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Chairman of the Board
ViveckGoenka
Sr.Vice President-BPD
Neil Viegas
Vice President-BPD
Harit Mohanty
Editor Viveka Roychowdhury*
Editorial Team
Lakshmipriya Nair
Kalyani Sharma
Kavita Jani
Neha Aathavale
DESIGN
Art Director
Pravin Temble
Senior Designer
Rekha Bisht
Senior Artist
Rakesh Sharma
Marketing Team
Rajesh Bhatkal
Ashish Rampure
Debnarayan Dutta
Production Co-ordinator
DhananjayNidre
Scheduling & Coordination
Pushkar Waralikar
CIRCULATION
Mohan Varadkar
CONTENTS
EVENTS
16 FDD CONCLAVE 2024: FORGING THE PATH FOR TOMORROW'S THERAPEUTICS
18 10TH EDITION OF PHARMALYTICA HELD IN HYDERABAD
22 IPAHOSTS GLOBAL PHARMACEUTICAL QUALITYSUMMIT 2024
RESEARCH IN FOCUS
32
BENGALURU: DRIVING INNOVATION IN INDIA'S PHARMA LANDSCAPE
43 LIPID-BASED NOVEL FORMULATIONS ARE ADVANCING MENOPAUSE MANAGEMENT
44 THE GROWING THREATOF ANTIBIOTIC RESISTANCE
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.
Revised Schedule M audits to test will, skill of regulators and regulated
From July 1, India's medicines watchdog, the Central Drugs Standard Control Organisation (CDSCO), will start risk based unannounced audits of pharma companies with a turnover over Rs 250 crore as per the revised Schedule M. Smaller companies have six months more to gear up for revised Schedule M audits.
But it is interesting to note that even as all global regulators, especially the US FDA, raise the bar on quality expectations, and major pharma companies in India express a willingness to learn from inspection outcomes, the US FDA has been facing scrutiny of its own processes and systems back home.
Giving the keynote address at the 9th Global Pharmaceutical Quality Summit organised by the Indian Pharmaceutical Alliance (IPA), Dr Arunish Chawla, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, reminded the audience of Prime Minister Modi's vision that all Made in India products to be “zero defect, zero effect on environment”, emphasising the push for quality at the highest level. "Our mission going forward is to make quality the centre of policy framework... The integrity of the Indian industry relies on every player's adherence to the highest standards. When one fails, it affects the entire industry. Therefore, we must collectively uphold quality to protect our reputation and ensure excellence in every aspect."
Dr Rajeev Raghuvanshi, Drug Controller General of India (DCGI) spoke about the several gains over the past year, like reducing approval timelines, increasing digitisation, and setting up internal quality audits with CDSCO, among many more. But he also candidly admitted that continuous quality improvements are both a matter of will and skill, on the part of the regulated and the regulators. The hope is that the audits for larger companies will serve as a warning signal to under-Rs 250 crore companies to shape up or ship out by their deadline, January 2025.
A joint IPA-McKinsey presentation pointed out that as of March 2024, as part of the quality drive in the past year, around 64 pharmacos licenses, 53 licenses were suspended, and 17 drug testing laboratories shut down for non-compliance with GMP or continued lapses. Analysing data over the past decade, Sathya Prathipati, Senior Partner, McKinsey & Company, pointed out that Official Action Initiated (OAI) outcomes for India's pharma industry improved significantly from (estimated) 26 per cent in 2014 to 13 per cent in 2023, lower than the global average 15 per cent.
He also cited that a five-year analysis of US FDA inspection data shows an approximately 20 per cent reduction in observations around essential cGMP training/capabilities and an approximate 45 per cent reduction in observations around lab controls and core manufacturing processes in 2023, versus 2018. Areas of concern remain, like the approximately 35 per cent increase in observations around ‘Facilities and Ancillary infrastructure’ and the approximately 25 per cent increase in observations around ‘Investigations and Root Cause Analysis’ in 2023, versus 2018.
While global regulators may acknowledge the progress, they emphasise that it's a long road ahead. Patrizia Cavazzoni, M.D.,
As the US FDA raises quality expectations, investigations into its inspection practices are being closely watched by biopharma honchos in India
Director, Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration flagged several areas for improvement. One of the most recent examples she cited are the data integrity concerns observed in BA/BE study data submitted by CROs in India (Panexcell/ Synchron, Semler, Synapse) to support applications. Cavazzoni indicated the implications of such findings on the approval of such medicines, their disqualification from certain procurement systems in the US, etc.
Back home, the US FDA has been the subject of a House Energy and Commerce Committee investigation into FDA inspection practices, since 2023. Following letters in July and December 2023, a February 6, 2024 oversight hearing to which the US FDA reportedly declined to make an official available to testify, a new letter dated June 21, 2024 from the three lawmakers spearheading the investigation, present findings that suggest 'vast differences in the skill, thoroughness, and competence of FDA inspectors', and also refers to 'reports of, and concerns about, foreign manufacturers attempting to bribe or improperly influence inspectors.'
Their analysis of the outcomes of US FDA inspections in India and China from January 2014 to April 2024 reportedly reveal 'tremendous variation in inspection outcomes.' Giving examples, the letter points out that while some FDA inspectors found compliance issues during all or almost all of their inspections, other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue over the course of a combined 24 inspections in India. By contrast, the letter states that 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted.
Consider that the House Energy and Commerce Committee was originally established in December 1795, to "regulate Commerce with foreign Nations, and among the several States". This ongoing investigation focusing on China and India, read along with the BIOSECURE bill introduced in the House of Representatives in January 2024, hints at the intentions of US lawmakers to red flag over dependence for services/products as a national security risk. It's fair to say that biopharma honchos in India are watching these headlines closely.
As the US heads into acrimonious Presidential debates prior to elections in November, India too buckles in for a potentially stormy monsoon Parliament session. Quality of medicines and medical products is sure to remain a hot button topic on both continents as lawmakers call out bad actors, ranging from compromised inspectors, lax companies and countries perceived to pose national security threat.
Hopefully the revised Schedule M audits and limelight will incentivise more pharma companies to start and continue to invest in quality systems. After all, healthy patients lead to healthy nations and healthy balance sheets as well.
HiCeITM Silicified Microcrystalline Cellulose, a high functionality excipient for Direct Compressible tablets, is a combination of binder, filler Microcrystalline Cellulose and glidant Silicon dioxide.
HiCel™ SMCC 90M
HiCel™ SMCC 50M
HiCel™ SMCC LM90
0.27-0.39
HiCel™ SMCC HD90
HiCel™ SMCC 90M SCG
0.27-0.30
Formulas in which a balance of flow and compaction is required.
Formulas in which optimal compaction and decent flow is required.
Equal to grade HiCel™ SMCC 90M but low moisture content (<1.5%) It is recommended for extremely moisture sensitive active ingredient.
Similar to HiCel™ SMCC 90M in particle size, but with higher densities. This grades have improve flowability and facilitate thinner tablets. This grade shows the best disintegration times.
Coarser than HiCel™ SMC 90M, This grade specially developed for high density with fine particles API's.
Note: All values are presented only for the purpose of basic reference and not as specifications
PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging,lab analytical and cleanroom solutions,and pharmaceutical ingredients
The 10th edition of PharmaLytica, organised by Informa Markets in India concluded at HITEX, Hyderabad. With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. This year’s edition saw participation from over 5,000 visitors and more than 200 exhibitors showcasing 1000+ brands. They reaffirmed the need and focus of PharmaLytica as an industry event to boost and facilitate the pharmaceutical sector.
Key exhibitors included Hetero, Emvee Engineers, Schneider Electric, Integrated Cleanroom Technology, Nicomac Taikisha Clean Rooms, HLE Glascoat, Scientific Research Instruments Company, Ami Polymer and many more. The expos were primarily supported by industry associations such as BDMAI (Bulk Drug Manufacturers Association (India), FOPE (Federation of Pharma Entrepreneurs) and IPC (Indian Pharmacopoeia Commission). Additionally, Telangana Life Sciences served as a supporting partner, while ETRIC was the e-mobility partner for the event.
The inauguration ceremony of the trade expo was marked by the presence of dignitaries such as Udaya Bhaskar, Director General, General of the Pharmaceuticals Export Promotion Council of India (Pharmexcil); AVPS Chakravarthi, Ambassador –World Packaging Organisation
and Board Member, Pharmexcil; Orhan Yalman Okan, Consul General, Consulate General of Turkey, Yogesh Mudras, MD, Informa Markets, India and Rahul Deshpande, Senior
Group Director, Informa Markets, India.
Highlighting the significant growth of the pharmaceutical industry, Udaya Bhaskar, Director General, Pharmexcil,
said “During the pandemic and post-pandemic period, the Indian pharmaceutical industry made significant contributions. We exported $ 27.8 billion worth of drugs in the
financial year 2024, achieving a 9.6 per cent growth rate despite numerous global challenges. We are expecting to reach more than $ 31 billion in the next financial year. 50 per cent of our exports are going to highly regulated markets. In North America and Europe, it's almost 55 per cent. In the US, we exported more than 8 billion with a 15 per cent growth rate, and to the UK, we achieved a 21 per cent growth rate. This demonstrates the robust growth of the Indian pharmaceutical industry, even in challenging situations. As long as India continues to manufacture quality drugs at affordable prices, the industry will remain unmatched.”
Emphasising the potential of pharma trade between India and Turkey, Orhan Yalman Okan, The Consul General, Consulate General of Turkey, said “Hyderabad is becoming a global city, particularly in the pharma sector, making it the pharma capital of India. Both India and Turkey are rising in this field, presenting significant trade and cooperation opportunities In 2022, the global pharmaceutical market reached a value of $ 1.5 trillion, with Turkey ranking 21st. The Turkish pharmaceutical market grew by an impressive 80 per cent, reaching around $ 38 billion and unit sales hitting $ 2.8 billion. The industry employs over 45,000 staff and offers over 12,000 products. Turkey's pharmaceutical exports were $ 2.2 billion, reaching over 170 countries. The medical devices market was $ 2.9 billion, and medical tourism contributed $ 2.5 billion. PharmaLytica 2024 aims to foster deeper understanding and cooperation within the
pharmaceutical domain. By sharing pertinent insights into Turkey's pharmaceutical landscape, including its remarkable growth trajectory, regulatory framework, and export prowess, we aim to cultivate a clearer understanding of the sector's potential.”
AVPS Chakravarthi, Ambassador, World Packaging Organisation and Board Member Pharmexcil, said, "Pharmalytica has grown into a permanent landmark of innovation in the pharmaceutical industry from Mumbai to Bangalore and now Hyderabad. In life-saving and lifesustaining industries, there's no room for compromise on quality. Our exports to highly regulated markets like the USA, where over 50 per cent of our products are consumed, reflect our uncompromising standards. The collaboration between India and US authorities aims to ensure the availability of safe, high-quality drugs. Hyderabad, often referred to as the second Silicon Valley of the world, integrates digital and chemical technologies, making it a hub for pharmaceutical inn ovation. The city hosts more than 214 USFDA-approved facilities, accounting for over 35 per cent of India’s pharmaceutical production. Additionally, Hyderabad is a significant centre for medical devices and packaging, having become self-sufficient even during the COVID19 supply chain challenges.”
Speaking on the sidelines of the inaugural, Dr Gaurav Pratap Singh, Senior Principal Scientific Officer, Indian Pharmacopoeia Commission said, “India's reputation as the 'Pharmacy of the World' is well-earned, with our commitment to supplying high-quality and affordable medicines globally. Our leadership in vaccine supply to WHO, coupled with meeting the generics demands of the USA, Britain, and Europe, underscores our pivotal role in healthcare accessibility. The significant growth in biosimilars approvals and manufacturing further enhances patient access to biopharmaceuticals. With strategic investments in developing
generic and biopharmaceutical versions, India stands poised to maintain its global pharmaceutical leadership. Innovation remains paramount, especially in emerging prophylactic and therapeutic products like medical devices, complex generics, monoclonal antibodies, and gene therapy. Setting robust regulations for their development and marketing is crucial for sustained growth. While quality concerns highlighted by WHO and other regulatory agencies necessitate stringent quality control measures, platforms like PharmaLytica 2024 play a
vital role in prioritising quality in the pharmaceutical sector. Looking ahead, there's immense potential to replicate the success of hubs like Hyderabad and Bengaluru in Tamil Nadu and Kerala, creating new avenues for growth in the pharma industry."
Addressing the opportunities in this sector, Yogesh Mudras, MD, Informa Markets, India said, “In 2024, the Indian pharmaceutical industry remains a global leader across the entire supply chain. It ranks third in production by volume and in terms of Active Pharmaceutical Ingredients
(APIs) globally. With over 500 different APIs manufactured domestically, India contributes 57 per cent of APIs to the WHO's prequalified list. The medical devices sector in India stands at a market size of $ 11 billion. By 2032, the India analytical laboratory instruments market is projected to hit $4142.85 million, propelled by the government's focus on boosting production, notably supported by the flourishing pharmaceutical sector.
Situated in Hyderabad, the epicentre of India's bulk drug production, and nestled within
South India's mature pharma ecosystem, Pharmalytica emerges as a vital regional hub for industry leaders and stakeholders with discussions surrounding emerging trends, prevalent challenges, and promising opportunities,” he added.
QualityConference
On the sidelines of the show, an exclusive two-day conference with the theme "Optimising Pharmaceutical Quality and Compliance," convened with over 35 key industry leaders engaging in strategic discussions about the future of the pharmaceutical sector. On the 1st day, experts delved into technology trends aimed at maximising pharmaceutical productivity, explored analytical advancements transforming pharma labs, and discussed regulatory and quality frameworks essential for biosimilar development. They also covered strategies for drug repositioning, integrating quality in clinical development, inn ovations in pharma packaging and machinery, and advancements in analytical instrumentation.
Day 2 was equally engaging, with a focus on strategies for India's evolution from a generic drug manufacturer to a hub for active pharmaceutical ingredient (API) production. Discussions included strategic collaborations with Contract Manufacturing Organisations (CMOs) and Contract Research Organisations (CROs), in nova tions in pharma manufacturing, green chemistry, advancements in analytical labs, and enhancements in the pharma supply chain and cold chain management. These sessions aim to improve quality and accessibility across production and distribution. Additionally, the conference addressed the industry's outlook on packaging, labelling, serialisation, and track and trace technologies. With renowned industry speakers, PharmaLytica 2024 offered insightful discussions and valuable networking opportunities, positioning itself as a key event for industry professionals.
July2024
IPAhosts Global Pharmaceutical Quality Summit 2024
Global quality experts call for strengthening quality culture and leveraging technological advancements
Indian Pharmaceutical Alliance (IPA) concluded the 9th edition of the Global Pharmaceutical Quality Summit. The theme for the summit was, ‘Advances in Manufacturing and Quality –Patient Centricity’. The twoday summit brought together industry leaders, global regulators, quality experts, and stakeholders to foster knowledge exchange and deliberate on areas of importance in shaping the pharmaceutical landscape in India.
The summit witnessed 16 sessions and 45 speakers from around the globe including
senior officials from the Government of India, USFDA, MHRA and IGBA. Sudarshan Jain, Secretary General, IPA, began with the welcome address, followed by opening remarks from Nilesh Gupta, Chair, Quality Committee, IPA and MD, Lupin and Patrizia Cavazzoni, Director, CDER, USFDA; special remarks by Rajeev Raghuvanshi, Drug Controller General of India, Government of India. Arunish Chawla, Secretary, Department of Pharmaceuticals, Government of India delivered the keynote address. Day 1 of the summit set the
stage for the pharmaceutical industry’s future by focusing on strategic priorities, quality management, and technological advancements. It featured the release of the IPA best practices guideline on Good Engineering Practices and Process Analytical Tools. The sessions reviewed the industry’s current landscape and future planning, emphasising robust quality frameworks. This was followed by deliberations on the transformative role of AI in enhancing pharmaceutical quality and operations, and the importance of cybersecurity in protecting
digital infrastructure and strategies to minimise crosscontamination, crucial for maintaining high production standards. The day concluded with insights into future data and documentation imperatives, highlighting meticulous record-keeping and data management for compliance and quality.
Day 2 began with opening remarks from Sarah McMullen, Country Director, USFDA. This was followed by a session on regulatory reforms by Chandrasekhar Ranga, Joint Drugs Controller, Government of India,
and Susana Almeida, Secretary General, International Generics and Biosimilar Association (IGBA); and on talent acquisition strategies, and skilling institutes for quality manufacturing by Global CHROs and Manufacturing Heads. The highlight of the day featured insightful panel discussions on charting the next decade of pharma quality and operations and the biopharma opportunity which saw leaders from leading pharma companies. The Summit concluded with closing remarks from Nilesh Gupta, emphasising continuous
EVENTS
improvement and building on the culture of quality for the sector.
Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance, said, “The Summit has indeed grown from strength to strength since its inception in 2016. This year’s theme, ‘Advances in Manufacturing and Quality with focus on Patient Centricity,’ highlighted the unwavering commitment of the industry to enhance the culture of quality in the pharmaceutical sector, always prioritising patient welfare. Quality remains fundamental to our industry, and the Indian Pharma Industry continues to strive to become a global benchmark in quality. Our focus is on reimagining the future of manufacturing and quality through leveraging technological advancements, seizing the digital future of pharma quality operations, and adopting a shift in mindset. The insights and collaborations will significantly advance quality in the pharmaceutical industry.”
Rajeev Raghuvanshi, Drug Controller General of India, Government of India, said, “Changing the culture is a slow process, but the journey has started well, and we are moving in the right direction. One of the most impactful initiatives is the risk-based inspections, where we inspected about 400 manufacturing units, closing more than 36 per cent for non-compliance. This has significantly improved perceptions and realities on the ground. The first group of industries with more than 250 crores of turnover will soon come under the compliance purview of the revised Schedule M, ensuring higher standards and better quality. Additionally, we are enhancing internal processes, including the transfer of 207 officers to raise a culture of quality and integrity. Our ongoing efforts aim to bring consistency and efficiency to the regulatory framework.”
Arunish Chawla – Secretary, Department of Pharmaceuticals, Government of India, said, “Quality is of
paramount focus – standing on three essential pillars: market, patient, and neighbour. Market quality commands a premium and builds reputation, which is our best defence against malpractices. Patient quality is driven by robust regulatory systems, and
India is progressing rapidly on this front. Our mission going forward is to make quality the centre of the policy framework. We’ve upgraded Schedule M of the Drug and Cosmetic Rules, surpassing WHO GMP standards in some areas. With the audits starting
in July 2024, we aim to produce world-class products, as emphasised by the Prime Minister’s vision of ‘Zero defect and Zero effect.’ Quality requires investment, and we support medium and small plants through reform initiatives. The integrity of the In-
dian industry relies on every player’s adherence to the highest standards. When one fails, it affects the entire industry. Therefore, we must collectively uphold quality to protect our reputation and ensure excellence in every aspect.”
Cutting-edge research,future-ready talent,next-gen infrastructure,judicious investments and strategic collaborations are crucial to fuel India's ascent as a biopharma powerhouse
By Lakshmipriya Nair
India has traced a journey of grit and glory to emerge as a major supplier of generic drugs and vaccines globally. Today, it is a key player in the global pharma landscape. However, as healthcare demands and the life sciences landscape evolves, it is now time to conquer new frontiers and expand its horizons far beyond generics.
With advancements in biotechnology, robust scientific capabilities, cost-effective manufacturing processes, a large workforce and a shift towards more complex biologic drugs, India is at the cusp of a huge opportunity to emerge as a leader in biopharma.
Brimming with potential
As per an Invest India report of 2023, the Indian Bioeconomy, valued at $137 billion in 2023, is targeted to reach $150 billion by 2025 and $300 billion by 2030.
IBER Report 2023 divulges, “The biopharma vaccines (non-COVID alone) market makes a significant daily contribution of approximately $38 million. On a monthly basis, this market adds around $1.16 billion.” It adds, “India notably leads global vaccine supply by volume, producing nearly two billion doses annually.”
The same report informs that “The biopharma therapeutics segment commands an annual value of $16.8 billion, On a daily basis, this sector generates approximately $46.03 million and contributes around $1.4 billion monthly.”
The Invest India report reveals, “The rise in domestic demand is fuelled by initiatives such as Aatmanirbhar Bharat and Make In India, while overseas demand for Indian vaccines and biopharma is due to the globally competitive efficacy of Indian products. India has about three per cent share in the global biotechnology industry.”
Thus, industry experts and analysts alike are bullish on India's biopharma sector. They point out the country's
We have traditionally spent a lot of time on process engineering to make medicines affordable and accessible. However,now we need to strengthen our quality systems.We need to harmonise quality across the industry and with international standards
Dr Arun Anand (Immuneel) COO and Board Director,Immuneel Therapeutics
It is imperative for Indian biotech players to understand the needs of their potential partners and global competitors. Meticulously tracking the changing global landscape,adapting quickly to change,and reinventing business models will require significant creativity and flexibility
Dr Cyrus Karkaria President – Biotech,Lupin
Indian companies can leverage the latest biopharma innovation happening in academia and invest in R&D for novel biologics.Building public-private partnerships can aid in capability building,while favourable policies and financial aid by the government can foster industry growth
Sasmitha Sahu Managing Consultant,GlobalData
Emphasising R&D,incentivising innovation through tax breaks and venture capital funding,along with investing in STEM education and research facilities will build a skilled workforce and a thriving ecosystem that can make India a successful global biopharma hub
Sibaji Biswas ED & CFO,Syngene International
competitive advantages, including cost-effective production, skilled workforce, and a growing pipeline of new therapies.
However, despite the promise and potential, it won't be all plain sailing for India Biopharma Inc. To achieve true global leadership, the sector will have to address several critical challenges and capitalise on its unique strengths.
As Sibaji Biswas, ED and CFO, Syngene International cautions, “Several essential areas for improvement in the current ecosystem need addressing to unlock its full potential.”
So, what are the challenges and complexities faced by India Biopharma Inc?
◆ Limited investments in R&D and innovation is a major one. Dr Arun Anand, COO and Board Director, Immuneel Therapeutics explains that risk aversion, longer timelines for ROI, lack of adequate early-stage funding, absence of an ecosystem that does not reward inn ovati on hamper investments in biopharma R&D in India.
Sasmitha Sahu, Managing Consultant, GlobalData states, “While India has demonstrated success in generic drug production, the same is not true for novel and biosimilar biopharma products.” He explains that there is limited interest in biopharma product research and development due to process-intensive and cost-intensive production associated with biopharma therapies, coupled with a complex regulatory environment and weaker IP framework that could translate to higher risks in this space.”
Dr Cyrus Karkaria, President – Biotech, Lupin concurs, “India has a good network of research labs and well-developed base industries, a large pool of qualified scientific talent, several research labs and R&D institutions. Despite these factors, there are hurdles facing biotech innovation in India. Indian academia,
industry and research labs lack a strong patenting culture, and the academia-industry linkages are weak.”
He adds, “Most academic and research institutions are not well equipped to undertake innovative and translational research. India needs support in setting up an ecosystem, in terms of scientific expertise and incubation centers with seed funding to help develop innovative ideas leading to sustainable growth.”
◆ Manufacturing and supply chain gaps also pose significant hurdles. As India's biopharma sector tries to keep pace with evolving market demands and patient needs, modernising existing biopharma manufacturing facilities and building future-ready facilities are crucial for India’s emergence as a biopharma global leader. This will be pivotal for ensuring quality compliance, managing cost pressures, and adapting to evolving regulatory standards too.
Dr Karkaria elucidates, “Manufacturing and end-toend supply chain are pivotal components within the biopharma industry. Over the past few years, several emerging trends such as pricing and inflation, technology implementation, focus on sustainability practices, transition toward personalised and next generation therapeutics, and innovative healthcare delivery models, are compounding the complexities within manufacturing and supply chain operations. These trends serve as crucial catalysts, necessitating a shift in priorities and a much-needed transformation of the manufacturing sector.”
He adds, “To sustain innovation and leapfrog to the next level, Indian players will have to focus more on preserving, optimising and investing capital, along with raising capital. Improving operating efficiency and building top-class infrastructure will be required to efficiently utilise capital amid funding constraints.”
◆ Lack of clarity in the IPR framework causes complexities. A robust IP framework is essential for fostering innovation in the biopharma sector. India has made strides in
improving its IP regime, but further reforms are needed to align with international standards.
The IP protection framework in India is perceived as
weak, with concerns over patent infringement and compulsory licensing. This hinders innovation and foreign investment.
As Sahu highlights, “With
India recognising patents on pharmaceutical products, there is an existing IP ecosystem in the country but a robust system with clear guidelines is still lacking to address
Slow and bureaucratic regulatory approval processes also often lead to delays in drug approvals and market access. Inconsistent enforcement of standards, lengthy approval timelines, and a lack of harmonisation with international regulatory practices are affecting India’s growth trajectory in biopharma.
◆ Plugging the skill gaps and retaining top talent is challenging. While India has a large workforce, there's a need for more specialised skills in advanced biopharma technologies.
Pointing this out, Sahu says, “Biopharma sector is still in nascent stages in India. As with any sector, creation of ample training, career and growth opportunities will be pivotal to develop and retain top talent in the biopharma sector as well.”
She underscores, “Changing advancements in digital innovations and a greater focus on data analytics means the skills employers need are shifting, changing the makeup of workforces across the sector. This also means employers are constantly in a state of assessing needs and hiring to ensure they have the right people in place to meet demand — the people who will create, develop and bring their solutions to market. Finding and retaining talent, however, has gotten more challenging due to a range of factors: skills gaps, greater competition within and outside the industry, and rising inflation.
Strategising for progress
So, what can be done to mitigate these risks and challenges? Let’s take a look at the strategies and measures recommended by experts to make India a prominent biopharma hub.
◆ Collaborate to conquer: Experts emphasise collaborations are key to build and sustain a robust ecosystem for the biopharma sector. They recommend different kinds of partnerships such as fostering
SWOTANALYSIS OFINDIA'S BIOPHARMASECTOR
STRENGTHS
■ Second-highest number of USFDA-approved facilities outside the US
■ Large pool of skilled STEM graduates and scientists
■ Strong position in generic drug production and vaccine manufacturing
■ Cost-effective manufacturing capabilities
■ Growing research base and increasing adoption of advanced technologies
■ Established ITand data analytics expertise
■ Experience in handling complexbiologic projects with short turnaround times
OPPORTUNITIES
■ Growing global demand for biopharma products and vaccines
■ Increasing interest in India as an alternative to China (China plus one strategy)
■ Potential for leadership in emerging areas like cell therapy and personalised medicine
■ Scope for increased collaborations and partnerships with global pharma companies
■ Leverage ITstrengths to advance biopharma R&D and manufacturing processes
■ Government initiatives supporting the sector (e.g.,PLI scheme,PRIP,BIRAC grants)
■ Growing domestic market for biopharma products
international tie-ups with leading biopharma companies and research institutions, encouraging PPPs to bridge the gap between academic research and commercialisation, developing consortia to tackle complex diseases and promote knowledge sharing etc.
For instance, according to Biswas, “Collaboration stands as a prerequisite in building a sustainable and scalable ecosystem within India's pharma sector, particularly through partnerships among raw materials manufacturers and the pharma product companies and the Contract Research Development Manufacturing Organizations (CRDMOs).”
He points out that to overcome the historical trend of sourcing from China due to cost advantages, we need to
share knowledge and work cohesively with the thousands of local manufacturers to build capability and scale in the ecosystem. This approach will help overcome existing challenges and build on the opportunities shaped by the current geopolitical landscape.
Sahu recommends, “Indian companies can leverage the latest biopharma innova tion happening in academia and invest in R&D for novel biologics. Building public-private partnerships can aid in capability building, while favourable policies and financial aid by the Government can foster industry growth.”
She also suggests, "India can foster collaboration between the IT and the biopharma companies through government or private
WEAKNESSES
■ RelativelylowR&D investment compared to global standards
■ Gaps in infrastructure and manufacturing facilities for advanced biopharma production
■ Regulatorycomplexityand lackof clarity,especially around CRDMO businesses
■ Limited focus on novel drug development and biosimilars
■ Weaker intellectual propertyframeworkcompared to some global leaders
■ Skill gaps in cutting-edge biotechnologydomains
■ Need for modernisation of manyexisting facilities
THREATS
■ Intense global competition in the biopharma sector
■ Rapidlyevolving regulatorylandscape and quality standards
■ Potential brain drain of top talent to other countries
■ Geopolitical tensions affecting global supplychains
■ Rising costs of R&D and manufacturing in advanced biopharma areas
■ Pressure on drug pricing affecting profitability
■ Challenges in balancing innovation with affordabilityof medicines
initiated collaborative channels - these can help facilitate discussions around latest technological advancements available that could help in overcoming challenges in biopharma drug development and advancement."
◆ Embrace technology to transform: Experts and observers also believe that technology will be the true gamechanger. With the immense potential of emerging technologies such as AI/ML, automation and data analytics, India can boost its strengths, mitigate risks and overcome its shortcomings across functions and processes in biopharma, like accelerating drug discovery and development, optimising clinical trial design, enhancing manufacturing processes
through predictive maintenance and enabling supply chain efficiencies. They strongly urge the industry to leverage the huge potential of technology to catapult their growth.
Biswas outlines, “Adopting advanced manufacturing technologies, including continuous processing, digitally programmed manufacturing systems (MES) and deep learning based continuous process improvements are factors that hold immense promise for transforming biopharma production. Unlike traditional batch processing, continuous processing involves maintaining steady-state operations over extended periods, potentially increasing productivity manifold and reducing costs significantly. This shift is
facilitated by the need for smaller facilities, improved process control, enhanced product quality consistency, and more efficient facility utilisation. Regulatory bodies like the US FDA and EMA are supportive of this transition, encouraging manufacturers to embrace these innovations.”
He adds, “Robust automation and digitisation for effective controls, and continuous manufacturing are likely to lead to productivity enhancements that far outweigh the initial investment costs. Like any other segment there is also an opportunity to build a layer of artificial intelligence that can continuously learn and improve the input parameters to enhance dependability and throughput of the manufacturing process. Indian pharmaceutical companies stand to significantly enhance their global competitiveness by aggressively pursuing these technologies, thereby positioning themselves as leaders in novel biopharma production.”
Dr Karkaria highlights, “Digital technology, data analytics, and artificial intelligence (AI)/machine learning (ML) hold the potential to transform the entire R&D value chain, from the intricate stages of drug discovery to the complexities of clinical development. This transformation can enhance efficiency and productivity, reduce costs and timelines, and improve patient access and diversity. Leveraging its robust IT capabilities, India has the potential to spearhead advancements in this field globally, and propel the innovation trajectory of the country's pharma industry.”
◆ Reward research, incentivise innovation: Biswas says, "Emphasising R&D, incentivising innovation through tax breaks and venture capital funding, along with investing in STEM education and research facilities will build a skilled workforce and a thriving ecosystem that can make India a successful global biopharma hub.”
He also recommends,
“Enhancing STEM education and aligning curriculum with industry needs can bolster the pool of skilled professionals. Collaboration between academia and industry is crucial to
bridge the gap between academic research and commercialisation.”
In his opinion, “Fostering a robust inn ovation ecosystem through policies supporting
R&D, technology transfer, and faster regulatory approvals is essential. Strengthening regulatory frameworks and bringing in much required clarity and support will ensure
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compliance and accelerate biopharma advancements. These measures collectively can aim to elevate India's biopharma sector to global leadership by fostering innova tion, Writetous ator sales.sales@mt.com CallTollFreeat 1800228884/18001028460 orvisitusat www.mt.com
enhancing production capabilities, and nurturing a skilled workforce.”
Dr Anand also opines that we need better synergies between biopharma players and investors. He adds that funding inn ovation requires a mindset that supports longterm growth and a scientific approach. He states that building a conducive ecosystem, improving R&D skills, fostering industry-academia collaborations, and developing an academic curriculum that rewards innovation are essential.
Dr Karkaria adds, “India must work to create such a favorable climate for attracting and managing investments, which in turn, fuel innovation. These have been facilitated by a climate of sizeable public funding, surpluses from traditional businesses of large corporations, protection for intellectual capital, vibrant venture capital participation, a competitive marketplace and a demanding environment for academic researchers.”
He emphasises, “To bridge the industry – academia gap, Indian education should focus on providing expertise in the areas of novel drug development, bulk drug production technology, regulatory practices, latest techniques in testing and quality control, IPRs, among others. Soon, there would be a need for such specialisations as more research and manufacturing clusters are set up in India.”
◆ Improve IP framework, make regulations robust: Strong intellectual property (IP) framework, empowered policies and effective regulations will be vital to fulfill India’s ambitions to become a powerhouse in biopharma. A robust IP framework is crucial for India's biopharma sector to thrive globally since it encourages investment in highrisk, high-reward research, attracts MNCs to conduct R&D in India and protects innovations by Indian companies and researchers. While India has made some progress in
The biopharma vaccines (non-COVID alone) market makes a significant daily contribution of approximately $38 million.On a monthly basis, this market adds around $1.16 billion.The biopharma therapeutics segment commands an annual value of $16.8 billion,On a daily basis,this sector generates approximately $46.03 million and contributes around $1.4 billion monthly
strengthening its IP laws, further initiatives such as measures to reduce patent application backlogs, improve enforcement of IP rights and awareness programmes about IP protection among researchers and entrepreneurs.
Sahu recommends, "Fostering a robust innova tion ecosystem through policies supporting R&D, technology transfer, and faster regulatory approvals is essential."
According to Dr Anand, our IP framework has been getting streamlined since 2005. However, our processes need to be faster and more transparent to foster innovation. He also roots for more focus on emerging areas like cell and gene therapies and says that we need an ecosystem and policies that support small companies in biopharma.
Thus the importance of a robust, clear, and supportive regulatory environment in fostering India's growth as a biopharma hub cannot be overstated.
◆ Top notch talent is an imperative : Building and retaining top talent in emerging biopharma areas require concerted and targeted measures like creating educational programs in advanced biotechnologies, offering competitive salaries and career development opportunities, fostering a culture of innovation and entrepreneurship within organisations, and providing incentives for
researchers and scientists to return to India after gaining experience abroad.
Our experts concur with these points.
Biswas highlights, “India has over a long period exported talent to advanced economies of the world, especially the US. To build a robust Indian industry around innovation and latest scientific pursuits, it's important we leverage this vast talent pool and invite them back to India. There must be proactive efforts from the government through incentivisation and creation of an enabling environment for these talent pools to flourish and foster innovation in India.”
Sahu recommends, “Strategic investments can be used to fund biopharma research and development (R&D) activities, build stateof-the-art facilities required for biopharma drug development and manufacturing, and to attract and retain top talent in the sector.
Dr Karkaria suggests, "Looking at current staff and providing appropriate training and career engagement to help them advance internally can help ensure that the company has the skills it needs to innovate ahead of the competition."
◆ Quality should be the cornerstone : "As global companies continue to face new challenges, it is imperative for Indian biotech players to un-
derstand the needs of their potential partners and global competitors. Meticulously tracking the changing global landscape, adapting quickly to change, and reinventing business models will require significant creativity and flexibility," underscores Dr Karkaria.
Dr Anand emphasises that we have traditionally spent a lot of time on process engineering to make medicines affordable and accessible. However, now we need to strengthen our quality systems. We need to harmonise quality across the industry and with international standards.
He also recommends that India should develop capabilities for manufacturing complex biologics and cell and gene therapies.
Sahu points out, "Notably, India has the most USFDA-approved plants outside of the US. Scaling up in terms of quality is a natural progression for the industry."
Advantage India
It is opportune that these measures are being implemented in India's biopharma sector to some extent. Industry stakeholders highlight some of them:
◆ Government initiatives: Biswas mentions, "Government initiatives like the Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme, Biotechnology Industry
Research Assistance Council (BIRAC) grants, and the PLI scheme for APIs, along with the 'Make in India' program, promote domestic drug production and foster targeted research."
Sahu states, "Notably, government initiatives like Make in India, Atmanirbhar Bharat, and the National Biotechnology Strategy (2021- 25) are encouraging the growth of India's technological and product development capabilities in biopharma.
◆ International collaborations: Sahu informs, "India and the US are collaborating to establish the first-ever National Science Foundation and Department of Biotechnology joint funding opportunity that will support collaborative research proposals to promote biotechnology innovation and advance the bioeconomy. The latest launch of the Bio-5 Biopharmaceutical Supply Chain Consortium and the announcement by India and the US to initiate development of a joint strategic framework for building biopharma supply chain optimisation envisages a significant step in this direction."
◆ IP framework: Sahu mentions, "India has recently notified the DBT IP Guidelines in September 2023 to ensure seamless transfer of IP from academia towards commercialisation for the development of novel products."
◆ Talent development: Dr Karkaria notes, "In their efforts to engage and nurture future talent, organisations are creating specific talent communities and content plans. They are investing in technologies to improve engagement, such as platforms to facilitate learning and development, peer-to-peer recognition or collaboration."
He adds, "Majority of Indian biopharma companies are investing in diversity, equity and inclusion (DEI) to enhance the talent experience during the talent acquisition process."
◆ R&D breakthroughs: Sahu
highlights, "Recently, there have been some breakthrough developments by Indian biopharma including the development of the first indigenous chimeric antigen receptor (CAR) T-cell therapy in India for the treatment of r/r B-cell lymphomas and leukaemia."
◆ Global interest: Dr Karkaria states, "India has become a chosen destination for collaborative R&D, contract research and manufacturing and clinical research as a result of growing compliance with internationally harmonised standards such as Good Laboratory Practices (GLP), current Good Manufacturing Practice (cGMP) and Good Clinical Practices (GCP)."
He adds, “The Indian biopharma industry is on the
brink of becoming a major global force in terms of manufacturing and research capabilities. We are witnessing dynamic changing trends such as large acquisitions by multinational companies in India, increasing investments, deeper penetration into the rural markets, growth and availability of healthcare and incentives for setting up special economic zones (SEZs).”
◆ Start-up ecosystem: He informs, “Over the last couple of years, India has emerged as a leader in the startup arena which reflects new, innovative entrepreneurial talent. This culture needs to be nurtured, which is possible only if we reward this talent and create a business environment in which commercial exploitation of new ideas are realised
with ease. Only then can tomorrow’s giant businesses emerge from today’s unicorns.”
As per IBER Report 2023, in 2022, 1390 new biotech startups joined the ecosystem, bringing the 10-year total to 6,755, at a CAGR of 29.8 per cent. The cumulative base grew to 6,755 from 732 startups in 2015—a multiple of almost 9.2 times in seven years.”
◆
Geopolitical factors: Biswas elaborates, “The pandemic highlighted the vulnerabilities of global supply chains, making diversification a strategic imperative. The BioSecure Act, which mandates a phased reduction in Chinese dependencies by 2032, underscores the need for the global pharma companies to recalibrate their global
supply chain strategies. Over the past few quarters, we have seen a steady shift, presenting significant opportunities for Indian CRDMOs to leverage the evolving pharma ecosystem and the large skilled workforce to attract global pharma companies. This positions India as a viable and resilient alternative to China. By capitalising on these strengths and navigating the evolving global landscape, we can solidify our position as a leader in the biopharma sector.”
An ongoing quest Thus, India's biopharma industry stands at a pivotal juncture. To grow and progress, the industry stakeholders will have to align with international standards for
drug quality, minimise manufacturing failures, and expedite market delivery, which, in turn, demands a multifaceted approach to usher significant improvements in operations, quality compliance, and control strategies. By addressing current gaps, leveraging its strengths in IT and manufacturing, and implementing strategic initiatives, India has the potential to emerge as a global leader in biopharma inn ovat ion. Success will require coordinated efforts from government, industry, and academia, but the rewards – in terms of growth, job creation, and improved global health outcomes – make it a worthy pursuit.
lakshmipriya.nair@expressindia.com
laxmipriyanair@gmail.com
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Bengaluru: Driving innovation in India's pharma landscape
Bengaluru Pharma Summit 2024 witnessed an array of pharma professionals congregate to assess the potential growth areas in the life sciences industry and explore opportunities to create value,drive innovation and promote long-term sustainability. Kavita Jani presents a detailed report on the key learnings of the event.
Bengaluru has emerged as a dynamic and rapidly growing hub for the life sciences industry. The city’s strategic location and ideal climatic conditions allow the numerous pharma companies, research institutions, and allied sectors to capitalise on Bengaluru’s geography. Coupled with state-of-the-art infrastructure and a robust talent pool nurtured by prestigious educational institutions, the city provides an ideal environment for fostering innovation and research.
Therefore, through Bengaluru Pharma Summit 2024, Express Pharma aimed to bring together experts, thought leaders and veterans from the industry and regulatory bodies to assess the potential growth areas in the life sciences industry and explore opportunities for businesses in this sphere to create value, drive innovation and promote long-term sustainability. It acted as an ideal platform to share experiences, learn from one another, and collaborate on new initiatives and projects that can drive innovation and growth in the pharma sector.
Bengaluru’s role in India’s pharma landscape
The summit commenced with a panel discussion titled - Bengaluru: Powering Innovation in India Pharma Inc. After gaining the title of the ‘Pharmacy of the World’ and emerging as a leading generics supplier globally, India’s pharma sector is looking towards new horizons to spur its growth. This panel discussed Bengaluru’s role in accelerating this growth and shifting India’s focus from volume to value.
The panel was moderated by
L-R: SiddalingaswamyCA,VP- Operations & Plant Head,Zuventus Healthcare; Dr Goutam Pujari,Member of Board of Directors,Head BE and Clinical Research,ApotexResearch; DAPrasanna,Health TechnologyExpert; Dr Arun Anand,COO and Board Director,Immuneel Therapeutics; Dr Manoj Kumar Singh,Senior VPAnalytical Development,Micro Labs
L-R: Manjunath Nadella,AVP& Head -Packaging Development,Strides Pharma Science; Elayaraja Natarajan, VP- R&D,Lyrus Life Sciences; Dr Rakesh Bhasin,Head R&D (Formulations),Biocon; MayankGarg,Head: MSAT- mAbs,Biocon Biologics; Chandrashekar Rao,VP-Corporate Quality,Althera Laboratories
DA Prasanna, health technology expert. He was joined by, Dr Arun Anand, COO and Board Director, Immuneel Therapeutics, Goutam Pujari, Member of Board of Directors; Head BE
and Clinical Research, Apotex Research, Manoj Kumar Singh, Senior VP - Analytical Development, Micro Labs and Siddalingaswamy CA, VP- Operations & Plant Head, Zuventus Healthcare. Prasanna started the conversation by discussing the qualities of leaders and their pivotal role in driving innovation and growth in a company. Prasanna said,
“The job of a leader is to set aspirational targets and to motivate their team by setting meaningful goals to achieve.” He explained how such goals shouldn’t always be led by numbers but should also provide qualitative meaning to the industry, the country and society. A leader must also keep their team’s morale high, and build a resilient attitude.
Following Prasanna’s lead, Siddalingaswamy elaborated on the importance of maintaining a favourable work environment. He stressed the need to educate the team members and keep them abreast with the developments and changes in the everchanging pharma landscape. Indian Pharma industry must focus on building and training talent, investing in the right talent at the right place will be a key factor in driving progress in the pharma industry. “We need to create favourable working environments where ideas and knowledge can be expressed freely for the mutual benefit of the employee and the organisation,” added Siddalingaswamy. However, driving progress will require innovation and outof-the-box thinking. Therefore, Dr Pujari emphasised the need to develop skilled R&D talent and highlighted the issue of quality compliance. He said, “Currently, India is the leading producer of generic drugs, but it must look for further avenues for growth, for which quality compliance will be paramount. India must shift its mindset from maximising profit to building a culture of quality. Quality assurance and cost-effective measures are what will set us apart from our growing competitors in other Asian countries.”
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Dr Kumar addressed the R&D aspect and emphasised, “Biopharma has a huge opportunity for growth in Bengaluru as the city is equipped with major R&D hubs and institutes like IISc.” However, he also spotlighted the need and importance of industry-academia collaboration and stated that Bengaluru is a very fertile ground for biopharma and pharma development due to its accessibility and abundance of talent.
Delving into Bengaluru’s potential for innovation, Dr Anand highlighted factors that make the city important for pharma/healthcare start-ups. First is the willingness to take risks by investing in start-ups. Second, he informs that Bengaluru generates plenty of capital that gets fuelled back into its ecosystem. This, in turn, allows good talent and innovative startups to flourish.
Sharing further insights, Dr Anand spoke on regulatory reforms. He said, “Regulators not only need to keep the industry practices in check but also need to reform regulations to keep abreast of what is happening and demand the same from the developers. The regulators and the industry are working to serve the patients; therefore, both must work together to ensure safety and quick access to the requirements of the patients.”
The significance of regulatorycompliance
Harish Jain Manawat, Director, Embiotic Laboratories also spoke on the evolving regulatory landscape and its impact. Accentuating that regulatory compliance is of utmost importance in the pharma sector, given its criticality. He cautioned that Indian pharma companies seeking to expand their portfolios and footprints must keep pace with evolving regulations since global markets, including the US, EU, Africa and LATAM, are getting more competitive and supportive of local players, especially post-COVID. Giving an overview of upcoming regulations and policies on national and international fronts, he educated the audience about the scenario post COVID, in various global markets.
Regulations are being used as non-tariff barriers and this could pose a lot of challenges for Indian players in these markets. Dr Jain pointed out, “We are moving away from enforcement and inspection to an era of compliance. Inspections and enforcement are now generally riskbased.” He also spoke on the impact of several key aspects such as price control, trade-margin rationalisations, growing competition from countries like
Vietnam, and Bangladesh, shifting market trends etc in his address.
Driving R&D to promote innovation
Innovation in drug formulations is going to be a determining factor for India Pharma Inc’s trajectory, and ramping up R&D will be extremely vital. With this goal in mind, Loganathan S, AVP (Device Development & Packaging), Stelis Biopharma delivered
an insightful presentation on ‘Driving R&D innovation in pharma, biopharma: Opportunities and Challenges.’
Highlighting a few key areas in product development that should not be overlooked while developing any product, he advised that it is important to understand the opportunity, the product and plan, the voice of the customer and the intended target. Loganathan emphasised, “You have to design your product considering all the parameters while making it so that the harms are not transferred,” stating that the developer must ensure that the needs are converted into design inputs and inculcated into the process of design transfer. He cautioned that this needs an efficient tech transfer technique since major issues primarily occur during the design output process. Lastly, after the product goes into commercialisation, companies must focus on receiving feedback and improve their product accordingly.
He also detailed the factors that will be essential to bring innovation in drug-device combinations such as the development of advanced medication, dosage compliance, ease of administration, safety and affordability, need for minimally invasive procedures, regulatory requirements, cost-effectiveness in healthcare, insurance funding and technological advancements.
Collaborate to grow
As India looks forward to developing and excelling in the pharma industry, alongside quality assurance and accelerating innovation in R&D; forming meaningful collaborations also needs to be a key area of focus. Forming key alliances will be pivotal in the modern business landscape to catalyse growth, innovation and global outreach. To emphasise this topic, Dr Anil Kumar R, Sr VP - R&D & MSAT, Strides Pharma gave a talk on ‘Exploring strategic alliances to enter new markets.’
Dr Kumar started by giving a brief overview of the global market, especially in generics, where there is huge competition, most of which is from Indian pharma majors. Therefore, collaborating
with a rival can leverage the portfolio and be mutually beneficial while entering new markets. “No matter what position you are in, try to look at each scenario as an entrepreneur would maximise the opportunities and leverage them,” he said. Even when considering drug innovations and R&D for new formulations, partnering can allow new drugs to come into markets faster, for the larger benefit of people and healthcare.
To reinforce his ideology, Dr Kumar gave the example of COVID-19. Given the needs of global healthcare, pharma companies witnessed substantial growth due to strategic alliances. Further, he emphasised how cultural fit and compatibility, quality standards and compliance, and experience and expertise are factors to be considered while forming key alliances. He also highlighted the benefits of strategic collaborations like risk-sharing, cost and success in the market.
The blueprint for progress Bengaluru Pharma Summit 2024 enabled a fruitful exchange of ideas and knowledge throughout the summit. The concluding panel discussion was also an interesting one that assessed the scope of India’s pharma industry. Titled, “Navigating India Pharma Inc’s Challenges and Opportunities” it explored how to leverage our strengths such as diversity, tech expertise, topnotch talent and a conducive business environment climate to fast-track growth and success.
The panel included Dr Rakesh Bhasin, Head R&D (Formulations), Biocon as the moderator, Elayaraja Natarajan, VPR&D, Lyrus Life Sciences, Mayank Garg, Head: MSATmAbs, Biocon Biologics, Chandrashekar Rao, VP-Corporate Quality, Althera Laboratories, and Manjunath Nadella, AVP & Head -Packaging Development, Strides Pharma Science.
Dr Bhasin kick-started the discussion by expressing the need to implement smart ways of doing things as opposed to the traditional methods. He stated, “As industry professionals, we need to find ways to manage our risks,” especially in critical systems like production, facilities
July2024
Harish Jain Manawat,Director,Embiotic Laboratorie
Loganathan S,AVP(Device Development & Packaging),Stelis Biopharma
Dr Anil Kumar R,Sr VP- R&D & MSAT,Strides Pharma
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and equipment, R&D and supply chains. He also urged the need for government aid and initiatives to accelerate the growth of the pharma industry.
Rao added to Dr Bhasin’s points and emphasised that the pharma landscape is evolving rapidly, so industry stakeholders too need to transform with the changing times. bringing in the constant need to keep up and change. Urging the industry to take measured risks, he reiterated that since the industry will undergo a constant transformation, challenges must be looked at as opportunities.
He also spotlighted three key shortcomings in the pharma industry, i.e. procedures are poorly followed, and investigation and
the competency of the employees. Additionally, he said, “We need to focus on bringing in a sustainable quality system rather than a stringent quality system,” stating the need for simple, effective and adaptable methods rather than traditional ones.
Recapitulating Bengaluru’s strategic advantages, Natrajan states, “Bengaluru is an ideal choice, due to its cosmopolitan industrial nature.” The rich and diverse ecosystem that Bengaluru provides is a pool of opportunities where industries like biologics and genomics are rising and parallel industries like IT also aid pharma development. He also shared the need to regularly participate in summits and meet other fraternity members
tance of emerging technologies like digitisation, automation, data analytics and AI/ML to reform and refine challenges in pharma processes such as the hurdles faced during tech transfer of biologics and its complexity due to the scale of production. Garg added, “If we can implement Pharma 4.0 in the right way then it ensures smooth manufacturing, reduces failures and enhances regulatory filing.”
Packaging will be a keyally Pharma-allied industries, such as packaging are also seeing a major transformation.
The use of novel materials, emerging technology, innovative design, evolving customer demands and the need for sustain-
lighted the role of innovative ideas for cost-effective and sustainable packaging solutions. Nadella added, “Understanding the design of the high volume products helps in increasing the yield through sustainable and efficient operations,” explaining the key to achieving smooth operations. He expressed the need to find eco-friendly alternatives to packaging material. Emerging smart packaging materials are providing alternatives to conventional PVC since it is being banned in several countries in Europe.
Dr Bhasin concluded the discussion by highlighting the necessary steps towards sustainability that the pharma industry must keep in mind as the sector
measures and investments.
Paving the path to progress
The inaugural Bengaluru Pharma Summit thus emerged as a platform to confer and converse on India Pharma Inc’s growth trajectory. It underscored Bengaluru's pivotal role in shaping the future of India's pharma landscape as well. Through insightful discussions and presentations, the summit highlighted the need for quality compliance, strategic alliances, and the adoption of emerging technologies to drive the industry forward. Vital topics such as sustainability and eco-conscious practices were also addressed. Thus, the conference laid a com-
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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 Innovations in active packaging. He highlighted the challenges of active packaging such as the possibility of dusting, moisture control, the size of the product, efficiency for odour removal and retaining the inorganic content.
Cilicant presented Frexil, its innovative and effective desiccant solution alternative.
The product comes in 2 different forms to meet the packaging needs. The tests conducted to prove the efficacy of the product indicate that it addresses several different challenges. 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.
Polymeric product solutions for the pharma industry
Polymers have myriad applications in pharma processes and systems, therefore to throw more light on their uses and advantages, Kabirdas B, Senior 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.
Kabirdas emphasised how precision-engineered polymeric products can help pharma companies meet regulatory standards while ensuring safety and efficacy. He also presented the significance of evaluating physical properties such as tensile strength, flex crack resistance, and opacity when selecting polymers for specific formulations and ensuring that the selected materials are chosen for the right applications.
He concluded his presentation by
conveying Ami Polymer's commitment to collaborate with strategic partners in the pharma industry and provide them with tailored polymer solutions that align with their specific drug manufacturing needs.
DhairySharma,Sr Executive - Business Development,Cilicant
Kabirdas B,Sr Manager – Business Development,Ami Polymer
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Emergent technologies and systems in steam sterilisation and glassware washing
India’s pharma landscape is evolving rapidly and the allied sector will have to match this pace with the help of emerging technologies and innovative solutions. Stinita Dsouza, Application Specialist, Equitron Medica talks about the Emergent technologies and systems in steam sterilisation and glassware washing. Equitron offers steam sterilisers, glassware washers, GMP washers and low-temperature hydrogen peroxide glass plasma sterilisers. They serve applications of microbiology quality control, organic chemistry R&D and healthcare pathology.
Dsouza emphasises that Equitron’s autoclave comes with several advantageous features such as compactness, and water conservation, by providing a closed-loop water circulation system. The glassware washers have a flexishelf system for flexible loading, optimal utilisation of space, and fewer wash cycles. Additionally, the storage space for accessories also reduces. The washers have an intuitive configura-
tion of wash cycles and a HEPA filter for drying. The machinery is accessible for inspection. 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.
GenAI in pharmaceutical manufacturing
As Pharma 4.0 plays out, we are witnessing a paradigm shift across its functions and systems.Highlighting the need of the hour, Pavithran Ayyala, Head, Digital Services & CIO, Utthunga Technologies gave a presentation on “Generative AI in pharmaceutical manufacturing.”
Gen AI can be quick and efficient for generating and processing content like checklists, maintenance plans, etc. Additionally, it aims to provide solutions for Pharma 4.0 to make organisations auditready. GenAI integration in manufacturing can help optimise drug manufacturing by quickly locating relevant standard operating procedures, and automatically generating checklists and guides for repeatable seamless operations.
AIML is also beneficial for rootcause analysis to obtain a data-integrated perspective visual representation of data and subsequently, customised corrective plans. AIML integration in daily operations will not only reduce human efforts but also ensure minimal to no room for errors.
Ayalla stressed that technological integration is of utmost importance given the current scale and pace of the
pharma industry, and collaboration is necessary to develop this technology further. “Technology may not be per-
fect from day 1, we need to co-create and innovate to take it to the next level,” said Ayalla.
Pavithran Ayyala,Head Digital Services & CIO,Utthunga Technologie
Technologyevolution in Pharma Water/Wastewater treatment
Krishnendu Roy,Sales Leader AI - India & Subcontinent,Veolia Water Technologies & Solutions
The right tools, systems and processes will be drivers of growth for the pharma industry. And, wastewater treatment is a significant process in the sector. Therefore, Krishnendu Roy, Sales Leader AI, India & Subcontinent and Santosh Hegde, Sales Leader, Pharmaceuticals & Chemicals from Veolia
Water Technologies and Solutions throw light on technology evolution in pharma water/wastewater treatment.
Hegde talks about two aspects that Veolia caters to, water for injection (WFI) or purified water and wastewater management in the form of zero liquid discharge. He explains the
Santosh Hegde,Sales Leader - Pharmaceuticals & Chemicals,Veolia Water Technologies & Solutions India
methods of WFI generation techniques and emphasises the newer, dual membrane system that lowers the capital expenditure and the operational cost. Veolia meets the purified water standards and is compliant with the latest USP, JP and Ph Eur standards, and cGMP requirements.
Visualisation of P&ID with Aseptsof
Siddharth Shah, Technical and Spandan Athaide, Technical Lead at Central Solutions Enterprise,gave a presentation on the visualisation of P&ID with Aseptsoft. Asepsoft from CSE is a solution that digitalises pharma process design, defines operations, phases, and instruments automates fluid stream path, generates functional specification for IQ /OQ documentation, eliminates mistakes and boosts process development. The automation addresses the communication gaps that occur during the development process. The O model structure of the software allows the user to edit and change the process whenever needed, at any stage. Aseptsoft is compatible with
Spandan Silvester Athaide,Technical Lead, Central Solutions Enterprise
Veolia Water Technologies offers a full range of compendium water testing methods to the life sciences industry, i.e. total organic carbon, conductivity, bacterial endotoxins testing and rapid bioburden/ rapid microbial methods through a portfolio of differentiated instruments a services.
AseptSoft is also capable of defining the process algorithms, parameters and variables,and conditions based on instruments and generating the URS for automation
AutoCAD and Viso.
AseptSoft is also capable of defining the process algorithms, parameters and variables, and conditions based on instruments and generating the URS for automation. It stores the data in user-customisable Excel files.
With Aseptsoft, CSE aims to make technical communications more precise and crisp, reduce confusion, minimise human effort and errors and most importantly, help the pharmaceutical industry to scale up its output.
RESEARCH
Lipid-based novel formulations are advancing menopause management
Arun Kedia,MD,VAVLipids discusses how lipid-based formulations are revolutionising menopause management by enhancing drug delivery and alleviating symptoms.Innovative solutions like bilosomes and phospholipid liposomes show promise in improving the quality of life for menopausal women
Menopause is usually diagnosed clinically when a woman hasn't menstruated for a year due to a decline in ovarian follicular activity. This condition generally occurs around 45–55 years of age. In India, there are approximately 150 million women experiencing menopause, as per data shared by the Indian Menopause Society (IMS). The average age of menopause in the country is 46.2 years, compared to the global average of 51 years.
Menopause is not a sudden event but occurs over several years. Moreover, the hormonal shifts linked to menopause can impact the physical, emotional, mental, and even social wellbeing of women. A survey conducted last October to coincide with World Menopause Day pointed out that 79 per cent of Indian women feel that menopause has a significant impact on their mental and physical well-being.
Menopause can potentiallyaffect the qualityof life Symptoms experienced during and post the menopausal transition vary significantly from person to person, with some experiencing minimal or no symptoms while others face severe ones that disrupt daily activities. As per the World Economic Forum, in the UK alone, it is estimated that 14 million working days are lost annually due to menopause and perimenopause. As many as one in 10 women experiencing menopausal symptoms resign from their positions at work. Some common symptoms include hot flushes and night sweats, characterised by sud-
den sensations of heat in the face, neck, and chest. The physical discomfort, often accompanied by skin flushing, sweating, and palpitations, can last several minutes. Other symptoms include menstrual irregularity and flow changes, leading to eventual cessation. Vaginal dryness, painful sexual intercourse, incontinence, insomnia, mood changes, depression, and anxiety are also associated with menopause. Sometimes, bone density is lost, contributing to higher rates of osteoporosis and fractures.
There are also unfavorable shifts in the lipid profile, indicated by a rise in low-density lipoprotein cholesterol (LDLC) and triglycerides, alongside a decline in high-density lipoprotein cholesterol (HDLC).
There are complementary medical therapies to manage these symptoms and improve the quality of life while dealing with this life-altering situation.
Lipid-based drug delivery systems are advancing the frontiers in alleviating menopauserelated symptoms. Here's a look at how this new technology works.
Lipid-based deliveryformulations for managing menopause
Poorly water-soluble drugs pose a significant challenge in conventional pharma drug development due to their limited oral bioavailability and therapeutic effectiveness. Lipidbased formulations have emerged as a promising approach to improve the delivery of such drugs by overcoming these challenges.
Several studies have shown that lipid-based formulations significantly enhance drug solubility and dissolution rate compared to conventional formulations. Additionally, encapsulating lipid-based formulations shields the drug from degradation and enhances its stability. Integrating lipid-based formulations into capsules is a promising strategy for improving drug delivery and managing different disorders, ailments, and even bodily conditions like menopause.
Bilosome-based drug delivery
Progesterone, the natural female sex steroid hormone, is primarily involved in female reproductive functions. It plays a crucial role in preparing the endometrial layer of the uterus for the implantation of a fertilised ovum. The production of progesterone is known to decrease majorly during menopause.
External administration of progesterone offers several clinical benefits, including the management of secondary amenorrhea, dysfunctional vaginal or uterine bleeding, hormone replacement therapy, treatment of endometrial hyperplasia, and contraception. However, progesterone, classified as a BCS class II drug due to its high lipophilicity, encounters various obstacles with oral delivery. These hurdles include limited water solubility, low oral bioavailability, enzymatic degradation, and hepatic first-pass metabolism. Enhancing the oral bioavailability of progesterone remains a critical concern for its long-term treatment.
Today, several innovative lipid vesicular systems are available that enhance the systemic bioavailability of progesterone. Bilosomes are one of them.
A bilosome is an innovative vesicular system integrating bile salts into the bilayer membrane composed of phosphatidylcholine and cholesterol. This combination with bile salts acts as a repellent to bile acids, enhancing the stability of bilosomes compared to liposomes within the gastrointestinal tract (GIT). Moreover, the bilosome system exhibits ultra-deformable properties, further enhancing its functionality.
This improvement is primarily attributed to the vesicles' enhanced permeability and reduced gastrointestinal tract (GIT) degradation. Thus, the novel bilosome system presents a promising solution to overcome the challenges associated with poor absorption
and low oral bioavailability of progesterone.
Phospholipid liposomes to manage menopauseinduced anxiety
In one clinical trial to assess the effectiveness and safety of phospholipid liposomes, a formulation was administered parenterally for managing anxiety and depression associated with menopause. The group treated with phospholipid liposomes exhibited significantly fewer symptoms such as anxious mood, tension, and fear than the placebo group.
Government support is needed to accelerate advancements
Incorporating lipid-based formulations into menopausal management strategies is a practical and effective approach to improving women's quality of life during this transformative period. As research in this field continues to evolve, lipid-based delivery systems have the potential to revolutionise menopausal care, offering women tailored and holistic solutions for symptom relief and overall well-being. To catalyse inn ovation in niche products like lipid-based formulations, the Government must support more research efforts in this field. Offering substantial backing to companies engaged in such research can accelerate advancements. Regulatory sanctions, including favorable policies and incentives, can significantly encourage the adoption of lipid-based drug delivery systems to manage natural biological transitions like menopause.
The growing threat of antibiotic resistance
Bhupendrakumar
Chudasama,Associate Dean,Research and Development Cell at Thapar Institute of Engineering and Technology,Patiala draws attention to the global health crisis caused by antibiotic resistance and highlights that nanoantibiotics could be strategic assets,offering innovative solutions to combat this crisis
The alarming rise of Mutli Drug-Resistant (MDR) superbugs is a significant threat to global health, with traditional antibiotics losing their efficacy at an unprecedented rate. Antibiotic resistance is one of the most pressing public health issues of our time. It occurs when microbes evolve mechanisms to withstand the drugs designed to kill them, rendering standard treatments ineffective and leading to persistent infections and increased risk of spread. This phenomenon poses a significant threat to global health, development, and sustainability. Microorganisms can become resistant to antibiotics through genetic mutation, horizontal gene transfer, Efflux pumps and enzymatic degradation. Several factors contribute to the rise of antibiotic resistance. Amongst them over use and misuse of antibiotics is the most distressing. Prescribing antibiotics when they are not needed such as for viral infections and patients not completing their prescribed courses of antibiotics also contribute to the resistance. The use of antibiotics in livestock for growth promotion and disease prevention can
lead to resistant bacteria that can be transmitted to humans through the food chain. Inadequate infection prevention and control measures in healthcare settings can facilitate the spread of resistant bacteria and remains a major threat to existing antibiotic drugs.
The consequences of antibiotic resistance are profound. Infections caused by resistant bacteria are harder to treat, leading to higher mortality rates and prolonged illness. Resistant infections lead to longer hospital stays, more intensive care, and the need for more expensive drugs, increasing healthcare costs significantly. Procedures such as surgeries, chemotherapy, and organ transplants rely on effective antibiotics to prevent and treat infections. Resistance undermines these advancements. Low and middle-income countries are disproportionately affected by antibiotic resistance due to limited resources for effective infection control and access to second-line treatments.
In response to this urgent crisis, nanoantibiotics have emerged as strategic assets, offering innovative solutions to
combat these resilient pathogens. Leveraging the unique properties of nanotechnology; nanoantibiotics promise to revolutionise the way we approach bacterial infections and drug resistance. Nanoantibiotics refer to antibiotics that are formulated using nanotechnology or combined with nanomaterials. These nano-scale interventions enhance the delivery, efficacy, and stability of traditional antibiotics while introducing new mechanisms to combat bacterial resistance. The unique physicochemical properties of nanomaterials such as their high surface area and reactivity make them particularly effective in this role.
Nanomaterials such as silver nanoparticles can attach to bacterial cell membranes, causing structural damage and leading to cell death. They can also generate reactive oxygen species (ROS) that induce oxidative stress in bacteria. Many MDR bacteria form biofilms, protective layers that shield them from antibiotics. Nanomaterials can penetrate and disrupt these biofilms, enhancing the efficacy of antimicrobial treatments. Combining nanomaterials with traditional antibiotics can produce synergistic effects, where the combined action is more potent than the sum of their individual effects. This approach can help overcome resistance mechanisms. Nanomaterials such as metal nanoparticles of gold and silver are being integrated into various applications to combat MDR bacteria. Nanomaterial-infused wound dressings release antimicrobial agents gradually, promoting healing and preventing infections by resistant bacteria. Coating medical devices such as catheters and implants with metal nanoparticles can prevent biofilm formation and reduce the risk of infections. Nanomaterial-based drug for-
mulations can enhance the effectiveness of existing antibiotics and reduce the emergence of resistance.
The future of nanomaterials in combating MDR bacteria looks promising, but several challenges remain. Ensuring the safety and biocompatibility of nanomaterials is crucial for their clinical applications. Additionally, large-scale production and cost-effectiveness need to be addressed for widespread adoption. Continuous monitoring and research are needed to understand and mitigate the potential for bacteria to develop resistance to antibiotics. Nanoantibiotics represent a transformative approach in the fight against drug-resistant superbugs. By harnessing the unique properties of nanotechnology; these innovative antibiotics offer new hope in overcoming one of the most critical challenges in modern medicine. Continued research and development, along with strategic investments and regulatory support, will be essential in bringing nanoantibiotics from the laboratory to the clinic, ensuring they become integral assets in our arsenal against superbugs.
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Newliquid filling machine for sterile ophthalmic products Oftalmica byRomaco Macofar
Romaco Macofar’s Oftalmica was specially developed for aseptic filling of sterile eye drops,nasal sprays and injectables.Meeting all GMPrequirements for safe processing of highly viscous,oily and foaming liquids,the machine additionally offers fast format changes and short cleaning times
The Oftalmica is Romaco Macofar’s latest technology for aseptic filling of sterile eye drops. This newly launched liquid filling machine is the pharmaceutical machinery manufacturer’s answer to the growing demand for ophthalmic products with no added preservatives. Much stricter GMP regulations apply when these modern pharmaceutical formulations have to be filled under sterile conditions, and the Oftalmica fulfils them all – especially where the sterility assurance level is concerned. The machine is therefore fitted with an oRABS barrier system (either passive or active) and can also be supplied with isolation technology if required. The Oftalmica is also prepared for bio-decontamination with vaporised hydrogen peroxide (VHP). Glove ports provide full access to all critical components without having to open the doors of the liquid filling machine, meaning the permissible SAL values for cleanroom class A are reliably maintained inside the machine. This facilitates process validation and production can be resumed more quickly.
Easyhandling of highly viscous,oilysuspensions and foaming liquids
The Oftalmica is used to fill all kinds of liquids, including sterile, highly viscous and oily suspensions as well as foaming fluids. The machine can be equipped with up to eight separately filling pumps individually controlled on the HMI, be they ceramic or stainless steel rotating piston pumps or peristaltic pumps, depending on the features of the products and needs of the customer. The Oftalmica’s dosing station also
enables a two-phase filling process to achieve a constant, high filling capacity while at the same time reducing the load on the pumps. This approach is especially recom-
mended for products with poor flow properties. In addition, filling in two steps has proved successful for bottles with very small necks, because ultra-fine filling needles with a corre-
spondingly lower flow rate are used here. The same applies when filling foaming products whose flow rate is limited solely by their physical properties. Thanks to the two-phase
filling technology, the Oftalmica by Romaco Macofar has a maximum output of up to 12,000 bottles per hour – regardless of the specifications of the liquids being filled or the
The Oftalmica aseptic liquid filling machine byRomaco Macofar
The Oftalmica byRomaco Macofar is ideal for aseptic filling of sterile eye drops,nasal sprays and injectables
dimensions of the containers. Suspensions can also be managed easily with complete recirculation circuit by means of an additional peristaltic pump connected to the main manifold, avoiding the separation and sedimentation of the compounds.
High qualityfor different products,containers and closures
The Oftalmica processes a vast range of plastic and glass bottles with a filling volume between 1 and 30 ml and can be used to apply the entire range of ophthalmic closures: from standard three-piece droppers with cap to two-piece containers like Nemera or Aptar. Depending on the type of closure, the machine can also be configured with up to three closing stations to assure the final torque control on 100% of the screw caps. The lightweight plastic bottles are held on the belt by vacuum as they travel through the machine, which leads to optimal process stability. For filling, the bottles are transported to the dosing sta-
tion in clusters by a walking beam transfer system. The machine can also be equipped with a weight control system to check 100% of the filled products and automatically set up the filling volume at the beginning of the batch.
The empty and full bottles can be inerted on request for oxygen-sensitive products. As an option, the Oftalmica can also be utilised to fill nasal sprays with the centering unit to manage the deep tube or sterile injectables, applying the standard bromobutyl stoppers and alu caps.
All steps are constantly monitored by the PLC using sensors, cameras and lasers, each of which selected for the specific application to ensure high quality throughout the entire process.
Fast product changes, short cleaning times
Overall, the Oftalmica offers numerous advantages whenever frequent product changes are common. To reduce the time for retooling, the formats were designed for a wide range
20 years of X20
of container sizes. All parts additionally support plug & play removal and installation in a few simple steps. What’s more these handy format parts can be autoclaved, which makes them easy to clean. On request, the dosing pumps too can be cleaned fully automatically using a CIP (cleaning in place) or SIP (sterilisation in place) system. GMP-compliant, easy to operate and high performing – these are the hallmarks of the new Oftalmica liquid filling machine by Romaco Macofar.
For more information on Romaco, visit our website and social media channels: www. romaco.com – Showroom –LinkedIn – YouTube
Romaco Group
Romaco is a leading international supplier of processing and packaging equipment specializing in engineering technologies for pharmaceutical products. The Group provides individual machines, lines and turnkey solutions for manufacturing, filling and packing powders, granulates, pellets,
tablets, capsules, syringes, liquids and medical devices. The company also serves the food and chemical industries. Through its various technologies, Romaco is committed to sustainable production and to systematically reducing CO2 emissions.
The Romaco Group has its headquarters in Karlsruhe (Germany) and is part of Truking Technology, a globally operating high-tech enterprise based in Changsha (China). Truking’s core competency is handling and filling pharmaceutical liquids.
Romaco operates from six production sites worldwide, with a broad portfolio comprised of seven established product brands. Noack and Siebler (Karlsruhe, Germany) supply blister, heat-sealing and rigid tube filling machines. Macofar (Bologna, Italy) markets technologies for filling sterile and non-sterile powders and liquids. Promatic (also Bologna, Italy) specializes in cartoners, track & trace systems and case packers. Kilian (Cologne, Germany) is a lead-
ing manufacturer of tablet presses. Innojet (Steinen, Germany) is in the business of granulating and coating fine solid particles. Tecpharm (Barcelona, Spain) offers tablet coating technologies.
More than 930 highly skilled and committed Romaco employees are dedicated to the development of future product technologies and to the continuous implementation of internal improvement processes. The Romaco Group’s multibrand system solutions are sold worldwide through nine Sales & Service Centers and a dense network of local agent organizations. Over 12,000 installations delivered by Romaco are currently in use in more than 180 different countries.
Company contact Susanne Silva Market Communications Romaco Group Am Heegwald 11 76227 Karlsruhe
Germany
T +49 (0)721 4804 0 E susanne.silva@romaco.com
The X20 has transformed industrial automation with its small size and potent features,enabling machines all around the world to function accurately and effectively
The X20 system has been an essential component of countless industrial applications for the last 20 years, providing dependable performance and pushing productivity to unprecedented levels. The X20 has transformed industrial automation with its small size and potent features, enabling machines all around the world to function accurately and effectively. Its inn ovative technology and sturdy design have continuously outperformed expectations, making it the preferred option for machine manufacturers in a variety of sectors.
The thoughtful details and sophisticated ergonomic
design make the X20 System a complete control solution. Depending on the user’s demands and individual application requirements, the X20 System family makes it possible to combine the exact components necessary. The X20 system is extremely compact, has a large selection of modules, and its 3slice design makes it very easy to wire and maintain. Marking 20 years of reliability and the epitome of excellence, B&R Industrial Automation marks this milestone with customers and partners for their trust and support.
Here’s to 20 years of success, innovation, and unparalleled performance with the B&R X20 system.
PHARMA PULSE
Precise measurement of volume flows with volume flowhood testo 420
With the volume flow hood testo 420,users can quickly and accurately fulfil the legal regulations on indoor air quality for ventilation and air conditioning systems in commercial buildings and workplaces
For humans to feel comfortable in a room, the air quality, among other factors, must be ensured. Assuming closed rooms, this quality results from the volume flows of the installed VAC system. In order to respect the regulations for Indoor Air Quality, regular checking of the total volume flow of the VAC system is necessary. It is not uncommon for an air conditioning technician to conduct up to fifty measurements at different air outlets in several rooms.
The extra-light and convenient volume flow hood testo 420 simplifies these measurements enormously. And, thanks to an integrated flow straightener, also allows a more precise measurement result to be achieved at larger swirl outlets.
The challenge
A high CO2 concentration in a room leads to fatigue and can even cause illness. For this reason, sufficient oxygen must be introduced by an exchange of fresh air, especially in commercial buildings, workplaces, hospitals, and schools. There are certain workplace directives too that require outside air flows, depending on the activity of the persons in the room like predominantly sitting or moving activities.
To meet these norms, the air conditioning technician has to regularly test the total volume flows of the VAC system. To do this, numerous measurements at different outlets might be necessary, which means a high physical burden. In addition to this, these rooms have large swirl outlets installed as standard, which do not blow the air into the room
straight, but instead continually swirl it. The consequence of this swirl: air flows are often incorrectly measured at these locations. And this complicates the determination of the volume flow substantially.
The solution
The volume flow hood testo 420 sets new standards regarding weight and precision. With only 2.9 kg and ergonomic handles, frequent or difficult measurements too, can be carried out comfortably, without inducing fatigue, and therefore safely. And the innovative flow straightener converts the turbulence at the swirl outlets into an almost uniform air flow, leading to a considerably more accurate measurement. In addition to this, the hood records the ambient climate using an integrated temperature and humidity sensor as well as an absolute pressure sensor. The application is simple too: Funnel-shaped tension rod sockets support easy and quick set-up, and the trolley included in delivery ensures safe transport. Via Bluetooth testo Smart App integration, smartphones and tablets can be used as a second display and remote
control. After the measurement, the app allows the finalisation and sending of the measurement protocol directly on site. Differential pressure or Pitot tube measurements are also possible with the removable measuring instrument by simply entering the duct geometry. With the volume flow hood testo 420, users can quickly and accurately fulfil the legal regulations on Indoor Air Quality for ventilation and air conditioning systems in commercial buildings and workplaces.
For more information, write to us at info@testo.in or visit www.testo.com
PHARMA PULSE
FormWeigh.Net®: Powerful solution for the dispensing application in pharma industry
FormWeigh.NET® offers full formulation control with visual displays that guide operators easily through the recipe-weighing process.It captures weight values automatically,storing them in a central database
Challenges associated with weighing in dispensing area
Inaccurate measurements, addition of wrong materials, false labeling or lost documentation are some of the reasons for inefficiencies. Experience has shown that manual inputs are more error-prone than automatic methods.
Solution
FormWeigh.NET® offers full formulation control with visual displays that guide operators easily through the recipe-weighing process. It captures weight values automatically, storing them in a central database. Qualification manuals and checklists complete the package and speed up your validation process.
FormWeigh.Net® encompasses a full set of possibilities needed for successful formulation of pharma production without quality problems and in compliance with regulations.
Automatic quantity adjustment of active ingredients makes it at the same time to a powerful tool to increase production yield and realize considerable savings in time and money.
Implement FDA21 CFR Part 11 compliance
US FDA has implemented 21 CFR Part 11 on request of the pharmaceutical industry with the target to simplify drug approval, specifically to move away from the huge amount of paper based documents toward electronic documentation. With 21 CFR Part 11 the electronic documents become the originals, while printouts on paper are non-binding copies. Companies wishing to comply with 21 CFR Part 11 will have to implement systems supporting it. One of them is FormWeigh.Net®. With
FormWeigh.Net® encompasses a full set of possibilities needed for successful formulation of pharma production without quality problems and in compliance with regulations
the 21 CFR Part 11 Module a major step towards compliance is achieved.
Automaticallyadjust the potencyof APIs in the recipe
The optional Active Substances Module helps you making full use of your API stock, even if its
potency varies from batch to batch.
This intelligent FormWeigh.Net® option automatically calculates the required amount of material in order to achieve the required potency in the end product. FormWeigh.Net® calculates the new target weight as well as the
new quantity of compensation material. The result is a stable product quality even if important parameters differ from one raw material batch to the other.
Designed for compliance from beginning
Thanks to full batch control in the dispensing and formulation
process you gain important benefits within your process:
◆ Full knowledge about the batch status in every production step
◆ Traceability over the material flow in the production process
◆ Assignment of end product batches to used raw materials
Additional information about METTLER TOLEDO can be found at www.mt.com
For more information Link: www.mt.com/formweighnet Call us Toll Free -1800 22 8884 / 1800 10 28460 or Email-sales.sales@mt.com
PHARMA PULSE
LUBRITAB® - a versatile excipient from JRS Pharma
Excipients are selected according to their properties, advantages, risks, regulatory status and many more attributes to design a pharmaceutical or nutraceutical formulation. Due to the benefits of low safety concerns, lipids have been become an interesting and promising category of excipients for multiple purposes.[1]
The term “lipid” describes a family of products having diverse physicochemical properties. Their composition includes oils, fats, waxes, fatty acids and their derivatives, and biosynthetically or functionally related substances to these compounds. [1] Naturally occurring lipids are typically triglycerides (triacylglycerols or triglycerides, TAGs), esters of glycerol and three fatty acids.
The nature and compositions of three fatty acid chains of a TAG molecule, defined as R1, R2 and R3, determine its chemical property. An important characteristic of TAGs is their crystallization behavior. The crystallization behavior (crystallization rate, crystal sizes and their network, crystal morphology and crystallinity) of the TAG is directly influenced by polymorphism, and by several external factors
such as temperature, pressure, solvent, rate of crystallization, impurities, etc. Due to the conformation differences, they present different melting points.[1] This difference helps in identifying particular TAG grade (eg Glyceryl mono-
stearate and distearate, Hydrogenated vegetable oil Type I and Type II, various grades of Polyoxylglycerides). This phenomenon is also important to define applications and process of specific TAG moiety.
The lipid excipients used in pharmaceutical development are derived predominantly from the food industry where they are used as additives for emulsification, solubilization, stabilization and lubrication since long. In pharmaceutics, short chain and unsaturated long chain fatty acids (liquids, semisolids and solids) are approved for use in creams, ointments, emulsions, dispersions, and suppositories. Long chain triglycerides, which have no practical ability to self-disperse, are digested rapidly in the intestine (lipolysis). Furthermore, their fatty acids and monoglycerides digestion products are solubilized by bile salt – lecithin mixed micelles, which are then absorbed. Besides, lipid excipients have been refined and fine-tuned for the pharmaceutical industry to provide solutions to drug delivery challenges including drug solubility, drug dissolution properties and also to resolve manufacturing issues. Over the last four decades, naturally occurring triglycerides have been modified physicochemicaly to develop excipients suitable for the development of drug delivery systems.[1]
In like manner, solid lipids became more and more interesting as pharmaceutical excipients for solid dosage forms. They are normally crystalline in nature and have melting ranges or melting points determined by their chemical structure (and composition).[1] They are chemically inert and their properties such as high hydrophobicity, high melting point and low density can be used to –
◆ Lubricate pharmaceutical dry powder blends
◆ As sustained release agent either alone or in combination
◆ Mask bitter tasting drugs
◆ Solubilize lipophilic drugs [1]
Several processing methods could be applied using solid lipids, such as –
◆ Direct compression
◆ Dry and wet granulation
◆ Melt granulation
◆ Melt pelletization
◆ Molding
◆ Spray congealing
◆ Hot melt coating
Furthermore, solid lipids used as sustained release agents provide different biopharmaceutical properties compared to conventional polymers. Fundamentally, the drug release mechanism is different and this provides formulators with broader options for controlling drug release scope to develop innovative dosage forms. [1] They can be used either alone or in combination with other agents.
Choosing the appropriate TAG for the use in pharmaceutical process, requires an understanding of their physicochemical properties and its associated effect on lubrication efficiency, API release and taste-masking effect.[1]
Hydrogenated vegetable oil is a mixture of triglycerides of fatty acids. The two types defined in the USP-NF are characterized by differences in their physicochemical properties like melting range and Iodine value. LUBRITAB® complies with Hydrogenated vegetable oil Type I. It is made from the seeds of varieties of Gossypìum hirsutum (L) or other Gossypium species by refining followed by hydrogenation.[1][2]
TYPICALPROPERTIES [5]
APPLICATIONS
LUBRITAB® is used in food products and oral pharmaceutical formulations, and is generally regarded as a nontoxic and nonirritant excipient. As discussed in previous section, being a solid lipid, LUBRITAB® has various application pertaining to pharmaceuticals.
Lubricant:
The primary function of lubricants in tableting is to reduce the force required to eject the compressed tablet from the die cavity. In capsule filling, where a plug is formed, lubricants perform essentially the same function by reducing the force required to transfer the plug from the dosators into the capsule. Without lubricants, these processes would be difficult or impossible and would result in significantly shorter tooling lifespan. LUBRITAB® is used
Structure Refer to Image 1; R1,R2 and R3 are mainlyC15 and C17
Acid value Max.2.0
Iodine value Max.5
Melting range 57° to 70°C
Loss on drying Max.0.1 %
Saponification value 175 to 200
as a lubricant in oral solid dosage forms at a concentration range of 1 – 6 % w/w. It act as a liquid film-lubricant. It can be used alone or in combination with other commonly used lubricants.[2][3]
Taste masking:
Being hydrophobic lipid in nature, LUBRITAB® does not dissolve into oral cavity. Hence, it can be used as barrier to mask bitter and/or unpleasant taste of APIs by various methods like melt granulation, hot melt coating and spray-congealing where drug particles can be entrapped in wax matrix or covered by wax layer.
Sustained release matrix: LUBRITAB® is additionally used as the matrix-forming material in lipid-based controlled-release formulations; it may also be used as a coating aid in controlled-release formulations. It has also been investigated in hydrophobic melt agglomeration. This application may find more relevant space, where usage of traditional polymers is restricted or limited due to patent or percentage level (regulatory) constraints.[2]
Binder:
LUBRITAB® may be used alone or in combination as a binder in dry and wet granulation processes. It helps to solve
Image 1: Structure of a Triglyceride
Image 2: SEM image of LUBRITAB® [4]
PHARMA PULSE
capping and lamination during tableting.[3]
Viscositymodifier:
Hydrophobic nature and miscibility with various oily materials, its use as a viscosity modifier in the preparation of oil-based liquid and semi-solid formulations is unique. It imparts this useful property during manufacturing of suppositories, to reduce the sedimentation of suspended components and to improve the solidification process; and in the formulation of liquid and
semisolid fills for hard gelatin capsules.[2]
Wax nature of LUBRITAB® makes it suitable alternatives to hard waxes in cosmetics and topical preparations.[2]
SUMMARY
LUBRITAB® is a plant-derived excipient made by hydrogenation of cottonseed oil. It serves as a lubricant in tablet and capsule formulations. It can also be used as a binder, a taste masking agent and in controlled release matrix tablets. It is used in oily liquid and
semi-solid dosage forms to alter viscosities.
REFERENCES
[1] Petrovick, G.F. (2015) Orodispersible Tablets Containing Taste-Masked Lipid Pellets with Metformin Hydrochloride for Use by Elderly Patients. The Faculty of Mathematics and Natural Sciences, The Heinrich Heine University in Düsseldorf.
In the rapidly evolving landscape of the biopharmaceutical industry, capability building and effective contract manufacturing have emerged as critical elements for success. As biopharma companies strive to keep pace with innovation and regulatory demands, they must enhance their operational capacities and refine their manufacturing processes.
This strategic approach ensures not only compliance with stringent quality standards but also fosters the development of cutting-edge therapies.
The Role of Contract Manufacturing in Biopharma
Biopharmaceutical contract man-
ufacturing involves outsourcing production activities to specialized firms. This trend is driven by the need for flexibility, cost-efficiency, and access to advanced technologies. By leveraging the expertise of contract manufacturers, biopharma companies can fo-
cus on core competencies such as research and development, while ensuring high-quality production standards are met.
This symbiotic relationship accelerates the time-to-market for new therapies and supports scalability.
Importance of Humidity Control in Pharmaceutical Manufacturing
A critical aspect of maintaining high standards in biopharma manufacturing is the control of environmental conditions, particularly humidity. Uncontrolled humidity can compromise product quality, leading to issues such as organic corrosion, biochemical reactions, and the growth of microorganisms. Each stage of the pharmaceutical process, from powder milling and tablet compression to storage and packaging, demands precise humidity control to ensure product integrity and efficacy.
Bry-Air Solutions for HumidityControl
Bry-Air's desiccant dehumidifiers play a pivotal role in maintaining optimal relative humidity (RH) levels across various stages of pharmaceutical manufacturing. These dehumidifiers can maintain RH as low as 1%, ensuring a stable environment regardless of ambient conditions.
In addition, Bry-Air dehumidifiers are precision-manufactured using CNC technology and feature a powder-coated finish. They incorporate high-performance Metal Silicate Fluted media, which is bacteriostatic and non-toxic, making them ideal for meeting the GMP requirements of the pharmaceutical industry.
PHARMA PULSE
Top notch solutions from Gandhi Automations
The company offers complete logistics solutions,by providing Dock Levelers,Dock Shelters, Sectional Overhead Doors and Dock Houses
Gandhi Automations – India's No.1 Entrance Automation and Loading Bay Equipment Company. This widely recognised position has been achieved over years of hard work, innovation, commitment to quality and reliable customer service. The company is also proud to be certified to EN ISO 9001:2015, EN ISO 14001:2015 and ISO 45001:2018 by TÜV Austria. Since inception in 1996, it has been manufacturing, importing, distributing and installing products that are problem-free and easy to operate.
The company offers complete logistics solutions, by providing Dock Levelers, Dock Shelters, Sectional Overhead Doors and Dock Houses.
Electro-hydraulic Dock Levelers offered by Gandhi Automations are not only “a bridge for connecting a vehicle,” but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy use and savings on heating and chilling costs, resulting in maintaining the quality of the transported goods. Dock Levelers offered by Gandhi Automations are designed per EN 1398 standard for the most demanding loading and unloading operations.
Efficient loading and unloading the goods
The importance of efficient loading the goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently, lesser qualified manpower is being utilised, which leads to damage to the goods.
doors slide vertically, stopping in the vicinity of the ceiling, they blend in with the architectural features of the building. Porto doors are built to ensure the highest ease and flexibility of use, which in turn ensures a quick, hassle-free, and accurate replacement of old doors. Their compact size ensures more available space both inside and outside the premises. Depending on the structure of the building and the requirements, a choice can be made between a standard lift, a vertical lift, a horizontal lift, low headroom, or an inclined lift. The Porto range comprises a wide series of track systems, panel options, and safety features. Special glazed doors provide excellent lighting and vision into the building.
It is possible to load and unload your products in a safe way and in the process obtain remarkable energy savings. The Dock Leveler remains with the Loading Bay in rest position and the Sectional Overhead Door closed, until the vehicle is positioned. The driver drives back, turning to the Dock Shelter, and stops the vehicle the moment it gets in contact with the bumpers.
The Sectional Overhead Door is then opened only when the vehicle is positioned, brakes are applied and the engine is shut off. This eliminates the exit of hot air and the intake of cold air (or the opposite in a hot area and in air-conditioned place). After the Sectional Overhead Door opens, the lip of the Dock Leveler connects to the truck bed for loading/unloading to take place. At the end of the loading/un-
The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes in the process. Gandhi Automations has always designed solutions based on such a scientific approach and feedback from clients. The Dock Levelers offered by the company ensure loading and unloading with lesser effort and minimal cost.
loading the Dock Leveler is put in rest position and the Sectional Overhead Door is closed, without moving the vehicle. The vehicle then departs at the end of the process. Following are the four types of Dock Levelers.
a) Radius Lip Dock Levelers
Radius Lip Dock Levelers are available in multiple sizes and capacities. It allows the dock to connect with the truck bed, thus making it convenient to drive directly on and off with forklift trucks, etc. Also, the self-cleaning lip-hinge system does not retain dust or dirt, which allows for smooth operation.
b) Telescopic Lip Dock Levelers
Telescopic Lip Dock Levelers are ideal for connecting vehicles unable to drive near docks, i.e., sea containers, side loading railway wagons, etc. These dock levelers can be supplied with a lip extending up to 1 m.
c) Edge-of-Dock Levelers
Edge-of-Dock Leveler is developed in compliance with the latest European safety standard, EN 1398. It has a capacity of 6000kg and is suitable for use with all types of material han-
dling equipment.
d) Forklift Roll-Off Barrier Lip
Dock Levelers
The newly introduced product, Forklift Roll-Off Barrier Lip Dock Leveler, adds run-off protection that prevents accidental forklift roll-off when the Overhead door is open and no trailer is stationed at the dock. These dock levelers are designed and built to provide all the benefits of the hydraulic dock leveler, along with the additional benefit of providing a formidable barrier.
Entrance door with automations
Gandhi Automations offers Porto and Max Vista - Automatic Sectional Overhead Doors, the ideal solution for all industrial and commercial needs.
Porto: Porto Sectional Overhead Doors are ideal for all industrial and logistics needs. The design and different solutions offered ensure the door is aesthetically pleasing and perfectly suited to any architectural environment, from modern and traditional industrial buildings to fine commercial buildings. As these
Max Vista: Max Vista Sectional Overhead Doors are ideal for industrial and commercial buildings. The doors are made with a combination of aluminium panels and transparent acrylic, grilled, or meshed windows, giving them a distinctive look and enhancing the look of a building. Max Vista Doors make the environment bright and pleasant to work in, as they allow natural light to pass through the large, clear areas.
Gandhi Sectional Overhead Doors provide heat insulation and soundproofing, thus improving the working conditions on the premises and saving energy. The products are affixed with a CE mark, making them reliable and safe.
Gandhi Automation’s Dock Levelers and Sectional Overhead Door are equipped with the most secure safety devices and accessories.
For further details, contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India
