BioSpectrum India October 2022

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Central India's Largest Agri Summit

November 25-28, 2022
Nagpur, Maharashtra, India

FUTURE FARMING

FOOD FEED AND FUEL

Integrated Technology through Research

Highlights of Agrovision National Expo 2022 Chief Patron

Around 25000 Sq.mt. display area Shri Nitin Gadkari
Expected Participation of over 400 Organisations
Hon'ble Union Minister of
Road, Transport & Highways

Shall be visited by Lakhs of Farmers from all across the country Free workshops for farmers
Special Pavilion
Govt. of Maharashtra & ICAR Labs Tentative workshop schedule
Agriculture, Horticulture & Allied Sectors Turmeric and Ginger cultivation and Processing
NSIC, MSME, Startups
Animal Husbandry Bamboo Production and Utilisation
Fruit Plants Nursery Production
Top Reasons to Exhibit in AGROVISION EXPO Banana and Orange-Export quality production

Sericulture, Goat Farming, Poultry, Beekeeping

Fisheries-Opportunities for Vidarbha

• Reach out to lakhs of farmers from central India and Conference
adjoining states
Tentative Conferences Topic
• Get connected with the policymakers, industry captains, Dairy Development in Vidarbha
eminent scientists etc.
Scope of Inland Fisheries in Vidarbha
• Excellent Opportunity to Launch Products/Services
• Special Tariff for Grassroot Level Innovators

Agrovision Secretariat : Bynosootouawkrll !

Nagpur : 0172-2555 249, 97647 96709 | Delhi : 011-4354 2737, 9818708445
Email : [email protected] Website: www.agrovisionindia.in

Organised By Event Sponsored By Supported By

4 BIO CONTENT BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

COVER STORY 21

COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.

Welcome Spike In

mRNA TECH?

At least three decades in the making, mRNA 25
vaccine technology has come a long way indeed.
While many researchers and scientists worked on “Most clinical-stage pipeline of
mRNA technology, tirelessly burning the midnight vaccines is owned by entities
oil, a few names do come to the forefront. in North America and Europe,
Dr Robert Malone, developmental biologists while operations are hindered
Paul Krieg and Douglas Melton, and molecular
biologists Tom Maniatis and Michael Green have by IP restrictions”
been the notable researchers who paved the
way for this technology. At the same time, there Dr Pradeep Nagalkar,
are doubts raised about the safety and efficacy
of mRNA vaccines. Moreover, challenges Head, Quality Control,
associated with the manufacture and the logistic Haffkine Bio-Pharmaceutical Corporation
needs of the mRNA vaccines are also some of
the areas that need more focus and innovation.
Let’s dig deeper into the world of mRNA tech.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com Top Video BIO CONTENT 5

Skin Diseases Ashish Sahai,
Additional
27 Director, Viral
Vaccines, Serum
IS POST-COVID Institute of India is
Derma Sector Booming? optimistic about
better regulatory
Speaking With approvals for
30 vaccines in times
to come.
“Treading on the COVID-19
vaccine opportunity undoubtedly Scan the QR Code »
has added a new dimension
to our capabilities” How is the
Vishnukant Bhutada, concept of virtual
clinics evolving in
Managing Director, India & what are
Shilpa Medicare Limited the challenges?
Saurav Kasera,
33 Co-Founder, Clirnet
tell us all.
“Regulatory framework to
protect IP, innovation and Scan the QR Code »
existing governance structures
ought to be strengthened” Rajiv Rao, President
Nakul Pasricha, – Industrial
Chemicals, Deepak
President, ASPA (Authentication Fertilizers &
Solution Providers’ Association) Petrochemicals
Corp shares his
Regulars thoughts on the
risk associated with
BioEdit ........................................................................06 usage of the non-IP
BioMail .......................................................................08 grade of Isopropyl
Policy and Regulatory News...................................10 Alcohol for pharma
Finance News............................................................14 industry.
Company News........................................................18
Start-up News...........................................................19 Scan the QR Code »
R&D News..................................................................38
People News..............................................................43
Academia News........................................................46
Supplier News...........................................................48
Let’s Talk Health........................................................50

6 BIO EDIT BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Ethics Vs Fistful of $$$

Freebies offered by pharma companies to doctors widely known as to how serious business is conducted
to prescribe their brand medicines are once in many such conferences. Check on freebies is
again in discussion. The reason being the recent required mainly for two reasons. Firstly, such a huge
charges by tax authorities as to how Micro Labs, amount of freebies naturally increases the cost and
producer of Dolo-650, allegedly distributed freebies subsequently the price of the medicine. Secondly,
worth Rs 1,000 crore to doctors. The company, for promoting certain brands doctors may prescribe
however, has termed the charge as unfeasible not-so-effective or appropriate drugs, prescribe them
claiming how it could spend so much amount when unnecessarily and may even prescribe higher doses,
its turn-over during the period was much less. which can create a problem for the patients. FMRAI
wishes to stop such practices by making the code
The ball was set in motion back in July when the for the pharma companies statutory and making the
Income Tax (IT) department raided 36 premises in companies criminally liable.
nine states of the Bengaluru-based Micro Labs for
its alleged tax evasion. The outcome of these raids, On the other hand, doctors have their own ethical
as per the IT department, was that the company code of conduct as prescribed in the Indian Medical
had spent a huge amount on providing freebies to Council (Professional Conduct, Etiquette and Ethics)
doctors for prescribing Dolo-650, a paracetamol regulations 2002. It includes, among other things,
drug, particularly to COVID-19 patients when the a description of doctors’ expected relationship with
‘pandemic was raging’. This charge was further pharma companies as well as allied health sector
brought to the Supreme Court’s notice in a public industries.
interest litigation (PIL) on the issue by the lawyer of
the Federation of Medical and Sales Representatives Despite both the sides having ethical codes, if the
Associations of India (FMRAI), quoting from a report problem still persists then it calls for a serious review
by the Central Board of Direct Taxes (CBDT). and action for stricter implementation of the codes.
Hence, the government is tightening the rules to bar
The ball kept rolling with the National drug making companies from offering expensive gifts
Medical Commission’s (NMC) Ethics and Medical and all-expenses-paid trips.
Registration Board (EMRB) seeking pertinent details
from the IT department including names, addresses The CBDT, too, has issued new guidelines due
and registration numbers of the alleged beneficiary to which the doctors are required to pay 10 per
doctors of Micro Labs as well as six other companies. cent tax deducted at source (TDS) on free samples
and expensive gifts if their value is over Rs 20,000.
Though the IT raids on Dolo makers brought For pharma companies, too, such restrictions are
the issue to the core, three months before that, the imposed. The current budget has brought the freebies
FMRAI had filed a PIL in the Supreme Court on under the ambit of taxation since they are no longer
the same issue. It had sought the court’s directive to be treated as business expenditure.
for the government to make the Uniform Code of
Pharmaceutical Marketing Practices (UCPMP) The problem is not proposing action on paper, but
a statutory one. The FMRAI has claimed that its implementation. For instance, although we have
seven pharma companies spent Rs 34,187 crore in a comprehensive anti-corruption Act, corruption is
marketing during eight years. This meant that the still rampant. Similarly, countless freebies are doled
companies were spending 20 per cent of the cost of out, skirting the ethical codes. Imposition of IT would
drugs on indirect marketing. work as a deterrent, but only to some extent.

This money goes in for the benefits given to A firm hand against erring companies and
doctors in various forms such as gifts and jaunts, professionals seems like the best viable solution.
hospitality for conferences. Doctors are invited for
conferences, sometimes even with families. It is Dr Milind Kokje
Chief Editor

[email protected]



8 BIO MAIL BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Scan Vol 20; Issue 9; September 2022
QR code Acknowledgements/ Feedback
to access Thank you for the wonderful coverage spread on Pfizer in
BioSpectrum BioSpectrum India’s September edition. It has come out great.

India - Ambuja Kashyap, Gurugram
Digizine The September edition of BioSpectrum India is a very
interesting one with several diverse stories. I enjoyed reading
it, especially the column on Monkeypox.

- Bhavani Giddu, New Delhi
I went through the GE Healthcare’s 5G interview in the September edition of BioSpectrum.
It is very well covered. The key points have been well articulated. Great work on the
pertinent questions.

- Girish Raghavan, Bengaluru
Glad to see our thesis article on synthetic biology featured in BioSpectrum magazine.
Thank you.

- Suraj Nair, Bengaluru
VAV Life Sciences appreciates BioSpectrum for publishing our articles over many editions.
We have been very happy with your methodical & meticulous way of working, reviewing our
articles and presenting them so well. The topics covered are innovative and informative.
New technologies and applications from other pharma and biotech industries is what makes
this publication really stand out. It is always a pleasure working with you.

- Arun Kedia, Mumbai

Vol 20; Issue 10; October 2022 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
Ravindra Boratkar Alok Srivastava Dr Manbeena Chawla Singapore
Editorial: National Business Head- Executive Editor MM Activ Singapore Pte. Ltd.
Chief Editor: Dr Milind Kokje Ad Sales & Marketing 103-104, Rohit House 3, Saradha Mani
[email protected] “NITON”, Block B, First Floor, Tolstoy Marg, Connaught Place, General Manager
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Dr Manbeena Chawla Mumbai Pune [email protected]
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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Govt unveils Pradhan Mantri TB Mukt Bharat Abhiyaan

The President of India, initiative to ensure additional launch event also showcased
Droupadi Murmu, virtually diagnostic, nutritional, and India’s accelerated progress
launched the Pradhan Mantri vocational support to those through the National TB
TB Mukt Bharat Abhiyaan. on TB treatment. The virtual Elimination Programme
Speaking on the occasion, (NTEP). The NTEP,
the President said that all previously known as Revised
citizens must give high National Tuberculosis Control
priority to ‘Pradhan Mantri Programme (RNTCP), aims
TB-Mukt Bharat Abhiyaan’ to strategically reduce TB
and make this campaign a burden in India by 2025, five
mass movement. It is because years ahead of the Sustainable
tuberculosis (TB) causes the Development Goals. In 2020,
largest number of deaths among the RNTCP was renamed as the
all other infectious diseases in NTEP to emphasize the aim of the
our country. The President also Government of India to eliminate
launched the Ni-kshay Mitra TB in India by 2025.

India launches Govt to open more
NCDC branches for timely
first indigenously disease surveillance
and monitoring
developed cervical
Dr Mansukh Mandaviya, Union Minister of Health and Family
cancer vaccine- Welfare, virtually laid the foundation stone for National Centre
for Disease Control (NCDC) branches in six states namely
CERVAVAC Andhra Pradesh, Arunachal Pradesh, Kerala, Maharashtra,
Tripura and Uttar Pradesh. NCDC branches in the states and
The Union Minister of State UTs will support the state governments in timely disease
(Independent Charge) Science & surveillance and monitoring and will enable early warning
Technology Dr Jitendra Singh has leading to timely intervention based on evidence gathered from
announced India’s first indigenously the field. The state branches will coordinate with NCDC HQR
developed vaccine, CERVAVAC for in New Delhi with real-time sharing of data and information
the prevention of cervical cancer. aided by cutting-edge technology. Currently, NCDC has eight
The vaccine would be costing Rs branches in states with a focus on one or few diseases, these
200-400 per dose. CERVAVAC will be repurposed and new branches are being added with the
is an outcome of a partnership of mandate for integrated disease surveillance activities, dealing
Department of Biotechnology (DBT) with Anti-Microbial Resistance (AMR), multi-sectoral and
and Biotechnology Industry Research entomological investigations etc. The Union Health Minister
Assistance Council (BIRAC) with the also inaugurated the NCDC Laboratory Block -1, Residential
Bill and Melinda Gates Foundation, Complex and national referral laboratories (NRL) of the
supported by Serum Institute of National Vector Borne Disease Control Programme. The
India for the indigenous development NCDC Laboratory Block will house state-of-the-art testing
of quadrivalent vaccine through and national referral laboratories concerned with bacterial,
its partnership programme ‘Grand viral, fungal and parasitic diseases of public health concern.
Challenges India’. The laboratory is equipped with 50 high-capacity labs which
include 30 Biosafety level 3 labs, five RT-PCR labs and 15 other
labs. The laboratories will be designed to not only offer the
testing facility but also provide hands-on training, capacity
building and quality assurance services to the whole network
of laboratories across the country.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com PARTNER CONTENT 11

Laboratory Generated Aerosols &
Sample Crosstalk- A Major Concern

Aerosol is defined as the dispersion of solid and liquid a false positive reaction. If a worker in a forensic science lab
particles in to the thin air. In a laboratory the pipetting performs PCR on a blood sample, the cross-contamination
action of pushing and releasing the plunger creates between samples could lead to false reporting, even if the
air displacement and formation of an envelope containing worker changes pipette tips between samples. A few blood
miniscule sized liquid and solid particles known as aerosol. cells could remain in the pipette shaft and then get ejected
These aerosols are free-floating entities and tend to enter into the next test sample. The Filter tip is an extremely useful
the pipette tip shaft through the cone which may contaminate tool in such experiments to prevent erroneous results and false
subsequent samples due to the up and down movement of air implications.
column inside the pipette assembly while pipetting.
Toxic, Corrosive & Radio-active agents:
Filter Pipette Tip contains a hydrophobic filter that acts as a It is highly undesirable to have aerosols with highly toxic
barrier by preventing the aerosol movement inside the pipette chemicals, corrosive elements and radio-active agents. While
assembly and thereby protects subsequent samples from cross performing Radio-immuno assays, repetitive pipetting of radio
talk while repetitive air displacement pipetting. The role of filter labelled antigens can generate dangerous levels of radio-
pipette tips come to the forefront in handling Infectious disease active aerosols. These radio-active aerosols can be easily
samples, Pure bacterial cultures, Polymerized Chain Reaction inhaled by laboratory workers and scientists who need to take
(PCR) Toxic & Corrosive agents and Radio-Immunological extreme care while handling the above mentioned agents.
Assays. Again the filter tips can to a great extend prevent the formation
of aerosols that are harmful to the mankind and animals in
Infectious Disease samples: the close vicinity of these laboratories that handle radioactive
Handling infectious laboratory samples have never been an reagents.
easy task due to the risk of contracting the disease depending Abdos SuperTM Filter Pipette Tips:
on the mode of transmission and spreading amongst others
who may come in close vicinity of the concerned lab worker Abdos SuperTM filter tips are fitted with
or any medium that finds its way to the unfortunate new host. hydrophobic PE filter that is additive free and
The aerosols from the infectious samples may travel out of the
laboratory on the apparel or body of the lab worker in some form does not absorb samples. The proprietary
and unknowingly be transmitted to other human being or animal pure porous hydrophobic PE filter helps in
who in turn may incubate it to bring out a highly virulent form of
the disease. The aerosol from a previous experimental sample recovering contamination free samples
can also contaminate subsequent samples due to improper from wetted filter and does not trap or
handling. A filter pipette tip can be a savior in such instances absorb the liquid into the filter. Abdos
thereby preventing untoward incidents and unexpected results.
Maintenance of Pure Bacterial Cultures: SuperTM filter tips are suited for all
Every reputed microbiology laboratory procures ATCC Biological applications and are Non
pure cultures from Virginia USA and maintains them as pure Cytotoxic (ISO 10993-5MRM,
cultures. For this step, it is necessary to handle these samples Minimal Essential Media
with utmost care to prevent cross contamination of the different Elution, GLP Compliant) The
strains of organisms. Even while performing certain critical filter offers 99.9% Bacterial
experiments the cross contamination of bacterial cultures can Aerosol Filtration Efficiency
be a letdown. The filter tips may be used in maintenance of (ASTM F21012).
pure cultures and avoid formation of mixed colonies or too
narrowly spaced colonies of multiple organisms. They prevent aerosols from passing through the filter, thus
Polymerized Chain Reaction: making the pipette shaft contamination free. The filter is Non
Hemolytic (Modified ASTM F 756-08 Hemolysis Direct Contact
PCR is a highly reliable GLP with human blood) All tips are manufactured from ultrapure
and widely used technique to USP Class VI certified virgin polypropylene to ensure the highest
amplify extremely small quantities quality, free from heavy metals, natural rubber & inhibitory
of valuable DNA that may be plasticizers. Abdos SuperTM filter tip has a universal & leak
required for subsequent series of proof fitment and the precise safety gap between liquid & filter
experiments. This DNA sample offers safety when using electronic pipette and while reverse
that is isolated by sensitive and pipetting. The precise graduation marks are provided for error-
tedious procedures may need to be free pipetting. The use of the latest injection moulding processes
stored as multiple sample copies produces high precision thin wall tips with high clarity and the
in order to have a backup in case diamond polished moulds ensure an extremely hydrophobic &
of unprecedented experimental smooth surface to ensure lowest retention in its class.
errors.
Another important factor is preventing the DNA sample Author:
contamination while pipetting the sample that is suspended E. Bijoy Varma
in molecular biology grade ultrapure water. If the sample to Head-Marketing & Strategy
be tested has even a single tiny strand contamination of DNA
from the target, the reaction may amplify this DNA and report

12 POLICY AND REGULATORY NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Govt launches Health Ministry launches
digital tools National Lists of Essential
developed by Medicines (NLEM) 2022
NPPA
Dr Mansukh Mandaviya, Union done after constant consultation
The Union Minister of Minister for Health and Family with stakeholders spanning from
Chemical and Fertilizers, Welfare launched National Lists academia, industrialists and
Dr Mansukh Mandaviya of Essential Medicines (NLEM) public policy experts etc., and
recently addressed the Silver 2022, in New Delhi. 384 drugs crucial documents like WHO
Jubilee Celebrations of the have been included in this list EML 2021.
National Pharmaceutical with addition of 34 drugs, while
Pricing Authority (NPPA) 26 from the previous list have
where two digital tools were been dropped. The medicines
launched by the Minister- have been categorised into 27
Integrated Pharmaceutical therapeutic categories. In NLEM,
Database Management the medicines are categorised
System 2.0 (IPDMS 2.0) and based on level of healthcare
Pharma Sahi Daam 2.0 App. system as- P- Primary; S-
IPDMS 2.0 is an integrated Secondary and T- Tertiary. The
responsive cloud-based NLEM was first formulated in
application developed by 1996 and it was revised thrice
NPPA with technical support earlier in 2003, 2011, and 2015.
from the Centre for Advance Revision of NLEM 2022 has been
Computing (C-DAC). It
is envisaged to optimise Centre approves three bulk drug
synergies in operations to parks in HP, Gujarat and AP
promote Government’s
thrust on ‘Ease of Doing The Department of a financial outlay of Rs 3,000
Business’ as it would Pharmaceuticals has conveyed crore notified in 2020, provides
provide a single window for ‘in-principle’ approval to the financial assistance to three states
submissions of various forms proposals of the three States for establishing bulk drug parks
as mandated under the Drug namely, Himachal Pradesh and aims to bring down the cost
Price Control Order (DPCO), (HP), Gujarat and Andhra of manufacturing bulk drugs by
2013. It would also enable Pradesh (AP) under the Scheme creation of world-class common
the paperless functioning for ‘Promotion of Bulk Drug infrastructure facilities supported
of NPPA and facilitate the Parks’, a key initiative to support by the Central Government
stakeholders to connect with bulk drug manufacturing in and thereby increase the
the National Pharma Pricing the country. The scheme, with competitiveness of the domestic
Regulator from across the bulk drug industry. The financial
country. assistance to the proposed Bulk
Drug Park in Gujarat and Andhra
Pradesh would be 70 per cent
of the project cost of common
infrastructure facilities. In the
case of Himachal Pradesh, being
a hilly state, financial assistance
would be 90 per cent of the
project cost. Maximum assistance
under the scheme for one Bulk
Drug Park would be limited to Rs
1000 crore.



14 FINANCE NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Novo Holdings leads $50M investment in MedGenome

MedGenome announced of South Asian genetic
a $50 million investment variants―its continued
led by Novo Holdings, an expansion will contribute
international leader in life to the most comprehensive
science investing. Novo’s genomic dataset in the
investment will strengthen world. The latest round
MedGenome’s scale beyond of funding will be used to
India and South Asia into broaden MedGenome’s
Africa and the Middle East product offering and
and democratise access to improve the reach of its
genetic testing and personal key diagnostic services,
healthcare across emerging including reproductive
markets. MedGenome is a and oncology services, as
co-founding member of the well as enhancement of
GenomeAsia 100K Project and MedGenome’s bioinformatics
has built the largest database and SaaS offerings.

Kedaara Capital Everstone buys
controlling stake in
invests $50M Softgel Healthcare

in Oasis Fertility Singapore-headquartered Everstone Capital, the private equity
arm of the Everstone Group, has announced the acquisition of
Oasis Fertility announced an investment a controlling stake in Softgel Healthcare (SHPL), a specialised
from Kedaara Capital for a significant niche dosage form-focused manufacturing player catering to the
minority stake in the company. This global nutraceutical, pharmaceutical and OTC segments. The
is Kedaara’s second investment in the partnership aims to transform SHPL into a scaled, diversified,
single speciality healthcare segment. and globally recognised contract research, development,
With this $50 million transaction and a and manufacturing organisation in India with the support
commitment to deploy further capital of the strategic resources of Everstone. Headquartered in
for strategic acquisitions, Kedaara Chennai, SHPL is part of the Madras Pharma Group, a leading
aims to support and fuel Oasis’ growth pharmaceutical contract manufacturing organisation in
towards realising its vision of becoming southern India, with eight manufacturing facilities covering all
the most respected and leading fertility dosage forms. SHPL specialises in the research, development
chain in India and adjacent markets. and manufacturing of soft gelatin capsules and probiotics. Its
The investment aims to strengthen customers span across the Americas, Africa, Asia and India
Oasis’ organic expansion and accelerate with over 80 per cent of its sales being in exports. It has a
inorganic partnerships across India and state-of-the-art manufacturing facility in Chennai, conforming
adjacent markets to further its mission to globally recognised certifications and registrations such as
of being a research-driven, clinical USFDA, TGA, EU-GMP, Health Canada, among others.
excellence-oriented fertility platform.



16 ADVERTORIAL BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Advancing Organic
Chemistry with Computer-Aided

Synthesis Planning

SYNTHIA™ Retrosynthesis Software Speeds Synthesis Planning

Synthesis planning can be a daunting SYNTHIA™…Problem Solved
task especially when one is working to Synthia™ Retrosynthesis Software is a
meet demanding project goals within
compressed timelines. Fortunately, there are decision support platform that assists both
commercially available software tools that can discovery and process chemists to design
help to accelerate this process. synthesis routes to structurally diverse chemical
targets. Since the software is not reliant upon
Reduce Risk & Improve Synthesis Outcomes the published scientific literature alone, synthesis
Developed over 15 years and powered routes to new and previously unreported
molecules can be planned with confidence.
by advanced algorithms that are coded
with the organic chemistry rules that we all In one of the recent editions of “Small
know, Synthia™ Retrosynthesis Software Molecules of the Month”, Drughunter.com
helps organic chemists to think beyond the presented an oral plasma kallikrein inhibitor,
published literature. Developing novel, yet berotralstat, which was recently approved as
robust routes to complex molecular targets the first non-steroidal treatment of hereditary
requires a synergistic human-computer angioedema (HAE).
interface that, by design, encourages the
end user to go further. SYNTHIA™ meets SYNTHIA™ designed an efficient,
this objective by proposing computer-vetted convergent, chiral synthesis starting with
routes that can be easily modified and moderately priced commercial compounds using
expanded based on the preferences of the the default automatic retrosynthesis settings.
end-user. Expert-coded chemistry rules that
know what reactions work and what reactions Computer-assisted synthesis planning can
won’t work in the context of a synthetic route also speed the development of new routes
are what differentiate this software from to existing drugs. As detailed in their 2020
other retrosynthesis platforms on the market publication in Chemical Science, Szymuc1
today. et al. detailed how her team was able to
quickly identify multiple viable routes to two
potential yet unproven COVID-19 therapeutics.
SYNTHIA™ was tasked with identifying

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com ADVERTORIAL 17

alternative routes to both remdesivir and Speeding up drug discovery
hydroxychloroquine given the global supply chain Many therapeutic candidates can now
disruptions at the time and the potential need to
source more widely available starting materials. be designed computationally, before being
synthesized and experimentally validated.
A similar strategy to address global chemical Identifying which of these compounds
supply chain disruptions was taken by Lin2 can be easily and rapidly synthesized is
et al. in the 2021 Nature Communications crucial to accelerating the drug discovery
publication detailing the syntheses of eleven 3 pipeline. Narrowing down lists of potential
of 3 potential COVID-19 therapeutics including drug candidates is particularly helpful for
the known anti-viral Umefenovir which is medicinal chemistswho runs a synthetic
primarily used to treat Influenza A and Influenza organic chemistry laboratory focused on drug
B viral infections. discovery and preclinical development.It would
be time consuming to manually evaluate the
In both examples, laboratory validation of potential synthesis pathways for each unique
synthetic routes suggested by SYNTHIA™ was proposed compound. Every compound that
performed and demonstrates the utility and comes through such computational drug
speed of the software to assist in the synthesis discovery project if goes through Synthia™,
planning. As commercial and academic organic it quickly becomes clear which compounds
chemists become more accustomed to using may be the easiest to make. Automated
computer-assisted synthesis planning software retrosynthesis planning through Software such
such as SYNTHIA™, we anticipate reading more as Synthia™gives researchers the ability to test
about the efficient and innovative approaches and validate compounds faster. The acceleration
used to produce commercially available helps scientists better respond to public health
high-value and structurally complex organic crises that demand novel therapeutics.
compounds that benefit humanity.

1 Szymkuć, S., et. al. Computer-generated “synthetic contingency” plans at times of logistics and supply problems: scenarios for
hydroxychloroquine and remdesivir. Chem. Sci. [Online], 2020, 11, 6736-6744. https://doi.org/10.1039/D0SC01799J

2 Lin, Y., Zhang, Z., Mahjour, B.et al.Reinforcing the supply chain of umifenovir and other antiviral drugs with retrosynthetic
software. Nat Commun12, 7327 (2021). https://doi.org/10.1038/s41467-021-27547-3

18 COMPANY NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Dr. Reddy’s, AstraZeneca India launches
Aurigene iPHARMACY to up-skill pharmacists
Pharma
ink MoU AstraZeneca India has launched provide standardised and quality
with DNDi its up-skilling programme for counselling, and support to the
to develop pharmacists, iPHARMACY. In people. AstraZeneca India has chosen
drugs for the first phase of the programme, Moodle as the learning platform
NTDs the company has partnered with to run this course. The entirety of
Neethi Medicals, Kerala State Co- the course module will take place
Dr. Reddy’s Laboratories operative Consumer`s Federation digitally. The pre-requisite for every
and Aurigene Ltd known as Consumerfed, to run participant would be to register
Pharmaceutical Services this programme in Kerala. As a next themselves, and subsequently, a
have announced a step, the company is planning to unique credential would be created
Memorandum of collaborate with large pharma-retail for every individual to run the
Understanding (MoU) chains from across India to expand course. This e-learning mobile
with the Drugs for this programme to other parts of the compatible programme has four
Neglected Diseases country. The programme will focus modules which can be completed at
initiative (DNDi), a not- on inventory management, good one’s own pace. The programme will
for-profit research and pharmacy practices, customisation remain active till the end of this year
development organisation. of pharmacy for the patient of for the pharmacists from Neethi.
The parties will explore the future, and management of The course can be completed within
a potential collaboration pharmacy during COVID. The this period, where each student will
to develop and market content and modules for the be awarded a completion certificate
novel and improved programme are created by the by the European body of CME/
drugs for the treatment team of experts from AstraZeneca CPD Academy. The total number
of identified Neglected and their partners, which will of participants from Neethi at this
Tropical Diseases (NTDs) equip pharmacists across India to phase would be around 200.
of national and global
importance. The parties Bharat Biotech’s COVID-19
will also seek to work intranasal vaccine gets
towards ensuring access of ‘emergency use’ approval
those drugs at affordable
prices to patients in Bharat Biotech has announced that iNCOVACC (BBV154)
need particularly in Low
and Middle-Income has received approval under Restricted Use in Emergency
Countries (LMICs) that
are disproportionately Situation for ages 18 and above. iNCOVACC is a
affected by these NTDs.
recombinant replication deficient adenovirus

vectored vaccine with a pre-fusion stabilised spike

protein. This vaccine candidate was evaluated

in phase I, II and III clinical trials with

successful results. iNCOVACC has been

specifically formulated to allow intranasal

delivery through nasal drops. The

nasal delivery system has been designed

and developed to be cost effective in

low- and middle- income countries. iNCOVACC was

developed in partnership with Washington University St

Louis, which had designed and developed the recombinant

adenoviral vectored constructs and evaluated them in preclinical

studies for efficacy. Product development and clinical trials

were funded in part by the Government of India through the Department of

Biotechnology’s, COVID Suraksha programme.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com START UP NEWS 19

Oncology, digital health startups to receive
Rs 65 lakh grant under Pfizer’s INDovation Prog

Programme partners Pfizer, Atal who will be given a grant of Rs 65 technical assistance to the startups
Innovation Mission (AIM), NITI lakh each will receive incubation and Social Alpha will provide
Aayog, Social Alpha, Foundation support from AIM, NITI Aayog programme acceleration support.
for Innovation and Technology and IIT Delhi. Pfizer will provide The winners under “Digital Health”
Transfer (FITT), IIT-Delhi the grant as well as mentorship and category include BrainSight
and AGNIi, with UN Health Technologies’ Voxel Box that uses
Innovation Exchange (UNHIEX) an AI-based computational engine
as the knowledge partner, have to extract brain connectivity and
announced the six winners of the activity patterns, and hard-to-
first edition of Pfizer INDovation understand structural features,
incubation initiative for healthcare as well as temporally dynamic
startups. The focus is on oncology symptoms. RAMJA Genosensor
and digital health, because of provides a rapid, easy, and cost-
the increasing burden of cancer effective novel paper-based device
in India and the emerging use to detect microbial infection and
of digital health to ensure better antimicrobial resistance in less
patient outcomes. The six winners than two hours.

Venture Center unveils Healthledger
MeitY SAMRIDH
Accelerator for digital Diagnostics raises
technology-based startups
seed funding to
Pune-based Venture Center, a not-for-profit technology business
incubator hosted by CSIR-National Chemical Laboratory (NCL), accelerate growth
has announced the launch of the “SAMRIDH Accelerator @
Venture Center” by Jitendra Vijay, CEO, MeitY Startup Hub, Pune-based startup Healthledger
MeitY, Government of India. The accelerator programme Diagnostics has raised a seed
will run for six months under round of an undisclosed amount
two tracks (Track 1: Digitech from A-League angel investors and
Launchpad and Track 2: Investor venture capitalists. The transactions
Readiness Programme) with a have been enabled by Quadra
highly selective cohort of eleven Advisors, and include VCs Nitish
participants across both tracks. Mittersain and Vikash Mittersain
Selected candidates will receive of Nazara Technologies, Narendra
in-depth and tailored hand Firodia of Sohamm Group, holistic
holding from the very experienced integrative medicine and lifestyle
mentors at Venture Center. Other coach Luke Coutinho, Netgraph
benefits include an opportunity Investments Dubai, Amit Jain
to pitch to a curated group of (Rewired Ventures UK), Balesh
investors, for investments in the range of Rs 50-400 lakh. The Sharma (CEO, PPF Telecom), and
cohort participants will also benefit from the high quality master Vishwanathan Iyer. The company
classes on fund-raising and a professionally designed and has generated $1 million in revenue
developed pitch deck. The SAMRIDH Accelerator at Venture in its inception year, having reached
Center brings on board a powerful investor network to accelerate 25 cities in eight states and having
and scale digital technology-based startups working on solutions touched more than 100k lives. With
that solve India’s problems while creating positive social impact. this fundraiser, the brand aims to
target a 7X growth with more than
150 operational centres in 15 states
across 50 cities by FY 23.

20 START UP NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

SPARC joins hands with Bangalore Bioinnovation Centre

In an effort to create a platform of BBC, there are difficulties
between big and established to secure early stage venture
biotech industry players and the funding for biotech startups and
startups,BangaloreBioinnovation it may be more meaningful that
Centre (BBC) conducted a established industry partners
town hall meeting between the with the startups to develop
representatives of Sun Pharma the Technologies/Products.
Advanced Research Company Through these partnerships,
(SPARC) and startups being startups can get access to capital,
Incubated at BBC. According mentorship and vast resources of
to Dr Jitendra Kumar, Director an established player.

Medyseva raises Rs 15M Human Edge raises
from AIC RNTU Bhopal
over $1.5M capital
Medyseva, an Indore- healthcare offerings in
based telemedicine Tier II and Tier III regions Human Edge, a longevity science startup
healthcare startup, has with a sustainable regional based in Mumbai, has raised over $1.5
raised Rs 15 million in outreach. It is focusing on million in new equity financing. The
pre-series funding under telemedicine in rural India investment was led by Bharat Innovation
Startup India Seed Fund and has set up Medyseva Fund, along with Lead Angels and
Scheme from AIC RNTU Kendras offering Force Ventures and several strategic
Bhopal. The company consultation and services angel investors from Singapore, the US
also received funds from like pathology, radiology, and India. The company is building a
a group of angel investors hospitalisation, ambulance proprietary platform for empowering its
like Mohit Gulati, Mandar and home care services. users to engage in daily ‘biohacks’- small,
Joshi, Yamika Mehra, The startup plans to utilise actionable, lifestyle-based modifications
Ankita Vashistha, Aarti the funds for expanding that focus on optimising a person’s energy
Gupta and Dr Vivek and strengthening its IT levels toward meeting a specific health
Bindra which was led infrastructure, adding outcome. The investment will allow
by Horses Stable for more services to its Human Edge to streamline its platform
building a robust network portfolio for providing through its first enterprise-wide mobile app
of its flagship initiative holistic patient care under experience targeted directly at white-collar
of Medyseva Kendra’s in one roof and onboarding employees. Further, the company will scale
rural India. The startup specialist doctors to ensure up their sales in the international market
is working towards smooth delivery of services by targeting global corporations. Ashika
empowering existing for the rural sector. Capital was an advisor to Human Edge in
this process.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com COVER STORY 21

Welcome Spike In

mRNA TECH?

At least three decades in the making, mRNA With the launch of India’s first mRNA
vaccine technology has come a long way vaccine by Pune-based Gennova
Biopharmaceuticals, India has something
indeed. While many researchers and scientists to cheer for. The Drug Controller General of India
worked on mRNA technology, tirelessly burning (DCGI) has given its consent on June 28, 2022
for a restricted emergency use for the country’s
the midnight oil, a few names do come to the first home-grown mRNA COVID-19 vaccine —
forefront. Dr Robert Malone, developmental GEMCOVAC-19. This is an achievement of one-of
biologists Paul Krieg and Douglas Melton, -its-kind as Gennova Biopharmaceuticals is among
and molecular biologists Tom Maniatis the few of the companies in the world that has
and Michael Green have been the notable undertaken the manufacturing of mRNA vaccines
researchers who paved the way for this for various diseases.

technology. At the same time, there are doubts The company noted that GEMCOVAC-19,
raised about the safety and efficacy of mRNA available as a lyophilised powder, uses Spike
vaccines. Moreover, challenges associated (S)-protein of the virus as antigen. One dose of
with the manufacture and the logistic needs of 0.5 ml contains the mRNA 10 μg, DOTAP 0.3
mg, Squalene 0.376 mg, Sorbitan Monostearate
the mRNA vaccines are also some of the areas 0.372 mg, Polysorbate-80 0.372 mg, Citric acid
that need more focus and innovation. Let’s dig monohydrate 1.05 mg and Sucrose 50 mg. The
GEMCOVAC-19 has been used in Phase I, II and
deeper into the world of mRNA tech.

22 COVER STORY BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Advantages of mRNA vaccine as to what is affordable and
over other vaccine strategies? deployable,” said Dr Sanjay
Singh, CEO, Gennova
Safety: Unlike live-attenuated or viral-vectored Biopharmaceuticals.

vaccines, mRNA is non-infectious and poses no As against GEMCOVAC-19,
mRNA-1273 COVID-19 vaccine
concern for DNA integration—mainly because it from Moderna which got the approval from DCGI
for restricted use in emergency situation in the
cannot enter the nucleus which contains DNA. Other country has more shelf life (7 months) as compared
to GEMCOVAC-19 (6 months). Cipla Ltd has got
strategies such as protein-based or inactivated the green signal to import the Moderna vaccine
on June 29, 2021 exactly a year ago from Gennova
vaccines also require chemicals and cell cultures to Biopharmaceuticals. The Moderna vaccine is stored
at -25ºC to -15ºC to keep the vaccine stable.
produce. mRNA is made through a cell-independent
Sharing his views about the
process and does not require inactivation; thus, it mRNA vaccines, S Dravida,
Founder and CEO, Transcell
poses no safety concerns due to contamination with Biologics said, “For India,
it will become a reality only if
toxic agents. the technology is indigenously
developed. Sustainability with
Efficacy: mRNA is rapidly degraded in the body, regards to production is a reality that
we have seen in Moderna like companies producing
and cells don’t readily take up foreign mRNA. Recent billions of units. All I foresee is mRNA vaccines
for new pathogens added into the portfolio as
technology has modified the mRNA molecule to options to participate in global immunisation
programmes.”
make it more stable and packaged the molecules in
Many academic institutions and contract
fats (called lipids), increasing cell delivery efficiency. manufacturing companies have initiated the
utilisation of the technology for various other
These advances increase the amount of spike protein vaccine candidates. Efforts in conducting research
for improving the technology e.g. developing a
produced on your cells, thereby stimulating a more formulation which can be stable at 2-8 °C are also
underway. The recent success of the mRNA vaccine
effective immune response. developed in India is a good advancement in this
direction.
Production: mRNA can be quickly designed
Bengaluru-based contract research, development
and scaled up, if necessary. The manufacturing and manufacturing organisation Syngene
International recently announced the completion
is sequence-independent, which makes it highly of a new 500 L microbial facility, that will aid
in the manufacturing of protein products and is
adaptable to different pathogens. The cost is also also suitable for manufacturing mRNA vaccines
by producing the plasmid DNA and the mRNA
lower than other platforms and will continue to material.

decrease as the technology expands. Talking about the contract
manufacturing of mRNA
Source: www.vumc.org vaccines, Dr Upendra K Jani,
Consultant Microbiologist,
III clinical trials, a number of participants received Hester Biosciences said,
one or two doses in Indian trials. The Phase I “A need to establish a mature
clinical trial was conducted in 82 healthy subjects Contract Development &
between the age of 18 and 70 years. Three dose Manufacturing Organisation (CDMO)
strengths of 5 μg, 10 μg and 25 μg were compared landscape and Contract Research Organisation
with placebo. The vaccine has shelf life of six (CRO) with appropriate improved services would
months. benefit RNA therapies, industry, and patients.”

GEMCOVAC-19 is indicated for active
immunisation of individuals ≥18 years old for the
prevention of COVID-19. The vaccine should be
administered in two doses, the second dose after 28
days of the first dose. A volume of 0.5 ml should be
administered intramuscularly. However, there is no
safety, immunogenicity or efficacy data to support
interchangeability of GEMCOVAC-19 with any other
COVID-19 vaccines.

GEMCOVAC-19 can be stored in a standard
medical refrigerator as it is stable at 2-8°C. Hence
this vaccine has an edge over its international peers
as it does not require sub-zero temperatures like
Pfizer-BioNTech and Moderna’s vaccines.

“Unlike in the West, where the vaccine has to be
stored at sub-zero temperatures, the challenge in
India was to be able to store the vaccine between 2
and 8 °C. We had to innovate to suit our local needs

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com COVER STORY 23

Challenges Could mRNA be double-edged?

The effective action of a vaccine rests on the There has been a hype around mRNA vaccine
mechanism of delivery. The complexity arises for the time being and a lot of research has been
because when the mRNA enters the human body, undertaken to show the efficacy, however, still a lot is
it is rapidly broken down. Hence, stabilisation is known about its side effects and long term effects.
essential to protect the mRNA strand until it reaches Side effects such as allergy, renal failure, heart failure,
its target. Apart from this, most vaccines are limited and infarction remain a risk, the vaccine mRNA
by their storage time (stability) and required holding may also be degraded quickly after administration
temperatures. Currently, mRNA vaccines require or cause cytokine storms. Logistics and storage
storage within a freezer or refrigerator, which issues of mRNA vaccines again remains a matter of
will affect their global distribution. Developing concern. Conventional vaccine development takes
vaccines that do not rely on cold supply chains will time and the process to manufacture is unsuited
significantly increase their applicability. to situations like the covid pandemic. A promising
alternative to conventional vaccine development is
mRNA vaccines are required to be kept at sub- the use of nucleic acid (DNA or RNA) in vaccines.
zero temperatures and it was a mammoth task for RNA is less stable than DNA vaccines and here
Gennova scientists to develop a thermostable mRNA we can draw examples where the Pfizer/BioNTech
COVID-19 vaccine. mRNA vaccine technology vaccine needs to be shipped on dry ice (–80°C), while
was a breakthrough during the pandemic as the the Moderna vaccine has to be shipped at a more
technology was implemented for the very first time manageable –20°C using gel packs.
in commercial vaccines. For developing countries Disadvantages
to manufacture mRNA vaccines is a huge challenge ● mRNA is unstable and easily degraded
when it comes to affordability. Further, they require ● Strong immunogenicity, triggering unnecessary
storage at freezing temperatures which raises a big
challenge for developing country vaccine supply immune response
chain infrastructure. ● Safety is lower than inactivated vaccines
● Effectiveness is lower than DNA vaccines
In addition to supply chain issue, the stringent
regulatory mechanism is another challenge for the Source: www.ncbi.nlm.nih.gov
companies. This regulatory system has on many
occasions delayed the launch of many vaccines Talking about the safety of
and other drugs. Some of the industry leaders who the mRNA vaccines, Dr Manoj
spoke at the recently held Vaccine Conclave were Kumar Chhikara, Chief
critical of how regulatory bodies function in India. Scientific Officer, Hester
Despite getting approvals from the United States Biosciences, said “The long-term
Food and Drug Administration (US FDA), vaccine safety data of currently licensed
manufacturers have to again go through a lengthy mRNA vaccines is yet to be evaluated,
process to get approval in India. However, they were the longevity of immune response has to be improved
optimistic about some positive changes as during the and more optimised formulations for safer and
COVID pandemic, certain vaccines were approved on more potent vaccine candidates are to be developed.
an emergency basis. Further, the Intellectual Property restrictions when
applicable may limit the small vaccine R&D and
Sharing his views on the challenges Dr Pradeep manufacturing institutes to develop the vaccines
Nagalkar, Head, Quality Control, Haffkine Bio- using the patented technology.”
Pharmaceutical Corporation said, “Intramuscular
administration requires skilled personnel, and Vaccine manufacturers need to overcome issues
products with stability at 4°C or ambient temperature related to patents and regulations, accessibility of
in the liquid formulation are currently not available. raw materials, storage risks, adverse effects and
Cost-effective and sustainable manufacturing manufacturing challenges.
methods are also lacking. Most of the clinical-stage
pipeline of vaccines is owned by entities in North Treatment options
America and Europe, and there is uncertain freedom
to operate in various countries owing to Intellectual Before the COVID-19 pandemic, the
Property (IP) restrictions. Some entities are also commercialisation of mRNA vaccines was focussed
based in Lower Middle Income Countries (LMICs) on high-cost personalised cancer vaccines, and
and face problems related to limited access to prophylactic vaccine development was slow
regulated facilities for clinical trial grade material and limited. With the demonstration of large-
production.” scale manufacturing of mRNA vaccines during

24 COVER STORY BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Dr Robert Malone’s warning the COVID-19 pandemic, the creation of local
on dangers of mRNA jabs manufacturing capabilities holds promise for more
equitable access to COVID-19 and other vaccines.
While hundreds of scientists have been working
on mRNA vaccines for over three decades, a special The number of RNA drugs under development,
mention can be made of Dr Robert Malone who and in clinical trials, is growing rapidly. The
became a celebrity overnight due to his research on rapid growth of RNA therapeutics has been due
mRNA vaccines. Research work undertaken by Dr to solving the problems of stability, delivery and
Malone was mired with controversies where mRNA immunogenicity. Whereas there is room for further
was seen as too unstable and expensive to be used improvement and innovation in each of these areas,
as a drug or a vaccine. Dr Malone had warned the FDA the solutions have advanced to the point that RNA
that the vaccines are dangerous. However, the FDA therapeutics are now feasible. Although several
didn’t listen to him instead, he was censored by Big dominating players in the RNA bio-pharma sector
Pharma and the FDA went ahead with the Emergency have emerged, new small biotech startups as well
Use Authorisation that has resulted in hundreds of as academic groups with transformative ideas are
thousands of injuries. According to Dr Malone, certain propagating. In addition, hospital-based RNA
critical experiments should follow high standards therapeutics programmes will facilitate RNA-based
and good laboratory practices. He adds that he is drug development and accelerate the translation of
not against all vaccines and mentions that he’s just transformative therapies from the lab bench to the
patient’s bedside.
concerned that the proper, usual
precautions haven’t been taken with Dr Arun Kumar, Preclinical
the mRNA vaccines for COVID-19 Vaccines Development Lead
and doesn’t think people should be at the Coalition for Epidemic
required to take them. He opines Preparedness Innovations
that the government should be (CEPI), Oslo, Norway while
transparent with the data and that speaking at Vaccine Conclave in
pharma companies are obligated Mumbai says, “mRNA vaccines
to fully disclose all the pros and are applicable for many kinds of
cons of the vaccines. therapeutic diseases, immunotherapeutics, cancer
and there is no limit.”
mRNA vaccines development landscape
A lot of research activities are currently being
According to a report published on February 11, undertaken for many diseases. Currently in
2022 in Nature, currently around 90 lead developers trials are SARS-CoV 2, Nipah virus, Congenital
of mRNA vaccines have been identified in a global muscular dystrophy, Respiratory Syncytial Virus,
landscape evaluation. These lead developers have 137 Flu, Zika virus, Epstein-Barr virus, rabies, Human
mRNA vaccine candidates in the pipeline; 76 per cent metapneumovirus, HIV etc. Work was undertaken
in preclinical/exploratory and 24 per cent in clinical for many diseases before COVID but the SARS-CoV 2
development. However, this is rapidly changing. The pushed up the licensure on short notice.
majority of mRNA vaccine development is being led
by biopharma companies based in Asia and Oceania Conclusion
or North America. Moderna will build its first mRNA
production facility in the Southern Hemisphere at The inherent challenges would remain as
Clayton in Melbourne’s south-east and is expected different pathogens emerge, however, the rapid
to produce up to 100 million vaccine doses each development of the COVID vaccines and their
year in Australia, including COVID-19, influenza and usefulness to control the pandemic has given us
respiratory syncytial virus (RSV). Though the pandemic hope for a better future in vaccine development.
has opened avenues for more research on mRNA Though India has been able to successfully launch
vaccines for COVID treatment, research activities were GEMCOVAC-19, it is a long and tough road ahead
already undertaken for other diseases as well. The for the subcontinent to get into the manufacturing
advantage of an mRNA vaccine is that a smaller dose of mRNA vaccines. Looking at the logistics, supply
is required given that the antigen (spike protein) will be chain and various other manufacturing issues and
created inside the body itself. adding to its affordability concerns, a lot more
initiative from the government and tie-ups with
Indian manufacturers is likely to have a positive
impact on the Indian market.

Sanjiv Das
[email protected]

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com COVER STORY 25

“Most clinical-stage pipeline of vaccines is owned

by entities in North America and Europe, while

operations are hindered by IP restrictions”
mRNA-based vaccines have several
benefits over conventional vaccines, «
in that they are precise and only
express a specific antigen and induce a directed Dr Pradeep Nagalkar,
immune response. These vaccines promote both Head, Quality Control,
humoral and cellular immune responses and Haffkine
induce the innate immune system. Dr Pradeep Bio-Pharmaceutical
Nagalkar, Head, Quality Control, Haffkine Bio- Corporation
Pharmaceutical Corporation weighs in on the
advantages and challenges of mRNA vaccines.

Are mRNA vaccines only limited to COVID degraded by cellular processes after the induction of an
immune response. The mRNA vaccine manufacturing
treatment? is easily standardised because a change in the antigen
does not affect the mRNA backbone’s physical-chemical
With the well-established field of small molecule characteristics. Additionally, the safety concerns for the
or antibody-based drugs, we now have a new class viral contaminants are minimised since production is
of RNA-based drugs. By developing these diverse based on an in vitro cell-free transcription reaction.
kinds of therapeutics together, it can be expected that Although there are several benefits of mRNA vaccines,
diverse diseases with no treatment method today will certain challenges also exist. Currently, a well-
be conquered in the near future. RNA Therapeutics established manufacturing platform for the generation
is a rapidly emerging field of bio-therapeutics. These of mRNA is lacking and several combinations of
therapies are based upon a powerful and versatile manufacturing steps are required. These can be
platform which has nearly unlimited capacity to grouped into upstream processing, which comprises
address unmet clinical needs. The number of RNA the enzymatic generation of mRNA, and downstream
drugs under development, and in clinical trials, is processing, which includes the unit operations
growing rapidly. The rapid growth of RNA therapeutics required to purify the mRNA product. In addition,
has been due to solving the problems of stability, the need for cold chain storage for mRNA vaccines
delivery and immunogenicity. Whereas there is room poses logical difficulties. Therefore, there is a need for
for further improvement and innovation in each of the development of thermostable vaccines for warm
these areas, the solutions have advanced to the point countries or those without reliable cold chain storage.
that RNA therapeutics are now feasible. Although
several dominating players in the RNA bio-pharma What are the challenges associated while
sector have emerged, new small biotech startups as
well as academic groups with transformative ideas manufacturing mRNA vaccines?
are propagating. In addition, hospital-based RNA
therapeutics programmes will facilitate RNA-based For next-generation mRNA vaccines to have an
drug development and accelerate the translation of impact, several challenges should be considered.
transformative therapies from the lab bench to the With regards to the targeted disease, multi-valency
patient’s bedside. has yet to be established across strains and other
pathogens. Clinical questions include reactogenicity
What could be the likely advantages? and its implications for risk-benefit profiles outside
of a pandemic setting, immunogenicity (pathogens
mRNA-based vaccines have several benefits over other than SARS- CoV-2 may need a greater cellular
conventional vaccines, in that they are precise and response) and durability of protective immunity.
only express a specific antigen and induce a directed For delivery, intramuscular administration requires
immune response. These vaccines promote both skilled personnel, and products with stability at 4°C
humoral and cellular immune responses and induce or ambient temperature in the liquid formulation are
the innate immune system. mRNA expression in the currently not available. Cost-effective and sustainable
body does not require nuclear entry, which diminishes manufacturing methods are also lacking. Most of the
the possibility of genomic integration. mRNA is quickly

26 COVER STORY BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

clinical-stage pipeline of vaccines is owned by entities required, together with obtaining regulatory agreement.
in North America and Europe, and there is uncertain This can be supported by applying process analytical
freedom to operate in various countries owing to IP technology to provide real-time results to feed into a
restrictions. Some entities are also based in lower continuous validation paradigm. The core objective is
middle income countries (LMICs) and face problems to demonstrate the consistency of the manufacturing
related to limited access to regulated facilities for process. As the characterisation of mRNA technology
clinical trial-grade material production. continues, adopting a risk-based approach can be
advanced, provided that different biotechnology
Developmental challenges companies are prepared to share knowledge.

mRNA vaccines can, theoretically, be produced The development of a vaccine needs to be planned
rapidly, and the field has been advanced through according to the principles of quality by design and
immunogenicity and efficacy. However, there are quality risk management. Consideration must be given
various factors to consider; developing vaccines is not to the design space and the design of experiments.
straightforward, given relatively high failure rates and Overcoming these challenges requires a combination
high time and monetary costs required to establish of knowledge capture, scientific reasoning, learning
the complex processes and production capabilities. from data analysis, and risk-based methodologies.
The development of any biotechnological product is
fraught with difficulties and misdirection. Will mRNA vaccines be accessible & sustainably

With mRNA vaccines, the main obstacles faced by produced for whole worldwide use?
developers include:
Around 90 lead developers of mRNA vaccines have
• Unintended effects: With patient safety, a been identified globally. The majority of mRNA vaccine
risk arises that the mRNA strand contained within development is being led by biopharma companies
the vaccine could elicit an unintended immune based in Asia and Oceania or North America. Regional
reaction (particularly inflammation and autoimmune vaccine manufacturing and distribution sites can
reactions). To address this, a key focus of development prevent barriers to vaccine access created by national
is on creating mRNA vaccine sequences that precisely and economic interests. The majority of mRNA
mimic those produced by human cells. manufacturing sites are located or announced in North
America, Europe and Asia and Oceania (>15 each).
• Delivery: The effective action of a vaccine rests Africa and Latin America also joined the race and
on the mechanism of delivery. The complexity arises recently announced mRNA manufacturing sites (>3),
because when the mRNA enters the human body, it is suggesting a growing interest in these regions. Before
rapidly broken down. Hence, stabilisation is essential the COVID-19 pandemic, the commercialisation of
to protect the mRNA strand until it reaches its target. mRNA vaccines was focussed on high-cost personalised
The strategy involves incorporating the mRNA within cancer vaccines, and prophylactic vaccine development
a larger molecule. This can be enhanced by further was slow and limited. With the demonstration
containment within particles or liposomes (spherical of large-scale manufacturing of mRNA vaccines
vesicles composed of lipid bilayers). For the COVID-19 during the COVID-19 pandemic, the creation of local
vaccines, the mRNA is protected by nanoparticles. A manufacturing capabilities holds promise for more
further delivery consideration is finding the most equitable access to COVID-19 and other vaccines.
effective way for mRNA to reach the cell. For the
vaccine to be effective, mRNA must penetrate the The World Health Organisation (WHO) has sought to
barrier of the lipid membrane to reach the cytoplasm facilitate mRNA vaccine technology hubs in developing
to be translated into functional protein. countries (for example, the South African consortium to
establish the first COVID-19 mRNA vaccine technology
• Storage: Most vaccines are limited by their transfer hub in Africa). This ambitious initiative is
storage time (stability) and required holding described as a training centre for mRNA vaccine
temperatures. Currently, mRNA vaccines require manufacturing. Similarly, the Pan American Health
storage within a freezer or refrigerator, which will Organization (PAHO) has selected centres in Argentina
affect their global distribution. Developing vaccines and Brazil to develop COVID-19 mRNA vaccines, and
that do not rely on cold supply chains will significantly private companies including Moderna and BioNTech
increase their applicability. have announced their intention to build manufacturing
capacity in Africa with sizable investments. This way
• A further challenge is with process validation. the vaccine will be accessible and sustainably produced
The standard regulatory requirement is for full- for worldwide use.
scale batches to be produced. Given the scarcity of
the material and the urgent need (in most cases) for Sanjiv Das
vaccines, adopting a risk-based strategy based on ICH [email protected]
Q9 to show equivalent validation at a smaller scale is

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com SKIN DISEASES 27

IS POST-COVID
Derma Sector Booming?

The past two years have witnessed a low period in the history of healthcare and wellness. Chasing
after a virus and implementing all sorts of quasi-scientific guidelines took precedence over

‘traditional science’. During these couple of years, those suffering from other ailments took a back
seat. Skin diseases are among such widely occurring conditions that afflict a wide spectrum of
citizens, irrespective of gender, race or economic background. The dermatology segment has,
thankfully, geared up to this challenge. Let’s examine what’s happening in this domain.

For years, India has been home to a number report has revealed that the segment is valued at Rs
of skin conditions and diseases such as 11,043 crore in May 2022, and it looks to be one of the
acne, psoriasis, dermatitis, vitiligo, fungal fastest growing therapies going forward. This spike in
and bacterial infections, to name a few. Although dermatology drug sales is a result of the increase in
mortality due to skin diseases is low, they contribute to demand for anti-acne, emollients, anti-fungal and skin
significant disability and stigma. Most of the data on brightening formulations, as people are resuming their
the epidemiology of skin diseases from India is in the normal activities.
form of small case series or surveys from hospitals or
communities and it does not give us the true picture of “The dermatology sector in India is set to boom
disease burden in the country. as people are facing factors such as lifestyle changes,
environmental changes, pollution, and also short
For instance, conditions like psoriasis pose a term factors like heat, humidity and pollution as they
financial burden along with psychosocial consequences resume their daily activities as pandemic-led concerns
due to the stigma attached to them. Thus, these skin subside. We see this opportunity as promising and
problems are often neglected and people refrain from are happy to boost supplies of novel dermatological
going to the doctor or end up doing self-treatment. medicines to allay the increasing skin complaints.
We also hope to capture a larger market share for
In addition, the anti-infectives, cardiac and being the pioneers in dermatology manufacturing, by
diabetes segments have been known to dominate the having a vast array of products both through our R&D
Indian pharmaceutical market, leaving very little space and in-licensed collaborations”, says Sanjeev Jain,
for the dermatology segment to grow and carve a niche Founder, Promoter and Director, Akums Drugs &
for itself. Pharmaceuticals.

The good news, however, is that things are looking Backing this trend is an observation by
up for dermatology. According to a recent AWACS Bengaluru-based healthcare platform MediBuddy
AIOCD report, the segment has increased to 30 per that has witnessed a manifold rise in dermatology
cent in May 2022 (in moving annual turnover). The

28 SKIN DISEASES BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

LEADING SKIN CONDITIONS/ DISEASES IN INDIA “We hope to capture a larger

● Psoriasis ● Alopecia market share for being the
● Vitiligo ● Hives
● Acne ● Ringworm pioneers in dermatology
● Dermatitis ● Xerosis
● Scabies ● Ichthyosis manufacturing.”
- Sanjeev Jain,
LEADING PHARMA PLAYERS IN THE
DERMATOLOGY SEGMENT IN INDIA Founder, Promoter and

● Akums Drugs & ● Galderma India Director, Akums Drugs &
Pharmaceuticals ● Sun Pharmaceutical
● Uniza Healthcare Pharmaceuticals
● Cipla ● Alembic
● GlaxoSmithKline With the transition to the human clinical stage, the
● Glenmark Pharmaceuticals company has now developed a space for itself in this
● Cadila domain and is now being approached by stakeholders
Pharmaceuticals for possible collaborations.
● Zota Healthcare Pharmaceuticals
Sharing more insights about the new dermatology
consultations. Data compiled reveals that in the last drug under development, Dr Parul Ganju, Co-Founder
few months, the portal has seen an overall growth of and Executive Director, Ahammune Biosciences says,
about 84 per cent in the number of people seeking “Our first new chemical entity has been developed
consultations for skin-related issues. for the treatment of skin depigmenting disorder,
vitiligo. With a first in class mechanism of action, this
“About 69.47 per cent of issues were relating is one of the first targeted treatments to be developed
to acne, with the rest pertaining to problems like for the disease which affects millions of patients
pigmentation, face tan, generic skin disease, ringworm, throughout the world. This drug candidate is currently
psoriasis, etc. The data on the platform also reveals in Phase I clinical trials. All our data establishes that
that of the total people who sought consultations about AB1001 is very safe in humans when tested in highest
75.9 per cent of people were males. Men and women concentrations.”
are both susceptible to dermatological issues and our
data shows that men are also increasingly seeking Ahmedabad-based Uniza Healthcare is another
professional help for dermatological issues rather than player focusing on vitiligo treatment by launching
ignoring them”, says Satish Kannan, Co-Founder and a lotion Vitellus in collaboration with a Canadian
Chief Executive Officer, MediBuddy. company Lucas Meyer Cosmetics and Indian company
Mumbai-based Amvigor Organics. The product
Pharma ups the game comprises of ingredients such as Greyverse that
stimulates melanogenesis and pigmentation and
The increasing prevalence of skin conditions, both decreases in oxidative stress; Melitane that helps in
infectious and non-infectious, has boosted the pharma promoting re-pigmentation of skin by stimulating
companies to manufacture medications thereby melanogenesis and decreasing inflammation.
increasing their R&D activities. For example, Mumbai-
based Sun Pharmaceutical is currently conducting Cadila Pharma, based in Ahmedabad, is also
phase-2 clinical trials for a potential oral treatment investing in developing new products in dermatology.
for atopic dermatitis and moderate to severe plaque Its latest development comes in the form of Laglo Soft
psoriasis. Lotion for treating dry skin conditions. It is proven to
be effective in treating skin conditions such as xerosis,
On the other hand, Mumbai-based Glenmark ichthyosis, atopic dermatitis, psoriasis and skin ageing.
Pharmaceuticals has recently launched India’s first
topical Minocycline 4% Gel for the treatment of According to Praveen Sikri, Chief Executive Officer,
moderate to severe acne, under the brand name Ikris Pharma Network, “Like all segments, developing
MINYM. In a study conducted by Glenmark in 2020, solutions for skin-related conditions has its own
on the prevalence of acne in India, it was observed that unique challenges for pharma players. While seeking
45 per cent of the patients were males and 55 per cent to address the dermatological or pathological aspects
were females; and almost 72 per cent of the patients of a condition, makers of skin products also have to
were in the adolescent group whereas 27 per cent be mindful of the cosmetic side of the treatment. So,
patients were in the adult group. sometimes a certain formulation may be effective in
treatment of the underlying condition but may not
Pune-based Ahammune Biosciences has emerged be cosmetically or aesthetically advisable. Therefore,
as the first drug discovery company in the country to selection of the right raw material and the ingredients
develop a targeted new treatment option for vitiligo. in order to prepare a certain formulation is very
critical.”

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com SKIN DISEASES 29

“Our first new chemical entity “One of the limitations
has been developed for the to the dermatology

treatment of skin depigmenting market’s expansion is the
disorder-vitiligo.” shortage of dermatology
- Dr Parul Ganju,
specialists.”
Co-Founder and Executive - Karan Chechi,
Director, Ahammune Research Director,
Biosciences TechSci Research

Another major pharma player in the dermatology “Like all segments,
segment is Vadodara-based Alembic Pharmaceuticals developing solutions for
that has recently acquired 100 per cent stake in skin-related conditions has
Aleor Dermaceuticals from its joint venture partner its own unique challenges for
Orbicular Pharmaceutical Technologies (Orbicular)
to strengthen its skin-related manufacturing and pharma players.”
marketing footprint. - Praveen Sikri,

Using technology for assistance Chief Executive Officer,
Ikris Pharma Network
Besides developing new medications for
various skin conditions, pharmaceutical firms “Men and women are both
are also exploring the use of technology for better susceptible to dermatological
diagnosis and treatment. For instance, Glenmark
Pharmaceuticals has launched a digital patient issues and our data shows
education tool ‘Hello Skin’ in collaboration with the that men are also increasingly
Indian Association of Dermatologists, Venereologists
and Leprologists, to help patients suffering from seeking professional help for
Dermatophytosis (Ring Worm or Tinea) in India, and dermatological issues rather
to adhere to the recommended treatment duration.
than ignoring them.”
Likewise, Janssen Pharmaceutical Companies - Satish Kannan,
of Johnson & Johnson has announced the launch
of icare4u, a comprehensive digital programme to Co-Founder and Chief Executive
support the physical and mental health of people Officer, MediBuddy
suffering from psoriasis and other skin conditions.
the transition from 2022 to 2023 and things shifting
Further, a number of startups have entered the their focus to digital mediums, a phone app is probably
dermatology segment with new technologies to detect making all the difference in people’s lives.
skin diseases. An artificial intelligence (AI) driven
smartphone app- DermaAId has been launched by “One of the limitations to the dermatology
New Delhi-based startup Nurithm Labs to address market’s expansion is the shortage of dermatology
the access and accuracy problems in clinical diagnosis specialists, but this problem can be resolved by online
of dermatological diseases, including skin cancer. doctor consultations for patients all over the world.
DermaAId can identify more than 50 skin diseases The dermatology market is anticipated to increase
with about 80 per cent accuracy. significantly in the coming years because of changing
lifestyles, and easy access to dermatology products in
Then, there is Bengaluru-based startup CureSkin less time and at a lower cost through e-commerce”,
that enables users to take photos and instantly get AI says Karan Chechi, Research Director, TechSci
analysis for acne, dark spots, pigmentation, wrinkles, Research.
and others for free. The startup has so far raised
funding worth $5.5 million. The digital tools being developed by the
industry are indeed putting the spotlight on the
Another breakthrough in these times of awareness of various infectious and non-infectious
digital expansion is the Fibon app backed by real skin diseases in the country, but there is also a
dermatologists, unlike the AI model used by similar need to give due importance to this segment in the
competitors. The dire need for Fibon arose for two national health policies. Although there is no direct
reasons: dermatologists not being easily accessible estimate of the socio-economic burden of skin
and the possibility of diagnosing the majority of skin diseases in a country like India, it is high time that
disorders at a glance and symptoms of a patient. With we stop ignoring them.

Sakura Koner

30 SPEAKING WITH BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

“Treading on the COVID-19 vaccine
opportunity undoubtedly has added
a new dimension to our capabilities”

« regulatory approvals, listed in NSE, BSE, I always felt
that something more needs to be done.
Vishnukant Bhutada,
Managing Director, It is with this thought that we set up Shilpa
Shilpa Medicare Biologicals at Dharwad, Karnataka to achieve
Limited a prominent position in Biopharmaceuticals
space with our own pipeline of Biosimilars, New
Shilpa Medicare Limited (SML) started its Biological Entity and CDMO services from our
operations as API manufacturer way back in world class facilities. Shilpa Biocare, the new site at
1987 at Raichur, Karnataka. The commercial Kadechur, Karnataka was envisioned even before
production in the SML was started in November 1989. the pandemic to have a world-class large scale
Today SML, with a consolidated revenue of R 1,159.76 facility for manufacturing of fermentation based
crore for the year 2021-22 against the previous API and therapeutic products on Microbial platform
years’ revenue of Rs 931.27 crore, has emerged as a (preferably E.coli and Pichia pastoris) to avoid
global brand within manufacturing and supplying dependency on imports. Now this project is of high
of affordable APIs and Formulations globally in relevance in the context of a pandemic situation
different regulated markets. The Group with over 20 where there was shortage of such products with
subsidiaries is now setting up a greenfield project high dependency on imports especially from China.
located in Karnataka. BioSpectrum India spoke to Our new project at Kadechur is in line with our
Vishnukant Bhutada, Managing Director, Shilpa government’s vision of Atma Nirbhar Bharat. The
Medicare Limited on the new facility and challenges investment is to the tune of Rs 400 crore.
and growth of the company. Edited excerpts;
Are you looking to raise additional funds for
this project?

At this stage we haven’t made a concrete
decision on this although we have been approached

Shilpa Group is setting up SBPL, a greenfield

project located in Kadechur industrial area

space spread across 30 acres in Karnataka.

How much is your investment in this

project? Please elaborate in the context of

organisational vision.

Shilpa Group started in 1989 with the
vision of becoming a pioneer in niche areas of
pharmaceuticals. We started with Oncology
API’s followed by finished dosage forms and
eventually evolved with diversified areas including
Therapeutic peptides, speciality polymers, advanced
intermediates, finished formulations (Injectables,
Oral solids, Transdermal patches, Opthalmics, Oral
thin films), Biologicals and Biosimilars.

With 3200 plus employees, 492+ patents
filed, 200+ DMF filings and several international

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com SPEAKING WITH 31

by financial institutions and likeminded companies. had this firm belief that if we have a clear vision,
Now that the project is in an advanced stage there right commitment and business principles laced
are various opportunities that are being evaluated with “Quality in Mind” we can always make our
in addition to manufacturing of our own NBE- presence felt irrespective of location.
“Recombinant Human Albumin”.
Could you give us some insight about your
When is it expected to be completed and
Biopharmaceutical SBU - Shilpa Biologicals?
become operational? How many jobs will it
Shilpa Biologicals started with a vision
create? Any particular reason to set up in to provide quality, affordable, accessible
Biopharmaceutical healthcare products to patients
Kadechur. across the globe. While in the pharmaceuticals
space we have achieved excellence and continue to
The project is expected to be completed by improve our products and services, we wanted to
Q4-2023 and it will create about 400 jobs. As a embark on a similar path for Biopharmaceuticals.
company we always “Think global but act Local”. Shilpa Biologicals is the biological site where we
We had set up our first manufacturing site in have a full range of capabilities right from “Concept
Raichur (200 kms from Hyderabad) but successfully to commercialisation”.
managed to get our facilities audited by several
international agencies including USFDA, EU, We have a unique Business model which
PMDA-Japan etc. and registered our products in is “Self-propelled and Synergistic”. While we
international markets much to the satisfaction of develop, manufacture, register and commercialise
our customers and shareholders. In this process our own Biosimilars and NBE, we are also a
we created huge employment opportunities for prominent CDMO (Contract Development and
many locals. Likewise Shilpa Biologicals (for our Manufacturing Organisation). Our Biosimilar
Biological Drug substance and Drug product pipeline includes high concentration Adalimumab
site in Dharwad) we were aiming at a location in (ORIADALI), Aflibercept, Abatacept, Tenectaplase,
Karnataka. Pembrolizumab and New Biological Entity-
“Recombinant Human Albumin’’ which is
Shilpa Biocare location at Kadechur was also developed for both Therapeutic and Non-
to set up a facility in Karnataka at a location therapeutic applications. We are the first company
other than Bangalore and in the process create in India to develop and successfully complete
local employment opportunities. Although we are Phase-III study of high concentrated biosimilar
located in Karnataka with manufacturing sites in Adalimumab, soon to be commercialised in
Raichur, Dharwad, Dabaspet, we have our R&D India. Our CDMO model from a very early stage
centre at Raichur, Bangalore, Ahmedabad and has started providing services to various clients-
Dharwad and offices in Mumbai, US, Europe and Sputnik-V and DNA Vaccine for COVID-19 have
employees from pan India. To summarise we been manufactured by us.

We have a world class Infrastructure:
● Our R&D has capability of Clone development,
Process development, Analytical development and
full product characterisation.
● We have dedicated drug substance
manufacturing facilities for microbial and
mammalian based products and three drug product
facilities for filling in PFS and Vials. Our highspeed
vial line with high throughput has been specifically
set up for high volume products especially vaccines.
In addition to above through our new division
‘Shilpa Biosciences”- domestic marketing
division we will improve the reach of our high-
end biologicals pan India directly and through
government institutions including but not limited
to “Pradhan Mantri Janaushadi Pariyojana”. We are
also in discussion with several domestic companies
and multinationals to in-license biological drugs to
improve the access of lifesaving drugs.

32 SPEAKING WITH BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

How is this new facility different from other It was a good learning. But we must be careful in
facilities? the future while investing in new areas. Treading on
the COVID-19 vaccine opportunity undoubtedly has
We are setting up about 250 KL large scale added a new dimension to our capabilities enhancing
fermentation facilities which, presently, we don’t our manufacturing capacities that will be put to full
have in any of our current facilities. use for Mabs business in near future. Our intent was
primarily to rise to the national demand for vaccine
Each facility of ours is different: security and hence it was a conscious decision to
1. API Facilities at Raichur, Karnataka venture into this. Unfortunate situations resulting
2. Oncology Formulation unit at Jadcherla, from unprecedented market dynamics which were
Telangana beyond anybody control, we missed the opportunity.
3. Film/TD Formulation unit at Dabaspet, Although it has been a setback from a financial angle
Bangalore there has been more pros than cons. With the vaccine
4. Biological unit at Dharwad, Karnataka experience, we are now being approached by a few
5. Fermentation facility at Kadechur, Karnataka multinationals for CDMO services.
Differentiation of Shilpa Biocare (new site at
Kadechur) stems from our vision to have a large You have a list of over 20 companies as
scale world class facility for manufacturing of subsidiaries, joint ventures, which ones are
fermentation-based products with equally sized giving good growth and how do you see the
downstream facility for purification of therapeutic growth for these firms in the post pandemic
proteins. The uniqueness is in the infrastructure era?
that allows manufacturing of multiple products
including but not limited to “Recombinant Human Globally most of the companies of our size
Albumin”, Recombinant Human Insulin and analogs, are ideally looking to consolidate their position
Recombinant Enzymes etc. In addition to this we depending on the degree of setbacks owing to the
have earmarked adequate space considering the need market situation and naturally a moderate progress
for expansion in near future. is expected. Having said that on the small molecules
front we are working to develop new products which
Can you give us some insight on how your are set to launch by next 2-3 years. Similarly our
current biopharma facility and the upcoming Therapeutic peptide division is also developing a good
one will bring overall growth to the group? pipeline of products some of which are going off patent
in next 2-5 years. Shilpa Biologicals (Biopharma
Shilpa Biologicals will set the launch pad for its Business), Shilpa Biocare (large scale facility) and
growth with the commercialisation of Adalimumab Shilpa Biosciences (Domestic marketing division) as
(ORIADLI) in India. This will be followed with mentioned earlier are expected to further elevate our
other biosimilars that will set the tone for overall position in domestic and international markets. We
organisation growth driven by improving the are reenergised in our quest for growth post pandemic
outreach of these biosimilars to patients across the era notwithstanding the moderate progress.
globe. Our US and EU strategy is well crafted and can
by itself change the entire landscape. Our distinctive What are the current challenges before the
CDMO services will also play a major role in this company?
growth path. Shilpa Biocare is again on the lines of
Shilpa Biologicals – “Self-propelled and Synergistic”. The main challenge is in monetising the
Our NBE by itself is a blockbuster product. While it investments made in the last few years which didn’t
has the potential to garner a major share from the progress as expected due to the unprecedented
~$6 billion market, our flexibility with the CDMO pandemic situation. This, apart from the dynamics
model will aid in self progress. Biopharmaceuticals/ in the regulatory environment due to lack of
biologicals are a slow growth but profitable business convergence in systems across various countries,
in the long run. Patience always brings promising are main challenges. Nevertheless, since our
results. Hence these two businesses in due course of Biosimilar Development programme has been built
time will definitely bring in overall growth of Shilpa in accordance with EU/US standards on the basis of
group. “Totality of Evidence” we expect that we will be able
to open up many markets that will have access to our
Manufacturing of COVID-19 vaccines has Biosimilars in the next few years thereby resulting in
not been a commercial success but you’ve, good progress overall.
nonetheless, developed the capabilities of
Recombinant vaccine manufacturing. What Narayan Kulkarni
was the major learning from this? [email protected]

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com SPEAKING WITH 33

“Regulatory framework to protect IP,
innovation and existing governance
structures ought to be strengthened”

The Ministry of Health and Family welfare «
was going to implement the Unique Device
Identification (UDI) for medical devices from Nakul Pasricha,
January 1, 2022, but deferred it until further notice. President, ASPA
Under Rule 46 of the Medical Devices Rules, UDI (Authentication
would have been mandatory for medical devices Solution Providers’
approved for manufacturing for sale or distribution Association)
or import. Globally, UDI is expected to play a pivotal
role in improving patient safety by enabling device is three nurses per 1000 people. This, coupled with
identification and tracking and most importantly the increasing need for healthcare services; medical
overcome counterfeiting. Expounding in detail devices creates a huge opportunity that can facilitate
about the counterfeiting menace in India and quick and accurate delivery of healthcare.
urging the government to bring into effect the UDI,
Nakul Pasricha, President, ASPA (Authentication What has made India boost domestic
Solution Providers’ Association) converses with production of medical devices?
BioSpectrum India in an exclusive interaction.
ASPA is a Non-Profit organisation that has 69+ India has been holding an important position in
member companies providing physical and digital the global healthcare landscape as the pharmacy for
authentication solutions. This industry body of the world. This has led to accumulation of meaningful
authentication solutions providers encourages its information about this industry. The huge demand
members to adopt best practices, standards, and and future scope for medical devices in the country
advanced technology in providing cost-effective, and across the world, coupled with the intelligence
anti-counterfeiting solutions. Edited excerpts: and insights that the industry has gathered over
the years, has motivated Indian manufacturers
How has the medical device landscape to participate aggressively. In recent years, the
changed in India? What led to this change technology-led perspective of the manufacturing
and how would you perceive its future industry has enabled the development of excellent
changes? products of world-class quality and capable of
delivering precision.
The healthcare sector in India is going through
a revolutionary transformation, resulting in a more Has the demand for precision medical
favourable environment for patient well-being. India devices spurred the circulation of
is playing a significant role in the global healthcare substandard and fake MedTech devices?
landscape, the country was already on the brink of
this transformation, and COVID-19 accelerated it. Increasing need and widespread popularity of
A substantial part of this transformation is multi- medical devices, especially the growing adoption
faceted innovation in medical devices aimed at of precision medical devices, has put pressure
precision in delivering healthcare to patients. New on manufacturers and the supply chain. The gap
age innovative and efficient medical devices driven in demand and supply essentially is seen as an
by intelligent technology are a massive support to opportunity by the illicit manufacturers and sellers.
medical practitioners and nursing staff. With the They are further motivated by a relatively immature
growing need for healthcare in the country, it has a market and low awareness levels. When customers
challenging task in front of them despite putting in are unaware of the ease with which spurious, fake or
its best efforts. There is a shortage of nursing staff substandard products can be infused into the market,
in the country; our country currently has 1.7 nurses
per 1000 people, while the WHO recommended rate

34 SPEAKING WITH BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

“It is a misconception that implementing
authentication solutions or building track
and trace systems is a considerable cost.
There are cost-effective tech-enabled
solutions which are highly effective.
Together with industry, governments,
authorities, and brands are responsible
for undertaking awareness campaigns
that would engage the medical
fraternity, nurses, pharmacists, and
consumers into actively being careful of
buying a fake device. Their participation
in the authentication system can be a
game-changer.”

it becomes easier for illicit traders to dupe them. How do illicit manufacturers and sellers get
Concerning a new product, customers are relatively
less aware of the device and are unaware of how into the ecosystem and supply chain?
to know if it is an authentic standardised device or
not. This gives the illicit manufacturers and sellers a Authentication solutions are implemented on
window to cheat them and sell copycat devices. Due some products, which can easily determine their
to technological advancement, counterfeiters can authenticity. But due to a lack of awareness about this
churn out low-quality precision medical devices and and low participation in the authentication process,
copycat packaging easily and quickly. illicit products are not identified and reported
correctly to enable corrective action.
What damages do illicit MedTech devices
Low awareness among consumers, medical
pose on various facets of the industry, fraternity, nurses and pharmacists about the
widespread presence of substandard and fake
society and ecosystem? products allows them to cheat them into buying
these. During a global crisis, a vulnerable supply
Fake, spurious or substandard MedTech devices chain also presents itself as an opportunity for these
do not go through quality checks and do not match criminals. The pandemic was one such eye-opener
the standards set for those devices. Thus, they in this regard.
undermine and hamper the delivery of good quality
and precise healthcare to the patients in need. Their Through the duration of the pandemic, a
inability to precisely deliver the device’s purpose disturbing number of incidents surfaced, which were
makes it impossible to provide a timely diagnosis or related to substandard and falsified medicines and
treatment. For instance, a substandard or fake Home medical products in India and globally. There was
Blood Sugar Monitor machine might not display an alarming spike of 47 per cent in the incidents
accurate results, and the patient’s health would be reported of falsified and substandard medical
at risk due to a delay in giving timely treatment. products during 2020-2021. It was also observed
The more crucial the device’s purpose, the more that these were mainly related to COVID-19
significant threat it is to the patient’s health. products such as vaccines, antibiotics, test kits,
sanitizers and face masks (Ref: ASPA’s Report to
Apart from the threat of endangering the lives the Nation). These incidents were observed in 23
and well-being of patients, illicit products hamper out of 29 Indian States and Union Territories of the
the faith of patients in the medical fraternity and country.
the whole ecosystem. Our medical fraternity,
hospitals, pharmaceutical companies, medical
device companies, etc., put in a lot of hard work and
investment into enabling good quality and timely
healthcare to patients. But, the presence of fake and
substandard medical devices and drugs can lead to
grave tragedies. Additionally, any illicit trade eats
into governments’ revenues and brands.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com SPEAKING WITH 35

Is there a proper regulatory framework that in our opinion, should not be delayed and should
be implemented as soon as possible. The regulatory
protects authentic MedTech devices and framework for protecting innovation and intellectual
property and existing governance structures needs to
innovations? be strengthened to stay attune to the new age changes.

MedTech space is changing rapidly, which How can the country, industry and brands
calls for the regulatory framework to adapt and prepare themselves to fight the problem of
become more inclusive to cover innovations and fake and substandard MedTech devices?
new technologies. Medical devices continue to be
regulated as drugs under the Drugs and Cosmetics The solution starts from acknowledging and
Act 1940. Efforts have undoubtedly been made to understanding the problem and its magnitude. We
bring medical devices under proper regulation by need to stay one step ahead of the criminals to make
amending the Drugs and Cosmetics Rule from time their task difficult and unrewarding. Government
to time. And it was only in January 2017 that the can guide the whole ecosystem towards a more
Medical Devices Rules were framed for the first time. nurturing environment for authentic products. They
A step in the right direction, but more improvements can take the lead by making it mandatory to use
are required. International norms have been authentication and traceability solutions to secure the
revised since then, and in some cases, Bureau of supply chain.
Indian Standards norms are not in conformity with
Indian Standards Organisation or International The MedTech brands that invest heavily into
Electrotechnical Commission requirements. producing world-class devices should take on
the responsibility of protecting the product by
The Ministry of Health and Family welfare was implementing physical and digital solutions. From
implementing Unique Device Identification (UDI) tamper-proof packaging such as one-time break
for medical devices from January 1, 2022, but this plastic sleeves to digitally enabled labels that easily
has been delayed till further notice. Under Rule give information about the origin and journey
46 of the Medical Devices Rules, UDI would have of the product to QR Codes that can be scanned
been mandatory for medical devices approved for through intelligent devices. It is a misconception
manufacturing for sale or distribution or import. that implementing authentication solutions or
Globally, UDI is expected to play a pivotal role building track and trace systems is a considerable
in improving patient safety by enabling device cost. There are cost-effective tech-enabled solutions
identification and tracking. Such positive initiatives, which are highly effective. Together with industry,
governments, authorities, and brands are responsible
for undertaking awareness campaigns that would
engage the medical fraternity, nurses, pharmacists,
and consumers into actively being careful of buying a
fake device. Their participation in the authentication
system can be a game-changer.

How practicable is it to implement a robust
track and trace infrastructure to secure the
supply chain and avoid pilferage?

It is possible to implement a robust track and
trace system that records, and provides information
on-demand about an authentic product in the
ecosystem. Getting this information is as easy as
scanning a QR Code or barcode or sending an SMS
from a mobile phone. Every product has a unique
identification that makes its location known in a few
seconds when attached to the track and trace system.
The track and trace system, due to its design, has
proved very effective in identifying pilferage spots in
the supply chain by showcasing inconsistencies. This
helps in identifying the defaulters and the culprits in
the system.

Anusha Ashwin

36 PARTNER CONTENT BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

How POC Diagnostics and
CLIA Immunology turn
catalysts for IVD Market

« potentially saving a patient’s life and valuable
time. POC Diagnostics or Testing has potential
Thomas John, operational benefits like the number of operational
Managing Director, bed requirements, optimal professional time, rapid
Agappe decision making, reducing dependency on skilled
technicians, standard care in a disaster situation,
A Proven Concept- POC Globally and reduction of patient waiting time. It’s a myth in
Point of care (POC) is a well-established India that POC Testing is expensive and premium
priced. If you make the right value proposition for
concept worldwide and the need for the POC POC Testing with the above-mentioned operational
is rapidly increasing in India too. In future, benefits, POC Testing is highly affordable to all
POC Testing (POCT) will play a vital role in classes of hospitals and clinics in India.
private and public healthcare. During and after
Pandemic, we all know the importance of time, Post-pandemic awareness and patient comfort
POCT is the tool that supports
healthcare professionals Awareness in point of care testing has
for faster diagnostics,
focusing on patient care increased many folds among the public.
and saving TIME. It’s
important to embrace new Knowledge on diagnostics tests and its importance
and developing technology
in POC Diagnostics and has created a huge awareness and demand for
Testing, currently POC
devices are manufactured high quality POC devices. POC Testing
with high-quality standards
and deliver the desired results MISPA benefits patients in saving time
to the clinicians. Post pandemic REVO by avoiding long waiting queues,
we could see a huge surge in the PLUS repeated visits and managing the
demand for POC Testing in India, it’s
really a welcoming trend and future of diagnostics with ease and stress-
the diagnostic industry.
free under the guidance of their
Patient centric and cost benefit
POC is the mode of near patient testing care healthcare professional.

to supplement the patient-centric approach Turn Around Time,
with bedside testing, and it’s very easy testing a re-look through POC
process. Present POC technologies give high-
quality results in a short time, enabling physicians Turnaround time (TAT) in
to quickly decide on the course of treatment, patient care is the key and
patient centric approach is
the need of an hour. For the
ICU (Intensive Care Unit) or
ER/ED (Emergency Room/
Emergency Department), TAT
is to be the Bed Turnaround time,
how fast the patient is directed to the
right department, or how fast the patient recovers
and moves to the general ward from ICUs and
keeps the bed available for the next needy patient.
To make faster decisions, you really need POC
Testing at the near-patient or bedside. For the
small labs and clinics, POC will add huge value
to their patients on faster Turnaround time in

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com PARTNER CONTENT 37

patient care and in all MISPA
possible ways to get patient REVO
confidence and delight.
it fully applicable to
Agappe POC division a various application
holistic solution provider environments of medical
laboratories. The design
Agappe launched POC orientation of i1000 could
diagnostics solutions with full product not only meet the routine
portfolio covering the critical needs of test requirements of medium
emergency department, ICU, Physicians’ offices and small hospitals, but also provide support
and to the stat labs with the product profile of to the assay development and STAT tests of
Mispa Chem Dx- Auto Dry chemistry analyser, large hospitals. The mature compatible system
Mispa HbX – Hb+ Hct meter, Creamatocrit Plus- of instrument and reagent, and strict system of
Mothers milk nutrition testing device, qLabs- Q3 metrological traceability could ensure the test
Plus Meter for Coagulation – PT INR and APTT results are accurate and reliable.
combo, yet to launch Mispa Immuno Dx – POC The CLIA analyzer throughput is 180T/hour
Immuno assay analyser and AG Arteria a with the support of 30 reagent positions and 50
Preheparinized Dry ABG Syringe. sample loading capacity at a time. The testing
time for the first test result is 14 minutes in case
Agappe & CLIA of cardiac parameters and 28 minutes for other
parameters. RFID incorporated reagent vials
Agappe, your best partner in diagnostics, is ensures the error proof reagent management
system. Barcode assisted disposable cuvettes
already marketing advanced Chemiluminescence are used for each test handled by a specialized
cuvette handling system.
Immunoassay (CLIA) systems, providing Agappe offers all the reagents in 1x100 T
pack size with inbuilt RFID along with two-point
affordable solutions in immunology including calibrators. The calibrators are included in the kit
and sufficient volume is provided for 5 times of
hormones & fertility, infectious panels, cancer calibration to fulfil the 35 days open vial stability.
Both the multianalyte and mono-analyte controls
markers, thyroid panel, metabolic panels etc. are available in different pack sizes. The reagents
are traceable to external quality controls like
We are proud to announce that Agappe Biorad and NIBSC.
We are aligned with the Prime Ministers’ vision
is the first Indian company to have inhouse on Atmanirbhar Bharat. In the Indian context, self-
reliance should not mean divorcing international
manufacturing licence for CLIA reagents from trade. India will have to seriously engage with
the region and the world, but at the same time,
the Central Drugs Standard Control Organisation strengthen its own domestic industry. Agappe
manufactures more indigenously
(CDSCO). Over 35 parameters are available in the developed medical devices and
its reagents for IVD, technology
first phase. Our R&D will be adding further menus transfer, and JV model products
which are all manufactured fully or
regularly to increase it to 125 plus parameters partly or assembled in our facility
to offer these products not only for
across CLIA segments, which would make it India, but also to the world to fulfill
the dream of Make in India.
unparalleled set of offerings in the Indian In Vitro We are proud to get license
for manufacturing CLIA
Diagnostics (IVD) Industry, including all available reagents in India and we will
be the torch bearer for CLIA
panels like thyroid, cardiac, fertility, infectious, manufacturing in India with
various joint venture partners
cancer, diabetic, autoimmune, bone chemistry as and technological partners
across the globe.
well as bone metabolism.

India has been relying on MISPA
imports for CLIA equipment HBX

and reagents all these years.

Now, Agappe plans to break this

chain of vicious dependence on

imports and make the technology

more accessible to masses at an

affordable price tag and convenient

pack size.

i1000 Automatic CLIA System

uses the magnetic microparticles

based Acridinium Ester (AE) direct

chemiluminescence technology. The

character of stable performance,

fast report, convenient operation

and reliable results could make

38 R&D NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Tata Memorial’s Indo-Spain project
to develop new
clinical trial offers antibiotics against
gram-negative bacteria
new hope to breast
Spain-based ABAC Therapeutics, together with the
cancer patients artificial intelligence (AI) company Peptris (based
in Bengaluru), and the Foundation for Neglected
Dr Rajendra Badwe, Director Tata Memorial Disease Research (FNDR), with scientific support
Centre, presented the results of a landmark from Medicines for Malaria Venture (MMV), is leading
multi-centre Indian breast cancer study at an international project to optimise a new chemical
the ongoing European Society of Medical structure that has shown effectiveness against Gram-
Oncology (ESMO) Congress in Paris, one of the negative bacteria, the greatest current threat to public
most prestigious cancer health. In recent decades, there has been a significant
conferences in the world increase in the incidence of infections caused by the
held annually in Europe. Gram-negative bacteria known as “the four killers”:
The trial in women Acinetobacter baumannii, Pseudomonas aeruginosa,
undergoing breast cancer Escherichia coli and Klebsiella pneumoniae. The two-
surgery involved the year project will be developed in four stages. Artificial
injection of a commonly intelligence and in silico methods will be used to
used drug around the analyse the screening data, and propose new chemical
tumour on the operating series, which will then be optimised for both their
table, just prior to surgery. antibacterial activity and their safety and tolerability.
The results of this trial ABAC has initially screened 145,000 compounds from
show that this simple, low- MMV’s compound collection against a range of bacteria.
cost intervention significantly and substantially Chemical series with a narrow spectrum of activity
increases the cure rates and survival with a against bacterial pathogens of interest were identified,
benefit that is ongoing for several years after and these include a new chemotype with demonstrated
surgery. The injection requires no additional activity against Gram-negative bacteria.
expertise, is inexpensive, and can result in
saving up to 100,000 lives annually globally.

IISc designs new method for TB vaccine
delivery using gold nanoparticles

Researchers from the Indian to develop a potential subunit bound particles released by
Institute of Science (IISc), vaccine candidate that contains some bacteria, and contain an
Bengaluru have designed a new only parts of the infectious assortment of proteins and lipids
method to deliver a vaccine bacterium to stimulate an immune which could induce an immune
candidate for tuberculosis (TB), response. They decided to use response against the pathogen.
caused by Mycobacterium Outer Membrane Vesicles (OMVs) Mycobacterium-derived OMVs
tuberculosis. It involves using that are spherical membrane- are usually unstable and come
spherical vesicles secreted in different sizes, making
by bacteria coated on gold them unsuitable for vaccine
nanoparticles which can then applications. But the OMVs coated
be delivered to immune cells. on gold nanoparticles were found
This can potentially trigger an to be uniform in size and stable. In
immune response and offer future studies, the team plans to
protection against the disease. develop gold-coated OMVs derived
While the BCG vaccine works well directly from Mycobacterium
in children, it is not as effective at tuberculosis and test them on
protecting adolescents and adults. animal models to take the results
This prompted researchers at IISc forward for clinical applications.

The 25th edition of Bengaluru Tech Summit - Asia’s largest IT, Deep Tech & Biotech event is
organized by the Dept. of Electronics, IT, Bt and Science and Technology, Govt. of Karnataka
is scheduled from 16th to 18th November 2022, with the theme, ‘Tech4NexGen’. The event
will be an in-person event at Bangalore Palace, Bengaluru.

Hon’ble Prime Minister Shri. Narendra Modi ji is intended to inaugurate the Summit along with heads of the Global Leaders.

The event will be attended by global technology leaders, India grown IT heads, Biotech, Deep tech and start-ups. BTS 2022

will provide the platform to access the best innovations, new products and cutting-edge ideas for building a collaborative,

global tech community. The theme for IndiaBio@Bengaluru Tech Summit is Leading the New Normal

BIOTECHNOLOGY BioPharma | BioAgri | BioIT | BioIndustrial | BioServices

CONFERENCE FOCUS 

EVENT SPECTRUM

• Multi-Track Conference • Global Innovation Alliance • Smart Bio Awards • Bio Posters

• International Exhibition • India Innovation Alliance • Unicorns Conclave • Bio Partnering

• India USA - Tech Conclave • R&D - Lab2Market • Biotech Quiz • B2B Meetings

HIGHLIGHTS OF BTS2022 Session Highlights

50+ 70+ 350+ • Towards 100$ Human Genome: Implications
• Smart Supply Chains in Biopharma
COUNTRIES SESSIONS SPEAKERS • Gene Editing and Agriculture
• One Health and Pandemic Preparedness
10000+ 400+ 1000+ • The Future of Genomic Medicine
• Bio Industrial and Bio Manufacturing
BUSINESS ATTENDEES EXHIBITORS START-UPS • Big data in Drug Discovery
• Bioinvesting
2500+ 50000+

ORGANISATIONS VISITORS

Contact: Ambika Kiran | [email protected] | +91 95359 99435 @blrtechsummit

www.indiabio.in | www.bengalurutechsummit.com

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42 R&D NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

IIT Mandi Scientists identify potential
marker for early detection of
discovers neuro-degenerative diseases

biochemical Scientists at Kolkata-based SN Bose National Centre for Basic
Sciences, an autonomous institute of the Department of Science
link between and Technology (DST), have explored how the hydration of proteins
gets altered as liquid-liquid phase separation (LLPS) sets in. The
fatty liver researchers have spotted the
crucial role of water in LLPS
disease and which holds the key to neuro-
degenerative diseases. They
type 2 diabetes found that some excipients or
inactive substances that serve
A team of researchers at the as the vehicle or medium for a
Indian Institute of Technology drug or other active substance
(IIT) Mandi has unravelled the like sucrose can stabilise LLPS
biochemical relationship between while some can inhibit it. Thus
fatty liver disease and Type 2 the aggregation process of these diseases could be modulated by
Diabetes Mellitus (T2DM). This altering water network dynamics using these excipients. In a paper
understanding enables newer published in J. Phys. Chem. Lett, the scientists under the leadership
techniques to diagnose the of Prof. Rajib Kumar Mitra, examined four excipients — arginine,
risk of diabetes among people glucose, ubiquitin, and bovine serum albumin.
with Non-Alcoholic Fatty Liver
Disease (NAFLD). The findings IIT Jodhpur develops fluorescent
of this research also offer new probe for Alzheimer’s detection
therapeutic pathways to control
or even reverse fatty liver- A multi-institutional team led by the Indian Institute of Technology
induced diabetes. This research is (IIT) Jodhpur has developed an efficient fluorescent molecular
important for India because the probe that can be used in the diagnosis of Alzheimer’s disease (AD).
prevalence of NAFLD is rapidly The research has been carried out in collaboration with the IIT
increasing in the country and Kharagpur, and the Council of Scientific & Industrial Research -
recent surveys show that 40 per Indian Institute of Chemical Biology (IICB), Kolkata. AD is believed
cent of Indian adults suffer from
it. NAFLD is often associated with to be caused by the abnormal
Type 2 Diabetes, with nearly 50 build-up of plaques in and
million Indian adults having both around brain cells. Plaques
diseases. The multi-institutional are aggregates of a type of
research team analysed blood small protein (peptide) called
samples extracted from fat-fed amyloid-beta (Aβ). The
mice and human NAFLD patients. researchers have successfully
Both samples had high amounts designed and developed a
of a calcium-binding protein series of benzothiazole-based
termed S100A6. This protein fluorescent molecules that
is released by the fatty liver can selectively bind to Aβ
and serves as a communication aggregates. All these molecules were seen to emit fluorescence in
link between the liver and the one colour when unbound, and the emission colour shifted towards
pancreas. S100A6 adversely red in the visible light (rainbow – violet indigo blue green yellow
affects the insulin secretion ability orange red) spectrum with a concomitant increase in fluorescence
of the β-cells, thereby resulting in intensity. This molecule was stable in biological fluids and could
or exacerbating existing T2DM. At easily traverse the blood-brain barrier. It was also selective to Aβ
a biochemical level, S100A6 was aggregates in the presence of competing biomolecules.
found to inhibit insulin secretion
by activating the Receptor for
Advanced Glycation End product
(RAGE) on pancreatic beta-cells.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com PEOPLE NEWS 43

ICGA Foundation appoints
Dr Suveera Dhup as COO

The Indian Cancer Genome executing the Foundation’s Alliance) and the International
Atlas (ICGA) Foundation, a strategy and vision. Dr Suveera Centre for Genetic Engineering
not-for-profit, public-private- has over nine years of experience and Biotechnology (ICGEB).
philanthropic partnership, in research and management,
announced the appointment of with a PhD in Life Sciences
Dr Suveera Dhup as its Chief and postdoctoral experience
Operating Officer, effective in regenerative biology and
August 2022. Dr Suveera cancer metabolism. She has a
will oversee ICGA’s ongoing decade of experience in research
operational and administrative administration and support,
functions. She will also support working with the DBT/Wellcome
the Board of Directors in Trust India Alliance (India

Meenakshi Nevatia joins Tushar Naik
APACMed as Chairperson for
India Executive Committee joins ICPA as VP

The Asia Pacific Medical Technology Association (APACMed) ICPA Health Products (ICPA) has
representing the medical device industry is delighted to appointed Tushar Naik as its new
welcome Meenakshi Nevatia, VP and MD, Stryker India, Vice President, Marketing & Sales
as its new chairperson for its India Executive Committee. division, effective August 2022. Naik,
Meenakshi has been intricately involved in the healthcare, who served as the Senior GM - Sales
medical technology, and pharmaceutical industries throughout & Marketing of the Biovation Division
her career, which spans over 25 years in a variety of key global of Immunology (Rheumatology &
leadership roles. A proven medical device leader with a strong Dermatology) at Zydus, will spearhead
passion for making healthcare better, her strengths include the pan-India
marketing team
building strategies that foster diverse at ICPA. He will
teams who are driven to deliver be responsible
differentiated innovation in service for marketing
to healthcare professionals and and product
patients. In her current role as strategy for
Vice President and Managing all product
Director of Stryker India based categories,
in Gurgaon, Meenakshi is brand
responsible for building positioning
Stryker’s business strategy and market
and setting up the expansion in conjunction with sales.
organisation for long- Naik, a pharma industry professional,
term, sustainable has over three decades of experience
growth in the Indian in the healthcare industry, especially
market. Additionally, in pharmaceutical, biotechnology and
one of Meenakshi’s cosmetology. He also headed the Sales
priorities is to build & Marketing of Ranbaxy’s Ortholands
a winning culture Division of Bone Health & Growth
and cultivate a strong Hormone. Naik has also recently
commitment to authored a book titled Medical
Stryker’s mission and Representative - An Indispensable
values in India. Medium For The Pharmaceutical
Industry.

44 APECOAPDLEEMNIECWSSNEWS BBIOIOSPSEPCECTRTRUUMM || OACUTOGBUESRT 20212 | www.biospectrumindia.com

World Stroke Cadila Pharma’s
Organization Dr Bakulesh Khamar bags
appoints Swadesh Samman Award
Dr Arvind
Sharma on Dr Bakulesh Khamar, Executive Director of R&D at Cadila Pharmaceuticals
its Board was bestowed with the Swadesh Samman Award at the Swadesh Conclave
2022 in Vigyan Bhavan, New Delhi. Dr Khamar was felicitated for his
Dr Arvind Sharma, a invaluable contribution to research in the field of medicine for innovative
neuro physician at Zydus product development in India at the hands of Dr Jitendra Singh, Union
Hospital in Ahmedabad, Ministry of Science and Technology and Ashwani Kumar Choubey, Union
has been elected as a Minister of Consumer Affairs, Food and Public Distribution. Dr Khamar
member of the Board of completed MBBS in 1975 and Master of Surgery Ophthalmology in 1980
Directors of the Geneva- from BJ Medical College, Ahmedabad. He researched cataract formation,
based World Stroke which was supported by ICMR and the Government of Gujarat. He also
Organization (WSO). The developed a medical device to predict visual potential in presence of opaque
elections for the WSO media e.g. cataract, vitreous haemorrhages for which was awarded the Col.
board of directors for the Rangachari award from the All India Ophthalmic Society.
period 2022-2026 took
place between July and 25, Zeon Lifesciences appoints
and 959 members of the Dr Vivek Srivastava as Senior VP
organisation placed their
votes. Dr Sharma, who Zeon Lifesciences has appointed Dr Vivek Srivastava as a Senior
is secretary of the Indian Vice President- innovation, Business Strategy & Scientific Affairs of
Stroke Association and the company. Dr Srivastava has worked
Director of Brain - Heart at various CXO level roles with several
Foundation, will take over initiatives in the domain of Nutrition &
as WSO Board member on Herbals during his 15 years of expertise in the
October 22 at the World field of Nutrition & Alternative medicine. Dr
Stroke Congress to be held Srivastava pursued his Masters in Alternative
in Singapore. Medicine with a specialisation in Herbals
and Phytonutrients followed by Doctorate in
Phytonutrients. He has executed innovative
research, product development, and curated
practical solutions with claims that are
backed by research in the health and wellness
industry. He has developed and marketed more than 75 formulations. Dr
Srivastava is also a member of MNI (Medical Nutrition Industry) and has
been instrumental in representing the food industry to implement food
regulation and its harmonisation.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com PARTNER CONTENT 45

10th Merck Bioforum India 2022

Next Generation Bioprocessing

for Process Intensification

Merck India has been creating various platforms This Bioforum India provided the latest insights
for the Bio-Pharmaceutical industry in India on delivering increased speed, greater flexibility and
to discuss the latest trends by bringing enhanced quality while reducing the cost and risks
together eminent leaders from the industry and the of navigating the evolving biopharma landscape
subject matter experts across the globe. from renowned industry experts like Dr. Rustom
Mody, Senior Vice President & Head R&D Biologics
10th Merck Bioforum India 2022 is a thought division, Sun Pharmaceutical Industries Ltd., Dr.
leadership program which is a part of the flagship Samir Kulkarni, Distinguished Professor,Department
Asia seminar series that Merck Life Sciences Pvt. of Chemical Technology, ICT, Mumbai, Dr. Ashish
Ltd. has been organizing annually. This is an annual Sahai, Additional Director, Production (viral vaccines),
knowledge-sharing platform to build a network of Serum Institute of India Pvt. Ltd., Dr. Ratnesh Jain,
end-users and discuss the evolving future trends of Associate Professor, Department of Biological
biologics manufacturing processes, technologies, Sciences and Biotechnology, ICT Mumbai along with
challenges, and process intensification.This year’s Merck experts like Dr. Subhasis Banerjee, Principal
Bioforum India was hosted in two different cities Application Expert, APAC Bioprocessing, Merck
in India (6th September 2022 in Pune and 8th KGaA, Dr. Simone Biel, Senior Regulatory Consultant,
September 2022 in Ahmedabad) focusing on Next Merck KGaA etc.
Generation Bioprocessing for Process Intensification.
The technical session was followed by panel
While the benefits of next-generation discussion on Next generation bioprocessing with the
bioprocessing are clear, there are multiple pathways great insights from the experts. Networking session
to success and many options across a range of in booths were conducted by Merck showcasing the
disciplines must be considered. For some applications technologies of Next Generation Bioprocessing along
and biomanufacturers, the focus will be on improving with Bioprocessing Virtual booth.
unit operation’s interoperability, for others the goal
will be connected or fully continuous processing. We have witnessed more than 309 elites of
Together with our customers and regulators, we biopharmaceutical personals attending the session
strive to accelerate access to biopharmaceuticals for with great enthusiasm and We as Merck look forward
patients worldwide. to creating similar platform in the future too.

46 ACADEMICASNNEEWWSS BBIOIOSPSEPCECTRTRUUMM || OACUTOGBUESRT 20212 | www.biospectrumindia.com

SIRO Manipal’s American University
of Antigua to commence
Clinpharm Pre-Med programme

unveils Manipal’s American University of Antigua (AUA) will commence the
current batch of its two-year Pre-med programme on the campus of Manipal
Clinical Academy of Higher Education, Karnataka from October 10, 2022. American
University of Antigua (AUA) is fully owned by the Manipal Education &
Research Medical Group. Students aspiring to pursue a medical degree in the US can
now start their journey from India right after the completion of senior high
Institute school, on the Manipal campus. The selection process deems the senior high
school graduates from English medium instruction, with a score of 65 per
Mumbai-based SIRO cent and above in the mandatory subjects of physics, chemistry and biology
Clinpharm has launched eligible to apply for this programme. The Pre-Med to MD programme is a 6.5
SIRO Clinical Research years programme designed for high school graduates and non-traditional
Institute (SCRI) to students who are all set to pursue an international career in medicine. The
create CRO industry- students complete the first two years of the programme and then move
ready professionals. to the Manipal’s American University of Antigua, College of Medicine to
With this initiative, the complete the next 4.5 years: 2.5 years of pre-clinical sciences in the state-
goal of SIRO is to give of-the-art campus in Antigua, the remaining 2 years of clinical rotations
back to the industry by across the US, the UK and Canada.
revolutionising it with
hand-on training and SciGenom, CHARUSAT
creating professionals for University announce industry-
pharmaceutical companies oriented PhD programme
and global contract
research organisations, SciGenom Labs, a genomics of genomics, proteomics,
through cutting-edge company with facilities in India microbiome and bio-nanotech in
learning concepts, a (Cochin, Chennai, Hyderabad) collaboration with CHARUSAT
strong curriculum, real- and the US (San Francisco), has University (Charotar University
world case studies, and announced a unique industry- of Science and Technology),
soft skill development. based PhD programme to support Gujarat. This industry-academia
Currently, the institute is research in the disciplines collaboration will provide students
offering the Post Graduate with an opportunity to participate
Diploma in Clinical in research activities with multiple
Research to anyone international universities and
who has a graduate or scientists from independent
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in areas like Pharma, solutions to real-world problems
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48 SUPPLIERS NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

Cybernetik to set up National Forensic Sciences
University, Thermo Fisher
5th manufacturing unveil CoE for DNA forensics

unit in Raigad Thermo Fisher Scientific, in technical collaboration with
National Forensic Sciences University (NFSU), has set up the
Industrial automation firm Cybernetik Centre of Excellence (CoE) for DNA Forensics at the NFSU
will set up a new manufacturing plant campus in Gujarat. Thermo Fisher Scientific has equipped
in Vile Bhagad MIDC, near the Goa- the facility with its entire DNA workflow which includes
Mumbai highway. At a location spanning sophisticated systems for DNA extraction, real-time PCR
20 acres, the new plant will cover an instruments, DNA sequencers/ genetic analyzers, next-
area of 80,000 square metres. With generation sequencers and rapid DNA technologies along
120 personnel, it will increase the firm’s with consumables, software and validation services. The
production capacity by 15x. This will be centre has been created to facilitate training and education
the company’s fifth manufacturing unit, for the students of NFSU and across forensic labs, and for law
besides the four existing ones in Pune enforcement experts (police, judiciary).
and Nadiad. The company undertakes
the designing, building and installation of
end-to-end, turnkey automation systems
for pharmaceutical, chemical and other
manufacturing industries.

Agilent collaborates with METTLER TOLEDO
to reduce errors in sample preparation

Agilent Technologies often leads to costly quality and digitalised LC or GC
has collaborated with investigations or rework. The workflow designed to
METTLER TOLEDO solution from Agilent and eliminate common errors
to address error-prone METTLER TOLEDO, launched in the weighing process.
sample preparation. This in Munich at Analytica 2022 in The complete solution
integrated solution allows June, offers a fully automated automatically transfers
the automatic and seamless weighing results to the
transfer of weighing latest release of Sample
results and the associated Scheduler for Agilent
metadata from METTLER OpenLab CDS. Sample
TOLEDO LabX Balance Scheduler retrieves the
software to Agilent OpenLab sample and weight data from
software. Sample preparation is the METTLER TOLEDO LabX
a critical part of many laboratory software and allows users to
workflows. It is a time-consuming seamlessly route sample and
bottleneck and a frequent source weighing information to any
of errors and inaccuracies that instrument in the laboratory.

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com SUPPLIERS NEWS 49

BD India unveils rapid molecular technique
to detect MDR-TB, infectious diseases

BD Diagnostics, a segment of BD The molecular thereby supporting
Life Sciences, has introduced the test enhances clinicians in
BD MAX molecular diagnostic the information prompt and
system and the availability of available to direct accurate patient
the BD MAX MDR-TB panel in the optimal disease diagnoses.
India. The MAX MDR-TB panel treatment for The state-of-
is included in WHO guidelines patients and rules the-art BD MAX
and now clinicians can use the out the need for
test to simultaneously detect a separate test for System also
bacteria that cause tuberculosis isoniazid (INH) empowers
(TB) and determine if the bacteria detection. The BD laboratories to
contain mutations associated with MAX System is a fully automate their unique
resistance to two important first- integrated, automated platform internally developed
line drugs - Isoniazid (INH) and that performs nucleic acid molecular assays, while accessing
Rifampicin (RIF) respectively. extraction and real-time PCR a rich and growing menu of
world-class assays.

QIAGEN launches Intech Additive Solutions
unveils flow reactor system
syndromic test for pharma industry

for QIAstat-Dx Bengaluru-based Intech Additive Solutions, India’s leading
Metal 3D Printing Original Equipment Manufacturer
device to combat (OEM), has launched Flow Reactor System. This new
paradigm is becoming increasingly popular among
Monkeypox manufacturers for it is much more compact and safer than
conventional equipment. The underlying technology is
QIAGEN has launched the QIAstat-Dx revolutionising the industry by enabling manufacturers
Viral Vesicular Panel RUO, the first to develop, scale up and implement continuous Active
syndromic test to differentiate between
monkeypox and five other pathogens Pharmaceutical Ingredients (API)
which cause similar symptoms. The new manufacturing processes
panel – currently for research use only within shorter periods,
(RUO) – comes in cartridge form to run in smaller facilities, and
on QIAGEN’s QIAstat-Dx automated under safer conditions.
syndromic testing devices. It tests for the The principle of flow
two known forms of monkeypox virus chemistry aims to achieve
(the so-called West African and Congo process intensification
Basin clades), herpes simplex virus 1
(HSV1), HSV2, human herpesvirus 6 by performing chemical
(HH6), varicella-zoster virus (VZV) and reactions in a ‘continuous
enterovirus – pathogens that all produce flow reactor’ as opposed to
similar-looking vesicular lesions. The a traditional batch reactor. The
panel’s RUO-status means it currently benefits of adopting a flow reactor system are the reduction
can only be used for the surveillance in time, cost and energy consumption. Intech’s robust
– not screening or diagnosing – of process skids, meticulously integrated with a selection of
monkeypox cases. But QIAGEN is ready high-end components, are a manufacturing powerhouse.
to make applications for clinical use The 3D printed flow reactors at the heart of it can be
should authorities in the US and the customised for any unit depending on the volume, heat and
European Union open new diagnostic mass transfer efficiency, and operating conditions required
pathways in light of this public health for the chemical reaction.
emergency.

50 LET’S TALK HEALTH BIOSPECTRUM | OCTOBER 2022 | www.biospectrumindia.com

An Emergency to Address

In both developed and developing countries, Even in situations when the stroke victim cannot
people are suffering from hypertension in large reach the hospital during this golden hour, there are
numbers, which continues to be the leading other modalities to remove the blockage up to 6-8
risk factor for causing brain stroke. According to hours after the stroke, but the earlier the treatment
the World Stroke Organisation, each year, over 13 is given, the higher the chances of recovery.
million people will have a stroke and approximately
5.5 million people will die as a result. Two clot-dissolving drugs are currently
approved by the Drug Controller General of
With brain stroke being the second most India (DCGI) for stroke treatment: Recombinant
common cause of death after coronary artery Tissue Plasminogen Activator (rtPA) or alteplase
disease in India, it is surprising to know that many and Tenecteplase. The use of rtPA has been
do not even consider brain stroke as a cause of the standard of care for treatment of stroke for
concern. several years, while Tenecteplase is a type of tPA
of increasing interest for stroke treatment due
According to a recent survey conducted by to advantageous drug characteristics and ease of
Germany-based pharmaceutical firm Boehringer administration.
Ingelheim, on 4,742 respondents across 12 cities in
India, only 22 per cent were aware of brain stroke But the utilisation of these drugs can be
and its risk factors, with awareness level dropping to considered a success only if timely diagnosis and
a meagre 10 per cent with respect to stroke-related intervention happens. And what better way than
treatment options. technology to be adopted in this situation. For
instance, the application of artificial intelligence
The survey also revealed that brain stroke (AI) in the assessment of stroke risk can help
literacy on FAST (Facial drooping, Arm weakness, achieve favourable results. Studies have shown
Speech difficulties and Time) symptoms was that AI algorithms can be used for early diagnosis
uniformly low across geographies. Only 2 per of atrial fibrillation using normal sinus rhythm
cent of respondents from mini metros knew all electrocardiographs, which allows for early
symptoms of brain stroke compared to 12 per cent intervention to reduce stroke risk.
of respondents from the metros.
For patients with atrial fibrillation, scientists
Generally, a stroke in the brain occurs when across the world have applied machine learning
the supply of blood is interrupted due to blood to develop a classification model for predicting
vessel rupture or a blockage. If the blood vessel is short-term probabilities of stroke, which had better
blocked, it is called ischemic stroke (80 per cent) predictive properties than the traditional methods.
and if it is ruptured, it is called hemorrhagic stroke Technology can also further reduce the possibility
(20 per cent). In an ischemic stroke, the core of an of overlooking other conditions such as seizure,
irreversibly damaged area is frequently surrounded encephalitis, abscess, subdural hematoma and
by non-functional but not irreversibly damaged much more.
area, called the penumbra. To save the penumbra
and reduce the patients’ disability, the artery needs This year, World Stroke Day on October 29,
to be immediately opened. is calling the government and key companies to
join forces and act on the unmet need of creating
This period which is within 3 to 4.5 hours after an enhanced understanding of stroke symptoms,
the initial stroke symptoms is called Golden Hour risk factors, treatment options and preventative
in the treatment of stroke, because if treated during measures in the country.
this time, there is a very high chance of complete
recovery. Within this time, a clot buster injection Dr Manbeena Chawla
helps to dissolve the clot in the brain and helps the Executive Editor
brain to regain its blood supply in most of the cases.
[email protected]