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141 views52 pagesBio Spectrum - October 2024
Bio Spectrum
Uploaded by
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© © All Rights Reserved
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BHARAT EYES GLOBAL
BIOMANUFACTURING
DOMINANCE:
Boosting Innovation,
Collaboration &
Entrepreneurship with
BioE3
Policy DYONING | Bogen’
Better Purification
and Recovery in
Bioprocessing
Chromatography technology, recognized as a prevalent method for separation and
purification, is extensively utilized in biologics manufacturing, such as antibodies,
vaccines and cell and gene therapies. Within these processes, chromatography resin
plays a crucial role.
Bogen Bio (part of the Duoning Group) offers several series of large-pore rigid gel
chromatography resins:
* HP Series: Suitable for purifying molecules or polypeptides and recombinant proteins
with a molecular weight below 200KD
* CP Series: Suitable for purifying molecules or recombinant proteins and antibodies with a
molecular weight of 100KD-300KD
* GP Series: Suitable for purifying molecules or viruses/vaccines with a molecular weight
above 150KD
Utilizing polymer microspheres as the matrix, our high-performance, large-pore rigid
gel chromatography will increase protein recovery rates, robustness and repeatability
in your separation and purification processes.
eg ea Naa ea
eae at
u.duoningbio.com/en to) \orni te lan)
3M™ Harvest RC Centrate
Single stage chromatographic clarification
encapsulated solution for centrate
‘The innovative synthetic fibrous AEX chromatographic Q-functional polyamide membrane which
clarification media enables a single-stage centrate distributes the flow across the AEX media bed and
clarification from CHO cell cultures with high product enables protection of downstream sterilizing grade
recovery and high fidelity of soluble and insoluble membrane filter. Also, the 0.2 um functionalized
impurity removal. Downstream of the fibrous polyamide membrane enables simple process
chromatographic clarification media is the 0.2 um endpoint measurement using pressure reading.
asymmetric
Expanding fibrous media platform
ee ey
Wrenn) UL
Bost
Publisher & Managing Editor:
ceo
‘sanaseehrstarnemctvcom
alvora:
‘alin eljesmact com
[Advisor Content: iy Thome
Vol 22; Issue 9; September 2024
Acknowledgement/ Feedback
Pharmexcil is actively involved in overcoming industry
challenges by organising awareness campaigns,
providing industry training, and facilitating dialogue
between regulatory bodies and pharmaceutical
companies. Our goal is to ensure that Indian
pharmaceutical products meet the highest standards globally.
-K Raja Bhanu, Hyderabad
‘Thank you BioSpectrum for organising an exclusive event for the BioSupplier
sector. All the panel discussions were very engaging and fruitful. Looking
forward to more such events from your side,
- V Sankaranarayanan, Chennai
‘The Biotech Innovations & Suppliers Conclave 2024 was very well organised in,
Navi Mumbai on 23 August. Congratulations
- Raghavendra Goud, Hyderabad
MM /
S0-Tech Communicators
oer a ee
See MM Activ Sci-Tech Communications
South Region ental india INTERNATIONAL
‘ora ean Spore Mat,
Manager Marge Srsegy & ‘Singapore
Strategy & Partnerships Peres [MM Acti Singapore Pe. La
ITO, No.1 pooramatapn@nmaciccom | Sada Man!
Bick Second Pr | Mle spay aga | Genera Manager
DE ae Lo un} North Bridge Road,
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Strategy & Marketing
Ankita
Social Media Communication
Poonam Bose
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Rest, General Manager HI and
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Production & Design
Mi Aci Tech Communications
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Subserption:
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‘Mobile: +91.9762003626
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Shankar Nagar Square,
‘Negpue 440 010.
Tel 0017122585 240
So-Tet Communications
Mobil: 45 00150305
Erma digitalommactvcom
“Biospeetrusn’ monthly publication i owned by MM Aci Sci-Tech Communications Pv Ld
Published and Printed by Rava Boratlar. Printed at Spectrum Offset, D/¢, Satya Industri Estate,
[Behind CDSS, Erandneaa, Pane 43 098 and Published at Ashsiad.30/4/,8.No 270, Palo Far,
Baner Road, Net Bonk of Baroda, Pune "al O15, Eitor: Narayan Kula,
Repeated for ete Cicltion \
Ravindra Boratkar
Publisher &
Managing Editor,
MD, MM Activ Sci-Tech
Communications Pvt. Ltd,
Letter from Publisher
Dear Readers,
Bharat’s bioeconomy is estimated to be valued around $300 billion by 2030,
‘making it the third largest biotech destination in Asia Pacific and one of the
top biotech destinations globally. With COVID-19 providing the industry with
a much-needed boost, the country’s bioeconomy reached $151 billion in 2023
and witnessed an exponential increase in valuation over the previous Il years.
As one of the top hubs for bioinnovation and blomanufacturing today, Bharat is
recognised as a rising sector and a crucial component of the country’s economic
growth plan, which aims to see its GDP grow to $5 trillion by 2027.
To set the country at the forefront of a more sustainable future, and remain
responsive to global challenges by accelerating and harnessing biomanufacturing
solutions, the government introduced the BioEg (Biotechnology for Eeonomy,
Environment, and Employment) Policy—a strategic framework designed
to propel India into the next era of industrialisation. The BioE3 Policy was
approved on August 24, 2024, by the Union Cabinet for “Fostering High-
Performance Biomanufacturing”. The policy chalks a strategic roadmap to
turn India into a global biomanufacturing hub through innovation, for the
development of bio-based products and building an infrastructure that enables
scale-up and commercialisation. With inputs from the industry captains
wwe have put together an elaborate story as to how the Bio Policy is set to
transform the biomanufacturing landscape in India.
‘The pharma representatives of the Laghu Udyog Bharati (UB), a not-for-
profit Pan India Organisation with an aim to empower MSMEs met with officials
from the Department of Pharmaceuticals, and discussed key issues such as Trade
Margin Rationalisation (IMR), Schedule-M extension, Revised PTUS Hurdles,
and the Drug Tribunal Board formation. The LUB Pharma proposed the
innovative “One Nation-One Molecule-One MRP" strategy and advocated that
the top 100 companies sell their generic brands at molecule name and affordable
‘Maximum Retail Price (MRP) for the benefit of patients. We are covering a story
with recommendations from industry associations to make TMR more effective,
balanced, and supportive of all stakeholders in the pharmaceutical supply chain.
India has already established itself asa global hub for pharmaceutical
‘manufacturing, earning the nickname the “Pharmacy of the world.” However,
while the country excels in generics and large-scale production. its contribution
to cutting-edge biomedical research and innovation still lags. We have an expert
article that addresses how collaboration between academia, which can provide
fundamental research and innovation, and industry, which ean offer resources,
funding, and practical implementation, will help bridge this gap.
Global Bio-India (GBI) 2024, organised by the Biotechnology Industry
Research Assistance Council (BIRAC), from September 12-14, witnessed
the launch of BioE3 Policy, and was a much bigger event compared to GBI
2023. Our team has covered the highlights of the event, which will surely be
informative.
I believe you will find this edition a great read, as always.
Thanks & Regards,
bee
Ravindra Boratkar,
Publisher & Managing Editor ficover
BHARAT
EYES GLOBAL
BIOMANUFACTURING
DOMINANCE:
Boosting
Innovation,
Collaboration &
Entrepreneurship
with BioE3 Policy
Bharat has demonstrated a strong economic growth in the past decade and
s poised to be amongst the global leaders in the next industrial revolution
by leveraging emerging technologies and new innovative solutions. Bharat
is competitively positioned to be amongst the global leaders in futuristic
manufacturing that leverages living systems. Biomanufacturing can
fundamentally transform the global economy from today’s consumptive
manufacturing paradigm to the one based on regener;
Biomanufacturing refers to the use of engineered microbial, plant, and
animal (including human) cells with increasing precision and control to
produce commercially important products on scale. These are versatile
processes that have the potential to create bio-based products allowing
efficient utilisation of resources, in a scalable and cost-effective manner
with reduced environmental impact. Keeping in view the national priority
of steering Bharat on the path of accelerated 'Green Growth’, an integrated
BioE3 (Biotechnology for Economy, Environment and Employment)
Policy for “Fostering High-Performance Biomanufacturing’ with an aim to
make a green, prosperous, and self-reliant Bharat was released on
September 12 at Global Bio-India (GBI) 2024, Let’s take a look at how the
BioE3 Policy for biomanufacturing is set to transform this landscape
Pern
ve principles. ATW
pn
COVER DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.
Trade Margin Rationalisation
for Brazil
high-au
competitive prices
Bruna Magnago, 26
ina ben Chane Can phi
trade margin
joast pharma growth? Counterfeit Drugs
28
Telangana wages war against counterfeit drugs
Speaking With
30
“Netravaad is for stroke
patients and also those
wholve very severe speech
issues or lost their speech’
Dr Rajesh Kannan Megalingam,
Founder, T2H Imovations
31
“ICMR has committed to
funding all aspects of
Phase | trials of Zika vaccine”
Dr K Anand Kumar,
Managing Director,
Inaian Immunological Lites
32
“To truly transform cancer
care in India, we need to focus
con improving training for
healthcare professionals
Pratima Reddy,
Country Speaker Merck nda & MO,
Merck Specialties
34
“While the regulatory landscape
is evolving, long approval
processes and strict compliance
requirements still act as barriers
to local production*
Kalavathi Gv,
Heac of Development Cente (OC) and
Execuve Directo,
Slemens Healhineers india
Collaboration
36
Why industry-ecademia
collaboration is crucial for
biomedical sciences
Vaibhav Patel,
Director of Quality Assurance and
Regulatory Afar, Univer of Manesota
Top Video
‘Scan the QR Code »
Event Report
Global Bio India 2024
a
Nitin Stephen Abel
Senior Director, Terumo
Interventional Systems,
‘Terumo india responds
to the question on how
minimally invasive
‘teatment has the potential
to transform Indies
healthcare ecosystem
‘Or Sanjay Sharma,
Corfounder of
FootSecure
discusses the rising
importance of
podiatry and foot
heath in india,
Bharat BioEconomy to touch
$30 trillion by 2050: IBER 2024
Regulars
BioMail 04
Letter from Publisher 05
BioEdit 08,
Policy and Regulatory News. 10
Finance News. 12
Company News 4
Startups News 16
Academics News 40
People News. 4
R&D News 43
Supplier News 47
Let's Talk Health 50 BIO EDIT
ith the passing of the Biosecurity
Act 2024 by the US House of
Representatives, Indian pharma could
capitalise on more export avenues on US shores.
However, one more hurdle remains, as the Bill
will now be discussed, before it's passed by
the senate. The huge margin of 306 for and 81
‘opposed to the Bill in question, is an indication of
the strong sentiments of the US over the issue. It is
highly unlikely that the Bill would not be passed in
the senate.
The Bill is kind of a seal over the tense
relationship between the US and China in
the biotechnology turf. The conflict had been
lingering for quite some time. The Bill has black-
listed Chinese biotech companies and their
US subsidiaries. It specifically names five such
companies to be black-listed.
‘The rationale behind the Biosecurity Act is
very clear. The US feels that China has become too
much of a monopolistic source of raw materials for
pharma products. It is now alarmed over the entire
dependence on China for the biotech supply chain,
‘Two other pinching points are the US's failure to
compete with China in the biotech field and also
possession of the US people's genomic data with
Chinese companies. As a result, the US lawmakers
initiated the legislative steps to protect national
security as well as commercial interests from the
Chinese companies. The Bill passed in the house
is the result and It is expected to deter the US
pharma companies from outsourcing to China.
‘The US Senate’s homeland security
committee gave approval in March to forward
a Bill restricting business with Chinese biotech
companies on national security grounds, Prior to
that, a similar Bill was moved in the US Congress
in January seeking to ban federally funded
‘medical providers from using the services of
any Chinese biotech company, particularly BGI
group, MGI and WuXi App Tech from accessing
genetic information of American people. The
Bill has been moved by two leading members of
the Congressional select committee on Chinese
US Biotechnology Endgame
‘Communist Party (CCP).
‘The legislation passed in the house was also
passed 40-1 by the House Oversight Committee
in May. Hence, the likelihood of its passing in
the senate too is very high. The main idea of all.
the legislative efforts is to develop an alternate
vendor ecosystem in event that China tries to
‘weaponise its capabilities on the pharmaceutical
raw materials side. Having an alternate vendor
that can support you is so important that it needs
to be developed even if at higher prices or higher
cost appears to be the general feeling among the
US policy makers,
Experts say, currently, an estimated over
100 biopharma drugs are being developed by
the US companies in partnership with Contract.
Development and Manufacturing Organisations
(CDMOs). The new Act is expected to delay
the development cycle of the new drugs and
disrupt the supply chains of the US life sciences
‘companies. This is where Indian pharma players,
particularly CDMOs, come into the picture.
In light of the impending snowball effect
of the Biosecurity Act, the Indian Ratings and
Research has projected a hike in orders for Indian
CDMO and Contract Research Organisations,
(CROs) segments from the US pharma companies.
‘The Indian CDMO market is expected to grow
from over Rs 18,000 crore in 2024 to almost Rs
38,000 crore by 2029. In Active Pharmaceuticals
Ingredient (API) exports, India is still lagging far
behind China with India exporting APIs worth
$4 billion while China exports $40 billion, Some
Indian companies have already initiated steps to
exploit this crucial opportunity.
While there is expected to be a scope for
immense growth for the Indian companies due to
the Biosecurity Act, there are some challenges too
to overcome. Notwithstanding the usual hurdles,
experts opine that the Indian companies should
leverage the opportunity as it presents itself, 1S)
Dr Milind Kokje
Chief Editor
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Cabinet approves ‘Vigyan Dhara’ scheme
of Department of Science and Technology
The Union Cabinet, chaired
by Prime Minister Narendra
Modi, has approved
continuation of the three
umbrella schemes, merged
into a unified central sector
scheme namely ‘Vigyan Dhara’
of Department of Science
and Technology (DST). The
scheme has three broad
components: Science and
‘Technology (S&T) Institutional
and Human Capacity Building:
Research and Development
and Innovation, Technology
Development and Deployment.
The proposed outlay for the
implementation of the unified
scheme 'Vigyan Dhara’ is Rs
10,579.84 crore during the
15th finance Commission
period from 2021-22 to
2025-26. The merger of the
schemes into single scheme
‘would enhance efficiency in
fund utilisation and establish
synchronisation among the
sub-schemes/programmes.
Health Ministry
approves introduction
of shorter treatment
regimen for drug-
resistant TB in India
Union Ministry of Health & Family Welfare has
approved introduction of the BPaLM regimen,
a novel treatment for Multi-Drug-Resistant
‘Tuberculosis (MDR-TB) under its National TB
Elimination Programme (NTEP) as a highly
effective and shorter treatment option. This regimen
includes a new anti-TB drug namely Pretomanid in
combination with Bedaquiline & Linezolid (with/
without Moxifloxacin). Pretomanid has earlier been
approved and licensed for use in India by Central
Drugs Standard Control Organisation (CDSCO),
‘The BPalM regimen, which consists of a four-
drug combination — Bedaquiline, Pretomanid,
Linezolid and Moxifloxacin, has been proven to
be safe, more effective and a quicker treatment
option than the previous MDR-TB treatment
procedure. The Department of Health & Family
Welfare, in consultation with the Department of,
Health Research ensured validation of this new
‘TB treatment regimen that witnessed a thorough,
review of evidence by in-country subject expert.
‘The Department of Health & Family Welfare has
also got a Health Technology Assessment done
through the Department of Health Research to
ensure that this MDR-TB treatment option is safe
and cost effective.
~
Centre launches National
Strategy For Prevention
of Unintentional Injury
‘The Ministry of Health and Family Welfare,
Government of India and World Health
Organization (WHO) released India's National
Strategy For Prevention of Unintentional Injury
at #Safety2024: 15th World Conference on Injury
Prevention and Safety Promotion on September
2 in New Delhi. The comprehensive roadmap,
developed in collaboration with The George
Institute for Global Health, aims to reduce the
burden of injuries in India. It calls for a review
and strengthening of India’s injury prevention
Jaws, prioritising enforcement and enacting new
legislation, as needed. It also calls for allocation
of dedicated and sustainable funding for injury
prevention initiatives across various levels. The
strategy prioritises four key injury mechanisms-
road traffic injuries, drowning, burns, and falls
from heights, and focuses on three vulnerable
population groups- workers, children, and older
people. DC especie com
Karnataka to unveil Global
Capability Centres Policy
at BTS 2024 in November
“Karnataka, home to over 400 Global Capability Centres (GCCs)
is ready with draft a policy on GCs and will be sharing with all
stakeholders soon so that it will be unveiled at the Bengaluru Tech
‘Summit 2024 (BTS 2024) set to take place from November 19
to November 21, 2024” said Priyank Kharge, Minister for IT, Bt,
Government of Kamataka. Speaking at the Global Innovation Alliance
(GIA) Partners meet at BTS 2024, Kharge said “Bengaluru is not just
the tech capital of India; it’s a globally recognised hub for innovation,
research, and technology-