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DRUG WAR INTENSIFIES

The pandemic has entered yet another phase, with the Omicron variant wreaking havoc across the globe. The high infection rate
of this new cause for concern, in India, has also triggered a ‘war of medical opinions’ between the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India (DCGI). Pharma majors are churning out viable treatment options at a feverish pace, in a bid to become the most widely accepted drug listed in COVID-19 treatment protocols. Merck’s Molnupiravir is one such drug that is embroiled in a ‘safety vs efficacy’ contest. Let’s investigate further

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Published by MMA Media, 2022-01-30 23:40:44

BioSpectrum India February 2022

DRUG WAR INTENSIFIES

The pandemic has entered yet another phase, with the Omicron variant wreaking havoc across the globe. The high infection rate
of this new cause for concern, in India, has also triggered a ‘war of medical opinions’ between the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India (DCGI). Pharma majors are churning out viable treatment options at a feverish pace, in a bid to become the most widely accepted drug listed in COVID-19 treatment protocols. Merck’s Molnupiravir is one such drug that is embroiled in a ‘safety vs efficacy’ contest. Let’s investigate further

Keywords: Pharma ,bioPharma ,healthcare

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

COVER STORY 20

DRUG
WAR
INTENSIFIES

The pandemic has entered yet another phase, with the Omicron COVER
variant wreaking havoc across the globe. The high infection rate DESIGN BY:
of this new cause for concern, in India, has also triggered a ‘war of DOMINIX STRATEGIC
medical opinions’ between the Indian Council of Medical Research DESIGN PVT. LTD.
(ICMR) and the Drugs Controller General of India (DCGI). Pharma
majors are churning out viable treatment options at a feverish pace,
in a bid to become the most widely accepted drug listed in COVID-19
treatment protocols. Merck’s Molnupiravir is one such drug that is
embroiled in a ‘safety vs efficacy’ contest. Let’s investigate further.

Anti-ageing Speaking With

24

Putting brakes on Ageing

26 28

The Business ‘Innovation in disruptive &
emerging tech is important to
of ‘Looking build new affordable products’
Dr Renu Swarup,
Good’ Soars
Former Secretary,
Dr Karishma Department of Biotechnology, New Delhi

Kagodu, 30

Cosmetic “Our oral semaglutide for
Surgeon, Founder diabetes treatment costs
& CEO, around Rs 10k/month”
Dr Karishma’s Vikrant Shrotriya,
Aesthetics
Corporate Vice President and
Managing Director, Novo Nordisk India

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

Speaking With Dr Sudhir P.
Srivastava,
31 Founder, SS
Innovations
“Stem Cell Science can talks about the
tackle numerous Untreatable unexplored disease/
Metabolic Diseases” therapeutic areas
Dr Anand Srivastava, where one can see
growth of robotic
Chairman and Co-Founder, surgeries/ machines
Global Institute of Stem Cell in the coming times.
Therapy and Research, USA
Scan the QR Code »
32
Prasanth
“We’re exploring AI, Madavana,
ML techniques for molecular Co-founder & CEO,
design & various predictions Fedo, Bengaluru
of drug candidates” unveils his
Dr Murali Ramachandra, startup’s mission
to reduce the out-
CEO, Aurigene Discovery Technologies Ltd of-pocket medical
expenses of
BioSpectrum Enzymes Ranking people.
36
Scan the QR Code »
Indian Industrial Biotechnology
(Enzymes) market hits Rs 2907Cr Dr Rajvi Mehta,
with 12% growth in 2020-21 Microbiologist
and Scientific
37 Consultant,
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Novozymes South Asia Pvt. Ltd tells us about
retains No 1 position in Indian Industrial how we can be
Biotechnology (Enzymes) Industry for 2020-21 more prepared for
future pandemic
Regulars outbreaks.

BioEdit .......................................................................... 06 Scan the QR Code »
BioMail ......................................................................... 08
Policy and Regulatory News..................................... 10
Finance News.............................................................. 12
Company News.......................................................... 13
Start-up News............................................................. 15
World News................................................................. 17
WHO News................................................................... 19
People News................................................................ 43
R&D News.................................................................... 45
Academics News........................................................ 47
Supplier News............................................................. 49
Let’s Talk Health.......................................................... 50

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

SInanfoevtyatRiveemPaipinssGPeanraemricount

As the Omicron variant sweeps the country, EUA, the USFDA made it clear that it must be
the number of cases has been increasing prescribed only when other authorised treatments are
every day, albeit with fewer hospitalisations inaccessible or not clinically appropriate.
than initially projected. In the wake of this rise, the
Indian Council of Medical Research (ICMR) has The USFDA statement makes it clear that the new
recommended that Merck’s new anti-viral drug pill must be prescribed only when other USFDA-
Molnupiravir not be used as it’s not been included in authorised treatments are inaccessible or not
the national COVID taskforce treatment citing several clinically appropriate. However, another expert feels
safety concerns. that its benefits outweigh the potential risk it may
have in high risk patients. They cite the approvals
Experts pointed out that there is rampant granted to it by drug regulatory authorities in
and irrational use of this drug. Its use should be different countries after going through safety data.
restricted as known and unknown harms outweigh
its claimed benefits. Its safety concerns are related Though the experts are divided over the issue, it
to teratogenicity, mutagenicity and bone damage. is not a good sign that two wings of the government
Even the NITI Aayog member (Health) has expressed – one involved in research and another in
concern over its misuse and overuse. regulation have different views on the same drug.
The regulator approved it but the researchers are
Warnings by NITI Aayog and ICMR are not warning against it.
unwarranted since during the second wave,
unchecked use of medicines was largely responsible These differences in opinion of the two wings are
for mucormycosis cases across India. Medical particularly detrimental when there are reports that
professionals and hospitals must exercise caution and the government is planning to amend New Drugs
use it only for those patients that might benefit. and Clinical Trials (ND&CT) Rules 2019 to allow
producing unapproved new drugs when they are
The Central Drugs Standard Control Organisation being developed, with certain conditions. The Drug
(CDSCO), India’s drug regulatory organisation Technical Advisory Board (DTAB) has recommended
had granted Molnupiravir an emergency use such an amendment. In such a situation both the
authorisation (EUA) in the last week of December wings of the government should have unified opinion,
2021 for restricted use in emergencies. The US resolving their differences internally. Regulator
Food and Drug Administration (USFDA) and UK’s approving the drug, allowing pharma companies to
Medicines and Healthcare products Regulatory produce it even when the clinical trials are on and
Agency (MHRA) have already approved it. Following accordingly, pharma companies producing it, but
CDCSO’s approval, Cipla planned to launch it here then the research wing not including it in its protocol
under the brand name Cipmolnu. Aurobindo Pharma can give rise to complex situations which must be
is another company that introduced Molnupiravir in avoided.
India under the brand name Molnaflu. It said that
it was for hospitalised adult patients under certain Such opposing views and opinions may baffle
conditions. Dr. Reddy’s Laboratories also announced the pharma producers, enough to affect their
that it would soon launch its generic version. In all 13 decision over producing the drug. It can also create
companies are in queue to manufacture the antiviral confusion in the minds of common people who may
oral drug. not exactly be privy to the responsibilities of the two
organisations.
Merck’s claim in Phase III trials that Molnupiravir
cuts the hospitalisation risk and deaths by half, The two organisations, not seeing eye to eye, must
indicated that it could become a game changer and not derail the treatment protocols for COVID-19 and
breakthrough drug. But experts were still divided put citizens in further jeopardy.
over its use. Even the USFDA approved it with
only a very narrow margin of 13 to 10. While giving Dr Milind Kokje
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8 BIO MAIL BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Vol 19; Issue 12; January 2022

Acknowledgements Thank you so much for the feature on Mylab BioSpectrum is synonymous with
Thank you for sharing the revenue Discovery Solutions in the new year edition. comprehensive analysis and knowledge
analysis of the BioSupplier sector in The Indian diagnostics industry witnessed for the healthcare sector. However, its
BioSpectrum. Glad to know we ranked healthy revenue growth in FY2021 with reach goes beyond the health ecosystem. It
second in this business. Thank you very COVID-19 related tests contributing to 20- is assuring to know the nation has reliable
much for giving us an opportunity to 25 per cent revenues, however, the revenues media like BioSpectrum, sharing the right
participate into this process. from other diagnostic modalities were information at the right time with us,
reduced for most players. especially in the times of pandemic.
- Dr Girish Mahajan, Mumbai
Thank you for the interaction with - Hasmukh Rawal, Pune - Vijender Singh, Mumbai
K Nandakumar, General Manager, TPP Techno Plastic Products India Thank you BioSpectrum for featuring
Honeywell India, for the cover story. sincerely thanks BioSpectrum for the Hester Biosciences as one of the
BioSupplier ranking article. companies in the Indian pharma
- Sangita Ghalay, New Delhi industry’s manufacturing and innovation
Thank you featuring the update on the - Dr Rajreddy Patil, Bengaluru ecosystem.
India AMR Innovation hub by C-CAMP. As the coronavirus pandemic continues
Please keep up your engagement with to wage on, people have very evidently - Rajiv Gandhi, Ahmedabad
C-CAMP for the future. started prioritising their health over other Corrigendum
things. The pandemic has taught many On page no 37, 38 of the January 2022
- Dr Debarshini Chakraborty, Bengaluru lessons to everyone including us in the issue of BioSpectrum, DSS Imagetech was
Looking forward to many more such healthcare industry. It was notable to see categorised as a Principal company in the
collaborations with NextGen Invitro all the opinions and expectations of the Top 20 BioSuppliers Companies 2021*
Diagnostics. Thank you for the cover industry experts through BioSpectrum’s table. Please read it is as a distributor
story piece. detailed analysis of the upcoming budget. company. The error is regretted.

- Ananya Sharma, Noida - Dinesh Chauhan, New Delhi - Editor

Vol 20; Issue 2; February 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.
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make proper enquires  Views expressed in advertisements in
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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

DCGI approves Biological E’s
protein sub-unit COVID-19 shot

Hyderabad-based Biological E has Biological E in collaboration with
announced that its CORBEVAX, Texas Children’s Hospital Center
India’s first indigenously developed for Vaccine Development (Texas
protein sub-unit vaccine against Children’s CVD) and Baylor College
COVID-19, has received the approval of Medicine (Baylor) in Houston,
from the Drugs Controller General Texas. Biological E plans to complete
of India (DGCI). CORBEVAX is production at a rate of 75 million
a “recombinant protein subunit” doses per month, anticipating 100+
vaccine, developed from the million doses per month from
receptor binding domain (RBD) February 2022. These capacities
of the spike protein on the virus’s will enable the Hyderabad-based
surface combined with Dynavax’s company to deliver 300 million doses
CpG 1018 adjuvant with alum, as promised to the Government
which helps the body build the of India. Soon, the company plans
immune response against the virus. to deliver more than one billion
The vaccine has been developed by additional doses globally.

AYUSH Ministry boosts National Oxygen
healthcare facilities in UP
with Rs 553.36 Cr investment Stewardship

The Ministry of AYUSH has announced a slew of major initiatives Programme
to push healthcare facilities in the state of Uttar Pradesh (UP).
A total amount of Rs 553.36 crore has been released by the opens in New Delhi
Government of India to Uttar Pradesh for various activities
under the National AYUSH Mission. In an effort towards Taking cognisance of the role of medical
building sustainable, effective and affordable healthcare in the oxygen as a life-saving public health
country, eight new 50 bedded integrated AYUSH hospitals have commodity and the need for capacity
been inaugurated. These are located in Deoria, Koushambi, building of healthcare workers in
Sonbhadra, Lucknow, Kanpur, Sant Kabir Nagar, Kanpur handling of medical oxygen, Dr Bharati
Dehat, and Lalitpur. These were built with a total capital outlay Pravin Pawar, Union Minister of State
of Rs 72 crore. A total of 500 new AYUSH Health & Wellness for Health and Family Welfare recently
Centres (HWCs) have also been inaugurated in different parts inaugurated the National Oxygen
of the state. Building upon this strong foundation of healthcare Stewardship Programme of the Union
for people, a foundation stone has been laid for a new AYUSH Health Ministry, at AIIMS, New Delhi.
Educational Institute for Ayurveda with a capital outlay Rs The initiative aims to empower all
49.83 crore. This new institute of Ayurveda will come up in healthcare workers engaged in oxygen
Ayodhya. Further, foundation stones have been laid for six new management and administration with
50 bedded hospitals which will come up in Unnao, Shrawasti, the essential knowledge and skills to
Hardoi, Gorakhpur, Sambhal and Mirzapur. ensure rational utilisation and avoid any
wastage of medical oxygen, especially
in resource constraint settings. It
envisages to identify and train at least
one “Oxygen Steward” in each district
across the country. These trained
professionals would be responsible for
leading the training on oxygen therapy
and management in their respective
districts and also support audit of
oxygen delivery and preparedness for a
surge scenario.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com POLICY AND REGULATORY NEWS 11

CSIR strengthens genomic Govt
surveillance of SARS-CoV-2 in India issues EUA
for Merck’s
Council of Scientific and Industrial As a co-lead of the Diagnostics COVID-19
Research (CSIR)-Institute of pill in India
Genomics and Integrative Biology Pillar of the Access to COVID-19
(IGIB), New Delhi has partnered Emergency Use
with the Foundation for Innovative Tools (ACT) Accelerator, FIND is Authorisation (EUA)
New Diagnostics (FIND), a global permission by the Drug
health non-profit based in Geneva, supporting India’s efforts towards Controller General of India
Switzerland, to aid India’s fight (DCGI) has been issued for
against COVID-19 by boosting the establishment of a robust the launch of Merck and
sequencing capacity across the Ridgeback’s Molnupiravir in
country. The partnership aims to genomic surveillance system. the country. DCGI, based on
decentralise genomic surveillance the review of clinical data of
of SARS-CoV-2, down to the district The partnership will provide Molnupiravir, has approved
level by setting up MicroLabs that the drug for the treatment
enable sequencing, analysis and strategic guidance to incorporate of COVID-19 in adults for
interpretation of sequencing data restricted emergency use
with minimal turnaround time next-generation sequencing in India. Cipla plans to
and infrastructure limited settings. launch Molnupiravir under
into broader national disease the brand name Cipmolnu,
while Torrent Pharma is
surveillance frameworks and introducing it under the
brand name Molnutor,
inform data analyses, management following DCGI’s approval.
Further, Sun Pharma will
and sharing based on global data be manufacturing and
marketing the drug under
policies and guidelines. It will the brand name Molxvir.
Earlier in 2021, Cipla,
provide a platform for knowledge- Torrent Pharma, Sun
Pharma and a few others
sharing and lessons learnt to had entered into a non-
exclusive voluntary licensing
inform national capacity-building agreement with Merck
Sharpe Dohme (MSD) to
efforts and policy guidance. manufacture and supply
Molnupiravir in India and
PM inaugurates second to over 100 low and middle-
campus of CNCI in Kolkata income countries (LMICs).

Prime Minister Narendra Modi edge infrastructure for cancer
has inaugurated the second diagnosis, staging, treatment and
campus of Chittaranjan National care. The campus is equipped
Cancer Institute (CNCI) in with modern facilities like Nuclear
Kolkata. The second campus of Medicine (PET), 3.0 Tesla MRI,
CNCI has been built at a cost 128 slice CT scanner, Radionuclide
of over Rs 540 crore, out of therapy unit, endoscopy suite,
which around Rs 400 crore have modern brachytherapy units etc.
been provided by the Union The campus will also work as an
government and the rest by the advanced cancer research facility
West Bengal government, in the and will provide comprehensive
ratio of 75:25. The campus is care to cancer patients especially
a 460-bedded comprehensive those from Eastern and North-
cancer centre unit with cutting Eastern parts of the country.

12 FINANCE NEWS BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Piramal Karkinos Healthcare raises
funds from Endiya Partners
Pharma invests
Oncology focused, managed healthcare platform Karkinos Healthcare
Rs 101.77 Cr has raised an undisclosed amount of funding from Endiya Partners,
one of India’s leading VC Funds in Technology, Healthcare and
in CDMO Lifesciences. The company is currently backed by Tata Group,
Reliance Digital Health and Rakuten Medical, along with a number
Yapan Bio
of eminent industrialists such as
Piramal Pharma Ltd (PPL) has Ratan Tata and Venu Srinivasan.
announced an investment of Karkinos Healthcare is pioneering
Rs 101.77 crore in Hyderabad- the Distributed Cancer Care
based Yapan Bio, augmenting Network model in India,
the capabilities of its addressing clinical needs that will
Contract Development and bring quality care closer to cancer
Manufacturing Organisation patients. According to reports
(CDMO) business, Piramal published by the World Health
Pharma Solutions (PPS). PPL Organisation (WHO), one in every
holds a 27.78 per cent equity ten Indians is estimated to get cancer during their lifetime. Over 70
stake in the company as a per cent of cancer cases in India are detected late, leading to poor
result of this investment. As health outcomes and survival rates. Founded by a highly experienced
PPS continues to strengthen team, Karkinos Healthcare started its operations in Kerala, and is
its capabilities and position looking to expand to Tamil Nadu, Maharashtra, Karnataka and West
itself as a leading CDMO, this Bengal. The company works with multiple healthcare institutions and
acquisition marks a significant professionals in the oncology ecosystem, successfully bringing cancer
addition to PPS’ global care closer to patients backed by a robust technology platform. It has
capabilities in the development also set up a Centre for Advanced Cancer Diagnostics in Kochi, to
and manufacturing of large provide world-class diagnostic services, including molecular tests and
molecules for human clinical immunohistochemistry tests, for cancer.
trials. Yapan Bio provides
process development, scale- Serum Institute injects
up, and cGMP compliant £50 M in ‘Vaccines Research
manufacturing of vaccines and Building’ at Oxford University
biologics/bio-therapeutics,
including high containment Oxford University has support facilities for scientific
product classes (up to BSL-2+), announced a £50 million research and academic
recombinant vaccines, RNA/ funding commitment from teaching and together will
DNA vaccines, gene therapies, Serum Life Sciences to establish form a unique hub that will
monoclonal antibodies, The Poonawalla Vaccines significantly contribute to global
therapeutic proteins, and other Research Building at the pandemic preparedness and
complex biologics. Yapan’s FY21 University of Oxford. Serum responsiveness. The main focus
turnover was Rs 12.4 crore. The Life Sciences is wholly-owned of the research taking place
company has already earned by the Poonawalla family, in the Poonawalla Building
revenues of Rs 11.8 crore for owners of the Serum Institute will be vaccinology. This new
H1FY22 and is poised for fast of India. The Poonawalla facility will house over 300
growth in response to strong Vaccines Research Building research scientists and itself will
market demand. will be built on the same site as provide the focus and scale for
the recently announced Oxford the University’s major vaccine
University Pandemic Sciences development programmes
Centre, on the University’s Old allowing a rapid, productive and
Road Campus. The buildings timely expansion of this fast-
will share infrastructure and growing translational area.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com COMPANY NEWS 13

‘Intuitive Telepresence’ makes remote
surgical case observation reality

Intuitive India has launched of working since the spread
of COVID-19, Intuitive has,
India’s first remote surgical with the ITP, reimagined
continuous learning for
case observation technology, surgeons by providing this
seamless and secure platform
‘Intuitive Telepresence’ to help bring learning to
the surgeons rather than
(ITP). The technology asking them to always
travel for advanced training.
enables surgeons to learn Intuitive has been running
programmes such as the Intuitive
from expert surgeons Robotic Onboarding Programme
and Education (I-ROPE) and the
without the need for travel Roving Robot Programme in a
continued effort to support strong
or time away from their robotics programmes throughout
India.
busy practice. The ITP uses

proprietary technology that

enables the real-time exchange being performed. ITP technology
is HIPPA (The Health Insurance
of audio and video between the Portability and Accountability Act)
compliant which provides a secure
remote observer and the operating platform for remote learning on da
Vinci Robotic platform. With the
surgeon. Through this, observers increased adoption of virtual ways

can be virtually present in the

operating room (OR) where a

procedure with a da Vinci system is

Bharat Serums and Vaccines Translumina to set up
opens R&D centre in Airoli
Asia’s largest heart
Bharat Serums and Vaccines (BSV) has opened a
world class R&D centre at Airoli, Maharashtra. The valve manufacturing
state-of-art centre was inaugurated by Rajesh Tope,
Maharashtra’s Health Minister. The R&D centre will facility at AMTZ Vizag
endeavor to bring scientifically advanced biological,
biotechnology products and novel drug delivery Translumina, based in India and Germany,
systems that deliver better patient outcomes in has recently performed the foundation stone
Women’s Health, Assisted Reproductive Technology laying ceremony of Asia’s Largest Heart Valve
manufacturing facility at Andhra Pradesh
and Critical Care & Medtech Zone (AMTZ) in Vizag. The company
Emergency Medicines. plans to complete the facility
The scientists at BSV have by December 2022 with
been working tirelessly more than 100,000 square
towards developing feet of manufacturing
Liposomal Amphotericin B space with state-of-
for battling Mucormycosis the-art equipment and
(Black Fungus) during the infrastructure. Heart valve
second wave of COVID-19 disorders which traditionally
and the company was able were treated by an open-
to manufacture close to heart Surgery, are prevalent
24,00,000 vials annualised significantly worldwide. However, in the last few
capacity, at its world-class manufacturing facility at years, Transcatheter Heart valve Implantation
Ambernath to support Maharashtra and rest of India, (using a catheter without opening the heart) has
in the fight against Black Fungus. BSV’s ongoing made the procedure simple, safe and effective
COVID-19 Antibody development Phase 1 trial also with a minimally invasive approach. However,
demonstrates its commitment towards delivering the prohibitive cost of the transcatheter valves,
probable solutions that can have a positive impact in along with niche indications, have made therapy
combating the disease. limited to very few patients.

14 COMPANY NEWS BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Piramal Pharma Solutions expands
in-vitro biology capabilities at Ahmedabad

Piramal Pharma Limited’s primary and secondary screening site. The benefits of this new
Pharma Solutions (PPS) capabilities of compounds investment will be seen in an
business, a leading Contract prepared at the Ahmedabad improved experience for PPS
Research, Development and discovery services customers.
Manufacturing Organisation With integrated chemistry and
(CDMO), has made a multi- biology services now available
million dollar investment to from a single site, we anticipate
create a world-class high- significant improvements to
throughput screening facility drug discovery cycle times.
that will augment the existing In addition, new personnel
in-vitro biology capabilities at with experience in biology
its drug discovery services site in services are being added to the
Ahmedabad. This new expansion, site team, complementing the
which is expected to go live in Q3 existing technical and operational
2022, will significantly add to the expertise.

Novavax’ Alkem Labs uses
4D bioprinting for diabetic
COVID-19 vaccine foot ulcer management

bags EUA in India Mumbai-based Alkem Laboratories has announced plans
to launch a unique patented technology for the treatment of
Serum Institute of India (SII) and US- Diabetic Foot Ulcer (DFU). The solution would be based on
based Novavax, Inc. have received disruptive 4D Bioprinting technology, which would be used
emergency use authorisation (EUA) to treat deep, non-healing chronic wounds and is expected
for Novavax’ recombinant nanoparticle to be launched in the Indian market in the latter half of 2022
protein-based COVID-19 vaccine post regulatory approval. This advanced technology for DFU
with Matrix-M adjuvant by the Drugs management has a high scope of preventing amputations in
Controller General of India (DCGI). diabetic patients. This technology will be available at affordable
rates to Indian patients at a time when there is no definitive
The vaccine will be treatment for DFU in India. Approximately, 12-15 per cent with
manufactured and diabetes suffer from DFU at least once in a lifetime. 5–24 per
marketed in India by SII cent of them will finally lead to limb amputation within 6–18
under the brand name months after the first evaluation. Alkem has collaborated with
COVOVAX. Novavax’ South Korea-based Rokit Healthcare Inc. to commercialise the
COVID-19 vaccine is technology in India to help reduce amputation amongst DFU
packaged as a ready-to- patients considering the negative impact of amputation on a
use liquid formulation patient’s quality of life and the associated economic burden on
in a vial containing ten the healthcare system.
doses. The vaccination
regimen calls for two
0.5 ml doses (5 microgram antigen
and 50 microgram Matrix-M adjuvant)
given intramuscularly 21 days apart.
The vaccine is stored at 2° to 8° Celsius,
enabling the use of existing vaccine
supply and cold chain channels. The
vaccine recently received Emergency Use
Listing (EUL) with the World Health
Organisation (WHO), EUA in Indonesia
and the Philippines.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com START UP NEWS 15

BlueSemi launches non-invasive ‘Even’ launches
consumer healthcare gadget EYVA in Bengaluru

BlueSemi has launched its providing daily insights to Even, a healthtech company
revolutionary product EYVA, a enable users to make better and healthcare provider that
non-invasive consumer health health and lifestyle decisions partners directly with top
tech gadget that is backed regarding fitness, nutrition hospitals to provide completely
by an innovative patented and stress management. Users cashless, quality healthcare
technology leveraging sensor can also avail a variety of paid to its members, has opened
fusion, accurate AI algorithms, plans that will allow them to the public in Bengaluru.
and smart IoT. The holistic access to advanced insights and Anyone who signs up and
health-tech device can accurately becomes a member can avail
measure six key body vitals- suggestions for changes in unlimited doctor consultations
blood glucose, ECG, heart diet and exercise. and diagnostics plus a yearly
rate, blood pressure, EYVA is hospitalisation cover of Rs 50
SPo2, and expected lakh. An Even member would
temperature. to become not have to pay anything at
With simple available to the hospital and at the end,
touch and BlueSemi’s their hospital bill will be Rs 0.
without go-to-market Memberships start at Rs 1500
the hassle a month. The product launch
of pricks and partners by March closely follows Even’s recent
blood, this gadget enables 2022. After the initially partnership with leading
users to know their health limited availability, the hospital chains in Bengaluru
status in merely 60 seconds. Hyderabad-based startup plans that include Narayana Health,
Priced at Rs 15,490, the gadget to make the device available to Fortis Hospitals, and Aster DM
comes with a free mobile app all consumers across multiple Healthcare. Even has received
e-commerce platforms by mid- a positive and encouraging
2022. response from over 40,000
waitlisted users who had early
SBI Foundation, Social access to its services. After
Alpha support assistive the launch in their home base
technology startups of Bengaluru, the company is
now gearing up to launch in
SBI Foundation and Social Alpha have jointly announced the launch of multiple Tier 1 cities including
the challenge, Techtonic: Innovations in Assistive Technology, inviting Delhi, Chennai and Mumbai.
innovators and entrepreneurs working on products and services that The startup plans to rid India
address the difficulties faced by people with disabilities and enable them to of out of pocket healthcare
lead an empowered life. The challenge expenses and mitigate illnesses
is structured to support early- early on with appropriate
stage assistive technology startups medical interventions with its
to accelerate their lab to market partner hospitals.
journey through comprehensive
support that includes access to Rs
15 lakh for ideating, prototyping,
and growth; access to R&D labs
for prototyping and infrastructure
for scaled-up manufacturing; and
access to mentors, incubation
facilities, industry players and end-users for product testing and
business model validation. The challenge focuses on the following areas:
Visual Impairment, Developmental Disorders & Chronic Neurological
Conditions, Locomotor Disabilities, and Speech & Hearing Disabilities.

16 START UP NEWS BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

DBT-backed InnAccel and Niramai get global recognition

Niramai Health Analytix and radiation-free, and painless
cancer screening tool with no
InnAccel Technologies, two known side effects. On the other
hand, InnAccel Technologies was
Bengaluru-based startups adjudged a winner of the Global
Women’s Health Tech Awards
supported by DBT-BIRAC, have for Fetal Lite, a next-generation,
AI-powered fetal heart rate
received the World Bank Group (FHR) monitor based on fetal
ECG signal extraction technology
and the Consumer Technology for mothers in labour or post 37
weeks of gestation. Fetal Lite has
Association’s Global Women’s next-gen ECG signal processing
and is more accurate, reliable, and
Health Tech Awards, which easier to use than the conventional
Doppler-based devices while being
recognises innovative startups that comfortable for the mother.

leverage tech to improve women’s

health and safety in emerging

markets. Niramai was selected

for its novel software-based

medical device that detects early- addressing a critical unmet need
in cancer screening. The solution
stage breast cancer in a simple developed is a low cost, accurate,
automated, portable, contactless,
and private way on women of all

age groups and breast densities,

IIM Bangalore selects Virohan opens
7 health startups for
incubation programme 10 new centres

Nadathur Sarangapani Raghavan Centre for Gurugram-based Virohan, an edtech startup in
Entrepreneurial Learning (NSRCEL), the startup healthcare, providing training for paramedical
hub at the Indian Institute of Management (IIM) professionals, has announced launching 10 centres
Bangalore, has selected seven early-stage healthcare across the states of Karnataka, Maharashtra and
startups for its final stage of the Incubation Gujarat in the country. The campus launch supports
Programme for Healthcare Startups, which are the startup’s PAN-India expansion plans and
currently undergoing a nine-month incubation aggregates the healthcare workforce in the country
programme. The programme is designed to support by providing aspiring AHPs with industry-relevant
MVP to commercialisation stage ventures that have education and preparing them for unprecedented
the potential to increase access and affordability challenges. The startup has launched four centres
of healthcare in India. The selected startups are in Karnataka and Tamil Nadu in Electronic city and
MedPiper Technologies, Dial4242 Ambulance Peenya in Bengaluru, and Trichy and Tellicherry
Services, Dockare, Daffodil Health, Onward in partnership with Nettur Technical Training
Assist, MayaMD and NeuroLeap. The structured Foundation (NTTF). Three centres are launched
incubation programme provides support to in Gujarat and Mumbai each; Gujarat centres in
healthcare innovators and entrepreneurs through Ahmedabad, Surat and Vadodara are launched
their ‘lab to market’ journey. With the NSRCEL in partnership with the International Institute
healthcare incubation programme, both clinicians of Import and Export Management (IIIEM) and
and hospitals can engage with startups and mentor Mumbai centres in Thane, Virar and Dahisar in
and monitor the progress of those startups which partnership with Rustomjee Academy for Global
can contribute to their strategic objectives. Careers. With centres across Delhi, Haryana,
Chattisgarh and Maharashtra and now Karnataka,
Gujarat and Mumbai, Virohan has plans to expand
to 160 centres across pan- India by 2022.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com WORLD NEWS 17

US donates 8.2L Japan, UNHCR
additional Pfizer-BioNtech support access
vaccines to Sri Lanka to healthcare
for Rohingya,
The United States has delivered an additional 820,000 Pfizer- Bangladesh
BioNTech vaccine doses to the Ministry of Health in Sri Lanka,
increasing the total US donation to 3.4 million jabs. So far, the The United Nations High
United States has successfully donated and delivered over 300 Commissioner for Refugees
million COVID-19 vaccines to more than 100 countries, including (UNHCR), the UN Refugee
Agency, has signed an agreement
Sri Lanka. The unprecedented scale, with the Government of Japan
speed, and complexity of this global for provision of $4.4 million to
vaccination effort have provided safe and improve access to healthcare
effective jabs in arms around the world, for Rohingya refugees and their
saving lives and protecting communities. Bangladeshi host communities in
These donations are part of the Biden Cox’s Bazar District, Bangladesh.
Administration’s global effort to end The three-year-project will
the COVID-19 pandemic, mitigate its support the construction of new
devastating social and economic impacts, in-patient facilities in Ukhiya
and build back a world that is better Specialised Hospital to facilitate
prepared for future outbreaks. In Sri access to specialised care,
Lanka, the United States has worked closely with the government to same-day surgeries and other
respond to the pandemic. To date, the US has provided over $17.9 services scarcely available in the
million in emergency supplies and critical services to Sri Lanka. This District, including assistance to
assistance has reached millions of people in Sri Lanka to control the mental health and psychosocial
spread of COVID-19, address urgent health needs, and mitigate the support. It will also support the
pandemic’s negative economic impacts. renovation and maintenance
of 39 healthcare and nutrition
Maldives to conduct evaluation facilities in the Rohingya refugee
of COVID-19 and HPV vaccination camps and allow for the provision
of critical medical supplies,
A brief meeting to mark full (or classic) PIE done for equipment and medicines to
the start of Maldives Joint COVID-19 vaccine globally, both refugees and Bangladeshis.
COVID-19 and Human although some countries have The project will be implemented
papillomavirus vaccine done mini-PIEs which are desk in close collaboration with the
(HPV) post-introduction reviews. The international Government of Bangladesh,
evaluation was recently held. and local teams will visit 7 including the Ministry of Health
Post-introduction evaluation atolls and visit health facilities, and Family Welfare and the
(PIE) is an exercise carried schools and meet community Office of Refugee Relief and
out after introduction of a members as well as visit Repatriation Commissioner,
new vaccine. In Maldives, selected resorts from the atolls. under the Ministry of Disaster
HPV vaccine was introduced The objective of PIE is to assess Management and Relief.
in 2019 and COVID-19
vaccination was started what went well during
in Feb 2021. This PIE the vaccine introduction
is conducted to review and roll-out as well as
the implementation of
COVID-19 vaccine what can be improved.
and HPV vaccine The final outcome will
in Maldives. be recommendations
This is the
first from the team to
strengthen the
vaccination
programmes.

18 WORLD NEWS BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Oxford Pfizer receives EUA of
booster shot for 12-15 age group
University
Pfizer Inc. and BioNTech SE have announced that the US Food and Drug
develops Administration (FDA) has expanded the Emergency Use Authorisation
(EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to
blood test include individuals 12 years of age and
older. The booster dose is the same dosage
to detect strength (30-µg) as the dose approved
in the primary series. A booster dose of
cancer and the Pfizer-BioNTech COVID-19 Vaccine
was previously authorised by the FDA
metastasis for emergency use after completion of a
primary series in individuals 16 years of age
A University of Oxford and older. The vaccine is also authorised
study outlines a new type for eligible individuals 18 and older who
of blood test that can be have completed primary vaccination with
used to detect a range a different authorised COVID-19 vaccine.
of cancers and whether Pfizer and BioNTech have delivered 1
these cancers have spread billion doses of the Pfizer-BioNTech COVID-19 Vaccine to low- and
(metastasised) in the body. middle-income countries. The companies expect to deliver an additional
The study analysed samples 1 billion doses to these nations in 2022.
from 300 patients with
non-specific but concerning FIND invests $21M to develop
symptoms of cancer, such affordable, multi-pathogen
as fatigue and weight loss, diagnostic platforms
who were recruited through
the Oxfordshire Suspected Switzerland-based FIND, the global alliance for diagnostics, has
CANcer (SCAN) pathway. The announced an investment of $21 million to accelerate the development,
researchers assessed whether manufacturing, and launch of affordable, multi-pathogen, molecular
the test could distinguish diagnostic platforms, specifically for use in decentralised settings in low-
patients with a range of solid and middle-income countries (LMICs). Following an open call for partners
tumours from those without
cancer. Their results show that and a competitive selection
cancer was correctly detected process, four companies with
in 19 out of every 20 patients promising new platforms have
with cancer using this test. In been selected for investment:
those with cancer, metastatic Biomeme, Inc (USA), Bioneer
disease was identified with Corporation (Republic of
an overall accuracy of 94 Korea), Qlife Holding AB
per cent. These results make (Sweden) and SD Biosensor,
this the first technology to Inc (Republic of Korea). The
be able to determine the investment is funded by the
metastatic status of a cancer German Federal Ministry
from a simple blood test, of Education and Research
without prior knowledge of (BMBF) through KfW and
the primary cancer type. This other donors, by way of grants
test shows promise to help to FIND. It will support the companies for a period of 12 months to develop
clinicians detect cancer and assays for the differential diagnosis of COVID-19 and other respiratory
assess cancer stage in the pathogens (such as influenza) and to optimise their systems to meet the
future. Future studies with needs of LMICs, in addition to the requirements for authorisation under
larger patient cohorts will the World Health Organization (WHO) emergency use listing (EUL)
further evaluate this technique and/or prequalification process (PQ).
for the earlier detection of
new cancers and potential
clinical applications.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com WHO NEWS 19

Increase vaccination campaigns in LICs:WHO

The heads of the International per cent of the populations in to COVID-19 Vaccines Global
Monetary Fund, World all countries by mid-2022. The Access (COVAX) and the
Bank Group, World Health emergence of the Omicron variant African Vaccine Acquisition
Organisation (WHO) and underscores the vital need for fair Trust (AVAT), encouraging
World Trade Organization and broad access to vaccines as LICs and LMICs to purchase
recently held high-level well as testing, sequencing, and additional vaccine doses, and
consultations with Gavi and treatments to end the pandemic. enhancing country readiness to
UNICEF, aimed at increasing Addressing vaccine inequity, deploy vaccines. Furthermore,
the use of COVID-19 vaccines particularly in LICs, requires to facilitate trade flows to
and other critical medical increasing the supplies of vaccines support the manufacturing
countermeasures in low-income and distribution of vaccines
(LIC) and lower middle-income and other COVID tools, export
(LMIC) countries and supporting restrictions must be rolled back
countries to be better prepared, and trade-facilitation measures
resourced, and ready to roll out must be put in place. Fully
vaccines. The experts agreed to funding the ACT-A Accelerator’s
work with countries to support Financing Framework would play
and strengthen their national an important role in narrowing
vaccination goals consistent with these gaps and reaching the global
the global target to vaccinate 70 target.

Convalescent plasma off WHO to strengthen
treatment protocol for non-
severe COVID-19 patients pandemic

The World Health Organisation (WHO) has updated its prevention and
living guideline on COVID-19 therapeutics to include
convalescent plasma. For non-severe COVID-19 patients, preparedness
WHO recommends against its use, while it should only be
used within clinical trials for In a consensus decision aimed at protecting
severe and critical COVID-19 the world from future infectious diseases
patients. Convalescent crises, the World Health Assembly has
plasma is a transfusion of agreed to kickstart a global process to draft
blood plasma from someone and negotiate a convention, agreement
who has recovered from or other international instrument under
COVID-19. Current evidence the Constitution of the World Health
shows that convalescent Organisation to strengthen pandemic
plasma does not improve prevention, preparedness and response.
survival or reduce the need for The decision by the Assembly establishes
mechanical ventilation, while an intergovernmental negotiating
it has significant costs. An body (INB) to draft and negotiate a
independent panel of experts, WHO convention, agreement, or other
the guidelines development international instrument on pandemic
group, looked at pooled data from 16 randomised prevention, preparedness and response.
controlled trials, including 16236 patients with non-severe, The INB will hold its first meeting by March
severe, and critical COVID-19 infection. While the evidence 1, 2022 (to agree on ways of working and
that convalescent plasma has no benefit in non-severe timelines) and its second by August 1, 2022
patients was certain, it was less so in the case of severe and (to discuss progress on a working draft). It
critically ill patients. So, randomised clinical trials for these will also hold public hearings to inform its
subgroups should continue. deliberations; deliver a progress report to
the 76th World Health Assembly in 2023;
and submit its outcome for consideration by
the 77th World Health Assembly in 2024.

20 COVER STORY BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

DRUG
WAR
INTENSIFIES

The pandemic has entered yet another phase, with the Omicron variant wreaking havoc
across the globe. The high infection rate of this new cause for concern, in India, has also
triggered a ‘war of medical opinions’ between the Indian Council of Medical Research
(ICMR) and the Drugs Controller General of India (DCGI). Pharma majors are churning out
viable treatment options at a feverish pace, in a bid to become the most widely accepted
drug listed in COVID-19 treatment protocols. Merck’s Molnupiravir is one such drug that is
embroiled in a ‘safety vs efficacy’ contest. Let’s investigate further.

Molnupiravir, the oral antiviral drug a game-changer in COVID-19 treatment. Even the
developed by Merck and its partner Drugs Controller General of India (DCGI) granted
Ridgeback Biotherapeutics, that received permission for restricted use of molnupiravir for
DCGI approval for the treatment of mild to treatment of adult patients with SpO2 93 per cent,
moderate COVID-19 in India, is being opposed by and who have a high risk of progression of the
the Indian Council of Medical Research (ICMR) due disease.
to safety concerns. Priced at Rs 1,399 for the full
five-day course, the drug is claimed to be one of the However, ICMR has come up with a word of
cheapest antiviral coronavirus therapies during the caution and has flagged certain side effects. The
pandemic. A repurposed COVID-19 drug, originally question remains - are these drugs required for
developed to treat influenza, it is meant for mild or the Indian market when on the one hand a sizable
moderately ill COVID-19 patients who are at risk of population has been vaccinated while on the other,
developing a serious illness. The pill, if administered the new variants are losing steam, according to the
during the first five days after contracting the latest trends.
infection, has the potential to prevent serious
illnesses. The ICMR gave a thumbs down to Merck’s
Molnupiravir, the antiviral drug that received
A host of pharma companies including Hetero, approval for emergency use by the DCGI. Prof.
Sun Pharma, Natco and Dr. Reddy’s Laboratories Balram Bhargava, ICMR Director General, has been
have rolled out the oral therapy. Approved by the voicing safety concerns of Molnupiravir. The drug,
UK’s drug regulator and recently by the US Food and according to Dr Bhargava, could trigger abnormalities
Drug Administration, the pills are projected to be in foetus development apart from other side effects
such as damage to muscles and cartilages.

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

COMPANIES BRINGING MOLNUPIRAVIR

Name of Company Brand
Mankind Pharma, New Delhi
Molulife
and BDR Pharma, Mumbai
Sun Pharma, Mumbai Molxvir
Lupin, Mumbai Molnulup
Brinton Pharmaceutical, Pune Molviton
Aurobindo Pharma, Hyderabad Molnaflu
Dr. Reddy’s Laboratories, Hyderabad Molflu
Cipla, Mumbai Cipmolnu
Hetero, Hyderabad Movfor
Torrent, Ahmedabad Molnutor
JB Chemicals and
Molunamax
Pharmaceuticals, Mumbai
ENTOD Pharmaceuticals, Mumbai Molentod
MSN Group, Hyderabad Molulow
Emcure Pharmaceuticals, Pune Lizuvira
Natco Pharma, Hyderabad Molnunat

All for the drug according to him, should be administered as soon
as possible after a diagnosis of COVID-19 has been
Leading health experts treating coronavirus made within five days of symptom onset.
patients across the country believe that the
COVID antiviral drug molnupiravir is reducing Dr S K Jindal, Medical Director and Sr Consultant
hospitalisation by 30-50 per cent, as well as the Pulmonology at Jindal Clinics Chandigarh; Former
severity of the disease. Countering what Dr Bhargava HOD, Pulmonology Medicine, PGIMER, Chandigarh
said, some sections of the experts said the benefits of opines, “Side-effects of mutagenicity does not matter,
the drug outweigh potential risks. if the drug is indicated for certain patient profiles, for
a treatment course of five days.
According to Dr Deepak Talwar, Senior
Consultant & Chairman, Metro Respiratory Centre, As new variants of the virus continue to
Pulmonology & Sleep Medicine, physicians have to emerge, it is crucial to expand the country’s
keep in mind the patient profiles while prescribing arsenal of COVID-19 therapies using emergency
any drug. He says, “We have to use the available use authorisation, while continuing to generate
therapy rather than counting its side-effects, that too additional data on their safety and effectiveness.
which are potential, but not known.” According to Patrizia Cavazzoni, Director of the
FDA’s Centre for Drug Evaluation and Research,
Agreeing with Dr Talwar, Dr Dhruva Chaudhry, Molnupiravir is restricted to situations where other
President-Elect ISCCM, Editor in Chief, Critical Care FDA-authorised treatments for COVID-19 are
Communications, a Nodal Officer for COVID-19 inaccessible or aren’t clinically appropriate and will
at PGIMS Rohtak and Head of the Pulmonary and be a useful treatment option for some patients with
Critical Care Medicine opines, “While approving, the COVID-19 at high risk of hospitalisation or death.
FDA, as well as DCGI, have gone through the safety
data of the drug. Only once satisfied this drug has Biophore India Pharmaceuticals has developed
been approved. Even in the phase-3 clinical trials and started manufacturing the key intermediates
Molnupiravir, which demonstrated a significant of Nirmatrelvir, one of the active ingredients of
reduction in the risk of hospitalisation or death with Paxlovid, the latest anti-COVID therapy, approved
no observed safety concerns when compared to the by the US FDA through the emergency use
placebo group.” authorisation route. The manufacturing is being done
in collaboration with Rakshit Group. This is expected
Dr Vasant Nagvekar, an infectious diseases to greatly reduce the dependence on imports,
consultant at Lilavati Hospital and member of the mainly from China, from where these intermediates
COVID task force, has prescribed it to 30 patients are being procured currently. Biophore is also
since its availability in the market. Molnupiravir,

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

‘‘We have to use the available ‘‘There would be a
therapy rather than counting its demand for these drugs

side-effects, that too which are as no other drugs in
potential, but not known.’’ the antiviral group are
- Dr Deepak Talwar, approved for COVID-19

Senior Consultant & Chairman treatment.’’
- Metro Respiratory Centre, - Akshay Daftary,
Director, SIRO Clinpharm
Pulmonology & Sleep Medicine
manufacturing Nirmatrelvir in a US FDA compliant
‘‘While approving, the FDA, as facility and has announced that they will be filing for
well as the DCGI, have gone approval with DCGI soon.

through the safety data of the Paxlovid’s breakthrough approval was given by
drug. Only once satisfied this the US FDA in December 2021 and is indicated for
the treatment of mild-to-moderate COVID-19 in
drug has been approved.’’ adults and paediatric patients.
- Dr Dhruva Chaudhry,
President-Elect ISCCM, Dr Jagadeesh Babu Rangisetty, CEO, Biophore,
says, “The development and manufacturing of
Editor in Chief, Critical Care these intermediates is extremely complex and is
Communications, a Nodal Officer significantly more challenging than earlier antivirals
that have been indicated for COVID.”
for COVID-19, PGIMS Rohtak
Natco Pharma has signed a non-exclusive license
‘‘Molnupiravir is restricted to agreement with the Medicines Patent Pool (MPP),
situations where other FDA- Switzerland to manufacture and sell Molnupiravir
capsules 200 mg for treatment of COVID-19. MPP
authorised treatments for had taken a licence from Merck Sharp & Dohme
COVID-19 are inaccessible or Corp (MSD), USA for the same, the company said in
aren’t clinically appropriate and a statement. Natco said with this licence agreement
will be a useful treatment option it can manufacture and sell Molnupiravir capsules
200 mg for the Indian market, which will be sold
for some patients.’’ under brand name MOLNUNAT for treatment of
- Patrizia Cavazzoni, COVID-19 infection in patients who have high risk of
Director of the FDA’s Centre for progression of the disease including hospitalisation
Drug Evaluation and Research or death.

Side-effects of mutagenicity In another development, Central Drug
does not matter if the drug is Research Institute (CDRI) scientists in Lucknow
indicated for certain patient are in the process of developing a drug for COVID
treatment without any side-effects. A team led by
profiles. chief scientist Ravi Shankar, is working on two
- Dr SK Jindal, combinations to provide the safest medication to
Medical Director and coronavirus patients. Scientists are working on two
Sr Consultant Pulmonology at combinations - Umifenovir with Molnupiravir (an
Jindal Clinics Chandigarh; Former antiviral) and Umifenovir with Niclosamide (anti-
HOD, Pulmonology Medicine, parasitic). A safe and efficacious combination of
PGIMER, Chandigarh Umifenovir with Niclosamide is being researched
for the exact dosage in the combination that can give
‘‘The present set of antivirals positive results.
will not prove to be a game-
changer; rather they may play Marketing strategy
a supporting role in pandemic
Vaccines are proven to be efficient against the
management.’’ latest variant of COVID so why is there a need for oral
- Dr Anup R Warrier, drugs when patients are bound to have side effects.
Head - Infectious Diseases and The medical fraternity is also confused a lot where
Infection Control, Aster DM DCGI has given a go-ahead on one hand and the
Healthcare - India Units

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

‘‘Marketing of covid pills ‘‘Molnupiravir, according
being launched in the to him, should be
Indian market is going
to be an uphill task.’’ administered as soon as
- Upendra Nath possible after a diagnosis of
Sharma,
Partner, COVID-19.’’
J Sagar Associates (JSA) - Dr Vasant Nagvekar,

Infectious Diseases

Consultant, Lilavati Hospital

other ICMR has come out with safety concerns. Focelite develops
Says Dr Anup R Warrier, Head - Infectious repurposed drug in oral form

Diseases and Infection Control, Aster DM Healthcare Bengaluru-based startup Focelite has
- India Units, “The present set of antivirals will not developed Welblu, an innovative product to treat
prove to be a game-changer; rather they may play COVID-19, in collaboration with its US partner.
a supporting role in pandemic management. The The repurposed drug in an oral form used in
volume of use typically depends on the marketing integration with a low visible light-emitting
strategy and the inherent fear of ‘not doing enough’ wristband device is effective in disruption of the
while facing this new disease that drives prescriptions lipid bilayer of coronavirus. This lipid bilayer acts
from the doctors.” as a skeleton for spike protein structural support
to mobilise virus into human cells. The emitted
Upendra Nath Sharma, Partner, J Sagar low wavelength light penetrates through the
Associates (JSA), says “Marketing of COVID pills dermal capillary of skin and into the blood vessels,
being launched in the Indian market is going to be catalyses response rate against the invasion of
an uphill task. With great difficulty, the efficacy of virus inside the human body and enables the
vaccines like Covishield and Covaxin had started transformation of the drug into two forms.
sinking into the minds of the masses in India. Hence,
to be able to provide a meaningful alternative, the certainly find it easier to buy a pill off the shelf and
effectiveness of such pills would have to be very well consume it.
established in the market and advertised well across
various media platforms.” Says Sharma, “Initially there would be a lukewarm
response and bulk orders may follow in due
Some experts have also opined that there is course, depending upon how the above-mentioned
rampant and irrational use of pills which can set a conditions are addressed.”
dangerous precedent.
Daftary opines, “Regarding cost; traditionally
Akshay Daftary, Director, SIRO Clinpharm India has been a generic market and cost is one of
mentions, “There would be a demand for these the major factors in deciding the use by the medical
drugs as no other drugs with the antiviral group fraternity or by the population. Looking at this, there
are approved for COVID-19 treatment. In later would be a significant response to these drugs if
phase studies, these drugs have proven efficacy in launched at a subsidised cost.”
preventing severe disease in the at-risk population
and this will be a factor propelling the demand.” Agree to disagree?

Pricing It is too premature to come to a conclusion
mentioning that the drug can do more harm. Also,
Going by the estimate of drugmakers, the the ICMR, DCGI, and the Central Drugs Standard
pill has been launched in 200 mg strength. The Control Organisation (CDSCO) should work together
recommended dose of Molnupiravir is 800 mg twice to come out with a conclusive report before coming
a day for five days, which means, the entire treatment out with individual reports and creating confusion
would require 40 tablets and the total cost would among doctors and patients alike. It needs to be
stand between Rs 1,600 and Rs 3,000. seen how these departments can work towards a
conclusive goal and help save precious lives amidst
A majority of Indians are particular about where various variants of covid.
and how much they are spending. The government
may have to underwrite part of the costs, to ensure Sanjiv Das
it is attractive enough for the common man. If [email protected]
pricing is reasonable and effectiveness established
against various mutations of the virus and adequate
education provided to the masses, people would

24 ANTI-AGEING BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Putting brakes on Ageing

Some researchers argue that slowing the rate of biological ageing could be the best way to
delay development of chronic diseases. Although a number of pharmacological agents targeting
basic ageing pathways to extend lifespan and health-span are presently under investigation in
different parts of the world, in-depth examination and comprehensive deliberations are currently
ruling this space of ‘anti-ageing’.

Time and tide wait for none; ageing is the price for backing a Silicon Valley scientist who had been
of growth. Yet scientists today are taking bold working on a cure for ageing.
steps towards slowing time, maybe stalling
ageing or seeking to reverse it as well. However, the Agelessness is in business
question that looms over us is- can a longer life really
be a favourable condition for our species? According to a recent report by Research and
Markets, from $194.4 billion in 2020, the global
Ageing is characterised by the nine unique market size for anti-ageing is set to cross $422.8
hallmarks: genomic instability, telomere attrition, billion by 2030, at an 8.6 per cent CAGR between
epigenetic alterations, loss of proteostasis, 2021 and 2030. Although the anti-ageing market
deregulated nutrient-sensing, mitochondrial
dysfunction, cellular senescence, was badly affected during the COVID-19
stem cell exhaustion, and altered pandemic, North America stands
intercellular communication. at generating the highest
Thus the goal is to impede revenue in this space on
these processes, effectively account of the rising volume
slowing the deterioration of non-surgical cosmetic
of our bodies with treatments, increasing
passage of time. skincare product
awareness, and surging
Moving in this volume of anti-ageing
direction is a recent treatments in Canada
announcement by and the US.
a team of Japanese Adding on, the
scientists who have most-significant
developed a vaccine players in the global
to delete cells anti-ageing market
that cause ageing include notable
among humans, names such as
owing to the fact Procter & Gamble
that Japan is ageing (P&G) Company,
fast and by 2036, Hologic Inc., Nu
people aged 65 and Skin Enterprises
over will represent a Inc., Unilever
third of its population. Group, Galderma SA,
Pierre Fabre S.A, Shiseido
Another interesting Company Limited, Home
information that is Skinovations, Candela
being heard is that after Corporation etc.
his retirement and space Although there is a potential
expedition, Amazon founder market for anti-ageing devices
Jeff Bezos is looking to invest in an and aesthetic plastic surgery
anti-ageing research startup Altos procedures globally, the
Labs working on reprogramming major challenge lies in the
human cells. In fact, this is not development of anti-ageing
something new for Bezos. Back in medicines or drugs.
2018, he was in the limelight

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com ANTI-AGEING 25

Very promising in this regard is rapamycin (also “What we want to do is make
known as sirolimus), which is already approved ageing a preventable disease.
by the US Food and Drug Administration (FDA) It is not acceptable to be sick
as an antibiotic and immunosuppressant drug. and frail at any age. The goal is
Similarly, metformin, the most widely prescribed to approach medicine from a
oral hypoglycemic medication for type 2 diabetes different angle and get healthier
worldwide, retards ageing in model organisms and
reduces the incidence of ageing-related diseases such in ways that we could not
as neurodegenerative disease and cancer in humans. imagine until recently.”
- Dr David A. Sinclair,
“We have found the epigenetic data on ageing
that is stored in the cells and seek to reverse it Co-Director, Paul F. Glenn Center for Biology of
in our laboratory. This should mean that we can Ageing Research, Harvard Medical School
eventually reverse ageing completely. What we want
to do is make ageing a preventable disease. It is not “The ongoing work is expected
acceptable to be sick and frail at any age. The goal to impact our understanding
is to approach medicine from a different angle and of events which govern the
get healthier in ways that we could not imagine until
recently”, says Dr David A. Sinclair, Co-Director, aged-associated inflammation,
Paul F. Glenn Center for Biology of Ageing Research, tissue injury and infection. Our
Harvard Medical School, US. work allows us to identify and
characterise molecules which
What seems remarkable is that Dr Sinclair and
his team have been able to reverse ageing in mice in regulate DNA damage which
just a week. They are equally optimistic about the fact leads to aging; initiation and
that these same pathways and mechanisms exist in maintenance of aged cells.”
humans.
- Dr Deepak Saini,
How is India re-setting the clock? Associate Professor, Department of Molecular

India’s elderly population (aged 60 and above) Reproduction, Development and Genetics,
is projected to touch 194 million in 2031 from 138 Indian Institute of Science
million in 2021, a 41 per cent increase over a decade,
according to the National Statistical Office (NSO)’s “Our current results indicate
Elderly in India 2021 report. that increasing protein

With Indian minds considered to be one of the aggregates may not always
brightest across the globe, solutions to stop the be ‘messy’ but ‘good’ and
age-clock have been emerging since a very long time are important to execute
from Indian scientists. For example, back in 2018, Dr evolutionary conserved
Keshav K Singh, a professor of genetics, pathology functions to protect from
and environmental health at the University of age-related degenerative
Alabama at Birmingham, demonstrated how boosting phenotypes.”
the function of the mitochondria, the powerhouse - Dr Swasti Raychaudhuri,
of cells, makes wrinkles disappear and restores hair Project Leader, Cellular Biochemistry and
growth.
Proteomics, Centre for Cellular and Molecular Biology
The quest is still ongoing in many laboratories
in India with researchers developing newer targets “With accumulating negative
to overcome ageing. Dr Deepak Saini’s laboratory habits and tissue damage, cells
at the Indian Institute of Science (IISc), Bengaluru,
is currently focusing on a class of receptors called G start struggling to maintain
protein-coupled receptors (GPCRs) and their role in the balance. Thus, we age! How
the event cascade leading to aged cells.
do we reverse this? Through
“The ongoing work is expected to impact our functional medicine- which is
understanding of events which govern the aged at the forefront of anti-ageing
associated inflammation, tissue injury and infection.
Our work allows us to identify and characterise research.”
molecules which regulate DNA damage which leads to - Dr Pradeep Mahajan,
aging; initiation and maintenance of aged cells; which
Regenerative Medicine Researcher,
StemRx Bioscience Solutions

26 ANTI-AGEING BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

The Business of attributed to the easy access of information about the
‘Looking Good’ Soars evolving anti-ageing solutions available.

Dr Karishma Kagodu, According to the United Nations World Population
Cosmetic Surgeon, Founder & CEO, Prospects 2019 report, the total population within
the range of 40-59 years of age was approximately
Dr Karishma’s Aesthetics 17,83,309 in 2019, and it is predicted to reach
20,46,991 by 2030, leading to an upwards trend in
The future of anti-ageing is looking very the rise of anti-ageing solutions hitting the market.
challenging and there is presently no Cosmetic methods are expected to grow at a CAGR
permanent medical method/technology that of 8.1 per cent from $191.5 billion in 2019 to $421.4
reverses the ageing process. As per the recent billion by 2030.
Asia Pacific Anti-Ageing Market Research Report
2021, India is the fastest growing market and is Similarly, there has been an increase in the number
predicted to grow at a compound annual growth of patients opting for Botox treatments globally
rate (CAGR) of 12-15 per cent in upcoming years. since 2019, as stated by the International Society of
The anti-ageing market in India is on par with global Plastic Surgery. On the other hand, method innovation,
market trends because of accelerating factors advancement in technology, increasing investment in
like globalisation, lifestyle changes, and advanced research and development by the plastic / cosmetic
innovations in cosmeceuticals. surgeons and scientists towards the innovation of
extremely safe and highly efficient skin care solutions
The rise in consumer demands for anti-ageing are expected to accelerate the anti-ageing market
solutions, with the increase in income and lifestyle worldwide in the same manner and India is no
standards among the population across India, is the different, keeping their current growth status in mind.
key factor driving the growth of this market, aside
from the fact that a large population in India has What’s the ‘In Thing’?
also become very savvy and prioritise the way they The top five cutting-edge, non-surgical anti-
look and present themselves more now, than ever ageing treatments are Botox, Laser resurfacing
before. A lot of growth in this trend can also be skin treatments, Medifacials/chemical peels,
dermabrasion, and dermal fillers to reduce ageing
signs. These treatment options aim to offer youthful-
looking skin by treating signs of ageing, such as
wrinkles, facial fine lines, frown lines, hydrating skin,
face volumizing, removing acne scarring, sun spots,
age-spots, freckles, melasma, pigmentation, and
helping in revitalizing your skin with the formation of
new healthy skin cells.
Botox is a large water-soluble protein that

regulate age-associated inflammation and the intrinsic ‘messy’ but ‘good’ and are important to execute
anti-aging mechanisms which are triggered when evolutionary conserved functions to protect from
cellular insults occur. We study the cellular responses age-related degenerative phenotypes. As I say, these
of aged cells using live cell imaging, pharmacological aggregates work as double-edged swords. Proper
and gene inactivation and metabolomics profiling balance is the key as uncontrolled aggregation defeats
approaches”, says Dr Saini, Associate Professor, the homeostatic purpose and invites undesired
Department of Molecular Reproduction, Development problems. Our job is to find out the balancing factors
and Genetics, IISc, Bengaluru. and regulate them to work for good only”, says
Dr Swasti Raychaudhuri, Project Leader, Cellular
On the other hand, Dr Swasti Raychaudhuri at Biochemistry and Proteomics, CCMB, Hyderabad.
Centre for Cellular and Molecular Biology (CCMB),
Hyderabad, is working on a prominent hypothesis In a recent development, Ashok Soota, former
which suggests that a gradual, age-dependent decline President of the Confederation of Indian Industry
of protein homeostasis (proteostasis) accompanied (CII), has established probably India’s first not-
by increasing protein-aggregation is the underlying for-profit entity in the private sector called SKAN,
cause of many age-related loss-of-function diseases. for ageing research, among others, with a fund
commitment of Rs 200 crore. The strategic partner
“Surprisingly, our current results indicate that for the ‘ageing project’ is the upcoming St. John’s
increasing protein aggregates may not always be

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com ANTI-AGEING 27

temporarily prevents muscle movement and help Institutes/Companies involved
treat fine lines and wrinkles in adults, besides it’s in ‘anti-ageing’ endeavour in India
medical usage to treat migraine/ neuropathic
pains/excessive sweating (Hyperhidrosis) in the ● Indian Institute of Science (IISc), Bengaluru
palms, feet and armpits. ● Centre for Cellular and Molecular Biology

Each year, approximately 6 million people (CCMB), Hyderabad
globally make it a prevalent choice to combat ● St. John’s Geriatric Centre, Bengaluru
anti-ageing. In addition, Botox has been available in ● Indian Institute of Technology-Guwahati (IIT-G)
India since 1994 for therapeutic purposes. ● Indian Institute of Science Education and

The name Botox is specifically used by the Research (IISER) Bhopal
company Allergan, and targets certified plastic ● Institute of Himalayan Bioresource Technology
surgeons and dermatologists trained in facial
aesthetics procedures to use this injection to aid (IHBT), Palampur
aging related appearance changes. Botox is a ● National Institute of Immunology, New Delhi
generalised term, and there are other pharmaceutical ● Manipal School of Life Sciences, Bengaluru
companies who also produce botulinum toxin ● Central Drug Research Institute (CDRI),
injections with various other names. These
treatments require extreme precision, knowledge, Lucknow
and expertise to administer and are not available on ● Stempeutics Research, Bangalore
the counter. In India, Botox is counted under the top ● StemRx Bioscience Solutions, Navi Mumbai
five minimally invasive procedures. ● Advancells, Noida
● Reliance Life Sciences, Mumbai
Anti-ageing has several quite different common ● Smart Metabolic Anti-Ageing Centre, New Delhi
meanings and connotations championed by a
particular group or the community. Each group or accumulating negative habits and tissue damage,
community has their own way of introducing the these cells start struggling to maintain the balance.
term anti-aging based on their strategy to penetrate Thus, we age! How do we reverse this? Through
the fabric of the industry. Owing to changes in functional medicine—by identifying the root cause of
lifestyle, advanced innovation in cosmetics and the problem and by adding more healthy cells to the
non-invasive solutions, escalating healthcare pool. There is ongoing research on genetic changes
expenditures are majorly elevating the market and alternative modalities like yoga, meditation, dance
growth in India and there is definitely a lot more and music therapies, magnetic field-based therapies,
scope of improvement. These disruptions and energy modulation as well, all of which aim to promote
technological breakthroughs experience a surge as healthy aging. Functional medicine is at the forefront
and when there is a rise in market demand trends of anti-ageing research”, says Dr Pradeep Mahajan,
which will further escalate the development of anti- Regenerative Medicine Researcher, StemRx Bioscience
ageing technologies in India. Solutions, Navi Mumbai.

Geriatric Centre (SJGC), to be located on the St Being the only species aware of our fate, we know
John’s Hospital campus in Bengaluru. that ageing is a biological certainty and yet can never
be prepared to face the consequences. Science has
Another tool that is being explored by the never known boundaries and the mysteries of the
researchers to overcome ageing is stem cell therapy body once revealed are often exploited for our benefit.
or regenerative medicine. Studies have shown that Recent times have seen bashful strides been made
stem cells, in combination with anti-ageing genes, towards understanding and combating ageing. One
can create a sophisticated shield, which can prevent might believe all questions worth asking demands
the effects of ageing. answers but it also makes one wonder if the quest
for life extension misplaced hubris or truly worthy of
Although there is not enough clinical data to be research.
able to state whether or not stem cells may be able
to cure ageing, it may be possible to slow the ageing Time will reveal if laboratory results prove
process. effective or not but the quest for anti-ageing drugs
has definitely carved a niche for itself. But the
“The concept of aging that we believe is a mistake. perception that a gap is expanding between what
The fountain of youth lies within us. We are talking science may offer as age-related interventions and
about tapping into our own resources, namely, what drug regulation can provide in response is
stem cells and growth factors within our body. They another area that needs deeper consideration.
function normally to maintain homeostasis. But, with
Sakura Koner

28 SPEAKING WITH BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

‘Innovation in disruptive &
emerging tech is important to
build new affordable products’

« the pandemic have been successfully developed and
deployed during the two years of this pandemic.
Dr Renu Swarup,
Former Secretary, The COVID-19 vaccines have clearly been
Department of the major success story which has not only been
Biotechnology, responsible for saving lives but has also put the
New Delhi country on the Global map. India was one of
the few countries to have supported a basket of
As has been stated one of the major vaccine candidates - we had different platforms
achievements during this pandemic has with involvement of different research institutes
been the building of a robust innovation and industries at different stages of development.
and translation ecosystem for biopharma products Mission COVID Suraksha was announced by the
specially diagnostics, vaccines and other affordable Government as a part of AtmaNirbhar Bharat. What
healthcare interventions. During the initial days of was delivered is a story every citizen of the country
the outbreak, it was unimaginable that in less than 12 is proud of — 3 Made in India Vaccines, the world’s
months we would be on the verge of having a vaccine largest Immunisation programme with over 150
ready for use. However, India’s scientific community crore vaccine doses delivered, the world’s first DNA
rose to the occasion and delivered. In conversation Vaccine. We have another 4-5 vaccines moving
with BioSpectrum, Dr Renu Swarup, Former rapidly towards approval - the mRNA, Nasal and
Secretary, Department of Biotechnology, Government thermostable vaccine candidates. This has given us a
of India, New Delhi shares more on this development. level of confidence that not only is India the world’s
Edited excerpts; largest Vaccine Manufacturer, but also a global
research player.
What have been some of the unique
achievements or highlights during the Another significant success story was in the
pandemic within the biotech sector? diagnostic development. In March 2020, when
widespread testing began, India was completely
2020 was marked by challenges posed by reliant on imported kits. With supply chain
COVID-19. In a year that tested our resilience, we disruptions and a global demand for diagnostic
witnessed how science and technology took giant kits, it was important for us to develop indigenous
strides to help India as well as the global community capacity for their production. The challenge was
to mitigate the impact of the virus. India has been taken up by startups and researchers across the
at the forefront of the global fight against COVID-19 country and within 60 days RT-PCR kits were
to deliver innovative solutions at scale not just for developed. Today we have over 100 indigenously
itself, but also the world. The learnings and successes manufactured antibodies, antigen and other novel
from the year, such as ramping up indigenous technology based diagnostics in the market. Not only
testing capacities and collaborating across sectors are we self-reliant but also ready to export. The key
and communities for innovation and development innovation was on the development of raw material
of vaccines and other interventions for healthcare, for this indigenous kit development
have helped us build a stronger ecosystem to fight
health crises in the future. S&T interventions to fight As part of the effort to address the shortage of
critical healthcare technologies in India and move
towards self-sufficiency, the DBT-AMTZ COMManD
(COVID Medtech Manufacturing Development)
Consortia was set up. Among its successful initiatives
was the building of India’s first I-Lab (Infectious
disease diagnostic lab), a mobile testing facility to
conduct COVID-19 testing across

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com SPEAKING WITH 29

The vibrant startup ecosystem also responded genomic markers for precision medicine have been
with over 200 solutions. From PPEs to Sanitisers to very successful. Similarly, areas of Agriculture
Ventilators and Patient Monitoring systems, Vaccine technology, climate change and clean energy also
carriers, there were a range of such innovations need special continued focus for both domestic and
which have been deployed. The year 2020-21 was a global challenges.
challenge but a huge opportunity for startups and for
promoting innovation India’s Bio-Economy is on its way to achieve

Amidst the major developments, what are a $150-billion target from the current $70
the bottle-necks that are still hindering
the process of bio-innovation in India, as billion by 2025’. What are your views on the
compared to the global counterparts?
strategies in place to achieve this target?
Innovation is a dynamically evolving process,
which requires a continuous development of enabling Our target of the Indian Biotech Sector
policies. The last few years have seen a number of becoming a $150 billion Bioeconomy by 2025 and
policies being brought out which have helped to a Global biomanufacturing Hub seems achievable
build a robust innovation ecosystem in the country. but the COVID actually gives us the confidence
We are moving towards becoming a global leader and that. This may be underestimated. The National
the pandemic has clearly put India in the spotlight. Biotech Development Strategy 2021 has a set of
The effort, now, is to ensure not just scale up of this key recommendations to achieve this. Primarily
ecosystem but also sustainability of this ecosystem. the focus has to be on capacity building — both
The way we have moved from Start up India to Human Resource and Infrastructure .and also on
Make in India, it is now imperative that we focus strengthening the robust translational ecosystem. We
on exponential growth and not just incremental have to now focus on Prioritising the target products
changes. Key areas which need special attention are which would help reduce import substitution and
Innovation policies focussing on enhance export potential. It is also important to
create biomanufacturing zones which not only
● Innovation Investment connect technical resource centres with translational
● Innovation capacity building —both human centres but provide a complete ecosystem for process
resource and infrastructure optimisation and scale up with both forward and
● Innovation scale up and validation for backward integration. The National Biopharma
deployment Mission of the Department of Biotechnology with
● Innovation through disruptive cutting edge World Bank implemented by Biotechnology Industry
technology. Research Assistance Council (BIRAC) is one such
successful model which needs to be replicated for
How do you foresee the growth of the biotech other areas .The success of our Biopharma sector in
industry in 2022 and beyond? its response to the pandemic is also because we had a
well laid out foundation and we quickly built on it to
There is an Ambitious target laid out by the meet our needs.
National Biotech Development Strategy 2021 —a
$150 billion Biotech Industry by 2025. We are well Our systems are in place, our targets have been
poised to achieve this. From Human Resource set, we now have to ensure timely implementation
to Infrastructure there is now a need to map the in a collaborative, cohesive manner with complete
domestic and global needs, identify gaps, and coordination and collaboration of all stakeholders.
strengthen the existing framework of Research
Institutions, Universities, Incubators and Industries. Dr Manbeena Chawla
Knowledge translational clusters and Technology [email protected]
clusters will facilitate seamless movement of ideas
from proof of concept to product. Technology
management is crucial and critical to enable
academic research to move out of laboratories.

To fuel the innovation pipeline continuously, it
is imperative that we do not move our focus away
from knowledge generation. Innovation in disruptive
and emerging technologies is important to build new
affordable products. Recent examples in Healthcare
of Cell and regenerative medicine, organ culture,

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

“Our oral semaglutide for diabetes
treatment costs around Rs 10k/month”

« European region, where the semaglutide pill has been
commercially launched. With a strong clinical profile,
Vikrant Shrotriya, we believe, it has the potential to revolutionise the
Corporate Vice treatment of type 2 diabetes, given that millions of
President and people do not achieve the targeted blood sugar levels
Managing Director, with currently available oral antidiabetic medications.
Novo Nordisk India Its launch coincides with our hundred-year centenary
of insulin discovery, which changed the life of people
with diabetes needing insulin.

Novo Nordisk has launched the world’s first and How cost-effective is it when compared to
only GLP-1 receptor analogue (GLP-1 RA)-
Oral Semaglutide in India. With Semaglutide, injection-based treatment?
indicated for the management of type 2 diabetes being
developed in an oral formulation for the first time, it The oral semaglutide will cost Rs 315 per pill or
is expected to be a game-changer for people with type around Rs 10000 for a full month treatment. We have
2 diabetes who prefer oral medications over injections. brought in India-based pricing to ensure access of
To find out more about this innovative solution, oral semaglutide to every person living with diabetes
BioSpectrum spoke to Vikrant Shrotriya, Corporate who needs it. The cost is currently equivalent to other
Vice President and Managing Director, Novo Nordisk GLP-1 injectables available in the market. Another key
India in detail. Edited excerpts; important factor we have looked at is that the pricing
of higher doses of oral semaglutide doesn’t increase
What are the USPs of this pill? more than 8-10 per cent. This in fact makes the cost
of treatment with oral semaglutide much lesser than
Oral semaglutide is a co-formulation of GLP-1RA many other injectables. Interestingly, the cost of oral
semaglutide with an absorption enhancer SNAC which semaglutide is much lesser as compared to the current
protects semaglutide from undergoing degradation price in the US.
in the stomach like other peptides and enhances
its absorption. Novo Nordisk invested 15 years of What marketing strategies are in place for rapid
continuous research, innovation, and development to
make oral formulation of semaglutide into a reality. availability of this product across India?
Due to this scientific breakthrough, it received the
Prix Galien Award in 2020, a prestigious award in We already have a very robust distribution
the industry, for the best biotech innovation. It has mechanism in place owing to our 80+ years of
undergone 10 rigorous Phase 3a clinical trials called uninterrupted supply of insulins in India. We are
PIONEER, across several countries including India. leveraging this existing distribution channel to ensure
The completed and ongoing global trials with oral the availability of oral semaglutide across every nook
semaglutide includes more than 10,000 patients of and corner of the country. We are committed to
which more than 1,000 participants are from India. In ensuring that oral semaglutide is available to every
addition to the unprecedented glycemic control, oral person with diabetes who needs it. Oral semaglutide
semaglutide demonstrated unsurpassed weight loss is already available in the nearest pharmacies, and
and consistent cardiovascular safety in clinical trials. by the end of January , it will also be available in the
Oral semaglutide has been approved by the Drugs farthest corners of the country. Lack of awareness
Controller General of India (DCGI) in 2020. and education on diabetes has always been our
biggest competitor. We believe awareness and early
What changes are you expecting with this new initiation of treatment can go a long way in ensuring
launch in the Indian market? better management of diabetes and further reducing
diabetes related complications. We will continue our
India is the sixth country, after the US and CME (continued medical education) programmes
with healthcare professionals and disease awareness
programmes for people living with diabetes to address
this need.

Dr Manbeena Chawla
[email protected]

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

“Stem Cell Science can tackle numerous

Untreatable Metabolic Diseases”
Diabetes is a progressively increasing
worldwide health problem that is causing a «
huge burden on all healthcare systems and
thereby on the world economy in general. Type Dr Anand Srivastava,

1 diabetes (T1D), traditionally termed ‘juvenile Chairman and

diabetes’, because of its onset at an early age, Co-Founder,

accounts for 5-10 per cent of the diabetic population. Global Institute of

A serious disease, T1D is often caused by the Stem Cell Therapy and

autoimmune destruction of the insulin-producing Research, USA

beta (β) cells of the pancreas. Insulin injection,

which is the predominantly used treatment for

T1D, is effective in ameliorating hyperglycemia.

However, it cannot relieve the underlying cause MSC treatment of diabetic cardiomyopathy, MSC

(autoimmunity), nor can it help regenerate lost islets. therapy of diabetic nephropathy, MSC treatment

Islet transplantation, an experimental treatment of diabetic polyneuropathy, MSCs in treatment of

for T1D, also suffers from a limited supply of diabetic wounds.

human islets, which is further exacerbated by poor

immunocompatibility. What is the status of this research and

Recent advances in regenerative medicine – application in India? Is indigenous research

especially stem cell therapy – have suggested several paving the way for treating Indians in a cost-

novel and potential cures for T1D. Mesenchymal stem effective manner?
cell (MSC) based cell therapy is among one of them. India has not been proactive in pursuing stem

BioSpectrum in a quest to understand more about the cell science, with an overly cautious approach. The

stem cell-based therapy for diabetes interacted with country’s regulatory agencies are not taking full

Dr Anand Srivastava, Chairman and Co-Founder, advantage of this innovation, which has the greatest

Global Institute of Stem Cell Therapy and Research potential for tackling numerous currently untreatable

(GIOSTAR), headquartered in San Diego, California metabolic diseases. I strongly suggest that the Indian

(USA). Srivastava shares with BioSpectrum India, scientific community take the lead in the field of stem

his knowledge about the application of MSC in cell science, and avoid ‘playing it safe’ in advancing

treating diabetes and the status of stem cell therapy this promising discipline.
in India. Edited excerpts;

Can digital technologies support this therapy

in any way?
Digital technology plays a strong impact on
Could you outline a few therapeutic
every facet of life, including medical sciences. Stem
outcomes of MSCs in diabetes?
The possible therapeutic effects of MSCs in cell science is a fast-growing field and can provide

diabetes are attributed to their capacity to generate effective therapeutic responses to several metabolic

insulin-producing cells (IPCs). These IPCs express and degenerative diseases which are untreatable. It is

multiple genes related to the development or function very important to share the original research findings

of pancreatic β cells, including high expression of of scientists working around the world among Indian

pancreatic and duodenal homeobox 1, insulin, and scientists and clinicians. Digital and information

glucagon. As such, they are able to release insulin in a technologies are essential for the quick dissemination

glucose-dependent manner that leads to amelioration of scientific data, to further progress stem cell science

of diabetic conditions. Several lines of evidence and enable its clinical application. Digital technology

suggest that in vivo hyperglycemia is an important also plays an important role in maintaining the

factor for bone marrow-derived MSCs differentiation quality of experimental design and uniformity of

into IPCs capable of normalising hyperglycemia in production of scientific data around the world, this is

a diabetic animal model. This includes animals with essential in ensuring a credible outcome for stem cell

chronic hyperglycemia and cardiomyopathy. Some of science. Anusha Ashwin

the many MSC treatment options available include

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

“We’re exploring AI, ML techniques
for molecular design & various
predictions of drug candidates”

« 1. Informatics
a. Information flow management: With
Dr Murali Ramachandra, availability of various software tools, management
CEO, of information became very easy and error free,
Aurigene Discovery helping save enormous time in the drug discovery
Technologies Ltd process. For example, various search engines like
PubMed, Thomson Reuters, Scifinder, Reaxys,
Aurigene is a clinical stage biotech MARPAT, STN etc. to name a few, help in gathering
company committed to bringing novel accurate and up-to-date information that would
therapeutics for the treatment of cancer have been taking very long otherwise. Almost
and inflammation. Based in Bangalore and Kuala all the research journals have made available
Lumpur, it has fully integrated Drug Discovery & online with searchable annotation and keyword
Development infrastructure from Hit Generation to enabled notification systems that help researchers
Clinical Development. In over 15 years of working keep themselves updated almost real-time.
with Pharma, Biotech and Academic partners, Many specialised bio and chemo informatics
in a variety of Therapeutic Areas, Biologies and databases have been made available over the last
Chemistries and over 80 integrated Drug Discovery few years that help in identifying high quality
projects, Aurigene has contributed to delivering drug discovery projects (biological target). These
over 15 small molecule and peptide drug candidates tools also help in designing right experiments
to its biotech and pharmaceutical partners. supported by knowledge bases accessible on the
Aurigene has out-licensed several first-in-class fingertip. In addition to the above explained
and best-in-class compounds to pharma and global informatics systems researchers also
biotech companies for global clinical development, create their own local informatics by using tools
while undertaking clinical POC studies in a few like electronic lab notebooks, data management
programmes in India. Dr Murali Ramachandra, systems and various inventory systems. These local
CEO, Aurigene Discovery Technologies Ltd shares tools gather historical data over the years to cater
his views with BioSpectrum, about the role of new future researchers with precious knowledge that
age technology in drug discovery. is organisational experience which was missing
Edited excerpts; before these information technology tools were
made available. All the tools and technologies
New-age technology-based interventions explained above help in improving the quality of
are playing a major role in transforming drug candidates and shortening drug discovery
pharmaceutical processes and operations. timeline significantly.
The same applies to drug discovery too. b. Project management: Drug Discovery is
How according to you has tech applications an expensive and time-consuming process. Using
been a major advantage in drug discovery? various project management tools tracking of the
project progress and project budget has become
New-age technological development has more streamlined. Important project milestones
revolutionised the drug discovery process like all could be tracked down effectively using various IT
other fields. I would like to divide the impact into tools.
three major buckets as follows: 2. Data Analytics: Usage of computer
software to calculate results from complex
experiments helped in improving data accuracy.
Now statistical analysis of these data with high
accuracy gathered over time generates power to
predict. Various data analysis tools using global

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

publicly available large data sets or locally available Personalised medicine is an emerging
small data sets enable predictability reducing time concept in the field of drug discovery,
and cost of innovation. especially in oncology. Due to extremely
high heterogeneity cancer of the same
3. Innovation support: In the highly organ (lineage) for two different patients
complex domain of drug discovery various could have very distinct characteristics.
computational algorithms developed over the last This heterogeneity could be in such a
few years that are helping in predicting certain high degree that the cancer of the same
aspects of drug design. AI and machine learning lineage of two different patients should
are being used more and more in recent times rather be called different diseases
powering computer aided drug design (CADD), requiring completely different treatment
however, one needs to wait before assessing the regimens. Under these circumstances it
effectiveness of these tools. is essential to analyse and understand
the character of the disease for each
How has your company exploited person separately and decide upon
technologies in drug discovery? Does it the treatment which is known as
have a significant impact on timelines and personalised treatment.
cost of the processes in drug discovery?
treatment. To my understanding, use of various
We have deployed almost all the above- technologies (e.g. next generation sequencing, cell
described tools and technologies in our drug signal pathway analyser) and informatics database
discovery process and operation. We have tools enabled personalised medicine to some
subscribed to many of the global databases extent. More than money, significant improvement
assisting our projects. We have developed in long term survival of patients with many cancer
electronic lab notebooks, compound and data types could be achieved due to personalised or
management systems and chemical inventory precision oncology therapy. However, constant
management systems etc. inhouse saving a development in fundamental research in biology
significant amount of money and time. We utilise is needed to make significant progress in this front
computer aided drug design technology for both globally and locally for India.
assisting novel drug design in many of our drug
discovery projects. All standard data analysis Has the pandemic had any influence on
tools and informatics databases are being used adopting technologies for drug discovery?
at Aurigene routinely to help reduce the overall
timeline for each project. Lately, we are exploring COVID-19 has taught all sectors how to work
AI and machine learning techniques for molecular remotely in a very effective manner. In drug
design and various predictions like efficacy and discovery also usage of various Virtual Reality (VR)
toxicity of the drug candidates. tools has become popular that helped in effective
team activity otherwise was not feasible without
Providing data-driven, personalised cure sitting across the table. One such example is usage
to patients and most importantly cost- of VR software for simultaneous viewing of crystal
effective cure is the need of the hour. What structures and molecular design from remote by
is your take on the use of technology to various team members.
deliver personalised medicine, in an Indian
scenario? Anusha Ashwin

Personalised medicine is an emerging concept
in the field of drug discovery, especially in
oncology. Due to extremely high heterogeneity
cancer of the same organ (lineage) for two different
patients could have very distinct characteristics.
This heterogeneity could be in such a high
degree that the cancer of the same lineage of two
different patients should rather be called different
diseases requiring completely different treatment
regimens. Under these circumstances it is essential
to analyse and understand the character of the
disease for each person separately and decide upon
the treatment which is known as personalised

34 PARTNER CONTENT BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Rise of Molecular
Diagnostic solutions

« less than 2 per cent to above 35-40 per cent during
the journey from pre-pandemic to post- pandemic
Dr (Prof) scenario and the trend is still continuing to contribute
D M Vasudevan, a lot to the Molecular biology platform.
Technical Director,
Agappe Diagnostics This was made possible by the inclusion of
advanced technologies, such as genetic testing,
The COVID-19 testing scenario has brought molecular diagnostics, polymerase chain reaction
significance of in-vitro diagnostic (IVD) solutions (PCR), RT-LAMP technology and next-generation
to the public at large and majority of people sequencing (NGS) in the IVD platform, which defines
who travel or moving or having fever are invariably the future.
subjected to COVID-19 testing process, either rapid
or RT-PCR or RT-LAMP. Never in history, diagnostic Need of the hour is to create quality and
industry as well as diagnostic labs got such a massive affordable, more accessible testing for SARS-CoV-2
acceptability and respect by the public, policy makers as well as all other infectious diseases on faster and
and other healthcare stakeholders. confirmatory platforms, which can be performed with
ease and without the service of untrained technicians.
As a rule, those IVD companies who took the
leap into COVID related diagnostic solutions could Neutralising antibody testing tools may evolve
skyrocket their business and others suffered as the next priority for advocating new doses of
temporary dip during the pandemic. As most of the vaccines depending on your immunity levels. There
domestic and international flights were drastically are unpublished reports that the efficacy of double
reduced. As most of the lab reagents and kits are vaccination may not be enough to provide a proper
imported from world over, transportation of kits was threshold of immunity, especially in a world of
a challenge. COVID-19 has generated a dual impact numerous mutants emerging within a short time. New
on the diagnostics industry. Thus, policy makers variant Omicron has proved its super-fast infectivity
started convincing about the necessity of uplifting the and spread in many countries including the United
indigenous healthcare industries. Kingdom recently.

Resultantly, many Atmanirbhar Yojanas have been For emergency preparedness, point-of-care (POC)
initiated by the government to a large extent, due to mobile diagnosis, right at the doorstep of the patient,
worldwide stagnancy and disruption in the supply will become a necessity in the coming days. The
chain segment, where 60-65 per cent dependability of POC segment of diagnostics with handy, handheld,
import needs to be addressed with greater emphasis. one step, cartridge-based multiple solutions will
It was a fact that Agappe could support 70 per cent of be the next generation tools in various platforms
COVID prognostic markers like CRP, DDimer, Ferritin like Immunofluorescence, Chemiluminescence, dry
etc. when our national supply was very badly hit by
irregular imports.

Corona pandemic lessons have established the
very preponderance of diagnostic tools, where the
molecular diagnostic (MDx) solutions as well as Point
of Care solutions emerged as noticeable players in
demand. Within the healthcare industry, there is now
a growing slant towards genomics also in a big way.
MDx sector has shown phenomenal growth from

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com PARTNER CONTENT 35

chemistry, hematology will pick up. PCR can take around 3 to 4 hours, RT-LAMP takes
Yet another change in diagnostics is the growing less than 40 minutes from sample collection. Agappe
has developed LAMP based technology named Mispa
relevance of connected devices, IoT-based gadgets, Lume with reagent LumeScreen n-Cov during 2020 for
where a new approach to self-monitoring has been confirmatory COVID-19 testing in less than one hour.
ushered in. User-friendly and easy-to-operate medical
devices for self-diagnosis like glucometers, BP Thereafter, a new reagent without RNA extraction
monitors, oximeters and even self-testing of COVID-19 step, AG InstaLume has been launched by Agappe
are in the market. which can perform the confirmatory test in just 40
minutes from collection of swabs. This has been
Large-scale testing, isolation and contact tracing approved by all regulatory bodies. This can be very
are central points to control the pandemic effectively, highly useful for airport screening, social functions,
especially in the light of new Omicron virus scare. hospitals etc, where the authorities get confirmatory
Since December 2019, COVID-19 has resulted in over results in less than 40 minutes. Many airports in India
one million deaths and put extreme pressure on health are presently using this technology for screening their
systems and economies. international passengers.

Clinical diagnostics laboratories currently rely AG InstaLume, the Rapid Molecular Diagnostic
on molecular tests based on the polymerase chain confirmatory test solution for COVID-19 strains, can
reaction (PCR) or Reverse-transcription Loop-mediated detect all the 13 major variants of the globe such as,
isothermal amplification (RT- LAMP) for detecting ο (Omicron) strains of South Africa, μ (Mu) strains of
SARS-CoV-2 infection in samples, such as throat/ Colombia, λ (Lambda) strain of Peru, κ (Kappa) strain
nose swabs. PCR-based tests are probably the most of India, ι (Iota) strain of America, Θ (Theta) Strain
widely used and are considered the gold standard in of Philippines, η (Eta) strain from multiple countries,
terms of sensitivity and specificity. But, of late, we have ζ (Zeta) Strain of Brazil, ε (Epsilon) Strain of USA, δ
developed other equally good or more specific testing (Delta) strain of India, γ (Gamma) strain of Brazil, β
methods to have better specificity and sensitivity. (Beta) Strain of South Africa, α (Alpha) strain of UK
(source WHO -Label detection About reactivity Mutant
RT-LAMP technology is a very strong platform for strain confirmed by Infectious Disease Research
diagnosing COVID-19 virus, with much shorter time Institute).
as compared to RT PCR method. This test facilitates
quicker analysis of genetic material than traditional Post-pandemic situation changes the structure of
PCR and has been successfully used in the detection society. New geopolitical, socioeconomic dynamics
of the COVID-19 virus. RT-LAMP achieves high will surface, values will change, and our lives and
specificity due to the target sequences. habits will also be subjected to modifications.
Countries have to prioritise their expenditure.
Its isothermal reaction allows higher amplification Weaker sections of society require all the possible
efficiency, as there is no need to wait for thermal assistance. Regardless of the devastation caused
changes, thus no time is lost. Whereas a traditional by the pandemic, the human population will prevail,
and humanity will still find the strength to recover.
Investing in public health, preparedness, and relying on
science will bring a better future.

Agappe will also take up the gauntlet to tap the
new market challenges and expectations of the
ensuing markets with new introductions in the Point
of Care segment in many divisions of IVD before long.
We have to gain momentum to run faster than the
market to get at the true meaning of our logo, ‘Agappe,
your best partner in diagnostics.’

We are equipping our team to be at the forefront
of this journey by developing cutting-edge products
and investing more and more in R&D. Currently, MDx
is the leading trend to reach the targeted corporate
goal along with the Chemiluminescence platform.
However, moving forward, we will be able to gain
more and more ground in public health and wellness
management, by providing quality, affordable and
faster diagnostic solutions.

36 BIOSPECTRUM ENZYMES RANKING BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Indian Industrial Biotechnology (Enzymes)
market
with
₹2907Crhits
12% GROWTH
IN 2020-21
Indian Industrial Biotechnology (Enzymes) market increasing demand for processed food in the country and
continued to witness a sturdy growth in 2020-21 at 12 per wide applications of the enzymes in the processed food
cent to touch Rs 2907 crore during the year as against industry. Moreover, innovation in food technology in the
10 per cent recorded in 2019-20 with industry crossing country and the increasing awareness about better-quality
Rs 2500 crore during the year. The Indian Industrial products, being manufactured by utilizing enzymes, are
Biotechnology (Enzymes) market recorded Rs 2360 crore for further driving the market.
the year 2018-19. Baring the few leading companies most of
the Indian companies have done well during the year ended The Indian enzymes market is anticipated to grow
March 31, 2021. attractively owing to increasing applications and use
The rapid development of India’s food and beverage, in the fermentation of milk to produce dairy products.
pharmaceutical and speciality chemical industry has been The success of the Indian dairy industry is expected to
supporting this growth and specialty enzyme demand will increase the enzymes market. The growing demand for
outpace industrial enzyme demand, going forward. recombinant enzymes across industries like detergents
There are about 20 major players in this market. and pharmaceuticals is another market driver. The constant
Most of these companies are either into marketing or innovation in research and development activities to increase
into formulations. But India has a few companies, both yield, improve enzyme specificity and stability, is expected
multinational and local, that manufacture enzymes used in act as a growth driver for the market. The increase in use
different industries such as pharmaceutical, food processing, of proteases in detergents, coupled with a growing use in
leather, detergents, paper and pulp and textiles. These animal feed, are projected to drive enzymes market growth
companies produce various enzymes and several other in India. Enzymes are biocatalysts that accelerate reactions
eco-friendly biological products. The product range and and generate desired results in a biological reaction. The
services are growing rapidly as the use of enzymes is gaining market faces restraints regarding issues with handling and
widespread acceptance. safety of enzymes and the high sensitivity of enzymes to
The market is dominated by multinational companies temperature and pH that can hamper market growth.
such as Novozymes South Asia Pvt. Ltd., Danisco (India) Pvt
Ltd, DSM Nutritional Products India Pvt. Ltd, Chr. Hansen Many companies in India are entering specialised area
(India) Pvt Ltd, E.I. DuPont India Pvt. Ltd and so on with their of probiotics and exporting to neighbouring countries. Now
competitive quality products. These companies are very small Indian players are looking for investors to expand their
active and controlling the food and beverage, pharmaceutical operations in terms of product portfolio and volume as well.
and biotechnology space by offering high quality products. Besides European companies, Chinese companies too are
While Indian companies are entering this space by offering looking at entering the Indian enzymes market.
quality food grade enzyme products in the last few years
and in the coming years they will take on competition with As India lacks having standardised regulatory guidelines
global players. There are a few local players in this space and harmonisation, it will continue to hamper the enzymes
who are offering formulated products at an affordable price market growth. High product prices as compared to
to meet the demands of the local market. High R&D capital, traditional ingredients, particularly in the food & beverage
unclear regulations, and an import-dominated market are and pharmaceutical & biotechnology industry, are among
some of the reasons leading to fewer domestic participants the key factors restraining industry growth. But high
in the food and beverages sector. prevalence of chronic diseases, increase in prevalence of
The market is witnessing rapid growth due to the digestive disorders, and surge in demand for biofuels,
will give a push to the growth of the enzymes businesses
mainly in food and beverage, pharmaceutical, nutraceutical,
bioenergy areas.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com BIOSPECTRUM ENZYMES RANKING 37

NOVOZYMES SOUTH ASIA PVT. LTD
RETAINS NO 1 POSITION

IN INDIAN INDUSTRIAL BIOTECHNOLOGY
(ENZYMES) INDUSTRY FOR 2020-21

Bengaluru-based Novozymes South Asia Pvt. Ltd. with sales revenue of ₹731.25 crore continued to lead the Indian
Industrial Biotechnology (Enzymes) market for the year 2020-21 at number one position followed by Mumbai-based
Rossari Biotech Ltd. with sales revenue of ₹688.47 crore (second position) and Thane-based Advanced Enzyme
Technologies Ltd. with sales revenue of ₹510.69 crore (at third position).

BioSpectrum Top Industrial Biotechnology (Enzymes) Companies 2021*

Sr. Company Revenue in Revenue in % Category Location Region
No 2020-21 2019-20 growth
(in crore) (in crore)

1 Novozymes South Asia Pvt. Ltd. 731.25 683.41 7 MNC Bengaluru South

2 Rossari Biotech Ltd. 688.47 600 15 India Mumbai West

3 Advanced Enzyme Technologies Ltd. 510.69 449.63 14 India Thane West

4 Titan Biotech Ltd. 123.12 69.88 76 India Delhi North

5 Antozyme Biotech Pvt. Ltd. 52 50 4 India Vadodara West

6 Tex Biosciences (P) Ltd. 41.76 39.04 7 India Chennai South

7 Aumgene Biosciences Pvt. Ltd. 23.97 26.13 -8 India Surat West

8 Fruzyme Biotech India Pvt. Ltd. 21.35 15.85 35 India Tirupur South

9 Infinita Biotech Pvt. Ltd. 13.34 3.35 298 India Vadodara West

10 Enzyme India Pvt. Ltd. 9.59 4.76 101 India Chennai South

11 Kaypeeyes Biotech Pvt. Ltd. 5.1 4.28 19 India Mysuru South

12 Iosynth Labs Pvt. Ltd. 2.25 1.28 76 India Bengaluru South

*We have not covered some of the leading MNC and local companies as they are unable to participate in the BioSpectrum Industrial Biotechnology (Enzymes) Survey 2021

Top 3 companies contribute Top 10 companies contribute

66.4% of the total Industrial 76.2% of the total Industrial

Biotechnology (Enzymes) market Biotechnology (Enzymes) market

BIOSPECTRUM INDUSTRIAL
BIOTECHNOLOGY (ENZYMES)
SURVEY AND METHODOLOGY
ENZYMES COMPANIES

BioSpectrum India, a leading B2B media paper and pulp and bioenergy. We highlighted the
platform in Lifesciences space since 2003 companies (both MNCs and domestic players) based
has re-launched its ranking special edition in on their achievements in the past financial years.
June 2019. We have delayed this survey and
ranking excise in 2021 due to COVID-19, as A detailed questionnaire (survey form) was shared
companies were given extended period to submit their to companies in this space to capture the needed
financial returns. information for the analysis. This was done during
In this survey we looked at only Industrial December 2020-January 2021. Companies shared
Biotechnology (Enzymes) Industry with companies information with us to the extent it was possible by
specialising in food & beverage, textile, them. We have collected information about listed
pharmaceutical, food processing, leather, detergents, companies from stock exchange and financial agencies
and Ministry of Corporate Affairs (MCA) as well.

#The revenues considered for the analysis are of Industrial Biotechnogy (Enzymes) products sales. In several cases, where revenue figures were not available, estimates
were arrived in discussion with industry experts.
#For all the ranking purposes, we have taken the Industrial Biotechnogy (Enzymes) business only into consideration. Wherever ‘Revenue is mentioned, it means, sales
turnover from Industrial Biotechnogy (Enzymes) products division. Therefore, revenue wherever mentioned is not necessarily the total sales turnover of the company.

38 BIOSPECTRUM ENZYMES RANKING BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

REVENUE NOVOZYMES SOUTH ASIA PVT. LTD.

₹731.25 crore Translating the market needs and
demands into biological answers
KRISHNA
MOHAN PUVVADA The Indian arm of Denmark headquartered biotechnology company
Novozymes South Asia saw a revenue generation of Rs 731.25 crore
Designation- for the financial year 2020-21 in the enzymes space, exhibiting a
Regional President- India growth of 7 per cent in comparison to the revenue generation of Rs
683.4 crore in the previous year.
“ In India, with the For India, the performance at Novozymes across industries during
government’s FY20-21 was varied and impacted in different ways by the pandemic. Many
mission to be a industries like household care, baking saw gains while industries like brewing,
$150 billion Bioeconomy and textiles were impacted due to restrictions and decreased consumptions.
by 2025, we see a
huge opportunity for As a part of community engagement, employees in India participated in
Novozymes to contribute a virtual fitness challenge to raise money for daily-wage earners. Observing
to this journey. With our local rules and guidelines, the employees walked almost 2.3 million steps in
strong foundation in a day, each step sparking a proportional contribution towards a donation
biology and our purpose totaling Rs 1.7 million. The sum was donated to state funds and organisations
in sustainability, we will in Mumbai and Bangalore engaged in disaster management and eradication
continue to work towards of hunger.
translating the needs and
demands of the market Globally, the company launched 18 new innovative products across
into biological answers varied industries in 2020 and moved towards commercial realisation in key
for our customers.” platforms. Novozymes acquired Precision Biotics Group and Microbiome
Labs, both related to biological solutions for human health.

The Consumer Biosolutions (CB) division announced a joint launch with
Firmenich, the world’s largest privately-owned perfume and taste company,
for a solution that brings unparalleled sugar reduction in dairy products.
During FY20-21, the company also entered into a research partnership with
Givaudan, the world’s largest flavour and fragrance developer, to work on
the research and development of innovative sustainable solutions in food &
beverages and household care.

Novozymes started operations in India in 1983 and is the largest supplier
of industrial enzymes and microorganisms in the region today. The region’s
operations cover India, Sri Lanka, Bangladesh, Nepal and Bhutan.

With over 500 employees, Novozymes India has grown into an
organisation spread across three sites in Bangalore covering research and
technology, manufacturing, business functions and a shared service center.
Some of the key business areas for Novozymes India are household care,
textiles, food & beverages, oils & fats, baking and beverage alcohol.

Novozymes invests nearly 14 per cent of its global revenue in research
and technology annually, with one of the key facilities located in Bangalore.

In addition, Novozymes gives high priority to having a good relationship
with relevant universities, students and graduates in India. From time to time,
Novozymes India invites students and graduates to come and receive first-
hand information on industrial biotechnology, enzymes and sustainability.
Students and graduates get the opportunity to attend discussions and
presentations on Novozymes, its solutions, sustainable practices, and
performance. Apart from that, the company also collaborates with key
universities towards diverse research areas that serve to further advance its
business and academic understanding of bioinnovation at its core.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com BIOSPECTRUM ENZYMES RANKING 39

REVENUE ROSSARI BIOTECH LIMITED

₹688.47 crore Evaluating opportunities
to launch new business lines
SUNIL S CHARI
Mumbai-based Rossari Biotech generated a revenue of Rs 688.47
Managing Director crore in the enzymes space during the FY 2020-21 exhibiting a
growth of 15 per cent in comparison to the revenue generation
“ As we move of Rs 600 crore in the previous fiscal.
forward, we The FY20-21 saw the company’s IPO launch with Rossari
are evaluating listed publicly on national stock exchange (NSE) and Bombay stock exchange
opportunities to introduce (BSE). Rossari raised Rs 100 crore through pre-placement of shares with
new business lines with institutional investors in February 2020. Further, the company raised Rs 50
distinguished offerings crore through the issue of fresh equity in July 2020. The proceeds from this
and unique product issue were used towards funding the company’s working capital requirements,
value, but which are prepayment of loans and for general corporate purposes.
centred on our four basic The company also fully operationalised Rossari Centre of Excellence, the
chemistries of acrylic, company’s new state-of-the -art and certified R&D laboratory, strategically
surfactants, silicones located on the Indian Institute of Technology (IIT) campus in Mumbai. The
and enzymes. This will facility is fully equipped with advanced testing and research equipment.
enable us to keep up with Rossari fully commissioned all phases of the Greenfield manufacturing
the constant technology facility at Dahej, Gujarat during FY20-21. A strong upcoming pipeline of new
evolutions happening product launches and new business lines within the four core chemistries of
in markets and will be acrylic, surfactants, silicones and enzymes is expected to enable the company
another strong growth to sustainably ramp-up utilisation levels at the Dahej unit over the next three
propeller for us, going to four years.
forward.” Other developments which took place within the company during 2020
included tie-up with Mumbai Airport to place branded dispensers and supply
sanitisers for the use of passengers and foray into e-commerce by listing
Home, Personal Care and Performance chemical (HPPC) products on the
Amazon platform.
While the company delivered strong performance in its HPPC business
led by accelerated momentum in hygiene products and anti-viral portfolio
sales, broader operating constraints and slowdown in demand impacted
performance of its textile specialty chemicals (TSC) and animal health and
nutrition (AHN) businesses during the first half of the fiscal. As the country
moved to the un-lockdown phase in H2 FY 2020-21, Rossari started seeing
a healthy uptick in consumption and demand, which further strengthened
through the course of the fiscal.
Rossari is one of India’s leading manufacturers and exporters of textile
chemical auxiliaries, enzymes, polymers and animal health care products. The
company’s enzymes portfolio is spread across a wide range of functions such
as Desizing Agent, Bioscouring Agent, Peroxide Killer, Biopolishing, Fading
and Washing Off catering to the textile chemicals section. Apart from this, the
company also has a large number of enzyme products such as Mannobac,
Phytobac, Protoxy Forte, Rosslipase, Rossphyte 5000/10000 and Xylot Ex in
the individual form; and Enzyfort, Maxi ex, Maxizyme Ex and Rosszyme Plus in
the cocktail form, within the Poultry Supplements & Additives sector.
The company has state-of-the-art research facilities both at its head office
in Mumbai as well as at the manufacturing plant in Silvassa in Gujarat. Rossari
is one of the few companies in the sector credentialed with a Department of
Scientific and Industrial Research (DSIR) certification.

40 BIOSPECTRUM ENZYMES RANKING BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

REVENUE ADVANCED ENZYME TECHNOLOGIES LTD

₹510.69 crore Leveraging the rising opportunities
in bio-catalysis, probiotics
V L RATHI
Thane-based research-driven company Advanced Enzymes
Chairman Technology garnered a revenue of Rs 510.69 crore during the
financial year 2020-21 in the enzymes space, exhibiting a growth
“ The world of 14 per cent as compared to Rs 449.63 crore generated in the
is becoming previous year. With a workforce of more than 750 employees,
increasingly aware around 68 enzymes and probiotics in its portfolio, 7 R&D and 9
of the harmful effects manufacturing units, the company caters to diversified industries and verticals
of chemicals on health. like human nutrition, animal nutrition and bioprocessing.
Natural alternatives to
boost the immune system In January 2021, the company completed the acquisition of SciTech
are gaining increased Specialities Private Limited (SSPL), a contract manufacturing company with
traction, which puts us in niche technology specialising in effervescent granules and tablets. The
good stead to leverage acquisition has strengthened the company’s manufacturing capabilities by
the rising opportunities in adding two manufacturing facilities for nutraceuticals and pharmaceuticals,
the areas of bio-catalysis taking the count from seven to nine.
and probiotics.”
In FY21, human nutrition vertical comprising active ingredient for
nutraceuticals and pharmaceuticals contributed 75 per cent of the revenues
followed by animal nutrition and bio-processing contributing 9 and 14 per
cent respectively and SciTech (new subsidiary) contributed 2 per cent.

Due to the pandemic, and lockdown restrictions as imposed from time to
time, the logistics costs rose significantly, the deliveries also took longer, and
lower consumption of animal feed product range, this impacted the Animal
Nutrition business. A large chunk of the animal feed business comes from
domestic markets. The Bio-processing business comprises the food and the
non-food businesses. With regard to the food business, the company’s focus
in FY20-21 was primarily on the European market. Due to lower consumption,
slow growth was witnessed. The non-food business consists of the industrial
processes like textile processing and effluent treatment, paper and pulp,
leather, and laundry solutions, etc.

The company has several enzymes for the food processing segment, have
filed 12 dossiers with the European Food Safety Authority and got positive
news for 4 of the product dossiers. Advanced Enzyme plans to launch more
products on immunity development, digestion improvement, and increase
nutritional level of feed. The company is also in the advanced stage to launch
its own B2C nutraceutical online platform targeting Indian customers; this
segment is expected to be the next interesting growth driver for the company.
Advanced Enzyme is also exploring other online avenues for selling the
products through parallel online sales channels.

The company is making significant investments in developing state-of-
the-art R&D facilities and intends to set trends in the R&D areas mainly for the
formulation of new applications and shall continue to significantly invest to
build its portfolio with focus on applications and industries. It is also looking to
expand and strengthen the R&D team. Advanced Enzymes is working towards
providing eco-safe solutions to a wide variety of industries like human health
care and nutrition, animal nutrition, baking, fruit and vegetable processing,
brewing and malting, grain processing, protein modification, dairy processing,
speciality applications, textile processing, leather processing, paper and pulp
processing, bio-fuels, biomass processing, bio-catalysis, etc.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com BIOSPECTRUM ENZYMES RANKING 41

TITAN BIOTECH ANTOZYME BIOTECH
LIMITED PRIVATE LIMITED

SURESH CHAND SINGLA PRAFUL PRAJAPATI
Managing Director Chief Executive Officer

Revenue: ₹123.12 crore Revenue: ₹52 crore

New Delhi-based Titan Biotech saw a revenue generation During FY20-21, Vadodara-based Antozyme Biotech
of Rs 123.12 crore in the financial year 2020-21 in the clocked-in a revenue figure of Rs 52 crore in the enzymes
enzymes space, exhibiting a growth of 76 per cent in space, with a growth of 4 per cent when compared to the
comparison to the revenue generation of Rs 69.8 crore in revenue generation of Rs 50 crore in FY19-20. Established
the previous year. It is one of the leading manufacturers in 2015, the company manufactures distillery enzymes,
and exporters of biological products used in the field pharmaceutical enzymes powder and food enzymes from
of pharmaceutical, nutraceutical, food & beverages, small to large scale quantities for a variety of industries
biotechnology, fermentation, cosmetic, veterinary & such as food, starch, distillery, brewery, wastewater
animal feed, agriculture industries, microbiology culture treatment, agriculture, detergent and pharmaceuticals.
media and plant tissue culture media, etc. With the The processing unit is well-equipped with all the required
experience of more than 25 years and a market presence extraction, isolation, purification, synthesis and fermentation
in 75+ countries, Titan Biotech is consistently pushing equipment and technology that allows Antozyme to
the boundaries of research and development to deliver undertake an ample order without any delay. The installed
the best quality of biological products. The company equipment and technology are regularly upgraded as per
emphasises on supplying at the most competitive the latest technical developments. The company is backed
prices to the market in order to cater and create a by a skilled team of 50 professionals with 4 scientists in
successful position in the marketplace. Titan Biotech is R&D. Further, the company offers training to professionals
currently in the process of developing more products for on a regular basis in order to keep them updated with all
microbiology. the latest technologies and techniques.

TEX BIOSCIENCES AUMGENE BIOSCIENCES
PRIVATE LIMITED PRIVATE LIMITED

ARAVINDHA PRAKASH KRISHNAMACHARI ANAND DAGA
Director Managing Director

Revenue: ₹41.76 crore Revenue: ₹23.97 crore

Chennai-based Tex Biosciences generated a revenue figure Surat-based Aumgene Biosciences generated a revenue
of Rs 41.76 in the enzymes space during FY20-21, showing of Rs 23.97 crore in the enzymes space during the FY
a growth of 7 per cent in business in comparison to the 2020-21 exhibiting a decline of 8 per cent in comparison
revenue generation of Rs 39.4 crore in the previous year. In to the revenue generation of Rs 26.6 crore in the previous
FY20-21, majority revenue came in through the animal feed fiscal. Founded in 2004, the company undertakes the
and leather sector. The company has a workforce of around development, manufacturing & marketing of enzymes,
200 people distributed within R&D (25), manufacturing probiotics and agri biotech products. The company has
(130), sales (30), and support (15) categories. In the midst in-house large scale fermentation facilities with more than
of a large and ambitious capacity expansion programme 100 cubic mt of fermentation capacity. The company has
currently, Tex Biosciences is expecting to achieve a revenue state of the art R&D facilities for high throughput screening
figure of Rs 65 crore in FY 21-22. An industrial biotech of microbial strains, fermentation process development and
company involved in the manufacturing of enzymes, purification of enzymes and biologics. A multi-disciplinary
probiotics, specialty chemicals and biotech Products, it team of scientists, engineers and project managers work on
operates in sectors namely animal feed, leather, textiles, various biotech products and molecules at Aumgene’s R&D
pulp & paper, detergents, wastewater and potable water facility in Surat. The company’s R&D facility is equipped
treatment. Incorporated in 1982, Tex Biosciences has an with state of the art infrastructure for product and process
export presence in 22 countries. Apart from manufacturing development of various biological products. It also offers
products under its own brand name, the company a wide range of contract research and fermentation / toll
undertakes contract manufacturing for clients in India, manufacturing services to pharmaceutical, biotechnology
America, Europe and Japan. and related companies.

42 BIOSPECTRUM ENZYMES RANKING BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

FRUZYME BIOTECH Enzyme India is one of the leading manufacturers of industrial
INDIA PRIVATE LIMITED enzymes offering a range that includes Cremo-Zyme, Batezyme,
Enviro-Nzyme G, Earth-Nzyme, Deter-Zyme X, Tropizyme P, Agro
G. P. KARTHIKEYAN Booster, bio feed, bakery enzymes and textile enzymes. With its
Managing Director business operations promoted by technocrats having with them
more than 25 years of experience in the field of chemicals, fine
Revenue: ₹21.35 crore chemicals and biotechnology sector, the company is presently
meeting the supply demands to agro, food, detergent, ice-cream,
Tirupur-based Fruzyme Biotech India roped in a revenue figure of textile and effluent treatment sector. Other than this, the company
Rs 21.35 crore during the FY20-21 in the enzymes space, thereby has plans to launch a full range of brewery and distillery enzymes,
growing at 35 per cent in comparison to the revenue generation of papain and biopharmaceutical intermediates.
Rs 15.85 crore in FY19-20. Incorporated in 2012, the company caters
to a wide range of industry applications such as flavor production, KAYPEEYES BIOTECH PRIVATE LIMITED
brewing, functional protein production, effluent treatment, meat
tenderization, to name a few. The company has developed an KRISHNA BHAT KADAPPU
ultra-refined papain powder which is a highly concentrated Managing Director
proteolytic enzyme prepared from the latex of Carica papaya fruit.
It is characterized by its ability to hydrolyse large proteins into Revenue: ₹5.1 crore
peptides and amino acids. The R&D laboratory at Fruzyme is fully
equipped to test the biochemistry and microbiological parameters Mysuru-based Kaypeeyes Biotech clocked in a revenue figure of
of the products with well-trained technical staff. Rs 5.1 crore during FY20-21 in the enzymes space exhibiting a
growth of 19 per cent in comparison to the revenue generated
INFINITA BIOTECH PRIVATE LIMITED in FY19-20 at Rs 4.29 crore. Approved by the Department of
Scientific and Industrial Research, Government of India, the
ADARSH DESAI company develops and manufactures innovative products for
Managing Director food, feed and other industrial applications such as amylases,
cellulases, proteases, pectinases, xylanases etc., in the basic form
Revenue: ₹13.34 crore and also in need–based formulations. Kaypeeyes Biotech was
incorporated in 1993. The manufacturing facilities are based
Vadodara-based Infinita Biotech clocked in a revenue figure of Rs in the Hebbal Industrial Area of Mysuru. The company has an
13.34 crore during the FY20-21 in the enzymes space exhibiting exclusive research and development (R&D) centre located at the
a huge growth of 300 per cent in comparison to the revenue Food Industry Complex Area in Mysuru. This facility has a fully
generated in the previous fiscal at Rs 3.35 crore. The majority dedicated pilot plant for the exclusive use of the R&D centre.
of the revenue was gathered from the detergents and cleaning
agents sector which stood at Rs 7.9 crore. The export business IOSYNTH LABS PRIVATE LIMITED
of the company summed up at Rs 11.2 crore while the domestic
figure was Rs 2.1 crore during FY20-21. Incepted in 2015, the PRASAD NAIR
company is engaged in the manufacturing and marketing of Managing Director
biotechnological enzyme-based biodegradable formulations
for various industries and the formation of customised enzyme Revenue: ₹2.25 crore
formulations for specialised industries. Infinita serves an array
of industries such as distillery, sugar, brewery, starch, wine, malt, Bengaluru-based Iosynth Labs generated a revenue of Rs 2.25
wastewater treatment, food, animal feed, agriculture, cellulosic crore in the enzymes space during the FY 2020-21 exhibiting a
ethanol, pharmaceuticals, detergent and biodiesel. growth of 76 per cent in comparison to the revenue generation
of Rs 1.28 crore in the previous year. Iosynth offers scalable
ENZYME INDIA PRIVATE LIMITED biocatalytic solutions and is one of the main suppliers of
enzymes in India to the pharma, agro-chemical, cosmetics and
VISHAL MEHTA fine chemical industry. Its warehouse and logistic setup allows
Director customers across India to streamline their supply chain operation
for their enzyme needs. Iosynth offers a large catalog of highly
Revenue: ₹9.59 crore pure and active R&D enzymes for a variety of different substrates
and reactions. Almost all of these enzymes are fully scalable
For FY20-21, Chennai-based Enzyme India generated revenue and are available to ton scale. The company develops enzymes
worth Rs 9.59 crore in the enzymes space exhibiting a growth and intermediates as products, and biochemical services which
of 100 per cent in comparison to the revenue generated in the address the full value chain from R&D to manufacturing.
previous fiscal at Rs 4.76 crore. Established in the year 1995,

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

Cardiothoracic specialist Granules India
Dr Kumud Dhital
joins SPARSH Hospital appoints KVS Ram

Globally renowned cardiothoracic specialist and heart Rao as JMD and CEO
and lung transplant surgeon Dr Kumud Dhital has
joined Sparsh Group of Hospitals to lead the heart and Hyderabad-based Granules India has
lung transplant unit at the soon-to-be-launched Sparsh announced the appointment of KVS Ram
Multi-organ Transplant Centre in RR Nagar, Bengaluru. Rao as Joint Managing Director and Chief
With over 24 years of experience as a cardiothoracic Executive Officer (CEO). Rao has over two
surgeon, Dr Dhital has been associated with top hospitals decades of experience in pharmaceuticals
across the UK, Europe, and Australia before joining and chemical industries. He holds a
Sparsh. Known for his expertise in complex heart and bachelor’s degree
lung surgeries, Dr Dhital specialises in the management in chemical
of the end-stage heart and lung failure including heart engineering
and lung transplantation as well as in the implantation from Osmania
of mechanical circulatory support devices. He is University,
globally renowned for being the surgical pioneer of DCD Hyderabad and a
(donation after circulatory death) Heart Transplantation, Master’s degree &
PhD in chemical
the first series of which he performed engineering from
as the principal surgeon leading Indian Institute
a dedicated team in 2014 at St of Science,
Vincent’s Hospital in Sydney, Bengaluru. He
Australia. At the Sparsh Multi- has over 29 years
organ Transplant Centre, Dr of experience
Dhital will build a comprehensive in the field of
thoracic transplant programme manufacturing,
and lead an expert team of R&D, business and customer service
specialists to establish Sparsh management. He worked as Executive
as a state-of-the-art centre Director & CEO for the CSM business of PI
for end-stage heart and Industries. He played a significant role in
lung failure, heart and Dr. Reddy’s Laboratories while working in
lung transplantation and various capacities from 2000 to 2018. He
mechanical circulatory has also worked with Jubilant Life Sciences
support. and Gujarat Heavy Chemicals.

Twin Health appoints Prabh Singh as India CEO

Twin Health, makers of the Whole Body Digital number of lifestyle-related diseases in the
Twin technology, has announced the appointment world after China. Singh was previously
of Prabh Singh as the Chief Executive Officer serving as EVP and Head of Subscriptions
(CEO) for its India operations. Founded in 2018, at the Disney-owned video streaming
Twin Health invented the Whole Body Digital service Hotstar and took over his new
Twin to reverse and prevent chronic metabolic position at Twin Health in January
diseases like Type 2 Diabetes, while improving 2022. Singh has two decades of
energy and physical health. The health tech consumer and technology experience
firm had recently raised $155 million Series C across India and Asia. He has worked
funding to scale its presence in India and the at Hindustan Unilever, Google and
US. Singh will head the India operations for most recently with Hotstar, where he is
strategy, marketing, regulatory, public policy, credited for building Hotstar as the
go-to-market, product, and technology divisions. #1 subscription service in India
He will be responsible for scaling Twin Health and the largest contributor to
in India as the country has the second highest Disney+ global subscribers.

44 APECOAPDLEEMNIECWSSNEWS BIOBSIOPSEPCETCRTURMUM| |FEBARUUGAURSYT 20212 | www.biospectrumindia.com

Sanofi India’s Anurag Yadav steps in as
MD Rajaram CEO of IHH Healthcare India
Narayanan exits
Anurag Yadav is appointed Enterprises. With over
Sanofi India has announced that its as the Chief Executive Officer 25 years of experience in
Board of Directors have accepted (CEO) of IHH Healthcare business leadership, financial
the resignation of its Managing India, effective January 14, management, strategic
Director, Rajaram Narayanan, 2022. Yadav joined IHH planning, mergers and
effective on April 10, 2022. Healthcare in April 2017 as acquisitions & post-merger
Narayanan has decided to pursue an the Chief Financial Officer integration, Yadav is well-
opportunity outside of Sanofi. His (CFO) of its India Operations positioned to take IHH India
successor will be appointed in due Division, where he oversaw to its next level of success.
course. He joined the company in the financial activities of
2014 as General Manager and was IHH’s network of hospitals
later elevated as Country Lead & in India (excluding Fortis).
Managing Director. In these roles, As the newly promoted CEO,
he has led the strategic reorientation he will provide leadership
of the organisation, sharpening and strategic direction to
its focus on core areas, developing IHH Healthcare India,
new business models, building ensuring that it continues to
future talent and driving digital deepen trust with patients,
transformation across all areas of employees, and other
the business. The company also stakeholders, in line with
took significant steps to streamline IHH’s vision to be the world’s
its portfolio, supply footprint and most trusted healthcare
go-to-market operations. He leaves services network. Prior
behind a strong leadership team to IHH, Yadav held
to steer the company forward. senior leadership roles
Narayanan will be joining Mumbai- in Fortis Healthcare
based animal healthcare company and Manipal Health
SeQuent Scientific. He will oversee
the company’s next phase of growth Aurobindo Pharma names
and expansion. SeQuent is backed K Nithyananda Reddy as MD
by global investment firm Carlyle.
After N Govindarajan stepped down as the Managing Director
(MD) of Hyderabad-based Aurobindo Pharma, the company
has named K Nithyananda Reddy as the new MD. Reddy’s

appointment came into effect
from January 1, 2022. The tenure
of his appointment will end on
May 31, 2024. Reddy has been
a key member of Aurobindo
leadership and has played a
pivotal role in the company’s
growth journey since inception. A
veteran of the pharma industry,
he has expertise in manufacturing
technology and has been actively
involved in the overall affairs
and the strategic decision making of the company. Reddy holds
a master’s degree in Chemistry. He has been associated with the
company since its initial days, as a promoter.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com R&D NEWS 45

IIT-Kanpur’s Hridyantra IIT-Mandi study’s
could become world’s most
advanced ‘artificial heart’ recommendations

The School of Medical Research and Technology (SMRT), at the to tackle future
Indian Institute of Technology (IIT) Kanpur, has announced the
launch of Hridyantra, a grand challenge-based programme to develop pandemic
the world’s most advanced Artificial Heart or a Left Ventricular Assist
device (LVAD). The programme, outbreak
in collaboration with the nation’s
leading hospitals, would promote Researchers from the Indian
the vision of Made in India for the Institute of Technology (IIT)
world. A team of innovators with Mandi have identified the states
relevant experience will be selected with a high probability of being
under the mentorship of a task force the first hotspots for the spread
composed of industry experts. The of COVID-19. The researchers
challenge to develop India’s first reviewed the spread of COVID-19
LVAD system will be open to basic and past pandemics in India for
sciences, medical and engineering this study. According to the study
graduates or graduates of any stream performed on 640 districts from
with relevant experience. Selected April 1 to December 25, 2020,
candidates will receive a fellowship the hotspots of the pandemic
and a milestone based ownership in in India have been states with
the commercial entity once the LVAD is successfully commercialised high international migration
and launched. Upon completing their clinical immersion, the fellows and districts located close to
will move to IIT Kanpur to begin the product development process large water bodies. States such
under the project. as Maharashtra, Tamil Nadu,
Gujarat, Rajasthan, Karnataka,
Study suggests Indomethacin Delhi, Uttar Pradesh, and Andhra
highly effective in treating Pradesh were the hotspots
COVID-19 infection for the COVID-19 pandemic
in India. Furthermore, the
Indomethacin, a nonsteroidal anti-inflammatory drug, is shown to researchers have examined the
be highly efficient in treating the COVID-19 infection as per a study temperature variations across
conducted by MIOT Hospitals in Chennai and IIT Madras in India. districts that are close to large
The first trial done during the first wave had 144 RT-PCR positive bodies of water to understand
the spread of COVID-19 in these
patients statistically matched in two areas. In epidemiology, the basic
arms, one treated with indomethacin reproduction number, commonly
and standard care and the other with known as R0, quantifies the
paracetamol and standard care. The disease spread and finds the
second carried out in the second wave expected number of cases
was a randomised control trial with 210 directly generated by one case
RT-PCR-positive COVID-19 patients. in a population. Researchers
They were allotted to two arms, as recommend a targeted approach
above, based on block randomisation; to be taken in states with a
103 and 107 patients were in the higher international migration
indomethacin and paracetamol arms, rate and recommend that strict
respectively. The primary endpoint was the development of hypoxia/ precautionary measures should
desaturation with SpO2 ≤ 93, while fever reduction and cough and be taken in districts near large
body pain resolution were the secondary endpoints. bodies of water before the
monsoon season begins. The high
R0 observed in these districts
during monsoon suggests that
these areas be given priority if
immunisation is available.

46 R&D NEWS BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

IIT-D identifies CDRI probes
new drug delivery
platform technology mitochondrion of

A technology has been developed for chemotherapy malaria parasite for
applications using Red Blood Cell (RBC) membrane by
a research group at the Indian Institute of Technology, alternative drug targets
Delhi (IIT-D) Centre for Biomedical Engineering (CBME).
The technology is a significant success in achieving Researchers at CSIR-Central Drug Research
personalised therapy as it can be based on the RBC Institute (CDRI), Lucknow are trying to
membrane of a patient, thereby minimising the side- identify proteins which influence the shape-
effects. The technology involves engineering the RBCs in function of the single mitochondrion that
the lab to produce smaller (nano the malaria parasite harbors as well as
sized) biocompatible vesicles. how it undergoes repair. Understanding
Drug molecules can simply be these processes will help decipher how
trapped inside the particle’s the parasite adapts to environmental
lipid bilayer and circulate for perturbations, mitigate drug-induced
a longer time. This work was toxicity (phenotypic drug resistance), drive
validated in an animal system recurrence of infection after completion
by Prof. Neetu Singh’s lab in of treatment, and relapse from dormant
collaboration with Prof. Sujata stages. The research group is using multi-
Mohanty from the All India pronged approaches to understand how
Institute of Medical Sciences the structurally-functionally diverged
(AIIMS), New Delhi. The concept utilises the body’s own components of genome and proteome
cells to load multiple drugs at the same time and reach maintenance pathways give a survival
tumour sites in significant concentrations. Interestingly, advantage to the malaria parasite. It is very
this nano-RBCs platform has synthetic tunability similar to intriguing that despite the vulnerability
other polymeric systems or the commonly used liposomes to genotoxic and proteotoxic stress, the
but have proved to be more efficacious. parasite maintains cellular homeostasis
even under hostile conditions and can
withstand immune surveillance mounted
by mosquito vectors and human hosts.

BHU raises prospects of Zika virus therapy

New drugs could soon be in the and immune evasion. The study cells. The increased expression
offing for Zika virus infection demonstrated that ZIKV-NS1 of microRNA-146a targets and
with a team of scientists at the compromised the immune reduces the expression of two
Institute of Medical Sciences response by increasing the genes - TRAF6 and STAT1, which
(IMS) in Banaras Hindu expression of a molecule called leads to reduced production of
University (BHU), Varanasi, microRNA-146a in the microglial cytokines and interferons from
getting new insights
into how the virus human microglial
multiplies inside the cells. This results
host. The researchers in the suppression
have found that the of cellular immune
virus interacts with response against
a set of cells called the Zika virus. This
microglial cells, which suppression of the
protect the brain host’s immune
from infections and response by ZIKV-NS1
that a protein in the might be a strategy
virus called ZIKV-NS1 adopted by the Zika
plays an important virus to promote its
role in its replication multiplication inside
the host.

BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com ACADEMICS NEWS 47

Indraprastha Institute, IIIT-Delhi join hands
for cutting-edge interdisciplinary research

The Indian Institute of research in cutting-edge areas projects and selected five projects
Technology (IIT), Delhi and namely Computer Science for a seed grant. The projects
Indraprastha Institute of and Engineering, Artificial include studies on human
Information Technology (IIIT- Intelligence (AI) and Machine brain structure and anxiety;
Delhi) had signed a Memorandum Learning (ML), Electronics and femtech and its future in India;
of Understanding (MoU) Communication Engineering, development of nanodevices;
earlier in 2021 to establish a Computational Biology, Social mathematics theories propounded
collaborative platform for mutual Science, Humanities and by Ramanujam; model agnostic
benefit. The MoU intended to Quantum Computing. An external evaluation of deep-model
initiate wide-ranging partnerships expert committee evaluated the transfer. Tenable for two years,
in academics, research, product the projects aim to attract full-
& process development, and fledged sponsorship from external
human resource development agencies based on their outcomes.
with profound socio-economic These projects will function
impact. Taking it forward, IIT through the Multi-Institutional
Delhi and IIIT-Delhi had invited Faculty Interdisciplinary Projects
joint research projects from (MFIRP) scheme of the Industrial
the faculty members of both Research & Development (IRD)
institutions for interdisciplinary Unit of IIT Delhi.

IIM Lucknow, Apollo Medskills Tamil Nadu to
unveil executive programme in
healthcare management add 11 new

Apollo Medskills and the Indian Institute of Management medical colleges
(IIM) Lucknow have decided to join hands and announce the
beginning of a relationship between the two institutions with a at cost of Rs 4K Cr
unique perspective to benefit the healthcare fraternity. The first
of many, under this initiative they have launched an Executive PM Narendra Modi has inaugurated
Programme in Healthcare 11 new medical colleges in Tamil
Management (EPHM). The Nadu. Shortage of doctors has
programme is designed by remained an issue for a very long
taking the necessary inputs time and the current government is
from both the public and making it a priority to address this
private health sector of India critical gap. In 2014, the country
and similar economies in had 387 medical colleges. In the last
the region. The uniqueness seven years, this number has gone
of this programme is the up to 596 medical colleges. This is
experiential learning that an increase of 54 per cent. The new
every participant receives by medical colleges are being established
way of attending the Immersion programme. All participants at an estimated cost of about Rs
will have the opportunity to experience the concepts they have 4000 crore, out of which around
been acquainted with in the classroom in a real time campus Rs 2145 crore has been provided by
immersion at IIM Lucknow and a field visit at Apollo hospitals. the Union Government and rest by
The ongoing developments in India’s healthcare industry is the Tamil Nadu government. The
paving way for creating millions of jobs in the sector. The districts in which the new Medical
Executive Programme in Healthcare Management is intended Colleges are being established are
to nurture and shape the career of hundreds of youth who Virudhunagar, Namakkal, The Nilgiris,
aspire to take leadership roles in the health industry. Tiruppur, Thiruvallur, Nagapattinam,
Dindigul, Kallakurichi, Ariyalur,
Ramanathapuram and Krishnagiri.

48 SUPPLIERS NEWS BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

QIAGEN strengthens digital PCR platform, QIAcuity ecosystem

QIAGEN N.V. has announced non-invasive prenatal testing methods such as amniocentesis
new additions to the growing (NIPT) solutions to QIAGEN’s that can endanger the fetus and
number of applications for dPCR franchise. NIPT requires mother. A co-exclusive licensing
QIAcuity, its ultrasensitive digital only a blood sample from the and co-marketing agreement with
PCR (dPCR) platform that has set mother, and
new standards by using so-called replaces more German life-sciences
nanoplates to process samples invasive testing startup Actome
in two hours rather than the five GmbH extends
hours required by other systems. QIAcuity’s reach
QIAGEN has entered into two beyond genomics
new collaborations into proteomics,
that extend enabling the
the QIAcuity quantification of
ecosystem. A proteins as well
collaboration as the analyses of
with Atila interactions between
BioSystems different proteins and
is to provide between proteins and target
genes.

B Medical H.E.L Group expands
operations in India
Systems opens
H.E.L Group (H.E.L), UK-based developer and manufacturer
manufacturing
of innovative laboratory tools for process optimisation, safety,
facility in Gujarat
and scale-up, has announced the expansion of its operations in
B Medical Systems, a global leader
in medical cold chain solutions, India, with an increased focus on high growth areas of biotech
headquartered in Luxembourg, has
inaugurated its new Indian manufacturing and battery testing industries. The move will see the creation
facility in Mundra, Gujarat. Built with
an investment of over Rs 100 crore, the of a wholly-owned subsidiary, H.E.L India, which will provide
facility has an annual production capacity
of 100,000 units of medical cold chain direct sales and marketing, service, and support operations
products such as vaccine refrigerators,
freezers, and transport boxes, which can to customers in India from February 2022. To support
also be quickly scaled up based on demand.
The facility in Mundra is the company’s India’s growing biotech and
first-ever manufacturing facility outside
Europe and is expected to generate pharmaceutical markets,
hundreds of employment opportunities in
the Kutch region. The company has also H.E.L will create a dedicated
recently unveiled the first made in India
multi-mode vaccine refrigerator/freezer regional hub to provide in-
and/or ice-pack freezer unit which will
play a big role in enhancing the National country support directly
Animal Disease Control Programme. B
Medical Systems has also announced that to customers. Until now,
the majority of the workforce on the factory
floor is comprised of women, towards services in India have been
contributing to women empowerment.
successfully operated through

a longstanding distributor

partnership with Skytech

Systems, one of India’s

leading analytical instrument

distribution companies.

H.E.L will continue to work

with Skytech to fully transition operations over the next

twelve months with the current team of experienced service

and support engineers transferring into the new subsidiary

to ensure continuity for existing customers. Supporting the

move, the company will be making several key appointments,

including recruiting an experienced General Manager to build

the regional team, alongside specialist product area capabilities.

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

BD puts focus on HiMedia Labs
high-throughput molecular
testing for infectious diseases bags CE-IVD

BD (Becton, Dickinson and Company) has expanded the BD COR certifications
System to include a new MX instrument for high-throughput
molecular testing for infectious diseases. The new instrument for COVID-19
and its first test for sexually transmitted infections have been CE
marked to the IVD directive 98/79/EC. The new MX instrument testing kits
is the final piece of the BD COR System, which also includes a PX
instrument that can prepare diagnostic samples by automating Mumbai-based HiMedia Laboratories
appropriate pre-analytical processing steps and a GX instrument - HiGenoMB has received CE-IVD
that can leverage the BD Onclarity HPV Assay with extended certifications for the new additions
genotyping to screen for HPV infections. The MX instrument is to its COVID-19 detection portfolio.
built off the proven BD MAX System molecular PCR (polymerase Receiving CE-IVD
chain reaction) technology platform, a medium-throughput certifications for
system typically found in hospital labs, and BD intends to the triplex RT
leverage the BD MAX System menu of infectious disease tests to PCR kit and
create assays that can be performed in high-throughput central Dry-swab
reference labs on the BD COR System. The first test available method
on the MX instrument is the BD CTGCTV2 for BD COR System, kit are
which is designed to use a single test to detect the three most two more
prevalent non-viral sexually transmitted infections — Chlamydia additions
trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas in the
vaginalis (TV). company’s
diagnostics
product range.
Hi-PCR COVID-19
Triplex Probe PCR Kit (MBPCR255)
triplex kit contains three genes- (N)
gene, RNA-dependent RNA polymerase
(RdRp) gene and internal process
control. Hi-PCR COVID-19 Detection
Kit-Dry Swab method (MBT189) is an
RNA Extraction- free test for COVID-
19 diagnosis which involves direct RT
PCR detection of the sample with quick
and minimal preprocessing steps.

Thermo Fisher Scientific Inc.
completes acquisition of PeproTech

Thermo Fisher Scientific Inc. manufacturing of cell and gene models. PeproTech’s recombinant
has completed acquisition therapies as well as in broader cell proteins portfolio complements
of PeproTech for a total cash culture applications, especially Thermo Fisher’s cell culture
purchase price of approximately for use in cellular research media products and will enable
$1.85 billion. Based in the US,
PeproTech is a privately held Thermo Fisher to provide
provider of bioscience reagents customers significant benefits
known as recombinant through an integrated offering.
proteins, including cytokines PeproTech will become part
and growth factors. of the biosciences business
Recombinant proteins are within Thermo Fisher and
used in the development and will be integrated into the Life
Sciences Solutions Segment.

50 LETS TALK HEALTH AND SCIENCE BIOSPECTRUM | FEBRUARY 2022 | www.biospectrumindia.com

Major win against oral cancer

Ahandheld device for early, accurate, and cost- pocket payments and charitable donations or a
effective detection of pre-cancerous lesions combination of these.
in the mouth developed by a Kerala-based
medtech startup has been winning multiple accolades Thus, early detection is very important to
lately. And the timing could not be better as the reduce the expenses and the mortality rate of
World Cancer Day, celebrated on February 4, every patients suffering from oral cancer. Also, since the
year, is just around the corner. conventional diagnostic methodologies are expensive,
time-consuming, need expert technicians, sometimes
After being adjudged the winner of Startup require surgical intervention, etc., there is a huge
India Grand Challenge 2021 and Anjani Mashelkar demand for oral cancer diagnostic techniques that are
Inclusive Innovation Award 2021, Sascan Meditech non-invasive, rapid, and easy-to use.
was recently in the news for its felicitation at the
National Startups Award 2021. The startup has built And we are glad that besides Sascan Meditech,
a biophotonics technology-based device for early there are multiple research projects currently being
detection of oral cancer. conducted in the country to address this concern.

The much required emphasis on the diagnosis For instance, the International Institute of
of oral cancer in India is indeed very crucial today. Information Technology in Hyderabad is working on
Oral cancer, ensuing with an unexplained growth in an automated solution that requires just a smartphone
the mouthparts such as lips, cheeks, sinuses, tongue, as an early oral cancer screening tool. On the other
hard and soft palate, the base of the mouth extended hand, scientists at Ahmedabad University’s School
to the oropharynx, is the most common cancer in of Arts and Sciences are developing a non-invasive
India amongst men. saliva-based test for early detection of oral cancer, in
collaboration with Johns Hopkins University, US. In
As compared to the west, the concern of oral line with this, Nagpur-based startup ErlySign is also
cancer is significantly higher in India as about 70 per working on building non-invasive, early test kits for
cent of the cases are reported in the advanced stages. detecting oral cancer using saliva.
In fact, India is considered as the world capital for
oral cancer cases as it shares one-third of the global Further, National Institute of Biomedical
burden. Genomics (NIBMG), Kalyani, an autonomous
institute funded by the Department of Biotechnology,
In India, epidemiologically, Kerala has the lowest has created a database of genomic variations in
incidence of oral cancer while West Bengal reports oral cancer; the first of its kind in the world. The
the highest. In the western regions of Maharashtra, repository - which will be updated annually with
the highest occurrence of oral malignancy is reported variation data from new oral cancer patients from
in the age group of 60 years, followed by between 40 different regions of India and southeast Asia - has the
and 59 years with a male to female ratio of 2:1. potential to support advances in oral cancer research.

Because of detection in the late phase, the chances These emerging advanced techniques, however,
of cure are very low, almost negative; leaving five- need the endorsement and encouragement of
year survival rates around 20 per cent only. professionals for integration in clinical diagnostic
practices. With Prime Minister Narendra Modi
According to a study published by the Tata announcing that January 16 will be celebrated as
Memorial Centre, the unit cost of treating advanced National Startup Day, a much required push has been
stages of oral cancer (Rs 2,02,892) was found given to innovation, thereby opening doors for many
to be 42 per cent greater than early stages (Rs more innovative products.
1,17,135). The study also revealed that India spent
approximately Rs 2,386 crore in 2020 on oral Dr Manbeena Chawla
cancer treatment, paid for by insurance schemes, Executive Editor
government and private sector spending, out of
[email protected]


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