Express Pharma (Vol. 19, No. 2) January 2024

VOL. 19 NO. 2 PAGES 68

www.expresspharma.in

EVENTS

PPL 2024: Championing innovation, powering progress

MARKET

Biotech and biopharma industry trends: What to watch for in 2024

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CONTENTS

Chairman of the Board Viveck Goenka

Sanjay Sharma Zydus Lifesciences

Dr Shrenik Shah Montage Laboratories

Dr Viranchi Shah Saga Lifesciences

Appasaheb Kabadagi Alembic Pharmaceuticals

Sr. Vice President-BPD Neil Viegas Vice President-BPD Harit Mohanty

Dr Pavan Bhat Natco Pharma

Tushar Maradwar Dr Reddy's Laboratories

Dr Prakash Shetiya Hetero Labs

Tanmay Behera Hetero Labs

DATA AND ANALYTICS

Viveka Roychowdhury*

Driving value in pharma manufacturing

Editorial Team

Experts shed light on the power and potential of data and analytics to enable manufacturing excellence, navigate complexities and understand regulatory nuances in a digital future

Mahesh Nerkar BDR Pharma

Harpal Vala Kepler Healthcare

Parimal Brahmbhatt Unison Pharmaceuticals

Naresh Gaur Amneal Pharma

Editor

Lakshmipriya Nair Kalyani Sharma

Badarinarayan Herur Dishman Carbogen Amcis

Tanveer Shah Eris Life Sciences

Kajal Patel Hester Pharmaceuticals

Suresh Pathi Granules India

Krishna Reddy Zenara Pharma

Venkatanarayan V Dr Reddy's Laboratories

Ajay Tomar SAS India

Dr. Damodharan Muniyandi Sai Lifesciences

By Viveka Roychowdhury

DESIGN Art Director Pravin Temble Senior Designer Rekha Bisht

EVENTS

Senior Artist Rakesh Sharma

14

PPL 2024: CHAMPIONING INNOVATION, POWERING PROGRESS

16

INFORMA MARKETS ORGANISES CPHI & PMEC INDIA 2023 SUCCESSFULLY AT INDIA EXPO CENTRE

Marketing Team Rajesh Bhatkal Ashish Rampure Debnarayan Dutta Production Co-ordinator Dhananjay Nidre Scheduling & Coordination Pushkar Waralikar CIRCULATION Mohan Varadkar

MARKET

Sathyanarayana (Sathyam) Ponnam Aurobindo Pharma

Bujji Reddy Kanchi Aragen Life Sciences

Dipen Shah Nupeak IT Solutions

STRATEGY

POLICY

P26: INTERVIEW

29

DR JITENDRA KUMAR MANAGING DIRECTOR, BIOTECHNOLOGY INDUSTRY RESEARCH ASSISTANCE COUNCIL

Dr Vellaian Karuppiah Gland Pharma

A NEW YEAR CALL FOR ACTION: ANALYSING 2023 FDA FORM 483 OBSERVATIONS FOR INDIAN STERILE MANUFACTURING FACILITIES

PACKAGING

24

BIOTECH AND BIOPHARMA INDUSTRY TRENDS: WHAT TO WATCH FOR IN 2024

31

PHARMA PACKAGING AND LABELLING TRENDS: WHAT'S HOT AND WHAT'S NOT

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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January 2024

EDITOR’S NOTE

Will 2024 be a year of regulatory renaissance?

O

n December 6, India's Central Drugs Standard Control Organisation (CDSCO) issued a letter asking state and union territory regulators to defer the proposed risk based inspections of manufacturing units and private testing labs scheduled between December 11-22, to focus on verifying the supply chain and quality of propylene glycol (PG), a key ingredient in cough syrups.

The letter has detailed instructions on verification at the cough syrup manufacturing plant, tracking back to the source (manufacturer or importer) of PG. The letter hopes that this exercise will ‘rule out possible quality issues related to DEG/EG and diversion of industrial grade PG in the pharma industry.’

The timing is crucial, as consumption of cough syrups spikes during the winter months. In fact, the December 6 letter on PG comes after the CDSCO chief urged pharma manufacturers to pay special attention to the quality of not just the APIs but also various excipients that are added to their products.

The CDSCO’s risk based inspection drive over the past year was spurred by global censure over the deaths of children in Gambia and other nations, allegedly after consuming coughs syrups imported from India. While WHO’s tests showed up higher than acceptable levels of DEG/EG, tests done by India’s regulators gave a clean chit to the manufacturer. The most recent twist in the tale is that a state regulator was allegedly bribed by the manufacturer Maiden Pharma to switch the samples. As expected, Maiden Pharma’s promoter refutes the charge but it is more important to unveil the ‘knaves among the knights’ to start changing public perception.

After a period of denial, the CDSCO started cracking down in December 2022, with a series of risk based inspections. There were training sessions for its regulators to ensure better coordination between central and state inspection officials.

A year later, after four phases of risk based inspections, covering over 300 inspections, it’s clear that these actions were designed not just to pull up pharma companies, but to shake up the regulators themselves.

30 per cent of the plants inspected received closure notices; while other companies had their licenses revoked or received warning letters.

Speaking recently at the 4th US Pharmacopeia South Asia Regional Chapter meeting, Dr Rajeev Raghuvanshi, Drug Controller General of India

10 EXPRESS PHARMA January 2024

2024 will be a year to rebuild trust in the CDSCO, with more stringent regulations, coupled with stricter implementation of these regulations.

However, the trickier part is weeding out the corrupt from its ranks, even while it aims to do the same with pharma companies

commented that the real value of the risk based inspections were not the closures of erring manufacturing plants. He stressed that post the risk based inspections, “the whole ecosystem of pharma manufacturing here is now sensitised towards the quality issues. And that is actually giving lots of advantages to us now as a regulator that things are getting aligned."

He was also frank enough to share the responsibility for the “aberrations” which came to light during the RBIs because “it’s not only the manufacturers but for me, the regulator is also responsible … because we let that happen and that is why that happened.” He went on to add that after all the sensitisation, “it’s time for fixing accountability also at the regulators.”

Going by these comments, it's clear that global and now domestic scrutiny on quality concerns might just turn out to be a blessing in disguise. Regulators now seem more amenable to introducing additional quality checks.

For instance, on December 21, the drugs controller of the state of Uttarakhand issued a ban on cough syrup manufacturers who do not have gas chromatography (GCs) systems in their quality control labs for testing of EG/DEG in propylene glycol used in cough syrups. Manufacturers who procure GCs must provide proof of such purchase and their manufacturing licence will be renewed only after a physical verification of such systems.

However, will the presence of GCs guarantee the required amount of testing? Will CDSCO prescribe standards which can be enforced, not just for EG/DEG levels but also for a host of other undesirable contaminants like residual solvents etc? And what will it take to break the nexus between corrupt officials and unethical manufacturers? Can it be expected to do a credible clean up outside, without first cleaning up its own backyard?

2024 will thus be a year to rebuild trust in the CDSCO, with more stringent regulations, coupled with stricter implementation of these regulations.

However the trickier part is weeding out the corrupt from its ranks, even while it aims to do the same with pharma companies

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

Q A

EVENTS

&

WITH SCHOTT GLASS INDIA

PRE EVENT

PPL2024: Championing innovation,powering progress

Q

A

PPL Conclave 2024 will be held on February 16-17, 2024 at Le Meridien, Hyderabad

P

ackaging and labellling in pharma has witnessed significant developments in response to evolving needs of the industry with an emphasis on safety, quality, sustainability and technological innovation.

Be it temperature-controlled packaging solutions to meet the exacting standards for biologics and vaccines, integration of drug delivery systems into packaging for better patient outcomes, enhanced patient engagement through interactive packaging, adoption of biodegradable options to minimise environmental impact, use of anti-counterfeiting technologies or colour-shifting inks, packaging and labelling done right are adding significant value to this industry.

As these trends continue to evolve, the future of pharma packaging and labelling holds exciting possibilities.

So, Pharma Packaging and Labelling (PPL) Conclave 2024 aims to identify and harness pivotal trends in the dynamic landscape of pharma packaging.

The conference will bring together industry experts to discuss strategies to achieve a balance between innovation and cost, functionality and aesthetics, as well as utility and sustainability. It will provide a platform for leaders and veterans in the pharma packaging and labelling industry to collaboratively address new challenges and surpass the mounting expectations within the pharma sector.

Some topics to be covered ◆ Packaging design: Optimising user experience for patient safety ◆ Packaging for high-value biopharmaceuticals and vaccines ◆ Supply chain resilience through intelligent packaging ◆ AI and automation: Revolutionising pharma packaging and labelling ◆ Enhancing track and trace capabilities in pharma packaging ◆ Pharma packaging regulations: Navi-

14 EXPRESS PHARMA January 2024

gating compliance in a global landscape ◆ Smart labelling technologies in pharma packaging: Barcodes, RFID, colourchanging inks and more ◆ Circular economy in pharma packaging and labelling: A moral and business imperative ◆ Branding and market differentiation with packaging and labelling

Why do biotech drugs pose higher requirements to the packaging material?

Schott Glass India: Many of the new developed drugs are biotechnologically produced drugs that resemble biological molecules.

These can be vaccines, monoclonal antibodies, special antibiotics, hormones, enzymes, DNA-recombinant molecules etc. Biological molecules are often quite sensitive to oxygen, water vapor and / or pH shifts in solution which is why a strong interaction with the glass packaging material should be avoided.

In worst case these interactions might lead to a degradation or malfunction of the drugs which is not acceptable. Type I glasses have the highest quality not only in terms of chemical stability but also in terms of temperature stability. This is what makes Type I glasses the best choice for parenteral packaging in general and specifically also for biotech drugs.

Pharma Packaging and Labelling (PPL) Conclave 2024 Organised by Express Pharma, PPL Conclave 2024 will be held on February 16-17, 2024 at Le Meridien, Hyderabad.

With opportunities galore for exchange of knowledge and networking of ideas, PPL Conclave 2024 is 'the' platform for packaging leaders, experts and veterans to come together confer, converse, on the current and future trends in the industry, their growth drivers and the challenges to tackle them as well as form meaningful alliances to fast-track progress in the pharma packaging industry.

For the 100+ leading pharma packaging professionals attending the event, the two-day event will give an opportunity to: ◆ Get updated on the advancements in India’s pharma packaging sector ◆ Demonstrate your pharma packaging capabilities ◆ Showcase your innovative packaging solutions ◆ Gain insights from thought leaders of the pharma, biotech and packaging industries ◆ Acquire access to solution providers with cutting-edge packaging technologies ◆ Discuss on the role of packaging in gaining a competitive edge ◆ Network with the who's who of the pharma packaging industry Pharma Packaging and Labelling (PPL) Conclave 2024 is committed to staying ahead of the curve and future-proofing progress.

To know more and register, check out: https://ppl.expresspharma.in

Q A

How can I protect my drug against light?

Schott Glass India : Certain drugs are sensitive to light, especially the light in the ultraviolet wavelength area of 200 - 400 nm. This is e.g. true for the vitamins A, B, D, E, K and C. These drugs have to be packed in a special packaging that blocks the light from getting through. For glass packaging this is done by adding either Iron (Fe) and Titanium (Ti) to the composition or Iron and Manganese (Mn).

Such glasses now bear a brownish (Fe, Ti) or greenish (Fe, Mn) color and absorb the uv light ensuring the protection. Additionally the light transmittance can also be controlled by the wall thickness of the glass container. The thicker the wall is the less light goes through it. And another factor is the annealing oven.

Here the temperature plays an important role. The higher the temperature is in the oven the darker the glass gets and the less light is going through.

For more information contact: santosh.jadhav@schott.com

EVENTS POST EVENT

Informa Markets organises CPHI & PMEC India 2023 successfullyat India Expo Centre CPHI and PMEC India expo attracted over 48,000 attendees from 120+ countries and over 1,500 exhibitors

Inauguration of CPHI & PMEC India 2023

I

nforma Markets in India recently organised the CPHI & PMEC India 2023 at the India Expo Centre in Greater Noida, Delhi-NCR. A statement from Informa markets informed, “As the largest and most exhaustive pharma industry gathering in South Asia, CPHI and PMEC India expo, drew an overwhelming positive response, attracting over 48,000 attendees from 120+ countries in a vast 100,000 sq m exhibition space.

This year's turnout exceeded previous editions, with over 1,500 exhibitors – a notable increase from last year. As the central hub of the pharma industry, the CPHI and PMEC India expo continues to grow in influence and scale. Across three dynamic days, the event served as a crucible for industry collaboration, hosting over 25,000 impactful buyer-seller meetings, fostering partnerships, and amplifying industry advocacy.”

It added, “From domestic powerhouses like Dr Reddy's

16 EXPRESS PHARMA January 2024

and Biocon to global leaders like IMA and Fette, alongside rising stars like Piramal Pharma and Hetero Labs, CPHI & PMEC India Expo brought together a diverse range of notable exhibitors.

Some of them such as Korber Pharma GmbH, Uhlmann India, Glenmark Lifesciences, Petals Engineers, Solara Active Pharma Science, Merck Life Science, Gufic Biosciences, Jubilant Pharmova etc joined for the first time to showcase cutting-edge products from AI-enhanced quality control to pioneering drug delivery systems and sustainable initiatives. “ The 16th edition of the event was supported by key industry associations, including Bulk Drug Manufacturing Association (BDMA), Federation of Pharma Entrepreneurs (FOPE); Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA), Organisation of Pharmaceutical Producers of India (OPPI), and PharmExcil, highlighting the

collaborative spirit driving India's pharma growth.

The event kicked off with an opening attended by industry leaders, including Dr Veeramani SV, Vice-Chairman, PHARMEXCIL; Harish Jain, President, FOPE; Raja Bhanu, Executive Director, PHARMEXCIL; Margaret Ma, President & CEO - Informa Markets Asia; Chris Eve, Executive Vice President - Informa Markets Asia; Adam Anderson, Executive Vice President - Pharma, Informa Markets; Yogesh Mudras, Managing Director, Informa Markets in India; Rahul Deshpande, Senior Group Director, Informa Markets in India; and Ranjith Paul, Group Director, Informa Markets in India.

The 'India Pharma Week’, held alongside the CPHI & PMEC India Expo, comprised a series of events including the Pharma Leaders Golf; PreConnect Congress; Pharma Leaders Roundtable; Women in Pharma; Pharma Talks; and India Pharma Awards. The

closed-door Pharma Leaders’ Roundtable underscored the importance of directing attention toward both incremental and revolutionary innovation.

The discussions also addressed the significance of cost efficiency and digital transformation to optimise operations and curtail expenses.

Other pivotal issues such as the innovation funding gap, need for strategic alliances with academia, biotech entities, and venture capital firms, establishment of innovation clusters to nurture collaboration and facilitate the exchange of knowledge were also discussed. Informa Markets informed that a white paper report on the key takeaways is being prepared.

Highlighting India’s promising position within the global market, Yogesh Mudras, Managing Director, Informa Markets in India said, “India has earned its way to becoming a pharma super power with over 200+ countries served by Indian pharma exports. And yet,

obstacles remain with nearly 30% of Indians lacking access to medicines. We are truly at an inflection point where we are finding innovative ways for seamless Geographical distribution of pharmaceutical access of quality supply.”

“For 16 years, CPHI & PMEC India has been at the pulse of the pharma industry's meteoric rise, evolving from a trade show to a global hub for innovation and collaboration.

We proudly represent the world's largest pharma community, fueling India's domestic muscle, surging R&D, and government support. This remarkable growth is driven by cutting-edge technology, breakthrough drugs, and a patient-centric focus, positioning India as a major player in the global pharma landscape.

CPHI & PMEC India remains dedicated to playing a vital role in India’s journey towards pharma excellence through its platforms enabling collaboration, knowledge sharing, and innovation,” he added.

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cover )

Sanjay Sharma Zydus Lifesciences

Dr Shrenik Shah Montage Laboratories

Dr Viranchi Shah Saga Lifesciences

Appasaheb Kabadagi Alembic Pharmaceuticals

Mahesh Nerkar BDR Pharma

Harpal Vala Kepler Healthcare

Parimal Brahmbhatt Unison Pharmaceuticals

Naresh Gaur Amneal Pharma

Badarinarayan Herur Dishman Carbogen Amcis

Tanveer Shah Eris Life Sciences

Kajal Patel Hester Pharmaceuticals

Suresh Pathi Granules India

Krishna Reddy Zenara Pharma

Venkatanarayan V Dr Reddy's Laboratories

Ajay Tomar SAS India

Dr. Damodharan Muniyandi Sai Lifesciences

18 EXPRESS PHARMA January 2024

Dr Pavan Bhat Natco Pharma

Tushar Maradwar Dr Reddy's Laboratories

Dr Prakash Shetiya Hetero Labs

Tanmay Behera Hetero Labs

DATA AND ANALYTICS

Driving value in pharma manufacturing Experts shed light on the power and potential of data and analytics to enable manufacturing excellence, navigate complexities and understand regulatory nuances in a digital future

By Viveka Roychowdhury

Sathyanarayana (Sathyam) Ponnam Aurobindo Pharma

Bujji Reddy Kanchi Aragen Life Sciences

Dipen Shah Nupeak IT Solutions

Dr Vellaian Karuppiah Gland Pharma

EXPRESS PHARMA

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January 2024

cover ) I

ndia’s pharmaceutical sector is slowly but surely reaping the benefits of digital transformation initiatives.

Early adopters like Cipla and Dr Reddy’s Laboratories, both part of the World Economic Forum's Global Lighthouse Network since October 2022, have shown how investments in digital technologies, result in rich data-driven insights, better quality metrics and added value in pharma manufacturing. Taking heart from such success stories, more companies are investing in digital infrastructure.

Leveraging data and analytics had addressed many pain points and delivered tremendous ROI, in terms of better product quality, improving manufacturing efficiencies, optimising product yields, reducing wastes, meeting ESG targets, improving profitability/profit margins, lowering overhead costs, predictive maintenance, etc.

Though the learning curve from data to discovery to deployment is steep, digital transformation is now even more of a business imperative, given the increasing competition, the race to make supply chains more resilient, and the complexity of compliance to evolving global quality norms.

To further explore the role of data and analytics in driving value in pharma manufacturing, Express Pharma, in collaboration with SAS, held two closed door roundtables with thought leaders and stakeholders across functional areas, spanning QA/QC, operations, manufacturing, formulation R&D. Agreeing that there is no choice but to go digital, the experts narrated their experiences with digital transformation initiatives within their organisations.

Moving from the initial implementation challenges to harnessing systems to collect, collate and analyse data in pharma manufacturing, the leaders also examined the role of historical and real-time data analysis for quality

20 EXPRESS PHARMA January 2024

control, operational efficiency, reduced production errors, and overall cost saving.

While discussing the role of data and analytics to monitor pharma production processes, the leaders acknowledged the value add of digital tools that could help identify and address quality problems early on to ensure compliance with regulatory requirements.

Participants highlighted some of the challenges in managing variability in manufacturing operations and quality, like putting in place the right data collection and collation systems, without which analysis becomes a major pain point. They also dis-

Digital is the way forward ...

In a continous pursuit for growth and excellence, the pharma sector is gradually adopting strategic approaches to move towards a new era of digital maturity. And, companies such as Dr Reddy's Laboratories and Cipla are steering this journey. The urgency and significance of embracing digitalisation has become evident in the dynamic pharma landscape, setting the stage for a paradigm shift in pharma operations.

As the Chinese philosopher Lao Tzu said, “The journey of a thousand miles begins with one step”. For Dr Reddy's Laboratories, the seeds for the digital-

transparency and reliability. He stressed that "getting a hang of “the unknown unknowns” is possible only by use of advanced analytics.

Adding the operational perspective, Tushar Maradwar, Head Operational Excellence, Dr Reddy's Laboratories underlined that management needs to be clear on the benefits (of digital initiatives) over the next six months. He emphasised that companies should not opt for a LIMS just because larger companies are using it.

Most larger companies, especially pharma MNCs, are today exemplars of digital maturity. As Naresh Gaur, Sr VP Manufacturing Operations, Amneal Pharma put it, "We

Pharma agreed that, "Going forward, there is no choice but to digitise. Not digitising is hiding from reality. For how long can you shy away from reality?

Technology is changing much faster than before. Revisions are happening in less than six months due to improvements."

have no choice but to digitise.

Digital data gives regulators confidence that companies are being transparent and are compliant."He narrated how Amneal has had 90+ inspections so far, with no adverse observations, as "our systems are rock solid."

Appasaheb Kabadagi, Head Site Operations, Alembic

tives hinge on the tangible advantages for business.

For instance, India's pharma sector is predominantly promoter-driven and this can work both ways. As Dr Pavan Bhat, Executive VP Technical Operations, Natco Pharma reasoned, "Digital transformation is low on the totem pole for pharma promot-

The people factor Leaders' mindset is the linchpin for a successful tech transformation. Leaders serve as influencers in shaping the organisational approach and adoption of digital initiatives.

Therefore, aligning leadership vision with the digital agenda and garnering support from all stakeholders is vital. And, their receptiveness to digital initia-

Experts at the roundtable discussion held in Ahmedabad

cussed how they are generating insights from production operations/quality data.

Experts from SAS and Nupeak gave case studies showing how pharma companies can further leverage analytics and AI in manufacturing operations, while anticipating future requirements.

isation programme which eventually led to Global Lighthouse certification were sowed in 2015. Narrating the journey, Venkatanarayan V, VP & Digital Transformation Leader, GMO, Dr Reddy's Laboratories highlighted how the company moved to the concept of digital data systems being the "single source of truth," leading to

Experts at the roundtable discussion held in Hyderabad

ers. But promoters will not shy away from investments if they see the benefits to the business, or if not investing harms the business." Thus the onus is on digital evangelists to first convince promoters and the top management of the business case for digital initiatives.

Throwing more insights on the pharma promoter mindset, Dr Prakash Shetiya, Formulation Head, Hetero Labs believed that, "Every promoter wants the best product for the patient."

Besides gaining promoter interest, Tanmay Behera Head - Development Quality Assurance Hetero Labs said it is equally important to convince the rest of the personnel in the organisation.

Sathyanarayana (Sathyam) Ponnam, VP-IPDO, Aurobindo Pharma pointed out that "going digital also serves the purpose of passing on knowledge to the next generation."

On a learning curve Despite obvious and siginficant benefits, the pharma sector continues to face formidable barriers in its journey toward digitalisation, rooted in the industry's legacy systems and practices, a fear of data, and regulatory challenges.

Referring to the pharma sector's traditional resistance to digital initiatives, Kabadagi pointed out, "While many sectors in India are leaders in digitisation, automation, Industry 4.0, etc, the pharma sector is

not as we fear data. We do not have quantitative data to substantiate our work and that is the reason we are hearing of 483s, import alerts etc. That is an opportunity for solution providers to offer solutions for pharma manufacturing."

He also pointed out that variability of data also arises as "pharma equipment makers in India are not mature enough, and pharma companies buy equipment based on low cost.

The low cost comes with its quality deficiencies. There are huge variabilities between data generated by equipment from different manufacturers, be they European, US or Indian.

We are faced with inconsistencies in basic requirements like batch reports, audit trails and

alarm reports. So while the products are robust and consistent across multiple batches, the digital data presented by the equipment are inconsistent. This variability kills productivity, as the management has to invest time in quality risk assessments and quality management systems."

However there are signs that companies are taking steps to counter such setbacks as Kabadagi revealed that pharma companies in India are now slowly making good investments in data centres, IT networks, etc.

Thus, a transformative shift towards standardised digital infrastructure is gradually gaining traction as some Indian pharma companies invest

strategically in data centers and IT networks to embrace and optimise the myriad benefits offered by digitalisation.

Nevertheless, size and scale do play a huge role in a company's digital journey. There are many companies that are already reaping the benefits while others are at the beginning of their journey.

Granules India is at the start of its digitisation journey, according to Suresh Pathi, Head Operational ExcellenceFormulation Cluster, Granules India. Reasoning that "poor data results in analysis, leading to paralysis, he said, "The company is exploring eBMRs, modules for AR/VR as well as continuous granulation."

In a similar manner,

EXPRESS PHARMA

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January 2024

cover ) Dr Vellaian Karuppiah, VP Operations, Gland Pharma explained how the company is using data analytics in the ESG function, as well as has a pilot model to analyse sudden quality management system (QMS) cues. And bringing up yet another use case, Bujji Reddy Kanchi, GM-QC, Aragen Life Sciences recounted how his organisation was exploring digital warehouse management systems.

Even though these companies are at the start of their digital journey, most seem to have learnt that patience pays. Describing his organisation's "baby steps", Krishna Reddy, Sr VPOperations, Zenara Pharma said, "If you have the right data and analytics tool, the insights can be very rich."

Some companies have managed to digitise faster than their peers. For instance, Eris Life Sciences seems to have had a smoother digital journey. Sharing his experience of going from zero to 90 per cent digital, Tanveer Shah, Head-Quality, Eris Life Sciences said, "When you digitise, it's the truth. Saving the data should be seen as an investment and employees should not worry about when the data will be used. The lack of data leads to variability, inconsistencies.

Therefore management should consider digitisation as an investment, there will be a payback."

Dr Damodharan Muniyandi, Chief Quality Officer - Global Quality & Regulatory Affairs, Sai Lifesciences recounted how his company has seen how data integrity has resulted in operational excellence, and his company's evolution from digitisation, digitalisation to digital transformation.

While core functions like manufacturing might be laggards in going digital, Harpal Vala, Founder Director, Kepler Healthcare pointed out that data analytics has already added immense value in the sales and marketing domain, allowing managements to track sales, derive real time insights on performance of both products as well we people and tweak strategies on the go.

22 EXPRESS PHARMA January 2024

Regulatory push for digital transformation Perhaps the most urgent push for digital transformation is driven by regulatory compliance. After the lull during the pandemic due to travel constraints, global regulators are doubling down on pharma manufacturing site audits. The past year (2023) has seen an uptick in risk-based regulatory audits.

For instance, the US FDA conducted simultaneous audits in four pharma companies across India in early December. An increase in site audits has naturally led to a corresponding increase in quality incidents, many of them linked to data integrity, human error and variability of manufacturing data.

Digitalisation is being touted as a must-have solution for improved quality systems and therefore better regulatory compliance.

As Parimal Brahmbhatt, Sr GM – QA, Unison Pharmaceuticals pointed out, "When your data is digital, it gives you the confidence to face audits without fear. Auditors too trust digital data." Hetero Labs' Shetiya too averred that digital data gives companies the confidence to face even seemingly irrelevant queries from auditors.

Highlighting a key concern, Mahesh Nerkar, VP-Site Head, BDR Pharma pointed out, "Human error is a huge concern and digitisation is the only solution.

Which is why systems like electronic batch records (eBMR) give a lot of confidence."

The resistance to change, the generation gap, the lack of personnel who understand both IT and pharma and lastly, budget constraints are the four main reasons for the poor uptake of digital initiatives, according to Dr Shrenik Shah, Director, Montage Laboratories.

He pointed out that even regulators of much smaller African nations insist on five-day audits, therefore there is no choice but to go digital.

However, as Dr Viranchi Shah, National President, IDMA & Director, Saga Laboratories cautioned, "Quality systems should be put in place to

produce quality products, not just to comply with regulators.

So the question is how does digitalisation help quality? The pharma sector in India currently has a low level of digitalisation. If capturing the data and analysing it to find areas for improvement, saves money, time and results in better products, then digitalisation contributes to quality."

Mentioning that Cipla and Dr Reddy’s Laboratories, with two of their plants making the transition to globally certified Digital Lighthouses, are an aspirational goal for the rest of the sector, "not just for regulatory compliance but because it makes sense for our business model. Only then will companies invest in digitalisation."

Shah also cautioned that the sector is not focusing enough on the product development phase, identifying the right process parameters, quality attributes, making a golden batch, etc which results in a lack of data and comes back to haunt the company at the scale-up phase.

Underlining another mindset change required, Shah lamented, "We don't consider the intangible benefits (of quality), only the costs."

Narrating her experience, Kajal Patel, Sr VP - Plant Operations, Hester Biosciences too agreed that due to a lack of investments in variability studies at the new product development stage, companies may have a lot of data but if it is not saved systematically, they cannot gain too many insights. This leads to repetition of past studies, which is a loss of time, effort and resources."

From data to insights Digitalisation also underscores the evolving role of data in the pharma sector. Leveraging data effectively can unveil pathways towards informed decisionmaking, improved manufacturing processes, enhanced product quality and operational excellence in the pharma landscape.

But, capturing digital data is just the first step. Extracting insights from this data is the next

crucial step. The rule of thumb is that in any digitalisation initiative, 80 per cent of the time is spent on data collation and only 20 per cent on extracting actual insights. And many companies stumble at this stage for a variety of reasons.

Experts also cautioned that many companies have made the mistake of using different systems for different functions and end up with siloed data. Without an integrated digital framework, which allows the different parts to "talk" with other, deriving analysis and insights would be a cumbersome process.

As Sanjay Sharma, Sr VP & Head of MS&T, Zydus Lifesciences, pointed out, "Data is being collected, but collating it and getting insights is now the pain point." Sharma also cautioned that regulators and industry have different perspectives of digitalisation. For instance, in April 2022, the US FDA came up with the Quality Management Maturity (QMM) model, according to which they want the industry to self-regulate. He spoke of the need to make digital transformation initiatives commensurate with anticipated regulations/regulatory expectations. As he put it, "The real value of digital transformation initiatives would be to help companies prepare for anticipated regulations/regulatory expectations, by reducing batch failures, quality incidents etc."

Navigating the digital future IDMA's Shah summed up the dilemma facing the sector well when he said, "Everyone agrees that digitisation is the way forward; the question is how and when."

As Ajay Tomar, Practice Lead, Healthcare and Life Sciences, SAS India explained, “In the goal of producing safe, highquality, and cost-effective products in a more agile way, a key imperative that SAS analytics suite delivers is to generate insights from existing data and deploy them in the manufacturing of future products, thus making the process pre-

dictable.”

A good place to start, suggested Dipen Shah, Head Consulting, Nupeak IT Solutions LLP, is Golden Batch Analysis, which according to him, is the best industry acceptable approach which can add value to Drug Manufacturing process.

Explaining further, he said, “Golden Batch can help formalise an operational focus on continuous improvement as it lays the foundation for datadriven operating procedures.

While it is initially reactionary, using historical data to identify ideal manufacturing conditions, Golden Batch can start a company on a journey toward preventative analytics.”

While regulators are using IT tools and platforms curated by companies like SAS to identify the pharma manufacturing sites with the highest risk, how can pharma companies also harness the same tools to proactively prepare for audits?

Experts were frank in their assessment of the areas for improvement. Abhay Sinha, Head CQA, Otsuka Pharma reiterated an oft repeated message, "We need to change our mindset, encouraging a quality culture. We need to understand that quality is not just the job of the quality assurance team but of each employee. We need to think more long term. There is a big gap between what we write and what we do. We need to make the system simple, feasible and acceptable."

Brahmbhatt of Unison Pharmaceuticals hinted at the lack of qualified QA/QC personnel while many other experts underlined the need for reliable validated equipment.

Thus, the journey to a digitally empowered future in the pharma industry necessitates cultural shifts, strategic use of technology, and investments in human and technological capital. This, in turn, will facilitate a holistic and sustainable evolution towards operational excellence, quality assurance, and regulatory compliance. viveka.r@expressindia.com viveka.roy3@gmail.com

MARKET

Biotech and biopharma industry trends: What to watch for in 2024 Dr Senthil Sockalingam, Head, IQVIA Biotech in Japan-Asia Pacific; Chief Medical Officer, IQVIA Asia Pacific opines that 2024 promises to be a crucial year for EBPs and the wider pharma and healthcare industries. He also outlines a few key developments to look out for in this article

E

merging biotech and biopharma (EBP) companies continue to drive global medical innovation, with Asia Pacific playing a central role. Novel drug discovery processes, advances in preventative care and the leveraging of big data sets make this a truly exciting sector to study. Although it won’t be plain sailing, 2024 promises to be a crucial year for EBPs and the wider pharma and healthcare industries. Here are a few key developments to look out for:

local partners with strong market access and commercialisation capabilities will be crucial for successful launches.

India’s influence on the biopharma sector continues to grow

Funding for EBPs remains hard to come by Against the backdrop of a tough financing environment, elevated by rising interest rates, the biotech and biopharma sector remains highly competitive, with many new and existing players competing for a finite pool of funding. Many venture firms are now focused on helping their existing portfolio companies survive the squeeze, resulting in reduced novel investments. HSBC has noted early investment in biotech startups was on pace to fall by 40 per cent in 2023 compared to 20221, and this downward trend is expected to continue into the upcoming year. This challenging financing environment may force many EBPs to rethink their valuation expectations.

Aside from venture capital funding, larger pharma companies, which serve as a significant funding source for EBPs, are also likely to be less interested in deal-making.

Ongoing economic pressures may hinder them from investing in small biotech firms and instead focus their capital on their existing pipelines or specific platform-play invest-

24 EXPRESS PHARMA January 2024

ments, similar to the trends observed in 2023.

Drug pricing pressures create ripple effects Drug pricing is under increasing scrutiny across markets, including economic powerhouses such as China and the US. Recent policy enactments, for example, the US’s Inflation Reduction Act to help reduce out-of-pocket prescription costs for patients2, and price negotiation systems, such as China’s price control system are starting to bite into profit margins, particularly affecting rare disease drugs and precision oncology medicines3.

Depending on the breadth and effectiveness of these initiatives, multinational pharma players may lose their motiva-

tion to invest, which in turn can lead to an innovation slowdown.

As a result, we may see more pharma companies entering strategic partnerships to mitigate the challenges associated with R&D and commercialisation. In August 2023, Daiichi Sankyo announced a multi-year, multi-asset partnership with Merck to support the commercialisation of their highly anticipated antibodydrug conjugate (ADC) portfolio.

This collaboration supplements their existing partnership with AstraZeneca, and will focus on the launch of their first ADC, Enhertu, in diverse markets.

There may be a surge in such partnerships in the coming years, especially as the world shifts towards deglobalisation.

In this environment, the value of

The Indian pharma industry is primed for exponential growth, with industry experts predicting a $130 billion valuation by 2030. The current growth trajectory indicates that the industry will surpass its projected 2045 valuation of $450 billion4, and there has been a significant 298 per cent jump in pharma-related investment deals during the third quarter of 2023 compared to the previous year5.

While India is well-established as a global powerhouse for generic medicines, there has been a gradual shift in R&D activities to other strategic areas such as biosimilars, complex generics, and new chemical and biological entities. The maturation of India’s regulatory environment coupled with vast patient populations and lower research costs makes India an attractive proposition for clinical research. This not only enables broader access to novel therapeutic innovations for Indian patients but also creates increased commercialisation opportunities in what is now the world’s most populous nation.

Higher interest rates have resulted in increased operational costs for businesses worldwide. Pharma companies are looking towards shifting a portion of their business operations to emerging markets such as India to achieve greater cost efficiencies. Several leading pharma companies have established their presence locally across diverse business seg-

ments, including R&D and commercial operations. A notable example includes Novo Nordisk’s commitment to doubling its manufacturing capabilities in India by 20256. India’s political and economic ambitions are clear and so it is likely to remain a competitive place for pharma players to do business for many years to come.

Decentralised clinical trials, but heavy traffic is slowing down wider implementation 2023 saw a perhaps predictable slowdown in the adoption of decentralised clinical trials (DCTs) compared to the COVID-19 pandemic years as many countries returned to their pre-pandemic status quo. Without the strong incentive to perform remote patient monitoring, more traditional clinical trial models have been favored. That said, legislation in some countries has set the scene for more decentralised implementation of clinical trials in the future. China, for example, has recently issued (July 2023) new guidelines supporting the implementation of DCTs through the use of telemedicine7. Moreover, regions such as Beijing, have also been encouraging local pharma players to run DCT pilot projects8. This formal recognition of the value of DCTs in China, may well pave the way for broader interest in DCTs across APAC in 2024, especially in a cost-constrained environment.

Cell and gene therapies break into the mainstream We are seeing the expansion of chimeric antigen receptor (CAR) T-cell therapy beyond its initial application to treat hematological malignancies such as

myeloma, acute lymphoblastic leukemia and non-Hodgkin’s lymphoma9, and into orthopedics, organ transplantation, and neurology. The world’s first CRISPR gene-editing therapy was approved in November 2023 in the UK for sickle cell disease and transfusion-dependent â-thalassemia10. This approval is a significant landmark for the biotech industry, potentially setting the stage for a new generation of gene-editing therapies to be approved for conditions that were previously considered untreatable, as well as injecting a timely boost into the gene editing R&D universe. CRISPRbased therapies face similar challenges as CAR-T in terms of cost and the substantial healthcare infrastructure needed for treatment administration, and therefore, 2024 holds potential for innovation beyond the treatment itself.

References 1. BioPharma Dive (2023). Earlystage biotech funding on pace to drop 40% in 2023, HSBC report shows. Available from: https://www.biopharmadive.com /news/biotech-venture-capitalhsbc-report-norris/689313/. 28 Nov 2023.

2. Greenberg Traurig LLP (2022). China on the Move: Lesson from China’s National Negotiation of Drug Prices in 2022 | Insights | Available from: https://www.gtlaw.com/en/insights/2023/2/china-on-themove-lesson-from-chinas-national-negotiation-of-drug-prices -in-2022. 28 Nov 2023.

3. POLITICO (2023). Why Big Pharma might think twice about running away to America. Available from: https://www.politico.eu/article/e u-drug-price-regulations-bigpharma-think-twice-america/ 28 Nov 2023.

4. Organization of Pharmaceutical Producers of India. Reimagining pharma and healthcare for India @100. 2023.

5. The Pharma Letter (2023). India’s pharma and healthcare sectors maintain investment appeal despi. Available from: https://www.thepharmaletter.co m/article/india-s-pharma-andhealthcare-sectors-maintain-investment-appeal-despite-volume-decline. 28 Nov 2023.

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6. Business Standard (2023).

Novo Nordisk to double India manufacturing, bring new drugs by 2025. Available from: https://www.businessstandard.com/companies/news/i ndia-part-of-all-global-clinicaltrials-of-danish-drug-majornovo-nordisk123062000553_1.html. 28 Nov

2023.

7. Pacific Bridge Medical (2023).

China Embraces Decentralized Clinical Trials (DCT), Bethesda CHPBM 7315 WAS 400W, Japan, Singapore, Kong H, India affiliate partners in, Indonesia, et al. Available from: https://www.pacificbridgemedical.com/news-brief/china-em-

braces-decentralized-clinical-trials-dct/. 28 Nov 2023.

8. Han Kun Law Offices (2023).

China DCT Regulation and Implementation (2023). Available from: https://www.hankunlaw.com/en /portal/article/index/cid/8/id/13 488.html. 28 Nov 2023.

9. Centre for Clinical Haematol-

ogy (2023). CAR T-Cell Therapy.

Available from: https://cfch.com.sg/cellular-therapy/. 28 Nov 2023.

10. TIME (2023). The World’s First Approved CRISPR Treatment. Available from: https://time.com/6336222/crisprtherapy-gets-u-k-approval-thefirst-in-the-world/. 28 Nov 2023.

STRATEGY I N T E R V I E W

I envision India becoming a magnet for the global biotech manufacturing market In a freewheeling chat with Viveka Roychowdhury, Dr Jitendra Kumar, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) explains why he feels that the funding winter will slowly turn into springtime very soon for start up biotechs, how BIRAC can provide soft landing options for global start ups interested in the India market, the planned investments to convert bioincubation centers into bio-foundries and how BIRAC is positioned to play a role in safeguarding the interests of startups Everybody is talking about the funding winter for startups. Do biotech startups have to worry about a funding winter? If yes, how do they prepare for it? How do they survive it?

A funding winter for biotech startups is a concern. It has been there since the inception of biotech startups. However, there has been constant improvement in the funding scenario for these startups. Many of them are trying to connect with foreign venture capitalists and attract capital, which was not so frequent earlier. The reason was that they were not ready for it. BIRAC has made many of them venture ready by funding them through proof of concept, Biotechnology Ignition Grant Scheme (BIG), and other grants.

However, we don't want these companies to move to different countries, at least not at this stage. Venture funding from a foreign country may force them to set up in that country, which some startups might do to attract venture funding.

These actions are not healthy for theIndian ecosystem, but I believe that over time, market forces will take over, and the indigenous capital infusion in biotech will grow. There will be many venture capitalists funding these companies.

So, there is a temporary

26 EXPRESS PHARMA January 2024

setback, and with the maturity of biotech funding, the scenario will change. As far as the current biotech funding in India is concerned, aside from grants, BIRAC also has a venture capital arm, or what we call alternate investment funds - Biotechnology Innovation Fund - AcE (Accelerating Entrepreneurs), etc. Here, we don't directly invest but partner with alternate investment funds and other venture capitalists who invest in biotech. We indirectly fund these venture funding companies. I think as the ecosystem grows, more such funds will emerge, so that the winter, as you mentioned, will slowly turn into springtime very soon.

Dr Kumar, you have been a biotech researcher, scientific mentor, entrepreneur, and have been part of various incubation centers before joining BIRAC. What do you feel are the pain points for biotech entrepreneurs in India? As your term as head of BIRAC has just started, what is your vision to address these pain points?

The primary challenge for startups lies in the availability of facilities and resources for proof-ofconcept studies. With 75 bio incubation centers in place (across India), startups can secure infrastructure and

equipment for such studies.

However, a critical gap exists in access to pilot-scale or scale-up facilities. For instance, manufacturing clinically graded materials for trials might not be feasible in the current incubation center setup, as GMP facilities are often unavailable. This inability to scale up poses a significant pain point. Startups might initiate projects at a smaller scale but face challenges when attempting to scale up to 100 litres or 1000 litres for field-level studies or clinical trials. GMP and even non-GMP facilities are not easily accessible, adding to the hurdle.

Another major pain point is the substantial regulatory challenges. Startups may lack awareness of the existing regulatory frameworks, and the

dynamic nature of innovation requires constant updates to these regulatory frameworks.

BIRAC's First Hub programme aims to bridge this gap by providing training sessions and fostering awareness.

Additionally, creating an interface between regulatory bodies like CDSCO and startups is crucial to ensuring a fair chance and streamlined processes.

The third challenge revolves around early-stage venture funding. While seed funding is available, subsequent funding for clinical trials may be insufficient. Government bodies like BIRAC face limitations in catering to all funding requirements.

To address this, BIRAC is exploring equity

participation and considering the establishment of a platform for startups to interact with venture funding companies.

Encouraging interactions between startups and larger companies, including MNCs, can offer mentorship and potential opportunities for acquisitions and mergers.

Addressing these challenges requires a multifaceted approach, including enhancing access to scaleup facilities, keeping regulatory frameworks updated, exploring equitybased funding strategies, and fostering collaboration between startups and larger companies to facilitate acquisitions and mergers.

You said that you would like to keep startups from India within India and not move out because then the

nation can benefit from their entrepreneurship and innovation. BIRAC introduced five global startups to India during the recent Global BioIndia 2023. What is your rationale for bringing global startups to India?

If our startups aim to explore foreign markets and expand globally, it is perfectly acceptable. In fact, becoming a global player is encouraged.

My concern lies in the practice of "flipping," where startups from India are acquired by multinational companies or venture capital mechanisms, leading to a shift in offices to another country. This results in the loss of innovation for our country, and the products developed abroad may return to India at a higher cost with

different branding. As we are the largest consumer market globally, it's crucial to be cautious about our most prominent innovations being harvested, repackaged, and sold back to us at a premium.

While market forces will inevitably operate, and startups seek exits and funding, I believe that, over time, as India's economy grows and the ecosystem matures, indigenous venture capitalists will emerge. This emergence could slow down the trend of foreign venture capitalists infusing money into our startups and subsequently relocating them.

BIRAC can play a crucial role in this scenario by helping startups grow and scale through the creation of alternate investment funds and venture creation

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STRATEGY mechanisms.

Despite the current challenges, I foresee a bright future for the Indian biotech ecosystem, with numerous startups emerging and the potential for deep tech startups from public-funded research institutions.

To enhance innovation, I propose creating mechanisms for generating spin-offs from public-funded research institutions. While industries may not invest in deep science tech due to a focus on quick returns, the translation of discoveries into new products or technologies can be facilitated through mechanisms like those BIRAC is working on.

Looking globally, we should identify startups interested in expanding into India. While acquisitions may occur due to market forces, my primary intention in bringing five startups here is to encourage them to explore the Indian market.

BIRAC can provide soft landing options, helping them navigate the Indian market and eventually set up operations.

I envision India becoming a magnet for the global biotech manufacturing market. Despite the capital strength of countries like the US, the market is in India. By showcasing India's potential at events like Global Bio-India, we can attract companies to set up manufacturing bases here,

28 EXPRESS PHARMA January 2024

offering a vast market for their products. The key is to make companies aware of the opportunities in India.

The complex landscape, which may include issues like finding free land, pollution control board clearance, etc., should not deter companies from manufacturing in India. By creating awareness and facilitating soft landing options, we can attract more companies to India, fostering a mutually beneficial global market for biotech startups.

India's biotech industry clocked $92.3 billion in 2022, and the vision is to achieve the ambitious targets of $150 billion by 2025 and $300 billion by 2030. What is BIRAC doing to achieve these targets?

To achieve our outlined objectives, a pivotal strategy involves the establishment of bio-foundries and a robust biomanufacturing base. The government is poised to allocate funds for the creation of these biofoundries, representing an advanced evolution of bioincubation centers.

These bio-foundries are designed to cater not only to startups but also to larger companies. They offer both pilot-scale and full-scale manufacturing capabilities, complete with regulatory clearance, experts in regulation and intellectual property, as well as process

engineers. This collaborative ecosystem is supported by both government initiatives and co-investments from stakeholders.

Drawing inspiration from successful models like the Catapult in the UK, efforts are underway to promote a similar framework in India through government intervention. This model aims to attract foreign investments and companies to India, while also encouraging larger Indian companies to establish their manufacturing units within these bio-foundries.

The primary goal is not solely for established companies to manufacture, but also to facilitate the development of pilot-scale facilities for startups, addressing the scaling-up challenges discussed earlier.

By creating these biofoundries, startups gain access to pilot-scale facilities within an ecosystem that includes both larger companies and startups.

This integrated environment is anticipated to foster numerous mergers and acquisitions, contributing to industry growth. The government has demonstrated a strong commitment to establishing these bio-foundries.

Additionally, a second crucial strategy involves fortifying the AcE funding mechanism. AcE funding, including venture capital

funding from the BIRAC side, requires reinforcement, particularly in terms of equity funding.

Recognising that sustainability cannot rely solely on grants, the third aspect centers around creating a robust regulatory landscape. This involves enhancing awareness and framing regulatory structures that accommodate the needs of startups and emerging innovations.

The fourth point emphasises the importance of interconnecting the entire Indian biotech ecosystem.

Collaboration between larger companies and startups is key, mirroring successful practices observed abroad where multinational companies have established corporate venture funds.

Furthermore, the fifth strategy encourages bigger companies to actively collaborate and financially support startups. Corporate venture funding is highlighted as a potential avenue for fostering collaboration and knowledge exchange.

However, it's acknowledged that negotiations between startups and larger companies may be challenging, potentially leading to acquisitions at lower valuations. To address this, BIRAC is positioned to play a role in safeguarding

the interests of startups, particularly when equity is involved.

Its reassuring that you would like India to be the magnet for biomanufacturing. What would you say to naysayers who predict that India will miss the biotech bus?

I would like to emphasise that we have not missed the biotech bus, especially when we contribute 90 per cent of vaccines and pharmaceuticals to the world. We are the pharmacy of the world. Indeed, we won't miss the bus.

The only area where we might lag is in early-stage innovation, but the field is exponentially growing. We are at a nascent stage, but with exponential growth. To ensure we stay on top, we need to provide significant support and emphasis on newer technologies like artificial intelligence, CRISPR, CAR T-cell therapy, and others, from the government side. We are already making strides in this direction.

I express my sincere gratitude to Dr Jitendra Singh, Minister of State (Independent Charge, Ministry of Science and Technology and Rajesh S Gokhale, Secretary, DBT, Government of India for their constant support. viveka.r@expressindia.com viveka.roy3@gmail.com

POLICY

Anew year call for action: Analysing 2023 FDAForm 483 observations for Indian sterile manufacturing facilities Dr Ajay Babu Pazhayattil, Management Consultant, cGMP World, highlights that an examination of 2023 FDA Form 483 observations showcases the multifaceted challenges faced by sterile facilities in India. He states that the conclusions drawn should be useful for organisations to take the recommended immediate actionable measures, including investing in training and technology to continue successfully serving the regulated markets

I

n response to the escalating regulatory scrutiny surrounding sterile facilities in India, a comprehensive evaluation of Form 483 observations was undertaken. This initiative was prompted by a proactive anticipation of heightened regulatory risks for manufacturing sites in India after the pandemic1. The assessment focuses on US FDA audit observations and sheds light on the current landscape. It is a valuable resource for organisations aiming to implement prompt remedial actions as they approach the upcoming year, 2024 challenges.

The meticulous assessment documented all critical 2023 Form 483 observations linked to Indian sterile manufacturing sites only. In addition to cataloging these observations, the analysis discerned crucial insights and patterns, enabling the authors to propose optimal strategies for addressing and preventing potential regulatory challenges. By offering proactive measures, the authors aim to guide pharma organisations in maintaining a continuous and secure supply chain, ensuring resilience in the face of evolving regulatory landscapes. The FDA Form 483 is a document that lists observations made by the FDA representatives during the inspection of a facility, highlighting any potential regulatory violations. It is issued when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may violate guidelines2.

Most observations (30 per cent) were associated with 21 CFR 211 sections 113, 192, 22, and 160. The Code of Federal

unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed, is to be thoroughly reviewed and investigated.

Section 22 discusses the responsibilities of the quality control unit. The responsibilities should be in writing, and the quality control unit is responsible for approving and rejecting all procedures or specifications impacting the identity, strength, quality, and purity of drug products. Section 160 covers the need for scientifically sound laboratory controls. Laboratory controls include establishing scientifically sound and appropriate test procedures designed to ensure that components conform to appropriate standards. Ensuring compli-

directly impacted nine organisations and was accompanied by extensive commentary from the FDA inspector. The primary focus of concern was aseptic behavioural issues, encompassing practices to prevent microorganism contamination during manufacturing.

These include utilising sterile instruments, adhering to proper gowning practices, and minimising movements to safeguard the product's sterility.

The aseptic technique demands operators to follow specific behaviours in the cleanroom, such as deliberate and slow movements, keeping body parts clear of HEPA-filtered air paths, and avoiding activities that may compromise product sterility—skills that require thorough training. The importance of the first air principle,

Figure 1: 2023 FDA Form 483 Observations for Indian Sterile Manufacturing Facilities

Figure 2: Isolator Systems provides a Grade A environment without maintaining a Grade B background, ensuring operational ease

Regulations (CFR) Title 21, Part 211, contains the minimum current good manufacturing practice for the preparation of drug products. Section 113 of the CFR Title 21 discussed the procedures for sterile drug products, specifically those designed to prevent microbiologi-

ance with these sections is crucial for ensuring ongoing risk mitigation at Indian sterile manufacturing facilities.

An in-depth examination was conducted on the 21 CFR 211 section 113(b) observations, representing the most prevalent findings. The observation

cal contamination of drug products purporting to be sterile, including the need for adequate validation of the aseptic and sterilisation processes.

Section 192 of the CFR Title 21 pertains to production record review, investigations of discrepancies, and failures. Any

especially in Grade A enclosures during aseptic filling assessments, was underscored, highlighting the critical role of unidirectional airflow in contamination prevention. Observations also focused on visualising air movement and ensuring first air integrity dur-

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POLICY ing aseptic processing. Crucially, addressing interventions emerged as a pivotal factor in ensuring the adequacy of aseptic processing simulations where organisations fell short.

The regulatory focus on addressing challenges in aseptic behaviour highlights a clear drive for organisations to shift toward resilient isolator technology immediately without second thinking. This transition aims to reduce dependence on personnel behaviours and environmental controls when producing aseptic products, marking a departure from hanging on to traditional RABS systems. It is important to note that RABS is still a viable option for terminally sterilised products and should be limited to this category.

As well established3, isolator technology offers significant technical advantages for aseptic filling by establishing a physical barrier between the sterile processing area and operators. This reduction of human activity, a significant source of contamination, leads to a higher sterility assurance level (SAL). Additionally, isolator systems support efficient decontamination processes, such as vaporised hydrogen peroxide (VHP) sterilisation, contributing to microbial control within the isolator. The aseptic processing of sterile drugs and the manipulation of sterile starting materials and components should occur in a Grade A setting with a Grade B backdrop. While the interior of the isolator must comply with Grade A standards, there is no mandate for the isolator to be situated in a Grade B environment. With advanced monitoring and control systems, isolator technology allows real-time tracking of critical parameters, enabling prompt identification of deviations and ensuring reliable aseptic filling processes.

The regulator wants to minimise contamination risks as much as possible and ensure organisations adopt technologies that allow the regulator to gain confidence. Organisations persisting with RABS systems are anticipated to encounter ongoing challenges with respect to justifying their con-

30 EXPRESS PHARMA January 2024

Figure 3: 483 Observation Trend

tamination control strategy (CCS). Regarding technological upgrades, regulatory tools like ICH Q124 may facilitate a seamless transition to isolator technologies, mitigating potential supply disruptions.

The second most observed 21 CFR Part 211 section is 192 about production record review, investigations of discrepancies, and failures. Almost all the observations were related to the inadequacy of a robust investigation. In one instance, the observed OOS TOC value was not thoroughly investigated to determine the root cause. Moreover, there was a notable absence of proactive measures for preventive maintenance. Regulators perceived this approach as insufficient in adequately addressing the identified observation. The Assay OOS was attributed to instrument malfunction and analyst error in another incident.

However, the assessment was not extended to the other products the instrument malfunction may impact. The regulator also found that multiple visual inspection failure investigations did not isolate and identify the white/black particulates to identify the root cause and determine the corrective and preventive measures. isolation and identification of particulates not having a root cause. Facilities had non-

viable particle counter excursions. However, the incidents did not require identifying root causes and an impact assessment of components and products present during the incident. There were several incidents of lab OOS investigation inadequacies, primarily where the hypothesis was not categorically supported by data and/or studies such as forced degradation. In one instance, glass contamination was determined as the root cause. However, the firm failed to identify what that contaminant was. Overall, the higher number of observations related to robust investigations questions the existence of a technically sound quality unit that can question the investigation inadequacies in a timely manner. Sterile facilities must develop a culture of developing sound hypotheses, validating their soundness through thorough evaluation of supporting evidence and determining the adequacy of the generated data to prove the hypothesis categorically. Beyond a wellRCA-trained quality unit investigation office, it is imperative to have a cross-functional, technically sound team to challenge all investigation plans and outcomes for organisations to succeed in today's environment.

21 CFR Sections 22 and 160

are related to the responsibilities of the quality control unit and the need for scientifically sound laboratory controls. According to the observations concerning section 22, the quality unit seemed to be struggling with issuing and controlling manual paper documents such as BMR, logbooks, etc., and managing manufacturing and lab non-electronic data. Data integrity continues to be questioned, which essentially calls for adopting qualified electronic systems on the floor and in the labs. The regulator has also questioned the lack of real-time camera oversight of aseptic operations. Organisations are still reluctant to have cameras for such critical operations, which backfires with continued operator violations of aseptic practices, inability to investigate and ultimately, loss of regulator confidence. Section 160 observations were primarily related to misses from the microbiology department. In certain instances, the sterility testing requirements were not followed.

The regulator was questioning the selection adequacy of the media supporting environmental isolate’s growth promotion.

It was found that the qualified incubation conditions were not followed for a bioburden study.

The regulator identified dehydrated media plates for monitoring as part of the walkthrough. There were instances where microbiology EM monitoring results were reported, although samples were not collected. In one case, the video proved that no settle plates were in place for EM. All these incidents highlight the essentiality of having a well-staffed 24x7 microbiology department to succeed.

The aseptic behavioural problems and the inadequacy of robust investigations underscore the critical need for organisations to rethink. The regulator's emphasis on aseptic techniques, first air principle, and interventions necessitates a shift towards resilient isolator technology to minimise reliance on human behaviours and environmental controls.

The observations related to investigations stress the impor-

tance of thorough and proactive measures, particularly in developing a culture of sound hypothesis generation and rigorous investigation supported by technically competent teams. Further, the observations indicate the need for organisations to modernise their data management systems and embrace technological solutions for enhanced oversight.

The deficiencies in microbiology controls emphasise the necessity of a well-staffed and technically sound microbiology department. The examination has brought to light the multifaceted challenges faced by sterile facilities in India with potential solutions. Our conclusions are based on hard evidence and should be useful for organisations to take the recommended immediate actionable measures, including investing in training and technology to continue successfully serving the regulated markets.

References 1. Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities https://www.outsourcedpharma.com/doc/key-post-pandemic-trends-in-global-fda-observations-for-drug-facilities-0 001 2. FDA Form 483 Frequently Asked Questions https://www.fda.gov/inspections-compliance-enforcementand-criminal-investigations/inspection-references/fda-form-48 3-frequently-asked-questions# 3. FDA Guidance for Industry Sterile Drug Products Produced

by Aseptic Processing- Current Good Manufacturing Practice, Appendix 1 https://www.fda.gov/regulatory-information/search-fdaguidance-documents/steriledrug-products-produced-aseptic -processing-current-good-manufacturing-practice 4. ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management https://www.fda.gov/regulatory-information/search-fdaguidance-documents/q12-technical-and-regulatory-consideratio ns-pharmaceutical-product-lifecycle-management-guidance

PACKAGING

Pharma packaging and labelling trends: What's hot and what's not Industry experts share insights on cutting-edge solutions, emerging trends, navigating opportunities and challenges, regulatory advancements, and more in the field of pharma packaging and labelling

Five trends that will influence the pharma label market

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he fight against counterfeit pharmaceuticals heavily relies on pharma labelling, which is increasingly popular due to its versatility, convenience, and variety of patterns and styles.

The pharma label market, including pressure-sensitive, glue-applied, sleeve, and inmould labels, is expected to reach $6.9 billion by 2025, with a compound annual growth rate (CAGR) of 5.3 per cent from 2020 to 2025.

The top five trends are expected to have an impact on the world market for pharma labels.

These five trends, according to the majority of industry participants and experts, will hasten advances in the pharma label sector in the near future. ◆ Adoption of label design for expanded content: The extended content label is a versatile, multipage solution for packaging containing regulatory and multiple language content. It can be applied to various sizes and forms, providing additional space for visuals and coupons, making it an effective marketing strategy. ◆ Increased demand for coloured labelling: Colour printing labels enhance brand marketing and consumer retention. They are increasingly used in healthcare for product differentiation, offering time savings and security measures.

Colour codes and pictures facilitate brand, size, and model differentiation. ◆ Cryogenic labelling: Pharma labels specifically designed to survive extremely low temperatures are known as cryogenic labels. Because there is a growing requirement for ultra-cold cryogenic storage, cryo labelling is expected to continue growing. Its use in labelling the package used to distribute the COVID-19 vaccination has helped it acquire popularity. ◆ Labels for counterfeiting protection: Labels are essential in protecting against pharmaceutical counterfeits, as they instill trust in customers. Businesses often use covet photos, descriptions, and verification techniques, along with tamper-proof labels, to prevent counterfeiters from selling inferior drugs. ◆ Use of recyclable and biodegradable

Pharma packaging has witnessed tremendous growth in terms of technology and innovation

C Avinash Kumar Talwar, VP - MRO & Pkg. Material Sourcing (Strategic & Plant), Global Supply Chain Management, Dr Reddy's Laboratories

label product: Label manufacturers are investing in eco-friendly labels and promoting sustainability. For e.g. Avery Dennison and UPM Raflatac have launched recyclable and biodegradable labels. The pharma labelling sector is evolving, and industry leaders must adapt to current/new developments. Pre-fillable syringes, inhalers, and containers will hold great potential.

Understanding development patterns is crucial for players to develop long-term strategies that will ultimately lead to success.

For instance, the following are some strategic factors that participants in the pharma label industry should take into account in order to capitalise on growth momentum: ◆ Enhanced capacity of pharma industry participants to create sustainable labels keeping recyclability in mind. ◆ Players' attention is drawn to near-field communication (NFC) tags and RFID labelling technologies. ◆ Investing in advanced technologies like high security anti-counterfeiting programs, such as tamper-evident labels, pallet-banding, and NFC tags, can enhance product security and prevent counterfeiting. ◆ Research and development efforts aimed at creating some affordable label solutions specifically for generic market.

hange is constant. This is aptly applicable for pharma packaging and labelling. The changes are continuous, sometimes easy to implement and sometimes very disruptive. Pharma packaging has witnessed tremendous growth in terms of technology and innovation to compete in generic market against giant brand leaders who have patented products.

When we talk about pharma packaging, primarily focus is on primary packaging, then secondary packaging. What’s hot is implementation of new Chapter 661 of USP Plastic Packaging Systems and Their Materials of Construction with sub chapters: Plastic Materials of Construction and Plastic Packaging Systems for Pharmaceutical Use. Implementation is December 1, 2025. The objective is establishing chemical safety assessment with combination of chemical testing and toxicological assessment. This chapter involves elaborate testing which requires about 30 USP reference standards.

Labels and labelling are part of cGMP requirements of any country and compliance to requirements is mandatory. Some safety related updates must be implemented immediately that disrupts supply chain in procurement of revised versions, packing operations and supply of that product to market as committed. The font size recommendations for text on labels by Health Canada has unlocked new avenue of multilayer labels from a conventional label to accommodate text with statutory font sizes in two languages English and Canadian French. This

Chandi Prasad R, Head-Packaging, Aurobindo Pharma

means new technology of substrate, printing machinery and suitability on labeling machines. Serialisation and aggregation as part of track and trace requirements of regulated and emerging markets again is an example of disruptive change, which was a major project of the Indian pharma industry for the last five years.

Digitalisation of prescribing, patient information and connecting medical practitioners and patients through QR code/Augmented Reality; smart packaging by device and IoT enabling patient convenience and adherence of dosage; inclusive packaging for people of all abilities; green or sustainable packaging using manufacturing techniques and packaging materials which reduces energy use and harmful impact of packaging on environment are future trends influencing pharma packaging.

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PACKAGING

The branding for devices via attractive labels can be a turning point

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ackaging and labelling have come a long way in the last few decades, especially in the pharma sector. In my opinion, labelling has a major role in the transformation of packages as it is the one seen and felt by the customer. First impression is always to be created.

Now, when you look over 2024 and beyond, the future is bright with newer technologies and young entrepreneurs trying to work on new ideas.

In yesteryears, most of the industries, especially Indian industry has looked upon packaging as a cost cutting, down gauging instrument rather than a marketing tool or a product

requirement. In the last decade though, industry has seen changes in packaging requirements, mainly due to serialisation requirements by various countries, however, it was more of a compliance than innovation. All companies making exports to the EU have started using tamper evident stickers, and a few have gone with self sealing of cartons with new machines in place, which is a huge investment by itself. Now, the market has to come up with the findings if there is a significant decrease in counterfeiting and how good was the consumer response.

Going forward as well, there are multiple regulations coming

Ajay Bapat, Consultant, Packaging Concepts

up and even our own Indian drug laws are being modified to cover many aspects of labelling and new guidance on devices.

We have also discussed much about smart packaging, but in my opinion, more was discussed than being implemented. Now, it is time to make them for consumers. Innovation is said to be successful only if it can be easily marketed .

I can also see a lot of growth in the devices segment, thereby a good amount of jobs for packaging and labelling for it. The branding for devices via attractive labels can be a turning point.

At the same time, attention is required over communication to consumers on failure of devices, root cause and why so many recalls are happening in this comparatively new segment.

While talking about new

labelling to brand the product, I am reminded of old products being marketed for the last few years, which also need a revamp.

A good rebranding exercise can be undertaken from a labelling perspective.

We have also seen good momentum in the vaccine world, entry of small batch manufactured products, gene therapy etc. This will create a good amount of work for industry in cold chain packages, its validation, and labelling.

Overall, a very challenging job for packaging guys in the industry and I am sure of success at the end.

Wishing all of us a wonderful 2024!

The integration of innovative technologies into pharma packaging is transforming patient interactions with medications

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he pharma industry is in a perpetual state of evolution, and it undergoes constant transformation driven by shifting consumer preferences and evolving regulatory frameworks. The trends shaping pharma packaging and labelling play a pivotal role in ensuring product safety, regulatory adherence and patient engagement.

What’s working Sustainability is a fundamental principle in the pharma sector, reflecting a heightened focus on environmentally responsible packaging solutions. It includes the adoption of eco-friendly materials, such as biodegradable, recycled and recyclable options, such as paperboard, plant-based plastics and bio-based inks for various packaging components.

Moreover, reducing packaging weight and simplifying packaging design to decrease material consumption and enhance resource efficiency is gaining traction, alongside the implementation of closed-loop systems for packaging retrieval, recycling and re-usability.

The integration of innovative technologies into pharma packaging is transforming patient interactions with medications. In-

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teractive features, such as QR codes, NFC tags and augmented reality is providing patients with access to detailed product information, dosage guidelines and interactive support materials.

Track-and-trace technology, including serialisation and barcoding systems, is enhancing supply chain visibility, helping in the prevention of counterfeiting, thus assuring product authenticity. Also, packaging, equipped with sensors and data communication capabilities, monitors environmental factors during storage and transport, ensuring optimal product quality and patient safety.

Another trend is the move toward personalisation in packaging solutions, aligned with the rising demand for patient-centric care. It involves printing personalised medication schedules, dosage instructions and warnings directly on packaging to improve adherence to dosage frequency and reduce medication errors. Multilingual labelling caters to diverse patient populations and complies with international regulations. Moreover, customisable packaging options enable personalised design elements, which aim to elevate patient engagement and

belling. Tamper-evident features, including seals, holograms and other security measures, safeguard product integrity and prevent unauthorised access. Data integrity systems ensure accuracy and traceability throughout the supply chain, complying with global serialisation and trackand-trace regulations to combat counterfeit drugs.

What’s not working.

Rrajesh K Khosla, President & CEO, AGI Glaspac

strengthen brand identity.

Accessibility and usability are gaining prominence in packaging design, while recognising the diverse needs of patients. The integration of universal design principles, such as large fonts, braille and tactile cues caters to patients with visual or physical impairments. Child-resistant closures have become a staple to enhance medication safety and prevent accidental ingestion. Similarly, senior-friendly designs, featuring easily openable closures and clear instructions, address the needs of older patients.

In response to increased regulatory scrutiny, compliance and security remain pivotal priorities in pharma packaging and la-

Obsolete practices are swiftly giving way to a new wave of standards that prioritise sustainability, innovation and enhanced user experiences.

Excessive packaging, once an accepted norm, now faces severe scrutiny as environmental concerns and consumer awareness intensify. The push for streamlined, eco-responsible packaging solutions is steering pharmaceutical companies towards using materials and designs that minimise waste, reduce the environmental impact and optimise resource use.

Similarly, the days of static and limited labelling are seeing a decline, replaced by a demand for interactive and informative packaging. Modern consumers seek more than just basic product information. They now want

interactive and engaging experiences that provide comprehensive details, dosage guidelines and user-friendly instructions.

One-size-fits-all approaches no longer suffice in an age where patient-centric care is paramount. Pharma companies are adopting personalisation to cater to individual patients’ needs.

Printing personalised medication schedules, dosage instructions and multilingual labelling have become essential practices.

Embracing stringent security protocols encompasses the adoption of tamper-evident features, such as seals, holograms and robust data management systems.

The evolving trends in pharma packaging and labelling reflect a broader industry-wide commitment to a healthier, more sustainable future. As companies pivot towards eco-friendly materials, innovative labelling, personalised solutions, accessibility enhancements and heightened security measures, they not only meet evolving consumer demands but also adhere to stringent regulations. This collective progress enhances patient engagement and user experiences, contributing to a sustainable future for both the industry and the planet.

PACKAGING

Trends and transformations in pharma packaging and labeling Packaging expert, Prabir Das, explores the dynamic evolution of pharma packaging and labelling trends, highlighting the industry's shift towards innovation, sustainability, and advanced technologies to meet the demands of global healthcare. He highlights that from material transformations to technological advancements, the sector is embracing a holistic approach to ensure product safety, convenience, and compliance with evolving regulatory standards

O

ver the years, human civilisation has crossed multiple milestones driven by various socio-economic and geo-political factors.

These changes have prompted people to adapt to their environment for survival with sustainability. The industrial revolution began in the pursuit of excellence in every aspect of our daily lives. With the inflation in population, large-scale demands triggered the need for mass-scale production and distribution. We adapted and promoted globalisation and consumerisation for better resource distribution and larger societal benefits. We have now reached the fourth stage of the industrial revolution in this evolutionary journey and are making rapid progress to create a pathway for the fifth.

Every industry sector is poised to grow by adopting changes infused by this massscale production and distribution system. The demand for all types of goods increased manifold due to consumerisation, and business processes became borderless due to globalisation.

The importance of essential items boosted due to lifestyle transformation. Human health, being critical for survival, received equal attention, and the healthcare sector progressed substantially to support a sustainable lifespan. Parallel evolution in science and technology not only helped identify the root cause of ailments but also aided in finding remedial actions, including the development of appropriate application processes.

All these progressed in tandem, and today we are much better equipped to support mass-scale production and distribution

processes for all types of healthcare products.

The first and foremost requirement for a product to be distributed is that it requires packaging for holding and protecting it from the external environment. It also requires a label for identification and delivery to the end user with safety and security. Healthcare or pharma products are no exception. Products and their packaging and labelling complement each other and are essential to support safe and secured distribution from the point of production to the point of delivery. We have witnessed a very swift transformation in the packaging and labelling sector too during the last five to six decades to keep pace with the lateral pressure from other in-

dustry sectors.

The beauty of the packaging and labelling sector is that it is essential for each category of products, utilising a variety of materials, including paper, plastics, rubber, glass, metal, wood, and composites (combinations of two or more materials). Accordingly, different conversion processes evolved to suit product requirements. While paperbased packaging replaced wooden packaging in many applications, different types of polymeric resins or plastics and composites changed the entire landscape of the packaging world. They replaced heavier materials like glass, metal, and woods in the majority of applications. When designing packaging and labelling for a product, multiple factors are

considered—compatible material options, operational flexibility, user convenience, logistics and distribution requirements, inclusion of promotion and protection features, impact on the economy and ecology, and so on.

All these need to be within set quality and regulatory norms from internal and external agencies. Printing, coding, stamping, embossing are integral parts of labelling (used to capture static and variable text /graphics/data) that also evolved simultaneously.

Globally, the pharma industry is considered one of the prestigious, progressive, and flagship industries, directly connected to the healthcare system for the survival and sustainability of human civilisation.

Good, healthy members of any community are the real assets for society to propel growth and development of civilisation.

Globalisation and consumerisation created new opportunities to do business beyond boundaries, and pharma packaging has spread its wings to cover a wide array of applications. Supply networks are spread across the globe to ensure access to essentials to the farthest corners of the world. Geographic and demographic challenges are new opportunities to find innovative solutions to keep the products as fresh as originals. Packaging and labelling, the real protector and trusted carrier of the products, are serving their duties with due diligence to facilitate it.

Over the years, our expectations have evolved alongside global competitiveness. Various new molecules discovered, new formulations developed, and new delivery and dispensing

systems have also emerged to meet these expectations. Packaging and labelling for all types of formulations (including solid and liquid orals, granules and powders, ophthalmic and injectables, small and large volume parenteral, creams and ointments, lotions and gels, ear and nasal drops, etc.) underwent various changes, and many formulations are supplemented by effective drug delivery and administration devices.

Such devices like inhalers, aerosols, PFS, nebulisers, patches, etc. are used for the precise delivery of drugs with better convenience. Different ancillary/supplementary items like custom-designed spoon, measure cup, dropper, cutter, syringe, applicator, etc. also evolved for ease in administration for many drug formulations.

Even though utmost care is taken during development and execution, external conditions sometimes cause damages to the product-packs that are beyond control. Apart from such physical transit damages, other external threats like duplication or cloning, theft or pilferage, adulteration, and diversion also increased in parallel and challenged the industry/suppliers to combat it. The industry has taken on the challenge, and suppliers have adopted various tools and techniques to overcome these challenges. However, unlike the earlier days, now the technology is evolving rapidly. New challenges are creating new opportunities, and new versions are quickly superseding the older versions.

We have walked a long way from slow and low-yielding

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PACKAGING manual operations to automated and integrated highyielding mass-scale processes with the progress of the industrial revolution at various phases. Additionally, with the adoption of digitisation and wireless technology, many of the processes realigned not only to boost productivity but also to control all the processes with more accuracy. Now, each unit operation is precisely controlled to ensure each finished pack meets stringent quality norms, thereby ensuring patients/users are safe and secured. The input material selection and the pack designs, equipment selection and their customisation, and packaging line setup are being improvised to envisage a linear process with as much simplicity and flexibility as feasible. The material conversion industry also geared up alongside, and a perfect end-to-end industrial ecosystem is established to support the cause.

Apart from basic requirements for assurance on product stability and quality, the current trends in pharma packaging and labelling are focused more on comfort and convenience to the consumers, safety and security to the supply chain, support to sustainability, protection to the environment and ecology, and so on. Evolution in automation is supplemented further by optics, electronics, digitisation, robotics, and wireless communication. All these have helped develop various safety and security features on packaging and labelling to strengthen consumer convenience, supply chain security, and customer communication. Many custommade technology-driven solutions, like nanotechnology, augmented reality, virtual imaging, digital graphics, personalised branding, interactive packaging, track and trace, blockchain, IoT, AI, etc. are derived to boost the entire industry sector in the quest for achieving excellence.

All these developments also brought precision in various process controls, which support quantity and quality with minimum variations. Process control is one of the critical requirements to ensure product-packs meet the designed specifica-

34 EXPRESS PHARMA January 2024

Apart from basic requirements for assurance on product stability and quality, the current trends in pharma packaging and labelling are focused more on comfort and convenience to the consumers, safety and security to the supply chain, support to sustainability, protection to the environment and ecology, and so on tions consistently. Each unit operation on a packaging line has certain fixed and certain variable parameters to set and control the process. These parameters are derived from the component and equipment specifications, qualifications, and validation. During the designing phase, components and equipment are customised for the intended operations. During the qualification phase, various challenge tests are done to verify the intended functionalities, and during the validation phase, parameters are optimised for the best operating range.

Process controls are designed and monitored depending on the product, packaging and the line configuration, keeping quality, regulatory and patient compliance in mind. There are two basic types of controls – protective (to support product stability and quality) and communicative (to support connectivity establishment with the user). Adequate controls are followed during product manufacturing stages to ensure products meet all the visual, physical, digital, chemical, and organoleptic properties. When a product comes for packaging, adequate precautions are taken to ensure the retention of its originality during various stages of operations. Visual checks are mostly qualitative and include the aesthetic appearance of the pack, intactness of the product inside the pack, absence of foreign material or defective product, labelling precision, clear legibility of static and variable data, accuracy of content inside the pack, etc. Physical checks like the correctness of input materials, suitability as per line configuration, behavior during high-speed run, rejection rate, seal integrity, etc.

Digital checks ensure electronic and wireless features are functionally compliant. Chemical and organoleptic checks involve parallel laboratory tests and specification compliance. The absence of abnormal color, odor, and taste are also ensured through chemical tests/checks.

Some of the significant transformations in packaging and labelling systems: ◆ Strip pack→Thermoform blister→Tropical blister and cold form blister ◆ Standard blister design→ Customised design (Calendar/Compliance packs) ◆ Glass bottle→Plastic bottle→Flexible sachet and pouch packs ◆ Glass ampoule or vial→Blowfill-seal container and prefilled syringe ◆ Aluminum tubes→Plastic or laminated tube packs ◆ Metal closures→Plastic closures with induction sealing provision, child-resistant and tamper-proof feature, closure with in-built desiccant options ◆ Tear-off or tear-down closure→Flip-off or flip-top seals ◆ Conventional closure→ Single dose and metered dose dispensers ◆ Conventional glass or metal container→Aerosol containers ◆ Custom designed ancillary items – Spoon / measure cup/dropper, drug delivery/dispensing/ administration devices like syringes/applicators, etc. ◆ Plastic container-closure system gradually replaced the glass and metal container-closure systems. ◆ Cold-form technology created its own space replacing the conventional strip and blister packs. ◆ BFS/FFS technology adopted for many small

/medium/large volume parenteral. ◆ Unit dose packs and card/wallet packs gradually made inroads to support mobility and convenience. ◆ Similarly, prefilled syringes gradually replaced or are replacing conventional glass ampoules and vials for mobility and convenience. ◆ Medicated patch/transdermal patches/mouth-dissolving thin films – These NDDS categories of drugs evolved to support convenience and accuracy. ◆ Aerosols/roll-ons are making inroads for many medications for effectiveness and convenience. ◆ Similarly, inhalers (MDI/DPI) are already established and created their own space for effectiveness and convenience. ◆ Plastic/lami-tubes gradually replacing the metal collapsible tubes for aesthetics and acceptability. ◆ Conventional blister with foil/PVC started using high barrier PVdC (Diofan), PVdC/PVC, PVC/PE/PVdC, PVC/ACLAR, and other combinations, which are now commercially available.

Halogen, vinyl, and nitrosaminefree materials are also being used commercially to avoid human health risks. Other materials like HDPE, PP, PET, COC, etc. are also being explored for mass-scale applications. ◆ Introduction of cold form material, blister in pouch with/without desiccants, tropical blister (thermoform-cold form combination), introduction of desiccant-coated lidding and forming materials (Dessiflex), paper-based laminates for lidding material, etc. ◆ Introduction of plastic bottles with induction sealing liners, inclusion of silica gel and other

moisture/ oxygen/odour-absorbing materials, development of closure with in-built desiccant, etc. Introduction of multilayer bottles for moisture/gas barrier, use of different colours in bottles for light protection.

Similar examples are there for all types of pharma dosage forms, including solid and liquid orals, granules and powders, ophthalmic and injectable formulations, small and large volume parenteral, creams and ointments, lotions and gels, ear and nasal drops, etc. Apart from product identification and characterisation, labels and labelling also underwent multiple transformations to cope up with the growing need from business.

Few significant transformations in labels and labelling over the years: ◆ Conventional cut or pregummed label replaced with pressure sensitive sticker label and shrink label. ◆ Plastic, metal, and composites (paper, plastic, metal based) replaced conventional paper as label substrate in many applications. ◆ Starch and silicate adhesive gradually disappeared due to the introduction of plastic resinbased cold and hot glue. ◆ Single color linear graphics transformed to multicolor tonal and digital graphics. ◆ Inclusion of functional valueadded features like braille text, multilayer label, hanger label, label with leaflet, etc. ◆ Inclusion of value-added smart features (including electronic digital features) to support brand promotion and brand protection. ◆ Interactive labels where a customised digital feature enables consumers for direct access or interact digitally. All such developments are happening and being implemented not only in compliance with internal operational and quality requirements but also in compliance with external statutory and regulatory norms. Evolution of digital technology and wireless communication in all industry sectors has brought new dimensions and set new directions to keep up the momentum for the next stage of industrial revolution.

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PHARMA PULSE

Enhancing efficiency and productivity in oral solid dosage lines A look at various types of consumables used in oral solid dosage line along with their applications and their role in enhancing manufacturing processes in the pharma industry

T

he pharmaceutical industry has witnessed significant advancements in manufacturing processes and technologies, particularly in the production of oral solid dosage forms. As manufacturers strive to improve efficiency and productivity, the choice of consumable supplies becomes crucial. In this article, we will explore the various types of consumables used in oral solid dosage line along with their application and how they can enhance manufacturing processes in the pharmaceutical industry.

Some of consumable supplies in OSD lines 1. Bellows: Bellows are flexible, accordion-like components typically made of materials like silicone or rubber. Bellows are commonly used in oral solid dosage lines to facilitate precise and controlled filling of medication into capsules or tablets. By creating a vacuum, the bellows enable accurate dosing and minimize air entrainment, ensuring consistent drug delivery and maintaining product integrity throughout the manufacturing process.

2. Dust cups: Dust cups are designed to capture and collect excess dust particles generated during the manufacturing process, ensuring product cleanliness and integrity. B and D tools, on the other hand, are specialised equipment used for tasks such as tablet compression and tooling changeovers, ensuring efficient and accurate production of oral solid dosage forms. These tools play a crucial role in maintaining quality and productivity in pharma manufacturing lines.

3. Inflatable seals: These seals, typically made of flexible materials like silicone or rubber, provide airtight and secure closures in pharmaceutical manufactur-

56 EXPRESS PHARMA January 2024

ing processes. By inflating and creating a tight seal, they prevent contamination and ensure product integrity during tablet compression, filling, and packaging operations. Inflatable seals enable efficient and reliable production while maintaining high quality and regulatory compli-

pharma applications, ensuring the integrity and quality of the oral solid dosage manufacturing process.

5. Silicone hoses: Silicone hoses are commonly used in oral solid dosage lines due to their excellent compatibility with pharmaceutical products. These hoses offer high temperature resistance, flexibility, and durability, making them ideal for conveying tablets, capsules, and granules.

They maintain product integrity,

particles, ensuring uniformity in size and eliminating any impurities. These devices play a crucial role in maintaining product quality, enhancing process efficiency, and meeting regulatory standards in pharmaceutical manufacturing.

7. O-rings and gaskets: O-rings and Gaskets are crucial components in oral solid dosage lines, ensuring proper sealing and containment of pharma products. These specialised rubber or elastomeric seals are used in equipment such as tablet presses, capsule filling machines, and packaging lines.

They provide a barrier against moisture, air, and contaminants, maintaining the integrity and

ance in oral solid dosage manufacturing.

4. Tubing: Thermoplastic Elastomer (TPE) tubing are commonly used in oral solid dosage lines. These flexible and durable materials provide excellent chemical resistance, allowing for the safe transfer of pharma ingredients and products. TPE tubing are designed to meet the stringent requirements of

prevent cross-contamination, and meet stringent hygiene requirements. Silicone hoses also exhibit good chemical resistance and are easy to clean, ensuring the safety and quality of oral solid dosage manufacturing processes.

6. Sieves and screen: Sieves and screens are vital components in oral solid dosage lines. They are used to separate and classify

quality of the dosage forms.

They play a vital role in ensuring the safety, efficacy, and shelf life of oral solid dosage production lines.

8. Diaphragms: Diaphragms play a crucial role in oral solid dosage lines. These thin, flexible barriers are placed within the equipment to regulate the flow of powders and granules during the manufacturing process. Di-

aphragms ensure uniform distribution and accurate dosing of the materials, preventing crosscontamination and maintaining product quality. They serve as key components in various equipment, such as tablet presses, capsule filling machines, and powder filling systems, enabling efficient and precise production of oral solid dosage forms.

Conclusion In the pharma industry, the choice of consumable supplies plays a critical role in optimising manufacturing processes. By incorporating these high-quality polymer-based solutions into their operations, pharma manufacturers can enhance efficiency, improve productivity, and maintain the integrity of their products.

Overview of Ami Polymer: Ami Polymer is a renowned manufacturer and exporter of high-quality rubber products and polymer-based solutions.

We specialize in producing a diverse range of products such as Silicone tubing & hoses, O-rings, Gaskets etc. The FDA, USP Class VI, REACH, and RoHS are just a few of the international standards and laws that Ami Polymer products abide by and these validate our adherence to international standards and underline our dedication to delivering reliable and sustainable solutions to industries worldwide.

Along with this we provide technical support and knowledge to our customers with a team of qualified professionals.

Contact Omraj Nakhawa Executive – International Marketing Mob: +91 7436000552 Website: www.amipolymer.com

PHARMA PULSE

Complete pharma Solution – testo Saveris Pharma Testo provides the best-in-class solution for comprehensive data monitoring and management for equipment as well as environmental parameters in pharma industry called as the testo Saveris Pharma

A

sector like pharmaceuticals which is, governed by strict norms and regulations must operate with utmost efficiency. Testo provides the best-in-class solution for comprehensive data monitoring and management for equipment as well as environmental parameters in pharma industry called as the testo Saveris Pharma. It is an automated system that is integrated in the facility and constitutes of wireless or Ethernet probes installed at different locations that are connected to one base station to document and monitor all measurement data of its own. The monitoring process is uninterrupted, and the system provides number of alarm options in case the measurement values violate the defined limit values. Some advantages of testo Saveris Pharma for environment and equipment monitoring system include: ◆ Holistic system comprising sensors, software, and services ◆ In accordance with 21 CFR Part 11 and GAMP compliance ◆ Provides seamless recording, automated tamper proof documentation ◆ Secure triple layer storage of the measurement data of all au-

dit-relevant parameters ◆ The data is stored in the probes, so even if software connectivity is lost the data is safe and can be downloaded once the software is logged in ◆ Real time alarm facility to highlight unexpected results Testo Saveris Pharma system consists of testo Saveris base V 3.0 which is the core component of the system. It manages and evaluates data

from all over the facility from 3000 channels. The four testo 150 data logger modules can be flexibly combined with the three communication modules (WLAN, LAN, testo UltraRange) making it very convenient and user-friendly system along with the web-based, intuitive cockpit to detect alarms, initiate corrective measures and to acknowledge them whenever necessary.

Application areas Manufacturing/ Production area | Research & QC labs | Cleanrooms and data centers | Warehouses and packaging | Deep freezers, refrigerators, cold rooms | Incubators, Stability test and walk-in chambers | Blood and tissue banks | Autoclaves and nitrogen tanks | Sterilizers and many more Testo's specially trained service team supports you

throughout the process in a very systematic way – from planning, documentation, system qualification and software validation through to service and support.

Testo also has a NABL accredited service and calibration LAB that takes care of the after sales support locally from Pune.

For more details, login to www.testo.com or write to info@testo.in

EXPRESS PHARMA

57

January 2024

PHARMA PULSE

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-

58 EXPRESS PHARMA January 2024

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

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/

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2022 – 24, PUBLISHED ON 5TH EVERY MONTH, POSTED ON 9TH, 10TH, AND 11TH EVERY MONTH POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001