BioSpectrum India May 2021

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

Defined solutions for cell cultures. relative genom ic titer Xell's AAV2 titer boost

HEK ViP Culture Media Commercial reference
for Optimized Vaccine Xell's HEK ViP NX
Production 4.0
3.5
All-in-one media: expansion, transfection or 3.0
infection and production 2.5
2.0
Suitable and Scalable: from R&D to large-scale 1.5
GMP production 1.0
0.5
100% chemically defined and animal-origin free 0.0
HEK cell line 1 HEK cell line 2
Manufactured in Germany at Xell’s
own production facility

Shortest lead and delivery times
due to our local distributor

Read our technical note on AAV
production here:

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

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

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

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

COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.

COVERSTORY 20.........................................................................................................................................................

INDIAN BIOSERVICES INDUSTRY
HITS RS 29,000 CR WITH
12% GROWTH IN 2019-20

Indian BioServices industry comprising over 1000 players in the field of clinical research, contract research,
contract development and manufacturing has seen significant growth in the recent past and witnessed a 12
per cent growth in 2019-20 by reaching Rs 29,120 crore as against 19 per cent growth recorded in 2018-19.
Contract research, development and manufacturing are contributing the most in BioServices industry with
less than 10 per cent coming from clinical research organisations.

33 ANALYSIS

Indian Industrial 17

Enzymes Market touches Is India’s war on
COVID-19 losing steam?
Rs 2596 Cr with

10% growth rate

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

GREEN CHEMICALS TOPVIDEO

39 Ashvini Danigond,
Executive Director
Industrial enzymes crucial & CEO, Manorama
to reduce carbon footprint Infosolutions,
Adarsh Desai, Kolhapur gives her
views on upskilling
Managing Director, the healthcare
Infinita Biotech, Vadodara workforce in India.

SPEAKING WITH Scan the QR Code »

40 Dr Arbinder
Singal,
“India should focus on innovating Co-founder & CEO,
drugs and molecules to emerge Fitterfly, Mumbai
as a global leader” talks about the
S Sridhar, challenges facing
the diabetes
President, Organisation of Pharmaceutical digital health
Producers of India (OPPI), Mumbai ecosystem.

41 Scan the QR Code »

“Made in India products need an Sushil Mehta,
ecosystem for commercialisation Chairman, NextGen
of innovations” Invitro Diagnostics,
Thomas John, Gurugram shares
his thoughts on
Managing Director, how TB diagnosis
Agappe Diagnostics, Ernakulam can be enhanced in
India.
43
Scan the QR Code »
“We are working on strategies
for improving the reach of
Insulins to LMICs”
Amol Shah,

Managing Director,
M.J. Biopharm Pvt. Ltd., Mumbai

45

“We need Indian patients in our
global clinical trials to enable
product commercialisation”
Vani Manja,

Country Managing
Director India, Boehringer Ingelheim

REGULARS

BioEdit ......................................................................................................... 06
BioMail ........................................................................................................ 08
Policy and Regulatory News.................................................................... 10
Company News......................................................................................... 11
Finance News............................................................................................. 12
Start-up News............................................................................................ 13
World News................................................................................................ 14
WHO News.................................................................................................. 16
People News............................................................................................... 46
R&D News................................................................................................... 48
Supplier News............................................................................................ 49
Let’s Talk Health & Science........................................................... 50

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

A rudderless approach

People believe that certain diseases are fatal and increase focus on indigenous research and
due to their nature, but sometimes more local production of drugs, creating a national
so due to the treatment cost. Rare diseases hospital-based registry of rare diseases for
are among them. For 95 per cent of the 7,000 to ensuring adequate data. It also provides for early
8,000 rare diseases, the approved treatment is detection, suggests a crowdfunding mechanism,
unavailable and for the remaining, the treatment and classifies rare diseases into three categories.
costs are exorbitant. The categories are disorders amenable to one-
time treatment, those requiring long-term
The economic status of the family and or lifelong treatment, and diseases for which
treatment options become two important factors definitive treatment is available but the challenge
in case of a rare disease. Hence, the National is to make an optimal patient selection for benefit.
Policy for Rare Diseases, 2021 announced on
March 30, 2021, comes at the right time. The policy announces financial support up to
Rs 20 lakh for one-time treatment to all those who
The first policy was formulated in 2017 but are eligible as per the 23 norms of Pradhan Mantri
was kept in abeyance due to limiting factors like Jan Arogya Yojana (PMJAY). This support is for
‘bringing states on board’. This was necessary as the diseases classified in the first category. For
public health is primarily a state subject. A new those in the second category, the policy suggests
policy was framed after an expert committee that the state governments should consider giving
reviewed the earlier policy to remove gaps and the the aid. But the caregivers, advocacy groups, and
new draft was published in January 2020 to invite ORDI are not satisfied with the amount pointing
views and suggestions. It was announced after the out that it does not reflect the actual cost.
Delhi High Court ordered to announce the policy
before March 31, 2021. The annual cost for a child’s treatment for a
rare disease is estimated to be between Rs 10 lakh
Having such a policy is a good beginning and Rs 1 crore per year and it increases with the
considering that there are an estimated 7 crore age and weight of the child. Experts estimate that
rare diseases patients in India. However, experts the total cost of treating the patients will be Rs 80
in the field have found some lacunae in the to 100 crore per year. So the Union Government
policy. The first and foremost, pointed out by the must partner with states for sharing the cost. That
Organisation for Rare Diseases India (ORDI) is will put a burden of only Rs 40 to 50 crore on the
that the policy lacks a definition of rare diseases. Union Government. The drugs for rare diseases
have to be imported as there are no domestic
Though rare diseases are defined on three pharma producers for these drugs. In this context,
parameters – the number of people affected by the Delhi High Court’s directive to set up a
the disease, prevalence and, fewer treatment National Consortium for Research, Development,
options – the main criteria for definition is the and Therapeutics (NCRDT) is very important for
small number of people affected by the disease. domestic drug development.
‘How small a number’ is the question. The US has
defined it as a disease affecting less than 2,00,000 When a policy is formulated for the first time,
people. The World Health Organisation (WHO) it is, no doubt, a good beginning. But if the main
defines it as a disease having a frequency of less stakeholders like ORDI find any gaps then the
than 6.5-10 per 10,000 people. We should have government should consider their say as final in
defined it in the context of our population. India the interest of the patients.
maintains that it lacks epidemiological data on
the prevalence here and hence has only classified Dr Milind Kokje
certain diseases as ‘rare.’ Chief Editor

The policy aims to lower the treatment cost [email protected]

complete Automation For COVID Detection

Column Based
Extraction System

InstaNX® (LA1056)

• InstaNX® Viral RNA
Purification Kit (MBIN013)

• Individually sealed cartridges
• Ready to use

InstaNX® Mag32 (LA1096) InstaNX® Mag96 (LA1097)

• HiPurA® Super 11 Pre-filled • HiPurA® Super 11 Pre-filled
Plates for InstaNX® Mag32 Plates for InstaNX® Mag96
(MB615MPF3211) (MB615MPF9611)

Magnetic Bead Based InstaQ96® Series
Extraction System (LA1073 & LA1074)

• Hi-PCR® Coronavirus
(COVID-19) Multiplex Probe
PCR Kit (targeting 4 genes)
(MBPCR243)

Reach out to us for more details

Corporate Office
T : +91-22-6116 9797
E : [email protected]
W : www.himedialabs.com

Copyright © 2021 - HiMedia Laboratories Pvt. Ltd. All rights reserved.

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

Vol 19; Issue 4; April 2021 Corrigendum
Acknowledgements Savli Technology & Business
Congratulations BioSpectrum for the Excellence Awards Incubator (STBI) was born as
2020. We hope you will keep this up because then we will Savli BioIncubator [SBInc], a BISS
encourage others to move along. Incubator Project awarded by
BIRAC (then, BIRAP of DBT, GoI)
- Dr Renu Swarup, New Delhi to Gujarat State Biotechnology
My journey started with BioSpectrum almost 15 years back. Mission (GSBTM). In 2017, the
I wish to congratulate you for contributing to the growth of support came from NEB, DST,
biotechnology in India. I am honoured to receive the ‘Product of Govt. of India; and as per the
the year award’ for 2019-20. requirement of DST, GoI; STBI
has been registered as a separate
- Dr Krishna Ella, Hyderabad legal entity as an autonomous
Venture Center is delighted with the results of BioSpectrum’s institution under the aegis of
Bioincubator Survey 2020. Congratulations to all the winners. Dept. of Science & Technology,
Govt. of Gujarat, Hence Savli
- Premath V, Pune Bioincubator (SBInc) project has
Thank you for the interview feature with Prof Thomas been transferred to STBI and Dr
Noll, Chairman, Supervisory Board, Xell AG, Germany. A.N Bhadalkar, Jt. Dir. (HRD)
Cooperation is much appreciated. of GSBTM has been allotted the
Charge of Director, STBI.
- Dr Nagaraj Rao, Navi Mumbai

Vol 19; Issue 5; May 2021 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
Ravindra Boratkar Alok Srivastava Dr Manbeena Chawla Singapore
Editorial: National Business Head- Executive Editor MM Activ Singapore Pte. Ltd.
Chief Editor: Dr Milind Kokje Ad Sales & Marketing 103-104, Rohit House 3, Saradha Mani
[email protected] “NITON”, Block B, Lower Ground Floor, Tolstoy Marg, Connaught Place, General Manager
Advisor - Content: Vijay Thombre 11/3, Palace Road, Bangalore 560001 New Delhi - 110 001 #08-08, High Street Centre,
Editor: Mobile: +91-9845128747 Mobile: +91-8861043732 1 North Bridge Road,
Narayan Kulkarni Tel.: +91-80-41131912/13 [email protected] Singapore - 179094
[email protected] [email protected] Tel: +65-63369142
Executive Editor: Fax:+65-63369145
Dr Manbeena Chawla Mumbai Pune [email protected]
[email protected] Mr. Nirav Mistry Ankit Kankar USA
Sub Editor: Asst. Manager- Sales Manager- Product & Digital BioSpectrum Bureau
Nitesh Pillai 1st Floor, CIDCO Convention Center, Strategic Communications MM Activ Sci-Tech
[email protected] Sector 30A, Vashi, Navi Mumbai, Ashirwad, 36/A/2, S.No. 270, Pallod Communications
Content Team: Maharashtra-400703. Farms, Baner Road, Pune- 411045 Mobile: +91-9579069369
Singapore: Hithaishi C. Bhaskar Mobile - 9586424033 Mobile: +91-9579069369 E-mail: [email protected]
[email protected] [email protected] [email protected] Europe
Social Media Communications: Mr. Stuart Smith
Ankit Kankar Nagpur 6 Cobden Court, Wimpole Close,
[email protected] Manisha Boratkar Bromley, Kent BR2 9JF
CFO & Special Correspondent: 402, Govind Apartments, Shankar Nagar Square, E-mail: stuart.smith@
Manasee Kurlekar Nagpur - 440 010. Tel. +91-712-2555 249 globalmediasales.co.uk
[email protected] E-mail: [email protected]
Production & Design: Printed and published by Tel: +44 (0)20 8464 5577
MM Activ Sci-Tech Communications Ravindra Boratkar on behalf of MM Activ Sci-Tech Communications Pvt Ltd Mobile: 07973 814753
Anil Walunj Printed at Spectrum Offset, D2/4, Satyam Estate, 1st Floor, Behind
Product & Marketing C.D.S.S., Erandawane, Pune 411004. Maharashtra. Tel : +91 20 2543 6556 for the accuracy or
Ankit Kankar TIN No: 09565712431 completeness of
[email protected] Published from Ashirwad, 36/A/2, S.No. 270, Pallod Farms, information provided
Circulation, Subscription and Near Bank of Baroda, Baner Road, Pune- 411045.Tel. No: +91 20 2729 1769 therein. Readers must
Media Enquiry: Website: www.biospectrumindia.com undertake research and
Asmita Thakar take professional advice
[email protected] Owner of the magazine support these views. before acting on any
will not be liable for any  Contents and information provided in
Disclaimer: consequences. BioSpectrum.
 Readers are advised to  Views expressed in advertisements in
the published articles BioSpectrum are purely
make proper enquires are personal opinions for information purposes
before entering into any of the contributors. and the Publisher &
commitment in relations BioSpectrum does not Editor of BioSpectrum
to advertisements necessarily claim to give no warranty and
appearing in this accept no responsibility
publication. The Printer,
Publisher, Editor and



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

PGIMER opens new facilities to
uplift medical and scientific community

Dr Harsh Vardhan, Union Minister of Health and hi-tech artificial intelligence software transforming
Family Welfare recently inaugurated various facilities the management of stroke patients. PGIMER has
at Post Graduate Institute of Medical Education & acquired 384 Slice, Dual Source, which is one of the
Research (PGIMER), Chandigarh. PGIMER is an world’s most powerful and fastest state-of-the-art C.T.
autonomous body under the Ministry of Health Scan Machine. This will be extremely beneficial to
and Family Welfare. The Minister inaugurated the patients who are critically ill, trauma cases, or children
National Resource Centre for Oral Health Care of who have difficulty in breath-holding.
Children & Elderly (OHSC-PGIMER), Advanced PET
CT Facility, Advanced Vascular Interventional Lab,
384 Slice Dual Source CT Scan and Refractive Surgery
Suite (SMILE) facilities at various departments in the
institute. The newly installed state-of-the-art robotic
arm-assisted PET/CT guided intervention device
at Advance PET-CT Facility provides real-time 3D
visualization of lesions for biopsies; fewer needle
manipulations, repeat punctures and repeat scans
during complex procedures. In addition, the Advanced
Vascular Intervention Lab is the first of its kind with

NITI Aayog reveals broad Health Ministry
spectrum of investment
opportunities in healthcare unveils revamped

NITI Aayog, a policy think tank of the Government of India, Integrated Disease
has released a report outlining the range of investment
opportunities in various segments of India’s healthcare Surveillance Programme
sector, including hospitals, medical devices and equipment,
health insurance, telemedicine, home healthcare and Dr Harsh Vardhan, Union Minister of Health
medical value travel. In the first section, this report provides & Family Welfare, has virtually launched
an overview of India’s healthcare sector, including insights the Integrated Health Information Platform
about its employment generation potential, the prevailing (IHIP). The IHIP is the next generation
business and investment climate as well as the overarching highly refined version of the presently used
policy landscape. The second section highlights the key Integrated Disease Surveillance Programme
drivers of growth for the sector and the third elaborates (IDSP). The new version of
upon the enabling policies and investment opportunities in IHIP will house the data
seven key segments—hospitals and infrastructure, health entry and management
insurance, pharmaceuticals and biotechnology, medical for India’s disease
devices, medical tourism, home healthcare as well as surveillance
telemedicine and other technology-related health services. programme. In
addition to tracking
33 diseases now
as compared to the
earlier 18 diseases, it
shall ensure near-real-time
data in digital mode, having done away with
the paper mode of working. Being termed as
the world’s biggest online disease surveillance
platform, it is in sync with the National
Digital Health Mission and fully compatible
with the other digital information systems
presently being used in India.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com COMPANY NEWS 11

Premas Biotech, Oramed announce oral COVID-19 vaccine candidate

Gurugram based Premas Biotech most common antibody in blood
has announced the development of and bodily fluids that protects
an oral COVID-19 vaccine that has against viral infections and
shown efficacy after a single dose, Immunoglobulin A (IgA) which
in conjunction with Jerusalem protects the respiratory and
based Oramed Pharmaceuticals gastrointestinal tracts against
Inc. Accelerating the vaccine’s infection. Premas’ protein-based
path to market, Premas, Oramed VLP (Virus-Like Particle) vaccine
and other shareholders, have candidate creates triple protection
formed Oravax Medical Inc. which against the SARS CoV-2 virus
has received exclusive licenses Spike, Membrane, and Envelope
from Oramed and Premas to targets. The vaccine candidate
develop oral COVID-19 vaccines. is also safe, efficacious and well-
After a single dose of the Oravax tolerated at normal to high doses,
COVID-19 capsule, efficacy and generated high titres of
was evident through antibody neutralizing antibodies. The VLP
production in a pilot animal is manufactured using Premas’
study. Oravax’s vaccine promoted proprietary D-Crypt platform,
both systemic immunity through which is highly scalable and can
Immunoglobulin G (IgG), the be manufactured on large scales.

Alkem Labs Medtronic unveils
launches affordable anti-
epileptic drug in India engineering and

Mumbai based Alkem Laboratories has announced the innovation centre
launch of Brivasure, an affordable anti-epileptic drug for
the treatment of epilepsy in India. Brivasure, Alkem’s anti- in Hyderabad
epileptic drug (AED) is a generic version of the parent
molecule. Alkem has launched the drug in the market at Medtronic plc has announced the
price, Brivasure 25mg Rs 79.50/strip, Brivasure 50mg Rs inauguration of its newly expanded
148.50/strip, Brivasure 75mg Rs 230/strip, Brivasure 100mg state-of-the-art Medtronic Engineering
Rs 295/strip, post-patent expiry of innovator product, of and Innovation Center (MEIC) in
Brivaracetam as on February 21, 2021. The drug has been Hyderabad. The 150,000 sq ft centre
approved by the Drugs Controller General of India (DCGI) in employs engineers currently in the
the adjunctive management of partial-onset seizure with or areas of software development and
without secondary generalisation. The drug has exhibited a testing, test automation, mechanical
faster onset of action, efficacy with a favourable safety profile. design, analysis and hardware. With
With the introduction of Brivaracetam, the company is this expansion, MEIC aims to leverage
optimistic about making steady progress and revolutionising the sizeable pool of diverse and skilled
epilepsy treatment in India as well as globally. talent in India to continue its pioneering
work in the medical technology space
and add further to Medtronic’s 150+
patents and 400+ IP disclosures
globally that MEIC has been a part
of. MEIC serves as a global hub for
development, testing and qualification
for some of the most advanced and
innovative technologies. The setting up
of a new R&D facility is a purposeful
step to create synergy by supporting
Medtronic’s businesses globally, in
various therapy areas.

12 FINANCE NEWS BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

ART Fertility Piramal Pharma acquires
Clinics injects Hemmo Pharma for Rs 775 Cr
Rs 250 Cr
for Indian Piramal Pharma Limited’s (PPL) Contract Development and
expansion Manufacturing Organisation (CDMO), Piramal Pharma Solutions
(PPS), has announced that PPL has entered into an agreement to
Gulf Capital, one of the largest acquire a 100 per cent stake in Hemmo Pharmaceuticals for an upfront
and most active alternative asset consideration of Rs 775 crore and earn-outs linked to the achievement
managers in Growth Markets, has
announced its two-year growth of milestones. This acquisition
plans for ART Fertility Clinics, marks PPS’ foray into the
the fastest growing provider of development and manufacturing
fertility treatment services in of peptide APIs, a capability
the Gulf Cooperation Council that complements PPS’ existing
(GCC) countries. With increased service offering. Hemmo is one
awareness coupled with the of the few pure-play synthetic
technological advancements in peptide API manufacturers in
the field, the fertility sector in the global marketplace. With the
India is forecasted to continue addition of Hemmo’s capabilities,
to grow at over 12 per cent PPS will gain access to the growing
CAGR annually, over the next 5 peptide API market and enhance
years. The new chapter of ART its ability to offer integrated
Fertility Clinics will see the services to its customers globally.
implementation of an ambitious The acquisition is expected to add
two-year rollout of 18 IVF clinics more than 250 employees to PPS, including several PhD scientists and
across India. The first two clinics a quality team of more than 60. The acquisition agreement is subject to
in Gurgaon and New Delhi have customary regulatory closing conditions.
commenced medical operations.
They are to be followed by clinics NIIFL invests Rs 2,100 Cr
in Ahmedabad and Hyderabad in Manipal Hospitals
(April), Mumbai and Chennai
(May), Bangalore and Kolkata National Investment and
(July). The rest of the rollout will Infrastructure Fund Limited
be announced in September 2021. (NIIFL) has announced an
investment of Rs 2,100 crore in
Manipal Hospitals through its focus on tertiary and quaternary
NIIF Strategic Opportunities care. The recent announcement
Fund (SOF), the direct private of their acquisition of Columbia
equity fund of NIIF. This Asia Hospitals, a leading chain
investment marks SOF’s first of hospitals, will augment
investment in the Indian their growth aspirations to
healthcare sector and will become a healthcare provider
support Manipal Hospital’s of choice with high-quality
journey of growth to become multi-specialty offerings and a
one of India’s largest hospital country-wide presence.
chains. The transaction has
been signed by both parties and
the closing of the transaction
is subject to receipt of certain
approvals. Manipal Hospitals,
headquartered in Bengaluru,
has a major presence across
India with 15 hospitals and a key

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com START UP NEWS 13

Fertility care platform Janani.life secures Rs 8 Cr seed investment

Janani.life, a digital tech-enabled technology to transform the
fertility care platform, has recently fertility management industry,
raised Rs 8 crore in a round of Janani aims to establish itself
funding led by major institutional as a leading end-to-end digital
investors. Prominent institutional fertility care service provider.
investors such as Venture The Bengaluru based startup
Catalysts, Apollo Hospitals, distinguishes itself by providing a
Inflection Point Ventures, and first of its kind science-backed, the
Lets Venture participated in the phase-wise answer to the problem
seed and angel rounds, along of infertility, assisting patients
with existing investors including right from conception planning
9unicorn and AL. The startup till the end of the pregnancy. All
will utilise the funding to build its their services including sample
technology stack and initiate full- collection and diagnostic tests can
fledged operations in three metro be accessed from the comfort of
cities in the country. Leveraging the patients’ homes.

MFine launches Niramai’s breast
monitoring tool for
blood oxygen saturation cancer screening

Digital Health startup MFine, based in Bengaluru, has test receives
launched the MFine Pulse, an app-based SPO2 (blood oxygen
saturation) monitoring tool, which enables users to keep CE mark approval
track of their oxygen saturation levels without needing an
additional device. Using the power of smartphones and AI, Niramai, a deep-tech healthcare startup
MFine Pulse helps users’ measure oxygen saturation using at Bengaluru offering an innovative
the phone camera and flash. In its beta roll-out, thousands of AI-based, radiation-free breast cancer
users have already used the tool and currently, hundreds of screening test, has now received the
readings are recorded every day. Moving beyond telemedicine prestigious CE mark approval, ISO 13485
consultations and services, MFine is working on next-gen AI and MDSAP (Medical Device Single Audit
technologies, which aims to convert the mobile phone into a Programme) International Certifications.
rich diagnostics and vitals monitoring tool. The startup will The CE mark approval indicates that the
launch more such vitals monitoring and diagnostics tools in product may be sold freely in any part of
the coming days, elevating the use of smartphones as the new the European Economic Area. The ISO
examination tool for vitals tracking. 13485 and MDSAP certifications endorse
medical device manufacturers for their
compliance with the international
medical device quality standards and
regulatory requirements. NIRAMAI’s
Thermalytix solution and quality
management processes were audited by an
international notified body consisting of
expert auditors from India, Germany and
Australia. This CE mark approval shows
that the product meets EU requirements
for medical devices under MDD93/42/
EEC for safety, and performance. With
these quality certifications, NIRAMAI‘s
Thermalytix solution can now be applied
to all countries of Europe, as well as
applicable to many Asian, African and
Middle-East countries.

14 WORLD NEWS BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

Canada boosts medical waste management in the Maldives

The Government of Canada has medical waste management across
made a donation in support of the
Maldivian government’s efforts to health centres of 10 more atolls,
boost medical waste management.
In collaboration with the World alongside atolls where the facilities
Health Organisation (WHO),
the Canadian government has have already been established. The
approved the project worth 1.35
million Canadian Dollars. The service is expected to encourage
project, titled ‘Disinfections of
Medical Waste’ will support the environmentally sustainable
government’s efforts to strengthen
medical waste management ways to dispose of medical waste.
nationwide as well as aid the
country’s efforts to combat the This will also address the policy

on how waste management

currently impacts climate change

and the environment and aims

to bring an end to the practice of

ongoing COVID-19 pandemic. burning medical waste, which in
40 autoclaves will be procured
to enhance the sanitization and turn minimizes impacts on the

environment.

Nepal, World Bank Bangladesh
sign $75M agreement
for COVID-19 vaccines strengthens response

The Government of Nepal and the World Bank have against COVID-19
signed an agreement for additional financing of
$75 million to support access to safe and effective The Asian Development Bank has agreed to
COVID-19 vaccines for Nepal’s prioritised populations. provide Bangladesh with $940 million in loan
The additional financing builds on the $29 million for coronavirus vaccine doses and healthcare
for the original COVID-19 Emergency Response service enhancement. For Bangladesh, this
and Health Systems Preparedness Project that was is the largest loan support is receiving for the
coronavirus vaccine. In addition, the World
signed in April Bank has approved $500 million in financing
2020. The from the International Development Association
project will be (IDA) to help Bangladesh vaccinate 54 million
implemented people against COVID-19. The additional
under the financing to the COVID-19 Emergency Response
leadership of and Pandemic Preparedness Project will help
the Ministry Bangladesh procure safe and effective vaccines,
of Health and expand vaccine storage facilities, and distribute
Population vaccines to about 31 per cent of its population,
by the in support of the government’s prioritized plan
Department of covering 40 per cent of the population in
of Health the first phase of vaccination. The country is
Services and also planning to issue vaccine passports that
associated institutional bodies. About 90 per cent of will allow people to travel abroad and attend
the additional financing will support the purchase, important events.
supply and distribution of safe and effective COVID-19
vaccines. The rest of the financing will support
existing public health measures to test, trace and
treat the COVID-19 infection through a strengthened
health system; community engagement and risk
communication to improve the demand and uptake
of COVID-19 vaccines; and project implementation,
monitoring and evaluation, and learning.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com WORLD NEWS 15

USFDA approves CEPI launches funding call
to develop vaccines against
non-surgical emerging SARS-CoV-2

device to The Coalition for Epidemic Preparedness Innovations (CEPI), based in
Norway, has launched a call for proposals to develop broadly protective
treat congenital SARS-CoV-2 vaccines and broadly protective Betacoronavirus
vaccines. CEPI plans to invest up to $200 million in promising vaccine
heart disease candidates up to clinical proof of concept. The main focus of this call
for proposals is to support the research and development of novel
The US Food and Drug immunogens (ie, antigens that elicit an adaptive immune response)
Administration (FDA) has for use in vaccines that can elicit durable, broadly protective immune
approved the first in the world responses. This opportunity will be open, worldwide, to research and
non-surgical heart valve to treat development organisations with expertise in vaccine development.
paediatric and adult patients The call for proposals invites funding application for the development
with a native or surgically- of a broadly protective vaccine against new emerging variants and
repaired right ventricular variants of concern of the SARS-CoV-2 virus, with funding up to 18-24
outflow tract (RVOT), the part months to achieve clinical proof of concept; and a broadly protective
of the heart that carries blood Betacoronavirus vaccine with funding potentially awarded for up to 4
out of the right ventricle to the years to demonstrate clinical proof of concept.
lungs. The device is designed
for patients who have severe Germany tests mutation-
pulmonary valve regurgitation specific vaccine against
(blood leaking backwards into malignant brain tumours
the right lower chamber of the
heart), a condition that often For the first time, physicians and cancer researchers from Heidelberg
results from congenital heart and Mannheim have carried out a clinical trial to test a mutation-
disease. The device, called specific vaccine against malignant brain tumours. The vaccine proved
the Harmony Transcatheter to be safe and triggered the desired immune response in the tumour
Pulmonary Valve (TPV) System tissue. Diffuse gliomas are usually incurable brain tumours that
by Medtronic, is intended spread in the brain and are difficult to remove completely by surgery.
to improve blood flow to the
lungs in patients with severe In many cases, diffuse gliomas share
pulmonary valve regurgitation a common feature: in more than 70
without open-heart surgery, per cent of patients, the tumour cells
which is the current standard of have the same gene mutation. An
care. The use of the Harmony identical error in the DNA causes a
valve may delay the time before single, specific protein building block
a patient needs additional to be exchanged in the IDH1 enzyme.
open-heart surgery. It can also This creates a novel protein structure,
potentially reduce the total known as a neo-epitope, which can be
number of open-heart surgeries recognized as foreign by the patient’s
required over an individual’s immune system. The team had already
lifetime. generated an artificial version of the
segment of the IDH1 protein with the characteristic mutation several
years ago. This mutation-specific peptide vaccine was able to halt the
growth of IDH1-mutated cancer cells in mice. In 2019, Platten was
awarded the German Cancer Prize for this discovery. Encouraged by
these results, they decided to test the mutation-specific vaccine for the
first time in a phase I study in patients newly diagnosed with IDH1-
mutated glioma (WHO grades III and IV astrocytomas).

16 WHO NEWS BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

WHO launches WHO reboots global
progress effort to end tuberculosis
indicators
for assistive An estimated 1.4 million fewer people received care for tuberculosis (TB)
technology in 2020 than in 2019, according to preliminary data compiled by the
World Health Organisation (WHO) from over 80 countries- a reduction
One of the biggest barriers of 21 per cent from 2019. The countries with the biggest relative gaps
to accessing assistive were Indonesia (42 per
technology is a lack of data. cent), South Africa (41 per
Without relevant, quality cent), the Philippines (37
information, decision-makers per cent) and India (25 per
face huge challenges in cent). Many people who
developing evidence-informed have TB are unable to access
policies and programmes the care they need. WHO
to improve access for their fears that over half a million
populations. The World more people may have died
Health Organisation (WHO) from TB in 2020, simply
has developed the WHA71.8 because they were unable
Progress Indicators for access to obtain a diagnosis. New
to assistive technology to guidance issued by WHO
collect high-level information aims to help countries
from all Member States to identify the specific needs of
track and measure progress communities, the populations at highest risk of TB, and the locations most
in achieving the resolution. affected to ensure people can access the most appropriate prevention
The Progress Indicators and care services. This can be achieved through more systematic use of
monitor the status of assistive screening approaches that employ novel tools.
technology access across ten
specific areas reported in WHO envisages a
the resolution: legislation, healthier post-COVID-19 world
population and geographic
coverage, budget, responsible COVID-19 has unfairly impacted some people more harshly than
ministries, human resources,
education and training, others, exacerbating existing inequities in health and welfare within
financial coverage, regulations
and standards, and specific and between countries. WHO is therefore issuing calls for urgent
assistive technology
initiatives. The WHA71.8 action to improve health for all people. The action points include-
urges all Member States to
take actions to improve access accelerating equitable access
to assistive technology and
requests the WHO to develop to COVID-19 technologies
a Global Report on Assistive
Technology based on the best between and within
available scientific evidence
and international experience. countries; invest in primary

health care; prioritise health

and social protection;

build safe, healthy and

inclusive neighbourhoods;

and strengthen health

information systems.

A recent WHO global

assessment shows that only

51 per cent of countries have

included data disaggregation in their published national health statistics

reports. The health status of these diverse groups is often masked when

national averages are used. Moreover, it is often those who are made

vulnerable, poor or discriminated against, who are the most likely to be

missing from the data entirely.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com ANALYSIS 17

Is India’s war on
COVID-19 losing steam?

As the vaccination drive continues, India is faced with a shortage of vaccines considering
the population of the country, which currently stands at a staggering 1,390,605,073, as per
Worldometer elaboration of the latest United Nations data. The Indian government, to address this
stark reality, has opened its doors to foreign vaccines and are fast-tracking their approval.

As the COVID-19 pandemic rages on, vaccines trials on 1600 participants within the country.
offer a glimmer of hope in these dark times. The firm also submitted the interim safety and
The world has moved swiftly in unison to immunogenicity data generated from this trial and
develop COVID-19 vaccines, with India leading from the data was found comparable with the data from
the front in terms of COVID-19 vaccine production the overseas clinical studies.
and supplying it to the rest of the world.
Bharat Biotech conducted Phase I/II clinical
India had approved the indigenously developed trials on approximately 800 subjects and the results
COVAXIN by Bharat Biotech and COVISHEILD demonstrated that the vaccine is safe and provides
(AstraZeneca) manufactured by Serum Institute of a robust immune response. The Phase III efficacy
India (SII) on January 3, 2021. The Drug Controller trial was initiated in India in 25,800 volunteers and
General of India (DGCI) had approved the vaccines on January 3, 2021, ~22,500 participants had been
on the basis of ‘restricted’ use in an ‘emergency’ vaccinated across the country and the vaccine was
situation, with the vaccination drive commencing found to be safe as per the data available. Bharat
on January 16, 2021. The Sputnik V developed by Biotech came out with the first interim analysis of
Gamaleya Research Institute of Epidemiology and COVAXIN on March 3, 2021 with an efficacy of 80.6
Microbiology and the Russian Direct Investment per cent.
Fund (RDIF) received the nod on April 12, 2021. The
centre procured 1.10 crore doses of COVISHEILD Dr Reddy’s presented the safety profile for
at the cost of Rs 200/dose (excluding taxes) and 55 Sputnik V, with Phase II study, and interim data of
lakh doses of COVAXIN. The cost of 38.5 lakh doses the Phase III study to the government. The vaccine
of COVAXIN was Rs 295/dose (excluding taxes) but is currently undergoing the Phase III clinical trial in
the company provided 16.5 lakh doses of COVAXIN India. Interim data analysis of the Sputnik V vaccine
free of cost to the central government reducing the has demonstrated 91.6 per cent efficacy.
cost to Rs 206/dose. The central government was
able to procure the vaccines at this price by putting a As the vaccination drive
price cap on the vaccine. The cost of Sputnik V hasn’t continues, India is faced
been announced as yet. This is a two-dose vaccine with a shortage of
that costs approximately $10 per dose in the global vaccines considering the
market. population of the country
which currently stands
The DCGI has approved the vaccines after at 1,390,605,073 (based
scrutinising the data that was submitted to the on Worldometer
Subject Expert Committee of Central Drugs Standard elaboration
Control Organisation. SII submitted data on safety, of the latest
immunogenicity and efficacy data generated on United
23,745 participants aged ≥ 18 years or Nations data).
older from overseas clinical studies. The Indian
The overall efficacy was found to be government, to
70.42 per cent. Further, SII was address this stark reality
granted permission to has opened its doors to
conduct Phase- foreign vaccines and is
II/III fast tracking the approvals
clinical for these vaccines.
As per the data

18 ANALYSIS BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

SII fixes COVISHEILD price and Rs 600/ dose for private hospitals. Whereas
in the global market the American Vaccines
Welcoming the recent announcement made
by Government of India’s Ministry of Health and could cost Rs 1500/dose and Russian
Finance Ministry to accelerate India’s and Chinese Vaccines could cost Rs 750/
vaccination drive, Adar C Poonawalla, dose. Referring to the prices, Poonawalla
CEO, Serum Institute of India (SII), on observed “Considering the global vaccine
April 21, 2021 said “For the next two prices, we are ensuring that our vaccines
months, we will address the limited are affordable in comparison to any other
capacity by scaling up the vaccine vaccines in the world.” On April 28,
production. Going ahead, 50 per cent Poonawalla twitted “As a philanthropic
of our capacities will be served to the gesture on behalf of @SerumInstIndia,
Government of India’s vaccination I hereby reduce the price to the states
programme, and the remaining 50 per from Rs 400 to Rs 300 per dose, effective
cent of the capacity will be for the state immediately; this will save thousands of
governments and private hospitals.” crores of state funds going forward. This
will enable more vaccinations and save
Following the Government of India countless lives.”
directives, SII fixed the COVISHEILD
price at Rs 400/ dose for governments

shared by the Health Ministry on April 13, 2021, vaccines that have been approved are far from perfect,
all the states and Union Territories have received with each having their own flaws. COVISHEILD also
13,10,90,370 doses with a total consumption of known as Vaxzevria (name change implemented by
11,43,69,677 doses (including wastage of 8-9 per European Medicines Agency on March 25, 2021)
cent), remaining doses with the states and UTs are globally has proven to be less effective against the
1,67,20,693 and the doses that are in the pipeline South African strain of the virus and there are reported
are 2,01,22,960. India has administered a total of cases globally about the vaccine causing blood clots.
11,11,79,578 doses as per the data mentioned on the Thankfully, no such cases have been reported so far in
Ministry of Health and Family Welfare website (April India. Several countries have gone ahead and halted
14). The vaccines that have been administered till the use of Vaxzevria till there is more concrete data on
date are COVAXIN and COVISHEILD as the Sputnik whether the vaccine is indeed, causing blood clots.
V has just been approved and till date, it was only
used for Phase II-III clinical trials by Dr Reddy’s. COVAXIN has also come under fire from experts
who believe that the approval process for the
The COVID-19 vaccines that are available in vaccine was rushed. Brazil has refused emergency
India currently have a vial capacity of 10 doses use authorisation (EUA) to the vaccine as it didn’t
(COVISHEILD), (COVAXIN) and 20 doses (COVAXIN meet manufacturing standards. Gagandeep Kang,
initial consignment). Currently there are no details Professor, Department of Gastrointestinal Sciences,
about the vial capacity of the Sputnik V. The vaccines Christian Medical College, Vellore, India voiced
that are currently available have a shelf life of six her opinion on COVAXIN approval, stating that
months. Notably, the shelf life of COVISHEILD was she couldn’t understand how approval was given to
increased from six months to nine months recently. Bharat Biotech without the submission of Phase III
Once the vaccine vials are opened they can only be clinical trials, as at the time of approval Phase III
preserved for four hours. The ideal temperatures to data had not been submitted to DCGI. All India Drug
store the Indian vaccines are 2-8 degrees Celsius as Network as well were left shocked with the hasty
was also mentioned by Dr Renu Swarup, Secretary, decision at the time, due to the lack of efficacy data
Department of Biotechnology during a media briefing. and lack of transparency. The All India Drug Network
Sputnik V can be stored at the same temperature as stated that the decision would raise more questions
COVISHEILD and COVAXIN. than answers and that could lead to losing faith in
scientific decision making bodies.
Roadblocks ahead
Unanswered questions
India’s vaccination drive, also being the world’s largest
COVID-19 vaccination drive, has been ongoing for As India has opened its doors to all vaccine
the last three months. The vaccination drive has hit manufacturers there are a lot of unanswered
several roadblocks in the last few months. Firstly, the questions. Questions pertaining to the process in

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com ANALYSIS 19

which the approvals will be granted, what is going to Bharat Biotech fixes COVAXIN price
be the price of the vaccines and will Indian citizens
have the option of choosing a vaccine, can be cited. On April 24, Dr Krishna Ella, Chairman
& Managing Director, Bharat Biotech
Johnson & Johnson currently is in talks with the International Limited (BBIL) in a statement
Indian government, to start clinical trials of its single- said “Bharat Biotech is honoured to develop,
dose COVID-19 vaccine. This vaccine is compatible manufacture & supply COVAXIN for India’s
with standard vaccine storage and distribution vaccine rollout at Rs 150/dose,
channels with ease of delivery to remote areas. The which is distributed for free by
vaccine is estimated to remain stable for two years the Govt. of India. We would
at -20°C, and a maximum of three months at routine like to state that more than
refrigeration at temperatures of 2-8°C. 50 per cent of our capacities
have been reserved for
Crunch time CentraI Government supplies.
Following the directive of the
As we gear up for an influx of various COVID-19 Govt. of India, we announce
vaccines in the Indian market, the Indian government the price of COVAXIN as Rs
needs to address the concerns of Indian vaccine 600 for state governments, Rs
manufacturers as well. Indian vaccine manufacturers’ 1200 for private hospitals and
production capacities are highly stressed due to $15-20 for exports.”
massive demands. European countries and the US are
withholding raw materials required to manufacture Unsustainable model
COVID-19 vaccines. Indian vaccine manufacturers
need to ramp up production capacities for which Kiran Mazumdar-Shaw, Chairperson and Managing
surplus funds are required, they also need to be Director, Biocon has voiced her opinion on the price
incentivised so that it further leads to innovation, cap of the vaccine. She tweeted, “COVID-19 vaccine
higher efficacy, quality control, higher production price is too low to sustain. She also provided further
capacities. There is also the issue of wastage of insights by breaking down the cost that private
vaccines which needs to be addressed if we want to hospitals can charge for administering a COVID-19
go ahead and win the war against COVID-19, as there vaccine, vaccine administration at government
aren’t enough vaccines currently available. hospitals are going to be free of cost. Private hospitals
empanelled with PM Ayushman Bharat Yojana and
Various states and UTs across India have been the Central Government Health Scheme (CGHS) will
reporting shortage of vaccines. Shortage of vaccines also offer vaccination, where Rs 250 can be charged
can derail the entire vaccination drive against the for vaccination, where the vaccine manufacturer
Coronavirus. The Indian government also needs to would get Rs 150 and the hospital would get Rs 100
iron out flaws in the vaccination drive infrastructure for administering it. She also referenced the WHO’s
to reduce wastage as there have been reports price cap for COVID-19 vaccines at $3, but in India
of CoWin app (COVID-19 vaccine registration the cost has been brought down further to $2.
application) servers being down and not enough
people turning up for vaccinations due to the chaos A feasible solution
and miscommunication as the vial capacity of the
vaccines of currently available are ten doses. As newer vaccines come to Indian shores, the
scope to vaccinate more citizens increases, but
Cost of jabs foreign vaccines cannot fulfil the vaccine deficit
that we might face in the coming months. The
There also needs to be a regulation in pricing of the feasible solution, or at least a part of it, rests with
vaccine as Covshield and COVXAIN are available for Rs Indian vaccine manufacturers who must skyrocket
150 currently per dose. Sputnik V has been approved their manufacturing capacities right away, so that
but the price of the vaccine is still unclear. Experts like India’s ambitious vaccine drive isn’t derailed.
KV Balasubramaniam, Former Managing Director, Vaccine diplomacy and ramping up production of
Indian Immunologicals Ltd and NK Mehra, ICMR vaccines will have a global impact, leading to a new
emeritus scientist and Former Dean, AIIMS, New normalised world. Nobody is safe till everybody is
Delhi are of the opinion that the cost can be reduced safe.
further to Rs 60-70. However, the crucial question is
whether it will be sustainable for foreign manufacturers Prabhat Prakash
to compete with COVISHEILD and COVAXIN, as the [email protected]
Sputnik V and Johnson & Johnson COVID-19 vaccine
retail for $10 per dose in the global market.

20 COVER STORY BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

INDIAN BIOSERVICES
INDUSTRY HITS

RS 29,000 CR WITH

12% GROWTH IN 2019-20

Indian BioServices industry comprising over 1000 players comprises which creates trust issues among potential clients
in the field of clinical research, contract research, contract and in turn, hurts the market.
development and manufacturing has seen significant
growth in the recent past and witnessed a 12 per cent BlueWeave Consulting, in its May 2020 report, observed
growth in 2019-20 by reaching Rs 29,120 crore as against that the presence of diverse climatic conditions and
19 per cent growth recorded in 2018-19. Contract research, acceptance of international guidelines and intellectual
development and manufacturing are contributing the most property rights are the key factors that fuel the market.
in BioServices industry with less than 10 per cent coming Availability of largest pool of patients and large number of
from clinical research organisations. hospitals, educated and accessible human resources, and low
The Indian clinical research market is dominated by operational cost due to cheap human resources are some
multinational organisations, followed by Indian companies, of the other factors that boost the market to reach its target
multinational pharmaceutical companies, and Indian during the forecast period.
pharmaceutical companies. Among these, the Indian
pharmaceutical companies are mainly engaged in Grand View Research, in its 2018 Indian clinical trials
conducting local trials. On the flip side, Indian companies are market forecast, reported that the market size value in 2020
dominating the contract research, contract development and was $2,064.30 million and it is expected to hit $3,125.16 million
manufacturing activities. by 2025 with a CAGR of 8.7 per cent from 2017 to 2025.
The western and southern regions of India hold a strong
position in the clinical research market due to availability of An article published in December 2020 by ProRelix
better infrastructure, education and a salubrious climate. Research, observed that the India Contract Research
This holds true for the contract manufacturing and research Organization Market is projected to grow at a CAGR of 20.4
services as well. However, the northern region has started per cent and is expected to reach $ 6,310.5 million by 2022.
growing and catching up due to larger and more diverse
genetic pool and the concentration of regulatory bodies in However, Mordor Intelligence revealed, in its latest report
northern India. The faster growth of hospitals in northern on the Indian Contract Manufacturing Organisations (CMOs)
India is favouring the clinical research market and has led market, that it was valued at $ 10.51 billion for 2020, and it is
to this shift. The growth of diseases needing specialised expected to reach $27.80 billion by 2026, at a CAGR of 17.6 per
care and treatments such as cancer is booming the clinical cent, during the period of 2021 - 2026. The rise in demand for
research market of this segment at a faster pace than other injectable drugs, especially in cancer research, will provide
segments. Support from the regulatory authorities such an upward trend to the Indian pharmaceutical contract
as Department of Biotechnology (DBT), Director Controller manufacturing market. Injectable drugs offer higher returns
General of India (DCGI), Directorate General of Foreign Trade as compared to other drug formulation types. Therefore,
(DGFT), and the Indian Council of Medical Research (ICMR), higher ROI and therapeutic efficiency are expected to fuel
has also supported the growth of the market. the growth of the injectable formulation segment in the
However, Market Research Future has noted that the country. Increasing outsourcing volume by big pharma
market is facing constraints that can hamper the growth companies is driving this market.
of the Indian clinical research market. There is a growing
concern regarding security, especially data security and The Indian Drug Manufacturers Association (IDMA)
patient security and the lack of collaboration between mentioned the rising costs and regulatory pressure in
universities and industry, etc. Sometimes, some unethical developed markets as a major driver, forcing many global
Indian clinical research organisations make dishonest pharmaceutical companies to reduce their internal capacities
in research and development. Besides, ageing manufacturing
facilities in Europe have forced companies to outsource their
research and manufacturing to India, which can expect a
significant growth in contract research, development and
manufacturing the coming years.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com COVER STORY 21

PIRAMAL PHARMA SOLUTIONS
RETAINS NO 1 POSITION

IN INDIAN BIOSERVICES INDUSTRY

Mumbai-based Piramal Pharma ■ Piramal Pharma ■ IQVIA RDS (India) ■ Aizant Drug Research
Solutions is leading the BioServices Solutions is a leading Private Limited is a Solutions Private
CDMO in India. leading MNC CLRO in Limited is a leading
Industry with sales revenue of India. Indian CRO in India.
Rs 3154 crore in 2019-20 ■ Syngene International
Ltd is a leading CRMO ■ Anthem Biosciences ■ Covance India
(Rs 2783 crore for the year 2018-19) in India. Private Limited is Pharmaceutical
at No 1 position followed by a leading CRISP Services Pvt Ltd is a
■ Vimta Labs Ltd is a company in India. leading MNC CRO in
Bangalore-based Syngene International leading Indian CLRO India.
Ltd with revenue worth Rs 2094 crore in India. ■ Aurigene Discovery
(Rs 1901 crore) at No 2 and Technologies Limited ■ Neuland Laboratories
Bangalore-based Jubilant Biosys Ltd ■ GVK Biosciences is leading DDDS Limited is a leading
with sales of Rs 1831 crore Private Limited is a company in India. CMS company in India.
(Rs 1687 crore) at No 3. leading CRDO in India.

BioSpectrum Top BioServices Companies 2020*

Sr. Name Revenue Revenue Per centage Area of Location State Region
No for 2019-20 for 2018-19 growth over Operation
(in Rs crore) (in Rs crore) last year (%) Mumbai
1 Piramal Pharma Solutions India CDMO Bangalore Maharashtra West
2 Syngene International Limited 3154 2783 13 India CRMO Bangalore Karnataka South
3 Jubilant Biosys Limited 2094 1901 10 India CDMO Bangalore Karnataka South
4 IQVIA RDS (India) Private Limited 1831 1687 9 MNC CLRO Hyderabad Karnataka South
5 GVK Biosciences Private Limited 1536 1308 17 India CRDO Hyderabad Telangana South
6 Suven Pharmaceuticals Limited 950 793 20 India CDMO Bangalore Telangana South
7 Anthem Biosciences Private Limited 852 India CRISP Chennai Karnataka South
8 ICON Clinical Research India Private Limited 750 670 12 MNC CLRO Bangalore Tamil Nadu South
9 Aurigene Discovery Technologies Limited 352 318 11 India DDDS Mumbai Karnataka South
10 Covance India Pharmaceutical Services Private Limited 280 211 33 MNC CRO Mumbai West
11 Covance Scientific Services & Solutions Private Limited 255 159 60 MNC CRO Maharashtra West
190 177 7 Maharashtra
(Formerly: Sciformix Technologies Private Limited) India
12 Neuland Laboratories Limited 188 91 107 India CMS Hyderabad Telangana South
13 Vimta Labs Limited 184 215 -14 MNC CLRO Hyderabad Telangana South
14 PPD Pharmaceutical Development India Private Limited 175 141 24 MNC CRO Maharashtra West
15 Eurofins Advinus Limited 168 105 60 India CRO Mumbai Karnataka South
16 Veeda Clinical Research Limited 153 224 -32 India CLRO Bangalore West
17 Aizant Drug Research Solutions Private Limited 144 151 -5 India CRO Ahmedabad Gujarat South
18 Accutest Research Laboratories (I) Private Limited 119 126 -6 MNC CRO Hyderabad Telangana West
19 Covance Clinical Development Private Limited 111 106 5 CLRO Navi Mumbai Maharashtra South
MNC Bangalore Karnataka
(Formerly: Chiltern Clinical Research India Private Limited) 104 93 12 India
20 APCER Life Sciences India Limited 60 60 0 India CLRO New Delhi New Delhi North
21 Siro Clinpharm Private Limited 55 56 -2 India CLRO Navi Mumbai Maharashtra West
22 Vivo Bio Tech Limited 54 41 32 MNC CRO South
23 Norwich Clinical Services Private Limited 27 28 -4 India CRO Hyderabad Telangana South
24 JSS Medical Research Asia Pacific Private Limited 26 29 -10 India CLRO Bangalore Karnataka North
25 Panexcell Clinical Lab Private Limited 25 19 32 India CLRO Faridabad Haryana West
26 Synapse Labs Private Limited 22 MNC CRO Navi Mumbai Maharashtra West
27 Kemwell Biopharma Private Limited 18 17 6 India CDMO Maharashtra South
28 RCC Laboratories India Private Limited 18 20 -13 MNC CRO Pune Karnataka South
29 Pharmaffiliates Analytics And Synthetics Private Limited 17 12 42 India CRO Bangalore Andhra Pradesh North
30 Novotech Clinical Research India Private Limited 16 3 433 India CLRO Hyderabad Haryana South
31 CliniRx Research Private Limited 14 13 8 MNC CLRO Panchkula Karnataka North
32 Vanta Bioscience Limited 13 7 81 MNC CRO Bangalore New Delhi South
33 Endpoint Clinical India Private Limited 13 19 -32 India CLRO New Delhi Tamil Nadu South
33 PAREXEL International Clinical Research Private Limited 9 6 50 India CLRO Chennai Telangana South
34 Eurofins Pharma Services India Private Limited 9 9 0 India CDMO Hyderabad Karnataka South
34 Divi’s Laboratories Limited 8 MNC CRO Bangalore Karnataka South
35 Spectrum Clinical Research Private Limited 5 4 25 MNC CLRO Bangalore Telangana West
36 Medpace Clinical Research Private Limited 4 India CLRO Hyderabad Maharashtra West
37 Quanticate India Private Limited 3 3 0 India CLRO Mumbai Maharashtra South
38 ICBIO Clinical Research Private Limited 3 India CLRO Mumbai Karnataka South
38 Catalyst Clinical Services Private Limited 2 3 -33 India CLRO Bangalore Karnataka North
39 Vipragen Biosciences Private Limited 1 1 0 MNC CRO Bangalore New Delhi South
40 CliniMed Lifesciences Private Limited 1 1 0 India CRO New Delhi Karnataka East
40 Maya Clinicals Drug Development Private Limited 1 7 0 CRO West Bengal South
40 Asiatic Clinical Research Private Limited CLRO Mysuru Telangana South
Kolkata Karnataka
Hyderabad
Bangalore

* We have not covered some of the leading BioServices Companies as they are unable to participate in the BioSpectrum BioServices Industry Survy 2020

■ CLRO - Clinical Research Organization ■ CRO - Contract Research Organisation ■ CDMO - Contract Development & Manufacturing Organisation
■ CMS - Contract Manufacturing Services ■ CRISP- Contract Research and Innovation Service Provider ■ CRMO -Contract Research & Manufacturing Organization
■ CRDO- Contract Research & Development Organization ■ DDDS- Drug Discovery & Development Services

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

BioSpectrum Top Indian BioServices Companies 2020*

Sr. Name Revenue Revenue Per centage Area of Location State Region
No for 2019-20 for 2018-19 growth over Operation
(in Rs crore) (in Rs crore) last year (%) West
South
1 Piramal Pharma Solutions 3154 2783 13 India CDMO Mumbai Maharashtra South
South
2 Syngene International Ltd 2094 1901 10 India CRMO Bangalore Karnataka South
South
3 Jubilant Biosys Ltd 1831 1687 9 India CDMO Bangalore Karnataka South
South
4 GVK Biosciences Private Limited 950 793 20 India CRDO Hyderabad Telangana South
West
5 Suven Pharmaceuticals Limited 852 India CDMO Hyderabad Telangana South
West
6 Anthem Biosciences Private Limited 750 670 12 India CRISP Bangalore Karnataka West
South
7 Aurigene Discovery Technologies Limited 280 211 33 India DDDS Bangalore Karnataka South
West
8 Neuland Laboratories Limited 188 91 107 India CMS Hyderabad Telangana West
South
9 Vimta Labs Ltd. 184 215 -14 India CLRO Hyderabad Telangana North
North
10 Veeda Clinical Research Limited 153 224 -32 India CLRO Ahmedabad Gujarat South
South
11 Aizant Drug Research Solutions Private Limited 144 151 -5 India CRO Hyderabad Telangana South
West
12 Accutest Research Laboratories (I) Pvt Ltd 119 126 -6 India CRO Navi Mumbai Maharashtra South
North
13 Siro Clinpharm Private Limited 60 60 0 India CLRO Navi Mumbai Maharashtra South
East
14 Vivo Bio Tech Limited 55 56 -2 India CRO Hyderabad Telangana South

15 Norwich Clinical Services Private Limited 54 41 32 India CRO Bangalore Karnataka Region

16 Panexcell Clinical Lab Private Limited 26 29 -10 India CLRO Navi Mumbai Maharashtra South
South
17 Synapse Labs Private Limited 25 19 32 India CRO Pune Maharashtra West
West
18 Kemwell Biopharma Private Limited 22 India CDMO Bangalore Karnataka
West
19 Pharmaffiliates Analytics And Synthetics Private Limited 18 20 -13 India CRO Panchkula Haryana South
South
20 CliniRx Research Private Limited 16 3 433 India CLRO New Delhi New Delhi
North
21 Vanta Bioscience Limited 14 13 8 India CRO Chennai Tamil Nadu North
South
22 Eurofins Pharma Services India Private Limited 9 6 50 India CDMO Bangalore Karnataka South
South
23 Divi's Laboratories Limited 9 9 0 India CRO Hyderabad Telangana South
West
24 Spectrum Clinical Research Private Limited 8 India CLRO Mumbai Maharashtra South
South
25 ICBIO Clinical Research Private Limited 3 3 0 India CLRO Bangalore Karnataka

26 Catalyst Clinical Services Private Limited 3 India CLRO New Delhi New Delhi

27 Vipragen Biosciences Pvt Ltd 2 3 -33 India CRO Mysuru Karnataka

28 CliniMed Lifesciences Private Limited 1 1 0 India CRO Kolkata West Bengal

29 Asiatic Clinical Research Private Limited 1 7 -86 India CLRO Bangalore Karnataka

* We have not covered some of the leading BioServices Companies as they are unable to participate in the BioSpectrum BioServices Industry Survy 2020

BioSpectrum Top MNC BioServices Companies 2020*

Sr. Revenue for Revenue for Per centage Area of Location State
No Name 2019-20 (in Rs 2018-19 (in Rs growth over Operation
crore) crore) last year (%) Bangalore Karnataka
CLRO Chennai Tamil Nadu
1 IQVIA RDS (India) Private Limited 1536 1308 17 MNC CLRO Mumbai Maharashtra
2 ICON Clinical Research India Private Limited 11 MNC CRO Mumbai Maharashtra
3 Covance India Pharmaceutical Services Pvt Ltd 352 318 60 MNC CRO
4 Covance Scientific Services & Solutions Private Limited 7 MNC Mumbai Maharashtra
255 159 CRO Bangalore Karnataka
(Formerly: Sciformix Technologies Pvt Ltd) MNC CRO Bangalore Karnataka
5 PPD Pharmaceutical Development India Private Limited 190 177 MNC CLRO
6 Eurofins Advinus Limited MNC New Delhi New Delhi
7 Covance Clinical Development Pvt Ltd 175 141 24 CLRO Faridabad Haryana
168 105 60 MNC CLRO Hyderabad Andhra Pradesh
(Formerly: Chiltern Clinical Research India Pvt Ltd) 111 106 5 MNC CRO Bangalore Karnataka
8 APCER Life Sciences India Limited MNC CLRO Hyderabad Telangana
9 JSS Medical Research Asia Pacific Private Limited 104 93 12 MNC CLRO Bangalore Karnataka
10 RCC Laboratories India Private Limited 27 28 -4 MNC CLRO Mumbai Maharashtra
11 Novotech Clinical Research India Private Limited 18 17 6 MNC CLRO Bangalore Karnataka
12 Endpoint Clinical India Private Limited 17 12 42 MNC CLRO Hyderabad Telangana
13 PAREXEL International Clinical Research Private Limited 13 7 81 MNC CRO
14 Medpace Clinical Research India Pvt Ltd 13 19 -32 MNC
15 Quanticate India Private Limited 54 25
16 Maya Clinicals Drug Development Private Limited 4
11 0

* We have not covered some of the leading BioServices Companies as they are unable to participate in the BioSpectrum BioServices Industry Survy 2020

BIOSPECTRUM BIOSERVICES SURVEY AND METHODOLOGY

BioSpectrum India, a leading B2B media platform in A detailed questionnaire (survey form) was sent to over 100
Lifesciences space since 2003, has re-launched its ranking companies (both MNC and Indian players) in this space to capture
special edition in June 2019 after a gap of two years. We the needed information for the analysis. This was done during
have delayed this survey and ranking excise in 2020 due January – March 2021. Companies shared information with us to the
to COVID-19, as companies were given extended period to extent it was possible by them. We have collected information about
submit their financial returns to December 2020. listed companies from stock exchange and financial agencies and
In this survey we looked at BioServices Industry specializing Ministry of Corporate Affairs (MCA) as well.
in Clinical Research Organization (CLRO), Drug Discovery &
Development Services (DDDS), Contract Research Organizations #The revenues considered for the analysis are of services part
(CROs); Contract Research & Development Organizations (CRDOs), of the companies as noted above. In several cases, where revenue
Contract Development & Manufacturing Organizations (CDMOs), figures were not available, estimates were arrived in discussion with
Contract Manufacturing services (CMS), Contract Research and industry experts.
Innovation Service Provider (CRISP) that support biotech and pharma
from discovery through commercialization. We highlighted the #For all the ranking purposes, we have taken the CROs business
companies based on their achievements in the past financial years. only into consideration. Wherever ‘Revenue is mentioned, it means,
sales turnover from CROs. Therefore, revenue wherever mentioned
is not necessarily the total sales turnover of the company.

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

01 PIRAMAL PHARMA SOLUTIONS

REVENUE Mumbai-based Piramal Pharma Solutions (PPS)
generated a revenue of Rs 3154 crore during the FY19-
₹3154 crore 20, exhibiting a growth of 13 per cent in comparison to
the revenue figure of Rs 2783 generated in the previous
PETER DEYOUNG year.
Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises
Chief Executive Officer Limited (PEL), offers a portfolio of differentiated products and services
through end-to-end manufacturing capabilities across 14 global
facilities and a global distribution network in over 100 countries.
PPL includes- Piramal Pharma Solutions, an integrated Contract
Development and Manufacturing Organization (CDMO); Piramal
Critical Care, a complex hospital generics business; and the Consumer
Healthcare business, selling over-the-counter products in India.
PPS is offering end-to-end development and manufacturing
solutions across the drug life cycle. It serves clients through a globally
integrated network of facilities in North America, Europe and Asia.
This enables the company to offer a comprehensive range of services
including drug discovery solutions, process & pharmaceutical
development services, clinical trial supplies, commercial supply of
Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
PPS offers specialised services such as the development and
manufacture of highly potent APIs, antibody drug conjugation, sterile
fill/finish with and without containment, and potent solid oral drug
product. This capability as an integrated service provider & experience
with various technologies enables it to serve innovator and generic
companies worldwide.
With a successful performance record of over 40 years, PPS
manufactures and supplies APIs through our sites in North America,
Europe, and Asia markets. The API facilities are inspected and
approved by global regulatory bodies, including the US FDA, Japan
PMDA, and UK MHRA, and meet the cGMP compliance standards.
PPS has grown as the preferred partner for big pharma and
biotech companies across North America and Europe with the total
reactor volume exceeding 500 KL (including pilot and multi-purpose
plants). The company has a record of accomplishment of over 30
launches and are capable of executing extensive small molecule API
requirements.
PPS assists its customers with services ranging from process
development to optimizing the existing lab-scale process, with
expertise in GMP manufacturing of materials to support Phase I to
Phase III clinical trials, as well as product registration.
The company is also a world-leading multi-product facility for
clinical and commercial manufacturing of antibody-drug conjugates
(ADCs) and other bioconjugates. Besides, it has robust process
development, characterisation, optimisation, and scale-up expertise
supporting successful GMP manufacturing.

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

02 SYNGENE INTERNATIONAL LTD

REVENUE During the FY19-20, Bengaluru-based Syngene
International generated a revenue of Rs 2094 crore,
₹2094 crore exhibiting a growth of 10 per cent in comparison to the
revenue figure of Rs 1901 generated in the previous year.
JONATHAN HUNT A major highlight for Syngene during the FY19-20
was the commissioning of the first phase of its new R&D centre in
Chief Executive Officer Hyderabad. The centre, located in Genome Valley, is spread across
& Managing Director 52000 sq. ft. with an initial strength of around 150 scientists. This is the
company’s first operational research centre outside Bengaluru. Built
with an investment of Rs 167 crore, it covers a total of 94000 sq. ft. and
can house around 270 scientists.
The new R&D centre is fully digitised based on an internet-based,
innovative, analytical laboratory solution that enables anytime,
anywhere, monitoring; remote and secure access; and minimizes
system downtime by monitoring the operational status of the systems.
The centre also has other digitisation and automation features
including electronic laboratory notebooks and analytical intelligence.
The FY19-20 also saw Syngene opening its Centre for Advanced
Protein Studies (CAPS) in collaboration with the Biotechnology
Industry Research Assistance Council (BIRAC) at Syngene’s campus
in Bengaluru to host a state-of-the-art GLP accredited analytical
laboratory. Spread across an area of 2000 sq. ft, the centre is
running under the ‘Innovate in India’ programme of the National
Biopharma Mission, Department of Biotechnology, announced by the
Government of India.
Apart from providing the necessary infrastructure support at an
affordable cost, the centre is focusing on advancing technical skill
development to global standards, by conducting various training and
workshops involving eminent subject experts.
The FY19-20 also saw Dr Mahesh Bhalgat joining the company
as the Chief Operating Officer (COO). He comes to Syngene from
Shantha Biotechnics, a Sanofi company, where he was responsible
for all manufacturing operations, supply chain, engineering projects,
manufacturing excellence and administrative services.
Further, Syngene also announced a collaboration with Narayana
Health, Agastya International Foundation (AIF) and Biocon Foundation
(Corporate Social Responsibility (CSR) arm of Syngene), for the launch
of CHAMPS (Child Health Activists Mentoring & Promoting Heath in
Society), a student mediated initiative focused on preventing and
managing the early onset of non-communicable diseases (NCDs).
For the future, Syngene intends to boost commercial-scale
manufacturing capacity for small molecules by completing the
construction and commissioning of its API manufacturing plant
at Mangaluru and invest in expanding its biologics manufacturing
capacity.

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

03 JUBILANT BIOSYS LTD

REVENUE Bengaluru-based Jubilant Biosys generated a revenue of
Rs 1831 crore during the FY19-20, exhibiting a growth of 7
₹1831 crore per cent in comparison to the revenue figure of Rs 1687
generated in the previous year.
MARCEL J. VELTEROP During the FY19-20, Jubilant Biosys announced that it
has chosen Collaborative Drug Discovery (CDD) Vault as its discovery
President – research informatics platform for the next 5 years. Jubilant will be
Drug Discovery Services & CDMO using CDD Vault as their informatics platform to facilitate and boost
the transparent distribution of research data and information. CDD
Vault manages biological assay data, involved chemical structures,
reactions and compound properties in a cohesive environment.
With a clear scientific focus on oncology, metabolic disorders,
central nervous system (CNS) diseases, pain and inflammation,
Jubilant Biosys has rapidly emerged as a leading collaborator for
pharmaceutical and biotechnology companies worldwide. In each of
these therapeutic areas, the company has developed a deep level of
expertise in discovery informatics, computational chemistry, medicinal
chemistry, structural biology, biology, in-vivo, in-vitro models and
translational sciences.
Combined with strong clinical development and manufacturing
capabilities from other Jubilant subsidiaries, Jubilant Biosys has
risen as a fully integrated contract research organization in India and
headquartered in Bengaluru with end-to-end solutions. Its brand new
and State-of-the-Art Chemistry Innovation Research Center (CIRC) in
Greater Noida is designed and constructed due to growing customer
demand for our range of functional and integrated drug discovery
services. The company has its Investigational New Drug Center (INDC)
located in Noida, National Capital Region (New Delhi).
Jubilant Biosys is a part of the Jubilant Pharmova family of
companies with R&D centres in India and business offices in Asia
and North America. With its global reach, Jubilant Biosys provides
comprehensive drug discovery services and contract research
services–from target discovery to candidate selection and with flexible
business models (FFS, FTE and risk shared)–in partnership with
leading worldwide healthcare companies.
Jubilant also offers clients a diversity of biology services ranging
from target validation, expression, structural characterisation to
the establishment of in-vitro and in-vivo models suited for the
testing of xenobiotics, as well as the evaluation of their safety and
pharmacokinetics profiles when administered.
In addition, the company employs a proven methodology to create
content databases curated from various data sources, as per customer
specification. These content databases are manually curated by MSc/
PhD level scientists guided through defined Good Curation Practice
(GCP), controlled vocabulary and ontology. The custom curation
services cover biology, chemistry and clinical trial domains across
many therapeutic and disease areas.

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

IQVIA RDS (INDIA) 04 GVK BIOSCIENCES PRIVATE 05
PRIVATE LIMITED LIMITED

Incorporated on November 21, 2002, IQVIA RDS (India), is an arm Hyderabad-based GVK Biosciences (GVK BIO) generated
of the American multinational company IQVIA. It is involved in a revenue of Rs 950 crore during the FY19-20, exhibiting
research and experimental development on natural sciences a growth of 20 per cent in comparison to the revenue
and engineering. This class includes systematic creative work figure of Rs 793 generated in the previous year. During the FY19-
in the fields of research and development in natural sciences, 20, GVK BIO and BE Pharmaceuticals Inc (BE Inc), a subsidiary
medical sciences, agriculture and engineering & technology. of Biological E. Limited, announced a strategic collaboration
It has generated a revenue figure of Rs 1536 crore during the in drug product development. As part of the partnership, GVK
FY19-20. IQVIA India draws on the strength and depth of its global BIO is developing a certain set of injectable products for BE Inc.
resources, deep domain expertise and local insights to help The FY19-20 also saw Aragen Bioscience, Inc, a subsidiary unit
biotech, medical device and pharmaceutical companies, medical of GVK BIO, entering into collaboration with Pune based Serum
researchers, not for profit and government agencies, payers and Institute of India Pvt. Ltd. for the development of multiple stable
other healthcare stakeholders deliver better health outcomes. cell lines to support Serum’s HIV programme.

SUVEN PHARMACEUTICALS 06 ANTHEM BIOSCIENCES 07
LIMITED PRIVATE LIMITED

For the FY19-20, Hyderabad-based Suven Pharmaceuticals Bengaluru-based Anthem Biosciences generated a
clocked in a revenue figure of Rs 852 crore. Suven Pharma, revenue figure of Rs 750 crore during the FY19-20,
a company incorporated in November 2018, has become showing a growth of 12 per cent in comparison to
wholly owned subsidiary of Suven Life Sciences. Suven Pharma is the revenue generation of Rs 670 crore in the previous
into new chemical entities (NCE)-based Contract Development fiscal. Anthem Bio is a Contract Research and Innovation
and Manufacturing Operations (CDMO) for over two decades, Service Provider (CRISP), with a built-up capacity to house
supporting the needs of the global life science industry and fine over 1000 researchers and manufacture novel commercial
chemical majors. While the CDMO vertical (Base CDMO and drug actives, from its two sites in Bengaluru. Over its short
Commercial CDMO) jumped 24 per cent over the previous year, history, since commencing operations in 2007, the company
specialty chemicals improved more than 40 per cent. Growth in has become a powerhouse for drug and new products
these knowledge-driven, return-accretive verticals has resulted in a development and manufacture, with equal emphasis on
healthy increase in profits and a decent uptick in profitability. biological and chemistry-based products and services.

ICON CLINICAL RESEARCH 08 AURIGENE DISCOVERY 09
INDIA PRIVATE LIMITED TECHNOLOGIES LIMITED

Chennai-based ICON Clinical Research India During the FY19-20, Bengaluru-based Aurigene
witnessed a growth of 11 per cent during the FY19- Discovery Technologies, a wholly-owned subsidiary
20 after generating revenue worth Rs 352 crore of Dr. Reddy’s Laboratories Ltd., generated a revenue
in comparison to the revenue generation of Rs 318 crore figure of Rs 280 crore, exhibiting a growth of 33 per cent in
in the previous year. An Indian arm of the Ireland based comparison to the revenue generation of Rs 211 crore during
firm, ICON is a global provider of outsourced drug and the FY18-19. The company announced its partnership with
device development and commercialisation services US-based firm Exelixis during the FY19-20, for bringing
to pharmaceutical, biotechnology, medical device oncology therapies to market. Aurigene, engaged in the
and government and public health organisations. The discovery and clinical development of novel and best-in-class
company specialises in the strategic development, therapies to treat cancer and inflammatory diseases, has
management and analysis of programs that support partnered with many large and mid-pharma companies
clinical development - from compound selection to in the United States and Europe and has 15 programmes
Phase I-IV clinical studies. currently in clinical development.

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

COVANCE INDIA PHARMACEUTICAL 11COVANCE SCIENTIFIC SERVICES

10SERVICES PVT LTD & SOLUTIONS PRIVATE LIMITED

For Mumbai-based Covance India Pharmaceutical Formerly known as Sciformix Technologies Private
Services, the revenue generation stood at Rs 255 crore Limited, Mumbai-based Covance Scientific
during the FY19-20, exhibiting a growth of around Services & Solutions clocked in a revenue figure of
60 per cent when compared to the revenue generation Rs 190 crore during the FY19-20, exhibiting a growth of
of Rs 159 crore in the previous fiscal. Covance by Labcorp 7 per cent in comparison to the revenue generation of
is a global contract research organisation and drug Rs 177 crore during the FY18-19. In 2018, Sciformix joined
development services company, for which India has been Covance to provide its customers expanded capabilities
an attractive market for drug development activities due to and global reach all while delivering excellent service,
its lower cost and large population. Employing over 26,000 deep expertise and superior quality. Earlier in 2015,
people worldwide, the company provides nonclinical, Covance was acquired by US-based Labcorp, operating
preclinical, clinical and commercialization services to one of the largest clinical laboratory networks in the
pharmaceutical and biotechnology industries. world.

NEULAND LABORATORIES 12 VIMTA LABS 13
LIMITED LIMITED

Hyderabad-based Neuland Laboratories Limited Hyderabad-based Vimta Labs generated a revenue figure
witnessed a 107 per cent growth during the FY19-20 after of Rs 184 crore during the FY19-20, exhibiting a decline of
generating revenue worth Rs 188 crore in comparison 14 per cent in its business when compared to the revenue
to the revenue generation of Rs 91 crore in the previous fiscal. generation of Rs 215 crore in the previous fiscal. Founded in 1984,
Neuland Laboratories is a contract manufacturing service Vimta is a leading contract research and testing organization,
provider and a leading manufacturer of active pharmaceutical providing bio and pharmaceutical companies with an integrated
ingredients (APIs) and an end-to-end chemistry-related scientific, technical and regulatory expertise to support all stages
solutions provider for the pharmaceutical industry. With two of drug development and manufacturing process. Its service
FDA-inspected facilities, 800+ drug master files (DMFs), 1000+ portfolio includes preclinical and clinical research; and cGMP
employees and customers in more than 85 countries, Neuland laboratory services viz., method development, microbiology,
supports some of the world’s best-known and most successful stability testing, extractables and leachables, process validation,
pharmaceutical research and manufacturing companies. quality control, physical characterization etc.

14PPD PHARMACEUTICAL EUROFINS ADVINUS 15
LIMITED
DEVELOPMENT INDIA PVT LTD

During the FY19-20, the Indian arm of the global Bengaluru-based Eurofins Advinus generated a
clinical research organization PPD, providing revenue figure of Rs 168 crore during the FY19-20,
broad, integrated drug development, laboratory exhibiting a growth of 60 per cent when compared
and lifecycle management services, generated revenue to the revenue generation of Rs 105 crore in the previous
worth Rs 175 crore. This marks a growth of around 24 per year. Eurofins Advinus is part of Eurofins Scientific, a EUR
cent when compared to the revenue generation of Rs 4.5 billion leading international group of laboratories
141 crore during the FY18-19. With offices in 47 countries providing a unique range of analytical testing services to
and more than 26,000 professionals worldwide, PPD the pharmaceutical, food, environmental and consumer
applies innovative technologies, therapeutic expertise products industries and governments. Eurofins Advinus
and a firm commitment to quality to help customers is also one of the pioneers in drug discovery services in
bend the cost and time curve of drug development and India, with a track record that is well demonstrated by
optimize value in delivering life-changing therapies to its path-breaking collaborations with the likes of Takeda,
improve health. Merck, J&J, Novartis, Celgene and DNDi.

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

VEEDA CLINICAL 16 AIZANT DRUG RESEARCH 17
RESEARCH LIMITED SOLUTIONS PRIVATE LIMITED

Ahmedabad-based Veeda Clinical Research Hyderabad-based Aizant Drug Research Solutions has
generated a revenue figure of Rs 153 crore during generated a revenue figure of Rs 144 crore during the
the FY19-20, exhibiting a decline of 32 per cent in its FY19-20, exhibiting a decline of 5 per cent in its business
business when compared to the revenue generation of Rs when compared to the revenue generation of Rs 151 crore in
224 crore in the previous fiscal. Veeda is a partner of choice the previous fiscal. Aizant is a rapidly growing contract research
for many global pharmaceutical companies as it offers a organisation with a diverse portfolio of capabilities, partnering
diverse range of clinical studies including bioequivalence with health care companies specialising in new molecular entities
as well as PK, PD and Clinical Endpoint studies for (NMEs), generics (ANDAs) and over the counter (OTCs) products
Generics, NCE and Biopharmaceuticals. The firm has two globally. It offers comprehensive solutions for preformulation,
clinical units in Ahmedabad - Shivalik and Vedant, which formulation development of conventional and novel drug
were established in 2004 and 2015 respectively, designed delivery products, bioavailability, bioequivalence, bioanalysis,
to meet world-class specifications. pharmacokinetics, biostatistics and clinical diagnostics.

ACCUTEST RESEARCH 18 19COVANCE CLINICAL
LABORATORIES (I) PVT LTD DEVELOPMENT PRIVATE LIMITED

Navi Mumbai-based Accutest Research Laboratories Previously known as Chiltern Clinical Research India Private
generated a revenue figure of Rs 119 crore during the Limited, Bengaluru-based Covance Clinical Development
FY19-20, exhibiting a decline of 6 per cent in its business generated revenue worth Rs 111 crore exhibiting slight growth
when compared to the revenue generation of Rs 126 crore in its business in comparison to Rs 106 crore generated in the
in the previous fiscal. Accutest is a global independent and previous fiscal. Following Covance’s acquisition of Chiltern in 2017,
internationally accredited Contract Research Organisation Covance Clinical-Biotech has been improving patient outcomes
founded in 1998. It offers services to customers around the world through innovative, efficient provider solutions and oncology
with operations in India, across Asia, and in Brazil. The company expertise. Now, Covance Clinical-Biotech works to help reach
has clinical pathology labs accredited by the College of American early development goals through comprehensive management
Pathologists (CAP) and National Accreditation Board for Testing strategies and our commitment to client success. Covance
and Calibration Laboratories (NABL), equipped to carry out tests provides contract research services to the drug, medical device and
for biochemistry, haematology, urine chemistry and serology. diagnostics, crop protection and chemical industries.

APCER LIFE SCIENCES 20 SIRO CLINPHARM 21
INDIA LIMITED PRIVATE LIMITED

The Indian arm of the global firm APCER Life Incorporated in 1996, Mumbai-based SIRO Clinpharm
Sciences generated a revenue figure of Rs 104 Mumbai generated a revenue figure of Rs 60 crore
crore during the FY19-20, exhibiting a growth of during the FY19-20. A Clinical Research Organisation
12 per cent in comparison to the revenue generation supporting trials from Phase II to Phase IV and beyond
of Rs 93 crore in the previous year. It was founded in post-launch of products, SIRO offers a range of services,
1987 in Hong Kong by APCER’s Chairman, Ravi Menon. from clinical operations to data services, data analytics
The company grew rapidly by developing markets in and medical writing in compliance with international
India, China, and South East Asia for APIs and finished standards. SIRO has been an industry pioneer for
formulations produced by Western pharmaceutical over two decades, sharing an incontestable record of
manufacturers. Offices were added in Mumbai and excellence in the pharmaceutical, FMCG and medical
Shanghai to satisfy the needs of both sellers and device industry. Its global delivery centre in Thane has a
buyers. seasoned team of more than 200 professionals hailing
from science and medical backgrounds.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com COVER STORY 29

VIVO BIO TECH 22 NORWICH CLINICAL 23
LIMITED SERVICES PRIVATE LIMITED

For the FY19-20, Hyderabad-based Vivo Bio Tech witnessed Bengaluru-based Norwich Clinical Services generated
a slight decline in its business with a revenue generation a revenue figure of Rs 54 crore during the FY19-20,
of Rs 55 crore, in comparison to Rs 56 crore generated in exhibiting a growth of 32 per cent when compared
the previous fiscal. Vivo Bio Tech is a full-service CRO offering to the revenue generation of Rs 41 crore during the FY18-
drug development & discovery services to pharmaceutical & 19. Norwich has state–of-the-art facilities, and exceptional
biotech companies worldwide, as per OECD - GLP, AAALAC & expertise to conduct Phase I, II and III studies, bioavailability and
IND guidelines. The company offers services in the areas of In bioequivalence studies, pharmacokinetic studies in patients &
vivo & In vitro toxicity studies, Pharmacological investigations, healthy subjects, drug metabolism studies, dose proportionality
Pharmacokinetic & toxicokinetic studies, Genotoxicity studies, multiple-dose studies and clinical developmental
screening, Analytical services etc. Its experienced & talented programmes. Its team has considerable experience in various
scientists offer advice on defining drug development paths dosage forms including parenterals, suspensions, topical
tailored to specific molecules. preparations and delayed-release formulations.

24JSS MEDICAL RESEARCH ASIA PANEXCELL CLINICAL LAB 25
PRIVATE LIMITED
PACIFIC PRIVATE LIMITED

During the FY19-20, Faridabad-based JSS Medical Research Panexcell Clinical Lab, based in Navi Mumbai, witnessed a
Asia Pacific witnessed a slight decline in its business with decline of 10 per cent in its business during the FY19-20
a revenue generation of Rs 27 crore, in comparison with Rs with a revenue generation of Rs 26 crore, as compared
28 crore generated in the previous fiscal. JSS Medical Research is to Rs 29 crore generated previously. An organization that
a full service clinical research organisation with strong academic has drug development and clinical research at the crux of its
affiliations, offering a wide range of services internationally. One operations, its expertise lies in facilitating the development of
of its distinguishing attributes is the methodological knowledge new chemical entities, evolving comprehensive and unique
and expertise in the design and execution of clinical studies. therapies and supporting research via medical research
These include all phases of development such as Phase I, II and papers. Formerly known as Drug Monitoring Research
III, and post-approval studies. The breadth of its experience Institute Private Limited, it started off in Sion, Mumbai with a
enables our clients to collaborate with the same partner small facility. Banking on their continued success, Panexcell
throughout the product lifecycle. shifted to a bigger facility in Rabale, Navi Mumbai.

SYNAPSE LABS 26 KEMWELL BIOPHARMA 27
PRIVATE LIMITED PRIVATE LIMITED

Founded in 2007, Pune-based Synapse Labs has During the FY19-20, Bengaluru-based Kemwell
generated a revenue figure of Rs 25 crore during Biopharma generated a revenue figure of Rs 22
the FY19-20. Synapse labs with its extensive crore. Kemwell is a contract biologics development
experience of over a decade helped deliver excellence and CMO company providing services to global biologics
on 780+ BA/BE studies and clear inspections from major organizations. Kemwell facilities are designed and developed
regulatory bodies like the USFDA, EMA, UKMHRA, etc. with technological support from a leading German
The company’s success is supported by its passionate pharma company. The company provides customers with
team of over 250+ professionals backed by deep scientific cost-effective access to state-of-the-art technology for all
knowledge and industry experience. Its customers come mammalian cell culture-based products’ development and
from the biotechnology and pharmaceuticals sector and manufacturing. Kemwell, having established in 1980, has had
are spread across geographies like Europe, India and the long term associations with pharma majors such as Bayer,
USA. Synapse Labs is equipped with extensive experience GlaxoSmithKline, Merck KGaA, Novartis, Pfizer and others for
of over a decade in supporting pharma companies. small molecule contract manufacturing and R&D.

30 COVER STORY BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

RCC LABORATORIES INDIA 28 29PHARMAFFILIATES ANALYTICS
PRIVATE LIMITED AND SYNTHETICS PVT LTD

Hyderabad-based RCC Laboratories India has generated Pharmaffiliates Analytics And Synthetics, based in
a revenue figure of Rs 18 crore during the FY19-20, Panchkula, has witnessed a decline of 13 per cent
exhibiting a slight growth when compared to the revenue in its business during the FY19-20 with a revenue
generation of Rs 17 crore during the FY18-19. RCC Laboratories generation of Rs 18 crore, as compared to Rs 20 crore
is one of the leading contract research organisations providing generated previously. Started in 2001 as a research based
preclinical and safety toxicology and chemical testing globally. organisation, Pharmaffiliates is known in the industry for its
The company maintains high quality standards and services and state-of-the-art research and development center located in
remains a leader in contract research services, internationally. Haryana. With a core team of subject matter experts which
RCC complies with the Organisation for Economic Co-operation is a blend of highly experienced and learned scientists along
and Development (OECD) principles of Good Laboratory with young and dynamic associates, Pharmaffiliates’ main
Practice (GLP) and is Certified by GLP monitoring authority of focus is synthetic research, analytical research, novel drug
the Government of India (NGCMA). delivery systems (NDDS) and regulatory consulting.

NOVOTECH CLINICAL RESEARCH CLINIRX RESEARCH PRIVATE 31
LIMITED
30INDIA PRIVATE LIMITED

Bengaluru-based Novotech Clinical Research India New Delhi-based CliniRx Research has generated
has generated a revenue figure of Rs 17 crore revenue worth Rs 16 crore during the FY19-20,
during the FY19-20, exhibiting a growth of 42 per exhibiting a huge growth of 433 per cent, in
cent when compared to the revenue generation of Rs comparison to the revenue generation of Rs 3 crore in the
12 crore during the FY18-19. Novotech is a subsidiary of previous fiscal. Founded in 2004, CliniRx is a full-service CRO,
Australia-based Novotech Health Holdings, a leading Asian conducting multinational clinical trials for pharma, biotech
Biotech CRO. Novotech Holdings employs approximately and medical devices companies around the world. Between
1,550 people in 21 offices across 12 geographies including its Indian headquarters, operational presence in the US,
Greater China, South Korea, South East Asia, India and the UK and the Netherlands, and through several leading
ANZ. It is a full-service CRO with integrated labs and phase partnerships, CliniRx is particularly well placed to cover key
I facilities providing drug development consulting and geographies. CliniRx has experience in several therapeutic
clinical development services. areas, with an extensive track record in CNS.

VANTA BIOSCIENCE 32 ENDPOINT CLINICAL INDIA 33
LIMITED PRIVATE LIMITED

Chennai-based Vanta Bioscience has generated a Hyderabad-based Endpoint Clinical India
revenue figure of Rs 14 crore during the FY19-20, generated a revenue figure of Rs 13 crore during
exhibiting growth of 8 per cent in the business the FY19-20, exhibiting growth of 81 per cent in
as compared to the revenue generation of Rs 13 crore in the business as compared to the revenue generation
the FY18-19. Vanta Bioscience is established as a centre of Rs 7 crore in the FY18-19. Their dynamic interactive
of excellence for good lab practice (GLP) toxicology response technology (IRT) solution, PULSE, for patient
and safety assessment offering services in India and randomisation and management, site management,
across the globe. It is housed in a new, 56,000 square and drug supply management and leading-edge
foot state-of-the-art facility specifically designed clinical supplies management tool, DRIVE, has proven
for compliance with GLP and AAALAC international to maximise the supply chain and minimise operational
guidelines for humane care and use of small animal costs, and ensure timely and accurate patient dosing.
species involved in Vanta Bioscience studies. The company is headquartered in San Francisco,
California, with offices across the US, EU, and Asia.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com COVER STORY 31

PAREXEL INTERNATIONAL 33 34EUROFINS PHARMA SERVICES
CLINICAL RESEARCH PVT LTD INDIA PRIVATE LIMITED

During the FY19-20, the Indian arm of the US-based clinical For Bengaluru-based Eurofins Pharma Services India,
research organisation generated revenue worth Rs 13 the revenue generation stood at Rs 9 crore during
crore, exhibiting a decline of 32 per cent in its business the FY19-20, exhibiting a growth of 50 per cent in
when compared to the revenue generation of Rs 19 crore in the comparison to the revenue generation of Rs 6 crore in
previous fiscal. PAREXEL provides services to help life sciences the previous fiscal. The firm helps (bio) pharmaceutical
and biopharmaceutical clients everywhere transform scientific companies move rapidly from the research stage of their
discoveries into new treatments. From decentralized clinical drug development to clinical stages with integrated services
trials to regulatory consulting services to leveraging real-world to compress timelines to market. It delivers comprehensive
insights, its therapeutic, technical, and functional ability is solutions to streamline the development and manufacturing
underpinned by a deep conviction. Also, the company offers of a variety of product types, delivery systems and dosage
translational medicine services with a specialisation in early- forms, from formulation screening and development,
stage biomarker strategy development and execution. analytical development to stability studies.

DIVI’S LABORATORIES 34 SPECTRUM CLINICAL 35
LIMITED RESEARCH PRIVATE LIMITED

Hyderabad-based Divi’s Laboratories generated Mumbai-based Spectrum Clinical Research generated
revenue worth Rs 9 crore during the FY19-20. Over revenue worth Rs 8 crore during the FY19-20. The
the past 30 years, various diverse teams have been firm aims to provide quality clinical research support
involved in providing high-quality generic APIs, custom to pharmaceutical companies and Contract Research
manufacturing solutions to several big pharma and Organisations in order to facilitate the development of new
most recently providing highly specialized nutraceutical chemical entities, evolve innovative therapies and support
ingredients. Divi’s has been a global leader in more than research on novel drug delivery systems, keeping the
10 generic APIs, supplying tonnes every year to customers wellbeing and safety of patients at the core of their endeavor,
in more than 95 countries. With 350 scientists working in ensuring compliance to the highest regulatory, scientific and
three R&D centres across functions, Divi’s quality control ethical standards by ICH, WHO, USFDA. Radiant Research, Inc.
testing and validation labs are fitted with state-of-the-art is extending its services from North America to India through
analytical equipment and testing facilities. a strategic partnership with Spectrum Clinical Research.

MEDPACE CLINICAL RESEARCH QUANTICATE INDIA 37
PRIVATE LIMITED
36INDIA PRIVATE LIMITED

During the FY19-20, the Indian arm of the US-based clinical Bengaluru-based Quanticate India generated revenue
research organisation generated a revenue figure of Rs 5 worth Rs 4 crore during the FY19-20. Having supported
crore, exhibiting growth of 25 per cent in its business when large scale Functional Service Provisions (FSPs) within
compared to the revenue generation of Rs 4 crore in the previous data-related services over many years, such as biostatistics and
fiscal. Medpace is a scientifically-driven, global, full-service clinical statistical programming, Quanticate has been implementing an
contract research organization (CRO) providing Phase I-IV clinical approach that provides the benefits of FSP through niche vendor
development services to the biotechnology, pharmaceutical and expertise and flexibility, coupled with the advantages of cross-
medical device industries. Medpace’s mission is to accelerate the functional support and cross-study centralisation. The creation
global development of safe and effective medical therapeutics of its Centralised Data Services (CDS) approach to clinical data
through its high-science and disciplined operating approach that outsourcing enables activities across functions to be supported
leverages regulatory and therapeutic expertise across all major areas in the most efficient way, utilising experts, global capabilities, and
including oncology, cardiology, metabolic disease, endocrinology, a centralized data storage/visualisation technology (iQ) to enable
central nervous system and anti-viral and anti-infective. optimal use of clinical and safety data.

32 COVER STORY BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

ICBIO CLINICAL RESEARCH 38 38CATALYST CLINICAL SERVICES
PRIVATE LIMITED PRIVATE LIMITED

Bengaluru-based ICBIO Clinical Research has generated New Delhi-based Catalyst Clinical Services generated revenue
a revenue figure of Rs 3 crore during the FY19-20. ICBio worth Rs 3 crore during the FY19-20. A Contract Research
Clinical Research is a full-service Contract Research Organization that acts as a strategic partner to the healthcare
Organization (CRO), providing comprehensive, quality & organisations, the primary focus area for the company is Clinical
integrated and an end to end clinical research solutions; Clinical Trials Management and Execution, Medical Writing, Independent
Trials (Phase II-IV), BA / BE studies (Bioequivalence studies), Auditing and Clinical Research Training. With regards to clinical
Clinical Endpoint studies, provide quality clinical research research and pharmacovigilance training, Catalyst has made
solutions in India and across the world to its clients for studies pioneering initiatives and has established itself as India’s largest
ranging from PK studies in healthily volunteers to patient trials clinical research and pharmacovigilance training providers both
for generics and NCEs. Its 32-bedded clinical facility has fully in terms of numbers as well as geographical reach. The contract
access-controlled state-of-art and UPS back-up. The company clinical research services have been widely appreciated by the key
also has an upcoming facility with state-of-art 100 beds. stakeholders at the national as well as international level.

VIPRAGEN BIOSCIENCES 39 CLINIMED LIFESCIENCES 40
PRIVATE LIMITED PRIVATE LIMITED

Mysuru-based Vipragen Biosciences generated a revenue of Rs Incepted in 2018, Kolkata-based clinical research
2 crore during the FY19-20 exhibiting a decline in the business’ organisation, Clinimed Lifesciences generated
growth in comparison to Rs 3 crore generated during the revenue worth Rs 1 crore during the FY19-20, doubling
previous financial year. Formed in 2012, Vipragen has in-depth its business when compared to Rs 50 lakh of revenue
research capabilities in Pre-clinical Biology, Microbiology, Molecular generated during the FY18-19. The company has been
biology, Cell culture, Pharmacology, Toxicology, Drug Metabolism founded to accelerate the process of clinical research
and Pharmacokinetics, drug discovery research, and new product for clients in the field of new drugs and medical devices.
development areas. The company brings forth scientific and research It has expertise in the development of remote patient
knowledge with deep expertise from a core team of scientists with a monitoring and telemedicine applications as well.
combined experience of over 120 years. Its team brings expertise from The management team comprises eminent doctors,
areas such as Molecular Biology, Cell Biology, Microbiology, Synthetic scientists and technocrats having gathered experience
Chemistry, Medicinal and Veterinary Biology. in various top-level MNCs like HCL, Wipro, ITC.

MAYA CLINICALS DRUG ASIATIC CLINICAL RESEARCH 40
PRIVATE LIMITED
40DEVELOPMENT PRIVATE LIMITED

Hyderabad-based Maya Clinicals Drug Development For the FY19-20, Bengaluru-based Asiatic Clinical
has generated a revenue of Rs 1 crore during the Research witnessed a huge decline in its business
FY19-20. The company is focused on working with a revenue generation of Rs 1 crore in
with bio-pharma startups and pharma companies in a comparison to Rs 7 crore generated during the FY18-19.
unique and flexible co-development fashion to accelerate Asiatic Clinical Research is a full-service clinical research
pre-clinical and clinical projects. Maya Clinicals has been organisation with full focus on Phase II - IV clinical
able to greatly increase the chance of success for its US trial support to the pharmaceutical, biotechnology
and European customers’ development programmes by and medical device companies. The firm aims to
utilising the greater manpower and expertise available in become a global CRO by integrating technology and
India and South East Asia and with focused US expertise nurturing captive sites from tier-II cities to bring a
and management. It is deeply focused on clinical trials and larger pool of investigators and patients into the clinical
related logistics and is based on an operational platform research world that would enable quicker new drug
with all the crucial pieces required for success. development.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com COVER STORY 33

INDIAN INDUSTRIAL
ENZYMES MARKET

TOUCHES RS 2596 CR

WITH 10% GROWTH RATE

Indian enzyme market has witnessed a slight increase over Rs 10 crore during 2019-20. During the year USA
in its growth rate in 2019-20 as compared with imported enzymes worth Rs 47.16 crore against previous
previous year’s growth rate of 7 per cent. In 2019-20 year’s import of Rs 71.17 crore; Denmark imported Rs
the Indian enzyme market touched Rs 2596 crore 26.07 crore; Germany (Rs 23.65 crore); Belgium (Rs 13
with growth rate of 10 per cent. The Indian enzyme crore); Iran (Rs 11.49 crore); China (Rs 11.23 crore) and
market recorded Rs 2360 crore for the year 2018-19. Bangladesh (Rs 10.58 crore).
However, the rapid development of India’s food and
beverage, pharmaceutical and chemical industry is In 2019-20, the enzymes industry witnessed a surge
starting to change this, and specialty enzyme demand in demand for Indian enzymes mainly from countries
will outpace industrial enzyme demand, going forward. like Sudan, Kuwait, Baharain, Algeria, Tunisia, Chile,
There are about 25 major players in this market. Nicaragua, Sweden, Burundi, Morocco, Malawi, Costa
Most of these companies are either into marketing or Rica and Ghana. These new markets will open up
into formulations. But India has few companies, both opportunities for Indian enzymes companies in the
multinational and local, that manufacture enzymes coming years.
used in different industries such as pharmaceutical,
food processing, leather, detergents, paper and pulp According to TechSci Research June 2020 report,
and textiles. These companies produce various enzymes the Indian Enzymes Market is anticipated to undergo
and several other eco-friendly biological products. The robust growth by 2025, owing to the growing
product range and services are growing rapidly as the application of enzymes for fermentation of milk to
use of enzymes is gaining widespread acceptance. produce dairy products like curd, yogurt, cheese etc.
India witnessed a marginal drop of 5 per cent in The flourishing dairy industry in India is anticipated to
import of enzymes in 2019-20 to Rs 819.84 crore from have a positive impact on the demand for enzymes in
Rs 863.51 crore in 2018-19. Top 10 enzyme exporters the coming years. Moreover, the increasing popularity
to India include China, Denmark, USA, Germany, of recombinant enzymes across various industries
Netherland, Singapore, Italy, Austria, Japan and Spain. like detergents, pharmaceuticals etc. is another factor
Except China, the Netherlands and Japan, all other behind the growth of this market. The constant
countries saw a drop in enzyme exports to India. China, innovations in research and development activities to
a leading exporter of enzymes to India continues to see increase the yield, improve enzyme specificity as well as
a growth of 29 per cent while the Netherlands also saw stability is further expected to propel the growth of the
a surge of 31.83 percent in exports. Indian companies market during the forecast period.
are now looking at buying enzymes from Thailand as it
witnessed a 107.82 per cent growth in export in 2019-20. Additionally, the increasing use of proteases in
On the other side, Indian manufacturers are not detergents, coupled with the growing use in animal
only supplying to local market but are also exporting feed, is projected to drive the growth of the enzymes
to a number of countries. According to the Directorate market in India in the coming years. Enzymes are
General of Commercial Intelligence and Statistics biocatalysts which accelerates the reaction and gives
(DGCI&S), India exported enzymes worth Rs 302.85 the desired results in a biological reaction. The market
crore in 2019-20 as against Rs 286.89 crore in 2018- also faces some constraints as there are issues with
19. The leading importers of Indian enzymes include the handling and safety of enzymes. Also, the high
USA, Denmark, Germany, Belgium, Iran, China and sensitivity of enzymes to temperature and pH can
Bangladesh where India has exported enzymes worth hamper the growth of the market. Companies are
investing in research and development activities to
bring new and more efficient enzymes to cater to the
growing needs of various end-user industries.

34 COVER STORY BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

NOVOZYMES SOUTH ASIA PRIVATE LIMITED
GAINS NO 1 POSITION

IN INDIAN INDUSTRIAL ENZYMES MARKET

Bangalore-based Novozymes South Top 3 Top 10
Asia Private Limited with sales revenue of Industrial Industrial
Rs 683.41 crore regained as number one position Enzymes Enzymes
among the Indian Industrial Enzymes Industry companies companies
for the year 2019-20 followed by Mumbai-based contribute contribute
Rossari Biotech Ltd with sales revenue of 67% of the 75% of the
Rs 600 crore (second position) and Thane-based total Industrial total Industrial
Advanced Enzyme Technologies Limited with Enzymes Enzymes
sales revenue of Rs 449.63 crore (at third position).
market market

BioSpectrum Top Industrial Enzyme Companies 2020*

Sr. Company Revenue in Revenue in % Category Location Region
No 2019-20 2018-19 growth

(in Rs crore) (in Rs crore)

1 Novozymes South Asia Private Limited 683.41 589.15 16 MNC Bangalore South

2 Rossari Biotech Ltd 600 516.22 16 India Mumbai West

3 Advanced Enzyme Technologies Limited 449.63 424.63 6 India Thane West

4 Titan Biotech Ltd 79.88 65.59 22 India Delhi North
5 Tex Biosciences (P) Limited 42.8 39.10 9 India Chennai South
6 Enzyme Bioscience Private Limited 37.54 29.19 29 India West
7 Aumgene Biosciences Private Limited 26.63 33.35 -20 India Surat West
8 Fermenta Biotech Limited 9.38 12.51 -25 India Surat West
9 Infinita Biotech Private Limited 3.35 2.51 33 India Mumbai  West
10 Noor Enzymes Private Limited 1.35 0.02 6650 India Vadodara East
Kolkotta

*We have not covered some of the leading MNC and local companies as they are unable to participate in the BioSpectrum Industrial Biotechnology (Enzyme) Survey 2020

BIOSPECTRUM INDUSTRIAL ENZYMES
SURVEY AND METHODOLOGY

BioSpectrum India, a leading B2B media information for the analysis. This was done during
platform in Lifesciences space since 2003 has January – March 2021. Companies shared information
re-launched its ranking special edition in June with us to the extent it was possible by them. We have
2019 after a gap of 2 years. We have delayed collected information about listed companies from
this survey and ranking excise in 2020 due to stock exchange and financial agencies and Ministry of
COVID-19, as companies were given extended period to Corporate Affairs (MCA) as well.
submit their financial returns to December 2020.
In this survey we looked at only Industrial Enzymes #The revenues considered for the analysis are of
Industry with companies specializing in food & Industrial Enzymes products sales. In several cases, where
beverage, textile, pharmaceutical, food processing, revenue figures were not available, estimates were arrived
leather, detergents, paper and pulp and bioenergy. We in discussion with industry experts.
highlighted the companies (both MNCs and domestic
players) based on their achievements in the past financial #For all the ranking purposes, we have taken the
years. Industrial Enzymes business only into consideration.
A detailed questionnaire (survey form) was sent to Wherever ‘Revenue is mentioned, it means, sales turnover
about 25 companies in this space to capture the needed from Industrial Enzymes products division. Therefore,
revenue wherever mentioned is not necessarily the total
sales turnover of the company.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com COVER STORY 35

01 NOVOZYMES SOUTH ASIA PVT LTD

REVENUE The Indian arm of Denmark headquartered biotechnology
company Novozymes South Asia saw a revenue generation
₹683.4 crore of Rs 683.4 crore in the financial year 2019-20 in the enzymes
space, exhibiting a growth of 16 per cent in comparison to
KRISHNA MOHAN the revenue generation of Rs 589.15 crore in the previous
PUVVADA year. Novozymes, which has operations in a number of countries
around the world, including China, India, Brazil, Argentina, United
Regional President, India Kingdom, the United States, and Canada, started operations in
India in 1983. It is the largest supplier of industrial enzymes and
microorganisms in the region today. The region’s operations cover
India, Sri Lanka, Bangladesh, Nepal and Bhutan. With over 500
employees, Novozymes India has grown into an organisation spread
across three sites in Bengaluru covering research, manufacturing,
business functions and a shared service centre. The company invests
nearly 14 per cent of its global revenue in research and technology (R &
T) annually, with one of the key R&T facilities located in Bengaluru.

Some of the key business areas for India include household care,
textiles, food & beverages, oils & fats, baking and beverage alcohol.
Novozymes also makes pectinase enzymes in India. Pectinases are
used in the wine and juice industries to squeeze more juice from
the fruit and improve the production processes. The company also
formulates other enzyme types in India to cater to the local market
needs.

Novozymes has a Detergent Design Centre in Bengaluru that
serves as a platform for engaging customers on how its biological
solutions can meet the customer’s needs in laundry detergents and
soap bars. Bengaluru is also home to the company’s textile application
centre to support the growing textile industry in the region.

To accommodate business growth and a consequent increase in
production and supply chain needs, Novozymes has obtained a tract
of land on a long-term lease in the Patalganga industrial area near
Mumbai. With an initial investment of Rs 300 crore, the company has
established a new enzyme production and supply chain facility.

Besides its business, education is also at high priority for
Novozymes as it aims to educate 1 million people about the potential
of biology. Novozymes India regularly offers internships for different
periods of time. They may be paid or unpaid, depending on the nature
of the internship. Either way, the company makes sure that one gets
great learning and development.

36 COVER STORY BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

02 ROSSARI BIOTECH LIMITED

REVENUE Mumbai- based manufacturing company Rossari Biotech
has generated a revenue of Rs 600 crore in the enzymes
₹600 crore space during the FY 2019-20 exhibiting a growth of 16
per cent in comparison to the revenue generation of Rs
SUNIL S CHARI 516.2 crore in the previous fiscal.
Rossari is one of India’s leading manufacturers and exporters of
Managing Director textile chemical auxiliaries, enzymes, polymers and animal health
care products. The enzymes portfolio at Rossari is spread across a
wide range of functions such as Desizing Agent, Bioscouring Agent,
Peroxide Killer, Biopolishing, Fading and Washing Off catering to the
textile chemicals section. Apart from this, the company also has a large
number of enzyme products such as Mannobac, Phytobac, Protoxy
Forte, Rosslipase, Rossphyte 5000/10000 and Xylot Ex in the individual
form; and Enzyfort, Maxi ex, Maxizyme Ex and Rosszyme Plus in the
cocktail form, within the Poultry Supplements & Additives sector.
Founded in 1997, Rossari Biotech was the brainchild of the two
founding partners, Edward Menezes and Sunil Chari. Interestingly,
most of the initial capital for the company was borrowed from friends
and family who reposed their faith in the founders’ vision and their
commitment to their goal. As the firm has grown in manpower and
market value, its offices have moved a good few times finally settling
at the current premises in Kanjurmarg in Mumbai which is now the
location of the 80-person strong head office.
The company has state-of-the-art research facilities both at its
head office in Mumbai as well as at the manufacturing plant in
Silvassa in Gujarat. Rossari is one of the few companies in the sector
credentialed with a Department of Scientific and Industrial Research
(DSIR) certification.
The research facilities at Rossari encompass all the divisions of
the company with Application Laboratories for textile and polymer
applications to Microbiology Laboratories for enzyme research and
Reaction Laboratories equipped with the appropriate facilities for
carrying out polymer reaction and emulsion research and product
development.
Rossari Centre of Excellence at IIT, Bombay is the new state-of-
the-art certified R&D laboratory that is fully equipped with advanced
testing and research equipment. Engaged in innovative and
developmental research, this R&D lab is intended to become a game-
changer in innovation, optimal efficacy, and indigenous technical
prowess.
For the future, the company plans to increase focus on the
corporate account; build a techno-commercial water treatment team;
have more focus on soap, detergent and cement industries; and
commence a new vertical for sugar and distillery.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com COVER STORY 37

ADVANCED ENZYME TITAN BIOTECH LTD
TECHNOLOGIES LIMITED

V L RATHI SURESH CHAND SINGLA

Chairman Managing Director
Revenue: ₹449.63 crore Revenue: ₹79.8 crore

Thane-based research-driven company Advanced New Delhi-based Titan Biotech saw a revenue
Enzymes Technology has garnered a revenue of Rs generation of Rs 79.8 crore in the financial year
449.63 crore during the financial year 2019-20 in 2019-20 in the enzymes space, exhibiting a growth
the enzymes space, exhibiting a growth of 6 per cent as of 22 per cent in comparison to the revenue generation
compared to Rs 424.63 crore generated in the previous of Rs 65.6 crore in the previous year. Titan Biotech is
year. With a workforce of more than 550 employees, one of the leading manufacturers & exporters of the
around 68 enzymes and probiotics in its portfolio, 5 R&D biological products used in the field of Pharmaceutical,
locations in India and Germany, and 22 patents granted Nutraceutical, Food & Beverages, Biotechnology &
to its credit, the company caters to diversified industries Fermentation, Cosmetic, Veterinary & Animal Feed,
and verticals like human nutrition, animal nutrition and Agriculture Industries, Microbiology Culture Media &
bio-processing. Although the company was incorporated Plant Tissue Culture Media etc. With the experience of
in 1989, its journey began in 1957 when the founder more than 25 years and a remarkable market presence
Late L. C. Rathi pioneered the extraction of papain, an in 75+ countries, Titan Biotech consistently pushing
enzyme complex derived from papaya fruit and widely the boundaries of research and development to deliver
used for pharmaceutical and medical purposes. He went the best quality of biological products. The company is
on to set up India’s first enzyme manufacturing plant in committed to a total customer satisfaction policy and
1958. emphasises supplying the most competitive prices
to the market in order to cater and create the success
situation in the marketplace.

TEX BIOSCIENCES (P) ENZYME BIOSCIENCE
LIMITED PRIVATE LIMITED

ARAVIDHA PRAKASH KRISHNAMACHARI RONAK PATEL

Director Chief Executive Officer
Revenue: ₹42.8 crore Revenue: ₹37.5 crore

Chennai-based Tex Biosciences clocked in a Surat-based Enzyme Bioscience saw a revenue
revenue of Rs 42.8 crore during the financial generation of Rs 37.5 crore in the financial year
year 2019-20 in the enzymes space, exhibiting 2019-20 in the enzymes space, exhibiting a growth
a growth of 9 per cent as compared to Rs 39.1 crore of 29 per cent in comparison to the revenue generation
generated in the previous year. The majority of this of Rs 29.2 crore in the previous year. The company is a
revenue was gathered by the domestic business. Tex manufacturer and provider of quality Enzymes Products
Biosciences is involved in the manufacturing and and services to the Bio Pharmaceuticals (Trypsin
marketing of enzymes, Probiotics & Specialty Chemicals Chymotrypsin Mix, Fungal Diastase IP, Papain), Food
for industrial applications. The company operates in (Malt Extract, Starch, Grain Processing, Meat Tenderize
Leather, Animal Feed, Textiles, Pulp & Paper, Detergents Enzymes), Feed (Phytase, Animal Health & Nutrition
and Waste Water Treatment Industries. Tex Biosciences Products such as quality feed additives and premixes)
is an ISO 9001, ISO 22000 Certified organization that industries since 2012. Enzyme Bioscience manufactures
employs over 230 staff and has an export presence in 22 enzyme formulations in both liquid and powder forms.
countries across the globe. The company also contract The company offers higher quality products such as
manufacture for many of the leading multinational higher enzyme activity, stability, less enzyme dosage,
companies in Europe and America in the Animal Feed, easier processing, higher yield, which are greatly helpful
Water Treatment and Leather Markets. to improve their finished products.

38 COVER STORY BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

AUMGENE BIOSCIENCES CATALYST CLINICAL SERVICES
PRIVATE LIMITED PRIVATE LIMITED

ANAND DAGA PRASHANT NAGRE

Managing Director Chief Executive Officer (CEO)
Revenue: ₹26.6 crore Revenue: ₹9.38 crore

Surat-based Aumgene Biosciences generated a Thane-based Fermenta Biotech Limited (FBL)
revenue of Rs 26.6 crore in the enzymes space clocked in a revenue of Rs 9.38 crore during the
during the FY 2019-20 exhibiting a decline of 20 FY19-20 in the enzymes space, showing a decline of
per cent in comparison to the revenue generation 25 per cent when compared to the revenue generation
of Rs 33.3 crore in the previous fiscal. Founded in of Rs 12.5 crore in the previous fiscal. Fermenta caters to
2004, the company undertakes the development, clientele across the globe, with a worldwide distribution
manufacturing & marketing of Enzymes, Probiotics & network. Its state-of-the-art R&D centre is based in
Agribiotech products. The company has in-house large Thane, and world-class manufacturing facilities are
scale fermentation facilities with more than 100 cubic located in Kullu, Himachal Pradesh and Dahej, Gujarat.
mt of fermentation capacity. The company has state of Apart from Vitamin D3, Fermenta also offers niche APIs,
the art R&D facilities for high throughput screening of integrated biotechnology platforms such as enzymes for
microbial strains, fermentation process development & antibiotic synthesis as well as environmental solutions for
purification of enzymes & biologics. A multi-disciplinary wastewater management and treatment. The company
team of scientists, engineers & project managers produces Penicillin G Amidase, CAL B Lipase and other
work on various biotech products and molecules at enzymes with applications across the pharmaceutical,
Aumgene’s R&D facility in Surat. The company’s R&D fine chemicals and personal care segments. Fermenta’s
facility is equipped with state of the art infrastructure enzyme technology for the synthesis of amoxicillin and
for product & process development of various biological cephalosporin antibiotics offers unique features and a
products. competitive edge for antibiotic producers.

INFINITA BIOTECH NOOR ENZYMES
PRIVATE LIMITED PRIVATE LIMITED

ADARSH DESAI SHABAAZ SOLANKI

Managing Director Chief Executive Officer
Revenue: ₹3.35 crore Revenue: ₹1.3 crore

Vadodara-based Infinita Biotech clocked in a For Kolkata based industrial biotechnology
revenue figure of Rs 3.35 crore during the FY19- company Noor Enzymes, the revenue generation
20 in the enzymes space exhibiting a growth of was Rs 1.3 crore during the FY19-20 in the enzymes
33 per cent in comparison to the revenue generated space. The company leverages the infrastructure of
in the previous fiscal at Rs 2.6 crore. The majority large scale contractual fermentation facilities for the
of the revenue last year was gathered through the manufacture of its enzyme concentrates. It presently
company’s export business which was around Rs 2.39 utilises fermentation units located at different parts of
crore. Incepted in 2015, the company is engaged in the Indian subcontinent to streamline the manufacture
the manufacturing and marketing of biotechnological of the wide range of products in its portfolio. The
enzyme-based biodegradable formulations for company caters to the textile processing industry with a
various industries and the formation of customised range of Amylase, Cellulase, Pectinase Enzymes; to the
enzyme formulations for specialised industries. Infinita Detergents industry with a range of enzymes such as
serves an array of industries such as Distillery, Sugar, Alkaline Protease, Alkaline Amylase and Alkaline Lipase
Brewery, Starch, Wine, Malt, Waste Water Treatment, for detergent formulations; and the Leather processing
Food, Animal Feed, Agriculture, Cellulosic Ethanol, industry with Acid Protease, Alkaline Protease, Acid
Pharmaceuticals, Detergent and Biodiesel. With a Lipase and Alkaline Lipase Enzymes for tanning
workforce of 20 employees, the company is working processes. Noor enzymes also have enzymes products
with more than 25 countries globally. for the paper processing industry, biofuel industry,
starch processing industry, and the animal feed industry
in its portfolio.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com GREEN CHEMICALS 39

Industrial enzymes crucial to reduce carbon footprint

Indian industry of enzymes is now poised to harness «
its science capabilities and technological knowledge
to have a global impact on a robust network, Adarsh Desai,
powered by creativity.
Managing Director,
Enzymes are considered green chemicals and
have very wide applications. Out of more than Infinita Biotech,
3,000 different known enzymes, only 150 to
170 are used commercially. The advancement in Vadodara
biotechnology, especially within the area of genetics
and protein engineering, has opened a new era of the industry grow, launch new products and compete
enzyme applications in many industrial processes with global players.
and experiencing major research and development
initiatives, resulting in both developments of several There are still limitations in the market since
new products and improvement in the process and there are concerns with the storage and preservation
performance of several existing processes also. of enzymes. The Indian enzyme industry’s challenges
include high temperature and pH toxicity to enzymes
Enzymes are useful in various areas like the and safety concerns with handling. Furthermore,
manufacturing of food and beverages, animal feeds, the tight regulations of the use of industrial
cosmetics, medicinal products and as a tool for enzymes often limit business expansion. The lack
research and development. Technical enzymes find of government legislation and controls to ensure
utility in detergents, pulp and paper applications, enzyme use will continue to hinder this market. Also,
textile manufacturing, leather industry, for fuel high capital and operational costs are associated
production and for the production of pharmaceuticals with it. Investors are apprehensive about funding
and chiral substances in the chemical industry. R&D activities because the developed products’
The use of enzymes in animal nutrition is vital and market performance cannot be pre-evaluated. Heavy
growing, especially for pig and poultry nutrition. investment in customer service and technical support
Animal feed enzymes offer the benefit of degrading is required to be made by enzyme companies which
specific feed components otherwise harmful or of put a heavy strain on their budgets.
no value to the livestock. In cosmetic products, it’s
used for skin peeling and future applications may be One major challenge for the enzymes
skin protection. Enzymes are also used as digestive manufacturers in India is the competition from the
aids. They can be used in chemical analysis and as a Chinese enzymes producers. Chinese companies
research tool in the life sciences. are encouraged to export at minimal prices due to
the support given by their government in terms of
Today, in manufacturing and testing facilities, incentives for exports. Cheap enzymes from China are
the Indian industrial enzymes market has reached always a threat to the Indian enzymes community.
critical mass. Indian industry of enzymes is now However, the quality of the Chinese imported
poised to harness its science capabilities and enzymes will always remain a questionable topic as
technological knowledge to have a global impact on a there are numerous cases wherein the quality of these
robust network, powered by creativity. The technical Chinese enzymes are not at par with the international
potential to manufacture such commodities is just standards.
part of the prerequisite for the company’s commercial
success. The organisation must be able to put its Use of industrial enzymes is a sustainable
thing on the market apart from technical capability. alternative to the use of harmful chemicals in the
Thus, technologically advancement and marketing industries as enzymes work under mild conditions
must go hand in hand to achieve full market and hence reduce energy consumption and in turn,
potential. decreasing greenhouse gases emissions. Industrial
enzymes minimise by-products generation and also
The government, through the Department of reduce the consumption of water and chemical waste
Science and Technology (DST), the Department of generation, thus posing minimal risk to humans
Biotechnology (DBT) and the Council of Scientific and the ecosystem. Hence, the usage of enzymes
and Industrial Research (CSIR) has been considerate in industries is considered to be eco-friendly, cost-
to the bio-industrial sector, and funding projects effective and safe as well.
associated with industrial enzymes. This may help

40 SPEAKING WITH BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

“India should focus on innovating drugs
and molecules to emerge as a global leader”

« Vaccine for children across the country. We hope to see
strong interventions in the area of adult immunisation
S Sridhar, and a stronger focus on public- private partnerships to
President, Organisation further enhance access to healthcare and medicines for
of Pharmaceutical the population of our country. Equally important is the
Producers of India National Research Foundation (NRF) with an outlay of
(OPPI), Mumbai Rs 50,000 crore over five years. We hope biological and
pharmaceutical research receives enough provision in
this outlay to nurture an innovation- driven ecosystem.

The Organisation of Pharmaceutical Producers How is the pharma sector looking to make life-
of India (OPPI) has elected S Sridhar as its next
President for a period of two years, effective from saving drugs accessible to the needy?
February 15, 2021. He takes over from Sharad Tyagi,
Former Managing Director, Boehringer Ingelheim OPPI and its member companies have been rigorously
India Pvt Ltd. Sridhar is currently serving as the working with the government to make life-saving drugs
Managing Director of Pfizer Limited and is heading accessible to people from all strata. Many of our member
Pfizer Inc’s commercial business in India. Sridhar has companies are partnering with Ayushman Bharat, the
been a member of the Executive Committee of OPPI largest government-funded healthcare programme
for the past six years and has also chaired its Finance in the world, which is expected to benefit 100 million
and Taxation Work Group. He is a strong voice of vulnerable families in the country by providing a cover
healthcare transformation in the country and was the of Rs 500,000 per family each year for secondary
chair of FICCI’s Pharma Committee till recently. In and tertiary care. OPPI and its member companies
conversation with BioSpectrum, S Sridhar talks about have a long and distinguished history in innovating
making a difference to patients, the industry and the and distributing life-saving medicines at economical
country via this new role. Edited excerpts; costs around the globe. The COVID-19 pandemic has
shown that India should focus on innovating drugs and
What is your vision for the pharma sector molecules, in order to emerge as a leader in the global
during your tenure as OPPI President? pharmaceutical landscape.

I am enthusiastic to be a part of the transformation that What are the most pressing issues in the pharma
OPPI envisions for the Indian healthcare sector. For us,
fostering an environment for research and innovation sector that require immediate attention?
in the country, increasing access and leveraging
technology would be the main patient- centric themes. Innovation - In promoting pharma innovation,
I believe the research-based pharmaceutical industry India needs to think big, as it has been doing in recent
has a great role to play in India’s journey to transform years in other spheres. Since India possesses one
its healthcare and bring in new and better solutions to of the largest talent pools of medical professionals,
in the country. which includes researchers, it should aim at emerging
as a global pharmaceutical leader by inventing and
Will the Budget 2021 help the pharma sector in developing new molecules and addressing solutions to
becoming self-reliant and sustainable? some of the long-standing healthcare problems.

OPPI is glad to note the proposal to increase the Regulatory compliance - Reduce regulatory
permissible Foreign Direct Investment (FDI) limit in compliance burden on the sector in order to improve
Insurance companies from 49 to 74 per cent. This would ease of doing business in the country.
help health and life insurance companies to seriously
explore and invest in the country. We are also enthused Access to Medicine – Ensuring access to
by in the proposal to make available Pneumococcal medicines is a challenge in a large country like India.
Judicious measures need to be adopted to make sure
that drugs are available to all those who need them and
when they need them.

Also, India needs more focused research and
development in APIs with dedicated facilities.

Prabhat Prakash
[email protected]

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com SPEAKING WITH 41

“Made in India products
need an ecosystem for
commercialisation of innovations”
Established in 1998, Ernakulam-based Agappe
Diagnostics is one of the rapidly growing «
companies in the in vitro diagnostic (IVD)
industry in India, having a wide range of products in Thomas John,
the pre-analytical and analytical segment. Focused on
research, design, and production of clinical chemistry Managing Director,
reagents and instrument, Agappe has over 1000
distributors and holds a significant place in the global Agappe Diagnostics,
original equipment manufacturer (OEM) business.
The company currently has a workforce of more Ernakulam
than 600 employees spread across sectors such as
R&D, manufacturing, sales, support and operations. Research (ICMR) and Central Drugs Standard
In conversation with BioSpectrum, Thomas John, Control Organisation (CDSCO). The test kits have
Managing Director, Agappe Diagnostics, Ernakulam been approved by National Accreditation Board for
shares his strategies and plans for the company’s Testing and Calibration Laboratories (NABL) for use
growth in the long run. Edited excerpts; by laboratories.

How has Agappe faced the challenges of We were also able to quickly gather our resources
COVID-19 in terms of production, technology to cater to the sudden demand for COVID-19
and revenue? prognosis. The parameters of D-Dimer, Ferritin, CRP
were identified for their benefits in prognosis and we
In a highly import-dominated IVD sector, Agappe has had ramped up our production to meet the demand.
always emphasised on the indigenous development Our team was able to roll out 1 million tests in 24
of technology. Our far-sightedness for developing days and make them available for the end-users.
in-house manufacturing has enabled us to envisage Even as the lockdown crippled functionality to the
products that are suitable for developing countries. bare minimum, we supported our employees and our
In line with this thought, we have focused on our R employees had taken up this challenge to support our
& D division, with a committed expenditure of over 5 efforts in this fight against COVID-19.
per cent of our revenues. The disruption of supplies
caused by the pandemic and the lockdown did not What are the major plans in store for 2021?
deter us, as our products were already in the pipeline
to be manufactured in India. For 2021 and beyond, we would like to be partners
in the Atmanirbhar Bharat campaign to achieve full
During this pandemic, we paced ourselves to self-reliance in the manufacture of IVD devices and
commercially launch Mispa Count X, India’s first reagents. After launching the first semi-automated
indigenously built blood cell counter, in partnership specific protein system in India in the year 2011, we
with L&T Technology Services, a leading global control the protein estimation segment in India and
pure-play engineering services company. We are the the neighbouring market, making specific protein-
first Indian company to indigenously design, develop based diagnosis and prognosis affordable to the
and commercialise the 3-part haematology analyser. masses. The first ‘Made in India’ 3-part haematology
Agappe also became the first Indian IVD company to analyser, under the brand name Mispa Count X, is
launch IoT based semi-automated clinical chemistry a testimony to our commitment to Aatmanirbhar
analysers during the peak of the pandemic. In tune Bharat. We intend to focus on molecular diagnostics.
with the need of the hour, Agappe’s R & D team has Molecular Diagnostics with its newfound prominence
developed the RT LAMP technology-based COVID-19 will be one of our major growth drivers and Agappe
test kits, Mispa LUME and Mispa Lume Screen nCov plans to make the process simplified so that mass
for the domestic market. These products are validated screening of COVID-19 can be done with ease.
and approved by the Indian Council of Medical We also plan to include more parameters in this

42 SPEAKING WITH BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

The pandemic exposed the big
gap in the availability of reliable
molecular diagnostic tools to
carry out confirmatory tests
and the need for affordable
diagnostics technology with
faster turnaround of results.
The Indian IVD sector will
be technology-driven in the
future, with the focus on
indigenous development of
devices that use high-end
software.

segment. We will be increasing our product portfolio to enhance our product portfolio. We are planning
with improved and updated products in all major to introduce compact and user-friendly systems in
segments. Our aim is to become the number one Haematology, Clinical chemistry, Immunology and
IVD company in India by 2025. Molecular Diagnosis. As part of the Atmanirbhar
scheme, we propose to be at the forefront to provide
How has the pandemic changed the face of affordable solutions in the IVD segment. Our
the IVD sector? What trends do you foresee compact user-friendly systems are the best to reach
in this sector? diagnostics solutions to the rural areas and to cater to
the masses in India and nearby developing countries.
COVID-19 brought out the importance of molecular
diagnostics in precisely diagnosing diseases. The What are your views on the government’s
pandemic exposed the big gap in the availability
of reliable molecular diagnostic tools to carry out recent announcements on the Medical Device
confirmatory tests and the need for affordable
diagnostics technology with faster turnaround Park & PLI scheme for the manufacturing
of results. The absence of a strong local IVD
manufacturing sector could be felt during the industries?
pandemic as imports were disrupted. The Indian
IVD sector will be technology-driven in the future, The IVD industry has generally welcomed the
with the focus on indigenous development of devices Government of India’s medical devices policy
that use high-end software. The focus will be on and the PLI scheme. The medical devices parks
technology than products, with an effort to become scheme is also a good effort towards Atmanirbhar
self-reliant and self-sufficient. Technology adoption Bharat. However, we feel that the policy needs to be
is likely to be faster owing to the changes in end-use. evaluated in the context of the lessons learnt during
With molecular science dominating the clinical side, the pandemic and fine-tuned accordingly.
molecular diagnostic tools cannot be left behind. Pre-
analytics and Post-COVID prognosis are also expected Given the fact that there are fewer home-grown
to be the main drivers for the industry. To facilitate units, the emphasis should be on quality and cost-
R & D investments, technology development and effectiveness. ‘Made in India’ products need an
adoption, the government should consider reforming ecosystem for commercialisation of innovations
the multiple regulatory and standardisation regime. and incremental innovations into quality products
because investments in the IVD industry comes
How do you plan to contribute to the growth in tandem with innovations and technology
of the IVD sector in the long run? development. The medical parks will hopefully cater
to the needs. However, companies that have invested
Agappe has a unique record of being an innovator time, energy and funds should be given recognition
in the IVD sector. Many of our products are and rewards. We are of the firm opinion that the
revolutionary. Our success mantras are Innovation, PLI scheme should reward domestic/homegrown
Quality and Affordability. We have industry-industry IVD companies by factoring in the expenditure
collaborations and Industry- academic partnerships incurred by them in R & D. Multiple regulation and
standardisation mechanisms should be reviewed.

Dr Manbeena Chawla
[email protected]

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com SPEAKING WITH 43

“We are working on strategies for
improving the reach of Insulins to LMICs”
With a master’s degree in business
administration and executive MBA from «
the prestigious Harvard business school,
Amol Shah brought strategic focus and business Amol Shah,
opportunities for the growth of the company. His Managing Director,
commitment for addressing the pressing need of M.J. Biopharm
Diabetes in the country has resulted in M.J.Biopharm Pvt. Ltd., Mumbai
becoming one of the leading insulin manufacturing
company in India. With the support from Krishna facilities are extremely expensive to set up. Further,
Prasad as Vice President & Director and Dhaval biotech facility also have long gestation period due to
Vashi as CFO & Director, Shah has been leading the stringent regulatory compliance requirements. MJ
company with total staff strength of 500+ (Technical acquired a semi constructed biotech facility in Pune
and skilled staff: 200) to take it to the next level as in the year 2012. With hard work, determination, and
it has set a target to hit Rs 200 crore for 2021-22 self-belief, we finally succeeded in completing the
from the last year’s sales of Rs 135 crore. In an email facility to manufacture rDNA Human Insulin and after
interview with BioSpetrum, Shah shared challenges lengthy clinical trials got the final approval in 2018 to
before the company and its growth plans for coming commercialise Human Insulin for Indian market.
years. Edited excerpts;
What are your views now on the institutional
What prompted you to look at offering sales model which you had opted earlier?
rDNA based human insulin raw material &
formulations as an area of opportunity in 2000? Congruent with the vision of founder of the company,
MJ started with the challenge of registering the
In 1990, M.J.Biopharm (MJ) entered into the insulin company with various institutions in India with a
business both in India and in Commonwealth of purpose of providing high quality domestic insulin at
Independent States (CIS) countries in a joint venture economical price. Over a period of three years, MJ
with Eli Lilly. MJ started with manufacturing and has emerged as one of the main suppliers to several
supply of animal insulin in India and we quickly institutions around the country and a preferred
realised that not only does India have a very large supplier of Insulin to the prestigious scheme
number of diabetic patients who are forced to rely “Pradhan Mantri Bharatiya Janaushadhi Pariyojna”
upon imported insulin but there is also a shortage (PMBJP) to ensure availability of medicines at prices
of insulin in the country keeping prices very high. lower than MRP to the common Indian citizens. MJ
Insulin was essentially monopolised by three large continues to provide Insulin at preferred prices to
multinationals, thus economically disadvantaged the various institution to fulfil company’s vision of
people of India could not have access to highly making India self-reliant to meet the requirement of
purified human insulin. Insulin for diabetic population of India.

To meet this gap and to provide high quality What were the challenges before M.J.
Insulin in India and globally at economical prices, Biopharm then and now?
then became a goal and a passion for MJ. This was
the starting point where MJ made alliance with a MJ is a family owned company and thus access
European API supplier “Diosynth” to import Insulin to capital and right manpower has been some of
Drug substance, which was then formulated into the significant challenges. However, putting that
Insulin injections for sale in India. aside the biggest challenge for any biotech product
manufacturer always comes from Regulatory
Within few years of launch of Human Insulin in requirements. Biotech regulatory landscape is
India by MJ, it became abundantly clear that to fulfil constantly changing and the registration process is
MJ’s long term vision of making India self-reliant getting more complicated with each passing year
for Insulin, it was important to develop own Insulin
Drug Substance. This was an aspirational and lofty
goal considering that Insulin fermentation technology
is not only extremely difficult, but also biotech

44 SPEAKING WITH BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

MJ is now working on in-licencing Over the next five years MJ intends to evaluate
agreements and strategic partnership possibility of launching a full range of diabetic
to launch modern insulins such as products in the domestic market. The ultimate
Glargine, Aspart and Lispro as well as aim for MJ is to reach every part of India with our
peptides for diabetics in India. Two diabetic range of products and to provide Affordable
of the products are already in clinical Quality Care in the fight against diabetes.
trials, and expected to be registered in
India before mid-2022, whilst two more Although diabetes is one of the global
modern insulin are under development
in the Product development Lab within concerns, how do you see the opportunity?
MJ Drug substance facility located in
Hinjewadi in Pune. With ~470 million Diabetic population worldwide
and ~77 million in India which is ~16 per cent, MJ
making it extremely onerous and expensive to register has a crucial role to play to improve the Affordability
a Biosimilar product. After registration of Insulin in and Accessibility of Biosimilars in Diabetes segment
about 30 countries, we have now embarked on the mainly Insulin, which is still a very effective line of
challenge of registering our product in US and EU. treatment along with oral antidiabetic products.

M.J. Biopharm is working on four Inspite of the competition and the challenges in
Recombinant Insulin range of products - domestic and international markets, MJ has fortified
Glargine, Liraglutide, Lispro and Aspart. its position in Diabetes with its strong manufacturing
When the customers can expect these range capabilities. We are also working on strategies for
of products from the company? improving the reach of Insulins to LMICs (Low and
middle income countries). With our ardent efforts
Biotechnology development is a long and tedious in setting up new facilities /expanding our current
process requiring abundant patience, plenty of facilities, product registration in European Union
resources and technical competencey in order to (EU)/US and prospective strategic alliances we will
succeed. MJ has over the last 8 years developed emerge as one of the largest Biosimilar company in
the technical competence in biotechnology and has Diabetes segment.
exhibited perseverance to achieve its goal as seen
with the successful launch of rDNA Human insulin What are your growth plans for the company?
and the ongoing clinical development of Glargine.
MJ now has end to end capabilities ranging from
MJ is now working on in-licencing agreements biopharmaceutical Process development to Drug
and strategic partnership to launch modern insulins Substance and Drug product manufacturing on a large
such as Glargine, Aspart and Lispro as well as scale. MJ has been involved in pharma & biopharma
peptides for diabetics in India. Two of the products manufacturing and services for almost two decades
are already in clinical trials, and expected to be with its “Virtuous Business Model”, which is self-
registered in India before mid-2022, whilst two driven and collaborative (manufacturing for their own
more modern insulin are under development in the captive requirements and providing manufacturing
Product development Lab within MJ Drug substance services to several companies in India).
facility located in Hinjewadi in Pune. We are working
diligently for initiating pre-clinical studies within this By the end of 2021 MJ will be setting up a GMP
year with a plan to register these analogue insulin compliant 100L Product development lab and a
by 2024. This will allow MJ to offer the full basket modern vial filling facility fully compliant with EU
of Anti diabetic injectables to the Indian diabetics so GMP /USFDA standards. This will enable MJ to
as to help them deal with diabetes economically and provide Contract Development and Manufacturing
effectively. Further MJ is also working ardently with (CDMO) services and support for drug substance
its Canadian partner Eastgate Biotech Corp for Oral of E. coli based products at 100L scale, commercial
Insulin which is under development. manufacturing of DS along with final formulations
of the drug product in vials and cartridges. A new
Do you have any plans of entering the branded cartridge filling facility along with Disposable pen
business with your own range of Recombinant assembly and Drug substance facility at 10,000L
Insulin products in the coming years? fermentation scale is also planned to be ready for
operation in the year 2023-24.

In addition to expanding our business in CIS,
LATAM, MENA we intend to register our Biosimilars
in US and Europe.

Narayan Kulkarni
[email protected]

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com SPEAKING WITH 45

“We need Indian patients in our global clinical
trials to enable product commercialisation”

Formerly the Global Head of Boehringer «
Ingelheim’s Go-To-Market and Business Steering
organisation in Germany, Vani Manja has recently Vani Manja,
stepped in as the Country Managing Director for India.
In this role, she has assumed responsibility for the Country Managing
company’s businesses in India and the neighbouring
markets. Her global experience in healthcare spans Director India,
nearly two decades across McKinsey & Company,
Becton Dickinson and Boehringer Ingelheim, and is Boehringer Ingelheim
characterised by strong global mobility and cross-
functional leadership assignments across healthcare and 3 Union Territories to improve the standard of
and management consulting. Speaking to BioSpectrum, care for stroke management. The partnership model
Vani Manja, Country Managing Director India, entails the development of an increased network of
Boehringer Ingelheim shares the company’s roadmap of stroke-ready centres across India. It also includes
partnerships and patient access programmes to sustain supporting healthcare professionals (HCPs) with
its growth momentum in 2021. Edited excerpts; world-class training to identify and treat stroke within
the recommended treatment window. We are also
What are your major plans for 2021? working towards enabling an ecosystem for stroke
care by bringing in multi-disciplinary teams that can
Boehringer Ingelheim India aspires to be amongst the top address disease management through the continuum of
five multinational pharmaceutical companies in India care. Boehringer Ingelheim India collaborates with 380
over the next few years. We have been enabling access centres, enabling support for over 10,000 patients to
to our innovator products to patients across India and access effective stroke care. Stroke is one of the leading
the neighbouring markets in diabetes, cardiovascular, causes of mortality in India attributing to around
stroke and respiratory diseases segments. Our plan in 30 per cent of the overall morbidity, with almost 70
these therapy areas is to build sustainable partnerships per cent of the stroke cases either being treatable or
to ensure an ecosystem of access and care for patients. preventable. Boehringer Ingelheim’s therapy for Acute
We have initiated action in that direction. In addition, Ischemic Stroke (AIS) treatment is in use in more than
Boehringer Ingelheim India’s Animal Health business, 85 countries.
which focuses on advanced, preventive health solutions
for pets and poultry, aims to more than double the sales What are your plans to enhance pharma R&D?
over the coming five years.
Boehringer Ingelheim’s R&D focus in human pharma
Please elaborate on the therapeutic areas is on cardiovascular and metabolic diseases, oncology,
currently being focused on for further growth. respiratory, immunology, diseases of the central
nervous system and retinal health. In India, our R&D
In diabetes, Boehringer Ingelheim’s research partnerships have been contributing to this end. So,
and development has been focused on bringing while globally there are huge investments taking place in
comprehensive solutions to the management of type R&D at BI, but for India how it will translate is a matter
2 diabetes and its related cardio-renal-metabolic of these partnerships. With the approval of a drug and
complications. The company has been investing clinical trial rules in 2019, there is now a recognition
significantly in understanding the condition in its that we need Indian patients in our global clinical
entirety. With our differentiated product portfolio trials to be able to support product commercialisation.
and our global learnings and experience in holistically With this strengthening of the infrastructure and the
managing type 2 diabetes and related health challenges, good practices in clinical trials in India, we are actively
we keenly share the vision of our doctors, health experts pursuing dialogues within the team to bring our
and patients to lead India towards becoming a diabetes- innovation in science and research to India.
care capital of the world, in partnership with other
stakeholders in the ecosystem. Meanwhile, in the area Dr Manbeena Chawla
of stroke, Boehringer Ingelheim India has established [email protected]
a partnership model to help hospitals across 23 States

46 PEOPLE NEWS BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

ISCR ropes in ABLE appoints
Dr Sanish Davis G S Krishnan as new President
as President
for 2021-23 G S Krishnan, former Regional President & Managing Director,
Novozymes South Asia, has taken charge as the new President
The Indian Society for of the Association of Biotechnology-Led Enterprises (ABLE).
Clinical Research (ISCR), an
association of clinical research He will head a 9-member executive
professionals, has announced council that was elected for a three-
the appointment of Dr Sanish year term on April 1, 2021. Krishnan
Davis as its President for the has vast leadership experience, from
term 2021-23. Dr Davis takes developing the market for businesses
over from Dr Chirag Trivedi, across industries to identifying new
who was President for two opportunities and strategic partnership,
terms from 2017-2021. He managing the organisation across
has served as the General functions, from over 30 employees to
Secretary of ISCR for 2017-19. over 550 employees, representing the
Dr Davis is currently working organisation as a thought leader in the
as the R&D Director at Janssen segment with external stakeholders
Pharmaceutical in Mumbai. and industry bodies. He has been at the forefront of developing
He has been in the clinical Novozymes business in India, as well as playing a leadership role in
research industry for over 10 the Industrial Biotechnology segment for over 25 years.
years and has worked on both
sides of the fence – in academia Siemens Healthcare
as well as in Pharmaceutical names Vivek Kanade as MD
Industry. He has been actively
involved in the domains of Vivek Kanade has been named as the Managing Director (MD)
Drug discovery Research/ of Siemens Healthcare, India, effective April 1, 2021. Siemens
clinical Operations/Medical Healthcare is the wholly- owned subsidiary company of the global
Affairs and Pharmacovigilance. MedTech company, Siemens Healthineers AG. Kanade will continue
He has extensive experience to lead the business for Siemens Healthineers India including,
in managing early and late manufacturing, sales and distribution, strategy for Zone India,
phase clinical development as comprising of neighbouring
well as external environment countries like Bangladesh, Nepal,
shaping activities in the Sri Lanka and the Maldives. During
domains of Clinical Research in his association with Siemens for
NCE, Innovative generics and over 27 years, he has held various
Branded Generics. positions across diverse functions
in Sales, Service Management,
Regional Management and Modality
Management. His priorities
have been ensuring Siemens
Healthineers strategic growth,
defining and executing a roadmap
to maintaining momentum in the
Indian market whilst strengthening its presence in the zone. He
has been leading the team in Zone India towards the common goal
of shaping the future of healthcare so that medicine becomes more
precise and affordable, value is at the heart of care delivery, patients
are treated as consumers, and healthcare becomes digital. Before
moving into Siemens Healthineers in India, his last assignment was
as Vice President of Global Sales and Marketing for the Refurbished
Business, based out of Forchheim, Germany.

BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com PEOPLE NEWS 47

AFC India appoints Ravindra Dr Mahajan
Boratkar as Addl Director steps in
as new
Ravindra Boratkar, Managing Director of MM Activ Sci-Tech NATHEALTH
Communications Pvt Ltd; Publisher, MM Activ publications; and President
Chairperson, Agrovision Foundation, has been appointed as Additional
Director on the Board of Directors of Agriculture Finance Corporation Dr Harsh Mahajan, Founder
(AFC) India Ltd, formerly known as Agriculture Finance Corporation Ltd, and Chief Radiologist,
Mahajan Imaging, has taken
a deemed government organisation over as the new President
fully owned by NABARD, other of NATHEALTH. He
commercial banks & Exim Bank of succeeds erstwhile President,
India. AFC is a premier national Preetha Reddy, Executive
developmental Consultancy Vice Chairperson, Apollo
organisation and an institution Hospitals. After completing
dedicated to rural prosperity. The his Post-Graduation in 1986,
Board of Directors of the AFC India he was awarded a Rotary
Ltd, in a meeting held on April Foundation Fellowship at
15, 2021, appointed Boratkar as the MD Anderson Cancer
Additional Director. The board’s Hospital & Research Institute
decision of his appointment was in Houston, Texas where he
communicated to him through developed a keen interest in
a letter by B. Ganeshan, MD, Magnetic Resonance Imaging.
AFC India Ltd. Boratkar is the In 1992, Dr Mahajan set-up
Publisher of AgroSpectrum, NuFFooDS Spectrum and BioSpectrum one of India’s first privately
(India & Singapore), B2B monthly magazines and web portals devoted run MRIs. Subsequently in the
to Agriculture, Nutraceuticals and Food Processing and Biopharma, Life year 1998 he was appointed
Sciences and Medtech. He is also President of an important economic as the Honorary Radiologist
think tank Maharashtra Economic Development Council (MEDC). His to the President of India and
other positions include Director, Cian Agriculture and Infrastructure he continues to hold that post
Ltd; Chairperson, PURTI Cooperative; Trustee, Bhavsar Foundation; and till date. He was awarded one
Founder Member, Indian Federation of Green Energy. of the highest civilian national
honour of Padma Shri in 2002
Dr Soosan Jacob receives recognition for his contribution to the
as woman ophthalmologist field of radiology and imaging.
He is the President of the
Dr Soosan Jacob, Director and Chief, Refractive and Cornea Foundation, Indian Radiology & Imaging
and Senior Consultant, Cataract and Glaucoma Services, Dr Agarwal’s Association (IRIA) and is also
Group of Eye Hospitals, has been featured in the international Power consultant to the International
List - 2021, a list of Top 100 most influential women Atomic Energy Association
ophthalmologists in the world. Dr Soosan has over 21 (IAEA), Vienna, Austria.
years of experience, specialising in cornea, refractive
surgery and cataract surgery. Her other fields of
interest in ophthalmology include cutting edge
cataract, complex and complicated cases, anterior
segment reconstruction procedures, glaucoma and
orbit and oculoplasty. She has been the recipient of
several prestigious international awards including
International Society of Refractive Surgery’s Kritzinger
Memorial Award; Connecticut Society of Eye Physicians’
Innovator’s Award, The Waring Medal, European Society of Cataract and
Refractive Surgery’s John Henahan Award for Young Ophthalmologist,
American Academy of Ophthalmology’s International Ophthalmologist
Education Award and many international oration awards.

48 R&D NEWS BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

IASST deploys deep learning network for breast cancer prognosis

A team from the Institute of for identifying malignant nuclei. H-score are used by pathologists
Advanced Study in Science and It possesses different intensity in the quantification of the
Technology (IASST) in Guwahati, based on which categories are immunohistochemical reaction
has presented the novel deep defined in terms of Allred score of oestrogen receptor (ER) and
learning (DL) based quantitative (ranges 0 to 3) respectively. progesterone receptor (PR)
evaluation of oestrogen or Scoring systems called Allred and tissue slides. Hormone receptors
progesterone status with the help contribute to predicting cancer
of Immunohistochemistry (IHC) progression and associated risk of
specimen to grade for prediction late recurrence of the disease. The
of breast cancer. The scientists team developed an algorithm that
developed a classification method indicated whether or not the cancer
based on DL network to evaluate cells have hormone receptors
hormone status for the prognosis on their surface. The proposed
of breast cancer. IHC strain is used architecture, namely IHC-Net, can
as a prognostic marker in breast semantically segment the exact
cancer pathology and involves positive and negative nuclei from
a special kind of colour staining tissue images.

CECRI designs wearable VIT works on
sensor capable of monitoring
biomarkers from sweat aptamer-based

A research team at Central Electrochemical Research Institute POC diagnostic
(CECRI), Karaikudi, Tamil Nadu, has introduced a flexible low
cost, wearable sensor that can track sweat for monitoring the kit for COVID-19
health and physiological status of the human body. It can obviate
the necessity of blood and other invasive tests. The wearable A research team from the Vellore
microfluidic sensor, which does not need a clean room, can be used Institute of Technology (VIT) has
for in situ monitoring of biomarkers such as lactate, Sodium (Na+), recently bagged a project, funded
Potassium (K+), and Alkaline/acidic nature (pH) simultaneously by the Science and Engineering
from sweat samples. Using the INSPIRE Faculty fellowship, Dr Research Board (SERB) of the
Vinu is improving upon the sensor to make it stretchable as well Department of Science & Technology
so that it can monitor the sweat during exercising and biking. The (DST), to develop an aptamer-based
sensor can analyse biomarkers from human sweat during exercise point-of-care (POC) diagnostic kit
activities without the transfer of signals. The high-throughput for the detection of COVID-19. An
sweat sampling ability of the sensor facilitates continuous capture aptamer-based biosensor, also called
and transport of sweat over the surface of the device resulting in aptasensor (APTAS), comprises of
real-time analysis. biorecognition element that detects
the target of interest, which then
undergoes transduction, to produce
a detectable signal. Aptasensor
uses aptamers as a biorecognition
element, which favours more benefits
over antibodies. When aptamer
conjugated nanoparticles and lateral
flow assay technology are integrated,
it shows colour with spike protein
of coronavirus, a breakthrough that
could enable rapid, instant, accurate
and real-time testing among a huge
population. It would be highly
sensitive and more user friendly.

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

SCHOTT delivers
vials for one billion
doses of COVID-19 vaccine

Thermo Fisher Global specialty glass leader vast demand in India and Asia.
and pharmaceutical packaging Owing to the soaring demand
unveils human supplier SCHOTT has delivered for quality glass packaging
vials to provide more than products, SCHOTT expanded its
plasma-like cell one billion doses of COVID-19 local tubing production capacity
vaccines. SCHOTT remains by 20,000 tonnes within one
culture medium well on track to deliver vials for year. This translates into enough
more than two billion vaccine glass for over three billion vials.
Thermo Fisher Scientific has doses through 2021. The vials The success of the COVID-19
launched the new Gibco Human were delivered to projects response is supported by
Plasma-like Medium (HPLM), around the world, with a focus the company’s multi-year,
the first cell culture medium on the US, Europe, and Asia. $1 billion global investment
on the market that mimics the Approximately 90 per cent in pharmaceutical glass and
metabolic profile of human of approved vaccines rely on packaging facilities announced
plasma that is designed to provide SCHOTT vials. SCHOTT’s plant early 2019 in response to
researchers with a realistic view in Jambusar, Gujarat is one of rising worldwide demand for
of cell growth within the human the five flagship pharmaceutical safer drug packaging. Despite
body. Gibco HPLM contains the tubing production sites, the pandemic, all expansion
same salt concentrations found responsible for catering to the projects are on track.
in human plasma, as well as the
same concentrations of over 60 Honeywell adopts
polar metabolites, such as amino ‘Make in India’ data-monitoring
acids, nucleic acids, sugars and solution for pharma shipments
small organic acids. By resembling
the natural cellular environment American multinational firm, Honeywell, has introduced a
found in the body, HPLM provides data-monitoring solution that leverages machine learning and
researchers with the ability to blockchain technology to capture critical shipping-condition data
study the impact of physiologically of temperature-sensitive goods ranging from pharmaceuticals
relevant cell media on their specific and perishables to electronics – and can even help address
research applications, including counterfeiting problems that can arise while goods are in transit.
cancer and other diseases. When A ‘Make in India’ offering, Honeywell BluTag 360 incorporates
supplemented with fetal bovine temperature and humidity sensors
serum (FBS), HPLM can support to monitor shipment conditions.
cell growth and viability that are BluTag 360 will be manufactured
comparable to that of conventional locally and is one of the first products
basal media formulations to be launched under the recently-
supplemented with FBS. For announced Impact by Honeywell
most cell lines, adaptation is brand. This is the only product that
not required to transition from has been entirely designed in India,
conventional medium to HPLM. at the company’s technology centre
in Bengaluru. The company is seeking
World Health Organisation certification for the product. BluTag
360 is the first of an upcoming portfolio of offerings with global
certifications to address various regulatory requirements enabling
safe vaccine distribution. Honeywell is already in touch with the
key pharma manufacturers in India to market this product further.

50 LET’S TALK HEALTH & SCIENCE BIOSPECTRUM | MAY 2021 | www.biospectrumindia.com

Vocalising pain is a must

Women have unique health issues. In fact, falsely believe that everyone must be going through
some of the health issues that affect both this. While it is very common for gynaecologists to
men and women can affect women very prescribe birth control to reduce the symptoms, this
differently. For instance, women are more likely to is not a cure and does not eliminate endometriosis
die following a heart attack than men; or the effects lesions, as drug therapy that can destroy
of sexually transmitted diseases (STDs) can be more endometriosis is yet to be discovered.
serious in women. Talking of STDs, there is a stream
of stubborn reproductive health disorders affecting Fortunately, groups such as the World
women of all ages, the complexity of which requires a Endometriosis Organisation are now working with
more intensive approach. the medical community and policy-makers to ensure
that physicians have a greater understanding of how
Did you know that every woman has a right to to screen for this condition.
sexual and reproductive health, no matter which
part of the world she hails from, what age she is, or Addressing this condition is all the more
what her ethnicity or religion is? This is the reason important as it is one of the biggest causes of female
the International Day of Action for Women’s Health infertility. According to the American College of
or International Women’s Health Day has been Obstetricians and Gynecologists, almost 40 per
observed every year on May 28 since 1987. cent of women who experience infertility have
endometriosis.
One of the most important commandments every
woman should follow to get optimum reproductive Although surgery is the only possible cure for
healthcare is to take your pain seriously. Many women endometriosis, it can cause menopause in women
consider pain to be a natural part of their reproductive who have not gone through it naturally. As a result,
life, but severe pain can have a debilitating effect on medical experts are working relentlessly towards
your physical as well as mental health. finding a better treatment. But more than the
treatment, it is the timely and convenient diagnosis
Endometriosis is one such problem that is which requires more attention. A huge relief in this
affecting about 200 million women worldwide. Out regard is being provided by a team of researchers
of this, approximate 25 million women are estimated from Penn State College of Medicine in the US, by
to be suffering in India. To put it straight, 1 in 10 developing a blood test to diagnose endometriosis.
women between the age group of 15 and 49 live with This could indeed shorten the time to diagnosis and
endometriosis. And studies have shown that genes treatment and may prevent years of uncomfortable
are likely to play a major role here. symptoms, and disease progression.

Endometriosis occurs when tissue starts to grow However, endometriosis is not the only
outside of the uterus on the ovaries, fallopian tubes reproductive health condition that can cause
or other areas near the uterus, such as the bowel or severe pain. Certain menstrual disorders, such
bladder. These growths lead to painful periods, pelvic as premenstrual dysphoric disorder (PMDD) or
pain between periods and/or pain with intercourse. fibroids, can also affect a woman’s quality of life.
On an average, it can take up to 10 years for women to Sometimes these conditions go unnoticed because of
receive a diagnosis of endometriosis. While in the past the subjective nature of pain. But the most painful
it was diagnosed through major abdominal surgery, fact is that research shows that women’s pain is taken
today laparoscopy is the most common method to less seriously, often dismissed as being the result
diagnose endometriosis and remove the tissue. of emotions. Perhaps, the fight for better care for
women’s health is one that is worth it.
Research has shown that endometriosis often
goes undetected because women’s reports of pain Dr Manbeena Chawla
and other symptoms aren’t taken seriously. In some Executive Editor
cases, women also diminish their own pain and
[email protected]