation alternatives. Experts also highlighted the importance of localised sourcing,
robust risk management strategies, and emergency preparedness to build resilience in times of disruption.
SecretaryGeneral,IPA
ite digital twins, blockchain and data analytics, to anticipate demand and disruptions, while ensuring transparency and traceability. She also urged investments in green solvents, zero liquid discharge systems, and energy efficiency to meet sustainability goals.
Her session also reinforced patientcentricity as the ultimate goal. Drawing on examples of medicine deliveries during lockdowns and digital prescription models, she accentuated the need for empathy-driven supply chains that cater to patients in both routine and crisis conditions.
She concluded by outlining that Indian pharma must co-create global health resilience through partnerships with governments, regulators, and industry players worldwide.
The address concluded with a powerful message—building smart, sustainable, and patient-focused supply chains is both a strategic imperative and a humanitarian duty.
L-R: Nihar Medh,Piramal Pharma; Viveka Roychowdhary,Express Pharma; Archana Jatkar,IPA; Anil Suri,SMT; KaifeelSheikh,Indoco Remedies and DhruvThakkar,DHLSupplyChain India at the lamplighting ceremony
Archana Jatkar,Associate
Supplier Engagement / Negotiation Strategy
The session titled ‘Supplier Engagement / Negotiation Strategy’ at the Pharma & Med Devices Supply Chain Conclave 2025,was led by Ashish Mohan, VP – Procurement & Supply Chain at Bharat Serums and Vaccines.
The session focused on effective supplier engagement models and strategic negotiation approaches that can build resilient and value-driven supply networks in the evolving pharma and medical devices landscape.
It aimed to address current challenges and strategic solutions in supplier relationship management, with Mohan drawing from his leadership experience in procurement.
During the session, Mohan highlighted that building mutually beneficial supplier relationships is
essential for sustainable business growth. Such relationships, when nurtured through transparency and shared value, can ensure supply continuity and long-term alignment. Strong supplier partnerships, he noted, not only help manage costs but also enable access to innova tion and improved product quality.
Mohan also emphasised the role of data-driven procurement, where analytics support better resource allocation, risk management, and value delivery.
This shift allows procurement functions to move beyond transactional roles and contribute directly to strategic business outcomes.
The session provided actionable insights into enhancing procurement maturity through collaboration and analytical clarity.
Powering advanced therapies with specialised supplychain
One of the key individual sessions at the Pharma & Med Devices Supply Chain Summit 2025 explored how India’s pharma logistics are adapting to the growing presence of advanced therapies in the healthcare landscape. The session focused on aligning supply chain capabilities with the unique demands of these emerging treatments, where time-sensitive delivery, product stability, and multi-stakeholder coordination play a critical role.
The session was led by Dhruv Thakkar, VP – Business Development, DHL Supply Chain India. Addressing an audience of industry leaders, logistics experts, and healthcare professionals, the session provided insights into how DHL is responding to the challenges and opportunities presented by unconventional therapies within the Indian market.
Thakkar’s presentation highlighted that as advanced therapies become more prevalent, traditional supply chain models must be reimagined. These therapies often demand unconventional logistics solutions—ranging from cryopreservation and temperature-controlled transport to strategic
DhruvThakkar,VP-Business Development,India,DHLSupplyChain India
partnerships across multiple stakeholders. Factors such as therapeutic windows and the rise of personalised
treatments further complicate logistics planning.
The session underscored the need
As advanced therapies become more prevalent, they often demand unconventional logistics solutions ranging from cryopreservation and temperaturecontrolled transport to strategic partnerships
for agility, precision, and innovation in building future-ready supply chains capable of supporting the next generation of healthcare solutions.
Ashish Mohan,VP-Procurement & SupplyChain,Bharat Serums and Vaccines
Panel Discussion: From factoryto patient –
Just-in-time deliveries
(L-R) Naresh Ranade,VP-SupplyChain,Sharon Bio Medicine; Arindam Bhattacharya,VP- SupplyChain Excellence,Amneal Pharmaceuticals; Meghna Bhatt,Director - Customer Service Operations,Medtronic; Dr Ashish Negi,VP- Service Logistics,DHLSupplyChain India; Jasvinder Kaur,DeputyGM,Sun Pharma; Kaifeel Shaikh,VP- Domestic Distribution & Global Logistics – EXIM,Indoco Remedies; and Anuj Agarwal,VP- SupplyChain,Par Formulations
The first panel discussion of the day, titled 'From factory to patient: Just-in-time deliveries,' brought together a powerhouse of supply chain experts from leading pharma and medtech organisations. Moderated by Naresh Ranade, VPSupply Chain, Sharon Bio Medicine, the session offered in-depth insights into how pharma and medtech companies are rethinking their supply chain strategies to meet the growing demand for agility, precision, and patientcentric delivery models.
The other panelists for this session were:Arindam Bhattacharya, VPSupply Chain Excellence, Amneal Pharmaceuticals; Meghna Bhatt, Director - Customer Service Operations, Medtronic; Dr Ashish Negi, VPService Logistics, DHL Supply Chain India; Jasvinder Kaur, Deputy GM, Sun Pharma; Kaifeel Shaikh, VPDomestic Distribution & Global
Logistics – EXIM, Indoco Remedies; and Anuj Agarwal, VP - Supply Chain, Par Formulations
The discussion began with an overview of the growing complexities in pharma supply chains. With heightened regulatory expectations, diverse market demands, and global disruptions, there is a growing need for robust just-in-time (JIT) delivery models. The panelists agreed that the traditional models of manufacturing and distribution is giving way to more agile, demand-driven approaches.
A key theme that emerged was the evolving role of Vendor Managed Inventory (VMI). The panelists asserted that by giving the responsibility for inventory management upstream to suppliers, companies can align inventory levels with real-time consumption patterns, and wastage.
The panel was candid about the challenges facing JIT implementation in
pharma and medtech. They advocated for a blend of technology, data intelligence, and deep operational understanding to improve supply chain efficiency. They also highlighted that regulatory compliance adds layers of complexity, as delays due to audits or documentation can easily derail JIT timelines.
The experts also emphasised the importance of predictive planning and real-time data and shared that modern logistics networks need to be equipped with advanced ERP systems, IoT sensors, and AI-based analytics to proactively address disruptions and maintain supply continuity. They also highlighted that workforce training and process standardisation are equally critical to make JIT a sustainable model.
The experts also pointed out that JIT cannot be applied as a onesize-fits-all strategy. It needs to be customised to the specific needs of
each product line, market, and logistics channel. They added that over-dependence on JIT without risk mitigation strategies can expose companies to inventory stockouts, particularly during global disruptions.
The panel concluded that strategic and selective application of the JIT model is the way forward. Organisations need to identify parts of the supply chain where JIT can be implemented effectively while maintaining buffer stocks or alternative strategies in high-risk areas.
In summary, the session provided a balanced and practical perspective on JIT in the pharma and medtech sectors. It offers myriad benefits such as reduced inventory costs, faster response times, and enhanced patient outcomes but also requires a careful blend of technology, collaboration, regulatory alignment, and strategic foresight.
Digital transformation in pharma and med devices
In today’s volatile, uncertain, complex, and ambiguous (VUCA) environment, the digital transformation of supply chains in the pharma and medical technology sectors is no longer optional—it is foundational.
Promoting these thoughts, Anil Suri, VP- APAC and Head of Supply Chain Management, Sahajanand Medical Technologies delivered a talk on the need of digital transformation in pharma and med devices.
Suri emphasised that technology is a great enabler. However, successful and meaningful supply chain transformations in the pharma and med devices sectors are driven by the mindset of the leaders and the culture of an organisation.
True change requires more than implementing digital tools—it demands a commitment to breaking down silos both within organisations and across the broader supply ecosystem. Collaboration with supply partners, grounded in transparency and shared goals, is essential to unlocking the full value of digitalisation.
The ability to respond to disruption, meet regulatory demands, and serve patients effectively hinges on building
Anil Suri,VP- APAC and Head of SupplyChain Management,Sahajanand Medical Technologies
agile, resilient, and intelligent supply networks.
Transitioning from reactive to pre-
dictive supply chain models delivers tangible returns on investment. These include enhanced forecast accuracy,
Building resilient and agile supplychains for medical devices
Recent global events like pandemics, geopolitical conflicts and extreme weather have exposed the fragility of complex, globally dispersed supply chains in the pharma and medtech sectors. Understanding these complexities, Mahesh Wade, SCM Cluster Head South Asia, B Braun Group expressed how building supply chains that are not only efficient but also resilient is no longer optional—it’s essential.
Wade highlights that this shift requires rethinking traditional models. Distributed distribution networks can reduce dependency on single regions and improve responsiveness. Investing in last-mile delivery solutions is crucial to ensure timely and secure access to temperature-sensitive drugs and
True change requires more than implementing digital tools—it demands a commitment to breaking down silos both within organisations and across the broader supply ecosystem
optimised inventory levels, and significant cost efficiencies. By harnessing data, advanced analytics, and real-time visibility, pharma and medtech companies can build future-ready supply chains that not only respond to change but anticipate it.
personalised therapies. Enhanced traceability, powered by digital tools, strengthens quality control and regulatory compliance. Addressing diverse geographic and demographic needs further supports equitable access to critical therapies.
Key strategies to fortify supply chains include comprehensive risk assessments, robust contingency planning, and sustained investment in digital transformation. Strong collaboration with partners, effective communication, and well-integrated quality management systems are equally critical. Scenario planning and simulation exercises help stress-test operations, while circular economy principles bring added resilience through waste reduction and resource efficiency.
Mahesh Wade,SCM Cluster Head South Asia,B Braun Group
Panel Discussion: Powering the smart supplychain
Digital transformation is reshaping the pharma and medical devices landscape. As supply chains evolve, embracing digitalisation is no longer optional—it is essential. From real-time tracking to predictive analytics, technology is becoming the foundation of efficient, agile, and responsive supply networks. Reflecting this shift, the second panel discussion at the Pharma & Med Devices Supply Chain Summit 2025 focused on the critical role of technology and collaboration in building smarter supply chains.
Titled ‘Powering the Smart Supply Chain,’ the session examined both the opportunities and challenges posed by digital integration. It addressed issues of regulatory alignment and the adoption of emerging tools such as
blockchain and drones, offering a comprehensive view of the sector’s readiness for intelligent supply chain transformation. The discussion brought together senior industry stakeholders to explore what defines a smart supply chain, why digitisation is crucial, where current gaps exist, who must lead change, and how evolving technologies and policies are shaping the way forward.
The session was moderated by Anil Damle, Senior President, Corporate Project & Supply Chain at Bharat Serums and Vaccines. The panel featured insights from Bijoy Peter Alappattu, GM – Technical Services, GS1 India; Vijay Shetty, Senior VP - Global Distribution and Supply Chain, Alkem Laboratories; and Manish Gahlaut, VP - Supply Chain Management, Tata 1Mg.
Building on this foundation, the discussion emphasised that true supply chain integrity depends on coordinated efforts among manufacturers, distributors, pharmacies, and regulatory authorities. Without collective participation, traceability and compliance initiatives risk becoming fragmented and ineffective.
The panel further underscored the need for stronger regulatory frameworks and standardised practices to ensure drug safety and data transparency. While technologies such as blockchain offer significant promise in securing supply chains, their adoption remains constrained by cost factors and trust deficits—particularly in environments where transparency is most needed.
Looking ahead, the panel also con-
sidered the role of emerging technologies like drones. Though still in early stages of deployment, drones are being tested for transporting lab samples and supporting warehouse operations. Their wider adoption is expected as regulatory clarity improves and costs decline.
Throughout the session, a recurring theme was the industry’s need to strike a fine balance between innovation and accessibility. In price-sensitive markets like India, technology must serve not just operational efficiency, but also economic viability.
The panel concluded that creative approaches are required to manage costs, enhance operational efficiency, and deliver value—without compromising on the safety or affordability of essential medicines.
(L-R) Anil Damle,Sr President,Corporate Project & SupplyChain,Bharat Serums and Vaccines (Moderator); BijoyPeter Alappattu,GM-Technical Services,GS1 India; VijayShetty, Sr.VP-Global Distribution and SupplyChain,Alkem Laboratories; Manish Gahlaut,VP-SupplyChain Management,Tata 1Mg
Panel Discussion: Advanced therapylogistics: The newfrontier
The concluding panel discussion at the Phamra Medical Devices Supply Chain Conclave 2025 discussed the new frontiers of advanced therapy logistics. Moderating this discussion was Ashish Sabnis, VPStrategic Buying & Compliance, USV. And panellists included Stanley Fernandes, Asst VP, Bharat Serums & Vaccines; Arijeet Banerjee, Associate Director Supply Chain Management, Ferring Pharmaceuticals; Ashu Gupta, VP-Supply Chain Management, Koye Pharmaceuticals; and Manoj Nolkha, India Deliver Lead, J&J.
The conversation began by discussing cold chain management, a crucial aspect of advanced therapy logistics. Panellists agreed that
maintaining a robust cold chain is critical in pharma and medtech logistics, especially for temperature-sensitive and advanced therapies. Real-time tracking, validated lane qualifications, and rigorous stakeholder training form the backbone of a reliable cold chain, helping ensure compliance and product integrity throughout transit.
Logistics for advanced therapies often involves complex, time-sensitive, cross-border routes that require precise coordination and adherence to rapidly evolving regulatory requirements. Deliveries must be meticulously planned to avoid delays or temperature excursions.
There’s a growing adoption of next-gen packaging solutions. Phase
Change Material (PCM) bottles and foam bricks can maintain ultra-low temperatures—down to -21°C—for up to 96 hours. Collapsible liners and thermal blankets are also gaining popularity due to their flexibility and space-saving benefits.
Panellists also highlighted that security innovations like digital locks and tamper-evident bottle seal packs are enhancing supply chain integrity. These systems often use OTP verification to unlock vehicle doors, providing added traceability, quality control and control over who accesses the shipment.
With regulatory scrutiny intensifying, end-to-end temperature monitoring has become standard. Tools like data loggers and real-time sensors help
detect any temperature excursions immediately, enabling rapid response. Comprehensive quality checks at every stage are essential, as any breach in cold chain conditions can compromise product efficacy and patient safety.
As cold chain logistics become more complex and critical to therapeutic success, especially with the rise of biologics and cell and gene therapies, the industry must continue to invest in innovation, training, and collaboration. Building a cold chain that is not only compliant but also intelligent and resilient is essential to safeguarding product integrity, meeting regulatory expectations, and ultimately ensuring that life-saving treatments reach patients safely and on time.
Express Pharma celebrates and honours excellence in pharma and med devices supplychains
The Champions of Change initiative spotlighted individuals who have demonstrated leadership, innovation,and resilience in streamlining and transforming supply chains within India’s pharma and medical devices sectors
The second edition of the Pharma & Medical Devices Supply Chain Conclave, hosted by Express Pharma, concluded with a Citations ceremony for supply chain leaders. The Champions of Change initiative spotlighted individuals who have demonstrated leadership, innovation, and resilience in streamlining and transforming supply chains within India’s pharma and medical devices sectors.
The event saw crucial discussions on making supply chains smarter, safer, and more responsive to the needs of patients across the country and beyond.
The evening began with a warm welcome from Viveka Roychowdhury, Editor of Express Pharma, Express Healthcare, and Express Nutra. She explained, This initiative seeks to acknowledge and applaud the sterling role you play in ensuring safe, efficient
While they shared their views on diverse topics ranging from embracing digitalisation and fostering resilient ecosystems to nurturing talent and sustainability,they were united by a common goal — advancing patient-centric outcomes through supply chain excellence
and timely delivery of critical medications and devices to patients, ultimately contributing to improved healthcare outcomes.”
She also highlighted how the pandemic underscored the critical importance of robust and agile supply chains, and how the individuals being recognised tonight have embraced this
challenge head-on to drive positive change.
Subsequently, the Citations were presented to each recpient for their contributions across various facets of supply chain management — from procurement and logistics to technology implementation and strategic planning.
The recipients this year were as follws:
◆ Arijit Banerjee
◆ Ashish Mohan
◆ Mahesh Wade
◆ Paresh Nair
◆ Vijay Shetty
◆ Vinod Nair
◆ Vipul Jain
Each awardee was invited to share a few words, and their remarks were a testimony to the dedication, collaboration, and forward-thinking that define supply chain leadership today. While they shared their views on diverse topics ranging from embracing digitalisation and fostering resilient ecosystems to nurturing talent and sustainability, they were united by a common goal — advancing patient-centric outcomes through supply chain excellence.
The ceremony concluded on a high note and it was folwed by a networking dinner to continue the celebration.
GLIMPSES OFPHARMA& MED DEVICES SUPPLYCHAIN CONCLAVE 2025
PRE EVENT
FDD Conclave 2025 to be held in Hyderabad this June
This year,it will focus on formulation and drug delivery strategies which can ensure that innovations translate into tangible benefits for healthcare systems and patients worldwide
The Formulation Development & Drug Delivery (FDD) Conclave 2025, now in its eighth edition, is set to bring together experts and leaders from the formulation R&D (FR&D) community to explore csutting-edge advancements and growth strategies in pharma formulation and drug delivery. Organised by Express Pharma, the two-day event will be on June 13 & 14, 2025, in Hyderabad.
Advancements in pharmaceutical sciences and novel technologies are reshaping how drugs are formulated and delivered. Be it artificial intelligence, precision medicine, advanced materials science or digital health technologies, their intervention is creating unprecedented opportunities for therapeutic innovation. However, true innovation is not just scientific advancement but meaningful improvement in patient outcomes and experiences.
Therefore, FDD Conclave 2025, now in its eight edition, aims to highlight the need to reimagine formulation and drug delivery through the lens of patient needs, experiences and outcomes. This year, it will focus on formulation and drug delivery strategies which can ensure that innovations trans-
late into tangible benefits for healthcare systems and patients worldwide.
With the theme 'From Lab to Life: Bridging science and care', FR&D experts and leaders will explore how India can leverage its unique strengths— skilled talent, manufacturing excellence and market understanding—to develop therapeutic solutions that enhance efficacy, compliance, and quality of life across diverse patient populations.
The conclave, through thought-provoking discussions and interactive sessions, will also explore and examine the role of supportive regulatory frameworks, sustainable funding models, talent development and collaborative ecosystems in enabling innovation.
Building on the momentum of previous conclaves, the 2025 edition aims to create a blueprint for India's pharma industry as a global leader in patientcentric therapeutic innovation. This year's conclave will spotlight how novel technologies are revolutionising drug formulation and delivery. However, the focus will be on scientific breakthroughs that lead to meaningful improvements in patient outcomes and experiences.
Experts in FR&D will dis-
cuss how India’s skilled talent, manufacturing excellence, and market insights can drive the development of therapies that enhance efficacy, compliance, and quality of life for diverse patient populations. The event will also emphasise the role of regulatory frameworks, sustainable funding models, and collaborative ecosystems in enabling and accelerating innovation.
Keyfocus areas at the conclave will include
Integrating patient insights into formulation and drug delivery design
The convergence of digital technologies with advanced formulation sciences
Overcoming long-standing formulation and drug delivery challenges
Scaling lab innovations into
commercially viable products
Fostering cross-disciplinary partnerships to accelerate therapeutic innovation
Regulatory support for novel drug delivery approaches
Topics to be covered
Accelerating OSD innovation: From R&D to market
Biologics and biosimilars: The next leap in patient-centric drug development
Injectable therapies 2.0: Enhancing patient-friendly parenteral drug delivery
Non-invasive treatments: The rise of topical and transdermal drug delivery
Painless drug delivery innovations: Moving beyond traditional injections
Future-ready formulations: Addressing challenges for special populations
For the 100+ pharma professionals attending, FDD Conclave 2025 will present a unique opportunity to engage with industry pioneers, showcase innovative solutions, and gain insights into the latest trends shaping the future of pharma formulation and drug delivery.
Stay tuned for further updates and speaker announcements on our websiteexpresspharma.in/events/
TECHNOLOGY
Driving change: Digital innovation and the future of drug discoveryin India
Dr Trupti Kad-Shinde, Senior member,Medical Research and content team,ImmersiveVision Technology and Dr Debashree Das, pharmacologist and medical writer,express that pharmaceutical education must undergo a fundamental transformation to realise India’s true potential in drug discovery
India’s pharmaceutical prowess is indisputable.
Home to nearly 10,000 manufacturing units, 3,000 companies (1), and more than 650 USFDA-approved facilities, the country plays a central role in the global supply of generics. This manufacturing strength is further complemented by a robust academic ecosystem with over 4,000 pharmacy institutions that generate a steady pipeline of graduates, patents, and publications.
The last mile challenge
Despite this impressive output, India still ranks 39th on the Global I nnovation Index (2), underscoring that while the country leads in generics, progress in new drug discovery is significantly slow (3). A major reason for this challenge is that pharma struggles in crossing the last but critical mile in the drug discovery— the preclinical to clinical leap (4).
At the heart of the problem is a research culture that often treats publications and patents as endpoints, not beginnings. Promising hypotheses are filed away in journals or locked behind IPRs, rarely progressing toward clinical application (5). It’s akin to drafting blueprints for a remarkable house but never actually building it.
Even academia is more production-oriented. It places way more emphasis on handson training for pharmaceutics, medicinal chemistry, and pharmaceutical analysis while sidelining practicals in foundational sciences like human
anatomy, physiology, pathophysiology, and clinical pharmacology. The outcome is a workforce well-prepared for manufacturing but underequipped for discovery and innovation.
Consequently, industry is more inclined to recruit from rather than collaborate with academia—a reality highlighted by India’s 86th rank in global academia–industry R&D collaboration, as reported by the World Intellectual Property Organization (6).
Thus, to realise its true potential, India must strive to forge deeper, more strategic partnerships between academia and industry. Industry must endeavour to invest not only in infrastructure but also in mentorship, facilities, and translational platforms (7). While academia needs to strive towards cultivating a translational mindset in future researchers, one that doesn’t stop at “what does this molecule do?” but extends to “how does it behave in a human system, and how will it improve
patient outcomes?”
The vital role of human biology
Drug discovery is not just a chemical or pharmaceutical challenge. It’s a biological one with human biology at its epicentre. According to the US Food and Drug Administration, the path of drug discovery and development follows four key stages: target identification and validation, lead discovery and optimisation, preclinical studies, and clinical
trials (8).
And across every step, one element remains consistently central—human biology. Let's take a look at how.
Identifying a molecular target involves discerning a disease-relevant druggable biomolecule. It demands a clear understanding of its anatomical location, along with its physiological role and how its function changes in disease. Optimising lead compounds, in turn, calls for deep insight into how even subtle chemical
The last mile challenge: Preclinical to clinical
Industry-academia collaboration
Dr Trupti Kad-Shinde Dr Debashree Das
modifications of the candidate can shift its activity within the complex biological systems (9).
Preclinical testing in animals must also be interpreted through a human lens to identify cases of false positives, false negatives, and other blind spots that may distort bench-to-bedside translation of the candidate (10). Thus, before a molecule can be developed into a successful medicine, it must not only demonstrate favourable physical and chemical properties and promising outcomes in animal models but also have its safety and efficacy rigorously vetted in human systems. This is where the complexities of human biology come sharply into focus (11).
Understanding human anatomy is crucial for identifying the sites where drugs are absorbed, metabolised, and
informed target identification and dosing strategies but also equips future researchers to recognise the micro-anatomical, physiological, and pathophysiological differences between animal models and human systems. By acknowledging these nuances, they can predict whether a candidate successful in the preclini-
while APHE II delves into human organ systems and physiological functions. The objective is clear: to align pharmaceutical training with the biological realities of the human body (14).
Yet the program often falls short, particularly in providing meaningful, hands-on, practical training.
exert their pharmacological effects. Physiology not only helps to understand the normal functioning of the human body, but also helps in understanding the processes by which drugs are bio-transformed, distributed throughout the body, and excreted. Pathology highlights how diseases alter these physiological processes and how a drug candidate can interact with the target biomolecules to mitigate pathological consequences (12). This integrated approach not only facilitates
cal phase will or will not be of equal value in clinical trials, potentially saving billions of dollars in failed attempts (13).
The APHE conundrum
Recognising this need to root pharmaceutical education in human biology, the All India Council for Technical Education (AICTE) introduced Anatomy, Physiology, and Health Education (APHE) into the B.Pharm. curriculum. Structured in two phases, APHE I focuses on cellular and tissue-level anatomy,
Medicine is both prescribed and produced. While MBBS students are trained to prescribe medicines, pharmacy students are taught to design them. But the educational journeys that shape these roles are strikingly unequal. Medical students benefit from clinical exposure, patient interaction, and cadaveric dissection. Pharmacy students, by contrast, must rely on plastic models, textbook diagrams, and abstracted illustrations of disease. Histology is rushed. Pathology is mentioned but rarely explored in depth. The result? Many students can describe disease in theory, but struggle to visualise its development and impact within the living system (15).
meaningful insight into the human body? That’s where digital transformation steps in.
Digital innovation in pharma education
In step with the age of AI, the field of pharmacy is adopting digital platforms to stay ahead. It is therefore essential for pharmaceutical academia to equip, next generation of professionals for the digital era of drug discovery and development (16). Among the diverse range of digital technologies available (17), one particularly promising approach for providing meaningful insights into the human body is the integration of an interactive digital dissection table, such as CADAVIZ (18), as a regular part of the
This disconnect between cognitive knowledge and embodied understanding is the APHE conundrum. And the key reasons why drug discovery in India is more theoretical than practical.
So, with cadaveric dissection off the table and clinical immersion out of reach, how do pharmacy students gain
pharma curriculum. This system allows for detailed exploration of human anatomy through realistic 3D visualisation, wherein the students can interact with the digital human body in real time to gain a clearer understanding of the crosstalk between various cells, tissues, organs, and organ systems under normal
From discoveryto surveillance,the patient is at the heart of it all
Educational difference between prescriber’s vs producers
Revolutionising pharmaceutical education with digital innovation
Visualising anatomywith virtual dissection table
TECHNOLOGY
physiological and pathophysiological conditions. What distinguishes such digital tools pedagogically is their ability to integrate multiple domains into a unified platform.
Beyond anatomy, CADAVIZ also integrates physiology, embryology, pathology, histology, and genetics, offering a comprehensive view of human biology. This multidisciplinary approach allows students to move beyond rote memorisation and actively visualise neural and vascular pathways, tracing the routes through which a drug travels following various modes of administration (19).
Using CADAVIZ, pharmacy students can trace the sites of absorption, metabolism, and excretion, as well as the anatomical structures involved in drug binding and those impacted by drug action. This will foster a deeper understanding of how molecular mechanisms relate to their anatomical and physiological contexts.
Students can also explore human microanatomy in vivid detail, learning to distinguish between healthy and diseased tissues with clarity and confidence. This early exposure to histopathological patterns builds a strong foundation for understanding how drugs interact with organs at the cellular level—knowledge that’s vi-
tal in preclinical research. By observing the microscopic effects of potential treatments, students will be able to gain insight into toxicity, dosage response, and disease progression. More importantly, they learn to recognise the similarities and differences between animal and human systems, equipping them to support the critical transition from lab-based discovery to tailored therapies.
The integration of digital
dissection technology will also empower students to explore real patient datasets through a DICOM viewer, providing valuable insights into tumour progression and organ pathology. This visualisation will aid in understanding clinical endpoints, a critical component in designing targeted drug delivery systems. By vividly mapping anatomical targets, students gain a clearer understanding of how drugs can be precisely delivered to affected areas.
Conclusion:
Driving change for a new pharmaceutical India
To realise India’s true potential in drug discovery, pharmaceutical education must undergo a fundamental transformation. For too long, the focus has remained on production over inn ovation. But the future demands a cultural reset. Digital tools must move from the periphery to the heart of learning. Technologies such as virtual dissection table do more than teach; they inspire. They prepare a generation of pharmacists to be cocreators in discovery, not just dispensers of the end product. If India is to move from the “Pharmacy of the World” to the “Cradle of Pharmaceutical Discovery,” inn ovation must no longer be an ambition—it must be the foundation.
References
1. Pathak, R., Sharma, H., Sachan, N., & Chandra, P. (2024). Pharma marketing in
India: Prospects and challenges. In R. Malviya, P. K. Srivastava, S. Verma, & S. Srivastava (Eds.), Pharma marketing and pharmacoeconomics (pp. 295–329). Apple Academic Press.
https://doi.org/10.1201/978100 3506362-14
2. World Intellectual Property Organization. (2024). India Ranking in the Global Innovation Index 2024. https://www.wipo.int/gii-ranking/en/india
3. Kogej, T., & Sato, A. (2024). Innovative Drug Discovery Research by Pharmaceutical Companies: A Perspective from the Pharmaceutical Industry. Journal of Medicinal Chemistry, 67(18), 9773–9781. https://doi.org/10.1021/acs.jme dchem.4c01180
4. Seyhan, A. A. (2019). Lost in translation: The valley of death across preclinical and clinical divide – Identification of problems and overcoming obstacles. Translational Medicine Communications, 4(1), 18. https://doi.org/10.1186/s41231019-0050-7
5. Akums Drugs & Pharmaceuticals Ltd. (2025, May 10). Pharma industry–academia partnerships: Accelerating innovation and impact. LinkedIn. https://www.linkedin.com/puls e/pharma-industryacademia partnerships-accelerating-innovation-impact-oukmc/
6. Office of the Principal Scientific Adviser to the Government of India. (2024, December). Industry-Academia Partnership for Research & Innovation. https://psa.gov.in/CMS/web/sit es/default/files/psa_custom_fil es/PSA_NOVEMBER%202024%20ISSUE_ 04%20DECEMBER%202024%20FINAL.pdf
7. DrugBank. (n.d.). The collaboration between industry and academia in drug development. https://blog.drugbank.com/thecollaboration-between-industry-and-academia-in-drug-development/
Visualising teratogenesis with virtual dissection table
Visualising 3D model of an abdominal desmoid tumor reconstructed from DICOM images,(20)
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S., Poyet, J.-L., Tsaioun, K., & Villoutreix, B. O. (2023). Drug discovery and development: Introduction to the general public and patient groups. Frontiers in Drug Discovery, 3, Article 1201419.
https://doi.org/10.3389/fddsv.2 023.1201419
9. Trajanoska, K., Bhérer, C., & Mooser, V. (2023). From target discovery to clinical drug development with human genetics. Nature, 620(7975), 737–745.
https://doi.org/10.1038/s41586023-06388-8Nature+5
10. Kaelin, W. G. Jr. (2017). Common pitfalls in preclinical cancer target validation. Nature Reviews Cancer, 17(7), 425–440.
https://doi.org/10.1038/nrc.201 7.32
11. Zhang, H., Xu, J., Wang, J., Gu, Y., & Sun, G. (2023). Application of multi-element integrated teaching in the human anatomy and physiology course in pharmacy majors. Indian Journal of Pharmaceutical Education and Research, 57(4), 1192–1195. https://doi.org/10.5530/ijper.57. 4.142
12. Longdom Editorial. (n.d.). Integrative physiology: Connection between anatomy and function. Longdom. Retrieved May 12, 2025, from https://www.longdom.org/open -access/integrative-physiologyconnection between-anatomyand-function-107352.html.
13. Sun, D., Gao, W., Hu, H., & Zhou, S. (2022). Why 90% of clinical drug development fails and how to improve it? Acta
14. All India Council for Technical Education. (n.d.). Syllabus for B. Pharm. Retrieved May 12, 2025, from https://www.aicteindia.org/downloads/bpharma. pdf.
15. Rathbone, A. P., Nazar, H., Harburn, J., Todd, A., & Husband, A. K. (2019). Exploring undergraduate pharmacy student experiences of learning human anatomy using cadaveric specimens. American Journal of Pharmaceutical Education, 83(8), Article 7103. https://doi.org/10.5688/ajpe710 3.
16. IIMTU Desk. (2024, August 27). Innovations in shaping the
future of pharmacy education: A prescription for success. IIMT University. https://iimtu.edu.in/blog/innovations-in-shaping-the-futureof-pharmacy education-a-prescription-for-success/.
17. Almeman, A. (2024). The digital transformation in pharmacy: Embracing online platforms and the cosmeceutical paradigm shift. Journal of Health, Population and Nutrition, 43(1), 60. https://doi.org/10.1186/s41043024-00550-2.
18. Kulkarni, S. P., Kad, T. D., & Sayyad, M. R. (2025). CADAVIZ – Expanding digital horizons of anatomy and physiology in Ayurveda: A review. Journal of Ayurveda and Integrated Medical Sciences, 10(3), Article 42.
https://doi.org/10.21760/jaims.1 0.3.42.
19. Bokil, P., Relekar, A., Nandy, R., Nishanth, R. D. S., Yadav, P., & Das, D. (2025). Advancing medical education: Exploring virtual dissection tables and skill labs for innovative visualisation and simulation techniques. Central India Journal of Medical Research, 4(1), 24–28.
https://doi.org/10.58999/cijmr.v 4i01.203
20. Marinozzi, F., Carleo, F., Novelli, S., Di Martino, M., Cardillo, G., Petrella, L., & Bini, F. (2020). 3D reconstruction model of an extra-abdominal desmoid tumor: A case study. Frontiers in Bioengineering and Biotechnology, 8, 518. .https://doi.org/10.3389/fbioe.20 20.00518
TECHNOLOGY
Multipurpose fluid bed processors from Romaco Innojet in use at Klocke Pharma-Service GmbH
When it comes to producing and coating granulates,contract manufacturer Klocke PharmaService GmbH puts its trust in fluid bed technology from Romaco Innojet.With its wide range of applications,short processing times,linear scalability,sparing use of raw materials and reliable, energy-efficient production processes,the VENTILUS technology is tailor-made for the requirements of a contract manufacturing organisation
The Klocke Group is one of Europe’s leading contract manufacturing and packaging suppliers. Klocke Pharma-Service GmbH, at home in Appenweier in south-west Germany, processes a variety of raw materials into powder granulates and pellets, mainly for compression into tablets. The contract manufacturer first started using VENTILUS fluid bed processors from Innojet, a Romaco Group company, in 2014 and has continuously enlarged its stock of these technologies ever since.
Klocke presently has six Innojet-built fluid bed processors at its disposal for carrying out wet granulation processes with aqueous and solvent-based binder media as well as for drying and pellet coating. In addition to a VENTILUS® pilot plant for batch sizes up to 50 litres, three production plants for up to 400 litres and two for up to 800 litres are in use today. The systems are designed to be compatible as regards product filters and spare parts, and upscaling from a smaller processing machine to a larger one is a simple matter.
“The VENTILUS fluid bed processors from Romaco Innojet helped us achieve a technological leap forward”, reports Alexander Pergande, Managing Director Operations at Klocke PharmaService. “The uniform flow conditions in the machines and the precise bottom spray technology mean we can produce granulates with a more homogeneous particle size distribution and hence better flowability, leading to higher tabletting speeds. What’s more, our service portfolio has been expanded on the basis of
this technology, and we’re now also in a position to coat pellets or film-coat micro-tablets, which we couldn’t do with top spray technology.”
Patented air flowbed technology
It is the air flow bed technology developed by Dr h. c. Herbert Hüttlin, which is internationally
patented and has received numerous awards in the past, that makes this possible. The air used for this process is introduced through a special OR-
BITER® booster plate consisting of overlapping circular plates. The innovative ORBITER flow technology results in a toroidal product movement in the cylindrical product container that gently intermixes the batch. The speed of the particles and their path through the container are clearly defined and reproducible, enabling the spray liquid evaporation rate to be precisely calculated and the dosage adjusted accordingly.
Significant
reduction in drying times and process air consumption
Drying is rapid and homogeneous because the flow of process air is heated. “The VENTILUS technology has improved the drying time of all of the products we manufacture –depending on the product properties, up to 30 per cent shorter processing times can be realised compared to conventional technologies”, Pergande explains. Furthermore, with certain products, Klocke has managed to halve its process air consumption per kilogram of product (m3/kg) without any reduction in output – a powerful lever when it comes to cutting energy costs
Improved rawmaterial usage
The Innojet technology has also resulted in improved raw material usage. Sediment formation on the booster plate is virtually eliminated owing to the innovative process air distribution system of the ORBITER®. The central ROTOJET® bottom spray nozzle, via which the spray liquid is applied, allows precise ad-
Klocke Pharma-Service GmbH of Appenweier/Germanyis part of the Klocke Group,one of Europe’s leading contract manufacturing and packaging suppliers
VENTILUS® fluid bed processor from Romaco Innojet in use at Klocke Pharma-Service
TECHNOLOGY
justment of the spray angle, effectively preventing spray loss. The SEPAJET® filter system, featuring filter bags that are continuously cleaned by a blowing-air rotor system, likewise plays a decisive role with respect to raw material usage. It ensures that, in the case of granulation, the powdery substances are held back in the process area, whereas during coating processes, abrasion and other fine particles are removed from the material to be treated. Hot, conditioned process air is used for filtering, avoiding any need for expensive compressed air.
“As a specialised contract manufacturer, efficient raw material usage is very important to us”, says Pergande. “Thanks to Romaco Innojet’s fluid bed processors, we can achieve the same output with 10-15 per cent less material on average, meaning we save between 3 per cent and 30 per cent depending on the product.”
Granulation and pellet coating in one process
Klocke currently manufactures around 40 different products in the form of classic powder granulates using Romaco Inno-
jet technologies. There are also a number of products for which the pellets are built up by coating. A simple parameter setting on the HMI panel is all it takes for machine operators to individually adjust the spray pressure, the volume of the airflow and the material sprayed when switching between granulation and coating. No mechanical
conversion work is necessary on the machine, and it is no longer essential to replace the spray nozzle. Accordingly, the VENTILUS does not have to be discharged at the end of the granulation step but can proceed directly to pellet coating. That not only adds up to a huge time saving for producers, but also, the risk of cross-contami-
sors and compulsory mixers either individually or in a tandem arrangement, giving the contract manufacturer considerable flexibility where production planning is concerned. The VENTILUS manages product drying extremely efficiently when installed in tandem, with upstream granulation in the compulsory mixer.
Development partnership for a newFLEXIJETnozzle
Romaco Innojet and Klocke Pharma-Service GmbH have steadily intensified their collaboration in recent years in the framework of a development partnership. At its facility in Appenweier, Klocke recently became the first user to go live with Innojet’s new FLEXIJET nozzle. It is more robustly designed and easier to handle than
Homogeneous particle size distribution results in better flowabilityand high tableting speeds
nation is reduced and employee health and safety improved whenever critical substances are involved, because the material is treated in a closed process.
Individual solutions
The fluid bed processors in use at Klocke were specifically adapted by Innojet to the contract manufacturer’s existing production infrastructure. Besides the standalone version, one 400-litre and one 800-litre VENTILUS system can be coupled to a compulsory mixer. Innojet has come up with a multisection transfer stainless steel pipe connection with a specially designed product conveying aid for combined lines, comprised of a compulsory mixer and a fluid bed processor. For example, the process air from the VENTILUS is utilised here for pre-drying in the compulsory mixer. Depending on their customers’ requirements, Klocke can use these fluid bed proces-
its predecessor, the ROTOJET®, yet achieves the same spray quality and has already proven itself in practice at Klocke in all manner of applications.
“We greatly appreciate the open cooperation with Innojet, especially when the aim is to jointly develop strategies and solutions for meeting the daily challenges of contract manufacturing. In the opposite direction, we’re happy to share our experience – and assist in driving the ongoing advancement of Innojet technologies – with significant benefits for both companies in the long run”, asserts Alexander Pergande, Managing Director Operations, Klocke Pharma-Service. “The efficient, scalable and reliable technologies, backed up by competent and prompt service, make Innojet the ideal partner in our efforts to position ourselves successfully and permanently in the market as the contract manufacturer of choice.”
Apatented booster plate with a central bottom spraynozzle reduces drying times and process air consumption
The VENTILUS technologyis used for drying,granulation and coating
TECHNOLOGY
Data cleaning and harmonisation: Acatalyst for innovation
Messy data remains a persistent challenge in modern drug discovery.The complementary processes of data cleaning and data harmonisation play a pivotal role in optimising workflows, each addressing distinct but interconnected challenges
Scientific discovery has always relied on good, clean data. Bad data leads to irreproducible outcomes, problematic solutions, and, ultimately, the need to revisit and acquire better data. Now that AI-driven predictive models are becoming more commonplace in early drug discovery workflows, the importance of data that is accurate and consistent across entire research workflows has never been greater.
Messy data remains a persistent challenge in modern drug discovery, causing scientists to spend considerable time resolving inconsistencies in entity naming, catching mismatched database formats, and correcting errors. Machines struggle to handle the nuances of complex datasets because they lack the contextual understanding needed to interpret ambiguity and inconsistencies. Human scientists are tasked frequently with identifying then rectifying issues hidden in data that technology is not equipped to address sufficiently.
For drug discovery teams, messy data creates a ripple effect, leading researchers to design experiments and build models based on flawed assumptions or incomplete information, ultimately wasting valuable resources. This is where the complementary processes of data cleaning and data harmonisation play a pivotal role in optimising workflows, each addressing distinct but interconnected challenges.
◆ Data cleaning: The process of having experts identify and correct errors, fill in missing values, and remove irrelevant information to ensure accuracy and reliability within individual datasets
◆ Data harmonisation: The human integration of information from multiple sources, standard-
that the findings drawn from this data are reliable and reproducible, leading to high-quality drug candidates.?
◆ Increased efficiency,reducing the time spent on troubleshooting and re-running analyses due to errors.
◆ Enhanced collaboration,facilitating better teamwork between teams, institutions, and industries by eliminating discrepancies between datasets.
◆ Refined predictive power, using the forming clean data to build the foundation for predictive models that can accurately forecast drug-target interactions, disease relationships, and more.
ising and unifying it into a cohesive framework to enable seamless analysis, comparability, and collaboration
The key to successful cleaning and harmonisation lies in human curation.
Data cleaning,the critical first step?
Before scientists can harmonise data, they must clean it. By eliminating the errors that arise from data entry, miscalculations, sensor malfunctions, or system glitches, scientists can build the data foundationrequired for harmonisation. Teams that rely on properly cleaned data gain:?
◆ Improved accuracy,ensuring
TECHNOLOGY
Harmonisation without proper data cleaning is like building on quicksand—fragile and unsustainable. When scientists clean data, they ensure that only the most relevant, reliable information is incorporated into downstream processes, providing an accurate view of the research landscape and a sturdy
mation is retained. The final step focuses on ensuring consistency of data definitions across datasets, which is essential for producing a cohesive foundation built with data from multiple sources.
Drug discovery teams can navigate complex data landscapes confidently by imple-
data foundation.
Astructured approach for successful data harmonisation
Data harmonisation (Figure 1) begins with establishingauthority constructsand naming standards. For example, this painstaking work ensures that entities like proteins are uniformly named and categorised across all sources and datasets for drug development purposes to enable target identification.
The next phase in harmonisation is substance linking, in which scientists identify and connect references to the same chemical substance across disparate datasets or databases. This process unifies different substance representations, synonyms, and identifiers into a single, consistent entity. This effort is essential to pharmacology and drug discovery, where varying conventions across sources often result in the same compound being described in different ways.
Further along in the harmonisation process, data scientists identify and manage exact and related documents, preventing data duplication and ensuring that only the most relevant infor-
menting a harmonisation workflow powered by human curation, resulting in reliable datasets primed for advanced analytics and predictive modelling. This systematic approach minimises errors and ensures
that all subsequent research is built on a solid, clean data foundation.
Harmonised data enhances the accuracyof predictive models
One of the most tangible benefits of data harmonisation is its impact on predictive models. To demonstrate the positive effect on prediction accuracy, CAS scientists used a newly harmonised dataset to retrain an existing ensemble model that predicts the activity of a ligandtarget pair.
The retrained model demonstrated significant accuracy improvements, reducing the standard deviation between predicted and experimental results by 23 per cent and decreasing the discrepancy in predicted versus experimental ligand-target interactions by 56 per cent (Figure 2). By normalising the target name and improving substance linking, scientists enhanced the data to describe the relationship between a substance and its target more consistently and accurately.
This predictive modelling underscores the essential role of human data harmonisation in refining model performance. By identifying and focusing on
the most promising candidates earlier in the screening process, teams may move faster through the hit-to-lead phase and proceed with development and trials.
Harmonised data fuels advanced analytics
Data harmonisation also optimises predictive models and advanced analytical tools like knowledge graphs and interaction networks that drive innovative drug discovery workflows (Figure 3). These tools help researchers explore relationships between targets, substances, and biological pathways to identify disease associations and new therapeutic modalities.
A unified, human-curated data foundation allows scientists to trace complex interactions across various biological levels, such as gene expression, protein interactions, and metabolic pathways, providing insights otherwise obscured by fragmented data sources.
This approach improves the precision of drug discovery and accelerates the identification of potential drug repurposing opportunities, as it reveals hidden connections between established compounds and emerging therapeutic targets.
Human curation forms the foundation of innovation Without the ability to appreciate contextual nuances, machines struggle to handle the ambiguity and inconsistencies inherent in biological datasets appropriately. Skilled professionals play a vital role by recognising subtle variations, resolving errors, and aligning data to ensure accuracy and relevance in ways that automated systems cannot.
This process is vital for those doing scientific research and organisations providing related services. For example, hundreds of CAS scientists clean, harmonise, and curatethe data used to build the CAS Content CollectionTM, the world's largest collection of human-curated scientific knowledge.
This effort pays off with enhanced reliability of downstream analyses and the acceleration of discovering potential drug targets and effective disease treatments. When applied to predictive models and advanced tools like network diagrams, humancurated, harmonised data drives breakthroughs in the life sciences and beyond. As organisations continue to prioritise data cleaning in research, they can ensure the quality of their findings and accelerate innovation.
In the world of biopharmaceutical manufacturing, precision is everything. Every gram of material counts, and minimizing waste is essential for quality, safety, and cost-effectiveness. One often overlooked but critical component in this process is the antistatic powder bag. Designed specifically to handle powders used in drug manufacturing, these bags are now a staple in the industry, helping ensure that no material is lost during transfer to mixing systems.
What Is an Antistatic Powder Bag?
An antistatic powder bag is a specialized container made from antistatic film—a material designed to prevent static electricity build-up. In biopharma environments, these bags are used to weigh, transport, and transfer powders into mixer bags. The antistatic film ensures that no powder sticks to the inside of the bag, reducing waste and improving accuracy.
Static electricity can cause powders to cling to surfaces, leading to inconsistent measurements and potential contamination. Antistatic bags prevent this, providing a clean, controlled way to move ingredients from one step to another in the manufacturing process.
Applications in Biopharma
Antistatic powder bags are most commonly used alongside mixer bags flexible containers used to blend various ingredients during drug production. The process usually follows these steps:
◆ Weighing: The exact amount of each powder is measured and placed into the antistatic powder bag.
◆ Transfer: The bag is sealed and moved to the mixing area.
◆ Dispensing: All contents are transferred from the powder bag to the mixer bag with minimal or zero residue.
This careful process is cru-
cial in biopharma, where exact formulations can affect the safety and effectiveness of the final product.
WhyAntistatic Bags Matter
The benefits of using antistatic powder bags in biopharma are significant:
◆ Precision: Since powders do not stick to the bag, exact weights can be transferred without loss.
◆ Efficiency: Reduces cleaning time and material handling risks.
◆ Product Safety: Lowers the chances of contamination or variation in drug formulations.
◆ Cost Savings: Minimizing waste helps cut costs, especially when dealing with expensive active ingredients.
Other Industries That Benefit
While primarily used in biopharma, antistatic powder bags also have applications in:
◆ Chemical manufacturing
◆ Food and beverage industry
◆ Cosmetics
◆ Electronics, where dust and powder management is essential
Certifications
◆ FDA 21 CFR 177.2600
◆ USP CLASS VI
◆ ISO 10993
◆ USP 85
◆ USP 788
◆ USP 661
◆ USP 381
Conclusion
As pharmaceutical manufacturing continues to demand higher standards of precision and cleanliness, tools like the antistatic powder bag play a growing role. These bags not only help reduce waste but also support strict regulatory requirements for accuracy and quality. With their simple yet effective design, antistatic powder bags are becoming an industry standard proving that even small innovations can make a big impact in the pursuit of better medicine.
Email: chinmaya.p@ amipolymer.com
Contact: +91 – 74360 03841
Chinmaya Ranjan Parida Senior Executive – Single Use System
The Quiet Saboteur in Pharma Factories
Let me take you inside a world where precision is everything—the pharmaceutical factory.
In this world, a single mistake, even something as simple as water droplets on a pipe, can undo years of hard work. That’s not a theory. It’s a hard lesson some big pharma companies learned recently.
Inspectors visited these factories and found water quietly seeping under tanks where medicines were mixed. They spotted tiny drops of water collecting on ceilings above sterile lines. To an
outsider, these might look like small issues. But inside a pharma plant, they’re dangerous. These moisture pockets became homes for mold and bacteria. Some factories even had to
recall their medicines—an expensive, embarrassing mess. Global health regulators didn’t take it lightly and sent strict warnings.
In some plants, even the lat-
est air systems failed because they weren’t properly maintained. Humidity crept in quietly. Powders became sticky. Packaging got damaged. Laboratories that were supposed to be super clean turned messy—thanks to ignored spills and wrongly stored garments.
Each case had its own story, but all had one villain in common: uncontrolled moisture.
The irony? All of it could’ve been avoided by doing one simple thing—controlling humidity properly.
That’s where dehumidifiers
become heroes, though they don’t wear capes or make noise. These machines are built especially for pharma environments. They keep the air dry, safe, and clean—ensuring medicines stay effective, and no surprise bacteria sneak in. They protect raw materials. They protect the final product. Most importantly, they protect a company’s reputation. In today’s world of strict rules and constant inspections, the gentle hum of a dehumidifier may be the quietest, yet most powerful protector in your pharmaceutical plant.
JRS Pharma - The Global MCC Manufacturing Network
Since its introduction in 1964, Microcrystalline Cellulose (MCC) has revolutionized the pharmaceutical industry, serving as a vital ingredient in various drug formulations due to its unique properties like compressibility, flowability, and stability. Today, it is one of the most widely used excipients in pharmaceuticals, cosmetics, food, and other industries. Its invention has significantly contributed to enhancing the efficacy, safety, and overall quality of pharmaceutical products. Another remarkable feature of MCC is its biocompatibility, making it safe for human consumption. The fact that it is derived from a natural and renewable source (cellulose from plant fibers) further adds to its appeal as a pharmaceutical excipient.
MCC is a crucial universal commodity with high demand and long term need for availability at almost all times. Being used in very high volumes in oral solid dosage forms, identifying, predicting and managing certain risk factors, which are mentioned below are a big challenge for procurement teams and also an essential part of a future oriented supply chain management strategy. Years in recent past have shown many sudden situations to us like once-in-a-century
pandemic and geo-political situations affecting businesses like never before. In addition to these, here are few risk potentials working adversely to global pharmaceutical operations
–
◆ Climate change / extreme weather conditions
◆ Natural calamities like Earthquakes / Floods / Droughts
◆ Epidemics
◆ Civil wars
◆ Transportation shortages
◆ Resource availabilities
◆ Digital and energy system instability
◆ Cyber crimes
◆ Currency fluctuations
◆ Accident, Fire, Explosion scenario
◆ Population growth
To overcome those risk potentials, JRS Pharma provides solutions optimized for individual customers’ global supply chain needs for pharmaceutical and other related industries. They offer a perfect high level partnership, combining synergies and advantages of a global manufacturing concept – based on standardized and quality regional production facilities:
Excellence in MCC know-how
JRS Pharma is one of the largest manufacturers of MCC across the globe. The know-
how is based on more than 25 years of experience in development of own processes. JRS innovated and improved these processes with advanced and specially designed equipments. It gives much better control, excellence and reproducibility of the process, end-product resulting in consistent quality.
Reliable
premium quality
Strict control on input raw material source, quality and other parameters also play important role on output consistency. The compliance with global compendial monographs and additional internal specifications, such as TUPs and high degree of brightness are tested by local quality control labs.
Technical support
In addition to these, JRS Pharma’s two Technical Competence Centers (TCC) carry out functionality and performance testing on our excipients periodically. In collaboration with TCCs, five regional application labs provides in-time technical support and advice. Regionally placed technical and sales representatives get in touch with respective customer departments and assist them to fulfill their requirements too.
Industryleading Supply
security
Being one of the leaders in MCC manufacturers is enabled by multiple units located scattered across the world. Flagship MCC brands VIVAPUR®, EMCOCEL® and FLOCEL®
Plus are manufactured at multiple production sites in three different continents follow standardized German production process technology. This regional manufacturing concept allows faster regional access and ensures optimized supply chain security. It also eliminates risk of supply due to plant maintenance or shutdown due to unavoidable circumstances or accident.
Cost-effectiveness
Regional manufacturing helps to offer better pricing to local customers as it minimizes duties, currency conversion and freight costs.
Better customer service
JRS Pharma has its presence in almost all regions by either having their own sales office or through efficient channel partner. It enables customer service in regional time zone and avoids response gaps.
Customized solutions
In case of specific customer needs, JRS Pharma can support new business initiatives
with tailor-made solutions. Time-to-time, they also come up with new grades to meet arising needs of the industry. Recent one in this line is PROSOLV® 730, which is MCC based high-functionality adsorbent.
SUMMARY
As a dedicated global solution provider, JRS Pharma meets all needs for excellent support and service –
◆ Technical assistance
◆ Worldwide logistics and warehousing
◆ Local sales offices with dedicated customer service
◆ Certified quality and regulatory system
◆ This helps to make business life much easier and more secure.
AUTHOR Krishnakumar Patel Technical Services, JRS Pharma, India Krishna.Patel@jrsindia.com
PHARMA PULSE
Protect Your facilitywith Sectional Overhead Doors: Unrivalled Safety,Thermal Insulation,and Soundproofing
Sectional overhead doors offer numerous benefits for commercial buildings, making them an excellent choice for both retail and industrial settings. These doors consist of multiple panels connected by hinges, allowing the door to bend/slide and open vertically. When fully opened, the door rests parallel to the ceiling, maximizing space both
Porto and Max Vista models, are designed for industrial and commercial buildings. They are available in multiple operational versions: manual pushpull, electrically operated, and chain-hoist operated by pulling an endless chain. This flexibility ensures our doors meet the diverse needs of various applications.
Additionally, both models
are offered with different lifting systems tailored to the available overhead space. The sliding system options include normal lift, high lift, vertical lift, low headroom lift, and inclined lift, providing optimal solutions for every setting.
◆ Porto Sectional Overhead Doors seamlessly blend with any architectural style. They are easy to use, quiet, and reli-
inside and outside the building. This design is ideal for a variety of environments, including industries, warehouses, retail stores, and service centres, where efficient space utilization and accessibility are crucial.
Sectional Overhead Doors by Gandhi Automations are renowned for their reliability and durability. We engineer them to withstand rigorous use while providing excellent thermal insulation and soundproofing. Customizable to fit a range of opening sizes and designed to meet high aesthetic standards, our doors enhance the appearance of your facility while contributing to long-term cost savings. Their robustness and energy-efficient features make them a smart investment, ensuring both operational effectiveness and financial benefits over time.
Our range of Sectional Overhead Doors, including the
able. Built with pre-painted, galvanized steel and 40 mm thick sandwich panels, they ensure robust protection and energy efficiency.
◆ Max Vista Sectional Overhead Doors combine aluminium panels with special glazed panels enhancing natural light, grilled, or meshed windows for a distinctive look. These doors provide ample
hanced comfort
◆ Bright indoor environments and attractive design aesthetics
◆ Constructed from prepainted, galvanized steel with a 40 mm thick sandwich panel
◆ Equipped with special nonaging rubber gaskets that seal the perimeter, preventing water, air, and dust infiltration
◆ Customizable as Gas Tight
natural light, creating a bright and pleasant work environment. They are durable and visually appealing, suitable for various commercial and industrial applications.
Key Features of Our Sectional Overhead Doors:
◆ Reliable and low-noise operation
◆ Extreme robustness for longlasting use
◆ Includes safety features in accordance with EN 13241-1 CE, including finger trap protection between the door panels to avoid the risk of fingers being pinched, and side trap guards where the side frames are completely closed to prevent injuries.
◆ Design-oriented surfaces and optimal light solutions
◆ Minimal bulk, providing more usable space indoors and outdoors
◆ Easy and practical to open and operate
◆ Energy savings and en-
Ripening Room Doors
◆ For easy access for people and small transport vehicles, a side door or pedestrian door can be provided to reduce the number of times the door is operated, making it energy efficient.
◆ Opening-closing speed: 0.2–0.4 m/s
◆ Available sizes: Width up to 15,000 mm, Height up to 10,000 mm
Sectional Overhead Doors by Gandhi Automations are the ideal solution for all industrial and logistic needs.
For more information, Contact: Gandhi Automations Pvt Ltd. Chawda Commercial Centre,Link Road, Malad (W), Mumbai – 400064, India.
Tel: +91 22 66720200 / 66720300 (200 lines)
Fax: +91 22 66720201
Email: sales@geapl.com Website : www.geapl.com
PHARMA PULSE
Truth Gas Tight syringe instrument
Truth Gas Tight syringe instrument - A gas-tight instrument syringe isa precision tool designed for ac-
curate and repeatable injection of both gases and liquids into various instruments, especially those used in gas chromatogra-
phy (GC) and other analytical techniques.These syringes are engineered to create a leakfree seal, ensuring the integrity
of the sample and the reliability of the analysis.
Feature –
◆ For Parallel Sampling
◆ Withdrawal & Dosage in Multi Syringe Pumps For Dis-
◆ Wetted Materials: 3.3
Borosilicate Glass, PTFE, Stainless Steel
◆ Accuracy / Precision +- 1% of total volume
◆ Pressure Up to 200 PSI Calibration Certificate on Request
For Precision Dosing in Fields of
◆ Chromatography
◆ Industrial Instruments Diagnostics
◆ Medical Inspection
◆ Biochemical Field
Top Syringe exports its products to over 40 countries worldwide and counting, keeping a single quality standard for local and export products.
The Instrument Gas Tight syringe is manufactured 100% in India by Top Syringe Mfg Co (P) Ltd. We are fully committed to supporting you with our full product range, spares, and technical assistance.
For more information, Contact:
Top Syringe Compound, W.E. Highway, Pandurangwadi, Mira road (East), Thane 401107 India. Mob: 81046 82560
REGD.WITH RNI NO.MAHENG/2005/21398,POSTAL REGD.NO.MCS/164/2025 – 27,PUBLISHED ON 5TH EVERY MONTH, POSTED ON 9TH,10TH,AND 11TH EVERY MONTH POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE,MUMBAI – 400001
