BioSpectrum India 2022

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

COVER STORY 20

Can INDIA COVER DESIGN BY:
Dethrone CHINA DOMINIX STRATEGIC

In API PRODUCTION? DESIGN PVT. LTD.

The past decade has witnessed a steady growth and commitment of the Indian government
in addressing issues like ‘self-reliance and self-sufficiency’ in all aspects of governance and
decisions. While sops and subsidies were, indeed, crucial to many concerns of industries and
stakeholders, key decisions and schemes were lacking, until numerous ‘Aatmanirbhar Projects’
were kicked off by the Centre. One such crucial initiative addresses the need for Bulk Drugs Parks
in India, making the country less dependent on Chinese Active Pharmaceutical Ingredients (APIs),
providing more employment and generating more revenue that will add to the country’s GDP. A
laudable step has been taken with the launching of three Bulk Drugs projects across three states
in the country, with an estimated time of completion set at 5 years. We shall take a closer look at

what the project entails and seek expert views from a few industry stalwarts.

Single-use Tech Speaking With

27 31

The Appeal of Single-use Tech “We plan to invest in 100 startups,
with ticket sizes ranging from
Rs 25 L to Rs 10 Cr”
Padmaja Ruparel,

Founder, BioAngels

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

Speaking With Sriram Natarajan,
Director, Molbio
32 Diagnostics
throws light on
“There are many diseases for how the rapid and
which mRNA approaches will be accurate testing of
life-saving, including cancers” dengue is making
Sir Richard J Roberts, a difference in
India. He also
1993 Nobel Laureate in talks about the
Physiology or Medicine related challenges.

33 Scan the QR Code »

“We’re more than hopeful Dr Soumya
that the government will Swaminathan,
create a separate department Chief Scientist,
of medical devices” World Health
Rajiv Nath, Organisation
(WHO) talks about
Forum Coordinator, Association of the new initiatives
Indian Medical Device Industry (AIMED) being taken by the
Science Division at
Looking Back WHO.

36

A Pharma Lens:
Looking Back at 2022
Vivek Sehgal,

Director General, Organisation of
Pharmaceutical Producers of India (OPPI)

Bengaluru Tech Summit 2022

38 Scan the QR Code »

Bengaluru Tech Summit (BTS) 2022 Manu Rikhye,
Partner, Merak
Karnataka launches Research, Ventures
Development and Innovation Policy elaborates upon
the criteria
Regulars investors look for
before selecting
BioEdit .........................................................................................06 a health-tech
BioMail ........................................................................................08 startup.
Policy and Regulatory News....................................................10
Finance News.............................................................................12 Scan the QR Code »
Company News.........................................................................13
Start-up News............................................................................15
WHO News..................................................................................17
World News................................................................................18
People News...............................................................................44
R&D News...................................................................................46
Supplier News............................................................................48
Let’s Talk Health.........................................................................50

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

Timely & Prudent Decisions

The Parliamentary Committee of the Ministry database to ensure quality and efficacy of medicines
of Health and Family Welfare (MoHFW) and uniform administration of the drug law. The
has made a logical and sensible suggestion committee will also examine the existing database
to the Union Government to shift the Department available with all authorities. The point here is that
of Pharmaceuticals (DoP) from under the current the committee has been appointed by the health
Chemical and Fertiliser Ministry to the Health ministry and not the chemicals and fertilisers
Ministry. Though different types of chemicals are ministry under which the DoP works.
the main ingredients in making the medicines,
ultimately, they are consumed by patients suffering Currently, the issues related to the drugs are
due to various health issues. The question is whether divided among the two ministries. The Ministry
the department should be looking at them from the of Chemicals and Fertilisers (MoC&F) looks after
ingredients angle or end users’. Looking at it from administrative and pricing related issues. The issues
the end users’ angle is more logical and hence the related to quality are handled by the MoHFW. If this
committee’s suggestion is right. bifurcation of subjects is to be done away with, the
only option that remains is to bring the entire sector
To overcome the challenges faced by the medical under one ministry, preferably the health ministry.
devices sector, the committee has recommended
shifting of the department from one ministry to When the committee gave its recommendation,
another. It felt that the mandate of the DoP is very there were news reports that the DoP was facing a
much related to the health sector like drugs and severe human resource crunch. It was reported that
medical devices and their production, development, over 65 positions in the department, its autonomous
control, regulation, promotion, education, bodies and public sector enterprises (PSEs) were
research and training. Though the committee’s vacant. In the case of some of the PSEs, the government
recommendation is with regard to the medical had infused extra funds to boost their activities. In such
devices sectors, its implementation is expected a situation, when senior level positions remain vacant,
to tackle various challenges assailing the pharma utilisation of funds can get delayed.
industry in general.
There is an urgent need to fill up these positions for
In the case of medicines, two main regulatory effective working of the department. It is also required
aspects are related to quality and price. The to ensure that such a position would not arise in
regulatory organisation looking into both the aspects future. Though several of the vacant posts, particularly
works under the MoHFW, which has also to look in the department, are administrative in nature, such
after the patients’ interests and welfare. That makes vacancies can impede the smooth functioning of the
MoHFW the main stakeholder with respect to drugs department. In the case of medicines, any laxity in
and medical devices, making it one more reason for checking, regulating and subsequent actions is not
the DoP to work under the MoHFW. affordable and having fewer people than the required
minimum can lead to shortcomings.
The DoP was set up back in 2008 to boost the
sector and has proven to be a prudent decision. The The department may or may not shift to the
pharma sector has witnessed rapid growth with India MoHFW, as recommended by the committee,
turning into the ‘Pharmacy of the World’ and growing but situations like having several posts vacant
the industry to $42 billion. Considering this growth should be avoided. By shifting the department, if
there appears to be a need to reconsider the existing such situations are avoided then the committee’s
administrative structure and make the required recommendation and the government’s
changes, including the recent decision in focus. implementation on it is really worth it.

In one more development, the MoHFW has Dr Milind Kokje
appointed a committee to develop the national drug Chief Editor

[email protected]



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

Scan Vol 20; Issue 11; November 2022
QR code Acknowledgement/ Feedback
to access Thank you for an excellent coverage of anti-microbial
BioSpectrum resistance (AMR) in the November issue of BioSpectrum
and for highlighting the efforts being done in India in
India the AMR diagnostics space. I am greatly interested in
Digizine knowing more about the microplastics in environment
and role in AMR. Please connect me with the right
people/researchers in this area in India.

- Dr Shridhar Narayanan, Bengaluru
The collaborations and urgent time bound action we saw in response to the COVID-19
crisis is what is needed to address the AMR issues. Thank you BioSpectrum for the
feature on AMR.

- Dr Renu Swarup, New Delhi
The first printed bio magazine copy I read in my college library is BioSpecturm, while
I was a student of Industrial Biotechnology. It has all the latest, modern, advanced,
cutting edge related topics, very descriptive interviews from inspiring leaders around,
future events and job opportunities. I enjoyed reading them, flipping specific pages
where there were short discussions about future scopes. And here I am today with
one of my most important milestones of 2022, writing an article for BioSpectrum
magazine to reach out to young students, freshers, experienced ones to upskill them
based on market demands. My sincere thanks to BioSpectrum India team for giving
me this opportunity to pen down my thoughts, and to Premas Life Sciences team for
being always supportive.

- Rajavarman Kittu, New Delhi

Vol 20; Issue 12; December 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
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[email protected] and Printed by Ravindra Boratkar, Printed at Spectrum Offset, D2/4, Satyam Industrial Estate, Behind CDSS,
Product & Marketing: Erandawana, Pune - 411 038. and Published at ‘Ashirwad’, 36/A/s, S. No. 270, Pallod Farms, Baner Road, Near
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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

India unveils blueprint for national medical oxygen grid

The Bill & Melinda Randeep, Commissioner, Health in the supply of medical
Gates Foundation, and and Family Welfare Services, oxygen throughout the
the Swasth Alliance, the Government of Karnataka and country. The report
One Health Trust (OHT) heralds the advent of self-reliance presents a comprehensive
embarked on an effort to assessment of the current
develop a national oxygen and future medical oxygen
grid, that can ensure timely needs of India and the
availability of medical design and implementation
oxygen which can save of a National Medical
lives, including those of Oxygen Grid (NMOG).
children suffering from The report finds that
respiratory ailments, the lack of utilisation of
pregnant women, patients medical oxygen, especially
with severe malaria, outside of major metros,
cardiovascular disease, and meant that there was both a lack
traumatic injuries. The “Blueprint of supply as well as a lack of
for a National Medical Oxygen personnel trained to use medical
Grid in India” was launched by D oxygen.

Andhra Pradesh and India’s first
Roche Pharma join
hands to strengthen national repository
cancer care
for life science data
The Andhra Pradesh (AP) government and Roche
Pharma jointly organised a large scale workshop on opens in Faridabad
breast cancer continuum of care in Tirupati to facilitate
capacity building, spread awareness and strengthen the The Union Minister of State (Independent
Charge) Ministry of Science and Technology,
cancer care ecosystem Dr Jitendra Singh dedicated to the nation,
in the state. Nearly India’s first national repository for life
200 healthcare science data-‘Indian Biological Data Centre’
professionals (IBDC) at Faridabad, Haryana. Supported
attended the by the Department of Biotechnology (DBT),
workshop to it has been established at Regional Centre
deliberate upon of Biotechnology (RCB), Faridabad with
creating awareness a data ‘Disaster Recovery’ site at National
about personalised Informatics Centre (NIC), Bhubaneshwar.
and targeted It has a data storage capacity of about 4
treatment options petabytes and houses the ‘Brahm’ High
in management of Performance Computing (HPC) facility.
breast cancer. Roche The computational infrastructure at IBDC
Pharma will join is also made available for researchers
AP government to interested in performing computational-
provide support to intensive analysis. It also hosts an online
strengthen the cancer care ecosystem in the state with ‘Dashboard’ for the genomic surveillance
advanced treatment solutions, enhanced capacity data generated by the Indian SARS-CoV-2
building and training programs for doctors. The Genomics Consortium (INSACOG) labs.
workshop aims to bridge the current gaps in cancer The dashboard provides customised
treatment and management in the city. data submission, access, data analysis
services, and real-time SARS-CoV-2 variant
monitoring across India.

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

Karnataka-US collaboration MTaI hails CDSCO
in anti-narcotics and
pharmaceutical manufacturing notice simplifying

Dr Rahul Gupta, Director of the White House Office of sale license
National Drug Control Policy (ONDCP), Washington,
DC, USA met with Dr CN Ashwath Narayan, Minister for requirements
IT & BT, Science & Technology, Higher Education, Skill
Development, Entrepreneurship & Livelihood, Government Medical Technology Association of
of Karnataka to deliberate on new avenues in anti-narcotics India (MTaI) has welcomed the Central
and manufacturing of Drugs Standard Control Organization
medication to treat drug (CDSCO) notice GSR 754 (E) simplifying
dependence for US and sale license requirements for retailers
other markets in the and wholesalers who are involved in
backdrop of firms globally stock or sale of medical devices by
pursuing the China-Plus- also allowing registration certificate
One strategy. Collaborative in its lieu. The association, which
engagements in the areas represents a significant portion of the
of enforcement, regulatory contact lens industry, also pointed
frameworks, transparency out that the simplified sale license
through effective IT requirements are well intended but
Systems, building of robust expressed concerns regarding their on-
frameworks for the growth of the pharmaceutical industry ground implementation. According to
were discussed. As per the New Education Policy (NEP), the Pavan Choudary, Chairman & Director
government unveiled its ambitious ‘Twinning Programme’ in General, MTaI contact lenses and lens
2021. A first-of-its-kind in India, it aims to internationalise care products are being sold for several
higher education. Cooperation in student exchange decades in the country outside of a sale
programmes, educational twinning programmes, curriculum license requirement in optical stores and
building, upskilling and job growth in leading edge programs contact lens clinics. He was of the opinion
in Healthcare, Biotech, Tele-health, IT and Data Security that the new sales license rules though
were also discussed in detail. welcome, would mean that thousands
of these optical shops now need to go
through this mechanism for registration.

Govt launches multiple health
infrastructure projects in Ahmednagar

Union Health & Family be built at a projected cost projected cost of Rs 5.6 crore
Welfare Minister Dr Mansukh of Rs 7.02 crore. The Health and the main building of the
Mandaviya inaugurated multiple Minister also inaugurated the PHC in Padhegaon, which is
health infrastructure projects construction of the main building built at a projected cost of over
at an event in Ahmednagar and staff quarters of the PHC Rs 2.14 crore. The Minister
(Maharashtra). The projects in Kharda, which is built at a also inaugurated Dr Vikhe
include three Primary Health Patil Nuclear Medicine Centre,
Care Centres in Ahmednagar which is equipped with facilities
which were inaugurated virtually for comprehensive cancer care
and the Dr Vikhe Patil Nuclear including both diagnosis and
Medicine Centre. Dr Mandaviya treatment. It is the first-of-its-
inaugurated the construction kind in the district and will cater
of the main building & staff to the population of Ahmednagar,
quarters of the Ralegan Siddhi Beed, Nashik, Aurangabad,
Primary Health Care Centre Solapur and peripheral areas of
(PHC). The PHC complex will Pune districts.

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

Kriya Medical ACT invests Rs 3.2 Cr towards
catalysing accessible &
receives affordable cancer care

Rs 4 Cr to ACT, a non-profit venture philanthropy platform, has recently brought
Periwinkle Technologies, Niramai Health Analytix and Navya Care on
develop board to improve access to affordable, quality cancer care in India. ACT
For Health will provide catalytic
saliva grant funding, accelerate scale
of the solutions by providing key
collection kit network interventions, and enable
widespread ecosystem adoption. Early
for infectious breast cancer detection is the key to
improving patient survival but 60 per
diseases cent of breast cancer patients in India
are diagnosed only at an advanced
screening stage (stages III and IV). Niramai’s
low cost, non-invasive, portable and
Technology Development radiation-free artificial intelligent (AI)
Board (TDB), Department based engine detects thermal signatures for abnormalities and aims to
of Science & Technology, is accelerate early stage cancer detection and treatment. Delivering cancer
supporting Chennai-based care that complies with standard clinical guidelines is often impacted
Kriya Medical Technologies due to the shortage of oncologists in the country. Navya Care’s AI based
for the development and Earthshot Engine is a simple digital user interface through which non-
commercialisation of saliva clinical staff can enter patient data. It then maps that data to NCG
direct sample collection (National Cancer Grid) and NCCN (National Comprehensive Cancer
kit. TDB has penned the Network) guidelines to determine compliant treatment protocols.
agreement to provide Rs 4
crore loan assistance out Eye-Q Vision to secure
of the total project cost of $9.9M in debt financing,
Rs 9 crore. The company driving access to quality eye care
intends to manufacture
and commercialise a Gurugram-based Eye-Q Vision will raise a debt funding of $9.9 million (Rs
saliva collection kit with a 81.5 crore) from the US government’s development finance institution, US
molecular transport media International Development Finance Corporation (DFC). Eye-Q has created
(MTM) that will advance
molecular diagnosis a unique position in India
of infectious diseases with its quality and safety
and cancer screening. focus and lean operational
The MTM enables the model. The company ensures
laboratory to skip RNA readily available, affordable
isolation protocol and and high quality, end to end
facilitates DNA isolation. ophthalmology services to
The current conventional populations in the Tier 2
collection method for to Tier 4 towns. With this
viral pathogens, viral financing from DFC, the
transport media (VTM), company will expand these
keeps the virus alive during quality services within &
lab manipulation. The beyond the Indian subcontinent by developing more centers – beyond its
company’s novel media current 39 centers - to sustain growth momentum and create access in
inactivates the virus at the underserved areas across Tier 2 to Tier 4 towns in India.
time of collection, thus
avoiding the accidental
spread of infections
which is inherent with
conventional VTM.

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

Indian Immunologicals Limited
transports animal vaccines through drones

Department of Animal terrains faster but also help in Minister for Agriculture
Husbandry and Dairying, providing critical vaccines on time and Animal Husbandry,
Government of India, for the protection of livestock Government of Arunachal
Department of Agriculture from several diseases. Tage Taki, Pradesh; Upamanyu
and Animal Husbandry, Basu, Joint Secretary
Government of Arunachal (LH), Department of
Pradesh, along with Animal Husbandry and
Indian Immunologicals Dairying, Government
Limited (IIL) transported of India; Dr Sujit Nayak,
animal vaccines through Joint Commissioner
the use of drones for the (NADCP), Department of
“first time in the world”. Animal Husbandry and
The maiden drone flight Dairying, Government
moved from Roing to Paghlam of India were present along with
in Arunachal Pradesh. Drone IIL’s representatives – D Banerjee
delivery of vaccines is expected and Mainak Sen, during the
to not only reach remote difficult event.

Novo Nordisk to Fujifilm expands
improve healthcare access
for patients with diabetes, pulmonology
obesity in Karnataka
solutions portfolio
The Novo Nordisk Education Foundation (NNEF), a non-
profit organisation established by the Denmark-based in India
biopharmaceutical firm Novo Nordisk, and the Government
of Karnataka have pledged to work together to improve Fujifilm India has expanded its
access to education, treatment, and care for people living with pulmonology solutions portfolio
diabetes and obesity in by launching a new slim video
the state. The parties bronchoscope called EB-710P,
will work together to which was unveiled at the National
create an action plan Conference NAPCON in Udaipur.
that positively impacts The EB-710P is a thin endoscope
the lives of people equipped with an exceptionally compact
who live with the two CMOS (Complementary Metal Oxide
chronic diseases. The Semiconductor) sensor. This technology
proposed action plan means that the tip is a mere 4.1 mm in
includes the setting up diameter, so that it may penetrate the
of multiple Centres of periphery of the lung much more easily
Excellence (CoEs) across than a conventional system. In addition,
medical colleges in Karnataka and the education of doctors there is a rotation mechanism which
and patients who live with the condition. According to Freddy allows the user to return the endoscope
Svane, Ambassador at the Royal Danish Embassy, to make a safely to its original position before the
meaningful impact in reducing the burden of chronic diseases, withdrawal. The ergonomic grip and
there is a need to use as many hands as possible. Public- the teardrop-shaped dial used with
private partnerships such as these are a great way for like the rotation function make for smooth
minded stakeholders to work on common goals. handling. With its extremely small
diameter and its rotation function, the
innovative EB-710P endoscope system
increases the safety and comfort of a
bronchoscopy.

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

AstraZeneca Biological E to test Corbevax on
& 4baseCare infants as young as six months
enhance
access to Biological E (BE), a Hyderabad- approximately 74 million doses of
genomic based vaccine and pharmaceutical CORBEVAX has been administered
testing company, has
for cancer recently announced to kids in India and
patients in the publication almost 33 million
India of CORBEVAX kids have completed
COVID-19 vaccine two-dose primary
Bengaluru-based phase II/III clinical vaccination, which
precision oncology startup trials conducted represents one
4baseCare has announced in paediatric of the largest
a collaboration with population (5 to paediatric
AstraZeneca for advancing <18 age group). campaigns
cancer care in India. The vaccine has globally. In August,
Under this collaboration, demonstrated CORBEVAX became
the two organisations excellent safety the first vaccine
will support advanced- profile in children in India to get
stage cancer patients with and adolescents. DCGI approval
targeted therapy options The vaccine also for a COVID-19
using affordable genomic demonstrated heterologous
solutions. AstraZeneca excellent booster shot. It can
and 4baseCare will work immunogenicity be administered
with the oncologist as measured by humoral and six months after
community to support a cellular immune responses. So far, two doses of COVISHIELD or
large number of patients COVAXIN for all adults.
by providing services
locally and also at a low OncoStem grants Zydus
cost ultimately increasing Lifesciences exclusive marketing
the chances of identifying rights for breast cancer test
optimal treatment options
thereby improving Ahmedabad-based Zydus Lifesciences has announced that it will be
clinical outcomes. After exclusively marketing CanAssist Breast, an innovative and a highly
doing massive research advanced prognostic test for breast cancer patients in the early stages to
in collaboration with top help clinicians decide whether the patient needs chemotherapy or not. With
hospitals and oncologists
from India, 4baseCare the aid of CanAssist
recently launched Breast and its precise
a gene panel called findings, clinicians can
TARGT IndieGene. It avoid chemotherapy
is India’s largest and for their patients based
first population-specific on scientific evidence.
tumour gene panel Bengaluru-based
derived from Whole startup OncoStem
Exome and Whole has developed this
Transcriptome data from test after five years of
over 1,500 cancer patients research and has generated a lot of data on patients suffering from breast
across 28 different cancer cancer in India and across the world. CanAssist Breast is a test to optimise
types. treatment selection in early stage (I & II) hormone receptor positive, HER2
receptor negative type of breast cancer. It determines the patient’s risk of
breast cancer recurrence and classifies patient as ‘low risk’ or ‘high risk’
using proprietary Artificial Intelligence/ Machine Learning methods.

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com STARUPS NEWS 15

Decode Age to raise $500k through Even Healthcare
strategic partners and VCs secures additional
funding of $15M
Decode Age, a Bengaluru- coming times. Decode Age
based longevity research is now set to raise $500,000 After having raised $5 million
company, raised around through strategic partners, in its seed round, Even, the
$150,000 in October 2021 and VCs so as to scale up Bengaluru-based healthcare
through multiple angel their gut microbiome test startup founded by Mayank
investors and now, in and preventive care range Banerjee, Matilde Giglio,
2022, aims to raise close to of products. A part of the Alessandro Ialongo, has raised
$500,000 through strategic funds would also be utilised additional funding of $15 million
partners, and VCs. Started to expand the geographical to expand personalised and
in 2021 as a bootstrap with market reach, funding preventive care in India. The
$125,000, the three founders for clinical research on healthcare startup has raised
of Decode Age – Darshit supplements, develop a $20 million over the past year.
Patel, Parth Amin and technology platform for The new capital comes from
Rakesh Somani, ventured end-to-end longevity as a new investors Alpha Wave and
into longevity research, service, marketing and spread Aspada (Lightrock) which now
with an aim to identify, awareness about longevity join existing investors Khosla
innovate, build, and create science, make an effective Ventures, Founders Fund, Lachy
awareness for what is going supply chain, and create tech Groom, Palo Alto Networks
to change healthcare in the for efficient user journey. CEO Nikesh Arora, CRED
CEO Kunal Shah, and DST
Ayu Health receives Global partner Tom Stafford.
additional funding of $5M, Even was founded to simplify
makes entry into Hyderabad healthcare in India which poses
unique challenges such as lower
Ayu Health Hospitals, a fast-growing healthcare startup based in penetration of health insurance
Bengaluru, has announced its maiden entry into Hyderabad. With and fee-for-service care that
an aim of providing healthcare for all, the company will be adding puts a disproportionate financial
more hospitals to its existing portfolio of 19 hospitals and 1500 burden on people. The startup
beds in the region. Recently, the company secured an additional $5 plans to utilise the funds to
million on the heels of its Series B funding secured earlier in the year strengthen its clinical team of
by investors such as Fundamentum Partnership, Stellaris Venture highly experienced doctors to
Partners, and Vertex Ventures. The company is making its entry into scale its preventive care for
the Hyderabad market through its unique asset-light business model India’s growing comorbidities
with the objective of building a trusted network of high-quality like diabetes, Polycystic ovary
hospitals through transparent pricing, insurance provision, and syndrome (PCOS), obesity, etc.
standard treatment protocols. Ayu Health will soon start working
with a few of the top hospitals, such as Sia Life, TX Uppal, and
Vrinchi Hospitals in Hyderabad, to bring quality healthcare to the
masses through the standardisation of healthcare services provided
by neighbourhood hospitals.

16 STARUPS NEWS BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

Behavioural Foresight introduces Israeli
technology to promote mental wellness

Bengaluru-based startup technology. The focus is on technology (used by the
Behavioural Foresight enhancing the mental well-being Israeli military), to India
(BF) has announced the of the workforce through real- to help individuals,
launch of its proprietary time assessment, programming corporates and
brand Ezun, a significant and personal training. Ezun educational institutions
step in changing the way brings the latest Israeli chart a new course. The
we think about mental full-fledged simulation
strength. BF caters to room is equipped to
a wide roster of clients monitor in real time,
from Olympians, racers, several mental health
cricketers, and golfers parameters (proven
to CEOs, high-level by research to show
executives, and company correlations between
owners. The company has physiological changes and the
recently partnered with Trident mental state) and train people,
Automobiles and MVP Rocket, to with no previous experience,
create a first-of-its-kind mental to control these parameters in
health experience in India using the quickest and most scientific
cutting-edge gamified biofeedback manner possible.

Instashield QubeHealth closes
Pre-Series-A funding
receives recognition
Mumbai headquartered QubeHealth, a ‘Fin-Tech
from Atal Incubation for Health-Tech’ early-stage startup, has raised an
undisclosed Pre-Series-A round led by the US-based
Centre at CCMB New Horizon Ventures, ThinKuvate (Singapore)
and existing investor, Keiretsu Forum. Axiomatic
Instashield, a health and wellness startup Ventures, Inflection Point Ventures, an existing
at Hyderabad, was recently honoured with investor, and other angel investors from India
‘Products Lift off by Startups’ Award by Atal and the US, also participated in the round that the
Incubation Centre- Centre for Cellular and company stated, giving them a runway of over 20
Molecular Biology (CCMB). The award was months. The funds raised will be used to scale up
given by Padmabhushan Dr T Ramasami, the business and to invest further in building the
Former Secretary, Department of Science & ‘healthcare commerce’ technical infrastructure and
Technology in Hyderabad. The ceremony was expanding its healthcare marketplace. QubeHealth is
organised to celebrate five years of the Atal focussed on solving the healthcare financing problem
Incubation Centre and recognised companies for healthcare expenditure that is not covered by
who have done exceptionally well in the field of health insurance. It offers No-Cost EMI Healthcare
technology. Hitesh M Patel, Promoter & Director Finance to employees of corporates that subscribe to
and CS Jadhav, CEO, Instashield received the its service.
award for creating an outstanding tech product,
which works on negative ion technology. This
technology is known for its benefits such as
reducing symptoms of depression, regulating
sleep patterns and mood, boosting the immune
system and improving cognitive performance.
Instashield, the product created by Hitesh’s
skilled and innovative team has a unique feature
of eliminating all sorts of viruses including the
SARS COV19 by 99.9 per cent efficacy as well.

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com WHO NEWS 17

WHO inks new MoU on WHO advises
health workforce priorities
immediate skin
The World Health Organisation (WHO) has signed a
Memorandum of Understanding (MoU) with the five to skin care for
members of the World Health Professions Alliance
(WHPA): World Dental Federation (FDI), International survival of small
Pharmaceutical Federation (FIP), International Council of
Nurses (ICN), World Physiotherapy, and World Medical and preterm babies
Association (WMA). Together these five organisations
represent more than 41 million health professionals WHO launched new guidelines to
worldwide and assemble essential knowledge and experience improve survival and health outcomes
from the key health professions in more than 130 countries. for babies born early (before 37 weeks
This signing ceremony represents an historic event, bringing of pregnancy) or small (under 2.5kg
together the five global organisations representing the at birth). The guidelines advise that
world’s dentists, pharmacists, nurses, physiotherapists and skin to skin contact with a caregiver
physicians with WHO to enhance their joint collaboration on – known as kangaroo mother care
protecting and investing in the health workforce to provide – should start immediately after
safe, quality and equitable care in all settings. birth, without any initial period in an
incubator. This marks a significant
change from earlier guidance and
common clinical practice, reflecting the
immense health benefits of ensuring
caregivers and their preterm babies
can stay close, without being separated,
after birth. The guidelines also provide
recommendations to ensure emotional,
financial and workplace support for
families of very small and preterm
babies, who can face extraordinary
stress and hardship because of
intensive caregiving demands and
anxieties around their babies’ health.

WHO updates recommendations to guide
family planning decisions

The World Health Organization It also expands guidance for
(WHO) released important women and young people at high
updates to its landmark Family risk of HIV. The manual details
Planning Handbook, which practical measures that support
provides health workers and policy continuity of family planning
makers with the most current services during epidemics. These
information on contraceptive include wider access to self-
options. Drawing on lessons from administered contraceptives,
recent outbreaks, this new edition and direct distribution of
details tangible measures for contraceptives through
frontline health workers to protect pharmacies. Health practitioners
access to family planning services can also take steps to support
during emergencies, such as ongoing contraceptive access
wider access to self-administered even where physical mobility is
contraceptives and the use of reduced, such as providing multi-
digital technologies by providers. month supplies.

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

Islamabad Healthcare Sweden to give
Regulatory Authority in
MoU with QUAD-A $10M to UNFPA to

Islamabad Healthcare Regulatory Authority (IHRA) and support midwifery,
the American Association for Accreditation of Ambulatory
Surgery Facilities (AAAASF) (QUAD-A) signed a reproductive health
Memorandum of Understanding (MoU) to improve the
quality, efficiency, and safety of healthcare services in in Bangladesh
Islamabad Capital Territory (ICT). As per MoU, healthcare
services will be improved in Sweden will provide $10 million to
the federal capital by adopting the UN Population Fund (UNFPA) to
evidence-based regulatory strengthen the quality and access to
standards for the registration midwives and comprehensive sexual and
and licensing of healthcare reproductive health services (SRHR)
establishments. This MoU in Bangladesh, including in the most
will allow IHRA to bring a remote areas affected by climate change.
truly global healthcare system, UNFPA and Sweden signed a new
infrastructure, and standards partnership for the period of 2022-2026
to the Capital Territory of at the Swedish embassy in Dhaka in the
Islamabad through a long- presence of Ambassador Alexandra Berg
term strategic partnership with von Linde and UNFPA Representative in
QUAD-A. It is imperative to Dhaka Kristine Blokhus. UNFPA aims to
establish healthcare systems equip Bangladesh’s health system with
that are more resilient, centered competent and empowered midwives to
around people’s needs and sustainable. The MoU was signed ensure that women and girls can access
in order to address the issues being faced by the country like gender-transformative healthcare.
access to affordable and quality healthcare services besides In a statement, Swedish Ambassador
alarming health indicators and high mortality rates. von Linde said that Sweden has a long
history of midwifery and has supported
Bangladesh midwives for over a decade.

Mount Sinai’s Arnhold Institute for Global
Health partners with KUSMS, Dhulikhel Hospital

The Arnhold Institute for Global developing clinical programmes, partnership will also engage the
Health at the Icahn School of courses, and training; faculty, Academic Model Providing Access
Medicine at Mount Sinai and the staff, and medical student and to Health (AMPATH) Consortium,
Kathmandu University School of resident exchanges to work or a global network of 15 universities
Medical Sciences (KUSMS) and train abroad; and joint scientific and academic health centers
Dhulikhel Hospital in Nepal have research and quality improvement that aims to improve healthcare
announced a multi-year agreement projects. Through Mount Sinai as in underserved communities by
that will advance clinical education, a lead anchoring institution, the fostering long-term, equitable
training, research, and care both in partnerships with ministries of
Nepal and throughout the Mount health and other stakeholders to
Sinai Health System, one of the build public health systems and
largest academic medical systems promote well-being. The Arnhold
in the New York metro area, with Institute for Global Health
more than 43,000 employees, will lend its expertise in global
to promote greater global health healthcare, training, and research
equity and access. The partners will throughout central Nepal, which
seek opportunities to collaborate has a population of about 2.2
in several areas, including million.

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com WORLD NEWS 19

Global Vaccine Market Report 2022
focuses on consistent inequities

The World Health vaccine against cervical
Organisation (WHO)’s cancer has only been
Global Vaccine Market introduced in 41 per cent
Report 2022, published on of low-income countries,
November 9, shows that even though they represent
inequitable distribution is much of the disease burden,
not unique to COVID-19 compared to 83 per cent
vaccines, with poorer of high-income countries.
countries consistently Affordability is also an
struggling to access vaccines obstacle to vaccine access.
that are in-demand by While prices tend to be tiered
wealthier countries. Limited by income, price disparities
vaccine supply and unequal see middle-income countries
distribution drive global paying as much, or even
disparities. The human more, than wealthier ones
papillomavirus (HPV) for several vaccine products.

Global agencies’ outline G20 launches the
plan to support Uganda-
led response to outbreak Pandemic Fund
of Ebola virus disease
to reduce risks
Following the declaration of an Ebola outbreak in Uganda in
September 2022, the outbreak has now spread to seven districts from epidemics
(Kasanda, Kyegegwa, Bunyangabu and Kagadi districts beyond
the original epicenter in Mubende district, and then to Kampala The G20 Presidency of Indonesia, in
City and Wakiso). The government-led response has activated partnership with the Pandemic Fund
the Incident Management System to control the outbreak. In secretariat, officially launched the
support of the Ministry of Health-led efforts, the Coalition for Pandemic Fund at a high-level event,
Epidemic Preparedness Innovations (CEPI), Gavi and WHO opened by Joko Widodo, President
have outlined a plan to accelerate research during the outbreak, of Indonesia, on the margins of
to ensure access to investigational doses, and to facilitate scaling the G20 Joint Finance and Health
up and access to any subsequent licensed vaccine. The Ministry Ministers’ Meeting. Speakers at
of Health has designated the Makerere University Lung Institute the event welcomed the launch of
to conduct vaccine and therapeutics clinical trials. The clinical the Pandemic Fund as a key part of
trial to evaluate candidate vaccines against this ebolavirus is co- the solution to reducing risks from
sponsored by the Ministry of Health in Uganda and WHO, and epidemics and pandemics in the
involves support from partners. most vulnerable parts of the world
and contributing to a healthier and
safer world. The Pandemic Fund is
intended to strengthen the capacity of
these countries to mitigate the risks
of future global health threats. It will
provide a dedicated stream of long-
term financing for PPR and address
critical gaps through investments
and technical support at the national,
regional, and global levels. The
Pandemic Fund is also expected to
incentivise countries to prioritise this
agenda and increase their own efforts.

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

Can INDIA
Dethrone CHINA

In API PRODUCTION?
The past decade has witnessed a steady growth and commitment of the Indian
government in addressing issues like ‘self-reliance and self-sufficiency’ in all aspects
of governance and decisions. While sops and subsidies were, indeed, crucial to many
concerns of industries and stakeholders, key decisions and schemes were lacking, until
numerous ‘Aatmanirbhar Projects’ were kicked off by the Centre. One such crucial initiative

addresses the need for Bulk Drugs Parks in India, making the country less dependent
on Chinese Active Pharmaceutical Ingredients (APIs), providing more employment and
generating more revenue that will add to the country’s GDP. A laudable step has been
taken with the launching of three Bulk Drugs projects across three states in the country,
with an estimated time of completion set at 5 years. We shall take a closer look at what

the project entails and seek expert views from a few industry stalwarts.

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

The much-anticipated bulk drugs parks have parks. The parks aim to bring down the cost of
come to reality with the Government of India manufacturing bulk drugs by the creation of world-
launching three parks across three states, class common infrastructure facilities supported by
namely, Gujarat, Himachal Pradesh and Andhra the Central Government and thereby increase the
Pradesh. India, being touted as the ‘Pharmacy of competitiveness of the domestic bulk drug industry.
the world’, the launch of bulk drug parks was much
awaited by the sector that was mostly dependent on As per the proposals submitted by these states,
China for procuring raw materials. the bulk drug parks will be established in 1402.44
acres of land at tehsil Haroli, district Una, Himachal
China’s dominance in the Active Pharmaceutical Pradesh, 2015.02 acres of land at tehsil Jambusar,
Ingredient (API) market, which is essential for drug district Bharuch, Gujarat and 2000.45 acres of land
development, has made the government take a quick at KP Puram and Kodhada of Thondagi Mandal of
decision to launch the drug parks. Moreover, supply East Godavari district, Andhra Pradesh.
chain issues have been hampered due to sudden
COVID lockdowns leading to disruptions. The bulk drug parks will provide common
infrastructure facilities in one place, thereby creating
Step Toward Self-reliance a robust ecosystem for bulk drug manufacturing in
the country and also reducing the manufacturing
The Department of Pharmaceuticals received 13 cost significantly. The scheme is expected to
proposals from state governments under the Scheme encourage domestic manufacturing of bulk drugs
for “Promotion of Bulk Drug Parks”, a key initiative to reduce import dependence and to establish a
to support bulk drugs manufacturing, off which the dominant position in the global market by providing
department has conveyed ‘in-principle’ approval to easy access to standard testing and infrastructure
the proposals of the three states namely, Himachal facilities.
Pradesh, Gujarat and Andhra Pradesh.
Work on the first bulk drug park in Gujarat
The Scheme, with a financial outlay of Rs started on October 10, 2022 with Prime Minister
3,000 crore notified in 2020, provides financial Narendra Modi laying the foundation stone at
assistance to three states for establishing bulk drug Jambusar in Bharuch district. It is estimated that

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

“Regaining the advantage the project worth Rs 2500 crore would further boost
and achieving self-reliance India’s pharmaceutical growth. The project will
will be a long-term process. play a key role in ensuring import substitution and
PLI Scheme for bulk drugs helping make India self-reliant for bulk drugs. In
are a significant step in this 2021-22, bulk drugs accounted for over 60 per cent
direction. The scheme provides of total pharmaceutical imports.
subsidies and creates clusters
for developing an ecosystem On October 13, the PM laid the foundation
for bulk drug manufacturers. stone for the second bulk drug park of the country
These clusters have been of in Una, Himachal Pradesh, which will be built at a
great help as they facilitate cost of over Rs 1900 crore. It is expected to attract
faster clearance, efficiency and investment of around Rs 10,000 crore and provide
product development initiatives. employment to more than 20,000 people. It will also
This is a much-called-for policy give a fillip to economic activities in the region.
initiative that will help the
Indian pharmaceutical industry In his address at the ceremony the Prime
Minister stated that Himachal Pradesh has
going forward.” played a crucial role in making India the number
- Dr Sudarshan Jain, one medicine manufacturer in the world and its
Secretary General, possibilities are only going to increase. “The entire
world has witnessed the strength of the medicines
Indian Pharmaceutical Alliance (IPA) manufactured in Himachal Pradesh”, Modi added.
He further pointed out that now that raw materials
“Several steps had to be for medicine manufacturing will be produced in
taken in terms of setting up Himachal Pradesh, India’s dependency on the
agencies and teams by the other nations is going to decrease significantly.
“The bulk drug park will give further strength to
central government such the government’s campaign to provide quality and
as Project Management affordable medical care to people”, he pointed out.
Agency by Department of
Pharmaceuticals, Scheme Jai Ram Thakur, Chief Minister of Himachal
Steering Committee, etc. The Pradesh, during his recent address to the members
states had to prepare Detailed of the State Pharmacy Council at Kasauli, mentioned
Project Reports and had to that the drug park in Himachal Pradesh will be
submit these to the Department a boon to the state. He hailed the move and was
optimistic about how India could become less
of Pharmaceuticals.” dependent on China for raw materials. He also
- Girdhar Balwani, mentioned that manufacturing costs will come down
thereby reducing the cost of medicines.
Independent Director,
Cadila Pharmaceuticals Andhra Pradesh received a Rs 1000-crore grant
from the Department of Pharmaceuticals for setting
“It seemed pharma was not as up a bulk drug park at K P Puram and Kodhada
high a priority as infrastructure villages in Thondangi Mandal, East Godavari
district.
and other basic things. Once
the ball is moving on that, the Objective

government seems to have India had exported pharmaceuticals worth
realised the importance of Rs 1,75,040 crore in the financial year 2021-22,
these and is moving forward including bulk drugs/ drug intermediates. Also,
India is one of the major producers of API or bulk
aggressively. Given the drugs in the world. India exported bulk drugs/ drug
renewed focus on pharma intermediates worth Rs 33,320 crore in the financial
and healthcare, especially post year 2021-22.
COVID, it certainly appears to be
a step in the right direction.” However, the country also imports various bulk
drugs/ APIs for producing medicines from various
- Uddhav Kanoria, countries. Most of the imports of the bulk drugs/
President, APIs being done in the country are because of
economic considerations.
Anglo French Drugs & Industries

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

As per estimates by the Ministry of Health and Envisaged Bulk Drug Parks
Family Welfare, in FY 2020-21, imports of APIs
stood at Rs 28,529 crore while exports were at Rs State Area Cost Estimated
32,856 crore. The size of the API and intermediates (in (Rs in Completion
market in India is estimated to be Rs 96,000 crore in Himachal Pradesh acres) crore) Time
FY 2019-20. As per data maintained by Directorate At Tehsil Haroli, (in years)
General of Commercial Intelligence and Statistics District Una
(DGCIS), the quantity of API imports were at Rs Gujarat 1402.44 1,900 5
3,90,476 metric tonnes (MT) and exports were at At Tehsil Jambusar,
3,24,331 MT for FY 2020-21. District Bharuch 2015.02 2,500 5
Andhra Pradesh
The government strives to minimise the K P Puram and 2000.45 1,000 5
country’s dependence on imports and to give a fillip Kodhada village of
to indigenous manufacturing. The Department of Thondagi mandal
Pharmaceuticals is implementing various schemes of East Godavari
and one of the key interventions is the Scheme for district
Bulk Drug Parks to make the country self-reliant in
APIs and drug intermediates. India’s tryst with China on APIs

In April 2021, the Department of India has been lately trying to be less
Pharmaceuticals launched the Production Linked dependent on China for APIs. The country buys an
Incentive (PLI) Scheme for bulk drugs, with a estimated 70 per cent of its APIs from China. With
financial outlay of Rs 6,940 crore across 53 APIs COVID-19 restrictions having an impact on the
over six years. The PLI scheme for the pharma supply chain issues, India put export restrictions
sector will improve affordability and accessibility of on 26 APIs and drugs.
pharma products.
India has imported pharma products worth
According to Dr Sudarshan Jain, Secretary $4.1 billion in April-September 2022, of which
General, Indian Pharmaceutical Alliance (IPA), India China’s share is 43 per cent ($1.74 billion). Out of
has lost the advantage of bulk drug manufacturing this, bulk drugs and drug intermediates consist
over the years. China has built their presence of 55.42 per cent of India’s total pharma imports
because of the support received in multiple areas worth $2.25 billion. According to government
right from plant prices, interest rates, and power figures, India imports about 68 per cent of its APIs
subsidies among others. from China.

He mentions, “Regaining the advantage and An ICRA report states that under a government
achieving self-reliance will be a long-term process. scheme launched two years back 35 APIs
PLI Schemes for bulk drugs are a significant step are being produced in India across 32 plants.
in this direction. The scheme provides subsidies According to ICRA estimates, 34 products
and creates clusters for developing an ecosystem approved in the first phase will result in less
for bulk drug manufacturers. These clusters have imports by 25-35 per cent by 2029.
been of great help as they facilitate faster clearance,
efficiency and product development initiatives. The Indian pharma exports witnessed a
API self-reliance is a global issue and is part of a growth of 103 per cent since 2013-14, from Rs
diversified supply chain approach. This has got 90, 415 crore in 2013-14 to Rs 1,83,422 crore in
implications for healthcare security. India has taken 2021-22. The exports achieved in 2021-22 is the
a positive step and is also evaluating options for pharma sector’ best export performance ever. It
increasing the production of intermediates. This is is a remarkable growth with exports growing by
a much-called-for policy initiative that will help the almost $10 billion in eight years. The pharma
Indian pharmaceutical industry going forward.” exports in 2021-22 sustained a positive growth
despite the global trade disruptions and drop in
However, the launch of the bulk drug parks took demand for COVID-related medicines. The trade
much longer since the time it was announced by the balance continues to be in India’s favour, with a
government. surplus of $15175.81 million.

Cause for delay

It has been almost two years since the plan to
set up bulk drug parks was announced officially.
Girdhar Balwani, Independent Director, Cadila
Pharmaceuticals while pointing out the likely

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

List of Applicants Approved under PLI Scheme for Promotion of Domestic
Manufacturing of critical KSMs, drug intermediates (DIs)/ APIs in India

S.No Name of the Applicant Name of the Eligible Product

Target Segment I – Key Fermentation Based KSMs/Drug Intermediates

1 Aurobindo Pharma (through Lyfius Pharma) Penicillin G

2 Karnataka Antibiotics & Pharmaceuticals
7 - ACA

3 Orchid Bio-Pharma

4 Kinvan Clavulanic Acid

Target Segment II – Fermentation Based Niche KSMs/Drug Intermediates/APIs

1 Natural Biogenex Betamethasone

2 Natural Biogenex Dexamethasone

3 Natural Biogenex Prednisolone
4 Symbiotec Pharmalab

5 Macleods Pharmaceutical Rifampicin

6 Karnataka Antibiotics and Pharmaceuticals Clindamycin Base

Target Segment III – Key Chemical Synthesis Based KSMs/Drug Intermediates

1 Emmennar Pharma

2 Hindys Lab 1,1 Cyclohexane Diacetic Acid (CDA)

3 Alkimia Pharma-Chem

4 Meghmani Para amino phenol
5 Sadhana Nitro Chem

6 Granules India Dicyandiamide (DCDA

Target Segment IV – Other Chemical Synthesis Based KSMs/Drug Intermediates/APIs

1 Rajasthan Antibiotics Meropenem

2 Centrient Pharmaceuticals Atorvastatin

3 Anasia Lab Olmesartan
4 Andhra Organics

5 RMC Performance Chemicals Aspirin
6 Alta Laboratories

7 Lifetech Sciences Ritonavir

8 Honour Lab Lopinavir

9 Hindys Lab Acyclovir

10 Dasami Lab Carbamazepine

11 Dasami Lab Oxcarbazepine
12 Hetero Drugs

13 Hazelo Lab

14 Sudarshan Pharma Industries Vitamin B6

15 Honour Lab

16 Honour Lab Valsartan

17 Anasia Lab Losartan

18 Hetero Drugs

19 MSN Life Sciences Levofloxacin

20 Vital Laboratories

21 Vital Laboratories

22 Global Pharma Healthcare Ofloxacin

23 Globela Industries

24 Kreative Actives

25 Amoli Organics Diclofenac Sodium

26 Vapi Care Pharma

27 Hetero Drugs Carbidopa
28 Hetero Drugs Levodopa

29 Andhra Organics Sulfadiazine

30 Sreepathi Pharmaceuticals Ciprofloxacin

31 Andhra Organics Telmisartan

32 Honour Lab Levetiracetam
33 Globela Industries Norfloxacin

34 Aviran Pharmachem Artesunate
35 K P Manish Global Ingredients

Source: Ministry of Chemicals and Fertilizers Department of Pharmaceuticals

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

API imports in India from FY 2012 to 2020 (Rs billion)

reasons for the delay in setting up of bulk drug Source: Statistica 2022
parks mentions, “Several steps had to be taken
in terms of setting up agencies and teams by the Scope of the Scheme for
central government such as Project Management ‘Promotion of Bulk Drug Parks’
Agency by Department of Pharmaceuticals, Scheme
Steering Committee, etc. The states had to prepare ● A Central Sector Scheme.
Detailed Project Reports and had to submit ● The total financial outlay of the Scheme is
these to the Department of Pharmaceuticals. 13
states submitted their proposals and these had Rs 3000 crore. Three bulk drug parks will be
to be evaluated in detail, especially in terms of supported under the Scheme.
financial viability. The Project Management Agency ● Maximum grant-in-aid for one bulk drug park
made recommendations to the Department of will be limited to Rs 1000 crore. The duration of
Pharmaceuticals which were then placed before the the Scheme is from FY 2020-202 1 to FY 2024-
Scheme Steering Committee. In principle, approval 2025.
has been given to three states. The projects which ● Under the scheme, a one-time grant-in-aid
cover setting up common infrastructure facilities are will be provided for the creation of common
to be completed within two years from the date of infrastructure facilities in selected bulk drug
release of the first instalment.” parks proposed by a state government.
● The scheme will be implemented through a
There have been some controversies regarding State Implementing Agency (SIA), a legal entity,
the bulk drug park in Andhra Pradesh. The set up by the concerned State Government.
government proposed to set up a bulk drug park ● The grant-in-aid will be 70 per cent of the
on about 2,000 acres at KP Puram and Kodhanda project cost of the common infrastructure
of Thondangi Mandal in the KSEZ in Kakinada facilities (CIF). In the case of North Eastern
district. Some political issues regarding the socio States and Hilly States (i.e Himachal Pradesh,
and ecological impact on the local communities and Uttarakhand, UT of Jammu & Kashmir and UT
coastal ecology due to the proposed bulk drug park of Ladakh), the grant-in-aid will be 90 per cent
in the Kakinada Special Economic Zone (KSEZ) have of the common infrastructure facilities.
been raised by some activists and politicians. ● The formulation units shall not be permitted in
the park

Source: https://pharmaceuticals.gov.in

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

Global production of Active Pharmaceutical Ingredients (API)

Setting up high-level committee Source: Market Wrap ICICI 2019

The Department of Pharmaceuticals has recently these inputs, especially for small and medium-
set up a high-level committee to monitor the status sized manufacturers. However, these parks must be
of the bulk drug parks. The high-level committee is managed efficiently so that the cost of these inputs is
headed by Dr Mansukh Mandaviya, Union Minister brought down significantly.
of Chemical and Fertiliser, with the Minister of State
Bhagwanth Khuba as Vice Chairman, and Secretary The government seems to be on a spree to lay the
(pharma), Drugs Controller General of India (DCGI) foundation stone of the bulk drug parks. And with
and other senior officials including industry experts state elections in various states around the corner,
as members. According to a memorandum issued the government seems to hit the right chord with
by the government, “The state of Gujarat, Himachal this move. With a slew of benefits as expressed by
Pradesh and Andhra Pradesh will present the details pharma analysts/speakers and a majority of the
of design, the strategy of selection of industrial pharma companies shying away from commenting, it
units along with the list of bulk drugs going to be needs to be looked at how these bulk drugs perform
manufactured in the parks, well before the allotment and whether they collectively will be able to take
of plots to ensure that through the scheme, the on China when it comes to the production of APIs.
intended objectives of domestic manufacturing of Issues related to logistics, manpower etc. need to be
critical bulk drugs is achieved.” relooked at and then only the bulk drug parks will be
successful in the long run.
The memorandum further states that
the committee will facilitate the alignment Sharing his views on the developments, Uddhav
of investments in the bulk drug parks with Kanoria, President, Anglo French Drugs & Industries
pharmaceutical industry requirements and public said, “It seemed pharma was not as high a priority
health needs. “It will further facilitate transfer as infrastructure and other basic things. Once
of technology and other interventions required the ball is moving on that, the government seems
to achieve the above objectives,” states the to have realised the importance of these and is
memorandum. moving forward aggressively. Given the renewed
focus on pharma and healthcare, especially post
An official, who wished to remain anonymous, COVID, it certainly appears to be a step in the right
revealed that the government wants to focus on direction. With government focus and large pharma
specific bulk drugs which India is importing in large within India, it appears that there is a huge missed
quantities, rather than produce bulk drugs which are opportunity that will now be harnessed. I am very
already amply available. hopeful for this.”

The future However, he opined that a slightly more
transparent and reasonable regulatory regime will
The setting up of common infrastructure make a huge impact on these types of projects.
facilities will help in bringing down the cost of
Sanjiv Das
[email protected]

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com SINGLE-USE TECH 27

The Appeal of
Single-use Tech

Single-use technology is the new norm in the pharma manufacturing process due to an array of
benefits. The availability of this technology has made new biopharmaceutical companies adopt
single-use systems, as it requires less upfront capital investment and enables quick advancement
of development efforts towards new products. Having an upper hand, the single-use technology is
vouched to be a game changer in the entire manufacturing process.

Asingle-use system (SUS) is biopharmaceutical In August 2022, US-based Repligen unveiled its
manufacturing (bioprocessing) equipment new customer experience centre for bioprocessing in
that is designed to be used once (or for a Bengaluru. Bioprocessing technologies from Repligen
single manufacturing campaign) and then discarded. are designed to deliver configurable options for end-
Pharma companies are adopting single-use to-end modern bioprocessing needs. Through this
technology (SUT) to speed up the manufacturing customer experience centre, the company intends
process and discard the stainless steel equipment to focus on biopharmaceutical process efficiency
that has been in use for quite some time. Contract and effectiveness through innovation in single-use
manufacturing organisations (CMOs) were amongst technologies in India.
the earliest adopters of SUT and over the past decade,
SUT has been adopted increasingly by a majority of According to Stephen K Tingley, Vice
Indian manufacturers. President, Sales, Repligen, “SUTs can help in
overcoming challenges such as cleaning, validation,
Single-use bioreactors, single-use bags, contamination and bring a lot of advancements to the
filters, etc. are used for some time and are used sophistication of the process. For instance, single-use
commonly whereas perfusion devices, membrane chromatography systems can solve the yield, shear,
adsorbers, powder handling systems, disposable and separation challenges of traditional systems,
chromatography devices, TFF systems, virus through expert engineering and technological
filtration systems are newer and expensive products. innovation of both hardware and flow path, and
These are at the lower end of adoption because the recover more products with lower hold-up volume.”
products tend to be newer and more expensive. SUS
equipment is typically made up of gamma-irradiated, “SUT can help in overcoming
sealed, and disinfected plastic parts. These systems challenges such as cleaning,
are manufactured in a cleanroom, double bagged, and validation, contamination and
sterilised using gamma, X-ray sterilisation methods, bring a lot of advancements
ensuring a sterile system for each batch.
to the sophistication of the
The SUT market process. For instance, single-
use chromatography systems
According to a report in Research and Markets,
the single-use bioprocessing market was valued at can solve the yield, shear,
$7 billion in 2020 and is estimated to reach $38.8 and separation challenges of
billion by 2030, growing at a CAGR of 18.4 per cent traditional systems, through
from 2021 to 2030. The report also mentions that
untapped markets like India and China hold huge expert engineering and
promises for the market. technological innovation of
both hardware and flow path,
Based on product, the market is divided into and recover more products with
bioreactors, tangential-flow filtration devices, depth
filters, disposable filter cartridges, media bags and lower hold-up volume.”
containers, mixing systems, tubing assemblies, - Stephen K Tingley,
sampling systems, and others.
Vice President, Sales, Repligen

28 SINGLE-USE TECH BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

In future, the maximisation With an ever-growing pipeline
of use of SUT, will be based
on higher volumes, higher of biosimilars, vaccines and

productivity, lower cost of regular biologics, the need
manufacturing, robustness of
supply chain, expansion of SU for SUS will only grow. The
supplier facility to manufacture
and store SUS to meet demand new facilities are being built

and cost effectiveness.” keeping in mind the SUS and
- Dr Cyrus Karkaria,
the existing facilities are either
President – Biotechnology, Lupin
modifying or adapting to the

single-use. - Sachin Joshi,

Founder, PharmNXT Biotech

PharmNXT recently unveiled its Pune facility Boston, MA recently. The DynaSpin system improves
where it will offer everything that goes into the and streamlines harvesting for cell culture separation
workflow of the manufacturing of biotherapeutics in single-use bioprocesses by reducing the number
for filtration, storage, Cll culture, mixing and of depth filtration cartridges required to complete
purification, including mixer, storage, bioreactor the harvest process. The DynaSpin solution delivers
bags, connectors, tubing assemblies etc. equivalent or improved product yield compared
to traditional harvest systems while enabling
Sachin Joshi, Founder, PharmNXT Biotech operational efficiency, cost savings and sustainable
mentions, “This is growing at a rapid pace. The practices in the production of biologics.
new facilities are being built keeping in mind the
single-use solutions and the existing facilities are Benefits
either modifying or adapting to the single-use. This
is growing by almost 21 per cent. With an ever- Pharma companies have been able to realise
growing pipeline of biosimilars, vaccines and regular the benefits and are using this form of technology
biologics, the need for single-use solutions will only to discard the loopholes and delays in the
grow.” manufacturing process. The main benefit of single-
use is the quick turnaround time, lean production
In 2020, the Serum Institute of India selected process, and scheduling flexibility provided to the
ABEC’s Custom Single Run (CSR) technology to production floor, as well as the lower start-up cost.
accelerate large-scale, single-use manufacturing Once qualified and validated, the implementation
of nearly one billion doses of the Novavax vaccine, time can be reduced.
which is designed against COVID-19.
The primary advantage of SUS over traditional
Biocon is among the early adopters of state-of- stainless steel (or less commonly used glass in
the-art single-use biomanufacturing technology in bioprocessing) is that the equipment is pre-sterilised,
India. The company is one of the early adopters of eliminating the need for cleaning, sterilisation, and
single-use bioreactor technology in the country and sterilisation validation before use.
has been leveraging this technology in its production
facilities since 2010. In 2021, Biocon Biologics According to Raheel Shah, Director, BDR Pharma,
commissioned a new facility with state-of-the-art the main benefit of SUT is the quick turnaround time,
SUT to support its monoclonal antibody portfolio. lean production process, and scheduling flexibility
The new facility when commercialised will support provided to the production floor, as well as the
the future growth and drug development pipeline. lower startup cost. Once qualified and validated, the
implementation time can be reduced.
Says Ganesh Reddy, Global Manufacturing Head,
Biocon Biologics, “As the global biosimilars space Single-use assembling speeds up the process
becomes more competitive in the coming years, by offering sterile, ready-to-use systems, allowing
Indian biologics manufacturers will increasingly companies to develop products faster. Moreover,
adopt SUT as it offers lower costs and reduction in it saves costs on chemicals by eliminating the need
biomanufacturing process timelines. Moreover, the for cleaning and sterilisation. Usage of SUT leads to
increasing global demand for personalised medicine making production smarter and cheaper, keeping
will also lead to higher demand for SUT as its use the supply chain intact. The adoption of SUTs helps
avoids the risk of contamination.” pharma companies rely on financial assets. It leads to
cost reduction through time savings, energy savings,
Thermo Fisher Scientific has unveiled the Thermo water savings; less instrumentation/utility demand
Scientific DynaSpin Single-Use Centrifuge system at required and lower investment sums.
the BioProcess International annual conference in

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com SINGLE-USE TECH 29

“SUT is the need of the hour “The main benefit of SUT is

since there are a lot of issues the quick turnaround time,

associated with reuse abilities. lean production process, and

It was a different scenario scheduling flexibility provided

5-10 years back in India when to the production floor, as well

systems were re-used. But now as the lower start up cost. Once

single-use technologies are qualified and validated, the

being preferred.” - Dr Suresh Beri, implementation time can be

reduced.” - Raheel Shah,

Additional Director, Polysaccharide

Conjugate Vaccine Division, Serum Institute of India Director, BDR Pharma

SUT has gained considerable importance in Gaining acceptance
biotechnology manufacturing over the years as it
employs single-use components that lessen the need With significant advantages over traditional,
for resource-intensive cleaning and quality-control reusable stainless-steel systems, single-use
procedures. The higher flexibility offered by SUT technologies (SUTs) are gaining acceptance globally
means shorter turnaround times during a batch and are defining the future of biopharmaceutical
or product changeover. This is crucial given the processing. With a focus on strengthening its
complexity involved in manufacturing biosimilars, global presence in biologics and biosimilars,
which results in long lead times. SUT also results in biomanufacturers in India are building their
savings on the facility design, as well as starting up capabilities regarding quality, reducing production
and qualification timelines. Moreover, tech transfer failures, and faster go-to-market strategies.
timelines from site to site are also significantly
shorter due to the standard design of single-use This was particularly seen during the COVID-19
manufacturing equipment. pandemic when drug and
vaccine manufacturers turned
Many companies take a hybrid approach using to single-use systems such
the combination of disposable and reusable stainless as bioreactors, storage and
steel/glass equipment to overcome certain limitations product handling solutions,
of SUT, like operating process scale, the technical because of the benefits
need of the unit operations, and cost-effectiveness. offered, including a reduction
The availability of this technology has made new in capital investment and
biopharmaceutical startups adopt SUS, as it requires increased deployment of
less upfront capital investment and enables quick product and batch changeover
advancement of development efforts towards new while eliminating cleaning validation requirements.
products. The adoption of SUT positively impacts
cost, quality, and time. The key benefits are lower Further, the trend in upstream processing
capital expenditure, improved flexibility, speed and is driven by a need for intensified cell cultures
efficiency for multi product manufacturing, reduction to improve the product titer. The HyPerforma
in utility (energy and water), space requirement, DynaDrive Single-Use product line is our latest
cleaning validation efforts and shortened scale-up advancement in Single-use Technology, as it
time. offers a host of advantages that include better
performance and scalability to large volumes.
Dr Cyrus Karkaria, President, Biotechnology, Additionally, the use of a superior-quality film also
Lupin opines, “Based on the latest offerings in SUT eliminates the concern of extractables, leachables
and current growth trend, its application through and other particles arising from the components
hybrid approach (combination of stainless steel used in single-use systems, which are critical for
and single-use) will benefit Indian industry to set drug safety and stability.
up a new facility with low initial capital investment.
In the current scenario, the hybrid technology The global supply of single-use technologies
will give an advantage of cost-effectiveness, and is a challenge that Thermo Fisher is addressing
overcome the risk associated with supply chain by expanding its manufacturing capabilities and
security and handling of high in-process volumes. enhancing supply chain services.
In future, the maximisation of the use of SUT will
be based on higher volumes, higher productivity, - Amit Chopra,
MD, India and South Asia, Thermo Fisher

30 SINGLE-USE TECH BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

“As the global biosimilars lower cost of manufacturing, the robustness of the
space becomes more supply chain, and expansion of SU supplier facility
to manufacture and store SUS to meet demand and
competitive in the coming cost-effectiveness.”
years, Indian biologics
manufacturers will Challenges

increasingly adopt SUT as Some of the challenges that biosimilar
it offers lower costs and manufacturers face include shortage of single-use
components and assemblies. Regulatory clarity
reduction in biomanufacturing and understanding of the regulations for single-use
process timelines. Moreover, bioreactor technology is a major challenge. Other
challenges include extractable & leachable (E&L),
the increasing global demand particulates, integrity assurance of large-size single-
for personalised medicine will use consumables i.e upstream bioreactor bags,
also lead to higher demand for limitation to implement single-use chromatography
SUT as its use avoids the risk of systems and columns, supply chain security, longer
lead times, high dependency of supplier on key
contamination.” starting material for SUS manufacturing, time taken
- Ganesh Reddy, to adopt during the change over to another single-use
material MOC, alternate vendor development, cost-
Global Manufacturing Head, effectiveness and regulatory requirements etc.
Biocon Biologics
The future
Heading Heading Heading Heading
SUT has gained immense significance and will
Advantages of SUT do so in the coming years. The application through a
● Reduced time to market and operational costs hybrid approach (combination of stainless steel and
● Reduce manufacturing cost single-use) will benefit the Indian industry to set up
● Improve sterility assurance new facilities with low initial capital investment. In
the current scenario, the hybrid technology will give
Risks associated an advantage of cost-effectiveness, and overcome
● Film related risks the risk associated with supply chain security and
● Unit operations risks handling of high in-process volumes.
● Supply chain issues
Dr Suresh Beri, Additional Director,
Prominent players in the Polysaccharide Conjugate Vaccine Division, Serum
single-use bioprocessing market Institute of India mentions, “SUT is the need of the
hour since there are a lot of issues associated with
● Thermo Fisher Scientific, Inc. reuse abilities. It was a different scenario 5-10 years
● Merck KGaA back in India when systems were re-used. But now
● Sartorius AG single-use technologies are being preferred.”
● Corning Incorporated
● Pall Corporation In future, the maximisation of the use of SUT will
● General Electric Company (GE Healthcare) be based on higher volumes, higher productivity,
● Eppendorf AG lower cost of manufacturing, the robustness of the
● Rentschler Biopharma SE supply chain, and expansion of SU supplier facility
● Lonza to manufacture and store SUSs to meet demand and
● Meissner Filtration Products, Inc. cost-effectiveness.
● JM BioConnect
● Boehringer Ingelheim GmbH Pharma companies need to be aware of the
● Infors AG benefits of SUT and help improve their production
● PBS Biotech, Inc. capabilities in the long run. Having said that, the
● Entegris, Inc. APAC region is going to witness considerable market
● Danaher Corporation growth due to significant demand for bioprocess
● Kuhner AG equipment including laboratory filtration systems
● Rentschler Biopharma SE and membrane-based microbial analysis among
many others.
Source: Grand View Research
Sanjiv Das
[email protected]

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

“We plan to invest in 100 startups, with

ticket sizes ranging from Rs 25 L to Rs 10 Cr”
Incorporated this year, New Delhi-based
BioAngels, an angel investor group, plans «
to invest Rs 350 crore over the next three
years. Padmaja Ruparel, Founder, BioAngels Padmaja Ruparel,
in interaction with Bio Spectrum India Founder,
reveals more about the investment and the BioAngels
way forward for startups. Edited excerpts;
aspects, legal (IP) are vetted, and investors find trust
How will your investments help startups in in the entrepreneurs to lead the journey.
the long run?
What are your plans for investing in startups
As the first sector-focussed angel investor group for the next five years?
focusing on biotech, healthtech, medtech, pharma,
cleantech, agritech, BioAngels has been set up as a BioAngels will continue to focus on seed to early-
unique partnership between BIRAC (an enterprise stage investments in healthcare, biotech, pharma,
of the Department of Biotechnology) and the Indian medtech, cleantech and agritech sectors. We plan to
Angel Network (IAN). BioAngels is focussed on invest in 100 startups over the next few years, with
furthering BIRAC’s efforts – by plugging the gap of ticket sizes ranging from Rs 25 lakh to Rs 10 crore and
early-stage funding in startups from these sectors. It follow-on rounds for future growth, providing good
aims to fuel the ecosystem through interactions with returns to investors. Moreover, domain expertise in
high-quality investors and industry leaders, whilst these sectors is extremely crucial. Hence, BioAngels
emphasising on a strong operational focus, framework, aims to create a pool of domain experts who will provide
processes and governance drawing from IAN. It brings their technical expertise to entrepreneurs and investors.
an amalgamation of private investor groups driving
the investment process along with access to domain
and technology experts embedded in the government
ecosystem.

Some reports say that startups are on the What are the major challenges being faced
by biotech startups? Are there any specific
verge of shutting shop. Will these forms of areas that you would be focusing on, while
working with startups?
investments help the cash-strapped startups?
Biotech startups need money from domain
There may be several reasons why a startup is experts who can understand their science/solution.
not able to scale, ranging from being in the wrong Moreover, they need scale-up and growth money
market, money running out, increased competition which is not easily available in India. We would be
and more. Biotech and health tech are promising and looking at all preventive and curative health issues
have moved rapidly in the last two to three years. that can be solved innovatively.
India’s BioEconomy in 2021 registered 14.1 per cent
growth over 2020 and was valued at $80.1 billion. How do you foresee the growth of biotech
The role that the government has been playing, to startups by 2030?
facilitate these sectors is phenomenal and is bound to
flourish further. The biotech/healthcare sector will grow
exponentially (13.25 per cent) and will see a lot
As an enabler of angel investment in the sunrise of innovation. With the pandemic, Outpatient
sectors: bio/health/medtech, pharma, agritech, Department (OPD) has moved to Do It Yourself
cleantech, BioAngels is addressing a void in this (DIY) so there is already a behavioural change
space which has high potential. We have access to happening. In addition, tech innovation in healthcare
domain experts to help investors understand the is increasing with precision medicine etc.
science behind a startup and fuel the ecosystem with
money, mentoring and market access – echoing Sanjiv Das
IAN’s genetics. We will fulfil the cash crunch in a [email protected]
startup once both the science and the commercial

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

« “There are many
diseases for which
Sir Richard J Roberts, mRNA approaches
1993 Nobel will be life-saving,
Laureate in including cancers”
Physiology
or Medicine

Sir Richard J Roberts, PhD, FRS, who was and the great humanitarianism of the company
honoured with the 1993 Nobel in Physiology struck me as worthy of global recognition. If we ever
or Medicine, was recently in India to take face another pandemic, I would give them full marks
part as a keynote speaker for the academic launch for preparedness. We could use them in the US &
of Maharashtra State Skills University. Currently Europe.
serving as the Chief Scientific Officer at New England
Biolabs in the US, Sir Roberts shared his views What is your take on the success rate of
with BioSpectrum India on the importance of doing mRNA-based vaccines in the future?
basic science and research. Edited excerpts;
After the immense global success of the mRNA
What are your views on the current application vaccines to combat COVID-19, it is clear that there
and future perspectives of CRISPR/Cas9 are many other diseases for which mRNA approaches
mediated gene editing technology in will be life-saving. Not only in their use for vaccines,
developing new disease treatments? but also for tackling other diseases including cancers.
The biggest advantages they offer are the speed with
CRISPR/Cas9 gene editing is very powerful, which they can be manufactured once the sequence of
but, not yet, as highly accurate as one would like. the etiological agent is obtained and the opportunity
Certainly it should not be used for germ-line editing to quickly redesign them if needed. They represent
at this stage. For somatic cell editing, where one a paradigm shift in disease prevention and it is
has many cells to choose from as targets of editing imperative that we educate the general public about
and where the products of editing can be carefully their potential and their inherent safety.
assayed to make sure that only those that have been
edited perfectly are used for therapy, this technology Would you say that we are exploring enough
is both powerful and can be employed. Thus, any research tools to counter AMR?
disease which affects somatic cells (and not germline
cells) would be suitable targets. For instance, Antimicrobial resistance (AMR) is a very broad
Haemoglobinopathies would be obvious choices. category of problems for which no single solution
will exist, nor would it be desirable. The extensive
How do you foresee the role of gene and cell deployment of antibiotics when they were first
therapies in downsizing the cancer burden? discovered gave them the aura of ‘wonder drugs’. And
Where does India stand in this regard? they were, until the bacteria began to gain resistance.
This is a continuing problem with Nature – evolution
Given the success of certain CAR-T therapies in of organisms in the face of threats leads to mutations
treating some cancers and alternative approaches for that overcome the threat. This is not insurmountable,
yet more, we do seem to be entering an age where but does mean that much basic science has to be done
cancer may not be the highly feared disease it once so that we constantly learn more about how bacteria
was. Nevertheless, we must proceed cautiously & work and constantly search for new drugs or tailor old
not raise unrealistic hopes for the very near future. ones to control them. Here is a good example of how
India’s strengths on the medical front lie elsewhere basic research will constantly feed the developers with
and I was incredibly impressed by my visit to the new material and new ideas to combat the deleterious
Serum Institute in Pune, where the level of the effects of constantly evolving pathogens.
science, the technical proficiency of the employees
Dr Milind Kokje
[email protected]

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

“We’re more than hopeful that the

government will create a separate

department of medical devices”
The medical devices sector has been
campaigning with the government for a «
separate department and things seem to
head towards the right direction. Rajiv Nath, Rajiv Nath,
Forum Coordinator, Association of Indian Forum Coordinator,
Medical Device Industry (AIMED) reveals Association of Indian
more about the likelihood of the medical Medical Device
devices sector in coming years in interaction Industry (AIMED)
with BioSpectrum India. Edited excerpts;

How was the year 2022 for the medical other hand, manufacturers face intense competition
from spare capacities created and are unable to pass
devices industry? on the cost increase fully to their clients.

India is known as the pharmacy of the world but On the other hand, on the policy front, 2022 has
in the medical devices sector, it lags far behind and been an eventful year with many strategic initiatives
is hugely dependent on imports. Currently, imported under deliverance whose impact will unfold over the
medical devices account for 80 per cent of the next few years. The positive developments that took
domestic market, hurting the profits of many small place in the Indian medical devices industry in the
manufacturers in the sector. year 2022 are just a few months ago, the government
announced an extension of the Production Linked
The medical devices imports continued to grow Incentive (PLI) Scheme, announced financial
unabated by 41 per cent in FY22. India imported assistance to four med tech parks in Himachal
medical devices worth Rs 63,200 crore in 2021-22, Pradesh, Uttar Pradesh, Madhya Pradesh and Tamil
up 41 per cent from Rs 44,708 crore in 2020-21, as Naidu; announced creation of a revamped Medical
per data from the Union Ministry of Commerce and Devices Promotion Council under Department of
Industry. Pharmaceuticals, then a Medical Devices Exports
Promotion Council to be located at Uttar Pradesh’s
China remained the top import source for India as Medtech Park and rescheduled the roll out of the
medical device imports from China grew 48 per cent Medical Devices Regulations to April 2023 and the
from Rs 9,112 crore in 2020-21 to Rs 13,538 crore in starting of the registration and regulatory process
2021-22. Imports from the US also increased steeply for resellers of medical devices and the launch of
by 48 per cent to Rs 10,245 crore in 2021-22 from Rs Indian Certification of Medical Devices (ICMED) Plus
6,919 crore in 2020-21. The value of medical devices Product Certification for medical devices.
from China was nearly the same as the combined
value of imports from Germany, Singapore and the In addition, the Parliamentary Committee on
Netherlands in 2021-22. Health came out with a set of recommendations to
create a separate law and regulatory framework for
It’s been a roller coaster ride as the capacity medical devices and various steps the government
utilisation of the domestic industry has dropped may consider to address the 80 per cent import
from the peak utilisation levels of 100 per cent (and dependence. We are also delighted that the union
expansion of capacities) in mid-2021 to less than 33 government has also consulted stakeholders in
per cent currently for COVID critical medical devices drafting a medical devices policy and look forward to
but there’s been a rebound for non-COVID related its announcement.
medical devices to pre COVID levels as elective
surgeries and other healthcare interventions that In addition to the steps taken by government to
were being postponed were taken up, while there’s encourage the manufacturing of medical devices,
rebounded demand but a cash flow tight market is the Parliamentary Committee has suggested, the
keeping this demand subdued. The manufacturers
are caught between highly inflationary times as prices
of plastics, steel, paper and energy cost spiked and on

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

government needs to make the manufacturing of an estimated market of Rs 160,000 crore at retail
medical devices in India to be a viable proposition as and institutional levels but with a huge investment
done for the consumer electronics and mobile phone opportunity of over Rs 80,000 crore.
industry by reviewing and consulting stakeholders
for a predictable tariff protection policy and for The vision ahead for a separate department for
protecting ethical marketing with a cap on MRP or medical devices is to make India one of the top five
trade margins. manufacturing hubs for medical devices worldwide
and be the nodal interface of the manufacturing
In September 2022, the government of India industry with all Central Government Department
set up the Exports Promotion Council for to catalyse the growth of the Indian medical device
Medical Devices. What impact will it have sector-Make in India, Made by India and Made for
on the medical devices sector for years to India.
come?
The 2022 Budget was a great disappointment
It’s great news, a big boost to Indian Medical
Devices Manufacturing. The long-sought and according to you as there was not much
requested Medical Devices Exports Promotion
Council is finally sanctioned to be created under scope to boost domestic manufacturing.
the aegis of Department of Pharmaceuticals. This
strategic step will go a long way in accelerating the Have things changed over the months?
exports and manufacturing growth of the medical
devices sector. The Indian Medical Devices Industry had been
hoping that the 2022 budget will be a Make in India
India currently exports Rs 23,766 crore (2021- push budget for an Atmanirbhar Bharat and though
22) of medical devices up from the previous year’s the Finance Minister highlighted the need to support
Rs 19,736 crore. The Exports Promotion Council for the manufacturing sector, we were disheartened
Medical Devices will help bring in coordinated inter- not to notice any changes in customs duty as done
ministerial policy measures for unleashing the huge for other sectors. The only positive announcement
export potential and investment potential of over Rs was on public procurement by allowing 75 per cent
80,000 crore for manufacturing medical devices for prompt payments and bringing in a weighted price
the global market in India’s quest to be one of the preference on account of quality which is especially
top five preferred supplier base of medical devices critical in healthcare-related medical devices.
worldwide and we are thankful to the Minister of
Commerce and Industry in taking this initiative to The Indian Medical Devices Industry’s
help realise our Prime Minister’s vision. expectations were:

You have approached the government for 1. Predictable tariff policy
a separate department of medical devices. 2. Graded increase of customs duty to 10-15 per
Is there a ray of hope for a separate cent from current zero to 7.5 per cent
department? 3. Reduced GST of 18 per cent where being
applied to 12 per cent as Medical Devices are not
We are more than hopeful and positive that the luxury goods.
government will act upon the request of the Indian 4. Not clear if Health Cess applied on some medical
Medical Device Industry for a Separate Department devices being also applied on other medical devices
of Medical Devices. This key strategic need has also
been recommended by the Parliamentary Committee
on Health.

India remains 80 per cent import dependent on
medical devices. The Department of Pharmaceuticals
and the Ministry of Chemicals & Fertilisers have
so far had limited success to carry out the mandate
given to them to boost the manufacturing of medical
devices and address the 70 to 80 per cent import
dependency and have limited expertise of this
industry as the high precision device industry has
very little synergy with chemical and fertilisers
industry. The imports of medical devices are up by a
record 41 per cent at Rs 63,200 crore in 2021-22 and

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

5. No announcement on R&D-related tax breaks essential healthcare equipment for the country,
to motivate indigenous development pushing the Indian medical devices sector to be
Atmanirbhar. The COVID-19 pandemic has reiterated
Supporting policies are needed so that Indian the need to strengthen the medical devices sector
Medical Devices Industry can make quality with a separate regulatory framework for medical
healthcare accessible and affordable for the common devices, otherwise, handling a crisis of such ferocity
masses, aim to place India among the top five medical and magnitude will continue to be a challenge even in
devices manufacturing hubs worldwide and help the future.
end the 80-85 per cent import dependence forced
upon us and an ever-increasing import bill of over Rs India needs a separate simple, implementable
46,000 crore. regulation for Medical Devices if the ‘Make in India’
of medical devices is to be encouraged and if the
Yes, things are moving in the right direction. government is keen to address the ongoing 80
The Government of India has taken steps to ensure per cent import dependence. The law needs to be
the growth of a vibrant ecosystem of medical device initially ‘civil’ in nature as is a case of Food Safety
manufacturing. We also appreciate the collaborative and Standards Authority of India (FSSAI) regulations
efforts of the government in approving the much- or under recent modern International Medical
needed schemes and policies for the promotion Device Regulations as done by Canada, Singapore
of the domestic manufacturing of medical devices etc. which no more seeks imprisonment for offences
in the country. As mentioned above, the Exports and most shortcoming/errors do not treat licensed
Promotion Council for Medical Devices is a big manufacturers as a criminal as making these devices
boost to the Indian Medical Devices Industry. We are as an engineering product and not like making
are delighted that the union government has also pharmaceutical medicines.
finally come out with a Medical Devices Policy. This
was long awaited. Amended medical device rules Medical devices are not drugs and in the past, a
and other related initiatives such as PLI schemes few of them have been attempted to be incorrectly
and the provision for medical device parks with an regulated as drugs under Drug Rules and Drugs
eye on shoring up domestic manufacturing. The Act until 2017 when Medical Devices Rules were
Indian medical devices industry has the potential to introduced that recognised the need for separate
reach $50 billion by 2030. Regulatory Controls but even these Rules were put
under the antiquated Drugs Act.
How are the current regulatory challenges
As we needed to have a separate FSSAI law
posing a threat to the medical devices for food products from drugs because of these
fundamental differences, similarly, we need to have
sector? How do you plan to overcome these a separate law to regulate engineering products like
medical devices which are diverse ranging from
challenges? low-risk stretchers or wheelchairs or spectacles to
higher risk thermometer or oximeter or syringe
The COVID-19-led global crisis has put the to yet higher risk device like a surgical blade or a
spotlight on medical devices in India as never before. needle with transient short term contact with blood
and tissues or an even higher risk contact lens or
The government relied heavily on Indian catheter or an even higher risk implantable devices
manufacturers to meet the rising demand for like an IntraOcular lens used in cataract surgery or a
coronary stent or heart valve or an orthopaedic knee
implant. The law needs to give a sense of direction
to policymakers and rule makers and the enforcing
regulators.

Regulations in India need to be layered to
separate Role of the Legislature from those of a
regulator and those of a supervising accreditation
body to assist the regulator, including Third- Party
Conformity Assessment Bodies who will Audit
the Manufacturer in line with the principle of
subsidiarity, with Key Policy principle - Minimum
Government – Maximum Governance.

Sanjiv Das
[email protected]

36 LOOKING BACK BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

A Pharma Lens: Looking Back at 2022

« their pharmaceutical demands. Moreover, the
need for a heavy dose of agility and resilience is
Vivek Sehgal, in order.

Director General, Pre-pandemic overview

Organisation of India had a great kick-start in building a
reputation as the world’s emerging pharma
Pharmaceutical innovation hub even before the pandemic
knocked. The pharma industry in India has the
Producers of India required scalability, capabilities and access to
a skilled talent pool; all of which point towards
(OPPI) the immense possibility to emerge as a centre of
innovation for pharmaceuticals. The domestic
The pharmaceutical industry across the industry has bolstered this reputation with its
globe and in India has had a rough timely adoption of digital processes leading to
decadal start with COVID-19 proving to improved transparency and strong mitigation
be the proverbial trial by fire. Pharmaceutical measures against potential data loss.
companies were forced to manoeuvre through a
once-in-a-century event with a sliver of margin In the post-pandemic era, the industry
for error. In the past three years, we have has scored well – in India and on the global
witnessed the pharma giants stepping up to the front, with its agility and ‘on-its-feet’ approach
occasion, by becoming innovative, agile and in ensuring a steady supply of life-saving
committing to India’s health with full vigour. As medicines and an efficient roll-out of two
2022 draws to a close and the threat of COVID-19 home-manufactured vaccines. No less a mean
ebbs, it is time to accelerate and brace for newer feat, considering India’s more than a billion
challenges and opportunities that the remaining population. In this context, as noted in an
decade has in offing. EY-FICCI pharma industry note, the pharma
industry in our country must consolidate these
The global pharma market growth trend of present advantages and undertake fundamental
the last decade is expected to spill well over in reforms to actualise the possibility of turning into
the current one. By 2023, the global market size a powerhouse of innovation for the world.
of pharmaceutical products is expected to cross
over the $1 trillion mark for the first time. For Visualising 2023
India, EY-FICCI Indian Pharmaceutical Industry
estimates the industry will touch $130 billion In the year to come, India should focus on
in value by the end of 2030, tripling from $41.7 building a strong foundation for innovation
billion in 2020. In other words, the growth of the in the pharmaceutical industry. To be able to
pharma industry in India is just starting, with create a thriving innovation ecosystem, the
another strong decade of yearly double-digit pharma research sector in India will need four
growth anticipated. key building blocks, namely infrastructure,
legal intellectual property rights (IPR)
As exhilarating an opportunity, it is framework, human resources, and financing. The
not devoid of challenges. Globally, pharma responsibility to meet these needs’ part lies with
companies will need to prepare against the the private sector and part with the government.
global macroeconomic challenges of inflation,
disruption in global supply chains, fluctuating India should seek to create a policy
market demands and higher labour costs. framework encompassing scientific research
With geo-political war tensions simmering, and education and skills development, ease of
the industry cannot afford to wish away these doing business, regulatory policies, intellectual
challenges at least before the end of 2023. On the property and technology commercialisation,
home ground, Indian counterparts will need to government procurement, and tax and financial
address challenges of low R&D spending, scarcity incentives. Through its effective prevention
of skilled manpower, weak intellectual property and treatment of COVID-19, the pharma
(IP) laws and rights and potential shrinkage in industry has demonstrated its ability to take
exports as more countries look inwards to meet huge, independent research risks, without

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com LOOKING BACK 37

comprising shareholders’ interests and public a boost to public-private partnerships across the
health responsibilities. The industry must country can create a plethora of opportunities
now collectively work towards supporting, that would transform India into a centre of
recognising, and rewarding these high-risk pharma excellence.
research and development behaviours.
COVID-19 also brought to light the need
The sector should aim to build on the in- for a thriving and cooperative private and
roads made during the pandemic. The entire public scientific and research community. This
pharma ecosystem must now collectively work can be actualised through the availability of
towards creating a conducive environment which highly skilled and technically trained human
would further boost the growth of innovation resources including but not limited to skilled and
and research-led companies. We are by now trained scientists, researchers, and technicians.
witnessing tremendous collaboration between Government investments in making this talent
companies, especially through voluntary pool available to the private sector and efforts in
licensing and tech transfers. More of these will retaining this talent will go a long way.
be needed, with an added commitment towards
sustaining them. Looking ahead

The ask from the Sector The year 2022 witnessed the strengthening of
partnerships between India’s pharma industry and
An innovative ecosystem needs critical the government. It is time for the industry to make
infrastructure such as a robust network that a strong case with the government for a tighter,
includes requisite facilities to conduct research. well-defined intellectual property ecosystem.
In-house pharma R&D, clinical infrastructure, Industry leaders should communicate passionately
biotech cluster, parks or incubators, startups, about the direct link between greater innovation
and IT infrastructure to name a few. We need and improved public health. A sound and effective
to channelise our current resources like youth policy environment that enables, protects, and
and skilled manpower from pharma and life supports innovation is worth striving for.
sciences backgrounds, developing partnerships
between industry, and academia fostered by the Such policy measures will make way for
government and aim to overcome the regulatory increased private-sector investments in pharma
hurdles, by working towards this common goal research and development. A higher score on
together: Making India the Reliable Pharmacy of the R&D metric will help the country’s pharma
The World. industry to open to greater foreign investments.
Industry-friendly measures will also bolster the
Thus, a business environment that embraces on-ground execution of the government’s vision
innovation and a healthcare system that of discovering India through innovation.
recognises and rewards the value of medicine
is adequately needed. The former deals with We should all laud the government and the
a public and private, direct, and indirect R&D pharma sector for the declining graph of India’s
financing mechanism, while the latter concerns COVID-19 daily caseload and attribute it to the
the overall public investment, insurance collaborative, creative and scientific approach
coverage, pricing, and reimbursement. that the governing bodies and the industry
showed to save the lives of the people in India
The development of vaccines in a short period and worldwide. It is thus time to shift gears
has boosted the government’s confidence in back to long-term strategies and execution as
pharmaceutical R&D. The private sector should pharma companies emerge from the two years of
leverage this confidence. Post-pandemic, both immense change and evolution. To succeed under
innovation and R&D are increasingly being these new and challenging conditions will require
incentivised and rewarded and the time is ripe to a renewed emphasis on operational strategies.
build on this well-earned recognition.
The future of the pharmaceutical sector now
Capturing India’s growth rests on how stakeholders across the industry
can collaborate with the government to leverage
India’s science and technology innovation the momentum and innovate to ensure equitable
eco-system has gained from the forward-looking access to safe and affordable healthcare for all.
initiatives of the Government of India such as All of this, without losing sight of the opportunity
Start-Up India, Make in India, Digital India to emerge as the world’s preferred investment
initiative etc. Increased government funding, a destination for pharmaceuticals is what is, our
well-defined policy including IP protection and top priority now.

38 BENGALURU TECH SUMMIT 2022 BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

Basavaraj S Bommai, Chief Minister of Karnataka unveiling the Silver Jubilee Commemoration Plaque of Bengaluru Tech Summit
2022 amidst a galaxy of dignitaries on November 16.

Bengaluru Tech Summit (BTS) 2022

Karnataka launches Research,
Development and Innovation Policy
India’s flagship technology event and Asia’s
largest tech summit, the 25th edition of the innovation capabilities across institutions and sectors
Bengaluru Tech Summit (BTS) 2022, witnessed and promote structures that nurture new enterprises
the launch of the Karnataka Research, Development (startups) and enhance the fluidity of knowledge
and Innovation Policy on November 16, the first flow among enterprises, universities and research
day of the three-day summit inaugurated by Prime institutions.
Minister Narendra Modi at a glittering ceremony in
the presence of a galaxy of leaders from the IT, Bt and Unveiling the policy Basavaraj S. Bommai, Chief
startup sectors. Minister of Karnataka said “The aim of the policy is
not only to finance research-based infrastructure and
The event was organised by the Department of institutions but also to provide support for a robust
Electronics, IT, Bt, S&T, Government of Karnataka and well-connected ecosystem, including easy access
along with Software Technology Parks of India to skilled talent base support for university-based
(STPI), and is the first full-fledged on ground version cutting edge research. The policy aims at fostering
of BTS post pandemic. The central theme of BTS this cooperation between industry and academia for
year was ‘Tech4NexGen’ to focus on Electronics, IT, innovative business startups.”
Deep Tech, Biotech, and Startups.
With this in mind the state policy embraces
The Karnataka Research, Development and five focus areas Strengthening the governance and
Innovation Policy will take a systemic view of the financial outlay of the research and innovation
research and innovation ecosystem to build a robust system, Strengthening the capacity for research and
and enabling environment to grow the state’s innovation, Research and innovation to drive the
competitiveness and leadership in a knowledge-based regional ecosystem, R&D and innovation to support
economy. The policy seeks to strengthen research and entrepreneurship and MSMEs and Promoting
R&D and innovation in priority sectors for societal

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com BENGALURU TECH SUMMIT 2022 39

transformations. Bengaluru is an inclusive and
Bommai also announced the setting up of six innovative city and home of technology
and thought leadership: Modi
new cities in Karnataka to promote the growth of the
knowledge and technology sectors in the state. These The Prime Minister Narendra Modi called
new cities will be developed in Kalaburagi, Hubballi- Bengaluru the home of technology and thought
Dharwad, Mangaluru, Mysuru and Bengaluru. leadership, an inclusive and innovative city. For
These cities will be well planned, high-tech and many years, Bengaluru has been number one
help promote IT, BT and startups. A dedicated in India’s Innovation Index, he added. He was
Startup Park will be developed near the Bengaluru addressing the Bengaluru Tech Summit 2022 via
international airport which will be multi-modal video message.
and help promote various spheres of the startup
ecosystem, he said adding that the state needs to do The Prime Minister informed that India jumped
much more for the growth of the startup industry. He to the 40th rank in the Global Innovation Index from
had also announced that Knowledge and Technology 81st rank in 2015 this year. The number of unicorn
City will be created near Bengaluru International startups in India has doubled since 2021, as India
Airport. emerges as the third largest start with 81000
recognised startups. The Indian talent pool has
He further added that the government will encouraged hundreds of international companies
begin work on developing these cities within the to have their R&D centres in India.
next six months. The chief minister also called
upon the leaders of the scientific world to innovate The Prime Minister emphasised that India is
for the betterment of the human race and develop no longer known for red tape. It is now known
technologies to create a new healthy human being for red carpet for investors. “Whether it is FDI
and better future for all. reforms, or liberalisation of drone rules, steps in
the semiconductor sector, the production incentive
In her address at the inaugural session, Dr Kiran schemes in various sectors, or the rise of ease of
Mazumdar Shaw, Chairperson, Vision Group on doing business, India has many excellent factors
Biotechnology, Government of Karnataka touched coming together”, he said.
upon India’s next target of achieving $500 billion
bioeconomy by 2047. This new bioeconomy target promote entrepreneurship and create a nurturing
comes after the earlier announcement of India ecosystem for Karnataka Startup Cell registered
attaining a $100 billion mark by 2025, followed by startups with ‘Financial Services’ offered by HDFC,
the next estimate of $300 billion by 2030. RazorPay, Paytm; ‘Acceleration Support’ offered by
Teeglobal Accelerator For Innovation Network (The
“The target of $500 billion is well synced with the GAIN); ‘Incubation Support’ offered by Dayananda
100 years of independence of our country in 2047. Sagar Entrepreneurship Research and Business
For every country, sustainability and agriculture will Incubation (DERBI); ‘Women-led Services’ offered by
be key pillars of the bioeconomy where health, food StrongHer Ventures and ‘Cloud Services & Business
and energy security will be paramount” said Dr Kiran Support’ offered by AWS Activate & Microsoft
Mazumdar. Corporation (India) Pvt Ltd.

Dr C N Ashwath Narayan, Minister for Dr Emmanuelle Charpentier, Nobel Laureate in
Electronics, IT, Bt and S&T, Higher Education; Chemistry for 2020 and Scientific and Managing
Skill Development, Entrepreneurship & Livelihood, Director, Max Planck Unit, Science of Pathogens
Government of Karnataka said “The state has been
enabling the right kind of learning and education in
a big way to promote the growth of the knowledge
sectors. The state government has set a target of
achieving a $300 billion digital economy by 2025,
the share of bio technology will be $36 billion. The
minister lauded the startup industry in Karnataka
for achieving distinction of the first and the 100th
unicorns in the country.

The minister launched the Booster Kit in
partnership with Google, Paytm, HDFC, Razorpay,
Microsoft and other Ecosystem Partners to provide
a gamut of pro bono services to further assist the
startups in their growth journey. The services
provided by the Ecosystem Partners are intended to

40 BENGALURU TECH SUMMIT 2022 BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

Prof Ajay Sood launches Bengaluru Science & Technology Cluster (BeST)

Principal Scientific Adviser to Prime Minister of Science, Technology, and Innovation Advisory
India Prof Ajay Sood launched Bengaluru Science Council (PM-STIAC) to build an Atmanirbhar
& Technology Cluster (BeST), an effort coordinated Bharat through S&T, the office of (O/o) PSA
by the Indian Institute of Science (IISc) in supports these initiatives.
partnership with Centre for Cellular and Molecular
Platforms (C-CAMP). The Bengaluru Science and Technology Cluster
(BeST), the latest in this set of O/o PSA supported
A proposal for funding for BeST was submitted clusters, has identified Health & Wellness, Urban
with Principal Investigator (PI) Prof Govindan Life, and Futuristic Technologies as its core
Rangarajan (Director, IISc) and co-PIs Prof sectors and has set up teams to work on areas of
Ambarish Ghosh (Professor IISc) and Dr Taslimarif One Health, Digital Health, Precision Agriculture,
Saiyed (CEO, CCAMP). The funding was recently Urban Transportation, Monsoon & Climate Change,
sanctioned by the Office of the Principal Scientific Quantum Technologies, Active Matter & Robotics
Adviser to the Government of India. and Jet Engine.

A science and technology cluster is a As Prof Sood explained, the BeST Cluster is
collaborative ecosystem in a city or a region, in envisaged as a platform of active collaboration
which scientists, engineers, social scientists, and for the entire R&D ecosystem in Bengaluru cutting
entrepreneurs working in academia, government across disciplines and mandates but retaining
labs, and industry identify and collaborate their individual autonomy. A Section 8 company is
to solve some socially relevant problems. being set up to catalyse this collaboration as an
Science & Technology (S&T) Clusters are being independent body, provide organizational support
established as formal umbrella structures for S&T and raise and manage resources.
organisations in various cities to work together
more effectively while retaining their autonomy. The earlier S&T Clusters in this programme
On the recommendation of the Prime Minister’s have been set up in Pune, Jodhpur, Delhi-NCR,
Bhubaneswar and Hyderabad.

in Berlin spoke on ‘A research journey towards the are likely to achieve unicorn status shortly. Karnataka
CRISPR-Cas genome engineering technology’ and is home to around 40 per cent of all unicorns in the
elaborated on how CRISPR-Cas is revolutionising country, and Bengaluru holds a rare distinction of
molecular medicine, on the second day of the producing the first and the hundredth unicorn of the
summit. country. Today, Bengaluru continues to retain India’s
top position as a startup hub.”
The finale of the Bengaluru Tech Summit
2022 included Innovators Conclave and Unicorn Karnataka is the first state in the country to
Felicitation ceremony. Speaking at the Innovators curate and design the Karnataka Preferential
Conclave - Unicorn Felicitation, Dr C N Ashwath Market Access, a specific policy to promote public
Narayan said, “The State of Karnataka is all set to procurement from startups. The Government has
strengthen its position as a hub of unicorns in the undertaken several initiatives such as Elevate 100,
country with the addition of another 20 unicorns Elevate WomEN, Grand Challenges Karnataka, New
soon. These startups have received funding of over Age Innovation Network, and Karnataka Digital
$3.5 billion in the last few years and several of them Economy Mission to name a few, to nurture and grow

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com BENGALURU TECH SUMMIT 2022 41

BTS Silver Jubilee Icon Awards Winners of Smart Bio Awards

Basavaraj S Bommai, Chief Minister of The Smart Bio Awards have been instituted
Karnataka, presented the BTS Silver Jubilee
Icon awards at the 25th edition of Bengaluru by the Department of Electronics, IT, BT
Tech Summit. The awards were given to
felicitate enterprises who have completed and S&T, Government of Karnataka with the
over 25 years of their presence in Karnataka
and have contributed towards building the IT, purpose of recognising biotechnology firms
Electronics and Biotech ecosystem in the State.
Biotech companies that received the award that have shown dynamic leadership and
include:
● Novozymes South Asia exciting technologies, standing out for their
● Novo Nordisk India
● Bhat Biotech contributions in their chosen areas in Biotech.
● Biocon
● Kemwell Biopharma Based on predetermined criteria the nominated
● Syngene International
companies were evaluated by a jury consisting
Winners of National level Bio Quiz
of a leading panel of experts from the Indian
India Bio@BTS hosted India’s largest National
Level Quiz on Biotechnology - BioQuiz 2022. entrepreneurship ecosystem, investors, policy
BioQuiz all these years was open to students
from B.Sc, B.Sc-Agri, B.E-Biotechnology & makers and respected business leaders. The
B.Pharma from across Karnataka state. Keeping
in mind the spirit of the new National Education winners of the award categories include;
Policy, it was decided to make it open to all the ● Startup of the Year- Natura Crop Care
students in undergraduate studies irrespective ● Innovator of the Year- Stempeutics Research
of their specialisation across the country. The ● Woman Entrepreneur of the Year-
15th edition of BioQuiz went National for the first
time with 1198 registrations from PAN India and Ankita Kumar (Mocxa Health)
participation of students from 24 states. ● Best Social Enterprise/ Institute-

The objective of the quiz was to create Centre for Incubation, Innovation
awareness about the fascinating world of
Biotechnology and encourage students to delve Research & Consultancy, Bengaluru
deep into the subject in a holistic manner. It was ● Best Product against COVID-19-
also an opportunity to showcase to the world, the
talent of our country in the fast-growing area of Emvólio by Blackfrog Technologies
Life Sciences.
● 1st Winner- South Zone, Mythili Padavu, the startup ecosystem in the state. These initiatives
have cemented Karnataka as a global technology hub
Manipal School of Life Sciences, Manipal, and earned the state the well-deserved tag of ‘Startup
Karnataka (Rs 50,000) Capital of India’.
● 2nd Winner- North Zone, Ishika Agrawal,
Motilal Nehru National Institute of The minister released a five-point declaration
Technology, Allahabad, Uttar Pradesh (Rs document adopted at the BTS 2022 as the curtains
25,000) went down on November 18. The declaration
● 3rd Winner- East Zone, Saheli Basu Roy, document envisages establishing a startup park near
Asutosh College, Kolkata, West Bengal (Rs Kempegowda International Airport in Bengaluru,
15,000) setting up research and development (R&D) labs in
● 4th Winner- West Zone, Jahnavee Palsodkar, 50 colleges in Karnataka, establishing science and
Institute of Bioinformatics and Biotechnology, technology research centres in universities, achieving
SPPU, Pune, Maharashtra (Rs 10,000) synergy between educational institutions and the
IT-BT companies and building relations between
academia and educational institutions.

The 25th edition of Bengaluru Tech Summit is a
testament of Karnataka’s commitment to innovation
and technology, supported by nimble policies and
initiatives aimed at making the state the innovation
hub of India. This journey began back in 1998, when
Bangalore IT.biz was the country’s first ever IT
focused event hosted by a city. It was inaugurated
by the then Prime Minister of India Atal Bihari
Vajpayee. This was followed by the Bangalore Bio
Summit in 2001, dedicated to the Biotechnology
industry. Both these flagship events put Karnataka
on the Global map, projecting its potential and
contribution to the respective sectors. In 2017, both
these flagship events were merged as Bengaluru

42 BENGALURU TECH SUMMIT 2022 BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com

Innovative products/solutions launched at BTS 2022

The Department of Electronics, IT, BT and S & T, Government of Karnataka launched 22 innovative products/
solutions by startups on the second day of the 25th edition of Bengaluru Tech Summit (BTS) 2022. Out of the 22
startups, eight startups are related to Med-Tech and healthcare.

Sr. No. Name of the Startup Sector Product Description
1 CareNX Innovations Med-Tech
2 Nanosafe Solutions Health Care Fetosense - which is a smartphone enabled Fetal Heart
Rate (FHR) monitoring device to perform Non-stress Test
3 Samasti Health Technologies Med-Tech (NST) & CardioTocoGraphy (CTG) Test - to early identify
prematurity.
4 Aikenist Technologies Med-Tech
5 Labezy Medtech Med-Tech NSafe mask (patent filed), India’s first copper treated
6 Dosetap IoT antimicrobial mask, reusable for 50 washes, with filtration
standards certified by SITRA.
7 ibloom HealthTech IoT RubSafe sanitising lotion and AqCure water bottle
8 Theranautilus Med-Tech developed by us are the first of its kind active copper
imbibed prolonged protection sanitising lotion and
antimicrobial water bottles respectively.

Svasthya is a remote clinical decision assistance
platform provides health equity by connecting the right
doctors to the patients for timely medical intervention,
clinical assessment, triage and care coordination with
referral pathways.

Aikenist provides Innovative and Patented QuickScan
technology which reduces MRI scanning time by half
using AI software.

Cancer screening device will be used as tool for
screening breast cancer through its trans illumination
method.

DoseTap is a smart pill box which connects to a mobile
application via Bluetooth. It contains a housing to store
medications for the whole week as per prescribed
dosage time and contains an integrated circuit board with
sensors to track patient usage.

iBloom is an IoT device for a prognosis heart attack at
home using doctor-assisted Ai and drone delivery of first
aid AED defibrillator devices at home.

Theradrive and Magnetic nanobots - reaching the entire
depths within the dentinal tissues to ensure a thorough
cleaning by targeting antibiotic resistant (AMR) bacterial
colonies using heat-based method that are out of reach
with the current state of the art tools.

Tech Summit. delegations, and 6 Ambassadors. The GIA Expo saw
The three-day summit which concluded on participants from Canada, Netherlands, Germany,
Australia, UKTI, South Korea, Pennsylvania, USPTO,
November 18 saw an overall participation of 32 Denmark.
countries, 405 speakers, 9356 delegates, 585
exhibitors, 25,738 registered business visitors, over Dr E V Ramana Reddy, Additional Chief
50,000 footfalls at the Expo, and the signing of 12 Secretary, Department of Electronics, IT, Bt and S&T,
Memoranda of Understanding (MoU). Adding to the Government of Karnataka; and Meena Nagaraj C.N.,
summit was the Global Innovation Alliance (GIA) Director, Department of Electronics, IT & Bt, and
Track which saw the participation of 20 countries, Managing Director, KITS, Government of Karnataka
164 delegates, 101 speakers, three minister level were also present at the summit.

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com PARTNER CONTENT 43

MISPA i3 – The Nephelometry Equipment
with Patented Technology from Agappe

Agappe, extending its 27 years of yeoman «
service to the patients through the IVD
industry, has consistently maintained on the Thomas John,
cutting edge of technology for the benefit of its clients Managing Director,
in lab diagnostics. Agappe stands for faster and Agappe Diagnostics
precise diagnosis with affordable cost to its ultimate
customer. profile. Hba1c and Microalbumin tests are part of the
Diabetic Profile and can be inexpensively and easily
It’s a moment of great pride and privilege for assessed without any calibration in this machine.
Agappe to receive the award of Technology Patent The sophisticated UCS Technology employed in the
in respect of Mispa i3 - New Technology as Patent Mispa i3 allows for easy estimation of elevated or
No: 409768 from Indian Patent Office on October lowered levels of CRP, RF, ASO, Ferritin, PCT, C3,
25, 2022. The title of the patent is ‘APPARATUS C4 due to infections or inflammation brought on by
AND METHOD TO MEASURE CONCENTRATION viral or bacterial reactions. Elevated levels of immune
OF PARTICULATES IN SOLUTION’. We would responses in the body like IgG, IGA, IgE, and IgM
like to draw your attention to the fact that Mispa can be examined on the Mispa i3 with zero reagent
i3 had been adored with three other Design waste and the shortest reporting time. This new
Registrations during 2016 itself. generation of instrument is nevertheless quite easy to
operate, in spite of its complex automation. Above all,
When Agappe set forth the introduction of Mispa I Mispa i3 stands out from other instruments because
Series in 2011, replacing the traditional latex method of its reasonably low equipment cost and practical
for protein quantification by integrating nephelometry and convenient pack sizes for all unique parameters.
and immunoturbidimetry technologies and paving the
way for wider measurement range, higher sensitivity, The R&D Team at Agappe, which makes up 10
and superior linearity at a more reasonable price tag. per cent of the entire company, including a number
of Masters and PhD holders, continues to develop
Later, the proprietary ‘UCS’ technology-equipped new IVD platforms spending 6 per cent of its total
semiautomatic protein analyzer Mispa i2 was revenue. Patents have a strong positive effect
introduced. Mispa i2 also has been awarded a on society as well as science as they promote
technology patent in 2018 with Patent No: 303381. innovation. The afore-mentioned new technology
patent proves that Mispa i3 is a revolutionary product.
The Mispa i3, the third member of the series, is an
Automated Specific Protein Analyzer that supports the Agappe was honoured with the prestigious
clinical management of a wide range of disorders and award from President of India, Ram Nath Kovind
provides high precision and quick turnaround results as the winner of National Awards 2018 for the
for all protein assays in blood. It covers a large assay ‘Indigenous Development of Technology and
panel of 23 parameters. It is a wholly indigenous piece Commercialisation’ of Mispa i3, the Automated
of nephelometry equipment that aids in quantitative Cartridge Based Specific Protein Analyser, in the
specific protein quantification by combining the presence of Dr Harsh Vardhan, the then Union
techniques of turbidimetry and nephelometry, both Minister for S&T and ES.
of which are considered to be the gold standard. In
order to deliver the best sensitivity and high linearity, Today’s customers are more aware. Patients
which ensure Channel shift and provide its high-quality and clinicians alike demand faster, most accurate,
findings, Mispa-i3 also uses proprietary technology. affordable technology which is also easy to access
and use. Agappe is committed to providing such
Mispa i3 provides flexible laboratory testing cutting-edge and innovative technologies for ultimate
with minimal investment. Cardiovascular risk patient wellness and better care.
profile, allergy profile, covid profile, diabetic profile,
rheumatology profile, osteoporosis screen profile, etc.
are all included in the assay panel. Numerous test
panels enable doctors to quickly identify diseases
and track patients’ progress. A better indicator of
early kidney failure than enzymatic creatinine is
cystatin C. The hs-CRP, Lp(a), D Dimer, Apo A1, and
Apo B indicators are part of the cardiovascular risk

44 PAECOAPDLEEMNIECWSSNEWS BIOBSIPOESCPTERCUTMRUM| |DECAEUMGBUESRT 20221 | www.biospectrumindia.com

HealthifyMe ResMed appoints Sandeep Gulati
picks as General Manager, South Asia
Stanford’s
Dr Shebani ResMed, a global leader in digital health, connected sleep and
Sethi as Chief respiratory care, is reinforcing its commitment to India by
Medical Officer strengthening its leadership with the appointment of Sandeep
Gulati as General Manager, South Asia. In his new role, Gulati will
In a first for a healthtech be responsible for further growth in the India market and ensuring
startup in India, Bengaluru- that there is increased awareness about sleep and
based HealthifyMe has respiratory disorders. A seasoned and dynamic
announced the appointment professional, Gulati brings a rich 23 year long
of Dr Shebani Sethi as its experience of leading sales and marketing
consulting Chief Medical Officer organisations in the pharmaceuticals and
(CMO). Dr Shebani is the medical device industry. He has been a part
Founding Director of Metabolic of ResMed since 2020 and will now be leading
Psychiatry, a term she coined from the front. In his two years at ResMed as
at Stanford University School Sales Head – India & South Asia, his long-term
of Medicine. She brings a vision and strategy led ResMed to achieve
decade of experience in obesity strong business results in a short span
medicine and psychiatry along of time. Gulati has previously worked
with cutting-edge knowledge in various assignments in sales &
of metabolic health. She will marketing in Novartis & Baxter for a
play an instrumental role in major part of his career.
building HealthifyMe 2.0 where
the larger organisational goal Dr Bipin Nair steps in as vice
is to put metabolic health at its chair of India AMR Innovation
core and weave key cognitive Hub’s Special Interest Group
and behavioural neuroscience
elements as a part of the Amrita Vishwa Vidyapeetham’s Additionally, four SIGs
company’s DNA across all Life Science, School of focusing on key areas are
its products. Dr Shebani is a Biotechnology, Dean Dr Bipin Human AMR, AMR in Human-
physician board-certified in Nair has been appointed as animal- Agri Interface, AMR
obesity medicine and psychiatry. the vice chair of one of the five stewardship, and Surveillance
Besides consulting with Special Interest Groups (SIG) of & Public Health Preparedness.
HealthifyMe, she is a Clinical the India AMR Innovation Hub Antimicrobial resistance (AMR)
Assistant Professor at Stanford (IAIH), a national-level body has been identified by WHO
University School of Medicine, engaged in research related as one of the top ten global
where she pursues metabolic healthcare threats that is
psychiatry research and runs to antimicrobial presently claiming 700,000 lives
a clinical programme in the resistance. Dr per year. In 2004, Dr Nair took
Department of Psychiatry and Nair will be over as Professor and Chairman
Behavioral Sciences. the AMR of the Centre for Biotechnology,
Environment Amrita Vishwa Vidyapeetham,
Committee’s Amritapuri Campus. Under
vice chair, his leadership, the School of
one of the Biotechnology has been a trail-
five SIGs of blazer in the Biotechnology
IAIH. arena for both undergraduate
and postgraduate academic
programmes as well as an active
PhD programme at the School.

BIOSPECTRUM | DECEMBER 2022 | www.biospectrumindia.com PEOPLE NEWS 45

Medikabazaar appoints two
industry stalwarts as CHRO & COO

Creaegis backed soonicorn the Brandon Hall Award for
best CHRO and HR practices.
Medikabazaar has announced Manish Gahlaut has been
named as the company’s Chief
two top level appointments Operations Officer (COO). He
will be spearheading supply
to their current management, chain management. Gahlaut
has more than 2.5 decades of
making it one of the high experience in the healthcare
sector, working with numerous
profile additions in recent multinational corporations
(MNCs) like Novartis, Abbott, and
times. Dr Sandeep Gandhi has Bausch & Lomb throughout India
and the Asia Pacific region.
been appointed as the Chief Dr Sandeep Gandhi Manish Gahlaut

Human Resources Officer

(CHRO). He will support the

company’s people-first culture positions with PepsiCo, Aircel

and human resources strategy. Dr Maxis, Vodafone, and Telenor,

Gandhi has close to 2.5 decades among others. He has three

of experience and has held consecutive years of winning

Society for Dr Amit Kakar
Emergency Radiology
appoints Dr Arjun joins MedGenome
Kalyanpur as President
Board of Directors
Dr Arjun Kalyanpur, Co-founder and Chief Radiologist
of Teleradiology Solutions has been appointed MedGenome has announced the appointment
President of the Society for Emergency Radiology of Dr Amit Kakar, from Novo Holdings, to
(SER), for 2022- 2024. SER is a not-for-profit society its Board of Directors. This announcement
established with the goal of promoting awareness, comes on the heels of MedGenome’s $50
education and research in emergency radiology. million funding round led by Novo Holdings
in August 2022. They have also appointed
During his tenure, Dr Navjeewan Khosla, Principal, Novo Holdings
Kalyanpur will focus on as Board Observer. Dr Kakar is Senior Partner,
leading and communicating Head of Novo Holdings Asia, and a healthcare
the larger vision of SER professional with over 30 years of experience
in India, driving key across key verticals including medical
initiatives with the support technology, R&D, manufacturing, pharma
of the executive committee, retail, drug discovery, clinical research, biotech,
enhancing connections hospitals and diagnostic centres, primary and
with other International specialty care centres, among others. His
Societies and further diverse experience also encompasses
promoting the educational investing, operational and
programs and activities of management roles across health-
SER across the nation and globe. Dr Kalyanpur is the tech companies. He is currently
Co-founder and Chief Radiologist of Teleradiology part of the Board of Directors
Solutions. In 2002, he founded Teleradiology of Singapore-based life science
Solutions, which currently provides Teleradiology company, ESCO, telemedicine
reporting services (CT, MRI, X-ray, and Ultrasounds portal – Doctor Anywhere
Reports) to over 100 hospitals in the United States, and leading health tech
Asia, and Africa. Dr Kalyanpur is trained at AIIMS, firm Qure.ai. As a Senior
New Delhi, Cornell University Medical Center and Partner, Dr Kakar’s
Yale University. He is a passionate advocate for the expertise will help
use of artificial intelligence (AI) in radiology. accelerate MedGenome’s
expansion plans.

46 ARC&ADDNEEMWICSS NEWS BIOBSIPOESCPTERCUTMRUM| |DECAEUMGBUESRT 20221 | www.biospectrumindia.com

IIT Roorkee IIT-M develops new-generation
super-abrasive tools for dental surgery
discovers
A newly developed technology can now produce new-generation multi-point/
3 anti-viral single-layer superabrasive tools for advanced grinding applications to meet
high productivity and energy-efficient material removal requirements. The
molecules tools produced also have enhanced tool life. A research team at the Indian
Institute of Technology Madras (IIT-M) has used advanced chemical bonding
for treating technology with an application-specific novel formulation of filler material and
controlled spacing of grits on the tools by an indigenously developed semi-
COVID-19 automatic grit-printing device. This indigenous tool supported by the Core
Research Grant (CRG) of the Science and Engineering Research Board (SERB),
A team of researchers a statutory body of the Department of Science and Technology (DST), offers a
at Indian Institute of competitive cost with a superior quality tool, which is also tailor-made as per
Technology Roorkee (IIT the needs of industries like aerospace, automobile, mining, and dental surgery.
Roorkee) has identified
anti-viral molecules that IIT-M, NASA study
can be used effectively potential impact of microbes
to treat COVID-19 on health of astronauts
infections. The
researchers identified Indian Institute of Technology Madras (IIT-M) and NASA (National
three such anti-viral Aeronautics and Space Administration in the US) Jet Propulsion Laboratory
molecules through researchers have studied the interactions between microbes in the
drug repurposing, International Space Station (ISS). The study will help devise strategies
computational and for the disinfection of space stations to minimise any potential impact
anti-viral experimental of microbes on the health of astronauts. Crews, during spaceflight, may
studies. The IIT Roorkee have altered immunity and limited access to terrestrial medical facilities.
team is executing protein Therefore, studying the microbes inhabiting the space station becomes
structure-based drug- important to understand the risks associated with short-term and long-term
repurposing research on space travel on the health of astronauts. The present study was motivated
SARS-CoV2 molecules by the earlier observations of the dominance of Klebsiella pneumoniae on
for clinical evaluation the surfaces of the ISS. This pathogen has been known to cause pneumonia
and eventual use as anti- and other nosocomial infections. The researchers were broadly interested in
viral therapeutics. The understanding how this bacteria affects the growth of other microbes in the
team used the Protein vicinity and the possible implications it could have.
Data Bank to target and
identify drug molecules
for the COVID-19
virus. They focused on
discovering molecules
that acted on a specific
part of the viral proteins
called the nucleotide-
binding pockets (NBPs).
As the name suggests,
the NBP binds to the
nucleotides – the
building blocks of RNA
and DNA – and helps
in the replication of the
virus. NBP-targeting
drugs are known and
used for viral diseases
such as HIV, hepatitis B,
hepatitis C, and herpes,
among others.

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

IIT-G develops AI model to IIT-D develops
predict bone repair outcomes
for fracture treatment VLP-based

Researchers at the Indian an optimum strategy can vaccine candidate
Institute of Technology be chosen for the patient
Guwahati (IIT-G) have depending on their personal against COVID-19
developed Artificial physiologies and fracture
Intelligence (AI) model type. Using such precision Researchers at the Indian Institute
to predict the healing models can reduce the of Technology (IIT) Delhi working in
of thigh bone fractures healing time, lighten the collaboration with the Translational
after surgery. The model economic burden and pain Health Science and Technology
developed by Dr Souptick for patients who need thigh Institute (THSTI), Faridabad have
Chanda, Assistant fracture treatment. The developed SARS-CoV-2 Virus-Like
Professor, Department research team has used Particles (VLPs), which are a possible
of Biosciences and a combination of Finite vaccine candidate. The VLPs tricked
Bioengineering, IIT-G, and Element Analysis and the the immune system into launching
his team can be used to AI tool, Fuzzy Logic to a counterattack in mice, just as it
assess the healing outcomes understand the healing does against SARS-CoV-2. In other
of different fracture process of fracture after experiments, the IIT Delhi researchers
fixation strategies so that various treatment methods. and their collaborators also utilised
these VLPs to understand how SARS-
CoV-2 could be invading cells in
the Central Nervous System (CNS).
COVID-19, while well-known as a
respiratory illness, can also affect the
nervous system, bringing on headaches
and fatigue and wiping out the sense
of smell, but it’s unclear whether
how these symptoms are caused. The
researchers showed that the VLPs
could get into brain cells in petri
dishes, and the process depended on
both cholesterol in the cell membrane
and an enzyme called dynamin.

Prayasta develops world’s first
3D printer for implant grade silicone

Bengaluru-based startup Prayasta hospital itself. 3D printing allows only improves outcomes of the
3D Inventions has developed personalisation of implants on surgeries for the patients but
the world’s first 3D printer for a one-to-one basis which not also reduces the average time a
implant-grade silicone and surgeon must spend for achieving
is partnering with the Centre the same results using standard
for BioSystems Science and implants. Prayasta and IISc will
Engineering (BSSE) at the Indian work together to accelerate the
Institute of Science (IISc). A translation of personalised soft
Memorandum of Understanding tissue implants from research
(MoU) was signed to formalise to hospitals, to test the 3D
this partnership earlier this year. printability of novel materials
Prayasta’s specialised 3D printer, in a fast-track mode and also to
Silimac, can directly 3D print develop the necessary skills for
implant-grade silicone material faster market penetration of 3D
to make an implant within the printing technology.

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

Samsung unveils ABB India opens first
AccE glass-free detector
for X-ray imaging smart instrumentation

Samsung has introduced a new flagship detector, factory in Bengaluru
the AccE Glass-Free Detector. The detector recently
received 510(k) clearance from the US Food and ABB Measurement & Analytics recently opened
Drug Administration for commercial use in the USA. its first smart instrumentation factory in
The AccE Glass-Free Detector has been designed to Bengaluru to support the region’s ambition
deliver high-resolution images of a digital detector, of transforming into a global design and
while offering exceptional user and patient benefits, manufacturing hub. Aligned with the local
including lightweight government’s ‘Make in India’ programme aimed
design: weighs at supporting the local economy, the factory is
approximately equipped with state-of-the-art manufacturing
4.5 pounds, technology to meet the growing demand for
which is 27 instrumentation devices that enables more
per cent lighter efficient and sustainable customer operations.
than the The new plant will manufacture field devices
conventional such as pressure and temperature transmitters,
model. It has IP convertors and electromagnetic flowmeters
clear visibility: for a wide variety of industries, including
exhibits a 76 per cent detective quantum efficiency power, oil and gas, pharmaceutical, water
(DQE), leading the market in glassless panel and other segments. The new factory uses a
technology. It features a non-glass flexible panel unique digital production management system
with center-engraving to position a patient, a side across all production lines and offers enhanced
chamfer to ease lifting and a rear grip to support connectivity through ABB’s Manufacturing
transportation. It can hold up to 881 pounds of Execution System (MES), an IoT enabler,
surface load and 441 pounds of patient load. It making processes seamless and paperless
enables users to employ the detector with confidence with complete cybersecurity. The factory also
in fast-paced environments. features innovative first-of-its kind automated
welding, enabling significant improvement in
productivity and superior quality.

Nikon enters into Indian healthcare sector
through System Product Microscopy business

Nikon India has announced its foray boost research and development in
into India’s healthcare sector through medicine. Nikon’s newly launched
System Product Microscopy business. product AXR Point scanning confocal
Nikon, which has had a presence microscope speaks its capability itself
in the Indian market for over four which provides “world’s largest field
decades through distributors, plans of view” of 25mm in one single shot,
to enter India’s healthcare sector which gives strength researchers to
through System Product Microscopy generate most accurate statistical
business; and aims at facilitating data while imaging. Nikon AX
direct sales, service, and distribution Point Scanning confocal is the
for their Microscopy Solutions. The “world’s fastest confocal system
product is targeted at premier research in the industry”,
institutes, research centres funded and which helps
established by the Government of India, researchers
academic educational institutions, to perform
clinical centres i.e- hospitals and fast Dynamics
medical research institutes, etc. to studies.

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

Thermo Fisher launches new solution
to help evolve cell therapy manufacturing

Thermo Fisher Scientific automated and closed system to the commercialisation of high
has unveiled the Gibco CTS help optimise the cell therapy performing therapies as well as
DynaCellect Magnetic Separation manufacturing process. As a the development of the next class
System (DynaCellect) to of cell therapy breakthroughs.
help cell therapy developers result, DynaCellect Designed to be used with
easily move from process helps ensure the right Dynabeads, the DynaCellect
and clinical development to cells are isolated system delivers exceptional
commercial manufacturing. and failures in performance, high-throughput
This next-generation cell manufacturing are capacity and process flexibility
isolation, cell activation, minimised. With while enabling an end-to-end
cell depletion and the cell therapy closed process. Cell therapy
Dynabeads magnetic manufacturers utilising the
beads removal market poised DynaCellect system can leverage
instrument for rapid growth, a highly efficient workflow that
provides a this evolution reliably delivers high-performing
scalable, flexible, in cell therapy target cells.
manufacturing
can support

CMP Scientific & Agilent Waters automates solid phase
extraction of biological samples
to advance capillary with Andrew+ Pipetting Robot

electrophoresis–mass Waters Corporation has introduced Extraction+ Connected
Device, a new software-controlled product for the Waters
spectrometry solutions Andrew+ Pipetting Robot that automates the preparation of
biological, food, forensics and environmental samples by solid
CMP Scientific Corp. has signed a phase extraction (SPE). The Extraction+ Connected Device
global co-marketing agreement with eliminates the need to manually pipette and extract samples with
Agilent Technologies to provide an a hands-free, automated approach to SPE. It can save scientists
integrated capillary electrophoresis– up to four hours of bench time for each sample set and reduce
mass spectrometry (CE-MS) solution the risk of user-to-user variability. It is one of several ‘connected
to the life science and pharmaceutical devices’ for the Andrew+ Pipetting Robot, which are controlled
industry. CMP and Agilent will using Waters’ OneLab Software. With a simple and intuitive
work together to implement new user interface, OneLab Software makes it easy for designing
applications for the CE-MS system, and executing automated sample preparation protocols such as
which is a sensitive, alternative pipetting, shaking, cooling and heating, and purifying genomic,
method to liquid chromatography- plasmid and mitochondrial DNA samples.
mass spectrometry (LC-MS) in
mapping biological components.
CMP first introduced the EMASS-
II CE-MS, which utilises an
electrokinetically pumped nanospray
sheath liquid interface to provide
reliable and robust performance, in
2015. Leading biopharmaceutical
companies now routinely use
the EMASS-II CE-MS ion source
in high sensitivity applications
ranging from mAb intact mass
analysis, charge variant analysis,
CE-SDS impurity analysis, subunit
analysis, peptide mapping analysis,
biosimilar comparisons to preclinical
biotransformation studies.

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

Why ‘Letting Steam Off’ Is Crucial

Anew study by Kingston University’s Business hormones, particularly the stress hormone cortisol.
School and Maynooth University in Ireland By rapidly increasing glucose levels, speeding the
has shown that people in the early stages heart rate, and increasing blood flow to the muscles
of their careers were more likely to be impacted by in our arms and legs, this stress response allows us to
workplace stress during the COVID-19 pandemic respond to a threat or situation.
than senior colleagues. On the other hand, a few
studies revealed that some individuals weathered the Because stress changes the way the brain’s neurons
stress of the pandemic better than others, in part, due communicate with each other, chronic stress can
to their genetics. cause our brains, nervous systems, and our behaviour
to adjust to a vigilant and reactive state which can be
Focusing on India, a Deloitte report says that 80 devastating and lead to newer problems and diseases.
per cent of the Indian workforce reported mental
health issues during the past one year and it has cost For instance, scientists in the US have shown that
organisations Rs 1.1 lakh crore or $14 billion. Out of stress, such as intraocular pressure (IOP) elevation in
the Rs 1.1 lakh crore, Rs 14,000 crore was the cost of the eye, can cause retinal tissue to undergo epigenetic
absenteeism, while presenteeism cost Rs 51,000 crore and transcriptional changes similar to natural ageing.
and employee turnover cost Rs 45,000 crore. Thus, continuous stress may induce features of
accelerated ageing in the eyes of young adults, further
Presenteeism, a phenomenon of attending to leading to age-related eye diseases.
work while under mental stress and thus performing
at low productivity, has a much higher effect than Researchers have also revealed that high levels
attrition and shows how much work stress can impact of stress is responsible for aggravating eczema, a
productivity. It’s high time we took a closer look at condition that causes uncomfortably dry, itchy skin,
the concept and science behind stress that is taking a and it is one of the most common chronic diseases
toll on our daily lives and overall health. In general, worldwide. There is a cyclical connection between
scientists think of stress as our body’s response to eczema and stress because stress can trigger or
being pushed out of balance. worsen eczema symptoms, for which there is no cure
in allopathy.
Most of the time, the stress response relaxes once
the perceived threat or situation passes, and our body While stress is a condition for which no allopathic
recovers its balance. When a threat continues over a drugs or interventions exists, technology is nowadays
longer period, however, the stress response stays in a being pitched as the best possible solution in the form
heightened state of alert. This chronic stress can take of health wearables or smart watches. The in-built
a long-term toll not only psychologically, but also sensors can measure biometrics like breathing or
physically. pulse rates, including the smallest variations in our
heart’s functioning, optimising our sleep, etc. Since
A stressful situation can trigger a cascade of these devices merely provide stress-related data and
stress hormones that produce well-orchestrated not any remedial measures, to what extent these
physiological changes such as fast heart rate, tensed devices can effectively assist stress management is
muscles, sweating, compromising the immune still largely unclear, many scientists argue.
system, etc. More preliminary research suggests that
chronic stress may also contribute to obesity, both Since our body constantly communicates with us
through direct mechanisms (causing people to eat and the outside world, presenting real-time ‘positive
more) or indirectly (decreasing sleep and exercise). and negative’ feedback, it would be prudent to act
upon these ‘signals from our body’ at the very first
Known as the hypothalamic-pituitary- instance.
adrenocortical (HPA) axis because it comprises
the hypothalamus, pituitary gland, and the adrenal Dr Manbeena Chawla
cortex, this stress response system regulates Executive Editor

[email protected]