BIoSpectrum India November 2021

Xell is now part of Sartorius

Boosting your Gene Therapy
Applications

Cell Culture Services and Media by Xell

Proprietary media and feed solutions for HEK and other
human cell lines

Process optimization and development

Liquid and powder manufacture

In-depth analysis of spent media to better understand your
cells and processes

Xell AG (Headquarters) RRR Labs Pvt Ltd (Distributor)

Bielefeld, Germany www.xell.de Mumbai, India www.rrrlabs.com

+49 521 96989 200 [email protected] +91 22 2783 3655 [email protected]

4 BIO CONTENT BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

COVER STORY 22

CAN ‘REVERSAL
PROGRAMMES’
BEAT DIABETES?

Our modern way of life is at odds with the optimal functioning and

upkeep of the ‘human machine’. Unreasonable demands on the

body and mind, coupled with erratic food habits has only added to

the overall deterioration of the body-mind equilibrium, leaving us

with numerous ‘lifestyle’ disorders, which could

have been avoided with a hard reset of our erring

way of life as it stands. Unfortunately, there

hasn’t been much of an improvement in

that department and consequently we are

faced with a burgeoning diabetes-affected COVER
DESIGN BY:
population. Healthcare providers are DOMINIX STRATEGIC
DESIGN PVT. LTD.
in the fray to launch various diabetes
27
reversal programmes, to tackle
Increased
this calamitous national (and awareness
boosts the
international) healthcare diabetes
diagnostic
challenge. We shall try and find market
Thomas John
out just how effective
Managing Director,
and viable these Agappe Diagnostics,
Ernakulam
programmes are.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com BIO CONTENT 5

Covid-19 Top Video

29 Purnima S.,
Associate Director,
Reasoning Omega Healthcare
behind Management
Experimental Services, Chennai
Booster Shots tells us how medical
coding is playing
Speaking With a critical role in
healthcare today.
34
Scan the QR Code »
“We are gearing up to produce
molded parts for biopharma Vikas Chawla,
and medical industries” Founder & Director,
Ritesh Patterson, Vedas Cure, New
Delhi discusses
General Manager, Performance Plastics, the career
Saint-Gobain India, Bengaluru opportunities in the
Ayurveda pharma
36 sector.

OEM by QIAGEN advancing Scan the QR Code »
with Asian molecular
diagnostic companies Dr Mohan
Dr Kay Koerner, Keshavamurthy,
Director Urology, Uro-
Vice President - Head of OEM by oncology, Andrology,
QIAGEN, Germany Transplant & Robotic
Surgery, Fortis
Gene Editing Hospitals, Bengaluru
reflects upon the
38 association between
prostate enlargement
Limitless potential of gene editing and Parkinson’s
disease.
Regulars
Scan the QR Code »
BioEdit .......................................................................... 06
BioMail ......................................................................... 08
Policy and Regulatory News..................................... 10
Finance News.............................................................. 14
Company News.......................................................... 15
Start-up News............................................................. 19
World News................................................................. 21
WHO News................................................................... 40
Academics News........................................................ 41
People News................................................................ 42
R&D News.................................................................... 44
Supplier News............................................................. 48
Let’s Talk Health.......................................................... 50

6 BIO EDIT BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

Hope on the horizon

The third wave of the pandemic is uncertain, of August 2021. They have concluded that the sole
although preventive steps in the form of mass reliance on vaccination as a primary strategy to
vaccination have already been undertaken mitigate COVID-19 needs to be re-examined. This
on a war footing. India has administered over 100 observation underlines the need for developing
crore vaccine doses from January to October which a permanent line of treatment to fight COVID-19
is a monumental achievement indeed. Now there is since vaccines alone may not prove totally useful.
a potential oral pill that could effectively be used to Molnupiravir trials are heading in that direction.
treat COVID-19.
Merck is collaborating with Cipla, Dr. Reddy’s,
Just prior to India’s achieving the administering Emcure, Sun and Torrent for clinical trials of their
of 100 crore vaccines, pharma giant Merck had new antiviral in India. Although it reduces the risk by
sought emergency use authorisation (EUA) from 50 per cent and that too in mild to moderate cases,
the US FDA for Molnupiravir, its antiviral oral it may lead the path for further development of a
pill to treat COVID-19. Merck has developed it ‘complete’ cure for COVID-19, irrespective of the
in collaboration with Ridgeback Biotherapeutics severity of the patients’ infection. Pfizer is already
and in clinical trials, it has reduced incidences developing a similar pill for COVID-19.
of hospitalisation and death among high risk
individuals. It cut down hospitalisation and deaths This development is extended to India too, as
by 50 per cent among non-hospitalised patients with two pharma companies here have sought permission
mild to moderate disease. to end late stage trials for the generic version of
the Merck’s oral pill. Both the companies have
Once approved, Molnupiravir will be the first presented their interim clinical data for moderate
antiviral medication against COVID-19 and that too patients. In addition to this, Merck has also entered
a simple pill to be taken orally. It is an experimental into licensing agreements with over six companies
antiviral medicine developed to treat influenza. for production of Molnupiravir, once it is approved.
It affects replication of viruses as it disrupts the This will make India a major production hub for
enzyme, ribonucleic acid (RNA) polymerase which these new drugs.
viruses use for replication.
Reports suggest that by the end of this year
The pandemic has created such havoc by the Molnupiravir the medication will surely hit the
number of patients and deaths, that there has been shelves and be available in the US by the end of this
a lot of anxiety across the globe over the disease, year. Merck plans to produce 10 million courses
its spread, treatment and prevention. The level of treatment by the year end and more doses are
of anxiety can be judged by a statement by the expected to be produced in 2022. In anticipation of
Japanese Prime Minister over the efforts to develop approval many countries are placing orders for the
such treatments. He has described them as ‘key drug. The Bill & Melinda Gates Foundation has also
Trump Card’ in the prolonged, uphill battle against committed $120 million for its generic version of the
COVID-19. drug destined for its access to low income countries.

Medication against COVID-19 is important since Yet, there are the usual apprehensions that much
there have been apprehensions over the efficacy like vaccines, ‘wonder drugs’ like Molnupiravir won’t
of different vaccines even now. A research article be available sooner, for low income countries. Hopes
based on the study of 68 countries published in the and aspirations of a life without the dread of a deadly
European Journal of Epidemiology, in September pandemic becoming a reality will be another global
2021, by S V Subramaniam and Akhil Kumar claims challenge.
that there appears to be ‘no discernable relationship’
between percentage of population vaccinated and Dr Milind Kokje
new COVID-19 cases in seven days in the first week Chief Editor

[email protected]



8 BIO MAIL BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

Vol 19; Issue 10; October 2021

Acknowledgements Thank you so much for the video
coverage in the October edition. It is
The story on home diagnostics turning always a pleasure being associated with
into inevitable necessity looks good. BioSpectrum. We also appreciate the
Thank you so much for featuring the new startup section that BioSpectrum
inputs by Suburban Diagnostics has started on its website.

- Sushant Kinra, Mumbai - Adarsh Desai, Vadodara

Very good coverage on the role that IITs Thank you for featuring insights
are playing in the field of neurological on effective stroke diagnosis and
diseases and others, through science management using technology by World
and technology. Stroke Organisation and Qure.ai.

- Dr Vaibhav V. Goud, Guwahati - Reena Rajan, Mumbai

Vol 19; Issue 11; November 2021 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
Ravindra Boratkar Alok Srivastava Dr Manbeena Chawla Singapore
Editorial: National Business Head- Executive Editor MM Activ Singapore Pte. Ltd.
Chief Editor: Dr Milind Kokje Ad Sales & Marketing 103-104, Rohit House 3, Saradha Mani
[email protected] “NITON”, Block B, First Floor, Tolstoy Marg, Connaught Place, General Manager
Advisor - Content: Vijay Thombre 11/3, Palace Road, Bangalore 560001 New Delhi - 110 001 #08-08, High Street Centre,
Editor: Mobile: +91-9845128747 Mobile: +91-8861043732 1 North Bridge Road,
Narayan Kulkarni Tel.: +91-80-41131912/13 [email protected] Singapore - 179094
[email protected] [email protected] Tel: +65-63369142
Executive Editor: Fax:+65-63369145
Dr Manbeena Chawla Mumbai Pune [email protected]
[email protected] Ankit Kankar Ankur Hange USA
Sub Editor: Senior Manager - Executive VoC BioSpectrum Bureau
Nitesh Pillai Digital Strategy & Growth Ashirwad, 36/A/2, S.No. 270, Pallod MM Activ
[email protected] 1st Floor, CIDCO Convention Center, Farms, Baner Road, Pune- 411045 Sci-Tech Communications
Content Team: Sector 30A, Vashi, Navi Mumbai, Mobile: +91-9834745564 Mobile: +91-9579069369
Singapore: Hithaishi C. Bhaskar Maharashtra-400703. [email protected] E-mail: [email protected]
[email protected] Mobile: +91-9579069369 Europe
Social Media Communications: [email protected] BioSpectrum Bureau
Poonam Bhosale MM Activ
[email protected] Nagpur Sci-Tech Communications
CFO & Special Correspondent: Manisha Boratkar Mobile: +91-9579069369
Manasee Kurlekar 402, Govind Apartments, Shankar Nagar Square, E-mail: [email protected]
[email protected] Nagpur - 440 010. Tel. +91-712-2555 249
Production & Design: for the accuracy or
MM Activ Sci-Tech Communications Printed and published by completeness of
Anil Walunj Ravindra Boratkar on behalf of MM Activ Sci-Tech Communications Pvt Ltd information provided
Product & Marketing Printed at Spectrum Offset, D2/4, Satyam Estate, 1st Floor, Behind therein. Readers must
Ankit Kankar C.D.S.S., Erandawane, Pune 411004. Maharashtra. Tel : +91 20 2543 6556 undertake research and
[email protected] TIN No: 09565712431 take professional advice
Circulation, Subscription and Published from Ashirwad, 36/A/2, S.No. 270, Pallod Farms, before acting on any
Media Enquiry: Near Bank of Baroda, Baner Road, Pune- 411045.Tel. No: +91 20 2729 1769 information provided in
Asmita Thakar Website: www.biospectrumindia.com BioSpectrum.
[email protected]

Disclaimer: Owner of the magazine support these views.
 Readers are advised to will not be liable for any  Contents and
consequences.
make proper enquires  Views expressed in advertisements in
before entering into any the published articles BioSpectrum are purely
commitment in relations are personal opinions for information purposes
to advertisements of the contributors. and the Publisher &
appearing in this BioSpectrum does not Editor of BioSpectrum
publication. The Printer, necessarily claim to give no warranty and
Publisher, Editor and accept no responsibility

YET TO HAVE

AGAPPE

IN YOUR LAB !!

with HEMATOLOGY ANALYZER

Lowest
CPT

Automated 3 Part Hematology Analyzer 5 Part Hematology Analyzer

Toll 1800 425 7151
Free 1800 891 7251
Coagulation Analyzer (Hemostasis)
1800 270 7151
“Agappe Hills”, Pattimattom (PO), Dist. Ernakulam, Kerala - 683 562, India.
TEL: + 91 484 2867000 | [email protected] | www.agappe.com

10 POLICY AND REGULATORY NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

NHA revises health benefit package of AB PM-JAY

The National Health Authority added. According to the NHA, illness etc., (iii) surgical package
(NHA), the apex body for rate revision has been done in the treatment for black fungus, (iv)
implementing Ayushman Bharat following categories: (i) radiation other procedures like right/left
Pradhan Mantri Jan Arogya oncology procedures, (ii) Medical heart catheterisation, PDA closure,
Yojana (AB PM-JAY) has revised Management procedures like Arthrodesis, Cholecystectomy,
the Health Benefit Package (HBP) procedure for dengue, acute febrile appendicectomy etc. Under
Master under the scheme. In the medical management procedures,
revised version of Health Benefit rates for ICU with ventilator has
Package (HBP 2.2), rates of been revised by 100 per cent, rates
some health packages have been for ICU without ventilator by 136
increased by 20 per cent to 400 per per cent, rates for HDU has been
cent under PM-JAY. Around, 400 revised by 22 per cent while prices
procedure rates have been revised for routine ward has been revised
and one new additional medical by 17 per cent. The HBP 2.2 is
management package related expected to be rolled out from
to black fungus have also been November, 2021.

Ayush Ministry opens India, Croatia
online licensing portal
for manufacturers collaborate for

The Ministry of Ayush has made the process to grant research in traditional
the license to manufacture Ayurveda, Siddha and Unani
(ASU) drugs swift, paperless and more transparent by medicine systems
bringing the application system online. Manufacturers
can now save the trouble of making a physical presence at Paving the way for academic collaboration
the office of the licensing authority and can now apply for in India’s traditional medicine systems,
the license online at www.e-aushadhi.gov.in. The license especially in the field of Ayurveda,
of the ASU drugs has been made perpetual i.e. with a one- between the two countries, the Ministry
time registration fee the license of the product will be valid of Ayush has entered into an agreement
lifetime subject to online submission of self-compliance with Croatia. The Memorandum of
declaration every year or unless suspended or cancelled. Understanding (MoU) was signed between
While before the notification it had a validity period of the All India Institute of Ayurveda
five years. The applicants will only have to get their Good (AIIA) and Croatia’s Kvarner Health
Manufacturing Practices (GMP) certification validated Tourism Cluster. AIIA is an autonomous
every five years to keep their license in force. The GMP body under the Ministry of Ayush. The
certificate can also be retained with online submission of MoU with Croatia is a significant step
a retention fee of Rs 1000. The manufacturing unit of the towards bolstering India’s ties with
ASU drugs will be subjected to inspection in a randomised other countries and promoting academic
manner every five years. Since the validity of the license research, clinical and educational
has been increased, the license fee has also been revised activities, medical education, training,
from Rs 1,000 to Rs 2,000 for any number of generic ASU and competency building. The two sides
drugs and Rs 3000 for up to 10 proprietary ASU drugs. will undertake academic activities in the
field of Ayurveda in collaboration with the
identified institutions. There will be close
cooperation and collaboration on research,
including study design and execution,
developing evidence-based guidelines
for integrating Ayurvedic principles
and practices with modern medicine,
conducting lectures, workshops, seminars
and conferences, and other such activities
on Ayurveda.

West’s award-winning NovaGuard® SA
Pro safety system is now available for
ISO 0.5mL standard and 1mL long glass
staked needle syringes

The COVID-19 has impacted lives, healthcare systems, the pharmaceutical industry, and pharmaceutical
packaging organizations, world-wide. The resultant treatments, therapies, and vaccines that are administered
by injection bring to mind a long-term safety concern – needle-stick injuries. A way to address this concern is
with safety systems.
Driven by innovation and committed to safety, West has developed and expanded our solution to help
prevent needle stick injuries: the NovaGuard® SA Pro safety system – a single-use accessory for pre-filled ISO
standard 0.5mL standard and 1mL long stakedneedle syringes. The system can be deployed using a
single-handed technique and was designed to prevent pre-activation during handling.

Key Benefits of the NovaGuard® SA Pro safety system include:

• Compatible with ISO 0.5mL standard and 1mL West’s NovaGuard® SA Pro safety system was
long glass staked needle syringes awarded at the 2019 India Packaging Awards for
Excellence in Design and User Experience.
• Comprehensive technical document provided
• Tamper resistant function to help prevent needle

recapping
• Ease of use assembly on low and high-speed

filling lines
• Transparent for drug inspection and labelling
• Compatible with standard or custom plunger

rods
• Functionality studies in temperatures ranging

from -40ºC to 60ºC
• Minimal impact for their use on pre-filled syringe

assembly lines
• Low activation force for end-user comfort in the

delivery of drug product
• Designed to not pre-activate during handling

The NovaGuard SA Pro product line is now even more comprehensive. It is available in 0.5mL device and
1mL long device, suitable for most drugs that use pre-filled syringes deliver doses between 0.1mL and
1.0mL fill volumes.

Learn more about the NovaGuard® SA Pro safety system by visiting
https://www.westpharma.com/products/prefillable-systems/safety-systems/novaguard-sa-pro
or contact Kriti Kotian ([email protected]) for more information.

West and the diamond logo, NovaGuard are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
©2021 West Pharmaceutical Services, Inc. All rights reserved.

12 POLICY AND REGULATORY NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

NITI Aayog PM unveils Ayushman
Bharat Digital Mission
accelerates
Prime Minister Narendra Modi launched the Ayushman Bharat
digital innovation Digital Mission through a video conference on September 27.
Ayushman Bharat Digital Mission will now connect the digital health
in collaboration solutions of hospitals across the country with each other. The mission
will not only make the processes of hospitals simplified but also will
with AWS & Intel increase ease of living. Under this, every citizen will now get a digital
health ID and their health record will be digitally protected. The
The National Institution for Prime Minister informed that India is working on a health model
Transforming India (NITI that is holistic and inclusive. It is model which stresses preventive
Aayog), the Government of healthcare and, in case of disease, easy, affordable and accessible
India’s national policy think treatment. A comprehensive network of All India Institute of Medical
tank, Amazon Web Services Sciences (AIIMS) and other modern health institutions is being
(AWS), and Intel have come established in the country and work on establishing one medical
together to establish a new college in every three Lok Sabha constituencies is going on. There are
experience studio at the NITI also steps being taken for strengthening health facilities in villages
Aayog Frontier Technologies in the form of primary health centre networks and wellness centres.
Cloud Innovation Center (CIC). More than 80,000 such centres have already been operationalised.
Located in NITI Aayog’s New
Delhi premises, the studio Health Minister launches ICMR’s
will be a hub for collaboration drone-based vaccine delivery model
and experimentation to
enable problem solving Mansukh Mandaviya, Union in collaboration with the Indian
and innovation between Minister for Health and Family Institute of Technology, Kanpur
government stakeholders, Welfare, has launched ICMR’s to test the capacity of drones
startups, enterprises, and Drone Response and Outreach to carry and transfer vaccines
industry domain experts. The in North East (i-Drone). The safely. The study was conducted
studio will help showcase the i-Drone has been designed to in Manipur, Nagaland and
potential of technologies such overcome these challenges by Andaman and Nicobar. These
as artificial intelligence (AI), deploying Unmanned Aerial studies provided promising
machine learning (ML), Internet Vehicles (UAV) / drones to results based on which the
of Things (IoT), augmented remote areas and hard to reach Ministry of Civil Aviation,
reality and virtual reality (AR/ terrains. Currently, the drone- Directorate General of Civil
VR), blockchain, and robotics based delivery project has Aviation and other regulatory
to accelerate their application been granted permission for authorities have granted
in public sector use cases. The implementation in Manipur and permission to fly drones.
studio will encourage open Nagaland, as well as the Union
innovation and serve as a hub Territory of Andaman and
for government, healthcare, Nicobar Island. This is for the
education, and nonprofit startups first time that a Make in India
from India to showcase their drone has been used in South
solutions. It will also provide Asia to transport COVID-19
startups with an option to access vaccine over an aerial distance of
necessary support to enhance and 15 kilometres in 12-15 minutes.
scale their solutions. ICMR conducted an initial study



14 FINANCE NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

SII invests £50 M in Oxford Biomedica

Serum Life Sciences (SLS), a by the Group during 2019 and suites are currently dedicated
subsidiary company of Serum the first phase of development, to producing COVID-19 vaccine
Institute of India, has agreed to totalling 45,000 sq ft, consisted at 1000L scale and one suite is
invest just over £50 million in of four GMP manufacturing producing lentiviral vector-based
Oxford Biomedica in return for suites, two fill and finish suites products for the Group’s other
new ordinary shares representing and supporting areas such as partners. The remaining 39,000
3.9 per cent of the outstanding warehouse, cold chain facilities sq ft will be developed using the
shares after the capital increase. and QC laboratories. Three proceeds of the transaction to
The proceeds of the transaction allow for flexible expansion and
will be used to fund the use. This is expected to include
development of the fallow area manufacturing capacity for viral
at Oxbox, the Group’s 84,000 sq vector-based products, including
ft manufacturing facility based vaccines. The investment from
in Oxford, UK, into a flexible SLS will allow Oxford Biomedica
advanced manufacturing space to continue to expand the
and the validation of several capacity of the Group’s world-
independent cGMP suites, class facilities in anticipation of
expected to come online in mid- growing demand for the Group’s
2023. Oxbox was constructed world-leading capabilities.

Dr Agarwals AlbaCore Capital inks
financing partnership
Eye Hospitals to with MindMaze

inject over Rs 300 Cr European credit investment firm AlbaCore Capital
Group has invested $125 million in Swiss firm
in Maharashtra MindMaze, a player in the digital neurotherapeutics
market, delivering seamless digital assessments
Dr Agarwals Eye Hospitals will invest over Rs 300 and therapeutics over the full continuum of care
crore in Maharashtra in the next 18-24 months in over 20 countries, serving thousands of patients
to set up 20 eye care facilities across Mumbai suffering from neurological conditions. The company
and the rest of the state. Chennai-based eye care currently collaborates with approximately 90
chain has devised a Rs 1,000 crore expansion healthcare providers and has a product portfolio
plan to increase its footprint across the globe by that has received three FDA clearances and four CE
establishing 100 new hospitals in the next three marks across eight clinical indications. MindMaze,
years and over 500 vision centres, along with a backed by Mumbai-based Hinduja Group, will use
strong digital presence. In a recent development, the proceeds to accelerate commercialisation of
Mumbai-based Aditya Jyot Eye Hospital has and enhance market access for, its approved and
merged with Dr Agarwals Eye Hospitals. Prof. Dr reimbursed neuro-rehabilitation platform as well as
S Natarajan, a third-generation ophthalmologist expanding its neuro-restorative portfolio.
will now be the Chief of Vitreo Retina services of
Dr Agarwals Group of Eye Hospitals. Aditya Jyot
Eye Hospital has cutting-edge facilities both for
basic and advanced diagnostic tests and surgeries.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com COMPANY NEWS 15

Molbio Diagnostics receives Eli Lilly
DCGI nod for Scrub Typhus test partners
with Cipla for
Goa-based Molbio Diagnostics has received approval from the Drug key diabetes
Controller General of India (DCGI) for its Truenat Scrub T test for products
Scrub Typhus, an infectious disease that can spread to humans through
the bite of an infected chigger (larval mites). Scrub Typhus affects Eli Lilly and Company has
announced its strategic
approximately partnership in India to
one million enhance the reach of
people in India Lilly’s Diabetes products
every year. As – Humalog [Insulin
per the PLOS Lispro IP (rDNA Origin)
report July 2021, injection] and Trulicity
the highest (Dulaglutide). As a part
densities of of this agreement, Lilly
cases were from will transfer its rights in
Tamil Nadu India to sell, promote and
(37.6 per cent distribute the aforesaid
of cases), Himachal Pradesh (11 per cent), Karnataka (8.8 per cent), two Lilly diabetes products
and Uttrakhand (8.5 per cent). Real-Time PCR is the most accurate – Humalog and Trulicity
and sensitive method of diagnosis of infection with Scrub Typhus. With to Mumbai-based Cipla,
Truenat testing at the point of care, the disease can be detected at an subject to all regulatory
early stage efficiently and can be controlled effectively. approvals. Lilly will
continue to maintain its
Roche introduces cobas pure existing operating model
integrated solutions analyser in India for the remaining portfolio
of products. Cipla will
Roche Diagnostics India has reagents allowing labs to expand leverage its capabilities
announced the launch of cobas their test menu. Built on the and robust distribution
pure integrated solutions analyser latest technology, cobas pure strengths to engage
with a more intelligent system integrated solutions analyser healthcare professionals
particularly suitable for a large provides labs with an integrated and expand access to these
number of labs and hospitals system that focuses on the treatments for patients
operating in India, to make automation of manual tasks. who need them.
better use of their space and It is able to perform up to 870
expand their offering of high tests per hour whilst providing
medical value tests for the benefit medium-sized labs with access
of patients. This new compact to the full clinical chemistry and
analyser combines clinical immunochemistry assay menu
chemistry, immunoassay, and from Roche which includes more
Ion Concentration Measurement than 230 diagnostic tests across
(ISE) diagnostic testing on a single a wide range of disease areas
platform helping labs simplify such as critical care, infectious
daily operations with limited
space and diseases including COVID-19,
resources. Women’s Health,
Cobas pure Oncology,
analyser Cardiology,
offers the Endocrinology
longest and TDM
onboard (Therapeutic
stability of Drug
Monitoring).

16 SPONSORED CONTENT BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com SPONSORED CONTENT 17

18 COMPANY NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

MedGenome brings Alkem Labs
easy-to-do genetic
screening to India launches lung care

Bengaluru-based MedGenome Labs has launched its direct- division Pulmocare
to-consumer category under the brand name Genessense
for consumers in India. Under Genessense, MedGenome Mumbai-based pharma firm Alkem
will offer specialised, evidence-based genetic screening Laboratories has launched Pulmocare, a
tests that can be ordered online through the Genessense division to enhance awareness, diagnosis
and management for lung diseases like
website or via e-commerce asthma, Chronic Obstructive Pulmonary
platforms in future. The Disease (COPD), allergy, advanced lung
company that operates one of diseases and lung infections through a
the biggest genomic testing wide range of products for lung care. The
labs with highly specialised objective is to bring a drastic change in lung
tests in South Asia will initially treatment accessibility in India by way of
offer two tests - namely early diagnosis, better patient reach and
Kardiogen and Curegen under signified health promotion. Taking the stock
the umbrella of personal of filling the massive gap of accessibility of
genomics. Kardiogen will be India’s first Polygenic Risk lung care for the larger populace in India,
Score based predictive test for Coronary Artery Disease the company has decided to take a big leap
(CAD) with a proven specificity of 90 per cent for the to address the huge lung diseases burden in
Indian population. Kardiogen will help one assess the risk the country by launching a comprehensive
of developing Coronary Artery Diseases (CAD) or heart lung care division.
attacks based on their genetic makeup while Curegen is
a genome-based drug response test that will outline an
individual’s reaction to different drugs or medications.
The test will help consumers in avoiding adverse drug
reactions and improving response to medications.

Fujifilm unveils new CAD EYE function for colon polyp detection

Fujifilm India has launched a and the compatible expansion and colonoscopes. CAD EYE
new software version of CAD unit EX-1 in combination with was originally developed to
EYE, a function that supports Fujifilm’s ELUXEO systems support real-time detection of
real-time detection of
colonic polyps during colonic polyps utilising
colonoscopy utilising AI AI technology. When
technology. The updated a suspicious polyp is
function will be essential detected within the
for colon polyp detection endoscopic image, a
and characterisation, Detection Box indicates
which will be achieved the area where the
by utilising a type of suspicious polyp has been
Artificial Intelligence detected, accompanied by
(AI) called deep learning. a sound signal. The new
The new detection CAD EYE Detection and
and characterisation Characterisation will assist
functionality of CAD clinicians by generating
EYE together with the a suggested histological
polyp detection function prediction by displaying
will be available with whether the suspicious
software EW10-EC02 polyp(s) in the image are
hyperplastic or neoplastic.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com START UP NEWS 19

Sterling Accuris secures Rs 250 Cr Twin Health raises
from Morgan Stanley PE Asia Rs 1000 Cr to
prevent chronic
Sterling Accuris Wellness, a pathology-focused diagnostic lab metabolic diseases
chain in New Delhi, has signed an agreement to raise Rs 250 crore
of equity funds from a fund managed by Morgan Stanley Private US and Chennai-based Twin
Equity (PE) Asia. Veda Corporate Advisors, a leading mid-market Health, makers of the Whole
investment bank, advised the company and its promoters on the Body Digital Twin precision
health technology, has announced
transaction. The Rs 1000 Cr in Series C funding
company is aiming as it scales its presence in India
to achieve a revenue and the US. The funds will help
of around Rs 250 to scale Whole Body Digital
crore in FY22. Twin technology to reverse
During the last three and prevent chronic metabolic
years, the startup diseases, including type 2
has significantly diabetes. Founded in 2018, Twin
expanded its lab Health invented the Whole Body
network, invested in Digital Twin to help reverse
digital technologies and prevent chronic metabolic
and built a strong diseases, while improving energy
backend infrastructure to offer a wide variety of routine and and physical health. Powered
specialised tests within quick turnaround times. The proceeds from by artificial intelligence, the
this fundraiser will help the company penetrate deeper into existing Whole Body Digital Twin is a
markets and enter new geographies. dynamic representation of each
individual’s unique metabolism,
Mylab acquires majority stake built from thousands of data
in PoC startup Sanskritech points collected daily via non-
invasive wearable sensors and
Pune-based Mylab Discovery Solutions has acquired a majority stake self-reported preferences. The
in Mumbai-based startup Sanskritech, the developer of Swayam, Whole Body Digital Twin is a
India’s first most advanced Point of Care (POC) Testing system with predictive model that provides
over 90 test parameters and telemedicine facility. Mylab will establish individualized nutrition, sleep,
POC testing labs at doctor offices, nursing homes, community health activity and breathing guidance
centres, airports, etc. through lab partners to enable patients to get to patients and their healthcare
test results faster, at a lower cost and without the need to wait for providers, helping to reverse
hours. Swayam is a portable diagnostic and telemedicine POC system and prevent multiple chronic
that can be used to create a small lab anywhere. Mylab will use its metabolic diseases.
expertise in diagnostic solutions development, biosensors, robotics,
liquid handling to further expand the test menu and embed Artificial
Intelligence which will facilitate faster reporting and consultation
with the doctor an even better experience.

20 START UP NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

Rapid prototyping facility µFab opens at C-CAMP

Centre for Cellular and Molecular Government of India, the facility capabilities to entrepreneurs
Platforms (C-CAMP), in is a first-of-its-kind in India and innovators to enable faster
Bengaluru, with support from aimed at providing holistic product-to-market. The facility
National BioPharma Mission design to pilot-scale production is envisaged to provide design
(NBM), has set up a national and prototyping support to
facility to specifically address the medtech startups in developing
commercialisation gaps faced low-cost, rapid and point-of-care
by Microfluidics technologies medical device solutions with
and medical devices developers applicability in healthcare, both
in their idea-to-market journey. human and animal health. It is
Inaugurated by Dr Renu Swarup, also geared to support serological
Secretary, Department of diagnostic devices, which could be
Biotechnology and Department of a huge boost for India’s budding
Science and Technology, Ministry COVID-19 molecular diagnostics
of Science and Technology, sector.

BBC launches innovative MFine to set up
products developed
by nurtured startups largest AI-powered

Bangalore Bioinnovation Centre (BBC), under the virtual hospital
aegis of Karnataka Innovation and Technology
Society (KITS), Department of Electronics, IT, BT and Digital health startup MFine, based in
S&T, Government of Karnataka has recently launched Bengaluru, has announced a $48 million Series
five innovative products developed by startups being C funding round co-led by Moore Strategic
nurtured there. Sclareolide, developed by Tojo Vikas, Ventures and BEENEXT with participation from
is a fermentation product of Sclareol and is a key existing investors, Stellaris Venture Partners,
fragrance intermediate in the development of amber SBI Group Japan, SBI Ven Capital Singapore,
notes. This is the first company from India to develop Heritas Capital, Prime Venture Partners, Y’S
this through synthetic biology approach. On the other Investment and Alteria Capital. MFine aims to
hand, Vyvuz has been developed by Atrimed Biotech, build one of the largest virtual hospitals in the
as a herbal supplement against COVID-19. FibroScar
gel, developed by Fibroheal, is effective for skin scar world and make
management and moisturisation. K cat Enzymatic high-quality
has designed engineered enzymes using 7D Grid healthcare more
Technology which is an Artificial Intelligence-based accessible and
enzyme engineering framework. In addition, Spike effective with
S1 protein and Pseudovirus have been developed the use of AI
by Neuome Technologies, to be used for COVID-19 and mobile
detection. These products are imported currently technologies.
and indigenous production by Neuome will help in Towards that
avoiding imports and developing our own capabilities vision, MFine
in research. is enabling
clinical decision
support for doctors using AI and bringing
vitals monitoring and health management to
consumers’ smartphones. The new round of
funding helps MFine extend its leadership in
digital health with investments into expanding
its hospital, diagnostics and e-pharmacy network
across the country and building tech-driven care
delivery products for both acute and chronic
conditions patients.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com WORLD NEWS 21

IVI leads Sanofi, GSK COVID-19 vaccine trial in Nepal

Global pharma majors Sanofi clinical trial, this Phase III study led
and GlaxoSmithKline (GSK) have by IVI will continue to build capacity
received approval for their Phase III and infrastructure for vaccine
clinical study in Nepal to assess the research and development in Nepal.
safety, efficacy and immunogenicity As COVID-19 vaccination becomes
of their adjuvanted recombinant- available, study participants are
protein COVID-19 vaccine candidate. encouraged to receive an approved
South Korea-based International COVID-19 vaccine during the study,
Vaccine Institute (IVI) will conduct if they wish to do so. As part of
the Phase III clinical trial in Nepal, the study design, all participants
expecting to enrol 4,000 volunteers including the control group will be
across three study sites in the offered the study vaccine as soon
country. In addition to generating as it is determined to be safe and
local data to support the global effective.

Australia, UNICEF delivers Bangladesh
essential COVID-19
equipment to Sri Lanka intensifies mental

United Nations Children’s flow splitters, 42 infusion health awareness
Fund (UNICEF), with the pumps, 47 syringe
support from Australia, pumps, 4 ventilators, campaign
has recently delivered 1000 regulators, over
a consignment of 137,000 bacterial and The Maternal and Child Health Division
urgently needed oxygen viral filters and other vital (MCHD) of the International Centre
concentrators and other equipment. This critical for Diarrhoeal Disease Research in
vital equipment to the support, funded by the Bangladesh has developed a web-based
Ministry of Health in Australian Department online platform to provide virtual mental
support of Sri Lanka’s of Foreign Affairs and health counselling services to both
ongoing response Trade (DFAT) through healthcare providers and COVID-19
to COVID-19. The UNICEF, aims to ease the patients. This counselling service is
consignment of equipment strain on the country’s currently operational in 16 districts of
includes 203 oxygen healthcare system due to the country. This initiative has been
concentrators, 100 oxygen the COVID-19 pandemic. funded by the United Nations Population
Fund (UNFPA) and the United States
Agency for International Development
(USAID), with technical support from
the Clinical and Counselling Psychology
Department, the University of Dhaka
under the leadership of the Non-
Communicable Diseases Centre (NCDC),
Directorate General of Health Services
(DGHS). The field staff distributed
education and awareness materials in
the selected hospitals of the 16 districts,
which included 360 copies of NCDC
developed guidebook on mental health
and COVID-19, 1,600 posters and
20,000 leaflets. These materials have
significantly increased mental health
awareness among hospital patients,
healthcare workers, attendants, and the
general people.

22 COVER STORY BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

CAN ‘REVERSAL
PROGRAMMES’
BEAT DIABETES?

Our modern way of life is at odds with the optimal functioning and upkeep of the
‘human machine’. Unreasonable demands on the body and mind, coupled with erratic
food habits has only added to the overall deterioration of the body-mind equilibrium,
leaving us with numerous ‘lifestyle’ disorders, which could have been avoided with
a hard reset of our erring way of life as it stands. Unfortunately, there hasn’t been
much of an improvement in that department and consequently we are faced with
a burgeoning diabetes-affected population. Healthcare providers are in the fray to
launch various diabetes reversal programmes, to tackle this calamitous national (and
international) healthcare challenge. We shall try and find out just how effective and
viable these programmes are.

India has turned into the diabetic capital of the diabetes like losing weight through diet or
world with an alarming number of Type 2 diabetic exercise or both, usage of continuous glucose
patients. As per estimates there are more than monitoring sensors, weight reduction
77 million diabetics in the country and by 2045, the medical procedures like bariatric
number is going to grow to 134 million globally. surgery, usage of supplements,
Known to damage kidneys, eyes and hearts, and practicing yoga and meditation,
amputation, diabetes occurs when there is a lack of undergoing massage, and
insulin being produced by the pancreas. spa therapies.

Doctors have been recommending several Mumbai-based startup
measures for diabetic patients. And a special mention Fitterfly Healthtech has
can be made about diabetes reversal programmes joined hands
which healthcare providers and medical professionals with Roche
have been insisting on. Though the reversal Diabetes,
programme doesn’t guarantee a diabetic free world, Lal Path
however, certain measures may lead to a decrease in Labs, USV
diabetes. Pharma
and leading
Latest treatment options doctors to
launch an
A growing economy and rapid urbanisation has led initiative.
many to adapt to a certain mode of lifestyle that Says Dr
is leading to obesity and other ailments which is Arbinder
ultimately leading to diabetes. It may be noted that Singal,
senior citizens in urban settings are most prone to the Co-
disease. founder

There are various treatment options to reverse

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com COVER STORY 23

and CEO, Fitterfly, “There is no cure for Type 2 Some of the pioneers in having
diabetes, but the silver lining is that diabetes reversal diabetes reversal programme in India
is possible, which means one can reign control over
the soaring blood sugar levels and keep them in ● SHARAN- Auroville, Tamil Nadu
check or within the normal range (less than 140 mg/ ● Fitterfly Healthtech - Mumbai
dL). This will save one from the clutches of diabetes ● Dr Mohan’s Diabetes Specialities Centre -
and also cut down on the cost of medicines and tests
that need to be done routinely to keep a tab on blood Chennai
sugars. The new-age diabetes care and management ● Breathe Well-being - Gurgaon
● Metromedi - Hyderabad
has taken a paradigm shift - ● Twin Health - Silicon Valley, US/ Chennai, India
advancements in medical ● Sugar.fit - Bengaluru
technologies have ● GOQii - Mumbai
helped make ● BeatO - New Delhi
diabetes treatment ● IDEA Clinics – Hyderabad
more personalised
and patient- remission, because there is more weight for them
centric, making to lose. It is estimated that around 15 kg weight loss
diabetes may be needed to achieve and maintain remission.
reversal a C stands for C-peptide. This is a test to measure the
possibility.” amount of insulin produced in the body. The better
For the C-peptide levels, the greater the chances for
patients remission. D stands for duration of diabetes. Those
with Type with shorter duration of diabetes are most likely to
2 diabetes revert to normal. E stands for enthusiasm. Unless the
in South person is highly enthusiastic and motivated, reversal
India, Dr. of diabetes is either difficult, or if achieved, will not
Mohan’s be sustainable.
Diabetes
Specialities In the north, Gurgaon-based digital therapeutics
Centre in company, Breathe Well-being addressing diabetic
Chennai people and assisting them to manage/reverse their
follows conditions, reduce their dependence on medication
the ABCDE and lead healthier lives. It has a personalised digital
philosophy. A therapeutics programme called Breathe Well-being
stands for Age and Diabetes Management Program (BDMP), which has
recently received recognition from the American
A1c. Those at younger ages and have less elevated Diabetes Association (ADA). BDMP provides
A1c, say an A1c of 7 -10 per cent are the ones who are education, lifestyle advisory and health-related
likely to achieve reversal. B stands for body weight content as part of a curriculum customised according
or body mass index (BMI). The higher the body to a patient’s health profile and preferences.
weight, the greater are the chances of going into
Speaking on the programme
Aditya Kaicker, Co-founder & Chief

Program Officer, Breathe Well-
being, said “Digital therapeutics
is a scalable and sustainable
solution to the growing problem
of Type 2 diabetes in India. At-

home intensive programmes
with high touch-point enables
real-time monitoring and
guidance for the patients, which
is not traditionally available in
hospitals and clinics.”

Metromedi, based in
Hyderabad, has partnered

24 COVER STORY BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

It is mostly in Type 2 diabetes that diabetes with BMS Fit Club to expand its footprint in the
remission can be attempted. Therefore, this is an remote care of lifestyle-related chronic illnesses such
area of personalised medicine. as diabetes and hypertension.
- DR V MOHAN,
Chairman and Consultant Diabetologist, With the goal of empowering people to reverse
Dr Mohan’s Diabetes Specialities Centre, Chennai and avoid chronic metabolic disorders like diabetes,
Twin Health, founded in Silicon Valley, California,
We expect and we hope that it becomes an area and Chennai, India, has invented the Whole Body
of personalised medicine and that more and Digital Twin service. Hundreds of India’s finest
more people actively work towards reversing their diabetologists, endocrinologists, and physicians
diabetes instead of just relying on medicine. use the Twin service to provide accurate treatment
- AJOY PRABHU, to people with Type 2 diabetes, which is defined
Co-Founder & CTO, Circee Health, Mumbai as maintaining normal blood glucose levels
while discontinuing all diabetic drugs, including
Diabetes reversal is the new modality of treating insulin. Twin Health also partnered on technology
diabetes, it may completely or partially control development and health research validation with IIT
it. We need to understand it requires meticulous Madras.
efforts by both physician and patient.
- DR GEETA A MAKHIJA, Talking about the Twin technology Prof. Shashank
Consultant Physician and Diabetologist, Joshi, Chief Scientist at Twin Health and Consultant
Jaslok Hospital & Research Centre, Mumbai Endocrinologist at Lilavati Hospital, Mumbai and
President of Indian Academy of Diabetes said, “As a
scientist, I am impressed by the ongoing randomised
controlled trial (RCT) results and the cutting-edge
Whole Body Digital Twin technology. Now, it has
been scientifically proven that Type 2 diabetes can
be reversed by healing the root cause of chronic
metabolic diseases including Type 2 diabetes with
highly personalised data-driven recommendations to
doctors and patients.”

And the number goes on. A lot of players have
ventured in this field to provide relief to diabetic
patients.

Succour from tech

Artificial intelligence and technological
breakthroughs in healthcare have played an essential
role in assisting diabetic patients. The scientific
approach to disease management is beneficial to both
patients and healthcare practitioners. Mobile phones
have been an integral part of the healthcare system
and everyday there are new technological innovations
in the domain. In diabetes reversal programmes, the
most commonly used are mobile phones and using
a coach or a diabetes educator. A diabetes educator
through an app keeps in touch with a diabetic patient
and constantly motivates them to achieve weight
loss and to stick to their lifestyle modification. An
app helps to manage steps that one takes per day,
the calories in one’s diet with a proper feedback
mechanism.

Monitoring has become one of the most
significant instruments for assisting in the reversal
process, and tools such as self-monitoring blood
glucose with a glucometer and gadgets like as
continuous glucose monitoring systems make it
simple for patients. GOQii has released healthcare

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com COVER STORY 25

apps that include a tracker for monitoring activity, Now, it has been scientifically proven that Type
sleep, and other vital signs. 2 Diabetes can be reversed by healing the root
cause of chronic metabolic diseases including
Sugar.fit, a healthtech firm sponsored by Cure.fit, Type 2 diabetes with highly personalised data-
Endiya Partners, and Tanglin Venture Partners, aims driven recommendations to doctors and patients.
to control and reverse diabetes through a data-driven - PROF. SHASHANK JOSHI,
digital health experience centred on the user. The Chief Scientist, Twin Health, Chennai & Consultant
company has launched its services in Hyderabad, Endocrinologist at Lilavati Hospital, Mumbai and
making it the fourth market to foray in India. President of Indian Academy of Diabetes

Fitterfly from Mumbai has been offering an Any expert who wants to make a difference to a
advanced digital therapeutic programme - Diabefly, patient’s life must look at personalising the advice
which uses advanced data tracking from continuous customised to that patient.
glucose monitoring devices and matches it with - DR AKSHAT CHADHA,
foods and exercise creating a personalised glycemic Consultant, GOQii, Mumbai
response assessment. Based on this assessment,
personalised plans for diet, stress and fitness are Handling diabetes will become another area of
provided to the patient. Diabefly Reverse DTx personalised holistic management.
programmes have achieved transformational - DILIP BYRA CHAKRAVARTHY,
outcomes with results presented at American and Founder & Managing Director,
European international conference. Fitterfly raised MetroMedi.com, Hyderabad
a $3.1 million pre-series A funding round in March
2021.

Personalised medicine

The diabetes reversal programme can be another area
of personalised medicine. Several digital therapies
are resulting in better outcomes and are taking the
shape of personalised medicine.

“Diabetes already is an area of personalised
medicine. What India lacks, is the use of personalised
lifestyle intervention. Most healthcare units that cater
to diabetics have personalised medicine but generic
diets and generic exercise guidelines. Since diabetes
is a metabolic disorder, it needs to be addressed
in a holistic manner which begins with a highly
personalised diet, exercise, stress management, and
medicine. Handling diabetes will become another
area of personalised holistic management,” said Dilip
C Byra Founder, MetroMedi.com, Hyderabad.

Echoing similar thoughts Dr Akshat Chadha,
Consultant, GOQii, Mumbai said, “Any expert who
wants to make a difference to a patient’s life must
look at personalising the advice customised to that
patient.”

Sharing his thoughts, Dr V Mohan, Chairman
and Consultant Diabetologist, Dr Mohan’s Diabetes
Specialities Centre mentioned, “Yes, indeed, because
not everybody with diabetes can attempt to go into
a remission stage. For example, those with Type 1
diabetes and many other forms of diabetes, long-
term remission is currently not possible. It is mostly
in Type 2 diabetes that diabetes remission can be
attempted. Therefore, this is an area of personalised
medicine.”

“We expect and we hope that it becomes an area
of personalised medicine and that more and more

26 COVER STORY BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

There is no cure for Type 2 diabetes, but the silver
lining is that diabetes reversal is possible.
- DR ARBINDER SINGAL,
Co-founder and CEO, Fitterfly, Mumbai

Digital therapeutics is a scalable and sustainable a medication-free state. However, there are criteria
solution to the growing problem of Type 2 available that predict the chances of reversing your
diabetes in India. diabetes.
- ADITYA KAICKER,
Co-founder & Chief Program Officer, “Diabetes reversal is the new modality of treating
Breathe Well-being, Gurgaon diabetes, it may completely or partially control it. We
need to understand it requires meticulous efforts by
people actively work towards reversing their diabetes both physician and patient. Also, the dietary methods
instead of just relying on medicine. We are not have encouraging results but still need more research
saying that medicines are not helpful. In fact, they to attain good long-term outcomes which are missing
have played a very important role in dealing with in present approaches”, said Dr Geeta A Makhija,
the ailment. However, our endeavour should be to Consultant Physician and Diabetologist, Jaslok
continuously improve and aim for better results as Hospital & Research Centre, Mumbai.
we move forward. Therefore, these disease reversal
initiatives need to become an important part of our The solution for diabetes reversal lies in the
system”, said Ajoy Prabhu, Co-Founder & CTO, patient’s understanding about the foods which may
Circee Health, Mumbai. increase or decrease the level of diabetes. One should
also consider how much of what food is working for
Bouncing back the individual’s body.

Structured diabetes reversal programme with “We don’t use the word ‘completely cured’ because
coaching and optimisation of therapy is the right way if a person regains the weight the diabetes is almost
to attempt reversal. It requires intense motivation definitely likely to come back. Sometimes the glucose
and hard work and having a coach or a programme values can be even much worse than when they
on this journey helps. Also, it decreases chances of started attempting the remission process. Some of my
untoward side effects like sudden lowering of blood patients however have achieved remission for over
sugars and other complications. Not everyone is five years and are doing well. But in the majority of
suitable for reversing their diabetes and achieving the studies, we do not have data on remission beyond
two years. In my experience, most people, after six
months or one year, have what I call as ‘re-reversal
of diabetes’, that is, they develop diabetes again
and need to take medications again to control their
diabetes. Long term sustainability is a huge problem
with reversal treatments,” Dr Mohan added.

A balanced and moderate lifestyle change with
proper sleep and stress management along with
multiple dietary options to increase compliance with
diet hold the key to success.

On how these reversal programmes can be a
gamechanger in aiding diabetes treatment, only time
can say.

Sanjiv Das
[email protected]

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com COVER STORY 27

Increased awareness boosts
the diabetes diagnostic market

India is called the ‘diabetes capital’ of the world and «
the burden is increasing day by day, especially in
urban areas. As per reports, 26.1 per cent urban Thomas John,
residents aged 60 years or more are diabetic and 9.3
per cent senior citizens living in India’s rural areas Managing Director,
are also diabetic. Among Indians over 45 years of
age, 11.5 per cent were diagnosed with high blood Agappe Diagnostics,
sugar levels.
Ernakulam
India Diabetes Market size is expected to grow at
an average CAGR of 6.5 per cent during 2016-2023. is further expected to increase if diabetes is not
Global market for Diabetes Diagnostics estimated controlled. Majority of the patients going for this
at $26.5 billion in 2020, it’s projected to reach test are confirmed diabetics. But with increasing
$42.4 billion by 2026, growing at a CAGR of 8.1 per awareness among people, this ratio is likely to
cent. Test Strip is projected to record a 8.3 per cent change, and many more people are expected to go
CAGR to reach $11.3 billion by 2026. Same rate will for the test independently, rather than the clinician’s
be applicable for India too. Increasing frequency advice.
and convenience in testing give a good boost to the
diabetes diagnostic segment. HbA1c testing market size is expected to reach
$1,992.44 million by 2025 at 12.24 per cent CAGR,
The Diabetes Market has been segmented as owing to the rise in adoption of micro-optical
Type 1, Type 2, and Gestational diabetes. detection method. Agappe stands at a very prominent
Based on the test, market is segmented into position in the Indian HbA1C market, with ‘AGA1C’
Random blood sugar test, Fasting blood sugar test, on the Nephelometry platform, called Mispa i2 &
Oral glucose tolerance test, Initial glucose challenge Mispa i3. Agappe HbA1C has NGSP Certification &
test and others. If we take it on the basis of devices, this product shows highest correlation with HPLC
it is segmented into Blood Glucose Monitoring method, the golf standard.
Devices, HbA1c Testing Devices, Continuous Glucose
Monitoring (CGM) Systems etc. Healthcare awareness

Need of the hour is for easier, economic, and Preventive healthcare also known as prophylaxis
efficient management of this epidemic, improving is the pivotal measure we take for preventing any
easiness and accuracy of machines, and development disease. Preventive healthcare includes the use of any
of non-invasive technology for simplification of medical service or precautions that fight against the
testing. Agappe Diagnostics successfully markets potential health crisis and it’s getting momentum.
Glucose Hexokinase reagent, ‘AGGLH’ with higher
linearity & excellent correlation with reference Due to increased general awareness on underlying
methods. reasons for non-communicable diseases such as
diabetes, cardiovascular diseases, through internet
HbA1C business In India and frequent educational articles in various health
magazines and weekly newspaper magazines, the
The market for HbA1c testing has been expanding public are aware of the reasons and diagnostic tools.
steadily and with better awareness of the healthcare Hence, most of the members from educated societies
regarding it increasing rapidly, the market is set to do opt for voluntary tests off and on, before going
boom for a few years too due to its convenience & to any physician, thereby influencing the diagnostic
three months average estimation. market in a big way.

HbA1c levels surge in most Indian cities over the Diabetic assisted markets
last 3-4 years. As per a release, at present, more than like Renal Function Tests
77 million people are living with diabetes in India
and the country’s annual spend is approximately Rs Diabetic nephropathy is one kidney disorder
64,500 crore on diabetes related healthcare which consequent to diabetes. Cardiovascular and renal

28 COVER STORY BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

complications share common risk factors such as stay active and flexible and maintain confidence and
blood pressure, blood lipids, linked with glycaemic better lifestyles. Insulin Pumps and CGM provide
control. The impact of diabetes on renal impairment flexibility and better control.
changes with increasing age.
CGM technology enables you to monitor your
As per Kidney/Renal Function Test (RFT) Market glucose levels 24 hours a day through a sensor
forecast, the growth of this segment is at a CAGR of that sends the readings to an insulin pump. This
6.1 per cent during (2017-2022), driven by the rising intelligent system predicts when you are approaching
prevalence of kidney disease, growing prevalence a low glucose level 30 minutes in advance and
of diabetes and hypertension, increasing geriatric automatically stops insulin delivery and again
population, and the rise in alcohol consumption. automatically resumes insulin delivery when your
Diabetes is the most important one among these glucose levels recover normal. In short, CGM
comorbidities which lead to kidney disorders. provides a more complete picture of your blood
RFT tools include dipsticks, reagents, disposables; glucose levels by giving you early warnings of lows
urine tests include: Urine Protein, Microalbumin, and highs that HbA1C or fingerstick testing alone
Creatinine Clearance), Blood Tests include Serum cannot deliver. In fact, use of CGM has been shown to
Creatinine, BUN etc. Higher incidence of diabetes lower HbA1c levels considerably.
will multiply the kidney function tests in India
especially in south India, directly proportional to the The awareness of CGM levels has increased widely
diabetes population. in India, and the market for monitoring devices is
expected to see high growth in the country with a
POC & Other Glucose Monitoring Devices CAGR of 9 per cent during the forecast period.

Glucose monitoring devices market in India was Indigenisation of technology
estimated around $209 million in FY-2020 and its
growth is expected to be at a CAGR of 10 per cent by COVID-19 has put the diagnostic industry at centre
FY 2026. India glucose monitoring devices market stage with unparalleled demand for diagnostic tests,
can be fragmented into self-monitoring glucose along with other critical medical supplies. Strained
devices and continuous glucose monitoring devices, global relations, disrupted supply chains have created
where the self-monitoring glucose devices segment a trust deficit. All efforts were made to rapidly ramp
overwhelmed the market until FY 2020 and the up manufacturing capacity and capabilities in India,
segment is expected to continue its leading position medical devices leaders are also looking outside
over the next five years as well. This can be attributed their normal sector boundaries to explore creative
to ease of use and cost advantage. solutions to further supplement capacity, such as
partnerships with companies outside the sector,
The India glucose monitoring devices market open-source equipment design, to support public-
is created by the growing amount of diabetes in health needs. After a temporary dip, the healthcare
the country, mainly Type 2 diabetes. Always faster industry has reemerged with the diagnostic industry
and safer diagnosis techniques for diabetes are getting maximum advantage. The pandemic has put
anticipated to expand the market in coming years. the In vitro diagnostics (IVDs) sector at central stage
Increased awareness among the population regarding due to higher requirement of diagnostic tools in all
the treatment of diabetes will boost the market sectors including diabetes.
growth.
India imports about 80 per cent of the medical
Continuous Glucose devices. Due to supply chain bottlenecks during
Monitoring (CGM) Devices pandemic, indigenous production has been given a
big boost by favourable government policies. The
Insulin pumps and CGM can help diabetic patients Prime Minister of India also underlines that this
crisis presents an opportunity to the Indian economy.
The current pandemic is global, but the solutions to
the challenge should be local.

Forecasts by global data indicate that the medical
devices market in India contributed about 13 per
cent of the Asia Pacific market in 2019 and would
grow at a CAGR of 7.5 per cent through 2025. Future
expansions will be with wearable glucose testing
machines; implantable continuous glucose monitors
or cloud-enabled continuous glucose monitoring
devices, among others.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com COVID-19 29

REASONING
BEHIND

EXPERIMENTAL

BOOSTER
SHOTS

Studies have shown a reduction in the efficacy of vaccines with newer variants. As the
world moves towards boosters doses, the efficacy of the COVID vaccines is becoming a
concern. According to researchers from the University of Oxford, UK, and the country’s Office
for National Statistics, Pfizer/BioNTechCOVID-19 vaccine efficacy fell to 90 per cent, 85
per cent, and 78 per cent after 30, 60, and 90 days, respectively, and AstraZeneca vaccine
efficacy dropped to 61 per cent by 90 days with the Delta variant. There are ongoing studies
for booster doses but certain governments and vaccine manufactures have advocated for
booster doses. Booster doses can become a burden for nations when some are struggling to
obtain vaccines for first and second doses.

With the second wave of COVID-19 in infection. But as time has progressed since the
the rearview, the cumulative COVID-19 approval of the vaccines globally there have been
vaccine doses administered in the country several cases of breakthrough infections, amongst
has surpassed the 100-crore milestone on October those who have been fully vaccinated. Then there
21, 2021. On this historic achievement, in a tweet, have been cases reported, of deaths of those who were
Prime Minister Narendra Modi congratulated the fully vaccinated (two doses) and also cases where
countrymen and expressed gratitude to the country’s fully vaccinated individuals were admitted with
scientific community and health professionals for severe cases of COVID-19 infections. The vaccines
working towards achieving this stupendous feat. as far as the data is concerned have been protecting
against the virus.
India has been adding more vaccines to its
armoury to beat COVID-19. The Drug Controller Efficacy of the vaccines with newer emerging
General of India has granted emergency use variants is another issue of concern. The SARS-
authorisation to vaccines manufactured by Serum COV-2 virus has mutated since it was first reported
Institute India (Covisheild), Bharat Biotech from Wuhan in China, also known as the Wuhan
(Covaxin), Zydus Cadila (ZyCoV-D), Moderna virus which caused the first wave globally, followed
(mRNA-1273), Gamaleya (Sputnik V), and Johnson & by the second wave with the Delta variant in India.
Johnson’s (Ad26.COV2.S). Globally there have been reports of emerging variants
as the virus tends to mutate quickly. The mutating
The vaccines have been effective in protecting characteristic of the virus has impacted the efficacy
those who have been vaccinated from death and of the currently approved vaccines and the number
hospitalisation with severe bouts of COVID-19

30 COVID-19 BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

“Pharmaceutical companies are

holding the world to ransom at

a time of unprecedented global

crisis. This is perhaps one of the

most lethal cases of profiteering

in history.” - Anna Marriott,

Health Policy Manager, Oxfam, United Kingdom

“It is criminal that the
majority of humanity is still

facing this cruel disease
unprotected because

pharma monopolies and
super-profits are being put

first.”
- Winnie Byanyima,

Executive Director, UNAIDS, Uganda

“The third dose of vaccine booster shots to the vulnerable population.
is not right, at least till Countries like India, Singapore, Switzerland, and
several other countries are mulling over the third
significant parts of the other dose (booster shot). The World Health Organisation
countries get two doses and is yet to release a statement on the booster dose, but
then, of course, we look into more variants emerging and the efficacy of vaccines
reducing due to the emerging variants could
a third dose or an annual probably change in due course.
booster shot or something like
According to the fourth serosurvey conducted
that.” by the Indian Council of Medical Research (ICMR)
- Adar Poonawalla, approximately 67 per cent of the population surveyed
had developed antibodies for COVID-19. The results
CEO, Serum Institute of India, Pune of the survey were made public after the second wave
had peaked in India, at the time the vaccination drive
“But, in future, hadn’t gained a lot of momentum as citizens were
recommendations for boosters skeptical to get vaccinated. India has completed nine
months of the world’s largest COVID-19 vaccination
will definitely come.” drive but still, there are no approved tests to check
for the efficacy of the vaccines or if antibodies have
- Priya Abraham, developed in those who have been vaccinated. The
Director, National Institute of Virology, Pune only data that is available on the efficacy of the
vaccines is based on the clinical trials that were
of cases that are being reported has seen a steep conducted when the vaccine was being tested to
incline. Several countries are struggling with the rise check whether it was effective against the coronavirus
in the number of cases even after a majority of their variant at the time. The ICMR has approved antigen
population has been vaccinated. tests to check if an individual has had prior exposure
to the coronavirus or not. Even experts believe that
Developed nations pushing for booster doses antibody tests to check for the antibodies cannot
determine if an individual is protected against
Countries like the UAE, France, the US, Germany,
the United Kingdom, and Israel are providing

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com COVID-19 31

COVID-19 or not, or there is no gold standard to MASS VACCINATIONS - A DEVASTATING
gauge the efficacy of the vaccines. This raises a lot of IMPACT ON THE POPULATION
questions as there is a gold standard to determine
whether an individual is infected with COVID-19, Vaccines are a tried and tested method to
but there are no approved tests globally to check the help large populations build immunity against
efficacy of the vaccines that have been administered. various life-threatening diseases. Typically, safe
Pharma majors manufacturing COVID-19 vaccines and effective vaccines hit the market after about
had conducted clinical trials to determine the efficacy 10 to 15 years of rigorous testing. End users and
of the vaccines and shared figures on the efficacy of governments alike can vouch for its safety and
the vaccines once the clinical trials were complete. intended result, as in the case of vaccinations for
However, there have neither been any follow-ups, measles, mumps, rubella and smallpox. However,
nor have the manufacturers addressed this important when COVID-19 was thrust upon the world, the
piece of information. healthcare systems became overwhelmed.
From the initial directives from the World Health
Big pharma monopoly Organisation (WHO) to the different national
agencies like the Indian Council of Medical
COVID-19 cases are escalating and a very large Research, the National Institutes of Health (NIH),
population, especially in Low and Low Middle- the Centre for Disease Control (CDC), all fumbled
Income Countries (LMIC) remains vulnerable as collectively to deliver a ‘scientifically sound’
the governments of these nations haven’t been able and logical course of action. Down the months,
to procure vaccines. Pfizer/BioNTech and Moderna nationwide ‘lockdowns’ were imposed to curb the
have sold over 90 per cent of their vaccines so far to spread of the virus.
rich countries, charging up to 24 times the potential
cost of production. mRNA-type vaccines produced by There are no scientific papers and historical
Pfizer/BioNTech and Moderna have been developed evidence to corroborate the rationale behind
through public funding to the tune of $8.3 billion. effectively quarantining the healthy. It is the gravely
Analysis of production techniques for the leading sick and infectious who need quarantine protocols.
mRNA suggests these vaccines could be made for Yet, this fact has been given a wide berth. Another
as little as $1.20 a dose. COVAX has been paying, curious guideline has been ‘social distancing’ of 6
on average, nearly five times more. COVAX has feet to prevent infection. This is ‘not’ how viruses
infect which has been proven over decades of
research into spread of infectious diseases.
‘Asymptomatic’ spreader is another ludicrous word
that has no scientific basis. Independent experts,
including virologists and epidemiologists (not
working for any agency, institute or government),
have categorically rubbished all of the above,
including vaccinating the entire world population in
the midst of a pandemic.

Experts opine that mass vaccinations will
prove to have a devastating impact on the
population’s immunity and create ‘openings’ for
new variants and resistant strains of the virus.
This is being witnessed in Israel, the USA, the UK,
Australia, among others. Armed with this much
data and ‘scientific temper’, where does the world
stand today? Afraid, cowed-down and unable to
ask basic questions pertaining to the long-term
side-effects and numerous adverse reactions
reported on the Vaccine Adverse Event Reporting
System (VAERS) website, in the US. Israel, which
had invited adverse event reporting via the
government’s Facebook page, had reportedly
received over 25000 adverse reporting from
citizens. Clearly this is not a small number.

32 COVID-19 BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

JABS FOR CHILDREN according to The Bureau of Investigative Journalism
pharma major Pfizer/BioNTech was accused of
Since the global vaccination drive commenced, bullying Latin American countries to provide them
there were no vaccines approved for children. In with sovereign assets as a guarantee against the cost
May, the US Food and Drug Administration had of any future legal cases.
granted emergency use authorisation (EUA) for
the Pfizer-BioNTech COVID-19 vaccine to include Anna Marriott, Health Policy Manager, Oxfam,
adolescents 12 through 15 years of age. A formal United Kingdom said, “Pharmaceutical companies
request has been submitted by Pfizer-BioNTech to are holding the world to ransom at a time of
the FDA for the EUA of the COVID-19 vaccine for unprecedented global crisis. This is perhaps one
children aged between 5-11 years. The company of the most lethal cases of profiteering in history.
released data obtained from a Phase II/III clinical Precious budgets that could be used for building
trial in September, the data were obtained from more health facilities in poorer countries are instead
2,268 subjects in the age group of 5-11 years. being raided by CEOs and shareholders of these all-
powerful corporations.”
India, as well, has approved two vaccines for
children developed by Zydus Cadila and Bharat Winnie Byanyima, Executive Director, UNAIDS,
Biotech. ZyCoV, the indigenously developed DNA- Uganda, shared, “I see lives being saved in vaccinated
based COVID-19 vaccine is needle-free, EUA has countries, even as the Delta variant spreads, and I
been granted and the vaccine will be available for want the same for developing countries. It is criminal
those in the 12-18 years age group. The availability that the majority of humanity is still facing this cruel
of the vaccine will depend on the scientific disease unprotected because pharma monopolies and
rationale and the supply situation. Bharat Biotech super-profits are being put first.”
began clinical trials of the children’s vaccine in
June, efficacy data hasn’t been made public yet. Efficacy and affordability
The Drugs Controller General of India (DCGI)
has received positive feedback from the Subject Studies have shown a reduction in the efficacy of
Expert Committee (SEC) on the efficacy and safety vaccines with newer variants. As the world moves
of the vaccine. DCGI’s decision on the approval towards boosters doses, the efficacy of these vaccines
is awaited. Once approved the vaccine will be is becoming a concern. According to researchers from
administered to children between the age-group of the University of Oxford, UK, and the country’s Office
2-18 years. for National Statistics Pfizer/BioNTechCOVID-19
vaccine efficacy fell to 90 per cent, 85 per cent, and
India may be on the brink of a third wave 78 per cent after 30, 60, and 90 days, respectively,
but there is no evidence to prove that the third and AstraZeneca vaccine efficacy dropped to 61
wave will be as severe as the second wave. per cent by 90 days with the Delta variant. There
The healthcare sector in association with the are ongoing studies for booster doses but certain
government has been ramping up its infrastructure governments and vaccine manufactures have
to tackle the third wave head-on. The vaccination advocated for booster doses.
drive is playing a major role in India’s fight against
COVID-19. But whether booster doses are going to Earlier in the year the Government of India (GoI)
be approved in the future to maintain the efficacy had fixed the prices at Rs 200 per dose (without
of COVID-19 vaccines in India will depend on the taxes) for Covishield and Rs 295 per dose (without
authorities and how India fares in the pandemic taxes) for Covaxin which have been revised over
with the approved vaccines that are being the months and the current rates being Rs 780 for
administered in the country. Covishield, Rs 1,410 for Covaxin, and Rs 1,145 for
Sputnik V (approved by Drugs Controller General
also struggled to get enough doses and at the speed of India in April 2021) was approved in private
required, because of the inadequate supply and hospitals. Prime Minister Narendra Modi in his
the fact that rich nations have pushed their way to address on June 7, 2021, stated that free vaccines
the front of the queue by willingly paying excessive would be available to all those who wanted them
prices. from June 21, 2021, but there have been major
hurdles in obtaining free vaccines. Government
An analysis done by the People’s Vaccine vaccination centres across India have had
Alliance firms Pfizer/BioNTech and Moderna are to shut down their
charging governments as much as $41 billion above vaccination
the estimated cost of production. Earlier this year drive on
several occasions due to the shortage of vaccines.

Recently Tedros Adhanom Ghebreyesus, Director-

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com COVID-19 33

General, WHO in an address in Budapest expressed “Some countries are
disappointment on the approval of booster doses by
countries that have excess stock of the COVID-19 administering booster doses
vaccines, while many poorer countries are struggling
to administer their citizens with the first and second to people who are already fully
dose. He said, “Some countries are administering
booster doses to people who are already fully vaccinated, while many people in
vaccinated, while many people in the poorest
countries are yet to receive a single dose, including the poorest countries are yet to
health workers, older people, and other vulnerable
groups.” receive a single dose, including

Ghebreyesus further commented, “That’s why health workers, older people, and
I have called for a global moratorium on booster
vaccines until at least the end of September, to allow other vulnerable groups.”
those countries that are furthest behind to catch up.” - Tedros Adhanom Ghebreyesus,

Dr Soumya Swaminathan, Chief Scientist, Director-General, World Health Organisation (WHO)
World Health Organisation has also echoed similar
sentiments. She is opposed to the idea of booster eligible. He commented “The third dose of vaccine
doses as several countries are suffering from acute is not right, at least till significant part of the other
shortages of COVID-19 vaccines. countries get two doses and then, of course, we
look into third dose or an annual booster shot or
In August 2021, Dr Cyrus Poonawalla, Chairman, something like that,” at a media interaction along
Serum Institute of India (SII), Pune along with with Kiran Majumdar Shaw, Chairperson, Biocon
7000-8000 employees of SII were administered after the announcement of the strategic partnership
the third dose of Covishield. Dr Poonawalla had forged between Biocon Biologics Ltd (BBL) and
also expressed concerns about the reduced efficacy the Serum Institute Life Sciences (SILS). He also
of vaccines after six months post the second dose. clarified his father’s statement about a booster
A month after Dr Cyrus Poonawalla’s statement, dose by mentioning that it may be required by the
Adar Poonawalla, CEO, Serum Institute of India, population that has weakened immunity.
Pune has expressed that a third booster dose would
be ‘unethical’ as various countries have not been Poonawalla commented, “Maybe some very
able to administer two doses to those who are vulnerable sections, immuno-compromised people
could do with some booster shots. There is no
evidence to show Covishield requires a third dose.”

Addressing the issue of booster doses in the
future, Priya Abraham, Director, National Institute
of Virology, Pune mentioned, “Studies on booster
dose have been going on overseas and at least seven
different vaccines have been tried out for booster
dose. Now, the WHO has put a stop to it till more
countries catch up with vaccination. This is because
there is an alarming vaccine gap between high-
income and low-income countries. But, in future,
recommendations for boosters will definitely come.”

How wise is the 3rd dose?

The GoI hasn’t approved a booster dose yet but SII’s
initiative to provide booster doses to its employees
and several countries approving a booster dose there
is a possibility of a booster dose being approved in the
future. This also highlights the issue of affordability
of the vaccines that have been approved. Lockdowns
imposed to curb the spread of COVID-19 have
impacted economies globally and driven millions
into poverty. Third-world countries have been
facing issues with the availability and affordability
of COVID-19 vaccines. Booster doses can become
a burden for nations when some are struggling to
obtain vaccines for first and second doses.

Prabhat Prakash
[email protected]

34 SPEAKING WITH BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

“We are gearing up to
produce molded parts for
biopharma and medical industries”

« injections, eye drops etc. Our products play a vital
functional role in transfer of these drugs from
Ritesh Patterson, production to finish and final fill vials and ampoules
General Manager, ensuring sterility and high yields of their end products.
Performance Plastics,
Saint-Gobain India, The Indian pharmaceutical industry is expanding
Bengaluru its product range towards development of oncology
and hormonal products requiring products providing
Saint-Gobain India, a part of the French inertness towards harsher chemicals. Saint-Gobain
multinational firm, is a leader in providing glass Life Sciences India has a local manufacturing setup for
and glass solutions. But, it is also active in other Platinum cured Silicon and Thermoplastic polymer
high-performing sectors that include Performance tubing at Bangalore delivering a comprehensive
Plastics (PPL) in Life Sciences. From being leading range of products for these diverse requirements
producers of Performance Plastics to association with of inertness. Our local manufacturing presence
pharmaceutical companies for providing medical ensures customised tubing, shorter lead times for
equipment, to even foraying into the Electric Vehicles product development and commercial supplies for
segment in India by introducing EV Battery Packs, our customers. In addition, biopharma and pharma
the PPL- Life Sciences have been aiming for strong customers need validation data to assess the fitness
growth. During an interaction with BioSpectrum, of a given product for their manufacturing processes
Ritesh Patterson, General Manager, Performance and risk assessments for submission to regulatory
Plastics, Saint-Gobain India, Bengaluru shares agencies. Our material formulation competencies and
his insights about the company’s strategies in the validation studies provide them support to meet these
biopharma and medical industries. Edited excerpts; stringent regulatory standards of agencies like USFDA,
European Medicines Evaluation Agency (EMEA)
What are the major contributions at Saint- or European Medicines Agency (EMA) and Drugs
Gobain India towards the growth of the life Controller General of India (DCGI).
sciences industry?
The Medical Component division under Life
Life sciences industry in India has built strong Sciences has a specialised portfolio of precision
capabilities across parts of the value chain to emerge injection molded parts, small diameter precision
as a big export hub for production of generic drugs tubing and other sub-components of medical devices
and vaccines. In manufacturing, India continues to which are used in various surgery and diagnostic
have the largest number of United States Food and equipment.
Drug Administration (USFDA) approved plants
outside the USA along with a large number of contract What are your latest innovations in this space?
development and manufacturing organisations
(CDMOs). Research and Innovation are at the heart of Saint-
Gobain’s strategy. The Group’s research focuses both
Saint-Gobain Life Sciences division has a product on breakthrough innovations and on continuously
portfolio of tubing, single use bags, assemblies, improving its products, processes and services in
filters and connectors used by pharmaceutical and a spirit of openness and attentiveness to customer
biopharmaceutical customers for manufacturing life- needs.
saving drugs like vaccines, monoclonal antibodies,
Single-use systems (SUSs) are becoming
increasingly common in bioprocessing operations
because of their low capital requirements and
validation costs. As this trend continues to develop,
pharmaceutical manufacturers are asking SUS
manufacturers to provide assurance that their
products comply with current good manufacturing

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com SPEAKING WITH 35

practices (CGMPs) and do not alter drug products by How was the company’s performance in the
exceeding established operating ranges. last fiscal and what are your projections for FY
2021-22?
Our competency in material formulations and
developing conceptual design for single use manifold We have had a strong growth in the last fiscal year
and assemblies helps our customers to eliminate driven by a surge in demand from both domestic and
manual connection leading to faster batch turnaround export customers. Considering the current demand
times, yield improvements and minimise risk of scenario in the Life Sciences market on both domestic
contamination. In addition, our enhanced level of and export front we would expect a strong result for
tubing validation certification offers a higher level FY 2021-22. We are currently at 100 per cent capacity
of quality assurance in single-use fluid handling utilisation and are in the process of significant capacity
components. Saint-Gobain validates the fluid path of and capabilities enhancement both globally and in
the tubing and single use manifold to meet the USP & India which should help us gain market share and
ISO standard industry requirements. service these strong growth of life sciences customers.

Strategically designed cell culture, processing and What are your investment plans for the Indian
preservation systems will pave the way for the next life sciences market?
generation of potent cell-based cancer therapies and
vaccines. Our Life Sciences business unit produces a Saint-Gobain Life Sciences manufacturing setup in
variety of disposable products for these promising new India currently has two dedicated class 7 cleanrooms
therapies, including cell culture and processing bags to manufacture silicone tubing, thermoplastic
to emerge as a preferred partner for these evolving elastomers tubing and silicone molded parts. We
requirements of the Life Sciences sector. have investment plans to expand our capacity for
both silicone and thermoplastic elastomers tubing
Did the pandemic bring in a change in business by putting additional extrusion lines for servicing
domestic and export requirements.
perspective towards the life sciences sector?
We have an ongoing investment in our Bangalore
COVID-19 has been a disruptor for all business sectors plant to produce single use bags and assemblies
and that applies to the life sciences sector too. The for our biopharma and pharma customers from
expected lead times for development of vaccines and the second half of 2022. In addition, we would be
drugs have been drastically reduced through excellent investing in state-of-the-art silicone molding presses
collaboration between different stakeholders. The to enhance our capabilities to produce molded parts
agility required to crash these developmental lead for biopharma and medical industries.
times has forced manufacturers and suppliers to
collaborate closely for an efficient supply chain for Are you planning any new launches for 2022?
drug manufacturing.
Saint-Gobain Life Sciences has augmented its product
The significant take away from this crisis is that portfolio through recent acquisitions of Netherland
local manufacturing of consumables for pharma, based company, Equflow B.V and a French company,
biopharma and medical industries has gained MS Technique & Transluminal.
impetus. Saint-Gobain Life Sciences with its strong
local manufacturing footprint in India combined Equflow is producer of Flowmeters, a product used
with application expertise and material formulation in precise measuring flow of liquid that meet the strict
competencies was able to support these emerging requirements and comply with USP Class VI high
requirements of shorter lead time requirements of quality standards. These products complement our
product development and commercial supplies. Our bioprocess solution portfolio and there are potential
local presence enabled strong collaboration with all applications across our Fluid Transfer and Medical
COVID-19 vaccine manufacturers in India during businesses. MS Technique & Transluminal have
the pandemic and helped us establish our products competency in high-precision thermoplastic extrusion
for their production lines, ensuring timely supplies and design expertise for minimally invasive catheter
to meet their tight production schedules. Another solutions with a strong focus into the cardiovascular
emerging requirement in all business sectors including market and it provides us a unique opportunity to
Life Sciences is usage of digital platforms to create cater to the emerging needs of domestic catheter
awareness of products and services, technical and manufacturers and assemblers.
commercial engagements through knowledge sharing
has gained traction. Saint-Gobain Life Sciences too Both these product lines would be formally
is undertaking initiatives for deployment of multiple available in the Life Sciences product portfolio to
digital touchpoints to facilitate a seamless customer service customer requirements in FY2022.
experience in their various interactions with us.
Sanjiv Das
[email protected]

36 SPEAKING WITH BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

OEM by QIAGEN advancing with
Asian molecular diagnostic companies

« and launched our WeChat official account in the
Chinese language to bring our OEM offerings
Dr Kay Koerner, closer to prospects. For the past two years, new
customers engaged our team for OEM collaboration
Vice President - opportunities from markets we seldom or never
collaborated with. In the years to come, I believe
Head of OEM by securing our supply chain with a network of
strategic partners and closing the gap in our virtual
QIAGEN, Germany engagement with emerging markets is something
we will recognise more in the OEM industry.
In light of the volatility of the last two years and Fortunately, those are precisely the business
the stress that many molecular diagnostics and strategies of OEM by QIAGEN.
assay manufacturers faced with their supply
chain management, BioSpectrum interacted with What are the major plans/launches/
Dr Kay Koerner, Vice President - Head of OEM by investments in store for 2022?
QIAGEN, Germany to understand how he views
the life sciences market in Asia. Edited excerpts; COVID-19 will still have an impact on the molecular
diagnostics and life sciences market in 2022.
How has the pandemic affected the OEM But companies also start to plan for the time
business? after COVID-19. We are planning and launching
innovations for our OEM partners, for example, the
COVID-19 was an unprecedented challenge for the new StableScript reverse transcriptase with improved
life science industry. The demand for all kinds of thermostability and inhibitor tolerance. Also, we
assay components and raw materials multiplied are one of the very few companies globally that
everywhere in the world at the same time. Even can offer a complete package for digital PCR as an
airfreight capacities or dry ice became scarce OEM solution, including the instrument, software,
resources at a certain point. Evidently, the situation plasticware and reagents. To ensure our message
was an intense stress test for many supply chains resonates with the OEM partners of key markets
in our industry. As a result, the most significant in Asia, we will soon launch our OEM websites in
change in our business was the increased speed with Chinese, Japanese, and Korean. This shows our
which supply networks evolved into true strategic commitment to localising our technological know-
partnerships. We supply many bulk enzymes (for how, making them relevant to our customers’ needs
example, polymerases, reverse transcriptases), and priorities. The pandemic has shown the need for
oligonucleotides, buffers to a multitude of diagnostic molecular testing in all parts of the world, so we also
assays for our OEM partners. During the pandemic, plan to expand our geographic footprint further to
we intensified communication and collaboration regions where we still see the potential for new OEM
with these partners to know their demands on time partners.
(or ahead of time when possible) and ensure we
give the same transparency to our raw materials Are you exploring new markets/regions as a
suppliers. This close cooperation definitely helped part of the APAC growth plan?
to navigate the volatility of 2020 and 2021. We also
increased the number of touch bases with local Yes. While QIAGEN already has a direct
manufacturers globally through enhanced business representation in many Asian countries, we still
presence online. Compared to 2019, our business need to improve our OEM services in some Asian
has grown in terms of online visibility on various regions. OEM is somewhat complex, so a profound
virtual platforms for 2020 and 2021, in the absence understanding of the local health markets, language,
of international trade shows. culture and regulatory requirements are essential
to serve our local OEM partners with what they
We have rebranded our LinkedIn channel need. After the OEM by QIAGEN grew in China
over the last years, we want to continue that growth
momentum and intensify our activities in Japan,
South Korea, India, Australia and South-East

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com SPEAKING WITH 37

Asia. We can contribute to regional value creation ● OEM by QIAGEN (a manufacturing solution
wherever we see a solid local life science and for your PCR assay) understands that Asia
molecular diagnostic industry.
will soon be a powerhouse of molecular
What new/unique trends do you foresee within
diagnostic (MDx) kit production, with
the life sciences space in the coming years?
emerging markets such as China, Japan,
The last decades have brought insights into molecular
biology that were unimaginable before. NGS, qPCR, South Korea and India changing the game
dPCR and many other techniques have allowed us
to analyse the building bricks of life in unbelievable for more efficient and cost-saving solutions.
detail. However, many of these insights have created ● OEM by QIAGEN is keen to expand the
many new questions – that’s how it is in science.
Genetics, as we know it, is no longer to decipher capabilities of Asian kit manufacturers by
our genomic DNA but also to understand the
extended universe of RNA, proteomics, lipidomics, offering high-quality reagents, enzymes and
transcriptomics and metabolomics. So, I believe the
journey will continue, looking at even more minor kit ingredients in bulk to complement their
details in single-cell analyses, RNA analysis, or
spatial multi-omics. I am also convinced that the locally manufactured kits that, if otherwise,
field of microbiome (microorganisms in a particular
environment) and epigenetics (how our environment would take more prolonged research and
affects our gene expression) research will continue to
generate many health-relevant insights in the future. development investment to produce.
OEM by QIAGEN offers access to the thousands ● OEM by QIAGEN is an outlet for QIAGEN’s
of patented molecular insight solutions trusted by
top life science researchers and cited by the latest molecular biology technology for customers
publications globally. Partnering with OEM by
QIAGEN ensures our partner’s business stays up to who want to rebrand, customise or custom-
date with the newest trend within the life sciences
space. develop products. Such custom-developed

How is the molecular diagnostics market products may include commercial enzymes

evolving in APAC post-pandemic? in bulk, high-purity oligonucleotides, master

Firstly, the COVID-19 pandemic has shown that mixes, nucleic acid purification kits, spin
molecular diagnostics is probably the fastest tool to
develop against new, emerging infectious agents, columns, PCR instruments and many more.
much quicker than vaccines or effective treatment. ● All eyes are on Asia and sequencing
Thus, I assume that most countries will continue to
increase and improve their molecular diagnostics possibilities. Sequencing technology will
capabilities, for example, reverse-transcription
polymerase chain reaction (RT-PCR) to respond continue to revolutionise how infectious
quickly to any new viruses in the future.
diseases (SARS-CoV-2 and TB), cancers,
Secondly, we have learned that we need a
complete molecular diagnostic infrastructure, not and epigenetics are being investigated in
just qPCR or NGS, but both. Both centralised high-
throughput labs and decentralised point-of-care Asia regionally and globally. QIAGEN has
testing (POCT) play an essential role in improving
healthcare accessibility. NGS could potentially been in the OEM market for many years,
accelerate turnaround for large-scale diagnostics,
suitable for extensive community testing and serving some substantial Next Generation
epidemiology studies. Authorities in the United
States and China gave clearance for selected NGS- Sequencing (NGS) companies in North
based COVID-19 diagnostics for emergency use.
Recently, the US Department of Defence has awarded America, Europe and East Asia. We are
a US$600,000 contract to QIAGEN to expand the
keen to support emerging Asian companies

venturing in MDx kit commercialisation.

manufacturing capacity of enzymes and reagent kits
used in COVID-19 molecular diagnostic tests. This
shows the growing recognition by the authorities
regarding the effectiveness and efficiency of a
complete molecular diagnostic solution. Meanwhile,
healthcare in developing markets such as India,
Southeast Asia and Central Asia would greatly benefit
from having more accessible POCT solutions in
limited-resource settings.

Thirdly, high-throughput labs and broader
adoption of POCT pose a high need for efficient
data integration and big data analytics. Apart from
hardware infrastructure, future diagnostic-test
manufacturers need to develop software that is easy-
to-use and powerful enough to turn big data into
meaningful healthcare insights.

Dr Manbeena Chawla
[email protected]

38 GENE EDITING BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

Limitless potential
of gene editing

« nucleases (TALENs) several years later. Although
much simpler in terms of design for targeting
Eric Rhodes, different sequences, the construction of each
Chief Executive Officer, tool itself was cumbersome and the end-product
ERS Genomics, extremely large and difficult to manipulate in cells.
Ireland
Enter CRISPR
Published in 2003, the first complete human
genome sequence triggered a scientific revolution In 2012 the world was introduced to a third-
in our understanding of how differences in gene generation gene editing tool courtesy of Dr
sequences led to different functional effects within Emmanuelle Charpentier and Dr Jennifer Doudna.
biological systems. We now had the basic sequence They were awarded a Nobel prize in 2020 for their
information for thousands of genes, but this was work on the discovery of the CRISPR/Cas9 gene
like having a complete dictionary of words with editing system.
associated definitions missing – the understanding
of how genes interacted with each other and the Scientists worldwide now have a platform accessible
impact of small differences at the DNA sequence to all, which can be applied across virtually all species,
level was lacking. from bacteria to plants, to the most complex species,
including humans. CRISPR/Cas9 regularly makes the
To make the most of the wealth of new DNA headlines globally. In the last few months, highlights
information, tools for manipulating sequences have included human treatments for Alzheimer’s,
in the context of living systems were needed. Sickle Cell Anemia and HIV. There have been
It wasn’t enough to simply know that differences innumerable stories of drug discovery, improvements
at the DNA level existed; knowledge was needed to in agricultural science and environmental impact
understand how sequence differences affect gene innovation. Precision gene editing has a long reach and
function. will impact many facets of life.

Advent of DNA manipulation CRISPR/Cas9 in India

Interestingly enough, it was also in 2003 that the In India, at a government level, advances in
first tool to manipulate DNA in vivo was introduced. biotechnology have been a focus for quite some
Based on a class of proteins called zinc-finger time. As far back as 1982 biotechnology was on the
proteins, this first generation tool allowed scientists radar of then Prime Minister, the late Rajiv Gandhi.
to introduce a cut in the DNA of a living organism at Following extensive deliberations, in 1986 the
a pre-designated site and then manipulate certain Indian government created a separate Department
changes at that location. Zinc-finger nucleases were for Biotechnology, within the Ministry of Science
revolutionary in what they could accomplish but and Technology. In keeping with this trend, Indian
came with the downside that each unique targeting companies have wasted no time when it comes
event required fairly significant design effort, which to embracing new technology, and CRISPR is no
was neither easy nor inexpensive. exception.

Further development in this space came along Most notably, India is leading the way when it
in the form of Transcription activator-like effector comes to COVID-19 testing. The ground-breaking
‘Feluda’ test was developed by Tata Medical and
Diagnostics Ltd. (TataMD), the healthcare venture
of the Tata Group in conjunction with the Council of
Scientific and Industrial Research’s constituent lab,
the Institute of Genomics and Integrative Biology
(CSIR-IGIB) based in New Delhi. This was the world’s
original paper-based rapid test for COVID-19 detection
and enabled fast, affordable mass testing. The Feluda

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com GENE EDITING 39

test has since been adapted to detect mutated variants By virtue of its ease of use and low cost,
quickly, owing to the test delivering results in 45 CRISPR has already opened up the use
minutes and requiring only a basic PCR machine – of genome editing to disciplines that
more complex machines such as those running RT- had previously not even considered it
PCR take longer to run and return results. a possibility. Outside of human disease
applications, gene editing is being used
A second truly inspiring use of CRISPR comes to create greener chemistries and enable
from the different, but no less globally important, the use of microbes to create industrial
area of agricultural research. The Indian Council of products that pre-CRISPR required precious
Agricultural Research (ICAR) and the Department of natural resources.
Biotechnology (DBT) are working together to realise
the potential of CRISPR gene-editing technology. mammalian platforms, there is a need to enhance their
focus on gene editing technology. Even companies
Scientists in India are also enabling a change that that are ahead of the game in domestic markets are
will make the world a better place – researchers in still grappling with issues related to manufacturing
India and the US discovered 29 genes in malaria- performance and production yield, and are exploring
causing mosquitoes that make the mosquito resistant both organic and inorganic ways to improve.
to insecticides. Around 2 per cent of global malaria
fatalities are in India, and up to 1.3 billion Indian Considering the criticality of time to markets
people are considered ‘at high risk’ of being infected in the biosimilars sector, it is important to support
with malaria. Discovering a way to potentially timely access to the technologies that will enable
neutralise and limit the threat of malaria would have companies to forge a competitive market entry or
an incredible impact on worldwide healthcare. maintain a leading position. Companies in this field
that are not using CRISPR/Cas9 need to embrace this
Researchers from the Institute of Bioinformatics new technology or risk getting left behind.
and Applied Biotechnology (IBAB) in Bengaluru, the
University of California, and the Tata Institute for What’s next for CRISPR Globally?
Genetics and Society (TIGS) collaborated to produce
a new reference genome for a sample of the malaria- By virtue of its ease of use and low cost, CRISPR
carrying mosquito from India. With knowledge of has already opened up the use of genome editing to
the entire genome, researchers are applying CRISPR disciplines that had previously not even considered it
to edit the ‘insecticide resistant’ genes in mosquitoes a possibility. Outside of human disease applications,
with the goal of understanding how they might one gene editing is being used to create greener
day eliminate these forms of resistance. chemistries and enable the use of microbes to create
industrial products that pre-CRISPR required
There are many projects right now with precious natural resources. To further support a
the potential to vastly change day to day life in sustainable future, gene editing will be used to
India. From health to environment to agriculture modify crops to better withstand the changing world
to bioenergy, the use of gene editing is part of climate conditions and increase food production.
the planning to tackle previously seemingly Gene editing is likely to become a major player in the
insurmountable challenges. treatment of genetic diseases. Perhaps much in the
same way that software has evolved to manipulate
What’s next for India: Biosimilars? a computer and robotic hardware, so too will gene
editing serve as a ‘coding tool’ for exploring and
Experts believe that biosimilars are essential to the exploiting the biological hardware of living systems.
future of affordable healthcare. This is especially The potential is limitless.
true for a country like India, where they lead to
greater competition and innovation in the market.
Biosimilars cause prices to drop and allow greater
access to medication for patients. India has firmly
established itself as a global leader in producing
similar biologics and, due to its population of 1.39
billion, India is also a huge market for these products.

Although the potential is high and the expectation
is huge for India, the challenges are enormous in
order to maintain global leadership in this field. To
get this right, Indian biopharmaceutical companies
need to embrace CRISPR. Although many Indian
companies have cracked the complex production
know-how of biosimilars in both microbial and

40 WHO NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

WHO recommends WHO reports global
groundbreaking malaria
vaccine for children shortfall in mental

The World Health Organisation (WHO) is recommending health investment
widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine-
trade name Mosquirix, developed by British drugmaker The World Health Organization’s new
GlaxoSmithKline (GSK), among children in sub-Saharan Mental Health Atlas paints a disappointing
Africa and in other regions with moderate to high P. picture of a worldwide failure to provide
falciparum malaria transmission. The recommendation people with the mental health services
is based on results from an ongoing pilot programme in they need, at a time when the COVID-19
Ghana, Kenya and Malawi that pandemic is highlighting a growing need for
has reached more than 800,000 mental health support. The latest edition
children since 2019. GSK is of the Atlas, which includes data from 171
working with partners to develop countries, provides a clear indication that
solutions to ensure equitable and the increased attention given to mental
long-term access to the RTS,S health in recent years has yet to result in
vaccine for the people who need a scale-up of quality mental services that
it. GSK has committed to donate are aligned with needs. Issued every three
up to 10 million RTS,S doses for years, the Atlas is a compilation of data
use in the pilots, and to supply provided by countries around the world
up to 15 million doses annually, on mental health policies, legislation,
following a recommendation financing, human resources, availability
and funding for wider use. A Product Transfer, including and utilisation of services and data
technology transfer for long-term antigen production, is collection systems. It is also the mechanism
also underway with Bharat Biotech. GSK will now work for monitoring progress towards meeting
closely with partners, funders and governments to support the targets in WHO’s Comprehensive
the additional supply of the vaccine, and has committed to Mental Health Action Plan.
making the 15 million annual doses available at no more
than 5 per cent above cost of production.

WHO prioritises diabetes, cancer
treatments in Essential Medicines Lists

The World Health Organisation affordable for all. However, high transporter-2 (SGLT2) inhibitors
(WHO) has published the new prices for both new, patented empagliflozin, canagliflozin and
edition of its Model Lists of medicines and older medicines, dapagliflozin as second-line
Essential Medicines and Essential like insulin, continue to keep therapy in adults with type 2
Medicines for Children, which some essential medicines out of diabetes. Four new medicines
include new treatments for reach for many patients. The list for cancer treatment were added
various cancers, insulin analogues includes Sodium-Glucose Co- to the model lists. They are
and new oral medicines for Enzalutamide, as an alternative to
diabetes, new medicines to assist abiraterone, for prostate cancer;
people who want to stop smoking, Everolimus, for subependymal
and new antimicrobials to treat giant cell astrocytoma (SEGA), a
serious bacterial and fungal type of brain tumour in children;
infections. The listings aim to Ibrutinib, a targeted medicine for
address global health priorities, chronic lymphocytic leukaemia;
identifying the medicines that and Rasburicase, for tumour lysis
provide the greatest benefits, and syndrome, a serious complication
which should be available and of some cancer treatments.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com ACADEMICS NEWS 41

IIT-R sets up Mehta Family IIT-K, REC
School of Data Science and AI Foundation to
support School
Indian Institute of programmes. The school will of Medical
Technology, Roorkee (IIT-R) welcome its first cohort of Research and
is collaborating with the Bachelor’s degree students in Technology
Mehta Family Foundation September 2022. The objective
(MFF), USA, to establish of the school is to develop In its efforts to get underway
the Mehta Family School of new and skilled manpower in the upcoming School of
Data Science and Artificial the areas of data science and Medical Research and
Intelligence. A Memorandum artificial intelligence along with Technology (SMRT),
of Understanding (MoU) an aim to empower existing the Indian Institute of
between the two organisations manpower by offering focussed Technology Kanpur (IIT-K)
was recently signed. Under training and certifications in the has signed a Memorandum
this collaboration, the new fields. The school will be housed of Agreement (MoA) with the
school will offer Bachelor’s, in a new dedicated building REC Foundation, the CSR
Master’s, and Doctoral Degree at the IIT Roorkee campus arm of REC (formerly Rural
developed with the support Electrification Corporation
provided by MFF. In addition Limited). REC Foundation
to the infrastructure, renowned has committed financial
global experts in the field of assistance of Rs 14.4 crore
AI will actively participate under its CSR programme
in designing the curriculum, to IIT Kanpur for the
faculty recruitment, monitoring construction of student
and suggesting new research housing facilities at the
ideas to the Indian students of upcoming SMRT. SMRT will
this school. be India’s first medical school
that aims to narrow the gap
CareerLabs partners between medical sciences
with Dr. Reddy’s for and technology disciplines.
chemical engineering As a part of the SMRT, the
certification programme institute will set up a 500-bed
super speciality hospital and
CareerLabs, a Bengaluru-based EdTech startup, has announced a new centres of excellence (CoEs)
industry certification programme for chemical engineers in partnership for pursuing R&D activities
with Hyderabad-based Dr. Reddy’s Laboratories. The partnership aims in futuristic medicine. The
at opening up avenues for students school is likely to offer
to pursue highly rewarding careers postgraduate and doctoral
in the pharmaceutical industry and programmes in various super
concurrently meeting the ever-increasing specialities.
demand for chemical engineers to cater
to the need of the hour with relevant
skill development. The new chemical
engineering certification programme
will be launched with select students
across India, who will be chosen through
a scholarship test administered at various colleges across the country.
Towards the end of the pilot programme, successful students will be
given the opportunity to pursue an internship and also be considered for
possible pre-placement offers at Dr. Reddy’s in Hyderabad.

42 APECOAPDLEEMNIECWSSNEWS BIOBSIPOESCPTERCUTMRUM| |NOVAEUMGBUESRT 2021 | www.biospectrumindia.com

Samina Hamied Samir Mehta takes
steps in as new charge as IPA President
Vice President
at IPA The Indian Pharmaceutical acquisitions. His emphasis on
Alliance (IPA) has appointed professional organisational
Samina Hamied, Executive Samir Mehta, Chairman of design, precise execution and
Vice Chairman, Cipla has taken Torrent Group as President operational efficiencies has
charge as the new Vice President of the IPA for 2021-2023. built a strong and globally
of the Indian Pharmaceutical Under his leadership, competitive generic business
Alliance (IPA). In 2013, she was Torrent Pharma took several platform in Torrent Pharma.
designated as ‘Head Strategic strategic initiatives,
Projects – Cipla New Ventures’. including forays A fine blend of business
She was appointed as an Executive into new therapies acumen and cautious
Director of the Company in and geographies, entrepreneurial
2015 and subsequently, she was large investments in optimism, Mehta has
elevated as the Executive Vice- product development positively influenced
Chairperson in 2016. She has infrastructure and aspects of the Group
been instrumental in driving the capabilities, building culture with his
company’s current transformation state-of-the-art contemporary
agenda. Samina has played a key manufacturing outlook and
role in successfully incubating facilities and innovative
and shaping Cipla Health, and ideas.
spearheading Cipla’s ambitious
foray into the US market with John M. Ballbach joins Board
strategic acquisitions. She has of Directors at Waters Corp
built a top-class leadership
pipeline for the company as it Waters Corporation has announced the appointment of John
continues to spread its wings M. Ballbach to its Board of Directors, effective October 5, 2021.
globally. As Executive Vice- Ballbach currently serves
Chairperson, she focuses on Board on the Board of RPM
and governance issues, in addition International, Inc., a leader
to furthering Cipla’s strategic in specialty coatings,
priorities through key global sealants, building materials
partnerships, corporate culture, and related services.
hiring right talent, and public Waters also announced the
advocacy. retirement of Dr Michael J.
Berendt from its Board of
Directors. Ballbach is also
the former chairman and
chief executive officer of
VWR International, LLC, a
global leader in laboratory
supply and distribution.
With leadership experience
in the chemicals and
coatings industries, Ballbach
was an independent director
for Valspar from 2012–2017,
when the company merged
with Sherwin-Williams. In
addition, Ballbach is a former corporate officer of Valspar, having
served as president and the chief operating officer from 2002–
2004 and in various senior management positions since 1990.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com PEOPLE NEWS 43

Aurobindo Pharma Dr Amit Singh honoured
with 2021 Shanti Swarup
MD N Govindarajan Bhatnagar prize

resigns Dr Amit Singh, Associate Professor at the Indian
Institute of Science (IISc), Bengaluru has received
N Govindarajan has stepped down as the the Shanti Swarup Bhatnagar prize in the field
Managing Director (MD) of Hyderabad-based of Biological Sciences for 2021. He is one of the
Aurobindo Pharma. His resignation has been 11 recipients of the prestigious award this year.
considered and accepted by the board of Dr Singh has made outstanding contributions
directors of the company. Govindarajan will to the fundamental understanding of host-
be relieved from the services of the company pathogen interaction
effective from December 31, 2021. He has in Mycobacterium
tuberculosis (Mtb)
more than and HIV, the
20 years of causative viral agent
experience of human acquired
across a immunodeficiency
variety of syndrome (AIDS).
domains such His work led to an
as Bulk Drugs, understanding of the
Contract intricate connection
research and between genetic
manufacturing mutations conferring
services drug resistance
(CRAMS), and their long-
Finished range physiological impact. The Shanti Swarup
Dosages and Biotechnology. He joined Bhatnagar Prize for Science and Technology is
Aurobindo Pharma as Chief Executive a science award in India given annually by the
Officer in late 2010, and has been looking Council of Scientific and Industrial Research
after the Active Pharmaceutical Ingredients (CSIR) for notable and outstanding research,
(APIs) Operations and CRAMS business applied or fundamental, in biology, chemistry,
of the company. The board has now taken environmental science, engineering, mathematics,
note of the appointment of S Damodharan medicine, and physics.
as Chief Operating Officer for the active
pharmaceutical ingredient (API) vertical,
following Govindarajan’s exit.

Biocon picks Naveen Narayanan as CHRO

Biocon Biologics, a subsidiary of Biocon, Narayanan was working at the ITC Hotels
has hired Naveen Narayanan as the as a training development executive,
Chief Human Resources Officer (CHRO). nurturing talent at the company. He also
Narayanan comes with more than two worked with Oberoi Hotels & Resorts for
decades of experience in HR and has two years as a training manager. After
worked across sectors in various HR roles, spending the initial phase of his career in
in leadership positions. Prior to this, the hospitality industry, Narayanan moved
Narayanan was leading the human capital to Oman United, a retail solutions company
consulting and transformation function in Oman, and took charge as its CHRO. His
at entomo (formerly KPISOFT), which next stop was AI-Futtaim where he joined
is an AI-based continuous-performance as CHRO after spending close to
platform for enterprises. At entomo, three years with Oman United.
Narayanan was delivering HR consulting He has also spent three years
and transformation to large conglomerates with HCL, as the global head
in Asia. In the early days of his career, of talent management.

44 R&D NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

IIT-D develops catalytic tech for
sustainable production of chiral APIs

India is heavily and Engineering Research Board catalytic technology
dependent on importing (SERB), a statutory body of using inexpensive
Active Pharmaceutical the Department of Science and natural feedstocks and
Ingredients (APIs), and Technology (DST), Government abundant metals for
a significant proportion of India, has funded this research the sustainable and
of those APIs are chiral work. The research team has economical synthesis
molecules, which are developed a Metal-Organic of enantiomerically
essential building Frameworks (MOFs) based pure chiral molecules.
blocks to produce The developed catalytic
pharmaceuticals, technology may play a
agrochemicals and crucial role in decreasing
biologically active compounds. the country’s dependence
A research group at the Indian on the import of the Active
Institute of Technology, Delhi Pharmaceutical Ingredients,
(IIT-D) has developed a catalytic which also means lowering of the
technology for the sustainable input cost for the industry that
and economical synthesis of would encourage it to pass on the
chiral molecules. The Science benefit to the society.

IIT-G makes water ASU paves way for
cancer treatment with
repellent material for Hippo pathway genes

wearable motion sensors A team of researchers from Gurugram-based
Apeejay Stya University (ASU) has found
Indian Institute of Technology, Guwahati (IIT-G) out new dimensions about the crucial role of
researchers have developed a novel water repellent key Hippo pathway genes in the progression
material that can be used for real-time monitoring of of cancer. During the study, the team of
human movements. The material developed is flexible, researchers observed that when targeted
non-stretchable and environmentally friendly that therapy drugs were administered to patients
after analysing multiple genes involved in
can detect low strains the Hippo signalling pathway, the patients
with high sensitivity. responded efficiently to the treatment and
The team has developed there were no relapses. The finding can pave
such a material that the way for a breakthrough in the treatment
is superior to existing of cancer. Targeted therapy or precision
strain sensors for both medicine is a cancer treatment that uses drugs
sensitivity and durability. to target specific genes and proteins that are
The researchers have involved in the growth of cancer cells. Thus,
developed a metal-free, a better understanding of the Hippo pathway
chemically reactive, and is essential to untangle tumour biology and
conductive ink, which to develop novel anticancer therapies. The
they deposited on a Hippo pathway was first discovered and linked
chemically reactive paper to human cancers in the year 2002. Hippo
in a specific pattern. signalling is a complex tumour suppressor,
The patterned interface and its deregulation is a key feature in
developed by the IIT-G team was found to be tolerant many cancers. The pathway regulates cell
to abrasion, highly water repellent, and sensitive proliferation and organ size.
to low strain levels. The unconventional interface
developed by the team holds promise for development
of devices in healthcare.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com 45

TICEL BIO PARK LIMITED

TICEL BIO PARK Ill - The cradle of life science enterprise is a joint venture of
Tamilnadu Industrial Development Corporation Ltd (TIDCO) and TIDEL Park which
spreads across a sprawling 10 acres and is strategically located right next to Anna
University. The ambitious project is spread across G+13 floors and offers cutting
edge facilities for Biotech, Pharma and IT / ITES Companies. High end lab spaces
stand out as unique value propositions of the facility.

TICEL BIO PARK – Phase III -The tallest building in Coimbatore
having a built-up space of 2.29 lakh sq. ft. It is fully functional and
allotting spaces at the price starting from Rs. 12.75/-* per sqft

*Terms and conditions applicable

TICEL BIO PARK LIMITED – III

Typical Floor (8 Modules) in Ticel Bio Park - iii (Area in Sq. Ft)

Area Lab 1A Lab1B Lab 2A Lab 2B Lab 3A Lab 3B Lab 4A Lab 4B Total
Carpet area 1056 1426 1505 1453 1056 1426 1505 1453 10880

Super built up area 1469 1984 2094 2021 1469 1984 2094 2021 15136

Key Features of TICEL – III Please reach us:
■ Labs with Compressed Air,
TICEL BIO PARK LIMITED
Vacuum, RO Water, STP/ETP etc No. 5, CSIR Road, Taramani, Chennai–600113
■ Uninterrupted Power Supply with 100% Backup
■ Fool Proof, Multi Tier Security EMAIL : [email protected],
■ Ample Parking Spaces [email protected]
■ Green Lung Spaces with Idyllic Landscaping Mobile : 91-44-2254 2060,
■ Strategic Location with Easy Connectivity 9445956404 / 9445956407
■ Food Courts, ATMs etc in the Campus Web : www.ticelbiopark.com
■ Fully Equipped Conference Hall

46 R&D NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

IIT-K targets IIT-H offers less invasive
key protein technique in ophthalmology
to fight
inflammatory A group of scientists at the Indian Institute of Technology, Hyderabad
diseases (IIT-H) has developed a hydrogel from discarded corneas from human
and bovine sources using a novel and simple method. Serendipitously,
For the first time, researchers they discovered the most striking feature of this tissue-specific hydrogel
have identified key molecules to prevent the cells from scar tissue formation, which is attributed to
within the immune system the microenvironment that cannot be offered by any synthetic or other
that may help fight the natural material. Capable of
inflammation that drives being injected owing to its
chronic diseases including two phases (liquid and gel)
cancers, sepsis and brain based on the incubation
disease. The University of temperature, the scientists
Queensland (UQ) in Australia explored its potential to serve
collaborated with the Indian as a material for minimally
Institute of Technology, invasive treatment to replace
Kanpur (IIT-K) on the complicated surgeries. Until
study. A key protein, known now, no strategy is available
as C5aR2, is a potential to prevent corneal scarring
therapeutic target for treating following an injury. The scientists demonstrated, for the first time, that
chronic disease, due to its this hydrogel can be applied immediately after injury which helps to
ability to moderate many regenerate the cornea without scarring. Furthermore, no treatment is
immune and inflammatory available other than partial donor corneal graft or corneal transplantation
processes. The researchers for scarring, which is already present in the visual acuity.
found key and specific
cell signals present when IISc puts face masks
the C5aR2 was activated, through rigorous testing
which may act to boost the
immune system’s response to Since the start of the COVID-19 pandemic, the use of homemade face
inflammation. They are now masks has been advised as a possible substitute for commercially
working to progress these available surgical or N95 masks. Researchers at the Indian Institute of
research findings into disease Science (IISc) in Bengaluru have carried out a detailed study on the fate
models and potentially enable of a large-sized surrogate cough droplet impinging at different velocities
scientists to design novel
drug molecules targeting (corresponding to mild to
C5aR2 to treat inflammatory severe coughs) on various
disorders. locally procured cloth
fabrics (stole, handkerchief,
cotton towel, and surgical
masks), specifically those
which are convenient for
people to use every day.
Based on their findings, the
researchers recommend
using a cotton towel (with
at least three layers) as
a face covering if the
person cannot use an N95 or a surgical mask. Masks with three or more
layers are ideally recommended since they can suppress aerosolisation
significantly. The team also analysed the effect of washing on mask
effectiveness, and results show a negligible influence of washing on mask
efficacy up to 70 wash cycles.

An Publication GRAB OPPORTUNITY
AND Read!

Renewing is now easier. Go for new safest and easiest
ways to renew your subscription of BioSpectrum

Checkout our Newly introduced plans and grab this one time opportunity To
Subscribe BioSpectrum with 20% Offer!

-- Digital -- -- Print -- -- Digital + Print --

Monthly Digital Monthly Print Monthly Digital &
Magazine Magazine Print Magazine

INR 750 – For 1 year INR 1500 – For 1 year INR 2175 – For 1 year
With 20% Discount – INR 600 With 20% Discount – INR 1260 With 20% Discount – INR 1800

(Including Delivery Charges) (Including Delivery Charges)

To avail Special offers of more than 1 year Subscription
Please write to [email protected] or call on +91 9834745564

Other Benefits Throughout The Membership To Subscribe

• Industry Daily news Visit our Website
• Thought Leadership Interactions www.biospectrumindia.com
• Industry Trends
• New Products & Technology Updates or Scan QR Code
• Life Science Webinar Series

To pay by Cheque or DD, please send it in favor of “MM Activ Sci-Tech Commuications Pvt. Ltd.” And send to our Pune Office.

MM Activ Sci-Tech Communications Pvt. Ltd.
"Ashirwad", 1st Floor 36/A/2, S. No.270, Pallod Farms Near Bank of Baroda, Baner Road, Pune 411 045

Tel: +91-20-2729 1769

48 SUPPLIERS NEWS BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

West Pharma launches NovaGuard SA Pro Safety System in India

West Pharmaceutical pre-activation during handling. equipment lines at customer
Services has launched Furthermore, the device design facilities. Earlier this
NovaGuard SA Pro Safety facilitates easy assembly of a glass year, West announced its
System, a single-use pre-filled syringe with minimal partnership with Haryana-
accessory for prefilled ISO change parts and changeover based Venus Remedies,
standard 0.5mL staked time needed to existing assembly whose brand Cloti-Xa
needle syringes, In India. utilises West’s NovaGuard
With the introduction of SA Pro 1mL safety system,
the 0.5mL version, West’s which is designed for use
award-winning NovaGuard with prefilled ISO standard
SA Pro safety system is now 1mL long staked-needle
available for ISO 0.5mL standard syringes. With its current launch
and 1mL long glass staked needle of the 0.5mL version for the
syringes. The NovaGuard SA Pro Indian market, West is aiming
safety system can be deployed to bring more value to local
using a single-handed technique customers and the healthcare
and is designed to prevent industry.

Thermo Fisher SCHOTT invests
70 M euros to
introduces On the expand pharma glass
facility in Gujarat
Go mobile app in India
SCHOTT is investing a total of 70 million euros in the
Thermo Fisher Scientific – On the Go mobile app expansion of its Indian tubing site in Jambusar, Gujarat,
is Thermo Fisher’s mobile commerce solution following several million investments in the last few
designed to enable science on the go for its users years. Against the backdrop of the growth trend in the
in India. Empowered by data science, the app Indian pharmaceutical business and the pandemic,
is designed to deliver an easy user experience. the supplier intends to commit to secure the supply of
The app offers personalised recommendations pharma glass. The additional tank is scheduled to go into
on content, products and promotions that operation at the beginning of 2023, with the second one
are tailored to the user’s area of interest. The following a year later. The expansion in Jambusar will
applications make it easy to find products and create new jobs for around 225 employees and is part of
get product recommendations from extensive a more than $1 billion strategic investment programme
catalogues by navigating through more than 100 of SCHOTT through 2025, leveraging the global pharma
workflows across biotech, pharma, healthcare, tubing and packaging business. With additional melting
food, forensics, industrial and applied sciences tanks and production lines, SCHOTT intends to ensure
industries. Based on Progressive Web Application that this Asian manufacturing hub can adequately
technology, the app is easily accessible even in supply high-quality pharma glass for the Indian pharma
poor network areas and is adaptable to diverse industry and neighbouring countries.
browsers. The intuitive app also enables support
via a 24x7 virtual assistant made possible by an
AI-driven chatbot.

BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com SUPPLIERS NEWS 49

Waters Corporation
introduces integrated
hi-res LC-MS system

US-based Waters Corporation has introduced the Waters

BioAccord System with ACQUITY Premier, a combination New BD cell

of the Waters BioAccord System and the breakthrough analyser includes

ACQUITY Premier UPLC with MaxPeak High Performance spectral analysis

Surface (HPS) technology. The integrated high-resolution capabilities

LC-MS system simplifies multi-attribute monitoring of Becton, Dickinson and Company (BD)
has announced the launch of a spectral-
biotherapeutics by improving analyte recovery and assay-to- enabled cell analyser, expanding
current cell analyser capabilities to at
assay reproducibility so that regulated laboratories can get least 34 parameters with live spectral
unmixing, enabling researchers to
needed medicines to patients faster. The compact, benchtop precisely analyse selected single cells
from complex samples. The new BD
BioAccord System with ACQUITY Premier features MaxPeak FACSymphony A5 SE Cell Analyser is a
fluorescence-activated, spectral-enabled
HPS technology and the SmartMS-enabled ACQUITY RDa cell analyser that offers researchers the
ability to choose between spectral or
mass detector allowing analysts of all abilities to monitor compensation-based cell analysis to meet
different flow cytometry needs. It is an
critical quality attributes of biotherapeutics and assess the important addition to the extended family
of BD FACSymphony Cell Analysers and
processes that make them, all while decreasing risk, thanks Sorters, including the recently announced
BD FACSymphony A1 Cell Analyser,
to compliant-ready acquisition and data workflows that which offers premium performance in a
benchtop format. For existing users of
deliver consistent data quality from user-to-user the BD FACSymphony A5 Cell Analyser,
software and hardware upgrades are
and system-to-system. MaxPeak HPS available to enable spectral analysis.

technology is a hybrid organic/

inorganic surface technology

that forms a barrier

between the sample and

the biocompatible metal

surfaces of both the

UPLC inlet and column.

With automated setup

and guided workflows

made possible with

SmartMS technology,

the BioAccord System

with ACQUITY Premier

is designed for easy

deployment.

Eppendorf brings Conical Tube SnapTec 50

The new Eppendorf Conical addition, the SnapTec 50 vessel maximum compatibility with
Tube SnapTec 50 offers all the is autoclavable, which opens up centrifuge rotors, mixers and
advantages of classic conical tubes further application possibilities. shakers. Typical applications for
50 mL. The decisive, innovative Its precise dimensions ensure conical tubes are mainly found in
detail is the SnapTec closure. A cell culture, bacterial culture, and
snap-on lid that can be opened protein or DNA/RNA extraction.
and closed with one hand and is Most important in these
firmly attached to the vessel so applications is contamination-free
that it does not come into contact handling and a smooth workflow.
with the laboratory bench. The Fast and safe opening and closing
risk of cross-contamination is as well as autoclavability of such
reduced and confusion with vessels contribute significantly to
other lids is eliminated. In meeting these requirements.

50 LET’S TALK HEALTH BIOSPECTRUM | NOVEMBER 2021 | www.biospectrumindia.com

Ending malaria with
multiple vax strategies

Ahistoric moment took place on October 6, 2021 Besides malaria, dengue fever is the next critical
when the World Health Organisation (WHO) mosquito-borne disease in the world that is most
recommended a groundbreaking malaria rapidly spreading. There has been a 30-fold increase
vaccine for children at risk. With more than 30 years in global incidence over the past 50 years. Although
in making, RTS,S/AS01 vaccine under the brand name a vaccine (Dengvaxia) has been developed for this
Mosquirix has emerged as the world’s first malaria disease, the maker Sanofi Pasteur had announced in
vaccine. 2017 that people who receive the vaccine and have not
been previously infected with a dengue virus may be
Developed by the British firm GlaxoSmithKline at risk of developing severe dengue if they get dengue
(GSK), non-profit organisation PATH and with support after being vaccinated.
by Bill & Melinda Gates Foundation, Mosquirix has
changed the course of public health history. For a Developing a viable vaccine against dengue
disease that can kill within 24 hours of symptom onset, virus has proved difficult over the years because the
this development is indeed remarkable. pathogen is actually four different virus types, or
serotypes. Unless a vaccine protects against all four, a
But the development of this malaria vaccine has vaccine can wind up doing more harm than good.
faced several obstacles, in terms of lack of a traditional
market, few developers, and the technical complexity of Preparing tools such as vaccines to fight these
developing any vaccine against a parasite since malaria diseases appears to be a common strategy, but did
parasites have a complex life cycle, and there is poor you know that these little super-spreader of diseases
understanding of the complex immune response to could actually transform into friends that can be used
malaria infection. to inject the vaccine in humans? The story goes back to
2010 when a group of Japanese researchers genetically
Malaria parasites are also genetically complex, engineered mosquitoes that spread vaccines instead
producing thousands of potential antigens. Unlike of disease. For their study, the researchers attached
the diseases for which we currently have effective SP15 vaccine against leishmaniasis, a parasitic disease
vaccines, exposure to malaria parasites does not confer spread by sand flies that can cause skin sores and organ
lifelong protection. Mosquirix has been developed to damage, to a malaria mosquito. These mosquitoes
trigger the immune system to defend against the first produced SP15 in their saliva, and mice bitten by
stages of malaria when the Plasmodium falciparum these mosquitoes produced antibodies against the
parasite enters the human host’s bloodstream through parasite. However, the team wasn’t sure whether the
a mosquito bite and infects liver cells. The vaccine immune response was strong enough to protect against
is designed to prevent the parasite from infecting infection.
the liver, where it can mature, multiply, re enter the
bloodstream, and infect red blood cells, which can lead Adding to it, the concept of a ‘flying vaccinator’
to disease symptoms. transgenic mosquito is not likely to be a practicable
method of disease control, because a ‘flying vaccinator’
Another promising malaria vaccine candidate is is an unacceptable way to deliver vaccines without
being developed by the US-based biotech company dosage limit and informed consent against current
Sanaria since 2010. It includes whole sporozoites, the vaccine programmes.
sexual form of the parasite extracted from mosquito
salivary glands, which have either been made non- With vaccines emerging as the most effective
infectious through irradiation or are administered solution to prevent a large number of deadly diseases
along with chemoprevention. A more effective vaccine globally, we might just end up using flying vaccine-
could also come in the form of the University of carrying syringes, marking another historic event.
Oxford’s R21 that recently showed good efficacy in an
early trial testing it among children 5- 17 months of age Dr Manbeena Chawla
in Burkina Faso, West Africa. Executive Editor

[email protected]