BioSpectrum India November 2020

Tofflon’s mAb Capabilities and Systems

Filling

Buffer preparation/Storage/Distribution

CIP Station Depth filtration

Ultrafiltration concentration
Virus filtration

Chromatography

Bioreactors
Single Use or Stainless Steel
Media preparation /Storage/Distribution

Features:

• Complete SS & Hybrid equipment solution by Tofflon
• Lower operating costs and downtime
• Our design offer high sterility assurance, reduced potential bioburden and
cross contamination
• Increased personnel and product safety
• High standard equipment ensure repetability, reproducbility and robustness of
the process
• Less reliance on personnel interventions and SOP’s
• Fastest delivery and execution of project
• Complies with all regulation for manufacturing, safety & data integrity
• High end automation and integration of all equiment aids reduce personnel
requirement in clean room
• Customization as per requirement of customer to offer flexible designs

Shanghai Tofflon Science and Technology Co.,Ltd.

Address : No.1509, Duhui Road, Shanghai, China 201108

Tel: +86 21 6490 1123

Fax: +86 21 6490 5148

E-mail: [email protected] (sales)

Website: www.tofflon.com



4 BIO CONTENT BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.

COVERSTORY 19.........................................................................................................................................................

REGULATE MEDICAL AESTHETICS

The market that is worth billions of dollars in India has witnessed significant growth in the demand for aesthetic
procedures owing to the rise in the number of doctors and surgeons providing effective medical aesthetic
treatments and the launch of technologically advanced products for the same. However, India lacks proper
guidelines to regulate the use of specific products and procedures for aesthetic treatment.

COVID-19 WORLD DIABETES DAY Q&A

26 30 33

Is COVID-19 Diabetes Specialist Nurses – “Strong evidence
sidelining NCDs? future ready health coaches showing positive impact
of Digital Vaccines candidate
for infectious diseases”

Bhargav Sri Prakash,

Founder & CEO, FriendsLearn, Chennai

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com BIO CONTENT 5

Q&A STARTUPS
40
35
ASPIRE-BioNEST
“We have 18 international startups launch hi-tech
patents granted for war against COVID-19
Stempeucel pooling technology” Dr Sreedhara R Voleti,
B N Manohar,
CEO,
MD & CEO, Stempeutics Research, Bengaluru ASPIRE-BioNEST, Hyderabad

37 REGULARS

“The aim is to prepare a BioEdit........................................................................06
workforce in pharma research BioMail.......................................................................08
to speed up drug discovery” Policy and Regulatory News....................................10
Sridhar Venkatesh, Company News..........................................................11
Finance News............................................................13
Managing Director, Start-up News............................................................14
GSK Pharmaceuticals India, Mumbai World News................................................................16
WHO News.................................................................18
CLINICALTRIALS People News..............................................................42
R&D News..................................................................46
38 Academic News.........................................................48
Supplier News...........................................................49
Virtual Clinical Trials –
An approach whose
time has come
Suneela Thatte,

Head, Research & Development Solutions,
IQVIA India, Mumbai

A Millipore® Mind knows our
high performance can help
power your efficiency

Understanding your world drives everything
we do. Our smart product designs,
rigorous product validation and world-class
manufacturing capabilities ensure consistent
high-quality, high-performance products
that continually evolve so your work shines.

To find out more, visit:
SigmaAldrich.com/MilliporeMind

Merck, the vibrant M and Millipore are trademarks of Merck KGaA, Darmstadt, Germany The life science business of Merck Preparation, Separation,
or its affiliates. All other trademarks are the property of their respective owners. operates as MilliporeSigma in the Filtration & Monitoring Products
Detailed information on trademarks is available via publicly accessible resources. U.S. and Canada.

© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.

6 BIO EDIT BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Digital leap

Digital health has been a buzzword in has announced the National Digital Health
India for the last few years. News media Mission (NDHM). Its roots are in the Niti Aayog
is reporting the adoption of digital proposal generated two years back to create a
technology in the health care sector on regular centralised mechanism to uniquely identify every
basis, which indicates its growing acceptance, participating user in National Health Stack and
usage and necessity. More such news was the National Digital Health Blueprint prepared by
published during the pandemic as the constraints experts’ committee in July 2019.
put by the pandemic and lockdown led to more
innovations and more use of digital technology Like Aadhar, every Indian citizen will get a
in healthcare. The change is rightly pointed unique health ID number and a card in which
out by Dr Harshit Jain, Founder and CEO, the entire medical records of the patient will be
Doceree, when he said, “In a way, coronavirus stored in digital form. This, along with other
outbreak accelerated the adoption of digital in the technologies like tele-consultation and tele-
healthcare sector.” This is the only silver lining to medicine, e-pharmacies will help overcome
the darkest cloud of the current pandemic. the problem of accessibility to health services
in rural areas, and in urban areas too. Use of
But even before the pandemic, India was at AI, machine learning, blockchain and robotics
the forefront in using digital technology. Future will bring much more precision in diagnosis,
Health Index (FHI) report of 2019 said that 76 treatments and surgeries, naturally improving
per cent of healthcare professionals in the country recovery rate.
are already using digital health records. In
digital healthcare, there are several technologies Having more and more data is always good
and applications. But applications of Artificial as its analysis helps in more perfection. With a
Intelligence (AI), alone, is expected to be worth Rs huge population of 130 crore, the availability of
432 billion by the next year, according to Research huge data will be of advantage. Many things can
& Markets. Telemedicine technology could save be done with such huge data – good one as well as
India $ 4-5 billion each year. The robust growth of bad one. Two-fold challenge for the mission while
digital healthcare in India is prompted by nearly handling such a huge data will be securing the
5000 startups in this space. data and designing an eco-system with necessary
rules and regulations where the people should
As the digital strategist Chris Boyer said, benefit and not those, who wish to misuse it for
“Using digital tools to reach patients is no longer their own benefit.
a question of ‘if’ – it is a question of ‘how’. And
it is a matter of now.” An expert has pointed out This is particularly important as the mission
that AI will not replace physicians, but physicians is going to be a part of the National Health
using AI will surely replace those, who do not use Stack, which will bring together all stakeholders,
it. including private healthcare players. It is crucial
to understand here that technology develops
In India, 60 per cent hospitals, 75 per faster than legal frameworks. The government will
cent dispensaries and 80 per cent doctors are have to ensure that its legal framework keeps pace
concentrated in urban areas serving only 30 with the emerging technology. So, along with the
per cent of the population. Nearly half of the growing investment more political engagement
population in rural areas need to make overnight will be needed. Only that will create empowered
trips for medical reasons and in urban areas patients and a robust digital health system.
traffic congestion causes accessibility problems.
Dr Milind Kokje
It is on this note for further growth in digital Chief Editor
health technologies, the Indian government
[email protected]



8 BIO MAIL BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Vol 18; Issue 10; October 2020 Acknowledgements-

Anand Mahindra Tweets Thank you so much for the
BioSpectrum Article lovely feature on Thermo
Fisher in the October edition.
Referring to BioSpectrum article in October
edition, titled ‘India Bracing for Mental - Shiny Kurup, Mumbai

Health Crisis’, Anand Mahindra, Chairman, The interview coverage
Mahindra Group, Mumbai tweeted- on Vevra Group is well
appreciated. Thank you.
“This is one of the gravest threats
of the pandemic. We need many - Punya Poonacha,
remedies, but amongst them it’s critical Bengaluru
to completely unlock access to sports
grounds so that children & adults have
an opportunity to play in open areas

with adequate precautions.’’

Vol 18; Issue 11; November 2020 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
Ravindra Boratkar Alok Srivastava Dr Manbeena Chawla
National Business Head- Executive Editor Singapore
Editorial: Ad Sales & Marketing 103-104, Rohit House 3, MM Activ Singapore Pte. Ltd.
Chief Editor: Dr Milind Kokje “NITON”, Block B, Lower Ground Floor, Tolstoy Marg, Connaught Place, Saradha Mani
[email protected] 11/3, Palace Road, Bangalore 560001 New Delhi - 110 001 General Manager
Mobile: +91-9845128747 Mobile: +91-8861043732 #08-08, High Street Centre,
Advisor - Content: Vijay Thombre Tel.: +91-80-41131912/13 [email protected] 1 North Bridge Road,
[email protected] Singapore - 179094
Editor: Tel: +65-63369142
Narayan Kulkarni Mumbai Pune Fax:+65-63369145
[email protected]
Executive Editor: Ankit Kankar Ankit Kankar
Dr Manbeena Chawla Manager-Prod. & Manager-Prod. & USA
[email protected] Strategic Commn. Digital Strategic Commn. Digital BioSpectrum Bureau
1st Floor, CIDCO Convention Center, Ashirwad, 36/A/2, S.No. 270, Pallod MM Activ Sci-Tech
Content Team: Sector 30A, Vashi, Navi Mumbai, Farms, Baner Road, Pune- 411045 Communications
Bengaluru & New Delhi: Maharashtra-400703. Mobile: +91-9579069369 Mobile: +91-9579069369
Dr Manbeena Chawla Mobile: +91-9579069369 [email protected] E-mail: [email protected]
Singapore: Hithaishi C. Bhaskar [email protected]
Europe
Social Media Editor: Ankit Kankar Nagpur Mr. Stuart Smith
[email protected] Manisha Boratkar 6 Cobden Court, Wimpole Close,
402, Govind Apartments, Shankar Nagar Square, Bromley, Kent BR2 9JF
CFO & Special Correspondent: Nagpur - 440 010. Tel. +91-712-2555 249 E-mail: stuart.smith@
Manasee Kurlekar globalmediasales.co.uk
Printed and published by E-mail: [email protected]
Production & Design: Ravindra Boratkar on behalf of MM Activ Sci-Tech Communications Pvt Ltd Tel: +44 (0)20 8464 5577
MM Activ Sci-Tech Communications Mobile: 07973 814753
Anil Walunj Printed at Spectrum Offset, D-101, 1st Floor, Satyam Estate, Behind
CDSS, Erandwane, Pune-411038. Maharashtra. Tel : +91 20 2543 6556
Product & Marketing TIN No: 09565712431
Ankit Kankar Published from Ashirwad, 36/A/2, S.No. 270, Pallod Farms,
[email protected] Near Bank of Baroda, Baner Road, Pune- 411045.Tel. No: +91 20 2729 1769
Website: www.biospectrumindia.com
Circulation, Subscription and
Media Enquiry:
Asmita Thakar
[email protected]

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



10 POLICY AND REGULATORY NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

NPPA caps Health Ministry issues
price for medical regulatory guidelines
oxygen cylinders for COVID-19 vaccine

The present situation of COVID-19 has resulted The Ministry of Health and Family Welfare has
in increased demand of medical oxygen (MO) in launched draft regulatory guidelines for development
the country and hence its availability is of utmost of vaccines with special consideration for COVID-19
importance. The government is committed vaccine. This document will provide guidance to
to uninterrupted supply of MO especially in the vaccine developers to ensure that vaccines are
the times of pandemic. Oxygen Inhalation well-characterized and manufactured consistently;
(Medicinal Gas) is a scheduled formulation, vaccines remain stable at the recommended storage
covered under the National List of Essential conditions for the duration of clinical trial during
Medicines (NLEM). Its existing Ceiling Price clinical development stage and throughout its shelf life
fixed by the National Pharmaceutical Pricing post approval. It will also ensure that post marketing
Authority (NPPA) is Rs 17.49 per cubic metre. surveillance including assessment of adverse events
However, due to absence of price cap on liquid following immunization (AEFI) and adverse events of
medical oxygen, manufacturers have hiked special interest (AESI) is carried out to assess vaccine
prices to fillers. As a result, necessary steps safety in post market scenario. The document also states
have been taken by the NPPA to cap the ex- that for a COVID-19 vaccine candidate consisting of a
factory price of liquid medical oxygen (LMO) novel product type and for which no prior nonclinical
at manufacturers’ end at Rs 15.22 per cubic and clinical data are available, nonclinical safety studies
metre exclusive of GST; and to further cap the will be required prior to proceeding to first in human
ex-factory cost of MO cylinder at filler end at (FIH) clinical trials.
Rs 25.71 per cubic metre exclusive of GST in
suppression of the existing ceiling price of Rs
17.49 per cubic metre, subject to transportation
cost fixation at state level, for six months.

India emphasizes on state-of-the-art ayurvedic institution

The Institute of Teaching and ayurvedic institution called with INI status in the AYUSH
Research in Ayurveda Bill 2020 the Institute of Teaching and Sector, and this will enable the
Research in Ayurveda (ITRA) institution to be independent
has been passed by Rajya Sabha. at Jamnagar, Gujarat, and to and innovative in the matter
The Bill was earlier passed in confer the status of Institution of deciding course content and
of National Importance (INI) pedagogy. It is expected that the
Lok Sabha on March to it. The ITRA is sought to be enactment of the proposal will
19, 2020. This established by conglomerating further provide autonomy to
paves the way the presently existing ayurveda the institute to develop patterns
to establish a institutes at Gujarat Ayurved of teaching in undergraduate
state-of- University campus in Jamnagar. and postgraduate education in
the- ITRA will be the first institution ayurveda and pharmacy.
art

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com COMPANY NEWS 11

Sanofi Pasteur introduces booster vaccine for preschoolers

Sanofi Pasteur India, the vaccines reducing parental anxiety. As containing full-dose antigens
global business unit of Sanofi immunity against diphtheria, stimulates adequate immune
has announced the launch of tetanus, and pertussis wanes over response with better tolerability.
Tetraxim (DTaP-IPV). The time, it is important to ensure This ensures preschoolers
booster vaccine is indicated receive the right vaccine with
for preschoolers and provides necessary protection by being the appropriate antigen content
protection against four major up to date with booster at the right time and have
diseases - diphtheria, pertussis,
tetanus and polio. Tetraxim vaccinations. A vaccine sustained protection
combines four vaccines against disease. With
into one, thus reducing Tetraxim, Sanofi Pasteur
the number of injections, currently protects school
increasing comfort and children in more than
improving vaccination 100 countries, with 63
compliance for children and million doses distributed
worldwide.

AliveCor enters India Bharat Biotech
with unique ECG device advances COVID-19
intranasal
AliveCor, the global leader in US Food and vaccine technology
Drug Administration (FDA) cleared personal
electrocardiogram (ECG) technology, has announced Bharat Biotech has announced a licensing
its entry in the Indian market with the revolutionary agreement with Washington University School of
launch of the most clinically validated personal ECG Medicine in the US for a novel chimp-adenovirus,
device, KardiaMobile 6L. Owing to the accessibility single dose intranasal vaccine for COVID-19.
challenges to quality healthcare in the country and Hyderabad based Bharat Biotech owns the rights
COVID-19 related infection fears, the portable and to distribute the vaccine in all markets except
technology enabled ECG device will help deliver USA, Japan and Europe. While the Phase I trials
affordable and convenient heart care to over 260 will take place in Saint Louis
million heart patients and those at risk, without visiting University’s Vaccine & Treatment
a hospital. KardiaMobile 6L is the only personal ECG Evaluation Unit, Bharat Biotech,
device in the world that can detect the three most upon obtaining the required
common arrhythmias or irregular heartbeat—atrial regulatory approval, will pursue
fibrillation (AFib), bradycardia, and tachycardia, further stages of clinical trials
which require regular monitoring and a healthy in India and undertake large
lifestyle. US based AliveCor’s innovative technology scale manufacture of the vaccine
gives patients the ability to record a medical-grade at its GMP facility located in
ECG in just 30 seconds, with no hospital visits and Genome Valley, Hyderabad. This
complete peace of mind. The device is small enough to intranasal vaccine candidate
fit in a pocket, allowing users to check in on their heart has shown unprecedented levels
anytime, anywhere right from their smartphone. of protection in mice studies;
the technology and data having been recently
published in the prestigious scientific journal
Cell and in an editorial in Nature. This vaccine
expands Bharat’s portfolio of vaccines that are
currently being developed and are in various
stages of clinical development including Covaxin,
which is currently in Phase II human clinical
trials in India.

12 COMPANY NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Indoco Remedies Hester Bio acquires
launches Favipiravir Brucella vaccine
400 mg tablets technology from IVRI

Mumbai based Indoco Remedies has Hester Biosciences has signed an agreement towards
announced the launch of Fevindo receiving the indigenously developed technology from
(Favipiravir) 400 mg tablets in India. Fevindo Indian Council of Agriculture Research – Indian Veterinary
400 is an antiviral drug, effective against Research Institute (ICAR-IVRI) in Bareilly, for developing
the RNA-based influenza virus. The drug the Brucella Abortus S19 Delta Per vaccine. While
has been approved by the Drugs Controller Ahmedabad based Hester is currently manufacturing the
General of India (DCGI) in the treatment of conventional Brucella Abortus S19 vaccine and supplying
COVID-19. Fevindo 400 reduces pill burden to all the states in India, the S19 Delta Per new generation
by 50 per cent and ensures convenient vaccine technology developed by IVRI will be a step forward
dosing and better patient compliance. The towards developing a Brucella vaccine with enhanced safety,
drug will be made available at all government immunogenicity, as well as assuring lifelong immunity with
approved COVID care centres and selected a single shot in calf-hood. The government has planned to
medical practitioners across the country. In immunize 4 crore female calves in India in the first phase
addition to Fevindo, Indoco has two more against Brucella through vaccination. Hester has been and
new products for launch in Covid Care range, commits to remain a part of the Government of India’s
i.e., Povidone Iodine Gargle and Immunity immunization program against Brucella in cattle. With this
booster chewable tablets with zinc, vitamin C vaccine Hester hopes to reach new heights not only within
and vitamin D. India but also become a channel for immunizing cattle
against Brucella, worldwide. Hester hopes to launch the
Brucella Abortus S19 Delta Per vaccine in 18 months.

Dr Reddy’s Laboratories to supply 100 M
doses of Sputnik V vaccine to India

The Russian Direct Investment platform with proven safety,
Fund (RDIF), Russia’s is undergoing clinical trials
sovereign wealth fund, and for the coronavirus pandemic.
Dr Reddy’s Laboratories, Deliveries could potentially
headquartered in Hyderabad, begin in late 2020 subject to
have agreed to cooperate on completion of successful trials
clinical trials and distribution and registration of the vaccine
of Sputnik V vaccine in India. by regulatory authorities in
Upon regulatory approval India. The agreement between
in India, RDIF shall supply RDIF and Dr Reddy’s reflects
to Dr Reddy’s 100 million the growing awareness of
doses of the vaccine. The countries and organizations to
Sputnik V vaccine, which have a diversified anti-COVID
is based on well-studied vaccine portfolio to protect
human adenoviral vector their populations.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com FINANCE NEWS 13

Sigachi files for Rs 60 Cr IPO IMCD acquires
Indian
Hyderabad based Sigachi MCC has varied applications speciality
Industries, one of the leading in the pharmaceutical, food, chemicals
manufacturers of cellulose based nutraceuticals and the cosmetic distributor
excipients in India, in terms of industries. Presently, the
volume with over three decades company manufactures 50 IMCD N.V. based in the
of experience and amongst the different grades of MCC at its Netherlands, has signed an
top 10 globally, has filed its draft manufacturing units, situated at agreement to acquire 100 per
red herring prospectus (DRHP) Hyderabad and Gujarat under the cent of Signet Excipients, one
to raise approximately Rs 60 brand named HiCel and AceCel. of the leading distributors of
crore, as per market sources. The The net proceeds of the issue excipients in India. Signet is
IPO is a fresh issuance of upto are to be used for expansion of well aligned with the IMCD
28,41,500 equity shares of face production facilities of MCC at business model and strategy
value of Rs 10 each. The company Dahej and Jhagadia in Gujarat and provides a significant
is engaged in the manufacturing between FY21 and FY22 as well platform for further growth
of microcrystalline cellulose as general corporate purposes. in India and the Asia-Pacific
(MCC), the polymer widely The proposed expansion will add region. Founded in 1986,
used for finished dosages in 3600 MTPA capacity to the Dahej Signet grew from a small
the pharmaceutical industry. and Jhagadia facility, augmenting distribution company to one
The inert non-reactive, free its capacity to 7890 MTPA and of the leading distributors
flowing and versatile nature of 5760 MTPA respectively. of excipients in India. It
focuses on the distribution of
Corona Remedies pick up pharmaceutical, nutraceutical
stake in La Chandra Pharmalab and bio-pharma excipients.
Based in Mumbai, Signet
Ahmedabad based pharma major Corona Remedies has picked up is also active in India,
Bangladesh, the Middle East
a minority stake in homegrown hormone active pharmaceutical and Africa. The transaction
will take place in two
ingredient (API) manufacturer La Chandra Pharmalab as a tranches, with IMCD now
acquiring 70 per cent of
part of a strategic collaboration between the share capital from the
founders and the remaining
the two companies. Corona Remedies 30 per cent by 2024. The
transaction is expected to
makes a range of products for have high single digit cash
earnings per share (EPS)
gastrointestinal therapy, pain accretion in the first full year
post acquisition. The founders
therapy, cardiovascular of Signet will continue to lead
the company post completion
therapy, gynecological of the first tranche.

therapy, among others. La

Chandra Pharmalab is an EU- GMP

compliant API manufacturer having its

production facility in Palanpur in north Gujarat.

It has emerged as a leading manufacturer and supplier of pregnancy

care drug Progesterone in India and holds international regulatory

approvals for a range of hormone APIs. This collaboration heralds

a new phase of exponential growth for the company. La Chandra’s

technical capabilities and expertise in sunrise technologies in API

manufacturing is expected to be greatly augmented with Corona’s

market strength.

14 START UP NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Chiratae BBC launches range of
Ventures products to fight COVID-19
invests in
WeInnovate Bangalore Bioinnovation Centre method of RNA isolation to be used
Biosolutions (BBC) under the aegis of Karnataka for detection of COVID-19; CoviDx
Innovation and Technology Society mPlex 3R and 4R is an in-vitro RT-
Chiratae Ventures (KITS), Government of Karnataka PCR qualitative assay for detection
have announced has recently launched a range of COVID-19 virus utilizing three
their seed investment of products, to fight COVID-19 and four genes identification;
in WeInnovate pandemic. In addition, BBC Dr Tapaman is a device, which
Biosolutions, a Pune has also signed a Memorandum measures body temperature
based startup working of Understanding (MoU) with as a symptom for COVID-19;
in the area of infection the Society for Innovation and SAFAE Biosecurity Solutions
prevention and control Entrepreneurship (SINE), an is a tunnel that provides for
as a part of their umbrella organisation at the automated temperature scanner,
DeepTech Innovators blood oxygen level check, mask
Programme 6th Indian Institute of Technology, detection, automated hand wash,
Cohort. The startup has Bombay (IIT-B) for fostering complete disinfection of body,
developed antimicrobial entrepreneurship and nurturing clothes and luggage, in addition
solutions that reduce tech start-ups. Some of the recently to contact tracing of people within
hospital-acquired developed products by the startups location of installation. Few other
infections and is at BBC include NucleoDx RT, novel discoveries include UVEE
helping save millions on which is a simple and cost effective beamer, which eliminates germs
hospitalization bills. The by denaturing their DNA; UVEE
funding from this round conveyor is an enclosed moving
will be used for product belt with a UV- C system that kills
approvals, sales, and germs on objects of varying sizes
marketing. WeInnovate and will be mostly useful and big
Biosolutions is on commercial spaces; and artificial
a mission of zero intelligence (AI) based chain
infections during a mobile app that uses chest X-ray
hospital stay, and images and gives instant COVID-19
aims to achieve this positive or negative result.
through its range
of antimicrobial Dozee raises Rs 12.5 Cr to
medical devices that enhance digital healthcare
are based on the
company’s patented Dozee, a Bengaluru based contactless remote health monitoring startup, has
unique, cutting-edge raised Rs 12.5 crore from Prime Venture Partners, YourNest Venture Capital
NanoAgCide technology. and 3one4 Capital. Exclusively designed and manufactured in India, Dozee
This DeepTech is already seeing a strong adoption for remote patient care, both in hospitals
Innovators Programme and at home. The startup will use the fresh capital to expand market outreach
by Chiratae Ventures and bring real-time vitals monitoring at the forefront of digital healthcare in
is the sixth edition India. Dozee will also use the funds to enhance product capabilities, complete
consolidating all the FDA and other global certifications, and enhance user experience for both
previous programmes physicians and patients. Dozee tracks key vitals of the human body such as
for the seed and early heart rate, respiration rate, oxygen saturation, sleep stages, stress recovery
stage startups with a and more with a medical-grade 98.4 per cent accuracy. The contactless
focus on solving real, sensor, placed under the mattress captures real-time body vitals without using
major problems through any external wires or touching the user’s body. The sensor captures micro-
deep-technology across vibrations produced by the body every time the heart pumps blood, during
sectors. inhalation, exhalation, muscle twitches, tremors and body movements.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com START UP NEWS 15

SeguraMAX brings plant based
technology to contain virus transmission

Ludhiana based startup has also proven to remain SeguraMAX has ascertained
SeguraMAX Global has effective after multiple washes. that its technology can
announced the launch of become the first shield of
Keep-U-Safe, a pathbreaking, hybrid protective wear to
first-of-its-kind technology fight infectious diseases and
in the world, which will prevent surface transmission
aid in achieving significant of viruses from the infected
reduction of viruses on to the uninfected, even while
surfaces of their products. pharma companies continue
The green plant based their effort to develop and
technology has been tested suitably deploy a vaccine
by various international in the coming months.
and accredited labs with SeguraMAX has developed
proven results to reduce upto a diverse range of Keep-U-
99 per cent viruses from Safe products treated with
various surfaces of fabrics, bio-organic additives that
garments and plastics in less reduces the presence of viruses by
than 1 minute. The technology up to 99 per cent on surfaces.

IISc startup develops rapid Thinkerbell Labs
COVID-19 RT-PCR kit designs COVID-19
contact tracing solution
Equine Biotech, a social entrepreneurial initiative by
Prof. Utpal Tatu, Department of Biochemistry, Indian Thinkerbell Labs has received a grant by Centre
Institute of Science (IISc), Bengaluru has engineered for Augmenting WAR with COVID-19 Health
and developed a sensitive, rapid, and affordable Crisis (CAWACH), an initiative by the Department
COVID-19 diagnostic kit that is approved by Indian of Science and Technology, Government of
Council of Medical Research (ICMR). Prof. Tatu’s Lab India for developing Chakravyuh, a product
at IISc, with over 23 years of experience in studying that helps to collect and analyze real-time data
infectious diseases, has a social entrepreneurial on COVID-19. The Bengaluru based startup has
developed Chakravyuh that seeks to address the
initiative called issue to keep the community safe. The product
Equine Biotech. analyzes and predicts spread patterns along with
This startup, collecting metadata important for contact tracing.
recognised by Thinkerbell’s Chakravyuh deploys a connected,
the Government smart, temperature measurement, and analytics
of Karnataka and solution for state and district administrations,
Government of providing them with quick and comprehensive
India, is involved access to the information they need to pre-empt
in developing the spread of COVID-19.
diagnostics
for emerging
infectious
diseases such as COVID-19. The company has now
developed a COVID-19 RT-PCR diagnostic kit called
global diagnostic kit for accurate and affordable
diagnosis. Equine Biotech is looking to license the
newly developed kit for large scale manufacturing
and sale. The agreement would involve technology
transfer and support in manufacturing of kits.

16 WORLD NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Beximco inks RDIF, Trinity Pharma to supply
COVID-19 25M doses of Sputnik V to Nepal
vaccine pact
with Serum The Russian Direct Investment recognize the importance of
Institute of India Fund (RDIF), Russia’s having a vaccine based on
sovereign wealth fund, and a human adenoviral vector
Beximco Pharmaceuticals Limited Trinity Pharmaceuticals, one platform in the coronavirus
(BPL) in Bangladesh and the of the leading pharmaceutical vaccine portfolio. The human
Serum Institute of India (SII), distributors in Nepal, have adenoviral vector platform
have announced an agreement in agreed to supply to the country is a well-researched vaccine
principle for a cooperation and 25 million doses of the Sputnik V platform that has been proven
distribution agreement to develop vaccine based on a well-studied safe over decades including
a COVID-19 vaccine, for which human adenoviral vectors through 75 international
Beximco will be the exclusive platform. The agreement will scientific publications and in
supplier in Bangladesh. SII has enable 90 per cent of population more than 250 clinical trials.
partnered with AstraZeneca, the of Nepal to get access to Sputnik Clinical trials of the Russian
Gates Foundation and Gavi, to V vaccine and provide country’s vaccine have shown no serious
produce more than a billion doses clinics with an anti-COVID adverse events, with Sputnik
of a vaccine for global supply. vaccine with proven safety V generating a stable humoral
Under the terms of the planned and efficacy. The agreement and cellular immune response
arrangement, Beximco will underlines that many countries in 100 per cent of participants.
make a financial contribution to
advance the development of the India strengthens clinical
vaccine, which will be adjusted trial research capacity
based on the vaccine price. for SAARC countries
SII will prioritise Bangladesh
to be one of the first countries The Department of Biotechnology (DBT) through the India Centric
to receive an agreed quantity Epidemic Preparedness mission for rapid vaccine development
of doses once the vaccine and supporting Indian vaccine development, which is aligned with
receives all necessary regulatory the global initiative of the Coalition for Epidemic Preparedness
approvals. Beximco will be the
exclusive supplier of the vaccine Innovations (CEPI), aims to strengthen
in Bangladesh and will facilitate the development of vaccines and
the needs of the Government associated competencies or technologies
of Bangladesh by offering the for the diseases of epidemic potential in
opportunity for it to reserve the India. One of the key focus areas of the
desired quantities for priority mission is to support capacity building
supply at prices to be agreed and regional networking with Low and
between the government and SII. Middle Income Countries (LMICs).
Keeping with the principles outlined by
Science Diplomacy initiatives, DBT has
initiated the first phase of the training
programme to strengthen clinical trial
research capacity for neighbouring countries in partnership with
Ministry of External Affairs, Government of India. The objective of
these trainings would be to support researchers and investigator
teams for enhancing and strengthening their clinical trial capabilities
for conducting clinical trials in compliance with the International
Conference on Harmonisation - Good Clinical Practice (ICH-
GCP). The training programme includes participation of different
departments from Nepal, Maldives, Bangladesh, Mauritius, Sri
Lanka, Bhutan and Afghanistan.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com WORLD NEWS 17

Illumina signs acquisition FDA sets up CoE
deal with GRAIL for $8B for digital health

Illumina, Inc. and GRAIL, both based in the US, The US Food and Drug Administration (FDA)
have entered into a definitive agreement under has announced that it is launching the Digital
which Illumina will acquire GRAIL for cash and Health Center of Excellence (CoE) within the
stock consideration of $8 billion upon closing of the Center for Devices and Radiological Health
transaction. In addition, GRAIL stockholders will (CDRH). The launch of the Digital Health CoE
receive future payments representing a tiered single is an important step in furthering the agency’s
digit percentage of certain GRAIL-related revenues. overarching dedication to the advancement
The agreement has been approved by the Boards of of digital health technology, including mobile
Directors of Illumina and GRAIL. As per the deal, health devices, software as a medical device
(SaMD), wearables when used as a medical
GRAIL will extend device, and technologies used to study medical
Illumina’s portfolio products. The agency is appointing Bakul Patel
to include cancer as the first director. Patel has been leading
screening, diagnosis regulatory and scientific efforts related to digital
and cancer monitoring, health devices at the FDA since 2010. The CoE
creating a portfolio is primarily focused on helping both internal
of best-in-class, and external stakeholders achieve their goals of
proprietary tests in each getting high quality digital health technologies
of the major oncology to patients by providing technological advice,
testing application coordinating and supporting work being done
areas. Illumina plans to leverage its global scale, across the FDA, advancing best practices, and
manufacturing and clinical capabilities to support reimagining digital health device oversight.
GRAIL’s commercialization efforts, realize the total
addressable market potential and drive significant
growth in the clinical value chain. Next-generation
sequencing (NGS) is poised to revolutionize
oncology care, and this acquisition allows Illumina
to participate more fully in the high value clinical
solutions that are enabled by its NGS sequencing
technology. With GRAIL, Illumina will continue as a
leading sequencing innovator and partner, while also
becoming a proprietary test provider.

Mylan buys Aspen’s thrombosis biz in Europe

Mylan N.V. has announced Mylan expects to utilize cash anticoagulants sold in
an agreement to acquire the generated from operations to Europe under the brand
related intellectual property make the final deferred payment names, and variations
and commercialization of EUR 378.7 million on June of the brand names,
rights of Aspen Pharmacare 25, 2021. The portfolio consists Arixtra, Fraxiparine,
Holdings Limited’s of well-established injectable Mono-Embolex and
thrombosis business Orgaran. These products
in Europe for EUR had combined net sales
641.9 million, subject of approximately EUR
to customary closing 231 million for the 12
conditions and European months ended June 30, 2020
regulatory clearances. Upon and are expected to be accretive
closing of the transaction, Mylan to Mylan’s consolidated adjusted
expects to fund an upfront EBITDA margins, as well as the
payment of EUR 263.2 million to anticipated consolidated adjusted
Aspen from existing cash. Also, EBITDA margins of Viatris.

18 WHO NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

WHO pushes availability of COVID-19 rapid tests for LMICs

A set of agreements to end-to-end effort, the Bill & (Ag RDTs), priced at
make available, for low Melinda Gates Foundation a maximum of $5 per
and middle-income has executed separate volume unit, over a period of
countries (LMICs), guarantee agreements with rapid six months. These tests
affordable, high-quality diagnostic test (RDT) producers provide results in 15–30
COVID-19 antigen rapid Abbott and SD Biosensor. These minutes, rather than
tests have been announced two arrangements will make hours or days, and will
by the Access to COVID-19 available to LMICs 120 million enable expansion of
Tools (ACT) Accelerator. antigen rapid diagnostic tests testing, particularly in
Organizations involved in countries that do not
the milestone agreement have extensive laboratory
include the the World facilities or trained health
Health Organization (WHO, workers to implement molecular
Africa Centres for Disease Control (polymerase-chain reaction or
and Prevention (Africa CDC), the PCR) tests. FIND and WHO are
Bill & Melinda Gates Foundation, working together to accelerate
the Clinton Health Access appropriate use by supporting
Initiative (CHAI), the Foundation implementation research that will
for Innovative New Diagnostics optimize Ag RDT use in multiple
(FIND), the Global Fund, Unitaid. LMICs, in line with WHO
As part of this comprehensive, guidance.

WHO, UNICEF WHO to stop spread
recommit to accelerate
health at all ages of harmful information

The World Health Organization (WHO) and UNICEF, also on pandemic
known as the United Nations Children’s Fund have signed
a new collaborative framework, which will accelerate The World Health Organization (WHO)
joint public health efforts that put the most marginalized together with the United Nations, specialised
and vulnerable populations first. The new strategic agencies and partners have called on
collaboration framework builds on a robust 70-year countries to develop and implement action
plans to promote the timely dissemination
collaboration between of science-based information and prevent
the two organizations, the spread of false
and prioritizes four information while
strategic areas for respecting freedom
immediate attention of expression. WHO
and action at all levels and partners urged
of the organizations: countries to engage
universal health coverage, through a primary health and listen to their
care and health systems approach; mental health and communities as they
psychosocial wellbeing and development; public health develop their national
emergencies. Additionally, the two organizations signed a action plans, and to empower communities
new joint programme on mental health and psychosocial to build trust and resilience against false
well-being and development of children and adolescents. information. UN has launched Verified,
This 10-year collaborative effort will promote mental an initiative aimed at delivering trusted
health and psychosocial well-being and development, information, life-saving advice and stories
increase access to care for mental health conditions, from the best of humanity. The initiative also
reduce suffering and enhance quality of life among invites the public to help counter the spread
children and adolescents, and their caregivers. of COVID-19 misinformation by sharing fact-
based advice with their communities.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com COVER STORY 19

REGULATE
MEDICAL
AESTHETICS
The market that is worth Over the years, the robust digital
billions of dollars in footprint of India has
India has witnessed played an instrumental
role in driving the growth of
significant growth in the technology in the healthcare
demand for aesthetic market. Going by the
figures, as per Invest India,
procedures owing to the the Indian healthcare
rise in the number of industry is projected to
be an approximately
doctors and surgeons $372 billion industry
providing effective by 2022. This
medical aesthetic growth can also be
treatments and the credited to significant
diversification of
launch of technologically healthcare services and
advanced products for easy accessibility for a
large part of the society.
the same. However, India As a result, healthcare is not
lacks proper guidelines only a need now but also a
to regulate the use of lifestyle requirement.
specific products and
One such lifestyle element in
procedures for aesthetic the healthcare market is the medical
treatment. aesthetics industry. The desire among the

Whatever your formulation needs,
we’ll find your perfect fit

Excipients for solid, semi-solid and liquid dosage forms? Drug delivery compounds?
High-risk applications?

Whatever your formulation requirements, our extensive portfolio and team
of technical and regulatory experts mean we’ll find a solution that fits your
requirements and ensures a smooth and successful journey to market.

To find out more, visit:
SigmaAldrich.com/PerfectFit

Merck, the vibrant M and SAFC are trademarks of Merck KGaA, Darmstadt, Germany or
its affiliates. All other trademarks are the property of their respective owners. Detailed
information on trademarks is available via publicly accessible resources.
© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.

20 COVER STORY BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Indian population to look young, fit, presentable partner module to explore this market till it becomes
and contemporary has led to the demand of a sizeable one. Local players understand the market
several medical aesthetics procedures such as skin and behaviour better and are accustomed to the
tightening, cosmetic implants, hair removal, hair consumer needs and requirements. India is a diverse
restoration, body contouring to name a few. and geographically challenging market. A lot of global
leaders are now looking for local collaboration not
In the past two decades, medical aesthetic only as a distribution partner but also a joint venture
procedures have become increasingly popular. The so that multiple resources could be injected and will
market that is worth billions of dollars in India has help to grow the market space”, points out Kuntal
witnessed significant growth in the demand for Debgupta, Vice President- Sales & Marketing, Reveal
aesthetic procedures owing to the rise in the number Lasers India, Mumbai.
of doctors and surgeons providing effective medical
aesthetic treatments and the launch of technologically Trends in India
advanced products for the same.
India ranks fourth in the world for the number of
“Reports about the growth of the medical cosmetic surgery procedures performed after US,
aesthetics market in India say that at the moment it is Brazil and South Korea. The North American market
ballooning at 10 per cent CAGR annually with a steady accounts for about 45 per cent of the global market.
or increasing growth rate expected with time. Back in However, the dominance is now shifting towards
2018, a growth of 5.5 per cent CAGR per annum and Asia, particularly in the energy based medical devices
a target of $73.6 billion mark were expected by 2022. segment. Asia is regarded as the next frontier and the
The market has grown more than anticipated and is number of physicians and clinics in China and India
growing faster than expected”, says Dr Debraj Shome, has been steadily rising, along with medical tourism
Director, The Esthetic Clinics, Mumbai. in the region.

Although many local players are registering India is a breeding hub for aesthetic surgeries
good growth and recognition in this sector, several with more than nine lakh procedures conducted
international companies are penetrating in India at each year and the number is gradually increasing.
a fast pace, which drives the business for both global At present, the aesthetic procedures much in
and domestic players. Some of the major companies demand include skin tightening, fat reduction of
in the Indian medical aesthetic device market include coolsculpting, anti-ageing, hair restoration and
Allergan Inc., Alma Lasers (Sisram Medical), Cutera, cosmetic implants.
Bausch Health, BTL, Lumenis, Pacific Aesthetic
India, Concord Medisys, and Timpac Healthcare.

On the global front, some of the leading players
operating in this space are Allergan-AbbVie, Alma
Lasers, Anika Therapeutics, Lumenis, Cutera, Inc.,
Cynosure, El.En. S.p.A., Fotona d.o.o., Merz Pharma
GmbH & Co. KGaA, Medytox, Inc., Sientra, Inc.,
Sinclair Pharma PLC, Syneron Medical, Venus
Concept, BTL and Bausch Health.

“When we compare the size of the market in
India to other developed countries it is very small
in number. It is a wise idea to work on a channel

LEADING AESTHETIC

TRENDS IN INDIA

● Skin tightening
● Anti-aging
● Cosmetic implants
● Fat freezing or Coolsculpting
● Hair restoration
● Tattoo removal
● Eye rejuvenation
● Nail treatment
● Hair removal

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com COVER STORY 21

The market for these aesthetic procedures is innovative product in this space of skin tightening,
typically segmented into energy and non-energy called the NuEra Tight with FocalRF technology. The
based medical devices, which are mostly imported. platform introduces a breakthrough in personalized
The energy based aesthetic devices include laser non-invasive radio frequency (RF) body treatments to
procedures, radio frequency (RF), light and match the unique needs of every patient. The product
ultrasound usage, while the non-energy based devices will be made available in India in 2021.
comprise of botox injections, dermal fillers, aesthetic
threads, microdermabrasion, implants etc. B. Coolsculpting
The only US Food and Drug Administration
A. Skin tightening (FDA) approved non-surgical fat reduction treatment,
There are a number of factors responsible for Coolsculpting delivers precisely-controlled cooling
causing skin laxity on the face, neck and body, such to target the fat cells underneath the skin, whilst
as aging, pregnancy, obesity and certain illnesses. leaving the skin itself unaffected. The science behind
Recently in India, the demand for the skin tightening this unique technology was developed by a team of
procedure has increased with increasing obesity in the researchers at the Harvard University years ago.
country. As a result, body contouring or fat reduction Unveiled few years back in India, this innovative
procedures are much in demand to tighten the skin. way to contour body by freezing unwanted fat with no
At present, various types of non-surgical skin surgery or downtime is picking up quite quickly. The
tightening devices are available, but the majority of cost can go up to several lakhs, depending upon the
the devices consist of laser energy, radiofrequency area where the procedure is conducted.
energy, ultrasound energy, or a combination of these Although Cryolipolysis or Coolsculpting is
energies to deliver heat to the skin tissue. Another currently the leading non-invasive fat removal
factor that is fueling the non-surgical devices segment technology because of its minor side effects and
is that these devices come with minimal side effects, non-invasive nature, it has certain limitations. As a
and no pain is involved in the treatment. As a number result, researchers at Harvard are now developing
of companies are planning to further establish in the a new form of the technology that can selectively
tier II cities of India, the potential demand for these reduce fat almost anywhere in the body using a safe,
devices is estimated to increase. injectable ice solution or slurry. The technology, not
For instance, Israel headquartered medical yet approved for use in humans, is being designed for
device company Lumenis has recently launched an removal of fat in the abdomen or other parts of the
body, virtually anywhere that can be reached with a
hypodermic needle.

C. Anti-ageing
The average life span of a person in India has
increased due to advancements in the field of
medicines. This has led to more people being subjected
to the anxiety that comes with the aging process.
Consequently, the motivation to look younger among
the population has increased, which is fueling the

LEADING PLAYERS OF MEDICAL
AESTHETIC DEVICES IN INDIA

● Allergan India (Bengaluru)
● Alma Lasers India (Mumbai)
● Lumenis India (Gurugram)
● Cutera Healthcare (Hyderabad)
● Venus Concept India (Surat)
● BTL India (Bengaluru)
● Bausch Health India (Gurugram)
● Pacific Aesthetic India (Mumbai)
● Concord Medisys (New Delhi)
● Timpac Healthcare (New Delhi)

22 COVER STORY BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

“Back in 2018, a growth of 5.5 per cent CAGR per demand for anti-aging products and devices in India.
annum and a target of $73.6 billion mark were Manufacturers of anti-aging devices and products
expected by 2022. The medical aesthetics market
has grown more than anticipated and is growing are making increasingly expensive and elaborate
faster than expected.” marketing campaigns to promote the concept of ideal
- DR DEBRAJ SHOME, image in the minds of the consumers. Additionally,
Director, The Esthetic Clinics, Mumbai technological advancements in such devices have
decreased the side-effects as well, making its youthful
“A lot of global leaders are now looking for local effect last longer on the skin. These factors are
collaboration not only as a distribution partner resulting in the increasing adoption of anti-aging
but also a joint venture so that multiple resources solutions in India.
could be injected and will help to grow the
market space.” The most common anti-ageing procedures include
- KUNTAL DEBGUPTA, the application of botulinum toxin (botox), chemical
Vice President- Sales & Marketing, peeling, microdermabrasion, skin rejuvenation and
Reveal Lasers India, Mumbai dermal fillers. Of lately, RecoSMA has emerged
as a revolutionary laser technology that is being
“As in India, all the dental equipment is imported increasingly used for antiaging treatment. Developed
as their quality hasn’t been different for many and patented by a European company Linline, it is the
years. Diamond burs are not specifically cheaper world’s first cold rejuvenation laser therapy for anti-
than the present alternatives but they are ageing, stretch marks and skin lifting treatments.
definitely cost effective in the long run.”
- MALAY DIKSHIT, D. Hair restoration
Founder & Chief Executive Officer, Majority of male population especially in their
Piscium Health Sciences, Mumbai 20s have been tackling with baldness issue. With
rise in concern over hair loss, consumers seek for
relevant solution or treatment on a long-term basis.
This one factor has led to increase in demand for hair
restoration treatments.
The current gold standard for hair transplants
is called Follicular Unit Extraction, which is an
advanced surgical hair restoration technique, less
invasive than traditional hair transplants. On the
other hand, Platelet Rich Plasma (PRP) therapy is
an advanced, non-surgical, therapeutic procedure to
treat hair loss conditions in India.
According to a recent study conducted in
India, a patented treatment for hair regrowth
therapy for men and women called QR 678, has
proven to be more effective than PRP as a hair loss
treatment. Invented by Dr Debraj Shome and Dr
Rinky Kapoor, cosmetic surgeons at The Esthetic
Clinics in Mumbai, QR 678 has shown significant
improvement in hair regrowth with almost 100
per cent reduction in hair fall. The formulation has
received patents in the US and India.
“PRP is used by all dermatologists and plastic
surgeons for hair growth. PRP involves extracting
platelets from human blood and injecting it into
the scalp to cause hair growth. But, the truth
of the matter is that this therapy is more based
on hope than actual science. There has never
been a randomised controlled trial showing that
PRP actually causes hair growth. That is why we
conducted a comparative trial between the QR678
and PRP treatments and no surprises that the QR678
treatment caused almost 300 per cent better results

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com COVER STORY 23

than the PRP”, shares Dr Rinky Kapoor, Cosmetic “Cost and affordability pose a major challenge for
Surgeon, The Esthetic Clinics, Mumbai. the medical aesthetics devices market in India.
Additionally, lack of reimbursement scenario
E. Cosmetic implants and non-coverage of several dermatological
Cosmetic implants have enabled convenient procedures under health insurance plans, social
replacement of dysfunctional or missing body parts stigma concerns might impede the market
and it is easier for patients to regain previous loss growth over the next few years.”
in aesthetics, or enhance the same. Dental implant - KARAN CHECHI,
is one of the major segments within the cosmetic Director, TechSci Research, Noida
implants market in India followed by facial and
breast implants. In the recent years, there has been “The dental implants that are imported are
an increase in the R&D activities to develop efficient expensive and the companies making them are
techniques, materials, and designs for these implants
resulting in the production of novel products. unwilling to share the technology, so we have
For instance, a group of researchers from Indian made indigenous implants.”
Institute of Technology, Delhi (IIT-Delhi) and
Maulana Azad Institute of Dental Sciences (MAIDS) - PROF. NARESH BHATNAGAR,
have developed a new technology for dental implants, Scientist, Department of
which they say would be user-friendly and affordable
solution for the treatment of missing tooth. These Mechanical Engineering, IIT-Delhi
implants can work for all kind of conditions like
single or multiple missing teeth and even for “Our country lacks the infrastructure required
providing full denture. to simplify new age technologies and enable
“It took us 10 years to come up with this researchers and clinicians to implement these in
technology. We have learnt to make it to the best of
perfections, tolerances and fits. The implants that are routine practice.”
imported are expensive and the companies making - DR PRADEEP MAHAJAN,
them are unwilling to share the technology so we have Regenerative Medicine Researcher,
made indigenous implants. A kit containing all types of StemRx Bioscience Solutions, Mumbai
surgical drills and components together with universal
prosthetic components has also been developed”,
mentions Prof. Naresh Bhatnagar, Scientist,
Department of Mechanical Engineering, IIT-Delhi.

Increasing male indulgence

When compared with female aesthetics market, male
grooming is a smaller one, but the gap is gradually
getting narrow due to dropping taboos. Moreover,
with the entry of many aesthetic treatments for
males, the Indian market is full of options as Indian
men are getting more conscious and are increasingly
indulging in self-care than ever before.

Anatomical differences between the two sexes
account for a majority of variation in facial soft
tissues and thus require customized procedures to
better meet male aesthetic goals. Out of the many,
body sculpting treatments through fat-freezing and
thermage using radio waves are among the most
popular for men across ages and income groups. In
fact, it is gynecomastia correction or the male breast
reduction surgery that has become a rage these days
but it comes with a set of side-effects.

“In contrast to minimally invasive surgery where
we just do liposuction for gynecomastia correction
and remove gland through periareolar incision, after

24 COVER STORY BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

LEADING GLOBAL PLAYERS “The truth of the matter is that PRP therapy is
more based on hope than actual science. There
OF MEDICAL AESTHETIC DEVICES has never been a randomised controlled trial
showing that PRP actually causes hair growth.
● Allergan-AbbVie (US) That is why we conducted a comparative trial
● Sisram Medical (Israel) between the QR678 and PRP treatments and
● Anika Therapeutics (US) no surprises that the QR678 treatment caused
● Lumenis (Israel) almost 300 per cent better results than the PRP.”
● Cutera (US) - DR RINKY KAPOOR,
● Cynosure (US) Cosmetic Surgeon, The Esthetic Clinics, Mumbai
● El.En. S.p.A (Italy)
● Fotona (Slovenia)
● Merz Pharma GmbH & Co. KGaA (Germany)
● Medytox, Inc. (South Korea)
● Sientra, Inc. (US)
● Sinclair Pharma PLC (UK)
● Syneron Medical (US)
● Venus Concept (Canada)
● BTL (Czechia)
● Bausch Health (Canada)

mastectomy and surgical breast reduction there is required to make the decision”, mentions Rahul
a down time, and leaves behind scar. Sometimes Choudhary, Country General Manager, Allergan
haematoma and infection also occurs. Rarely one Aesthetics India, Bengaluru.
can see skin necrosis but numbness persists for few
months”, says Dr Vinod Vij, Consultant, Cosmetic Another big challenge is the pricing issue. Due
& Reconstructive Surgery, Apollo Hospitals, Navi to fierce competition, aesthetic practitioners charge
Mumbai. a huge amount of money for these treatments.
There is yet to be a good solution to overcome this
Challenges and issues malpractice.

Though the aesthetic industry is experiencing a “Cost and affordability pose a major challenge
boom, India lacks proper guidelines to regulate the for the medical aesthetics devices market in India.
use of specific products and procedures for aesthetic Additionally, lack of reimbursement scenario and
treatment. There exist only limited mechanisms to non-coverage of several dermatological procedures
prevent the use of demonstrably harmful procedures. under health insurance plans, social stigma concerns
One of the most important challenge in this field is might impede the market growth over the next few
that patients often come with unrealistic expectations years. Clinical risks and complications associated
fuelled by misleading advertisements and are with different cosmetic procedures might also restrict
pressurized to undergo procedures, which may or the market growth. To overcome the challenges, there
may not be beneficial to them. is a strong need to implement guiding principles on
the practice of aesthetic medicines by the medical
“The Indian law that regulates quality and safety industry. Evidence-based practice is probably the
of medical devices now applies to all medical devices, best approach and doctors should be competent and
effective April 1, 2020. However, there is still a lot adequately trained before performing any treatment
to be done to make sure that credibility, safety and or procedure on a patient”, shares Karan Chechi,
efficacy of all medical devices have been validated Director, TechSci Research, Noida.
and registered. Consumers today, still lack channels
to access information, which will empower them Innovative alternatives
to make the sound decision about their treatment
option. The industry should put in more efforts Stem cell therapies are at the forefront of regenerative
on educating consumers on how they can make a aesthetic medicine. Clinical trials are being conducted
fair judgement, to understand and differentiate in different countries on performing stem cell
between the varying qualities of medical aesthetics replacement for aesthetic treatments and India is
products and services, how to find well trained no exception. A number of aesthetic procedures are
and experienced doctors, how to make the most being offered using stem cells for hair transplant,
of a doctor consultation to obtain the information cosmetic dentistry, anti-aging, skin resurfacing etc.
But then again, there persist challenges related to

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com COVER STORY 25

“In contrast to minimally invasive “The industry should put in more efforts on educating
surgery where we just do liposuction consumers on how they can make a fair judgement, to
for gynecomastia correction and understand and differentiate between the varying qualities
remove gland through periareolar of medical aesthetics products and services, how to find
incision, after mastectomy and surgical well trained and experienced doctors, how to make the
breast reduction there is a down time, most of a doctor consultation to obtain the information
and leaves behind scar.”
- DR VINOD VIJ, required to make the decision.”
Consultant, Cosmetic & Reconstructive - RAHUL CHOUDHARY,
Surgery, Apollo Hospitals, Navi Mumbai
Country General Manager,
Allergan Aesthetics India, Bengaluru

regulations and ethics concerning clinical application for implants. “We have grown nano sized synthetic
of such therapies. diamonds on a specialized grade metal for a long
lasting smoother cavity. Our diamond burs are the
“Everyone looks for minimally invasive world’s first ever product of its kind in the market
therapeutic modalities and this is where regenerative and it has a huge potential. As in India, all the dental
medicine or stem cell therapy scores. This effective equipment is imported as their quality hasn’t been
treatment minimizes the risk of infection possible different for many years. Diamond burs are not
due to surgery, treatment duration, and recovery specifically cheaper than the present alternatives but
period. Individuals therefore have begun to choose they are definitely cost effective in the long run as
this over conventional treatments. Nonetheless, they are long lasting and they give better results to
despite increasing awareness regarding the complete patients, which is the main concern with any doctor”,
potential of regenerative medicine, cell-based says Malay Dikshit, Founder & Chief Executive
therapy etc., the science is still in nascent stages. Our Officer, Piscium Health Sciences, Mumbai.
country lacks the infrastructure required to simplify
new age technologies and enable researchers and Though nanotechnology is considered to be the
clinicians to implement these in routine practice”, most promising and revolutionizing field, there are
says Dr Pradeep Mahajan, Regenerative Medicine huge controversies regarding the toxicity and safety
Researcher, StemRx Bioscience Solutions, Mumbai. of the nanomaterials. Various researches are being
carried out to determine the possible health hazards
Besides stem cell therapy, another innovative and toxicity. However, with the recent release of
alternative is nanotechnology. The technology is guidelines for the evaluation of nanoformulations
being increasingly used to encapsulate actives that by the government, the much required streamlining
are water-soluble and hard to penetrate in skin might come into play.
such as vitamin C, peptides and retinol and drive
them deeper into skin where they could deliver their Considering the fact that beauty enhancement is
benefits of rejuvenating skin. an essential part of our lifestyle, we need to relook at
streamlining the medical aesthetic sector in order to
Bhubaneshwar based startup Clinilogic Aesthetics ensure patient safety. There is a strong need to create
and Wellness Clinic is utilizing nanotechnology to more awareness on the different aesthetic procedures
develop an innovative nano-encapsulated serum and their consequences. In addition, the ongoing
for skin hyperpigmentation treatment. The startup pandemic has given India an opportunity to increase
is currently being supported and funded by the domestic manufacturing of the aesthetic devices and
Biotechnology Industry Research Assistance Council open a new era of business.
(BIRAC).
Dr Manbeena Chawla
Another startup being funded by BIRAC in this [email protected]
space is Mumbai based Piscium Health Sciences
that has developed nano engineered dental burs (with inputs from Pooja Yadav)

26 COVID-19 BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Is COVID-19
sidelining NCDs?

The pandemic has affected the supervision of non-communicable diseases (NCDs) not only in
terms of overshadowing their severity and hazards but also in prioritization of their therapeutic
consideration. Although a number of initiatives are being carried out by the industry and
government to address this, there is also the urgent need to build a national strategic framework
for managing NCDs during a pandemic.

India has seen a rapid socioeconomic transition like infections as well as consequent complications.
in recent decades, which has resulted and This leads to an even more vulnerable situation when
reflected in a transition of disease epidemiological a patient suffering from diabetes also has kidney
patterns. Mortality due to communicable, maternal, involvement or diabetic-nephropathy, chronic kidney
neonatal, and nutritional diseases (CMNNDs) has disease etc.,” says Dr Jitendra Singh, Minister for
seen a decline while that from non-communicable Development of North Eastern Region, Government
diseases (NCDs) and injuries has seen a rise. As per a of India, New Delhi.
study by Indian Council of Medical Research (ICMR),
Public Health Foundation of India (PHFI), Institute In addition to the pathophysiological
for Health Metrics and Evaluation (IHME) and susceptibilities of NCD patients, operational aspects
Ministry of Health and Family Welfare (MoHFW), have also impacted chronic care management.
NCDs contribute to 61.8 per cent deaths from major Healthcare staff in the areas of NCDs have been
disease groups, an increase of approximately 25 per given responsibility to manage COVID-19 patients
cent in the last 25 years. impacting NCD medical advice, monitoring,
restricted inpatient, outpatient, emergency
With an average 9.7 million deaths in India in a treatment, palliative care and reduced laboratory
year, NCDs such as cardiovascular diseases, chronic investigations thereby limiting ability to diagnose
respiratory diseases, cancer and diabetes fall in new NCD patients.
the top 5 disease groups contributing to mortality
burden. NCDs continue to cast their effect while Further, hospitals have been converted
the country remains at its forefront to battle the into dedicated COVID-19 care centers, elective
COVID-19 pandemic. The pandemic has affected
NCD supervision not only in terms of overshadowing
their severity and hazards but also in prioritization of
their therapeutic consideration.

Fear of contracting COVID-19 has forced people
to stay isolated leading to postponement in seeking
medical attention. Health authorities worldwide are of
the opinion that coronavirus possesses higher threat
to patients with comorbid conditions. For instance,
underlying conditions such as hypertension, heart
disease, diabetes and chronic lung diseases are risk
factors as SARS-CoV-2 leads to activation of the local
renin angiotensin system (RAS) in lungs and heart
predisposing comorbid patients to a cytokine storm.

“Those suffering from diabetes have an immuno-
compromised status, which tends to reduce their
resistance and make them more vulnerable to corona

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com COVID-19 27

procedures have been postponed and certain private PPeerrcecnetnotfodfedatehasthtosttootatlodtaeal tdhesaths
practitioners and nursing homes are temporarily
closed. It has also been reported that average daily 30% 28%
hospitalization under the Centre’s health insurance
scheme, Ayushman Bharat-Pradhan Mantri Jan 25%
Aarogya Yojana (AB-PMJAY) dropped by 70-90 per
cent during the lockdown. However, critical services 20% 16%
such as chemotherapy and dialysis saw a controlled 15% 11%
decline of 15-20 per cent, indicating the need for 10% 8% 7%
a balanced approach to tackle NCDs amidst the
pandemic, and not sidelining them. 5%

Bringing solutions at doorstep 0%

Given the situation it becomes vital to control NCD Cardiovascular Diarrhoea, lower Chronic Cancers Diabetes,
risk factors and in parallel explore solutions ensuring respiratory urogenital, blood,
essential medical advice is accessible to patients. The diseases respiratory &
government has taken multiple initiatives to cover diseases and endocrine
the umbrella of NCDs in order to manage their timely other infectious diseases
screening, diagnosis and treatment. This includes
approving and releasing guidelines for usage of diseases
telemedicine and further launching tele-consultation
service e-Sanjeevani offering free e-health services Source- healthdata.org
for a number of diseases including NCDs. In addition,
the government has also launched Ask Ayushman DROP IN OPD VISITS
chat bot on WhatsApp, a 24 x 7 artificial intelligence
(AI) enabled assistant for locating the nearest Disease April 2020 (%) June 2020 (%)
empaneled hospital along with a hospital ranking 64
dashboard’ to rank empaneled hospitals on basis of Acute Heart Disease 70 35
beneficiaries’ feedback. 59
Diabetes 44 36
“It is painful to know that in few districts the
fatality rate due to COVID-19 is higher than the Oncology 74
national average. We need to ensure that non-
COVID-19 services and programmes like National Stroke 57
Tuberculosis Elimination Programme (NTEP),
maternal and child health, dialysis, chemotherapy, Source- National Health Mission- Health Information
vaccination, immunization etc. are not hampered Management System (as on Sept 26, 2020)
due to emphasis on COVID-19 management. The
data available with the states on Health Management disease across the globe, accessible heart care has
Information System (HMIS) for various diseases may never been more important. AliveCor’s expansion
be optimally utilised for risk profiling”, shares Dr into India is pivotal to our mission of providing
Harsh Vardhan, Union Minister of Health and Family remote, medical-grade heart care to those, who
Welfare, Government of India, New Delhi. need it most. Considering the ongoing health crisis,
use of KardiaMobile 6L reassures optimal clinical
Besides key steps being taken by the government, control and caters to the need for efficient tools for
the industry is also working on a number of solutions safe out-of-hospital management. For patients with
to help the country manage the increasing burden of pre-existing conditions or those, who feel a symptom,
NCDs at this critical hour. For instance, with more it provides convenience to track heart health on-the-
than 250 million people at the risk of heart disease in go without hospital visits”, says Priya Abani, Chief
India and stay- at- home regulations, it is becoming Executive Officer, AliveCor, USA.
difficult for people to track their heart conditions. As
a result, US based AliveCor has launched a personal Regular monitoring of blood pressure (BP) is the
ECG device KardiaMobile 6L in India, for the basic way to keep heart disorders under track. BP
detection of the three most common arrhythmias or devices therefore form a rudimentary component for
irregular heartbeats—atrial fibrillation, bradycardia sustaining a healthy lifestyle. In consequence, sales of
and tachycardia in 30 seconds at home. BP monitoring devices have seen a spike. Gurugram
based Omron Healthcare India has recorded a growth
“With hundreds of millions at risk for heart of 30 per cent in sales of its BP monitoring devices.
The company therefore has added digital BP monitors
in their portfolio with innovative features. The
company has also partnered with artificial intelligence
(AI) enabled healthcare management player
PhableCare, based in Bengaluru, to provide a one-stop
remote hypertension management services at home.

“With autonomous and digital healthcare
becoming a reality in the new normal, this association
will usher in India’s first-of-its-kind remote
hypertension management service. So far, we have
been contributing towards empowering people to
keep track of their heart health by providing quality
digital BP home monitoring solutions. However, with

28 COVID-19 BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

“Those suffering from “With autonomous and digital
diabetes have an immuno- healthcare becoming a reality in
the new normal, our association
compromised status,
which tends to reduce their with PhableCare will usher in
resistance and make them India’s first-of-its-kind remote
more vulnerable to corona
hypertension management
like infections as well as service.”
consequent complications.” - Masanori Matsubara,
Managing Director,
- Dr Jitendra Singh,
Minister for Development of North Eastern Region, Omron Healthcare India, Gurugram

Government of India, New Delhi

“We need to ensure that the merging of our synergies with PhableCare, we
non-COVID-19 services will be able to make millions of patients utilise the
monitoring services efficiently under the supervision
and programmes are not of doctors from the comfort of their homes. The
hampered due to emphasis patients will get access to an accurate monitoring
on COVID-19 management. device, proper diagnosis, prescription, real time
The data available with the tracking and monitoring, and even efficient drug
states on Health Management delivery and risk analysis under this solution”, points
Information System (HMIS) out Masanori Matsubara, Managing Director, Omron
for various diseases may be Healthcare India, Gurugram.

optimally utilised for risk With medical care getting advanced, home based
profiling.” care for cancer patients is also gradually picking
- Dr Harsh Vardhan, up provided there have been no adverse reactions
after initial chemotherapy sessions and protocol is
Union Minister of Health and Family Welfare, approved by the oncologist. Bengaluru based Portea
Government of India, New Delhi Medical has launched chemotherapy at home services
in Delhi, Bengaluru, Mumbai, Chennai and Kolkata
“Considering the ongoing with plans of expansion in tier 2 cities.
health crisis, use of
On the other hand, Bengaluru based startup
KardiaMobile 6L reassures Niramai has launched home screening services for
optimal clinical control breast cancer. In light of the inaccessibility of hospital
Outpatient Departments (OPDs) and diagnostic
and caters to the need for labs in recent times and possibly in the near future,
efficient tools for safe out- launch of this new format comes as a boon to women.
of-hospital management for
“In recent weeks, there has been a sea-change in
heart care” the way consumers access various healthcare services.
- Priya Abani, There is a growing acceptance of digital and home-
based services. Keeping in mind the importance of
Chief Executive Officer, AliveCor, USA routine breast health screening for early detection
of abnormalities, we have launched home screening
“Keeping in mind the service in Bengaluru to start with. We also look
importance of routine breast forward to working with partners and offering this in
other cities. The process is privacy-aware and since
health screening for early it is entirely non-invasive, it works well with the
detection of abnormalities, requirement for physical social distancing in these
times”, shares Dr Geetha Manjunath, Founder &
we have launched home Chief Executive Officer, Niramai, Bengaluru.
screening service in Bengaluru
In order to manage the increasing number of
to start with. We also look chronic respiratory diseases during the ongoing
forward to working with pandemic, an innovative solution has been
developed by the researchers at the Indian Institute
partners and offering this in of Technology (IIT) in Kharagpur in the form of
other cities.”
- Dr Geetha Manjunath,
Founder & Chief Executive Officer,
Niramai, Bengaluru

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com COVID-19 29

“Making life-changing “We have partnered with
technology available online emerging Indian business such
enables more diabetic patients as Phable, Wellthy Therapeutics
to remotely access the care they
need, which is especially critical and PharmEasy to create a
and timely given the current holistic ecosystem of care for
diabetes by joining hands with
pandemic environment.”
- Kalyan Sattaru, like-minded partners.”
- Omar Sherief Mohammad,
General Manager, Diabetes Care, Country Head,
Abbott India, Mumbai
Roche Diabetes Care India, Mumbai

an affordable diagnostic intervention for Chronic “SenFlex.T can be used at home
Obstructive Pulmonary Disease (COPD) based on by COPD patients without
the internet-of-things medical devices (IoT-MD) having to visit diagnostic
integrated with AI. The product cost has been
estimated at about Rs 2500. centres as against the current
practice.”
“SenFlex.T can be used at home by patients - Dr Dipak Kumar Goswami,
without having to visit diagnostic centres as against
the current practice. This will also address the critical Professor, Department of Physics, IIT, Kharagpur
issue of addressing COPD at an early stage and by
means of advanced healthcare technology, a boon for Care has announced new partnerships with startups
both patients and the overall healthcare system”, says providing digital healthcare services in order to
Dr Dipak Kumar Goswami, Professor, Department of enhance its reach to people with diabetes. Roche has
Physics, IIT, Kharagpur. also reported higher growth during the pandemic
with online sales for blood glucose monitoring
In addition, with studies showing that patients devices increased from 5-8 per cent to 15 per cent of
with diabetes face an increased risk of a severe the overall sales.
form of the COVID-19 disease and resultant
death, diabetes management has become a huge “We have partnered with emerging Indian
cause of concern lately. In the past few months, businesses such as Phable, Wellthy Therapeutics
teleconsultation services by hospitals and diabetes and PharmEasy. These are part of the company’s
clinics have been of great assistance and this is public-private-partnership model to create a holistic
apparent with the spike in online consultations. ecosystem of care for diabetes by joining hands
with like-minded partners”, mentions Omar Sherief
In a move to expand access and empower Indian Mohammad, Country Head, Roche Diabetes Care
patients to take charge of their health especially at India, Mumbai.
this crucial time, American multinational medical
devices and healthcare company Abbott and Although a number of initiatives are being carried
Gurugram based online pharmacy and healthcare out by the industry and government, there is also the
platform, 1mg have recently announced their urgent need to build a national strategic framework
collaboration to make Abbott’s continuous glucose for managing NCDs during a pandemic. The World
monitoring (CGM) products available online, Health Organisation (WHO) since declaring COVID-19
including its professional flash glucose monitoring as a pandemic has also suggested that COVID-19
system, FreeStyle Libre Pro. could continue to affect countries across the world,
even if the current pandemic subsides, suggesting the
“An on-site phlebotomy service will be provided possibility of outbreaks later in the future.
at the patient’s home with a phlebotomist helping
the patient administer the sensor and take readings With the recent launch of the National Digital
of the data after 14 days, enabling them to start using Health Mission, this agenda for optimal management
the device. Making this life-changing technology of NCDs with the most appropriate available healthcare
available online enables more patients to remotely resources using a strategic framework is in need of
access the care they need, which is especially critical immediate attention for better health outcomes.
and timely given the current pandemic environment”,
says Kalyan Sattaru, General Manager, Diabetes Care, Swati Shrivastava
Abbott India, Mumbai.

Another key player in the space, Roche Diabetes

30 WORLD DIABETES DAY BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Diabetes Specialist Nurses –
future ready health coaches

This World Diabetes Day (November 14, 2020) with the theme ‘Diabetes: Nurses Make The
Difference’ focuses on empowering Diabetes Specialist Nurses (DSNs) to improve patient
outcomes and deliver cost-effective diabetes care. Today nurses are increasingly becoming ‘health
coaches’ and in future, they will play a significant role in preventive medicine.

Ever since the COVID-19 outbreak happened greater risk of COVID-19 among diabetics across
in China, much attention has been given to the world, the World Health Organization (WHO)
people with diabetes because of poor prognosis and the International Diabetes Federation (IDF)
in those with the infection. Initial reports were this year, has focussed its efforts on empowering
Diabetes Specialist Nurses (DSN), who can be
mainly on people with type 2 diabetes, although instrumental in diabetes management even during
these unprecedented times. So, the theme for this
recent surveys have shown that individuals with type year’s World Diabetes Day, observed on November
14, 2020 is ‘Diabetes: Nurses Make The Difference’.
1 diabetes are also at risk of severe COVID-19. Now, The campaign aims to raise awareness around the
crucial role that nurses play in supporting people
another study published in the New England Journal living with diabetes.

of Medicine reveals that there is a bidirectional Role of Diabetes Specialist Nurses

relationship between COVID-19 and diabetes. Diabetes Specialist Nurses (DSN), are central to
good patient care and outcomes that include building
The report says that diabetes is associated with confident self-care management among patients.
Dr V Mohan, Chairman & Chief Diabetologist, Dr
an increased risk of severe COVID-19 as well as Mohan’s Diabetes Specialities Centre, Chennai says,
“DSNs are a valuable addition to any diabetes clinic.
researchers find new-onset diabetes and severe They play a vital role, both in the outpatient diabetes
clinic and also in the in-patient diabetes services.
metabolic complications of pre-existing diabetes, In the latter situation, they can help in starting of
intravenous fluids, form part of the team for the
including diabetic ketoacidosis and hyperosmolarity treatment of diabetic ketoacidosis, hypoglycemia
or other diabetes emergencies like a hyperosmolar
for which exceptionally high doses of insulin are and nonketotic coma. In some clinics, DSNs are also
trained to screen other comorbid conditions like
warranted, have been observed in patients with hypertension and depression. The role of DSN is
therefore multifold and they form one of the most
COVID-19. These manifestations of diabetes pose important team members in the diabetes clinics.”

challenges in clinical management and suggest According to Elizabeth Joseph, Chief of Nursing,
Wockhardt Hospital, Mumbai, the DSN is often the
complex pathophysiology of first point of contact for the patient and also a liaison
between patient and other healthcare professionals.
COVID-19–related diabetes. This multidisciplinary team includes physician and

All these scientific

evidence indicate that

diabetes management during

COVID times and even post

the pandemic will become a

priority for both healthcare

providers and people alike. This

new development also gives

much scope to diabetes clinics

to expand their services and

introduce newer packages

and reach out to as many

people across the country.

Moreover, in keeping

with the scope and

In 2020, according to the International Diabetes Federation
(IDF), 463 million people have diabetes in the world and 88 million people
in the Southeast Asia region. Of this 88 million people, 77 million belong to India.
The prevalence of diabetes in the population is 8.9 per cent, according to the IDF.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com WORLD DIABETES DAY 31

other specialists such as neurologists, nephrologists, “To master the skills and
diabetologists, ophthalmologists, foot surgeons, knowledge they will need for
dietitian, physiotherapist and clinical pharmacists.  this level of responsibility, it is
imperative that they commit
Likewise, Dr Sweta Budyal, Consultant
Endocrinologist & Diabetologist, Fortis Hospital, themselves to a rigorous
Mumbai shares a perspective on how the role differs educational programme leading
between in-patient and out-patient services, “For
inpatients, the first and foremost is to implement to an associate’s degree that
the protocols set for screening all admitted patients will likely involve the study of
for detecting high glucose and to monitor patients nutrition, microbiology, anatomy
with diabetes and non-diabetics found to have high
glucose for the first time. Then subsequently the and physiology, acute care,
focus is on executing the plan made by the treating pharmacology, medical/surgical
team for the management of high glucose, along with
ongoing education and sensitisation of the patients nursing and possibly maternal
about the importance of lifestyle modification, insulin and newborn nursing.”
injection technique etc. The role and responsibility of - Dr Wasim Ghori,
the nurses on the other hand is completely different
in outpatient setups. They help the clinicians in Group Medical Director, Physician & Diabetologist -
obtaining the basic information, creating proformas AMSYS Heart & Diabetes Clinics, Mumbai
for good data-keeping and doing preliminary
examinations like vitals and anthropometry data. The “The DSN is often the first
role of nurses with respect to patient education is of point of contact for the
paramount importance when it comes to educating
and empowering patients about various aspects of patient and also a liaison
care, along with nutritionists and diabetes educators. between patient and other
They complement the roles and responsibilities of
each of the care team member.” healthcare professionals.
This multidisciplinary team
However, in India, the concept of DSNs is less includes physician and other
understood and sometimes even undervalued. specialists such as neurologists,
But there are some healthcare providers, who are nephrologists, diabetologists,
increasingly focusing on reiterating the significance ophthalmologists, foot surgeons,
of DSN teams. Some ways by which healthcare dietitian, physiotherapist and
providers can empower DSNs to improve patient
outcomes include through proper education and clinical pharmacists.”
training and using technology. - Elizabeth Joseph,

Through education and training: “I think the Chief of Nursing, Wockhardt Hospital, Mumbai
most effective approach would be to take them
through a structured Diabetes Education Programme TOP 20 DIABETES CLINICS IN INDIA
along with ongoing training about various aspects
of diabetes care like nutrition, exercise, basics of S No Name
insulin and oral diabetes medications, management 1 Advanced Diabetes Centre
of hypoglycaemias, daycare of diabetic patients, foot 2 Ahalia Diabetes Hospital
care, and screening for associated Cardiovascular 3 Atharva Speciality Clinic
Diseases (CVD)”, say Dr Sweta.  4 Ayur DiabaPro Diabetes Clinic
5 Centre Of Excellence For Diabetes & Obesity
Similarly, Elizabeth explains that a diabetic 6 DEW Clinic
specialist nurse plays a crucial role in various 7 Diabcare India Diabetes Center
teaching and training activities related to diabetic 8 Diabetacare
programmes. They undergo specialised diabetes 9 Dr. Manohar K Nageshappa Clinic
training programmes in diabetic management. 10 Dr. Mohans Diabetes & Specialities Centre
The certified Diabetes Nurse Educator is a health 11 Dr.Vishal Gupta’s Advantage
professional, who possesses comprehensive 12 GD Hospital & Diabetes Institute
knowledge and experience in pre-diabetes, diabetes 13 Gleneagles Global Hospitals
prevention and management in consultation with the 14 Glucowell Diabetes Centre
physician. The eligibility criterion for admission to 15 Kandar Diabetes Centre
16 Life Span Diabetes Clinics
17 M V Hospital For Diabetes
18 My Diabetes Clinic
19 Samatvam Diabetes Centre
20 Swasthya Diabetes Care

Source: SiliconIndia

32 WORLD DIABETES DAY BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

“DSNs are a valuable addition to “Online diabetes courses
any diabetes clinic. They play a and modular about diabetes
vital role, both in the outpatient training can be an important
diabetes clinic and also in the resource. Sharing of experience
with other nurses and nursing
in-patient diabetes services. The societies across the globe to
role of DSN is therefore multifold learn about the best practices
in the field, would make a huge
and they form one of the most
important team members in the difference.”
- Dr Sweta Budyal,
diabetes clinics.”
- Dr V Mohan, Consultant Endocrinologist & Diabetologist,
Fortis Hospital, Mumbai
Chairman & Chief Diabetologist, Dr Mohan’s
Diabetes Specialities Centre, Chennai

this programme is a graduate degree in nursing. The admissions. Nurses can run telephone helplines, as
duration of this course is for three months. Diabetic well as hold telephone appointments or ‘check-ins’,
educators are empowered to manage their diabetic to support rather than substitute direct contact care”,
patients by teaching, coaching and guiding them to explains Dr Ghori.
understand the disease and the effects on personal,
professional and behavioural aspects of an individual Likewise, Dr Sweta adds, “Online diabetes courses
and how to improve their health. On the other hand, and modular about diabetes training can be an
they facilitate in training other nursing staffs to be important resource. Sharing of experience with other
professionally skilled in handling diabetic patients. nurses and nursing societies across the globe to learn
about the best practices in the field, would make a
Adding to this, Dr Wasim Ghori, Group Medical huge difference.”
Director, Physician & Diabetologist - AMSYS Heart
& Diabetes Clinics, Mumbai, shares, “To master the Role in times of COVID
skills and knowledge they will need for this level
of responsibility, it is imperative that they commit Experts observed that DSNs have played a pivotal
themselves to a rigorous educational programme role in the current COVID-19 pandemic, right from
leading to an associate’s degree that will likely involve screening and segregating of patients at the entry
the study of nutrition, microbiology, anatomy and point, implementation of safety protocols set by the
physiology, acute care, pharmacology, medical/ institutional Infectious Disease Department, smooth
surgical nursing and possibly maternal and newborn running of the diabetes clinics, boosting the morale
nursing.” of patients in difficult times, along with their regular
roles and responsibilities related to diabetes care.
Empowering using technology: We are all aware
that technology has not only emancipated healthcare “During these unprecedented times, nurses have
providers but have raised the quality of patient care been on their toes to provide round-the-clock care and
in every aspect of healthcare delivery. Hence, the support to patients with diabetes. The sole motto was
effective use of technology is extremely crucial to to make sure that the patients receive timely care and
diabetes caregivers. “Increasing the accessibility and intervention. Routine care of diabetes was significantly
convenience of care is important and telemedicine disrupted during the current COVID-19 pandemic.
is now viewed as a way to provide guidance to Stress levels and disruptions to diet and physical
patients about next steps or when to seek advice activity also contribute to worsening outcomes
from a health professional. Telemedicine involves during a pandemic. Hence, with the help of an online
specialist assessment and active listening to meet platforms DSNs and the patients can easily connect
patients’ information needs and educate them on and modify necessary treatment regimens and ensure
symptom control and is particularly well-received better diabetes management”, says Elizabeth.
for people with long-term conditions. Furthermore,
diabetes care should be patient-centred and tailored In the same light, nurses today are increasingly
to the individual to promote confidence in self- becoming ‘health coaches’ and in future, they will
management. Telemedicine is a cost-effective way for play a significant role in preventive medicine. It is
nurses to deliver care. As well as enabling follow-up time that this diabetes day, the industry, patient
for some recently discharged patients without them communities and decision-makers of healthcare
needing to visit a clinic or make an appointment, it policies in India stand up for the remarkable efforts
purportedly reduces the number of acute hospital taken by the nursing community to curb and manage
the diabetes epidemic in our country.

Raelene Kambli

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com Q&A 33

“Strong evidence showing positive
impact of Digital Vaccines
candidate for infectious diseases”
Digital Vaccines, a new frontier of disease
prevention through technology is touted to «
bring in new scientific breakthroughs for
future disease management and epidemics. Bhargav Bhargav Sri Prakash,
Sri Prakash, who is a US-based engineer and deep Founder & CEO,
tech entrepreneur of Indian origin, is the inventor FriendsLearn,
of Digital Vaccines. He has founded the Silicon Chennai
Valley and Chennai based life science company
called FriendsLearn that has developed this first in decade of life science research and clinically proven
class neurocognitive training technology platform innovations led by scientists and domain experts
and serves as the research translation partner of the at Carnegie Mellon University, Johns Hopkins
Digital Vaccine Project. He elaborates on how the University Bloomberg School of Public Health,
company has expanded a longstanding partnership Baylor College of Medicine, Stanford University
with data scientists and AI researchers at the Heinz School of Medicine, Hofstra University, the
College of Information Systems and Public Policy University of Michigan - Ann Arbor, Children’s
at Carnegie Mellon University (Pittsburgh, USA) to Mercy Hospital, Kansas University Medical Center,
undertake a proposed population health human trial National University of Singapore, Oxford University
with a Digital Vaccine candidate. In an interaction & Voluntary Health Services Hospital in Chennai.
with BioSpectrum explains how their research Based on this scientific work to prove the safety and
will lead to new frontiers for precision prevention. efficacy of neurocognitive training in a paediatric
Edited excerpts; population, which has been published in paediatrics,
we have innovated an artificial intelligence (AI)/
What is a Digital Vaccine? And where does virtual reality (VR) enabled approach to improve user
this concept originate from? engagement and empowerment to lower the risk of
lifestyle disease.
Digital Vaccine (DV) are a subcategory of the
growing intersection of technology and medicine How does one go about designing a Digital
called Digital Therapeutics. The primary focus Vaccine and what are the mechanisms
of DV is in creating clinically validated robust involved? Which are the technologies utilised
evidence that results in statistically and medically in developing this programme?
significant behaviour changes for the prevention
of disease. The field is being defined by a multi- Our candidate and methods are based on AI-
institutional and international consortium of enabled immersive mobile VR/mixed reality
world-renowned researchers, led by Prof. Rema (MR) technology to modulate biological pathways
Padman via the Digital Vaccine Project at Carnegie originating in the brain. Through neurocognitive
Mellon University. We at FriendsLearn are the first training and through targeted modulation of
to develop this first in class neurocognitive training the central nervous system, we hypothesise that
technology platform and serves as the research the pathway to the gut-brain axis and the gut
translation partner of the Digital Vaccine Project. microbiome, as well as through the immune
DV were featured as “a new frontier in disease system, is able to induce immunological memory.
prevention” by Carnegie Mellon University and Through multi-label dictionary learning (MLDL)
among the top breakthroughs in their Year in Review techniques we are able to evaluate and dynamically
publication. configure neurocognitive training mechanisms
from our platform.
How does this work? What kind of scientific
evidence do you have to back this?

Our platform of DV has been created based on a

34 Q&A BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Is this would target more for lifestyle What will be the bases of this human trial and
disease? how are you going to utilise the data of the
outcomes?
The focus of the research thus far has been in
the context of prevention of lifestyle disease, FYA-003 is being adapted and scaled based on
as well as in the treatment and management ‘fooya!’, to build on the established body of evidence
of paediatric Type 1 Diabetes. The insights pertaining to safety, ethics, risk and outcomes, which
may also hold in the prevention of lifestyle- have already been established through previous trials.
related diabetes, cardiovascular disease (CVD), Our goal is to conduct longitudinal randomised field
hypertension and cancer. Given the versatile trials involving many thousands of participants, to
applicability of our platform, our pathology gather and analyse evidence of positive behavioural
targets are now being expanded to other health and physiological outcomes. We are working to
conditions. design, implement, and deploy the technology at
scale, particularly within populations that are at high
Who are your partners in this programme? risk. The key outcomes will be tracking the incidence
of COVID-19, time trends, transmission rates, as well
The Digital Vaccine Project at Carnegie Mellon as uptake of health-hygiene practices.
University is the primary partner. Other partners
include researchers from the institutions named If this trial is successful, do you think Digital
earlier. FriendsLearn is an independent company Vaccines can be utilised to prevent or at least
that is focused on translating this research and for curb future outbreaks/epidemics?
the commercialisation of this platform globally.
FriendsLearn has recently entered India and is Strong evidence showing the positive impact of the DV
partnering with about a dozen of the top schools in candidate (FYA-003) for infectious diseases on diet,
the country, who have demonstrated commitment physical activity and health-hygiene practices of the
towards protecting the health of their children as population could spur global adoption to help alleviate
a high priority and have been accredited through a health challenges caused not only by COVID-19 but
rigorous application and selection process. They are also to address future infectious diseases to come. We
now able to offer our ‘fooya!’ App-based platform anticipate that the study will contribute high-quality,
via iOS or Android devices, to deliver content- statistical evidence regarding the efficacy of digital
driven education protocols as part of the School interventions for paediatric behaviour change on
Health Co-curricular programme. health and hygiene practices and related outcomes.
Furthermore, the proposed low-cost and easily
You are now expanding your partnership scalable behaviour-change intervention can inspire
with Carnegie Mellon University to new research directions in the field of technology-
undertake a proposed population health enabled preventive medicine and paediatric health
human trial with a Digital Vaccine candidate education. Finally, the lessons from the proposed trial
- FYA-003, for COVID-19. Tell us more could also have implications for the uptake of DV-
about this. enhanced preventive care policies and practices at the
local, national and global levels.
Given the dire need to prevent and mitigate
both infectious and non-communicable diseases Now you see all these innovations that are
amongst children, especially in view of the ongoing currently being fostered are based on data
pandemic, the aim of this population health trial sciences. Going forward, what are the other
is to introduce FYA-003 as a module of a digital ways in which healthcare providers can utilise
solution, envisioned as a paediatric DV candidate, data sciences to improve health services?
for targeted behaviour changes. This research
aims to: Design and implement the DV candidate, Evidence-based medicine has been built upon
which is an evidence-based digital therapeutic the core principles of data science. As such, new
intervention to induce a healthy diet, hygiene, data sets, which can be generated through myriad
and physical activity-related behaviour change sensors can provide real-world and real-time health
and learning through neurocognitive training; data that can become extremely valuable from a
and Conduct a randomised field trial with school health perspective. However, novel techniques
children as participants in the US, as well as in of data analysis and statistical methods of deep
India, Singapore, and in other countries, to evaluate learning, such as the type of work at Carnegie Mellon
its efficacy and impact in informing, educating, and University - the home of AI - open up new frontiers
empowering children, as well as their families, with for precision prevention.
positive health outcomes.
Raelene Kambli

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com Q&A 35

“We have 18 international
patents granted for
Stempeucel pooling technology”

Bengaluru based Stempeutics Research has «
received regulatory approval from the Drug
Controller General of India (DCGI) for the B N Manohar,
launch of Stempeucel in India. Indicated for the MD & CEO,
treatment of critical limb ischemia (CLI), the product Stempeutics Research,
is the first allogeneic cell therapy to be approved Bengaluru
for commercial use in India and the first stem cell
product to be approved globally for CLI treatment. disease that is caused by severe blockage in the
The company has partnered with Mumbai based arteries thereby reducing blood flow. The symptoms
pharma company Cipla for the marketing and of CLI include pain in the legs, which initially will
distribution of the product. BioSpectrum interacted be on prolonged walking, and gradually even during
with B N Manohar, Managing Director & Chief rest. There can be ulcers in the limb, which may
Executive Officer, Stempeutics Research, Bengaluru progress to gangrene, leading to amputation of the
to find out more about this innovative product. foot or entire limb. Currently only limited treatments
Edited excerpts; are available for CLI disease. Stempeucel drug works
through anti-inflammatory and immuno-modulatory
What are the key highlights of Stempeucel? properties and by inducing angiogenesis in ischemic
muscle, ultimately leading to improvement in
The key feature of Stempeucel is that it is an on- the clinically relevant endpoints for CLI. Dosing
demand, cryo-preserved, allogeneic regenerative of Stempeucel is based on body weight. The
medicine targeting unmet needs. It is physician recommended dose is 2 million cells/kg body weight
prescribed and the drug is administered through administered intramuscularly (IM) as 40 to 60
intramuscular injections around the calf muscle region multiple injections in the calf muscle and multiple
and around the site of ulcers for CLI treatment. There injections around the ulcer/s. Stempeucel should be
is a unique patented stem cell pooling technology administered by a qualified physician, who is trained
involved. We have 57 filed patents for this product, 18 in the management of peripheral arterial diseases.
international patents granted for Stempeucel pooling
technology, including United States, France, UK, What is the cost of this therapy?
Germany, Italy, China, Japan, Australia, New Zealand,
Singapore, South Africa and Philippines. It is the Under the agreement signed between Stempeutics
first stem cell product with pooling technology to be and Cipa, Cipla has received exclusive rights to
classified as an Advanced Therapy Medicinal Product market and distribute the product in India by
(ATMP) and granted Orphan Drug Designation by leveraging its expansive distribution strengths
the European Medicines Agency (EMA) in 2015. across the country. Price of the product is yet to be
Few other indications where this product is being announced by Cipla. But it will be introduced in the
explored includes an ongoing Phase 3 clinical trial for country at an affordable cost.
osteoarthritis and diabetic foot ulcer, ongoing Phase
1/2 study for perianal fistula due to Chron’s Disease How are you ensuring the availability of the
indication; and we are starting Phase 2 COVID-19 product across India?
acute respiratory distress syndrome (ARDS) study
with the government support. Cold chain logistics and transportation of
Stempeucel in India is being worked out with our
Please share more details about the CLI
treatment procedure.

CLI is a progressive form of peripheral arterial

36 Q&A BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

partner Cipla. The product will be manufactured disease. Currently, Stempeutics is working on a
at our GMP facility at Manipal and in future at strategy for other international markets, including
Kemwell in Bengaluru and shipped to designated US, EU and Japan in the long run. The global critical
hubs in India based on forecasted demand. limb ischemia treatment market is expected to reach
From hubs the product will be shipped to the $5.39 billion by 2025, at a CAGR of 8.1 per cent
designated hospitals based on patient needs. We between 2020 and 2025.
will use dry shippers to ship Stempeucel. Well
established safety practices and procedures are in What are the current challenges facing stem
place for charging and transporting dry shippers. cell treatment in India and how can those be
Data logger is used to record the temperature addressed?
during shipment and to check that it maintains
a temperature between -185 and -196 degrees. India is already seen as the world’s low cost
Temperature holds good for 7 days. pharmacy as far as conventional therapies
are concerned and the recent economic and
Are you planning to make the product epidemiological changes present a good opportunity
available outside of India as well? What are for the Indian biotechnology industry to replicate
the major plans in this regard? this success in the emerging field of novel and
innovative healthcare therapies like regenerative
Yes. We have applied for the certificate of medicine (stem cells and cell based products).
pharmaceutical product (COPP) from the state drug In order to fast track and make progress in this
controller. Once we get necessary export permit, we promising field, Association of Biotechnology Led
are planning to export Stempeucel to South Asian Enterprises (ABLE) has requested government
countries, South East Asian countries, North and authorities to implement a single window clearance
Central Asian countries and East African countries, concept and help the industries avoiding going
based on in-country regulatory approval. through multiple committees for clinical trials
approvals and to follow multiple guidelines
How will it contribute to the CLI treatment published by the governmental agencies. Industries
market in India & globally? are facing huge challenges and undue delays to
adhere to all the guidelines. Currently there are
It is estimated that about 5 million patients in India two national guidelines for stem cells research
are impacted by this debilitating disease. With and product development, one published by the
the current contemporary vascular techniques, Indian Council of Medical Research (ICMR) and
it is estimated only 25 per cent of patients can be the other published by the Central Drugs Standard
managed with satisfactory clinical outcomes. So Control Organisation (CDSCO). Then there are
expected market opportunity in India is big. We also the new clinical trial rules stating that stem
believe that the Stempeucel is a game-changer, cell derived product, gene therapeutic product or
offering an advanced therapeutic treatment for xenografts is designated as new drug and hence
millions of patients suffering from this dreadful need to follow the rules laid down in Drugs and
Cosmetics Act. ABLE has requested the government
that these two guidelines can be merged as a single
guidance document that needs to be followed by the
industries for commercializing stem cell and cell
based products. India has the opportunity to become
a leading global player for stem cell and cell based
products and services and the government needs
to react with speed in implementing a clear policy
for cell therapy including (a) gazette notification
regarding stem cell definition (b) to include the
provision of expanded access programme for major
unmet medical needs like COVID-19 (c) emergency
compassionate programme for major unmet medical
needs should be permitted in which the approved
drug can be used under compassionate program to
these patients of unmet medical need.

Dr Manbeena Chawla
[email protected]

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com Q&A 37

“The aim is to prepare a workforce in
pharma research to speed up drug discovery”

With recent increase in health and «
pharmaceutical research, there is urgent
need for trained biostatisticians and Sridhar Venkatesh,
bioinformaticians in India. To address this concern, Managing Director,
British multinational pharmaceutical company GSK Pharmaceuticals
GlaxoSmithKline has joined hands with the India, Mumbai
government of India to develop doctoral programmes
(PhDs) in the fields of biostatistics and bioinformatics. scientific research. Distinguished faculty from the
Launched in 2019, the Trust in Science programme RCB, and industry mentorship and exposure from
has completed one year and is ready to offer much GSK are key highlights of the PhD programme.
more in its second year. BioSpectrum spoke in The PhD scholars also get an opportunity to intern
detail with Sridhar Venkatesh, Managing Director, at GSK’s R&D centre at Bengaluru. Additionally,
GSK Pharmaceuticals India, Mumbai about this and importantly, GSK also brings the industry
new career initiative for biotechnology students. perspective to the academic course.
Edited excerpts;
How has bioinformatics become the
What is the progress so far for the launch of foundation/core component of pharma R&D?
Trust in Science programme?
Traditional drug research is subject to long
We launched the Trust in Science programme last development cycles, high cost and failure risk. This
year in collaboration with the Regional Centre for is the kind of research that requires large amounts
Biotechnology (RCB) to build the next generation of data to be analysed and validated. This is where
of pharma researchers equipped in the domains of bioinformatics has the potential to manage and
bioinformatics and biostatistics. Since the launch process large-scale biological and medical data, at a
of the programme, there have been two cycles of relatively low cost and high throughput. The various
PhD admissions at the RCB, and on a year-on-year tools and methodologies are now helping researchers
basis, we have received an extraordinary response accelerate their processes without compromising on
to the programme. RCB is responsible for creating safety and efficacy. During the COVID-19 pandemic,
the programme content, logistics and running the bioinformatics has played a key role in helping
courses. GSK reviews course content to ensure researchers to process large amounts of information
that the programme is designed appropriately to and data sets, and accelerate the drug repurposing and
better prepare students for future careers in the vaccine development process.
pharmaceutical industry. We had recently launched a
webinar of the ‘Trust in Science’ series that saw eager How will bioinformatics and biostatistics
participation from students. This indicates that these transform research in the coming years?
fields will pick up in the future and we are expecting
the PhD programme to scale up in the coming years. In the coming years, it will be increasingly important
for the research community to deliver results in
What is in store in its second year? as short a time as possible, without compromising
safety and efficacy. This will require both the tools
With increased awareness about the programme, and methodologies to analyse medical data, and the
we are expecting to create a larger pool of young statistical expertise to help researchers infer and take
researchers, who are aware of the promising fields of correct decisions, and minimize uncertainty. This
bioinformatics and biostatistics. is where bioinformatics and biostatistics will play a
crucial role.
What can students expect from this
programme and how will it benefit the R&D? Dr Manbeena Chawla
[email protected]
The PhD programme under Trust in Science aims
to prepare a future ready workforce in pharma
research and has been designed keeping in mind
the need to speed up R&D in drug discovery and

38 CLINICAL TRIALS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Virtual Clinical Trials – An
approach whose time has come

« trials as a requisite to the drug development process.
It is incumbent on all stakeholders in the industry
Suneela Thatte, to now work together to ensure that clinical trials
Head, Research continue to be conducted within a safe and ethical
& Development framework, that there is transparency and disclosure
Solutions, IQVIA India, within legally accepted norms, and that the general
Mumbai public is aware that a clinical trial is not a magic
wand that can deliver results overnight and there is
The COVID-19 pandemic will surely go down as rigor in its process.
a major event of the century and an event that
will leave a long-lasting impression on our way The virtual environment we are now in has also
of living and working. When the year 2020 began, forced us to reflect on the overall approach to clinical
little did anyone imagine how the lives of people trials in India and consider the adoption of new ways
across the globe would change, irrespective of which of working without compromising on the rights,
country they belonged to, whether they were living safety and wellbeing of patients, and quality and
in a rural or urban setting, whether unemployed, ethics. The role of technology-enabled innovation has
self-employed or employed with an organization, and become very evident and unless we fundamentally
irrespective of gender or age. We have gone through change the manner in which we approach drug
so much in the last six months but contrary to our development, we will not be able to address the
initial fears and impression, not everything that came already existing unmet medical need and those
with the pandemic has been bad. accelerated by the pandemic.

The pandemic has defined new paradigms of It is heartening to note that soon after the
doing business shaped by remote working, enabled pandemic started, the Drugs Controller General
by technology and facilitated by skills that call for (India) allowed for subject expert committee
a more collaborative and empathetic approach to (SEC) meetings to be held virtually and ensured
work. Restrictions imposed by the lockdown in India continuity of review of clinical trial proposals,
saw the growth of remote approaches to healthcare protocol amendments and new drug applications.
treatment like online consultation and telemedicine. In April 2020, the Indian Council of Medical
Research (ICMR) too released national guidelines
The government of India released the updated for ethics committees to ensure ongoing review of
telemedicine practice guidelines in March, which and oversight on clinical trials during the pandemic.
recognizes that digital health is a critical enabler for This has eliminated any possible delays in scheduling
the overall transformation of the health system and face to face meetings or discussions due to the non-
enables registered medical practitioners to provide
healthcare using telemedicine.

Most important and relevant to our field has been
the increase in awareness about clinical trials. Public
opinion has tilted largely in favour of clinical trials
and the narrative has changed from ‘Do we need
clinical trials?’ to ‘Why are we not seeing more trials
on drugs and vaccines for COVID-19?’ and ‘When will
a vaccine for COVID-19 be available’?

From a few years ago when the understanding
of clinical trials in India was fraught with
misinformation, we are today at a stage where there
is better understanding and acceptance of clinical

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com CLINICAL TRIALS 39

availability of invitees and has allowed for a faster sample delivery to labs? How should televisits be
and more seamless process, thereby overall further done and at what frequency? How do we facilitate
reducing clinical trial timelines. home health nursing particularly in smaller towns
and more remote locations? What about technology
The lockdowns imposed by the pandemic have and power backups? Multi-stakeholder consultative
also highlighted, more than ever before, the need to meetings will need to be conducted by the regulators
seriously evaluate how we can adopt virtual clinical to deliberate on these issues and put together an
trials. Rather than inviting patients to sites for approach note for India.
participation in clinical trials, we need to review how
we can take clinical trials to the doorstep of patients. Remote access to data will be of paramount
importance in such a setting and is particularly
Virtual clinical trials (VCTs), also called remote critical for a country like India where we do not
or decentralized trials, represent a relatively new have electronic health records in most hospitals
method of conducting clinical research taking full and need to facilitate remote review of records and
advantage of technologies such as apps, electronic ensure patient confidentiality. The government’s
monitoring devices, telemedince and online social National Digital Health Mission: Health Data
engagement platforms. Moving away from the Management Policy is a first step towards digitizing
traditional method of keeping sites/hospitals at the patient records, while laying down guidelines for
centre of activities, this new approach to clinical trial the protection of individuals’ data privacy. When
conduct is patient-centric and utilizes technological enacted, there will be additional requirements from
advances to deliver all trial related activities at their sites and investigators in obtaining patient consent.
doorstep.
Most important is the need for a regulatory
In a country like India, VCTs have a tremendous framework for the conduct of VCTs. During
advantage in expanding the reach of clinical trials the pandemic, we saw the US Food and Drug
and providing access to diverse patient populations, Administration (FDA) publish a guidance document
but it would also help address one of the toughest on the Conduct of Clinical Trials of Medical Products
challenges in a clinical study which is that of during COVID-19 Public Health Emergency to
patient recruitment. The latter challenge is further ensure the continuity of clinical trials during the
compounded in the current environment as studies pandemic, while placing patient safety at the
indicate that patients are hesitant to go in for in- forefront of considerations. The ICMR Guidelines
person hospital visits, a situation that could continue for Ethics Committees Reviewing Biomedical and
until preventive treatment is available for COVID-19. Health Research during the COVID-19 Pandemic also
advocated the need to explore alternative procedures
VCTs will require us to review and evaluate for patients in isolation and the use of technology and
every step of the existing clinical trial process interactive platforms to ‘explain information related
and put in place measures to address some of the to a study and to electronically document informed
likely challenges and bottlenecks. What would the assent/consent the same.’
informed consent process, with the requisite of
audiovisual recording, need to be like in a virtual The current pandemic is an opportune time to
world? Do we have reliable cold chains to ensure pilot VCTs. Its long-term benefits are immense and
Intellectual Property (IP) delivery to patients and include accelerated recruitment, enhanced patient
retention because of personalized interaction,
reduction in the cost of trial conduct, reduced
complexity and trial timelines and improved data
quality.

While VCTs may not be suited to every study like
studies that require complex treatment procedures,
in-patient care or observation, or involving acutely ill
patients, its relevance to a country like India are huge
given some of the challenges outlined earlier. They
are after all trials designed around the patient, who
is the pivot around, which any clinical trial revolves.
Regulators are increasingly interested in the use of
digital technology and connected devices to improve
clinical research. As long as the protocols are sound
and adhered to, most regulators see virtual trials as
an opportunity.

40 STARTUPS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

ASPIRE-BioNEST startups launch
hi-tech war against COVID-19

« developing an in vitro Lung Organoid model that
would be utilized to screen for COVID-19 in a
Dr Sreedhara R Voleti, throughput fashion for rapid screening of drugs.
CEO, ASPIRE-BioNEST, OncoseekBio envisages a vision of developing
Hyderabad in vitro and in vivo screening platforms for
specific diseases in identifying therapeutics, by
The ‘Entrepreneurial Vertical’ of the University of avoiding animal models. Dr Suresh Poosala,
Hyderabad, the Association for Scientific Pursuits in CEO of OncoseekBio, has returned to India after
Innovative Research Enterprises (ASPIRE) is a not- over 25-years of in vivo experience, leading
for-profit organization managing the university’s teams at senior level management from different
innovation and entrepreneurial activities. Of the organizations in USA like National Institutes
three incubation centers that are being managed of Health (NIH), Bristol-Myers Squibb (BMS),
under the ASPIRE, the ASPIRE-BioNEST is a life University of Maryland, and St. Jude’s Research,
sciences bio-incubator set-up with the support of the Memphis.
Biotechnology Industry Research Assistance Council
(BIRAC). It has created a plug-and-play life science OncoseekBio has also received another prestigious
ecosystem for incubation to start ups. grant from United States India Science & Technology
Endowment Fund (USISTEF) under the category
ASPIRE BioNEST is currently incubating more of COVID-19 Ignition Grant for “Development and
than 20 startups engaged in divergent areas screening of drug or Zinc nanoparticle conjugated
of biology and biotechnology. Quite a few antibodies to neutralize SARS-CoV-2 virus that
of these are engaged in addressing the challenges causes COVID-19” in collaboration with Dr Avery
of COVID-19 pandemic, including OncoseekBio, August from Cornell University, Ithaca, New York
Reagene Innovations, KJB Diagnostics, and VINS and Oncosimis Private Limited, and ReaGene
Bioproducts. These startups have established Innovations Private Limited.
tie-ups with leading academic institutions and
industries such as Centre for Cellular & Molecular VINS Bioproducts Pvt Ltd is a well-known
Biology (CCMB), IT giant Tech Mahindra, domestic antisera manufacturing company, whose research
and international biotech/pharma industry arm is led by Dr Krishnamohan. VINS Bioproducts
ProdIGY, INDRAS, Cornell University etc. and is involved in developing antibody fragment-
received highly competitive national (BIRAC) based immunotherapy for immediate treatment
and international (United States India Science & for COVID-19. In this project VINS Bioproducts is
Technology Endowment Fund (USISTEF)) grants. collaborating with Prof. Nooruddin Khan, faculty
The technologies include discovery and development of Animal Biology, and CSIR-Centre for Cellular
of drugs through drug-repurposing, cutting edge and Molecular Biology (CCMB), which is led by
technologies like 3D bioprinting, Organoids/ Dr Krishnan Harinivas. Through this tripartite
spheroids for drug screening, and antigen-antibody collaboration, the team is in the process of raising
based diagnostic kits, and developing antibody- neutralizing antibodies from horses for a variety
fragment-based immunotherapy for COVID-19 of life-threatening pathologies in humans as
patients. anti-venoms, anti-toxins and anti-virals such as
COVID-19.
Funded by the BIRAC of DBT as part of special
COVID-19 call, OncoseekBio Private Limited is Horse-based immunoglobulins can be produced
in large quantities as a promising alternative,
affordable, and available therapy to humanity. The
collaborative teams are quite hopeful about this
treatment, and the outcome of such collaboration
would bring productive, efficient, and safe mode of
treatment of COVID-19 infection. Siddharth Daga,
CEO of VINS Bioproducts Pvt Ltd had expressed
his confidence in the fast track development of
COVID-19 solution by leveraging the complementary

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com STARTUPS 41

strengths of the team at the University of Hyderabad founder of ReaGene expressed his excitement about
and CCMB. working together with ProdIGY on the new treatment
modalities to COVID-19.
ReaGene Innovations Pvt Ltd, led by co-
founder Dr Uday Saxena, is focused in developing Dr Saxena, Co-founder and Chief Ideator at
intellectual technologies through 3D-printing of ReaGene expressed his enthusiasm about the
cells for screening of novel chemical entities thus complementary collaboration towards finding
avoiding animal usage in preclinical drug discovery. a solution to the major global health burden of
It is being developed in collaboration with In Silico COVID-19. Dr Subra Iyer, Chief Scientific Officer
Discovery Research Academic Services Private of ProdIGY said that he is looking forward to the
Limited (INDRAS), led by Dr Sreedhara Voleti, partnership with ReaGene creating a cornerstone
CEO. The firm consults, contracts, and collaborates technology to eliminate COVID-19.
on the computational aspects of drug design. It is
performing drug-repurposing aspects of mitigating KJB Diagnostics led by Dr Jayanth Bhanushali,
COVID-19 and is funded by the IT giant Tech who had previously co-promoted Amar Diagnostic
Mahindra on a drug-repurposing project. In this Company, has developed a IgG-based ELISA kit for
endeavour, INDRAS would provide the rationally detection of COVID-19 antibodies. The kit recently
identified Food and Drug Administration (FDA) got the approval from the Indian Council of Medical
approved drugs through molecular modelling and Research (ICMR) after several validation studies and
Tech Mahindra’s Artificial Intelligence (AI) methods. is planning to bring more kits through production
These prioritized repurposed drugs (antivirals, mode for larger screening capability through third-
nutraceuticals, GRAS molecules, and generally FDA party vendor. Currently self-funded, KJB Diagnostics
approved therapeutic drugs) would then be validated is propelled to project its diagnostic kit for enhanced
using 3D bioprinted humanized vascular lung and screening capability.
pharmacological assays by ReaGene Innovations.
The objective of their collaboration is to stop the In total, several startup companies are engaged
entry of virus into lung airway epithelial cells by in combating COVID-19, led by competent scientists
interacting with the COVID-19 proteins through with an entrepreneurial mindset, in collaboration
repurposed drugs because the high transmission rate with academia, research institutes, industry of
of COVID-19 is attributed in part to tight attachment India and abroad, through the plug-and-play
of the virus that facilitates its entry into lung cells. incubation system provided by ASPIRE-BioNEST.
The development of ASPIRE-BioNEST within a
Dr Ratnakar Palakodeti, Vice President of short span of just over two years, has garnered it the
Life Sciences vertical of Tech Mahindra said, Associate Partner status of BIG grant of the BIRAC.
“This collaboration will bring valuable findings in
therapeutic interventions through a faster route than Prof. Appa Rao Podile, Chairman, ASPIRE and
conventional drug discovery as well as add invaluable the Vice Chancellor of University of Hyderabad
intellectual property”. Tech Mahindra, the technology (UoH) said that ASPIRE-BioNEST is poised
frontrunner, will utilize the decades of scientific to play a major role in shaping India’s biotech
drug design and discovery expertise of Dr Saxena entrepreneurship scenario. He said that it is
and Dr Voleti in this collaboration, along with the recognized to be the associate partner for the BIG
contributions from internal teams of Tech Mahindra initiative of the BIRAC itself is a big shot in the
on artificial intelligence. arm for such a young incubator. He further said
“Innovation ecosystem at UoH under the ASPIRE,
ReaGene Innovations has also entered into an continues to work non-stop during the pandemic, led
agreement with the USA based ProdIGY Biotech by the incubates associated with ASPIRE-BioNEST,
Inc, to develop novel immunotherapeutics for speaks about our commitment to the nation in
COVID-19. ReaGene and ProdIGY will synergize promoting the entrepreneurship to strengthen the
discovery, development, and platform technologies Atmanirbhar strategy of the Government.”
for identifying therapeutics directed to mitigate
COVID-19. Prof. P Reddanna, Founder-Project Coordinator,
ASPIRE-BioNEST said that the incubation centre
ProdIGY Biotech is guided by Dr Susan Weiss, is unique in terms of access to state-of-the-art
who is a Professor at the University of Pennsylvania infrastructure, equipment, cell and microbial culture
in PA, USA, world’s leading Corona virologist. In facilities, cold room, board rooms, networking centre
addition, ReaGene will collaborate and partner with a capacity of housing more than 100 individuals.
with DBL Pvt Ltd of Vadodara and Dr Tamishraha ASPIRE-BioNEST is now incubating about 20
Bagchi to complete the development of the COVID-19 startups engaged in frontline areas of biology and
product(s). Dr Subrahmanyam Vangala, CEO and co- biotechnology with about six companies graduated
post initial incubation.

42 PEOPLE NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

Dr Bushra Ateeq Schott AG appoints
receives double new MD for Indian
recognition for pharma glass biz
cancer research
Schott AG, a leading international specialty glass and technology
Dr Bushra Ateeq, Associate group, has announced Pawan Kumar Shukla as the new Managing
Professor at the Indian Institute Director for Schott Glass India.
of Technology, Kanpur (IIT-K) Shukla brings over 25 years in
has received the prestigious the glass, lighting, pipes and
Shanti Swarup Bhatnagar (SSB) electronics industry and comes
Award 2020 in the medical with a strong background in
sciences category. In addition, techno-commercials. Prior to
she is also a recipient of Central this role, he was the President
Drug Research Institute (CDRI) Operations at Surya Roshni,
Award 2020 in biological an Indian multinational
sciences. An alumnus of Aligarh manufacturer for specialty glass
Muslim University (AMU), Dr tubing and lighting. An alumnus
Bushra’s research focuses on of the prestigious Indian
cancer biomarkers and the chain Institute of Technology, Kanpur
of events at the molecular scale (IIT-K), in ceramic engineering
that result in prostate and breast as well as material science and
cancer. Her research group at metallurgy, Shukla has also worked with Corning JV in the CRT
IIT-K is exploring the genetic Division as a manufacturing head for 12 years.
and epigenetic changes that
trigger cancerous growth and Dr Subhadeep Chatterjee
progression of the disease using wins SSB award in biology
novel strategies and approaches.
With her research, Dr Bushra’s Fourteen scientists were 26, 2020. Dr Subhadeep
overarching goal is to aide in the announced winners of the Chatterjee from the Centre
discovery and development of prestigious Shanti Swarup for DNA Fingerprinting and
more effective therapies against Bhatnagar (SSB) Award, the Diagnostics in Hyderabad was a
specific causative pathways or country’s highest science prize. winner in the biology category.
alterations in prostate and breast The awardees were announced Dr Chatterjee was chosen for
cancer. by Dr Harsh Vardhan, Union identifying a reversible, non-
Minister for Health & Family genetic process that bacterial
Welfare, at the Foundation cells use to regulate their
Day celebration of the Council population, with a process
for Scientific and Industrial known as quorum sensing
Research (CSIR) on September (QS). The discovery has served
as a landmark contribution
since its publication, inspiring
further interesting areas of
work in theoretical modelling
of QS in bacteria. Discoveries
made though Dr Chatterjee’s
research have also thrown
light on fundamental systems
that bacteria use for social
communication, how bacteria
metabolise iron, and other
kinds of regulation in bacteria.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com PEOPLE NEWS 43

Biocon hires Anupam Jindal as CFO S Aparna
assumes
Bengaluru based Biocon has recently announced that Anupam Jindal charge as
has been appointed as the company’s new Chief Financial Officer Union Pharma
(CFO). Jindal will head the finance function at Biocon and be part Secretary

of the Executive Leadership Team. He S Aparna, a 1988-batch
will report into the company’s Chief IAS officer of Gujrat cadre,
Executive Officer & Managing Director, has assumed charge as
Siddharth Mittal. Prior to joining Biocon, Secretary in the Department
Jindal worked with the Vedanta Group of of Pharmaceuticals Ministry
companies for 22 years, where he held the of Chemicals and Fertilizers,
position of Group Chief Financial Officer Government of India. Aparna
at Sterlite Technologies since 2006. Jindal has replaced Dr PD Vaghela,
played a key role in growing the company’s who superannuated on
revenue exponentially through organic September 30, 2020. Aparna
capacity expansion and acquisitions, in was appointed to the post of
India and abroad. He was also instrumental Executive Director, World
in driving several strategic initiatives, Bank in 2017, representing
such as the inception and growth of new business verticals. Jindal is the Constituency of India,
a Chartered Accountant from the Institute of Chartered Accountants Bangladesh and Sri Lanka. In
of India and a Company Secretary from the Institute of Company 2019, she was given a proforma
Secretaries of India. promotion as Additional
Chief Secretary (ACS) while
Dr Shravan Subramanyam joins she was on deputation in
Wipro GE Healthcare as MD Washington DC as Executive
Director, World Bank. She has
Wipro GE Healthcare has announced the appointment of Dr Shravan also served as the Principal
Subramanyam as President and Chief Executive Officer (CEO), GE Secretary to the then Gujarat
Healthcare India & South Asia and Managing Director (MD), Wipro GE Chief Minister. Born in 1963,
Healthcare, effective October 1, 2020. Dr Subramanyam joins Wipro the new Pharma Secretary has
from Roche Diagnostics where he was their Managing Director, India and also served both Centre and
Neighbouring Markets, responsible for commercial operations, market the state on several important
access, customer experience and assignments including in
digital transformation efforts. the Department of finance,
He succeeds Nalinikanth (Nal) planning, Urban and Housing
Gollagunta, who will be taking Development, Textile etc.
up a new role as the Global
Chief Operating Officer (COO)
of the GE Healthcare Digital
organization post transition.
Dr Subramanyam will be
responsible for building on Wipro
GE’s expansion plans, delivering
on commercial outcomes,
strategic growth objectives,
and driving partnerships in
the region. He will continue to
advance the company’s agenda of
innovating disruptive technology
and business solutions to enhance access to high-quality, affordable
healthcare solutions. He has over 15 years of senior management and
leadership experience in global and regional leadership roles at Roche,
Novartis, Dade Behring and Ehrlich Laboratories.

44 SPONSORED CONTENT BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com
ADVERTORIAL

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com SPONSORED CONTENT 45

46 R&D NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

JNU discovers novel
peptide to fight malaria

Researchers at Special glideosome, to propel IIT-I identifies new
Centre for Molecular and invade the host cell. treatment for typhoid
Medicine, Jawaharlal Myosin A and Myosin A
Nehru University (JNU), Tail Interacting Protein A team of scientists at the Indian Institute of
New Delhi along with (MTIP) are two proteins, Technology, Indore (IIT-I) is finding new ways
collaborators from which are part of this to tackle Salmonella enterica, the pathogenic
Shiv Nadar University, glideosome machinery bacterium that causes typhoid fever. The
Noida have identified that are essential for scientists have identified three regions in the
a novel anti-malarial the mobility of parasite. genome of the Salmonella enterica bacterium
peptide that could be They generate the force that can be used as drug targets to combat
used in combination with required by the parasite it. The target regions were located in various
other antimalarials for to actively invade host essential genes in the Salmonella enterica
blocking the plasmodium cells. If they are made genome: while one is involved in regulating
falciparum parasite dysfunctional, parasite the virulence of the bacterium inside the
from infecting blood will be immobilised human host, the second and third are involved
cells. The malaria and it will not be able in regulating the transport of maltose sugar
parasite uses molecular to infect the red blood and iron transport. Maltose and Iron ion are
motor machinery called cells and cause malaria. essential nutrients for the survival and growth
The researchers used a of the pathogen. The pathogen is transmitted
novel approach to stop via contaminated food and water and has
the parasite entry. They caused numerous pandemics in the past.
searched the library of Besides the high prevalence, the bacterium is
lab synthesised library of also turning out to be a major public health
proteins with trillions of issue due to the rapid emergence of drug
entries. By combing the resistance.
library, they found one
peptide, a short chain of
amino acids, called ZA1
fits the Myosin A.

IIT-M makes nano-coated Mg alloys to fix bone fractures

Indian Institute of Technology, Magnesium is the fourth abundant and used it for developing
Madras (IIT-M) researchers metal in the body and is known to magnesium mesh cage implants.
have developed nano-coated accelerate the healing of bones. Further, they coated these
magnesium (Mg) alloys that can For this study, the researchers implants with polycaprolactone
repair bone defects in rabbits. deployed AZ31 alloy of magnesium and nano-hydroxyapatite by
Encouraged by these results, dipping and electrospinning.
the research team, which is This nano-coated magnesium
partnering with several other mesh was then used to heal the
institutions, is planning to study bone defect in femur of rabbits.
medical applications of nano- The team is exploring funding
coated magnesium alloys in other opportunities to further test this
animals and repairing human newly-developed nano-coated
bones. Alloys of magnesium are magnesium alloy in repairing
being considered as a good option bone defects in large animals such
for orthopaedic applications as as goat or sheep to demonstrate
magnesium is biocompatible, the efficacy of the product and
biodegradable and has other show clinical significance of this
important mechanical properties. research.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com R&D NEWS 47

IIT-GN focuses on IIT-G designs algorithm
targeted therapy to protect health data
for prostate cancer
A group of researchers from the Indian Institute of
Researchers at the Indian Institute of Technology, Guwahati (IIT-G), in collaboration with scientists
Technology, Gandhinagar (IIT-GN) from the University of Pardubice, Czech Republic, is working
have discovered a new molecule, which towards developing indigenous algorithms that can protect
can be used as a targeted therapy the nation’s digital data from
for prostate cancer. This research cyberattacks by advanced
is being conducted in collaboration computers. The team has also
with scientists at Louisiana State been credited with designing
University Health Center, US and the encryption architectures that
University of Manchester in the UK. can be used to protect sensitive
The researchers have discovered a new health data that is transmitted
molecule called J54, which has shown through the internet. The
great potency not only in cells but also team, consisting of faculty
in animals (mice model) to completely and research scholars, has
reduce tumour of prostate cancer) in developed various post-
50 days, as observed in male mice. quantum cryptography based
According to the researchers, since encryption algorithms and
J54 combination therapy is targeted to designed indigenous soft IPs, which can be integrated into
a specific protein, it is expected to be Systems-on-Chip (SoC) to protect them from cyberattacks. The
more effective and personalised for the scientists are also working towards enhancing data security in
treatment of a particular patient. the healthcare sector, which could be beneficial in the time of
the pandemic and years to come.

48 ACADEMIC NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

ICMR IIT-D partners with ILBS for
launches enhancing medical research
prescribing
skills course for Indian Institute of Technology, Delhi (IIT-D) and Institute of Liver
medical graduates and Biliary Sciences (ILBS), Delhi have signed a Memorandum
of Understanding (MoU) to establish ILBS-IITD Collaborative
The Indian Council of Medical Platform initiating wide-ranging collaborations involving
Research (ICMR) has launched an academic, research, product, process and human resource
online course on prescribing skills development. The mission of the ILBS-IITD Collaborative
for Indian medical graduates (IMG) Platform is to help in critical identification of the problems faced
pursuing or completed internship. by the practicing doctors in metabolic and liver diseases, ranging
The course is meant for improving from the primary health centre to tertiary care super-specialty
prescription practices among IMG and hospitals and to initiate the work jointly by the engineering
will be run by National Institute of and medical teams for sustainable solutions. The scope of
Epidemiology (ICMR-NIE), Chennai. collaboration focuses on liver diseases and encompasses to make
ICMR through its institute - NIE has intramural funding for the projects in both IIT-D and ILBS, to
successfully completed a basic course initiate the collaborative research among different medical and
in biomedical research. The course engineering disciplines of these two institutions. The objective
has now been made compulsory for also involves registration of PhD students of both institutions to
postgraduates by the Medical Council attend lectures and courses relevant to their area of research in
of India. The new course constitutes each other’s institutions and imitating joint PhD supervision and
40 video lectures of 20 minutes to developing Technology Business Incubator (TBI).
be taken online over three months at
learners’ pace. The course involves a
pre-test to evaluate participants’ prior
knowledge, multiple choice questions
(MCQs) to be answered after seeing
the modules, evaluate a prescription
for appropriateness, all this to assess
if the course has improved the
participants’ knowledge.

IACP, ACPE advance quality of pharmacy education

The India Association of the both IACP and ACPE are now and technology to the benefit of
Colleges of Pharmacy (IACP) poised to achieve their goals by both students and practitioners.
has signed a Memorandum of focusing on upgrading education, The MoU coverage is focused
Understanding (MoU) with upskilling, and employing the on knowledge transfer in
the Accreditation Council for latest advancements in science the areas including quality
Pharmacy Education (ACPE) to assurance standards, policies
build cooperation to advance the and procedures and tools and
quality of pharmacy education publications. Both associations
internationally. The MoU will exchange visitor programmes
marks the coming together of that will help them to observe
associations dedicated to realising in-depth each other’s operating
combined goals of standardising processes. The partnership entails
pharmacy education and elevating no financial commitment on part
the canons and importance of the of either association and is non-
role of pharmacists. Equipped with exclusive, thereby allowing both
years of learning and experience organisations to successfully
in their respective markets, continue existing collaborations.

BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com SUPPLIER NEWS 49

Agilent expands line of innovative flow cytometers

Agilent Technologies has in the same run. The resolution the power of the highly intuitive
announced the launch of the easily discerns particles in NovoExpress software package,
Agilent NovoCyte Penteon, a the range of 100 nanometers, the system can be fully automated
sensitive flow cytometer with five and the precision fluidics are and is easy to use, providing an
lasers and up to 30 fluorescence considered to be among the best exceptional user experience in
channels. The NovoCyte Penteon on the market. Coupled with data acquisition, analysis, and
provides excellent sensitivity, reporting. The product line is an
resolution, speed, and flexibility. innovative breakthrough in flow
It has a large dynamic range cytometry. It capitalizes on the
of 7.2 log, along with
fully automated global success of the
compensation Agilent line of flow
features, enabling cytometers, including
users to pick up the NovoCyte, the
both dim and NovoCyte Quanteon,
bright signals and the NovoCyte
Advanteon.

Thermo Fisher Kool-ex to build
temperature controlled
enhances lab pharma distribution centres

plastics production Mumbai based pharma cold chain logistics service provider
Kool-ex is gearing up to become a full stack, end to end supply
Thermo Fisher Scientific is investing chain solutions provider to the pharma industry. The spread
more than $140 million to further expand of services will include warehousing, secondary distribution,
its laboratory plastics consumables passive packaging, and blockchain for end to end tractability
production to support significant global of pharma products, apart from its core existing business
demand for COVID-19 testing, as well of providing temperature-controlled transportation. For
as development and manufacturing of warehousing, Kool-ex has partnered with IndoSpace in
therapies and vaccines. The rapid increase Mumbai to build customized, temperature-controlled,
in production related to COVID-19 testing, pharma distribution centres across the country. IndoSpace
and development and manufacturing has the only pan-India network of grade A warehouses in
of therapies and vaccines, has created the country, and the partnership with Kool-ex will enable
historic demand for laboratory plastics, IndoSpace to venture into pharma warehousing. Kool-ex and
including pipette and automation tips, IndoSpace will jointly design and set up three warehouses in
storage tubes and plates, transfer pipettes, the first phase by 2021 in proximity to Mumbai, Delhi and
and packaging vials and bottles. To Bengaluru. At 42,000 pallet positions in each warehouse,
support these needs, Thermo Fisher is each of these will be the largest standalone cold chain facility
creating more than 1,000 jobs across in the country.
manufacturing sites globally, increasing
automation capabilities and optimizing
warehouse and sterilization capacity to
improve supply chain agility. Thermo
Fisher offers an extensive range of
laboratory plastics, including Thermo
Scientific Nalgene and Nunc plasticware
and the Thermo Scientific manual and
electronic pipetting systems. From bottles,
beakers, funnels and tubes to pipettes,
tips and diagnostic plates, Thermo Fisher
consumables are supporting critical
COVID-19 work globally.

50 SUPPLIER NEWS BIOSPECTRUM | NOVEMBER 2020 | www.biospectrumindia.com

RedShiftBio Waters establishes flagship
inks distribution innovation and research lab
deal with
Spinco Biotech Waters Corporation has announced the establishment of Immerse
Cambridge, a new Waters’ research laboratory in the heart of
RedShift BioAnalytics has Cambridge’s Kendall Square in the US. Immerse Cambridge will serve
announced its award winning as a strategic, collaborative space in the community, where Waters
AQS3pro, based on Microfluidic can partner with academia, research and industry to accelerate
Modulation Spectroscopy the next generation of
(MMS) technology, is now scientific advancements.
available in India. The US Immerse Cambridge’s
based company has appointed open innovation concept
Chennai based Spinco Biotech features the latest cutting-
as exclusive Indian distributor. edge analytical, informatics
This partnership adds to recent and automation tools
distributor agreements signed that apply to a variety
in China and Japan, in response of disciplines across life
to the rapid growth in global sciences. The laboratory
demand for the novel AQS3pro. is purpose-built for
Designed specifically for protein innovation and discovery
characterization applications in with both speed and agility. It is also optimized for disseminating
the biopharmaceutical industry, and expanding ideas through training, joint research and mentoring
the technology has already seen experiences for students and up-and-coming industry professionals.
wide adoption in the analytical Waters has announced that a cornerstone project at Immerse
toolkit of companies developing Cambridge will feature researchers from both Boston University
life-saving biotherapeutics and Waters co-developing more effective Influenza A virus vaccines.
and vaccines. The partnership The collaboration, aided by the Massachusetts Life Sciences Center,
with Spinco Biotech will will harness breakthrough ion mobility-mass spectrometry and
satisfy the growing demand bioinformatics technologies to develop more effective methods and
from the Indian biopharma techniques for measuring protein glycosylation.
industry for multi-functional,
easy to use biophysical Bio-Rad launches dye with
characterization tools for unique fluorescent nanoparticles
protein secondary structural
analysis. The AQS3proA allows Bio-Rad Laboratories has nanometer offers researchers
biopharmaceutical companies announced the launch of improved brightness to resolve
to accelerate and de-risk their StarBright Violet 515 (SBV515) rare and low antigen density
drug development pipelines with Dye, the first of a new populations more easily.
ultra-sensitive measurements range of unique fluorescent It has a narrow emission
of minute protein structural nanoparticles, for use in flow profile to reduce spillover
changes. cytometry. StarBright into neighboring filters and
Dyes are conjugated
to a growing range minimal excitation by other
of antibodies and are lasers, making it suitable
compatible with most for inclusion in multicolor
flow cytometers and panels. StarBright Violet 515
experimental protocols. Dye is compatible with Bio-
The StarBright Violet 515
Dye with an excitation Rad’s ZE5 Cell Analyzer,
maximum at 401 S3e Cell Sorter, as well
nanometer and emission as other cytometers,
maximum of 516 and it is suitable for
both conventional
and spectral flow.