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CONTENTS
POLICY EVENTS
14 AMPLELOGIC CELEBRATES AL IDEATHON 2024
16 TOWARDS A HEALTHIER,MORE EQUITABLE AND INNOVATIVE INDIAN HEALTHCARE SECTOR
INTERVIEW
P18
SUNEELATHATTE
VPAND HEAD - HEALTHCARE R&D FOR INDIA,MERCK KGAADARMSTADT
MARKET
24 GREEN MANUFACTURING IN PHARMA: SUSTAINABLE OLIGONUCLEOTIDE PRODUCTION ON AN INDUSTRIAL SCALE
TECHNOLOGY
26 OPTIMISING SPEND, MAXIMISING GROWTH
Regd.With RNI No.MAHENG/2005/21398.Postal Regd.No.MCS/164/2022 - 24.Printed and Published byVaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press,Plot No.EL-208,TTC Industrial Area,Mahape,Navi Mumbai-400710 and Published at Mafatlal Centre,7th floor,Ramnath Goenka Marg,Nariman Point,Mumbai 400021.
Quality was once again in the spotlight at two recent industry meets. While regulators kept their sights on raising the compliance bar, industry chiefs pledged adherence to these codes. Not surprisingly, most speakers focused on the importance of trust.
At the Indian Pharmaceutical Alliance's (IPA) virtual 9th Advanced Good Manufacturing Practices (GMP) Workshop Dr Rajeev Raghuvanshi, Drugs Controller General of India, CDSCO, Government of India commented, “At the heart of the pharmaceutical industry lies one unwavering principle: Quality. It’s not just a goal; it is the foundation of our global leadership, and the trust placed in us. The world is increasingly looking towards India, not just for our contributions to generic medicines, but for our growing leadership in advanced areas like biologics, medical devices, and digital health.”
Nilesh Gupta, Chair, Quality Forum, IPA and Managing Director, Lupin spoke about how "our industry’s reputation, and more importantly, the trust of millions of patients worldwide, are built on the cornerstone of quality. It is encouraging to see that the Indian pharmaceutical sector is making significant strides towards becoming a global benchmark for quality through capability building, process improvements, talent development, digitalisation, and fostering a quality-first mindset.”
A few days later, IDMA's 23rd Pharmaceutical Analysts Convention (PAC), had the theme: "Quest for Sustainable Quality - IDMA Leads the Way."
Chairing a session titled, CEO's Vision on Sustainable quality, Mehul Shah, honorary Secretary General, IDMA and CMD, Encube Ethicals alluded to the ''power of compounding" in India's pharma industry but also made the point that quality is a challenge, unless the sector transitions from reactive to proactive regulatory compliance, both seen and unseen. Therefore if companies demonstrated a quality mindset on a voluntary basis, it would build trust.
Bhushan Akshikar, MD, GSK Pharmaceuticals India's comment that the company's 100 years in India landmark coming up this November, is because the company is now not just "a trade mark but a trust mark" made the point that trust requires time
It is considerably more difficult to live up to these professed codes of conduct off stage,as it needs to flow right from the CEO/promoter to every employee at every location of the company
to build up, but also needs consistency through the decades.
Dr Viranchi Shah, national president, IDMA and Director, Saga Laboratories’s comment about the need for "smart/optimal regulation" as "under regulation puts patients at risk, over regulations could weaken industry" reiterate the need to balance the economic viability of compliance measures with patient safety. Mid-size companies have often seen more stringent regulations as an unfair business practice, as it strains their resources, while larger counterparts can absorb compliance related capex much better.
Pranay Godha, MD, & CEO, IPCA's analysis that "the quality journey is about leaders asking uncomfortable questions ...seeking discomfort. The standards that you walk past, are those that you accept " also struck a chord with the audience.
But it is considerably more difficult to live up to these professed codes of conduct off stage, as it needs to flow right from the CEO/promoter to every employee at every location of the company.
DCGI Raghuvanshi summed it up best when he advised, "Quality should be at the core of strategy. The moment we shift from quality to profitability the company suffers. Quality is not episodic, it should be part of the DNA of the company. Quality is one of the ingredients of the product. Due to competition, we have started compromising quality with cost. It is actually a fight between Saraswati (the goddess of knowledge) and Lakshmi (the goddess of wealth). Keep Saraswati in front, Lakshmi will follow. It is never vice versa. Keep quality in front, profits will follow."
That is an apt message to reflect on this Deepavali . The Express Pharma team wishes all readers a happy and safe Deepavali. May the light of knowledge mark our continuing journey along the path of quality affordable medicines.
The event focused on Reshaping Lifesciences Operations by offering a global platform for the exchange of innovative ideas and collaboration in the life sciences industry
AmpleLogic achieved a significant milestone by successfully hosting AL Ideathon 2024 on September 28th at Novotel, Hyderabad. The event focused on Reshaping Lifesciences Operations by offering a global platform for the exchange of innovative ideas and collaboration in the life sciences industry. By gathering leading experts from the pharmaceutical sector, AL Ideathon 2024 highlighted the need for adopting advanced technologies to drive progress and uphold India’s reputation as the "Pharmacy of the World".
As India continues to be the global leader in pharmaceutical manufacturing, it becomes crucial for the industry to integrate advanced digital solutions, automation, and artificial intelligence to enhance pharma operational efficiency, regulatory compliance, and product quality. AL Ideathon 2024 was a strategic move in this direction, offering participants a unique opportunity to showcase ideas that could revolutionise pharmaceutical manufacturing and quality management.
Indulge in digital transformation in pharma One of the central themes of AL Ideathon 2024 was the digital transformation of pharmaceutical operations. Esteemed leaders from the industry emphasised the need for technological integration to streamline processes, ensure compliance with regulations, and boost productivity.
Sauri Gudlavalleti, COO of Sai Lifesciences Limited, highlighted the significance of a digital culture in pharma, stating that digital intervention is essential to ensure quality and accuracy while fostering innovation. He further elaborated on how technologies such as data visualisation applications, data management software,
and analytical systems can optimise workflows. His perspective aligned with the broader industry shift towards leveraging technology to enhance operational efficiency, a trend that pharmaceutical companies are increasingly embracing to stay competitive.
Gudlavalleti also drew parallels between the pharma industry and other sectors like semiconductor manufacturing and automotive industries, where technology has been successfully implemented to achieve substantial process improvements. By adopting these proven technologies, the pharmaceutical sector can address key challenges related to quality, efficiency, and compliance.
Navigating pharma challenges and future trends
Bhaskar Reddy Pabbatireddy, Plant Head of Hetero Drugs Limited, took the stage to address the challenges facing the pharmaceutical industry today. He identified five critical pain points of the industry: human errors, root cause investigation, lack of customer feedback, process concerns, and cleaning
and hygiene issues. These challenges, if left unaddressed, could hinder the growth and innovation potential of pharmaceutical manufacturing.
Pabbatireddy offered actionable solutions, advocating for the implementation of Quality Management Systems (QMS), Manufacturing Execution Systems (MES), and CAPA (Corrective and Preventive Action) tools to mitigate these challenges. These systems, he explained, play a pivotal role in ensuring compliance with key regulations, including the US FDA 21 CFR Part 11 and Good Manufacturing Practices (GMP), which are essential for maintaining product quality and safety standards.
He also delved into specific techniques for addressing Outof-Specification (OOS) and Out-of-Trend (OOT) issues in pharma. Techniques such as the 5 WHY’s, Pareto Analysis, and Fishbone Diagram were recommended for Root Cause Analysis (RCA) to help manufacturers identify and resolve process deviations, thus
improving overall product quality and operational efficiency.
AI: The game changer for pharma manufacturing
The integration of Artificial Intelligence (AI) into pharmaceutical manufacturing was another highlight of AL Ideathon 2024. Ranjit Menon, Site Director at AL Shifa Pharma, and Dr C.V. Lakshmana Rao, Executive Director of Quality at Laurus
Labs, shared their insights on how AI is transforming the industry.
AI’s potential to revolutionise pharma production by improving accuracy, reducing human intervention, and ensuring regulatory compliance was a focal point of their presentations. Both speakers emphasised that AI-driven solutions are not just a future trend but a current necessity for pharma companies looking to enhance their production processes. With AI’s ability to analyse large datasets, automate complex tasks, and predict outcomes, pharmaceutical companies can unlock new levels of efficiency and compliance, ultimately driving cost savings and product innovation.
Empowering keynote address byDr Chava Dr Satyanarayana Chava, Founder & CEO of Laurus Labs, served as the Guest of Honour and delivered a keynote address on the importance of compliance and Good Manufacturing Practices (GMP) in the pharmaceutical industry. He praised AmpleLogic for launching the AL Ideathon,
Inauguration of ALIdeathon 2024
Felicitation of Dr Satyanarayana Chava,CEO,Laurus Labs byMr Manne V.Chowdary,CEO,AmpleLogic
recognising it as a bold step toward fostering a culture of innovation and collaboration.
Dr Chava's address emphasised the significance of staying ahead of the curve by adopting new technologies to meet evolving regulatory requirements and maintain the highest standards of product quality. His insights were a testament to AmpleLogic’s vision of shaping the future of pharma through digital transformation and technological innovation.
“One vendor,one platform,multiple solutions”
In a powerful keynote address, Manne V. Chowdary, Founder and CEO of AmpleLogic, introduced the concept of One Vendor, One Platform, Multiple Solutions. He elaborated on the transformative potential of Application Platform as a Service (aPaaS) and how it can streamline operations across various domains, from manufacturing execution to quality management.
By offering a comprehensive platform that integrates Manufacturing Execution Systems (MES), Quality Management Systems (QMS), and other critical software solutions, AmpleLogic is positioned to drive substantial improvements in operational efficiency, compliance, and product quality. Chowdary’s vision for the future of pharma is clear: a unified platform that enables seamless operations, ensuring that companies can meet regulatory standards while maintaining high levels of productivity.
Acelebration of innovation and excellence
AL Ideathon 2024 was designed to foster a spirit of creativity and forward-thinking within the life sciences industry. With registration opening in August, the event invited submissions of innovative ideas across four key categories, receiving over 544 proposals from across the globe. Out of these, 201 ideas were considered, and 89 ideas finally made it into the evaluation process that took place
between 20th to 23rd September. In total, 14 exceptional ideas emerged as winners for AL Ideathon 2024.
The esteemed jury members
AL Ideathon 2024's success was made possible by the contributions of a distinguished jury panel consisting of industry experts who evaluated the submissions. The jury included Dr Antony Raj Gomes, Head of Global OSD and API Quality, Viatris; Hemant Kulkarni, AGM - Quality Assurance, Serum Institute; Ranjit Menon, Site Director, AL Shifa Pharma; Anwar Sulaiman, VP - Quality, Apitoria; Dr Debabrata Sanyal, Group HeadDigital Automation, MSN Labs; Sauri Gudlavalleti, President, Sai Life Sciences; Hemanth Panasa, Vice President, Cipla; Parimal Brahmbhatt, Head – CQA, Unison Pharmaceuticals; Amar Padmanabhuni, Joint Managing Director, Meenaxy Pharma; Rajesh Kulkarni, Cluster Quality Head, Sun Pharma; Dr Routhu Srinivas, Plant Head, Immacule Life Sciences Pvt Ltd; Karan Sharma, Head of IT, Saurav Chemicals Limited; Milind Gujar, VP Chief Quality, RPG Life Sciences and Sanjay Pathania, Associate Vice President, Tirupati Group. Their expertise played a crucial role in identifying the most
promising ideas that have the potential to transform the future of the pharmaceutical industry.
Recognising the trailblazing innovators
The event culminated in the celebration of groundbreaking ideas and technological solutions. Anurag Aniruddha Gokhale took home the Golden Innovation Award along with a cash prize of Rs 3,00,000 for his innovative idea to Integrate Voice Search Technology into QMS and DMS. His proposal aimed to improve user interaction and compliance by leveraging voice technology, making it easier for employees to access and manage critical documents.
Shailendra Gupta received the Silver Innovation Award and a cash prize of Rs 1,50,000 for his idea of Implementing AI in Outof-Specification (OOS) Investi-
gations, enhancing the process by automating data collection and improving overall efficiency.
Manoj Mathur was honoured with the Department Dynamo Award along with a sum of Rs 43,000 for his idea on Digital Integration and Predictive Analysis in Regulatory Affairs.
Honouring the Top 10 Innovators
Additionally, ten remarkable innovators were honoured with a cash prize of Rs 25,000 each for their impactful contributions. The winners included Sandeep Haribhau Shirke, Satyanarayana CHVV, Yendru Veera Raghava Chowdary, Deepjyoti Das, Ravindrakumar Paliwal, Devalla Anil Srikanth, Anuj Pandey, Pravin Bhatkulkar, Lingaraju BS, and Sachin Bhandari. These innovators presented groundbreaking ideas that promise to signif-
icantly impact the future of the pharmaceutical industry. A Special Award was given to Smruti Rajan Nanda for his exceptional idea that resonated with the judges.
Future Forward: AL Ideathon 2025 in Mumbai
Building on the immense success of AL Ideathon 2024, AmpleLogic is already planning AL Ideathon 2025, which will be held in Mumbai. The upcoming event is expected to be even more impactful, with a focus on addressing new challenges, fostering greater collaboration, and driving technological advancements in the pharmaceutical industry. By continuously fostering a culture of innovation, AmpleLogic aims to remain at the forefront of digital transformation in the life sciences sector.
(Advertorial)
JuryMembers and ALIdeathon Winners
POLICY
Towards a healthier,more equitable and innovative Indian healthcare sector
Rishabh Bindlish,MD & Partner,Co-leads Boston Consulting Group Healthcare practice in India and Ayushi Shukla,Senior Knowledge Analyst,BCG highlight that the government needs to pave the way for a healthier,more equitable future with strategic investments and policy reforms
In the past few years, the Indian government has strengthened its focus and allocation to healthcare. The Union Health Ministry received an allocation of about Rs 90,650 crores in the recent budget of 2024-25, a 12.5 per cent increase over 2023-24. Specific highlights of the budget for the sector include an increase in outlay for research and development and for the A yushman BharatPradhan Mantri Jan Arogya Yojana (PM-JAY) , the government's universal health coverage scheme, which saw a 10 per cent budget increase to Rs 7,300 crores. Other announcements include benefits for cancer patients and changes in custom duty for components of X-Ray machines to encourage local manufacturing and competitiveness.
There is, of course, more to be done to address the sector's urgent needs and reshape India's healthcare and pharma landscape.
Strengthen health infrastructure and reach
Currently, India’s health expenditure stands at 2.1 per cent of GDP and it has to increase to at least 2.5 to 3 per cent of GDP. Higher expenditure would be pivotal to strengthening healthcare infrastructure, particularly in rural and underserved areas, and fulfilling the increasing demand on healthcare resources in the country amidst an ageing population, increasing disease burden and a growing incidence of NCDs and lifestyle diseases.
The increased funding for Ayushman Bharat is a definite step towards moving closer to universal health coverage, and such coverage should in-
clude modern treatments such as TAVI/ TAVR involving valve implantation or replacement. Focus also needs to be laid on strengthening the insurance systems to improve the reimbursement mechanisms and deepen the involvement of the private health sector. Going forward, policies promoting MedTech innovation, R&D incentives, and digital health infrastructure development will be crucial for improving patient care and operational efficiency, especially fulfilling requirements in rural areas.
The pharma sector has been an important focus point in recent years, with several targeted initiatives to strengthen the domestic manufacturing landscape and make India self-reliant. The increase in R&D outlay is a welcome step. A continued thrust towards streamlining production
linked incentive (PLI) schemes, incentivising indigenous R&D in advanced manufacturing technologies, and novel chemical entity (NCE) research are needed to further grow the sector. Establishing Centers of Excellence and leveraging artificial intelligence for pharma research can advance India’s capabilities in NCEs, biologics, and biosimilars, placing it at the forefront of global pharma innovation.
Enable global competitiveness
The MedTech sector aspires to reduce import dependence and become globally competitive. There needs to be a phased reduction of customs duties, improving export incentives under schemes like Remission of Duties and Taxes on Exported Products (RoDTEP) and strengthening the Production Linked Incentive (PLI) to foster local manufacturing and innovation. Reducing import duties and lowering GST on locally procured raw materials for critical medical devices can make treatments more affordable and encourage local manufacturing and innovation. Additionally, regulatory frameworks that facilitate innovation while ensuring patient safety are essential, emphasising streamlined approval processes for MedTech startups.
Enhance accessibility, affordabilityand preventive care
On the hospital front, there is a pressing need to alleviate the urban-rural divide in healthcare accessibility and affordability. Bridging this disparity would require a multi-pronged strategy of infrastructure development, workforce enhancement, and leveraging digital technologies effectively. Enhanced funding for rural healthcare infrastructure and encouraging public-private partnership models in healthcare delivery could be a positive step in the right direction. Additionally, manpower shortage would have to be addressed by developing focused training programs to enhance the skillset of the existing workforce and establishing more medical and nursing colleges to bridge the manpower gap.
The growing incidence of
Acontinued thrust towards streamlining PLI schemes,incentivising indigenous R&D in advanced manufacturing technologies,and NCE research are needed to further grow the pharma sector
non-communicable diseases (NCDs) also calls for measures to promote the adoption of preventive health screenings and the adoption of alternative healthcare services dedicated to preventive care and the management or reversal of chronic conditions like diabetes. Increased funding for infrastructure and accessibility in preventive healthcare is required along with fiscal incentives to promote the adoption of preventive health checkups and genetic testing. Genomics plays a crucial role in disease management and treatment, necessitating public awareness, government support, and robust regulation. Also required is a reduction in GST to stimulate consumer spending in diagnostic services, making these essential services more affordable and widespread.
The alternative healthcare sector is primarily catered to by startups developing apps integrating health with technology. A reduction of 18 per cent GST on such services can promote the adoption of such integrative health technologies. The startup sector also seeks privileges such as property tax exemptions, better access to debt funding, etc. to foster innovation in the sector.
In conclusion, there are multifaceted needs in India's healthcare and pharma sectors, and a conducive environment is required to enable their growth. With strategic investments and policy reforms, the government can pave the way for a healthier, more equitable future. This comprehensive approach will not only enhance the nation's healthcare infrastructure but also foster innovation, making India a global leader in medical research, diagnostics, and treatment.
Rishabh Bindlish
Ayushi Shukla
INTERVIEW
Data and digital is a force to reckon with when it comes to India
In a recent interview, Suneela Thatte,VPand Head - Healthcare R&D for India,Merck KGaA Darmstadt discussed the evolution and strategic significance of the company’s Global Capability Center (GCC) in India,established in 2020.She highlighted that while the GCC was initially set up for cost savings in drug development,the focus has shifted to harnessing India's vast talent pool, particularly in the scientific and medical fields,in an interview with Viveka Roychowdhury
India seems to have become a hub for pharma GCCs. Merck too set up its GCC in India in 2020. Was the strategy any different, given that it started a couple of years later than other pharma GCCs?
We see GCCs coming to India mainly for talent today. In all companies, Merck included, our initial thought process was to take some activities to India that allow us to save some costs as drug development is a very, very costly affair.
With a long gestation period. Yes, exactly. You have to also account for the fact that you know not all drugs that you develop are going to make it. Essentially, the whole thought process was, let's kind of create this as a saving case whereby we then plough that money back into our R&D and we can then have more shots at the goalpost, with more drugs in development.
But very quickly the organisation realised that it's not just about the savings. There is huge untapped talent here, especially in the scientific and medical field. Therefore, the strategy needs to encompass a more holistic strategy whereby we get the hub to be part of the strategy. The R&D strategy has to be front and center to the hub and vice versa. We thought that we have to look at it from the point of view of going beyond the traditional “GCC rules.”
Therefore we started building more centers of
excellence. I would say that this journey happened fairly quickly for us and we realised early on in the game, that if we have to really get disproportionate value out of the hub here, then we have to move very quickly into more technical, more strategic, more decision making rules and we are on that journey. Have we reached our destination? Not quite. but I
think we are moving in the right direction. We have created some centers of excellence already. We are trying to see how we can constantly upscale our talent so that when these senior level roles come to India they will be well positioned to step into that role. If you look at our overall strategy too, we have invested a lot into developing the
talent. The thought process was that this is a place where you have a lot of talent that can be groomed easily to work in a global setting and how can we get in here and leverage that talent.
This has been the journey since we started in a small way in 2020 in Bangalore. Every pharma company was looking at either Bangalore or Hyderabad but since we were
familiar with Bangalore where we had our IT services centre, we started there. We realised there is tremendous talent available here and we can really zoom into really bigger and better.By 2021, we grew further in capacity and capabilities as a team. It was a 15–20-member team when we started in 2020. By the time I joined in 2021, we were about 100 people. Today we are close to 500 people, so it's been a 5X scale up in three years.
It's been an interesting journey and our philosophy has been to invest in the talent and let's see how we can make the talent more global in the approach, whether it is working on a project or an initiative or delivering to a set of KPIs or SLAs.
We also expanded into many many things. We started mainly in certain regulatory roles, which can be easily centralised. Like regulatory submission management etc.
But then we added pharmacovigilance, certain functions in clinical trial management, biostatistics, clinical measurement sciences, and some R&D strategy roles.
You mentioned that at the Merck’s GCC in Bengaluru, you are making the talent more global in the approach, which would mean you are getting global best practices into your GCC.How are you doing this?
Our approach has been that we never treated India as an off site. The remit was that we
(the Bengaluru GCC) are part of global R&D and my message to people always was whether you are sitting in Bangalore, working remotely from any city in India, based in Germany, or the US, we work only to one standard.
What I have seen some GCCs doing is they treat the offshore locations like an internal vendor and the service level agreements (SLAs) and KPIs for the GCC are what you would typically have for your vendor.
The SLAs and KPIs we followed are exactly the team sitting anywhere would be following so there was no option but to be compliant with all the global norms with no process deviations. We didn't encourage that right from day one. The message is your work is location agnostic, you are working for a global organisation as a part of global R&D. There is only one standard that we work to and that's our global standard. We groomed our people right from day one from that point of view.
In addition to technical training, we also did a lot of cultural integration training because German culture and Indian culture are different. Letting people here know how to deal with stakeholders in other nations and vice versa is part of this training. It's good to know that people are taking the cultural angle very seriously. I think this is very important for every GCC because while it's the same process, SOP, and technology, people are people at the end of the day. How you read a piece of paper and assimilate it can vary from how I am doing it. The interpretation can vary due to my cultural background. Getting that kind of an integration was very important. That has helped us a lot also.
What I feel very strongly about, and we did this in Merck, is that when you are working for a clinical trial, you very easily develop a sense of purpose. You go to the hospitals, and even if you don't see the patient yourself, you are reading patient records.
You get involved with the journey of the patient. Though you have never seen a patient you start feeling happy when the patient is improving. If the patient has any adverse event you also get as worried as them. Therefore, the sense of purpose comes in.
But in a GCC, in an office many steps removed, you are removed from the clinical reality. We did a lot of things to develop that sense of purpose. The first thing was having a vision statement which said that our vision is to leverage the talent and technological advances in India to contribute to Merck's R&D efforts so that we can bring more medicines to more patients faster. We were very particular about the patient angle.
People may not be dealing with patients, but somebody who is doing case processing of an adverse event, must not look at it only as a document to fill in data. Having that sense of purpose has also helped us in terms of employee engagement. People get a better appreciation of how their work can impact so many other steps.
In fact we also tied up with a hospital in Bengaluru. We deal with clinical trial data all the time, but if you want to understand how a hospital works in a clinical trial, we need to go and talk to clinical trial coordinators to see how a day in their life looks like, when a patient comes for consenting, to understand what they have to go through. We encourage our people to do that on a voluntary basis. Many people came forward. You develop a more holistic angle.
I think these things have helped us. We also focus big time on upskilling, not just looking at the technical skills. In every GCC 90% of your population will be individual contributors. While everybody talks about managerial training, (but what about) the effectiveness of an individual contributor?
I don't think people want to measure it at the end of the year. That also has to be built
and you need training. So we also have programs focused on personal effectiveness, simple things like communication, planning prioritisation, presentation skills etc. It's an investment but it pays off and it's much better to do this investment and give that sense of development to people.
If you just go after experienced people, that's not a very sustainable strategy. These things have helped us tremendously.
The general view is that GCCs replace jobs from other more expensive locations like Europe. We have seen a lot of pharma companies laying off staff, while hiring at their GCCs. Merck itself went from 5x in three years. Is that a concern or is that the reality?
I would say yes and no. The starting point was cost arbitrage but it did not stop there. You are following the IT model of BPO. Pharma went actually little ahead of the IT model of a BPO because in pharma, that value creation can be much more significant.
People started building teams here and obviously when it was cost arbitrage, jobs in the more ‘expensive’ geography had to be replaced but then consider that India is a large demography that needs to be represented in clinical trials and research.
India is a talent hub of the future given the demographic advantage and focus on skill building.You look at the number of MPharms, PhDs, medics that India churns out … you know that's phenomenal. India has over 400,000 pharma students that graduate every year in India. India produces roughly 70,000 to 80,000medical graduates with an MBBS degree each year.This estimate is based on the total number of seats and the typical graduation rate.India produces slightly over 24,000 doctoral graduates each year.
The typical geographies which are declining demographically cannot
match it. So people realise that typically the access to talent in India is unmatched. Plus everybody speaks English. A medic in India has done all her education in English.
This is a language you use for dealing with the officials, whether it is regulatory authorities, whether it is office permissions and all that. That kind of global mindset because of the language advantage was already present here. So then people started seeing centralisation opportunities.
Centralisation always helps any process. This is very agnostic not just limited to pharma.
What started as a cost arbitrage very quickly moved on and people said okay maybe I don't have to actively lay off people in my other geographies but if my build up has to happen this is where it will happen because it's easier to get the talent I want. I pull the right levers and the talent will stay.
Every GCC faces one challenge. When you look at typical European companies, the attrition is in single digits. In some companies, people join and they will only retire from that. That's the very European mindset.
Here it's not like that. But there are ways in which it can be managed. They realise that and that's where now the growth in GCCs is not dependent on layoffs in other locations.
That has been disconnected now. People now are growing here because you have centralisation opportunities. You can also run your transformation projects easily. Bengaluru is a very nice sandbox environment, when you run transformation projects like process improvement.
Given the sheer cost of drug development or the kind of regulatory compliance we have to maintain for established products in pharma, You have to constantly think how to improve processes because otherwise your cost of operation will just go up. So
GCCs provide a very nice sandbox environment where these initiatives can be piloted.
These advantages have started playing out. What has also helped is what's happening in India today on the digital front and the digital innovation that we are seeing as a country. That is not limited to just things like GPay and other things that we do. The data and digital is again a force to reckon with when it comes to India.
If I'm going to have the digital capabilities, AI ML competencies are going to be good here and then I have the transformation and centralisation opportunities. This is the main reason.
Should you measure cost arbitrage? The answer is definitely yes because money matters at the end of the day. But that's not the primary reason. It's more of a secondary outcome.
Do the policies in India support this environment that Merck would like here? The GCC and beyond GCCs? I think the policy definitely supports the general focus on talent. If you see, there's been so much focus on education in the last few years. The number of IITs, IIMs, AIMs, NIPERS, have only gone up and they have grown. For so many years, we used to have one AIIMS. But now you have so many AIIMS. Similarly for IIMs. Generally, there is that understanding which is very much in line with Indian philosophy. When we are saving money, our thought process is that I'm saving this for my children's education. But that goes very well with the talent pool that GCC needs. There are enough opportunities today supported by the government. The private organisations have also played their role. There are so many private universities which are offering very good, cutting-edge courses today.
The education scenario and the focus of government, semi-government and the private sector is on improving
November 2024
INTERVIEW
the quality of education. We see so many collaborations with the likes of Harvard here, which was never the case a few years ago.
That has helped GCCs tremendously.
What needs to happen in my view, is that organisations have to really come forward and bring this to the fore, and probably there has to be some incentive. Organisations today are doing it because there is a talent arbitrage. There is also cost arbitrage which is not going to go away ) given the currency exchange factor and the inflation in other countries versus inflation in India etc.
But it would be foolish of us to think that no other country will also be where we are
today. For example, the Philippines is coming up very strongly as a global services hub. There is no reason why tomorrow they cannot be a talent hub.
The same scenario that the IT sector is facing today. Exactly. They are going to South Africa, Mexico and all that. Even from a science point of view, there will be compelling locations.
Organisations will also want to do it. Again, it is not the right strategy to put all your eggs in one basket.
There has to be something to incentivise organisations to use India extensively for their global talent needs. What that incentive is, I think that the
industry needs to come together and think through. But our approach is always very reactive.
If there has to be one thing that the GCC industry has to do proactively is to start thinking about what incentives an organisation can get, apart from the standard benefit of talent. That is important in my view. State governments are doing a little bit of that.
The Telangana government, for example, I believe has set up a GCC centre.
State governments are doing this because this is a job creation opportunity. A lot of state governments are looking at it like any CEO of a company. Which is good.
I think Kerala and Andhra Pradesh are doing this. We will see a clear differentiator where that support is there. You will see GCCs thriving there.
People will benefit because ultimately companies are there for talent. We also talked about India's digitech infrastructure. Digital innovation is going to impact drug development and the role of AI in drug development. It's not going to be limited to headquarters today.
So the GCCs will very much be part of that digital journey.
When you talk about the work that the GCC is doing, is it work on innovative
technologies or is it still the generic part of it? What is your perspective?
Our team supports not just our established products but also our products in the pipeline. And I think this is the journey that every GCC goes through. You initially start with ‘low risk’ and then you gradually up the game. The other thing that we are really looking at is in terms of digital innovation, data and digital strategies. How can we really utilise the expertise in India? We are not keeping ourselves really limited to just doing the standard centralised roles but creating centres of excellence.
viveka.r@expressindia.com
vivekaroy.3@gmail.com
November 2024
MARKET
Green manufacturing in pharma: Sustainable oligonucleotide production on an industrial scale
Philipp Markolin,Scientific Marketing Manager at peptide and oligonucleotide manufacturers
Bachem,shares their expertise on sustainable production methods in the pharma industry
Oligonucleotides are at the forefront of modern medicine, and have emerged as powerful tools in treating diseases in recent years. Oligonucleotides – short DNA or RNA molecules that host a range of applications in genetic testing, research, and forensics – have seen a marked growth in significance as therapeutics. As their clinical application widens, methods of production must be robust to ensure demand is met.
Demand for oligonucleotides in medicines is steadily increasing, with a pressing need for an eco-friendly manufacturing process which satisfies green manufacturing standards without compromising yield or process efficiency. Thus, the responsibility lies with manufacturers to ensure end users receive their medications, while striving for sustainable production methods.
The importance of sustainable oligonucleotide synthesis
The need for sustainability in oligonucleotide manufacturing is increasing rapidly, driven by the growing use of these therapeutics to treat a diverse variety of conditions. With the oligonucleotide and peptide therapeutics market projected to grow at an annual rate of 17.5 per cent through 2030, the industry faces significant challenges such as high production costs, waste, and energy-intensive processes.
With new oligonucleotidebased drugs being approved for development on a regular basis, the need for affordable and eco-friendly methods of
November 2024
production becomes more urgent.
The benefits of green manufacturing are twofold: sustainable practices help reduce environmental impact, but also address economic and regulatory demands, leading to improved efficiency and accountability.
What steps can pharma manufacturers take to improve sustainability?
Advancements in green manufacturing technology by innovators have seen sustainable production become widely accessible across the pharmaceutical industry. By prioritising cutting waste, promoting
recycling, process efficiency, and inn ovation of synthesis methods, manufacturers can reduce both their environmental footprint and production costs.
1. Reducing waste and boosting recycling
The purification process in manufacturing oligonucleotides can be a costly process. It can produce high levels of waste and detrimental environmental impacts if not carried out in line with the latest technological developments to mitigate these effects. Techniques such as Multicolumn Countercurrent Solvent Gradient Purification (MCSGP), developed by
Bachem, mark a major advancement in sustainable production. By continuously recycling mixed fractions, solvent consumption can be reduced by over 30 per cent in comparison with traditional batch methods. Being a fully automated system, MCSGP not only enhances sustainability but also increases efficiency, delivering on average 10 per cent higher product yield and purity while potentially cutting cycle times by 70 per cent. Originally developed for peptides, this technology has now been successfully scaled for oligonucleotide manufacturing, offering a less wasteful and more cost-effective solution to
previous purification methods.
2. Optimise production to maximise yield and quality
Maximising both yield and quality is essential for sustainable oligonucleotide production. Continuous chromatography techniques like MCSGP generally offer higher capacity and yield, while cutting down on solvent use compared to traditional batch purification methods.
These automated systems, which operate around the clock, can significantly shorten purification cycle times. This method not only boosts efficiency but also promotes sustainability by reducing Process Mass Intensity (PMI). Notably,
these advanced purification technologies maintain or even increase the quality of active pharma ingredients (APIs), proving that increased productivity and sustainability can still be achieved in large-scale oligonucleotide manufacturing.
3. Achieve lower PMI with alternative synthesis methods
Process Mass Intensity is a key metric in measuring sustainability in oligonucleotide manufacturing, calculating the total mass of materials used per mass of product. This is vital in pinpointing areas for optimisation, with traditional synthesis methods often resulting in a PMI of 4300 kg of waste per kilogram of API for a 20building block oligonucleotide – a significant amount of waste when replicated on a large scale.
To tackle this issue, new techniques like one-pot liquidphase oligonucleotide synthesis are being explored. This hybrid approach combines the advantages of both solutionphase and solid-phase synthesis; instead of solid-phase resins, liquid anchor molecules or "tags" are used, enabling efficient separation of products from byproducts while yielding higher volumes.
By significantly cutting down on solvent usage—one of the primary contributors to high PMI—this method minimises the need for excessive washing steps, potentially reducing the PMI from solvents by half.
4. Improve production capacity by scaling up your operation
Dedication to innovation must be implemented across each step of the manufacturing process, to ensure efficiency improves as a whole. To scale oligonucleotide production sustainably, Bachem has established large-scale oligonucleotide synthesiser within the synthesis stage, customised with advanced process control and crude API purity enhancements. In the cleavage and deprotection phase, these automated systems can significantly enhance both production safety and efficiency, again reducing waste.
Manufacturing products on
a large scale sees numerous advantages, in comparison to small-batch production processes. Yield and purity are significantly improved as a result, while solvent consumption is reduced and process mass intensity is lowered.
Meanwhile core competencies in lyophilization and clean room operations ensure a streamlined, high-quality isolation process, preventing bottlenecks.
5. Promoting worker-level in-
novation
Promoting sustainability begins at a grassroots level. By actively engaging the workforce in sustainable innovation, industry leaders can levy collective expertise and experience to drive technological advancements, and improve processes from the ground upwards. As a result, manufacturers can better deliver products and services, while navigating the evolving landscape of sustainable manufac-
turing as an organisation.
This culture of continuous improvement improves efficiency, by optimising business processes, and identifying advanced manufacturing technologies in collaboration with those that use them.
With the application of oligonucleotide-based therapeutic drugs continuing to expand, it is vital that manufacturers modernise production processes as a matter of urgency, in order to meet de-
mand and ensure end users have access to medication. As processes continue to improve with technological advancements, manufacturers should look to continuously evaluate and upscale their operation, with technology evolving at a rapid pace. It is their responsibility to ensure that environmental standards are met and exceeded, delivering their services at optimum efficiency, while not at the expense of the climate.
TECHNOLOGY
Optimising spend,maximising growth
ExpressPharma,in partnership with IPAand CHEMEXCIL,powered by SAP,recently organised a thought leadership conclave on 'Reimagining spend management and supply chain' where cross functional experts explored strategies to drive value through supply chain transformation
India’s pharma and chemical companies are now set to integrate deeper into global supply chains, and back integrate, with China plus one initiative and other regulations, triggering more investments. Though supply chain shocks could derail these early success stories, a deep dive at a recent thought leadership conclave revealed many opportunities and strategies to tackle the challenges.
Express Pharma, in partnership with Indian Pharmaceutical Alliance (IPA) and CHEMEXCIL, powered by SAP, recently organised a thought leadership conclave titled, Reimagining Spend Management & Supply Chain for Pharma and Chemical Industry. Cross functional experts explored how smart supply chain technology optimises spends and maximises global growth opportunities, extracted learnings from success stories, and shared real-world experience and solutions to evolve up the global pharma value chain.
Speakers explored how they could pivot materials and export logistics to the next level with advanced supply chain technology, and shared success stories highlighting greater gains from supply chain technology and automation. They also explored how smart AI contracting across the pharma and chemicals supplier universe could link spends, RoI and result in value creation. There was broad consensus on the critical need for technology material traceability to insulate pharma and chemical exports from supply chain shocks.
In a Fireside chat, titled Future Proofing the Chemicals and Pharma Supply Chains, moderated by Viveka Roychowdhury, Editor, Express Pharma and Express Healthcare, two association chiefs dis-
Nikhil
Kamat,SAPDirector demonstrated howSAPhas worked with pharma and chemical companies to improve supplychain productivity,leveraging the existing ecosystem to get the right insights,helping clients focus on intelligent work,thus improving on-time delivery performance.
The discussion centered on the increasing number of mid-market/MSME pharma companies turning to SAPin the post COVID years,to support their growth plans.As they scale up and need the support of proper auditable systems,these companies are now moving online,using systems like SAP’s vendor cockpit and transitioning to a vendor portal approach,where theycan leverage SAP's global vendor portal,with access to around eight million vendors and sixlakhs in India.
Kamat also highlighted howdigital invoicing has not just saved time but also has a positive ESG impact as it replaces manual paper-based invoices,giving the example of one client project
where SAPinfluenced 6 of their 17 UN sustainable development goals just by automating the purchase order system.Kamat also spoke about vendor riskassessment, management strategies,which can be deployed when onboarding newvendors using the vendor riskdashboard which evaluates vendors on a range of parameters running from regulatory, environmental,financial,operational,etc.
cussed the impact of COVID-19 on the pharmaceutical and chemical supply chains, highlighting the invaluable lessons learned for future policy formulation.
Sudarshan Jain, Secretary General, IPA highlighted how the pandemic served not only as a formidable crisis but also as a unique opportunity for advancement within the sector. During the height of the pandemic, a daily “war room” was established, uniting top pharma executives and government officials to tackle realtime challenges. This collaboration was vital; it fostered communication among stakeholders, allowing them to swiftly address production hurdles and supply chain uncertainties that arose from both international raw material shortages and unpredictable
Fireside chat on Future
Proofing the Chemicals and Pharma SupplyChains,with Sudarshan Jain,SecretaryGeneral,IPA(extreme left) and Abhay Udeshi,Chairman,CHEMEXCILand Chairman,Jayant Agro Organics (extreme left),moderated byViveka Roychowdhury,Express Pharma and Express Healthcare
SAPSUPPLYCHAIN SOLUTIONS FOR PHARMAAND CHEMICALCOMPANIES IN INDIA
COVID outbreaks.
Moreover, the crisis prompted remarkable regulatory improvements, demonstrating that when push comes to shove—or when a virus comes knocking—regulatory bodies can indeed accelerate processes. Vaccines, which typically require years of development, were birthed in a mere 12 months, proving that necessity is the mother of invention, and possibly a rather impatient mother at that. India emerged as a global supplier of medicines during this tumultuous time, delivering to over 200 countries despite significant obstacles. As we move forward, the insights gained from this experience will undoubtedly shape policies, emphasising the need for continued collaboration, adaptability, and a regulatory framework that can keep pace with the demands of our ever-changing world.
During the meeting, the moderator questioned whether the lessons learned during the pandemic have been incorporated into policy to reduce red tape and improve efficiency in critical areas, like for instance, recent reports about substandard IPA (Isopropyl Alcohol) imports from China, which are not suitable for use in the pharmaceutical sector .
In response, Jain acknowledged that crises often drive faster action, but once the crisis ends, the sense of urgency fades. He pointed out that efficient systems involving collaboration, regulatory approvals, and digitalisation need to be established and sustained beyond emergencies. He also commented on the challenges of working with China, noting that Chinese regulators are secretive, and inspections of imports from China do not take place, raising concerns about the quality of materials supplied.
He agreed on the importance of oversight for critical ingredients, emphasising that moving forward, greater care must be taken to ensure the quality of essential imports. However he also noted that the limited domestic capacity to replace such imports creates a difficult balance. Ultimately, he
EXPRESS PHARMA 27
stressed the importance of building stronger systems to address these issues in the future.
Raising the issue of capacity building in the pharmaceutical sector, specifically citing isopropyl alcohol (IPA) as an example, Roychowdhury asked
Abhay Udeshi, Chairman, CHEMEXCIL and Chairman, Jayant Agro Organics about CHEMEXCIL's role in addressing these challenges and how COVID-19 has shaped policy in the chemical sector, as supply chain challenges have left the sector vulnerable, especially in
attempts to move away from China-based suppliers. For India to capitalise on global opportunities, the pharmaceutical sector must strengthen its supply chains and integrate backward into chemical production.
In response, Udheshi high-
lighted the importance of the chemical industry in supporting pharmaceuticals, noting that India is the sixth-largest chemical producer globally and third in Asia. The industry, valued at $220 billion, is expected to reach $300 billion by 2030 and potentially $1 trillion by
TECHNOLOGY
2040. He explained that chemicals are essential to almost all manufactured goods, making the sector a key player in various industries, including pharmaceuticals.
Udheshi then addressed the specific challenges posed by the pandemic. He explained that the Indian chemical industry, like many sectors, faced significant disruptions early in the pandemic due to global supply chain issues. Demand for many sectors dropped, but certain chemicals, such as IPA, acetones, and other inputs for pharma production, saw a surge in demand. Despite the crisis, the industry showed resilience and has now surpassed pre-pandemic levels. He also noted that CHEMEXCIL played a critical role in maintaining export levels during the pandemic, working closely with government agencies to resolve issues related to supply chain disruptions.
Udheshi concluded by explaining that CHEMEXCIL not only focuses on exports but also plays a key role in import substitution. During the pandemic, CHEMEXCIL was in constant communication with government departments and international stakeholders, working to keep exports running while also supporting domestic needs. He highlighted the importance of digital tools in maintaining global connections, organizing webinars, and facilitating business continuity during the crisis.
Roychowdhury highlighted the government's PLI (Production Linked Incentive) scheme for the pharma industry and inquired if a similar initiative is being considered for the chemical sector. Udheshi confirmed that discussions with the government are ongoing, and while the pharma sector was prioritized during the pandemic, there is now recognition of the shortages in input chemicals used for pharma manufacturing. He added that the government is reviewing representations from the chemical industry and urged collaboration to identify critical chemicals in short supply so that relevant schemes can be implemented.
Roychowdgury shifted focus to another concern area, raising concerns about the frequent changes in regulations, particularly the recent stricter nitrosamine guidelines, which will require pharma companies to focus on material traceability by 2025, pointing out that the pharma industry could streamline compliance through digital solutions.
Jain explained that it is es-
sential to assess global regulations and determine their applicability in India. He noted that while India’s Drug Control General Department is proactive, it takes time to study and implement regulations like Schedule M. Although India is a large democratic country with different challenges, the government is actively pushing regulatory advancements and offering incentives for manu-
facturers to meet new requirements.
Circling back to Udheshi, Roychowdhury asked about the role of digital technology during the pandemic and in scaling up operations, particularly in vendor management. Udheshi elaborated on how digitalisation, decentralisation, and decarbonisation became key during the pandemic. Many offices were closed, and operations
Keytakeaways: Future-proofing the pharmaceutical and chemical supplychain
Sudarshan
Jain,SecretaryGeneral,IPAemphasized digitalisation as the primaryfocus, highlighting its role in various areas,including office operations,medical records,supplychain management,and healthcare access.He pointed out that digitalisation will be essential for ensuring smooth medicine supply,improving medical care,and supporting advancements like telemedicine and online pharmacies.However,he stressed the need to balance digitalisation with personalisation in healthcare,emphasising the human touch in medical services.
AbhayUdeshi,Chairman,CHEMEXCILand Chairman,Jayant Agro Organics supported the importance of digitalisation,particularlyfrom the government's perspective.He mentioned the government’s initiatives to build capacityat the grassroots level through platforms like e-commerce, with collaborations such as those with Amazon.Additionally,the government is focusing on infrastructure development,including the creation of chemical parks near port areas,which would facilitate better environmental compliance and ease of operations.These efforts are aimed at addressing infrastructure challenges,including road conditions,and ensuring the chemical industry has room to grow.
moved online, with staff working remotely. He also pointed out that digitalisation not only reduced pollution but also improved efficiency. The government has also embraced digital platforms, such as UPI for payments, EBRCs for banking, and the GeM portal for procurement, which have made it easier to do business. He emphasized that digitalisation is here to stay and will continue to play an important role in making processes more transparent and accessible, benefiting businesses and citizens alike.
Reimagining Spend Management & Supply Chain for Pharma and Chemical Industry
The panel discussion, moderated by Viveka Roychowdhury, Editor, Express Pharma and Nikhil Kamath, Business Director at SAP, featured insights from Ashish Mohan, VP of Procurement & Supply Chain at Bharat Serums and Vaccines; Kaifeel Shaikh, VP of EXIM, Global Logistics & Domestic
November 2024
The panel comprised (l to r) Viveka Roychowdhuryfrom Express Pharma and Express Healthcare, Nikhil Kamath,from SAP(moderators), Ashish Mohan,from Bharat Serums and Vaccines; Ajitsingh Patil from Shalina Healthcare,Kaifeel Shaikh from Indoco Remedies and Vinodkumar Nair from ACG World
TECHNOLOGY
Distribution at Indoco Remedies; Vinodkumar Nair, VP of Global Supply Chain at ACG World, and Ajitsingh Patil, Global Head of Manufacturing at Shalina Healthcare.
The focus of the discussion was about the digital transformation and integration of the pharma & chemical supply chains, an imperative for the global growth of both sectors.
Panellists discussed how they are linking spends to value creation, aiming to integrate deeper into global supply chains, and back integrate, by leveraging digital and automation technologies for real time materials traceability from port to plant, smart contracting and logistics tools to insulate and de-risk supplier networks from disruptions, combined with sustainable practices to combat the climate crisis.
The key takeaways from the panel discussion on digital transformation and integration in the pharmaceutical industry, based on success stories shared and lessons learnt:
◆ Strategic planning over technology: Effective integration requires a strategic approach before diving into technological solutions. While technology can enhance operations, it must align with the organisation's specific needs and capabilities.
◆ AI and automation: Companies should explore integrating AI and machine learning within their existing frameworks, especially for tasks like shipment tracking. Tools such as temperature and humidity loggers can enhance traceability and ensure compliance for critical shipments.
◆ Business continuity planning: Given the various external factors impacting the pharmaceutical industry, maintaining a robust business continuity plan is essential. This should encompass compliance with local and international regulations and ensure quality management at all levels of operation.
◆ Data integrity: Clean, organized data is fundamental for effective decision-making. Or-
ganisations should prioritise maintaining accurate data as it serves as the backbone for analysis and operational intelligence.
◆ Three Cs and two Ps: Focus on three critical factors—cost reduction, cash management (controlling inventory), and
compliance. Alongside these, prioritise process optimisation and the development of skilled personnel to drive successful digital transformation.
◆ Culture of quality management: Integrating quality management practices across all functions, from production to
finance, fosters a culture of excellence and compliance, essential for meeting industry standards.
◆ Gradual implementation: Not all areas may be ready for full digitisation; companies should prioritise key segments for initial digital initiatives and gradually expand based on success stories and learnings. These takeaways highlight the importance of strategic integration, data management, and continuous improvement in achieving effective digital transformation within the pharmaceutical sector.
Drug Repurposing: Unlocking access to rare solutions
Drug repurposing,a quick,cost-effective path to deliver existing treatments to patients,can serve to expedite and expand healthcare access for patients with rare diseases
In the marathon of drug development, where billions of dollars and over a decade of research are the norm, drug repurposing is quietly reshaping the landscape. This approach is particularly beneficial for rare diseases, where the treatment options are woefully limited. For conditions affecting fewer than 200,000 individuals, traditional development is economically daunting and repurposing emerges as a pivotal strategy, offering faster, affordable solutions for conditions that have long been left behind in traditional drug pipelines. According to the National Institutes of Health (NIH), of the estimated 6,000 to 8,000 known rare diseases, only about 5 per cent have FDA-approved treatments. According to a report from the Ministry of Health and Family Affairs, approximately 96 million people in India are affected by various rare diseases, many of which are genetic or acquired through viral or bacterial infections. Over 70 per cent of these conditions lack a cure and often go unnoticed, presenting a significant opportunity for drug repurposing in India. In this context, the ability to bring effective therapies to market more quickly and at lower costs, positions drug repurposing as a crucial focus for the pharmaceutical industry.
Streamlined regulatory pathways
One of the biggest enablers of drug repurposing is the regulatory framework designed to expedite approvals for already-approved compounds. The FDA’s 505(b)(2) pathway and the European Medicines Agency's (EMA) Hybrid Pathway offer routes for drug developers to rely on previously submitted clinical data, cutting down approval times significantly. According to research from Alacrita, a pharma and biotech consulting firm, between 2013 and 2018, nearly 50 per cent of
Repurposed drugs already have a significant safety profile,which means that companies can focus their efforts on proving efficacy for new indications
Sanjay Vyas President and Managing Director of Parexel India
India’s regulatory framework is not yet fully optimised for drug repurposing. Although the New Drugs and Clinical Trials Rules 2019 have improved timelines,there is still no distinct regulatory pathway for repurposed drugs,leading to delayed approvals and increased costs
Dr Vikram Venkateswaran Partner at Deloitte India
Exploring existing approved generic or orphan drugs to treat other rare diseases is more realistic than developing new drugs.There is a need for awareness among the medical and scientific community to focus on this and create a list of products and indications
Prasanna Shirol Co-Founder and Executive Director of Organisation for Rare Diseases India (ORDI)
High initial prices due to orphan drug status often lead to significant price hikes upon regulatory approval for rare disease treatments.Pharma companies find it difficult to redirect funds towards repurposing drugs for rare diseases due to the small patient base and low financial returns
Sagar Pawar Partner and Lead for Life Sciences & Medical Devices at KPMG
in India
all New Drug Applications (NDAs) approved by the FDA were based on the 505(b)(2) pathway.
Dr Saadia Basharat of Alacrita in her recently published article notes that these pathways can reduce approval times for repurposed drugs down to just 3 to 12 years; much shorter than new-in-man programmes that generally take between 10 to 17 years.
Potential galore
Sanjay Vyas, President and Managing Director of Parexel India, is among those who see significant potential in drug repurposing. He explains that Parexel’s research and development strategy includes drug repurposing for several clients, especially in the rare disease space. “The high cost and lengthy development process of new drugs, particularly for rare diseases, present significant challenges. Drug repurposing offers a promising solution, as it can expedite the development of treatments for smaller patient populations,” Vyas says.
The primary advantage of drug repurposing is that companies can leverage existing data and research, reducing the risk and cost typically associated with traditional drug discovery. Vyas elaborates, “Repurposing reduces risks, lowers costs, and shortens timelines compared to traditional drug discovery. Additionally, it optimises resource allocation and maximises returns on investment.” This is particularly important in the development of treatments for rare diseases, where patient populations are often small, making it difficult for pharma companies to justify the expense of developing new drugs from scratch.
The COVID-19 pandemic demonstrated the potential of drug repurposing on a global scale, as treatments like Favipiravir, Remdesivir, and Tocilizumab were repurposed to treat the virus. Vyas points out
that repurposed drugs have already undergone rigorous testing for toxicity during their development for other indications, meaning they are proven safe. This allows them to be fasttracked through the approval process and brought to market more quickly. “Repurposed drugs already have a significant safety profile, which means that companies can focus their efforts on proving efficacy for new indications,” says Vyas.
Vyas concludes, “The traditional one-size-fits-all approach to treating diseases is evolving into a more personalised strategy based on a thorough understanding of individual biology, disease mechanisms, and genetics. By understanding diseases at a molecular level, we can seamlessly repurpose drugs to treat multiple conditions, thereby maximising their benefits.”
The role of technologyin drug repurposing
Advances in technology are also playing a pivotal role in streamlining the drug repurposing process. Parexel, for instance, uses modelling and simulation techniques to support first-inhuman (FIH) study designs. Vyas explains, “By simulating various dosing scenarios, Parexel can identify the most promising candidates for repurposing and streamline the transition from preclinical to clinical phases.” These simulations allow companies to gather valuable data on how existing drugs might perform in treating new diseases, reducing the time and cost associated with traditional clinical trials.
Additionally, Parexel has partnered with Partex, a datato-drug pharma platform that integrates artificial intelligence
(AI) and big data into the drug repurposing process. The goal of this partnership, according to Vyas, is to advance the efforts of drug developers working to understand the probability of clinical success for assets in their portfolios. “By using AI and big data, we can recommend other disease indications for which a company’s assets may be clinically viable,” says Vyas. This technology-driven approach allows pharma companies to identify new opportunities for repurposing existing drugs, further accelerating the development process.
AI-assisted drug repurposing employs sophisticated algorithms to identify potential new uses for existing drugs. This involves analysing extensive chemical and biological data to pinpoint new molecular targets, predict drug binding affinities,
assess potential side effects and interactions, and identify patient populations that could benefit from repurposed therapies.
GlobalData’s analysis highlights the global companies leading innovation in this space, evaluating the reach and impact of their patenting activities across various applications and regions. Over 470 companies, including technology vendors, established pharmaceutical firms, and emerging start-ups, are engaged in developing and applying drug repurposing AI.
Ginkgo Bioworks stands out as a leading patent filer in AIdriven drug repurposing. The company utilises AI tools and software to engineer enzymes, proteins, and drug molecules. A pioneer in digital health, Ginkgo combines computational design with a synthetic biology platform and ultra-high-throughput
genetic engineering in process development and manufacturing scale-up.
In terms of application diversity, DNAnudge leads the field, followed closely by Memorial Sloan Kettering Cancer Center and Ginkgo Bioworks. Geographically, BostonGene takes the top spot, with MeMed Diagnostics and Worldwide Innovative Networking also prominent in the personalised cancer medicine consortium.
Challenges in drug repurposing
Despite these technological and regulatory advancements, the journey of drug repurposing is not without its challenges. Evolving regulatory frameworks: One of the biggest hurdles is navigating the complex regulatory landscape that governs clinical drug development.
STRATEGY
Vyas opines that while the regulatory guidelines for new and repurposed drugs are well-defined, the primary difference lies in the stage of clinical trials required. “For repurposed drugs, early-stage trials such as Phase 1 or 2 might be sufficient, provided there is existing safety data on the compound,” Vyas explains.
Dr Vikram Venkateswaran, Partner at Deloitte India, emphasises the need for a fast-track process for pricing approvals and an exclusive pricing framework for repurposed drugs under the National Pharmaceutical Pricing Authority (NPPA) to balance affordability and accessibility. However, he asserts that India’s regulatory framework is not yet fully optimised for drug repurposing. “Although the New Drugs and Clinical Trials Rules 2019 have improved timelines, there is still no distinct regulatory pathway for repurposed drugs, leading to delayed approvals and increased costs,” says Dr Venkateswaran. Lack of awareness: On the other hand, Prasanna Shirol, CoFounder and Executive Director of the Organisation for Rare Diseases India (ORDI), emphasises the need for greater awareness among the medical and scientific communities about the potential of drug repurposing. “Exploring existing approved generic or orphan drugs to treat other rare diseases is more realistic than developing new drugs,” Shirol says. He also highlights the need for India to develop policies that accommodate faster market authorisation for repurposed
drugs. “There is a need for awareness among the medical and scientific community to focus on this and create a list of products and indications,” Shirol explains.
Unsustainable costs: While drug repurposing offers numerous advantages, one of the biggest challenges remains pricing. Repurposed drugs, especially those for rare diseases, often come with high costs that are unsustainable for most patients. Venkateswaran points out that treatments like eculizumab, a drug used to treat rare blood disorders, are prohibitively expensive despite their global availability. “To address this, India should consider adopting differential pricing models and government-backed reimbursement schemes,” he says, adding that programs like Ayushman Bharat could be expanded to include rare disease therapies at negotiated prices. “The National Policy for Rare Diseases (2021) currently offers financial support of up to ?20 lakhs (~$24,000 USD) for treatments, but this should be expanded to include all repurposed drugs with proven efficacy,” he adds.
Sagar Pawar, Partner and Lead for Life Sciences & Medical Devices at KPMG in India, also weighs in on pricing trends.
“High initial prices due to orphan drug status often lead to significant price hikes upon regulatory approval for rare disease treatments,” Pawar explains. He notes that geographical variations in pricing, coupled with limited financial returns due to small patient populations, make
it challenging to fund repurposing efforts. Further he adds, “Pharma companies find it difficult to redirect funds towards repurposing drugs for rare diseases due to the small patient base and low financial returns. This limits research and development efforts, particularly affecting smaller entities and nonprofits that struggle to bring these drugs to market. The lack of patent protection and the competitive nature of generic drugs further discourage investment, as recouping costs becomes challenging.”
Tapping into opportunity
To overcome these challenges, Dr Venkateswaran suggests that expedited approval timelines and lowering barriers for clinical trials on repurposed drugs, such as permitting more adaptive trial designs, are crucial. “Advocating for a separate category for repurposed drugs under the Central Drugs Standard Control Organisation (CDSCO) could also be beneficial. This could be similar to the US FDA’s "505(b)(2)" application process, which allows repurposed drugs to bypass much of the traditional approval process,” he adds.
In India, the momentum for drug repurposing is growing, but the progress has been slow. Dr Venkateswaran, points to the innovative use of GLP-1 agonists, initially anti-diabetic drugs, now repurposed as anti-obesity treatments. These treatments have had a significant global impact, and Venkateswaran believes that India has the potential to replicate this success in other
therapeutic areas. “In India, investor enthusiasm for repurposed drugs is moderate but gradually increasing, particularly in fields like oncology and infectious diseases,” says Venkateswaran.
One of the key factors in attracting more investment to drug repurposing in India is collaboration between the government and the private sector. Venkateswaran suggests that India adopt a model similar to its successful vaccine development strategy, relying on public-private partnerships to pool resources. “Joint funding initiatives could significantly boost drug repurposing efforts in India,” he says, adding that incentives like streamlined approval processes and tax breaks could further encourage investment. Venkateswaran also highlights the role that Biotechnology Industry Research Assistance Council (BIRAC) could play in supporting drug repurposing efforts. “BIRAC could establish a dedicated fund for drug repurposing, particularly for rare diseases,” he suggests.
Despite the challenges, drug repurposing presents a unique opportunity for the pharma sector, particularly in India. “Multipartner collaborations can pool resources and expertise, making it easier to navigate the complexities of drug repurposing. For instance, the CURE ID platform facilitates collaboration by allowing clinicians to share data on off-label uses of existing drugs,” states Pawar.
“As the world's largest manufacturer of generic medicines,
India has vast potential to utilise repurposed drugs. This approach could accelerate the accessibility of treatments for diseases like COVID-19, which may emerge in the future without existing vaccines, as these drugs would already be in circulation globally,” states Venkateswaran.
Dr Venkateswaran suggests that rare neurological disorders like spinal muscular atrophy (SMA) and Duchenne muscular dystrophy offer promising avenues for repurposing efforts in India. “India, with its vast population and genetic diversity, has the opportunity to leverage existing treatments and supply chains to make a lasting impact on the rare disease landscape,” he explains.
Apath forward
Thus, drug repurposing is an innovative approach that provides faster, affordable solutions for underserved patient groups affected by rare diseases. By leveraging existing research and streamlined regulations, this strategy aims to improve access to effective treatments for millions,
In the Indian context, drug repurposing exemplifies a strategic approach that the pharma industry can embrace to continue its growth momentum and improve access to affordable medication. It strikes a delicate balance between efficiency, affordability, and effective solutions for underserved patient populations.
nehaaathavale75@gmail.com
neha.athavale@expressindia.com
November 2024
Accelerating pharma's sustainabilityefforts
Avinaw Prasad,Director,Climate Change
& Sustainability,Deloitte India explains why integrating sustainability into the
pharma business strategy is essential for long-term success,analyses key focus areas and policy pushes which can incentivise companies to further evolve on the sustainability path
Integrating ESG considerations into core pharma operations
India, known as the "Pharmacy of the World," produces over 20 per cent of the global supply of generic medicines and plays a vital role in vaccine production, as per the Investindia.gov.in website. It meets the healthcare needs of over 1.4 billion people domestically while providing affordable medicines to over 200 countries, significantly contributing to global public health.
As sustainability gains global focus, India's pharma sector should integrate ESG considerations into its core operations. Only about 20 per cent of companies in the life science and healthcare sector are well-prepared to handle ESG requirements, with around 30 per cent moderately prepared and another 30 per cent somewhat prepared. This indicates that, despite some progress, a significant portion of the sector still needs to elevate its ESG practices, as per an October
2023 report from Deloitte, titled, ‘Embedding environmental sustainability into pharma’s DNA’.
Embedding sustainability into the core business strategy is essential for long-term success. This includes reducing environmental footprints, ensuring ethical supply chains, fostering inclusive workplaces, and maintaining transparent governance. One key aspect is value-chain sustainability, where initiatives such as the Pharmaceutical Supply Chain
Initiative (PSCI) and the Sustainable Medicines Partnership (SMP) play a pivotal role. These initiatives help standardise best practices across the industry, ensuring that sustainability efforts extend beyond the company’s operations to include suppliers, manufacturers, and other key stakeholders in the value chain.
Collaboration across the industry to share best practices and reduce costs is crucial, as is investing in innovation to develop more sustainable manu-
STRATEGY
facturing processes. Leveraging digital technologies to optimise resource use, minimise waste and educate stakeholders on the business case for sustainability will ensure broad support. Additionally, setting science-based targets aligned with global climate goals and maintaining transparency through rigorous sustainability reporting will build trust and drive long-term value for both business and society.
Keyfocus areas in sustainable manufacturing practices
From drug discovery and manufacturing to packaging and patient engagement, sustainability should be embedded in every facet of pharma operations. In a sector focused on saving lives, ESG considerations are not just a regulatory requirement but a core component of our commitment to public health, particularly as we confront the challenges posed by climate change. This responsibility extends beyond patient care to how we manage the environmental and social impacts of our business operations. Early wins in sustainability are crucial for driving longterm investments and proving the viability and profitability of sustainable practices.
As companies see returns, they are more likely to expand these efforts, leading to a more resilient and profitable sector. Key focus areas include energy efficiency, where audits and management systems can quickly identify savings. Upgrading to LED lighting, optimising HVAC systems, and using energy-efficient equipment can reduce costs and energy use. Innovative mechanisms to reduce post-consumer waste, such as drug take-back programs, can also play a significant role in reducing the environmental impact of pharmaceuticals, as these programs provide a secure and environmentally sound way to dispose of leftover and expired medicine. Wherever feasible, returning products to the manufacturer should be the first choice, as they are likely to have effective disposal methods that allow for the recycling
Collaboration across the industry to share best practices and reduce costs is crucial,as is investing in innovation to develop more sustainable manufacturing processes.Leveraging digital technologies to optimise resource use, minimise waste and educate stakeholders on the business case for sustainability will ensure broad support
of components wherever possible.
Supply chain improvements are also vital; collaborating with suppliers on sustainable practices and optimising transport routes can make supply chains more efficient. Lastly, fostering a culture of environmental responsibility through employee training is essential, as informed employees can significantly contribute to reducing waste and improving resource efficiency across the organisation.
Policypush for going green
The revised Schedule M, introduced in January 2024, ensures that India's pharmaceutical manufacturing aligns with international standards for safety and quality. To support MSME pharma companies in meeting these new standards, the government could implement several targeted incentives.
First, tax breaks for investments in sustainable technologies would encourage MSMEs to adopt eco-friendly practices. Additionally, subsidies for renewable energy and low-interest green loans could reduce operational costs, making it easier for smaller companies to upgrade their facilities. Incentives for eco-design-based pharma manufacturing could further drive the adoption of sustainable design principles, such as using biodegradable materials and optimising production processes to minimise waste and energy use, thereby reducing the environmental impact from the outset. A fasttrack approval process for fa-
cilities that meet sustainability criteria would also expedite compliance and reduce associated costs. Grants for sustainability-focused R&D could further drive innovation, helping MSMEs adhere to the new standards. Recognition programs could highlight leaders in sustainability, encouraging broader adoption. Technical assistance programs would ensure that MSMEs have the knowledge and resources to implement these measures effectively.
Finally, preferential treatment in government procurement for sustainable products would provide a strong financial incentive, and participation in carbon trading schemes, and implementing Internal Carbon pricing could offer an additional revenue stream by monetising emissions reductions. If these incentives are implemented, India's MSME pharma sector could rapidly modernise, further accelerating its transformation into a sustainable, globally competitive industry that sets new standards in quality, innovation, and environmental stewardship.
Evolution of the sustainabilityjourney
Over the years, in my experience of working with pharma companies, I have seen a significant evolution in their approach to sustainability. The focus has shifted towards embedding sustainability throughout the product value chain—from R&D to manufacturing, packaging, and logistics.
A key best practice is the creation of specialised ESG
committees at the board level, ensuring that sustainability is integrated into decision-making processes. This governance structure is vital for driving impactful sustainability initiatives. In waste management, many companies have set ambitious targets, such as achieving zero operational waste and reducing single-use plastics. These goals are supported by robust recycling programs and continuous improvement efforts that enhance both environmental impact and operational efficiency. Energy efficiency has also seen considerable progress, with companies moving from diesel to cleaner fuels, investing in renewable energy, and optimising energy use. For instance, the use of bio-based boilers for API manufacturing plants and the deployment of large captive renewable assets are significant advancements. These efforts are backed by energy audits and technologies that boost fuel efficiency and reduce emissions.
Supply chain sustainability has advanced significantly as well, with companies launching Sustainable Procurement Programs and setting targets like achieving net-zero supply chains by mid-century. Innovations such as the use of recyclable insulin syringes further exemplify the commitment to minimising environmental impact across the supply chain.
To encapsulate, adopting strong governance, efficient waste management, energy optimisation, and sustainable supply chains will enable MSMEs to accelerate their sustainability efforts and meet in-
dustry standards.
Best sustainability practices from other industries
Pharma companies have a unique opportunity to draw inspiration from best practices in other industries to accelerate their sustainability efforts. For instance, they can significantly reduce emissions by investing in energy-efficient equipment and adopting renewable energy sources like solar and wind— mirroring the tech industry's shift to 100 per cent renewable energy. Adopting green chemistry principles from the chemical industry allows them to minimise hazardous chemicals, optimise processes, and reduce waste, thereby improving safety and cutting disposal costs. In terms of packaging, the FMCG sector offers valuable insights; pharma companies can reduce packaging waste by using recyclable, biodegradable materials and eliminating unnecessary layers, making packaging more functional and sustainable. Additionally, by embracing circular economy practices from the agriculture industry, pharma companies can turn waste into resources through waste-to-energy programs and recycling initiatives, significantly lowering their environmental footprint. Inspired by the beverage industry's approach to water conservation, pharma companies can implement advanced water recycling and treatment systems to reduce freshwater usage and minimise wastewater discharge, particularly in waterscarce regions. Lastly, by following the lead of retail and FMCG sectors in enforcing sustainability standards among suppliers, pharma companies can ensure ethical sourcing and enhance sustainability across the entire supply chain.
Optimising cloud provisioning for pharmaceutical compliance and operational excellence
Suresh Perikala,Senior Engineering Lead – DevOps and Cloud Engineering Practice,Altimetrik
Optimising cloud provisioning for pharmaceutical compliance and operational excellence
In the last few years, we have witnessed the pharmaceutical industry in its most intense form. With the onset of the COVID-19 pandemic, they have spared no effort in providing crucial vaccinations to protect the world. Today, they are utilising advanced technologies to speed up the creation of therapies and treatments to eliminate life-threatening diseases. However, executing this is easier said than done. The pharmaceutical industry operates within an elaborate regulatory environment that often demands a delicate balance between innovation and compliance. Adhering to stringent compliance with regulatory standards – such as GxP (Good Practice), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) – helps to ensure the safety, quality and efficacy of the products. The industry demands solutions that help both ensure compliance and enable operational excellence.
Challenges
in pharmaceutical cloud infrastructure
Playing within a stringent regulatory landscape, pharmaceutical companies often come across significant hurdles in managing their cloud infrastructure. With extremely sensitive patient data in their hands, ensuring data security and privacy is non-negotiable. This demands strong encryption with strict access controls. Moreover, since pharmaceutical operations often involve crosstalk between diverse systems across global operations, integrating these systems adds to the complexity while demanding seamless in-
teroperability and performance.
With cloud provisioning, pharmaceutical operations can enable flexibility, scalability, and cost efficiency while ensuring compliance with industry standards.
Importance of Data Security,Privacyand Governance
Data security, privacy, and governance are crucial pillars in the pharmaceutical domain due to the sensitive nature of patient data and proprietary research. These call for robust security measures such as encryption and access controls, to safeguard against breaches and unauthorised access. Additionally, effective governance frameworks align data management practices with regulatory requirements, limiting risks and fortifying stakeholder trust.
Infrastructure as Code (IaC) and Automation
Infrastructure such as Code (IaC) and automation have been ground-breaking for cloud provisioning in the pharmaceutical industry. With IaC, companies can manage and allocate cloud resources via code. This allows for consistency, repeatability, and reduced manual errors. On the other hand, automation streamlines processes, considerably limiting the time and effort required for infrastructure management.
Ultimately, IaC and automation are a tag team that helps improve operational efficiency and scalability and ensures a compliant and secure cloud ecosystem that supports faster innovation and effective resource management.
Ensuring compliance through automated processes
With cloud provisioning, pharmaceutical operations can enable flexibility, scalability,and cost efficiency while ensuring compliance with industry standards
Compliance checks are as common as they get in the pharmaceutical sector's workflow. Automating these processes can be critical in helping pharmaceutical companies manage their cloud infrastructure. They can help limit the risk of human errors while also ensuring consistent adherence to regulatory requirements like GxP standards.
Automation can help in various ways—it can help monitor and enforce security policies, conduct timely audits, and
even generate comprehensive reports for regulatory bodies. With the automation of compliance processes, pharmaceutical companies can experience an enhancement in their efficiency and reduced operational costs, all while maintaining a robust and secure cloud environment that is in line with all regulatory mandates.
Business outcomes of optimised cloud provisioning
With cloud provisioning in the pharmaceutical sector optimised, companies can experience a considerable uptick in business outcomes. Here are some illustrative examples on how it can pan out.
Establishment of self-service capabilities: A leading pharmaceutical company implemented a self-service portal for its research and development teams. This allowed scientists to provision virtual machines and storage on-demand, reducing the average provisioning time from several days to just a few hours. As a result, researchers could quickly access the computing resources needed for data analysis, leading to faster drug discovery timelines.
Increased efficiency through automation: A global pharmaceutical firm automated its cloud infrastructure provisioning using Infrastructure as Code (IaC) tools. The company reduced manual provisioning efforts by 70 per cent by scripting the deployment process, allowing IT staff to focus on strategic projects rather than routine tasks. This automation also led to a 30 per cent decrease in infrastructure-related errors, enhancing overall operational reliability.
Creation of launch constraint roles and policies: A biotech startup established a set of launch constraint roles
and policies within its cloud environment to manage access to sensitive data and applications. The company ensured only authorised personnel could deploy new applications by implementing role-based access control (RBAC) and automated compliance checks. This approach secured sensitive patient data and streamlined the approval process for new application launches, reducing the time-to-market for new therapies. Implementation of code management practices: A pharmaceutical organisation adopted GitOps practices for managing its cloud infrastructure configurations. By using version control for infrastructure code, the company achieved greater scalability and reusability of configurations. This allowed teams to replicate successful setups across multiple projects, reducing deployment times by 50 per cent and enabling quicker responses to changing regulatory requirements.
The future of cloud provisioning in the pharmaceutical industry
The optimisation of cloud provisioning will continue to be a critical strategy for pharmaceutical companies that are striving for compliance and operational excellence. As regulations become more stringent and complex, adopting newer technologies such as IaC and automation will become the norm.
The potential benefits that it brings – in the form of compliance, efficiency, and cost savings – make it a worthwhile investment, despite the challenges along the way, all while driving business growth. Together, pharmaceutical companies can ensure they are well-positioned to meet the demands of the future.
Vadodara Pharma Summit 2024 brought together industry leaders and experts to highlight the city's pivotal role in India's pharma landscape and explore collaborative strategies to strengthen India's pharma innovation ecosystem
Inaugural Session
Vadodara Pharma Summit 2024, recently organised by Express Pharma focussed on fostering an ecosystem that promotes innovation, excellence, and growth within the pharma industry.
This summit brought together leaders, innovators, and experts from Vadodara’s vibrant pharma sector, highlighting the city’s critical role as a significant hub for pharma production and research.
It also served as a vital platform for dialogue on pressing topics that shape the future of pharma, ranging from cuttingedge advancements in technology and R&D strategies to navigating complex regulatory landscapes and enhancing sustainability practices.
The Vadodara Pharma Summit also offered ample opportunities for networking and interaction, enabling participants to connect, collaborate, and share valuable experiences.
It commenced with a ceremonial lamp lighting, followed by a welcome address from Express Pharma, setting the stage for a day filled with knowledge exchange and collaboration.
Innovations in active packaging
Active packaging has emerged as a vital aspect in securing the safety and efficacy of medicines. And, as an evolving sphere, it has witnessed several advancements.
Dhairy Sharma, Senior ExecutiveBusiness Development, Cilicant gave further insights on the role of active packaging . He highlighted the challenges of active packaging such as the possibility of moisture control while retaining the inorganic content.
Cilicant’s Accuflip, an equilibrium relative humidity regulator maintains the level of ERH within a specific range to protect the product and prevent the drug from losing its potency. With its line of products, Cilicant aims to aid the pharma industry by providing effective active packaging solutions that eliminate packaging and storage issues of the medicine and ensure its shelf-life, safety and efficacy.
Cilicant’s Accuflip, an equilibrium relative humidity regulator maintains the level of ERH within a specific range to protect the product and prevent the drug from losing its potency
The lamplighting ceremonyat Vadodara Pharma Summit 2024
DhairySharma,Sr Executive - Business Development,Cilicant
Panel discussion: Next growth frontiers for India Pharma Inc
The inaugural panel on the event was moderated by Sunil Durge, Site Operation Head - API, Amneal Pharmaceuticals and panelists included Mayur Patel, Head-Formulation Development, Apnar Pharma; Satyashodhan Patil, Deputy GM (R&D) - Device Development (Global Market), Sun Pharma; Dr Tarang Shah, HeadBioequivalence and Pharmacovigilance, Alembic Pharmaceuticals; Nagesh Nanda, Director, Novel Consultants.
The discussion began by highlighting the current scenario of the industry and drew attention to relevant focus areas. Experts agreed that India is poised for significant growth d. Innovations in drug development, API manufacturing, automation and datadriven decision-making are some emerging frontiers.
The panel discussed new-age technologies like digital pills and their potential to disrupt the pharma and healthcare industries. They emphasised the various features and advantages of digital pills such as real-time monitoring and timely adherence to medications. They pointed out how drug and device combinations, comprising inert material, can provide useful data through its software. Such features can be beneficial for patients with critical conditions and mental disorders such as schizophrenia, bipolar disorders etc. The data can be helpful for healthcare providers.
However, there are notable ethical implications regarding the use of this technology as it concerns patient privacy. Additionally, digital pills could cost more than the generic/non-digital version of the same medication. Given these challenges, the technology is yet to reach the market stage and debates are still ongoing regarding its ethical concerns.
Another area of innovation is in the self-administered drugs segment. The panel highlighted the current use of this technology and its growth potential in Indian and global markets. In cases where people are unable to visit a clinic or healthcare facility to obtain their medication, self-administration can be a hassle-free option. The infrastructure, manufacturing capabilities and
◆ Digital pills can disrupt the pharma and healthcare industries.It can bring better patient adherence and health outcomes, especiallyfor patients with critical conditions and mental disorders.
◆ Innovative therapies are costly,however,their benefits offset their expensive nature
◆ Regulatoryauthorities are closelymonitoring emerging technologies and regulating the manufacturing and marketing process of drug-device combinations.
◆ Indian pharma majors must partner with smaller research organisations to develop newchemical entities.NCEs offer significant growth potential for India Pharma Inc.
◆ India Pharma Inc.must prioritise innovations and solutions that are critical for the Indian populace.
engineers required to manufacture such devices are still in a nascent stage in India, h owever, there is immense scope for the growth of this technology. Given the high cost of such technologies, its implementation does pose a challenge, however, as the country develops and the purchasing power of an individual grows, it creates room for such devices.
Innovative therapies are costly, however, their benefits offset their expensive nature as they can be user-friendly,
and more accurate than the conventional methods. Emerging tech-driven pharma innovations have the potential to be immensely beneficial for patients, their caretakers and healthcare providers. Additionally, the panel agreed that the regulatory authorities are closely monitoring emerging technologies and regulating the manufacturing and marketing process of combination drug devices.
Innovations in drug formulation was another significant area of discussion.
Experts emphasised that India needs to shift focus towards developing new chemical entities. To enhance our research capabilities, it is important to work on these goals collectively. In order to achieve this objective, Indian pharma majors must partner with smaller research organisations to develop NCEs as they offer significant growth potential for the Indian pharma industry. India Pharma Inc must prioritise innovations and solutions that are critical for the Indian populace.
Polymeric solutions for the pharmaceutical industry
Polymers have myriad applications in pharma processes and systems, therefore to throw more light on their uses and advantages, Prabhat Balyan, Manager - Business Development, Ami Polymer gave a presentation on polymeric product solutions for the pharma industry. He elaborated on the diverse applications of tubing and hoses in the life sciences sector and highlighted the importance of tailoring these solutions to meet the unique requirements of various pharma products.
Balyan emphasised how polymeric products can help pharma companies meet regulatory standards while ensuring safety and efficacy. He also presented on the significance of evaluating physical properties such as tensile strength, flex crack resistance, and opacity when selecting polymers for specific formulations and ensuring that
Precisionengineered polymeric products can help pharma companies meet regulatory standards while ensuring safety and efficacy
the selected materials are chosen for the right applications.
Emergent technologies and systems in steam sterilisation and glassware washing
Stinita Dsouza, Application Specialist, Equitron Medica, showcased the emerging technologies and systems in steam sterilisation and glassware washing. She informed that Equitron offers steam sterilisers, glassware washers, GMP washers, and lowtemperature hydrogen peroxide glass plasma sterilisers. They serve applications in microbiology quality control, organic chemistry R&D, and healthcare pathology.
Dsouza highlighted that Equitron’s autoclave comes with several advantageous features like compactness, and water conservation by providing a closed-loop water circulation system. The glassware washers have a flexishelf system for adaptable loading, optimal utilisation of space, and fewer wash cycles. Additionally, the storage space for accessories is also reduced. The washers have an intuitive configuration of wash cycles and a HEPA filter
for drying. Equitron has the EU Pressure Equipment Directive (PED) certification for the design, manufacture and conformality assessment of stationary pressure equipment with a maximum allowable pressure greater than 0.5 bar.
Prabhat Balyan,Manager – Business Development,Ami Polyme
Trends and challenges in complexdrug development
Dr Vasanthakumar Ramu, VP & Head R&D - Peptides & Complex APIs, Alembic Pharma, provided an insightful session on the complexities of developing and manufacturing peptide-based APIs at the Vadodara Pharma Summit 2024. He emphasised the growing importance of therapeutic peptides, unique molecules with distinct benefits and challenges that include their high potency, selectivity, low toxicity, and suitability for targeting a broad range of diseases such as diabetes, cancer, and cardiovascular conditions.
D. Ramu outlined key development areas, from synthetic approaches like solid-phase and solution-phase synthesis to advances in recombinant methods. He discussed challenges around the stability, solubility, and bioavailability of peptides, particularly for oral formulations, which are constrained by rapid degradation and poor membrane
permeability.
The session highlighted essential manufacturing control strategies, underscoring the significance of process parameters such as temperature, reaction conditions, and protective group selection to p revent undesired reactions. Dr Ramu provided an overview of quality control through rigorous characterisation techniques, including amino acid sequencing, stability studies, and impurity profiling by methods like LC-MS.
He advocated for a Quality by Design (QbD) approach, wherein critical quality attributes (CQAs) are systematically identified to ensure consistent, high-quality manufacturing outcomes.
In conclusion, Dr Ramu underscored the critical role of advanced analytics, automation, and regulatory support in enabling the continuous synthesis and reliable supply of peptide therapies.
Building partnerships with CDMOs,academia,and global markets
Dr Girish Achliya, Head of R&D at Gowrie Research, gave a compelling session on establishing and strengthening partnerships across CDMOs, academia, and global markets to propel drug development. This session explored the synergies created when combining academic innovation with the manufacturing and commercialisation capabilities of CDMOs. Dr Achliya emphasised the importance of bridging the gap between academia and industry to unlock innovation potential, vital for accelerating drug discovery and development.
Key discussion points included the role of CDMOs in the pharma industry, specifically how outsourcing drug development and production can significantly reduce costs, improve efficiency, and speed up the time to market. The session also addressed strategies for successful partnerships, emphasising on the importance of clear IP agreements, regulatory considerations, and well-defined project goals.
He also presented case studies, in-
Dr Girish Achliya,Head-R&D,Gowrie Researc
cluding successful models like the BioNTech-Pfizer COVID-19 vaccine partnership and Amgen’s collaboration with the University of Toronto.
Dr Achliya concluded that environments that prioritise transparency, shared goals, and ongoing innovation are vital for progress. These environments
Dr Achliya emphasised the importance of bridging the gap between academia and industry to unlock innovation potential,vital for accelerating drug discovery and development
will drive the future of drug development, as partnerships become key to tackling the complexities and regulatory demands of global pharma markets.
Dr Vasanthakumar Ramu,VP& Head R&D - Peptides & ComplexAPIs,Alembic Pharma
Creating the birthplace of scientific breakthroughs
Emphasising the importance of a well-designed and ergonomic lab, Ranjeet Singh, VP- Sales and Marketing, GD Waldner India presented on the offerings of his company that provides lab solutions for the pharma and biopharma industry.
He spoke on products such asThe SI3 fume hood, metal furniture, enclosures, table frames, and accessories that are made in India. He informed that the SI2, secuflow fume hoods, dimensions service systems, laminate furniture, room controllers and automation are made in Germany and supplied to India. Thus, they combine German engineering with Indian manufacturing proficiency. The installation is done by a combined team for faster site execution.
GD Waldner offers HVAC, gas piping, electrical, and plumbing along with an in-house MEP team. The endto-end turnkey capabilities offered are
Ranjeet Singh,VP-Sales & Marketing,GD Waldner India
Future trends in excipients with lownitrite
Santosh Kakad, AGM - Sales and Marketing, Nitika Pharmaceutical Specialities, discussed the impact of excipient selection on nitrosamine formation in drug products. The presentation highlighted how managing nitrosamine impurities can be a challenge for the pharma industry, as nitrite levels in excipients like microcrystalline cellulose (MCC), lactose, and superdisintegrants significantly influence nitrosamine formation.
Nitika offers products such as MCC, magnesium stearate, and sodium stearyl fumarate with low nitrite levels. These excipients are part of a strategy to mitigate nitrosamine risk and enhance patient safety. Kakad emphasised the importance of selecting low-nitrite excipients to reduce the risk of nitrosamine formation and improve product safety. This approach is crucial for high-risk formulations and aligns with regulatory guidelines to ensure the safety and efficacy of pharma products.
The end-to-end turnkey capabilities offered are hightech,safe, personalised and energy-efficient to provide the optimal output for scientists and the R&D community
high-tech, safe, personalised and energy-efficient to provide the optimal output for scientists and the R&D community.
Nitika offers products such as MCC,magnesium stearate,and sodium stearyl fumarate with low nitrite levels.These excipients are part of a strategy to mitigate nitrosamine risk and enhance patient safety
Santosh Kakad,AGM - Sales and Marketing,Nitika Pharmaceutical Specialtie
R&D strategies for innovation
Dr Aravind Badiger, Technical Director, BDR Pharmaceuticals’ session on ‘Research strategies for innovation’ at Vadodara Pharma Summit 2024 provided valuable insights into the dynamic processes reshaping the pharma industry. Dr Badiger focused on the rapid advancements in research and development, emphasising the role of emerging technologies, collaborative efforts, and evolving regulatory frameworks in driving innovation.
The key trends he highlighted included the rise of personalised medicine, precision therapies, real-time diagnostic tools and customised treatment approaches. Dr Badiger also stressed on the importance of genetic information in tailoring precision therapies, aiming to achieve better patient outcomes with minimised side effects.
The session delved into technolo-
Dr Aravind Badiger,Technical Director,BDR Pharmaceuticals
gies like Zip Dose, which streamlines drug delivery, and the practice of drug repurposing, a critical lesson drawn from the COVID-19 pandemic. Dr Badiger discussed identifying new treatment gaps and exploring areas like female sexual dysfunction, showcasing BDR Pharma’s focus on addressing unmet medical needs.
Dr Badiger concluded by underscoring the need for continuous learning and adaptation to overcome challenges such as drug resistance. He stressed the industry’s responsibility to align innovation with patient needs, improving accessibility and affordability of life-saving drugs. The session also provided an in-depth look at BDR Pharma’s strategies towards their research endeavours.
This session highlighted on R&D innovation to bring forth more effective, patient-centered therapies for the global market.
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Panel Discussion: Building a pharma ecosystem: Science,Business,Ethics
The concluding panel discussion at the Vadodara Pharma Summit 2024 centered around a critical theme: Building a Pharma Ecosystem: Science, Business, and Ethics. This session brought together thought leaders from across the industry to discuss the importance of harmonising scientific innovation, business growth, and ethical standards, to ensure a balanced approach which is crucial for sustainable growth.
Moderated by Dr Ajay Khopade, VP FR&D at Sun Pharmaceuticals, the session featured an impressive lineup of experts: Bharat R Desai, MD, Bharat Parenterals; Appasaheb Kabadagi, COO, Synergy Pharmaceuticals Corporation; Pradipta Kumar Swain, COO, Innoxel Lifesciences; Nitish Chakravarty, Pharma Expert; and Hitesh Thakkar, Head of Formulation Development, Alembic Pharmaceuticals.
The discussion began with a focus on aligning science, business, and ethics, with panelists agreeing that integrating these three pillars is crucial for the long-term sustainability of India Pharma Inc. The experts emphasised that achieving a balance ensures the sector not only advances in commercial success but also contributes meaningfully to societal well-being. They noted that India’s pharma ecosystem, with its rapid growth and expanding global presence, has a responsibility to maintain high ethical standards and quality while driving business outcomes.
Panelists expanded on this by identifying four core values—quality, compliance, patient centricity, and sustainability—that must underpin any efforts to build a sustainable pharma ecosystem. These values are essential in maintaining trust and ensuring that healthcare remains accessible, affordable, and equitable. The industry representatives also pointed out that the life-saving nature of pharma necessitates stringent ethical practices, transparent pricing, and responsible processes.
Another central theme was the role of inn ovat ion in the ecosystem. The panelists highlighted how research and
◆ It is keyto align scientific innovation,business growth and ethical practices to drive sustainable growth,create societal impact and ensure commercial success
◆ As a life-saving industry,we need the right practices,the right pricing,the right processes and the right people.
◆ The right balance of science,business and ethics will be paramount to enable access to equitable and affordable medicines and healthcare services
◆ Global concerns like nitrosamine impurities require both preventive and corrective measures that are safe,collaborative, ethical and strategic
◆ Values like quality,compliance,patient centricityand sustainabilitymust be the pillars for India Pharma Inc's continued growth and success
development in new therapies, drug formulations, and packaging solutions are essential for India to remain competitive globally. However, they stressed that innovation must go handin-hand with ethical responsibility. They shared that a focus on ethical in-
novation is critical, especially as companies face complex challenges, such as the presence of nitrosamine impurities in medicines. They asserted that addressing such global concerns requires both preventive and corrective strategies that prioritise safety, qual-
ity, and ethical considerations.
Panelists concluded that as the industry evolves, it must address critical challenges such as affordable access to medicines, adherence to compliance standards, and the proactive management of safety concerns.
PHARMA PULSE
Reshaping pharma safetywith active packaging innovations
CILICANTis revolutionising active packaging with solutions tailored for the most sensitive formulations.Meet the innovators driving stability,safety,and impurity control in pharma packaging at CPhI India
In pharmaceutical packaging, where quality and safety are requisites for a shelf-stable formulation, Cilicant has understood this concern very well and is committed to providing the right solutions to protect the formulations from the harmful effects of moisture and oxygen, which are well-known factors affecting stability.
Over the years, CILICANT has established itself as an innovative manufacturer of active packaging solutions with notable patented technologies. The latest inn ovation, the Oxabide Canister, is specifically designed to stabilise oxygen-sensitive products, addressing a key concern in pharma formulations.
Oxabide Canister is one of the most efficient active packaging solutions to keep oxygen-sensitive products stable whilst addressing a specific concern with certain formulations that need the oxygen scavenger to be used along a desiccant.
Likewise, Frexil desiccant
canisters, which are activated carbon-based desiccant canisters, are one of their notable innovations that addresses the concern of carbon dust particle contamination common with generic activated carbonbased desiccant canisters.
Frexil desiccant canisters consist of compressed, non-
CILICANTis not just creating new solutions; they’re pushing boundaries and exploring issues that impact the industry
dusting desiccant tablets that can effectively adsorb odour and/or moisture without imparting any carbon dust particles, depending on the variant you choose.
As a trusted partner in pharma packaging, CILICANT is not just creating new solutions; they’re pushing
boundaries and exploring issues that impact the industry, like “Does specific active packaging hold the key to controlling N-nitrosamine impurities?”
If you’re heading to CPHI India from November 26-28 at the India Expo Centre, Greater Noida, be sure to stop
by Booth 14.A58. Don't miss the chance to meet the team behind these innovations and see firsthand how CILICANT is reshaping active packaging for pharma packaging.
For more information, please visit, www.cilicant.com
Frexil
Oxabide Canister
Adaptive Manufacturing: -The newflexibilityin medical device assembly
Unlike traditional,rigid production lines,B&R's adaptive machines seamlessly adjust to the requirements of each device,dynamically adapting to each unique process
For manufacturers to succeed in the industry and meet the increasing expectations of the marketplace, they must be apprised of developments. Medical device manufacturing is a sophisticated, iterative process that involves multiple crucial stages. It commences with the ideation and conceptualization phase, where manufacturing and medical expertise are crucial. As they convert innovative medical concepts or procedures into workable and functional goods; engineers, scientists, and healthcare professionals must work closely together throughout this phase. In all these human errors cannot be neglected and to assure an error free process, usage of automation and adaptive practices helps to curb out any errors in the process. This flexibility and precision help manufacturers innovate and manufacture sustainably.
Challenges and possibilities
The manufacturing of medical devices is one of the most dynamic industries since it is always changing to satisfy the needs of consumers for better health and well being. The regulatory environment in which medical device makers operate is complicated, with changing norms and obligations. One of the biggest challenges facing manufacturers is keeping up with evolving laws and harmonizing international standards. But it's also critical to keep up to date. Some of the difficulties can be avoided by keeping up with legislative changes, investing in compliance knowledge, and upholding strong quality management systems. Also, for the manufacturing of medical devices, the emergence of patient-specific devices and per-
sonalized therapy offers both potential and obstacles. Technological developments like adaptive manufacturing and 3D printing make it possible to produce devices that are specifically suited to each patient. By offering specialised medicines and treatment options, personalized medicine manufacturing has the potential to completely transform the healthcare industry. This is even more of a problem from the manufacturer's perspective, though where one must be cautious and depend on robust solutions. Economy of scale is one of the most important factors as it indicates that firms can grow their market share through more error-free production. To achieve the desired result, one must prepare a checklist where its production can run seamlessly. Manufacturing defect zero is a dream to medical device manufacturers. Adaptive manufacturing to some extent will curb out manufacturers issues and will provide a sustainable solution that will run long.
Medical device assembly with B&R
Successful medical device makers are adopting automation to handle the problems of rapidly shifting demand, which is a result of both changing markets and medical advancements. Manufacturers are adopting recycling programs, streamlining production procedures to cut waste, and using eco-friendly products more and more. The medical device business is also
adopting the idea of a circular economy, which reuses or repurposes resources. The production of medical devices necessitates a deep comprehension of manufacturing procedures and the highest level of consistency, which standard manufacturing partners cannot provide. The best course of action is to choose a manufacturing partner who has experience adhering to the strictest standards and who is knowledgeable about the complexities of the healthcare sector. B&R has been working with the Indian
manufacturers and abroad to simplify the complexities of medical device assembly manufacturers. Revolutionising the assembly of medical devices with adaptive manufacturing is the key step in optimizing the efficiency and quality of the production. Adaptive manufacturing inculcates some of the solutions for medical technology-
Flexibilityfor product change
B&R's Mechatronics Systems – ACOPOStrak, SuperTrak and ACOPOS 6D – are ex-
tremely flexible and adapt effortlessly to different production requirements. Our unique shuttles and track diverters can be easily reconfigured to support different line layouts or products while maintaining real-time control of each individual product throughout the process.
Qualitycontrol and traceability
By integrating B&R Machine Vision into the mechatronics systems, quality checks can be executed in real time during the assembly process. At the same time, traceability enables precise production tracking. By reducing errors and implementing real-time quality control, scrap costs can be reduced.
Increased productivity
B&R's expertise increases efficiency and enables optimization and control of each individual product during the assembly process. This raises overall productivity. The result is Higher production output and the potential for significant increases in sales.
Elevate your assembly processes and gain a competitive advantage with B&R’s adaptive solutions. Unlike traditional, rigid production lines, B&R's adaptive machines seamlessly adjust to the requirements of each device, dynamically adapting to each unique process. This flexibility is driven by the integration of cutting-edge technology into a unified system, enabling efficient, automated changes in real time. The potential of adaptive machines is reshaping the future of industries like medical device manufacturing, assembly, and packaging—ushering in a new era of precision, efficiency, and agility.
Top Syringe offers a unique extensive range of disposable Glass Micro Capillary Pipettes for pharma R&D as well as QC laboratories,with some options available with Calibration certificates
Top Syringe Mfg Co (P) Ltd manufactures a range of Disposable Micro capillary pipettes under the brand name 'Mucaps.' The group established its first manufacturing unit in 1964 in Mumbai through technical collaboration with Top Corporation, Japan to make glass syringes. At the same plant, the indigenous production of disposable microglass capillary pipettes was started in 1975, through technical collaboration with senior scientists from the prestigious Indian Institute of Technology Mumbai. Today, Top Syringe makes a number of products in glass tube engineering and is proud of the variety offered in the Disposable Micro capillary pipettes portfolio which caters to the laboratory and medical fields. 100 per cent Made in India at its plant by Special drawing Machines, the capillaries are made of uniform bore in borosilicate 3.3 expansion glass tubing. The range of capillaries includes Graduated Capillaries as per ISO 7550, Melting Point Capillaries, Endto-End capillaries and Thin layer chromatography capillaries. The medical range of capillaries includes Hematocrit Capillaries as per ISO 12772, BTCT, Rat & Mice Bleeding capillaries and diagnostic kits capillaries. Each micropipette is intended to be used once only and then discarded.
Common applications in the laboratory include
1. Handling small amounts of liquids, blood sampling, microfluidics, and manipulating biological samples
2. For manual TLC sampling at the Research and Development (R&D) labs
3. Easy to be positioned with the Multipurpose Spotting Guide TLC plates
4. Storage of small amounts of liquids or for the determination of melting point - tubes which are open at one end and can be
easily sealed in a Bunsen flame
5. For precise predetermined volume dispensing
6. Microbiology to determine bacterial motility or measure bacterial growth rates
7. Sampling and measuring the interaction between chemical and biological molecules, such as surface tension, viscosity, surfactant concentration, etc
8. Used to purify and identify the chemical and physical properties of different compounds, such as viscosity, surface tension, wettability, and flexibility
9. Hematocrit capillaries are used to measure the percentage of red blood cells in a blood sample. They are used in a variety of applications, including immunoglobulin, Anemia and polycythemia diagnosis. The dosed heparinised solution is adjusted to not affect the determination of pH- and calcium levels, as it is possible when adding not neutralised heparin saline solutions. Sodium heparin is the common anticoagulant used. We have also introduced Ammonium heparin which does not interfere with sodium identifications.
Graduated
(GR) Capillaries with Colour Code
'MUCAPS' Precalibrated
Pipettes are intended for applications where accurate capillary tube volume is required. The pipettes are in conformity
with ISO 7550. The Pipettes have a standard length of 125 mm and the colour-coding on each pipette is the volume, which is measured from the
base and up to the thin black ring mark. The sizes offered include 5?l, 10?l, 20?l, 25?l, 50?l, 100?l, 200?l. A calibration certificate can be made available on request.
TLC Glass Capillaries for Spotting
'MUCAPS' Non-calibrated tubes are made from 3.3 expansion borosilicate glass for use with aqueous and organic solutions. Useful for depositing
small amounts of sample onto a Thin Layer Chromatography (TLC) Plate. This prevents overloading and helps to achieve an accurate and clear TLC in preparation for running a small column. Used widely at all leading Pharma R&D. Available with a very small bore size of 0.55mm, they are available in 4-inch, 5-inch, 8-inch and 10inch lengths.
End To End Capillaries (ETE)
'MUCAPS' End-to-End Micro Pipettes without marking are said to contain specification volume when filled completely the pipettes are in conformity with ISO 7550. The Intended application includes the Collection and Dispense of Fluid, Blood
samples collection etc. The Precision bore capillary tube is attached to our unique dispensing bulb to form a unique micropipette for easy collection & dispensing of samples. Available in sizes of 0.5?l, 1?l, 2?l, 3?l, 4?l, 5?l, 10?l, 20?l, 25?l, 44?l, 50?l, 100?l, 150?l, 200?l. The standard length is 29mm upto 50?l.
Melting Point Micro Capillaries
'MUCAPS' Melting point Capillary Tubes are perfect for handling and transporting of small volumes of liquid, Melting Point determinations and many other purposes. Melting Point tubes are uniform and cut at right angles. Available with Both End Open or One End Sealed. These
capillaries are cut to constant lengths 75mm, 100mm, and 125mm.
Blood Sampling Capillaries
'MUCAPS' Micro Haematocrit
Tubes are quality products that conform to international standard ISO 12772. The tubes are a
colour-coded end in order to identify the particular product especially, the Heparinised Cap-
illaries (Red Tip Band on each capillary) and Non Heparinised Capillaries (Blue Tip Band on each capillary). Some capillaries are customised as per customer requirements of a particular volume selection or packing size as well, especially for diagnostic kits. Standard Mice and Rat bleeding capillaries can be used for blood sampling from respective species. The pipettes are packed in a plastic vial with a dispenser top, that makes it easy to shake out one tube at a time thereby ensuring hygienic handling. Economical box packing is also available as a standard product for a few products. Special requirements regarding marking, dimensions, packing or impregnation (coatings) are possible. Using a disposable glass product is more environmentally friendly as compared to a disposable plastic product, thus keeping a positive outlook on the natural world we live in.
Top Syringe exports its products to over 40 countries worldwide and counting, keeping a single quality standard for local and export products.
Contact today and start your journey with the laboratory liquid handling MUCAPS Disposable Glass Micro Capillary Pipettes.
Contact
Top Syringe Compound W.E. Highway, Pandurangwadi, Mira Road (East), Thane 401107 India Mob: 81046 82560
There are several critical applications in the industry like research and development that demand for continuous & reliable monitoring of important environmental parameters. From medical, bio-technical, chemical and pharmaceutical laboratories to cleanrooms, biobanks up to blood and tissue banks, a holistic monitoring system is very necessary which reliably records different measurement parameters in these rooms and at equipment. Wherever there is a need to adhere to necessary standards, ensure traceability and audit compliance, especially Pharma, these solutions become crucial in the facility operation.
The most efficient way to address this requirement is the implementation of fully automated environmental monitoring system testo Saveris Pharma. It monitors and documents temperature, humidity, differential pressure, and other parameters without interruption and compliantly with GxP so that audits and inspections are conducted smoothly. As a complete solution, testo Saveris Pharma combines
◆ High-precision measurements with secured data communication
◆ Intuitive and pro validation software
◆ Comprehensive services.
The system consists of following components
Data logger and communication modules
Data loggers are the components that measure / log the data continuously at different locations in the facility. They communicate with the base unit to transfer the recorded data. Because there are numerous tasks to fulfil in research and development, there are various models of data logger to measure different parameters.
Another important task is data transfer and for that communication modules are used. Each data logger can be flexibly connected to one of the three communication modules.
◆ WLAN Module
◆ LAN Module
◆ Radio via Testo Ultra range communication Module testo UltraRange ensures that a strong and robust radio signal is available even over long distances or in closed rooms. All data loggers can be exactly calibrated, and depending on the model, can record temperature and relative air humidity. As per the applications, Data Loggers are selected for Environment Monitoring for Warehouse, Analytical/ Microbiology Lab, Animal house or Equipment Monitoring like Refrigerator, Freezer, Chiller, Walk in chamber, etc.
The base station
The base is literally the heart of testo Saveris Pharma system. It can connect with 1000 different Data Loggers at a time. It collects measurement values and analyse it limit value violation or any other critical event occurs. It plays an important role in prompt alarm management. The base unit can be positioned centrally at a given facility location or office. Base station delivers alarms to users via an alarm relay and an LTE stick that enables alarms by
SMS as well in addition to visual and audible alarms.
Digital and analog sensors
The instrumentation utilised to measure parameters like temperature and humidity is in the form of variety of digital and analog sensors that are easy to handle and install. The Digital sensors has advantage over analog sensors as it can be quickly exchanged during continuing operation for calibration or defect correction. Calibration of Digital Sensor is independent of its Logger. Thus, it ensures no gap in the measurement values or documentation. The measuring ranges of the temperature probes extends from -200 °C to +1300 °C, covering almost any possible scenario in the field of research & development.
The integration of other measurement parameters such as differential pressure, particles etc. also work smoothly with the analog coupler as a standardized interface.
System software
Once the data is recorded by
Loggers and analysed by the base station, the testo Saveris Pharma software comes into play where all readings are collated, stored, visualized, and backed up seamlessly. Automatic reports are generated and sent over email to concerned users. Some important features are applied like electronic signature, Electronic Record, Access Control, Audit Trail, Alarm Logs. There are two versions of the testo Saveris software;
◆ testo Saveris PRO softwareIt is suitable for the automated and uninterrupted data monitoring with less stringent regulations, normally other than Pharma Industry.
◆ testo Saveris CFR softwareIt guarantees unconditional adherence to US 21 CFR Part 11 as well as Annex 11 of the EU guidelines for GMP. In addition to the range of function of the PRO version, it offers Audit Trail and electronic signatures.
In addition, we provide Web access to the data with testo Saveris Pharma Cockpit - a web based and intuitive user interface which allows data access from different end devices. Alarms can be identified and acknowledged via a smartphone, tablet or PC at any time. It also supports features like digital signature post any action as well as a mandatory comment on the event.
Comprehensive Services
The most important aspect of any solution is after sales service. This is one of the strongest values offered by Testo to its customers. Testo extends its support from site survey, Installation commissioning, IQ-OQ documentation to annual maintenance work and recalibration. So, all the end-to-end services are offered under one roof as an OEM by Testo. Thus, user do not have to run pillar to post to get support, Testo ensures rich user's experience throughout life cycle of the system.
Areas of application
◆ Area Monitoring in Labs, Production, Warehouse, Animal House in Pharma
◆ Equipment monitoring for QA/QC, Microbiology in Pharma
◆ Clean room area Monitoring in Pharma
◆ Refrigeration and deepfreezer applications in Pharma
◆ Uninterrupted cold chain monitoring & controlled freezing in blood and bio banks
◆ Applicable for lab equipment from laboratory extractor to water bath
◆ Data centre Area Monitoring
◆ Calibration and Testing Lab area monitoring
For more details, login to our website www.testo.com or write back to us on info@testo.in
PHARMA PULSE
Ensuring clean room integritywith prime clean reset high-speed doors
Prime Clean Reset high-speed doors ensure airtight seals,minimising air permeability and contamination in clean rooms.Designed for sensitive environments,they enhance operational efficiency and meet rigorous regulatory standards,making them ideal for pharmaceutical and biotech industries
High-speed doors for clean rooms are specialised industrial doors essential for maintaining controlled environments. These doors are engineered to be airtight, creating a reliable barrier between different areas of a facility. Their design ensures durability and minimal maintenance, reducing the frequency of repairs and replacements.
High-speed clean room doors offer a range of critical benefits essential for maintaining stringent environmental control. These doors enhance hygiene by providing an airtight seal that effectively isolates clean room environments, preventing the ingress of dust and other contaminants. This capability is especially crucial in sectors such as pharmaceuticals, biotechnology, and food production, where maintaining sterility is non-negotiable.
In the pharma and life sciences industries, compliance with rigorous regulatory standards necessitates the manufacture of products within controlled clean room environments. A high-performance clean room door is an integral component in ensuring the integrity of these spaces, safeguarding product quality and patient safety.
Beyond contamination control, these doors are engineered with advanced safety mechanisms, including automated sensors and emergency stop functions, which mitigate the risk of operational hazards. Moreover, high-speed clean room doors are designed to maintain precise overpressure or under pressure conditions within the environment. This is vital for preventing cross-con-
tamination and ensuring that the clean room remains in a state of controlled integrity, even under varying operational demands.
Given the critical role these doors play in maintaining the purity and safety of highly specialised environments, selecting the appropriate door system is a decision of strategic importance.
Prime Clean Reset, our high-speed door is designed specifically for clean rooms. This innovative solution is engineered to meet the stringent requirements of controlled environments, ensuring exceptional performance and reliability. Designed with precision to meet the stringent requirements of controlled environments, Prime Clean Reset is the epitome of performance and reliability, ensuring that your clean room operations consistently meet the highest standards of regulatory com-
pliance and product integrity.
Prime Clean Reset is suitable for clean rooms up to ISO Class 5, offering an unparalleled air permeability rate of less than 12 m³/m² h at ? 50 Pa. This ensures that even in the most sensitive environments, the door effectively maintains the critical pressure differentials required to prevent contamination, thereby safeguarding your processes and products.
Engineered with cuttingedge European technology and innovative design principles, Prime Clean Reset offers rapid cycle times for both opening and closing, making it the optimal solution for medium to large entrances in clean room applications. The door's construction is specifically tailored to minimise air leakage and particulate infiltration, ensuring that it supports the rigorous cleanliness standards necessary for applications such as
pharma manufacturing, semiconductor fabrication, food processing, and other highly specialised sectors.
With its robust design and reliable performance, Prime Clean Reset seamlessly integrates into your clean room infrastructure, providing a critical barrier that preserves the integrity of controlled environments. Whether you are operating in a pharmaceutical, biotechnology, electronics, or defence industry, Prime Clean Reset offers the precision, durability, and compliance needed to maintain your competitive edge in highly regulated markets.
Key features of Gandhi Automations' High-Speed Clean Room Doors include:
◆ Low Air Permeability: Designed to maintain low air permeability in pressurized rooms with both positive and negative air pressure.
◆ Compact Design: The doors
are designed to fit inside the columns, with a self-supporting construction that minimises air leakage.
◆ Customisable Transparency: They can be equipped with transparent PVC horizontal sections or vision windows for visibility.
◆ Specialised Side Guides: The special side guides ensure a tight integration of the curtain, providing high leak tightness.
◆ Efficient Operation: The doors offer high efficiency and low permeability values, compliant with EN 12426 and EN 12427 standards, ensuring < 12 m³/m² h ? 50 PA.
◆ Durable Control Device Enclosure: The control device enclosure is made of StainlessSteel SS 316, ensuring durability and resistance to corrosion. These high-speed doors are meticulously engineered to minimise air leakage and maintain strict environmental control, making them indispensable for clean room operations. Their rapid opening and closing operation ensure that the internal facility remains isolated from external conditions, effectively upholding the cleanliness and controlled environment essential for maintaining the integrity of clean rooms.
For further information on our high-speed doors offering, contact:
The most common method of drug delivery is oral dosage form of which tablet and capsule are predominant. Tablet is more accepted as compared to capsule due to many reason such as cost, tamper resistance, ease of handling, ease of identification and manufacturing efficiency. Tablet compression process understanding is resulted in development of formulation. Recent advances in the design of tablet compression equipment has conducted resulted in higher efficiency, minimized tablet variation, greater flexibility.
Tablets are compressed by compression machines using punches and dies. Punches are used to apply pressure on powder or granules to form tablets. Two types of punches are used, Upper punch and Lower punch Upper Punches are in direct contact with upper punch guiding cam and due to direct contact, and friction is produced, so lubrication is required at regular time intervals at this contact point. Sometimes excessive use drips downward along with a punch barrel and is mixed in powder or granules and contaminate the product. Due to the poor dust collection system of compression machine, fine powder in the granules is suspended in the turret chamber and settles down over the upper punch holders and guiding cam.This fine powder is mixed with lubricant and due to friction and upward and downward movement of punches in punch holders, this fine powder is converted into black particles. These black particles shredded from punch barrel settle down over the rotating die table and contaminate the product. So back particles are produced on compressed tablets.
To prevent tablet contamination with dripping lubricant and black particles Dust cups or Bellows are used.
Bellows/Dust Cups finds ap-
plication in wide range of in Packaging, Baking, Cartooning, Robotics, Tablet Compression, and for a variety of automated material handling applications involving metal, glass, food, plastics, paper, and wood.
DUSTCUPS
Dust cups may also know as dust holders and act as a reservoir for dripping lubricant. Dust cups are usually made of silicon material. Dust cups are attached to the tips or barrels of the upper punches and collect the black powders or dripping lubricant and safeguard the product from contamination.
Types of the Dust cups:
Dust cups are of two types
i. Conventional or Standard dust Cup
ii. Barrel dust cup
◆ Conventional or Standard dust Cups These dust cups are also known as tip dust cup. These dust cups are attached to the tips of the upper punch. These dust cups are not precut. These dust cups are cut according to the tip size of the upper punch. After cutting tip of upper punch is passed through the hole of the dust cup.
◆ Barrel dust cup These dust cups are for punch barrel. These are pre-cut according to barrel size. Barrel dust cup is inserted in the barrel and is used for the same purpose as tip dust cup.
BELLOWS
Granulation contamination
during the tableting process can cause costly manufacturing problems. Bellows used in punching tablets helps to prevent contamination and black spots on the tablet during the tablet compression process.
ABOUTPROTECTING TOOLING AND PRESSES?
AMI POLYMER PVT. LTD. stocks tip - mounted, barrel, and below styles of dust cups, each made from silicone. We also offer metal detectable as well as food grade silicone version. Dust cups are a low-cost
solution to keep formulation off tools, lubrication off tablets and reduce issues like tool binding & contamination
Advantages of Silicone Silicone Dust cups/Bellows provide an advantage in certain manufacturing situations as their physical properties are mostly retained at temperatures of up to 250° Celsius. This allows dust cups to run on presses at higher temperatures for an extended period of time increasing potential production times Silicone rubber also resists oils, solvents, and other chemicals at higher temperatures than other plastics. In AMI POLYMER PVT. LTD. Dust Cups and Bellows are made with FDA-approved materials, and are selected to meet specific requirements for stability, wear-resistance, cleaning, and flexibility.
Metal detectable Dust cups and Bellows
Dust cups are a low-cost solution helping to keep lubrication off die tables and out of tablets. Bellows provide additional protection for tooling and presses by blocking formulation from collecting on tools, reducing tool wear and binding.
The increasing standards of the safety and quality, has enabled the pharmaceutical, food and beverage industry to build up a true partnership with the dust cups and bellows .The
dust cups keeps off the lubrication from the tablets die and bellows provide an addition support and protection to the tools and increasing the life of the tools .Sometimes these dust cups and bellows may undergo excessive wear and tear on a continuous stretch, and usage. This may sometimes lead to the generation of small sized particles, resulting in the contamination of the entire process.
To detect any early detection of contamination, complying with all the rules and regulations of the FDA, we have introduced the feature “Metal Detectable”.As the name suggests, these helps us to detect the presence of any unwanted particles into our lots at a very early stage.
WHYCHOOSE APPL METALDETECTABLE BELLOWS/DUSTCUPS?
AMI POLYMER PVT. LTD.
Provides metal detectable dust cups and bellows are made of silicone and infused with trace amounts of an iron additives which follows all FDA guidelines. It is simple, non-reactive, and effective and improves the quality of tablets. If a dust cup or bellow begins to break down, sensors in metal detectors will reject the contaminated tablets. Currently all metal detectable dust cups are made in Grey and Blue colour and bellows produced are black in
PHARMA PULSE
grey and brown colour. Metal detectable dust cups and bellows are available in sizes #1, #2 and #3. In the tipmounted style dust cups sizes B, D are available and FS12 for barrel style dust cups. For bellows B and D sizes are available. Any customization is also taken into consideration.
AMI POLYMER PVT. LTD. recommends our customers to enjoy the superior quality and performance of the Metal Detectable features.
◆ A potential cost saving to the food and beverage, and pharmaceutical manufacturers.
◆ These cups/bellows work well and is highly resistant to mechanical and temperature factors.
◆ They prevent from microbial attacks.
◆ Nullifying and reducing the Production downtime. Hence increases productivity.
◆ Easy to use, fit and clean.
◆ Easily designed and suits your machine specifications.
◆ Contamination free production.
Metal detectable dust cups and bellows also provide an advantage in certain manufactur-
ing situations as there is almost no change in their physical properties even at temperatures of up to 150 degrees Cel-
sius (302 degrees Fahrenheit.) This will allow them to run on presses at higher temperatures for an extended period of time
CONTRIBUTOR’S CHECKLIST
❒ Express Pharma accepts editorial material for regular columns and from pre-approved contributors / columnists.
❒ Express Pharma has a strict nontolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form,without giving due credit in the industry-accepted format. All authors have to declare that the article/column is an original piece of work and if not,they will bear the onus of taking permission for re-publishing in Express Pharma.
❒ Express Pharma's prime audience is senior management and pharma professionals in the industry.Editorial material addressing this audience would be given preference.
❒ The articles should cover technology and policy trends and business related discussions.
❒ Articles for columns should talk about concepts or trends without being too company or product specific.
❒ Article length for regular columns: Between 1200 - 1500 words.These should be accompanied by diagrams, illustrations,tables and photographs, wherever relevant.
❒ We welcome information on new products and services introduced by your organisation for our various sections: Pharma Ally (News,Products, Value Add),Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information.
¡V possibly increasing production efficiency.
AMI POLYMER PVT. LTD. recommended and provided Metal detectable Dust cups and Bellows to our prestigious customers like INTAS PHARMACEUTICALS, KTT PHARMA, AUROBINDO PHARMA LTD, MICRO LABS, ERIKS, and MANY MORE.
For any query please feel free to contact, Thanks & Regards, Ramandeep Singh B. Bhalla M.E( Rubber Technology) Sr. Executive- Sales & Marketing-Gujarat
Contact No : +91-8425994984 Email: id- guj@amipolymer.com, ramandeep.b@amipolymer.com
❒ Besides the regular columns,each issue will have a special focus on a specific topic of relevance to the Indian market.
❒ In e-mail communications,avoid large document attachments (above 1MB) as far as possible.
❒ Articles may be edited for brevity,style, and relevance.
❒ Do specify name,designation,company name,department and e-mail address for feedback,in the article.
❒ We encourage authors to send their photograph.Preferably in colour, postcard size and with a good contrast.
Email your contribution to: The Editor, Express Pharma, Business Publications Division, The Indian Express (P) Ltd, Mafatlal Centre,7th floor, Ramnath Goenka Marg, Nariman Point,Mumbai 400021 viveka.r@expressindia.com viveka.roy3@gmail.com
PHARMA PULSE
Powerful Process Control with IND500xWeighing Indicators
Ensuring consistent quality in hazardous environments, particularly in Ex-Areas (Zone 1/21, Division 1), is a critical aspect
Full NetworkConnectivity
Modern industrial environments demand seamless integration with various control systems. The IND500x meets
device includes pre-installed applications that simplify complex tasks such as filling and formulation, ensuring users can achieve optimal results
of industrial operations. The IND500x weighing indicators from METTLER TOLEDO provide a robust solution for these challenging settings, offering optimized safety and productivity.
Versatile Applications
The IND500x is designed to handle a wide range of applications, thanks to its high-resolution capabilities of up to 30,000d. Whether used for simple weighing tasks or more complex automated processes, it supports inventory control, filling, and formulation with precision and reliability.
Error-Free Operation
To minimize the risk of operational errors, the IND500x incorporates features such as error messages and step-by-step operator guidance. These functionalities ensure that tasks are performed accurately and efficiently, reducing downtime and enhancing overall productivity.
this requirement by offering flexible connectivity options, including high-speed interfaces compatible with PLCs or DCS systems. This ensures smooth data communication and process management across the entire network.
Maximum Process Control
The indicator supports both manual and automated control operations, providing unparalleled flexibility. It is particularly effective in filling or formulation processes, where precise control over material flow is essential.
KeyFeatures of IND500x
1. Global Approvals: The IND500x comes with global approvals, making it suitable for use in standardized operations across different regions.
2. Flexible Communication Options: It integrates easily with PLC or DCS systems, offering various communication protocols to suit different industrial setups.
3. Built-in Applications: The
with minimal effort.
The IND500x weighing indicators are a powerful tool for industries operating in hazardous areas. By combining
versatility, error-free operation, full network connectivity, and maximum process control, they help optimize both safety and productivity. For industries requiring precise and reliable weighing solutions, the IND500x stands out as a toptier choice.
About METTLER TOLEDO
METTLER TOLEDO is a leading global manufacturer of precision instruments. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. The Company also holds top-three
market positions for several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the Company is the world’s largest manufacturer and marketer of metal detection systems used in production and packaging. Additional information about METTLER TOLEDO is available at www.mt.com.
Visit us: www.mt.com/IND500x Email us at –sales.sales@mt.com Call us toll-free at – 1800 22 8884 & 1800 1028 460
Hydrocolloids are high molecular weight hydrophilic polymers (usually Proteins and Polysaccharides chemically), which contain polar or charged functional groups, rendering them soluble in water. They are produced or extracted from various sources, such as plants (trees, seeds, tubers and pulses), animal (milk, meat, animal by-products) and microorganisms (bacteria, fungi and yeast) etc. A few examples include locust bean gum, carrageenan, pectin, starch (plant), chitosan (animal), xanthan gum (microbial fermentation), carboxymethyl cellulose, hypromellose, methylcellulose, alginates (chemical modification of natural polysaccharides) and many more. [1] [2]
Chemically, hydrocolloids generally consist many hydroxyl groups and polyelectrolytes, which make them hydrophilic in nature. They are incorporated into food formulations mainly to control rheology and structure. In aqueous environments, hydrocolloids swell, increasing their hydrodynamic volume, thereby increasing the viscosity of the system. In addition, if the hydrocolloids entrain sufficient water due to their concentration, their chains will interact, yielding a gelled network. These gels can be produced at high concentrations of polymer, or by reducing the solvent quality (i.e., alteration of pH or ionic strength). For example, addition of sufficient Calcium ions to a liquid Sodium or Potassium Alginate solution yields a gel. Due to their swelling behavior, hydrocolloids are required only in low concentrations to confer the desired effect. [1] [2] They are used in a variety of industries to perform a number of functions, including –
◆ Thickening
◆ Gelling and binding
◆ Coating
◆ Syneresis control
◆ Stabilization of foams
◆ Emulsions and dispersions / suspensions
◆ Stabilization of pH
◆ Enhancement of heat resistance
◆ Improvement of salt tolerance
◆ Control release formulations and many more [3]
JRS offers a range of hydrocolloids, useful in solid, liquid, semi-solid products for pharmaceuticals, nutraceuticals and food applications, the portfolio consists of –
◆ VIVAPUR® MCG (Microcrystalline Cellulose Gel) [5]
VIVAPHARM® Alginates are linear Polysaccharides consisting blocks of Guluronic acid and Mannuronic acid. [5] They are derived from a rich field of brown Algae (a type of Seaweed) off the French coast. [4]
As mentioned above, the range consists of –
◆ Sodium Alginate
◆ Calcium Alginate
◆ Alginic acid
TYPICALPROPERTIES AND BENEFITS
Natural
◆ Extracted from sustainable harvested seaweed / No animal origin / Vegan
◆ During manufacturing process, no solvent or alcohol is used
◆ No allergens
◆ Clean label-friendly
◆ Recognized as GRAS [4]
Solubility
fibers and formation of a gel. This leads to hemostasis and subsequent healing. Other properties like biodegradable, biocompatible and non-im-
gel preparations. [4]
Anti-reflux raft barrier
Alginate based anti-reflux preparations have been in use
Solubilitybehavior is most important aspect for most functionalities of Hydrocolloids.Considering that, Sodium and Potassium salts are water soluble,whereas Calcium salt and acid are insoluble. [4] The table belowelaborates their solubilityprofile in more detail
Solubilityincoldwater
Solubilityinhotwater
Gelation via ion-exchange
In the liquid, semi-solid or textured products, Sodium Alginate helps through gelling without applying any temperature. Infusion of Calcium Chloride or other suitable Calcium ion source leads to ionexchange between Calcium and Sodium, which results into gelation. [4] This is beneficial to products and actives where higher temperatures may prove detrimental.
Precise control on gelling
The gel setting time and its consistency can be very precisely controlled by adjusting the rate of addition and concentration of Calcium ion into the liquid system of Sodium Alginates. [4] This gives uniform batch results of viscosity, gel strength, consistency and texture to food and pharmaceutical products.
Thermostable and water insoluble gels
Gels made with Alginates exhibits improved heat and moisture stability. This results into less or no melting and no sticking of the final product in hot climatic conditions, e.g. maintains capsule integrity. [4]
Hemostasis
When Calcium alginate dressing comes into contact with wound exudate, there is an exchange between the Calcium ions in alginate and the sodium ion in blood or exudate, resulting in swelling of alginate
munogenic make it useful for these applications. [4] [8]
Film formation
Alginates are excellent filmforming agents. They give instant gelling for strong, flexible, clear, glossy and consistent film-strips. [4]
Versatile
Its viscosity modifying, gelling and film-forming properties in various conditions make Alginates one of the most versatile polymer. [4]
APPLICATIONS
Owing to these unique and versatile properties and benefits we can impart to various food products and pharmaceutical formulations, Alginates are widely used and generally regarded as non-toxic and nonirritant excipient. Pharmaceutical and medical applications are discussed in this section.
Medical wound dressing
Calcium alginate is useful in this application due to hemostasis properties and benefits stated in previous section. It can absorb 15-20 times of their own weight of wound exudates. Dressing with Calcium alginate provides moist environment to the affected area and is easy to remove. [4]
Dental care
Precise gelation and control over consistency makes Sodium alginate suitable for dental impression and dental
for the symptomatic treatment of heartburn for many years.
Calcium alginate and Alginic acid gels are used to form protective layers in the stomach. Another element of action of these formulations is the floatation of the gel layers in the form of protective raft. When bicarbonates (Sodium and/or Calcium) and sodium alginate solution comes into contact with gastric acid, chemical reaction occurs, and Alginic acid and/or Calcium Alginate (insoluble gel layer) is generated respectively along with Carbon dioxide. Floatation is achieved by embedding Carbon dioxide bubbles in the gel layer. [4] [6] [8]
Thickener / suspending agent
Alginates modify viscosities of aqueous systems. This can be effectively applied to oral solutions and dispersions to provide structure and / or retard sedimentation of suspended particles. Alginates are widely used as a thickening and suspending agent in a variety of pastes, creams, and gels, and as a stabilizing agent for oil-in-water emulsions. [5][8]
Film-former
With Sodium Alginates, films with oil-barrier properties, anti-sticking and protective coatings can be prepared. This is quite useful when usage of conventional film-formers are restricted. [4]
Image 1: Manufacturing process of VIVAPHARM® Alginates [4]
SodiumAlginateCalciumAlginateAlginicacid
Table 1: Solubilityof VIVAPHARM® Alginates [4]
PHARMA PULSE
Binder
Due to polymeric structure, Alginates can be used as a binder in granulation techniques. [5]
Controlled-release polymer
Alginate matrices are highly suited for modified/controlled release of highly acidsoluble drugs. At low pH in stomach, it forms an insoluble gel layer acts as a functional diffusion barrier, which limits the release of the API. In the intestine, it turns to sodium salt due to higher pH. It behaves as soluble viscous layer, which releases API by diffusion and erosion. [4] [7] [8]
Disintegrant
The solubility profile of Calcium alginate and Alginic acid shows that they do not get dissolved but swell in cold water. This property makes them suitable to be used as disintegrants in oral solid formulations. [4] [8]
Enteric polymer
Being anionic in nature and exhibiting pH dependent solu-
REFERENCES
[1] O’Sullivan, J.J. and O’Mahony, J.A.; Food Ingredients,
Multiple grades are available under VIVAPHARM® Alginates umbrella,which consist of Alginic acid,Calcium Alginate and Sodium Alginates.Ashort summaryis given here –
Table 2: Various grades of VIVAPHARM® Alginates and related applications
JRS OFFERINGS OF GRADES UNDER VIVAPHARM® ALGINATES
SUMMARY
VIVAPHARM® Alginates consist of Alginic acid, Calcium Alginate and Sodium Alginates. They are of natural origin extracted from brown seaweed. Their different solubility profiles make them suitable for various applications in food, medical and pharmaceuticals.
School of Food and Nutritional Sciences, University College Cork, Cork, Ireland (2016).
[2] Gawai, K.M., Mudgal S.P., Prajapati J.B.; Chapter-3, Stabilizers, colorants, and exopolysaccharides in yogurt; Yogurt in Health and Disease Prevention (2017).
[3] McArdle R. and Hamill R.; Utilisation of hydrocolloids in processed meat systems; Teagasc Food Research Centre, Ireland and J. P. Kerry, University College Cork, Ireland (2011).
info/brochures/brochures/vivapharm-alginates.php)
[5] JRS Hydrocolloids - Innovations based on renewable resources (jrspharma.com) (https://www.jrspharma.com/ph armawAssets/docs/brochures/brochur e-hydrocolloid-gb-210216web.pdf)
[6] The Use of Alginates in AntiReflux Suspensions - JRS Pharma (https://www.jrspharma.com/ph arma_en/technical-
