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 Dr Shrenik Shah Dr Viranchi Shah Appasaheb Kabadagi Dr Pavan Bhat Tushar Maradwar Dr Prakash Shetiya Tanmay Behera
Zydus Lifesciences Montage Laboratories Saga Lifesciences Alembic Pharmaceuticals Natco Pharma Dr Reddy's Laboratories Hetero Labs Hetero Labs

Sr. Vice President-BPD

Neil Viegas DATA AND
Vice President-BPD
Harit Mohanty
ANALYTICS
Driving value in
Mahesh Nerkar Harpal Vala Parimal Brahmbhatt Naresh Gaur
BDR Pharma Kepler Healthcare Unison Pharmaceuticals Amneal Pharma

Editor
Viveka Roychowdhury* pharma manufacturing
Experts shed light on the power and potential of data and analytics
to enable manufacturing excellence, navigate complexities and
Editorial Team understand regulatory nuances in a digital future
Lakshmipriya Nair By Viveka Roychowdhury
Badarinarayan Herur Tanveer Shah Kajal Patel Suresh Pathi
Dishman Carbogen Amcis Eris Life Sciences Hester Pharmaceuticals Granules India

Kalyani Sharma

DESIGN
Art Director
Pravin Temble
Krishna Reddy Venkatanarayan V Ajay Tomar Dr. Damodharan Muniyandi Sathyanarayana (Sathyam) Ponnam Bujji Reddy Kanchi Dipen Shah Dr Vellaian Karuppiah
Zenara Pharma Dr Reddy's Laboratories SAS India Sai Lifesciences Aurobindo Pharma Aragen Life Sciences Nupeak IT Solutions Gland Pharma

Senior Designer
Rekha Bisht
EVENTS MARKET STRATEGY POLICY
Senior Artist
PPL 2024: A NEW YEAR CALL
Rakesh Sharma
14 CHAMPIONING
INNOVATION,
P26: INTERVIEW
DR JITENDRA KUMAR
29 FOR ACTION:
ANALYSING 2023
Marketing Team POWERING MANAGING DIRECTOR, FDA FORM 483
PROGRESS BIOTECHNOLOGY OBSERVATIONS
Rajesh Bhatkal
INDUSTRY RESEARCH FOR INDIAN
Ashish Rampure INFORMA
Debnarayan Dutta 16 MARKETS
ORGANISES CPHI
ASSISTANCE COUNCIL STERILE MANUFAC-
TURING FACILITIES

& PMEC INDIA 2023

Production Co-ordinator
Dhananjay Nidre
SUCCESSFULLY
AT INDIA EXPO
PACKAGING
CENTRE
PHARMA
Scheduling & Coordination
BIOTECH AND
31 PACKAGING AND
Pushkar Waralikar
24 BIOPHARMA
INDUSTRY
LABELLING
TRENDS: WHAT'S
HOT AND WHAT'S
CIRCULATION TRENDS: WHAT NOT
TO WATCH FOR
Mohan Varadkar
IN 2024

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 9
January 2024
 EDITOR’S NOTE

Will 2024 be a year of

regulatory renaissance?
O
n December 6, India's Central Drugs commented that the real value of the risk based
Standard Control Organisation inspections were not the closures of erring
(CDSCO) issued a letter asking state manufacturing plants. He stressed that post the risk
and union territory regulators to defer based inspections, “the whole ecosystem of pharma
the proposed risk based inspections of manufacturing here is now sensitised towards the
manufacturing units and private testing labs quality issues. And that is actually giving lots of
scheduled between December 11-22, to focus on advantages to us now as a regulator that things are
verifying the supply chain and quality of propylene getting aligned."
glycol (PG), a key ingredient in cough syrups. He was also frank enough to share the
The letter has detailed instructions on verification responsibility for the “aberrations” which came to
at the cough syrup manufacturing plant, tracking light during the RBIs because “it’s not only the
back to the source (manufacturer or importer) of PG. manufacturers but for me, the regulator is also
The letter hopes that this exercise will ‘rule out responsible … because we let that happen and that is
possible quality issues related to DEG/EG and why that happened.” He went on to add that after all
diversion of industrial grade PG in the pharma the sensitisation, “it’s time for fixing accountability
industry.’ also at the regulators.”
The timing is crucial, as consumption of cough 2024 will be a Going by these comments, it's clear that global and
syrups spikes during the winter months. In fact, the year to rebuild now domestic scrutiny on quality concerns might just
December 6 letter on PG comes after the CDSCO turn out to be a blessing in disguise. Regulators now
chief urged pharma manufacturers to pay special trust in the seem more amenable to introducing additional quality
attention to the quality of not just the APIs but also CDSCO, with checks.
various excipients that are added to their products. For instance, on December 21, the drugs controller
The CDSCO’s risk based inspection drive over the more stringent of the state of Uttarakhand issued a ban on cough
past year was spurred by global censure over the regulations, syrup manufacturers who do not have gas
deaths of children in Gambia and other nations, chromatography (GCs) systems in their quality
allegedly after consuming coughs syrups imported coupled with control labs for testing of EG/DEG in propylene glycol
from India. While WHO’s tests showed up higher than stricter used in cough syrups. Manufacturers who procure
acceptable levels of DEG/EG, tests done by India’s GCs must provide proof of such purchase and their
regulators gave a clean chit to the manufacturer. The implementation manufacturing licence will be renewed only after a
most recent twist in the tale is that a state regulator
was allegedly bribed by the manufacturer Maiden
of these physical verification of such systems.
However, will the presence of GCs guarantee the
Pharma to switch the samples. As expected, Maiden regulations. required amount of testing? Will CDSCO prescribe
Pharma’s promoter refutes the charge but it is more
important to unveil the ‘knaves among the knights’ to
However, the standards which can be enforced, not just for
EG/DEG levels but also for a host of other undesirable
start changing public perception. trickier part is contaminants like residual solvents etc? And what will
After a period of denial, the CDSCO started it take to break the nexus between corrupt officials
cracking down in December 2022, with a series of risk
weeding out the and unethical manufacturers? Can it be expected to
based inspections. There were training sessions for corrupt from its do a credible clean up outside, without first cleaning up
its regulators to ensure better coordination between its own backyard?
central and state inspection officials.
ranks, even while 2024 will thus be a year to rebuild trust in the
A year later, after four phases of risk based it aims to do the CDSCO, with more stringent regulations, coupled
inspections, covering over 300 inspections, it’s clear with stricter implementation of these regulations.
that these actions were designed not just to pull up
same with However the trickier part is weeding out the corrupt
pharma companies, but to shake up the regulators pharma from its ranks, even while it aims to do the same with
themselves. pharma companies
30 per cent of the plants inspected received companies
closure notices; while other companies had their
licenses revoked or received warning letters.
Speaking recently at the 4th US Pharmacopeia South VIVEKA ROYCHOWDHURY, Editor
Asia Regional Chapter meeting, Dr Rajeev [email protected]
Raghuvanshi, Drug Controller General of India [email protected]

10 EXPRESS PHARMA
January 2024
EVENTS
Q A
WITH
& SCHOTT GLASS
INDIA
PRE EVENT
Q Why do biotech drugs pose higher

PPL2024: Championing requirements to the packaging

material?

innovation,powering A Schott Glass India: Many of the new devel-

progress oped drugs are biotechnologically produced

drugs that resemble biological molecules.
These can be vaccines, monoclonal antibod-
ies, special antibiotics, hormones, enzymes,
PPL Conclave 2024 will be held on February DNA-recombinant molecules etc. Biological
molecules are often quite sensitive to oxygen,
16-17, 2024 at Le Meridien, Hyderabad water vapor and / or pH shifts in solution
which is why a strong interaction with the
glass packaging material should be avoided.

P
ackaging and labellling in pharma gating compliance in a global landscape In worst case these interactions might lead to
has witnessed significant develop- ◆ Smart labelling technologies in pharma a degradation or malfunction of the drugs
ments in response to evolving packaging: Barcodes, RFID, colour- which is not acceptable. Type I glasses have
needs of the industry with an emphasis on changing inks and more the highest quality not only in terms of chem-
safety, quality, sustainability and techno- ◆ Circular economy in pharma packaging ical stability but also in terms of temperature
logical innovation. and labelling: A moral and business im- stability. This is what makes Type I glasses
Be it temperature-controlled packag- perative the best choice for parenteral packaging in
ing solutions to meet the exacting stan- ◆ Branding and market differentiation general and specifically also for biotech
dards for biologics and vaccines, integra- with packaging and labelling drugs.
tion of drug delivery systems into
packaging for better patient outcomes, en- Pharma Packaging and Labelling
hanced patient engagement through inter- (PPL) Conclave 2024
active packaging, adoption of biodegrad- Organised by Express Pharma, PPL
able options to minimise environmental Conclave 2024 will be held on February
impact, use of anti-counterfeiting tech- 16-17, 2024 at Le Meridien, Hyderabad. Q How can I protect my drug against
nologies or colour-shifting inks, packaging With opportunities galore for exchange of light?
and labelling done right are adding signifi- knowledge and networking of ideas, PPL
cant value to this industry. Conclave 2024 is 'the' platform for pack-
As these trends continue to evolve, the aging leaders, experts and veterans to
future of pharma packaging and labelling come together confer, converse, on the A Schott Glass India : Certain drugs are sensi-
holds exciting possibilities. current and future trends in the industry, tive to light, especially the light in the ultravi-
So, Pharma Packaging and Labelling their growth drivers and the challenges to olet wavelength area of 200 - 400 nm. This is
(PPL) Conclave 2024 aims to identify tackle them as well as form meaningful al- e.g. true for the vitamins A, B, D, E, K and C.
and harness pivotal trends in the dy- liances to fast-track progress in the These drugs have to be packed in a special
namic landscape of pharma packaging. pharma packaging industry. packaging that blocks the light from getting
The conference will bring together in- For the 100+ leading pharma packag- through. For glass packaging this is done by
dustry experts to discuss strategies to ing professionals attending the event, the adding either Iron (Fe) and Titanium (Ti) to
achieve a balance between innovation two-day event will give an opportunity to: the composition or Iron and Manganese (Mn).
and cost, functionality and aesthetics, as ◆ Get updated on the advancements in Such glasses now bear a brownish (Fe, Ti) or
well as utility and sustainability. It will India’s pharma packaging sector greenish (Fe, Mn) color and absorb the uv
provide a platform for leaders and veter- ◆ Demonstrate your pharma packaging light ensuring the protection. Additionally the
ans in the pharma packaging and la- capabilities light transmittance can also be controlled by
belling industry to collaboratively ad- ◆ Showcase your innovative packaging the wall thickness of the glass container. The
dress new challenges and surpass the solutions thicker the wall is the less light goes through
mounting expectations within the ◆ Gain insights from thought leaders it. And another factor is the annealing oven.
pharma sector. of the pharma, biotech and packaging in- Here the temperature plays an important
dustries role. The higher the temperature is in the
Some topics to be covered ◆ Acquire access to solution providers oven the darker the glass gets and the less
◆ Packaging design: Optimising user expe- with cutting-edge packaging technologies light is going through.
rience for patient safety ◆ Discuss on the role of packaging in
◆ Packaging for high-value biopharma- gaining a competitive edge
ceuticals and vaccines ◆ Network with the who's who of the
◆ Supply chain resilience through intelli- pharma packaging industry For more information contact:
gent packaging Pharma Packaging and Labelling [email protected]
◆ AI and automation: Revolutionising (PPL) Conclave 2024 is committed to
pharma packaging and labelling staying ahead of the curve and
◆ Enhancing track and trace capabilities future-proofing progress.
in pharma packaging To know more and register, check out:
◆ Pharma packaging regulations: Navi- https://ppl.expresspharma.in

14 EXPRESS PHARMA
January 2024
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 and Biocon to global leaders collaborative spirit driving closed-door Pharma Leaders’ obstacles remain with nearly
recently organised the like IMA and Fette, alongside India's pharma growth. Roundtable underscored the 30% of Indians lacking access
CPHI & PMEC India 2023 rising stars like Piramal The event kicked off with importance of directing atten- to medicines. We are truly at
at the India Expo Centre in Pharma and Hetero Labs, an opening attended by indus- tion toward both incremental an inflection point where we
Greater Noida, Delhi-NCR. A CPHI & PMEC India Expo try leaders, including Dr and revolutionary innovation. are finding innovative ways for
statement from Informa mar- brought together a diverse Veeramani SV, Vice-Chairman, The discussions also ad- seamless Geographical distri-
kets informed, “As the largest range of notable exhibitors. PHARMEXCIL; Harish Jain, dressed the significance of bution of pharmaceutical
and most exhaustive pharma Some of them such as Korber President, FOPE; Raja Bhanu, cost efficiency and digital access of quality supply.”
industry gathering in South Pharma GmbH, Uhlmann In- Executive Director, transformation to optimise op- “For 16 years, CPHI &
Asia, CPHI and PMEC India dia, Glenmark Lifesciences, PHARMEXCIL; Margaret Ma, erations and curtail expenses. PMEC India has been at the
expo, drew an overwhelming Petals Engineers, Solara Ac- President & CEO - Informa Other pivotal issues such as pulse of the pharma industry's
positive response, attracting tive Pharma Science, Merck Markets Asia; Chris Eve, Exec- the innovation funding gap, meteoric rise, evolving from a
over 48,000 attendees from Life Science, Gufic Bio- utive Vice President - Informa need for strategic alliances trade show to a global hub for
120+ countries in a vast sciences, Jubilant Pharmova Markets Asia; Adam Ander- with academia, biotech enti- innovation and collaboration.
100,000 sq m exhibition space. etc joined for the first time to son, Executive Vice President ties, and venture capital firms, We proudly represent the
This year's turnout exceeded showcase cutting-edge prod- - Pharma, Informa Markets; establishment of innovation world's largest pharma com-
previous editions, with over ucts from AI-enhanced quality Yogesh Mudras, Managing clusters to nurture collabora- munity, fueling India's domestic
1,500 exhibitors – a notable in- control to pioneering drug de- Director, Informa Markets in tion and facilitate the ex- muscle, surging R&D, and
crease from last year. As the livery systems and sustainable India; Rahul Deshpande, change of knowledge were also government support. This
central hub of the pharma in- initiatives. “ Senior Group Director, discussed. Informa Markets remarkable growth is driven
dustry, the CPHI and PMEC The 16th edition of the event Informa Markets in India; and informed that a white paper by cutting-edge technology,
India expo continues to grow was supported by key industry Ranjith Paul, Group Director, report on the key takeaways is breakthrough drugs, and a pa-
in influence and scale. Across associations, including Bulk Informa Markets in India. being prepared. tient-centric focus, positioning
three dynamic days, the event Drug Manufacturing Associa- The 'India Pharma Week’, Highlighting India’s promis- India as a major player in the
served as a crucible for indus- tion (BDMA), Federation held alongside the CPHI & ing position within the global global pharma landscape.
try collaboration, hosting over of Pharma Entrepreneurs PMEC India Expo, comprised market, Yogesh Mudras, Man- CPHI & PMEC India remains
25,000 impactful buyer-seller (FOPE); Karnataka Drugs and a series of events including the aging Director, Informa Mar- dedicated to playing a vital role
meetings, fostering partner- Pharmaceuticals Manufactur- Pharma Leaders Golf; Pre- kets in India said, “India has in India’s journey towards
ships, and amplifying industry ers' Association (KDPMA), Or- Connect Congress; Pharma earned its way to becoming a pharma excellence through its
advocacy.” ganisation of Pharmaceutical Leaders Roundtable; Women pharma super power with over platforms enabling collabora-
It added, “From domestic Producers of India (OPPI), and in Pharma; Pharma Talks; and 200+ countries served by In- tion, knowledge sharing, and
powerhouses like Dr Reddy's PharmExcil, highlighting the India Pharma Awards. The dian pharma exports. And yet, innovation,” he added.

16 EXPRESS PHARMA
January 2024
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 cover )

Sanjay Sharma Dr Shrenik Shah Dr Viranchi Shah Appasaheb Kabadagi

Zydus Lifesciences Montage Laboratories Saga Lifesciences Alembic Pharmaceuticals

Mahesh Nerkar Harpal Vala Parimal Brahmbhatt Naresh Gaur

BDR Pharma Kepler Healthcare Unison Pharmaceuticals Amneal Pharma

Badarinarayan Herur Tanveer Shah Kajal Patel Suresh Pathi

Dishman Carbogen Amcis Eris Life Sciences Hester Pharmaceuticals Granules India

Krishna Reddy Venkatanarayan V Ajay Tomar Dr. Damodharan Muniyandi

Zenara Pharma Dr Reddy's Laboratories SAS India Sai Lifesciences

18 EXPRESS PHARMA
January 2024
 Dr Pavan Bhat Tushar Maradwar Dr Prakash Shetiya Tanmay Behera
Natco Pharma Dr Reddy's Laboratories Hetero Labs 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 Bujji Reddy Kanchi Dipen Shah Dr Vellaian Karuppiah
Aurobindo Pharma Aragen Life Sciences Nupeak IT Solutions Gland Pharma

EXPRESS PHARMA 19
January 2024
 cover )
Digital is the way

I
ndia’s pharmaceutical sec- control, operational efficiency, transparency and reliability. He Pharma agreed that, "Going
tor is slowly but surely reduced production errors, forward ... stressed that "getting a hang of forward, there is no choice but
reaping the benefits of dig- and overall cost saving. In a continous pursuit for “the unknown unknowns” is to digitise. Not digitising is hid-
ital transformation initiatives. While discussing the role growth and excellence, the possible only by use of ad- ing from reality. For how long
Early adopters like Cipla and of data and analytics to moni- pharma sector is gradually vanced analytics. can you shy away from reality?
Dr Reddy’s Laboratories, both tor pharma production adopting strategic approaches Adding the operational per- Technology is changing much
part of the World Economic processes, the leaders ac- to move towards a new era of spective, Tushar Maradwar, faster than before. Revisions
Forum's Global Lighthouse knowledged the value add of digital maturity. And, compa- Head Operational Excellence, are happening in less than six
Network since October 2022, digital tools that could help nies such as Dr Reddy's Labo- Dr Reddy's Laboratories un- months due to improvements."
have shown how investments identify and address quality ratories and Cipla are steering derlined that management
in digital technologies, result problems early on to this journey. The urgency and needs to be clear on the bene- The people factor
in rich data-driven insights, ensure compliance with regu- significance of embracing digi- fits (of digital initiatives) over Leaders' mindset is the linch-
better quality metrics and latory requirements. talisation has become evident the next six months. He empha- pin for a successful tech trans-
added value in pharma manu- Participants highlighted in the dynamic pharma land- sised that companies should formation. Leaders serve as
facturing. Taking heart from some of the challenges in scape, setting the stage for a not opt for a LIMS just because influencers in shaping the
such success stories, more managing variability in man- paradigm shift in pharma larger companies are using it. organisational approach and
companies are investing in ufacturing operations and operations. Most larger companies, es- adoption of digital initiatives.
digital infrastructure. quality, like putting in place As the Chinese philosopher pecially pharma MNCs, are to- Therefore, aligning leadership
Leveraging data and ana- the right data collection and Lao Tzu said, “The journey of a day exemplars of digital matu- vision with the digital agenda
lytics had addressed many collation systems, without thousand miles begins with one rity. As Naresh Gaur, Sr VP - and garnering support from all
pain points and delivered which analysis becomes a ma- step”. For Dr Reddy's Labora- Manufacturing Operations, stakeholders is vital. And, their
tremendous ROI, in terms of jor pain point. They also dis- tories, the seeds for the digital- Amneal Pharma put it, "We receptiveness to digital initia-
better product quality, im-
proving manufacturing effi-
ciencies, optimising product
yields, reducing wastes, meet-
ing ESG targets, improving
profitability/profit margins,
lowering overhead costs, pre-
dictive maintenance, etc.
Though the learning curve
from data to discovery to de-
ployment is steep, digital
transformation is now even
more of a business imperative,
given the increasing competi-
tion, 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 manufactur-
ing, Express Pharma, in collabo-
ration with SAS, held two
closed door roundtables with
thought leaders and stake-
holders across functional
areas, spanning QA/QC, oper-
ations, manufacturing, formu-
lation R&D.
Agreeing that there is no
choice but to go digital, the ex- Experts at the roundtable discussion held in Ahmedabad
perts narrated their experi-
ences with digital transforma- cussed how they are generat- isation programme which even- have no choice but to digitise. tives hinge on the tangible ad-
tion initiatives within their ing insights from production tually led to Global Lighthouse Digital data gives regulators vantages for business.
organisations. operations/quality data. certification were sowed in confidence that companies are For instance, India's
Moving from the initial Experts from SAS and 2015. Narrating the journey, being transparent and are com- pharma sector is predomi-
implementation challenges to Nupeak gave case studies Venkatanarayan V, VP & Digi- pliant."He narrated how Am- nantly promoter-driven and
harnessing systems to collect, showing how pharma compa- tal Transformation Leader, neal has had 90+ inspections so this can work both ways. As
collate and analyse data in nies can further leverage ana- GMO, Dr Reddy's Laboratories far, with no adverse observa- Dr Pavan Bhat, Executive VP -
pharma manufacturing, the lytics and AI in manufactur- highlighted how the company tions, as "our systems are rock Technical Operations, Natco
leaders also examined the role ing operations, while moved to the concept of digital solid." Pharma reasoned, "Digital
of historical and real-time anticipating future require- data systems being the "single Appasaheb Kabadagi, Head transformation is low on the
data analysis for quality ments. source of truth," leading to Site Operations, Alembic totem pole for pharma promot-

20 EXPRESS PHARMA
January 2024
Experts at the roundtable discussion held in Hyderabad

ers. But promoters will not shy Sathyanarayana (Sathyam) not as we fear data. We do not alarm reports. So while the strategically in data centers
away from investments if they Ponnam, VP-IPDO, Aurobindo have quantitative data to sub- products are robust and con- and IT networks to embrace
see the benefits to the business, Pharma pointed out that "go- stantiate our work and that is sistent across multiple batches, and optimise the myriad bene-
or if not investing harms the ing digital also serves the pur- the reason we are hearing of the digital data presented by fits offered by digitalisation.
business." Thus the onus is on pose of passing on knowledge 483s, import alerts etc. That is the equipment are inconsis- Nevertheless, size and scale
digital evangelists to first con- to the next generation." an opportunity for solution tent. This variability kills pro- do play a huge role in a com-
vince promoters and the top providers to offer solutions for ductivity, as the management pany's digital journey. There
management of the business On a learning curve pharma manufacturing." has to invest time in quality are many companies that are
case for digital initiatives. Despite obvious and siginficant He also pointed out that risk assessments and quality already reaping the benefits
Throwing more insights on benefits, the pharma sector variability of data also arises as management systems." while others are at the begin-
the pharma promoter mindset, continues to face formidable "pharma equipment makers in However there are signs ning of their journey.
Dr Prakash Shetiya, Formula- barriers in its journey toward India are not mature enough, that companies are taking Granules India is at the
tion Head, Hetero Labs be- digitalisation, rooted in the in- and pharma companies buy steps to counter such setbacks start of its digitisation journey,
lieved that, "Every promoter dustry's legacy systems and equipment based on low cost. as Kabadagi revealed that according to Suresh Pathi,
wants the best product for the practices, a fear of data, and The low cost comes with its pharma companies in India are Head Operational Excellence-
patient." regulatory challenges. quality deficiencies. There are now slowly making good invest- Formulation Cluster, Granules
Besides gaining promoter Referring to the pharma huge variabilities between data ments in data centres, IT net- India. Reasoning that "poor
interest, Tanmay Behera Head sector's traditional resistance generated by equipment from works, etc. data results in analysis, leading
- Development Quality Assur- to digital initiatives, Kabadagi different manufacturers, be Thus, a transformative shift to paralysis, he said, "The com-
ance Hetero Labs said it is pointed out, "While many sec- they European, US or Indian. towards standardised digital pany is exploring eBMRs, mod-
equally important to convince tors in India are leaders in digi- We are faced with inconsisten- infrastructure is gradually ules for AR/VR as well as con-
the rest of the personnel in the tisation, automation, Industry cies in basic requirements like gaining traction as some Indian tinuous granulation."
organisation. 4.0, etc, the pharma sector is batch reports, audit trails and pharma companies invest In a similar manner,

EXPRESS PHARMA 21
January 2024
 cover )
Dr Vellaian Karuppiah, VP Regulatory push for produce quality products, not crucial step. The rule of thumb dictable.”
Operations, Gland Pharma ex- digital transformation just to comply with regulators. is that in any digitalisation ini- A good place to start, sug-
plained how the company is us- Perhaps the most urgent push So the question is how does dig- tiative, 80 per cent of the time is gested Dipen Shah, Head Con-
ing data analytics in the ESG for digital transformation is italisation help quality? The spent on data collation and only sulting, Nupeak IT Solutions
function, as well as has a pilot driven by regulatory compli- pharma sector in India cur- 20 per cent on extracting actual LLP, is Golden Batch Analysis,
model to analyse sudden qual- ance. After the lull during the rently has a low level of digitali- insights. And many companies which according to him, is the
ity management system (QMS) pandemic due to travel con- sation. If capturing the data and stumble at this stage for a vari- best industry acceptable ap-
cues. And bringing up yet an- straints, global regulators are analysing it to find areas for im- ety of reasons. proach which can add value to
other use case, Bujji Reddy doubling down on pharma man- provement, saves money, time Experts also cautioned that Drug Manufacturing process.
Kanchi, GM-QC, Aragen Life ufacturing site audits. The past and results in better products, many companies have made the Explaining further, he said,
Sciences recounted how his or- year (2023) has seen an uptick then digitalisation contributes mistake of using different sys- “Golden Batch can help for-
ganisation was exploring digi- in risk-based regulatory audits. to quality." tems for different functions and malise an operational focus on
tal warehouse management For instance, the US FDA con- Mentioning that Cipla and end up with siloed data. Without continuous improvement as it
systems. ducted simultaneous audits in Dr Reddy’s Laboratories, with an integrated digital framework, lays the foundation for data-
Even though these compa- four pharma companies across two of their plants making the which allows the different parts driven operating procedures.
nies are at the start of their digital India in early December. An in- transition to globally certified to "talk" with other, deriving While it is initially reactionary,
journey, most seem to have crease in site audits has natu- Digital Lighthouses, are an aspi- analysis and insights would be a using historical data to identify
learnt that patience pays. De- rally led to a corresponding in- rational goal for the rest of the cumbersome process. ideal manufacturing conditions,
scribing his organisation's "baby crease in quality incidents, sector, "not just for regulatory As Sanjay Sharma, Sr VP & Golden Batch can start a com-
steps", Krishna Reddy, Sr VP- many of them linked to data in- compliance but because it Head of MS&T, Zydus Life- pany on a journey toward pre-
Operations, Zenara Pharma said, tegrity, human error and vari- makes sense for our business sciences, pointed out, "Data is ventative analytics.”
"If you have the right data and ability of manufacturing data. model. Only then will companies being collected, but collating it While regulators are using
analytics tool, the insights can be Digitalisation is being touted invest in digitalisation." and getting insights is now the IT tools and platforms curated
very rich." as a must-have solution for im- Shah also cautioned that the pain point." Sharma also cau- by companies like SAS to iden-
Some companies have man- proved quality systems and sector is not focusing enough on tioned that regulators and in- tify the pharma manufacturing
aged to digitise faster than their therefore better regulatory the product development phase, dustry have different perspec- sites with the highest risk, how
peers. For instance, Eris Life Sci- compliance. As Parimal identifying the right process pa- tives of digitalisation. For can pharma companies also
ences seems to have had a Brahmbhatt, Sr GM – QA, Uni- rameters, quality attributes, instance, in April 2022, the US harness the same tools to proac-
smoother digital journey. Shar- son Pharmaceuticals pointed making a golden batch, etc FDA came up with the Quality tively prepare for audits?
ing his experience of going from out, "When your data is digital, which results in a lack of data Management Maturity (QMM) Experts were frank in their
zero to 90 per cent digital, Tan- it gives you the confidence to and comes back to haunt the model, according to which they assessment of the areas for im-
veer Shah, Head-Quality, Eris face audits without fear. Audi- company at the scale-up phase. want the industry to self-regu- provement. Abhay Sinha, Head
Life Sciences said, "When you tors too trust digital data." Het- Underlining another mind- late. He spoke of the need to CQA, Otsuka Pharma reiter-
digitise, it's the truth. Saving the ero Labs' Shetiya too averred set change required, Shah make digital transformation ini- ated an oft repeated message,
data should be seen as an invest- that digital data gives compa- lamented, "We don't consider tiatives commensurate with an- "We need to change our mind-
ment and employees should not nies the confidence to face even the intangible benefits (of qual- ticipated regulations/regula- set, encouraging a quality cul-
worry about when the data will seemingly irrelevant queries ity), only the costs." tory expectations. As he put it, ture. We need to understand
be used. The lack of data leads to from auditors. Narrating her experience, "The real value of digital trans- that quality is not just the job of
variability, inconsistencies. Highlighting a key concern, Kajal Patel, Sr VP - Plant Opera- formation initiatives would be the quality assurance team but
Therefore management should Mahesh Nerkar, VP-Site Head, tions, Hester Biosciences too to help companies prepare for of each employee. We need to
consider digitisation as an invest- BDR Pharma pointed out, "Hu- agreed that due to a lack of in- anticipated regulations/regula- think more long term. There is
ment, there will be a payback." man error is a huge concern and vestments in variability studies tory expectations, by reducing a big gap between what we
Dr Damodharan Muniyandi, digitisation is the only solution. at the new product development batch failures, quality incidents write and what we do. We need
Chief Quality Officer - Global Which is why systems like elec- stage, companies may have a lot etc." to make the system simple, feasi-
Quality & Regulatory Affairs, Sai tronic batch records (eBMR) of data but if it is not saved sys- ble and acceptable."
Lifesciences recounted how his give a lot of confidence." tematically, they cannot gain too Navigating the digital Brahmbhatt of Unison Phar-
company has seen how data in- The resistance to change, many insights. This leads to rep- future maceuticals hinted at the lack of
tegrity has resulted in opera- the generation gap, the lack of etition of past studies, which is IDMA's Shah summed up the qualified QA/QC personnel
tional excellence, and his personnel who understand both a loss of time, effort and re- dilemma facing the sector well while many other experts un-
company's evolution from digiti- IT and pharma and lastly, sources." when he said, "Everyone agrees derlined the need for reliable
sation, digitalisation to digital budget constraints are the four that digitisation is the way for- validated equipment.
transformation. main reasons for the poor up- From data to insights ward; the question is how and Thus, the journey to a digi-
While core functions like take of digital initiatives, accord- Digitalisation also underscores when." tally empowered future in the
manufacturing might be lag- ing to Dr Shrenik Shah, the evolving role of data in the As Ajay Tomar, Practice pharma industry necessitates
gards in going digital, Harpal Director, Montage Laboratories. pharma sector. Leveraging data Lead, Healthcare and Life Sci- cultural shifts, strategic use of
Vala, Founder Director, Kepler He pointed out that even regu- effectively can unveil pathways ences, SAS India explained, “In technology, and investments in
Healthcare pointed out that data lators of much smaller African towards informed decision- the goal of producing safe, high- human and technological
analytics has already added im- nations insist on five-day audits, making, improved manufactur- quality, and cost-effective prod- capital. This, in turn, will facili-
mense value in the sales and therefore there is no choice but ing processes, enhanced prod- ucts in a more agile way, a key tate a holistic and sustainable
marketing domain, allowing to go digital. uct quality and operational imperative that SAS analytics evolution towards operational
managements to track sales, However, as Dr Viranchi excellence in the pharma land- suite delivers is to generate in- excellence, quality assurance,
derive real time insights on Shah, National President, scape. sights from existing data and and regulatory compliance.
performance of both products as IDMA & Director, Saga Labora- But, capturing digital data is deploy them in the manufactur-
well we people and tweak tories cautioned, "Quality sys- just the first step. Extracting in- ing of future products, thus [email protected]
strategies on the go. tems should be put in place to sights from this data is the next making the process pre- [email protected]

22 EXPRESS PHARMA
January 2024
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 bio- local partners with strong ments, including R&D and com-
pharma (EBP) compa- market access and commercial- mercial operations. A notable
nies continue to drive isation capabilities will be example includes Novo
global medical innovation, with crucial for successful launches. Nordisk’s commitment to dou-
Asia Pacific playing a central bling its manufacturing capabil-
role. Novel drug discovery India’s influence on the ities in India by 20256. India’s po-
processes, advances in preven- biopharma sector litical and economic ambitions
tative care and the leveraging of continues to grow are clear and so it is likely to re-
big data sets make this a truly The Indian pharma industry is main a competitive place for
exciting sector to study. Al- primed for exponential growth, pharma players to do business
though it won’t be plain sailing, with industry experts predict- for many years to come.
2024 promises to be a crucial ing a $130 billion valuation by
year for EBPs and the wider 2030. The current growth tra- Decentralised clinical
pharma and healthcare indus- jectory indicates that the indus- trials, but heavy traffic is
tries. Here are a few key devel- try will surpass its projected slowing down wider
opments to look out for: 2045 valuation of $450 billion4, implementation
and there has been a significant 2023 saw a perhaps predictable
Funding for EBPs remains 298 per cent jump in pharma-re- slowdown in the adoption of de-
hard to come by lated investment deals during centralised clinical trials (DCTs)
Against the backdrop of a tough the third quarter of 2023 com- compared to the COVID-19 pan-
financing environment, elevated pared to the previous year5. demic years as many countries
by rising interest rates, the While India is well-estab- returned to their pre-pandemic
biotech and biopharma sector lished as a global powerhouse status quo. Without the strong
remains highly competitive, for generic medicines, there has incentive to perform remote pa-
with many new and existing been a gradual shift in R&D ac- tient monitoring, more tradi-
players competing for a finite tivities to other strategic areas tional clinical trial models have
pool of funding. Many venture such as biosimilars, complex been favored. That said, legisla-
firms are now focused on help- generics, and new chemical and tion in some countries has set
ing their existing portfolio com- biological entities. The matura- the scene for more decen-
panies survive the squeeze, re- ments, similar to the trends tion to invest, which in turn can tion of India’s regulatory envi- tralised implementation of clini-
sulting in reduced novel observed in 2023. lead to an innovation slowdown. ronment coupled with vast pa- cal trials in the future. China, for
investments. HSBC has noted As a result, we may see more tient populations and lower example, has recently issued
early investment in biotech Drug pricing pressures pharma companies entering research costs makes India an (July 2023) new guidelines sup-
startups was on pace to fall by create ripple effects strategic partnerships to attractive proposition for porting the implementation of
40 per cent in 2023 compared to Drug pricing is under increas- mitigate the challenges associ- clinical research. This not only DCTs through the use of
20221, and this downward trend ing scrutiny across markets, ated with R&D and commercial- enables broader access to novel telemedicine7. Moreover, re-
is expected to continue into the including economic power- isation. In August 2023, Daiichi therapeutic innovations for In- gions such as Beijing, have also
upcoming year. This challenging houses such as China and the Sankyo announced a multi-year, dian patients but also creates in- been encouraging local pharma
financing environment may US. Recent policy enactments, multi-asset partnership with creased commercialisation op- players to run DCT pilot proj-
force many EBPs to rethink for example, the US’s Inflation Merck to support the portunities in what is now the ects8. This formal recognition of
their valuation expectations. Reduction Act to help reduce commercialisation of their world’s most populous nation. the value of DCTs in China, may
Aside from venture capital out-of-pocket prescription costs highly anticipated antibody- Higher interest rates have well pave the way for broader in-
funding, larger pharma compa- for patients2, and price negotia- drug conjugate (ADC) portfolio. resulted in increased opera- terest in DCTs across APAC in
nies, which serve as a signifi- tion systems, such as China’s This collaboration supplements tional costs for businesses 2024, especially in a cost-con-
cant funding source for EBPs, price control system are start- their existing partnership with worldwide. Pharma companies strained environment.
are also likely to be less inter- ing to bite into profit margins, AstraZeneca, and will focus on are looking towards shifting a
ested in deal-making. particularly affecting rare dis- the launch of their first ADC, portion of their business opera- Cell and gene therapies
Ongoing economic pressures ease drugs and precision oncol- Enhertu, in diverse markets. tions to emerging markets such break into the mainstream
may hinder them from invest- ogy medicines3. There may be a surge in such as India to achieve greater cost We are seeing the expansion of
ing in small biotech firms and Depending on the breadth partnerships in the coming efficiencies. Several leading chimeric antigen receptor
instead focus their capital on and effectiveness of these initia- years, especially as the world pharma companies have estab- (CAR) T-cell therapy beyond its
their existing pipelines or tives, multinational pharma shifts towards deglobalisation. lished their presence locally initial application to treat hema-
specific platform-play invest- players may lose their motiva- In this environment, the value of across diverse business seg- tological malignancies such as

24 EXPRESS PHARMA
January 2024
myeloma, acute lymphoblastic 6. Business Standard (2023). 2023. braces-decentralized-clinical-tri- ogy (2023). CAR T-Cell Therapy.
leukemia and non-Hodgkin’s Novo Nordisk to double India 7. Pacific Bridge Medical (2023). als-dct/. 28 Nov 2023. Available from:
lymphoma9, and into orthope- manufacturing, bring new drugs China Embraces Decentralized 8. Han Kun Law Offices (2023). https://cfch.com.sg/cellular-ther-
dics, organ transplantation, and by 2025. Available from: Clinical Trials (DCT), Bethesda China DCT Regulation and Im- apy/. 28 Nov 2023.
neurology. The world’s first https://www.business- CHPBM 7315 WAS 400W, plementation (2023). Available 10. TIME (2023). The World’s
CRISPR gene-editing therapy standard.com/companies/news/i Japan, Singapore, Kong H, India from: First Approved CRISPR Treat-
was approved in November ndia-part-of-all-global-clinical- affiliate partners in, Indonesia, et https://www.hankunlaw.com/en ment. Available from:
2023 in the UK for sickle cell dis- trials-of-danish-drug-major- al. Available from: /portal/article/index/cid/8/id/13 https://time.com/6336222/crispr-
ease and transfusion-dependent novo-nordisk- https://www.pacificbridgemed- 488.html. 28 Nov 2023. therapy-gets-u-k-approval-the-
â-thalassemia10. This approval is 123062000553_1.html. 28 Nov ical.com/news-brief/china-em- 9. Centre for Clinical Haematol- first-in-the-world/. 28 Nov 2023.
a significant landmark for the
biotech industry, potentially set-
ting the stage for a new genera-
tion of gene-editing therapies to
be approved for conditions that
were previously considered un-
treatable, as well as injecting a
timely boost into the gene edit-
ing R&D universe. CRISPR-
based therapies face similar
challenges as CAR-T in terms of
cost and the substantial health-
care infrastructure needed for
treatment administration, and
therefore, 2024 holds potential
for innovation beyond the treat-
ment itself.

References
1. BioPharma Dive (2023). Early-
stage biotech funding on pace to
drop 40% in 2023, HSBC report
shows. Available from:
https://www.biopharmadive.com
/news/biotech-venture-capital-
hsbc-report-norris/689313/. 28
Nov 2023.
2. Greenberg Traurig LLP
(2022). China on the Move: Les-
son from China’s National Nego-
tiation of Drug Prices in 2022 |
Insights | Available from:
https://www.gtlaw.com/en/in-
sights/2023/2/china-on-the-
move-lesson-from-chinas-na-
tional-negotiation-of-drug-prices
-in-2022. 28 Nov 2023.
3. POLITICO (2023). Why Big
Pharma might think twice about
running away to America. Avail-
able from:
https://www.politico.eu/article/e
u-drug-price-regulations-big-
pharma-think-twice-america/ 28
Nov 2023.
4. Organization of Pharmaceuti-
cal Producers of India. Reimagin-
ing pharma and healthcare for
India @100. 2023.
5. The Pharma Letter (2023). In-
dia’s pharma and healthcare sec-
tors maintain investment appeal
despi. Available from:
https://www.thepharmaletter.co
m/article/india-s-pharma-and-
healthcare-sectors-maintain-in-
vestment-appeal-despite-vol-
ume-decline. 28 Nov 2023.

EXPRESS PHARMA 25
January 2024
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 setback, and with the
the funding winter for maturity of biotech funding,
startups. Do biotech the scenario will change. As
startups have to worry far as the current biotech
about a funding winter? If funding in India is
yes, how do they prepare for concerned, aside from
it? How do they survive it? grants, BIRAC also has a
A funding winter for biotech venture capital arm, or what
startups is a concern. It has we call alternate investment
been there since the funds - Biotechnology
inception of biotech Innovation Fund - AcE
startups. However, there has (Accelerating
been constant improvement Entrepreneurs), etc. Here,
in the funding scenario for we don't directly invest but
these startups. Many of partner with alternate
them are trying to connect investment funds and other
with foreign venture venture capitalists who
capitalists and attract invest in biotech. We
capital, which was not so indirectly fund these venture
frequent earlier. The reason funding companies. I think
was that they were not ready as the ecosystem grows,
for it. BIRAC has made more such funds will emerge,
many of them venture ready so that the winter, as you
by funding them through mentioned, will slowly turn
proof of concept, into springtime very soon.
Biotechnology Ignition
Grant Scheme (BIG), and Dr Kumar, you have been a
other grants. biotech researcher,
However, we don't want scientific mentor,
these companies to move to entrepreneur, and have
different countries, at least been part of various
not at this stage. Venture incubation centers before
funding from a foreign joining BIRAC. What do
country may force them to you feel are the pain points
set up in that country, which for biotech entrepreneurs
some startups might do to in India? As your term as
attract venture funding. head of BIRAC has just
These actions are not started, what is your
healthy for theIndian vision to address these
ecosystem, but I believe that pain points?
over time, market forces will The primary challenge for
take over, and the startups lies in the
indigenous capital infusion availability of facilities and
in biotech will grow. There resources for proof-of-
will be many venture concept studies. With 75 bio
capitalists funding these incubation centers in place
companies. (across India), startups can
So, there is a temporary secure infrastructure and

26 EXPRESS PHARMA
January 2024
equipment for such studies. dynamic nature of participation and nation can benefit from different branding. As we
However, a critical gap innovation requires considering the their entrepreneurship are the largest consumer
exists in access to pilot-scale constant updates to these establishment of a platform and innovation. BIRAC market globally, it's crucial
or scale-up facilities. For regulatory frameworks. for startups to interact with introduced five global to be cautious about our
instance, manufacturing BIRAC's First Hub venture funding companies. startups to India during most prominent innovations
clinically graded materials programme aims to bridge Encouraging interactions the recent Global Bio- being harvested,
for trials might not be this gap by providing between startups and larger India 2023. What is your repackaged, and sold back to
feasible in the current training sessions and companies, including MNCs, rationale for bringing us at a premium.
incubation center setup, as fostering awareness. can offer mentorship and global startups to India? While market forces will
GMP facilities are often Additionally, creating an potential opportunities for If our startups aim to inevitably operate, and
unavailable. This inability to interface between acquisitions and mergers. explore foreign markets and startups seek exits and
scale up poses a significant regulatory bodies like Addressing these expand globally, it is funding, I believe that, over
pain point. Startups might CDSCO and startups is challenges requires a multi- perfectly acceptable. In fact, time, as India's economy
initiate projects at a smaller crucial to ensuring a fair faceted approach, including becoming a global player is grows and the ecosystem
scale but face challenges chance and streamlined enhancing access to scale- encouraged. matures, indigenous venture
when attempting to scale up processes. up facilities, keeping My concern lies in the capitalists will emerge. This
to 100 litres or 1000 litres The third challenge regulatory frameworks practice of "flipping," where emergence could slow down
for field-level studies or revolves around early-stage updated, exploring equity- startups from India are the trend of foreign venture
clinical trials. GMP and even venture funding. While seed based funding strategies, acquired by multinational capitalists infusing money
non-GMP facilities are not funding is available, and fostering collaboration companies or venture into our startups and
easily accessible, adding to subsequent funding for between startups and larger capital mechanisms, leading subsequently relocating
the hurdle. clinical trials may be companies to facilitate to a shift in offices to them.
Another major pain point insufficient. Government acquisitions and mergers. another country. This BIRAC can play a crucial
is the substantial regulatory bodies like BIRAC face results in the loss of role in this scenario by
challenges. Startups may limitations in catering to all You said that you would innovation for our country, helping startups grow and
lack awareness of the funding requirements. like to keep startups from and the products developed scale through the creation of
existing regulatory To address this, BIRAC is India within India and not abroad may return to India alternate investment funds
frameworks, and the exploring equity move out because then the at a higher cost with and venture creation

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EXPRESS PHARMA 27
January 2024
STRATEGY

mechanisms. offering a vast market for engineers. This funding from the BIRAC the interests of startups,
Despite the current their products. The key is to collaborative ecosystem is side, requires particularly when equity is
challenges, I foresee a bright make companies aware of supported by both reinforcement, particularly involved.
future for the Indian biotech the opportunities in India. government initiatives and in terms of equity funding.
ecosystem, with numerous The complex landscape, co-investments from Recognising that Its reassuring that you
startups emerging and the which may include issues stakeholders. sustainability cannot rely would like India to be the
potential for deep tech like finding free land, Drawing inspiration from solely on grants, the third magnet for
startups from public-funded pollution control board successful models like the aspect centers around biomanufacturing. What
research institutions. clearance, etc., should not Catapult in the UK, efforts creating a robust regulatory would you say to naysayers
To enhance innovation, I deter companies from are underway to promote a landscape. This involves who predict that India will
propose creating manufacturing in India. By similar framework in India enhancing awareness and miss the biotech bus?
mechanisms for generating creating awareness and through government framing regulatory I would like to emphasise
spin-offs from public-funded facilitating soft landing intervention. This model structures that that we have not missed the
research institutions. While options, we can attract aims to attract foreign accommodate the needs of biotech bus, especially when
industries may not invest in more companies to India, investments and companies startups and emerging we contribute 90 per cent of
deep science tech due to a fostering a mutually to India, while also innovations. vaccines and
focus on quick returns, the beneficial global market for encouraging larger Indian The fourth point pharmaceuticals to the
translation of discoveries biotech startups. companies to establish their emphasises the importance world. We are the pharmacy
into new products or manufacturing units within of interconnecting the entire of the world. Indeed, we
technologies can be India's biotech industry these bio-foundries. Indian biotech ecosystem. won't miss the bus.
facilitated through clocked $92.3 billion in The primary goal is not Collaboration between The only area where we
mechanisms like those 2022, and the vision is to solely for established larger companies and might lag is in early-stage
BIRAC is working on. achieve the ambitious companies to manufacture, startups is key, mirroring innovation, but the field is
Looking globally, we targets of $150 billion by but also to facilitate the successful practices exponentially growing. We
should identify startups 2025 and $300 billion by development of pilot-scale observed abroad where are at a nascent stage, but
interested in expanding into 2030. What is BIRAC doing facilities for startups, multinational companies with exponential growth. To
India. While acquisitions to achieve these targets? addressing the scaling-up have established corporate ensure we stay on top, we
may occur due to market To achieve our outlined challenges discussed earlier. venture funds. need to provide significant
forces, my primary intention objectives, a pivotal strategy By creating these bio- Furthermore, the fifth support and emphasis on
in bringing five startups involves the establishment foundries, startups gain strategy encourages bigger newer technologies like
here is to encourage them to of bio-foundries and a robust access to pilot-scale facilities companies to actively artificial intelligence,
explore the Indian market. biomanufacturing base. The within an ecosystem that collaborate and financially CRISPR, CAR T-cell
BIRAC can provide soft government is poised to includes both larger support startups. Corporate therapy, and others, from
landing options, helping allocate funds for the companies and startups. venture funding is the government side. We are
them navigate the Indian creation of these bio- This integrated highlighted as a potential already making strides in
market and eventually set foundries, representing an environment is anticipated avenue for fostering this direction.
up operations. advanced evolution of to foster numerous mergers collaboration and knowledge I express my sincere
I envision India becoming bioincubation centers. and acquisitions, exchange. gratitude to Dr Jitendra
a magnet for the global These bio-foundries are contributing to industry However, it's Singh, Minister of State
biotech manufacturing designed to cater not only to growth. The government has acknowledged that (Independent Charge,
market. Despite the capital startups but also to larger demonstrated a strong negotiations between Ministry of Science and
strength of countries like companies. They offer both commitment to establishing startups and larger Technology and Rajesh S
the US, the market is in pilot-scale and full-scale these bio-foundries. companies may be Gokhale, Secretary, DBT,
India. By showcasing India's manufacturing capabilities, Additionally, a second challenging, potentially Government of India for
potential at events like complete with regulatory crucial strategy involves leading to acquisitions at their constant support.
Global Bio-India, we can clearance, experts in fortifying the AcE funding lower valuations. To address
attract companies to set up regulation and intellectual mechanism. AcE funding, this, BIRAC is positioned to [email protected]
manufacturing bases here, property, as well as process including venture capital play a role in safeguarding [email protected]

28 EXPRESS PHARMA
January 2024
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 escalat- unexplained discrepancy and directly impacted nine organi-
ing regulatory scrutiny sur- the failure of a batch or any of sations and was accompanied
rounding sterile facilities in its components to meet any of by extensive commentary from
India, a comprehensive evalua- its specifications, whether the the FDA inspector. The pri-
tion of Form 483 observations batch has already been distrib- mary focus of concern was
was undertaken. This initiative uted, is to be thoroughly aseptic behavioural issues, en-
was prompted by a proactive reviewed and investigated. compassing practices to pre-
anticipation of heightened reg- Section 22 discusses the re- vent microorganism contami-
ulatory risks for manufacturing sponsibilities of the quality con- nation during manufacturing.
sites in India after the pan- trol unit. The responsibilities These include utilising sterile
demic1. The assessment fo- should be in writing, and the instruments, adhering to
cuses on US FDA audit obser- quality control unit is responsi- proper gowning practices, and
vations and sheds light on the ble for approving and rejecting minimising movements to safe-
current landscape. It is a valu- all procedures or specifications guard the product's sterility.
able resource for organisations impacting the identity, The aseptic technique de-
aiming to implement prompt strength, quality, and purity of mands operators to follow spe-
remedial actions as they ap- drug products. Section 160 cov- cific behaviours in the clean-
proach the upcoming year, ers the need for scientifically room, such as deliberate and
2024 challenges. sound laboratory controls. Lab- slow movements, keeping body
The meticulous assessment oratory controls include estab- parts clear of HEPA-filtered air
documented all critical 2023 lishing scientifically sound and paths, and avoiding activities
Form 483 observations linked appropriate test procedures that may compromise product
to Indian sterile manufacturing designed to ensure that compo- sterility—skills that require
sites only. In addition to cata- nents conform to appropriate thorough training. The impor-
loging these observations, the standards. Ensuring compli- tance of the first air principle,
analysis discerned crucial in-
sights and patterns, enabling
the authors to propose optimal
strategies for addressing and
preventing potential regulatory
challenges. By offering proac-
tive measures, the authors aim
to guide pharma organisations
in maintaining a continuous
and secure supply chain, ensur-
ing resilience in the face of
evolving regulatory land-
scapes. The FDA Form 483 is a
document that lists observa-
tions made by the FDA repre-
sentatives during the inspec-
tion of a facility, highlighting Figure 1: 2023 FDA Form 483 Observations for Indian Sterile Figure 2: Isolator Systems provides a Grade A environment without
any potential regulatory viola- Manufacturing Facilities maintaining a Grade B background, ensuring operational ease
tions. It is issued when, in an in-
vestigator’s judgment, the ob- Regulations (CFR) Title 21, cal contamination of drug ance with these sections is cru- especially in Grade A enclo-
served conditions or practices Part 211, contains the minimum products purporting to be ster- cial for ensuring ongoing risk sures during aseptic filling as-
indicate that an FDA-regulated current good manufacturing ile, including the need for ade- mitigation at Indian sterile sessments, was underscored,
product may violate guide- practice for the preparation of quate validation of the aseptic manufacturing facilities. highlighting the critical role of
lines2. drug products. Section 113 of and sterilisation processes. An in-depth examination unidirectional airflow in con-
Most observations (30 per the CFR Title 21 discussed the Section 192 of the CFR Title 21 was conducted on the 21 CFR tamination prevention. Obser-
cent) were associated with 21 procedures for sterile drug pertains to production record 211 section 113(b) observations, vations also focused on visual-
CFR 211 sections 113, 192, 22, products, specifically those de- review, investigations of dis- representing the most preva- ising air movement and
and 160. The Code of Federal signed to prevent microbiologi- crepancies, and failures. Any lent findings. The observation ensuring first air integrity dur-

EXPRESS PHARMA 29
January 2024
POLICY

ing aseptic processing. Cru- are related to the responsibili- tance of thorough and proac-
cially, addressing interventions ties of the quality control unit tive measures, particularly in
emerged as a pivotal factor in and the need for scientifically developing a culture of sound
ensuring the adequacy of asep- sound laboratory controls. Ac- hypothesis generation and rig-
tic processing simulations cording to the observations orous investigation supported
where organisations fell short. concerning section 22, the by technically competent
The regulatory focus on ad- quality unit seemed to be teams. Further, the observa-
dressing challenges in aseptic struggling with issuing and tions indicate the need for or-
behaviour highlights a clear controlling manual paper docu- ganisations to modernise their
drive for organisations to shift ments such as BMR, logbooks, data management systems and
toward resilient isolator tech- etc., and managing manufac- embrace technological solu-
nology immediately without turing and lab non-electronic tions for enhanced oversight.
second thinking. This transi- data. Data integrity continues The deficiencies in microbiol-
tion aims to reduce depend- to be questioned, which essen- ogy controls emphasise the ne-
ence on personnel behaviours tially calls for adopting quali- cessity of a well-staffed and
and environmental controls fied electronic systems on the technically sound microbiology
when producing aseptic prod- floor and in the labs. The regu- department. The examination
ucts, marking a departure from lator has also questioned the has brought to light the multi-
hanging on to traditional RABS lack of real-time camera over- faceted challenges faced by
systems. It is important to note sight of aseptic operations. Or- sterile facilities in India with
that RABS is still a viable op- ganisations are still reluctant potential solutions. Our conclu-
tion for terminally sterilised to have cameras for such criti- sions are based on hard evi-
products and should be limited cal operations, which backfires dence and should be useful for
to this category. with continued operator viola- organisations to take the rec-
As well established3, isolator Figure 3: 483 Observation Trend tions of aseptic practices, in- ommended immediate action-
technology offers significant ability to investigate and ulti- able measures, including in-
technical advantages for asep- tamination control strategy viable particle counter excur- mately, loss of regulator vesting in training and
tic filling by establishing a (CCS). Regarding technological sions. However, the incidents confidence. Section 160 obser- technology to continue suc-
physical barrier between the upgrades, regulatory tools like did not require identifying root vations were primarily related cessfully serving the regulated
sterile processing area and op- ICH Q124 may facilitate a seam- causes and an impact assess- to misses from the microbiol- markets.
erators. This reduction of hu- less transition to isolator tech- ment of components and prod- ogy department. In certain in-
man activity, a significant nologies, mitigating potential ucts present during the inci- stances, the sterility testing re- References
source of contamination, leads supply disruptions. dent. There were several quirements were not followed. 1. Key Post-Pandemic Trends In
to a higher sterility assurance The second most observed incidents of lab OOS investiga- The regulator was questioning Global FDA Observations For
level (SAL). Additionally, isola- 21 CFR Part 211 section is 192 tion inadequacies, primarily the selection adequacy of the Drug Facilities
tor systems support efficient about production record re- where the hypothesis was not media supporting environmen- https://www.outsourced-
decontamination processes, view, investigations of discrep- categorically supported by tal isolate’s growth promotion. pharma.com/doc/key-post-pan-
such as vaporised hydrogen ancies, and failures. Almost all data and/or studies such as It was found that the qualified demic-trends-in-global-fda-ob-
peroxide (VHP) sterilisation, the observations were related forced degradation. In one in- incubation conditions were not servations-for-drug-facilities-0
contributing to microbial con- to the inadequacy of a robust stance, glass contamination followed for a bioburden study. 001
trol within the isolator. The investigation. In one instance, was determined as the root The regulator identified dehy- 2. FDA Form 483 Frequently
aseptic processing of sterile the observed OOS TOC value cause. However, the firm failed drated media plates for moni- Asked Questions
drugs and the manipulation of was not thoroughly investi- to identify what that contami- toring as part of the walk- https://www.fda.gov/inspec-
sterile starting materials and gated to determine the root nant was. Overall, the higher through. There were instances tions-compliance-enforcement-
components should occur in a cause. Moreover, there was a number of observations re- where microbiology EM moni- and-criminal-investigations/in-
Grade A setting with a Grade B notable absence of proactive lated to robust investigations toring results were reported, spection-references/fda-form-48
backdrop. While the interior of measures for preventive main- questions the existence of a although samples were not col- 3-frequently-asked-questions#
the isolator must comply with tenance. Regulators perceived technically sound quality unit lected. In one case, the video 3. FDA Guidance for Industry
Grade A standards, there is no this approach as insufficient in that can question the investi- proved that no settle plates Sterile Drug Products Produced
mandate for the isolator to be adequately addressing the gation inadequacies in a timely were in place for EM. All these by Aseptic Processing- Current
situated in a Grade B environ- identified observation. The As- manner. Sterile facilities must incidents highlight the essen- Good Manufacturing Practice,
ment. With advanced monitor- say OOS was attributed to in- develop a culture of developing tiality of having a well-staffed Appendix 1
ing and control systems, isola- strument malfunction and an- sound hypotheses, validating 24x7 microbiology department https://www.fda.gov/regula-
tor technology allows real-time alyst error in another incident. their soundness through thor- to succeed. tory-information/search-fda-
tracking of critical parameters, However, the assessment was ough evaluation of supporting The aseptic behavioural guidance-documents/sterile-
enabling prompt identification not extended to the other evidence and determining the problems and the inadequacy drug-products-produced-aseptic
of deviations and ensuring reli- products the instrument mal- adequacy of the generated of robust investigations under- -processing-current-good-manu-
able aseptic filling processes. function may impact. The regu- data to prove the hypothesis score the critical need for or- facturing-practice
The regulator wants to min- lator also found that multiple categorically. Beyond a well- ganisations to rethink. The reg- 4. ICH Q12 Technical and regu-
imise contamination risks as visual inspection failure investi- RCA-trained quality unit inves- ulator's emphasis on aseptic latory considerations for phar-
much as possible and ensure gations did not isolate and tigation office, it is imperative techniques, first air principle, maceutical product lifecycle
organisations adopt technolo- identify the white/black partic- to have a cross-functional, and interventions necessitates a management
gies that allow the regulator to ulates to identify the root technically sound team to chal- shift towards resilient isolator https://www.fda.gov/regula-
gain confidence. Organisations cause and determine the cor- lenge all investigation plans technology to minimise re- tory-information/search-fda-
persisting with RABS systems rective and preventive meas- and outcomes for organisa- liance on human behaviours guidance-documents/q12-techni-
are anticipated to encounter ures. isolation and identifica- tions to succeed in today's en- and environmental controls. cal-and-regulatory-consideratio
ongoing challenges with re- tion of particulates not having a vironment. The observations related to in- ns-pharmaceutical-product-life-
spect to justifying their con- root cause. Facilities had non- 21 CFR Sections 22 and 160 vestigations stress the impor- cycle-management-guidance

30 EXPRESS PHARMA
January 2024
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 packaging has witnessed
pharma label market tremendous growth in terms of
technology and innovation
T
he fight against counterfeit pharmaceu-
ticals heavily relies on pharma labelling,

C
which is increasingly popular due to its hange is constant. This is
versatility, convenience, and variety of patterns aptly applicable for pharma
and styles. packaging and labelling. The
The pharma label market, including pres- changes are continuous, sometimes
sure-sensitive, glue-applied, sleeve, and in- easy to implement and sometimes
mould labels, is expected to reach $6.9 billion very disruptive. Pharma packaging
by 2025, with a compound annual growth rate has witnessed tremendous growth
(CAGR) of 5.3 per cent from 2020 to 2025. in terms of technology and innova-
The top five trends are expected to have an tion to compete in generic market
impact on the world market for pharma labels. against giant brand leaders who
These five trends, according to the majority of have patented products.
industry participants and experts, will hasten Avinash Kumar Talwar, VP - MRO & Pkg. Material When we talk about pharma
advances in the pharma label sector in the near Sourcing (Strategic & Plant), Global Supply Chain packaging, primarily focus is on pri-
future. Management, Dr Reddy's Laboratories mary packaging, then secondary
◆ Adoption of label design for expanded con- packaging. What’s hot is implemen-
tent: The extended content label is a versatile, label product: Label manufacturers are invest- tation of new Chapter 661 of USP
multipage solution for packaging containing ing in eco-friendly labels and promoting sus- Plastic Packaging Systems and
regulatory and multiple language content. It tainability. For e.g. Avery Dennison and UPM Their Materials of Construction Chandi Prasad R, Head-Packaging,
can be applied to various sizes and forms, pro- Raflatac have launched recyclable and with sub chapters: Plastic Materi- Aurobindo Pharma
viding additional space for visuals and coupons, biodegradable labels. The pharma labelling sec- als of Construction and Plastic
making it an effective marketing strategy. tor is evolving, and industry leaders must adapt Packaging Systems for Pharmaceu- means new technology of substrate,
◆ Increased demand for coloured labelling: to current/new developments. Pre-fillable sy- tical Use. Implementation is De- printing machinery and suitability
Colour printing labels enhance brand marketing ringes, inhalers, and containers will hold great cember 1, 2025. The objective is es- on labeling machines. Serialisation
and consumer retention. They are increasingly potential. tablishing chemical safety and aggregation as part of track
used in healthcare for product differentiation, Understanding development patterns is assessment with combination of and trace requirements of regu-
offering time savings and security measures. crucial for players to develop long-term strate- chemical testing and toxicological lated and emerging markets again
Colour codes and pictures facilitate brand, size, gies that will ultimately lead to success. assessment. This chapter involves is an example of disruptive change,
and model differentiation. For instance, the following are some strate- elaborate testing which requires which was a major project of
◆ Cryogenic labelling: Pharma labels specifi- gic factors that participants in the pharma la- about 30 USP reference standards. the Indian pharma industry for the
cally designed to survive extremely low tem- bel industry should take into account in order Labels and labelling are part of last five years.
peratures are known as cryogenic labels. Be- to capitalise on growth momentum: cGMP requirements of any country Digitalisation of prescribing,
cause there is a growing requirement for ◆ Enhanced capacity of pharma industry partic- and compliance to requirements is patient information and connecting
ultra-cold cryogenic storage, cryo labelling is ipants to create sustainable labels keeping re- mandatory. Some safety related up- medical practitioners and patients
expected to continue growing. Its use in la- cyclability in mind. dates must be implemented immedi- through QR code/Augmented Real-
belling the package used to distribute the ◆ Players' attention is drawn to near-field com- ately that disrupts supply chain in ity; smart packaging by device and
COVID-19 vaccination has helped it acquire munication (NFC) tags and RFID labelling procurement of revised versions, IoT enabling patient convenience
popularity. technologies. packing operations and supply of and adherence of dosage; inclusive
◆ Labels for counterfeiting protection: La- ◆ Investing in advanced technologies like high that product to market as commit- packaging for people of all abilities;
bels are essential in protecting against pharma- security anti-counterfeiting programs, such as ted. The font size recommendations green or sustainable packaging us-
ceutical counterfeits, as they instill trust in cus- tamper-evident labels, pallet-banding, and NFC for text on labels by Health Canada ing manufacturing techniques and
tomers. Businesses often use covet photos, tags, can enhance product security and prevent has unlocked new avenue of multi- packaging materials which reduces
descriptions, and verification techniques, along counterfeiting. layer labels from a conventional la- energy use and harmful impact of
with tamper-proof labels, to prevent counter- ◆ Research and development efforts aimed at bel to accommodate text with statu- packaging on environment are fu-
feiters from selling inferior drugs. creating some affordable label solutions specif- tory font sizes in two languages ture trends influencing pharma
◆ Use of recyclable and biodegradable ically for generic market. English and Canadian French. This packaging.

EXPRESS PHARMA 31
January 2024
PACKAGING

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

P
ackaging and labelling requirement. In the last decade We have also discussed much labelling to brand the product, I
have come a long way in though, industry has seen about smart packaging, but in am reminded of old products be-
the last few decades, es- changes in packaging require- my opinion, more was discussed ing marketed for the last few
pecially in the pharma sector. In ments, mainly due to serialisa- than being implemented. Now, it years, which also need a revamp.
my opinion, labelling has a major tion requirements by various is time to make them for con- A good rebranding exercise can
role in the transformation of countries, however, it was more sumers. Innovation is said to be be undertaken from a labelling
packages as it is the one seen of a compliance than innova- successful only if it can be easily perspective.
and felt by the customer. First tion. All companies making ex- marketed . We have also seen good mo-
impression is always to be cre- ports to the EU have started us- I can also see a lot of growth mentum in the vaccine world,
ated. ing tamper evident stickers, in the devices segment, thereby a entry of small batch manufac-
Now, when you look over and a few have gone with self good amount of jobs for packag- tured products, gene therapy
2024 and beyond, the future is sealing of cartons with new ma- ing and labelling for it. The etc. This will create a good
bright with newer technologies chines in place, which is a huge branding for devices via attrac- amount of work for industry in
and young entrepreneurs trying investment by itself. Now, the tive labels can be a turning point. cold chain packages, its valida-
to work on new ideas. market has to come up with the Ajay Bapat, Consultant, Packaging At the same time, attention is re- tion, and labelling.
In yesteryears, most of the findings if there is a significant Concepts quired over communication to Overall, a very challenging
industries, especially Indian in- decrease in counterfeiting and consumers on failure of devices, job for packaging guys in the in-
dustry has looked upon packag- how good was the consumer re- up and even our own Indian root cause and why so many dustry and I am sure of success
ing as a cost cutting, down sponse. drug laws are being modified to recalls are happening in this at the end.
gauging instrument rather than Going forward as well, there cover many aspects of labelling comparatively new segment. Wishing all of us a wonderful
a marketing tool or a product are multiple regulations coming and new guidance on devices. While talking about new 2024!

The integration of innovative technologies into pharma packaging is transforming

patient interactions with medications

T
he pharma industry is in teractive features, such as QR belling. Tamper-evident features, interactive and engaging experi-
a perpetual state of evolu- codes, NFC tags and augmented including seals, holograms and ences that provide comprehen-
tion, and it undergoes reality is providing patients with other security measures, safe- sive details, dosage guidelines
constant transformation driven access to detailed product infor- guard product integrity and pre- and user-friendly instructions.
by shifting consumer prefer- mation, dosage guidelines and in- vent unauthorised access. Data One-size-fits-all approaches
ences and evolving regulatory teractive support materials. integrity systems ensure accu- no longer suffice in an age where
frameworks. The trends shaping Track-and-trace technology, in- racy and traceability throughout patient-centric care is para-
pharma packaging and labelling cluding serialisation and barcod- the supply chain, complying with mount. Pharma companies are
play a pivotal role in ensuring ing systems, is enhancing supply global serialisation and track- adopting personalisation to cater
product safety, regulatory adher- chain visibility, helping in the pre- and-trace regulations to combat to individual patients’ needs.
ence and patient engagement. vention of counterfeiting, thus as- counterfeit drugs. Printing personalised medica-
suring product authenticity. Also, tion schedules, dosage instruc-
What’s working packaging, equipped with sen- What’s not working. tions and multilingual labelling
Sustainability is a fundamental sors and data communication ca- Rrajesh K Khosla, President & Obsolete practices are swiftly have become essential practices.
principle in the pharma sector, pabilities, monitors environmen- CEO, AGI Glaspac giving way to a new wave of stan- Embracing stringent security
reflecting a heightened focus on tal factors during storage and dards that prioritise sustainabil- protocols encompasses the adop-
environmentally responsible transport, ensuring optimal strengthen brand identity. ity, innovation and enhanced tion of tamper-evident features,
packaging solutions. It includes product quality and patient Accessibility and usability are user experiences. such as seals, holograms and ro-
the adoption of eco-friendly ma- safety. gaining prominence in packaging Excessive packaging, once an bust data management systems.
terials, such as biodegradable, re- Another trend is the move to- design, while recognising the di- accepted norm, now faces severe The evolving trends in
cycled and recyclable options, ward personalisation in packag- verse needs of patients. The inte- scrutiny as environmental con- pharma packaging and labelling
such as paperboard, plant-based ing solutions, aligned with the gration of universal design princi- cerns and consumer awareness reflect a broader industry-wide
plastics and bio-based inks for rising demand for patient-cen- ples, such as large fonts, braille intensify. The push for stream- commitment to a healthier, more
various packaging components. tric care. It involves printing per- and tactile cues caters to patients lined, eco-responsible packaging sustainable future. As companies
Moreover, reducing packaging sonalised medication schedules, with visual or physical impair- solutions is steering pharmaceu- pivot towards eco-friendly mate-
weight and simplifying packag- dosage instructions and warn- ments. Child-resistant closures tical companies towards using rials, innovative labelling, person-
ing design to decrease material ings directly on packaging to im- have become a staple to enhance materials and designs that min- alised solutions, accessibility en-
consumption and enhance re- prove adherence to dosage fre- medication safety and prevent imise waste, reduce the environ- hancements and heightened
source efficiency is gaining trac- quency and reduce medication accidental ingestion. Similarly, mental impact and optimise re- security measures, they not only
tion, alongside the implementa- errors. Multilingual labelling senior-friendly designs, featuring source use. meet evolving consumer de-
tion of closed-loop systems for caters to diverse patient popula- easily openable closures and Similarly, the days of static mands but also adhere to strin-
packaging retrieval, recycling tions and complies with interna- clear instructions, address the and limited labelling are seeing a gent regulations. This collective
and re-usability. tional regulations. Moreover, cus- needs of older patients. decline, replaced by a demand progress enhances patient en-
The integration of innovative tomisable packaging options In response to increased regu- for interactive and informative gagement and user experiences,
technologies into pharma pack- enable personalised design ele- latory scrutiny, compliance and packaging. Modern consumers contributing to a sustainable fu-
aging is transforming patient in- ments, which aim to elevate pa- security remain pivotal priorities seek more than just basic prod- ture for both the industry and the
teractions with medications. In- tient engagement and in pharma packaging and la- uct information. They now want planet.

32 EXPRESS PHARMA
January 2024
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 considered—compatible mate- systems have also emerged to
civilisation has crossed rial options, operational flexibil- meet these expectations. Pack-
multiple milestones ity, user convenience, logistics aging and labelling for all types
driven by various socio-eco- and distribution requirements, of formulations (including solid
nomic and geo-political factors. inclusion of promotion and pro- and liquid orals, granules and
These changes have prompted tection features, impact on the powders, ophthalmic and in-
people to adapt to their environ- economy and ecology, and so on. jectables, small and large vol-
ment for survival with sustain- All these need to be within set ume parenteral, creams and
ability. The industrial revolution quality and regulatory norms ointments, lotions and gels, ear
began in the pursuit of excel- from internal and external agen- and nasal drops, etc.) under-
lence in every aspect of our daily cies. Printing, coding, stamping, went various changes, and
lives. With the inflation in popu- embossing are integral parts of many formulations are supple-
lation, large-scale demands trig- labelling (used to capture mented by effective drug deliv-
gered the need for mass-scale static and variable text /graph- ery and administration devices.
production and distribution. We ics/data) that also evolved simul- Such devices like inhalers,
adapted and promoted globali- taneously. aerosols, PFS, nebulisers,
sation and consumerisation for Globally, the pharma indus- patches, etc. are used for the
better resource distribution and try is considered one of the pres- precise delivery of drugs with
larger societal benefits. We have tigious, progressive, and flag- better convenience. Different
now reached the fourth stage of ship industries, directly ancillary/supplementary items
the industrial revolution in this connected to the healthcare sys- like custom-designed spoon,
evolutionary journey and are tem for the survival and sustain- measure cup, dropper, cutter,
making rapid progress to create ability of human civilisation. syringe, applicator, etc. also
a pathway for the fifth. Good, healthy members of any evolved for ease in administra-
Every industry sector is community are the real assets tion for many drug formula-
poised to grow by adopting for society to propel growth and tions.
changes infused by this mass- development of civilisation. Even though utmost care is
scale production and distribu- processes for all types of health- dustry sectors. Globalisation and consumerisa- taken during development and
tion system. The demand for all care products. The beauty of the packaging tion created new opportunities execution, external conditions
types of goods increased mani- The first and foremost re- and labelling sector is that it is to do business beyond bound- sometimes cause damages to
fold due to consumerisation, quirement for a product to be essential for each category of aries, and pharma packaging the product-packs that are be-
and business processes became distributed is that it requires products, utilising a variety of has spread its wings to cover a yond control. Apart from such
borderless due to globalisation. packaging for holding and pro- materials, including paper, plas- wide array of applications. Sup- physical transit damages, other
The importance of essential tecting it from the external en- tics, rubber, glass, metal, wood, ply networks are spread across external threats like duplication
items boosted due to lifestyle vironment. It also requires a la- and composites (combinations the globe to ensure access to es- or cloning, theft or pilferage,
transformation. Human health, bel for identification and of two or more materials). Ac- sentials to the farthest corners adulteration, and diversion also
being critical for survival, re- delivery to the end user with cordingly, different conversion of the world. Geographic and de- increased in parallel and chal-
ceived equal attention, and the safety and security. Healthcare processes evolved to suit prod- mographic challenges are new lenged the industry/suppliers to
healthcare sector progressed or pharma products are no ex- uct requirements. While paper- opportunities to find innovative combat it. The industry has
substantially to support a sus- ception. Products and their based packaging replaced solutions to keep the products taken on the challenge, and sup-
tainable lifespan. Parallel evolu- packaging and labelling comple- wooden packaging in many ap- as fresh as originals. Packaging pliers have adopted various
tion in science and technology ment each other and are essen- plications, different types of and labelling, the real protector tools and techniques to over-
not only helped identify the root tial to support safe and secured polymeric resins or plastics and and trusted carrier of the prod- come these challenges. How-
cause of ailments but also aided distribution from the point of composites changed the entire ucts, are serving their duties ever, unlike the earlier days, now
in finding remedial actions, in- production to the point of deliv- landscape of the packaging with due diligence to facilitate it. the technology is evolving rap-
cluding the development of ap- ery. We have witnessed a very world. They replaced heavier Over the years, our expecta- idly. New challenges are creat-
propriate application processes. swift transformation in the materials like glass, metal, and tions have evolved alongside ing new opportunities, and new
All these progressed in tandem, packaging and labelling sector woods in the majority of appli- global competitiveness. Various versions are quickly supersed-
and today we are much better too during the last five to six cations. When designing pack- new molecules discovered, new ing the older versions.
equipped to support mass-scale decades to keep pace with the aging and labelling for a prod- formulations developed, and We have walked a long
production and distribution lateral pressure from other in- uct, multiple factors are new delivery and dispensing way from slow and low-yielding

EXPRESS PHARMA 33
January 2024
PACKAGING

manual operations to auto- moisture/ oxygen/odour-ab-

mated and integrated high- sorbing materials, development
yielding mass-scale processes Apart from basic requirements for assurance on of closure with in-built desic-
with the progress of the indus- cant, etc. Introduction of multi-
trial revolution at various product stability and quality, the current trends in layer bottles for moisture/gas
phases. Additionally, with the
adoption of digitisation and
pharma packaging and labelling are focused more barrier, use of different colours
in bottles for light protection.
wireless technology, many of on comfort and convenience to the consumers, Similar examples are there for
the processes realigned not all types of pharma dosage
only to boost productivity but safety and security to the supply chain, support to forms, including solid and liquid
also to control all the processes
with more accuracy. Now, each
sustainability, protection to the environment and orals, granules and powders,
ophthalmic and injectable for-
unit operation is precisely con- ecology, and so on mulations, small and large vol-
trolled to ensure each finished ume parenteral, creams and
pack meets stringent quality ointments, lotions and gels, ear
norms, thereby ensuring pa- tions consistently. Each unit op- Digital checks ensure electronic /medium/large volume par- and nasal drops, etc. Apart
tients/users are safe and se- eration on a packaging line has and wireless features are func- enteral. from product identification and
cured. The input material selec- certain fixed and certain vari- tionally compliant. Chemical ◆ Unit dose packs and characterisation, labels and la-
tion and the pack designs, able parameters to set and con- and organoleptic checks involve card/wallet packs gradually belling also underwent multiple
equipment selection and their trol the process. These parame- parallel laboratory tests and made inroads to support mobil- transformations to cope up
customisation, and packaging ters are derived from the specification compliance. The ity and convenience. with the growing need from
line setup are being improvised component and equipment absence of abnormal color, odor, ◆ Similarly, prefilled syringes business.
to envisage a linear process specifications, qualifications, and taste are also ensured gradually replaced or are re- Few significant transforma-
with as much simplicity and and validation. During the de- through chemical tests/checks. placing conventional glass am- tions in labels and labelling over
flexibility as feasible. The mate- signing phase, components and Some of the significant poules and vials for mobility and the years:
rial conversion industry also equipment are customised for transformations in packaging convenience. ◆ Conventional cut or pre-
geared up alongside, and a per- the intended operations. During and labelling systems: ◆ Medicated patch/transder- gummed label replaced with
fect end-to-end industrial the qualification phase, various ◆ Strip pack→Thermoform mal patches/mouth-dissolving pressure sensitive sticker label
ecosystem is established to sup- challenge tests are done to verify blister→Tropical blister and thin films – These NDDS cate- and shrink label.
port the cause. the intended functionalities, and cold form blister gories of drugs evolved to sup- ◆ Plastic, metal, and compos-
Apart from basic require- during the validation phase, pa- ◆ Standard blister design→ port convenience and accuracy. ites (paper, plastic, metal based)
ments for assurance on product rameters are optimised for the Customised design ◆ Aerosols/roll-ons are making replaced conventional paper as
stability and quality, the current best operating range. (Calendar/Compliance packs) inroads for many medications label substrate in many applica-
trends in pharma packaging Process controls are de- ◆ Glass bottle→Plastic bot- for effectiveness and conven- tions.
and labelling are focused more signed and monitored depend- tle→Flexible sachet and pouch ience. ◆ Starch and silicate adhesive
on comfort and convenience to ing on the product, packaging packs ◆ Similarly, inhalers (MDI/DPI) gradually disappeared due to
the consumers, safety and secu- and the line configuration, keep- ◆ Glass ampoule or vial→Blow- are already established and cre- the introduction of plastic resin-
rity to the supply chain, support ing quality, regulatory and pa- fill-seal container and prefilled ated their own space for effec- based cold and hot glue.
to sustainability, protection to tient compliance in mind. There syringe tiveness and convenience. ◆ Single color linear graphics
the environment and ecology, are two basic types of controls – ◆ Aluminum tubes→Plastic or ◆ Plastic/lami-tubes gradually transformed to multicolor tonal
and so on. Evolution in automa- protective (to support product laminated tube packs replacing the metal collapsible and digital graphics.
tion is supplemented further by stability and quality) and com- ◆ Metal closures→Plastic clo- tubes for aesthetics and accept- ◆ Inclusion of functional value-
optics, electronics, digitisation, municative (to support connec- sures with induction sealing ability. added features like braille text,
robotics, and wireless commu- tivity establishment with the provision, child-resistant and ◆ Conventional blister with multilayer label, hanger label, la-
nication. All these have helped user). Adequate controls are fol- tamper-proof feature, closure foil/PVC started using high bar- bel with leaflet, etc.
develop various safety and secu- lowed during product manufac- with in-built desiccant options rier PVdC (Diofan), PVdC/PVC, ◆ Inclusion of value-added
rity features on packaging and turing stages to ensure prod- ◆ Tear-off or tear-down clo- PVC/PE/PVdC, PVC/ACLAR, smart features (including elec-
labelling to strengthen con- ucts meet all the visual, physical, sure→Flip-off or flip-top seals and other combinations, which tronic digital features) to sup-
sumer convenience, supply digital, chemical, and organolep- ◆ Conventional closure→ Sin- are now commercially available. port brand promotion and
chain security, and customer tic properties. When a product gle dose and metered dose dis- Halogen, vinyl, and nitrosamine- brand protection.
communication. Many custom- comes for packaging, adequate pensers free materials are also being ◆ Interactive labels where a
made technology-driven solu- precautions are taken to ensure ◆ Conventional glass or metal used commercially to avoid hu- customised digital feature en-
tions, like nanotechnology, aug- the retention of its originality container→Aerosol containers man health risks. Other materi- ables consumers for direct ac-
mented reality, virtual imaging, during various stages of opera- ◆ Custom designed ancillary als like HDPE, PP, PET, COC, cess or interact digitally. All
digital graphics, personalised tions. Visual checks are mostly items – Spoon / measure etc. are also being explored for such developments are hap-
branding, interactive packaging, qualitative and include the aes- cup/dropper, drug delivery/dis- mass-scale applications. pening and being implemented
track and trace, blockchain, IoT, thetic appearance of the pack, pensing/ administration devices ◆ Introduction of cold form ma- not only in compliance with in-
AI, etc. are derived to boost the intactness of the product inside like syringes/applicators, etc. terial, blister in pouch ternal operational and quality
entire industry sector in the the pack, absence of foreign ma- ◆ Plastic container-closure sys- with/without desiccants, tropi- requirements but also in com-
quest for achieving excellence. terial or defective product, la- tem gradually replaced the glass cal blister (thermoform-cold pliance with external statutory
All these developments also belling precision, clear legibility and metal container-closure form combination), introduction and regulatory norms. Evolu-
brought precision in various of static and variable data, accu- systems. of desiccant-coated lidding and tion of digital technology and
process controls, which support racy of content inside the pack, ◆ Cold-form technology created forming materials (Dessiflex), wireless communication in all
quantity and quality with mini- etc. Physical checks like the cor- its own space replacing the con- paper-based laminates for lid- industry sectors has brought
mum variations. Process con- rectness of input materials, suit- ventional strip and blister ding material, etc. new dimensions and set new di-
trol is one of the critical require- ability as per line configuration, packs. ◆ Introduction of plastic bottles rections to keep up the momen-
ments to ensure product-packs behavior during high-speed run, ◆ BFS/FFS technology with induction sealing liners, in- tum for the next stage of indus-
meet the designed specifica- rejection rate, seal integrity, etc. adopted for many small clusion of silica gel and other trial revolution.

34 EXPRESS PHARMA
January 2024
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EXPRESS PHARMA January 2024 35

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IMPLANT / CO-EXTRUSION SETUP

36 January 2024 EXPRESS PHARMA

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POLSTAT 1000
HEATING AND
COOLING SYSTEM
FOR LABORATORY,
PILOT AND
PRODUCTION

MADE IN
INDIA

FEATURES
Ÿ High Precision Temperature Controlling - ( +/ - ) 0.5 Deg.C Ÿ Remote Operations

Ÿ Temperature Range ( - ) 40 to 200 Deg. C Ÿ Available for Zone-1 Installation

Ÿ Intelligent Temperature Controller Ÿ Made in India

Ÿ Automatic Execution of Temperature Profiles Ÿ 100% Substitute for Imported

Ÿ Enhanced Heating & Cooling Capacities Ÿ DCS/ PLC Compatible

Ÿ Flexible to Customize as per Process Need Ÿ Supports Modbus TCP / IP Protocol

Ÿ Safety Interlocks Ÿ Digitally Connected

POLMON’S CAPABILITY MATRIX

• INSTRUMENTS • AUTOMATION • HEAT TRANSFER SYSTEMS
• SERVICES • MEDICAL DEVICES

CORPORATE OFFICE
POLMON INSTRUMENTS PVT. LTD.
Polmon House, Nizampet Road, Kukatpally, Hyderabad - 500 085 Telangana India
Authorised System Integrator T: +91 40 2305 7308 / 3046 [email protected] www.polmon.com
& Galaxy Partner Since 2001 Your trusted partner for Process & Analytical Instrumentation

EXPRESS PHARMA January 2024 39

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40 January 2024 EXPRESS PHARMA

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M. K. Silicone Products Pvt. Ltd.

OsmoTECH® XT Single S I L I C O N E T R A N S P A R E N T T U B I N G
- Sample Micro-Osmometer for the Quality Conscious….

Now available!
Best-in-class osmolality performance,
designed with you in mind.

HIGHLIGHTED FEATURES:
Offers the widest range of osmolality testing (0 – 4000 mOsm/kg H2O)
RTIFIED
Supports 21 CFR part 11, GMP and EU Annex 11 compliance Quality CE
Meets Pharmacopeia osmolality testing guidelines
3 Level user access and password protection
Products IS0 8
INDIA Since
Storage: unlimited data storage for access QM 002

1997 L

M
C
An ISO 9001-2015 COMPANY EA O
Audit trail: Preserve unlimited results and events NRO
Database backup, protects your data with automatic or manual backup

208, Hill View Industrial Premises,

No. 127, Bussa Udyog Bhavan, Tokershi Jivraj Road, Sewri West, Mumbai-400015, Amrut Nagar, Ghatkopar (W), Mumbai - 400 086, India.

Blue Heaven
Maharashtra, Landline : +91 022 - 24166630 Mobile : +91 9833286615
Mob.: 9321965968 / 9869412342
E-mail : [email protected]

42 January 2024 EXPRESS PHARMA

 BUSINESS AVENUES EXPRESS PHARMA

TSA solves process and high purity

challenges for pharma and biotech
companies everywhere.
Water System, Process Vessels and Sterilizer
Let's talk about Water System,
Process Vessels and Sterilizer

Reverse Osmosis with Electro de ionisation

Pure Steam Generator Autoclave Multi Effect Distillation Skid

Sterile Mixing Vessels

#701, Star Hub 1, Behind ITC Maratha Hotel, Sahar Road, [email protected]
Andheri East, Mumbai - 400 059. India
www.tsaprocessequipments.com
+91-22-69607000

EXPRESS PHARMA January 2024 43

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® ® ®

44 January 2024 EXPRESS PHARMA

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To Advertise in

Business Avenues

Email: [email protected]
[email protected]

46 January 2024 EXPRESS PHARMA

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EXPRESS PHARMA January 2024 47

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st
1 Indian Company to launch ‘CE’ approved products
st
1 Indian Company to launch LOW RH Humidity Chamber
Following GMP Guidelines

BOD Incubator Walk In Humidity Chamber Cold Chamber

Temp Range : 10°C - 60 °C Temp Range : 20°C - 60 °C

Temp Range : 2° C to 8 °C
Accuracy : ±0.2 °C Humidity Range : 40%RH to 85%RH
Accuracy : ±1.5 °C
Uniformity : ±1 °C Accuracy : ±0.2 °C / +2.0 % RH
Uniformity : ±2 °C
Uniformity : ±1.0 °C / +3.0 % RH

93200 65656 [email protected] www.mackpharmatech.com

48 January 2024 EXPRESS PHARMA

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54 January 2024 EXPRESS PHARMA

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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 in- particles, ensuring uniformity in aphragms ensure uniform distri-
dustry has witnessed sig- size and eliminating any impuri- bution and accurate dosing of
nificant advancements in ties. These devices play a crucial the materials, preventing cross-
manufacturing processes and role in maintaining product contamination and maintaining
technologies, particularly in the quality, enhancing process effi- product quality. They serve as
production of oral solid dosage ciency, and meeting regulatory key components in various
forms. As manufacturers strive standards in pharmaceutical equipment, such as tablet
to improve efficiency and pro- pharma applications, ensuring manufacturing. presses, capsule filling ma-
ductivity, the choice of consum- the integrity and quality of the 7. O-rings and gaskets: O-rings chines, and powder filling sys-
able supplies becomes crucial. In oral solid dosage manufacturing and Gaskets are crucial compo- tems, enabling efficient and pre-
this article, we will explore the process. nents in oral solid dosage lines, cise production of oral solid
various types of consumables 5. Silicone hoses: Silicone hoses ensuring proper sealing and dosage forms.
used in oral solid dosage line ing processes. By inflating and are commonly used in oral solid containment of pharma prod-
along with their application and creating a tight seal, they pre- dosage lines due to their excel- ucts. These specialised rubber Conclusion
how they can enhance manufac- vent contamination and ensure lent compatibility with pharma- or elastomeric seals are used in In the pharma industry, the
turing processes in the pharma- product integrity during tablet ceutical products. These hoses equipment such as tablet choice of consumable supplies
ceutical industry. compression, filling, and packag- offer high temperature resist- presses, capsule filling ma- plays a critical role in optimising
ing operations. Inflatable seals ance, flexibility, and durability, chines, and packaging lines. manufacturing processes. By in-
Some of consumable sup- enable efficient and reliable pro- making them ideal for conveying They provide a barrier against corporating these high-quality
plies in OSD lines duction while maintaining high tablets, capsules, and granules. moisture, air, and contaminants, polymer-based solutions into
1. Bellows: Bellows are flexible, quality and regulatory compli- They maintain product integrity, maintaining the integrity and their operations, pharma manu-
accordion-like components typ- facturers can enhance efficiency,
ically made of materials like sili- improve productivity, and main-
cone or rubber. Bellows are com- tain the integrity of their prod-
monly used in oral solid dosage ucts.
lines to facilitate precise and Overview of Ami Polymer:
controlled filling of medication Ami Polymer is a renowned
into capsules or tablets. By cre- manufacturer and exporter of
ating a vacuum, the bellows en- high-quality rubber products
able accurate dosing and mini- and polymer-based solutions.
mize air entrainment, ensuring We specialize in producing a di-
consistent drug delivery and verse range of products such as
maintaining product integrity Silicone tubing & hoses, O-rings,
throughout the manufacturing Gaskets etc. The FDA, USP
process. Class VI, REACH, and RoHS are
2. Dust cups: Dust cups are de- just a few of the international
signed to capture and collect ex- standards and laws that Ami
cess dust particles generated Polymer products abide by and
during the manufacturing these validate our adherence to
process, ensuring product clean- international standards and un-
liness and integrity. B and D derline our dedication to deliver-
tools, on the other hand, are spe- ing reliable and sustainable solu-
cialised equipment used for tions to industries worldwide.
tasks such as tablet compression Along with this we provide tech-
and tooling changeovers, ensur- ance in oral solid dosage manu- prevent cross-contamination, quality of the dosage forms. nical support and knowledge to
ing efficient and accurate pro- facturing. and meet stringent hygiene re- They play a vital role in ensuring our customers with a team of
duction of oral solid dosage 4. Tubing: Thermoplastic Elas- quirements. Silicone hoses also the safety, efficacy, and shelf life of qualified professionals.
forms. These tools play a crucial tomer (TPE) tubing are com- exhibit good chemical resistance oral solid dosage production
role in maintaining quality and monly used in oral solid dosage and are easy to clean, ensuring lines.
productivity in pharma manu- lines. These flexible and durable the safety and quality of oral 8. Diaphragms: Diaphragms
facturing lines. materials provide excellent solid dosage manufacturing play a crucial role in oral solid Contact
3. Inflatable seals: These seals, chemical resistance, allowing for processes. dosage lines. These thin, flexible Omraj Nakhawa
typically made of flexible mate- the safe transfer of pharma in- 6. Sieves and screen: Sieves and barriers are placed within the Executive – International
rials like silicone or rubber, pro- gredients and products. TPE screens are vital components in equipment to regulate the flow Marketing
vide airtight and secure closures tubing are designed to meet the oral solid dosage lines. They are of powders and granules during Mob: +91 7436000552
in pharmaceutical manufactur- stringent requirements of used to separate and classify the manufacturing process. Di- Website: www.amipolymer.com

56 EXPRESS PHARMA
January 2024
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 pharmaceu-
ticals which is, gov-
erned by strict norms
and regulations must operate
with utmost efficiency. Testo
provides the best-in-class solu-
tion for comprehensive data
monitoring and management
for equipment as well as envi-
ronmental parameters in
pharma industry called as the
testo Saveris Pharma. It is an
automated system that is inte-
grated in the facility and consti-
tutes of wireless or Ethernet
probes installed at different lo-
cations 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 meas-
urement values violate the de-
fined limit values. Some advan-
tages of testo Saveris Pharma dit-relevant parameters from all over the facility from Application areas throughout the process in a very
for environment and equip- ◆ The data is stored in the 3000 channels. The four testo Manufacturing/ Production systematic way – from planning,
ment monitoring system in- probes, so even if software con- 150 data logger modules can be area | Research & QC labs | documentation, system qualifi-
clude: nectivity is lost the data is safe flexibly combined with the Cleanrooms and data centers | cation and software validation
◆ Holistic system comprising and can be downloaded once three communication modules Warehouses and packaging | through to service and support.
sensors, software, and services the software is logged in (WLAN, LAN, testo Ultra- Deep freezers, refrigerators, Testo also has a NABL accred-
◆ In accordance with 21 CFR ◆ Real time alarm facility to Range) making it very conven- cold rooms | Incubators, Stabil- ited service and calibration LAB
Part 11 and GAMP compliance highlight unexpected results ient and user-friendly system ity test and walk-in chambers | that takes care of the after sales
◆ Provides seamless recording, Testo Saveris Pharma sys- along with the web-based, intu- Blood and tissue banks | Auto- support locally from Pune.
automated tamper proof docu- tem consists of testo Saveris itive cockpit to detect alarms, claves and nitrogen tanks | Ster-
mentation base V 3.0 which is the core initiate corrective measures ilizers and many more For more details, login to
◆ Secure triple layer storage of component of the system. It and to acknowledge them Testo's specially trained www.testo.com or write to
the measurement data of all au- manages and evaluates data whenever necessary. service team supports you [email protected]

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) is the per- Bioreset® represents the
peroxide (V-PHP or fect solution for complying most technologically ad-
VHP) bio-decontami- with all Annex 1 requirements vanced, effective and rapid
nation is a process of surface for bio-decontamination of biodecontamination systems
sterilisation that has been ex- isolators, cleanrooms and for reducing the microbiolog-
tensively validated and used in RABS as it provides: ical contamination of air and
the pharma industry for many Microbial efficacy: Annex 1 surfaces in classified environ-
years. In fact, VHP is one of the requires that the isolator and ments or all areas sensitive
most commonly used sporici- RABS are thoroughly decon- to biological contamination.
dal agents for bio-decontami- taminated and that there is no Produced in Italy by Amira,
nation of cleanrooms, isolators, evidence of microbial contam- Bioreset® range includes dif-
RABS and other controlled en- ination after the decontami- ferent models and solutions
vironments. nation process. VHP bio-de- meeting the specific needs of
Annex 1 of the European contamination is capable of different applications, from
Union's Good Manufacturing achieving the same target of the biodecontamination of
Practice (GMP) guidelines sets sterilisation on exposed sur- single room and isolators, to
out the requirements for the faces, being able to provide a the design and construction
manufacture of sterile medici- consistent and reproducible 6 of integrated systems in con-
nal products. Annex 1 includes log reduction on most resist- trolled contamination envi-
specific requirements for the ant microorganism (Geobacil- ronments. Bioreset® solu-
design and operation of clean- lus stearothermophilus). tions are extensively
rooms and other controlled en- Validation: Annex 1 requires installed and used worldwide
vironments, including RABS that the decontamination for rapid and effective biode-
systems. These requirements process is validated to ensure contamination of multiple ap-
cover areas such as environ- that it is effective in removing plications including clean
mental monitoring, personnel or destroying microbial con- room for sterile production,
and material flow, contamina- taminants. VHP bio-deconta- isolator, autoclave, BSL-3
tion control and bio-decontam- mination can be easily vali- laboratory, pass box, aseptic
ination procedures. dated as it is able to reach all filling line machine and wash-
difficult areas and provide re- ing machine.
V-PHP biodecontamina- liable results over time also in If interested in 6 Log re-
tion in Annex 1 decontaminated by a validated and specifies the implementa- complex layouts. duction on all exposed sur-
Bio-decontamination is widely method prior to each manufac- tion of properly validated Minimising the risk of prod- faces, no residue, effective
mentioned in chapter 4 - turing campaign. …” methods to achieve this result. uct contamination: Annex 1 and repeatable cycles, fast
Annex 1. In fact, a properly validated This is also well mentioned requires that the bio-deconta- restoration of operating con-
As explained in the Annex 1 bio-decontamination process in chapter 4.22 (ii) where An- mination process be designed ditions, high flexibility, maxi-
glossary, bio-decontamination can achieve, on exposed sur- nex 1 specifies about RABS bio- to minimise the risk of prod- mum safety for the operator
is intended to be a process able faces, the same result as a ster- decontamination: “The sporici- uct contamination. H2O2 vapor and the environment, user
to eliminate all biological con- ilisation process (e.g. 6 Log re- dal disinfection should include leaves no residues behind friendly and graphically inno-
tamination from exposed sur- duction on most resistant the routine application of a spo- demonstrating to be in full vative software, pre-sales
faces via use of a chemical spo- microorganism Geobacillus ricidal agent using a method compliance with this require- consultancy and after-sales
ricidal. stearotehrmophilus) that has been validated and ment. assistance, among the Biore-
The first time this word is V-PHP is also mentioned in demonstrated to robustly in- Safety: Annex 1 requires that set® models there is your best
mentioned is in chapter 4.20 (i) the Annex 1, specifically in clude all areas of the interior the decontamination process ally.
Isolators- point b: “Key consid- chapter 4.36: “Where fumiga- surfaces and ensure a suitable is carried out safely, with ap-
erations when performing the tion or vapour disinfection environment for aseptic pro- propriate consideration given Find out more on Bioreset® line,
risk assessment for the CCS of (e.g.Vapour-phase Hydrogen cessing.” to the health and safety of per- visit: https://www.amirasrl.com/
an isolator should include (but Peroxide) of cleanrooms and Validation of proper distri- sonnel and the environment. en/biodecontamination/bioreset/
are not limited to); the bio-de- associated surfaces are used, bution of sporicidal agent, as VHP is a perfectly safe and
contamination program, […]” the effectiveness of any fumiga- well as assurance of a proper environmentally friendly spo-
This provides immediate tion agent and dispersion sys- Log reduction compatible with ricidal agent as it turns into
evidence that this process is ex- tem should be understood and aseptic environment, are par- oxygen and water at the end
tremely critical for any isolator validated”. ticularly important in RABS of the decontamination
working in aseptic processes. The key to successful asep- Bio-decontamination as men- process.
In chapter 4.21 (ii) the bio- tic manufacturing is to main- tioned in the regulation.
decontamination process is also tain a rigorous control of the Bioreset® Systems: The
mentioned as alternative to microbiological contamination V-PHP meets Annex 1 best ally for V-PHP
sterilisation: “For RABS, gloves either in isolators, RABSs and requirements for RABS, biodecontamination
used in the grade A area should cleanrooms. For this reason, isolator and cleanroom Using vapor-phase hydrogen
be sterilised before installation Annex 1 pushes on routine bio- bio-decontamination peroxide (H 2O 2 V-Phase) as a
and sterilised or effectively bio- decontamination programs Vapor-phase hydrogen cold sterilising agent,

58 EXPRESS PHARMA
January 2024
 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