Evolving Packaging Trends Across Pharma Value Chain - Jasubhai Media
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VOL 19 | ISSUE 10 | MAY 2021 | MUMBAI
www.jasubhaimedia.com
Evolving Packaging Trends Across Pharma Value Chain
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CONTENTS
COVER STORY INTERVIEW
From the desk of Guest Editor 20 Spearheading Lipid Manufacturing To
Produce Vaccines
40
Chakravarthi AVPS
MD, Ecobliss India Pvt Ltd
Honorary Advisor & Director on Board Arun Kedia
PHARMEXCIL, Govt. of India, Guest Editor Managing Director
VAV Lifesciences Pvt Ltd
“Packaging industry is significantly changing
the healthcare spectrum”
26
Gautama Buddha
How Single-Use Technologies Support
Global Manufacturing Success
57
Former Head Packaging Develoopment
Dr Reddys Laboratories Ltd, Packaging Consultant
“New medicines require specialized
packaging for shelf life”
29
Narayana Rao Sean DeFusco
Sriman Banerjee Vice President of Biopharma General Manager, Single-Use
Head of Packaging Development & CDE Asia, Middle East and Africa Solutions & Fluid Handling
R&D Pharma Science
The Necessities and Mandates of Packaging 30 GUEST COLUMN
Prabir Das
How Covid-19 Brought A New Sphere of
Pharmaceutical Packaging
44
Head Packaging Technical Services
OSD India , VIATRIS
“Packaging validation is still a nascent stage
in the Indian Pharma industry”
32 Jayanti Sawant
Packaging Development Consultant
Chandi Prasad Ravipati
Head - Packaging Development COLUMN - LEGAL
Aurobindo Pharma Limited
Regulations in Pharma Product Packaging 49
“Molecule entities are throwing up newer
challenges in-terms of establishing
36
Adv. Gautam Panchal
product-pack compatibility” Proprietor , Gautam & Co.
Advocates High Court, Bombay and IP Attorneys
Santanu Chowdhury
Sr. General Manager,
Packaging Development, Sun Pharma The Evolution of Law and Ethics in the
Pharma Sector: The Role of the Executive and
53
“Smart packaging can reduce supply chain
losses & enhance environmental monitoring” 37 Judiciary in India - II
R. S. Raveendhren
Soumyanath Mishra Advocate, High Court of Madras & Legal Expert in
General Manager & Head-Packaging the Institutional Ethics Committee of SRM Medical
Development, Mankind Research Centre College Hospital & Research Centre.
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PHARMA BIO WORLD
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CHAIRMAN
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PUBLISHER & CEO Hitech Applicator...................................................2
Hemant K. Shetty
EDITOR Horizon Polymer Engineering Pvt Ltd............7
Mittravinda Ranjan
CREATIVES Komal Scientific Co............................................. 13
Arun Parab
Mettler-Toledo India Pvt. Ltd..............................3
GENERAL MANAGER SALES
Amit Bhalerao
Prashant Koshti Tapflo Fluid Handling India Pvt Ltd.................5
BRAND MANAGER
Sudhanshu Nagar West Pharmaceutical Packaging
India Pvt. Ltd...........................................................9
SALES
Godfrey Lobo
Priyaranjan Singh
Chandrahas M Amin IMPACT FEATURES
Yonack Pradeep
Sunil Kulkarni Exact Weighing 60
Results Through Clever
The Publishers and the Editors do not necessarily Ergonomic Design
individually or collectively identify themselves with all
the views expressed in this journal. All rights reserved.
Reproduction in whole or in part is strictly prohibited An Accurate and Cost-efficient 62
without written permission from the Publishers.
Pharmaceutical Industry Solution
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64
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TESTIMONIALS 18
NEWS 10
PRODUCTS 66
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PHARMA BIO WORLD
NEWS
BioMed X Institute and Merck we received from Merck over the past eight
years since we started our collaboration,”
Extend Collaboration Of Novel
Christian Tidona, Founder and Managing
Research in Oncology and Director of the BioMed X Institute said.
Autoimmunity “This new agreement with Merck is a great
validation of our unique innovation model,
showing that it delivers sustained translational
value to the early R&D pipelines of our
pharma partners.”
Merck was the first pharma company to enter
a partnership with BioMed X, beginning in
2013. Since then, the partnership has steadily
grown and the previously initiated research
projects have led to 25 scientific publications
on topics such as in-silico design of selective
kinase inhibitors, myeloid-derived suppressor
cell activity, Golgi stress, and DNA damage,
as well as several new potential drug target
genes which have been further investigated in
10
pre-clinical studies at Merck.
Christian Tidona, Founder and Managing Director
BioMed X Institute
Heidelberg, Germany: BioMed X, a leading
Aceto Expands Life Science
independent biomedical research institute, Manufacturing with Acquisition of
today announced the extension of its Finar Limited
ongoing collaboration with Merck. Under the
Port Washington, United States: Aceto, a
new agreement, Merck will start up to six
leading global provider of specialty materials
additional research projects at the BioMed
for life sciences and advanced technology end
X Institute, building on ongoing research
markets, announced today the acquisition of
projects in the fields of oncology (DNA
a majority stake in Finar Limited. Finar is a
damage response and RNA splicing) and
leading manufacturer, supplier, and distributor
autoimmunity (intestinal epithelial barrier
of pharmaceutical excipients, lab chemicals,
in autoimmune diseases). The next joint
aquaculture inputs, and food grade additives.
global crowdsourcing project will explore
The acquisition complements Aceto’s growth
mechanisms of immune senescence and
strategy, enhancing and expanding the
mitochondrial dysfunction in regulatory T cells
company’s manufacturing footprint, R&D
and other T cell subsets that are shared in
capabilities, and quality expertise.
human autoimmunity and aging.
“We are excited to bring together Finar and
“We are very grateful for the trust and support
MAY 2021 www.jasubhaimedia.comHVAC E NER GY SAV I N GS . A LL TH E TIME . Talk to one of our experts to find out more Energy Performance Upgrades always start with the heart. To learn more, visit armstrongfluidtechnology.com.
PHARMA BIO WORLD
NEWS
manufacturing capabilities but also align with
our customer centric philosophy,” added Gilles
Cottier. “Finar’s established reputation as a
partner and supplier to the global pharma
industry and commitment to producing high
quality products, mirrors Aceto’s guiding
business principles and is complementary to
our other recent acquisitions of Syntor, A&C
and IsleChem.”
“We live by our motto of consistently
providing customers high-quality products
and exceeding their expectations,” said Amit
Maheshwari, CEO of Finar Limited. “Both
Finar and Aceto create long-term relationships
Amit Maheshwari, CEO, Finar Chemicals with customers by providing best-in-class
customer service and treating each customer
Aceto to give customers of both companies with integrity and respect. These attributes are
more solutions to support their supply chains an important part of our company culture and
globally,” said Gilles Cottier, CEO of Aceto. we appreciate that Aceto shares this business
12 “With the Finar team’s help, we continue philosophy. We look forward to providing
to strengthen our manufacturing expertise our combined customers with access to
and expand our product offerings for the our manufacturing expertise and diversified
pharmaceutical, biopharmaceutical, and product portfolio.”
vaccine end markets.”
Finar manufactures high quality pharma Dr. Reddy’s Laboratories Gets
ingredients including GMP/Pharma Emergency Use Authorisation for
grade solvents, advanced intermediates,
Sputnik V in India
and GMP excipients used in both small
and large molecule applications. Finar Hyderabad, India: Dr. Reddy’s Laboratories
provides customers complete regulatory Ltd. announced that the first consignment
& documentation support including Drug of imported doses of the Sputnik V vaccine
Master Filing and has a strong R&D team with that landed in India on 1st May, 2021, received
expertise in developing specialized excipients regulatory clearance from the Central Drugs
for complex formulations. The company is Laboratory, Kasauli. As part of a limited pilot,
based in Ahmedabad, India. the soft launch of the vaccine has commenced
and the first dose of the vaccine was
“We’re weaving together an exciting story of
administered in Hyderabad.
growth with the acquisition of organizations
that not only enhance our R&D and Further consignments of imported doses
MAY 2021 www.jasubhaimedia.comPHARMA BIO WORLD
NEWS
are expected over the upcoming months.
Subsequently, supply of the Sputnik V vaccine
will commence from Indian manufacturing
partners. The imported doses of the vaccine
are presently priced at an MRP of Rs 948 +
5% GST per dose, with the possibility of a
lower price point when local supply begins.
The Company is working closely with its
six manufacturing partners in India to fulfill
regulatory requirements to ensure smooth and
timely supply.
Dr. Reddy’s will work closely with stakeholders
in the Government and private sector in
India to ensure the widest possible reach of
Rory McGoldrick, CEO, Inspira
the Sputnik V vaccine as part of the national
inoculation effort. This is a reaffirmation of
inhaled formulation of Inspira’s lead drug
the Company’s commitment to explore every
candidate for the treatment of COVID-19.
avenue in the fight against the COVID-19
pandemic in India. Inspira’s research focuses on proprietary IPX
14
formulations, which are based on processed
G V Prasad, Co-Chairman and Managing
and purified extracts from a plant source.
Director, said: “With the rising cases in India,
These extracts contain proteolytic enzymes
vaccination is our most effective tool in our
that have been shown to rapidly inactivate the
battle against COVID-19. Contributing to
SARS-CoV-2 virus in vitro. The IPX technology
the vaccination drive in India is our biggest
platform has additional potential applications
priority right now to help Indians be healthy
in other lung infections and treatment of
and safe.”
biofilms associated with respiratory disease.
To date, Vectura has undertaken a feasibility
Vectura And Inspira
study on Inspira’s inhaled IPX formulation
Pharmaceuticals To Develop candidates with positive results. This new
Potential Inhaled Treatment For agreement will see the company perform
COVID-19 further testing and development work, to
prepare initially for Phase 1 clinical studies
Chippenham, UK : Vectura Group plc, an
using its FOX® vibrating mesh nebuliser to
industry leading inhalation CDMO, and Inspira
deliver the IPX formulations directly to
Pharmaceuticals Limited, a new UK-based
the lungs
company focused on developing therapies
for respiratory and infectious diseases, “We are delighted to have partnered with
announced an agreement to develop an Vectura, a company with a strong track
MAY 2021 www.jasubhaimedia.comPHARMA BIO WORLD
NEWS
record in the successful development of Glenmark Pharmaceuticals
pharmaceuticals for respiratory indications.
Receives ANDA Approval For Single-
Leveraging Vectura’s expertise and network,
Inspira is well placed to accelerate the
Dose Prefilled Syringe
development of our novel IPX formulations Mumbai, India: Glenmark Pharmaceuticals
for pulmonary delivery. As we move from
Limited (Glenmark) has received final
pandemic to endemic COVID-19 it will be ever
approval by the United States Food & Drug
more important to have new treatments that
Administration (U.S. FDA) for Icatibant
are cost effective, easy to distribute and easy
Injection, 30 mg/3 mL (10 mg/mL) Single-
to administer. We are targeting a treatment
Dose Prefilled Syringe, the generic version of
that has the potential to be effective at the
Firazyr 1 Injection, 30 mg/3 mL (10 mg/mL)
early phase of infection, to minimise the
risk of hospitalization and reduce the need Single-Dose Prefilled Syringe, of Shire Human
for ventilatory support in intensive care. We Genetic Therapies, Inc. This marks Glenmark’s
hope that our human clinical trials of IPX first synthetic decapeptide injectable approval
formulations will prove as successful as our and will be manufactured in their North
initial laboratory studies,” Rory McGoldrick, American manufacturing facility based in
CEO of Inspira commented. Monroe, North Carolina.
Mark Bridgewater, Vectura Chief Commercial According to IQVIATM sales data for the 12
15
Officer commented: “The work carried out by month period ending March 2021, the Firazyr
Inspira demonstrates the potential to develop Injection, 30 mg/3 mL (10 mg/mL) Single-
a highly-effective treatment for COVID-19, and Dose Prefilled Syringe market2 achieved
our initial studies show that our FOX nebuliser annual sales of approximately $223.4 million*.
offers an extremely efficient delivery method. Glenmark’s current portfolio consists of 172
We are excited to continue supporting Inspira
products authorized for distribution in the U.S.
on this lead programme’s development
marketplace and 44 ANDA’s pending approval
towards the clinic, combining our expertise
with the U.S. FDA.
of formulation and device development with
Inspira’s innovative research to add to the In addition to these internal filings, Glenmark
treatments available to manage this global continues to identify and explore external
pandemic disease.” development partnerships to supplement and
All studies will be undertaken at Vectura’s accelerate the growth of its existing pipeline
Chippenham, UK facility, which is home and portfolio.
to advanced pharmaceutical development
laboratories, manufacturing suites and
offices where the company’s differentiated
technology and skills are used to develop
customers’ inhaled products, from high quality
generics to novel therapies.
www.jasubhaimedia.com MAY 2021PHARMA BIO WORLD
NEWS
Dishman Carbogen Amcis Limited USD 49.31 mn, which includes majorly growth
capex related to the planned expansion in
Records 3% Growth, 529 Crore Net
Switzerland and France. Net Debt excluding
Sales lease liabilities was USD 101 mn as on March
Bavla, India: Dishman Carbogen Amcis 31, 2021 against USD 100 mn as on March
announced the Net Revenue at Rs 5,293.2 31,2020.
mn in Q4 FY21 up by 3.4%. YoY CRAMS Funds raised in the Offer for Sale undertaken
revenue declined by 1.9% YoY primarily due to by the promoter shareholder entity have
-CRAMS India revenue decreased due to past already been infused in the company to the
EDQM observations but on account of certain extent of Rs. 72 crores.
successful customer audits and production
of certain complex intermediates, this is Some of the Business Highlights are
expected to improve going forward. CRAMS pertaining to the issues raised by the
Carbogen Amcis AG revenue increased by European drug regulator (EDQM), the
23.1% due to increase in commercial revenue company received the Final Audit Closure
during the quarter. Marketable Molecules Report from EDQM in October 2020, wherein
revenue increased 21.2% YoY primarily due the company’s approach to remediate the
to - Carbogen Amcis BV revenue increased by deficiencies were considered as being
12.0% due to increase in sales of cholesterol appropriate.
16 segment The company has a strong basket of about 16
EBITDA Margin at 16.7% in Q4 FY21 due APIs in Phase III development. The company
to- Negative margins in CRAMS India due to is focused on improving its capacity utilization
decline in production on account of EDQM at its manufacturing facilities by targeting
observations. Margins at Carbogen Amcis BV small and mid-sized global biotech companies
decreased in Q4 FY21 to 26.0% compared to and diversifying across new geographies.
FY21 average of 32.2% due to lower share of Recently, the company’s Switzerland-
revenue from Vitamin D analogues based subsidiary, Carbogen Amcis AG, ,
The financial results for QIV and full year FY announced a joint funding agreement with
2021, contained two one offs -Deferred Tax a longstanding Japan-based customer to
Liability expense of Rs. 962.8mn on account build a site extension at the Bubendorf site in
of the change in Tax law relating to goodwill Switzerland.. Carbogen Amcis will produce
depreciation from 1.4.2020. exclusively for the signatory customer a
complex highly potent drug component for a
There shall not be any cash outflow on commercial antibody-drug-conjugate
account of this and this liability will reverse (ADC) API.
in the future years. One time impairment of
inventory of CHF 2.77mn due to one project Concluded a commercial supply agreement
cancellation at Carbogen Amcis AG. Capital to manufacture a Hypoparathyroid drug for
expenditure for FY 2021 was approximately one of our Clients, a compound that has been
MAY 2021 www.jasubhaimedia.comPHARMA BIO WORLD
NEWS
in development for several years and will
now be launched by the Client in the coming
months. 12 of our 16 late phase projects are
now being prepared for validation during
FY 2021-22 which is a record in the 40-year
history of the company. These projects span
therapeutic areas such as Antibacterial
Quantum Leap
Infection, Lymphoma, Multiple Myeloma,
Myeloid Leukemia, Hypersimplex and Gastric
related disease. your Business
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1 Additional early phase III project has moved
into the late phase arena during Q4 FY2021. Dynamic
‘Pharma Bionetwork’
The campaign to produce a highly complex
GMP precursor for a commercial oncology platform
product for a Japan based client has
commenced. This product is manufactured Directly Reach the Inboxes of
every 2 years by CGAM. 40,000+Affluent Leaders & Business
Influencers’ from the Pharma
Our development teams continue their Industry each month with the
PharmaBio World Digital Edition 17
progress on 3 new projects in the Synthetic
Cholesterol, and Vitamin D2 areas that we are
prioritizing across both India and Netherlands
sales@jasubhai.com
R&D teams.
Awaiting the imminent publication of the www.jasubhaimedia.com
results of studies performed by Boston
University with support and product from
DCAL. The data has been collated, compiled,
and prepared for publication which is
anticipated during the next 4 weeks in the
American Journal of Clinical Nutrition
Bavla facility successfully completed several
virtual customer audits during QIV FY 2021.
Manufacturing of many CRAMS products
underway at Bavla site. EDQM remediation
plan being implemented and on track at
Bavla site.
www.jasubhaimedia.com MAY 2021PHARMA BIO WORLD
TESTIMONIALS
“Under current circumstances everyone is coming up with
digital version. Even newsletters are coming out which are
useful because their frequency is much more. We can even go
for lesser pages and bring out information in newsletters. It’s a
yes for digital reading”
Dr. P. Reddanna
Executive President,
Federation Of Asian Biotech Associations
“Pharmabio World has been able to enable people by providing
contemporary news and information from the healthcare discipline through
education, knowledge-share, and more recently introducing entrepreneurs
contributing their voice on novel latest technologies, research and
development, and products that are altering conditions to lead better lives.
18 The print magazine so far has been a visual treat for a wider audience.
Although the rudimentary processes of hand-hold-magazine feel is
missed, I completely endorse the electronic/digital alternatives for simple
reasons and an optimistic view that the accessibility of the knowledge and
information should be the contemporary life. I completely endorse the
digital version of Pharmabio World with strong wishes to its success”
Dr. Sreedhara R VOLETI
CEO, ASPIRE-BioNEST
“One of the major consequences of this lockdown has been a shift of
trend from conventional offline services to digital resources. Media has
experienced the same trend as well. The shift from offline magazine and
newspaper distribution to online stories publishing, I think digital media
has got an extra point for covering every household even in the pandemic
situation. That too without the fear of getting exposed to the virus ”
Rajat Garg
CEO, Co-founder, myUpchar
MAY 2021 www.jasubhaimedia.comPHARMA BIO WORLD
TESTIMONIALS
“Just gone through the digital edition, extremely professionally
done, liked everything. Only one feedback, see if its possible
to zoom page wise, I have seen it possible in other digital
magazine.
Again, good job done on this.”
Sunit Maity, PhD
Director , Product Development, Zumutor
“It is a welcome change, may be long overdue!
(a) Better content delivery – in digital edition, dense diagrams in smaller
fonts, could be included, as readers could zoom in to read those. Therefore,
it becomes possible to deliver more and precise content
(b) more creative in designing the book : the publishers would not be
bound to keep the layout be fixed in A4, A3 format or so. They shall have the 19
full flexibility to design the layout without trying to fit in the contents to the
physical limitations of traditional boundary of print-edition once selected or
of the font size. Each edition could carry the size needed to best deliver the
message of the current content.”
Aditya Sharma
Senior Vice President Asia | Boson Energy SA
“I really loved the magazine. It surprisingly delighted me by giving the
experience of reading a paperback magazine. In fact, sometime back I had
twitted tagging most publications saying, “Why don’t you make newspaper
PDFs easily available. We ( the readers) are ready to pay for PDFs but
not the typical e-paper which is so low on readability with multiple ads
popping on the screen and causing major distraction.”
You have taken that ‘wish’ of the readers to another height. So, I greatly
enjoyed it.
I will also share the link through social media handles over the weekend
and I am sure people will love it.”
Gauri Chaudhari
Co-Founder Brand Innerworld
www.jasubhaimedia.com MAY 2021PHARMA BIO WORLD
COVER STORY
Evolving Packaging Trends across
Pharma Value Chain
From the desk of Guest Editor
20
Chakravarthi AVPS
MD, Ecobliss India Pvt Ltd
Honorary Advisor & Director on Board
PHARMEXCIL, Govt. of India Guest Editor
I
t gives me immense pleasure to be for their valuable contributions. Each of
the guest editor for the May edition them are proven leaders in their field
of Pharma Bio world. I appreciate the and their insights will be of immense
team led by Ms. Mittravinda Ranjan and value. I complement PBW team for taking
Jasubhai Media for choosing the theme cognizance from the growing demand for
‘Evolving packaging trends across pharma various product innovations across drug
value chain’ which is of great utility value delivery, dosing and dispensing of new
for industry. products, sustainable packaging getting
traction, smart packaging and labelling
I thank Gautama Buddha, Prabir Das,
solutions gaining rapid ground and so on
Chandi Prasad, Sriman Banerjee, Santanu
in this current edition.
Chowdhury and Soumyanath Mishra
MAY 2021 www.jasubhaimedia.comPHARMA BIO WORLD
COVER STORY
The future of pharma packaging will be
driven by two major factors the first one
being ‘User Centricity’ and the other being
‘Sustainability’ at large. Every packaging
development revolves around patient
needs because it is the influencing factor
to shape the market.
Under the current pandemic situation,
Quantum Leap
consumer behavior has completely your Business
changed in every aspect. Physical via
interactions between patients and doctors Dynamic
are declining rapidly. With advanced digital ‘Pharma Bionetwork’
communication being easily available platform
every corner, consultations are happening
remotely. Directly Reach the Inboxes of
40,000+Affluent Leaders & Business 21
I would like you to recall my statement, Influencers’ from the Pharma
“Packaging will be your second physician”. Industry each month with the
PharmaBio World Digital Edition
It is really apt under today’s situation.
It is evident from the fact that ease
of administration, dosage accuracy, sales@jasubhai.com
dose monitoring, minimising (zeroing)
medication errors have become the key www.jasubhaimedia.com
factors, apart from safeguarding drug
efficacy, providing product information
while following regulatory framework in
designing a pharmaceutical packaging.
At the end of the day, I sincerely believe
that every innovation has to help mankind
to benefit at large.
I once again congratulate team PBW and
wish all the readers safe and successful
days ahead.
www.jasubhaimedia.com MAY 2021PHARMA BIO WORLD
COVER STORY
Packaging will be your second physician
I
ndia is the pharmacy of the world and role in maintaining product quality and
supplies 18 percent of global generic efficacy throughout the supply chain
medicines, apart from the domestic gamut. And it acquires even more
market. Its position is unabated even relevance, given the lifesaving and life-
under this pandemic situation. So, the sustaining nature of pharma and medical
packaging industry is expected to come up devices, Today, the healthcare industry
with these requirements too, along with a is witnessing an unparalleled demand
new set of challenges. The critical role of for personal protective equipment (PPE),
packaging cannot be undermined whether diagnostic kits, medical ventilators and
it is uninterrupted supply of essential so on. This is in addition to the spurt in
drugs, expediting PPEs and testing kits, demand for critical medicines and hygiene
or supplying the vaccines which are products like sanitizers and hand rubs.
critical in the current pandemic situation Packaging plays a vital role in ensuring the
22 to several nations simultaneously meeting safety and security of all the above items
huge domestic demand. Pharmaceutical until they reach the hands of people who
packaging is always designed to meet need them the most. And its role cannot
the safe use of medicines by patients and be undermined in bringing the vaccines to
as we are aware, buying medication is across the globe.
extensively different from buying some
We have witnessed an accelerated
consumables in a supermarket
demand for healthcare-based packaging
The world has changed forever. This as a result of impulse buying in hygiene,
pandemic can probably be called the healthcare, and critical medicines. In
mother of all disruptions, at least for our packaging, the top of the table were rigid
generation. Life will never be the same plastics, blister foils, paper and paper
even after it settles down. The industry board packaging that comprise the
which is surviving well under the current necessary labels, cartons and shippers.
pandemic situation all over the world, While paper board, paper, glass, plastic,
despite a slew of hurdles and umpteen metal, rubber and others come under
challenges, is pharma and healthcare. basic raw material, the packaging products
Obviously, the packaging industry, being made out of all these materials meet a
an integral part of the pharma industry host of requirements viz. folding cartons,
also is contributing to this pandemic Display units, Paper Labels, Leaflets,
situation. Packaging plays an important Ampoules, Bottles, Vials, Syringes,
MAY 2021 www.jasubhaimedia.comPHARMA BIO WORLD
COVER STORY
Cartridges, Closures, Bags, Tubes, I would like you to recall my statement,
Laminates with paper or foil aluminum, “Packaging will be your second
Collapsible tubes, Rigid cans, Needles, physician”. It is apt under today’s
Gas cylinders, Pressurized containers, situation. It is evident from fact that ease
Closures, plungers among many others. of administration, dosage accuracy,
dose monitoring, minimizing (zeroing)
Role of Packaging in Time of medication errors have become the key
Pandemic factors, apart from safeguarding drug
efficacy, providing product information
Under the current pandemic situation,
while following regulatory framework in
consumer behavior has completely
designing pharmaceutical packaging.
changed in every aspect. Physical
interactions between patients and doctors It is a fact that India is still a developing
are declining rapidly. With advanced digital country and so affordable and efficacious
communication being easily available in drugs are in demand, but this does not
every corner, consultations are happening deter the accessibility of technological
remotely. advancements to the customers (ex.
Revolution in mobile communication). The
23
pharma and packaging industries always
Packaging will be your have great synergies and gregarious
relationships. The innovation in each
second physician. It is apt
industry inspires the other to excel. The
under today’s situation. It is demand to optimize the drug delivery for
evident from fact that ease healthcare professionals and patients in
of administration, dosage today’s circumstances is much larger than
accuracy, dose monitoring, ever before.
minimizing (zeroing)
Sustainable Packaging
medication errors have
become the key factors, Packaging plays a crucial role in
maintaining the quality, safety, and efficacy
apart from safeguarding drug
of all pharmaceutical products throughout
efficacy, providing product the value chain. In pursuit of making
information while following packaging sustainable we also must
regulatory framework in realize the fact that any packaging that
designing pharmaceutical falls short of serving its defined purpose
can never sustainable – no matter the
packaging.
amount of material reduced, recyclability,
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or use of more recycled materials. include consumables like solvents, inks
and adhesives.
Designing sustainable packaging for
pharmaceutical products is not an easy Design Thinking in Packaging
task. The packaging design must ensure
that all product packaging must comply Designing pharmaceutical packaging
with the local packaging regulations is a tad different from doing it for other
and look for ways to reduce their products. While sustainability, protecting
environmental impact. the environment must be taken into
consideration several other issues like
There are a lot of new sustainable product safety and efficacy throughout
packaging materials which can be reused the supply chain gamut, regulatory
or recycled are now available. Though it is compliance, patient convenience must be
not possible to use for every application given priority while designing a packaging.
(for example the primary packaging for Well, if you think the drug for which you
a complex molecule) several sustainable need to design the packaging is one of
materials like PCR plastic or recycled the most effective and efficacious, the
24 plastic and biodegradable material like packaging must not only safeguard those
recycled paper, paperboard, films derived qualities but use all the factors that convey
from natural resources are also available this message viz., the graphics, the colors,
for certain applications. The material the text, and words in the labeling; on the
that has a negative carbon footprint and packaging and of course the material used
easily recyclable eventually wins in the for the packaging itself.
sustainability race. Pack that weighs less
or occupies less space while fulfilling The design thinking in pharmaceuticals
their purpose also contributes to the must facilitate a better connectivity and
sustainability journey. The world health patient-centricity.
organization identified three directives to
The consumer must always have a feeling
help reduce and eliminate waste: reducing
at the first instance that the product is
packaging that is not essential to the
well designed. If it’s an OTC product
protection of the drug, making as much
its more important to consider several
of the packaging as possible recyclable,
aesthetic factors to give the FMT feel to
and making contaminated packaging
the customer. One must not forget the fact
incinerator safe.
that your customer may or may not see the
In true sense, all packaging products must promotions in print, electronic or even in
be designed keeping sustainability in mind digital media. Invariably all the customers
paying attention to all components that will see what is there in and on packaging.
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This is the reason packaging is referred as around patient needs because it is the
a tool to extend your brand. influencing factor to shape the market. Its
noteworthy that, self-administered devices
Now consider designing Child-resistant
with advanced technology, especially
packaging.
for combination drugs are on the rise.
The packaging must ensure an easy Smart inhalers and nasal sprays will gain
access to the needy (read the senior more demand. Transdermal patches are
citizens or even people with arthritic currently used for pain relief and normal
hands) at the same time deter the child healthcare. Similarly, a lot is happening in
from accessing the product. So, it is oral dissolvable films. This format is very
essential to design a packaging that useful for pediatric and geriatric patients.
enables people an easy-open solution, We have heard that Gilead Sciences is
simultaneously makes it difficult for developing an easier-to-administer version
children to access the medicines. that can be inhaled for the sought-after
antiviral drug Remdesivir for COVID-19.
Similarly, a medical device or a prefilled
syringe must be hermetically sealed to The use of Artificial Intelligence in every
field will be on the rise. Concepts of
25
provide all the production, the medical
staff or even the patient who needs to smart packaging with advanced NFC
access it must have an easy opening components may become a norm for
option. User experience should always certain products. The evolution of ultra-
be in forefront while designing a product thin ICs that can be embedded in any
and it must communicate effectively and package has given scope for incorporating
emotionally the objective to the consumer more features. Implantable medical
and in a nutshell the design thinking devices gain ground as they are very
must elicit a meaningful experience to the appropriate for regulated drug delivery in
patient in the simplest possible manner. certain cases. Wearable medical devices
are another segment to watch. Many of
Future Trends them are already finding their applications,
not just for diagnostics and monitoring
The future of the pharma market will purposes but also respiratory, therapeutic
be having a focused market approach pain management and others.
rather than a saleable model. We started
seeing these trends catching up in some At the end of the day, I sincerely believe
segments already. The Pharma industry’s that every innovation must help mankind
approach today is more customer to get benefited at large.
centric. Every development revolves
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“Packaging industry is significantly
changing the healthcare spectrum”
26
Gautama Buddha
Former Head Packaging Develoopment
Dr Reddys Laboratories Ltd
Packaging Consultant
O
ne of the major developments service offered from doctors abroad to
in the Healthcare sector is patients across the globe.
Telehealth which is a major
outcome of IOT . It is now not limited to Consumer Trends
geographical boundaries. A doctor can
Global markets see increased online
see his patient from any parts of the world.
retailing and continue to grow which is
The best example is in the current COVID
driven by internet penetration. This will see
treatment doctors are advising medication
elevated demand for the right packaging
through audio-video mode and continuous
solutions especially for secondary and
engagement with the patients. Also,
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tertiary packs like CFB formats and cold to translation errors or incorrect
chain packaging. specifications and versions being used, all
share the human element as the consistent
Consumer awareness and increased
point of failure. Any of these issues can
interest in their own health matters leading
lead to a regulatory breach, a delay in
to a healthier lifestyle. This is boosting
getting a product to market, a recall, or
demand for packaged goods e.g., gluten-
even a critical consequence for the patient.
free, organic, nutritional supplements, etc.
Another important area is providing
E-commerce and globalization of
assurance to the customer on genuineness
international trade are also stimulating
and safety and overcome the counterfeit
demand for RFID labels, smart tags, etc. to
issue.
protect from counterfeits. The 21st-century
consumer is less brand loyal due to the Scale-up and packaging validation
Internet and the availability of multiple of primary, secondary, and tertiary
brands. This is stimulating interest in packaging. Failures can happen largely if
customization or versioned packaging. not focused on packaging validation. There 27
is no scope for safe assumption even the
The above developments in the health
packaging system may be the same for
care sector have a greater influence on
a new product or pack. It needs to be
the packaging. Packaging needs to gear
validated.
up for customization and the online sale of
medical devices and wearable devices that
can monitor drug penetration and maintain
Global markets see increased
health. Also, cold chain packaging to
meet the drug requirements and to reach
online retailing and continue
remote areas. to grow which is driven by
internet penetration. This will
Critical Points of Failure see elevated demand for the
In terms of potential risk, the packaging
right packaging solutions
and labeling process is one of the most especially for secondary
vulnerable elements of a product’s life and tertiary packs like CFB
cycle. The risks, ranging from incorrect formats and cold chain
or incomplete product information packaging.
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New innovations in pharma and
biopharma packaging that you look
forward to sustainable packaging solutions
with minimum or reduced impact on the
environment.
Compliance packs to adhere to the dosage
regimen. Quantum Leap
Medical devices which are patient- your Business
friendly and with safety features for via
administration. Overt counterfeit features Dynamic
for easy identification at the same time ‘Pharma Bionetwork’
difficult to duplicate. Your expectations platform
from a pharma packaging supplier.
Packaging supplier or partner has an Directly Reach the Inboxes of
28 important role to play in new product 40,000+Affluent Leaders & Business
Influencers’ from the Pharma
or pack development. Continuous Industry each month with the
engagement from design to development PharmaBio World Digital Edition
till implementation to understand the
customer requirements is very much
sales@jasubhai.com
necessary. Providing timely inputs in terms
of processability and availability will help www.jasubhaimedia.com
in decision-making.
Informing and updating customers on
the changes in current process, input
materials is necessary.
Support the customer with required
data to meet regulatory requirements or
amendments from time to time.
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COVER STORY
“New medicines require specialized
packaging for shelf life”
29
Sriman Banerjee
Head of Packaging Development & CDE
R&D Pharma Science
T
akeda Pharmaceutical Company The new medicines require specialized
Limited. The 19th century was packaging for shelf life, cryogenic
focused on IT and the 20th century conditions, and delivery systems
will see a focus on Healthcare. The trend specifically in the areas of gene, cell, and
started even before the pandemic and plasma therapy. This is a new niche area
evolved as we strive to remain healthy and of packaging being developed on material
live longer. With advances in our lifestyles, science and formats. While the packaging
the ecosystem of health becomes industry tends to manufacture based on
important. We see a lot of new medicines volumes, there is a new opportunity to
being developed enabled by Science & develop and manufacture custom products
Technology leveraged by research. catering to the new age medicines.
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The Necessities and Mandates of
Packaging
30
Prabir Das
Head Packaging Technical Services
OSD India , VIATRIS
T
he necessities and mandates in the In Branding, the Pack Design, Graphic
Category of Product Range include Design, Use of Smart Features and in
Physical, Chemical and Organoleptic Logistics focus on Storage, Handling
properties, Shape, size, colour, Fragility, & Distribution, Mode of Transportation,
Sensitivity level, Bulk density, Viscosity, Excursion, Study, Shipment Study are
Flow properties. considered.
In terms of Process, the Design, Flow, During the Customers phase, Domestic
Scope of Automation, Standardisation and or Export, Demography, Convenience,
Harmonisation are observed. Dispensing ease,
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Disposal ease, Authenticity are followed. • Track & Trace: This brings traceability
and transparency in supply chain
In Regulator, the Local rules & Regulations,
operation with security and ensures
Environment friendliness, Child protection,
customer safety.
‘Supply chain safety & security and in
• Supply Network: Well-knit strong
Competitors, the Bench marking, Cost
connectivity is must for clear visibility
sensitivity, Uniqueness (USP) and in
of the goods in network. This helps to
Technology, Availability & Adaptability,
improve speed to market / customers
Cost-benefit analysis, Feasibility for
and in customer services.
hybridizing, Sustainability is noted.
• Awareness Building & Training:
Future Development Strategy This is one of the strong elements
for building a good understanding
• Multi-Skilled Trained People: Just
to strengthen product-people
like all-rounders in a team, this will
connectivity through packaging.
bring flexibility, improve productivity
Understanding is a hybrid result from
level and help in any kind of crisis 31
reading, writing, speaking, listening
management.
and watching.
• Indigenisation: In many areas we
• Regulatory Guidelines: Regulatory
are still dependent on imports due to
and statutory guidelines vary based
unavailability of suitable indigenous
on country / region, which indirectly
substitutes. Import substitution is
generates varieties at workplace
needed to promote self-reliance,
and all other activities, including
improve cost efficiency and
supply chain. There is a scope of
procurement cycle time.
standardization and harmonization to
• Automation: It brings discipline at optimize resources and efficiency.
workplace, apart from enhancement
• Communication, Collaboration &
in Quantity and Quality. It also helps in
Cooperation: This is the final directive
resource optimization in the long run.
for seamless sustainability of the
• Smart Features: These are used on business. Internal or external, at each
product-packs for multiple purpose level this is must. Academy, Industry
like brand promotion and protection, and Regulators need to ensure this
prevention of theft, diversion and for all.
Cloning.
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“Packaging validation is still a nascent
stage in the Indian Pharma industry”
32
Chandi Prasad Ravipati
Head - Packaging Development
Aurobindo Pharma Limited
P
harmaceutical Industry is a the end of 2020. The journey of the
lifeline industry and forms an Pharmaceutical industry of India for
ecosystem with the healthcare the last two decades is phenomenal
industry that provides goods and becoming one of the largest exporting
services to treat patients with curative, countries of generic drugs to the world.
preventive, rehabilitative and palliative The role of the packaging industry is
care. It is one of the fastest-growing equally outstanding in meeting the
industries across the globe with a stringent demands of regulated and
turnover of 390 billion USD at end of Emerging Markets.
2001 reached to 1.27 trillion USD at
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Emerging Trends in Pharma data, and audio-visual presentation
Packaging of usage can play role in making
user-centric packs. While design
Change is constant. This applies to a container-closure system for a
the pharmaceutical industry very aptly product, packaging technologists
due to stringent regulatory changes should consider optimization in view
from almost every importing country of sustainability. Many packaging
periodically. Child-Resistant and materials can be reduced using
Senior-Friendly packs for blisters in electronic media and reduce waste
the USA are becoming more and more generation.
strict. Compliance to requirements
and developing a cost-effective pack Dent the reputation of the organization.
desires lot of innovation in blister Technological development in the
designing and packaging materials. inspection and rejection of faulty
The focus of the Indian Pharma packs on packing lines is still not
industry for the next decade is more on robust to avoid packing and labeling 33
developing specialty drugs, parenteral errors. They may be due to human
formulations, and novel drug delivery interference, bypassing inspection, or
systems. All these necessitate special
packaging.
Packing and labeling errors
User (Patient) Centric Packaging cause monitory losses and
and Sustainability are two areas dent the reputation of the
of focus and play an important role organization. Technological
in the sustenance and creating a development in the
brand image for generic products in
inspection and rejection of
regulated and emerging markets. The
faulty packs on packing lines
packs besides meeting statutory and
labeling requirements of the country
is still not robust to avoid
they are consumed should facilitate packing and labeling errors.
pharmacist, administrator, and end- They may be due to human
user convenience. interference, bypassing
inspection, or failure of the
The advancement of the Internet of
inspection system
Things, digitalization, barcoding of
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failure of the inspection system. There Packaging validation is still a nascent
are frequent market complaints on stage in the Indian Pharma industry.
missing tablets or capsules in blister, Both packaging technologists and
less count in bottles, missing labels, production packaging personnel
and or literature. Wrong labeling is very should prepare and implement
critical and it can happen from vendors packaging validation appropriate to
of labels and foils or wrong dispensing their packing machinery and lines. This
which could not be detected on will greatly help in reducing market
packing line by men or machine. It will complaints due to packing and labeling
be a joint effort by manufacturers and errors.
providers of hardware and software of
packing lines. Serialization (Track & Trace)
Of Pharmaceutical Products
Automation Of Packing Lines
Serialization of packs of products at
Even though automation in the different levels, aggregation between
34
pharmaceutical industry is growing these levels, and data submission
on the fast track, many secondary to country of port became a global
and tertiary packing operations are requirement now. The requirements
manual. Emphasis on developing slightly change from country to
efficient automation in primary country. It is one of the best tools
packing operations and automation of track and trace to avoid spurious
of secondary and tertiary packing medicines in the market and provide
operations will be a priority to authenticity of the medicine to the
increase productivity and avoid user. This is an example of the failure of
packing and labeling errors. It is very pharma packaging solutions providers
important that packing machinery as the entire track and trace system is
manufacturers must concentrate on a combination of:
developing inspection system which
• Conveying the pack properly,
is tested and validated for worst-case
situations. They should make research • Printing of barcodes and human-
and development a continuous readable data with variable data
program to overcome failures and on each pack with a unique serial
provide foolproof inspection systems. number on each pack
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• Inspection of printed data to pass
correctly printed data with grading
and rejection of wrong or illegible
and non-readable packs.
Element of Information Technology is
the backbone of entire serialization.
No Indian hardware and software Quantum Leap
provider is efficient in all these fields
and all have experimented. With a lot
your Business
via
of deliberations between the pharma
Dynamic
industry and service providers for
‘Pharma Bionetwork’
almost a decade, it is now stabilizing.
platform
Innovations Pharma &
Biopharma Packaging Directly Reach the Inboxes of
40,000+Affluent Leaders & Business 35
Influencers’ from the Pharma
As the patents are diminishing,
Industry each month with the
the need for new drugs and drug PharmaBio World Digital Edition
delivery systems is increasing, Indian
Pharma industry started increasing
sales@jasubhai.com
their Research & Development and
investing more funds for innovation in www.jasubhaimedia.com
developing new medicines. Packaging
of novel drug delivery systems requires
innovative packaging systems to
maintain the efficacy of the products.
It is obvious that the Indian Packaging
industry also focuses on Research &
Development. The role of packaging
institutes is very important for
research and development and the
packaging industry can benefit from
their research as ours is a developing
economy.
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“Molecule entities are throwing up newer
challenges in-terms of establishing
product-pack compatibility”
36
Santanu Chowdhury
Sr. General Manager - Packaging
Development, Sun Pharma
T
he changes in Healthcare sector Critical points of failure for Pharma
vigorously influencing the packaging Packaging solutions providers in
industry are molecule entities are my experience and suggestions for
throwing up newer challenges in-terms improvement would be the absence of
of establishing product-pack compatibility long term data availability on performance
and stability during its long shelf life. of said packaging material coupled with
lack of interest to establish machine
One such concern being surfaced out is
performance result are some of the
oxygen & heat sensitivity. The dynamics
low confidence factors that prevails in
of regulatory landscape ,government
the mind of heath care user industry in
/ insurance policies , stringent quality
connection with reliability/credibility
requirement are some of the contemporary
quotient of packaging solution provider.
that healthcare industry is gearing up to
address while selecting the cost effective
packaging options.
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COVER STORY
“Smart packaging can reduce supply
chain losses & enhance environmental
monitoring”
37
Soumyanath Mishra
General Manager & Head-Packaging
Development, Mankind Research Centre
D
uring the challenging days of the Patients who previously considered the
COVID-19 pandemic, as citizens only way of receiving health care was by
around the world have moved contacting their doctor, meeting them
into lockdown with limited movement, face-to-face, explaining their symptoms,
vast swathes have become reliant being examined and ultimately getting
on technology for maintaining social diagnosed and treated have, in a few short
connectedness or even obtaining essential weeks found other mechanisms to receive
supplies such as medicine. Products care. Patients have found themselves
with names that had limited awareness interacting via apps, online tools and video
have become household lifelines, such as conferences, in many cases, with a more
Zoom®, Teams®, Uber eats and the plethora responsive approach. So, in the face of
of other communication and delivery such disruption, there is a huge influence
services. in Pharma packaging. Major changes can
happen in the packaging industry.
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Impact of Economic & home) packaging materials to reduce the
Demographic Growth on leakage of packaging materials into the
Packaging environment.
As the global economy grows & tends New Innovations Pharma &
to incline towards sustainability, the Biopharma Packaging
packaging industry will address this issue
alongside offer thrust to lightweight, • Device & Self-Administration:
patient centric and user friendly Medical devices are taking a leading
packaging. role in the health care sector.
Changing hospital administration
• Consumer (Patient) Trends: The to the self-administration process is
global pharma market is seeing increasing rapidly in the market.
an increase in online purchase of
medicines which will drive the demand • Connected Medical Devices: A
of specific type of packaging and self- connected medical device can collect
demonstrating packaging. and store data about patient use and
38 trace the effectiveness of a particular
• Packaging Design: We did not device and treatment to help them to
expect much demand from the do so.
healthcare/pharma packaging sector
due to the regulatory environment.
Moreover, pharma packaging is In response to volatile raw
very different from other types of
materials cost & high cost
packaging due to strong emphasis
on product functionality. Now the
of recycling of pharma
pharma & biopharma packaging packaging, companies
solution providers are offering the could test new avenues for
manufacturers bold and innovative promoting the sustainability
packaging solutions to enable them
agenda—for example,
create differentiation in the market and
improving bottom line sales. by introducing truly
biodegradable (compostable
In response to volatile raw materials
at home) packaging materials
cost & high cost of recycling of pharma
packaging, companies could test new to reduce the leakage of
avenues for promoting the sustainability packaging materials into the
agenda—for example, by introducing environment.
truly biodegradable (compostable at
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