VOL. 19 NO. 3 PAGES 64 www.expresspharma.

in
MARKET
2024:
Healthcare
and Life Sciences
Investment Outlook

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 CONTENTS

Chairman of the Board

Viveck Goenka

Sr. Vice President-BPD

Neil Viegas

Vice President-BPD
Harit Mohanty

Editor
Viveka Roychowdhury*

Editorial Team
Lakshmipriya Nair Pg18
Kalyani Sharma

DESIGN
Art Director
Pravin Temble

Senior Designer
Rekha Bisht
MARKET IT@PHARMA STRATEGY HR
Senior Artist
LIFE SCIENCES
Rakesh Sharma
24 AND GEN AI 27
REVOLUTIONISING
OUTCOMES:
AGILE CROS LEAD
28
HOW FLEXIBILITY
FUELS INNOVATION
IN INDIA’S PHARMA
Marketing Team THE WAY AND HEALTHCARE
Rajesh Bhatkal EVENT
Ashish Rampure
PPL 2024: PHARMA TECHNOLOGY
Debnarayan Dutta
26 CHAMPIONING
INNOVATION, CASE STUDY:
Production Co-ordinator POWERING
PROGRESS
29 HEMOFARM
OPTIMISES
Dhananjay Nidre
CLEANING
PROCESSES WITH
Scheduling & Coordination QUICK-CHANGE
2024: HEALTHCARE
Pushkar Waralikar
14 AND LIFE
SCIENCES
PARTS AND
SECOND
IDENTICAL DIE
CIRCULATION INVESTMENT
TABLE
OUTLOOK
Mohan Varadkar

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EXPRESS PHARMA 9
February 2024
 EDITOR’S NOTE

Decoding the skirmish over

revised Schedule M
R
ecent regulatory changes have underlined General of India (DCGI).
the fissure between the large and mid- Acknowledging the need to upgrade to global MGP
MSME segments of the pharma sector. standards, the TN PMA asked for three years to
The most recent evidence of this fissure is implement the Revised Schedule M. They then
the representations of the pharma MSME approached the state government to take up their
sector to the Prime Minister's Office (PMO) and to state concerns with the central government about adoption
governments to defer the implementation of the Revised of the Revised Schedule M.
Schedule M of the Drugs Act 1940 that was amended by A Punjab-based pharma Special Purpose Vehicle
the Ministry of Health & Family Welfare vide (SPV) Pundrug Research Foundation, comprising 10
Notification GSR 922 (E) dated December 28 last year. pharma companies in Punjab, has also petitioned the
On January 25, the SME Pharma Industries PMO that if the government does not extend the
Confederation (SPIC) wrote to the Prime Minister timeline for pharma companies to comply with the
reasoning that the new Schedule M and price control Revised Schedule M, there may be multiple closures,
are incompatible, as they will lead to shortages of drugs leading to the shut down of their common facility due to
on the National List of Essential Medicines (NLEM). lack of users.
The association also predicts that supply of In the representation to the PMO dated January 9,
medicines to Pradhan Mantri Jan Aushadhi Kendras Both, large and 2024, Jagdeep Singh, Chairman, Pundrug Research
(PMJK) would also dry up in a year’s time, as less than 20 mid/small size Foundation pointed out that if the Revised Schedule M
per cent MSEs would survive after implementation of Notification is implemented within one year as
the Revised Schedule M. The remaining 20 per cent pharma stipulated, it would wipe out more than 130 units out of
would be unable to produce medicines for PMJK or companies, are 140 units in Punjab simply because units in Punjab bore
most of the NLEM medicines because the production the brunt of tax holiday in the neighbouring hill states
cost post implementation of the Revised Schedule M vital parts of for 14 years from 2003 to 2017. Therefore he stated that
would be higher than the permitted MRPs. India’s pharma the promoters of the SPV are unwilling to proceed (to
The SPIC letter claims that 80-90 per cent MSEs deploy the grants received) ‘unless the timelines for
have a turnover of below Rs.10 crore, as they are not sector, one implementation are spread between 5-10 years for units
based in states which enjoyed tax holidays from 2003 to serving export outside the erstwhile Tax Holiday States which includes
2017. These companies did not have the 30 per cent Punjab.’
advantage of their counterparts in tax holiday states and markets, the These representations underline the widening divide
are therefore nowhere near the Rs.250 crore slab
mentioned in the Notification. The letter alleges that
other serving the between the large and mid/small size pharma
companies. In fact, these associations are predicting that
such turnovers are prevalent in only 2000 units in the domestic the implementation of the revised Schedule M could
erstwhile tax holiday states for whom the Notification is
appropriate.
markets with spur shut downs, consolidations and mergers among the
MSME pharma sector. Both sides are vital parts of
As per the SPIC letter, the recent risk based joint affordable India’s pharma sector, one serving export markets, the
inspections also proved that 90 per cent of pharma units other serving the domestic markets with affordable
do not comply with the previous Schedule M,and
quality quality medicines. As we wait for the Interim Budget
therefore questioned its upgradation. The conclusion is medicines. The 2024-25 budget, it is not likely that Finance Minister
that the ‘amendment is motivated by Big Pharma and Nirmala Seetharama will make any big changes in the
vested interests - who claimed to be leaders of MSMEs.
government will last budget before the Narendra Modi government
Their real motive is profiteering by closing down need to engage readies itself for elections later this year. More
MSMEs to create pre 1960 conditions when prices of incentives for R&D and local manufacturing as well as
medicines was highest in India and shortages were
with and simplifying compliances to improve ease of doing
common.’ incentivise both, business sums up the basic pre-budget wish list for the
The letter concludes, that if affordable medicines pharma sector. In addition, the government will need to
especially for the poor have some significance in the especially in an engage with and incentivise both large and MSME
country, pharma MSMEs and their capacity to produce election year, to pharma companies, especially in an election year. While
affordable drugs needs to be preserved and hence the the temptation would be to merely placate the sector
New Schedule M should be kept in abeyance for MSEs bridge the and then ignore it, we only need to look back two-three
having less than Rs.10 crore turnover outside the widening divide years, to the start of the COVID pandemic, to convince us
erstwhile tax holiday states. that a healthy pharma sector is necessary for a healthy
Earlier, The Tamil Nadu Pharmaceutical between them population.
Manufacturers Association (TN PMA), representing
150-odd micro and small drug manufacturing companies VIVEKA ROYCHOWDHURY, Editor
of that state, had made a similar request in a letter to the [email protected]
Union Health Minister and to the Drug Controller [email protected]

10 EXPRESS PHARMA
February 2024
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MARKET
2024: Healthcare and Life Sciences Investment Outlook
Kapil Khandelwal, Managing Partner of El-Toro Finserve LLP highlights factors influencing the
industry, including geopolitical considerations, emerging trends, and specific outlooks for various
sub-sectors within healthcare and life sciences

I
n 2024, the world will be as and its returns will tend to out- new age skills certification, CME
uncertain, if not more, as it perform the market, as yields with AI-tools
was and anticipating what decline. ◆ What’s going right: Skill-mix
will happen next is an ever more ◆ As new Generative AI capabil- churn, upgradation of skills, AI
challenging task for our algo- ities emerge, the investments in for frontline workers
rithms and our teams. Since human capital for newer skills
2013, our algorithms have been are emerging. Also, newer mod- Med tech innovation and
accurately predicting the invest- els of ‘sweat’ equity/debt are life sciences discovery and
ment heatmap in the healthcare emerging. clinical development
and life sciences in India with ◆ Investments in newer health Capacity creation and new prod-
95 per cent accuracy on the sec- and wellness solutions to uct development continues as
toral investment cycle in India weather climate change are get- India is now into the China+1
till the end of 2019. Since the ting exciting. club. Expect a few IPOs this year
Covid pandemic in 2020 we low- ◆ M&A and buyouts are ex- in this sector. Government grant
ered levels of prediction accu- pected to continue, but lower funding will temper
racy like we started back in 2013. from the peak of 2022. down. Geo polities is a key
The fake narratives and echo ◆ How India plays its geopolitics risk to create supply chain
chambers that were peddled will also determine the quality disruptions.
during the pandemic years of and quantum of foreign invest- ◆ 2024 Outlook: Hot
2020-22 vitiated our predictions ments in India in the various sub ◆ What’s going wrong: IP regula-
during the pandemic years. 2023 sectors. tion, regulatory bottlenecks on
was even more unpredictable in clinical development, newer skill
many ways. Our algos do not Healthcare financing sets for research and accelera-
penetrate the terrorists, govern- Newer products for financing tion, PLI policy for sub sector,
ment intelligence and security healthy lifestyle for the Gen geo politics, supply chain disrup-
networks and hence are unable cated to China in their Asia Out- appear riskier, so the lower Alpha and Gen Z are emerging. tions
to consider events that play out look till 2022. However, health- prices in many kinds of equity in- Financing ‘idleness’ and healthy ◆ What’s going right: Human
in the Middle East, impacting care and life sciences sub sectors vestments might well yield at- entertainment lifestyle through capital, emerging social innova-
geopolitics, investments in In- in India have its divergence to tractive returns over time. innovative business models are tion models, right products se-
dian healthcare and life sciences the overall India outlook for ◆ Companies listed on the the key. There is a consumer lection, market appropriate so-
since some part of the invest- 2024. We have endeavored to bourses have always underper- shift for spending on healthy lution development, peptide
ment flows from offshore. bring out the deeper analysis formed the broader index in the lifestyle which is a personal in- based products, chronic dis-
Hence, we have made attempts and specifics out of the broad last two general elections of 2014 vestment in longevity of healthy eases product innovation for co
to analyse international ‘geo pol- ‘India Positive’ Outlook for 2024 and 2019 by -4.5 to -6.5 per cent. life. morbidities
itics’ as a separate factor and for the healthcare and life sci- We are expecting the elections ◆ 2024 Outlook: Moderate
bolt-on-top of our algo predictive ences sector in India. results to be neutral this time on ◆ What’s going wrong: slower Pharma and therapeutic
models to adjust our heat map The wave of optimism for the Indian bourses. A few big market/product innovation, solutions
for 2024. This would accurately 2024 in Indian healthcare and names to IPO in 2024. right bite for the consumers, Geo politics may affect supply
predict whether the heat is on in life sciences stems from the fol- ◆ With one-third of India’s popu- reach and penetration to New chain and missed topline and
our 2024 Heat Map. lowing: lation now constituting Gen Al- Gen consumers, financing costs profitability estimates. Cost
◆ The pace of digitisation is now pha and Gen Z, the health and ◆ What’s going right: India stack competitiveness like Chinese
2024: A year of geopolitics veering toward mainstream wellness aspirations of this co- digitisation, uberisation, AI solu- players to compete globally is
than geo economics adoption of Generative Artificial hort is the growing aspirational tions the key for growth. Expect a few
The biggest political event in In- Intelligence (AI) tools and solu- class that wants to live life post IPOs, buyouts and exits via sec-
dia in 2024 will be the Lok Sabha tions across that are being pi- Covid-19 differently and different Medical education ondary sale.
General Elections. Hence H1 loted. products and services will serve Valuations are correcting and ◆ 2024 Outlook: Moderate
2024 will not see any major pol- ◆ New business models/incuba- as the next growth opportunity. consolidation activity is acceler- ◆ What’s going wrong: price
icy or budgetary directions to tion for investments are emerg- ◆ The valuations have come ating. New regulatory regime controls, wrong product portfo-
the sector till the new ing that will be cross-domain back to realistic levels to the pre- will come into force and will re- lio, capacity scale up, global or
government takes over in New ◆ The bills and laws introduced Covid levels for primary and sec- quire investments in managing China-level cost competitive-
Delhi by June 2024 and presents in the Parliament are yet to ondary investments. the delivery and quality of con- ness, exit of PLI incentives,
its budget. For the first time, in shape bounce in investments. ◆ Debt and equity requirements tent. New skills for the new AI shortage of skilled workforce
the post pandemic era, almost all ◆ Muted returns in the private have stabilised as the cash- tools and newer consumer’s ◆ What’s going right: distribu-
global funds, analysts and markets will continue in 2024 as crunch situation during the pan- requirements are accelerating tion infrastructure, digital busi-
bankers have a unanimous con- the winter of private invest- demic have ‘normalised’ and so but not in the curriculum. ness models, government incen-
sensus on India’s positive out- ments continues in 2024. Let us are the return expectations. ◆ Outlook: Moderate tive programs
look for 2024, some even cover- understand that the best invest- Both are negatively correlated ◆ What’s going wrong: Align-
ing India as a separate chapter ments tend to occur during with yields globally. In other ment to new consumers and Healthcare providers
in their reports which was dedi- times when investment outlooks words, investments in equity care, increasing debt burden, High levels of leverage is still a

14 EXPRESS PHARMA
February 2024
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concern. Private equity invest- slowing improving as pricing fund and buy-outs, secondary growth. search, new product develop-
ments are slowing down due to and products are rationalized. exits. Expect an IPO. ◆ 2024 Outlook: Very Hot ment, inflated valuation, new
valuation expectations. Expect a Expect two IPOs of two ◆ 2024 Outlook: Hot ◆ What’s going wrong: regula- mass market business models,
few IPOs, buyouts and exits via major players. New products ◆ What’s going wrong: regula- tion, maturity to scale, new mass repeat sales, spurious social me-
secondary sale. Capacity cre- innovation for newer tion, operating margins, spuri- market business models, repeat dia channels, fake outcome/
ation is slowed down due to fund consumer’s requirements is ous social media channels affect- sales, spurious social media claims
crunch. lagging. ing consumer confidence, health channels, fake outcome/ claims ◆ What’s going right: discre-
◆ 2024 Outlook: Moderate ◆ 2024 Outlook: Hot UPI, time to scale ◆ What’s going right: newer tionary consumer spending,
◆ What’s going wrong: margin ◆ What’s going wrong: product ◆ What’s going right: consolida- cross-vertical innovative busi- newer cross-vertical innovative
pressures, price controls, execu- fit to consumer needs, product tion, newer cross-vertical inno- ness models, corporate wellness business models, mainstream
tion of programs on the ground, approvals, IPOs pricing and val- vative business models, prof- spending complementary treatment
supply and demand mismatch in uation itability focus, AI adoption and
micromarkets, debt financing ◆ What’s going right: Consumer models Alternative therapies Moving forward
costs, gun powder churn, oper- demand, reduced loss ratios New Gen consumers are seeking As one iconic smart investor
ating cash runway, liquidity and Wellness unique experiences. Their dis- said one should be investing in
working capital crunch, not ex- Health retail 2021 was the highest growth cretionary spends on mental healthcare and life sciences be-
ploring newer formats The Pharmacy Bill 2023 brings year in the last 10 years on the health and rejuvenation are cause you believe smart invest-
◆ What’s going right: asset-lite its own set of challenges. AI pi- back of discretionary consumer increasing. ing will yield results that are
models, medical tourism lots once mainstream will re- spending on wellness. Digital ◆ 2024 Outlook: Very Hot beneficial for society, not just to
duce costs and margin pressure business model innovation is still ◆ What’s going wrong: maturity enrich oneself.
Healthcare insurance albeit very slowly. The valuation lagging. Corporate Wellness to scale, consumer education Happy investing and stay
Loss ratios and profitability is is still a challenge for raising spends to continue to fuel and confidence, clinical re- strong!

The 2024 India Healthcare and Life Sciences Investment Heat Map

16 EXPRESS PHARMA
February 2024
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 cover )

Pharma companies in India should

advantageously position themselves with
strategic investments and collaborations
to harness the immense potential of cell
and gene therapies

By Lakshmipriya Nair

18 EXPRESS PHARMA
February 2024
EXPRESS PHARMA 19
February 2024
 cover )
T
he global cell and gene
therapy market is ex-
pected to reach $80 bil-
lion in 2029, with a high CAGR
of 51.6 per cent between 2023
and 2029, according to Global-
Data. In its recent survey,
healthcare industry profes-
sionals scored cell and gene
therapy (C&GT) as the indus-
try trend to have the greatest
impact on the pharma industry
in 2024. Oncology is expected
to continue its lead as the indi-
cation and area of major devel-
opment for cell and gene thera-
pies, accounting for 44 per
cent of the CGT market by
2029.
Urte Jakimaviciute, Senior
Director of Market Research
at GlobalData, informs, “Cell
and gene therapies are gradu-
ally becoming more important
focus areas within the health-
care industry and their full po-
tential is still unrealised. While
this is a relatively new area,
with the first autologous den-
dritic cell therapy Provenge
approved in 2010 for prostate
cancer, these therapies prom-
ise life-changing treatments
for a broad spectrum of com-
plex diseases ranging from ge-
netic conditions to cancers.”
Giving a more detailed view, Source: OPPI - EY report: Reimagining pharma and healthcare for India@100
Dr Senthil Sockalingam, Head,
IQVIA Biotech in Japan-Asia
Pacific; Chief Medical Officer,
IQVIA Asia Pacific outlines in
his article, ‘Biotech and Bio-
pharma Industry Trends: What
to Watch for in 2024’, published
in Express Pharma’s issue in
January 2024, “We are seeing
the expansion of chimeric anti-
gen receptor (CAR) T-cell
therapy beyond its initial appli-
cation to treat hematological
malignancies such as
myeloma, acute lymphoblastic
leukemia and non-Hodgkin’s
lymphoma, and into orthope-
dics, organ transplantation,
and neurology. The world’s
first CRISPR gene-editing
therapy was approved in No-
vember 2023 in the UK for
sickle cell disease and transfu-
sion-dependent ß-thalassemia.
This approval is a significant
landmark for the biotech in-
dustry, potentially setting the
stage for a new generation of

20 EXPRESS PHARMA
February 2024
gene-editing therapies to be affordability’, India has the po- became the generics leader of can be met by developing af- panies can leverage their ex-
approved for conditions that tential to become the next the world.” fordable and accessible pertise to develop personalised
were previously considered bright spot in the ‘next gener- ◆ Focus on rare and genetic C&GTs. Moreover, the growing C&GT solutions.
untreatable, as well as inject- ation therapeutics space’, and diseases: India has a high bur- focus on precision medicine is ◆ Government support:
ing a timely boost into the potentially emerge as a den of rare and genetic also spurring growth in this Initiatives like the Biotechnol-
gene editing R&D universe. frontrunner similar to how it diseases. These unmet needs segment. Indian pharma com- ogy Industry Research
CRISPR-based therapies face
similar challenges as CAR-T in
terms of cost and the substan-
tial healthcare infrastructure
needed for treatment adminis-
tration, and therefore, 2024
holds potential for innovation
beyond the treatment itself.
This spells good news for
India Pharma Inc. Why? Let’s
take a look.

The India advantage

The pharma industry in India
has a rich history of generic
drug manufacturing and ex-
port. In recent years, the in-
dustry is undergoing a shift
through adoption of cutting-
edge technologies towards de-
velopment of innovative thera-
pies such as cell and gene
therapies (C&GT). As a result,
there is burgeoning growth of
cell and gene therapies in In-
dia. While the sector is still in
its early stages, it has gained
significant momentum in re-
cent times.
A report released last year
by OPPI and EY, ‘Reimagining
pharma and healthcare for
India@100’, informs, “During
the span of last six years (2015-
2021), cell and gene therapies
(C&GT) and DNA/ RNA ther-
apies have seen a growth of
30 per cent and 46 per cent,
respectively.”
This growth is underpinned
by several factors such as:
◆ Cost benefit: There is an ur-
gent need for affordability in
advanced therapeutics to de-
mocratise healthcare and it
presents a huge opportunity
for India. As the OPPI and EY
report outlines, “This is a big
step ahead for India in the
right direction. The need is
now to increase the overall
pace and scale of innovation.
Most new modalities are avail-
able at very high prices glob-
ally. The increasing pricing
pressures and new pricing reg-
ulations are coming up across
all regions. With its dual
strength of ‘quality with

EXPRESS PHARMA 21
February 2024
 cover )
Assistance Council (BIRAC) development and approval
and Startup India provide
funding and incubation sup-
INVESTMENTS AND PARTNERSHIPS (2021- PRESENT) process for these innovative
therapies. Likewise, industry
port to promising C&GT start- stakeholders will have to build
ups. The Indian government is ◆ In Jan 2024, Natco Pharma acquired a 5.38 per cent stake in Cellogen Therapeutics. Reportedly, robust manufacturing infra-
also streamlining the regula- Natco Pharma is investing over $2 million in this company to develop bi-specific CAR-T cell structure as well as attract and
tory pathway for C&GTs, mak- therapies for cancer retain skilled professionals in
ing it easier to conduct clinical this segment to ensure pace
trials and gain faster approvals ◆ Laurus Labs invested Rs 80 crore in ImmunoACT, a cell and gene therapy company developing and sustainability of progress.
in the country. For instance, the personalised therapies for cancer and metabolic diseases in August 2023. It is also establishing Investments in these key areas
guidelines tailored for gene a facility specifically for manufacturing cell and gene therapy products. In Oct 2023, the CDSCO are essential to meet the strin-
therapy products were re- approved India’s first indigenously developed CAR-T cell therapy, NexCAR19, developed by gent quality and safety stan-
leased in 2020. In Oct 2023, the ImmunoACT dards mandated for these ad-
Central Drugs Standard Con- vanced therapies.
trol Organisation (CDSCO) ap- ◆ Immuneel Therapeutics, headquartered in Bengaluru, is awaiting regulatory approval for their At the same time, leverag-
proved ImmunoACT’s CAR-T CAR-T cell therapy named Varnimcabtagene in India, post encouraging initial findings emerging ing emerging technologies is
cell therapy, NexCAR19 which from the IMAGINE study also crucial. Industry experts
was indigenously developed in and analysts also acknowledge
India. ◆ In 2022, a consortium including three major Indian pharma companies – Alkem Laboratories, this. The OPPI-EY report em-
◆ Evolving clinical trial NATCO, and Biological E invested in Eyestem Research, a cell therapy company with a vision to phasises, “Digital technology,
landscape: As an established develop a scalable cell therapy platform to treat incurable diseases data analytics, and Artificial
global CRO hub, India has sig- Intelligence (AI)/Machine
nificant expertise in clinical ◆ Dr Reddy's Laboratories secured exclusive rights to market Shenzhen Pregene Biopharma’s Learning (ML) hold the poten-
trials and regulatory affairs, anti-BCMA CAR-T cell therapy in India in 2021 tial to revolutionise the entire
crucial for C&GT develop- R&D value chain, spanning
ment. Likewise, India's vast
population offers a rich pool
for clinical trials, providing
valuable data for global C&GT
development. Increased in-
vestments in research facilities
and skilled personnel are
further strengthening India's
clinical trial capabilities.
Dr Sockalingam informs,
“While India is well-estab-
lished as a global powerhouse
for generic medicines, there
has been a gradual shift in
R&D activities to other strate-
gic areas such as biosimilars,
complex generics, and new
chemical and biological enti-
ties. The maturation of India’s
regulatory environment cou- Source: OPPI - EY report: Reimagining pharma and healthcare for India@100
pled with vast patient popula-
tions and lower research costs research institutions to access promising and exciting, several resources. In the OPPI-EY from drug discovery to clinical
makes India an attractive cutting-edge technologies and challenges loom on the hori- CXO survey, the need for sub- development. This transfor-
proposition for clinical re- expertise, thereby enhancing zon. GlobalData anticipates stantial investments over an mation can enhance efficiency
search. This not only enables their capabilities in this field. that while cell and gene thera- extended gestation period, and productivity, reduce costs
broader access to novel thera- Several biotech start-ups in pies are set to become an es- coupled with high risk of fail- and timelines, and improve pa-
peutic innovations for Indian India are also focusing on inno- tablished treatment modality ure, emerged as the foremost tient access and diversity.
patients but also creates in- vative C&GT solutions for local in the years to come, higher de- barriers impeding the indus- Globally, numerous start-ups
creased commercialisation op- and global markets. And, many velopment and production try's advancement in the realm are emerging to offer R&D
portunities in what is now the of them are entering into col- costs, the risk of clinical trial of innovation.” platforms and solutions, some
world’s most populous nation.” laborations and partnerships failures, and intensifying It adds that government in- of which have already
with Indian and global pharma pricing and reimbursement centives, tough intellectual achieved initial success. Given
Mounting investments companies for clinical develop- pressures will continue to property protection, and a India's robust IT capabilities,
With the rising interest in cell ment, manufacturing, and place further stress on these flourishing domestic market the country has a substantial
and gene therapies, there is a commercialisation, creating a innovations. for novel drugs were accentu- opportunity not only to lead in
surge in investment and win-win situation. See Box 1 Similarly, the OPPI-EY ated as crucial aspects to suc- this domain, but also to catal-
collaboration opportunities. report states, “While novel cess and growth. yse the innovation journey of
Indian pharma companies are Challenges to conquer drug development promises Thus, India’s regulators and the Indian pharma industry.”
increasingly partnering with While the trajectory for high returns, it also requires a policy makers need to further Another area of importance
global biotech firms and growth in this segment looks high investment of time and refine and streamline the is developing pricing models

22 EXPRESS PHARMA
February 2024
that will enhance access and af-
fordability of cell and gene ther-
apies. Making these therapies
accessible to a broader popula-
tion without compromising
quality and efficacy is crucial.

Going ahead
The business potential of cell
and gene therapies in the In-
dian pharma industry is signif-
icant. As the country positions
itself as a hub for innovation,
strategic investments, regula-
tory support and collaborative
efforts will be pivotal in unlock-
ing the full potential of cell and
gene therapies. Proactive
measures by industry players,
regulatory bodies and aca-
demic institutions will pave the
way for progress in this field.

[email protected]
[email protected] Source: OPPI - EY report: Reimagining pharma and healthcare for India@100

EXPRESS PHARMA 23
February 2024
IT@PHARMA

Life sciences and Gen AI

Gen AI will have a very high impact on the healthcare and life sciences value chain, with the
potential to benefit every aspect — from clinical services to customer operations, finds EY Report
titled 'The AIdea of India: Generative AI’s potential to accelerate India’s digital transformation'. It
highlights that Gen AI applications are contributing to the life sciences sector in many ways,
including drug development, highly targeted therapies, supply and demand planning, and
operational efficiency improvement

Excerpts from the report

G
lobally, AI has ushered shortage of clinical and non- Sector-wise impact of Gen AI on GVA (2029-30)
in a transformative era clinical talent in the Indian
for the healthcare and healthcare system. Almost 60
life sciences sector. It holds the per cent of our survey respon-
potential for catalysing drug dents from the healthcare and
discovery, aiding clinical trials, life sciences sector believe that
enabling precision medicine, Gen AI will have a very high im-
and streamlining healthcare pact on the entire value chain,
operations. AI-powered algo- making it more efficient and re-
rithms can adeptly analyse vast sponsive to market dynamics.
datasets, identify potential In healthcare, Gen AI holds
drug candidates and curtail de- the promise of benefiting every
velopment timelines and costs. facet of the value chain, from
Personalised treatment recom- clinical services to customer
mendations, rooted in patient operations and branding.
data, have markedly enriched Similarly, in life sciences,
healthcare outcomes. the potential of Gen AI applica-
The healthcare and life sci- tions have to become too com-
ences sectors have been rela- pelling to disregard. It is poised
tively conservative in adopting to expedite the assimilation of
digital technologies. Gen AI cutting-edge technologies
may change that with its ability across the value chain.
to reduce the demand-supply The transformative impact Impact on sectoral GVA (X-axis) and additional GVA due to Gen AI (Y-axis) depicted here reßects the mid-point of the
range-bound impact for each sector
imbalance caused by acute of AI on the life sciences sector

The agenda for enterprises

Reimagining Rebuilding the Equipping the AI Shielding with

digital-AI Þrst Tech Stack workforce Responsible AI
Enable new business Rebuild the tech Empower employees Put in place new
models, customer stack–apps, data, with the skills for the governance–AI policies,
journeys, products infrastructure coming change data privacy, responsible
and services approaches

24 EXPRESS PHARMA
February 2024
 Gen AI: Illustrative use cases from clinical services to customer operations and branding

Clinical Branding and Customer Non-Clinical Audit and

Services and Community Service and Operations Compliance
Operations Outreach Experience

Clinical Targeted Digital Frontdoor Insurance: Billing IdentiÞcation of

Documentation Marketing and for Self-Service and Query Compliance Gaps
and Decision Branding Resolution
In-hospital Preventive Flags
Support
On-the-go engagement HR Operations
Digital Forensics
Personalized Care content creation
Contact Centre Revenue Cycle and Fraud
Plans
Personalized Co-pilot Management Detection
Patient Monitoring engagement
and Outcome
Prediction

is large, ranging from through its platform, ADDI- ing side effects are some appli- In India, Gen AI use cases tions are now contributing to
catalysing drug discovery, clin- SON™. Meanwhile, Pfizer is cations where Gen AI can po- and breakthroughs have been drug development and highly
ical trials, and enabling preci- leveraging Gen-AI-powered tentially assist R&D and drug mostly patient centric and wit- targeted therapies, which is
sion medicine to streamlining chatbots to deliver personalised discovery before moving to clin- nessed in or confined to cus- likely to put India in the global
healthcare operations. AIpow- messages to clinical trial partic- ical trial stage. tomer growth. The expansion clinical trial map. There is a
ered algorithms’ ability to ipants. Novartis is creating per- Further, with Gen AI’s abil- of biotech incubators and start- likely fast followership in Gen
analyse vast datasets and iden- sonalised recruitment materi- ity to quickly analyse and inter- ups is expected to play a key AI in process optimisation
tify potential drug candidates als for clinical trials. Companies pret vast amounts of data, pro- role in driving the growth of across value chains, such as
is dramatically curtailing devel- like Janssen and Merck are us- tocol designers can predict the the Indian biopharma industry supply and demand planning
opment timelines and costs. ing Gen AI tools for drug de- roadblocks in trial protocols and they are likely to be early and operational efficiency im-
Global pharma companies signing. Data analysis and inte- from the beginning and en- adopters of AI and Gen AI provement, to enhance the effi-
including Pfizer, Sanofi and gration to identify patterns, hance clinical trial efficiency. It tools. ciency and productivity. Life
Merck KGaA are using Gen AI potential biomarkers, using is also likely to impact regula- While the Indian life sci- sciences companies have to fo-
tools for lead identification and Gen AI to screen molecules that tory compliance procedures ences enterprises initially exer- cus on creating co-pilots in
drug discovery. Merck, for in- interact with target life sciences (by automating and simplifying cised caution regarding AI many of the above areas and
stance, is harnessing Gen AI to and Gen AI proteins, repurpos- risk assessment) and the audit adoption and trailed other sec- bring in necessary skills into
revolutionise drug discovery ing existing drugs and predict- and monitoring process. tors, numerous Gen AI applica- new ways of working.

The adaptive machine

Your competitive advantage
▪ Increased productivity with a smaller footprint
▪ Ability to respond to new consumer trends
▪ Increased product customization
▪ Profitable small batch production
br-automation.com/adaptive

EXPRESS PHARMA 25
February 2024
EVENT
PRE EVENT

PPL2024: Championing innovation,

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

P
ackaging and labellling
in pharma has wit-
nessed significant devel-
opments in response to evolv-
ing needs of the industry with
an emphasis on safety, quality,
sustainability and technologi-
cal innovation.
Be it temperature-con-
trolled packaging solutions to
meet the exacting standards
for biologics and vaccines, inte-
gration of drug delivery sys-
tems into packaging for better
patient outcomes, enhanced
patient engagement through
interactive packaging, adoption
of biodegradable options to
minimise environmental im-
pact, use of anti-counterfeiting
technologies or colour-shifting
inks, packaging and labelling
done right are adding
significant value to this
industry.
As these trends continue to
evolve, the future of pharma
packaging and labelling holds
exciting possibilities.
So, Pharma Packaging and
Labelling (PPL) Conclave
2024 aims to identify and har-
ness pivotal trends in the dy-
namic landscape of pharma safety moral and business imperative try, their growth drivers and of the pharma, biotech and
packaging. The conference ◆ Packaging for high-value bio- ◆ Branding and market differ- the challenges to tackle them packaging industries
will bring together industry pharmaceuticals and vaccines entiation with packaging and as well as form meaningful al- ◆ Acquire access to solution
experts to discuss strategies ◆ Supply chain resilience labelling liances to fast-track progress providers with cutting-edge
to achieve a balance between through intelligent packaging in the pharma packaging in- packaging technologies
innovation and cost, function- ◆ AI and automation: Revolu- Pharma Packaging and dustry. ◆ Discuss on the role of pack-
ality and aesthetics, as well as tionising pharma packaging Labelling (PPL) Conclave For the 100+ leading aging in gaining a competitive
utility and sustainability. It and labelling 2024 pharma packaging profession- edge
will provide a platform for ◆ Enhancing track and trace Organised by Express Pharma, als attending the event, the ◆ Network with the who's who
leaders and veterans in the capabilities in pharma packag- PPL Conclave 2024 will be held two-day event will give an op- of the pharma packaging in-
pharma packaging and la- ing on February 16-17, 2024 at Le portunity to: dustry
belling industry to collabora- ◆ Pharma packaging regula- Meridien, Hyderabad. With ◆ Get updated on the advance- Pharma Packaging and
tively address new challenges tions: Navigating compliance in opportunities galore for ex- ments in India’s pharma pack- Labelling (PPL) Conclave 2024
and surpass the mounting ex- a global landscape change of knowledge and net- aging sector is committed to staying
pectations within the pharma ◆ Smart labelling technologies working of ideas, PPL Con- ◆ Demonstrate your pharma ahead of the curve and
sector. in pharma packaging: Bar- clave 2024 is 'the' platform for packaging capabilities future-proofing progress.
codes, RFID, colour-changing packaging leaders, experts and ◆ Showcase your innovative
Some topics to be covered inks and more veterans to come together con- packaging solutions To know more and register,
◆ Packaging design: Optimis- ◆ Circular economy in pharma fer, converse, on the current ◆ Gain insights from thought check out:
ing user experience for patient packaging and labelling: A and future trends in the indus- leaders https://ppl.expresspharma.in

26 EXPRESS PHARMA
February 2024
STRATEGY
Revolutionising outcomes: Agile CROs lead the way
Vivek Chopra, Partner, Vector Consulting Group, and Alka, Senior Consultant, Vector
Consulting Group detail the evolving role of Indian CROs from research facilitators to valued
partners and recommend strategies for CROs to enhance productivity, reduce errors, and
improve csutomer satisfaction

C
linical trials attest to the overloaded, causing essential 4. Faster detection and res-
safety and efficacy of activities to be overshadowed olution of error: Processes
pharmaceuticals. But, and subsequent errors/rework should enable to raise and re-
they're not cheap to conduct. when trying to rush. solve queries on current studies
By 2020, out of the mammoth 4. Training gaps: With doc- on ongoing basis, so as to re-
$200 billion pumped into tor’s limited available capacity duce open issues post comple-
pharma research, a whopping and extensive training needs for tion of study.
$48.4 billion went into clinical support teams before the trials 5. Adopt train the trainer ap-
trials. Given the current trajec- can begin, the coordination for proach: Decentralised protocol
tory, the figures could balloon to training becomes difficult. As a training in small groups can en-
$68.9 billion by 2025 and ap- result, the training regime often sure better retention and appli-
proach $84.44 billion by 2030. suffers, leading to errors during cation and reduces the chal-
the trials. lenge for sync
CROs: The torchbearers 5. QA stumbling blocks: In a Some new work practices
To strike a balance between highly regulated environment, also have to be adopted:
quality and cost, global pharma- all issues need to be reported 1. Align inter-departmental
ceutical giants have, since 2005, and resolved. It becomes diffi- workflows: A shared priority
leaned towards Indian clinical cult for Quality assurance get- framework can enhance inter-
research organisations (CROs), Vivek Chopra, Partner, Vector ting hamstrung by constant Alka, Senior Consultant, Vector departmental cohesion and
especially for generics. This Consulting Group backlogs. This slow response Consulting Group timely report completion.
was catalysed by India's align- 2. Kick-off only post readi-
ment with the TRIPS Agree- ness: Ensure all prerequisites
ment. India's draw mainly lies
in its lower overall costs, pool of
It is well known that fast-tracked generics pharma are ticked off before diving into
tasks to minimise disruptions
expert scientists and large vol- products garner market advantage. Afterall, every and waiting for information.
unteer base. Consequently, In- 3. Shift from deadlines to
dia now anchors about 20 per subsequent generic launch chip away at the price. task frequency: Daily monitor-
cent of global trials.
However, the economic ad-
Therefore, while cost matters, pharma firms also ing can pre-empt issues, en-
couraging proactive solutions.
vantage once provided by India
is waning due to escalating
measure CROs by their ability to deliver quality 4. Boost transparency: The
daily monitoring of individual
costs. Undeterred, Indian CROs research results quickly tasks in a study can be enabled
are evolving, pivoting from be- by a project management soft-
ing mere research facilitators to ware system providing the ex-
valued partners who promise swift regulatory nods, better mechanism further compounds bility responses or in protocol pected time of completion
global standards and swift volunteer access, and efficient issues preparation as required. This (ETC) of all reports. This goes
study timelines. study execution. But this ambi- 6. Report merging delays: will ensure these tasks are done a long way in providing visibil-
tion often meets roadblocks: After trials, coordinating for re- on time without interrupting ity and timely actions.
Setting CROs apart: 1. Initial proposal bottle- ports across departments be- current studies.
Excellence and speed necks: Sometimes drafting a comes a herculean task, delay- 2. Implement work prioriti- Conclusion
It is well known that fast- proposal to send to a client be- ing the final report dispatch to sation: An agreement on prior- Adopting these steps can am-
tracked generics pharma prod- comes a drawn-out affair, some- patrons. ity and limiting number of tasks plify efficiency, potentially cut-
ucts garner market advantage. times pushing clients to explore handled simultaneously can ting down observations/devia-
Afterall, every subsequent other CRO options. Diagnosis and remedies help CRD complete pressing re- tions by 40-50 per cent and
generic launch chip away at the 2. Protocol designing hic- What is evident is that since ports fast without stretching hastening report generation by
price. Therefore, while cost cups: Once a client is on- CRD (especially PIs) contribu- themselves thin. 25-35 per cent post-trial. Such
matters, pharma firms also boarded, protocol design if tion is needed for all the tasks 3. Streamline processes: prowess not only facilitates
measure CROs by their ability rushed through and done with- from proposal to report, man- Processes have to be set up to CROs to handle more studies
to deliver quality research re- out proper due diligence, can aging their time efficiently and ensure that time available for but also skyrockets client satis-
sults quickly. lead to errors. Further result- productively is the key to break- nurses, phlebotomists, and faction levels. With cleaner
ing in extended approval cycles ing free from this vicious cycle. PIs in between their regular processes, regulatory queries
CROs’ hurdles to start study or poorly de- Some decisive actions are re- rounds of current studies is op- post-submission can also dwin-
CROs envision impeccable signed study to start with. quired for this: timally used to close open ob- dle. CROs able to achieve this
services for their clientele. This 3. CRD's juggling act: Clini- 1. Redefine CRD tasks: Dedi- servations from previously con- proficiency position themselves
encompasses quick feedback cal Research Departments cated teams can spend quality cluded studies that need their as indispensable allies to their
loops, expedited study design, (CRD) often find themselves time either taking care of feasi- inputs pharma clients.

EXPRESS PHARMA 27
February 2024
HR

How flexibility fuels innovation in India’s

pharma and healthcare
Yeshasvini Ramaswamy, Serial Entrepreneur & CEO, Great Place To Work India explores how
embracing flexibility not only empowers healthcare professionals but also catalyses innovation,
reshaping the future of patient care in the country
Prescribing a future: The

I
n the heart of India's speaks volumes about the in-
pharma and healthcare dustry's commitment to pur- leadership imperative
landscape, a silent revolu- pose driven growth and ad- As leaders within the pharma
tion is taking place—one fu- vancement. and healthcare sectors, it is
eled not only by groundbreak- Delving deeper, a notable imperative for organisations
ing medical advancements 44 per cent of employees ex- to recognise the symbiotic re-
but also by a fundamental press a strong belief that they lationship between flexible
shift in how work is ap- experience ample innovation work models and innovation.
proached. The fusion of tech- opportunities within their Nurturing an environment
nology and flexible work mod- workplace. This signifies a that values experimentation
els is shaping a new era in shift from the conventional and provides room for
patient care, one where em- norms of the traditional unconventional thinking is
powerment and innovation go healthcare sector practices, the key to establishing high
hand in hand. indicating a proactive ap- trust sustainable workplace
In a world where health- proach towards fostering cre- cultures that will only propel
care professionals navigate ativity and originality. the industry forward.
the delicate balance between Encourage a culture where
tradition and progress, the Diagnosing success: failures are viewed not as set-
adoption of flexible work Insights from workplace backs but as steppingstones
arrangements emerges as a dynamics toward progress. Celebrate
game-changer. Beyond the ob- Beyond the surface, the data those who dare to challenge
vious benefits for individual reveals profound correlations the status quo and reward
employees, this shift is prov- between flexible work models, ingenuity, fostering an atmos-
ing instrumental in driving in- employee satisfaction, and or- phere where every team
novation, ultimately enhanc- ganisational success. member feels empowered
ing patient outcomes and Firstly, companies that cul- to contribute their unique
experiences. tivate an environment where perspectives.
employees feel positive about Invest in technology that
The pulse of progress: taking time off boast a 10 per facilitates seamless collabora-
General trends in flexible cent higher retention rate. In tion and communication,
work models
As per the India’s Best Work-
As per the India’s Best an industry where burnout is
a constant concern, acknowl-
transcending physical bound-
aries. The ability to work
places™ in Pharmaceuticals, Workplaces™ in edging and encouraging the flexibly shouldn't compro-
Healthcare, and Biotech 2023 need for personal time be- mise efficiency; rather, it
report, the component of flex- Pharmaceuticals, Healthcare, comes a strategic move to- should enhance it.
ibility stands strong in com- wards sustaining a dedicated In conclusion, as we navi-
parison to other industry sec- and Biotech 2023 report, the and motivated workforce. gate the intricate landscape
tors. A remarkable 81 per cent
of employees across all organ-
component of flexibility stands Secondly, the connection
between innovation opportu-
of healthcare, let us embrace
the transformative power
isations in this industry enjoy strong in comparison to other nities and positive organisa- of flexible work models. By
workplace flexibility. This is a tional perception is undeni- doing so, we not only em-
testament to the industry's industry sectors. A remarkable able. Employees who power our caring hands but
adaptability, acknowledging
the unique demands placed on
81 per cent of employees across encounter ample innovation
opportunities at work show-
also catalyse a wave of
innovation that will redefine
healthcare professionals. all organisations in this industry case a remarkable 25 per cent the future of patient care in
What stands out even higher positive perception re- India.
more is the resounding belief enjoy workplace flexibility. This is garding their organisation as The prescription for suc-
shared by 82 per cent of em- a great workplace. This aligns cess lies in the hands of lead-
ployees that individuals dar- a testament to the industry's with the understanding that a ers committed to fostering a
ing to explore new and im-
proved ways of doing things,
adaptability, acknowledging the dynamic and creative work
environment not only retains
workplace where flexibility
and innovation intertwine,
irrespective of the outcome, unique demands placed on talent but also attracts creating a healthier, more
are celebrated. This culture of new, forward-thinking profes- resilient industry for genera-
embracing experimentation healthcare professionals sionals. tions to come.

28 EXPRESS PHARMA
February 2024
PHARMA TECHNOLOGY

Case Study: Hemofarm optimises cleaning

processes with quick-change parts and
second identical die table
An extensive product portfolio and frequent product changes coupled with diverse production
requirements make quick and easy cleaning of its tablet presses a vital necessity for Hemofarm,
the Serbian pharma manufacturer. The generics producer relies on Romaco Kilian’s simple-to-
clean machine design for this reason. Jan Clement, Sales Director, Romaco Kilian explains how
Hemofarm has maximally reduced the cleaning-related downtime of two KTP 420X and KTP
590X high-speed presses at its headquarters in Vršac by using quick-change parts and
additional, identical die tables

H
emofarm is market tablet processing areas and the
leader in the Serbian product-contacted press parts
pharmaceutical sector is a must. On top of this, partial
and Serbia’s largest exporter of cleaning is carried out between
drugs. Since 2006, Hemofarm batches of the same product.
– which produces more than 6.6
billion tablets and capsules an- Far fewer components
nually – has been a part of the than other presses
German STADA Group, one of Romaco Kilian’s modern tablet
the biggest generic pharmaceu- presses have far fewer compo-
tical firms in the world. nents than conventional mod-
Based in Vršac, Serbia, He- els in the compaction area,
mofarm manufactures both which is decisive for cleaning – a
proprietary drugs and prod- major advantage in everyday
ucts for the STADA Group, production. “The small number
many of them on two KTP of product-contacted parts, the
420X and 590X tablet presses optimised hygiene concept and
from Romaco Kilian. The KTP various special features like the
420X achieves a maximum out- patented closed punch bellows Hemofarm reduces cleaning time by using identical die tables, which are
put of 360,000 mono-layer turn cleaning a KTP series simply exchanged at the end of a batch
tablets per hour. The KTP
590X, with a maximum hourly press into child’s play”, ex-
output of 511,200 tablets, was plains Ivan Djokic, production
developed for fast changeover manager at the Hemofarm site
between mono- and bi-layer in Vršac. “All interchangeable
production as well as high- parts are lightweight and can
speed production of efferves- be dismantled without tools,
cent tablets. and they’re just as straightfor-
The demands placed on the ward to insert again. That’s
tablet presses could hardly be why our machine operators say
more diverse: all in all, more it’s a pleasure working with the
than 200 pharma products Kilian presses.” Even the fill
with very different formula- shoe can be removed by a sin-
tions are manufactured in gle person without any prob-
batch sizes from 100 to 2,200 lem because the gearbox is lo-
kg. Compression forces from 5 cated outside of the
to 80 kN are possible, and the compaction area. Apart from
ingredients can be either the die table, all of the Kilian
processed in the form of wet or press’s interchangeable parts
dry granules or compressed di- weigh less than 15 kg.
rectly. One or two product
changes per week take place on Compact, hermetically
the KTP 590X and about three sealed compaction area
or four on the KTP 420X, so The Kilian KTP 420X and 590X
that intensive cleaning of the Hemofarm is Serbia’s largest pharmaceutical company and part of the STADA Group presses are additionally char-

EXPRESS PHARMA 29
February 2024
PHARMA TECHNOLOGY

acterised by strictly separated

compaction and service areas,
so that tablet dust is prevented
from penetrating the machine
cabinet. The compaction area
is very small and reminiscent of
a hermetically sealed, stainless
steel cage. The surface to be
cleaned has been reduced by
about a third, resulting in sig-
nificantly shorter cleaning
times.
All presses in Kilian’s KTP
series have a very small foot-
print owing to their compact
design and small window areas,
for example 1,080 x 1,115 mm
for the KTP 420X or no more
than 1,230 x 1,325 mm in the
case of the KTP 590X. If the
windows are opened, the KTP
420X measures a mere 2,303 x
2,268 mm and the KTP 590X
2,567 x 2,472 mm. Thanks to
this economical use of space,
energy consumption in the
cleanroom is proportionally
less, leading to sustainably
lower running costs.

Interchangeable parts A single machine operator requires just 10 to 15 minutes to install the The KTP 590X high-speed press is in use at Hemofarm 24/7 and is com-
cleaned while working in interchangeable parts and the die table pletely retooled and cleaned once or twice a week
batch mode
The two sets of interchange-
able parts used by Hemofarm
for both tablet presses include
the fill shoe, tablet scraper, up-
per punch cover, suction noz-
zles and cover between the
pressure roller blocks. These
parts are kept ready in a closed
transfer trolley and are in-
stalled in the tablet press’s pro-
cessing area in the event of a
product change. The parts re-
moved following the previous
batch are cleaned while manu-
facturing the next batch.
Hemofarm currently has eight Romaco Kilian tablet presses in total The use of identical die tables helps optimise a tablet press’s OEE and TCO
Additional die table
increases availability The die tables are cleaned by cluding cleaning the inter- completed in approximately reports. “And if any service is-
In order to further reduce removing the upper cam track changeable parts and the die one hour. sues arise, we also benefit from
downtime during product together with the upper and table, for which around six the Kilian team’s short re-
changes, Hemofarm uses a sec- lower punches, while the lower hours are needed. Only 10 to 15 “Versatile, robust, and sponse times and competent
ond identical die table for each cam track remains in the com- minutes are required to install reliable” support – with Romaco, the
of the two tablet presses in addi- paction area. To prevent dust the exchanged parts along with Hemofarm has been using Ro- customer really is king, and
tion to the quick-change parts. from getting into the machine’s the die table. Between two maco Kilian technologies since that’s something we very much
“People often underestimate “gray” area during cleaning, a batches of the same product, 2002, and currently has eight appreciate.”
the impact of an identical die blind cover is fitted after remov- the tablet presses are partially Kilian tablet presses in total op-
table when it comes to optimis- ing the die table. The punches, cleaned using a vacuum erating at its five production Company contact
ing a tablet press’s OEE and dies, and other interchangeable cleaner as per the cleaning val- sites. The KTP series single- Susanne Silva
TCO”, comments Gerd Heinen, parts are cleaned in an indus- idation: the die table, dies, and sided rotary presses in Vršac Market Communications
the Area Sales Manager re- trial washing machine. The die punches as well as all other run in three shifts, either five Romaco Group
sponsible for Hemofarm at Ro- table itself is manually cleaned product-contacted parts re- (KTP 420X) or seven (KTP Am Heegwald 11
maco Kilian. “By investing in at Hemofarm. main in the compaction area, 590X) days a week. “The Kilian 76227 Karlsruhe
identical die tables, Hemofarm A single Hemofarm em- and only the fill shoe and inlet presses have proven to be very Germany
is demonstrating a pioneering ployee takes care of the com- funnel are dismantled. This versatile, robust and reliable in T: +49 (0)721 4804 0
approach.” plete product change cycle, in- partial cleaning process can be our day-to-day work”, Djokic E: [email protected]

30 EXPRESS PHARMA
February 2024
 BUSINESS AVENUES EXPRESS PHARMA

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IMPLANT / CO-EXTRUSION SETUP

32 February 2024 EXPRESS PHARMA

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36 February 2024 EXPRESS PHARMA

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EXPRESS PHARMA February 2024 37

BUSINESS AVENUES EXPRESS PHARMA
M. K. Silicone Products Pvt. Ltd.
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
for the Quality Conscious….

RTIFIED
CE
Serving
INDIA
QM 002
Since IS0 8 ® ® ®

1997 L
M

An ISO 9001-2015 COMPANY

C

EA O
NRO

208, Hill View Industrial Premises,

Amrut Nagar, Ghatkopar (W), Mumbai - 400 086, India.
Blue Heaven

Mob.: 9321965968 / 9869412342

E-mail : [email protected]

38 February 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 February 2024 39

BUSINESS AVENUES EXPRESS PHARMA

OsmoTECH® XT Single
- Sample Micro-Osmometer
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)
Supports 21 CFR part 11, GMP and EU Annex 11 compliance
Meets Pharmacopeia osmolality testing guidelines
3 Level user access and password protection
Storage: unlimited data storage for access
Audit trail: Preserve unlimited results and events
Database backup, protects your data with automatic or manual backup

No. 127, Bussa Udyog Bhavan, Tokershi Jivraj Road, Sewri West, Mumbai-400015,
Maharashtra, Landline : +91 022 - 24166630 Mobile : +91 9833286615

40 February 2024 EXPRESS PHARMA

 BUSINESS AVENUES EXPRESS PHARMA

Temperature Range: 20°C to 60°C

Humidity Range: 40%RH to 85% RH

FULL VIEW GLASS DOOR

Full door is of toughened

glass with polysulphides Stand by
to view the samples Humidity System
without disturbing the
test conditions and
human safety

SCANNER

Event data, Log data,

All operations are driven
Audit trail data,
through PLC with data
E-Records & E- Signature,
storage capacity of upto
Graphical analysis &
1100 lines
Data acquisition

Features

Ethernet PLC Touch Screen Door Access Alarms Mobile Alerts Email Facility Safety 21 CFR Software Document

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PARADE GROUND, SECTOR-17, CHANDIGARH BOMBAY EXHIBITION CENTRE, MUMBAI

8625948585 [email protected] www.mackpharmatech.com

EXPRESS PHARMA February 2024 41

BUSINESS AVENUES EXPRESS PHARMA

To Advertise in

Business Avenues

Email: [email protected]
[email protected]

™
Cleanroom Bucket/Trolley System
Ÿ Autoclavable.
Ÿ With & without down press wringer & slinger.
Ÿ Durable stainless steel components. Autoclavable at 121°C for up to one hour.
Ÿ Compatible with all common disinfectant solutions and most common
solvents.
Ÿ Available local made & imported.

SS Flat Mop Slinger SS Flat Mop Wringer

+91 22 40787979 | [email protected] | www.june4gmp.com

42 February 2024 EXPRESS PHARMA

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50 February 2024 EXPRESS PHARMA

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EXPRESS PHARMA February 2024 51

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

D
ue to the crucial neces- be modified and the audits can
sity and its direct im- be easily complied with.
pact on human health
and welfare, pharma is proba- Service and calibration
bly the most important and made easy
critical sector among others. As Testo also has an established
a consequence of which, it be- state-of-the-art NABL accred-
comes essential to store ited service and calibration
pharma products, vaccines, lab- LAB in accordance with the
oratory samples or units of standard ISO/IEC 17025:2017,
blood at the right temperatures that takes care of the after sales
to ensure that they remain ef- support locally from Pune.
fective and that quality is main- Testo service and calibration fa-
tained. Another reason for the cility is highly cost effective as
pharma division to ensure it delivers international stan-
safety measures and controlled
environment is stringent regu-
lations and inspection of the fa-
cilities. This elementary need
for climate control can only be
ensured with right data moni-
toring systems. Testo, being a
market leader in testing and
measurement sector, provides
the best in class data loggers
and data monitoring systems
for the pharma division.

Ensuring end to end critical for production quality and anytime. In case of crises
climate monitoring – Testo assurance where the tempera- and deviations, it is provided
Data Loggers ture has to be frequently with an alarm by e-mail, or op-
Pharma goods must be stored checked at various points in tionally by SMS.
well in every situation as any production processes. Using Another important and cru-
deviation in the ambient tem- thermocouple probes, data log- cial application of a pharma in-
perature or humidity values gers can also record data in the dustry involves validation of
may lead to deteriorated qual- kinds of extreme temperature sterilisation and freeze-drying
ity of the product. Testo data ranges. The probe's fast re- processes. Not only that, vali-
loggers can be used to test the sponse also contributes in the dating cleaning and disinfecting
optimum conditions for specific validation processes and qual- equipment is equally necessary.
products or surroundings. ity standard optimisation in QA In order to allow a seamless op-
Temperature and humidity units and clean room applica- erating procedure, the valida-
data loggers are often used in tions. These instruments are tion process and the documen-
pharma industries to monitor the most convenient and pocket tation work must be as efficient pharma products during pro- dards very conveniently within a
the conditions in which drugs, friendly solution for all pharma and smooth as possible which duction, storage or transit of week’s time. Instruments of any
medicines, vaccines are kept. application areas. could be easily achieved with goods. Real time data monitor- brand/make can be calibrated
Not only storage, but during the The testo Saveris 2 WiFi testo 190 data logger solution ing is important for the quality and serviced locally maintain-
transit of goods, testo transport data logger system is the sim- that has innovative data loggers of pharma goods and also en- ing necessary standards.
data loggers are useful to meas- ple, flexible and reliable solution for temperature and humidity, ables the supplier to improve The accredited parameters
ure the transport conditions. to humidity and temperature smart software and acces- the life of the goods. Transporta- include humidity, pressure, ab-
The range of data loggers is monitoring in cold storage area sories. tion trucks, warehouses, cold solute pressure, contact type
very extensive. A temperature like blood banks. This innova- rooms etc. can now be remotely temperature, non-contact type
and humidity logger such as 174 tive monitoring system is ideal Data compliance for monitored via Testo data log- temperature (infra red ther-
T guarantees continuous mon- for high product quality and audits and inspections gers and data monitoring sys- mometer, thermal imager). In
itoring in a storage or ware- eliminates manual work of Testo offerings are majorly re- tems. Our data loggers are EN fact, Testo is the first and only
house. Also, data loggers with reading out or documenting lated to the data security along 12830 and 21 CFR Part 11 com- lab in India to get NABL ac-
multi channels for connecting measurement data. With a se- with comprehensive analysis pliant which ensure complete creditation for Dew Point Tem-
external sensors and thermo- cure online storage of all read- and evaluation of all the documentation of parameters, perature as well.
couples, like testo 176 are avail- ings in Testo Cloud the data can recorded measurement data. be it humidity, temperature or
able for ensuring secured work be managed and analysed on- Testo data loggers ensure con- absolute pressure. They come For more details, login to website
process in labs. line by the user via smart tinuous monitoring of tempera- with professional software www.testo.com or write back to
These data loggers are also phone, tablet or PC anywhere ture and relative humidity of where the data recorded cannot [email protected]

52 EXPRESS PHARMA
February 2024
PHARMA PULSE

Procedures for tubing selection in pharma and biopharma applications

Kabir Das, Sr Consultant - Business Development, Ami Polymer outlines crucial considerations
for selecting tubing in pharma and biopharma applications, emphasising factors such as material
compatibility, manufacturing conditions, regulatory standards, sterilidation methods, and the
capabilities of the supplier

T
ubing are hollow cylin-
ders used for fluid trans- Sr No Description Applications Product
port. Tubing has various
forms like hose, pipe and many 1. Product in contact, Pressure less than 1.5 Single use, welding, Sealing, peristaltic pump TUBING
more. These are differentiated bar, sterilisation possibility, SIP and CIP
by the applications, flexibility,
portability and many more. 2. Product in contact, Pressure more than 1.5 Repeated use, non-peristaltic pump application, Pressure and HOSE
Particularly in pharma and bar, Sterilisation possibility, SIP and CIP Vacuum application
biopharma industry, the tubing,
hose and pipes are used based
on their criticality and applica- need to be aware of tests that 3. Manufacturing condition the degree of sterilisation nec- Pharma and biopharma manu-
tions. Media transfer, disinfec- should be performed to confirm Although tubing is sterilised essary. facturing often involves the re-
tant application, fluid transfer, that any extractable in the tub- prior to use, it makes sense to 6. Tubing compatibility tention of batch samples, which
downstream & upstream appli- ing’s make up do not have an af- start with the cleanest possible Absorption, adsorption, and are specimens of the drug or
cations, tangential flow filtra- fect the product flowing within. product. Learn about the condi- permeability absorption (the substance being produced.
tion, media fill trial, fill finish, Validations are also important, tions in which the tubing is penetration into the mass of These liquid samples are fre-
SIP, CIP, aseptic welding and as they verify that the tubing se- manufactured. The clean room one substance by another), ad- quently stored in small bags
sealing, single use technology, lected has gone through neces- manufactured product will be sorption (when molecules of a with tubing attached or within
manifold, connectors and many sary testing. free from foreign particles substance collect on the surface a section of the tubing itself.
more are the applications Coming to the point, even which may contaminate the of another), and permeation This tubing must be perma-
where tubing are used. though tubing may look simple, product in contact. Better to (the diffusion of one substance nently sealed without breaking
Tubing for single-use bio- the criticality is severe. As have information about how through another substance) are sterility, preferably inner wall to
process and pharma applica- products are passed through your tubing is produced. Is it details to examine when evalu- inner wall using heat and com-
tions has particular require- these tubing, more care and at- produced in a clean room? If so, ating tubing. Materials differ pression, to prevent spillage
ments. Among them are the tention is needed while select- what level (ISO 6, 7, 8)? How is greatly in how they contribute and contamination. Tubing ma-
ability to withstand various ing the suitable tubing. The fol- it handled and stored after to these factors and the fluids or terials such as silicone cannot
sterilisation processes, the de- lowing are some points which manufacture? Has it been gases for which the tubing is in- be heat sealed and require the
livery of favourable test results need to be kept in mind during tested for contaminants by an tended need to be considered. use of mechanically applied fit-
regarding extractable sub- tubing/hose selection. independent laboratory? TPE (thermoplastic elastomer) tings or connectors to stop flow
stances, and the absence of 1. Material of construction 4. Product standards tubing, for example, is much or to join two pieces of tubing
animal-derived ingredients. The most important considera- The tubing being selected shall less permeable than typical sili- together. Other materials like
Flexibility, permeability, per- tion in the selection of suitable meet all your regulatory re- cone tubing. How does the tub- thermoplastic elastomers work
formance in pumps, and weld- tubing for any application is the quirements. Will the tubing ing material you’re considering very well in typical heat sealing
ing and sealing capabilities are compatibility of the tubing ma- meet USP, FDA, ISO, BPOG, perform when it comes to these processes. Tube welding – a
also common considerations. terial with the media to be con- EU, TGA, ANVISA, or other elements? Consider this if you procedure where two open ends
Additionally, these critical in- tained. The minimum and max- standards? Some applications use preservatives in your prod- of tubing are thermally and per-
dustries should be aware of the imum operating temperatures will demand that the tubing it- uct. manently connected to each
environment in which the tub- for the various tubing materials self meet certain standards, 7. Validations and extracta- other – is another common
ing is manufactured, associa- are also to be considered during while others will be satisfied bles function often employed in
tion standards must be met and selection process. when the tubing ingredients Tubing materials like platinum pharma and biopharma manu-
costs. 2. Material Ingredients (the raw materials plus addi- cured silicone are inherently facturing. As with heat sealing,
One of the most important Today’s pharma and biopharma tives) meet those guidelines. purer than peroxide-cured sili- silicone cannot be welded but
concerns involves ingredients. manufacturers have found that 5. Sterilisation cone and offer fewer extracta- TPE’s can.
Those derived from animal the best way to eradicate ani- What methods can be used to bles (substances that can be 9. Multiple tubing materials
sources are typically undesir- mal ingredients and their possi- sterilise the tubing? Autoclave drawn out of a material). Test- Many pharma manufacturers
able because of their potential ble effects on finished products (steam sterilisation), EtO (eth- ing should be performed to con- use a peristaltic pump and sili-
effects on finished pharma and is to start with processing com- ylene oxide) gas treatment, firm that any extractable or cone tubing in their processes.
biopharma products. Silicone ponents that do not contain any gamma irradiation, something substances in the tubing’s But as noted above, tubing that
oils found in some tubing mate- animal ingredients or animal- else? These questions should be makeup do not adversely affect can be heat sealed and welded is
rials can also be detrimental to derived ingredients. Another researched or posed to suppli- the product flowing through it often needed at some point
the end product. substance that can be trouble- ers to help you make an in- and vice versa. Has the tubing along the fluid path. Some man-
Another crucial topic is vali- some is silicone oils. The oils formed decision. Another point you’re considering undergone ufacturers use one material for
dations and extractable studies. can react with other compo- to consider is whether you will the necessary tests to ensure its certain sections of their process,
Certain tubing materials like nents and leave a residue in the receive tubing that is pre-ster- suitability for your application? connect a piece of silicone tub-
platinum-cured silicone are in- final product. Check with sup- ilised or if you will handle that Without validated test certifica- ing for the peristaltic pump sec-
herently purer than peroxide- plier to find out if tubing con- process. If you’ll be ordering tions, you may put your prod- tion, and then return to the first
cured silicone and offer fewer tains animal-derived ingredi- pre-sterilised tubing, you need ucts, as well as lives, at risk. tubing material. This setup in-
substances that can be drawn ents or other undesirable to make sure that the supplier’s 8. Sealing and welding capa- volves multiple barbed fittings,
out. Users of single-use tubing elements. process has been validated to bilities cable ties, and the potential for

EXPRESS PHARMA 53
February 2024
PHARMA PULSE

leaks and contamination, as well come up with SUS and cus-

as human error. Situations have tomisation. The supplier shall
even occurred where an opera- Tubing, hose and pipes are used based on their be capable of providing cus-
tor has installed the wrong sec-
tion of tubing in a pump, result-
criticality and applications. Media transfer, tomisation in short notice,
shorter delivery periods and so-
ing in lost pharma product,
equipment replacement, and
disinfectant application, fluid transfer, lution provider. During manu-
facturing due to various appli-
hours of time and labour. Tub- downstream & upstream applications, tangential cations, at times tubing and
ing material such as TPE’s meet hoses are needed in same MOC.
the requirements for a flexible, flow filtration, media fill trial, fill finish, SIP, CIP, This is a major challenge with
high purity, peristaltic pump
tubing that may be welded and
aseptic welding and sealing, single use various suppliers. Ami Polymer,
India has a solution to these
sealed, thereby eliminating mul- technology, manifold, connectors and many more types of challenges. You can
tiple materials. Like silicone, rely on Ami Polymer for quality
certain TPE’s can be moulded are the applications where tubing are used products, with ease of customi-
into connections such as Y’s sation and shorter delivery pe-
(wyes) and T’s (tees), further re- nate because savings can be re- instance, your cost to purchase penses. There are fewer con- riods. Contact Ami Polymer for
ducing the need for fittings and alised not only in the acquisition 5,000 feet of a single material nections to make, which means your samples and queries.
the possibility of leaks. Consider cost but in terms of labour and may be less than buying 2,500 fewer fittings and tie wraps to
whether a single tubing material inventory as well. As noted in feet of two different materials. purchase, too. One tubing ma- Visit & contact
can be used in your application. “Multiple tubing materials,” us- Using a single tubing material terial also saves engineering ex- www.amipolymer.com
10. Cost ing one type of tubing has many also decreases the cost of carry- penses, because there’s less de- for more details
When tubing is just one part of a benefits. It can reduce the ini- ing inventory (stocking one tub- sign work involved.
fluid system, it is sometimes an tial purchase cost because your ing type verses two). Another 11. Capability of the supplier Email - [email protected]
afterthought. This is unfortu- buying power is improved. For benefit is lower labour ex- Today’s fast moving world has Mobile - 9136660529

54 EXPRESS PHARMA
February 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