Express Pharma (Vol. 19, No. 1) December 2023

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VOL. 19 NO. 1 PAGES 106

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www.expresspharma.in

INDIA'S FOREMOST PHARMA & BIOTECH MAGAZINE SINCE 1994

This Issue is Brought to you by

DECEMBER 2023, ` 40

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HALL No : 08 STALL NO : 8.Q01

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VOL. 19 NO. 1 PAGES 106

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Pharma’s most integrated partner to manufacturers of solid dosage products.

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CPHI & PMEC INDIA 28 – 30 November 2023 India Expo Centre, Greater NOIDA, Delhi NCR

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who advances drug delivery?

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® Registered trademark, Ashland or its subsidiaries, registered in various countries ™ Trademark, Ashland or its subsidiaries, registered in various countries ©2023, Ashland PHA23-057

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CONTENTS INTERVIEWS Chairman of the Board Viveck Goenka

P43: KYLE FORCIER

P62: AMIT RAJ SINHA

P32: MANISH JAIN

SENIOR DIRECTOR, LIFESCIENCE PRODUCT MARKETING, MODEL N

MD & CEO, SIGACHI INDUSTRIES

MD, CILICANT

Sr. Vice President-BPD Neil Viegas Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury*

P52: MARK BITTERWOLF P59: LOUISE MADDEN

P28: DR VAISHALI TAWDE MD, IDEAL CURES

Editorial Team

CMO AND DIRECTOR OF SALES, JULABO GMBH

CEO, H.E.L GROUP

56

BUILDING RESILIENCE AND RETHINKING STRATEGIES FOR GROWTH

67

OFF-PATENT BUT NO GENERIC IN SIGHT

Lakshmipriya Nair Kalyani Sharma DESIGN Art Director Pravin Temble Senior Designer

P60: JÖRG PIEPER

P60: SANJEEV A. NIMKAR

Rekha Bisht

CEO, ROMACO GROUP

MD, ROMACO INDIA

Debnarayan Dutta

P57: RAJESH VEDAK

P54: ROHIT RAUT

Production Co-ordinator

MD, KÖRBER PHARMA INDIA

MD, RETTENMAIER INDIA (JRS PHARMA INDIA)

34

DR BAILEY RISTEEN, GLOBAL SUSTAINABILITY MANAGER PHARMA SOLUTIONS, BASF

37

QR CODING TAKES ON COUNTERFEITING IN INDIA'S PHARMA INDUSTRY

38

CONSOLIDATION IN PHARMA: A MAGIC PILL OR A DOUBLE-EDGED SWORD?

Senior Artist Rakesh Sharma Marketing Team Rajesh Bhatkal Ashish Rampure

Dhananjay Nidre Scheduling & Coordination Pushkar Waralikar CIRCULATION Mohan Varadkar

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2022 - 24. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021.

Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EXPRESS PHARMA

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December 2023

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EDITOR’S NOTE

Navigating the shift from low cost to highest value

A

s we wind up another year and mark Express Pharma's 29th anniversary, let us review the government's expectations from the life science segment, which are both aspirational and inspirational.

At the recent CII 5th Life Sciences Summit 2023, Arunish Chawla, Secretary, Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, said, "India has the potential to grow 3-4 times in value by achieving a shift from 10 per cent share of Pharma and MedTech in the manufacturing sector in 2020 to a 20 per cent share in 2030."

The DoP Secretary highlighted the sector’s achievements, such as having the largest number of US FDA approved plants outside the US, exports valued at more than $50 billion to 200 countries, and meeting two-third of the WHO’s global vaccines requirements.

As a reality check, he also listed areas for improvement. Even though there is innovation happening in India, (citing evolution of MedTech, assistive technology, and smart medicine), there is a need for a streamlined innovation strategy and breaking the silos between academia, laboratories, and industry.

The CII statement goes on to recommend a shift from publications to patents. Further, it states that a mechanism for research-oriented sponsored degrees from industry is the need of the hour to foster innovation. India must utilize its technical resources, demographic dividend, skilled manpower, forwardlooking government policies, and economies of scale to become a world leader in pharmaceuticals.

Do we have the right policies, infrastructure, and mindset to achieve these aspirations?

On the policy front, a quick look at the 21-page approach paper of the Draft National Pharmaceuticals Policy 2023, currently open for stakeholder comments, lists initiatives started in the past few years. These include setting up the Production Linked Incentives (PLI) scheme, Bulk Drug Parks, the Pharmaceutical Technology Upgradation Assistance (PTUAS) Scheme, the National R&D Policy, and the Promotion of Research and Innovation in Pharma-MedTech (PRIP) Scheme.

More importantly, perhaps acknowledging the less than satisfactory response or implementation of these initiatives, the draft policy admits that ‘the pursuit of Vision 2047 for Amrit Kaal necessitates a reinvigorated, concentrated, and results-driven holistic approach.’

A significant statement is the stated need for India’s pharma manufacturing to shift from the existing mindset of focusing on “exceptional quality at low cost” to “exceptional quality at the highest value.”

The draft suggests that this shift would come from a focus on innovation and, at the same time, retain the cost competitiveness and scale of India’s

22 EXPRESS PHARMA December 2023

The Draft National Pharmaceuticals Policy 2023 advocates a shift from “exceptional quality at low cost” to “exceptional quality at the highest value.”

Will implementation live up to the stated vision?

advantage in generics.

The draft policy comes against the backdrop of persistent Good Manufacturing Practices (GMP) violations, and authorities nudging manufacturers to upgrade to the revised Schedule M. In the latest instance, eye drops made by Mumbai-based Kilitch Healthcare India were withdrawn from pharmacies in the US. As per the inspection report, US FDA inspectors observed violations like staff working without proper protective gear in sterile areas and others filing backdated test results to show batches of eye drops were sterile.

Will the implementation of the draft policy live up to the stated vision? No one disputes that all change needs time, effort, and patience to show results.

On the infrastructure front, some relief comes from early predictions that the industry is already on course.

For instance, on the bulk drug side, a CRISIL study of 55 bulk drug makers, which accounted for over 20 per cent of the ~Rs 1.35 lakh crore segment’s revenue last fiscal, offers some cheer. As per the CRISIL study, import dependence is expected to somewhat reduce over the medium term, as domestic production increases gradually because of capital spending under the PLI scheme.

Of the originally envisaged capex commitment of ~Rs 6,500 crore under the PLI scheme for bulk drugs, domestic companies have already committed ~Rs 4,100 crore. Aniket Dani, Director-Research, CRISIL Market Intelligence & Analytics, points out that a large portion of the upcoming capacity is for two key APIs: para-amino-phenol and penicillin, which, once commissioned and ramped up, will be sufficient to almost entirely replace imports for these products. He adds that at the aggregate level, too, new capacities under the PLI scheme will help reduce import dependence for bulk drugs by ~one-fifth.

This month's edition is also a CPHI India Special edition, and a survey by the organizers confirms that India has the highest confidence in outsourcing growth globally among its pharma professionals. As per a release, executives from India have offered up the most positive outlook for 2024 – with 61 per cent being ‘highly positive’ and a further 37 per cent ‘moderately confident’. This result contrasts with a global average of just 37 per cent ‘highly positive’ and 54 per cent ‘moderate’ in all executives.

Thus, on the mindset front, while we do not lack confidence, we need a large dose of a quality mindset to reduce GMP violations. If we want a global footprint, we must also live up to global regulatory standards.

VIVEKA ROYCHOWDHURY, Editor viveka.r@expressindia.com viveka.roy3@gmail.com

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CPHI-PMEC SPECIAL

Breaking new ground in pharma excipients and coating systems industry Dr Vaishali Tawde, MD, Ideal Cures, shares insights into the company's differentiating factors, flagship offerings, client-centric approach, and strategic initiatives propelling the company towards an ambitious future roadmap

T

he pharmaceutical excipients and coating systems market in India is poised for remarkable growth, driven by increased demand and the booming pharma industry. Factors like research and development advancements, drug delivery technologies, and generic drug production further boost demand. Amidst these opportunities, clients encounter challenges with regulatory compliance, product stability, bioavailability, and cost-efficient manufacturing. Ideal Cures, a leading player in the industry, recognises these challenges and addresses them effectively through their high-quality products. With a focus on customisation and technical support, the company collaborates closely with clients, offering tailored solutions to overcome challenges and achieve desired outcomes, contributing markedly to the industry's growth and success.

Ideal Cures’ flagship offerings The company's flagship products, INSTACOAT, consist of a comprehensive line of pharma excipients and readyto-use coating systems tailored for pharma and nutra products. Specifically engineered for tablets and capsules, the ready-to-use coating systems offer enhanced filmcoating solutions, safeguarding the medication, enabling controlled release, and promoting better patient compliance. Addressing regulatory concerns is a top priority for the company, ensuring swift resolution and seamless compliance.

“Our company stands out

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Addressing regulatory concerns is a top priority for the company, ensuring swift resolution and seamless compliance from competitors due to several key factors. Firstly, our products are the result of rigorous research and development, reflecting our deep expertise in the pharma industry. Furthermore, we prioritise quality and regulatory compliance to ensure safety and efficacy. Innovation

and customer-centricity enable us to provide customised solutions and exceptional technical support. Our strong market reputation and enduring customer relationships further enhance our differentiation in this segment”, shares Dr Vaishali Tawde.

In terms of personalising solutions, the firm’s client engagement process commences with a comprehensive assessment of specific requirements, formulation needs, and challenges. Thereafter, expert consultations enable tailored recommendations for excipients or coating systems, considering crucial factors like

product stability and bioavailability. In-house compatibility studies and sample evaluations ensure client satisfaction, post which smooth transitions are facilitated with technical support, training, and ongoing assistance. A robust feedback loop drives continuous evaluation and optimisation of products and services, aligning with evolving client needs, keeping Ideal Cures at the forefront of proactive client-centricity.

“Our team comprises highly skilled professionals with extensive expertise in pharma excipients and coating systems. Our combined experience spans various disciplines which enables us to develop innovative solutions and provide comprehensive technical support to our clients.

Our team's expertise is a crucial asset for our firm's growth, allowing us to stay at the forefront of industry trends, collaborate with clients on complex projects, and deliver high-quality products that meet the evolving needs of the pharma industry,” shares Dr Vaishali Tawde.

Future roadmap Having started as a smallscale operation, the company's journey has been remarkable. The unwavering focus on providing top-notch pharma excipients and coating systems has led to exceptional growth and a prominent position in the market.

The team’s dedication to customer satisfaction has earned Ideal Cures a diverse and expanding clientele, ranging from local to international markets. Through successful geographical expansion and strategic partnerships, the

As a trusted provider of pharma excipients and coating systems, the firm aims to meet evolving global demands with a robust supply chain firm has furthered their impact on the global pharma industry.

Ideal Cures is charting an ambitious future roadmap, driven by a commitment to growth and innovation in the pharma industry. As a trusted provider of pharma excipients and coating systems, the firm aims to meet evolving global demands with a robust supply chain. The company’s strategy encompasses diverse initiatives like investing in research and development to tackle emerging drug formulation challenges, staying at the forefront of innovation through collaborations and cuttingedge technologies, expanding manufacturing capabilities with state-of-the-art facilities and regulatory compliance, forging strategic partnerships to leverage collective expertise and drive customisation, and prioritising customer support services to empower clients with knowledge and tools for success.

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CPHI-PMEC SPECIAL I N T E R V I E W

CILICANT is the go-to partner for customers to choose the best active packaging solution In this interview, Manish Jain, Founder & MD, CILICANT, speaks on his company evolution as a leader in active pharma packaging, its innovative solutions, commitment to quality, and its proactive customer-centric approach How has CILICANT positioned itself as a leader in active pharma packaging over the years?

Over the years, CILICANT has established itself as a forerunner in the pharma packaging industry with its active packaging solutions due to its expertise in sorbent chemistry, exceptional quality, and timely service.

CILICANT has established itself as the go-to partner that not only offers but also helps customers choose the best active packaging solution, thanks to strong teamwork.

What sets CILICANT apart is the way we treat our customers; our team is proactive in providing timely support, right from sampling to commercial projects.

CILICANT products are manufactured in a classified clean room within state-ofthe-art cGMP-compliant facilities, and every stage of the manufacturing process goes through stringent quality checks as the quality and safety of the product are of utmost priority.

The backbone of CILICANT is its state-of-theart manufacturing facilities, which are now the largest in India. With facilities that have grown from a single 10,000 sq ft. location to over 100,000 sq ft. spread across multiple sites, we are able to be on par with rising customer demands across various industry segments.

These aspects of CILICANT, along with trust and support from our industry partners, have helped shape our exceptional growth story from a manufacturing company to a

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trusted brand in the pharma industry.

What are the innovations that CILICANT has brought to the field of active pharma packaging to address the evolving needs of the industry?

Over the years, I have seen a dynamic shift in the growth pattern of the Indian pharma industry. From being a

generic manufacturing hub of the world to an innovation-led dynamic industry, the Indian pharma industry has paved the way for the generational growth of the Indian economy.

This has encouraged us to develop innovative active packaging solutions to meet the challenges of shelf life preservation arising from complex formulations and drug deliveries.

Our R&D team plays a significant role in our success in the market today. Since our inception, we have been conducting stability studies of our products with a two-

pronged approach, testing various products from our clients and ones available in the wider market. This combined approach has enabled us to provide viable results to our existing clients while also developing new solutions that are futureready.

Frexil desiccant canisters are one example of such an approach.

Frexil, a stellar product of CILICANT, was developed considering the issue of dusting observed in activated carbon-based canisters, which led to many market

complaints and an unpleasant consumer experience.

It is formulated using Cilicant’s patented technology, which works as well as standard desiccants and prevents dusting.

We designed Frexil in canisters, especially keeping in mind customer acceptance and ease of usage, as canisters are one of the most widely used forms of desiccants. Our Frexil canisters not only prevent dusting but are also spill-proof.

Another example is Oxabide, an oxygen scavenger that is one of the most compact oxygen scavenging solutions available in the active pharmaceutical packaging industry. Oxabide is designed and formulated using Cilicant’s patented technology to fit the least amount of headspace and give outstanding results in terms of oxygen absorption.

Our innovations and latest developments will be showcased at booth 14.A58 at Cphi India this year.

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CPHI-PMEC SPECIAL

Medicines for healthy people and planet: Three sustainability trends in the pharma industry Dr Bailey Risteen, Global Sustainability Manager - Pharma Solutions, BASF discusses emerging key sustainability trends in pharma: carbon transparency in the value chain, drug product ecodesign, and responsible sourcing

I

n the past several years there has been a large wave of ESG-related corporate targets from companies in the pharma industry, including dozens of commitments to the Science-Based Targets Initiative (SBTi) where CO 2 reduction targets are aligned with climate science. Retailers, pharmacies, and healthcare systems are also taking action – for example, the UK’s National Health Service announced its ambition to be the world’s first net zero national health service, including emissions from medical devices and medicines.1 The industry is now facing the challenge of prioritising sustainability initiatives and driving impactful action on a relatively short time scale with 2030 targets approaching quickly. While there are numerous meaningful sustainability topics being discussed in the pharma industry, three topics in particular are emerging as key trends: carbon transparency in the value chain, drug product eco-design, and responsible sourcing.

which measure the greenhouse gas emissions associated with a product along its life cycle in kg CO2 equivalents per kg product. For example, a supplier could calculate the PCF of a resin, reagent, solvent, or excipient, and a pharma company could use this data to assess CO 2 hotspots in their Scope 3 emissions and make procurement decisions towards lower CO2 raw materials.

Industry trend #2: Drug product eco-design

Industry trend #1: CO2 transparency in the value chain Key environmental data that need to be calculated and shared in the pharma value chain are carbon (CO2) emissions. Value chain or “indirect emissions” (formally called Scope 3 emissions), which include emissions from upstream raw materials and services and downstream use and disposal of products, can make up more than 90 per cent of total CO2 footprint for a typical pharma company. 2 This is in contrast to other sectors, such as chemicals,

34 EXPRESS PHARMA December 2023

paper, and steel, which have higher direct emissions (Scope 1 and Scope 2) from manufacturing operations and electricity purchases.3 Given the pharma indus-

try’s commitment to nearterm CO 2 reduction targets and, ultimately, a net zero future, there is an urgent need to accurately calculate these indirect emissions and track

their reduction in close coordination with suppliers. One way that suppliers and pharma companies can do this is through product carbon footprint (PCF) data,

In parallel to corporate-level CO2 accounting and reduction initiatives, many pharma companies are also developing “eco-design” or “sustainability by design” programs to take a deeper dive into the environmental impact of drug products early in the development pipeline. Under an ecodesign lens, aspects beyond raw material carbon footprints are also assessed, such as manufacturing and formulation processes (e.g., water, energy use), packaging design (e.g., circularity), and shipping requirements (e.g., cold chain). The goal is to balance environmental impacts with other important product requirements such as safety, cost, technical specifications, regulatory compliance, and shelf-life.

Eco-design programs will set pharma companies up for success in the future, especially when environmental regulations tighten, as proactive sustainability interventions will inevitably be more effective and potentially cheaper than reactive re-design of drug products already on the market with the associated regulatory hurdles.

As eco-design programs become more common and

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CPHI-PMEC SPECIAL mature, there will be new opportunities for the value chain to collaborate. For example, joint R&D between license holders and CDMOs to reduce the number of manufacturing steps or excipients suppliers developing new innovations that allow license holders to formulate their drug products more efficiently.

Industry trend #3: Responsible sourcing With the globalised supply chain becoming increasingly complex and consumers scrutinising how their products are made, pharma companies are taking a closer look into how key raw materials are sourced - especially those that are nature-based, which come with their own risks and challenges.

For example, thanks to its versatility, unique chemistry, and high yield, palm oil has been in high demand in several industries, including pharma, where it’s used as a raw material in many lipidbased excipients. The popularity of palm (kernel) oil has led to issues around the loss of biodiversity, human rights violations, and deforestation and draining of peat lands, both of which serve as valuable carbon sinks. But palm oil is not the only nature-based raw material that has undergone increased scrutiny. Cellulose, sugar, castor oil, fish oil, corn, soy, natural rubber, and more

36 EXPRESS PHARMA December 2023

It is important to note that sustainability is a continuous journey, and pharma companies should regularly review and update their strategies to align with evolving best practices and industry standards

its Oleochemical excipients using 100 per cent mass-balanced RSPO certified palm (kernel) oil, and offers ingredients like Ibuprofen and PVP K30 (Kollidon® 30) with a carbon footprint that is estimated to be at least 30 per cent lower than the market average.

References have all had reported negative human rights and environmental impacts in the supply chain.4-7 Certification bodies are key to addressing many of these issues. For palm oil specifically, there’s the Roundtable on Sustainable Palm Oil (RSPO) – a global multi-stakeholder forum founded in 2004 that completes on-the-ground audits and maintains strict criteria for certification with a focus on: smallholder inclusion, protection of workers’ rights, no deforestation, and no new planting on peatlands.8 Pharma companies have already started to trace supply chains for their key natural raw materials and in the future will rely on certification bodies like RSPO and others (MarinTrust, Forest Stewardship Council, Bonsucro, etc.) to ensure that their standards for responsible sourcing are met.

How pharma companies can reach their sustainability goals There are some strategies

that pharma companies can take to reach their sustainability goals. Pharma companies can adopt sustainable practices in their manufacturing processes, such as reducing energy and water consumption, minimising waste generation, and implementing recycling initiatives.

Pharma companies can work towards sourcing raw materials and ingredients from sustainable and ethical sources. This includes using environmentally friendly farming practices and ensuring fair labor conditions throughout the supply chain.

Pharma companies can invest in energy-efficient technologies and renewable energy sources to reduce their carbon footprint. This can include using solar panels, implementing energy-saving measures in facilities, and exploring opportunities for green energy procurement.

Pharma companies can prioritise research and development efforts towards sustainable solutions, such as developing greener manufac-

turing processes, reducing the environmental impact of drugs, and exploring alternative, eco-friendly ingredients.

Collaborating with other organisations, NGOs, and research institutions can help pharma companies share best practices, access expertise, and find innovative solutions to sustainability challenges.

Pharma companies should strive for transparency in reporting their sustainability efforts and progress. Regularly publishing sustainability reports and sharing goals, achievements, and challenges can help hold companies accountable and encourage continuous improvement.

It is important to note that sustainability is a continuous journey, and pharma companies should regularly review and update their strategies to align with evolving best practices and industry standards.

Ingredients suppliers are increasing their efforts to produce and supply raw materials with a reduced environmental impact. BASF Pharma Solutions, for example, produces

1.NHS England, “Delivering a net zero NHS.” Available at: https://bit.ly/3N37Gyy 2.Data based on sciencebased targets and corporate sustainability reports from 22 companies in the pharmaceutical industry (2022) 3.“CDP Technical Note: Relevance of Scope 3 Categories

by Sector” (2022). Available at: www.cdp.net 4.Mighty Earth, “A Bridge Too Far? Social and Environmental Concerns in Bridgestone’s Liberian Rubber Plantation and a Plan for Remediation” (2020) 5.Know The Chain, “How food and beverage companies tackle forced labor risks in sugarcane supply chains” (2017) 6.The Dutch Soy Coalition, “Soy - big business, big responsibility. Addressing the social- and environmental impact of the soy value chain” (2008) 7.WWF, “Responsible sourcing of forest products: The business case for retailers” (2017) 8.https://rspo.org

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QR coding takes on counterfeiting in India's pharma industry Dr K Madan Gopal,Advisor – Public health administration at National Health Systems Resource Center – MOHFW, GOI, and Dr K S Uplabdh Gopal, Professional Health Consultant, outline strategies that India can adopt to successfully implement QR codes for the top 300 brands and strengthen its fight against counterfeit medicines

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ounterfeit medicines significantly threaten public health and safety worldwide, including in India.

They contain incorrect ingredients, dosages, or low-quality standards, endangering lives.

This challenge requires protecting public health, ensuring genuine medicines, and addressing associated risks.

Counterfeits erode trust in healthcare, risking patient safety and worsening medical conditions. Economically, legitimate pharmaceutical companies suffer revenue loss, governments face healthcare costs, and tax revenues decline. Counterfeits damage the reputation of trusted manufacturers, necessitating a lengthy brand-rebuilding process.

WHO estimates that approximately 10 per cent of drugs worldwide are counterfeit, with even higher percentages in developing countries. In India, around 20 per cent of the pharma market comprises counterfeit drugs. Implementing QR coding for the top 300 brands in India has become mandatory to combat this issue, revolutionising the fight against counterfeiting and enhancing traceability in the pharma industry.

Counterfeit medicines endanger lives and contribute to ineffective treatments. In lowand middle-income countries, the prevalence of counterfeit medicines ranges from 10 per cent to 41 per cent, while in high-income countries like the US, it remains below one per cent. India faces a significant challenge, with up to 20 per cent of pharma products supplied being counterfeit. These counterfeit drugs often enter the market through unregulated channels, including online platforms, street vendors, and

Dr K Madan Gopal

fake pharmacies. Anti-malarial, antibiotics, anti-diabetics, cardiovascular medications, antituberculosis drugs, and anticancer drugs are India's most commonly counterfeited pharma products.

The pharma supply chain is complex and is vulnerable to counterfeit medicines at every stage, requiring measures to strengthen supply chain management, enhance transparency, and implement effective traceability. Counterfeiters adapt to new technologies, employing advanced printing techniques, counterfeit packaging, and replicated QR codes.

Addressing this requires continuous innovation in anticounterfeiting technologies and proactive detection measures. Cross-border trade and online platforms are significant channels for counterfeit medicines, necessitating international cooperation and stringent regulations to control them effectively.

Addressing these challenges requires a comprehensive approach involving regulatory authorities, pharma manufacturers, law enforcement agencies, technology providers, and healthcare professionals. Collaboration, infor-

mation sharing, stricter regulations, public awareness campaigns, and advanced technologies are essential to combat the scourge of counterfeit medicines and protect public health. QR coding has emerged as a powerful tool in the fight against counterfeiting.

The Indian government has introduced the mandatory implementation of Quick Response (QR) codes on the labels of the top 300 brands. QR codes for API are already in place. This technology allows consumers, healthcare providers, and regulators to verify the authenticity of pharma products instantly.

By scanning the QR code, individuals can access realtime information about the product's manufacturing details, expiration date, batch number and authorised distributors.

The Ministry of Health issued a notification on November 17, 2022, introducing the Drugs (Eighth Amendment) Rules, 2022. A new Schedule H2 was introduced per these rules, listing the top 300 brands. The amendment also mandated the affixing of QR codes on the packaging of these formulations starting from the August 1, 2023. The

Dr K S Uplabdh Gopal

QR code would contain essential details such as the drug’s generic name, product identification code, brand name, manufacturer's name and address, batch number, license number, date of manufacture, and date of expiry. This measure aims to ensure the authenticity and traceability of these medicines.

Addressing these challenges will require collaboration between stakeholders, including pharma companies, authentication solution providers, retail outlets, regulatory bodies, and the government. By working together, implementing necessary infrastructure improvements, providing support and training, and enhancing regulatory capacities, India can overcome these challenges and establish a robust QR coding system to combat counterfeiting effectively.

Implementing QR coding in the pharma industry offers enhanced product authentication, improved supply chain traceability, consumer empowerment, and regulatory compliance. However, challenges exist in its implementation for the top 300 brands in India, including robust infrastructure, cost considerations, counterfeiters'

adaptability, retail outlet integration, regulatory capacities, public awareness, data privacy and security. Retail outlet integration and regulatory capacities must be prioritised to overcome these challenges.

Collaborative stakeholder efforts, infrastructure investments, regulatory support, education, continuous monitoring, technological advancements, international collaboration, data sharing, and a commitment to improvement are crucial for successful QR code implementation and combating counterfeit medicines.

By adopting these strategies, India can successfully implement QR codes for the top 300 brands and strengthen its fight against counterfeit medicines. A collaborative and multi-faceted approach will protect consumers, improve supply chain integrity, enhance regulatory oversight, and ensure the availability of safe and genuine medicines to safeguard public health.

Implementing QR coding for the top 300 brands in India marks a significant milestone in the fight against counterfeiting in the pharma industry. By leveraging technology, fostering collaboration, addressing challenges at retail outlets, and strengthening regulatory capacities, India can establish a robust authentication system that protects consumers and enhances public health outcomes, as China and South Korea successfully did.

QR coding empowers individuals to make informed decisions about their health while ensuring the integrity of the pharma supply chain. Together, we can eradicate counterfeit medicines and ensure the safety and well-being of patients across India.

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Consolidation in pharma: Amagic pill or a double-edged sword?

Amit Mookim, Managing Director, IQVIA South Asia and Shantanu Gharpure - Principal, Consulting Services opine that mergers can offer potential benefits, but also come with risks and challenges. They also outline some cautionary steps that should be taken to ensure that pharma deals do not turn into a double-edged sword

Amit Mookim

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onsolidation through mergers and acquisitions is a common phenomenon in the ever-evolving pharma industry. These mergers have not only been about combining resources and R&D pipelines, but they offer valu-

Shantanu Gharpure

able lessons in terms of what has worked and what has not.

While there are some key lessons that can be learned from successful transactions that have delivered its promised “magic pill” potential to the acquirers, there are also a few

cautionary tales of pharma deals highlighting the pitfalls to be aware of and the lessons to takeaway.

Whether a healthcare merger is beneficial or not depends on various factors, and it's essential to carefully evalu-

ate each case to determine its impact on the quality and affordability of healthcare services. What makes pharma transactions turn into magic pills?

1. Closely reviewing product portfolio: Pharma mergers often lead to expansion and diversification of product portfolios. This is crucial in an industry where product portfolio is really everything! Consolidation allows companies to add complementary products to their lineup, reducing their dependence on select few drugs. For example, more than a decade ago, a French pharma giant acquired a biotech company which helped it rapidly expand its range of rare disease treatments. That acquisition continues to bode well for the acquirer.

2. Managing market overlaps: Successful pharma mergers often result in companies gaining a faster access to new geographies, clinicians, and distribu-

tion networks. When two large Indian pharma companies merged in 2014, it provided the acquirer with access to several

emerging markets that it had hitherto not been present in.

Similarly, a Swiss Pharma company’s acquisition of an ophthalmology focused company provided it with an entirely new set of clinicians and distribution channels worldwide.

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CPHI-PMEC SPECIAL 3. Driving R&D synergies: Mergers in the pharma industry provide an opportunity for companies to pool their research and development resources. This collaboration often accelerates drug discovery and development processes. An example of this is the merger of two American pharma companies, which combined their R&D capabilities, leading to the creation of innovative drugs in oncology, cardio-vascular health as well as in vaccines.

4. Driving cost synergies: Consolidation often results in reduction of redundant operations, elimination of overlapping functions and thus leads to cost savings and increased efficiency.

Mergers in the healthcare industry are not a "magic pill" that can solve all the challenges and issues in the sector. While they can offer potential benefits, they also come with risks and challenges. To ensure that pharma deals do not turn into a double-edged sword, there are some cautionary steps that should be taken.

1. Inadequate due diligence: One of the most common reasons for failed mergers is inadequate due diligence. When companies do not thoroughly assess the financial, legal, and operational aspects of their potential partner, they expose themselves to risks that can be detrimental. Besides some of the FDA related issues that have plagued pharma transactions in India, there are certain other aspects such as tax related issues, receivables (especially from countries undergoing political or economic turmoil) as well as IP and consumer litigation that need to be considered.

2. Regulatory challenges: Given that the industry is heavily regulated and antitrust concerns are fairly common, ensuring that aspects such as overlaps, label change, filing of appropriate documentation for dossiers, trademarks, etc are handled in a timely manner and is critical to successful deal closure and derivation of deal synergies. The proposed merger between an Anglo-Swedish multi-national company and a global pharma giant faced

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significant regulatory hurdles, leading to its eventual abandonment.

3. Poor integration: Because of the regulated nature of the industry, it is critical to have a well-defined integration roadmap from Day 1 of the merger, right from Board com-

position and determining region level synergies, down to the level of when, whether and how the product labels will change. Detailed integration plans, including processes for combining technology, systems, and human resources, are vital for a successful merger.

The lessons from the lesser successful mergers underscore the importance of thorough due diligence, regulatory compliance, cultural alignment, realistic synergy projections, effective integration planning and the careful assessment of merger complexity. By

learning from these mistakes and leveraging the insights from successful transactions, pharma companies can enhance their chances of successful mergers and navigate the challenges inherent in this dynamic yet extremely critical industry.

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Leading the charge: Women driving innovation and quality in pharma Uma Rao, CHRO, Granules India emphasises that empowering women in pharma isn't just about achieving equality; it's a catalyst for driving innovation, enhancing patient care, and improving decision-making processes

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he pharma sector, long hailed as a symbol of scientific progress, is undergoing a significant transformation. While the industry has seen an influx of talented women, there remains a stark gender gap in leadership positions. It's imperative that we recognise empowering women in pharma isn't just about achieving equality; it's a catalyst for driving innovation, enhancing patient care, and improving decision-making processes.

In 2022, more than half of the new entrants to the global pharma industry were women, marking a positive trend. However, this optimism is tempered by the fact that nearly three-quarters of pharma Csuite members are men. Addressing this disparity is not only a matter of gender equality but a key driver for the industry's progress. Studies, such as one by McKinsey1, emphasise that bridging gender gaps could significantly boost a country's GDP, underlining the economic importance of diversity and inclusion.

The power of diversity and inclusion Fostering diversity and inclusion (D&I) in the pharma sector is pivotal for several reasons: ◆ Driving innovation and creativity: Diverse teams, encompassing women from various backgrounds and experiences, bring a wealth of perspectives to the table. This diversity of thought leads to innovative solutions tailored to women's healthcare needs, whether it's developing effective treatments, reducing

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ship Circle reveals that female leaders outperform their male counterparts across every management level and age group and women consistently outperform men in connecting with others, authenticity, and systems awareness, showcasing their creative competencies. Moreover, organisations with at least 30 per cent women in leadership roles, as highlighted by a research 2, are 12 times more likely to be in the top 20 per cent for financial performance. This demonstrates that women leaders contribute to positive outcomes for businesses, extending beyond diversity efforts.

Strategies for an inclusive future

medication costs, or advancing solutions for women-specific health conditions. ◆ Capturing global diversity: A diverse leadership ensures a more inclusive approach to clinical trials and patient-centric care. Tailoring healthcare solutions to specific demographic groups ensures effectiveness and relevance, moving away from the one-size-fits-all approach. ◆ Improved decision-making: Research consistently demonstrates that diverse groups make better decisions.

In the high-stakes pharma industry, diverse perspectives enhance decision-making processes, ensuring well-

rounded and thoughtful strategies.

Research from the Leader-

Creating a more inclusive future for women in pharma requires concerted efforts: ◆ Commitment at the top: Female leaders must champion women's empowerment, setting the tone for the organisation's culture and paving the way for women to lead and shape the industry's future. ◆ Inclusive hiring: Implement blind recruitment techniques, diverse interview panels, and clear diversity goals to eliminate biases in hiring practices. ◆ Diverse leadership development: Invest in mentorship programs, leadership training, and progressive initiatives that nurture diverse talent for leadership roles. ◆ Inclusive culture: Foster an environment where every female employee feels valued and respected. Cultivate a culture of openness, conduct diversity training sessions, and establish groups to support

employees' needs. ◆ Data-driven approach: Use data to measure progress and identify areas needing improvement. Regularly assess diversity metrics, gather feedback, and address gender-related issues promptly. ◆ Collaboration for change: Collaborate with external organisations and experts to introduce fresh perspectives and best practices. Networking and partnerships create a supportive ecosystem that fosters the growth and empowerment of women in the sector.

Embracing the future The pharma industry is poised for a ground-breaking era of evolution. Leaders, stakeholders, and advocates must collectively ensure women in pharma receive the opportunities, support, and recognition they deserve. By providing equal opportunities, the industry can unlock its full potential. In the capable hands of women, the pharma sector can continue saving lives, discovering groundbreaking solutions, and pushing the boundaries of what's possible. The time for change is now, and the future of pharma shines brighter with women leading the way.

References https://www.mckinsey.com/industries/healthcare/ourinsights/women-in-healthcareand-life-sciences-the-ongoing-stress -of-covid-19 https://www.forbes.com/sites/kevi nkruse/2023/03/31/new-researchwomen-more-effective-than-menin-all-leadershipmeasures/?sh=1da20a91577a

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CPHI-PMEC SPECIAL I N T E R V I E W

One of the game-changers with CPHI is its ability to draw global players into India An Express Pharma exclusive with Olga PonomarevaStepnaya, Brand Manager, CPHI India, on trends and challenges in pharma sector, and what to expect at this year’s CPHI India How would you describe the current pharma scene in India, and what imminent trends do you see coming out of the show floor at CPHI India 2023?

We're witnessing a fascinating evolution in India's pharma sector. According to our recent CPHI Annual Report, India is stepping into the spotlight as the go-to destination for contract services, coupled with a surge in the biological production of commercial drugs. With a robust base of drug manufacturers and a growing pool of R&D talent, it's no surprise that much of the drug development cycle is finding its home here.

Before CPHI India 2023 kicks off, everyone's feeling the buzz about India's powerhouse position in the global pharma game. Propelled by favorable tailwinds, analysts anticipate India to outperform most other regions. Moreover, the evolving and expanding supply chains within India are seen as instrumental in supporting the industry's growth. Against this backdrop, CPHI India is identified as critical to sustaining India's momentum and influencing the wider

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CPHI-PMEC SPECIAL region's trajectory into 2024.

ability to draw global players into India. Partners from Europe, the US, and Asia converge during the event, providing a unique opportunity for attendees to meet and forge alliances in quick succession.

This not only opens new opportunities for India but also streamlines the process, avoiding the complexity of extensive research for ideal partners.

Could you identify the key challenges faced by the pharma sector in India?

Like many other countries with a substantial pharma manufacturing base, supply chain security is a pressing concern in India. National efforts are underway to safeguard and locally produce crucial APIs and starting materials. Diversification of partners is a key strategy, something we actively promote at CPHI India through our meeting platforms. Access to a diverse range of partners is crucial for sustained growth, making attendance at our event highly beneficial.

How do you feel this year’s event will be helpful to the pharma sector in India?

This year's CPHI India event comes at a crucial time, aligning with India's shift towards innovation-focused development. The scale of CPHI is its standout feature, bringing together various supply chain components to stimulate fresh ideas and partnerships. We're not just talking about your regular networking; we're talking about connections that could spark innovation at an unprecedented pace.

Can you elaborate on how CPHI India fosters global collaboration and market expansion?

Absolutely! One of the gamechangers with CPHI is its

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This year's CPHI India event comes at a crucial time, aligning with India's shift towards innovation-focused development. The scale of CPHI is its standout feature, bringing together various supply chain components to stimulate fresh ideas and partnerships

As we approach CPHI India 2023, what should attendees be particularly excited about?

Attendees should be thrilled about the platform CPHI India 2023 provides. It's not just an event; it's a community builder, a space where you want to be if you're looking to ride the wave of the pharma industry's future. The excitement on the show floor is palpable, making CPHI India 2023 a must-attend for those wanting a front-row seat to the pharma industry's next big moves.

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Increased reporting complexity, administrative burden increase regulatory risk of US pharma market With more states in the US set to introduce pharma price transparency laws to help control spending and understand price increases, and with the Inflation Reduction Act looming on the horizon, Kyle Forcier, Senior Director, Lifescience Product Marketing, Model N explains the impact of such laws, increased cost of compliance due to administrative challenges and fallout of non compliance, in an interview with Viveka Roychowdhury Governments across the world have been trying to reduce the cost of medicines and medical care. How are drug prices regulated/ monitored/controlled in the US? Although the US lacks

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CPHI-PMEC SPECIAL federal drug price controls, nearly half of states have their own price transparency laws. The statutes apply to US and foreign drugmakers and require pharma companies to generate and publish reports on triggering events, such as wholesale acquisition cost (WAC) price increases, annual price lists, new drug pricing, newly acquired products, and new drug applications. The individual state legislatures created these laws to help control pharma spending and better understand the rationale for price increases.

Each state has unique reporting thresholds, formats, data requirements, deadlines, and processing methods, creating significant administrative challenges for manufacturers.

The federal government’s Inflation Reduction Act (IRA) authorises the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for selected drugs with high total spending and high expenditure, single-source drugs without generic or biosimilar competition. The new law also requires drug companies to pay a Medicare rebate on prices that rise faster than the inflation rate.

The 340B Drug Pricing Program requires pharma manufacturers to enter an agreement, called a pharmaceutical pricing agreement (PPA), with the government in exchange for having their drugs covered

by Medicaid and Medicare Part B. As part of this agreement, pharmaceutical manufacturers must provide outpatient drugs at discounted prices to certain healthcare organisations serving low-income and uninsured patients. The manufacturers cannot charge covered entities prices more than statutorily defined 340B ceiling prices for covered drugs.

Manufacturers determine the 340B price from related price calculations, including

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average wholesale price (AWP).

State transparency laws create a significant administrative burden on manufacturers.

Drug makers must manage all relevant data and comply with each state's unique rules, requirements, deadlines, and formats average manufacturer price (AMP), best price (BP), and the Medicaid unit rebate amount (URA), each of which requires extensive data and complex formulas.

To date, 22 states have introduced pharmaceutical price transparency laws to help them control spending and understand price increases. Has this reduced the cost of care for patients? If yes, by how much?

Transparency laws are relatively new, so long-term

impacts are yet to be determined. Early research suggests states with these laws have seen fewer drug price increases trigger reporting requirements, but launch prices and overall spending on prescription drugs continued to increase.

According to Maine's drug price transparency report, when generic drug prices decrease, payers and consumers may continue paying higher prices due to the complicated relationship between the list price set by manufacturers and the

How have such laws impacted industry stakeholders in the pharma supply chain, like pharma manufacturers, pharmacy benefit managers, wholesalers, pharmacies, hospitals, insurers etc?

State transparency laws create a significant administrative burden on manufacturers. Drug makers must manage all relevant data and comply with each state's unique rules, requirements, deadlines, and formats. Reporting complexity grows with each product on the market because each medicine requires a report.

Additionally, the federal government and all 50 state legislatures constantly propose, pass, or modify new legislation, requiring companies to monitor all of this legislative action. At any given time, more than 500 proposals may be under consideration.

Pharma companies can no longer rely on spreadsheets to manage this complex information. These laws underscore the urgency of digital transformation to handle compliance.

Has the cost of compliance with price transparency laws increased? If yes, by how much?

While we know the cost of price transparency compliance has increased, the exact amount is impossible to quantify.

Associated costs include: ◆ Necessary technology investments. ◆ Additional staffing and time for reporting. ◆ Adjustments to market pricing strategies. ◆ Fines for noncompliance.

How will the Inflation Reduction Act further impact pharma/medical pricing in the US? Medicare drug price negotiation will impact more than just the 10 drugs on the current negotiation list. The

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CPHI-PMEC SPECIAL reduced prices for these medications will create competition across the entire therapeutic category, potentially diminishing revenue and forcing manufacturers to adjust other drug prices, resulting in higher commercial drug prices.

What do pharma companies serving the US market need to do to ensure better compliance with state medicine price transparency laws?

Pharma companies should create and/or maintain a central repository to track each state's specific transparency reporting requirements, deadlines, formats, and data needs.

Manufacturers must closely monitor all 50 states for new and changing legislation, updating their databases as necessary.

Manual Excel trackers are woefully inadequate in this complex regulatory environment. Implementing automated solutions allows companies to generate statespecific reports on schedule using accurate data from multiple sources. These systems also enable crossdepartment visibility and maintain detailed reporting records in case of audits.

Are there different medicine/medical care pricing models that the US or other regulators are discussing/debating?

Value-based and outcomebased pricing models are growing in popularity. Valuebased strategies set prices based on a drug's value to patients. Germany, Australia, Canada, and some European countries use this approach.

The UK is exploring a Netflix-style subscription model where pharmaceutical companies receive upfront payment for their drugs rather than being paid based on prescription volume.

Theoretically, decoupling financial incentives from sales volume reduces pressure to sell large amounts and encourages new

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drug development for rare diseases.

The outcomes-based model is an evolution of value-based models. In this case, there is a tiered pricing structure wherein the payer pays different prices for the same drug depending on a

successful outcome for the patient. For example, an insurer will pay up-front for a one-time treatment. If the patient does not reach predefined goals, the company will refund the insurer's money. This model is becoming more common in

healthcare but is still rare in pharmaceuticals.

The challenge with these models is the lack of consensus around metrics to define value as well as the inability to track and measure value and outcomes effectively. The current US

system also presents a number of implementation barriers, such as the Medicaid Drug Rebate Program’s (MDRP) “best price” requirement. viveka.r@expressindia.com viveka.roy3@gmail.com

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Elevating India’s pharma landscape through quality management Aditya Chaudhary, Director of Sales, Hexagon Manufacturing Intelligence highlights that the incorporation of ETQ in India's pharma quality management is not just a tech upgrade; it's a cultural shift and details how ETQ is an invaluable asset for not just meeting but exceeding regulatory and consumer quality expectations

I

n the pharma domain, the term "quality" reverberates with profound gravitas. For an industry responsible for millions of lives, the quality isn't just a metric—it's a sacred commitment. As the global pharma market has established India as a preferred destination, there’s a compelling need to ramp up quality control measures.

This is where ETQ, or Enterprise Quality Management Software, offers a path forward.

Rooted in both a deep understanding of technological synergies and a spiritual commitment to societal wellness, it’s time to envision how ETQ could be the lever that lifts the entire industry to global excellence. At the end of the day, quality in pharma isn't just compliance; it's a covenant with society.

Bridging the gaps: The Indian pharma backdrop Ranked third globally in pharma production by volume1, the industry's commitment to quality with low pricing makes it a preferred destination for international investors. While impressive, this statistic conceals the prevalent quality issues. For the Indian pharma industry, the journey from mass production to world-class quality has seen its own share of bumps. The learnings along the way will not be dissimilar to the ancient Chinese proverb on rowing a boat – if we don’t move upwards, we will surely be drifting down.

Integrating ETQ: The intersection of tech and trust Drawing close to two decades of my experience in technology and innovation, I've come to appreciate that the most powerful digital transformations are those

46 EXPRESS PHARMA December 2023

that expand human possibilities.

ETQ serves as a conduit between the industrial mechanics and the end goal of consumer trust. In the spirit of practical spirituality, ETQ goes beyond

the data metrics. It offers a moment of reflection, a rare pause to ask, "Are we doing right by our consumers?"

ETQ's power lies in its ability to harmonise diverse processes,

almost akin to an orchestra producing a melodious symphony.

The platform aligns various quality aspects from compliance and risk management to supplier quality and corrective and preventive action (CAPA). ETQ emerges as a linchpin for quality management, serving as the backbone of smart manufacturing in pharma. This Quality Management System (QMS) is far more than just software; it is a digital ecosystem that optimises the entire product life cycle— from design to post-sales. By bridging the critical gap between finished product quality control (QC) and in-process quality assurance (QA), ETQ is an invaluable asset for not just meeting but exceeding regulatory and consumer quality expectations.

The power of ETQ is also further realised through its exceptional data management capabilities, essentially dissolving operational silos that have long been an impediment to efficiency and profitability. By intelligently generating non-confor-

As the global pharma market has established India as a preferred destination, there’s a compelling need to ramp up quality control measures. This is where ETQ, or Enterprise Quality Management Software, offers a path forward.

Rooted in both a deep understanding of technological synergies and a spiritual commitment to societal wellness, it’s time to envision how ETQ could be the lever that lifts the entire industry to global excellence

mance reports (NCR) and initiating CAPA, the system not only ensures that quality issues are identified and addressed in real time but also lays down a digital trail that can be invaluable during audits. In a world that demands both speed and quality, ETQ proves to be the digital catalyst that propels manufacturing into a new era of excellence and reliability.

Future-forward: Navigating through change Let's accept it; the pharma landscape is as dynamic as a Jackson Pollock painting—a blend of pre-

dictable patterns and surprising bursts of change. Being prepared isn’t a luxury; it’s a necessity. India recently observed its inaugural National GMP (Good Manufacturing Practice) Day, a day that underscores the nation's commitment to fostering a culture of pharma excellence.

The integration of WHO-GMP certification into India's revised Schedule M is a monumental stride toward elevating the nation's pharmaquality standards.

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CPHI-PMEC SPECIAL Key regulations in revised Schedule M The revamped Schedule M prescribes comprehensive standards spanning the complete pharma manufacturing process.

From Pharmaceutical Quality System (PQS) and Quality Risk Management (QRM) to Product Quality Review (PQR), these new mandates are designed to align Indian Pharma with international quality benchmarks, thus boosting exports and fostering trust in the industry.

Areas of importance in Schedule M ◆ Equipment qualification and validation: Strict guidelines ensure the reliability of manufacturing processes, thereby enhancing product quality. ◆ Supplier audit and approval: Rigorous audits of suppliers mitigate supply chain disruptions, ensuring adherence to quality parameters. ◆ Stability studies: These studies validate the safety and efficacy of pharmaceutical products throughout their shelf life. ◆ Validation of computerised systems: This ensures accurate and consistent data handling, vital in today's technology-centric environment. ◆ Transition period: Recognising the challenges of implementing these new norms, the government has allotted additional time for compliance.

Our role in this epochal shift Innovation isn't confined to the upper echelons of management; it’s a collective aspiration. As members of this great nation engaged in nation-building in some form or the other – small or big, our engagement with quality is more than professional. It is rather a spiritual commitment to our collective well-being. In today's dynamic pharma ecosystem, Quality Management Systems are critical. With an expected market value of nearly $4 billion by 2030, QMS is increasingly becoming an integral part of pharma production[2].

ETQ software thus, serves as a cornerstone for organisations aiming to enhance their quality management protocols. From agile adaptation to cost-effi-

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ciency, ETQ empowers pharma companies to meet and exceed regulatory requirements while fast-tracking market entry.

It’s time to act, reflect, and elevate The incorporation of ETQ in India's pharma quality manage-

ment is not just a tech upgrade; it's a cultural shift. To the CXOs, technologists, and every one of you involved in this sector: Don’t just be the change. Lead it.

Because, in an industry that lives on precision, we should never forget the precision of integrity and compassion. As someone

who has always viewed technology as a means to elevate human potential, I find the promise of ETQ in reshaping the Indian pharma landscape to be a soulstirring prospect. Let's start today because tomorrow’s quality is built on today’s commitments.

Onward and upward!

References [1] Annual Report 2022 – ’23: Government of India, Ministry of Chemicals & Fertilizers, Department of Pharmaceuticals [2] Europeanpharmaceuticalreview – Report by Meticulous Research

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AI-infused revolution in pharma Suresh Pareek, Venture Capitalist, Co-founder of Elephant Canvas and Ex Founder of Ideal Cures outlines the impact of AI on ANDA filing, its benefits and challenges, and the evolving landscape of regulatory compliance

T

he pharmaceutical industry, a cornerstone of healthcare, is witnessing a paradigm shift with the integration of Artificial Intelligence (AI). In this age of rapidly advancing technology, there is a need to delve into the multifaceted ways and understand that AI is reshaping pharma practices, from expediting regulatory compliance to optimising production quality and ensuring the availability of medicines to those who need them. This revolutionary technology is more than just a tool and redefines the scope of AI's application in businesses beyond drug discovery and development. Additionally, it can be very helpful in the production and submission of regulatory documents like Drug Master Files (DMFs) and an Abbreviated New Drug Applications (ANDAs). The AI-driven wave of innovation has significantly influenced the filing of ANDAs, which is an essential step in the approval process for generic pharma products.

This article explores the impact of AI on ANDA filing, its benefits and challenges, and the evolving landscape of regulatory compliance.

Understanding ANDA Filing An ANDA filing is the pathway for generic drug manufacturers to seek approval from regulatory bodies, such as the US Food and Drug Administration (FDA), to market and sell generic versions of brand-name drugs. The filing process requires meticulous documentation and adherence to strict regulatory guidelines, ensuring that the generic drug is bioequivalent to its reference product.

Predictive analytics In drug development, AI's current and potential uses are transformative. From target identification and drug repur-

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duces a need for handling sensitive and confidential information. Ensuring robust data security measures and compliance with privacy regulations is imperative to uphold trust and meet legal requirements.

This data-driven approach is not only transformative in personalised medicine but also proves essential in optimising resource allocation. By providing insights, AI contributes significantly to the accessibility of medicines, marking a substantial leap forward in the pharmaceutical landscape.

Adaptive compliance to regulatory changes posing to patient stratification for clinical trials, machine learning (ML) models are accelerating the identification of potential drug candidates. Predictive modeling for drug efficacy and safety holds the promise of reducing the time and costs associated with traditional drug discovery processes and fostering breakthroughs in the treatment of various diseases. AI streamlines the ANDA filing process, reducing the time and resources required for submission. It accelerates the identification of potential drug targets by analysing biological data, genomics, and other omics data to predict disease mechanisms and vulnerabilities. It aids in designing and optimising drug candidates by predicting their properties, interactions, and potential side effects, reducing the time and resources needed for development. This efficiency can be crucial in getting generic drugs to market more quickly, providing cost-effective alternatives to consumers.

The evolving role of AI in ANDA filing Artificial intelligence algorithms are highly proficient in data processing and analysis, which

greatly minimises the time and effort needed to examine huge datasets. The technology can be employed to review and analyse textual information in ANDA submissions, helping to identify key data points, relationships, and potential areas for improvement. AI systems can continuously monitor and analyse regulatory changes, helping businesses stay updated on evolving requirements. AI can help evaluate the large quantity of clinical and scientific data in an ANDA submission, helping to find essential information and any problems more quickly than with traditional approaches.

Data security and privacy AI's analysis of genomic data is instrumental in advancing personalised medicine and tailoring treatments to individual patient characteristics. This technology plays a pivotal role in crafting personalised treatment plans, maximising efficacy, and minimising adverse effects. By identifying relevant biomarkers, AI enables the stratification of patient populations, facilitating the development of more targeted and individualised therapies.

In the context of an ANDA filing, the integration of AI intro-

The exploration and integration of Artificial Intelligence (AI) and Machine Learning (ML) into the drug development process have positioned the US Food and Drug Administration (FDA) at the forefront of technological advancements. The agency's experience with these technologies highlights their potential for enhancing decision-making, spanning from clinical trial design to post-market surveillance. The FDA's proactive engagement1 with AI signifies a commitment to staying abreast of technological advancements, ensuring that regulatory frameworks evolve to accommodate the dynamic landscape of pharmaceutical innovation. This adaptability not only mitigates the risk of non-compliance but also facilitates the seamless integration of new regulatory requirements.

The complexity of ensuring compliance with ever-evolving regulatory standards is evident.

The management of the extensive array of documents involved in ANDA filings can be overwhelming. AI-powered document management systems can efficiently organise, categorise, and retrieve documents, ensuring that essential information is readily available for reg-

ulatory review. Additionally, AI tools excel at conducting comprehensive risk assessments by analysing historical data, pinpointing potential pitfalls in the ANDA filing process.

AI's ability to continually monitor and adapt to regulatory changes streamlines the ANDA filing process, reducing the likelihood of errors and enhancing submission accuracy. This not only guarantees that ANDA and DMF filings comply with the latest regulations but also ensures precision and adherence to regulatory standards. This proactive approach empowers businesses to address issues before they become critical, significantly improving the likelihood of a successful application.

Beyond the regulatory sphere, AI's impact on production processes is equally transformative. Predictive analytics, fueled by machine learning, enables companies to proactively optimise manufacturing processes. By foreseeing potential issues, production disruptions are minimised, resulting in consistent, high-quality outputs.

Real-time monitoring and quality assurance Real-time monitoring through AI-driven smart sensors has revolutionised quality assurance, ensuring reliable and safe pharma production output. AI's real-time monitoring capabilities bring a new dimension to quality control in production lines.

Smart sensors and machine learning algorithms work in tandem to detect deviations from established quality standards.

This ensures that corrective actions are taken promptly, minimising the likelihood of defects and contributing to the production of medicines of consistently high quality. Although there are very few innovative start-ups that are helping pharma companies achieve AI-powered transformation in the entire drug

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Thus, the true potential of AI in the life sciences industry unfolds through collaborative efforts between AI researchers and scientists. This synergy is pivotal for driving innovation. AI researchers bring cutting-edge algorithms and computational methodologies, while scientists contribute invaluable domain knowledge and insights. This collaboration accelerates the development and implementation of AI solutions tailored to the specific needs of drug discovery and development.

Innovative pricing strategies for market access Predictive analytics helps businesses identify and prevent bottlenecks in production, reduce waste, and lower manufacturing costs. This cost-effectiveness, in turn, contributes to making essential medicines more economically accessible to a broader population. AI empowers pharma companies to develop innovative pricing strategies. By analysing market trends, production costs, and competitive landscapes, AIdriven pricing models strike a balance between profitability and affordability. By automating routine tasks and accelerating the review process, AI can contribute to significant cost savings for pharma firms involved in ANDA filings. This cost-effectiveness allows companies to allocate resources more strategically. These strategies contribute to sustainable business practices, ensuring the continued availability and accessibility of essential medicines to diverse patient populations. By harnessing the power of AI in post-marketing surveillance, the industry can enhance its ability to detect, understand, and respond to potential safety issues associated with drugs after they enter the market. This contributes to a more proactive and data-driven approach to ensuring the ongoing safety and effectiveness of pharma products.

In conclusion, it's important to note that the successful integration of AI in the pharma sector requires collaboration be-

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tween data scientists, bio-informaticians, clinicians, and other stakeholders. Additionally, as technology continues to evolve, the collaboration between AI and regulatory processes is likely to become more sophisticated, revolutionising the generic drug approval process

and ultimately benefiting patients with increased access to affordable medications. At the same time, regulatory considerations and ethical concerns need to be addressed to ensure the responsible and safe implementation of AI technologies in drug development. As the industry

navigates this transformation, addressing challenges and ensuring regulatory alignment will be essential for the successful integration of AI in the ANDA filing. The integration of AI into the life science industry represents a paradigm shift, promising increased efficiency, innova-

tion, and accessibility for the greater good of global health.

References https://www.fda.gov/scienceresearch/science-and-researchspecial-topics/artificial-intelligence-and-machine-learningaiml-drug-development.

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Sustainability: The bedrock for growth of pharma sector Rajesh Khosla, CEO, AGI Greenpac highlights that sustainability is a strategic imperative in the pharma industry. Adopting eco-friendly practices not only aligns with global imperatives for a greener future, but also improves operational efficiency and regulatory compliance ndia’s pharma sector is seeing the continuance of a cadence oriented towards growth. Currently valued at approximately $50 billion, the sector is expected to grow at a 10 per cent CAGR to reach a size of $130 billion by 2030. Factors such as the increasing demand for affordable medication, robust manufacturing capabilities, growth in exports, and steadfast government support continue to be key drivers of India’s reinforcement as a global pharma hub.

However, this upward trajectory faces challenges stemming from global factors influencing sectoral growth within a globalised economic framework, along with geopolitical considerations. Challenges such as escalating costs, increased competition, and growing scrutiny from regulators pose potential obstacles to the meteoric growth and expansion of the sector.

This is where the adoption of a sustainable approach can serve as the remedy needed for the pharma sector's growth.

I

sources, and prudent waste management, pharma companies can reduce their emissions and thus actively participate in climate change mitigation.

Furthermore, the pharma industry consumes a significant amount of natural resources, particularly water and energy. Pharma companies can significantly reduce their resource consumption by diligently implementing sustainable techniques such as water conservation and enhancement of energy effi-

Economic benefits

ciency measures, thereby contributing to the larger cause of environmental preservation.

Aside from resource consumption, the industry must deal with pollution caused by both, manufacturing processes and waste by-products. However, by prioritising sustainable practices such as waste reduction and pollution prevention, pharma companies can significantly reduce their pollution footprint, effectively taking on the role of environmental custodians.

The pharma industry is known for its substantial energy and resource consumption, incurring significant expenses. Embracing sustainability practices holds the potential for substantial cost reductions and operational improvements.

Employing sustainable energy sources and efficient equipment reduces reliance on conventional power grids, diminishing operational costs and enhancing cost efficiencies. Water conservation is of paramount importance, considering the pharma industry accounts for 10 per cent of India's industrial water usage.

Employing basic practices like rainwater collection and

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wastewater recycling can pare down water expenses by up to 30 per cent. Waste reduction, particularly concerning hazardous waste, not only cuts disposal costs but also enhances operational efficiency. Sustainable practices enable material reuse and recycling, further reducing costs and environmental im-

pact.

Moreover, sustainabilitydriven manufacturing leads to higher product quality, minimising contamination risks and reducing defective product occurrences.

Greener pharma, greener future The pharma industry wields

significant influence over environmental sustainability. Its energy-intensive manufacturing processes and extensive transportation networks contribute significantly to greenhouse gas emissions.

Nonetheless, by implementing sustainable practices such as energy efficiency, incorporation of renewable energy

Meeting regulatory and consumer expectations The global pharma industry now prioritises environmental and social governance (ESG)

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Simultaneously, stricter regulations on hazardous waste and emissions necessitate investments in advanced technologies. Regulatory authorities are increasingly demanding transparency in sustainability reporting. This requires pharma companies to establish robust management systems. Consumer demand for sustainable products, exemplified by the preference for green labels, is reshaping the market.

Pharma companies championing sustainability not only attract but also retain a discerning clientele. The willingness to pay a premium for sustainable products, especially among younger consumers,

The global pharma industry now prioritises environmental and social governance (ESG) factors in regulatory decisions. Proactive efforts in sustainability by pharma companies ensure compliance with evolving standards reinforces this trend. Hence, companies positioning their offerings as sustainable can command higher prices, marking a convergence of ethical consumption and economic viability.

Sustainability: Catalysing innovation Pharma companies are actively investing in new technologies and processes to reduce their environmental impact and improve their social and governance practices.

This dedicated investment drive is spurring the emergence of innovative strategies in pharma manufacturing, distribution, and usage. Particularly noteworthy is the pioneering of green chemistry techniques that diminish the dependence on dangerous chemicals in drug manufacturing. Furthermore, there is a concerted effort to develop methods for recycling and repurposing waste materials.

Sustainability is a driving force behind pharma industry

innovation in new product development. Companies are developing drugs that are less harmful to the environment and there is a concerted effort to improve drug delivery methods for greater efficiency and less waste. For example, the development of inhalable drugs aimed at direct delivery to the lungs reduces drug quantities required and reduces waste generation.

Pharma companies are also considering long-term business models to shift to cir-

cular economy paradigms in which products and processes are designed to reduce waste and maximise material reuse.

Collaborative models with stakeholders in the healthcare ecosystem are under investigation to drive cost efficiencies and improve environmental performance.

Sustainability is a strategic imperative in the pharma industry. Adopting eco-friendly practices not only aligns with global imperatives for a greener future, but also improves operational efficiency and regulatory compliance.

Sustainability fuels a culture of continuous progress, from innovative technologies to eco-friendly drug development. It is a transformative force, ushering in a new era in which responsible business practises and robust growth are inextricably linked.

Solutions in Process Safety H.E.L provides a suite of safety tools to help you identify and mitigate sources of risk during the scale-up process.

Raw material hazard screening Reaction calorimetry Reaction mix hazard screening Adiabatic testing Hazard and operability assessment

TSu Phi-TEC I Phi-TEC II Simular www.helgroup.com

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We are focussing our efforts on implementation of energy-efficient and eco-friendly technologies Mark Bitterwolf, CMO and Director of Sales, JULABO GmbH gives details about his company's progress and achievements, plans and focus areas for future growth, innovative solutions offered by the company and more, in an exclusive interview with Express Pharma How has JULABO evolved as a leading provider of temperature control solutions since its inception?

Can you share the most significant milestones of the company?

JULABO was founded in 1967 and has since then established a strong reputation for innovation, reliability, and customer-centric solutions.

Over the years, the company's growth has been marked by several significant milestones that have cemented our position as a worldwide industry leader in the temperature control sector.

JULABO's journey began with pioneering advancements in temperature control technology, introducing cutting-edge solutions that set new standards in precision and efficiency within the industry.

As an example, we introduced the first fully electronic lab circulator in the early 1970s or microprocessor electronics already in the early 1990s.

Over the years, JULABO strategically expanded its global presence, effectively penetrating key markets worldwide. This expansion broadened the company's reach, enabling us to further adapt to specific customer needs. Through relentless research and development efforts, JULABO consistently diversified its product portfolio, now offering a comprehensive range of temperature control solutions across various industries.

These innovations not only showcased the company's commitment to staying ahead of technological

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advancements but also demonstrated our willingness and adaptability to evolving customer demands.

What sets JULABO apart from its competitors?

Beside the top-quality products with cutting edge technology, JULABO's commitment to customer satisfaction has been a cornerstone of our success since the beginning. By prioritising customer needs and providing unparalleled service and support, we managed to build enduring relationships with our clients, earning their trust and loyalty.

Could you elaborate on the technological advancements and innovations that JULABO has introduced to the field of liquid temperature control?

JULABO has been at the forefront of introducing groundbreaking technological advancements and innovations in the field of liquid temperature control.

Some of the key contributions include: 1. Precise temperature regulation: JULABO has pioneered advanced temperature regulation systems, offering highest precision and accuracy in controlling liquid temperatures. Our products ensure stable and dynamic temperature control, crucial for various scientific and industrial processes.

2. State-of-the-art control interfaces: Over the years, we have developed user-friendly and intuitive control

interfaces, enabling operators to manage and monitor temperature settings with ease. These interfaces often include advanced features such as remote access, data logging, and programmable temperature profiles, enhancing operational efficiency and flexibility.

Current models include high resolution, modern TFT touch displays that show all important information at a glance and are easy to operate with a fingertip.

3. Application-specific solutions: Ever since, JULABO not only provides standard products from the shelf, but tailored temperature control systems to meet individual customer requirements. These innovative solutions ensure optimal performance and efficiency for a diverse range of industries and applications, whether it's pharma, biotech, automotive, or research and development.

Can you provide examples of applications in the life sciences industry where JULABO's solutions excel?

JULABO's temperature control solutions are used in various life sciences applications, including: 1. Biotechnology research: Facilitating controlled cultivation of cells and microorganisms for biopharma research.

2. Clinical diagnostics: Supporting accurate diagnostic testing by providing consistent temperature conditions in clinical laboratories.

3. Tissue culture and cell

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4. DNA analysis and sequencing: Ensuring reliable and reproducible results in genetic research and genome sequencing through precise temperature control.

5. Protein engineering and biochemistry: Supporting protein folding studies and biochemical assays by maintaining stable temperatures for accurate analysis and experimentation.

How does JULABO envision the future of temperature control technology, and what can we expect in terms of upcoming innovations and improvements?

With a growing emphasis on sustainability, we are focussing our efforts on the implementation of energyefficient and eco-friendly technologies to reduce the carbon footprint of all products.

JULABO envisions a future of temperature control technology marked by: 1. Energy efficiency: We are committed to enhancing energy-efficient solutions through eco-friendly cooling technologies and sustainable manufacturing processes, reducing energy consumption.

2. Natural refrigerants: All newly developed products from JULABO will use natural refrigerants, reducing environmental impact and promoting sustainability.

3. Tailored solutions: JULABO will offer individual solutions, allowing each customer to configure their desired product, ensuring that specific industry requirements and unique needs are met efficiently.

Can you discuss JULABO's strategies for expanding its global presence and market reach in the coming years?

What are your specific goals for the Indian market?

JULABO has a strong global presence since many decades.

Of course, we aim to stabilise and further strengthen our position through different strategies, including strategic partnerships and collaborations with local distributors, businesses, or research institutions. We will also strengthen our approach of customised solutions to meet the specific needs and preferences of different regional markets.

Regarding specific goals for the growing Indian market, we already have a very good position thanks to the close teamwork with our long-standing partners from SRICO (Scientific Research Instruments Company).

Based on this strong partnership, we will actively work with existing and potential customers all over India, focusing on cultivating long-term relationships through exceptional customer service, product reliability, and ongoing technical support.

Are there plans for strategic partnerships/collaboration s or any recent or upcoming M&As that may be part of JULABO's growth strategy?

Especially in fast developing and growing markets in India, we will strengthen the cooperation with SRICO even more – always having the customer experience in mind.

This will strongly address the rapidly growing need for temperature control equipment and help our customers and partners to jointly succeed in the path of growth in the large economy in India. We are proud to be part of this growth path!

For further information please contact: SRICO FOR JULABO SRICO - Scientific Research Instruments Co. Pvt. Ltd. #42-43, 'Shashi', 2nd & 3rd Floor, 1st Cross Raghavendra Residential Layout, Off Gubbalala Main Road, 560 061 Bangalore, Karnataka, India Mobile: +91 99 00674407 Email: info@srico-labworld.com Website: www.julabo.com/en-in

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Future of Indian pharma sector looks promising, driven by a strong domestic demand base Rohit Raut, MD, Rettenmaier India (JRS Pharma India) in an interaction with Express Pharma talks about his company's vision and strategies towards future accomplishments Could you elaborate on JRS’s long-term vision for the current decade and the key strategies it plans to employ to achieve that vision?

Let me take this opportunity to thank you for featuring us. I would like to share the longterm vision for JRS India, as well as the key strategies that will help us achieve this vision in the coming years. It is important for all of us to understand our vision and work together towards a common goal for the betterment of this society.

Our vision for the current decade is to become the leading excipient manufacturer in the pharma industry. JRS Pharma is known for its cutting-edge technologies, exceptional products, and unmatched customer experiences. We aim to revolutionise the way our industry operates by constantly pushing the boundaries of what is possible and delivering solutions that exceed the customer expectations.

In order to achieve this vision, we have identified several key strategies that we will be focusing on: ◆ Innovation and solution provider: We are in the process to invest particularly in KRM and final excipient lab, which is the real need of the contemporary hour as per the new FDA standards. This crucial investment shall provide us an extra edge over our competitors. We seek for new and groundbreaking ideas that will keep us a step ahead of other competitors. We foster the culture of innovation, encourage and motivate the teammates to think outside the box and contribute their innovative ideas. ◆ Customer-centric

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We are in process to invest expansively in pharma Excipients units which is the real need of the hour. This heavy investment keeps us stronger & better than Competitors. We always seek for new and groundbreaking ideas that will always keep us a step ahead of other local & international players approach: Our customers’ satisfaction is the most fundamental factor of our work.

We always strive to deepen our understanding of their needs and preferences, simultaneously tailor our products and provide the services to go beyond their expectations. We build longlasting communication with

our customers by providing exceptional support and personalised know-hows. Local team goes beyond expectation to deliver as per the need of customer locally. ◆ Talent development: Our employees are our greatest asset. As a leader of the organisation, I call them not merely employees but also a

strong backbone of our company. We work as family and we have deep roots of our 146 years legacy. We always focus on the supportive and comprehensive work environment, where everyone has the opportunity to grow and thrive. Training and development programs is the key to enhance my people’s skillset and capabilities. We ensure that we have the right talent to drive our vision forward. It’s a continuous process & not just a onetime resolution. ◆ Strategic partnerships: Collaboration is key to our success. We will seek strategic partnerships with other industry leaders, distributors, and research institutions to leverage their expertise and resources. This will enable us to accelerate our growth and bring radical solutions to the challenging market dynamics more rapidly. ◆ Sustainability and social responsibility: We are committed to operating in an environment sustainable manner and giving it back to the communities where it has come from. We prioritise sustainable practices throughout our operations, minimise our carbon footprint, and actively support social initiatives that align with our values, like paper bags and avoiding plastic in the warehouse.

These strategies are the foundation of our actions over the next decade. As responsible employees, each one of us play a vital role in driving our vision forward. I encourage everyone to think about how our individual contributions can align with these strategies and help to achieve our shared goals

together. I always encourage team to use their 6th sense and make a positive difference in work.

I am confident that with our collective efforts, dedication, and teamwork, we will successfully apprehend our long-term vision, positioning ourselves as industry leaders and creating a long lasting impact on our customers as well on the society.

Under CSR activity, we run multiple programs to contribute to the society’s wellbeing.

How is it positioned to capitalise on current market trends and future opportunities? ◆ Digital transformation: The pharma industry is undergoing a significant digital transformation. We have also invested in technology advancements in order to improve our reach and to offer new and better solutions to various market needs. ◆ Biopharma and biosimilar: The demand for biopharma and biosimilar is growing rapidly, driven by factors such as the rise in chronic diseases and the need for cost-effective treatments. We will expand our portfolio to include more biopharma and biosimilar, leveraging our expertise in biotechnology and manufacturing capabilities at JRS Celonic plants located in Basel, Switzerland and Heidelberg, Germany. This will allow us to tap into this lucrative market segment and meet the evolving needs of our customers. ◆ Global expansion: The pharma industry has rapidly globalised, with expanding markets in emerging

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CPHI-PMEC SPECIAL economies. We will focus on expanding our presence in key evolving markets, establish partnerships and collaborations with local companies, same time, adapt our current & upcoming products and services to meet the specific needs of these markets. By doing so, we can tap into new sources of revenue and gain a competitive edge over our competitors.

These strategies will enable us to position ourselves at the forefront of the pharma industry, capturing current market trends and future opportunities. It is important for each of us to align our individual efforts with these strategies, fostering a culture of innovation, collaboration, and customer-centricity. Together, we can drive the company's growth and success in this everchanging industry. We are the market leader in excipient industry and we are expanding future in cellulose derivatives.

As the pharma landscape continues to evolve, how does JRS anticipate staying adaptable and agile to meet the changing needs of its customers and markets?

Testing of quality excipients, internal as well as external Labs : We are in process to invest particularly in testing of Nitrite and Nitrate which is the real need of the hour.

The following 4 Ps of marketing plays significant role at all times: ◆ Product: Quality product made as per customer’s expectations, having wide variety within the standard limits. ◆ Place: We have different products that fits the local market and at the same time they are also equipped for the global market. ◆ Promotion: JRS being global brand & market leader, the promotion is integral part which is the continuous process. ◆ Price: Being a global brand we believe in reasonable pricing for more and more local benefits.

In the context of industry 4.0, how is JRS integrating

GMW-3 Cotton Source CCS New Plant in Gujarat

advanced technologies to optimise its processes and outcomes?

The pharma industry is undergoing a significant digital transformation, with the adoption of new technologies like artificial intelligence, big data analytics, and tele-health.

We will are investing continuously in these technologies to improve our operational efficiency, enhance our research and development capabilities, and deliver personalised and convenient healthcare solutions to our customers. These technologies would be beneficial to be aligned with the current practices. We are actively present in social media to create awareness and to provide the viewers the current update of our activities and development.

What is JRS strategy for India, given the changing landscape? What unique value propositions does JRS offer to its customers in India and other cost-sensitive markets?

The pharma industry in India has been experiencing significant growth and evolution in recent years.

Several factors contribute to the changing landscape, including increasing healthcare awareness, rising disposable incomes, and favorable government policies. Here are some key strategies and trends in the Indian pharma industry: ◆ Focus on R&D: Indian pharma companies are

investing heavily in R&D to develop innovative products and meet global standards.

This shift toward creating differentiated and value-added products which have enabled India to emerge as a prominent player in the global pharma market. ◆ Tap Expansion of generic drug market: India remains a leading provider of affordable

generic drugs globally. With the increasing prevalence of lifestyle-related diseases, the demand for generic medicines is expected to grow steadily.

Indian pharma companies are leveraging this opportunity by expanding their product portfolios and targeting niche therapeutic segments. ◆ Embracing digital health technologies: The digital revolution has brought significant changes to the healthcare sector in India.

Pharma companies are adopting digital health technologies like telemedicine, wearable devices, and AIassisted diagnostics to enhance patient care, improve drug delivery, and gain valuable

insights for drug development. ◆ Shift approach towards specialty and generic medicines: There is a growing trend towards specialty medicines in India, primarily driven by an aging population and an increase in chronic diseases. Pharma companies are focusing on specialised therapies, such as oncology, immunology, and rare diseases, to cater to specific patient needs and capture higher market shares. ◆ Collaborations and strategic partnerships with local manufacturers: Indian pharma companies are increasingly forming collaborations and strategic partnerships to access new markets, strengthen product portfolios, and leverage each other's strengths. Joint ventures, licensing agreements, and acquisitions are becoming common strategies for growth and global expansion. ◆ Regulatory reforms and intellectual property protection: The Indian government has been implementing reforms to enhance the ease of doing business in the pharma sector and protect intellectual property rights. These measures aim to boost investments in R&D, attract foreign pharma companies, and promote innovation in the industry. ◆ Growing emphasis on quality and compliance: In recent years, there has been a heightened focus on quality, compliance, and regulatory

standards in the Indian pharma industry. With the tightening of regulations and increased scrutiny, pharma companies are investing in state-of-the-art manufacturing facilities, implementing stringent quality control measures, and enhancing their supply chain management systems.

In conclusion, the Indian pharma industry is witnessing significant strategic shifts and evolving trends. From R&D investments and digital health adoption to the expansion of generic and specialty drug markets, companies are actively adapting to changing consumer needs, regulatory environments, and global market dynamics. The future of the Indian pharma sector looks promising, driven by a strong domestic demand base and increasing global recognition for its capabilities and costeffective solutions.

Have there been any recent acquisitions or divestures by JRS? How have they contributed to enhancing the company's growth prospects and competitive advantage?

Our parent company JRS believe in expanding their business and product range. We had acquired multiple business in the past and still a continuous process.

Recently JRS has a second manufacturing site for Alginates in our Group of Companies.

Under the government’s #VocalforLocal campaign, we have started our Indian manufacturing facility in Gujarat for most demanded grades for our pharma business. This will not only ease product availability but also create employment in our own country. As on date we have four facilities dedicated for India & Asia market. With reduced lead times, products are now readily available and also enable us for faster delivery to our customers all across India. Under the make in India , we have expanded our CCS/SSG disintegrant into the additional new facility known as GMW-3 in Gujarat. We are launching these products in CPHI India 2023.

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Building resilience and rethinking strategies for growth Mukesh Khare, Partner & Head - India Operations, Kaizen Institute emphasises that there is a need to upskill the industry, overhaul existing models and processes, and undertake a vital transformation of the supply chain

R

enowned as the "Pharmacy of the World," the Indian pharma sector has come to occupy a pivotal position within the global pharma industry. At present, India is ranked third worldwide in terms of pharma production by volume and maintains the 14th position in terms of production value.

As per a recent report by EY FICCI, the Indian pharma market is anticipated to reach $130 billion in value by the end of 2023. This projection derives impetus from the rising consensus regarding the paramount importance of delivering new and innovative medicinal solutions to patients in need.

In the midst of a world reeling under the far-reaching impacts of the COVID-19 pandemic on communities and industries, the pharma sector emerged as a resilient force, rising to the occasion. Aspiring to become a hub for cost-effective manufacturing and groundbreaking research and development, the pharma industry is embarking on a growth trajectory.

However, the path ahead is not devoid of challenges, as there exists a discernible gap between the strategic vision and the practical operational reality of the industry. There is thus, a need to upskill the industry, overhaul existing models and processes, and undertake a vital transformation of the supply chain.

Understanding challenges In the midst of the continuous growth and expansion, supply chains in the pharma sector have become increasingly global, complex, and opaque, posing concerns about product quality and safety, causing multiple repercussions. The presence of multiple stakeholders, combined with the absence of cohesive integration across the

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tions gets further exacerbated when companies in the sector rely on a single region for sourcing critical materials, which puts them at the risk of shortages during natural disasters and local conflicts.

Adding to this is the lack of transparency vis-a-vis the value chain. More often than not, companies lose visibility and control of the product’s movement, and this dearth of insight into the operational procedures of the suppliers can pose a substantial risk for pharma firms.

Upskilling the industry and building resilience

Moving forward, having an endto-end view of the supply chain (supply-and-demand mapping and rationalisation) is vital for developing an understanding of the processes, thereby facilitating the identification of potential vulnerabilities network, impairs the visibility and traceability of products as they move up in the value chain.

Further, when talking about supply chains, there are a number of elements causing complexity – scattered manufacturing facilities leading to multi-layer networks and material movement with increased costs, decentralised R&D centres creating complexity in technology transfer

and lengthening timelines for regulatory approval, and complex and unequipped distribution networks which fall short of fulfilling the exigencies of drug storage and handling.

Furthermore, disruptions to the pharma sector, including natural disasters, international trade tensions, cyberattacks, and global pandemics have become commonplace, negatively impacting the supply chain.

The impact of these disrup-

Reducing complexities that afflict pharma supply chains in a scenario like this becomes imperative, offering myriad of advantages. As a first step, it is important to consolidate the fragmented network and establish an ecosystem that facilitates smooth communication among the diverse stakeholders — suppliers, manufacturers, distributors, and customers.

Moving forward, having an end-to-end view of the supply chain (supply-and-demand mapping and rationalisation) is vital for developing an understanding of the processes, thereby facilitating the identification of potential vulnerabilities.

What becomes even more important here is to adopt risk assessments practices. Leveraging scenario planning and simulation models to anticipate vulnerabilities can help quantify potential risks and their plausible impact, while also granting additional time for implementing mitigation strategies.

Further, in the discourse related to disruptions, one simple practice for building resilience would be to expand the network of suppliers. Reliance on a single source for critical com-

ponents or raw materials can be a vulnerability, as can depending on multiple suppliers concentrated in the same place.

Thus, firms should constantly look to diversify their sources.

Additionally, being able reroute and redirect components between sites can help sustain production during a sudden upheaval, should the need arise – robust digital systems, however, may be required to explore favourable scenarios in this context.

In addition to building a resilient supply chain, there is also a need to strengthen quality processes. To sustain its global standing and keep up with the changing medicinal landscape, it is imperative for

India to establish a robust quality organisation – with visibility and oversight across all good manufacturing practices in the supply chain, both internal and external. Thus, quality control professionals must be equipped to ensure that products meet international standards, enabling them to address mounting regulatory demands and heightened scrutiny.

In this scenario, there is a need to foster more government-industry-academia collaborations to strengthen innovation, focus on quality manufacturing, ensure affordability, and advocate for environmentally friendly practices – which will be key to ensuring the growth and success of the Indian pharma industry.

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We are committed to delivering excellence across the pharma supply chain Rajesh Vedak, MD, Körber Pharma India speaks about his company's innovative solutions, strategies to maintain its technological leadership, adapt to evolving industry needs and position itself as an ecosystem provider for comprehensive pharma supply solutions, in an exclusive interview with Express Pharma How does Körber contribute to safe and efficient processes in the manufacture, inspection, and packaging of pharma products? Can you share some examples of innovative solutions or technologies that your company has developed for the pharma industry?

In the dynamic landscape of pharma manufacturing, we are standing as a beacon for safe and efficient processes.

With a comprehensive portfolio spanning packaging equipment, innovative materials (including 100 percent plastic-free rapid tests and recyclable carton monomaterial), and cuttingedge software solutions available as cloud services, we are committed to delivering excellence across the pharma supply chain.

One of our notable contributions is the development of digital solutions that seamlessly connect machines. The Line Optimiser, for instance, revolutionises conventional setups by enabling employee training using techniques rather than focusing on specific machines. This not only streamlines workflows such as format changes and line clearance but also enhances machine availability by up to 30 per cent, reduces familiarisation times, and lowers training costs.

The integration of Artificial Intelligence (AI) is another hallmark of our commitment to innovation.

AI-powered inspection

leveraging digitalisation and automation in your technologies to consolidate its leading position in the pharma sector?

In terms of technological leadership, we leverage digitalisation and automation to consolidate our position in the pharma sector. With a dedicated digital unit, we bring new products to the market, capitalising on our extensive know-how in pharma production and packaging processes. This approach involves connecting machines and data to improve Overall Equipment Effectiveness (OEE) and maintain a leading edge in the industry.

We leverage digitalisation and automation to consolidate our technological leadership, connecting machines and data to improve Overall Equipment Effectiveness (OEE) and maintain a leading edge in the pharma sector solutions, implemented within production operations, can significantly reduce false reject rates by up to 90 per cent while increasing the detection rate

by 40 per cent. The result is a substantial improvement in inspection efficiency and a more streamlined workflow.

How is your company

What opportunities and possibilities offer further growth and development for your company?

The future growth and development hinge on several opportunities. We embrace new modalities such as cell and gene therapy, continually adapt to ongoing digitisation trends in the pharma industry and position ourselves as an ecosystem provider for fullline supply, offering comprehensive consulting services.

How does your company maintain its position as a market leader through technological leadership in the pharma industry?

Maintaining market leadership requires continuous innovation and staying attuned to evolving customer needs. We achieve

this by bundling our extensive know-how, extending our portfolio to create a holistic ecosystem, and remaining close to our customers. Investing in R&D is a cornerstone of our strategy, ensuring that we not only keep pace with but drive innovation in the pharma industry.

How is your company staying ahead and adapting to evolving customer needs in the life sciences industry?

As we look forward, we actively pioneer projects and initiatives that reinforce our position in the pharma sector. Our commitment to innovation is evident in our forward-thinking solutions, ensuring we remain at the forefront of pharma manufacturing.

In addition to our dedication to cutting-edge technologies, we prioritise adaptability. We enable flexible production capacities through agile and scalable solutions, reducing time-to-market for our clients. Our focus on maximising cost efficiency is geared towards sustainable growth, overcoming industry pressures, and optimising capital expenditure investments. With a steadfast commitment to innovation, close customer collaboration, and a holistic approach, we continue to lead in the pharma industry, shaping the future of manufacturing processes for a safer and more efficient tomorrow.

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One of the fastest growing markets for H.E.L is in biotechnology Rajeev Kumria, General Manager of H.E.L India, discusses how H.E.L Group's automated solutions are transforming the pharma and biotech sectors. He elaborates on how the company's pioneering products are advancing research and development in these industries H.E.L Group is known for providing automated solutions in various industries. Could you explain how your solutions specifically benefit the pharma and biotech sectors?

Supporting a healthier, more sustainable, and safer world, H.E.L Group (H.E.L) is a leading supplier of instrumentation, software, and equipment in laboratories and testing facilities around the world. These products and services are used to optimise the efficiency, safety, and productivity of critical processes across chemistry and biology applications, with a focus on providing proprietary automated solutions for the battery, pharma, biotech, chemical, and petrochemical sectors.

In pharma and Active Pharmaceutical Ingredient (API) development and manufacture, scaling up benchtop reactions to production volumes can carry a variety of risks – reactions may be exothermic and require cooling measures, or components may become unstable under certain operating conditions, leading to additional thermal hazards.

H.E.L offers a range of solutions to identify thermal hazards at a laboratory scale, such as; Thermal Screening Unit (TSu) for thermal reaction screening; Simular reaction calorimeter with dual reactor options to investigate the thermal properties of a chemical reaction; and the Phi-TEC range of adiabatic calorimeters for the characterisation of thermal runaway hazards. API development involves complex chemistries, which often

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include exothermic stages such as nitrations and hydrogenations, which must be carefully evaluated and managed to minimise risk.

For synthetic chemistry applications, H.E.L offers some pathbreaking solutions for automated lab synthesisers, parallel process development, crystallisation, and catalysis.

H.E.L pioneered parallel process development from discovery to optimisation with the revolutionary PolyBLOCK platform, offering independent monitoring and control of up to eight reaction zones. We also offer the fully customisable AutoLAB, a reactor platform which can be designed and configured to meet the customer’s application requirements, and the CrystalEYES and CrystalSCAN, for the identification of crystallisation parameters.

One of the fastest growing markets for H.E.L is in biotechnology. Our BioXplorer range allows scientists to control and monitor a number of experiments simultaneously.

With their configurable design, our benchtop parallel bioreactors offer a tailored solution to our customers' needs. In June 2023, we launched the new BioXplorer 400P and 400XL, enabling efficient, cost-effective development and optimisation of industrial bioprocesses. The unique BioXplorer 400P consists of four parallel bioreactors capable of running bioprocesses up to 10 bar pressure. On the other hand, the BioXplorer 400XL features eight 500ml bioreactors for fast optimisation of aerobic fermentations.

webinars and podcasts on modern, safe, and green chemistries, which in the future will expand more into biotechnology.

What are the key strategies and challenges you've deployed to extend your product reach in India?

Geographically, we see that the vast majority of our customers are situated in Western and Southern regions of India, with Gujarat, Telangana, AP, Karnataka being the major hubs. As such, we have based our corporate HQ in Mumbai with a significant presence in Western region, while also opening new positions and recruiting people in Southern cities of Bengaluru and Hyderabad.

In addition, we have entered into collaborations with academics locally, including a partnership with the Indian Institute of Technology Kanpur (IIT Kanpur). Through this agreement, we are developing new testing laboratories to conduct research into battery storage and new chemistry development as part of a national initiative in sustainable energy.

Looking to build our profile and expand our knowledge base, H.E.L has initiated a series of lectures and seminars with such as ICT, IISER, and NMIMS. In a similar way, we have initiated a series of

H.E.L Group offers a wide range of scientific instruments and software.

Can you describe some realworld applications where these systems have made a significant impact on research and development in the pharma and biotechnology fields?

H.E.L’s products and instruments have a wide range of applications across the pharma and biotech industries.

Through academic collaborations and industry partnerships, we are supporting our customers to build a healthier, more sustainable world.

Several pharma companies, CRO’s, CDMO’s utilise our PolyBLOCK platform for controlling and monitoring up to eight optimised reactions simultaneously. These companies are using H.E.L equipment at the discovery stage where most of the work was typically done manually in vials and tubes. They are now using our 500ml reactors for process optimisation, mimicking plant conditions.

This automated approach allows even the safety parameters and the mitigating actions to be programmed in the recipe.

Pharma companies like Pfizer have also implemented our process safety tools, such as our Phi-TEC platform and Tsu, in their processes. In our recent webinar, Pfizer’s

process safety principal scientist John Weaver discussed the importance of implementing process safety methodologies in the pharmaceutical industry.

In a recent collaboration with Stéphane Guillouet, Professor at INSA Toulouse, France, scientists used H.E.L’s BioXplorer as part of their metabolic and biochemical engineering research. Using a commercial gas mix and atmospheric pressure, the research group was able to increase the amount of biomass produced by over an order of magnitude. Using CO2 as a carbon source, and the oxidation of H2, Guillouet et al., achieved isopropanol production with levels comparable to those using sugars as a carbon source, avoiding competition with resources for human feeding.

In the rapidly evolving fields of chemistry and biotech, what emerging trends or technologies do you see as having a significant impact on your business, and how is H.E.L Group preparing to adapt to these changes?

A common trend that is emerging in the pharma and biopharma industries is the increased need for automatic analytical tools, including device calibration and control, process planning and reconfiguration, and real-time data capture. Many biopharma development processes do not currently provide the opportunity to monitor and adapt single and parallel processes in real time. This real-time analysis and testing can offer valuable insights and improve the efficiency of

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CPHI-PMEC SPECIAL processes.

In response to this, manufacturing equipment must be compatible in terms of hardware but also support the appropriate software to process data and convert it into actionable insights and reports. Incorporating data management, security, and analytical tools in a compliant manner is critical to saving time and money at a later stage.

In the pharma space, researchers are looking for more automated solutions coupled with real-time in-situ analytical tools, requiring increased flexibility and

scalability in their tools. More than 60 per cent of our business comes from configurable and customised solutions, allowing for the flexibility required. Our solutions are also compatible with third-party analytical and monitoring tools.

Automation and digitalisation are transforming many industries. How is H.E.L Group leveraging technology to stay at the forefront of automation in the pharma and biotech sectors?

H.E.L is a pioneer in providing automated solutions for

chemical sciences, with the ability to capture data for control and monitoring in realtime. Our software solutions provide effortless efficiency to laboratory automation, making them ideal for the pharma and biotechnology industries. Data analysis using our analytical tools allows vital information to be extracted to aid process improvements.

Our WinISO and labCONSOL software are able to display and log all reaction parameters in real-time with the option of high-frequency data collection modes. Our approach towards uniformity in our software workflows

across all of our product ranges allows H.E.L to deliver superior value to our customers.

What are the goals and milestones that H.E.L Group has set for the next five to ten years, and how do you plan to achieve them?

Specifically, from H.E.L India perspective, we are focused on providing automated process development and discovery platforms. This focus ensures that our customers can adapt to the pharma and biotech industry shift from manual working to automated processes with in-situ type

analytical tools.

Process safety tools are often neglected in this shift to automation, but implementing tools and methodologies is crucial in ensuring safe and efficient processes. A major problem the industry faces today is the lack of trained human resources for process safety.

This is where our partnerships with academia in India are particularly important and will ensure that safety in the chemical sciences is part of the training curriculum through our educational awareness programs and workshops.

I N T E R V I E W

We have several pharma companies deploying H.E.L’s products to support their research Louise Madden, CEO, H.E.L Group, shares strategic insights into expanding product reach in India and the global market. She highlights real-world applications of H.E.L's scientific instruments, explores emerging trends and outlines the company's growth goals in an interview with Express Pharma What are the key strategies and challenges you've deployed to extend your product reach in India?

Having worked for almost two decades with a channel partner in India, we felt that we would be better able to support our customers through a direct sales model which we established in February 2022. Since then, we have expanded our sales, marketing and support efforts and invested in our people. We now have a team of eight and recently our service team spent time in the UK being trained at the Group’s new facility. For us to best serve the growing Indian market we will also be appointing channel partners to expand our reach in the region and enhance our product focus.

H.E.L Group offers a wide range of scientific instruments and software.

Can you describe some realworld applications where these systems have made a significant impact on research and development in the pharma and biotech fields?

In the biotech industry we have collaborated with organisations such as Solugen, working on decarbonising the chemical industry with highpressure BioXplorer systems.

These pressurised bioreactors have also been utilised at Newcastle University, UK, to increase process efficiency in the production of high-value products from waste gas.

We have several pharma companies deploying H.E.L’s products to support their research. Pfizer has implemented our process safety range (Tsu and PhiTECs) globally for their process safety procedures.

In the rapidly evolving fields

of chemistry and biotech, what emerging trends or technologies do you see as having a significant impact on your business, and how is H.E.L Group preparing to adapt to these changes?

Process safety and scale-up chemistry remains a key application area for H.E.L,

with a great opportunity being driven by our software/informatics capabilities. This is an essential part of safe manufacturing process design, which saves lives and significant cost and reputational damage. The Company’s move to direct operations in India provides the opportunity to develop our offering in this growing market.

The biggest growth area for H.E.L is within biological applications. H.E.L has the opportunity to carve out a niche revenue stream in applications that have a combination of; low volume/small scale; multi-day culture growth processes; and a need for fine control of reactor conditions e.g. high pressure, pH etc.

What are the goals and milestones that H.E.L Group

has set for the next five to ten years, and how do you plan to achieve them?

We are working hard with market-led product development, most recently, with the launch of the newest members of the BioXplorer range, the Bioxplorer 400P and BioXplorer 400XL. Increasing our offering and capabilities in bioprocessing and providing flexible, configurable, and tailored solutions to our customers.

We recently moved our global headquarters to new facilities in Hemel Hempstead, London, which will allow us greater throughput and better logistics capabilities, as well as a great working environment for our team – this will have a positive impact on our customers across the globe. The new site will support us as we continue to grow, both organically and through acquisitions.

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Indian pharmaceutical companies are increasingly becoming global players The Indian pharmaceutical market is developing rapidly and gaining international importance.

Jörg Pieper, CEO of the Romaco Group, a leading international supplier of machinery and integrated system solutions for the development, production and packaging of pharmaceuticals, and Sanjeev A. Nimkar, Managing Director of Romaco India and Head of the Sales & Service Center headquartered in Mumbai, explain the importance of comprehensive solution concepts and local service offerings for the international competitiveness of India What changes are you observing in the Indian pharmaceutical market and how can machine manufacturers like Romaco respond to them?

One significant change we see is the increased entry of Indian pharmaceutical companies into the European and American markets. About 50 percent of the products manufactured in India are now exported there.

This is a great development, as it shows the growing importance of the Indian pharmaceutical world.

However, this international orientation also brings new challenges. Indian pharmaceutical manufacturers need partners in the field of machine manufacturing who can help them to produce competitively and meet all the requirements of the world market efficiently. We are moreover seeing a reevaluation on the part of our Indian customers with regard to their investment decisions.

The basis for decision-making is changing from the rule of thumb “low cost medication require low cost machines” to an assessment of machine performance and therefore the actual cost competitiveness of production. Exactly this is where we at Romaco see our task. Based on high-quality European mechanical engineering, we provide our customers with technologies that have a very good priceperformance ratio, offer quality in production, deliver high

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Jörg Pieper, CEO Romaco Group

performance and provide excellent OEE. Also, we support them in fulfilling sustainability requirements, which have become a crucial economic factor.

To give a few concrete examples, that we will also be presenting at the upcoming CPHI: We implement avoidance, for instance, through the machine design, which prevents product and material losses and thus conserves resources. The double-sided rotary press E 710 Smart from Romaco Kilian, which minimizes product waste thanks to the floating product scraper with magnets, is a prime example here.Reduction is among other things about reducing process times. The

Sanjeev A. Nimkar, Managing Director, Romaco India Pvt. Ltd.

levers we use for this are precision and a high degree of automation. The innovative process air distribution system inside the cylindrical product container of our Romaco Innojet VENTILUS® Lab fluid bed processor reduces processing times by up to 25 percent. And these are just a

few examples that not only allow to comply with legal regulations of different markets, but also save costs and time during production, which in turn increases competitiveness.

Romaco is a one stop solution provider in the areas of processing and packaging.

What exactly does that mean – especially for Indian pharmaceutical companies?

First of all, it describes our line competence. We offer technologies and expertise for the entire pharmaceutical manufacturing process – from powder to pallet, so to speak.

But that is only one aspect of it.

What customers appreciate is that we can support them not

only in the purchase and implementation of an entire line, but also in each individual machine and its integration into an existing line. It also means we can advise and help at every stage: purchase, operation and service.

Through our broad portfolio, we understand production processes and the associated systems from all angles and can use this holistic approach to assist customers exactly where it matters.

To this end, we have strengthened our capacities in India in particular and are training service technicians to become experts on Romaco machines. This enables them to provide customers here with optimum and rapid on-site

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CPHI-PMEC SPECIAL support, and also with the necessary language skills. It was extremely important for us to place the know-how locally.

This is the only way we can ensure that downtimes are kept to a minimum and that our customers can work at the highest level. In addition, this is also a question of sustainability.

Transcontinental travel is no longer necessary to consult highly qualified technicians.

The concrete application of our local expertise approach takes place, for example, in the aftermath of CPHI, where we let customers test one of our highlights, the VENTILUS® Lab fluid bed processor from Romaco Innojet for granulating, drying, and coating particles of any size from 10 μm to 2 mm, in their own production environments, supported by our trained service technicians. This allows

ROMACO – A ONE STOP SOLUTIONS PROVIDER From powder to pallet Romaco covers the entire process chain with its technologies for granulation, tableting, coating, filling and packing.

From laboratory to high volume equipment Romaco offers machinery in all dimensions from lab to production scale for pharmaceutical, nutraceutical, food, cosmetic and chemical applications.

From single machines to integrated line solutions Supported by strong project management, we offer stand-alone machines, lines and turnkey solutions including third party system integration. them to experience the benefits of the technology under their individual practical conditions and thus know exactly what to expect. We already have over 6 interested companies.And in case that special questions arise that cannot be solved directly on site, we have a fast, efficient answer ready in the form of remote services. This way experts from Europe can be directly involved in solving problems, during a live stream

for example.In order to be able to respond quickly and flexibly to all support requests, Romaco India has its own spare parts warehouse in addition to the dense service network.

Furthermore, Romaco India plans to set up its own laboratory with a focus on granulation, coating and tablet presses, to provide customers with the opportunity to carry out trials there as well.In our experience, quality in

production requires more than state-of-the-art machines; service is an important component and indispensable for a turnkey supplier.

Are there also approaches at Romaco and Romaco India that directly affect the Indian market and surrounding regions?

Absolutely. Basically, everything we have just listed strengthens Indian

pharmaceutical companies not only in their entry or business on a global stage but is also extremely important domestically. Here, too, competition is strong, from both local and competitors from Europe and America, whose top companies are present in India. This means that companies focusing on the Indian market benefit from the innovations, sustainability, high-quality production and reliable service that we provide.

In the medium term, there are additionally plans to turn Romaco India into a service center for the surrounding countries and regions. Thanks to the very good training provided, we have a very good foundation for this. Romaco India's technicians enjoy a high reputation among colleagues and experts – both at home and abroad.

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Sigachi has successfully navigated evolving pharma and nutra industries by prioritising innovation, collaboration, and customer focus Amit Raj Sinha, MD & CEO, Sigachi Industries, discusses the company's strategies for staying competitive and innovative in the pharma and nutra industries. He shares Sigachi's plans for R&D, global expansion and strategic partnerships and details its vision for the future The pharma and nutra industries have evolved significantly in recent years. How does Sigachi adapt to these changes and stay at the forefront of industry trends and innovations?

Sigachi has successfully navigated the evolving pharma and nutra industries by prioritising innovation, collaboration, and customer focus. The company's commitment to continuous research and development, strategic partnerships, and active engagement with industry trends has enabled it to stay at the forefront of new product development and regulatory compliance.

Additionally, Sigachi's customer-centric approach, compliance to quality, and focus on sustainability have cemented its position as a leading provider of pharma excipients. By embracing digitalisation and fostering a culture of continuous improvement, Sigachi is poised for continued growth and success in the dynamic pharma and nutra industries.

How has the pharma and nutra excipient market evolved over the years, and what are the factors driving its growth and innovation?

The evolution of the pharma and nutra excipient market has been driven by a convergence of factors that have reshaped the industry landscape. These factors include the growing demand

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for safe and effective drug formulations, technological advancements in drug delivery thereby necessitating the development of co-processed multifunctional excipients, stringent regulatory requirements, a focus on patient-centric formulations, the rising demand for nutraceuticals, the globalisation of the pharma industry, sustainability considerations, the growing adoption of personalised medicine and data-driven decision-making. These factors have collectively driven significant growth and innovation in the pharma and nutra excipient market, with excipient manufacturers continuously developing new and improved excipients to meet the evolving needs of the pharma and nutra industries.

The pharma excipient market is expected to witness significant growth in the coming years, driven by factors such as rising demand for pharmaceuticals, increasing focus on patientcentric formulations, technological advancements, and growing emphasis on quality and safety

What are the prospects for the pharma excipient market in the coming years, and how is Sigachi positioned to capitalise on these opportunities?

The pharma excipient market is expected to witness significant growth in the coming years, driven by factors such as rising demand for pharmaceuticals, increasing focus on patientcentric formulations, technological advancements, and growing emphasis on quality and safety.

Sigachi is well-placed to capitalise on these

opportunities by leveraging its innovation prowess, global presence, quality focus, customer-centric approach, and sustainability commitment. The company's strong track record of innovation and investment in R&D will enable it to develop new and improved excipients that meet evolving industry needs.

Historically Sigachi has been investing a lower singledigit percentage of revenue into our R&D which over the next couple of years we intend to take it to a midsingle-digit percentage of revenue. The global reach of Sigachi will allow it to tap into growth opportunities in both developed and emerging markets. Sigachi's unwavering commitment to quality and regulatory compliance will make it an attractive supplier to pharmaceutical companies requiring consistent highquality excipients.

Can you share some strategies or key factors that have contributed to Sigachi's growth, especially in expanding your presence across continents?

Sigachi believes in always walking the last mile and serving the customers at their doorsteps. Sigachi US was born out of this thought way back in 2017. Exports as a percentage of total revenue have consistently been higher than two-thirds of the total revenue over the last decade.

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CPHI-PMEC SPECIAL Sigachi MENA, Dubai is helping in strengthening our business and taping into opportunities in the Middle East and African region.

Sigachi MENA has very recently entered into a JV partnership with Saudi National Projects Investment, signifying Sigachi’s entry Saudi pharma food and nutrition market.

In today's rapidly changing business landscape, what is Sigachi's long-term vision, and how does it plan to stay ahead in the pharma excipients, nutra, and food ingredients sectors?

We are progressively diversifying our product mix for pharma, food, and

nutrition as we transform to become a vertically integrated pharma player.

Our strategic priorities are defined to enable “Experience Excellence” for all our stakeholders. These include promoting a company-wide financial template for sustained growth, diversification and de-risking, multilevel transformation of the business, as well as maintaining and strengthening the Sigachi culture of excellence.

Could you provide insights into Sigachi's research and development efforts and the role of innovation in maintaining a competitive

edge in the market?

Sigachi's dedication to innovation and customer satisfaction propelled its transformation from a mere supplier to a valued solution provider. The establishment of a cutting-edge excipient R&D lab (2014) and food application lab (2018),

coupled with consistent investments over the years, has cemented Sigachi's reputation as a leader in excipient development and food industry solutions. This unwavering commitment to excellence has earned Sigachi recognition from the Government of India's Department of Science and Technology and established it as a sought-after partner for pharma and food manufacturers worldwide.

Could you discuss any recent partnerships or collaborations that Sigachi has engaged in, and how these initiatives have contributed to the company's growth and

product development?

In a strategic move to expand our global presence, Sigachi MENA FZCO, a subsidiary of Sigachi Industries Limited, has partnered with Saudi National Projects Investment (SNP) to form a joint venture named Sigachi Arabia. This venture aims to establish a strong foothold in the rapidly growing Saudi Arabian market, catering to the pharmaceutical, food, and nutrition industries.

With plans to set up a manufacturing facility in Riyadh within three years, Sigachi Arabia is poised to serve the local market and eventually expand its reach to the entire GCC region.

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India Pha arma Award ds 2023

28th November 2023 India Expo Centre, Greater Noida

Informa Markets in India is pleased to announce the esteemed jury to recognize the excellence in the Pharmaceutical domain for the 10th edition of India Pharma Awards.

JURY PANEL

Anil Matai Director General OPPI

BG Barve Dr. Sunil Bambarkar Joint Managing Managing Director Director Gattefossé India Blue Cross Laboratories Pvt. Ltd.

RK Agrawal National President BDMA

Harish Jain Chairman FOPE Regulatory and Technical Committee

S. V. Veeramani Sudarshan Jain Chairman and Secretary-General Managing Director Indian Pharmaceutical Fourrts Laboratories Alliance

For more details, please contact: Nester Carvalho M: +91 96649 88221 E: nester.carvalho@informa.com

Process Advisors

Kaushik Desai Secretary General IPEC India

Suresh Pattathil Managing Director & General Manager AbbVie

Under the Aegis of

Ranga Iyer Senior Advisor Lincoln International

Yugal Sikri Managing Director RPG Life Science

Media Partner

Visit: www.indiapharmaawards.com

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CPHI-PMEC SPECIAL

Off-patent but no generic in sight Suhayl Abidi, Consultant, Centre for VUCA Studies,Amity University & Research Advisor, Govt of Guj-AMA Centre of International Trade advises Indian manufacturers to move into complex generics such as injectables. One strategy could be to work on those drugs which as yet, do not have a generic product

I

ndian pharma companies are one of the largest holders of ANDA approvals and control 40 per cent of the US generics market. However, most generic drugs soon spawn a large number of copycats resulting in price pressures and slim margins.

When Sitagliptin went off patent, nearly 200 brands were vying for a share of the market. Similarly for dapagliflozin, over 80 generic brands were launched within a short time in 2021 and the count hit 156 brands in 2022.

For vildagliptin, too, around 150 brands were launched in 2020, and the total stood at over 200 in 2022. The competition in generics is intense and countries like Bangladesh, Jordan and China which were non-existent in the US generics markets not so long back are giving competition to Indian dominance.

Therefore, it becomes imperative for Indian manufacturers to move into complex generics such as injectables.

One strategy could be to work on those drugs which as yet, do not have a generic product.

FDA, at regular intervals publish List of Off-Patent, OffExclusivity Drugs without an Approved Generic (OPOE list). While the FDA’s December 2022 list of OPOE Drugs with No Approved Generics had four new applications for prescription drugs, the June 2023 list saw a sharp increase — 20 new applications were added during this period.

These include glycopyrrolate (a drug used to treat peptic ulcers in adults), atropine sulfate (pupil dilation and the treatment of anticholinergic poi-

soning), bortezomib ( blood plasma cell cancer), cabazitaxel (prostate cancer), carmustine (chemotherapy), citalopram hydrobromide (depression and anxiety), cocaine hydrochloride (local anesthesia for diagnostic procedures and surgeries), and epinephrine (allergic reaction). Almost onethird of the prescription products – 176 out of 500 – are drug products delivered as injectables while there are 76 entries for oral solid dosage forms (such as tablets, capsules and modified release forms).

The June 2023 list has a total of 60 OTC drug products.

These include antiseptic agent chlorhexidine gluconate, nonsteroidal anti-inflammatory drug ibuprofen, anti-allergy drug loratadine and painkiller acetaminophen. Out of the 60 OTC drug products on the list, 19 are delivered as oral solid dosage forms (such as tablets, capsules, modified release forms, etc.).

The list can be downloaded at: https://www.fda.gov/media/169384/download?attachment

The list consists of two parts: Part I of the list identifies those prescription drug products for which FDA could immediately accept an ANDA without prior discussion.

With this list, the FDA

Almost one-third of the prescription products – 176 out of 500 – are drug products delivered as injectables while there are 76 entries for oral solid dosage forms (such as tablets, capsules and modified release forms)

hopes to bolster competitiveness in the generics market.

Such updates are a part of FDA’s initiative to improve transparency and encourage the development and submission of abbreviated new drug

applications (ANDAs) in markets with little competition.

Part II identifies prescription drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA. Injectables are the largest component of this list with over one third drugs without any generic alternative.

According to a market research firm, The worldwide generic injectable market size was $90 billion in 2022 and will grow to $326.39 billion by 2032, expanding at a CAGR of 13.8 per cent during the forecast period from 2023 to 2032.

North America region has the largest market with a revenue share of around 46 per cent in 2022.

Indian firms that have developed the expertise to develop complex drugs should aggressively file ANDAs for OPOE drugs, especially injectables which will have fewer competitors than solid dosage.

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Continuous Coating

Coating, Drying and Laminating the basic functions of the «KTF-S» The system is available in a powder-coated steel or full stainless steel version depending on customer requirements

The use of a production machine is not financially viable for research and development purposes The most economical solution is our continuous coating system of modular design for various materials such as paper, textile, copper, aluminum and plastic foils

Market leaders are using Mathis technology

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Low Humidity Conditions 25°C to 40% RH 40°C to 25% RH 30°C to 35% RH

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PLC Control

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21 CFR Software

PLC Based Safety Cut-offs

Product List Humidity Chamber

Ultra Low Deep freezer

Walk in Incubator

Stability Chamber

Photostability Chamber

Walk in BOD Incubator

BOD Incubator

Pharma Refrigerator

Muffle Furnace

Bacteriological Incubator

Dual Zone Chamber

Laboratory Oven

Cold Chamber

Freeze Thaw Chamber

Air Handling Unit (AHU)

Deep Freezer

Hot Air Oven

Dynamic & Static Pass Box

Walk in Humidity Chamber

Walk in Cold Chamber

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CPHI-PMEC SPECIAL

AI-automated into the GMP future Less manual intervention, more automation: Annex 1, which has been mandatory since August 2022, promotes the pursuit of increased pharmaceutical safety. What impact can new automation solutions have? Will these solutions have a positive effect on the ongoing shortage of skilled workers?

N

ew challenges lead to new solutions – often through a phase of incremental improvements until the benefits clearly outweigh any potential drawbacks. The introduction of isolator technology is one example; initially several hour-long decontamination cycles were opposed to the first reproducible decontamination results.

A new approach to isolator systems has emerged that eliminates the need for glove ports and opens up new possibilities.

While manual intervention can have both benefits and drawbacks, those who have the chance to manually retrieve a costly drug batch will likely opt for GMP-compliant glove ports.

However, there is no guarantee of consistent intervention and the gloves themselves pose a pharmaceutical risk, which is addressed through established methods.

Glove ports: Less is more The idea of an isolator without glove ports is fascinating. GMPcompliant operation via glove ports can be trained, but ultimately people cannot be “programmed”. Even the slightest mistake, such as handling a decontaminated but not steamsterilized glove over a stopper sorting bowl, could compromise the “first air principle” as outlined in Annex 1 for product contact parts.

This creates a demand for automation innovations that minimize potential pharmaceutical risks while reducing the number of needed personnel to counteract the shortage of skilled workers.

who know their aseptic processes and the potential contamination risks, to develop an appropriate production strategy or production rationale, as described in Annex 1.

New functions – also for high performance systems

“In order to reduce glove ports, Optima Pharma uses robots controlled by artificial intelligence.” ment additional pharmaceutical processes automation. Differentiated technical solutions will be necessary for various sections of the system.

Optima Pharma understands the importance of ensur-

ing that high output systems have access to these functions.

This has significant advantages, since the vast majority of aseptic liquid drugs for patient care will be produced using such systems.

Therefore, it is a priority for Optima Pharma to minimise, not eliminate, the number of glove ports.

Regulatory reference: With new technical functions, Optima Pharma wants to offer users,

Optima Pharma is using pilot projects to put the first new functions into practical use. The priority in developing new automation solutions is to minimize glove ports on production systems wherever possible – especially for medium and high output filling and closing systems.

Optima Pharma also envisions the benefits of introducing glove port minimization technology in systems for personalized medicine, including systems with a lower output. While keeping individual glove ports for product recovery may be necessary for processing expensive drugs, the benefits of glove ports should be weighed against their drawbacks. If safer and more efficient alternatives exist, glove ports should be avoided.

A glimpse of what’s to come Optima Pharma achieves the minimisation of glove port with new functions and technologies.

A glimpse of what’s to come

Improving reproducibility and solving labor shortages It is certain that no single technology can be used to imple-

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Strategically, isolator systems with fewer glove ports make sense for medium and high-performance outputs. Shown: AI-controlled robotic solutions for inline troubleshooting of an incorrectly placed stopper.

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CPHI-PMEC SPECIAL from Optima: For example, Petri dishes are still placed over glove ports to record a potential germ load in the isolator-protected area. This process can be risky and laborious, as machine operators must manually remove the dishes from the isolator through the glove ports for incubation and evaluation at regular time intervals.

In contrast, a new system targets the automatic detection of germ occurrence in the isolator in real time. This method analyses a large volume of air per minute, guiding air through an isokinetic funnel, and detecting and documenting potentially present germs using laser light and biofluorescence particle counting, while counting nonliving particles parallel and analogous. This means there is potential in the near future to (almost) automate environmental monitoring of aseptic processes - avoiding glove ports, which are otherwise necessary for the production isolator or up-stream for handling Petri dishes.

Optima Pharma has installed this new system at various pharmaceutical companies, parallel to the “traditional” germ collection system using Petri dishes. Data is currently being generated that will allow comparisons and lead to independent findings with regard to the precision and reliability of the measurement results of the new system.

plies according to GMP guidelines, meaning that the HEPAfiltered air must first flow over the object to be processed without any deflection as it will later come into direct contact with the product. Second, the robot must not run the risk of touching any other system components.

Automation of high-tech and pharmaceutical requirements Simulations support the design department to implement the current GMP Annex 1 requirements, in particular the “First Air Principle”, optimizing the filling and closing systems. The laminar flow is precisely reproduced.

Manual interference with glove ports must be carried out in compliance with GMP guidelines, e.g. by camera recordings.

Thinking ahead: artificial intelligence In order to reduce glove ports, Optima Pharma uses robots controlled by artificial intelligence. This system is already proven to correct misaligned stoppers in the infeed to the pick-and-place transfer station that would cause an error message. Controlled by cameras, the system recognises whether and where stoppers are incorrectly positioned. If intervention is required, it is done inline, i.e. in the continuous high-speed process with a robot, equipped with a steam-sterilisable tool complying to high technical and pharmaceutical standards.

The performance or movement speed of the intervening robot must be synchronized

The evaluation of system data obtained by sensors, like force and torque sensors, provides a proactive approach – leading to fewer unexpected system downtimes and improving overall process reliability.

with the process speed of medium and high-performance filling and closing systems – which would not be feasible with a “conventional” technical approach. Conventionally controlled robot movements would simply be too slow to intervene with a running process in real

time without interrupting or risking errors. First, the robot movements must comply with pharmaceutical GMP requirements. This means that moving parts, in this case the robot arm or head, must not be located or move over the stopper. Here, too, the “First Air Principle” ap-

How do you reconcile these complex requirements? The solution lies in the artificial intelligence that Optima Pharma incorporates into the process control. Virtual planning using a digital twin that runs ahead of the real process, mapping out the exact processes that the real system will undergo. This provides a look into the future, and the opportunity to simulate various scenarios to identify potential problems before they arise without the risk of negative consequences. This prevents pharmaceutical integrity from being violated by robot intervention or collisions in the real system.

Critical robot movements and processes would be recognized in advance in the digital twin.

The robot technology, which is initially too slow for medium and high outputs, is harmonised with the use of artificial intelligence, interaction with the comparatively faster processes of the filling and closing system without duplicating robot stations. This additional automation function avoids the need for glove ports in this area. Here again, Optima Pharma is looking at systems in the field that are already equipped with this new technology.

An automatic feeding system for sterilised stoppers or other container components is another option to avoid glove ports.

If the stoppers are fed into the system conventionally in bags and docked to the RTP ports, operators have to manually operate the inside of the RTP port, using glove ports to transfer the stoppers into the system. With a new transfer solution, this process can be automated and glove ports completely avoided directly at the system. Optima Pharma has al-

ready equipped several machines with this system.

New technologies in use There are already several options to reduce the number of glove openings in isolator-protected systems – explicitly in systems with medium and high output.

Another possibility are rescue ports. Rescue ports are only installed at locations without regular hands-on work through glove ports. These fallback locations serve as reinsurance, to intervene manually in the event of a fault and to “save” a batch in a GMP-compliant and documented manner through glove ports. As a result, except for situations where manual intervention is necessary, the potential disadvantages and complex decontamination process of glove ports are largely eliminated.

Technology diversity will increase The development of machines designed with a reduced number of glove ports, including systems with low, medium and high outputs, has picked up speed.

These systems meet today’s GMP requirements – and reduce operator intervention as much as possible to counteract the shortage of skilled workers.

These systems do not rely on any singular new technology – more exciting innovations in system automation are to come!

Important for you ◆ New automation solutions meet current GMP requirements and help pharmaceutical manufacturers counteract the shortage of skilled workers ◆ Optima Pharma plans the minimization of glove ports, even for systems with high output ◆ Existing and future automations including: Inline environmental monitoring with germ analysis, inline stopper correction in pick-and-place infeed, product path handling, container infeed with automated RTP ports, rescue solutions ◆ The implementation of robot control techno-logy, which includes artificial intelligence, has unlocked new possibilities, and the first function has successfully been executed

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Our focus is on becoming world's No.1 preferred supplier of pharma equipment Manoj Chaudhari, Director, Mack Pharmatech speaks on his company's solutions, growth plans and vision, in an interview with Express Pharma Mack_Ptech offers equipment for a wide range of industries. Can you tell us about the specific types of products or equipment that you supply for the pharma sector?

We supply lab equipment required in different departments of the pharma industry like the chemical laboratory, microbiology laboratory and production department.

Our product portfolio includes Humidity Chambers, Stability chambers, BOD Incubators, Bacteriological Incubators, Cold Chambers, Deep Freezers (-20°C to -40°C), Ultra low Deep freezers (80°C), Photostability Chambers, Pharma Refrigerators, Dual Zone Chambers, Freeze Thaw Chambers, Hot Air Ovens, Laboratory Ovens, Vacuum Ovens, Water Baths, Walk in Humidity Chambers, Walk in Cold Chambers, walk-in Incubators, Walk-in BOD Incubator etc.

The capacity of these equipment range from 200 liters to 1000 liters for standalone chambers. For walk-in chambers we provide equipment with a capacity of up to 1.5 lakh liters and as per customers' requirement.

We also supply Cleanroom Panels and Partitions, Air Handling Unit (AHU), Dynamic Pass Box, Static Pass Box, Horizontal Laminar Airflow Unit, Vertical Laminar Airflow Unit, Reverse Laminar Airflow Unit, Biosafety Cabinet, Fume Hood, Mobile Trolley, Air Shower, GMP Model (Muffle Furnace), Economical Model (Muffle Furnace), and Starter Series Model (Muffle Furnace) to the pharma industry.

What are the key advantages

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that Mack_Ptech offers to clients in terms of efficiency, convenience, and costeffectiveness?

MACK PHARMATECH's success lies in quality and customer service. It is firmly focussed on R&D and manufacturing of quality products with international standards. We offer equipment that is best in quality, yet costeffective. In turn, it has resulted in constant increase of satisfied customers for the past 24 years.

We are going to celebrate 25 years of success soon.

Technology has been advancing rapidly.

Consequently, we have been equipping and hiring service engineers with in-depth knowledge and a greater range of skills so that they can competently handle and maintain today's sophisticated systems. Attention to training endorses our commitment to service. Our engineers receive regular external training on new equipment. Support from in-house personnel with expertise in electronics, electrical and mechanical engineering, along with technical assistance from our calibration department ensure that our engineers have the ability to provide professional maintenance and breakdown service for all types of plants and environmental test equipment.

We have our service centers across India. We have also established our presence globally. We are present in countries like Saudi Arabia, Bangladesh, Vietnam, UAE, South Africa, Canada, China, Ukraine, Turkey, Thailand and many others.

The pharma sector often requires sensitive and

Our logistics is handled by leading service providers. We also impart training to our logistics partners for safe handling of our equipment.

specialised equipment. How does Mack_Ptech handle sourcing, logistics, and delivery of such equipment to ensure it reaches clients in optimal condition?

Pharma equipment are sensitive and specialised, so we take utmost care of these equipment from receipt of the raw materials till delivery of equipment at the customer's door step.

We train our employees to handle raw materials as well as processed and final products.

We also impart training on packing and dispatching equipment to our employees.

We use standard quality raw materials and packaging materials to ensure that equipment remains in good condition until it reaches the customer's door step. For export, we use special quality packaging material to cage the equipment and ensure that there is no damage to them.

India has a diverse and dynamic business landscape.

How does Mack_Ptech adapt to changing market demands and industry trends to remain a reliable partner for its clients?

We always review the changes in market demands and upgrade ourselves as per the requirement of our clients to provide best-in-class equipment and services.

Our objectives are to: 1. Exceed customer expectation by delivering the best quality product with quality swift service. We have our own R&D facility to adapt to the market changes.

2. Adopt and devise advanced manufacturing techniques for ceaseless enhancement in quality 3. Supply technologically advanced products and 24x7 service to our customers We also have a special technical support team at back office and specialised engineers on field. We use very advanced PLC based equipment with s21 CFR complaint software as required in the pharma industry as per WHO guidelines and adhere to ALCOA+ principal at the customer end. The main motto of MACK PHARMATECH is customer satisfaction.

The pharma sector is highly regulated and requires adherence to strict quality standards. How does Mack_Ptech ensure that the equipment it supplies complies with industry regulations and quality

requirements in the pharma field?

Our company has an ISO 9001: 2015 Quality Management System approved by BSI. Our products are also CE certified.

We are committed to ensure that our products are in compliance with GMP and other manufacturing regulations. Our software is in line with the WHO and global guidelines.

Looking ahead, what are the strategic goals and growth plans for Mack_Ptech, and how do you foresee the company's role evolving in the industries you serve?

We have charted a road map for the growth of our organisation.

Our focus is on becoming world's No.1 preferred supplier of pharma equipment.

Enabling sustainability is one of the pillars of MACK PHARMATECH. It is embedded in our DNA and demonstrated in our innovation process, manufacturing approach and product quality through which we partner with our customers to assist them on their own sustainability journey.

Shortly, MACK PHARMATECH is going to enter into its 25th year existence. We have traced a fabulous journey and achieved a strong presence in the domestic and global market.

We are celebrating our Silver jubilee Year with the same approach and enthusiasm. The journey will continue for many more decades with more momentum, passion and customer-centric focus.

MACK PHARMATECH is committed to offer indispensable and matchless solutions for environmental testing.

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Ensuring pharma compliance with testo data measurement technology Testo being a market leader in testing & measurement sector provides the best in class data loggers and data monitoring systems for the Pharma division

D

ue 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 & 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 & measurement sector provides the best in class data loggers and data monitoring systems for the Pharma division.

Ensuring end to end climate monitoring – Testo data loggers 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 & 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 & humidity logger such as 174 T guarantees continuous monitoring in a storage or warehouse. Also, data loggers with multi channels for con-

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 & calibration made easy necting external sensors & 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 & clean room applications. These instruments are the most convenient and pocket friendly solution for all pharma application areas.

The Testo Saveris 2 WiFi data logger system is the simple, flexible and reliable solution to humidity and temperature monitoring in cold storage area like blood banks. This in-

novative monitoring system is ideal for high product quality & eliminates manual work of reading out or documenting measurement data. With a secure online storage of all readings in Testo Cloud the data can be managed and analyzed online by the user via smart phone, tablet or PC anywhere and anytime. In case of crises and deviations, it is provided with an alarm by e-mail, or optionally by SMS. Another important and crucial application of a pharma industry involves validation of sterilization 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 190 data logger solution

that has innovative data loggers for temperature & humidity, smart software and accessories.

Data compliance for audits and inspections Testo offerings are majorly related to the data security along with comprehensive analysis & evaluation of all the recorded measurement data. Testo data loggers ensure continuous monitoring 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 & data monitoring systems. Our data loggers are EN 12830 and 21 CFR Part 11 compliant which ensure

Testo also has an established state-of-the-art NABL accredited service & calibration LAB in accordance with the standard ISO/IEC 17025:2017, that takes care of the after sales support locally from Pune. Testo service & 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 (Infra Red Thermometer, Thermal Imager). In fact, ours is the First and Only Lab in India to get NABL Accreditation for Dew Point Temperature as well.

For more details, login to our website www.testo.com or write back to us on info@testo.in

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New E 710 Smart double-sided rotary press from Romaco Kilian

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omaco will take advantage of this year’s CPHI & PMEC India to show its latest development in the high-productivity tableting sector and demonstrate the enormous energy saving potential of its innovative fluid bed technology.

magnets. The sparing use of natural resources is totally consistent with Romaco Kilian’s sustainability strategy.

VENTILUS® Lab fluid bed processor from Romaco Innojet

E 710 Smart doublesided rotary press from Romaco Kilian The E 710 Smart expands Romaco Kilian’s product portfolio with a new double-sided rotary press that was particularly developed for high production volumes with low margins.

This economical tablet press for mono- and bi-layer production is based on Kilian’s proven four-column design. The single-piece, deep-drawn process area ensures hermetical separation between the compaction and technical areas. A closed V-ring seal underneath the die table additionally prevents tablet dust from entering the “grey” area. With between 51 and 85 press stations and a pitch circle diameter of 712

E 710 Smart double-sided rotary press from Romaco Kilian

mm, the Kilian E 710 Smart achieves a maximum output of up to 1,020,000 tablets per hour. Brake magnets permit absolutely homogeneous filling of the dies without any wear on the punch shafts. Moreover, special Kilian bellows protect the tablets from contamination in the form of black spots. The fill shoe is quick and simple to clean because the gear is external. Owing to the small number of interchangeable parts and the good accessibility to individual components, retooling and cleaning times

VENTILUS® Lab fluid bed processor from Romaco Innojet

are significantly reduced. The tablet scraper and chute are mounted together on a swivel arm for easy removal. Product loss is minimized thanks to the floating product scraper with

Designed for laboratory-scale applications, the VENTILUS® Lab fluid bed processor from Romaco Innojet is used for granulating, drying, and coating particles of any size from 10 μm to 2 mm. This multipurpose lab unit is intended for batch sizes from 0.7 to 7.0 liters. With its innovative process air distribution system inside the cylindrical product container, the VENTILUS® Lab shortens batch processing times by up to 25 percent because the required power can be used far more efficiently. The process air is introduced through the circular ORBITER® booster, ensuring homogeneous flow conditions and extremely gentle intermixing of the batch. In combination with the ROTOJET®, the central bottom spray noz-

zle, the ORBITER® booster plate forms a unique functional unit enabling much simpler scale-up processes. The patented fluid bed components invented by Dr. h. c.

Herbert Hüttlin lie behind the remarkably accurate application of the spray liquid with a precisely defined droplet size.

With controlled release formulations, for instance, the modified release profiles are achieved using 10 to 15 percent less material. This targeted reduction in spray liquid usage also means less power consumption, so that the VENTILUS® Lab results in substantially fewer carbon dioxide emissions from fluid bed processes. Furthermore, the rotating SEPAJET® filter system minimizes general product loss by returning particles retained by the filter to the process rather than discharging them.

On show at CPHI & PMEC India 2023 from November 28 to 30, 2023 (India Expo Centre, Greater Noida, Delhi NCR, Hall 10, Stand C03).

Eppendorf's Mastercycler X40 PCR cycler: For the digital future in your lab Combined with the intuitive touch-screen user interface and ergonomic one-hand operation the new Mastercycler X40 raises your standard in PCR

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ith the Mastercycler X40 your daily lab routines will not only be reliable and efficient but elevated: Eppendorf's new product offers proven reliability and the high-quality thermal cycler is now available for every lab. Discover the Mastercycler X40 and all its advantages that will raise your work to a new standard. Reproducible nucleic acid amplification and reliable temperature homogeneity are a must for Eppendorf's Mastercycler X40 PCR cycler.

Combined with the intu-

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itive touch-screen user interface and ergonomic one-hand operation the new Mastercycler X40 raises your standard in PCR. Feel free to use 0.1 mL, 0.2 mL tubes or tube

strips and your choice of any type of 96-well PCR plate, the SafeLid securely protects your samples from evaporation. The 12-column gradient facilitates optimisation of dif-

ferent temperature steps in your PCR protocol. When transferring protocols from slower cycler models to the Mastercycler X40 you can benefit from the convenient program migration feature that automatically adapts the ramp rates to match your well-proven PCR protocol with the exact same runtime.

For the digital future in your lab Mastercycler X40 can be directly connected to Eppendorf's VisioNize Lab Suite for monitoring, audit trails and documentation.

For meeting sustainability

goals Mastercycler X40 comes in a pure cardboard box with minimal dust-protecting plastic bags and a reduced short manual. The small footprint and low weight reduce the CO2 footprint originated by shipping and its low energy consumption contributes to daily reduction of CO2 emission.

The clean and modern design is centered on an intuitive and comfortable user experience.

More information about the Mastercycler® X40 can be found at https://www.eppendorf.com /en/mastercycler-x40/

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Vhp Biodecontamination In Pharma Industry Pietro Beltramo, Amira Srl – Italy, explains how Bioreset® Systems are the best ally for V-PHP bio-decontamination to meet Annex 1 requirements

V

apor-phase hydrogen peroxide (V-PHP or VHP) bio-decontamination is a process of surface sterilisation that has been extensively validated and used in the pharma industry for many years. In fact, VHP is one of the most commonly used sporicidal agents for bio-decontamination of cleanrooms, isolators, RABS and other controlled environments.

Annex 1 of the European Union's Good Manufacturing Practice (GMP) guidelines sets out the requirements for the manufacture of sterile medicinal products. Annex 1 includes specific requirements for the design and operation of cleanrooms and other controlled environments, including RABS systems. These requirements cover areas such as environmental monitoring, personnel and material flow, contamination control and bio-decontamination procedures.

V-PHP biodecontamination in Annex 1 Bio-decontamination is widely mentioned in chapter 4 Annex 1.

As explained in the Annex 1 glossary, bio-decontamination is intended to be a process able to eliminate all biological contamination from exposed surfaces via use of a chemical sporicidal.

The first time this word is mentioned is in chapter 4.20 (i) Isolators- point b: “Key considerations when performing the risk assessment for the CCS of an isolator should include (but are not limited to); the bio-decontamination program, […]”

This provides immediate evidence that this process is extremely critical for any isolator working in aseptic processes.

In chapter 4.21 (ii) the biodecontamination process is also mentioned as alternative to sterilisation: “For RABS, gloves used in the grade A area should be sterilised before installation and sterilised or effectively bio-

decontaminated by a validated method prior to each manufacturing campaign. …”

In fact, a properly validated bio-decontamination process can achieve, on exposed surfaces, the same result as a sterilisation process (e.g. 6 Log reduction on most resistant microorganism Geobacillus stearotehrmophilus) V-PHP is also mentioned in the Annex 1, specifically in chapter 4.36: “Where fumigation or vapour disinfection (e.g.Vapour-phase Hydrogen Peroxide) of cleanrooms and associated surfaces are used, the effectiveness of any fumigation agent and dispersion system should be understood and validated”.

The key to successful aseptic manufacturing is to maintain a rigorous control of the microbiological contamination either in isolators, RABSs and cleanrooms. For this reason, Annex 1 pushes on routine biodecontamination programs

and specifies the implementation of properly validated methods to achieve this result.

This is also well mentioned in chapter 4.22 (ii) where Annex 1 specifies about RABS biodecontamination: “The sporicidal disinfection should include the routine application of a sporicidal agent using a method that has been validated and demonstrated to robustly include all areas of the interior surfaces and ensure a suitable environment for aseptic processing.”

Validation of proper distribution of sporicidal agent, as well as assurance of a proper Log reduction compatible with aseptic environment, are particularly important in RABS Bio-decontamination as mentioned in the regulation.

V-PHP meets Annex 1 requirements for RABS, isolator and cleanroom bio-decontamination Vapor-phase

hydrogen

peroxide (V-PHP) is the perfect solution for complying with all Annex 1 requirements for bio-decontamination of isolators, cleanrooms and RABS as it provides: Microbial efficacy: Annex 1 requires that the isolator and RABS are thoroughly decontaminated and that there is no evidence of microbial contamination after the decontamination process. VHP bio-decontamination is capable of achieving the same target of sterilisation on exposed surfaces, being able to provide a consistent and reproducible 6 log reduction on most resistant microorganism (Geobacillus stearothermophilus).

Validation: Annex 1 requires that the decontamination process is validated to ensure that it is effective in removing or destroying microbial contaminants. VHP bio-decontamination can be easily validated as it is able to reach all difficult areas and provide reliable results over time also in complex layouts.

Minimising the risk of product contamination: Annex 1 requires that the bio-decontamination process be designed to minimise the risk of product contamination. H2O2 vapor leaves no residues behind demonstrating to be in full compliance with this requirement.

Safety: Annex 1 requires that the decontamination process is carried out safely, with appropriate consideration given to the health and safety of personnel and the environment.

VHP is a perfectly safe and environmentally friendly sporicidal agent as it turns into oxygen and water at the end of the decontamination process.

Bioreset® represents the most technologically advanced, effective and rapid biodecontamination systems for reducing the microbiological contamination of air and surfaces in classified environments or all areas sensitive to biological contamination.

Produced in Italy by Amira, Bioreset® range includes different models and solutions meeting the specific needs of different applications, from the biodecontamination of single room and isolators, to the design and construction of integrated systems in controlled contamination environments. Bioreset® solutions are extensively installed and used worldwide for rapid and effective biodecontamination of multiple applications including clean room for sterile production, isolator, autoclave, BSL-3 laboratory, pass box, aseptic filling line machine and washing machine.

If interested in 6 Log reduction on all exposed surfaces, no residue, effective and repeatable cycles, fast restoration of operating conditions, high flexibility, maximum safety for the operator and the environment, user friendly and graphically innovative software, pre-sales consultancy and after-sales assistance, among the Bioreset® models there is your best ally.

Find out more on Bioreset® line, visit: https://www.amirasrl.com/ en/biodecontamination/bioreset/

Bioreset® Systems: The best ally for V-PHP biodecontamination Using vapor-phase hydrogen peroxide (H 2O 2 V-Phase) as a cold sterilising agent,

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Client-centric service and solutions are our business model In this exclusive interview with Express Pharma, Dr Kiran Badgujar, Founder and Director, Aureole Pharma-Tech, delves into the core aspects of Aureole PharmaTech's operations, details their product offerings for the pharma sector, and elaborates on the company’s vision and strategies for growth Aureole offers equipment for a wide range of industries. Can you tell us about the specific types of products or equipment that you supply for the pharma sector?

Aureole PharmaTech manufactures Laboratory equipment, which includes Stability Chambers, BOD Incubators, Cold Chambers, Deep Freezers, Ovens and Walk-in Chambers. We target industries such as pharma, chemical, oil and gas, steel, glass, construction, textile, packaging and laboratories.

We also have a plan to introduce new products in our portfolio.

As a supply chain provider, what are the key advantages that Aureole offers to clients in terms of efficiency, convenience, and costeffectiveness?

We believe in customer satisfaction and providing

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customer-oriented services.

We do in-house production, ensuring the quality of our products. Our software, Secure and Integrated Solutions for Applications, Products, and Processes (SISAPP), will manage sensitive data across various applications, products, and organisational processes, guaranteeing robust security and compliance with 21 CFR Part 11.

landscape. How does Aureole adapt to changing market demands and industry trends to remain a reliable partner for its clients?

Client-centric service and solutions will be our business model. We strive in product development, and our focus will be on all aspects fabrication, software, processes (internal as well as for customers and suppliers).

The pharmaceutical sector often requires sensitive and specialized equipment. How does Aureole handle the sourcing, logistics, and delivery of such equipment to ensure it reaches clients in optimal condition?

We have a quality check at different stages, and before delivery, we conduct a final QC check. FAT can be initiated to verify newly manufactured equipment meets its intended purpose. Aureole

The pharma sector is highly regulated and requires adherence to strict quality standards. How does Aureole ensure that the equipment it supplies complies with industry regulations and quality requirements in the pharma field?

Our teams are highly enthusiastic, driven by the desire to achieve great goals and deliver their best performance. Our people are

PharmaTech takes care while packing all equipment.

Corrugated box and thermocol packing will be made. Goods will be delivered up to the factory premises.

India has a diverse and dynamic business

our most valuable assets, and we hold them in the highest regard. We follow GMP/ICH Guidelines & Compliance with 21 CFR Part 11 norms while manufacturing equipment.

Looking ahead, what are the strategic goals and growth plans for Aureole, and how do you foresee the company's role evolving in the industries you serve?

Aureole PharmaTech has established certain goals and vision. We are going to move ahead with a pragmatic approach that will cover new installations, AMC, migration. We are sure to be a trendsetter in the pharma equipment industry with an unconventional way of working. With our customercentric approach and service model, we are planning to grow our business and ramp up our team up to 200 (currently 50) by March 2025.

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Change made easy with APEXby Kimberly-Clark Professional Based on decades of global industry expertise in delivering innovative solutions for critical environments, Apex protects the process while enhancing efficiency and performance

C

hange can be disruptive, especially in environments where personal safety and contamination control are essential.

That’s why Kimberly-Clark Professional has developed The Apex Program, a consultative approach that ensures a seamless transition to Kimtech Brand of products.

Based on decades of global industry expertise in delivering innovative solutions for critical environments, Apex protects the process while enhancing efficiency and performance.

The Apex program has a cleanroom and non-cleanroom approach to ensure the safety and quality of the company's programs. The first step in the cleanroom approach is assessment, where the customer’s process, equipment, chemicals, and hazards involved are evaluated. Then, the process is assessed to ensure that it is optimised for safety, quality, and efficiency.

The equipment used is evaluated to ensure that the solutions proposed protect the process. The company also assesses whether there are any chemicals and hazards to be careful of. The customer’s pain points and sustainability goals are identified to ensure that the program is aligned with Kimberly-Clark's common values and objectives. By conducting a thorough assessment, the company can identify any potential risks and develop a plan to mitigate them, ensuring that the program meets the highest standards of safety, quality, and sustainability.

After conducting a thorough assessment, the next

step in cleanroom approach is preparation. This involves stakeholder management, where the company engages with all relevant parties to ensure that everyone is aligned with the plan and understands their roles and responsibilities. Kimberly-Clark also establishes success criteria to ensure that the objectives are met and measure progress.

Qualification documentation is prepared to ensure that all personal protective equipment (PPE) proposed meet the required standards. The company updates its standard operating procedures (SOPs) to ensure that they reflect the latest best practices and regulatory requirements. Finally, product forecasting is conducted to align the company's supply chain and logistics to meet the customer’s demand.

By preparing thoroughly, Kimberly-Clark ensures that its program is well-designed, well-documented, and wellequipped to meet the customer’s end goals.

The implementation phase is a critical step in its cleanroom approach. it begins by providing customised training

to the operators to ensure that they understand the plan and their roles and responsibilities. This training includes a hands-on experience with the cleanroom PPE involved, as well as classroom instruction on best practices and safety protocols. The gowning qualification is conducted to ensure that the relevant team members are properly trained in the use of PPE and gowning procedures. Visual management is an important aspect of the implementation process, as it helps to ensure that the operators are following the correct procedures and protocols. The company's uses training collaterals such as donning-doffing posters and size guides to reinforce key concepts and provide a visual reminder of best practices. These materials are designed to be clear and concise, with easy-to-understand graphics and step-by-step instructions. By providing customised training and using visual management tools, the company ensures that its team members are well-prepared to execute the plan and meet implementation objec-

tives.

The final step in the cleanroom approach is results, where the success of our program is evaluated and areas for improvement are identified. Kimberly-Clark conducts a post-Apex satisfaction survey to gather feedback from the stakeholders on the experience and effectiveness of the program. It also confirms success metrics to ensure that the objectives set at the beginning are met. Observation reports are used to identify any areas where improvements can be made and to ensure that operators are following the correct procedures and protocols. The comapny also provides trainthe-trainer support to ensure that operators undergoing Apex are well-equipped to train new hires and maintain the program over time. Refresh training is also provided to ensure that they are up-todate on the latest best practices and regulatory requirements. Finally, continued support is provided to ensure that the program remains effective and aligned with Kimberly-Clark's objectives over time. By evaluating the results

of the program and providing ongoing support, the company ensures that its cleanroom approach is effective, efficient, and sustainable over the long term.

Similar steps are taken for the non-cleanroom approach for environments such as Research Labs, Semi-conductor Production, Advanced Manufacturing, which also includes assessing the chemical permeation data and a fit-and-feel session for the operators besides the other steps in the cleanroom approach.

Contact today to learn more about the Apex programme and how it can benefit your organisation.

Learn more about how Kimberly-Clark Professional can help your glove selection on: www.kcprofessional.com/en-in Contact for enquiries & details: West, North & East India: Bharatkumar Mistri, bharat.mistri@kcc.com, +91 9825053582 South India: Ravi Kumar C., ravikumar.c@kcc.com, +91 9391330669

®/™ Trademarks of Kimberly-Clark Worldwide, Inc. or its affiliates. © KCWW

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LabXLaboratory Software: Digitalise your weighing processes LabX is not just a connection to an instrument; it is a complete laboratory solution. LabX automates all administrative work. LabX makes your laboratory lean and provides highest security

L

abX Laboratory Software connects to multiple METTLER TOLEDO lab instruments. Benefit from increased workflow efficiency, optimal security support and centralised management of one or multiple instruments, users and data. LabX is not just a connection to an instrument; it is a complete laboratory solution.There is no need for PCs in the laboratory, the system works remotely via the network. LabX automates all administrative work. The paperless lab is a reality. LabX makes your laboratory lean and provides highest security.

Start your weighing task

with just one touch on your balance display. LabX Balance guides you step-by-step through your SOP with clear onscreen instructions at the balance. All results and process metadata are documented and saved in a centralised database, calculations are performed automatically and transcription errors are eliminated. LabX provides a seamless flow of data throughout the entire analysis workflow, guaranteeing a high degree of process security. LabX can also support you with the fulfilment of the FDA ALCOA+ requirements for data integrity. Welcome to the digital laboratory

quired for subsequent analyses.

Automatic Documentation

where your data is available from anywhere 24/7 and you are always audit-ready.

Seamless Integrated Dataflow LabX integrates fully with laboratory information systems, such as LIMS and chromatography software, and sends your weighing results directly to where the weight values are re-

LabX automatically saves weighing data, including all metadata, in a secure, centralized database at the time of creation. Customised result reports can be generated at any time, including automatically at the end of a procedure.

Central Balance Management User profiles, weighing tasks and balance configurations can be managed centrally. LabX monitors each balance’s test and calibration history and automat-

ically initiates routine tests or blocks the balance when necessary.

Improved Efficiency Thanks to the intuitive instructions on the balance display and automatic documentation, using LabX saves a considerable amount of time and significantly reduces errors. Efficiency is improved and output increases.

To know more, visit: www.mt.com/LabX Email at – sales.sales@mt.com Call toll-free at – 1800 22 8884 & 1800 1028 460

Towards laboratory of the future This article describes the tools offered by LabWare, for the digitalisation of the laboratory increasingly conceived as an enabling technology for the future of the laboratory

E

very laboratory, be it QC or R&D has the potential to be digital to increase data managed, find complex correlations, and share information in real-time with subjects even very far from each other. Work efficiently, collaboratively and transparently.

Digitalising the laboratory is the fundamental basis for planning the future. At the same time, it is a complex step, which also radically changes the very way of working.

In recent years there has been a lot of talk about digital evolution in industry and in the laboratory. But the reality is that in many cases we have stopped transferring the information and flows onto a computer system of work that was adopted on paper.

We therefore speak of the "Digitisation" of the processes.

The next step is "Digitalisation"- that is, using digital information to simplify and make processes more efficient.

These two terms are both conceived as "Digitalisation"

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even though they are different concepts.

True transformation occurs when you embrace technologies as an integral part of the processes themselves, instead of considering them just auxiliary tools. As always, LabWare is committed to introducing all the tools necessary to adapt to the new challenges of the laboratory of the future.

trative or repetitive ones. It also allows for better management and organisation, also reducing human errors. Data becomes more accessible and enables more collaborative work for scientific progress. An increase in efficiency also means increasing productivity and the ability to predict what may happen.

LabWare's motto also says it: Results Count.

What is meant by laboratory digitalisation?

What advantages does LabWare offer to its partners in the journey towards the Lab of the Future?

Historically, laboratories have always been based on paper: all the trials and tests were reported in the "famous" laboratory notebooks. Digitalisation can be explained as the adoption of a digital infrastructure that aims to work efficiently, collaboratively, and transparently, allowing operators to dedicate more time to scientific processes rather than adminis-

There are many advantages, it's impossible to list them all.

Organisations deal with a large amount of data generated by research, experiments and tests of products or processes.

LabWare's LIMS and ELN can efficiently manage this data, facilitating access, search,

and analysis. These capabilities help improve decision-making and research collaboration, as well as accelerate the development of products and processes.

Some laboratories need to collect data from remote locations in the field and the LabWare Mobile App for smartphones and tablets allows technicians to record samples for collection in real-time and to have access to information from any site. LabWare Mobile App communicates with instruments while technicians process samples remotely.

LabWare LIMS and ELN allow researchers to systematically document and track each step of the activity, ensuring the reproducibility of results and facilitating knowledge sharing between team members.

Other advantages are the improvement in inventory management, the security and sharing of data which allows multiple researchers to work simultaneously on the same project, to share their knowledge, making the entire com-

pany more effective and competitive.

How does LabWare support companies in developing and implementing sustainable technologies?

LabWare Analytics offers advanced Data Analysis and Visualization capabilities, leveraging Machine Learning (ML) and Artificial Intelligence (AI) technologies to transform complex laboratory data into actionable insights.

LabWare Analytics offers predictive analytics, helping organisations identify trends, optimise workflows, and predict potential problems in laboratory operations through the tools and products developed in the LIMS ecosystem.

Overall, LabWare LIMS and ELN provide an integrated and efficient approach to managing laboratory data, ensuring compliance, optimising workflows, and promoting collaboration, all critical for companies seeking to develop and implement sustainable technologies.

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New shuttle functions for product transport system from B&R New additions to the company's ACOPOStrak, SuperTrak and ACOPOS 6D portfolio, creates possibilities in new areas of application, opening new market opportunities for machine builders and manufacturers

B

&R presents new components for its mechatronic product transport systems. New additions to the company's ACOPOStrak, SuperTrak and ACOPOS 6D portfolio, that creates possibilities in new areas of application, opening new market opportunities for machine builders and manufacturers.

ACOPOStrak – Production technology for cleanrooms: An IP69K-rated variant of the intelligent track system is now available. With this washdown version, the track can be cleaned with high pressure and temperatures up to 80°C and is also completely dust protected.

In this way, B&R is addressing the requirements of industries such as food and beverages or pharma, where the highest standards of hygiene are required. The new shuttles are optimised for smooth and thus low-wear operation and can be operated together with existing transport units. They also offer greater accuracy, opening new applications in areas such as the assembly of electric vehicle batteries and medical devices.

The increased precision offers key advantages when working with lightweight components such as catheters and insulin pumps.

SuperTrak – The right angle makes the difference: With a new 90° curved segment, SuperTrak has more layout options with a smaller footprint.

Compared to conventional conveyor systems, this adds even more freedom in track design.

The new curved element gives machine builders the ability to fit more processing stations inside the track, rather than around the outside.

ACOPOS 6D – Aseptic/Hygienic shuttles: The new generation of aseptic and hygienic shuttles for ACOPOS 6D allows small batches to be produced economically in a wide range of industries. In addition to float-

ing silently over the surface with high precision, these magnetically levitating ACOPOS 6D shuttles now also meet the highest hygiene requirements and are easier to clean. Customers

who require a germ-free environment can opt for this aseptic and hygienic variant. From food and beverages to cosmetics and pharma, strict hygiene regulations make every square

meter of production space valuable.

Contact B&R Industrial Automation (A member of the ABB Group) |

Pune Email: marketing.in@ br-automation.com | Tel: 020 41478999 Website: www.brautomation.com

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Körber – AnewAI enabled Inspection machine Increase quality and cut costs with AI-powered pharma inspection

T

he pharma industry faces unique challenges in manufacturing and production processes– especially in times of rapid digital technology transfer. One critical process in parenteral pharma manufacturing is the visual inspection of primary packagessuch as syringes, vials, or ampoules. In this process, potential product defects, impurities, or contaminants must be detected in each individual product, hence the term: 100 per cent inspection.

The automatic visual inspection (AVI) is a common practice in the industry.This inspection method however brings along false reject rates (FRR), which can lead to costly re-inspections.

Ensuring reliable detection results with traditional vision tools requires at least 5 to 15 product samples per defect and configuring up to 18 cameras per machine. This process is expensive, time-consuming and error-prone, costing the pharma industry up to $740 million per year (source for data) due to false reject rates that can range from 1 to 45 per cent, depending on product complexity. In addition to the costs associated with re-inspections, false reject rates can lead to delayed product releases and missed market opportunities.

Getting started with AI-supported inspection To counteract this, significantly reduce costs and achieve improved quality in the long term, AI-supported inspection processes are future-proof and should be part of companies' data and AI strategy. Instead of measuring physical values, AI models scan for good and defect patterns in the product, which significantly increases the detection rate (DR) while minimising the false rejection rate. This approach enables a more accurate and efficient inspection process by detecting even the smallest deviations or defects from the norm that may not be

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AI-supported inspection processes are futureproof and should be part of companies' data and AI strategy. Instead of measuring physical values,AI models scan for good and defect patterns in the product, which significantly increases the detection rate (DR) while minimising the false rejection rate visible through traditional, physical measurements.

For this purpose, AI models are trained with large data sets, whereby the quality and relevance of the data are crucial for the accuracy and effectiveness of the resulting models. To ensure the highest quality of training data, experts with in-depth knowledge of pharma products and manufacturing processes are involved in the creation.

They identify the relevant defects and impurities that need to be detected and develop the criteria for labeling the data – always with the individual production line in mind.

AI models are trained with advanced algorithms that enable them to recognise patterns

and make accurate predictions, based on the input data. The trained models then areintegrated into automated visual inspection (AVI) systems to detect defects and contaminants even better than with the conventional approach, by keeping up the same inspection speed.

Faster time to market and cost reduction through increased efficiency The result of implementing AIpowered inspection solutions within a company's own production operations are remarkable.

The deployment can reduce the false rejectrate (FRR) by up to 90 percent, while increasing the detection rate by up to 40 per cent. This not only results in

more good products within a batch, but also in improved inspection efficiency and a less time-consuming workflow.

And faster time to market is not the only benefit. Using AI in visual inspection can also lead to significant cost savings. For example, pharma companies save up to $750,000 per year by avoiding a false reject rate of just five per cent (based on an annual production volume of 10,000,000 containers and a production cost of $1.50 per container). In addition, companies can save up to $940,000 by eliminating the need for semi-automatic inspection machines for post inspection, assuming two inspection machines were previously used. With these cost

savings, the return on investment (ROI) for AI-powered inspection solutions can be achieved in as little as one year.

Why choose Körber as a strategic partner for implementing AI in the pharma industry?

Körber understands the critical importance of visual inspection and the unique needs and constraints of the pharma industry. With many years of experience, Körber offers a modular and scalable approach that allows our AI solutions to be fully integrated into existing vision systems without having to adapt the machine floor plan regardless of the manufacturer of your inspection line. Körber’s AI models and solutions stand for reliable, trustworthy, and compliant project execution and assure you of the highest data security in compliance with GxP regulations.

Don't let false rejection rates cost your business millions annually. Choose AI-powered solutions for accurate and efficient visualinspection.

CTA: Get in touch for your path to digital production

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