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RAJNISH ROHATGI CEO,ORCHID AMS
16 HOWWAREHOUSE AUTOMATION IS CREATING IMPACT ON MEDICAL DISTRIBUTION
18 NAVIGATING THE CHANGING PHARMALANDSCAPE WITH INNOVATION
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Speaking at the recent ASSOCHAM Annual Pharma Summit 2024, Secretary, Department of Pharmaceuticals, Dr Arunish Chawla’s review of the regulatory reforms needs to go hand in hand with the growth opportunities. But lost among the headlines that 50 greenfield pharma plants would be completed in the next two years under the PLI scheme, and pharma and medtech becoming India’s fourth largest sector for merchandise exports, Dr Chawla’s comment that “we want to make India not just a pharmacy of the world, but a reliable pharmacy of the world” deserves more spotlight. (https://www.expresspharma.in/50new-pharma-plants-under-pli-scheme-to-be-completed-in-twoyears/)
A recent CRISIL report, based on a study of 190 drug makers, accounting for about half of the Rs 4.1 lakh crore market last fiscal, projects that the pharma sector is set for 8-10 per cent revenue growth this fiscal, due to healthy exports to regulated markets, recovery in exports to semiregulated markets and steady domestic demand. As per Aniket Dani, Director, CRISIL Market Intelligence & Analytics, formulation exports are expected to grow 12-14 per cent in rupee with the regulated markets of the US and Europe witnessing a growth of 13-15 per cent, driven by continued drug shortages, easing pricing pressures in the US generics market and the volume uptick expected from new product launches as well as players shifting focus towards niche molecules and speciality products. On the other hand, exports to semi-regulated markets will grow 810 per cent this fiscal, led by improving forex reserves, strengthening of local currencies against the dollar, and easing economic crises in select African and Latin American countries.
On the domestic front, Aditya Jhaver, Director, CRISIL Ratings predicts that with strong cash flows and healthy balance sheets, players are increasingly focusing on inorganic growth opportunities in the API and the formulation space, to either diversify the product portfolios by acquiring the brands/businesses and/or to consolidate market share in the targeted therapeutic areas.
Reports from India Ratings and Research (Ind-Ra) highlight that sustainability of the US business remains key to support the low margins in other markets. Rating the 1QFY25 performance of a sample of 18 leading pharma companies, the Ind-Ra report points out that normalisation of drug prices in the US and a softening in raw material prices will help companies to keep revenue growth of 9 per cent yoy and EBITDA margin of about 22 per cent during FY25. Ind-Ra sees the pharma industry moving up the value chain in the US, with increased focus on developing complex generic products (injectables, patches, inhalants, nasal, ophthalmic) over the past five to six years, which offsets the price erosion in existing molecules.
However, it won't be smooth sailing. Let’s consider two major factors: China and non-compliance with manufacturing norms.
As India positions itself as part of the China+plus one strategy, China has a counter-strategy: dumping of low-cost imports and competing at unsustainable rates in export
As India positions itself as part of the China+plus one strategy,China has a counter strategy: dumping of low cost imports and competing at unsustainable rates in export markets
markets. Ind-Ra reports point out that API prices have witnessed a steep decline over the past year in domestic and export markets, due to aggressive Chinese pricing/dumping, stabilisation of supplies from China, excess capacity caused by past capex and ProductionLinked Incentive scheme-led capacities coming online, and lastly, factors like weakness in export demand etc. While the fall in domestic API prices has been in the range of 15-40 per cent, price declines have been steep in the export API business, upwards of 25 per cent.
For instance, the report states that domestic API prices of paracetamol crashed 40 per cent over the past year. Other examples include metformin (15-20 per cent), ibuprofen (25-30 per cent) and ciprofloxacin (15-20 per cent). Export price/kg of ciprofloxacin declined 69 per cent while paracetamol declined 35 per cent.
Export volumes of APIs have also declined over the past two quarters, with inventory destocking by customers in regulated markets, weakness in demand scenario and competition from Chinese suppliers.
Some relief comes from a decline in the raw material prices since 1QFY23, led by a multitude of factors, majorly Chinese dumping, which resulted in better gross margins for Indian API companies. China’s role in predatory pricing is well known and will continue, as a pushback to India’s new pharma plants under the PLI scheme getting to production stage over the next two years.
Secondly, on the compliance front, an increase in USFDA inspections in FY25 is also expected which might impact growth prospects. Though Ind-Ra predicts that these are unlikely to cause significant disruptions, a recent inspection report should have pharma companies on high alert. A Form 483 highlights serious deviations at Granules India’s Telengana facility, including disposing off truckloads of torn manufacturing documents, bird droppings and feathers on some air purification units and improper cleaning of manufacturing equipment leading to the possibility of cross-contamination. Such incidents could derail growth projections, not just at the defaulting company as more stringent regulatory oversight measures could extend across the sector.
India’s drug watchdog the CDSCO too has pulled up many pharma companies for not-of-standard quality (NSQ) (substandard) drugs but most pharma majors claim that these batches are spurious and not manufactured by them. For instance, Alkem has pointed out that there are differences between the CDSCO samples and the actual batches manufactured by Alkem in terms of physical appearance, colour, and text when labelling the two products. Companies have also pointed out that QR codes are missing from these batches. While these incidents make a case for increased investments in anti-counterfeiting measures, public awareness of such features needs to increase. The onus is on all stakeholders: government, pharma companies and the public, to use these features to check if the pills we are popping are authentic and safe.
VIVEKA ROYCHOWDHURY, Editor viveka.r@expressindia.com viveka.roy3@gmail.com
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We are in the process of launching over 40 SKUs,rolled out over the next two months
Rajnish Rohatgi ,CEO,Orchid AMS (a division of Orchid Pharma) outlines the company’s strategies to combat antimicrobial resistance (AMR) while ensuring responsible antibiotic usage in healthcare,in an interview with Lakshmipriya Nair
Canyou give us details about Orchid AMS products and projects? What are its major business goals for the next five years, and how do you plan to achieve them?
We are offering a comprehensive range of products to clinicians. It is a core part of our strategy and aligns with our "First, Do No Harm" commitment. We recognise that sales representatives with limited product ranges may inadvertently contribute to antimicrobial resistance (AMR) by promoting unsuitable drugs for specific patient situations.
To address this, we are planning to launch over 40 SKUs of more than 30 antimicrobials, including both antibiotics and antifungals. Our sales team's incentive structure is uniform across all products, ensuring that our profits and sales team's motivations don't skew recommendations towards higher-margin drugs, which are often “reserve” drugs. This approach contributes to prolonging the effective life of these critical last-line defense drugs for society.
How is the antimicrobial solutions landscape evolving, and how is Orchid AMS positioning itself to leverage emerging opportunities in this segment?
Pharma companies have primarily taken a productcentric approach to developing antimicrobial solutions. With growing awareness of AMR, particularly among clinicians in top-tier cities and hospitals, Orchid AMS is positioning itself as a comprehensive solution provider.
In phase 1, we aim to
leverage Orchid's existing brand equity in antibiotics, especially Cephalosporins, to establish ourselves as a worthy and credible solution provider – not only vendor of products –to private hospitals, which result in demonstrable benefits to hospitals.
Our focus will be, apart from pledging to “First, Do No Harm”, (data, guideline driven selection of molecules and recommendations, without distortions of profit and incentives of sales team):
◆ New drugs: We will continue to explore promising drugs in our R&D pipeline, building on the success of ORBLICEF (CefepimeEnmetazobactam), the first Indian-invented drug to receive USFDA approval.
◆ Revive old drugs: Among the more than 330 antimicrobial drugs approved by India's CDSCO, less than 75 are currently manufactured and marketed. While the majority of these unused antimicrobials have been justifiably phased out, there may be untapped potential in a select few. Our objective is to conduct thorough research into these overlooked antimicrobials, identifying those that could still demonstrate efficacy against certain pathogens. Furthermore, we aim to assess their commercial viability with the goal of potentially reintroducing them to the market, thereby expanding the arsenal of available treatments in the fight against microbial infections.
◆ Consultative support: As a knowledge partner, we will assist hospitals in implementing or improving anti-microbial stewardship programmes. These programmes aim to establish
clear guidelines for clinicians to minimise the use of “reserve drugs,” thereby slowing the development of pathogen resistance.
What is the impact that Orchid AMS wants to have on India's healthcare landscape and public health over the next decade? What are the strategies to realise them?
Orchid AMS recognises that addressing AMR requires a multifaceted approach due to various contributing factors, including:
◆ Self-medication
◆ Over-the-counter antibiotic sales
◆ Antibiotic use in agriculture and livestock
◆ Economic pressures on patients leading to hasty antibiotic use
◆ Mispromotion among tier 2 doctors reliant on sales representatives for updates
◆ ICU doctors often feel compelled to use stronger antibiotics before culture results to save critically ill patients. However, this urgency may accelerate the development of resistant pathogens, complicating future treatment efforts. While we can directly contribute to reducing AMR in tier 1 hospitals within our
reach, we acknowledge that the broader challenge requires a nationwide, multistakeholder effort — akin to the ‘Swachh Bharat Abhiyan.’ Orchid AMS aspires to be both a catalyst and contributor to such comprehensive efforts in the future.
Could you share details about the investment plans for this new vertical? How much capital has been allocated, and how will it be utilised?
Our investment strategy for this new business vertical focuses primarily on sales and marketing efforts. We plan to leverage existing manufacturing capabilities and support services such as quality control, regulatory affairs, and finance from our established bulk API business.
Are there any new product launches or services planned in the antimicrobial segment? If so, when are they likely to hit the market? We are in the process of launching over 40 SKUs, which will be rolled out over the next two months. This launch includes our flagship product, Orblicef (CefepimeEnmetazobactam) — the only Indian-invented drug across all therapeutic categories to have obtained both US FDA and EMA approvals. This achievement is a source of pride not just for Orchid but for the entire Indian pharma industry.
Our next product in the pipeline is likely to be Cefiderocol, developed by Japan's Shionogi. This launch is being facilitated by Global Antibiotic Research and Development Partnership (GARDP), an organisation under the WHO's aegis.
GARDP has selected Orchid for manufacturing and supplying this drug to several developing countries.
In your view, what are the major challenges in battling AMR, and how is Orchid AMS preparing to address them?
One of the biggest barriers for doctors in adhering to AMR guidelines is managing the vast and rapidly changing information. This includes tracking the resistance patterns of various pathogens to multiple drugs, which are constantly changing due to pathogen mutations and the introduction of new drugs, each with its own drug interactions and side effects.
To address this, Orchid AMS would love to explore possibility of Digital Support System. This system aims to simplify the complex process of selecting the right antibiotic by providing clinicians with up-to-date information and guidelines at the patient's bedside, taking into account the constantly changing resistance patterns.
Are there any international partnerships or collaborations that Orchid AMS is pursuing to leverage global expertise in fighting AMR?
We are actively developing our relationship with GARDP, which has already signed an agreement for the manufacture of Cefiderocol.
GARDP's extensive access, reach, and expertise in the field of AMR make them an invaluable partner in our efforts to combat this global health challenge.
lakshmipriya.nair@expressindia.com laxmipriyanair@gmail.com
Nirav Doshi,Founder & MD,NIDO Group explores how warehouse automation—through technologies like autonomous mobile robots (AMRs),conveyor systems,and high-speed sortation equipment—enhances the efficiency and accuracy of healthcare logistics.He states that by minimising human errors and ensuring rapid,reliable distribution,automation is revolutionising medical supply chains and paving the way for a more robust and scalable future in healthcare delivery
Efficient and safe delivery of medical supplies, equipment, and pharmaceuticals depends on effective health care supply chains. They provide timely, safe access to necessary healthcarerelated resources. Warehouse automation may mark a sea change for the medical distribution industry, smoothing out traditional pain points and yielding a massive change in gains related to increased efficiency, precision, and fiscal responsibility. Top healthcare organisations are smoothing their operations and reporting exceptional overall performance improvement through the strategic deployment of automation technologies.
The healthcare supply chain is an outlier because problems are layered on top of other layers of complexity in this industry segment. Healthcare supply chains require detailed, often labor-intensive management of sensitive and perishable products, with strict regulations and accurate control of inventory counts. Manual processes that include a chance for human error can be seriously delayed, with major mistakes entailing additional costs, which may turn out severe. The COVID-19 pandemic brought into view how fragile global supply chains are and the need for further agility and robustness. This crisis underlined the essentiality of efficient and correct medical supply distribution with rapidity, which heightened the interest in automation technologies.
Automation of the healthcare sector warehouse would
The COVID-19
pandemic
brought into view
how
move products, and even more sophisticated solutions for moving products. All these technologies are finding rapid applications in the healthcare sector for better efficiency, accuracy, and reliability in their supply chains.
Apart from high-speed sortation systems, dimensioning and weighing systems, carriage belt sorters, automation also offers fulfillment and consolidation services and AMRs.
scalability, allowing healthcare facilities to adapt quickly to changing demands while reducing operational costs. By minimising errors and ensuring consistent operations, automation improves reliability in medical distribution. As healthcare logistics evolve, automation remains essential in creating resilient, responsive, and cost-effective supply chains that meet modern healthcare needs.
fragile global
supply chains are and
the need for
further agility and robustness. This crisis underlined the essentiality of efficient and correct medical supply distribution with rapidity, which heightened the interest in automation technologies
involve the use of cutting edge technology, including robotics, automation, and special machinery, with a view to enhancing operations at the warehouse. Thus, automation
ranging from fulfilling orders, inventory control, and tracking shipment is being put into place. Highly sophisticated systems boast robotic pick-andsort arms, conveyor belts to
Fulfillment in healthcare involves the picking, packing, and dispatching of medical supplies in a timely and correct manner, from pharmaceuticals up to complex medical devices. The introduction of AMRs into the warehouse environments has dramatically improved these processes. Such robots, fitted with advanced sensors and highly accurate positioning systems, will be able to navigate efficiently through warehouses, reducing the time it takes to locate an item and to transport it.
In return, this can fast-track the process of order fulfillment by means of automation, hence enabling every health facility to deliver critical supplies to healthcare providers with no delay.
Additionally, warehouse automation is revolutioniinsg healthcare supply chains by enhancing fulfillment efficiency and optimising the consolidation of medical supplies. Autonomous systems streamline order processing, ensure precise handling, and effectively navigate space-constrained environments, leading to faster, more accurate deliveries. These systems also provide
Warehouse automation has changed the game in medical distribution increasing sales and productivity. Automation elevates the speed at which orders are completed accurately, thus ensuring timely delivery of medications, accuracy in delivery, and enhanced customer satisfaction and loyalty. This also equips pharmacies with better ease in peak seasons, facilitates operation scaling, and increases inventory management for improved patient outcomes and resilient health supply chains.
The impact of warehouse automation on the health supply chain is great, and several issues affecting this industry find their solutions in the said technology. Automation ensures that medical supplies do, in fact, reach their destinations fast and with good reliability due to how improved efficacy, accuracy, and scalability are able to enable the supply system. This would then mean that it is a fact-the future of medical distribution is beginning to look brighter with the health industry growing in acceptance of these technologies.
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Shelja Jose Kuruvilla,Head – Knowledge and Research,Vector Consulting Group underscores that the Indian pharma industry faces mounting pressure on profit margins due to price erosion, operational inefficiencies,and regulatory challenges.She recommends embracing innovation and operational excellence across manufacturing,quality control,and R&D to sustain growth
The Indian pharma industry, long hailed as a global powerhouse, finds itself at a crossroads. Once a beacon of growth and profitability, the sector is now grappling with a complex web of challenges that are eroding margins and inflating overheads.
In recent years, Indian pharmaceutical companies have seen a substantial decline in profitability, dropping by approximately 20-30 per cent over the past six to eight years, aside from a brief surge during the pandemic. This decline is primarily driven by the ongoing price erosion in the US market, the chief destination for Indian generics. Intensified competition and the consolidation of distributors in the US have increased their bargaining power, exerting downward pressure on prices and compressing profit margins for Indian pharmaceutical firms.
The decline has led many pharma companies to aggressive cost-cutting, including reducing QA/QC staff, cutting R&D investment, and throttling raw materials. Some of these short-term fixes, often driven by trying to achieve industry benchmarks, often harm long-term capacity and adaptability to market changes. This is especially important since the signals from the export markets are not uniform. While the general trend may be a price decline in most drugs, there are frequent windows of opportunity
that open up, for example due to supply shortages. Without agility, companies cannot respond and take advantage of these opportunities.
However, if organisations need to have both agility and low-cost operations to sustain profitability, it is essential to move beyond current methodologies and adopt innovative strategies. And the path lies in achieving operational excellence while maintaining high resource productivity. This transformation must encompass a strategic overhaul in pharma operations, including 1) manufacturing, 2) quality assurance and control (QA/QC), and 3) research and development (R&D).
1) Operational excellence:
The new imperative
Many pharma plants struggle with very little room for flexibility in operations in this environment wherein processes are under stringent regulatory control. Resultant, extended lead times, typically ranging from six to nine months, hinder prompt responses to market demand fluctuations, often resulting in excessive inventory or costly expedited processes. For instance, while the desired inventory level is two to three months, the average finished goods (FG) inventory in US warehouses of Indian pharma companies is around five to six months of sales. Emergency air shipments — costing one to two per cent of sales — further strain resources.
The solution? Firstly, moving away from forecast-based procurement is crucial. Tradi-
tional methods often lead to unreliable production plans and inventory issues, exacerbated by frequent forecast revisions. Adopting a ‘pull’ based system with daily replenishment signals from strategic buffers can improve agility and efficiency in pharma manufacturing, reducing lead times by 25-50 per cent and inventory levels by 20-40 per cent.
Secondly, it is necessary to reevaluate current finite scheduling methods that tend to optimise multiple work centres by scheduling each one back-to-back. This approach ignores the system’s inherent variability, which can jeopardise production at the actual bottleneck—the point that controls the plant's output. Instead, the focus should be on generating a finite schedule specifically for the identified bottleneck while allowing other work centres to operate with adequate time buffers.
Material flow on the shop floor should not be controlled according to a fixed schedule in many non-constraint work centres. This will ensure that constraint machines are never starved while the system’s work-in-progress (WIP) is minimal. This approach allows for dynamic adjustments to production plans, enhancing capacity utilisation of pharma plants and reducing airfreight costs by over 75 per cent.
Lastly, enhancing visibility and integration with API suppliers is vital. Companies should integrate supply chain planning with both internal units and outsourced API partners to eliminate inefficiencies, such as excess inventory and wastage. This strategic integration can lead to a 20-40 per cent reduction in inventory and substantial cost savings.
2) Quality control: A balancing act
Maintaining quality systems in the highly regulated US market is expensive, but failing to meet standards can be even costlier. Companies facing FDA 483s understand the severe consequences of lapses in GMP or GLP processes. To prevent such issues, Indian firms must transition from 'Inspection Readiness' to 'Perpetual Regulatory Readiness.' This shift ensures that FDA inspections become routine, not disruptive. Firms should enhance their root cause analysis (RCA) capabilities for all quality incidents, aiming to reduce invalid OOS by over 70 per cent and lab incidents by 50-70 per cent.
3)
efficiency: Maximising output
Many generic pharma R&D projects try to align closely with patent expiries to maximise launch value since delays can worsen price erosion and render a drug unviable due to high costs, including regulatory fees and bioequivalence studies. To avoid this, companies often start R&D projects early. Yet, shared resources and the iterative nature of work lead to system overload, with many firms working on project pipelines that exceed capacity by 60-100 per cent. This results in slow project progress, delayed department responses, and procurement issues. Transitioning to project flow management, with clear capacity definitions and agile planning, can improve performance significantly, reducing lead times by 30-50 per cent and increasing project output by 50 per cent.
The Indian pharma industry stands at a pivotal juncture, where traditional practices can no longer guarantee sustained success. As profitability declines and operational challenges intensify, the path forward is clear: embracing innovation and operational excellence is not just an option— it's a necessity. By rethinking manufacturing processes, enhancing quality control measures, and optimising R&D efficiency, Indian pharma companies can not only navigate the turbulent landscape but also secure their place as global leaders.
The Indian pharma industry has ambitious goals to grow and foster innovation.However,a skilled and efficient R&D workforce is imperative to achieve this lofty target and to ensure a seat among the global majors of the industry,emphasises Kavita Jani
Over the past years, India has re-emerged as a hub for clinical research due to its cost-effective nature and evolving regulatory landscape.
Simultaneously, the Indian pharma industry is exploring its options to move beyond manufacturing generics. The pharma
Skill gaps in pharma R&D
However, there are many gaps that need to be plugged in this area.
Vinod Arora, Principal Advisor, Institute of Good Manufacturing Practices India (IGMPI) and Member, Indian Pharmaceutical Association (IPA) cites
These efforts address talent shortages and prepare India's youth for a global economy, emphasising the need for sustained investment and collaboration.Training institutes are promoting the objectives of the skill development policy, and improved allocation of funds towards private and public institutions will further accelerate the goal
Vinod Arora
Principal Advisor,Institute of Good Manufacturing Practices India (IGMPI) and Member,Indian Pharmaceutical Association (IPA)
industry has the potential for immense growth in India, however, ever-evolving regulations, rapidly transforming technology, and increasing healthcare demands necessitate the pharmaceutical sector to keep up with these emerging trends. To align the industry with its ambitious goals, fostering and continuously skilling the right talent is crucial, especially in R&D.
machine learning to predict clinical trial outcomes and optimise trial designs. In addition, studies show increased use of biomarkers to identify patient subgroups more likely to respond to treatment.” To combat the long timelines, the FDA and EMA have expanded expedited
The landscape is evolving rapidly,with opportunities expanding beyond Contract Research Organisations (CROs) to include ITgiants like IQVIA, Wipro,TCS,and Mahindra,each having a life sciences division. Currently,there are over 250,000 job vacancies globally in this sector
Kanishk Duggal COO,ICRI
high failure rates in clinical trials, long development timelines, limited innovation, high cost, data integration challenges, patent engagement and complex regulatory requirements as major gaps and challenges in pharma R&D. He suggests mitigation methods that must be encouraged and says, “Recent publications highlight the use of AI and
foremost require the R&D personnel to be competent and adept, and keep pace with latest advancements, therefore intensifying the need for skilling and continuous upskilling.
A workforce that can operate and comprehend emerging AI/ML technology, be abreast of
One of the biggest hurdles academic institutions face is keeping their curricula aligned with the rapid advancements in the pharma industry. Breakthroughs in drug discovery, evolving regulatory landscapes, and the rise of digital health technologies often make academic content outdated
Dr Satish Gupta COO, PharmaState Academy
pathways for promising therapies, as witnessed during COVID-19.
His recommendations include research-based partnerships with biotech firms to drive innovation, novel mechanisms of action and PPPs to share costs and risks, particularly in earlystage research.
However, implementing these remedial methods will
Companies must prioritise skilling and training
SuneelaThatte, VP and HeadHealthcare R&D for India, Merck KGaA Darmstadt offers insights and states that emerging technologies like AI/ML are enabling more efficient data processing, predictive model-
R&D professionals must now be adept in not only scientific skills but also in data-driven decision-making and technology integration. Continuous learning and upskilling in these areas are essential for staying relevant and competitive in the evolving pharmaceutical landscape
Suneela Thatte
VPand Head - Healthcare R&D for India,Merck KGaADarmstadt
the developments in the regulatory landscape and generally be open to upskilling themselves to keep up with the demands of the industry has become an imperative for success in pharma R&D
Fortuitously, pharma companies have recognised this need and have implemented several initiatives to upskill their R&D talent.
ling, and automation of routine tasks, thus enabling researchers to focus on strategic thinking and innovation. “As a result, R&D professionals must now be adept in not only scientific skills but also in data-driven decisionmaking and technology integration. Continuous learning and upskilling in these areas are essential for staying relevant and competitive in the evolving
pharmaceutical landscape,” adds Thatte.
Giving an overview of Merck’s endeavours in this direction, Thatte informs that the company implements constructive skilling methods, promotes cross-functional collaboration, and fosters knowledge-sharing, and mentorship programmes. She explains that cross-functional training sessions within R&D India helps Merck’s employees understand the roles and responsibilities of their counterparts in different functions to develop clear insights into the skill sets that the industry demands.
Thatte explains, “We are also enabling our employees with the opportunity to explore Generative AI, equipping them with valuable insights and skills that can help them stay ahead of the curve. Moreover, regular feedback mechanisms help us identify skill gaps and adapt our training to align with evolving industry needs.”
Training to lead Pharma associations can aid in addressing major gaps in R&D skills by incentivising initiatives across its member companies and many have taken the lead in this direction. Arora explains that pharma associations like the Indian Pharmaceutical Association (IPA) organise training and development programmes through sessions, workshops, and webinars focused on the latest trends and technologies in R&D. These programmes cover areas such as regulatory changes, advanced research methodologies, and digital tools in drug development. It collaborates with universities and research institutions to create specialised courses tailored to the needs of the pharma industry.
Arora says, “IPA advocates for government policies that promote skill development in the pharma sector, including pushing for funding and support for training initiatives.” Thus, acting as a mediator between the government and the industry. IPA also emphasises the importance of digital skills by providing resources and training related to data analytics, artificial intelligence, and other emerging technologies that are
October 2024
reshaping R&D. Furthermore, initiatives aimed to enhance knowledge sharing through publishing white papers, guidelines and research reports as well as providing network opportunities to foster dialogue between the industry and regulators assures that the industry remains informed.
In August 2023, the government introduced the Scheme for Promotion of Research and Innovation in the Pharmaceutical and Medical Technology Sector (PRIP), 2023, under the National Policy on Research and Development and Innovation in the pharma and medtech sector (1).
An article titled “Zoomed Out | Why PRIP is a groundbreaking enabler for the pharma and med-tech sector” written by Neha Aggarwal and Nitish Palagummi from Deloitte Touche Tohmatsu India, affirms that the PRIP scheme can prove to be revolutionary provided that its complementary factors can facilitate its scalable impact.
However, the importance of specialised and experienced pharma researchers cannot be overstated, if India is looking to scale its pharma R&D sector. Therefore, the government has also incentivised schemes and programmes to skill its youth population to foster economic growth for the nation. The Union Budget 2024-2025
aims to prioritise employment and skilling, recognising its crucial role towards attaining its goal of Viksit Bharat. Likewise, Arora explains how the National Skill Development Corporation (NSDC) drives industry collaboration through innovative finance mechanisms like the Skill Impact Bond, which has trained and placed thousands of youths, including a significant proportion of women. The Directorate General of Training (DGT) also partners with major corporations to provide industry-relevant skills training, preparing trainees for Industry 4.0 and beyond.
Arora maintains that while India faces significant challenges with its skill gap, the government's proactive initiatives have shown progress in bridging this divide. “These efforts address talent shortages and prepare India's youth for a global economy, emphasising the need for sustained investment and collaboration. Training institutes are promoting the objectives of the skill development policy, and improved allocation of funds towards private and public institutions will further accelerate the goal,” he says.
Academia’s contribution is key
While continuous upskilling is essential, creating industryready talent at academic institutes is also very important. As the industry continues to grow faster than ever, students must
be exposed to all the latest developments and evolving skill sets required to enter the field wellequipped. Therefore, academia needs to match up with the everincreasing expectations of the industry and revamp their outdated curriculums.
As per the responses received from the surveyed companies in the Assessment of Skills Requirements of the Indian Pharma Industry (2), clinical research, pharmaceutics, pharmaceutical analysis, medicinal chemistry, and pharmacology and toxicology are currently in major demand in the country. Yet about 0. 71 per cent of the surveyed students were looking for jobs and wanted to join the industry rather than going for higher studies and only about 52 per cent of the surveyed students were looking for hard-core R&D jobs. And, this is a point of concern.
A KPMG report titled “Human Resource and Skill Requirements in the Pharmaceutical Sector” recognises the lack of focus on research to be the reason behind fewer PhDs and Post-Doctoral fellows entering the industry. Since the industry lacks innovative ideas and primarily focuses on reverse engineering, it makes the job role less attractive (3). The report determines that students are reluctant to join the pharma sector as they aren’t preferred for placements and lucrative streams are more palatable compared to the pharma sector. Additionally, the employees lack productivity due
to poorly designed training processes, and industry professionals aren’t concerned with academic curriculum.
The All India Survey on Higher Education (AISHE) report 2021-22, also highlights the talent pool in India with advanced skills is limited to only 429 PhD Pharmacy pass-outs. This number is significantly low compared to the pharma industry’s unquantified need for highly skilled talent that can contribute to innovation in the manufacturing sector and bolster the industry’s vision (4).
Bridging the industry-academia gap
In an earlier interview with Express Pharma, Kanishk Duggal, COO, ICRI, highlighted the need to build a future-ready workforce, prioritising investment in education and specialised training programmes in clinical research, pharmacovigilance, and data management to address the skills gap. He states, “The landscape is evolving rapidly, with opportunities expanding beyond Contract Research Organizations (CROs) to include IT giants like IQVIA, Wipro, TCS, and Mahindra, each having a life sciences division. Currently, there are over 250,000 job vacancies globally in this sector.”
Thus, there are opportunities galore, but all stakeholders take concerted measures to optimise them.
As a step in this direction, Dr Satish Gupta, COO, PharmaState Academy calls for robust industry-academia collaborations deeming it crucial to ensure the exchange of resources and expertise, ultimately leading to a more capable and future-ready workforce.
He cautions, “One of the biggest hurdles academic institutions face is keeping their curricula aligned with the rapid advancements in the pharma industry. Breakthroughs in drug discovery, evolving regulatory landscapes, and the rise of digital health technologies often make academic content outdated.”
He also urges the industry to regularly revise educational content and offer industry-relevant training through webinars, workshops, and certifications.
Doing so can ensure that the students are equipped with the latest knowledge and skills that are demanded in the field.
Additionally, academic research projects provide a practical platform for students to acquire industry-relevant skills.
“When pharma companies collaborate with academic institutions on real-world projects, students are exposed to the latest developments and can develop practical expertise that enhances their employability,” adds Dr Gupta.
Continuous learning is key Dr Gupta further observes that a substantial gap arises in the pharma industry due to the lack of continuous education and training. “Often, both employees and companies overlook the importance of ongoing professional development, leading to a gradual erosion of skills and knowledge. To counter this, continuous training should be embedded as a cultural norm,” he says. Skilling must start at the academic level and continue throughout the length of an individual’s career. Gupta suggests that academia and industry must recognise this need and offer a range of continuing education programs, such as certifications in Quality Risk Management (QRM) and Clinical Research.
The curriculum requires input from current industry professionals to ensure that the freshly acquired talent is equipped to handle real-world scenarios. Laying the right foundation through skill-building at a nascent stage can even ensure less money spent on training employees at a later stage. The industry must incentivise training programmes for the students and also proactively design and implement upskilling initiatives for its employees.
The government too must focus intently on formulating regulations to promote employment for pharma students. Simultaniously, incentivise the professors to foster fruitful education and the industry to collaborate with academic institutions.
Looking forward
As we aim for immense growth in an already formidable sector,
investing in skilling the pharma R&D workforce, can reap significant benefits for the Indian pharma industry. R&D is a strong asset and a crucial part of drug development, therefore, equipping its workforce with the right skills and competency of the latest technology, evolving regulatory landscapes, and fast-
track drug development by encouraging cross-learning, exchange of ideas and collaborating is vital for growth and success.
References
1. https://www2.deloitte.com/ in/en/pages/life-sciences-andhealthcare/articles/zoomed-out-
why-PRIP-is-a-groundbreakingenabler-for-the-pharma-andmed-tech-sector.html
2. https://pharmaceuticals.gov.in /sites/default/files/Assessment%20of%20skill%20requirement%20of%20Indian%20 Pharma%20Industry_Under%20PMPDS%20scheme%20%
281%29.pdf
3. https://skillsip.nsdcindia.org /sites/default/files/kps-document/Pharmaceuticals.pdf
4. https://cdnbbsr.s3waas.gov.in /s392049debbe566ca5782a3045cf 300a3c/uploads/2024/02/ 20240719952688509.pdf
Vishal Goel,MD,Rx Propellant elaborates how Indian CROs,CMOs,and CDMOs can enhance their competitive edge by investing in quality management,leveraging advanced technologies, aligning with international standards and adapting to new regulations
Bioeconomy is a critical growth multiplier of the Indian economy –according to the India BioEconomy Report 2022, BioEconomy accounts for nearly 2.6 per cent of India’s GDP in 2021.1 Courtesy of contract research organisations (CROs), contract manufacturing organisations (CMOs), and contract development and manufacturing organisations (CDMOs), India’s life sciences sector is rising steadily. The CRO sector in India, growing at a compound annual growth rate (CAGR) of 10.75 per cent, is projected to reach $2.5 billion by 2030.2 Similarly, India’s pharmaceutical contract manufacturing market is expected to increase at a CAGR of 14.67 per cent, hitting $44.63 billion by 20293
Indian CROs have evolved from being low-cost service providers to key players in advanced drug discovery, clinical development, and regulatory affairs, particularly in Western markets. This shift is driven by India’s cost advantages, a skilled and cost-effective workforce, and a regulatory framework that provides strong support. The cost to conduct clinical trials in India is estimated to be 40 per cent70 per cent lower compared to the US or the EU,4 making the country a magnet for research and clinical development. Manufacturing costs in India are also 30 per cent-35 per cent lower than those in the US and Europe, 5 further sweetening the deal for global pharmaceutical companies. However, understanding the complex global regulatory environment is essential for Indian CROs, CMOs, and CDMOs to take full advantage of
these opportunities. While challenges exist, compliance brings many benefits. Adhering to global standards ensures the safety and effectiveness of pharma products and medical devices and opens doors to enhanced market access, sustaining the growth of Indian life sciences companies.
The US Biosecure Act, aimed at curbing US dependence on
Chinese biotechnology, opens new avenues for Indian CDMOs. With their focus on delivering reliable and varied manufacturing services, these firms stand ready to address the shortfall restricted Chinese players created. 6 In response, Enzene Life Sciences is expanding its capabilities with its EnzeneX platform, which enhances productivity and reduces costs. This strategic alignment with the Biosecure Act’s objectives makes
Enzene an attractive partner for Western companies seeking dependable alternatives outside China7
Compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards is crucial for accessing regulated markets like the US and EU. Following these standards can help Indian firms emphasise quality and ethical practices, build trust, and establish long-term partnerships to ensure continuous investments in infrastructure and training. 8 The renewal of Good Manufacturing Practice (GMP) certificates for Biocon Biologics Limited’s facilities in India and Malaysia, issued by the Health Products Regulatory Authority (HPRA) on behalf of the European Medical Agency (EMA), underlines the importance of meeting global standards to enter new markets.9
The European Medicines Agency (EMA) operates within a regulatory framework that includes key regulations such as the Medicinal Products Regulation, the Medical Devices Regulation, and Good Manufacturing Practice (GMP)10. These regulations ensure the safety, efficacy, and quality of medicines and medical devices within the EU. Biocon Biologics gained EMA approval to manufacture biosimilar Bevacizumab at its advanced facility in Bengaluru, enhancing its credibility internationally. International Council for Harmonisation - Good Clinical Practice (ICH-GCP) is another significant global regulatory standard that ensures ethical, high-quality clinical trials to protect patient rights and enhance data integrity. 11 For ex-
ample, Asiatic Clinical Research in Bengaluru adheres to ICH-GCP by providing phase II-IV support with trained sites across India. Similarly, CliniRx in New Delhi leverages ICH-GCP to offer comprehensive services for Phase II-IV trials globally, benefiting from its affiliation with the JK Organisation for financial stability and global reach.12
In life sciences, ISO 13485 and ISO 9001 certifications confirm the safety and quality of product manufacturing. ISO 13485 focuses on the safety and efficacy of medical devices, which are essential for EU compliance, while ISO 9001 emphasises customer satisfaction. ABX-CRO, with ISO 9001:2015 and ISO 13485:2016, exemplifies how these standards can be integrated13. Telangana-based Sai Life Sciences, certified in ISO 14001 and ISO 45001, adheres to environmental management and occupational safety protocols.14
The EU AI Act, effective from August 1, 2024, introduces a risk-based framework for AI systems, imposing stringent requirements on high-risk categories, including medical devices.15This regulation presents considerable opportunities for Indian life sciences companies. For instance, Sigtuple, which specialises in AI-aided medical diagnostics, is adopting comprehensive risk management practices and complying with pre-marketing testing mandates. This alignment with the Act’s requirements supports Sigtuple’s market entry into the EU and boosts its global reputation and competitiveness.16
Remaining competitive will require Indian CROs, CMOs, and CDMOs to continuously invest in quality management and swiftly adapt to evolving global regulations. According to the report “A Bold Future for Life Sciences Regulations: Predictions 2025” by Deloitte17, embracing advanced technologies such as AI, blockchain, and real-world evidence (RWE)— which could reduce time to market by up to 24 per cent— will be crucial in the near future. As global regulations become more harmonised and compliance is simplified, Indian firms should strategically expand into new markets, leveraging a deep understanding of regional regulations and forming local partnerships. Proactively incorporating these innovations and responding to regulatory shifts will empower life sciences players in India to lead in the global market and turn regulatory compliance into a strategic asset for innovation and growth.
1. 1658318307_India_Bioeconomy_Report_2022.pdf (birac.nic.in)
2. https://pharmaceuticals.gov.in/ sites/default/files/CRO%20Market%20Report_High%20Resolution.pdf
3. https://www.mordorintelligence.com/industry-reports/indiacontract-manufacturing-organization-market
4. https://www.georgeclinical.com/ global-coverage/india-cro
5. https://www.ibef.org/industry/ pharmaceutical-india
6. https://www.businesstoday.in/ industry/pharma/story/why-indian-cros-and-cdmos-stand-togain-from-the-us-biosecure-act437334-2024-07-16
7. https://www.biopharma-reporter.com/Article/2024/06/06/Th ree-Indian-CDMOs-ready-to-seizethe-BIOSECURE-Act-opportunity#:~:text=Enzene%E2%80%8B,I ndian%20CDMO%20market%20to %20thrive.
8. https://www.seclifesciences.com/
blog/the-golden-trio-of-qualitygmp-gcp-and-glp-the-pathway-tosuccess-and-compliance/
9. https://www.biocon.com/ema-approves-biocon-biologics-new-mabsfacility-in-india-and-renews-gmpcertifications-for-india-and-malays ia-sites/ 10. https://www.ema.europa.eu/en/
homepage
11. https://pharmaphorum.com/rd/ unravelling-impact-ich-e6r3-goodclinical-practice
12. https://www.pharmatutor.org/ articles/list-of-clinical-research-organizations-in-india
13. https://abx-cro.com/
14. https://www.sailife.com/sai-lifesciences-receives-iso-140012015and-iso-450012018-certification/
15. https://www.ibanet.org/impacteuropean-union-artificial-intelligence-act
16. https://economictimes.indiatimes.com/tech/technology/indian-
ai-firms-may-face-extra-costs-aseus-ai-act-kicks-in/articleshow/110572036.cms?from =mdr
17. https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-HealthCare/gx-life-sciences-regulationpredictions-2025.pdf
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Arecent report from Access to Medicine Foundation assesses current approaches adopted by some of the largest pharma companies to measure and report patient reach,mapping the existing landscape and highlighting interventions that are critical to ensure more patients benefit from increased access to medicine.Excerpts from the report
Pharmaceutical companies play a pivotal role in ensuring that their products reach patients worldwide. However, despite comprising 80 percent of the global population, people in low- and middle-income countries (LMICs) still face significant challenges in accessing essential healthcare products. Reaching patients in these underserved regions is a central component of advancing overall healthcare equity.
Several essential health products are produced by only a few companies or even single suppliers, and in certain markets, there is little to no availability of quality products. As demand for these essential products increases in LMICs, there is now a pressing need for pharmaceutical companies to optimise their efforts to expand access to their products and focus specifically on how many people are benefitting from them. By determining how many patients are being reached through their access efforts, companies face a unique opportunity: they can address critical health needs while also unlocking significant growth potential in these emerging markets.
This report from the Access to Medicine Foundation assesses how companies are approaching patient reach across their businesses. By outlining how the 20 pharmaceutical companies within the scope of the upcoming 2024 Access to Medicine Index are tracking patient reach, this first-of-its-kind analysis provides a comprehensive overview of current industry practices to establish a base-
line for measuring progress. In identifying examples, as well as areas that require more action, the report outlines oppor-
tunities for companies to learn from existing approaches and scale up their expansion efforts.
Companies are utilising a variety of approaches to monitor and track patient reach.
Among these approaches, several are new while others are applied to long-standing programmes. Five key findings illustrate the industry’s current practices regarding patient reach, highlighting areas for improvement and opportunities for scaling successful strategies.
Companies are prioritising patient reach, yet goals and approaches vary in ambition and scope.
The Foundation’s assessment of the 20 companies shows that, overall, they are engaging in efforts to measure patient reach. While some of these approaches are newly developed, others have evolved from the groundwork laid by companies through access programmes and initiatives implemented in LMICs over the years.
Five findings from this assessment highlight positive developments in the industry, as well as areas needing improvement going forward.
1. 19 out of 20 companies have established approaches, though only a handful are comprehensive so far
Encouragingly, a majority of the companies have established an approach to measure and track the patients they reach with their essential medicines in LMICs. This highlights that companies and their leadership recognise the importance of understanding patient reach across their operations. However, only 12 out of 42 approaches reported are comprehensive,
providing detailed insights into the equations, metrics, assumptions and limitations behind the calculations. By having a well-defined measurement framework, companies can accurately collect data on patient reach, measure the effectiveness of their strategies, drive improvements and allocate resources effectively.
2. Sales volume is the primary measure of patient reach for product-focused activities
Given their core role in the development, manufacturing and distribution of pharmaceutical products, companies predominantly use approaches that quantify and assess the reach of their product-related activities in LMICs. Of the 42 approaches reported, 35 measure the reach of product access efforts. Sales volume divided by dosing assumptions is the main metric used in these calculations. However, some companies have started to include additional assumptions, such as patient adherence, indicating a shift towards more nuanced measurement frameworks that go beyond just tracking sales.
3. Patient reach approaches vary widely in product and country coverage
Some companies focus their patient reach approaches on individual products, while others assess reach across their entire product portfolios. Geographic scope also varies, with some companies measuring reach in all countries where they operate, including those within the Index’s scope, while others cover only a subset of countries. Notably, six companies – Astellas, AstraZeneca, MSD, Novartis, Pfizer and another company reporting under an NDA –share patient reach approaches that encompass all countries where they operate (including those within and beyond the Index’s scope), as well as all products in scope and some that are out of scope. Overall, the data demonstrates that across the
19 companies which reported, there are both product and geographic gaps in the approaches used to measure patient reach. This means that in some places, and for some diseases, the number of patients being reached is simply unknown.
4. Patient reach numbers are regularly published
Patient reach numbers are regularly published for most approaches. However, 10 approaches did this for the first time. This is understandable when the goal is new. But in other instances, it is less clear
why public reporting has not taken place previously. Nearly all companies that publicly disclose their patient reach numbers also demonstrate year-on-year improvements in those numbers. This reporting allows for assessing whether a company is effec-
tively expanding access to medicines for more patients. It also fosters greater accountability, ensuring that companies remain committed to their objectives and goals of expanding patient reach and steadily improving health outcomes.
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5 . Many commitments by the industry, but only a few companies set ambitious goals to address high-burden diseases
Most companies have commitments addressing various diseases, with initiatives ranging from improving product delivery and eradicating diseases to enhancing access to care for specific populations, such as women and insulindependent individuals in LMICs. Among the identified goals associated with patient reach approaches, a few commitments, including those set by Johnson & Johnson, Bayer and GSK, are clear, measurable and ambitious, with targets aligned with high global burdens. However, the potential for addressing high-burden diseases means goals could be more ambitious, with ample opportunities to set higher targets. Additionally, some goals could not be adequately measured against disease prevalence due to a lack of specificity or undefined timelines, indicating a need for further refinement in their definition.
How can companies expand efforts to measure and track patient reach?
As outlined in this report, most companies have already set goals to expand the reach of their essential health products to more people in lowand middle-income countries (LMICs) and have established approaches to track and measure their progress.
Building upon these efforts, companies now have an opportunity to further strengthen and expand their current approaches to measure patient reach, as well as to collaborate and learn from one another. Increasing transparency and integrating patient reach goals and metrics into collaborations will help companies and their partners ensure that more people can benefit from the essential health products. Complemented with actions such as product registration, implementing pricing strategies aimed at affordability and ensuring sustainable supply, companies can effectively reach underserved patients who are often left out.
1. Transparently and frequently report methods and results to drive accountability, unlock new partnerships and drive impact Companies should take additional steps to publicly disclose their patient reach approaches overall. This includes being transparent about the underlying equation, metrics, assumptions and limitations of their measurement frameworks. In addition, companies must continue to consistently and regularly report on the number of patients being reached with their products and ac-
cess initiatives over time. Some companies have demonstrated full public transparency of their patient reach calculations and numbers, paving the way for others to follow their lead. By being fully transparent, companies can better measure impact, pinpoint gaps and identify areas of improvement in broadening access to lifesaving treatments.
2. Ensure comprehensive assessment of patient reach across all products and countries
Most companies analysed have approaches to measure and track the number of patients reached by their products. However, there is a need for more consistent applica-
tion of these measurement frameworks. As a first step, companies should ensure that every product in their portfolio included within the Index’s scope, as well as all in-scope countries where these products are sold or donated, are covered by an approach for measuring patient reach. To further build on this work, companies should consider disaggregating and publicly reporting the number of patients reached per product and country. This will allow for more accurate gaps in access to medicine to be established at a country and product level.
3. Refine methods to fit different contexts and scenarios
Not all companies are expected to track and report patient reach figures in identical ways; nuance is essential to yield the most helpful and accurate outputs. Companies should strive to identify metrics, equations and assumptions tailored to specific scenarios, customising methods to suit different product types, patient demographics, treatment modalities and healthcare environments. For example, measuring the number of patients reached with products and initiatives across primary and secondary care settings, or estimating reach in underserved markets, will require tailored approaches that go beyond simply tracking volumes of products sold or delivered. By
considering different scenarios and tailoring metrics accordingly, companies can establish the most effective denominators, assumptions and principles over time, ultimately enhancing the precision and relevance of their approaches to achieve more accurate patient reach numbers. This approach could also help move towards more standardised approaches across the industry, aligned with specific scenarios.
4. Work with partners to collate and track more granular, on-the-ground data for monitoring patient reach so efforts can be expanded
A few companies analysed are working with partners to gather on-the-ground information regarding their patient reach. This helps companies understand which
populations are being reached with each product and facilitates broader integration of these practices throughout the supply chain. From the outset, companies and their partners should establish specific activities to measure, report and improve patient reach. For example, by incorporating processes to collect and report patient reach data within partnership contracts and agreements, companies can better track patient reach beyond the point of delivery and demonstrate their impact on underserved and harder-to-reach patient populations.
5. When establishing patient reach goals and approaches, consider prevalence, disease burden and the number of treatment-eligible patients
When setting patient reach goals, companies should integrate factors such as disease burden in LMICs, the number of treatment-eligible patients and the competitive landscape. These considerations are crucial for establishing clear, measurable objectives that are both ambitious and achievable. By incorporating these factors, companies can set goals that provide direction and facilitate effective monitoring. Establishing defined timelines allows for objective progress tracking, while breaking down objectives into specific, manageable sub-goals helps develop targeted interventions. This structured approach ensures that the goals are not only welldefined but also actionable and impactful, leading to meaningful improvements in expanding access to essential treatments in underserved regions.
6. Drive progress by collaborating and sharing knowledge with industry peers
To drive progress in patient reach measurement, companies can collaborate and harmonise the types of assumptions, equations and metrics that have proven effective in tracking and measuring the reach of particular products across various settings. This will not only facilitate greater consistency in patient reach measurement frameworks across the industry, but also standardise reporting to appeal to investors and other stakeholders. While certain elements may need tailoring to specific contexts and products, companies can contribute case studies that highlight the challenges faced, lessons learned and the impact of their refined patient reach measurement strate-
gies on informing decisions around their access in LMICs.
7. Take action towards improving patient reach approaches while prioritising affordability and access Companies should prioritise measuring and tracking patient reach through robust approaches, but they also need to ensure they are focusing on the access and affordability of products. This way, while they have effective methods to measure patient reach, they are simultaneously expanding it for true impact. To overcome barriers that restrict products from reaching patients, companies should implement strategies such as equitable pricing and initiatives to strengthen local healthcare capacity and supply chains, all while collaborating with partners.
Goa Pharma Summit 2024 explores strategies to cement Goa’s status as a premier pharma hub and outlines key drivers shaping India's pharma landscape with a focus on innovation and global competitiveness
Express Pharma recently organised the Goa Pharma Summit 2024 with a vision to co-create an ecosystem that nurtures innovation, excellence, and growth within the pharma industry.
This summit brought together leaders, innovators, and experts from the state’s pharma sector to discuss Goa’s pivotal role as a major hub for pharma production and research.
The Summit served as a platform for experts to converse on critical topics shaping the future of pharma— ranging from advancements in technology and innovation strategies to navigating regulatory landscapes and fostering sustainability.
The event also offered opportunities galore for networking and interaction.
It commenced with a ceremonial lamplighting and a welcome address by Express Pharma, setting the tone for knowledge exchange.
Dhairy Sharma, Sr ExecutiveBusiness Development, Cilicant, delivered an engaging presentation on ‘Innovations in active packaging’ at the Goa Pharma Summit 2024. He highlighted cutting-edge developments in active packaging technology and their impact on the pharma industry. Sharma also pointed out how these advancements play a crucial role in maintaining product stability, extending shelf life, and enhancing patient safety.
The presentation accentuated the increasing relevance of intelligent active packaging solutions, and detailed how Cilicant's offerings address the industry's evolving needs. Sharma also provided a comprehensive overview of active packaging's function: not onlprotecting contents and interacting with them to preserve efficacy and safety.
A highlighted product was Cilicant's FREXIL dust-proof canisters. Sharma informed that they address the common problem of dusting associated with activated carbon-based canisters. He explained how FREXIL canisters not only protect pharma products from potential
DhairySharma,Sr Executive - Business Development,Cilicant
Frexil,an advanced form of desiccant, eliminates the possibility of dusting,fights odour,and maintains product quality
contaminants but also eliminate the dusting issue to maintain packaging cleanliness and safety.
Sharma offered insights into Cilicant's smart active packaging solutions and their capabilities to optimise packaging strategies, enhance product quality, and boost customer satisaction.
He concluded by informing that Cilicant is geared to not only meet current industry needs but also anticipate future challenges in ensuring drug stability and safety.
L-R: Dr Praveen Khullar,Executive Director,VerGo Pharma,President, GPMA(Moderator); Vikas Bhargava,Director Operations (Site Head),Marksans Pharma; Sameer Inamdar,Associate Director,Cipla; and Pravin Salunkhe,DeputyGeneral Manager (Production head),Indoco Remedies
The knowledge sharing sessions at Goa Pharma Summit 2024 kickstarted with a panel discussion that explored the state's path towards global excellence in the pharma industry. Moderated by Dr Praveen Khullar, Executive Director of VerGo Pharma and President of GPMA, the panel also comprised Vikas Bhargava, Director Operations (Site Head), Marksans Pharma; Pravin Salunkhe, Deputy General Manager (Production head), Indoco Remedies; and Sameer Inamdar, Associate Director, Cipla
The discussion began with an overview of Goa's current position in India Pharma Inc. Panelists highlighted the state's significant progress over the past decades, noting its transformation from a tourism-centric economy to a key player in India's pharma manufacturing sector.
They also shared insights on the operational challenges and opportunities facing pharma companies in Goa and emphasised the need for continuous improvement in manufacturing processes. They also urged the industry stakeholders to adopt cutting-edge technologies to maintain competitiveness on the global stage.
◆ Goa's pharma industryshould increase focus on sustainability,adopt measures like renewable energysources,optimised packaging,reduced use of plastics,water harvesting and recycling,better waste management practices etc
◆ Innovation should be a continuous process.It needs to be pursued and applied at all levels of pharma operations
◆ Data analytics and predictive maintenance will help improve the productivityand efficiencyof pharma processes in a big way
◆ Skilling is keyto creating future-readytalent.Goa's pharma industryshould collaborate with academic institutes to implement initiatives to skill,upskill and reskill for tomorrow's pharma workforce
◆ Compliance and qualityare keyfor pharma.All endeavours in this industryshould be focused towards these objectives.This is vital to serve patients effectively
The conversation also addressed regulatory compliance and quality standards. The experts stressed the importance of maintaining rigorous quality control measures and staying abreast of evolving international regulations to ensure that India’s pharma products meet global standards.
Innovation and R&D were key topics addressed during the discussion. They recommended the industry to implement initiatives that can foster a culture of innova tion and quality within Goa's pharma ecosystem and
highlighted the potential for collaboration between industry and academia to drive future growth.
The panelists collectively also identified several challenges facing Goa's pharma industry, including infrastructure limitations, need for improved logistics, attracting and retaining skilled talent, balancing environmental concerns with industrial growth, and navigating complex global regulatory environments.
However, the panel was also cautiously optimistic about Goa’s future in
the pharma sector. They discussed several opportunities for growth and development such as leveraging Goa's strategic location for export-oriented manufacturing, developing advanced capabilities through collaboration, investing in emerging technologies to drive sustainable manufacturing practices, and expanding into emerging markets.
The discussion emphasised the importance of cohesive strategy involving government, industry, and academia to propel Goa towards global excellence.
At the Goa Pharma Summit 2024, Rupesh Patil, Sr Manager – Business Development, Ami Polymer presented on the vital importance of polymer solutions in the pharma industry. His session showcased Ami Polymer's comprehensive range of products designed to meet the evolving requirements of the pharma and biopharma sectors.
Patil elaborated on the significance of selecting appropriate tubing and polymer solutions to ensure safety, effectiveness, and regulatory compliance in the life sciences industry. He explained how various tubing and hose types are utilised across different processes, noting that different
At the Goa Pharma Summit 2024, Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries, delivered an in-depth presentation titled ‘Nitrosamines and MCC’. His session explored key challenges in tablet manufacturing, focusing on the pivotal role of excipients in maintaining quality and regulatory compliance. Dr Gothoskar provided valuable insights into how strategic excipient selection, particularly microcrystalline cellulose (MCC), can significantly improve tablet formulations, ensuring efficacy and safety for patients while aligning with stringent regulatory demands.
Dr Gothoskar’s presentation focused on nitrosamines, a class of impurities that have garnered significant attention due to their potential health risks. Regulatory bodies worldwide are now paying close attention to nitrosamine levels in pharma products. He explained that excipients, particularly those used in tablet formulations, play a crucial role in managing these impurities. The right choice of excipient can help reduce nitrosamine contamination, thereby ensuring regulatory compliance and product safety. Therefore, manufacturers should re-evaluate their excipient selection processes, looking beyond cost and availability to factors like chemical stability and purity.
The session also shared details about
Dr Abhijit Gothoskar,Technical Expert,Sigachi Industries
MCC, a widely used excipient in tablet manufacturing. Dr Gothoskar described MCC as a multifunctional excipient known for its excellent compressibility, binding capabilities, and ability to enhance tablet integrity and stability. He
pharma products often necessitate specific polymer solutions.
His presentation also featured an overview of Ami Polymer's product line, including silicone, TPE, and fluoropolymer tubing. Patil stressed that these offerings are developed to comply with international standards and testing protocols. Patil also mentioned Ami Polymer’s ongoing efforts to expand and enhance their product range to address the industry's evolving needs.
He concluded by asserting Ami Polymer's readiness to support pharma companies in identifying the right polymer solutions for their manufacturing processes.
Managing nitrosamine impurities is a major challenge in the industry. Nitrosamines form from nitrites reacting with amine-containing APIs or impurities. The levels of nitrites in excipients also influence nitrosamine formation
further explained how MCC can play a significant role in ensuring consistent product quality across different batches. He cited examples where MCC had offered marked improvements in both production efficiency and product quality.
In closing, Dr Gothoskar emphasised that Sigachi Industries is well-positioned to be a trusted partner for pharma companies seeking high-quality excipients and technical expertise.
Dr Madhu Raju Saghee, VP-Quality, Encube Ethicals, delivered a compelling presentation on ‘Building a holistic quality culture’ during the Goa Pharma Summit 2024. The session offered insightful perspectives on fostering a robust quality culture within the pharma industry, pointing out that the root causes of failures are more behavioral than technical.
Dr Saghee began his presentation with a quote that people need to be reminded more than they need to be instructed. He highlighted that recurring compliance issues with current Good Manufacturing Practices (cGMP) often arise from inconsistencies in implementation rather than a lack of technical knowledge. His key message was that simple solutions are for simple problems, and the industry’s challenges with regards to quality requires better organisational culture and leadership.
Dr Saghee also spoke about the vi-
Ashok Gourish, Managing Director and Avinash Patil, Sales Head from Fette Compacting Machinery India delivered an insightful presentation titled ‘From Lab to Production,’ at the Goa Pharma Summit 2024. The session showcased Fette's offerings in tablet production technology.
The session began with an overview of Fette's credentials and deep dived into their product offerings and services.
The speakers informed about Fette's offers customer support throughout the entire product lifecycle and their services span from early development stages to ongoing production. They emphasised their role as a technology and process partner and highlighted Fette's R&D press and lab services.
The speakers shared an overview of their innovations and milestones through the presentation, from the first computer-controlled tablet press in 1970 to the launch of the digital-ready F10i in 2019.
They also showcased their latest innovation, the FE CPS (Continuous Processing System) for continuous manufacturing technology. The FE CPS was presented as a modern solution for con-
AshokGourish,MD,Fette Compacting MachineryIndia; and Avinash Patil,Sales HeadRegion and KeyAccounts,Fette Compacting MachineryIndia
cious circle of quality issues as a result of lack of attention to behavioral causes. He also reiterated that our compliance with cGMPs is consistently inconsistent, leading to recurring quality failures.
Dr Saghee emphasised the importance of aligning three key elements to break this vicious cycle: GMP, quality systems, and quality culture. He explained that consistent implementation of GMP requires a robust pharma quality system (PQS) that is lean, agile, and adaptable.
The presentation outlined practical steps for creating a quality culture, including developing accountability at all levels, moving beyond a traditional compliance-oriented approach, and focusing on continuous education rather than just training. He stressed the need for strategic investments to empower leaders become systems thinkers and adopt a structured, risk-based decision-making process.
Fette Compacting Machinery is working to bring innovation to tablet production. It is a holistic technology and process partner for the pharma industry
tinuous dosing, mixing, and conveying of raw materials.
Overall, the presentation informed about Fette's capabilities in tablet production technology and their services to support customers from the early stages of product development through to fullscale manufacturing.
L-R: Mahesh Gurnasinghani,Former Director - MS&T,Teva & Visiting Faculty,Goa College of Pharmacy(Moderator); Nilesh Hegu,Director,Cipla; Subhrangshu Chaudhury,VP& Head of Quality,Centaur Pharmaceuticals; Dr Rajashree Gude,Head of Department (Pharmaceutics),Goa College of Pharmacy; and Urmila Naik, Head of QualityAssurance,FDC
The Goa Pharma Summit 2024 hosted an interesting panel discussion on ‘Innovation strategies for the next decade.’ This session brought together industry leaders to discuss the pivotal role of innovation in shaping the future of pharma. It underscored the need for a blend of technology, talent, and collaboration to navigate the upcoming challenges in the pharma landscape.
The panel discussion was moderated by Mahesh Gurnasinghani, Former Director - MS&T, Teva and Visiting Faculty, Goa College of Pharmacy. Subhrangshu Chaudhury, VP & Head of Quality, Centaur Pharmaceuticals; Urmila Naik, Head of Quality Assurance, FDC; Dr Rajashree Gude, Head of Department (Pharmaceutics), Goa College of Pharmacy, and Nilesh Hegu, Director, Cipla were the other panelists.
The discussion touched upon and addressed several trends and concepts which are driving progress.
Pointing out the need for proactive approaches, the panelists focused on how predictive maintenance can be a game-changer for the industry. They underscored that predictive maintenance should become the standard in pharma operations to proactively address issues
◆ Predictive maintenance must become the norm.This proactive approach will usher more efficiency,qualityand effectiveness along with significant cost savings
◆ Analyse your needs thoroughly,understand the gaps in your current systems,train your resources effectivelybefore choosing and adopting newtechnologies and equipment
◆ Cross-industrycollaborations are an imperative to spur innovation and become future-ready
◆ We need to gear up for the era of personalised therapies.It needs strategic investments in people and technology
◆ We need to move from a mindset of mere compliance to patient centricity.This will be keyto driving qualityand innovation in the pharma sector
before they escalate, leading to significant gains in efficiency, cost and product quality.
However, the panelists also cautioned that a thorough analysis of organisational needs is vital before adopting new technologies or equipment. They stressed understanding the gaps in current systems and comprehensive training of resources to ensure smooth adoption and utilisation of new tools. They also advised investments in innovation to deliver optimal value and stay aligned with the company’s long-term goals.
The experts also advocated cross-in-
dustry collaborations with technology providers, healthcare institutes and academia, to foster innovation, share expertise, and accelerate the development of groundbreaking therapies. They pointed out how partnerships can help bring fresh perspectives, enhance research, and speed up product development cycles
The panelists called for strategic investments in both people and technology as tailored treatments based on genetic makeup and health conditions represent the next frontier in healthcare.
A critical message from the panel was that the industry needs to shift from a mindset focused on compliance to one centered on patient needs. Emphasising outcomes that prioritise patient well-being will not only meet regulatory requirements but also improve trust and deliver better healthcare solutions.
The panel discussion at Goa Pharma Summit 2024 served as a platform for thought leadership on the future of pharma innovation. It provided key insights into how the industry can stay competitive and responsive to emerging trends.
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XPR Essential balances embody the renowned durability of METTLER TOLEDO products.These balances are designed to endure intensive use,offering reliable performance and a low cost of ownership for years to come
Introducing the XPR Essential Analytical Balances, engineered to deliver highly accurate and fast results with all the essential features you need for precise laboratory work. With their high-performance load cell and innovative hanging weighing pan design, these balances are perfect for weighing small samples with exceptional accuracy, ultimately reducing waste, and saving costs.
Manufactured in Switzerland with high-quality materials, XPR Essential balances embody the renowned durability of METTLER TOLEDO products. These balances are designed to endure intensive use, offering reliable performance and a low cost of ownership for years to come. The robust load cell and advanced electronics ensure consistent, dependable results, making these balances a longterm investment for any laboratory.
The unique hanging weighing pan, combined with the highperformance load cell, allows for precise weighing of small samples. The gap-free design not only ensures the accuracy of your measurements but also protects the balance’s mechanics, making spills easy to clean and maintaining the integrity of your equipment.
Compliance is made simple with the XPR Essential Analytical Balances. We incorporate Good Weighing Practice® methodology and include built-in features such as StatusLight, which indicates when the balance is ready
for use. Additionally, the comprehensive data management options help you comply with regulatory requirements, ensuring that your laboratory maintains high standards of quality and reliability.
Designed with user comfort in
mind, the XPR Essential balances feature motorised doors that open with a single touch, allowing for easy dosing onto the low weighing pan. The balance display can be positioned conveniently, and the ErgoClip accessories enable ergonomic placement of tare vessels, enhancing the overall
With their high-performance load cell and innovative hanging weighing pan design,these balances are perfect for weighing small samples with exceptional accuracy,ultimately reducing waste,and saving costs
user experience.
The XPR Essential balances offer flexible data management solutions by connecting seamlessly to LabX software. This integration allows you to save your results automatically, ensuring traceability and simplifying data management processes. Users receive stepby-step guidance on the balance display while their progress is monitored remotely, streamlining workflows and enhancing productivity.
In summary, the XPR Essential Analytical Balances from METTLER TOLEDO are designed to deliver precise, reliable results with all the essential features you need. Their durability, accuracy, and userfriendly design make them an indispensable tool for any laboratory striving for excellence in their weighing processes.
For more information: Visit: www.mt.com/ XPR-Essential-analytical Email at – sales.sales@mt.com Call toll-free at – 1800 22 8884 & 1800 1028 460
Electro-hydraulic,pneumatic,and mechanical dock levelers,each designed to ensure fast, smooth,and safe transitions between vehicles and loading bays
At Gandhi Automations, we are proud to be recognised as India’s No.1 Entrance Automation and Loading Bay Equipment Company. This achievement is the result of our relentless pursuit of excellence, innovation, and a steadfast commitment to delivering quality. Over the years, we have earned a reputation for providing reliable solutions backed by exceptional customer service. Our dedication to maintaining the highest standards is reflected in our certifications, including EN ISO 9001:2015, EN ISO 14001:2015, and ISO 45001:2018, accredited by TÜV Austria.
Since our inception in 1996, we have been at the forefront of manufacturing, importing, distributing, and installing products that are both reliable and user-friendly.
Among our range of innovative solutions, our dock levelers play a crucial role in enhancing the efficiency and safety of loading and unloading operations. We offer Electro-hydraulic, pneumatic, and mechanical Dock Levelers, each designed to ensure fast, smooth, and safe transitions between vehicles and loading bays. Designed to meet EN 1398 standards, our dock levelers are engineered for the most demanding environments. The platform surface features an MS almond-shaped anti-slip checkered plate, with a robust 12+2 mm thickness, providing enhanced durability and safety for optimal performance. Available in capacities of 6, 9, and 12 tonnes, our dock levelers are versatile enough to meet a wide range of operational needs.
To meet diverse loading needs, we provide a comprehensive range of dock levelers:
a) Radius Lip Dock Leveler-
sAvailable in various sizes and capacities, our Radius Lip Dock Levelers connect the dock with the truck bed, facilitating easy drive-on and drive-off opera-
tions for forklifts and other equipment. Their self-cleaning lip-hinge system prevents the accumulation of dust and dirt, ensuring smooth operation.
b) Telescopic Lip Dock LevelersIdeal for situations where vehicles cannot dock closely, such as sea containers or sideloading railway wagons, these
levelers come with an extendable lip that can reach up to 1 meter, providing flexibility in various loading scenarios.
c) Edge-of-Dock LevelersCompliant with the latest EN 1398 safety standards, our Edge-of-Dock (EOD) Levelers are ideal for facilities without an existing pit, where the height difference between the loading dock and the truck bed is minimal. These levelers are particularly suited for environments with consistent truck heights, such as warehouses, distribution centres, and retail facilities. EOD levelers offer an efficient, space-saving solution for quick loading and unloading in locations where installing a pit-style leveler is not feasible. They offer reliable performance and safety for efficient loading operations.
d) Forklift Roll-Off Barrier Lip Dock LevelersOur newly introduced Forklift Roll-Off Barrier Lip Dock Leveler includes a run-off protection feature that prevents accidental forklift roll-off when the overhead door is open and no trailer is present. This leveler combines the benefits of hydraulic dock levelers with the added security of a robust barrier.
All our dock levelers can be seamlessly interlocked with existing doors and vehicle restraint systems, ensuring topnotch performance and security in every loading operation.
For further details, contact: Gandhi Automations Pvt Ltd Chawda Commercial Centres Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300
Fax: +91 22 66720201
Email: sales@geapl.com
Website: www.geapl.com
Testo data loggers ensure continuous monitoring of temperature and relative humidity of pharma products during production,storage or transit of goods
Due to the crucial necessity and its direct impact on human health and welfare, pharma is probably the most important and critical sector among others. As a consequence of which, it becomes essential to store pharmaceuticals, vaccines, laboratory samples or units of blood at the right temperatures to ensure that they remain effective and that quality is maintained. Another reason for the pharma division to ensure safety measures and controlled environment is stringent regulations and inspection of the facilities. This elementary need for climate control can only be ensured with right data monitoring systems. Testo being a market leader in testing and measurement sector provides the best in class data loggers and data monitoring systems for the pharma division.
Pharma goods must be stored well in every situation as any deviation in the ambient temperature or humidity values may lead to deteriorated quality of the product. Testo data loggers can be used to test the optimum conditions for specific products or surroundings. Temperature and humidity data loggers are often used in pharma industries to monitor the conditions in which drugs, medicines, vaccines are kept. Not only storage, but during the transit of goods, testo transport data loggers are useful to measure the transport conditions. The range of data loggers is very extensive. A temperature and humidity logger such as 174 T guarantees continuous monitoring in a storage or warehouse. Also, data loggers with multi channels for connecting external sensors and thermocouples, like testo 176 are
available for ensuring secured work process in labs. These data loggers are also critical for production quality assurance where the temperature has to be frequently checked at various points in production processes. Using thermocouple probes, data loggers can also record data in the kinds of extreme temperature ranges. The probe's fast response also contributes in the validation processes and quality standard optimisation in QA units and clean room applications. These instruments are the most convenient and pocket friendly solution for all pharma application areas.
Another important and crucial application of a pharma industry involves validation of
sterilisation and freeze-drying processes. Not only that, validating cleaning and disinfecting equipment is equally necessary. In order to allow a seamless operating procedure, the validation process and the documentation work must be as efficient and smooth as possible which could be easily achieved with testo data loggers solution that has innovative data loggers for temperature and humidity, smart software and accessories.
Testo offerings are majorly related to data security along with comprehensive analysis and evaluation of all the recorded measurement data. Testo data loggers ensure continuous mon-
itoring of temperature and relative humidity of pharma products during production, storage or transit of goods. Real time data monitoring is important for the quality of pharma goods and also enables the supplier to improve the life of the goods.
Transportation trucks, warehouses, cold rooms etc. can now be remotely monitored via Testo data loggers and data monitoring systems. Testo's data loggers are EN 12830 and 21 CFR Part 11 compliant which ensure complete documentation of parameters, be it humidity, temperature or absolute pressure. They come with professional software where the data recorded cannot be modified and the audits can be easily complied with.
Service and calibration made easy
Testo also has an established state-of-the-art NABL accredited service and calibration LAB in accordance with the standard ISO/IEC 17025:2017, that takes care of the after sales support locally from Pune. Testo service and calibration facility is highly cost effective as it delivers international standards very conveniently within a week’s time. Instruments of any brand/make can be calibrated and serviced locally maintaining necessary standards.
The accredited parameters include humidity, pressure, absolute pressure, contact type temperature, non-contact type temperature (infrared thermometer, thermal imager). In fact, testo has the first and only lab in India to get NABL accreditation for Dew Point Temperature as well.
For more details, login to website www.testo.com or write to info@testo.in
Ateam of Eppendorf experts would conduct the training on various modules such as liquid handling,centrifugation,extraction and quantification of biomolecules and PCR technique
Eppendorf India and Rajalakshmi Engineering College, Chennai have signed the extension of the existing Memorandum of Understanding (MoU) in setting up a framework to enable mutually beneficial and collaborative engagements in training to improve scientific research and development in the field of Biotechnology.
Eppendorf is committed to skill development by offering tailor-made training programs for graduate students of Biotechnology. Eppendorf India’s training facility in Chennai includes state-of-the-art laboratories as well as conference and classroom facilities. A team of Eppendorf experts would conduct the training on various modules such as liquid handling, centrifugation, extraction and quantification of biomolecules and PCR technique. Training includes intensive sessions with balanced theoretical and hands-on modules ensuring the participants gain proficiency, nuances and troubleshooting skills.
Eppendorf develops, pro-
duces and distributes equipment, consumables and services that are used in laboratories around the world. The product portfolio of the divi-
sion’s liquid handling, consumables, separation and instrumentation and bioprocess includes pipettes, pipette tips, centrifuges, mixers, ULT freez-
ers and bioreactors for cell and gene research.
Rajalakshmi Engineering College is an autonomous institution affiliated with Anna Uni-
versity, Chennai. The college presently offers 12 Undergraduate and 10 Postgraduate programmes, with an annual intake of 1950 students.
The development of coprocessed, multi-functional excipients has enabled formulators to address multiple challenges with a single excipient, resulting in enhanced production and better finished product quality.
WhyPROSOLV® SMCC?
Attaining good hardness at low compaction forces is quite essential while considering suitability of excipient for tablet formulation. Microcrystalline cellulose is one of the widely used and accepted excipients in tablet dosage form. Compactability of microcrystalline cellulose (MCC) is of prime importance during compression.PROSOLV® SMCC is a novel high-functionality tableting excipient. The material is manufactured by co-processing MCC with colloidal silicon dioxide (CSD) and can be used to improve flow, lubricant sensitivity and tablet strength. The addition of CSD in MCC helps to improve compactability [1][2] .
It has been reported that silicification appears to have no apparent effect on the primary chemical and polymorphic characteristics of MCC. This suggests that bulk modification of MCC does not occur during silicification and that the CSD, either by providing surface modification or by modifying strengthening interactions, is primarily responsible for the improvements in functionality, in particular tablet strength. This may be solely due to a morphological property or some other silicon dioxide MCC interfacial interaction. Based on scanning electron microscopy studies together with electron microprobe analysis, it was stated that silicon dioxide is primarily located at the surface of the SMCC particles. While certain amounts of silicon dioxide were detected in the internal regions of some particles, the colloidal silicon dioxide particles present
PROSOLV® SMCC is available in following grades[3]
PROSOLV® SMCC 50 LDBest in class binder (improves tabletability)
PROSOLV® SMCC 50Formulas in which optimal compaction and decent flow are required
PROSOLV® SMCC 90Formulas in which a balance of flow and compaction are required
PROSOLV® SMCC HD 90Formulas in which optimal flow and consolidation are required
PROSOLV® SMCC 90 LMEquivalent to PROSOLV® SMCC 90, with lower moisture content
at the surfaces of the SMCC particles are shown to be uniformly distributed[2][4]
PROSOLV® SMCC provides solutions to the problems often encountered by formulation scientists while using conventional diluents having low bulk density (BD), poor flow, low compactability or loss of compactability during processing, sticking and sensitivity to lubricant(s). This article will focus on physico-chemical properties, applications and advantages of PROSOLV® SMCC 50 & PROSOLV® SMCC 50 LD.
SMCC grade, it is having benefits like it improves the tablet hardness and re-compactability issues after roller compaction.
PROSOLV® SMCC 50 LD can be first choice.
PROSOLV® SMCC 50 can be useful when both tablet hardness and powder flow are required.
Following are the case studies to evaluate the effect of physiochemical properties of PROSOLV® SMCC 50 and PROSOLV® SMCC 50 LD on tablet dosage form.
Roll compaction is necessary
PROSOLV® SMCC 50 LD is the Lowdensitygrade from PROSOLV® familyof excipients having belowcharacteristics –
Particlesize(d50)Bulkdensity
Around 50 μm0.20-0.30 g/cc
PROSOLV® SMCC 50 is the grade from PROSOLV® familyof excipients having belowcharacteristics –
Particlesize(d50)Bulkdensity
Around 65 μm0.25-0.37 g/cc
These grades offers several benefits to formulation development scientist(s) during development and production at later stage. These benefits along with a few case studies will be elaborated in next section of this article –
Benefits of PROSOLV® SMCC 50 and PROSOLV® SMCC 50 LD in Roller Compaction Applications [3][4]: As stated above,Silicification of Microcrystalline cellulose results in an increase in surface area. This increase in surface area increases binding interaction between the individual particles by reducing the interparticulate cohesion. As a result, silicification improves both the flowability and re-compaction properties of compacts.
PROSOLV® SMCC 50 LD is a low-density PROSOLV®
to improve bulk density, flowability, compactability & to improve content uniformity in the tablet dosage form.
In this study the comparison of MCC 101, PROSOLV SMCC 50 & PROSOLV SMCC 50 LD was studied & evaluated in roller compaction. The Powder blends used consisted of 75% of the Cellulosic compound (either MCC or SMCC) and 25% Dicalcium phosphate dihydrate.Material were blended for 10 mins.Different roller compaction forces were adjusted and the compacts were milled. The resulting powder was tested for particle size distribution and flowability. Furthermore, placebo tablets containing 0.5% of the lubricant, Sodium Stearyl fumarate (PRUV®), were compressed (Tablet weight- 400 mg, round,
Ingredients Percentage
PROSOLV® SMCC or MCC 75 %
DCP (EMCOMPRESS®) 25 %
PRUV® (Extra granular) 0.5 %
101
ated. After roller compaction compacts density plays an important role to get desired Granules: Fines ratio. This is important step for the flow & content uniformity point of view.
Conclusion:
The silicification of MCC has
SMCC 50
SMCC 50 LD
Observation: MCC 101,PROSOLV® SMCC 50 and PROSOLV® SMCC 50 LD yield nicelyshaped hard compacts at 25kN compaction force. From above picture we can conclude that PROSOLV® SMCC 50 LD yields dense compacts compare to Microcrystalline cellulose.
Flowability
In this studythe flowof milled compacts was evaluated.
Observation: Compacts were milled.It was found that PROSOLV® SMCC 50 exhibit best flowabilityfollowed byPROSOLV® SMCC 50 LD and MCC 101.
13mm diameter) and hardness as well as disintegration time of compressed tablets was analyzed.
Compacts comparison:
In this study, the comparison of compacts at 25 KN was evalu-
been shown to significantly influence the hardness and the flowability of compacts in roll compaction process, as well as the hardness of tablets made from granules obtained from the milled compacts. If the overall target in tablet production is
Tablet Hardness
In this studythe effect on Tablet harness of roller compacted granules was evaluated.
Observation: Tablets were manufactured byusing lubricant sodium stearyl fumarate (PRUV®) & compressed in to tablets. Compacts based on PROSOLV® SMCC 50LD yield 30% harder tablets.Compacts based on MCC 101 and PROSOLV® SMCC 50 have nearlyidentical tablet hardness profiles over the entire range of compression forces.
the highest possible tablet hardness, the use of PROSOLV® SMCC 50 LD recommended [3][5][6].
If both, the particle flow and the tablet hardness is the target PROSOLV® SMCC 50 is the best choice [3]
[1] Tobyn, M.J., McCarthy, G.P., Staniforth, J.N., Edge, S. (1998) Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose. Int. J.Pharm. 169, 183-194.
[2] Sheskey, P.J., Cook, W.G., Cable. C.G. (2017) Handbook of Pharmaceutical Excipients, 8th edition, Pharmaceutical Press, 1007-1009.
[3] PROSOLV® SMCC (jrspharma.com)
(https://www.jrspharma.com/ph arma_en/products/excipients/pr osolv-smcc.php)
[4] Sherwood, B.E., Becker, J.W. (1998) A new class of high functionality excipients: silicified microcrystalline cellulose. Pharm. Tech. 22, 78-88.
[5] Staniforth, J. N., Tobyn, M. J. (1996) towards a new class of high functionality tablet binders. III: Physical characteristics and particle morphology of silicified microcrystalline cellulose (SMCC). Proc. AAPS Conf. PT6162
[6] Sherwood, B. E., Hunter, E. A., Staniforth J. N. (1996) Silicified microcrystalline cellulose (SMCC): a new class of high functionality binders for direct tableting. Proc. AAPS Conf. PT 6164
AUTHOR Prashant Bhangdiya Business Development Manager –Pharma Rettenmaier India Private Limited Prashant.bhangdiya@jrsindia.com
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