BioSpectrum India July 2022

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

COVER STORY 21

COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.

PROVIDING Drone technology has ceased to
SUCCOUR being just a mere fanciful and
BY UAVS impractical aspect of Hollywood
blockbusters, making headway into
almost every aspect of modern
industries and services. Naturally,
healthcare isn’t far behind in
leveraging this nifty and reliable
tech to its advantage. Let’s see
how deep has been the penetration
of this aerial supply chain wonder
gadget.

GUEST EDITOR Speaking With

10 25

Biopharma’s “Rapidly expanding
Future Lies In Better medtech sector presents
Production Economics immense opportunities
for domestic companies”
DR S D RAVETKAR, Anish Bafna,

Executive Director, CEO & MD, Healthium Medtech
Serum Institute of India
Biomaterials
Analysis
27
18
Biotech
Have jabs Way of
turned Boosting
redundant? Self-Reliance of
Indian Military

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

Eye Care Gaurav Jain,
Senior Vice
29 President,
Technologies, IKS
Addressing Glaring Health talks about
Gaps in Ocular Healthcare the transformation
of ‘human-led to
Animal Vaccine tech-led’ future of
healthcare.
33
Scan the QR Code »
Growth and Challenges of
Animal Vaccine Market in India Dr Sanjay Singh,
Rajiv Gandhi, Chief Executive
Officer, Gennova
CEO & MD, Biopharmaceuticals
Hester Biosciences throws light on
the role of mRNA
CDMO platform in
oncology research.
35
Scan the QR Code »
Why Indian Pharma Must
Evolve As ‘Value Creator’ Maharukh
Dr Mahesh Bhalgat, Rustomjee,
Chief Scientist
Chief Operating Officer, and Founder,
Syngene International Amaterasu
Life Sciences
Lipid Nanotechnology highlights the
challenges facing
37 the skin care
market in India.
Why Lipid-based Gene
Therapy Is A New Frontier Scan the QR Code »
in Cancer Management
Arun Kedia,

Managing Director,
VAV Life Sciences

Assam Biotech Policy

40

Assam Rolls Out Red Carpet
for BioTech Investments

Regulars

BioEdit .......................................................................... 06
BioMail ......................................................................... 08
Policy and Regulatory News..................................... 12
Finance News.............................................................. 15
Company News.......................................................... 16
Start-up News............................................................. 17
People News................................................................ 44
R&D News.................................................................... 47
Supplier News............................................................. 48
Let’s Talk Health.......................................................... 50

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

Skimping On Quality

Strides Pharma, a unit of Bengaluru-based Strides have increased, Abbreviated New Drug Applications
Pharma Science, has, since May, begun recall of (ANDA) approvals for Indian companies have also
nearly 679,000 bottles of its Losartan Potassium increased. In 2021, the 635 ANDA approvals by the
blood pressure lowering tablets of three strength USFDA were lower than 761 of the previous year and
variants, in the US. Strides Pharma is a distributor of much lower than 844 in 2017. Still, Indian pharma
the tablets produced by Tamil Nadu-based Vivimed companies have bagged 210 approvals. The credit of
Life Sciences. The drug is being recalled as the AZIDO securing 33 per cent of the total approvals goes to the
impurity levels were above acceptable limits and also due intensive R&D efforts of Indian companies.
to deviations in current good manufacturing practices.
There has been a jump in the overall recall of
Strides Pharma is not the only Indian pharma products in the US in several sectors, including pharma,
manufacturer faced with recall of drugs. Around in the first quarter (Jan-Mar) of 2022 as per the latest
the same time in May, Sun Pharma’s US arm began U.S. product recall index report by Sedgwick. In the
recalling 10,500 bottles of a generic drug used for pharma sector, the average pharmaceutical recall of
treating depressive disorders, in the US market. The all types of medicines, in the US has hit a 15-year-high
lot, produced at the company’s Halol (in Gujarat) in the first quarter of 2022, with total number of units
production facility, is being recalled due to the recalled surpassing 435 million.
presence of foreign substances.
As overall pharma recalls increased, it is but natural
The United States Food and Drug Administration that recalls of Indian pharma companies, which are
(USFDA) conducted a Good Manufacturing Practices big exporters to the US, would also increase naturally.
(GMP) inspection of the Halol production facility and Still, the incidents of recall must be reduced to enhance
issued a Form 483 with 10 observations regarding the credibility of products. The various associations of
conditions that may constitute violations of Food, the industry can take lead in this direction. The Indian
Drug and Cosmetic and other related Acts. In yet Pharmaceutical Alliance has taken a lead in the recent
another development, Sun pharma also faced a major past to guide its members in improving production
issue recently as its US-based subsidiary Ranbaxy had facilities to align with the USFDA requirements and
to enter a Rs 3700 crore ($485 million) settlement with avoid the regulator’s observations in Form 483.
two groups in an antitrust litigation in a US district Similar systematic efforts could significantly bring
court. The case involved three drugs and included down such recalls.
multiple antitrust, consumer protection and civil
Racketeer Influenced and Corrupt Organisations Act Reports indicate that post pandemic, the USFDA
(RICO) class actions. Of course, the case is old, prior to has intensified its production site inspections which
Ranbaxy’s acquisition by Sun Pharma. The latter is the could explain an increase in recalls. On the other hand,
fourth largest speciality generic pharma company with the United States Trade Representative, in its special
global revenue of $4.5 billion, having 40 production report on intellectual property (IP) protection and
facilities and selling drugs to 100 countries. Enforcement has continued to put India on the priority
watch list due to absence of required IPR protection.
In November 2021, Sun Pharma and Lupin recalled
some of their products. Sun Pharma recalled 22,750 Providing proper IPR protection is in the purview
blister packs of Loratadine-D tablets due to failed of the government, which needs to initiate the process.
moisture limits, while Lupin recalled 16,200 bottles When the US is the major export destination of Indian
of Gatifloxacin Ophthalmic Solution due to failed pharma, all out efforts are required from all - the
stability specifications. This medicine was produced at government, the industry, industry bodies, export and
the company’s Pithampur plant in Madhya Pradesh. trade authorities - to minimise such actions.

Industry experts point out that while the incidents Milind Kokje
of recall regarding the Indian pharma companies Chief Editor

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

Vol 20; Issue 6; June 2022

Acknowledgements No.1 position in your bioincubator
survey for FY 20-21. The survey
Thank you very much for this important takes so many parameters into
ranking on the bioservices sector. Veeda account, and it surveys so many
Clinical Research would like to further other bioincubators across the
update that the company has three country. We’re really really happy to
clinical units – two in Ahmedabad - see ourselves ranked at No. 1 in such
Shivalik and Vedant; & one at Mehsana, a credible pan-india survey.
which were established in 2004, 2015
and 2018 respectively, designed to meet - Dr Pinky Raychaudhuri, Pune
world-class specifications.
Thank you so much for featuring
- Siddharth Baad, Ahmedabad Syngene International in your ranking
survey for the bioservices sector. Quite
Piramal Pharma Solutions retains interesting.
No 1 position in Indian bioservices
industry survey for FY 20-21. Thank you - Krishnan G, Bengaluru
BioSpectrum for this.
Thanks so much BioSpectrum for the
- Edith Bert, Mumbai IQVIA feature in the June edition.

Venture Center is absolutely - Melissa Arulappan, Bengaluru
delighted to find ourselves at the

Vol 20; Issue 7; July 2022 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
Ravindra Boratkar Alok Srivastava Dr Manbeena Chawla Singapore
Editorial: National Business Head- Executive Editor MM Activ Singapore Pte. Ltd.
Chief Editor: Dr Milind Kokje Ad Sales & Marketing 103-104, Rohit House 3, Saradha Mani
[email protected] “NITON”, Block B, First Floor, Tolstoy Marg, Connaught Place, General Manager
Advisor - Content: Vijay Thombre 11/3, Palace Road, Bangalore 560001 New Delhi - 110 001 #08-08, High Street Centre,
Editor: Mobile: +91-9845128747 Mobile: +91-8861043732 1 North Bridge Road,
Narayan Kulkarni Tel.: +91-80-41131912/13 [email protected] Singapore - 179094
[email protected] [email protected] Tel: +65-63369142
Executive Editor: Fax:+65-63369145
Dr Manbeena Chawla Mumbai Pune [email protected]
[email protected] Ankit Kankar Ankur Hange
Sub Editor: Dy. General Manager Business Development USA
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10 GUEST EDITOR BIOSPECTRUM | JULY 2022 | WWW.BIOSPECTRUMINDIA.COM

BIOPHARMA’S FUTURE LIES IN
BETTER PRODUCTION ECONOMICS

DR S D RAVETKAR, The routinely recommended vaccines
were developed early in the 20th century.
Executive Director, These included vaccines that protect
Serum Institute of India against Pertussis (1914), Diphtheria
(1926), and Tetanus (1938), these three
Going back to the time when the vaccines were combined in 1948 and given as the
British were concerned about DTP vaccine. Polio vaccine was licensed in 1955.
In 1963, the measles vaccine was developed, and
the health of their personnel, and by the late 1960s, vaccines were also available to
establishing about 15 institutes, protect against mumps (1967) and rubella (1969).
These three vaccines were combined into the MMR
beginning in the 1890s. India’s vaccine in 1971. During the 1970s, smallpox vaccine
greatest strength lies in its people was eliminated due to successful eradication efforts.
- knowledge is critical to research, The vaccine for Haemophilus influenzae type b
was placed on recommended schedule in 1989
develop and manufacture any and Hepatitis B vaccine in 1994. More vaccines
technologies that are designed like Varicella, Rotavirus, Hepatitis A, Pneumococcal
to meet the specific need. The vaccine, Influenza, acellular pertussis vaccine became
biopharma industry remains a available during 1995 to 2010.

vibrant and exciting segment, Historically, vaccines were deemed to be ‘only
partly because of the promise for children’. However, vaccines for adults became
it holds for a better future for increasingly common and necessary. In 2012, the
each of us. Much of the energy Centers for Disease Control and Prevention (CDC),
the national public health agency of the United States,
comes from the dedication recommended that pregnant women get a dose of
of this industry’s participants, Tdap during each pregnancy between 27 and 36
weeks’ gestation. In 2019, the CDC recommended
its inventors, managers, and that Tdap or Td vaccine could be used for booster
innovative suppliers. Let’s look at dosing every 10 years. In late 2020, the first COVID-19
the past, examine the present and vaccines were approved for use in response to the
look at what the future holds for COVID-19 pandemic. Most adults were recommended
to get this vaccine, but limited supplies required adults
the biopharmaceutical industry. to be assigned to eligibility groups in order to protect
those most at risk first.

As more biopharmaceutical manufacturing is
performed worldwide, companies are working to
standardise products and manufacturing processes
on a worldwide basis. The past 20 years have seen
a maturation of the biopharma industry, and it has
transformed from a technology-focused industry
to a process-based and patient-focused. Better
understanding of bioprocess requirements resulted
in dedicated facilities, to produce dedicated process
trains, to multipurpose facilities.

For the next 25 years, manufacturing will be
aligned with global patient care. The transition from
highly specialised processes performed within a small
number of specialist companies in equally specialised
facilities, to those performed on a world-wide basis in

BIOSPECTRUM | JULY 2022 | WWW.BIOSPECTRUMINDIA.COM GUEST EDITOR 11

all continents, with major growth areas outside the US equipment, particularly for upstream manufacture
and EU. In the current environment of poor product (e.g., bioreactors), now thoroughly dominates. Single
pipelines and broader customer bases, the traditional use technology will become cheaper and easier to
commercial operations model of driving revenue with operate with positive modifications for the cost of
ever larger sales forces is no longer sustainable. a developmental programme, meaning that drug
development will become faster and more efficient.
Improvements in manufacturing Single-use process technologies are creating the
The improvements in biomanufacturing today opportunities to reduce clean room footprints and
is having a profound effect on global healthcare. utilities required in the clean rooms. The cost of
Emergence of mammalian cell culture resulted in human healthcare will decrease with increased
the phenomenal increase in titers. Due to changes in productivity and highly efficacious products coming
the expression systems and cell engineering, design, out of single use systems. On the other side we need
clonal selection, and metabolic engineering, the to address the waste management of all the single
industry has witnessed multi-fold improvements in use disposable materials. Green manufacturing will be
product titers, yields, and productivities, across a wide part of new human healthcare with the expansion of
range of products (therapeutic proteins and vaccines). eco-friendly disposable use.
Improved manufacturing will permit greater global
accessibility, will dramatically reduce manufacturing New manufacturing technologies
costs, and will ultimately increase the overall number Decades-old technologies such as
of biological products going into clinical trials. Thus, mRNA technology, Isolator technology, novel
the changes and improvements in manufacturing Chromatography are re-emerging as viable routes
operations today are being directly translated into to more efficient, lower cost, and higher quality
improvements in how patients will be treated in bio-processing. Isolators offer protection of the
the future. Overall improvement in manufacturing exposed sterile drug product during its aseptic
efficiency has avoided the production bottleneck manufacture. Isolator technology is widely used in
that was of concern several years ago. Automation aseptic processing with the minimum environmental
of manufacturing and formulation processes have conditions of Grade D for the room in which the
completely changed the bio-manufacturing arena and isolator is located. The move is expected to reduce
contributed to reducing cost and increasing yield costs, processing times and risk to the product as well
The removal of animal-derived components as provide a safer and more comfortable environment
from all aspects of production, standardisation for operators.
and harmonisation will allow us to better evaluate
the effectiveness of one product compared with a What the near future holds
similar product produced by a different institution Biopharmaceutical manufacturing outside of
or a different process, allowing better choices to be the major market countries is increasing. Mergers,
made. Better controlled commercial manufacturing acquisitions and partnering are becoming more
processes providing more reliable and sustainable strategic. Corporate mergers and acquisitions are
delivery of new biopharmaceuticals for the treatment being directed to improving R&D pipelines. Many large
of life-threatening diseases to improve patient’s lives. companies are now focusing more on acquiring smaller
This will result in higher quality production and release companies and licensing-in candidate products.
of product. Increased standardisation of Bioassays, This means bioprocesses will be simpler, smaller,
Validation parameters have become more stringent. disposable, requiring minimal utility and energy inputs,
There has been movement for harmonisation when while capable of standing up to increased regulatory
the same assay is performed at multiple sites. and quality requirements. The focus will be on
designing robustness (eg.,QbD, PAT) and being able to
Emergence of single-use tech deploy processes to all parts of the globe. Over the next
The trend towards adoption of single-use few years, improved production economics will help
equipment continues, with rapid growth in this market to develop new therapeutics and vaccines designed to
projected. As confirmed by survey data, single-use treat more targeted and specific diseases.

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

DBT renews CORBEVAX bags DCGI nod as
MoU with Bill & heterologous COVID-19 booster dose
Melinda Gates
Foundation Hyderabad-based Biological E (BE) has announced that its CORBEVAX
COVID-19 vaccine has been approved by the Drug Controller General of
The Department of India (DCGI) as a heterologous COVID-19 booster dose to individuals
Biotechnology (DBT) and the aged 18 years and above after six months of administration of primary
Bill & Melinda Gates Foundation vaccination (two doses) of COVAXIN or COVISHIELD vaccines
have renewed the Memorandum
of Understanding (MoU), for restricted use in an emergency. BE’s
originally signed in 2012, to CORBEVAX is the first such vaccine in India
support innovative approaches to be approved as a heterologous COVID-19
for developing new preventions, booster. Recently, BE has furnished its clinical
therapies and interventions trials data to the DCGI who after a detailed
needed to solve health evaluation and deliberations with the Subject
(human and animal), food and Experts Committee, granted their approval for
nutritional inequities on June 7, administering the CORBEVAX vaccine as a
2022 in New Delhi. The renewed heterologous booster dose to people who have
MoU pledged a combined already taken two doses of either COVISHIELD
$50 million investment to the or COVAXIN. BE’s clinical trial data showed
joint initiative, to continue to that the CORBEVAX booster dose provided
explore and expand funding significant enhancement in immune response
arenas and mechanisms to and the excellent safety profile required for an
support innovators, focused on effective booster. BE has conducted a multicentre
early-mid stage research and Phase III placebo-controlled heterologous
product development to tackle booster clinical trial in 416 subjects from 18 to 80 years of age who
health and developmental were previously vaccinated with two doses of either COVISHIELD or
issues. The event also saw the COVAXIN at least 6 months before the administration of CORBEVAX
announcement of the latest open as a booster dose. The booster dose of CORBEVAX increased the
call for funding on Diagnostics neutralising antibody titres in the COVISHIELD and COVAXIN groups
for Neglected Tropical Disease significantly when compared to the placebo.
(NTD)- Lymphatic Filariasis
(LF). The call focuses on ICMR issues guidelines for
developing point-of-care, novel management of Type 1 Diabetes
cost-effective diagnostics for
lymphatic filariasis for use in The Indian Council of Medical Research (ICMR) has released guidelines
national Lymphatic Filariasis for the management of type 1 diabetes in the country. The ICMR type
elimination programs. The 1 diabetes guidelines come at a time when the SARS-CoV-2 pandemic
goal of this challenge is to has disproportionately affected people with diabetes, exposing them to
have a reasonably inexpensive, a high risk for severe illness and mortality. The ICMR type 1 diabetes
durable and accurate point of guidelines is a comprehensive document providing advice on care
care testing method(s) that can of diabetes in children, adolescents and adults with type 1 diabetes.
be used in developing/remote All chapters in this guideline have been provided with formation to
geographies. reflect advances in scientific knowledge and clinical care that have
occurred in the recent past. The guidelines focus on several aspects
related to diabetes such as epidemiology, lifestyle, drugs, monitoring,
complications, education etc. There are still formidable challenges in
providing equitable treatment to everyone with type 1 diabetes in the
world and India is no exception to this. It is hoped that with improved
diabetes control, the dreaded complications of diabetes like blindness,
kidney failure, amputations, heart attacks and stroke, not to mention
diabetic ketoacidosis, impotence and painful neuropathy can all be
reduced, if not totally eliminated.

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14 POLICY AND REGULATORY NEWS BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Health Ministry issues guidelines to manage Monkeypox

In view of the increasing reports of specimens should be transported NIV (Pune) routed through the
Monkeypox (MPX) cases in non- to the Apex Laboratory of ICMR- Integrated Disease Surveillance
endemic countries, as part of a Programme (IDSP) network
proactive and risk-based approach of the respective district/state.
for management of Monkeypox and The Guidelines on Management
to ensure advance preparedness of Monkeypox Disease include
across the country, Union epidemiology of the disease
Ministry of Health and Family including host, incubation period,
Welfare has issued ‘Guidelines period of communicability and
on Management of Monkeypox mode of transmission; contact
Disease’. As per the Guidelines, and case definitions; clinical
a confirmed case is laboratory features and its complication,
confirmed for monkeypox virus diagnosis, case management,
by detection of unique sequences risk communication, guidance on
of viral DNA either by polymerase Infection Prevention and Control
chain reaction (PCR) and/ (IPC) including use of personal
or sequencing. All the clinical protective equipment.

Govt invests North India’s
first Biotech Park
Rs 4.87 Cr in opens in Jammu

high-powered Dr Jitendra Singh, Union Minister of State (Independent
Charge) Ministry of Science and Technology, recently
magnetron tech inaugurated North India’s first industrial biotech park in
Ghatti, Kathua, Jammu along with Manoj Sinha, Lieutenant
The government is supporting indigenous Governor, UT of Jammu & Kashmir (J&K). The biotech
development of high-powered magnetron park would act as a hub for incubation of new ideas and will
technology used mainly for cancer act as a robust platform to support the agri-entrepreneurs,
radiation therapy. A Memorandum of startups, scientists,
Understanding (MoU) has been signed scholars and students
not only from J&K
between Technology and Ladakh but also
Development Board from nearby states of
(TDB) of Department Punjab, Haryana and
of Science and Himachal Pradesh. The
Technology and park at Kathua has the
Panacea Medical potential to produce 25
Technologies, startups in a year which
Bengaluru to provide will be among its great
financial support for contributions to this
development and commercialisation of region. Work on the two
‘S Band Tunable Magnetron for Particle industrial biotech parks, one at Ghatti, Kathua, Jammu
Accelerators’. TDB has agreed to provide and the other in Handwara, Kashmir jointly funded by
loan assistance of Rs 4.87 crore, out of the Department of Biotechnology, Government of India,
the total project cost of Rs 9.73 crore to Ministry of Science & Technology and Jammu & Kashmir
the company. High-powered Magnetron Science, Technology & Innovation Council was started
developed by CSIR-Central Electronics in February 2019. CSIR-Indian Institute of Integrative
Engineering Research Institute, Pilani for Medicine, (IIIM) Jammu has been entrusted with the
commercial use will be a groundbreaking responsibility of implementing the project.
technology for oncologists to treat even 2
mm diameter brain tumour with precision
radiation with very little side-effects.

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com FINANCE NEWS 15

Eight Roads Ventures Multiples
announces $250M Private Equity-
healthcare fund for India led consortium
invests Rs
Eight Roads Ventures has announced the first dedicated $250 6,850 M in
million healthcare and life sciences fund for India. The new fund is BDR Pharma
amongst the largest for the sector in India, reinforcing the company’s
commitment to the country by bringing the total amount managed Multiples Private Equity is
by Eight Roads in India to $1.6 billion. The new fund will continue to leading an investment of Rs
focus on early to growth-stage investments in life sciences, healthcare 6,850 million, along with a
few other marquee financial
services, consumer health and digital investors, for a ~9.3 per cent
health. With this new fund, the team will stake in BDR Pharmaceuticals
make minority investments in a further International. Multiples is
15 to 20 ambitious companies looking the first private equity (PE)
at both smaller investments as well as investor in Mumbai-based
investments up to $40 million. Eight BDR Pharma. The consortium
Roads has backed innovative businesses of investors participating
in India since 2007. The launch of this along with Multiples include
healthcare fund reflects its confidence in institutional investors such as
the evolution of the Indian market and the investment arm of Times
a commitment to helping ambitious founders scale. The Eight Roads Group, QRG Invest (Havells
network constitutes one of the largest venture platforms in the world, Family Office), and high
which now manages over $8 billion of capital across China, India, networth individuals Nishant
Japan, Europe and the US. This ecosystem lends capacity and scale, Agarwal of Avighna Group, and
setting up powerful efficiencies, deep domain expertise, and the ability Mallika Srinivasan of TAFE.
to trace trends and understanding across geographies. The funds will be used by the
company to build additional
Pristyn Care acquires Ratan Tata research and development
& Tiger Global-backed Lybrate capabilities in current and
emerging areas, accelerate
Gurugram-based Pristyn Care has announced the acquisition of investments in manufacturing
the health-tech platform Lybrate to bring in synergies on overall capacity expansion and
healthcare delivery and foray into primary care. In the coming days, enhance the degree of vertical
the companies will work towards combining the business operations integration. The company
seamlessly. The pandemic has brought about massive shifts in patient will also selectively pursue
behaviour, especially most of them seeking online consultations and inorganic opportunities to
communicating with doctors through build scale.
text, voice, and video from anywhere,
anytime. However, for secondary care
surgeries, OPDs and offline consultations
continue to be an important factor with
technology bringing in improved access,
convenience, and hassle-free experience.
Many such changes have accelerated the
way healthcare delivery is seen in India,
leading to higher digital adoption, which will further shape the future of
the healthcare industry. With this partnership, Pristyn Care’s plans to
expand its existing health-tech capabilities and offerings in primary care.
The partnership will help Pristyn Care further promote excellence in the
delivery of healthcare services with an enhanced pan-India footprint.
Lybrate’s 150 employees will be joining Pristyn Care’s family.

16 COMPANY NEWS BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Medtronic launches new tech to treat brain aneurysms

India Medtronic, a wholly owned Since brain aneurysms are most
subsidiary of Medtronic plc,
has announced the launch of prevalent between 35 and 60 years
CE marked fourth-generation
flow diverter, Pipeline Vantage of age and about 40 per cent of the
with Shield Technology for
endovascular treatment of brain ruptures are fatal, a great number
aneurysms. Pipeline Vantage with
Shield Technology is a new flow of disability adjusted life years are
diverter with enhanced design
features to both the delivery system lost. Advances in flow diversion
and implant. These features allow
physicians to deliver, deploy over the last 10 years has helped
and treat brain aneurysms,
intracranial aneurysms with to significantly reduce the rate of
greater ease and reliability while
providing a scaffold that promotes aneurysm rupture. Medtronic’s

newest Pipeline Vantage

Embolization Device comes with

growth of cells in the inner lining a one-of-its-kind warranty for
of the target blood vessel. Every
year in India, around 76,000 to device efficacy. With this, the
200,000 cases of aneurysmal
subarachnoid haemorrhage (SAH) company hopes to boost patient
are reported to have occurred.
assurance on its offerings while

encouraging flow diversion as a

form of therapy for aneurysms.

Stryker’s Global Trivitron Healthcare
Technology Centre open
for business in Gurugram unveils RTPCR-based

US-based medical technology company Stryker has kit for monkeypox virus
opened a new research and development facility,
Stryker’s Global Technology Centre (SGTC), at the Chennai-based Trivitron Healthcare has
International Tech Park, Gurugram. The 150,000 sq developed the Real-Time PCR-based kit for
ft facility will help accelerate innovation in India and the detection of monkeypox (Orthopoxvirus)
globally, and further support the company’s mission virus. The kit is four-colour fluorescence-based,
to make healthcare better. The centre is designed to which can differentiate between smallpox
connect with healthcare professionals and develop and Monkeypox in a one-tube single reaction
new technologies to meet their needs. Customers can format, with a total turnaround time of one
access a range of Stryker’s products and learn more hour. In this four-gene RT-PCR kit, the first
about the engineering behind the company’s life- target detects the viruses in the wider orthopox
changing technologies and innovations. Stryker is one group, the second and third targets detect and
of the world’s leading medical technology companies differentiate the monkeypox and smallpox
and, together with its customers, is driven to make virus respectively and the fourth target detects
healthcare better. The company offers innovative the internal control corresponding to human
products and services in Medical and Surgical, cell to address the assay performance and aid
Neurotechnology, Orthopaedics and Spine that help in following its epidemic spread. This kit is
improve patient and healthcare outcomes. available as Research-Use only (RUO) and
based on literature search and in-silico design.

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com START UP NEWS 17

Mankind Pharma invests C-CAMP kicks
in medtech startup EzeRx
off flagship
Bhubaneswar-based MedTech startup EzeRx Health Tech has
received seed funding from certain promoters of Mankind startup
Pharma, including Sheetal Arora, Chief Executive Officer,
Mankind Pharma. The collaboration is aimed at strengthening investment
the healthcare infrastructure while
integrating more advanced screening initiative ‘TiE
solutions accessible across the country,
taking a more patient-centric approach. India Angels’
The fund raised will be used for scaling
up its operations and marketing along Bengaluru-based Centre for Cellular
with boosting its sales in various and Molecular Platforms (C-CAMP)
markets across India, Africa, and South has inked a Memorandum of
East Asia, seeking global certifications Understanding (MoU) with TiE
and boosting its R&D efforts. EzeRx, India Angels (TIA), an initiative of
founded in 2018, has developed an easy, TiE global, represented through
painless and non-invasive screening TiE India Foundation, to kick off
solution to identify primary health an ambitious entrepreneurship
parameters at an early stage such as cum technology transfer initiative,
ailments in liver, kidney, lungs and blood glucose level and C-CAMP Lab Ventures. C-CAMP Lab
common problems like anaemia, in less than a minute without Ventures aims to transfer C-CAMP’s
withdrawing blood from the human body. formidable portfolio of cutting-
edge, market-ready and translated
BIRAC celebrates 10 years with technologies to select early-stage or
Biotech Startup Expo 2022 aspiring bio entrepreneurs against
a significant investment funding
To celebrate 10 years of Biotechnology Industry Research of up to Rs 100 lakh annually
Assistance Council (BIRAC)’s enabling efforts towards from TIA. Under its mandate to
progressing India’s Biotech Sector, an event was organised on foster bio sciences research and
9-10th June, 2022 at Pragati Maidan, New Delhi, inaugurated innovation in India, C-CAMP has an
by Prime Minister Narendra Modi. The event comprised of established translational research
programme, the Discovery to
Biotech Startup Expo Innovation Accelerator (DIA) which
which showcased 75 through validation, de-risking and
successful startups licensing, bridges exciting scientific
supported by BIRAC, discoveries to mature technologies
75 specialised biotech with strong commercial and impact
incubation centres potential. The DIA portfolio has
supported by BIRAC, several key technologies in the
21 IITs/ universities, areas of Healthcare, Agriculture
50 successful and Environment ready for
startups supported commercialisation. Through
by the Department C-CAMP Lab Ventures, this portfolio
for Promotion of will be up for grabs by seasoned
Industry and Internal startups, entrepreneurs across India
Trade (DPIIT), as well as aspiring bio entrepreneurs
infrastructure created by BIRAC, helpdesks and various national from diverse backgrounds like
and international programmes of BIRAC. In addition, the event management, engineering,
also witnessed the launch of an e-Portal of 750 biotech products, clinical & other domains. Selected
products developed during the 75th year of independence and the entrepreneurs from this programme
coffee book of 75 women biotech entrepreneurs. will receive seed funding by TIA as
well as hand holding and mentorship
by C-CAMP to increase their chances
of success as bio-businesses.

18 ANALYSIS BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Have jabs
turned

redundant?

The time has come to introspect on whether there is a need for new vaccines or can be done
with the existing ones. In the face of existing data and research, natural immunity in large

population groups indicates greater resilience against the evolving SARS-COV-2. With experts
predicting that COVID-19 will become endemic sooner than we imagined, the government

should be on the same page with the National Technical Advisory Group on vaccines and take
calculated steps based on independent research and ‘solid’ scientific data when it comes to
launching new vaccines or pushing for boosters.

When things seems to be getting normalised, where we are today. Vaccinations keep us safe as
reports started coming in of three schools individuals and as part of society. If we step back and
in Ghaziabad, Noida being shut after 18 strive to understand, BA.2 variant data is what we see
students were found infected with COVID-19 and the isn’t a surge in the pandemic, but the new realities of
overall cases going up in Delhi and Mumbai. While COVID-19 as an endemic.
it is understood that ‘cases’ alone do not indicate
illness, the alarm has been sounded yet again. The vaccine scenario

Though India has been able to administer over Vaccinating a large and diverse population as
195.07 crore COVID-19 vaccines, a sizable population in India is inherently complex, although India has
below the age of 12 are yet to be vaccinated. The experience in running highly successful children’s
vaccination for the age group 12-14 years was immunisation programmes. It also has a reputation
started on March 16 and so far, more than 3.51 crore for producing large amounts of different life-saving
adolescents have been administered with the first vaccines of high quality and at a lower cost.
dose of COVID-19 vaccine (as on June 12). A few
of the vaccines are in the pipeline to be launched, The Government of India had set a target of
however, apart from COVISHIELD and COVAXIN vaccinating 100 per cent of the population by
none of the other vaccines has been able to make its December 2021, however, the magic figure could not
mark in the Indian market. be achieved. Things were better as compared to the
US and the UK where the vaccine hesitancy was more
Though there have been very less cases of deaths and is still so.
due to COVID in recent days, the XE variant of
coronavirus has triggered fresh concerns about a new Says Dr Virander Chauhan, Distinguished Visiting
wave. Amidst these scenarios, the need has risen to Professor, Institutions of Eminence, University
go for booster doses, the need for more new vaccines of Delhi, and Founder ETI, “By and large, India’s
and to approach the unvaccinated to get them jabbed. COVID-19 vaccination programme has been very
successful, although, the country was somewhat
According to Former Food and Drug behind other countries in rolling out vaccines for the
Administration (FDA) Associate Commissioner population below 18.”
Professor Peter Pitts, vaccinations are what got us
Dr Anup R Warrier, Head - Infectious Diseases

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com ANALYSIS 19

and Infection Control, Aster DM Healthcare - India ‘‘India has data on COVID
Units says, “We have done exceedingly well to deaths but there are no
vaccinate the majority of the population with at least statistics to establish
two doses of the vaccine. Newer data suggest that which vaccine prevents
the protection against death and hospitalisation lasts hospitalisations.’’
much longer than previously believed with just the - Dr Gagangdeep Kang,
two doses. Thus, while we will strive to complete the Virologist
boosters for the eligible population, we are in a much
safer zone compared to what we were a year ago.” ‘‘I do not believe that
there is a need for more
Though a majority of the Indians have faith
in COVID vaccines, it seems all the excitement vaccines.’’
has fizzled out like it was two years back when - Dr Subhrojyoti Bhowmick,
the coronavirus stuck. COVISHIELD and Clinical Director, Academics
COVAXIN became the most popular ones and were
administered the most to the Indians. and Research Depts,
Peerless Hospital, Kolkata
Saizen Global Insights and Consulting in
collaboration with HEAL Foundation have conducted ‘‘Unvaccinated people
INDIA VAX-SCENE Survey on vaccine perception in have higher concerns,
February 2022. Over 90 per cent of Indians believe and effective healthcare
the vaccine’s role is vital in fighting against COVID-19 communication is the key
and 85 per cent of Indians consider COVID-19 to address the concerns.’’
vaccines to be safe and effective. - Dr Swadeep Srivastava,

Dr Swadeep Srivastava, Founder, HEAL Founder,
Foundation says, “The survey has revealed one more HEAL Foundation
thing that unvaccinated people have higher concerns,
and effective healthcare communication is the key ‘‘We have done exceedingly well
to addressing their half-cooked information and to vaccinate the majority of the
convincing them to go for the vaccination without
hesitation at the earliest.” population with at least two
doses of the vaccine.’’
GOQii’s India Fit Report 2022 recently conducted - Dr Anup R Warrier,
a ‘COVID-19 Trust in Vaccines and Vaccination’
survey with over 10000+ users. The report mentions Head - Infectious Diseases and
how 91 per cent of Indians feel vaccination will Infection Control, Aster DM
protect them from COVID-19. Healthcare - India Units

Is there a need for more vaccines? ‘‘By and large, India’s COVID-19
vaccination programme has
Though COVISHIELD and COVAXIN have been very successful.’’
vaccinated a majority of the Indian population, the - Dr Virander Chauhan,
Government of India has approved vaccines from
Moderna and Johnson and Johnson, which are not Distinguished Visiting Professor,
so popular in the Indian market. Even the Sputnik V Institutions of Eminence,
from Russia, which underwent clinical trials in India, University of Delhi,
couldn’t make its mark in the Indian market. Even and Founder ETI
Covaxin trials for those below the age of 12 have been
conducted, however, the efficacy is not clear.

Even India recently began administering
precaution doses of COVID to above 18 years of age.
The Technology Development Board (TDB), Ministry
of Science & Technology has supported Hyderabad-
based startup Sapigen Biologix for the development
and commercialisation of two novel vaccines – the
Intranasal COVID-19 Vaccine.

The Drugs Controller General of India (DCGI)
has recently approved US-based Novavax and Serum
Institute of India’s (SII) emergency use authorisation

20 ANALYSIS BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

The DCGI gave an emergency use nod to make its mark clear.
to Biological E’s Corbevax in children The World Health Organisation (WHO), on April
between the ages of 12 and 18 years,
however, the National Technical 2 has suspended the supply of Bharat Biotech’s
Advisory Group (NTAGI) seemed to Covaxin through the UN agencies after finding issues
differ from the stand taken by the with the good manufacturing practices. It has led to
government and a member of the confusion among many who have taken COVAXIN
working group of NTAGI went on and questions are being raised on how CDSCO and
to say that NTAGI did not give any DCGI could approve certain vaccines when the
recommendation to the Centre on a vaccine data is not in place.
vaccine for children below 15 years of
age. Experts have raised concerns over We are all aware about the controversy pertaining
the vaccine’s efficacy and safety data to Molnupiravir, the first oral anti-covid drug and
which are not in the public domain. in January, 2022, Dr Balram Bhargava, Director
General, the Indian Council of Medical Research
(EUA) for Novavax’s protein-based COVID-19 (ICMR), then said, “The drug (Molnupiravir) has
vaccine for adolescents aged ≥12 to <18 years in major safety concerns’. The issue was raised after
India. The vaccine, also known as NVX-CoV2373, is DCGI and CDSCO approved the drug in the last week
manufactured and marketed in India by SII under the of December. It may also be noted that CDSCO had
brand name Covovax and is the first protein-based granted permission to 13 Indian pharma companies.
vaccine authorised for use in this age group in India.
A study conducted by University of Virginia
Jabs against recommendations Health, US reveals emerging differences in COVID-19
infection rates in recipients of different vaccines. The
The government some time back announced study also finds that older recipients of the Pfizer
that Hyderabad-based Biological E’s Corbevax will vaccine generated fewer antibodies than did younger
be used to vaccinate 12-14-year-olds in the country. recipients, but this wasn’t the case for Moderna,
The approval is for use as a booster dose, but as a where age did not appear to be a factor.
standard two-dose vaccine for 12-14-year-olds only.
The DCGI gave an emergency use nod to “Corbevax” Cases like this are many. In the Indian context,
in children between the ages of 12 and 18 years, the Health Ministry should have taken proactive
however, the National Technical Advisory Group steps to report adverse events due to vaccines, among
(NTAGI) seemed to differ from the stand taken by adults and children and provide a clear picture to the
the government and a member of the working group citizens rather than fueling doubt and apprehension
of NTAGI went on to say that NTAGI did not give among many. On one hand we are celebrating on
any recommendation to the Centre on a vaccine for achieving certain targets while on the other ignoring
children below 15 years of age. Experts have raised the fact that there may be serious health hazards for
concerns over the vaccine’s efficacy and safety data many who have taken certain vaccines for COVID-19.
which are not in the public domain. A glaring oversight is the lack of easy accessibility
and informed consent of Adverse Events Following
According to Dr Subhrojyoti Bhowmick, Clinical Inoculation (AEFI) reported so far.
Director, Academics and Research Depts, Peerless
Hospital, Kolkata, “I do not believe that there is a Much ado about nothing?
need for more vaccines although we have a larger
portion of our population below 12 years of age which Companies are in a rat race to launch new
has not been vaccinated and no approved vaccine vaccines and currently, they are being charged. It will
exists for the same.” be a challenging task for the government to insist
on its population going in for the booster dose, let
Opposed to scientific data aside a sizable population yet to be vaccinated. Also,
numerous vaccines are in the pipeline and time will
The Central Drugs Standard Control Organisation say whether these are required knowing that the virus
(CDSCO) has consistently failed to support its own is slowly becoming endemic.
approvals and has lacked transparency in public
health matters. On some occasions it has even As a virologist, Dr Gagangdeep Kang, rightly points
maintained an uncanny silence where it is supposed out that India has data on COVID deaths but there
are no statistics to establish which vaccine prevents
hospitalisations. Data is important because we need to
be prepared for future pandemics. Data will give us an
idea about what needs to be done next.

Sanjiv Das
[email protected]

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com DRONES 21

PROVIDING
SUCCOUR
BY UAVs
Drone technology has ceased to being just a mere fanciful and impractical
aspect of Hollywood blockbusters, making headway into almost every aspect of
modern industries and services. Naturally, healthcare isn’t far behind in leveraging

this nifty and reliable tech to its advantage. Let’s see how deep has been the
penetration of this aerial supply chain wonder gadget.

Drones also referred to as unmanned aerial in the sector. The drone technology in healthcare,
vehicles (UAV), are slowly making their previously envisioned for aerial and military use,
presence felt in the healthcare sector. is touted to become the future of healthcare. With
Gone are the days when sending the advent of drones, it is possible to deliver blood,
emergency life-saving medicines to vaccines, birth control, snake bite serum and other
the remotest part of the country was medical supplies to rural areas, where it can reach
unthinkable and the victims who require immediate medical attention
would take days to
reach. within minutes. The need for drones was more
With the relevant
advent when
of drone COVID-19
technology vaccines
and healthcare
and medtech were
companies transported
adopting to remote
it in a new corners during the
way plus pandemic. Though
the government’s worldwide
push, has opened a drones have
new era for drones in been used in the
the health sector. healthcare industry
for quite some time, India
The usage of drones in is slowly adapting drones to
the healthcare industry is ensure the last mile delivery
becoming a new norm that of medicines, vaccines etc.
is set to bring in a revolution
The drone market

22 DRONES BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Reforms in the drone sector Shortcomings in
have been well received by our healthcare can be
addressed using drones
startups, industry, academia and lives can be saved
and people at large by adopting advanced
- Amber Dubey, logistics in the sky
Joint Secretary, - Rashmi Pimpale,

Government of India, CEO, RICH
Ministry of Civil Aviation

There are possibilities of regulatory approvals from competent authorities for
confusion and lack of clarity various kinds of drones and utilising air space for
delivering medical supplies restricted to medicines,
on standard operating vaccines and surgical materials.
procedures
Amber Dubey, Joint Secretary, Government of
- Prof. (Dr) Balram Bhargava, India, Ministry of Civil Aviation, says, “Reforms in the
Director General, drone sector have been well received by our startups,
ICMR industry, academia and people at large. I compliment
ICMR for their stellar role in conducting experimental
Trials aim to demonstrate a drone-based vaccine deliveries in the North East
faster supply chain for sample region and Andaman islands.” According to ICMR,
collection by effectively using the longest drone flight under this project carried
3525 units of medical supplies from Mokokchung to
drone delivery technology the district Tuensang in Nagaland (approx 40 km). A
- Ankit Kumar, total of 17,275 units of medical supplies were delivered
CEO, through drones in the states of Manipur and Nagaland.

Skye Air Mobility The ‘Guwahati Declaration,’ unveiled by
Dharmendra Pradhan, Union Minister of Education,
Drones resolve the issues Entrepreneurship and Skill Development and Dr
of rapid sample collection, Himanta Biswa Sarma, Chief Minister of Assam
medical supplies delivery, during North East Research Conclave (NERC) 2022
diagnosis and much more mentioned drone technology development and
application during where IIT Guwahati is going to
- Vikram Thaploo, play a major role.
CEO,
Drones in use
Apollo Hospital’s
HealthNet Global Over 15 startups in India are into manufacturing
drones where apart from the healthcare, the uses
According to a recent report from FICCI and are in the Agri sector also. Companies such as
EY, there are estimates that the drone market in ideaForge have developed Netra, which is built
India will surpass $900 million in the next two to for aerial surveillance and is being actively used
three years. A report by 6Wresearch states that the by BSF, NDRF and state police departments.
Indian UAV market is poised to grow at a CAGR of Additionally, companies such as Kitemaps AMS
18 per cent during 2017–23, in terms of revenue. BIS (Redwing Aerospace Labs), General Aeronautics,
Research predicts that the market for commercial IoTechWorld Avigation and TartanSense, amongst
drones superseded the military market by 2021, others support various aspects including surveillance,
cumulatively hitting approximately $900 million. R&D in analytics and aerial robotics, commercial
data acquisition, as well as AI-based robotics for
The Indian Council of Medical Research (ICMR) agriculture support, and many more.
recently released ‘Guidance Document for use of
Drones in Healthcare’. The institute has published More specifically in healthcare, companies such as
the document based on the field experience in Marut Drones use AI to predict mosquito population
Manipur and Nagaland. The objective of this density and larvae count, and create a location,
document covers areas such as how to obtain gender, species and subspecies-wise density maps,
thus helping eradicate serious infection spread.
Daybest Research is another innovative Indian

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com DRONES 23

Drones are expected to continue SRL diagnostics has
their trajectory in healthcare completed the successful
industry with its adoption
spreading across the globe trial for sample delivery
- Aarti Chitale, between two locations in
Senior Industry Analyst, Gurgaon and plans to do
Healthcare & Lifesciences,
Frost and Sullivan these trials in Mumbai
- Anand K,

CEO, SRL Diagnostics

startup that worked with ICMRs iDrone Project to The drone technology has to
enable vaccine delivery in remote India. overcome logistics hurdles
and is perhaps a solution,
Redcliffe Labs, a unit of Redcliffe Lifetech in the a game-changer and not
US, has launched the first commercial drone flight a challenge to use in rural
in the country’s healthcare sector. The company areas
has recently opened its commercial drone corridor - Dheeraj Jain,
between Uttarkashi and Dehradun. Redcliffe Lab Founder, Redcliffe Labs
delivered 5 kgs payload in temperature-controlled
boxes from Gyansu, Uttarkashi to Vivek Vihar, There is a need to constantly
Dehradun, which is 60-kms aerial distance. Based monitor when drones are being
on the successful trial runs Redcliffe Lifetech is operated in the air because we
gearing for commercial roll-outs. The company is
confident that drone technology will prove to be a need to differentiate between
game-changer as it will help to speed up the process the genuine and foreign ones
and increase the level of efficiency as it will be able
to penetrate the sub-cities, semi-urban and remote - Shishir Kumar Upadhyaya,
areas as well expanding the horizon of its diagnostic Principal Adviser - University of
services.
Southern California
Piramal Foundation piloted automated drones
for faster transportation of sputum samples for requisite temperature for 6-8 hours,” says Anand K,
screening and diagnosis in hard-to-reach areas CEO, SRL Diagnostics.
of Kalahandi district, Odisha. The pilot project in
collaboration with Redwing Labs saw a significant Initiatives
time reduction to cover the distance to the diagnostic
centre. With the deployment of drones, a distance of Apollo Hospital’s Healthnet Global, World
36 kms of remote, hilly, uneven and forest-covered Economic Forum (WEF) with the Government of
terrain which usually takes ~55 minutes by road, was Telangana and NITI Aayog has come up with an
covered in half the time, around 20 minutes. Lately, insight report on ‘Medicine from the Sky’, a drone-
Aster DM Healthcare has commenced drone delivery based method of taking healthcare to the masses.
trials with drone technology-based logistics firm Skye The report highlights a comprehensive look at the
Air Mobility in Kerala. The companies recently joined Medicine from the Sky project whereby, in the first
hands to transport essential medicine and critical lab scheme of its kind, vaccines were delivered beyond
samples from Aster MIMS Hospital to Aster Mother the visual line of sight (BVLOS) using drones.
Hospital Areekode using drones.
Says Vikram Thaploo, CEO, Apollo Hospital’s
Ankit Kumar, CEO, Skye Air Mobility said, “These HealthNet Global, “Drones can make the delivery
trials aim to demonstrate a faster supply chain for of essential medicines, vaccines and other essential
sample collection by effectively using drone delivery supplies, especially to remote areas, faster and more
technology. The technology illustrates the cost- accessible. Transportation barriers happen to be the
effectiveness and reduction in delivery time.” leading cause of lack of healthcare access. Just like
telehealth solves the problem of unavailability of
SRL diagnostics has completed the successful trial doctors at remote locations, drone delivery resolves
for sample delivery between two locations in Gurgaon the issues of rapid sample collection, medical
and plans to do these trials in Mumbai soon. “Sample supplies delivery, diagnosis and much more.”
transfer using a drone takes not more than an hour
in most cases. Samples are carried in temperature- WEF states that drones can be used to bring quality
controlled boxes that are designed to maintain the healthcare to people in the remotest areas of India

24 DRONES BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

There is a general perception that Challenges
drones will make the matter easy for
the healthcare industry. However, There is a general perception that drones will
getting regulatory approvals from the make the matter easy for the healthcare industry.
government for startups and drone However, getting regulatory approvals from the
manufacturers can be a daunting government for startups and drone manufacturers
task. Also, with many terror attacks can be a daunting task. Also, with many terror attacks
being planned via drone from the being planned via drone from the neighbouring
neighbouring country, all aspects need country, all aspects need to look into before giving
to look into before giving a go-ahead. a go-ahead. It may be noted that the entire North
It may be noted that the entire North East region has international borders and a proper
East region has international borders tracking mechanism should be in place to ensure that
and a proper tracking mechanism drones are not misused for human fatality.
should be in place to ensure that
drones are not misused for human Prof. (Dr) Balram Bhargava, Director General,
fatality. Apart from the above concerns, ICMR opines, “Since the usage of drones in the
investing in drones in rural areas can healthcare sector is a relatively new venture in the
be quite challenging due to lower country, there are possibilities of confusion and lack
affordability leading to significantly of clarity on standard operating procedures.”
lower adoption.
Apart from the above concerns, investing in
citing results of a new experimental programme. Over drones in rural areas can be quite challenging due
a 45-day trial, healthcare professionals delivered to lower affordability leading to significantly lower
vaccines, COVID-19 testing samples and medical adoption. Drones run on batteries and limited
products to a population of over 300,000 people, battery life could limit their usage across longer
covered by eight healthcare centres in Telangana. distances, especially in the rural/ remote locations
in India. Also, drones do require the corresponding
Aarti Chitale, Senior Industry Analyst, Healthcare infrastructure such as landing stations, as well
& Lifesciences, Frost and Sullivan, mentions, “With as communication systems, with good Internet
suitable regulatory policies, the country is expected to connectivity, a lack of which will have a direct impact
promote more and more startups to build innovative on their usage.
technologies further advancing the drone market
in the country. Drones are expected to continue When delivering temperature-sensitive
their trajectory in the healthcare industry with their medical supplies such as cold-stored vaccines, the
adoption spreading across the entire globe.” environmental temperature, humidity and air and
weather conditions can not only deplete the quality
According to Rashmi Pimpale, CEO, Research of the medical supplies but also delay the supply
and Innovation Circle of Hyderabad, drones present timelines.
a tremendous opportunity to address supply chain
shortcomings in the healthcare sector, reducing Says Dheeraj Jain, Founder, Redcliffe Labs, “The
stockouts and wastage. Health system shortcomings, drone technology has to overcome logistics hurdles
especially those felt in rural communities that suffer and is perhaps a solution, a game-changer and not a
from a lack of infrastructure and forecasted growth challenge to use in rural areas.”
that outpaces investment, can be addressed using
drones and lives can be saved by adopting advanced The future
logistics in the sky.
There is tremendous scope for drones in the
Shishir Kumar Upadhyaya, Principal Adviser - healthcare sector. However, the easy availability of
University of Southern California says, “There is a drones will lead to security issues where terrorist
need to constantly monitor when drones are being attacks take place using drones. It may be noted
operated in the air because we need to differentiate that India’s Ministry of Civil Aviation notified the
between the genuine and foreign ones. For countries new liberalised Drone Rules, 2021. The previous
like India, there can be a risk of terrorism involved rules which were revealed in March 2021 were
here. This could add up to the existing challenges for called restrictive by stakeholders, after which
drone application.” the government moved forward with certain
amendments that are now in force. With proper
regulations in place, the drone culture in India’s
health sector can be a win-win situation for the
government, healthcare providers and patients.

Sanjiv Das
[email protected]

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com SPEAKING WITH 25

“Rapidly expanding medtech sector

presents immense opportunities

for domestic companies”

Bangalore- based Healthium Medtech Limited «
(formerly known as Healthium Medtech
Private Limited) is a global medtech Anish Bafna,
company focused on products used in surgical,
post-surgical and chronic care. It operates across CEO & MD,
three key markets, India, UK and Rest of the World
and four focus areas: advanced surgery, wound Healthium Medtech
care, urology and arthroscopy, encompassing
52,000 SKUs. One in five surgeries conducted capital firms, government funding and promising
globally uses a Healthium product as on March 31, startups and independent medical devices companies
2021. Having started its operation in 1992 it has developing products specifically for the Indian
become one of the largest independent medical market. The industry currently aims to promote
device companies in India and second largest in orderly growth in order to satisfy the underlying
the surgical consumables market in India with goals of accessibility, affordability, safety, and
its consolidated revenue touching Rs 727 crore quality while focusing on self-sustainability and
for 2020-21. In an interaction with BioSpectrum innovation. Furthermore, recent government and
India Anish Bafna, CEO & MD, Healthium industry initiatives have aimed to help the sector
Group, shared his views about India’s medtech reach its full potential by developing a robust
landscape and future trends. Edited excerpts; regulatory framework with feedback mechanisms,
creating an enabling ecosystem for medical device
How has the med-tech landscape changed manufacturers in the country, focusing on technology
in India? What led to this change, and how innovation, supporting training and capacity building
would you perceive its future changes? programmes, along with promoting higher education
to foster fresh talent and skilled resources in line with
India is currently Asia’s fourth-largest medical the industry’s needs.
device market and one of the top 20 worldwide. In
India, the Medical Technology (med-tech) market Technological advancements have expanded the
is on the upswing with an increasing demand for role of medical technologies to play a critical role
medical products and devices. The Indian medical at all stages of the healthcare chain – increasing
devices size was valued at $ 7.3 billion in 2020 and access, screening, diagnosis, treatment, preparation,
is expected to reach $ 11.25 billion by 2025 as per and monitoring. Moreover, with India looking to
the Frost & Sullivan report. This is partly due to improve self-sufficiency in MedTech as a part of the
rising income levels in India, increased private sector “Make in India” initiative, the rapidly expanding
investment in healthcare, increase in insurance sector presents immense opportunities for domestic
penetration, a growing trajectory of various surgeries, companies such as ours.
and government incentives in the med-tech space.
What has made India boost domestic
Today, India is on the cusp of epidemiological production of medical devices and what has
transition. There is a significant shift in health made the need for precision medical devices
burden from communicable to include non- increase?
communicable diseases, which in turn is driving
the med-tech segment. There is a growing need to The medical device sector is an essential aspect
effectively use med-tech innovations to address of the healthcare ecosystem, and it has been
India’s vast gap between demand and supply of recognised for its role in managing the pandemic
healthcare services.

The Indian med-tech innovation ecosystem
is fast evolving with academic research, venture

26 SPEAKING WITH BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

by rapidly developing economical products at scale and to the company’s brand image and reputation.
within a short period of time. However, the industry Healthium spends considerable budgets in
remains heavily reliant on imports, and high-quality,
low-cost medical devices for patients remain a gap. R&D as well as in clinical testing of new products
Medical devices have been designated as a sunrise and to also ensure that our devices are compliant
sector by the Indian government as part of the ‘Make to global standards and certifications such as
in India’ campaign, which promotes indigenous CDSCO, US FDA, ISO, TGA and EU. Materia-
manufacturers and reduces reliance on imports. vigilance teams also are actively involved in
According to India’s Engineering Export Promotion ensuring device safety and actively tracking any
Council, consumables and disposables are the most untoward incidents.
critical export categories today, accounting for 47
per cent of all exports. The Government itself has strengthened
safety norms on device safety and the stringent
As per the Frost & Sullivan Report, the regulations with EU MDR have created further
penetration of surgical procedures in India has deterrents to counterfeit products. These will help
grown from 1,500 per 100,000 people to 2,000 the industry in a positive manner.
per 100,000 people between 2015 and 2019. In
addition, the gap between India and other emerging How is Healthium placed in the field of
countries has been narrowing over the last few
years as the Indian government has undertaken developing precision medical devices?
various initiatives to increase access to healthcare
across India and to promote exports. The China plus What are the company’s future plans and
One policy has also contributed to the increase in
precision medical devices in India. how does your company intend to make

The pandemic has spurred the demand for easy access of precision med devices
precision medical devices? What is your take
on this? globally?

COVID-19 has spurred the state and central It is our vision to deliver Access to precision
governments to enhance domestic manufacturing MedTech for every patient, globally. We have been
and healthcare infrastructure to ensure self- launching products at a sturdy pace in these focus
sustenance and adequate coverage. areas and adjacencies to serve customer needs
better and fill in need gaps. We have launched
Promoting local manufacturing of medical devices 30 new products since 2018 and have 64 patents
in scale and quality will attract investments in the in US, Europe and India including pending
sector. The spirit of Atmanirbhar Bharat has spawned applications. In addition, Healthium continues
independent precision medical devices companies in to invest heavily in R&D and is opening an R&D
India, which have emerged as global leaders, pioneers centre at Noida soon.
and innovators. The critical success factors for
medical device companies can be outlined as follows: Our manufacturing facilities have several global
accreditations including US FDA, CE, TGA, ISO,
• High-quality standards on devices as these CDSCO etc. We have focused on access across
products play a vital role in surgical outcomes India, UK and the rest of the world. Our products
are present across 80 countries and our sales
• Cost-effectiveness due to global focus on teams cover 90 per cent of the districts in India
rationalising cost and expanding access to healthcare with secondary healthcare facilities, covering
40,000 surgeons across 18,000 hospitals.
• Strong distribution channel across geographies,
effectively reaching out to a fragmented buyer We believe we have a significant opportunity
universe given our differentiated value proposition of
providing high-quality, innovative products at a
• Intellectual property and new product compelling value. Our business strategy is aimed
development engine at exploiting this opportunity by deepening our
geographical presence and market access to expand
Do you think this demand has caused our customer base both in India and globally.
counterfeit medical devices to creep into the
market? If yes, can you suggest ways to beat Expanding our product portfolio to deepen
this threat? our customer relationships with focus on R&D,
product portfolio expansion in our focus areas and
We do not have any data to support trends on selective adjacencies. And, focusing on operational
the rise of counterfeit medical devices but these excellence through manufacturing capabilities with
can cause significant damage to both patient health robust quality and global certifications to continue
to deliver superior value to our customers will be
our priorities.

Anusha Ashwin

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com BIOMATERIALS 27

Biotech Way of Boosting
Self-Reliance of Indian Military

In the recent days, there is much talk about India being self-reliant, intending to reduce the
dependence on importing various materials from overseas. The Indian Military, as well, has
adopted this motto. The Ministry of Defence (MoD) and the Defence Research and Development
Organisation (DRDO) are determined now to boost procurement of indigenous materials and
products that serve the armed forces.

In the first fortnight of January 2022, marking The MoD has adopted a policy that raises
the occasion of Army Day, the Indian Military participation of indigenous firms in manufacturing
unveiled its new combat uniforms with a Digital ‘technical textile’ for the Armed Forces. Technical
Camouflage pattern. This new Army Combat Uniform, textile implies its use for specialised products like
designed by National Institute of Fashion Technology bullet-proof jackets, high altitude clothing, and high-
(NIFT), intends to boost operational readiness and grade medical textiles. As defence services have a
sustainability of combating soldiers while huge stake in technical textiles, the products under
blending more effectively with the battle
environment. The uniform can be worn the MoD’s new policy implementations include
in different terrains as the fabric has now high altitude inner clothing, three-layered gloves,
been made lighter and sturdier making it multi-purpose boots, snow boots, crampons, and
comfortable to be worn for longer durations. sleeping bags and other such products made of
As you read this, you might wonder what
relevance would the new Army combat technical textile.
uniform have with the application of Armed forces also use a lot of fibre
biotechnology in Indian Defence?
material for different purposes like
To answer that I am putting forth insulation, covering, lining, etc.,
a fact. An estimated 55 lakh meters which must be waterproof, long
of fabric is required for the Indian
army’s summer uniform alone and lasting and possess elasticity.
if all the requirements of Navy, Air Senior officers have also identified
Force, and Para Military forces are upcoming areas that would require
added then the requirement may go special technical clothing for space
beyond 1.5 crore meters per annum. missions, stealth technology-based
Much of this textile requirement is clothing for special forces, special
fulfilled by importing fabric from dressing bandages for medical
China and other foreign countries. purposes, insect, and mosquito
repellent clothing as an emerging
To reduce the country’s dependency area of interest for armed forces.
on imported fabric from China and other Textile researchers are also working
countries, the DRDO is helping the Indian on developing advanced textiles
textile industry produce yarns for making blends using yarns of polyester/nylon
military uniforms that suit our country’s 6,6/ cotton/polyurethane/rayon that
climate as well as terrain conditions. The will enhance operational capabilities and
material used in the uniform has to offer comfort of Indian Armed Forces.
superior comfort and also help the combat Biotechnology plays a big part in
force enhance their fighting capability and production of technical textiles. Whether
increase their endurance on the battlefield. it is products for the treatment of wounds
The source of material for the uniform is or fabrics, many materials have been
the concern here as our country wants to developed using biotechnological
decrease the dependency on imported techniques and processes. As an
fabric. This is where biotechnology example, biosynthetic fibres consisting
has a larger-than-life role to play. of polymers made from renewable
resources, are developed using biotech
processes. Biopolymers, commercially

28 BIOMATERIALS BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Genetically engineered plants and production of materials, chemicals, and energy could
insects, we know, have made inroads amount to $200 billion to $300 billion in global
into the production of textile material. market growth. The prediction is that as biotech-based
The involvement of genetic engineering innovations meet downstream demands, a new wave
techniques in the development of novel of the Bio-Revolution in chemicals and materials
biomaterials has also considerably having enormous impact will unfold for good.
advanced. The scopes of developing
genetically engineered biomaterials There are biomaterials that have been part of our
are leading to improve biological daily lives for long, like wooden houses or woolen
features of materials that can enhance clothes. But it is the bio-revolution that brought
the applicability and properties biofuels and high-performance enzymes into the
of materials used in various fields world. Biotech has helped researchers successfully
including the Indian Defence. produce materials like nylon using genetically
engineered microbes instead of petrochemicals,
available today, have come from renewable sugars, alternative leather from mushroom roots, and cement
starches and lipids (corn, sugar cane, beets, plant oils) from bacteria.
and include polymers that are 100 per cent bio based
as well as partially bio based. Different technologies Genetically engineered plants and insects, we
are currently being developed to produce biosynthetic know, have made inroads into the production
textiles from a broader range of raw materials, of textile material. The involvement of genetic
including biomass and algae, fungi and bacteria. engineering techniques in the development of
novel biomaterials has also considerably advanced.
Biotech in deriving valuable biomaterials The scopes of developing genetically engineered
biomaterials are leading to improve biological
Biotechnology has impacted the textiles industry features of materials that can enhance the
through the development of more efficient and applicability and properties of materials used in
environmentally friendly manufacturing processes, various fields including the Indian Defence.
as well as enabling the design of improved textile
materials. And biotechnology based-processes and Untapped potential
applications in the textile industry have helped create
biomaterials that can be used suitably in the Indian Recently, to foster self-reliance, the Department
Defence. The scope of demand for biotechnology of Defence Production under the Ministry of Defence,
applications in the Indian Defence seems limitless approved a central sector scheme under Innovations
and inferred here in this article are a few examples of for Defence Excellence (iDEX) with budgetary
how the Indian Defence is embracing biotechnology support of Rs 498.78 crore for the next 5 years from
to its best. 2021-22 to 2025-26. The objective of the scheme is
to provide financial support to nearly 300 Startups/
We definitely know that biotechnology is MSMEs/ individual innovators and about 20 Partner
vested with the potential to play a key role in the incubators through Defence Innovation Organisation
development of entirely new materials with greatly (DIO) giving impetus to locally developed products.
improved and modified properties. So, it is in the Highlighted here are two innovators supported by
new-age textile industry that biotechnology-based grants from DRDO.
processes are finding their way. A stream of its own,
the production and application of biotechnology in Conclusively, we can say that there is huge
the textile industry have been playing a major role to untapped potential in biotech and even medtech in
develop fabrics that are sustainable, renewable, and the defence domain. India needs to exploit biotech
most importantly comfortable and durable and also with a view to strengthening its armed forces to fight
carry medicinal value in some cases. effectively. Visualizing the potential of biotechnology
in warfare, an increasing number of countries are
McKinsey Global Institute research has found incorporating biotechnology into their national
that as much as 60 per cent of the physical inputs to defence programmes. China and the United States
the global economy today are either biological (wood both are not only investing heavily in biotechnology
or animals bred for food) or nonbiological (cement capabilities but have dedicated strategies for
or plastics) but could in principle be produced or harnessing their use in the military as well as
substituted using biological means. Over the next commercial settings. Thus, India can easily consider
10 to 20 years, advances in the use of biology in the biotechnology as the most versatile and innovative
technology of the 21st Century, whose exploits for
defence are yet to be fully realised.

Anusha Ashwin

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com EYE CARE 29

Addressing
Glaring Gaps

in Ocular
Healthcare

The World Health Organisation (WHO) estimates that half of the population of the world may
be myopic by 2050. Lately, concerns have been raised about whether the period of lockdown
may have worsened the burden of myopia across the globe due to significantly fewer hours
spent outdoors and increased screen time at home, for both adults and children. Studies have
revealed that by 2050, population ageing, growth, and urbanisation might lead to an estimated
895 million people with distance vision impairment or myopia, of whom 61 million will be blind.
Let’s explore some crucial eye health interventions that need urgent attention.

Eye conditions and vision impairment are ageing, and changes in lifestyle.
widespread, and far too often they still “The World report on vision sets out concrete
go untreated. Globally, at least 2.2 billion
people have a vision impairment, and of these, proposals to address challenges in eye care. The
at least 1 billion people have a vision impairment key proposal is to make integrated people-centred
that could have been prevented or is yet to be eye care, embedded in health systems and based on
addressed. strong primary healthcare, the care model of choice
and scale it up widely. People who need eye care
This 1 billion people includes those with must be able to receive high-quality interventions
moderate or severe distance vision impairment without suffering financial hardship. Including eye
or blindness due to unaddressed refractive error care in national health plans and essential packages
(88.4 million), cataract (94 million), glaucoma (7.7 of care is an important part of every country’s
million), corneal opacities (4.2 million), diabetic journey towards universal health coverage”, says Dr
retinopathy (3.9 million), and trachoma (2 million), Tedros Adhanom Ghebreyesus, Director-General,
as well as near vision impairment caused by World Health Organisation.
unaddressed presbyopia (826 million).
It is imperative to point out that vision
As usual, this burden is not borne equally. impairment led to global productivity loss of $410.7
It weighs more heavily on low- and middle- billion in 2020, according to the recent Lancet
income countries, on older people, and on rural Global Health Commission Report. If we look
communities. Most worrying is that projections at India, the cumulative gross national income
show that global demand for eye care is set to surge (GNI) loss due to blindness is Rs 9,062 billion for
in the coming years due to population growth, adults and Rs 3,311 billion for children. That is an

30 EYE CARE BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

“Replacing the lost cells via “Myopia is the most important
stem cell therapy is one such cause of visual impairment in
promising treatment for age- children and as per a study by
related macular degeneration AIIMS, 17 percent of children
(AMD). Some companies are
or 1 out of 6 children in India
also trying to address the between the ages of 5 and
genetic changes underlying 15 years are suffering from
myopia.”
AMD with gene therapy.” - Nikkhil K Masurkar,
- Dr Rajani Battu,  Executive Director, ENTOD Pharmaceuticals

Co-Founder and Chief Medical Officer, Eyestem

unfathomable loss. become partially or fully blind, if not treated in
Reflecting upon this situation, Dr Rishi Raj time. The cases of preventable blindness occur
due to cataract, diabetic eye disease, vitamin A
Borah, Country Director, Orbis India says, “Tele- deficiency and trauma related blindness.
consultation and telehealth have proven to be
effective avenues for eye care service to patients To address these problems, there are major
during the lockdown and technology will play players operating in the Indian vision care market
a ground-breaking role in future as well given such as Luxottica India Eyewear, GKB Rx Lens,
the COVID-19 situation. Our success does not Essilor India, Carl Zeiss India, Bausch & Lomb
lie in isolated initiatives or interventions but in India, Titan Industries, Auro Laboratories, Johnson
collaborations and partnerships. It goes without & Johnson and many others. These market players
saying, then, that collaborations are imperative to are constantly making efforts to launch novel
eliminate avoidable blindness and accelerate the products for vision care in the form of eye drops,
fulfilment of the larger sustainable development lens, spectacles, surgery devices, imaging and
goals.” monitoring systems.

Sharing her perspective on how the recent Mumbai-based ENTOD Pharmaceuticals
pandemic situation made things worse for eye has very recently got the approval to carry out
healthcare in India, Dr Kshipra Aphale, Consulting phase 3 trials across India for their 0.05 per cent
Eye Surgeon, says, “During the pandemic, many atropine eye drops from the Drugs Controller
people developed viral conjunctivitis, which was General of India (DCGI). This higher strength
most probably due to COVID-19, but as it was not of low-dose atropine eye drops is not available
very serious, it was not given much importance.
Clotting phenomenon in COVID-19 patients led to
fungal eye infections (mucormycosis) and many
people lost their eyes. This combination of virus
and fungus was new to the medical world. Because
of many cases of dry eye, multiple tear substitute
eye drops have come up and devices for increasing
tear flow were developed like lipiflo. That led
to severe cases of corneal infections, glaucoma
attacks, over ripe cataract cases which also damage
the vision.”

What is India’s vision for the future?

There are several common eye problems in
India that one may notice in men, women and
in children. Some of these are conjunctivitis,
myopia, diabetic retinopathy, cataract, glaucoma,
amblyopia, dry eye syndrome, blepharitis,
entropion, macular degeneration, presbyopia to
name a few.

India has the world’s largest population of
the blind, and it is estimated that the country has
12 million preventable blindness cases, who will

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com EYE CARE 31

“Tele-consultation and “Including eye care
telehealth have proven to in national health

be effective avenues for plans and essential
eye care service to patients packages of care is
an important part of
during the lockdown and every country’s journey
technology will play a towards universal health

ground-breaking role in coverage.”
future as well.” - Dr Tedros Adhanom Ghebreyesus,
- Dr Rishi Raj Borah, Director-General, World Health Organisation
Country Director, Orbis India

commercially anywhere in the world, and ENTOD of childhood myopia in India. Myopia is the most
Pharmaceuticals would be the first company important cause of visual impairment in children
to launch this in India subject to a successful and as per a study by All India Institute of Medical
demonstration of safety & efficacy in clinical Science (AIIMS), 17 per cent of children or 1 out
studies. of 6 children in India between the ages of 5 and 15
years are suffering from myopia.”
Low-dose atropine has emerged as an effective
approach to slow the progression of myopia in A new player in the market, Mumbai-based
children and has recently garnered a lot of interest Optocred Pharmaceuticals has launched Diminfect
from ophthalmologists. and Diminfect D that are India’s first Moxifloxacin
and Moxifloxacin-Dexamethasone eye drops
Sharing more details about the need of such available in 10ml vials each, to fight eye diseases.
products, Nikkhil K Masurkar, Executive Director,
ENTOD Pharmaceuticals, says “We have already The other product Credohyl, according to
recruited several clinical research sites across Optocred, is the game-changer in the ophthalmic
India to start phase 3 trial studies and hopefully, industry. It is the first sodium hyaluronate
we should be the first company in the world to ophthalmic solution with 0.18 per cent Sodium
get approval for marketing 0.05 per cent atropine hyaluronate combined with Coenzyme Q10 and
eye drops from the DCGI. Being market leaders Tocopherol (Vitamin E) for extra lubrication and
in paediatric ophthalmology medicine, we hope with one of its kind antioxidant action. Credolube
this new therapeutic addition to the low-dose eye drops is India’s first ultimate coolant with the
atropine range will allow us to tackle the menace advanced effect of D-panthenol and Allercred is
India’s first ophthalmic anti allergic kit.

On the other hand, Advanced Micro Incision
Glaucoma Surgery (using istent- developed by
US-based Glaukos Corporation) was recently
conducted for the first time in India at Shree
Ramkrishna Netralaya, Mumbai. This is the world’s
smallest medical device known to be implanted in
the human body.

It’s a micro-invasive glaucoma surgery
procedure, which not only helps in managing
glaucoma effectively and safely but also helps in
fighting the key issue of non-adherence to current
medication i.e. eye drops, the key reason for
glaucoma progression in 53 per cent of treated
patients. Since glaucoma is asymptomatic, the
damage is already advanced once the patient
realises that he has visual problems.

American-Swiss company Alcon has
commercially launched the first and only
presbyopia-correcting intraocular lens (PC-IOL)
with wavefront-shaping technology - the AcrySof
IQ Vivity IOL (Vivity) in India. Approved by the
Central Drug Standard Control Organisation, Vivity

32 EYE CARE BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Leading eye-health problems in India Modi, Country Franchise Head, Surgical, and
Country Manager, Alcon Laboratories India.
● Conjunctivitis
● Myopia With technology being the ‘new hero’ of this
● Diabetic retinopathy era, Aravind Eye Hospital has recently introduced
● Cataract the use of artificial intelligence powered eyeglasses
● Glaucoma manufactured by Bengaluru-based software
● Amblyopia company Smart Global Technology in collaboration
● Dry eye syndrome with US-based NGO, Vision Aid. The device is
● Blepharitis claimed to be the first of its kind launched in the
● Entropion country for the visually impaired.
● Macular degeneration
● Presbyopia While the industry is continuously developing
new products to counter the eye health problems,
“Because of many cases of dry more work needs to be done to improve eye health
eye, multiple tear substitute research in India.
eye drops have come up and
With advancements being made in the field
devices for increasing tear flow of stem cells and genomics, these areas can
were developed like lipiflo. That be well explored to find better solutions to the
growing eye problems in both children and adults.
led to severe cases of corneal Greater resource allocation by the government
infections, glaucoma attacks, and introduction of a ‘real’ research culture in
over ripe cataract cases which our medical colleges can make the future more
promising. For instance, LV Prasad Eye Institute
also damage the vision.” Hyderabad campus is now equipped with state-
- Dr Kshipra Aphale, of-the-art ophthalmic research biorepository, said
to be the first in the country. Biorepositories are
Consulting Eye Surgeon collections of human tissue for future research on
disease mechanisms, therapeutics and diagnostics.
is now available to Indian ophthalmologists for
their patients undergoing cataract surgery. “Age-related macular degeneration (AMD)
is the most common cause of blindness in
“The new generation of seniors spend people older than 60 years worldwide. About
significant time with technology screens like 15 -25 million people in India suffer from AMD,
phones, tablets and computers, and currently a disease affecting the eye’s nerve called the
experience a massive gap in near and intermediate retina. While there is no definitive treatment to
vision post-surgery. Vivity addresses this gap halt the progression of dry AMD, there has been
and the desire of patients who want to get rid of remarkable scientific progress over the last few
cataracts and presbyopia at the same time. As a years, making a cure likely in the medium term.
result, patients can be less dependent on glasses for Replacing the lost cells via stem cell therapy is one
most activities post-surgery, enhancing their visual such promising treatment. Many companies are
satisfaction and quality of life. Vivity is the first working on replacing the RPE cells via surgical
and only extended depth of focus lens with Alcon’s procedures to achieve this. Others are trying to
proprietary X-WAVE technology, which stretches address the genetic changes underlying AMD with
and shifts light without splitting it”, explains Shalav gene therapy”, says Dr Rajani Battu, Co-Founder
and Chief Medical Officer, Eyestem.

In addition, more adequately trained
ophthalmologists are required to manage these
problems. Major effort is required to improve the
quality of residency training across the country
and increase funding for better research. Only then
can we have enough professionals who can offer
comprehensive ophthalmic care and adopt faster
to the newer ideas and technologies. Until then,
myopia, cataract, glaucoma, AMD etc. will remain
as our ongoing challenges into the future.

Hradhaya B Parchure

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com ANIMAL VACCINE 33

Growth and Challenges of
Animal Vaccine Market in India

The emphasis on animal health has never been «
greater given the recent life-altering events of the
COVID-19 pandemic. In spite of its devastation, Rajiv Gandhi,
the pandemic was an eye-opener that finally
turned the world’s gaze to ‘One Health’. One CEO & MD,
Health recognizes that human, animal, and
environmental health are interconnected and Hester Biosciences
must be viewed as one; they cannot and should
not exist in isolation. products meat, egg, and milk, in India, has
significantly increased.
In order to achieve One Health, securing
animal health globally will be key. Thus health More importantly, the Government of India’s
advocates voice animal health as a top priority new policy for animal husbandry and animal
for the international community to ensure health calls for an aggressive and extensive
sustainability in multiple sectors including vaccination programme of livestock animals for
health, business, food security, and development, immunisation against diseases such as Brucellosis
to name a few. Furthermore, vaccination against and Foot & Mouth Disease (FMD). Government-
numerous animal diseases will play a key role, led programmes have also provided an impetus to
especially the threat posed by emerging diseases animal vaccine manufacturers.
and in achieving and sustaining One Health.
Secondly, pet parents and animal owners are
The Indian animal vaccine market is now aware of the core vaccination schedule as
projected to reach $232 million by FY advised by veterinarians, Veterinary Council of
2026, according to market research reports. India (VCI), and World Small Animal Veterinary
The objective of animal vaccines is to prevent Association (WSAVA) guidelines are being
animal diseases thereby improving the health followed in clinical practice. Many organisations
and welfare of production as well as companion and state governments are actively working
animals. The other most important objective is to towards the eradication of rabies and other
prevent the transmission of diseases from animals zoonotic diseases. Some local and state bodies
to humans. On the whole, animal vaccines have are now making it mandatory to keep the record
already made significant and visible impacts not of vaccination for pets/animals in residential
only on animal health, welfare, and production societies.
but also on human health.
Scope
Several technologies have evolved for the
development of veterinary vaccines, which involve Some vaccines are not recommended to be
the whole organism either live or inactivated, developed with the whole organisms due to the
genetically modified gene deletion mutants, disadvantages of improper inactivation, reversal
genetically engineered vaccines to produce to virulence, or developing newer variants in the
chimeras, vectored vaccines, necked DNA case of live attenuated vaccines. In such cases,
vaccines, etc. subunit vaccines or DNA vaccines are developed
by western countries. Vaccines with multiple
Factors for Growth of immunogens in a single shot are very popular for
Animal Vaccines Market immunising poultry and animals. These vaccines
are available for poultry and companion animals
Initially, during the early days of organised in India, and going forward the focus must be on
poultry and animal farming, there were lesser- developing such vaccines for cattle, sheep, goats,
known diseases and only vaccines for a few and swine as well.
diseases were made or were imported to India
from the west. But with the increase in population
and increased incomes, the demand for animal

34 ANIMAL VACCINE BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Continuous development of vaccines Respiratory Syndrome Virus infection in swine.
is essential given the rise in the Comprehensive development of a newer
emergence of different animal diseases
resulting from the significant growth generation of animal vaccines combined with a
of the poultry and animal industry, large and widespread vaccine marketing network
increase in pet ownership, scientific covering the remotest parts of India is the key to
husbandry practices in the large animal human and animal health. In addition, developing
industry, and several government-led more robust R&D capabilities, new-age therapies,
programmes to strengthen animal and an innovative product mix to meet the
husbandry and health. These trends are expectations of veterinarians, and animal owners
creating and will continue to create a including livestock and pet owners is crucial.
large and growing demand for animal
vaccines. These emerging trends, new Having said that, there remain certain hurdles
and cutting-edge innovations with faced by the industry which must be overcome to
higher efficacious biologicals are the fulfill the demand for animal vaccines and realise
future for animal vaccines. Apart from the One Health vision. These include limited
the available vaccines, heterologous infrastructural facilities, high costs for vaccine
immunoglobulins, monoclonal storage, inadequate reporting systems, and a
antibodies, passive immunisation shortage of skilled field professionals to name a
against parasites, and protozoa will be few. These challenges must be addressed through
the future of the Indian market. a multisectoral approach for successful and
comprehensive control of animal diseases.
Challenges
Key trends
In spite of a wide scope for growth, certain
challenges remain in terms of service delivery of Continuous development of vaccines is
vaccines. Challenges such as communication and essential given the rise in the emergence of
outreach, to the rural population, to convince different animal diseases resulting from the
them of the benefits of vaccination still remain. significant growth of the poultry and animal
To close these gaps, there are many ongoing industry, increase in pet ownership, scientific
government-led programmes. However, vaccine husbandry practices in the large animal industry,
companies also need to expand their marketing and several government-led programmes to
resources to cater to the requirement of backyard strengthen animal husbandry and health. These
poultry and livestock producers. At Hester trends are creating and will continue to create a
Biosciences, we have developed a special division, large and growing demand for animal vaccines.
to reach livestock owners in the remotest part of
the country, with vaccines and health products. In order to leverage these emerging trends,
new and cutting-edge innovations with higher
We need to focus our research to address and efficacious biologicals are the future for animal
control the emerging diseases of poultry and vaccines. Apart from the available vaccines,
livestock in our country, which has seen recent heterologous immunoglobulins, monoclonal
outbreaks of Avian Influenza in poultry, African antibodies, passive immunisation against
Swine Fever, and Porcine Reproductive and parasites, and protozoa will be the future of
the Indian market. Government grants and
financial aid for veterinary vaccine research
and development will be an added bonus to this
mammoth effort to achieve One Health.

To conclude, the animal vaccines market will
be one to watch out for. With emerging animal
diseases threatening the future of our world,
immunisation of animals in every corner of the
globe will become a necessity. In addition, an
increase in livestock production and consumption,
pet ownership, and large-scale vaccination
programmes will set the demand soaring for
animal vaccines. However, pressing challenges
must be addressed swiftly and sustainably for
the successful realisation of One Health and the
survival of our world.

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com CDMO 35

Why Indian Pharma Must
Evolve As ‘Value Creator’

As the third-largest drug producer in the world, «
India is already a major global pharmaceutical
player. However, when it comes to the value of Dr Mahesh Bhalgat,
production, India ranks fourteenth. A deeper dive
into the details reveals an important fact: India Chief Operating Officer,
is the largest producer and supplier of generic
medicines globally, delivering a 20 per cent share. Syngene International
India’s pharmaceutical sector has the highest
number of USFDA-approved manufacturing plants The Indian CRO/contract development and
outside the USA, 3,000 pharmaceutical companies, manufacturing organisations (CDMOs) industry has
a network of 10,500 manufacturing facilities and a also started moving towards integration of services.
rich talent pool. So, why does it lag so significantly Earlier companies started out with standalone,
in deriving value from its assets? Is there an siloed services. Consequently, piece-meal activities
opportunity for the Indian pharmaceutical industry in chemistry, biology were outsourced, but most of
to evolve in a way that moves India up on the value the value creation work remained within the pharma
scale by increasing innovation – and what will it companies. Over time, CROs and CDMOs have
take? Let’s find out. started integrating services in the value chain. This
helps in plotting a course through innovation, solving
Contract Research Organisations (CROs) problems and moving a molecule through discovery
constitute one such opportunity. Focusing into development and manufacturing, ultimately,
on the early years of drug discovery and for the benefit of patients. This has been an essential
development, CROs offer a smart avenue for factor that is driving more collaborations between the
pharmaceutical companies to conduct their research pharma/biotech companies and CRO/CDMOs.
activities by outsourcing to a competent entity that
specialises in pharmaceutical research. The dynamics Innovation in this space is increasingly driven
are similar to the journey of the IT services industry by small and medium-sized biotechs, with few
in India that has evolved with time, and today, they molecules, a very limited pipeline and limited
partner around sophisticated end-to-end solutions resources with no desire to set up their own large
that add value to the sector in many ways. The scale R&D facilities. CROs in the emerging world
pharmaceutical companies today appreciate the value have been successful in advancing molecules along
that Indian CROs can add by critiquing, challenging the discovery and development value chain by
and adding to their scientific ideas and hypotheses. providing qualified scientific talent, laboratory
They expect their outsourcing partner to bring in capacity and quality assurance combined with a cost
their own experience and expertise to the table. advantage.
It’s about the intellectual added value that segues
perfectly. However, for the strategic partnering brought
by strong CRO’s cost is no longer seen as a deciding
Source: Biopharma outsourcing goes international factor; Globally cost over the years have seen an
upward trend. The rise in attrition as an example
has increased manpower costs in the east and the
west. Cities such as Bangalore offer the adjacency
for the pharma-biotech industry to the IT industry,
which help drive innovation and offer technological
solutions for problem solving and bringing in
efficiencies. Today pharma and biotech companies
are willing to offer a higher rate for CROs/CDMOs
that deliver world-class quality, innovative solutions

36 CDMO BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

and delivery commitment to continuously grow the It will be important not to stop here. The Indian
research pipeline and supply the market. pharmaceutical sector must continue to focus on
moving upstream following the path of companies like
A big differentiator for the Indian market is its Syngene International that deliver discovery research,
abundant availability of scientific educated talent development and manufacturing of small and large
pool. A work force graduating from close to 1000 molecules to create the next generation of medicines
universities and around 40,000 colleges in India is and materials while building value for investors.
reflective of India’s young population. It is estimated
that 70 per cent of the workforce in India is under 40, The path ahead
and this key factor needs to be leveraged further to
drive growth of the pharma-biotech sector. Building R&D capabilities is a path well travelled
in other parts of the world and the requirements
India emerging in the forefront are clear: educational institutions committed to
nurturing world class researchers, a well-established
The COVID-19 pandemic changed attitudes IP framework, and funding to attract research and
towards pharmaceutical research. It has investment incentives.
demonstrated the value of exploring novel
therapeutic approaches, conducting complex According to the Brookings report, India has
clinical trials and nurturing specialised skills and a mere 216.2 researchers per 1 million population
expertise to navigate through the drug discovery and as against 1200 in China, 4300 in the US, and
development process. India has played a crucial role 7100 in South Korea. The Indian Government has
in the pandemic as the largest vaccine manufacturer shown intent to reverse the brain drain with the
in the world. However, the sources of innovation have New Education Policy, 2020. This is certainly an
been the traditional players in the US and Europe. important step towards creating a better academic
ecosystem but there is more to do to incentivize
While battling COVID-19 and struggling to get academia to build educational environments and
the vaccines approved, the key was speed. The role curricula that produce talent that are industry ready
of Indian providers in facilitating speedy trials is to hit the ground running.
now widely acknowledged: AstraZeneca’s vaccine
development programme included a clinical research Then there is funding. To date, the percentage
organisation from India to expedite efforts and of GDP invested in R&D in India has been very
generate reliable data for regulatory approvals. low at 0.7 per cent, which is among the lowest.
Similarly, ICON provided clinical trial services to Countries, like Israel (4.6 per cent), South Korea
the Pfizer and BioNTech COVID-19 vaccination (4.5 per cent), Germany (3 per cent), or Brazil (1.3
programme. The biopharma industry has also per cent) have consistently invested more. The
played a role in developing and deploying vaccines biologics-fueled pharmaceutical ecosystem requires
closer to home. India tackled the pandemic with a significant additional investment in facilities to
record-breaking vaccination campaign and the effort drive a step change in capacity and capability
continues as companies like Akston Biosciences while the talent pipeline builds. Although private
are conducting human trials of second generation investment is growing, it may not be enough for
COVID-19 vaccines in India. the top 10 pharmaceutical majors of India (7.8 per
cent) to equal half the amount of the top 10 global
With the COVID-19 as a template, CROs and pharmaceutical companies (16.5 per cent) spends on
CMOs have put India front and center of the global R&D, as a percentage of their revenue.
stage for their agility, capability and quality in
supplying effective vaccines in large quantities. Nearly 80 per cent of all new drugs are biologics,
so, CROs - particularly those working with large
molecules as well as small molecules - can play a
critical role in building greater value for the Indian
pharmaceutical industry. Collaborating with the
government to build an attractive ecosystem, a
supportive education system, a legal and regulatory
environment aligned with global practices; and
sustained research funding, will be imperative. The
pandemic has provided an inflection point. It is time
to realign priorities and build momentum to foster
pharmaceutical innovation and move the industry
from a volume provider to a position of value creator
for India.

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com LIPID NANOTECHNOLOGY 37

Why Lipid-based Gene Therapy Is A
New Frontier in Cancer Management

With advances in modern medicine, «
pharmacological treatment has been steadily
progressing into many new therapeutic areas. Arun Kedia,
There is more emphasis now on understanding Managing Director,
and eliminating the underlying factors. Or as one VAV Life Sciences
would say, ‘treating the root cause’, rather than
just treating symptoms. The last few decades The siRNA is extremely target specific and
have seen a lot of research being undertaken acts by binding itself to a foreign mRNA to induce
in gene therapy based on lipid nanotechnology cleavage of the mRNA. (mRNA is a messenger
(lipid nanoparticles- LNP). Many diseases, both RNA that is responsible for protein production in
acquired and genetic, have been treated using cells. It uses the information in the genes to create
such systems. Let’s explore further. a blueprint of the proteins). This mRNA is then
recognised as abnormal by the host cell. The host
Genetic mutations or deletions lead cell then inhibits the further translation of the
to many different types of genetic abnormal mRNA and the gene is silenced.
disorders in metabolic pathways and
cell cycle regulation. These can now be treated In the case of cancers and other such
by transferring exogenous nucleic acids which incurable diseases, target-specific siRNA delivery
specifically target the diseased cell of the body mechanisms use lipid-based carriers for drug
without causing serious side effects. Lipid carrier delivery. These lipid carriers assemble them
systems are used for gene delivery in such into supramolecular complexes with enhanced
systems. functional properties during the delivery process.

Initially, lipid-based gene therapy was used to Lipid-based siRNA delivery systems
treat genetically acquired disorders. Now it is also
used for treating acquired complex diseases like Applications in Ocular Therapy.
cancer, AIDS, ocular diseases, arthritis, and many
peripheral vascular diseases. One of the emerging The human eye is a good target for RNA
technologies in this area is siRNA, also known as interference (RNAi) therapy mainly because it
silencing RNA. offers a confined space to enable local delivery
of small siRNA. This is done either topically or
Targeted gene therapy using siRNA

siRNA is currently being evaluated for its
application in a wide range of drug formulation
development processes. It has gained a lot of
significance as a potential therapeutic agent due
to its ability to regulate gene expression and
inhibit specific genes in many genetic diseases. It
has been considered for the treatment of cancer,
ocular therapy, and advanced nanomedicine.

‘siRNA’ or a silencing RNA or small interfering
RNA is a synthetic double-stranded RNA
molecule that is noncoding and since its discovery
in the 1990s, it has been garnering a lot of interest
due to its possible applications in a wide range
of therapeutics. The siRNA is a powerful tool in
targeted drug therapy because it can modulate
gene expression by repressing the translation or
transcription of genes.

38 LIPID NANOTECHNOLOGY BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

by injection. siRNA targeting critical molecules The latest findings indicate lipid-based
involved in the pathogenesis of glaucoma, retinitis nanotechnology provides a pathbreaking ocular
pigmentosa, and neovascular eye disease have drug delivery mechanism. Hybrid delivery
been successfully tested and some are also in the technology using elemental silicone coupled with
clinical trial phase. lipids and amino acids has shown an increased
ability to deliver siRNA effectively. The presence
However, due to unfavourable characteristics of lipids in the composition improves the loading
like easy degradation in the blood, siRNA still of the siRNA and helps to deliver it safely to
poses some barriers in clinical applications. LNP the target cell site. This siRNA gene silencing
based siRNA technology is now of significant mechanism based on LNPs can be used to treat a
interest as it provides an advanced mechanism for wide variety of corneal diseases.
delivering siRNA to target cells in a stable way.
The technology enables better bioavailability and Applications in Cancer Therapy
enhances siRNA properties.
The successful application of siRNA in cancer
Lipid-based particles such as liposomes treatment requires the development of a clinically
are suitable carriers for drugs and nucleic safe and effective drug delivery system. Most
acid delivery because of their excellent cancers are caused by oncogene being over-
target specificity, potency, versatility and expressed or due to some kind of gene mutation.
biocompatibility, biodegradability, low toxicity It may be possible to treat cancer by suppressing
and immunity, structural flexibility, and ease the diseased gene by using lipid enhanced siRNA
of large-scale preparation. The most important design and delivery mechanism. siRNA are more
factor is nuclease stability. They are used for the useful as drugs since they don’t need any genomic
transfection of cells with siRNA. integration and they can be easily synthesized.

There are many types of lipid-based siRNA siRNA offers a high degree of safety and
delivery systems. However, the most common efficacy in cancer treatment. However, siRNA is
approaches include - liposomal delivery, where unstable in various physiological conditions. It is
siRNA is encapsulated within vesicles composed easily degraded by enzymes in the blood system
of a phospholipid bilayer and lipoplexes, a siRNA, and renal clearance is also a major issue. Hence,
and a cationic lipid complex. Liposomes are they need to be packaged into carriers.
probably the most used artificial gene delivery
vector. Modified liposomal technology also helps Advanced lipid-based vectors or carriers for
to overcome the intrinsic physical barrier, efficient anti-cancer siRNA delivery offer hope in this area.
drug clearance mechanism & complexities of siRNA encapsulated with neutral lipids offers
ocular tissues such as cornea & retina which poses more biocompatibility. The most preferred lipid-
significant challenges to ocular siRNA delivery. based vectors that are used for clinical trials are
the SNALPs (stable nucleic acid-lipid particles).
SNALPs are a kind of lipid nanoparticles about
120 nm in size and are used to encapsulate siRNA
and deliver it to the target cells. SNALPS are
highly bioavailable due to enhanced permeability
and higher retention in the blood. After
accumulation at the cancer growth site, SNALPs
are easily taken up by the cancer cells and siRNA
is delivered successfully into the cancer cell.

Overcoming challenges

siRNA encapsulated in liposomes offer a great
advantage in cancer and ocular therapy since they
offer higher efficacy, biostability, and unrestricted
choice of targets. However, challenges still exist
in bringing it to its full potential in clinical use.
A good delivery system like using lipid enhanced
nanotechnology systems is the key to siRNA drug
development and delivery. With breakthrough
research, siRNA will occupy a strong position in
the cancer and ocular drug market.

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com PARTNERS CONTENT 39

Finding the Right Media for Your Bioprocess–

Should You Try Before You Buy?
Sartorius has recently acquired Xell AG, a cell
culture company specialising in developing,
producing, and marketing media and feed
supplements, particularly for manufacturing viral «
vectors used in gene therapeutics and vaccines.
As a result, Sartorius can now offer an expanded Catherine Buchere,
media portfolio to support cell culture for a variety of Product Manager,
applications. Sartorius

The new HEK media portfolio is designed for
the long-term, high-performance suspension culture
of HEK293 and other mammalian cell lines. Fully
chemically defined and free from animal components, lines. Our performance data demonstrate that
the media and feed in this collection are suitable HEK293 cells can be rapidly transitioned to growth
for both research and commercial-scale GMP in suspension simply by centrifugation and media
manufacturing. exchange, without affecting cell viability.

The portfolio has been developed with particular How can users decide which media and feed
attention to the production of viral vectors used in are the most suitable for their application and
gene therapy and vaccine applications, serving which should be used across different process
our customers in this rapidly expanding market. steps?
Here, Catherine Buchere, Product Manager for
Virus-Based Therapeutics at Sartorius, discusses With an increasing diversity of modalities and
finding the best media for your application.
applications, it can be difficult to know precisely

what growth conditions suit your unique process.

Our HEK media portfolio is broad and covers a

variety of conditions to support maximum growth and

What challenges are customers likely to face production for even the most challenging modalities,

when developing cell lines and selecting media such as transient transfection and infection. They

for the production of newer modalities, such as are also designed to be all-in-one solutions, meaning

AAVs, lentiviruses, and vaccines? users don’t have to use different formulas across

Because these modalities are newer and are process steps, such as during transient or stable

increasingly diverse, there are often knowledge gaps transfection procedures.

on how best to produce and purify the final products

at the required yield or scale. Upstream process How do customers know what media is right

decisions include the selection of a suitable cell line for them? Are such ‘trial-and-error’ approaches

and culture system to secure cell viability, maximise associated with increased risk?

productivity, and improve overall process robustness. This is true - trial-and-error might appear to be

One solution that we are really encouraging our the only way to approach finding the right media

customers to consider is transitioning their adherent and growth conditions, but with such expensive

cell lines to suspension culture, which is much more reagents and time-consuming processes, it can also

readily scalable. We also recommend switching from be risky and cause significant delays. At the same

traditional serum-containing media to fully defined, time, you want to ensure your cell line is stable and

serum-free media to limit lot-to-lot variability and as productive as possible, as this will improve yield,

simplify regulatory approvals. efficiency, and support process intensification in

next-generation facilities. To help our customers with

Will these adapting cells to new culture their medium selection process and limit risk, waste,

conditions require significant optimisation and time, we are running a HEK Media Sample Kit

time? Program. This free program allows users to test

While the process of adapting adherent cells different formulations at once as part of your process,

to suspension culture might seem like a significant allowing you to identify the best formulations for your

hurdle, our media portfolio and protocols currently cell line, modality and process.

support a direct adaptation for most HEK cell Sign up to the program today to get your free kit!

40 ASSAM BIOTECH POLICY BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Seen in the picture from L-R are dignitaries Kailash Karthik N, Chief Executive Officer, Guwahati Biotech Park; Queen Ojha, Member of Parliament;
Keshab Mahanta, Minister of Science Technology and Climate Change, Assam; Dharmendra Pradhan, Union Minister of Education; Dr Himanta Biswa
Sarma, Chief Minister of Assam; Dr Ranoj Pegu, Minister of Education, Assam and Professor T G Sitharam, Director, Indian Institute of Technology
(IIT) Guwahati while releasing the Assam Biotech Policy 2022-27.

Assam Rolls Out Red Carpet

for BioTech Investments
Assam Biotech Policy, 2022-27 was launched
during the inaugural ceremony of the Key governmental initiatives
Technology Incubation Centre of Guwahati
Biotech Park at Amingaon, Guwahati and Assam The Biotech Policy focuses on developing biotech
Biotech Conclave 2022 on May 20, 2022 in the infrastructure, improving biotech education, research
august presence of Chief Minister of Assam, Dr and innovation, advancement in technology and
Himanta Biswa Sarma, Union Minister of Education, entrepreneurship support, development of biotech
Dharmendra Pradhan and Minister of Science industry, introducing business support cells,
Technology and Climate Change, Assam Keshab managing accreditations and quality certifications,
Mahanta. Ranoj Pegu, Minister of Education, Assam, Single Window Clearance through Nodal Agency,
Queen Ojha, Member of Parliament and Professor T North East Vision Group on Biotechnology, and
G Sitharam, Director, Indian Institute of Technology Centre of Excellence in Bioinformatics & Applied
(IIT) Guwahati. Biotechnology.

The vision of this policy shall be to attain high Government would promote and facilitate both
capability in biotechnology education, research the public and the private sectors in developing
and commercialisation and utilising biotechnology essential high quality infrastructure such as
to build up a sustainable industry ecosystem for Biotechnology Parks, research and training facilities
creation of wealth, income generation, employment and other supporting infrastructure for production,
generation and promotion of equity. testing, accreditation etc. There will be collaborative
partnerships and provisions of incentives/
“Assam, being one of the world’s 34 biodiversity concessions between the state and the private
hotspots, is an appealing investment destination partners. The type and quality of the infrastructure
due to its immense natural resources, rapid growth will be chosen considering different agro-climatic,
rate, tranquil labour environment, and qualified agro-economic and other socio-economic parameters
manpower. Now that the Biotechnology Policy specific for a region.
for the State of Assam 2022-2027 is in force, the
Government of Assam has opened up doors for The State Government proposes to facilitate and
investment opportunities with pro-industry policy support development of general and sector specific
measures where a win-win ecosystem will help both biotechnology parks and incubation centres. They
the investors and the State”, says Keshab Mahanta. would also facilitate setting up laboratory facilities
primarily in colleges and universities for human
resource development and capacity building. This

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com SPOT LIGHT 41

Microbial cultures exhibiting poor growth?

Lab grown organisms such as bacteria sometimes exhibit poor growth due to various factors that deviate from their natural
habitat. Some of the laboratory induced changes that must be taken into account are Growth & maintenance of cultures,
Optimum growth temperatures, Methods of sterilization of media that are used to grow them & Glassware for media
preparation and the Quality of petri dishes that are used to grow them.

Growth & Maintenance of Bacteria: Therefore, it is advisable to check the prepared media for any
Growing bacteria in pure culture is still one of the most widely growth before using it for any culturing or testing purposes.
used methods in microbiology. Many bacteria, particularly those Microbiological media plates may be incubated at different
that cause diseases and those used in scientific studies, are temperatures (for 5 Days) to rule out the growth of molds at
heterotrophic, which means that they rely on organic compounds 25°C for 72 hours followed by growth of bacteria at 37°C for
as food, to provide energy and carbon. Some bacteria also another 48 hours.
require added nutritional components such as vitamins in their
diet. An appropriate physical environment must be created, Methods for sterilizing media and glassware:
where important factors such as temperature, pH, and the The thoroughly washed glass ware and most media
concentration of atmospheric gases (particularly oxygen) are components are sterilized by heat or steam and the sterilized
controlled and maintained. For short term maintenance & use, materials are removed when temperature cools down and
a quadrant streak technique of bacteria on rich agar petri plate, used according to the procedure adopted. While the carefully
like nutrient agar is preferred. prepared heat-labile components of the media are sterilized
using 0.2micron membrane filtration apparatus. Denser
media components are sterilized using stacked filters of
different pore sizes while the final filter remains 0.2 micron.
Apparatus containing glass and silicon tubing, disposable tips
for micropipettes, glass bottles with screw caps, magnetic
stirrer bars, screw caps, silicon tubing, topper-rubber, silicon,
membrane filters may be autoclaved at 15 lb/in2 (=121°C) for 20
minutes. Glassware, glass coverslips, glass slides, instruments,
Pasteur pipettes, pipettes, test tubes, etc. may be subjected to
heat sterilized using a suitable hot air oven at 160°C/ 1 hour.

The bacterial cells must not be incubated beyond the desired Quality of Plastic wares/ Petri Dishes :
Petri dishes used to culture these organisms must be
time; else the cells may die. Agar plates are preferred medium free of Nucleases, Endotoxins, Human DNA, ATP, Heavy
metals as seen in ABDOS-make whose products are
for short term storage of bacteria because it is easy to verify that ideal for Environmental, Water, Food & Beverage Testing,
Pharmaceutical Quality Control and Life Sciences applications.
the plate contains only one type of colony. Alternatively, an agar
About ABDOS:
slant or broth may also be used to grow bacterial cells. ABDOS group is 55 years old and the Life Sciences
division of ABDOS has been successful in providing high
Lyophilization is the best method for the long-term quality, innovative products that add value and improves lives
storage of bacterial cells. Under these conditions, the of people around us. Since 2009, our Life Science products are
microbial cells are dehydrated and their metabolic used extensively in various applications from Research to Drug
activities are stopped; as a result, the microbes go into a Discovery or from Quality Control to Molecular Diagnostics.
dormant state and retain viability for years. Lyophilized or ABDOS Life Science range includes Microbiology,
freeze-dried pure cultures are then sealed and stored in Centrifuge Ware, Liquid Handling Consumables, Standard,
the dark at 4°C in refrigerators. Microbial cells can also be Filter and Low Retention Pipette Tips, Cryo Ware, PCR plastic
stored at very low temperature with a cryo-protectant such wares, Cell Culture ware, Multipurpose Racks and Boxes,
as DMSO. Cryopreservation (i.e., freezing in liquid nitrogen General Laboratory Products, Bench Top Equipment’s and
at -196°C or in the gas phase above the liquid nitrogen at Laboratory Organizers. ABDOS has also launched Horizontal
-150°C) helps the survival of pure cultures for long storage and Vertical electrophoresis systems along with suitable power
times. It is done in the presence of stabilizing agents such packs to complement the range. For more information, please
as glycerol or dimethyl sulfoxide (DMSO) that prevent cell contact: [email protected]
damage due to the formation of ice crystals and promote
cell survival.

Optimum temperatures to rule-out molds: About author :
Sensitivity of microorganisms to incubation temperature Bijoy Varma
is well known, however there are several different incubation (Head–Marketing & Strategy)
strategies used within pharmaceutical quality control labs that
monitor environmental contamination. There is always a balance
to be struck between incubation times and temperatures. For
fungal growth low temperature of 20-25°C is required and
for bacterial growth high temperature of 30-35°C is required.

42 ASSAM BIOTECH POLICY BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Thrust areas identified for the total registered sale deed value subject to a ceiling
biotech development in the state of Rs 5 crore; and special incentives are available for
Biotech Education, Research, Assam Bio-Innovation
A) Agriculture Biotechnology Fellowships and Patent.

B) Animal Biotechnology Eligible startups and incubators will be provided
interest subsidy at the rate of 9 per cent per annum
C) Pharmaceutical Biotechnology subject to a ceiling of Rs 2 lakh per year. Such interest
subsidy shall be eligible for a maximum duration
D) Traditional Medicine and Herbal Technology of two year. Eligible startups will be entitled to
interest subsidy assistance from the date of making
E) Bio-Resource Based Industries application or when actual interest repayment to
the lending financial institutions, after moratorium,
F) Microbial Biotechnology if any, begins based on their choice. However, the
startup will be entitled for interest assistance only
G) Processed Foods if the interest repayment has begun during the
operative period of the current policy.
H) Seri Biotechnology
Assam Bio-Innovation Fellowship (ABF)
I) Petroleum Biotechnology programme has been launched by Guwahati Biotech
Park. ABF is a highly competitive scheme instituted
J) Medical Biotechnology by the Assam Biotechnology Council (ABTC) under
the Science, Technology and Climate Change
K) Bio-Energy and Environmental Biotechnology Department, Government of Assam to recognise and
reward scientists below the age of 55 with an excellent
L) Tea Biotechnology track record and have made significant scientific
contributions in Biotechnology and allied areas.
will ensure an environment conducive for teaching
and R&D. The government intends to facilitate the Government shall provide financial support
interested private partners and collaborators, for not exceeding Rs 5 lakh for a period of 12 months
development of biotechnology infrastructure facilities limited to 10 researchers per annum. The scheme
by providing decision support logistics, in the form of will also be applicable to scientists interested in
location and feasibility reports. sabbatical research work. The programme and
engagement of the researchers shall be approved by
The state will provide fund for creation the ABTC.
of biotechnology department in colleges and
universities as well as intensify programme support Further, the State Government proposes to
to biotechnology departments in the institutions. establish a fund titled the “Assam Biotechnology
Industrial Support Fund”. The fund shall be provided
The State proposes to facilitate biotechnology from the state budget and will have an allocation of
businesses by providing a globally competitive Rs 400 crore for five years. This fund shall be used
investment environment. To achieve this goal, the to provide fiscal incentives to biotech parks, units,
state will be setting up four support cells - startups and incubators.

Investment support cell, IPR & patent cell, R&D The government also proposes to establish a
support cell and Bio-economic cell, which will venture capital fund for supporting startups and
operate from the office of the Assam Biotechnology first generation entrepreneurs in the biotech sector,
Council. to support high-risk, high return entrepreneurship
ventures of public importance. The fund shall also
A North East Vision Group on Biotechnology raise investments from the market and support
will be created to lead and drive the Biotechnology through government bank guarantees. The
Sector of Assam by leveraging the bioresources contribution of the state government to the fund shall
of the State. The Vision Group will also ensure be provided from the state budget and will have an
implementation of the objectives of the Policy. The allocation of Rs 25 crore for five years.
Government of Assam will facilitate establishment
of the Centre of Excellence in Bioinformatics and Biotechnology requires coordination among its
Applied Biotechnology to promote research and multiple interfaces and stakeholder facilitation. The
academic growth in the sector. The government shall state proposes to provide a hassle-free, investor
also frame appropriate safety regulation to restrict friendly environment, facilitating coordination
the generation of GMO/ hazardous micro-organisms between interfacing agencies, departments and
in the environment within permissible limits. enabling stakeholder interaction.

Fiscal incentives and concessions

Investors can benefit from various subsidies
under the policy. Capital Subsidy for Biotechnology
Parks, Biotech Units and Biotech Startups, and
Biotech Incubators/Incubation Centres; Land
Purchase Subsidy for Biotechnology Parks will be
provided, Land purchase subsidy @ 30 per cent of



44 PAECOAPDLEEMNIECWSSNEWS BIOSBPIOESCPTERCUTMRUM| |AUGJUUSLYT 20212 | www.biospectrumindia.com

Dr P K Desai Johns Hopkins Bloomberg
joins Beacon School of Public Health
Board as honours Dr Cyrus Poonawalla
advisor
The Johns Hopkins Bloomberg School of Public Health has awarded
The Beacon Board the Dean’s Medal to Serum Institute of India (SII) Chairman, Dr Cyrus S
has announced the Poonawalla for his outstanding work in developing and delivering affordable
appointment of Dr P K vaccines and contributing to the Indian biosciences industry for decades now.
Desai as an advisor from The honour was presented
May 2022 onwards to to Dr Poonawalla
Gujarat-based Beacon during the Convocation
Diagnostics. As a doctor, ceremony held on May 21,
Dr Desai is an experienced 2022. Past award winners
professional with over 40 include social justice
years in Span Diagnostics advocate Cheryl Dorsey,
India where he developed Pulitzer Prize–winning
many indigenous journalist Laurie Garrett
products to replace and former Baltimore
imported ones during that Health Commissioner Leana Wen. Founding the Serum Institute of India
tenure. He is currently (SII) in Pune in 1966, Dr Cyrus Poonawalla’s foresight has helped SII achieve
the president of Span global leadership in terms of production with 4 billion doses annually. SII had
Diagnostics Sarl, France. partnered early on with UNICEF and the Pan-American Health Organization
As a pathologist, Dr Desai (PAHO). Its measles vaccine supply to UNICEF and PAHO between 1990 and
held many positions. 2016 has prevented 22 million deaths.
He was the president of
Association of Diagnostics Jawed Zia steps in as
Manufacturers of India CEO of Cadila Pharma’s
(ADMI), a member of Domestic Prescription Business
Federation of Indian
Chambers of Commerce Jawed Zia has joined as the Chief Executive Officer (CEO)
& Industry’s (FICCI) of Cadila Pharmaceuticals. Zia, who will report to
biotechnology committee the Board of Cadila Pharmaceuticals, will lead the
and a member of FICCI’s strategy and business operations of Cadila’s branded
Expert Group for prescriptions pharmaceuticals business. A seasoned
Immunodiagnostics. Dr industry professional with more than three-and-
Desai published more a-half decades of experience, he last served as vice
than 20 scientific papers. chairman of healthcare startup Rivaara Holdings. A
strategic thinker with versatile experience, Zia has
deep knowledge and extensive experience in building
and managing businesses in the healthcare
industry. His innate ability to drive the growth of
people and businesses, build brands, transform
operations and scale capabilities has been the
hallmark of his success. He joined Novartis
in 1987 and had a successful career, passing
over 30 years across market research,
brand management, marketing, and
other functions in Ireland, Singapore,
Saudi Arabia, Canada, Switzerland,
Turkey, and India.

BIOSPECTRUM | JULY 2022 | WWW.BIOSPECTRUMINDIA.COM PARTNER CONTENT 45

Health Sciences education at UPES
is tech-ahead and research-driven

From new age programs and specialisations such as
Biomedical Engineering and Genomics, to collaborating
with industry and academia for research, education
at UPES School of Health Sciences and Technology
is aligned with the rapid technological and research
advancements in the field

I UPES EDITORIAL TEAM

We are living in an era wherein the healthcare industry skills. “There is a project where we are working on individual
is witnessing technological breakthroughs everyday. responses to the Covid vaccine using a biomedical device,
New therapies based on gene editing, genotyping, which can be made in India. This can contribute to Prime
gene therapy, and stem cell research are expected to shift the Minister Narendra Modi’s vision of self-reliance. In the material
focus away from cures and toward prevention, particularly in department, we have researchers working on biosensors,
diseases like cancer, diabetes, neurology, and cardiovascular which can have many uses for the environment and healthcare.
disease. Advanced technologies such as 3D printing of cells Thus, we have been successfully integrating technology and
and organs, nanobots and nanochips for diagnostics, drug research in health sciences education,” says Smriti.
delivery and monitoring, and artificial organs have received
a lot of attention. Prosthetics and exoskeletons, as well as Undergraduate students at UPES School of Health
predictive analytics and wearable healthcare monitoring Sciences and Technology are heavily involved in research
devices, are expected to revolutionise disease prevention, projects, having published patents and research papers, given
diagnosis, and treatment, giving patients far greater control presentations at international conferences, and collaborated
over their health. with faculty mentors on editorials. Students also intern with
non-profits, start-ups, government agencies, and industry,
Keeping pace with the technological advancements in exposing them to real-world issues. They interact with industry
the field, UPES School of Health Sciences and Technology experts who share their knowledge, ideas, and professional
offers new-age programs and specialisations such as Clinical experiences.
Pharmacokinetics and Regulatory Affairs, Dietetics and Holistic
Wellness, Nutraceutical and Nutritional Policy, Food and UPES School of Health Sciences and Technology has
Environmental Microbiology, and Medical and Pharmaceutical signed agreements with several prestigious medical institutions
Microbiology. such as AIIMS Rishikesh, Drishti Eye Institute and Taipei
Medical University. The partnerships seek to promote research
Says Smriti Arora, Assistant Professor at UPES School of and development, academic excellence and exchanges among
Health Sciences and Technology (SoHST), “We are starting two students and faculty, as well as encourage joint participation in
courses this year: Biomedical Engineering, where Engineering international conferences, seminars and workshops.
and Life Sciences come together to bring solutions in
healthcare and research; and M.Sc. Genomics, which is going Over the next decade, the healthcare industry is expected
to be the next frontier in health sciences. These programs have to grow at a double-digit rate. Apart from traditional healthcare
components of technology, application and healthcare. We also jobs like medical doctors, nurses, and physiotherapy, the
have ongoing tech-ahead programs such as Biotechnology.” industry has developed new opportunities in areas like
pharmaceutical sciences, biotechnology, microbiology,
SoHST fosters a culture of research and collaboration wellness, food technology, and more.
through transdisciplinary and practical learning that prepares
students for the future. Aside from classroom instruction, The technology and research-driven education at UPES
students receive clinical and community experience to help School of Health Sciences and Technology enables students
them become active change-makers and solution providers in to work in the pharmaceutical, biotechnology, clinical research,
the healthcare industry. “There are UPES-funded seed projects food and wellness industries, as well as in production quality
in collaboration with the UPES School of Engineering, wherein control, quality assurance, regulatory affairs, product design,
we are working on water technology, which can contribute to formulation research, drug discovery and development,
the sustainability of the environment. We also team up with the pharmacovigilance, diagnostics, scientific or medical writing,
UPES School of Computer Science, where they add the tech and other fields. Nutritionists, dieticians, pharmacists,
component, and we bring in healthcare insights,” Smriti adds. regulatory officers, researchers, and intellectual property
officers are some of the career pathways they can pursue after
The industry-aligned curriculum, developed with the help graduating from the university.
of industry and academic experts who serve on the SoHST’s
Board of Studies and Industry Advisory Board, and active
collaborations with industry leaders, enable students to gain
the professional abilities needed to address the world’s health
concerns. The emphasis is on project-based learning, which
helps students develop critical thinking and problem-solving

46 PEOPLE NEWS BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com

Sanofi India appoints Redcliffe picks
Preeti Futnani
as GM, Vaccines Ishaan Khanna as

Sanofi India has announced the appointment of Director - Reproductive
Preeti Futnani as the Company’s General Manager
(GM) – Vaccines, with effect from June 1, 2022. Her Medicine and Genetics
transitions from Sanofi’s Greater Gulf MCO (a cluster
of six countries including Saudi Arabia, the UAE, and Redcliffe Labs, unit of US based Redcliffe
Lifetech Inc, has announced Ishaan Khanna as
Kuwait) where she Director - Reproductive Medicine and Genetics.
was the Franchise Khanna is a techno-commercial leader with
Head for Dupixent over 19 years of experience in institutional
Dermatology. and commercial healthcare businesses. He has
Preeti has over effectively built organisations from the ground
two decades of up and demonstrated success in establishing
experience in successful; diagnostic business models in India
delivering growth and abroad. He started his career as a scientist
and transformation with assignments spanning across Australia
that spans several and the UK. After coming back to India he
therapeutic areas worked in business development leadership
and functions within roles in biotech and pharma companies such
healthcare (primary and speciality care, medical as Avesthagen and Krishna Antioxidants.
technology) and finance. She started her journey His last assignment was at Lifecell where he
with Sanofi over six years ago in Specialty Care was the Chief Executive Officer, Biobank and
Gulf, after various roles of increasing responsibility Diagnostics where he spent over a decade.
in Novartis marketing and commercial operations
across Switzerland, the UK, and India. She has
held leadership roles in marketing, sales, and
management across several geographies from
mature markets in the UK and the EU to emerging
markets in Asia and the Middle East. Preeti succeeds
Annapurna Das, who is elevated to Head of Vaccines,
Asia. Preeti will be based in Mumbai.

ADMI names Thomas John as new President

Association of Diagnostics to do bigger things in life led him
Manufacturers of India (ADMI) to start a business of his own
has announced a new leadership along with his family members
team for the period 2022- as co-promoters. Thus, Agappe
2025. The new leadership team Diagnostics was born in 1995 in
comprises Thomas John as the a factory premises in Mumbai.
President. John is serving as the Under the leadership of Thomas
John, Agappe is now the fastest
Managing Director (MD) at growing IVD company with more
Agappe Diagnostics, Kerala. than 700 strong workforce pan
John started his career as India. He has been bestowed
a Production Engineer in with various awards under
equipment production with widely recognized magazines and
Transasia Bio-Medicals, platforms for his role in guiding
Mumbai. Further his Agappe and his exemplary
entrepreneurial skills performance in business.
combined with his ambition

BIOSPECTRUM | JULY 2022 | www.biospectrumindia.com R&D NEWS 47

IISc develops footwear to help
prevent diabetic foot complications

Researchers in the Department may lead to complications that developed by the IISc-
of Mechanical Engineering, require amputation in extreme led team is 3D printed
Indian Institute of cases. The footwear, a pair of
Science (IISc), in specially-designed sandals, and can be customised
collaboration with the to an individual’s foot
Karnataka Institute dimensions and walking
of Endocrinology and style. Unlike conventional
Research (KIER), have therapeutic footwear, a
developed a set of snapping mechanism in
unique self-regulating these sandals keeps the feet
footwear for persons well-balanced, enabling
with diabetes. Foot faster healing of the injured
injuries or wounds in region and preventing
persons with diabetes heal at injuries from arising in other
a slower rate than in healthy areas of the feet. The team
individuals, which increases is collaborating with startups
the chance of infection, and Foot Secure and Yostra Labs to
commercialise their product.

World’s first synthetic IIT Jodhpur, WMU
jaw-bone graft trial by
Amrita Vishwa Vidyapeetham leverage ML for

Amrita Vishwa Vidyapeetham has got a Central Drugs neonatal and infant
Standard Control Organisation (CDSCO) approval for
conducting a pilot clinical trial for a novel bone graft mortality predictors
developed jointly by Amrita School of Nanosciences,
Amrita School of Medicine and Amrita School of Dentistry, Researchers from the Indian Institute of
Kochi. The project was funded by the Department of Technology (IIT) Jodhpur and Western
Sciences and Technology, Government of India, in the Michigan University, USA, have identified
initial lab phase and significant neonatal and infant mortality
then by Biotechnology predictors using multiple machine
Industry Research learning (ML) techniques. The study
Assistance Council uses nationwide household survey data
(BIRAC) for the from India. The primary objective of this
translational large research was to identify early warning
animal testing and signs of child mortality that community
regulatory testing health workers can use such as observable
phases. The synthetic biological characteristics, demographic
bone graft, named Nanotex Bone, provides a first-of-its- characteristics and socio-economic factors
kind solution in the world for patients who lose part of of households, mothers and new-borns.
their lower jaw (mandibular bone) due to cancer, injury, The early warning indicators identified
or trauma. The product, patented by Amrita Vishwa in this study do not require advanced
Vidyapeetham, also accepts tooth implants, enabling medical knowledge and can be easily
patients to lead a close-to-normal life even after losing a used by community healthcare workers.
portion of their oral cavity bone. The clinic trial, which The study uses a range of machine
entails testing on ten patients, will be conducted at Amrita learning algorithms to assess the relative
School of Medicine and Amrita School of Dentistry, Kochi. importance of characteristics such as
It is expected to be completed in two years. being first-borns, being born in poorer
households, and having a low birth
weight.

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

Waters unveils mass spec products
to accelerate drug development

Waters Corporation has confirmation app for the waters_ forensics, metabolite
unveiled new instruments, connect software platform identification, metabolomics
software and product and an electrospray and extractables and leachables.
enhancements to drive ionisation source for the The CONFIRM Sequence app
drug discovery and high-resolution Waters on the waters_connect software
development. The SELECT SERIES Multi- platform helps scientists using
products include Reflecting Time of Flight a Waters LC-MS System to
the new Xevo G3 (MRT) mass spectrometer. confirm the nucleic acid sequence
quadrupole The new Xevo G3 QTof of therapeutics and identify
time-of-flight system is a high- impurities that could compromise
(QTof) mass performance, benchtop product safety and efficacy. The
spectrometer, mass spectrometer Waters SELECT SERIES MRT
CONFIRM for characterising and System is now compatible with
Sequence - a new quantifying molecules UPLC-MS with an available
oligonucleotide in applications such electrospray ionisation (ESI)
sequencing as biotherapeutics, source.

Agilent launches Thermo Fisher improves
proteomics research productivity
oligonucleotide
Thermo Fisher Scientific Inc. is helping proteomics
analysis software for researchers increase productivity and free up time for more
value-added activities when generating high quality samples
biopharma research for analysis, using a new automated sample preparation
system that integrates within any LC-MS workflow.
Agilent Technologies has announced the The Thermo Scientific AccelerOme Automated Sample
release of its MassHunter BioConfirm Preparation Platform eliminates the need for labour-intensive,
12.0 software, which now supports data
generated by Agilent high-resolution LC/ manual sample
MS for oligonucleotide purity analysis preparation for
and sequence confirmation. Agilent LC-MS analysis,
MassHunter BioConfirm 12.0 software including the
introduces enhancements to existing associated method
capabilities for protein analysis and adds development and
support for oligonucleotide analysis. reagent sourcing.
The addition of oligonucleotide support This allows users
significantly extends the capabilities of to focus on higher
MassHunter BioConfirm, adding critical value tasks.
functionality for assessing oligonucleotide Automated sample
purity and sequence confirmation – preparation
important analytical steps in the use also overcomes
of oligonucleotides for biotherapeutics the challenge of
and vaccine research and development. maintaining reproducibility with manual methodologies, and
The new MassHunter BioConfirm 12.0 the new platform’s pre-built validated methods and kit format
workflows allow researchers to identify reagents further reduce any risk of user error. The resulting
full-length products and potential peptide samples are of consistent high-quality. A novel built-
impurities. The innovative MS/MS- in UV measurement of final peptide concentration prior to
based sequence confirmation enables LC-MS analysis allows the standardisation of sample peptide
confirmation of oligonucleotide sequences input for LC-MS analysis, another metric that adds to the
in minutes instead of days or weeks of quality, reliability and robustness of the final experimental
manual interpretation. result.

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

Targeting Residual Cancer

While many forms of cancers are diagnosed leukaemia (ALL), is the only US FDA approved
at a curable stage, a few patients treatment of MRD. But it may cause serious side
experience recurrence at a distant site effects that can be severe or life-threatening.
during their lifetime. This is because after treating These include cytokine release syndrome (CRS),
cancer, any remaining cancer cells in the body infusion reactions, and neurologic problems
can become active and start to multiply, causing a such as seizures, difficulty in speaking or slurred
relapse of the disease. Commonly referred to as the speech, loss of consciousness, trouble in sleeping,
minimal or measurable residual disease (MRD), it confusion and disorientation.
can be well detected but may remain incurable.
Treating a patient when only MRD is present
Use of prognostic molecular tools may be is preferable to waiting for clinical relapse because
able to directly screen those patients that are the smaller number of tumour cells in MRD
most likely to harbour MRD, but the relationship increases the chance of eradication of all tumour
between these predictors and MRD detection is cells and is associated with a lower likelihood
yet undefined. Further challenges include the lack of the following cancer-promoting factors. As a
of a definitive assay for MRD with established result, certain drugs may have greater efficacy
clinical utility, and difficulty in selecting potential against MRD than against the same cancer at the
interventions due to limitations in understanding time of relapse. Additionally, patients may tolerate
the biology of MRD. drugs better when only MRD is present.

The most widely used tests for MRD detection As a result, companies across the globe are
are flow cytometry (FCM), polymerase chain investing in ideas to enhance MRD detection
reaction (PCR) and next-generation sequencing with a possibility of making it curable in the long
(NGS), depending on the type of cancer. For run. US-based Twist Bioscience Corporation
instance, MRD in case of lymphoma is detected has launched a custom solution that can be
through FCM and PCR, while MRD testing in added to a standard NGS workflow, offering fully
myeloma uses FCM, NGS and imaging tests. customisable and highly cost effective panels to
detect MRD in as few as five days. On the other
NGS is considered more accurate at detecting hand, US-based C2i Genomics has partnered with
MRD and can lessen the chances of it going an Indian startup Karkinos Healthcare to launch a
undetected. It is also easier to complete in several whole-genome sequencing (WGS) MRD test in the
hours than PCR and FCM, because the process is country for the first time.
so automated. Although by using these assays, it
can be quantified whether a patient has MRD, the Ultimately, MRD is a reminder that we need to
real difficulty lies in fixing it. be more aggressive in cancer treatment to try and
prevent the cells from coming back. Thus, there is
In a leukaemia patient, if there is MRD after a need to study these residual cancer cells in order
the first cycle of chemotherapy treatment, it to find new vulnerabilities. Through research,
indicates that probably there is a need to give we can hope to identify new treatments that we
more treatment, either a different medication or can use to specifically eliminate MRD. Looking
a different course of treatment. If there is still ahead, precise targeting of MRD through genetic,
MRD after many rounds of chemotherapy, that is transcriptional, functional, and other predictive
an indication that the patient may need to have a biomarkers might be the next step towards
stem cell transplant, when otherwise it might not improving outcomes for patients.
have been appropriate.
Dr Manbeena Chawla
In addition, Blinatumomab, a bispecific T-cell Executive Editor
engager (BiTE) associated with improved survival
in relapsed or refractory acute lymphoblastic [email protected]