BioSpectrum India September 2021

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��I_,.,_ .. .J ......... .
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4 BIO CONTENT BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

COVER STORY 20

GUNG-HO
PHARMA R&D
INVESTMENTS
SURPASS $3B
While the pharmaceutical industry helped combat
22 COVID-19, from R&D actions on potential treatment COVER DESIGN BY:
Aurobindo strategies to balancing the medicines supply chain DOMINIX STRATEGIC
Pharma Limited in the time of crisis, it struggled to maintain the
natural market flow. As a result, many pharma DESIGN PVT. LTD.
K. Nithyananda Reddy companies had to abort some of their ongoing R&D
investment plans. However for FY20-21, the average
Vice Chairman, R&D expenses constituted 7.2 per cent of the total
Aurobindo Pharma Limited revenues of the pharma companies, with Lupin,
Alembic Pharma and Dr. Reddy’s spending more
than others. The cumulative R&D expenditure of the
leading 10 pharma companies has been around Rs
10,627 crore ($1.43 billion) in the previous fiscal. This
figure eventually reaches an approximate amount
of Rs 22,500 crore ($3.03 billion) after considering
the cumulative expenditure by other small and
medium players of the India pharma industry.

22 23 24
Torrent Alkem Lupin Limited
Pharmaceuticals Ltd. Laboratories Limited
VINITA GUPTA
SAMIR MEHTA SANDEEP SINGH
Chief Executive Officer,
Executive Chairman, Managing Director, Lupin Limited
Torrent Pharmaceuticals Ltd. Alkem Laboratories Limited

25 26 26
Dr. Reddy’s Alembic Sun Pharmaceutical
Laboratories Limited Pharmaceuticals Ltd. Industries Limited

K SATISH REDDY CHIRAYU AMIN DILIP S. SHANGHVI

Chairman, Dr. Reddy’s Chairman & Chief Managing Director,
Laboratories Limited Executive Officer, Alembic Sun Pharmaceutical
Pharmaceuticals Ltd. Industries Limited

27 28 29
Ajanta Cadila Healthcare Cipla Limited
Pharma Limited Limited (Zydus Cadila)
UMANG VOHRA
YOGESH M. AGRAWAL PANKAJ R. PATEL
Managing Director &
Managing Director, Chairman, Group Chief Executive Officer,
Ajanta Pharma Limited Cadila Healthcare Limited Cipla Limited

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com Top Video BIO CONTENT 5

Cardiac Care Dr Angeli Misra,
Co-founder, Lifeline
30 Laboratory, New
Delhi is of the view
How tech innovations impact cardiac care that India needs
more tissue banks
3D Printing for strengthening
the area of organ
donation.

33 Scan the QR Code »

3D printing moulds healthcare innovations Dr Debojyoti Dhar,
Director, Leucine
SARS-CoV-2 Rich Bio, Bengaluru
envisions
36 microbiome-based
testing to soon be
SARS-CoV-2: A the “go to test” for
Biochemical Treatise on many ailments.
its Past, Present & Future
Dr Ashok Kumar, Scan the QR Code »

President, Centre for Research and Dr Shubhang
Development, Ipca Laboratories Ltd, Mumbai Aggarwal, Senior
Joint Replacement
Speaking With Surgeon, NHS
Hospital, Jalandhar
38 talks about
bone death & its
“R&D outsourcing has association with
become a ‘must have’ COVID-19.
than ‘good-to have’ strategy”
Manni Kantipudi, Scan the QR Code »

Chief Executive Officer, Regulars
Aragen Life Sciences, Hyderabad
BioEdit .........................................06 World News................................18
40 BioMail ........................................08 People News...............................43
Policy and Regulatory News....10 R&D News...................................44
“Truenat diagnostic tests Finance News.............................13 Supplier News............................48
will be available for 30 more Company News.........................14 Let’s Talk Health & Science......50
diseases in next 2 years” Start-up News............................16
Sriram Natarajan,

Director & Chief Executive Officer,
Molbio Diagnostics, Goa

42

“Virology, epidemiology and
biochemistry research need
governmental push to
catalyse vax development”
Amit Sharma,

Head of Sales, Bioprocess Solutions-
Asia, Sartorius, Singapore

6 BIO CONTENT BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

Commercialising

Indian medicinal flora

The Union Government is attempting to The age-old system of traditional treatments based
promote AYUSH products using the two on herbal and medicinal plants had naturally initiated
important pillars in the pharma sector – global trade in such plants. Thus, global exports in
research and export. On one hand, the government traditional medicine, medicinal plants and associated
has concluded a long-pending issue in the sector by products have grown from $128 billion in 2002 to
setting up AYUSH Export Promotion Council, on the $251 billion in 2016. With natural remedies and
lines of Pharmaceutical Export Promotion Council traditional treatments gaining popularity, industry
(PHARMEXCIL), to boost the exports of AYUSH experts expect that by 2050, the overall international
products. On the other hand, it is making efforts to set trade in medicinal plants and their products will be
up the world’s first biobank for Ayurveda, which is a five trillion dollars.
large collection of biological or medical data and tissue
samples, amassed for research purposes. However, India’s share in the global exports is very
less. Despite its domination in the traditional system
During his recent visit to the All India Institute of of healthcare due to its rich heritage in the area, rich
Ayurveda (AIIA), Sarbananda Sonowal, Union AYUSH biological resources, traditional medicinal products
Minister assured to provide all help to establish the and large number of species of medicinal plants, its
biobank and also suggested intensifying scientific export (in 2016-17) was a mere $4.4 million. The
research and investigation. The issue of setting up an AYUSH Export Promotion Council is thus of crucial
export promotion council has been in the offing for importance.
quite a long time. That is now settled with a separate
export promotion council for AYUSH beginning its But, several challenges in exports must be
operations with the help of the Commerce Ministry addressed, starting with the assured supply of quality
and PHARMEXCIL. raw material. More than 75 per cent of medicinal
plants are sourced from forests and 70 per cent of
Promoting medicinal plants, herbals, Ayurveda is these are harvested in destructive ways. To overcome
the right move as the tradition of Ayurveda in India the problem, the National Medicinal Plants Board
goes back to 5,000 years with rich knowledge & deep (NMPB) has undertaken promotion of cultivation.
insight into the human body, diseases & cures. Though Still, it accounts for only 22 per cent of the medicinal
knowledge is crucial, it is notable that India is home to plants procured for the industry. Moreover, the
more than 8,000 species of medicinal plants. That is cultivation acreage of medicinal plants has dropped in
a rich heritage of raw material for traditional healing the last five years.
systems. In 1678 itself, the oldest printed book on
medicinal flora in India was the Hortus Malabaricus, The scientific basis of using direct plant derivatives
a 12-volume treatise on the medicinal plants of the in medicine is questioned by many people as the
Malabar region along India’s west coast. This attests products are difficult to test. Apprehensions regarding
the country’s rich heritage of medicinal plants. standardisation and safety of products, toxicity and
side effects is another important issue. People’s
Medicinal plants also play an important role in unfounded notions on this issue must be changed.
drug discovery. At least 25 per cent of medicines are Maybe, research using the proposed biobank will help
derived, directly or indirectly, from medicinal plants. resolve these issues. As it stands, to effectively promote
The World Health Organisation (WHO) estimates exports, simultaneous stress on research is imperative.
that a range of 70 to 95 per cent people in several It is encouraging to note that recent developments in
developing countries rely largely on traditional both the areas have the potential to change the future
medicines for primary healthcare. These people are of AYUSH products.
depending upon more than 70,000 plant species that
were being used in medicines worldwide as per an Dr Milind Kokje
estimation done in 2006. Chief Editor

[email protected]



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

Vol 19; Issue 8; August 2021 I would like to thank Bio Spectrum for engaging
Acknowledgements with Glenmark and covering detailed insights
In response to Dr Vinod Scaria, Scientist, on our innovative brands Ryaltris and Ryaltris-
Institute of Genomics and Integrative Biology AZ as part of the interview, in their August
(IGIB) tweet, “One important point to consider 2021 edition. We look forward to continue our
regarding K417N (B.1.617.2 with the new K417N engagement with the BioSpectrum team in the
mutation) is evidence suggesting resistance future.
to mAbs casirivimab and imdevimab”, in your
article titled- ‘Is antibody cocktail offering the - Alok Malik, Mumbai
right mix?’, Roche would like to clarify that the The feature on Dassault Systemes in the cover
casirivimab and imdevimab cocktail retained story has turned out very well. Thank you
its neutralising activity against all COVID-19
variants tested. - Dikshita Rajoria, New Delhi
Thank you for the coverage and filing stories on
- Rajan S, Bengaluru the Indian Institute of Technology (IIT). Much
appreciated. We look forward to collaborating
The article on 5G is very informative. You have with you in the future as well.
raised very pertinent controversies that the lay
public should be aware of. Congratulations for - Akhil Vaidya, New Delhi
your effort.
Thank you.

- Dr Madhuchanda Kar, Kolkata

Vol 19; Issue 9; September 2021 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

DBT develops Health Ministry unveils
guidelines to genome sequencing lab for AMR
promote research
& innovation Union Minister of Health (Print, Audio & Video) on
and Family Welfare, seven priority zoonotic
The Department of Biotechnology Mansukh Mandaviya virtually diseases namely Rabies,
(DBT), Government of India, inaugurated the Whole Scrub Typhus, Brucellosis,
has developed guidelines for Genome Sequencing National Anthrax, CCHF, Nipah,
the promotion of research and Reference Laboratory for Kyasanur Forest Disease
innovation through data exchange, Antimicrobial Resistance in India. Mandaviya also
referred to as Biotech-PRIDE. These (AMR) and biosafety level unveiled the IEC materials.
guidelines will be implemented (BSL) 3 Laboratory at the The Union Health Minister
through the Indian Biological Data National Centre for Disease has also launched the National
Centre (IBDC) at Regional Centre Control (NCDC) along with Dr Health Adaptation Plan on
for Biotechnology (RCB), supported Bharati Pawar, MoS (HFW), in Air Pollution and National
by DBT. Other existing datasets/ New Delhi. The L3 laboratory Health Adaptation Plan on
data centres will be bridged to this complex has five floors and Heat along with infographics
IBDC which will be called Bio-Grid. houses 22 BSL 2 laboratories. and the first newsletter under
The Biotech-PRIDE guidelines will The Division of Zoonotic the ‘National Programme on
enable the exchange of information Disease Programme at NCDC Climate Change and Human
to promote research and innovation under the ‘National One health Health’ developed by the
in different research groups across Programme for prevention Centre for Environmental and
the country. The guidelines aim at and Control of Zoonoses’ Occupational Health, Climate
providing a well-defined framework has created IEC materials Change and Health at NCDC.
and guiding principle to facilitate
and enable sharing and exchange of Govt opens India’s first
biological knowledge, information biobank for heart failure research
and data and is specifically
applicable to high-throughput, The National Heart Failure Biobank (NHFB), which would
high-volume data generated by collect blood, biopsies, and clinical data as a guide to future
research groups across the country. therapies, was recently inaugurated at the Sree Chitra Tirunal
These guidelines do not deal with Institute for Medical Sciences and Technology (SCTIMST)
a generation of biological data per in Thiruvananthapuram. Prof. Balram Bhargava, Secretary,
se but are an enabling mechanism Department of Health Research (DHR) and DG, Indian Council
to share and exchange information of Medical Research (ICMR) virtually inaugurated the NHFB.
and knowledge generated as per the The biobank will provide insights into heart diseases and heart
existing laws, rules, regulations and
guidelines of the country. failure among Indian children and adults,
which are different from that seen in
the West. The storage facilities include
-20, -80-degree mechanical freezers and
a liquid nitrogen storage system that
can store bio-samples at – 140 degrees
perpetually for years. Currently, there
are facilities to store nearly 25000
biosamples. The biosamples include the
blood, serum, tissue samples obtained
during open-heart surgery and peripheral
blood mononuclear cells (PBMCs) and genomic DNA collected
from heart failure patients. The biobank activity is supervised by a
Technical Advisory Committee (TAC) with a member from ICMR.
The Biobank has already signed an MoU with InStem Bengaluru
for collaborative research in hypertrophic cardiomyopathy,
which runs in families with thickening heart muscles.

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

Centre advises States to conduct sero-prevalence surveys with ICMR

The Union Government has studies in their own States/UTs in such studies can then be utilised
advised all States/UTs to conduct consultation with ICMR, so that quickly by the respective State/
sero-prevalence surveys in such studies follow a standardised UT to guide objective, transparent
consultation with the Indian protocol, and the findings of and evidence-based public health
Council of Medical Research response to COVID-19. It has
(ICMR) to generate district-level been pointed out that the Indian
data on sero-prevalence which is Council of Medical Research
essential in formulating localised (ICMR) has conducted the
public health response measures. recent National Sero-survey in
The Union Health Ministry has 70 districts of India. According
referred to the findings of the to the survey, the highest sero-
4th round of National Sero- prevalence of 79 per cent was
Prevalence Survey done by ICMR observed in Madhya Pradesh,
and has advised the States to while the lowest at 44.4 per cent
conduct the sero-prevalence was found in Kerala.

Cabinet NHA releases
consultation paper on
approves MoU Unified Health Interface

with Denmark The National Health Authority (NHA) has released a consultation
paper on the Unified Health Interface (UHI). UHI is intended to
for health and be an open, interoperable platform to connect all digital health
solutions. The consultation paper provides an overview of the
medicine proposed design, scope and role of UHI. In light of the upcoming
national rollout of National Digital Health Mission (NDHM)
The Union Cabinet chaired by comments from the public are invited to ensure that UHI is
Prime Minister Narendra Modi designed and developed
has approved the Memorandum in a collaborative and
of Understanding (MoU) between consultative manner.
the Ministry of Health & Family Through the UHI, NDHM
Welfare of the Government of aims to transform the way
the Republic of India and the digital health services are
Ministry of Health of the Kingdom rendered in India. Currently,
of Denmark on Cooperation in patients and healthcare
the field of Health and Medicine. providers need to be on the
The bilateral MoU will encourage same application to avail
cooperation between the two and provide digital health
countries through joint initiatives services, respectively. It is
and technology development in envisioned that the open
the health sector. It will strengthen network created by UHI
bilateral ties between India and will serve as the digital
Denmark. This will facilitate in infrastructure for patients and healthcare providers to engage in the
improving the public health status discovery, booking, payment and fulfilment of a variety of digital
of the people of both the countries. health services across applications. The services include but are not
limited to, teleconsultation and the discovery of pharmacies and
hospitals. Over time, the services enabled by the platform will evolve
with the market ecosystem. UHI is designed to be similar to the
UPI (Unified Payments Interface) ecosystem which has emerged for
digital payments.

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com FINANCE NEWS 13

BPEA buys Hinduja Group’s PAG invests
healthcare biz for $1.2B $145M
in CDMO
Mumbai-based Hinduja Group’s the enterprise is valued at $1.2 firm Acme
business process management billion. HGS’ Healthcare Services Formulation
entity, Hinduja Global Solutions business supports payers,
Limited (HGS) has entered providers, laboratories, durable PAG, a Mumbai-based
into definitive agreements to medical equipment firms and private equity firm, has
divest its Healthcare Services pharmaceutical companies with reached an agreement to
business to funds affiliated solutions that augment clients’ acquire a controlling stake
with Baring Private Equity Asia healthcare teams to deliver in Himachal Pradesh-
(BPEA), one of the largest private better patient, member, business based Acme Formulation, a
alternative investment firms in and financial outcomes. The contract development and
Asia. The transaction-based on Healthcare Services vertical has manufacturing outsourcing
over 20,000 employees across (CDMO) company with a focus
four geographies – India, the on complex pharmaceutical
Philippines, the US and Jamaica products. Acme focuses
– and recorded revenues of on products such as sterile
approximately $400 million in injectables, hormones, and
FY2021. Post completion of the other complex oral solid
transaction, HGS will transfer all formulations. It exports to
client contracts, employees, and more than 40 countries. PAG
assets, including infrastructure will invest $145 million to
related to the Healthcare Services acquire a controlling stake
business. in the company. The private
equity firm is currently
Healthium acquires investing out of its $6 billion
AbGel to strengthen PAG Asia III buyout fund,
portfolio in surgical care with a strong commitment to
investing in the Indian market
Healthium has acquired AbGel gelatin sponge business from Mumbai- since 2019. Following the
based Shri SGK Labs, adding to its product portfolio focused on surgical Acme acquisition, PAG will
and post-surgical care. Earlier this financial year, the company had have completed investments
acquired VitalCare Group in the UK to grow its urology portfolio and of more than half a billion
expand its market in Europe and the US. Bengaluru-based Healthium dollars in India. PAG’s latest
aims to further expand the deals include investments in
market access of this portfolio Edelweiss Wealth Management,
using its wide network of one of India’s largest wealth
hospitals across India. AbGel advisory firms, and Anjan
is an absorbable gelatin Drug, a leading manufacturer
sponge, manufactured from of active pharmaceutical
highly purified neutral gelatin ingredients (APIs).
with haemostatic capabilities
and is designed to control
blood oozing in instances of
haemorrhage from multiple
small vessels, and is completely absorbed in four to five weeks with no
residue or encapsulation. It is non-toxic, non-allergic, non-immunogenic
and non-pyrogenic. AbGel is beneficial in effectively managing this across
a wide variety of specialities including abdominal surgery, neurosurgery,
gynaecological surgery, ENT surgery, dental surgery and oncosurgery.

14 COMPANY NEWS BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

Premas Biotech to Wipro GE Healthcare
commercialise VLP
vaccine tech against introduces remote
Delta variant
monitoring solution
Gurugram-based Premas Biotech has signed a licensing
deal with Oravax Medical for the development and for COVID-19 patients
commercialisation of its virus-like-particle COVID-19
vaccine technology. Oravax Medical is a joint venture Wipro GE Healthcare has introduced Remote
between Israel-based Oramed Pharmaceuticals and Monitoring Solution, Tele-ICU, along with
Premas Biotech. Oravax brings together a virus-like the Centricity High Acuity Critical Care
particle (VLP) vaccine technology, developed by Premas Solution (CHA-CC), which is tailor-made
Biotech with Oramed’s proprietary protein oral delivery to connect Intensive Care Units (ICUs)
(POD) technology in the development of oral vaccines that in different locations or within the same
are now only available via injection. As Oravax maintains building to central sites. The technology has
its focus on oral vaccines, it has licensed to Premas the so far connected 800 beds across several
right to develop an injectable version of its VLP technology hospitals in India to the hub hospital where
to address the urgent need for a vaccine that is effective highly skilled healthcare professionals can
against the delta variant. Premas plans to manufacture, remotely provide advanced consultation
test, and potentially commercialise the injectable version and care to their critically ill patients. The
of the VLP vaccine in India. Oravax is gearing up to hospitals which have deployed this solution
commence clinical trials for its oral COVID-19 vaccine, first include Apollo Hospitals-Hyderabad, Kainos
in Israel, then in additional clinical sites internationally. Hospital-Rohtak and Apex Hospital-Jaipur.
Currently, the ICU beds are connected from
the states of Jharkhand, Assam, Maharashtra,
Haryana, Andhra Pradesh, Odisha, Rajasthan
and Madhya Pradesh. Designed and developed
in GE’s John F Welch Technology Center,
Bangalore, Tele-ICU works on a hub and spoke
model where it enables clinicians to provide a
similar level of advanced consultation, care
and monitoring to their critically ill patients
without having to physically transfer them to
a super-speciality hospital.

Merck launches Pergoveris Pen for fertility treatment in India

Merck Specialties, the healthcare improved treatment experience administration by patients
business of Merck in India, has for patients with severe FSH and during infertility treatment.
launched Pergoveris Pen for LH deficiency upon prescription In addition, by eliminating the
advanced infertility treatment by an IVF specialist. The need for mixing, Pergoveris Pen
in India. The launch emphasises novel first-hand version of the is the world’s first combined
the company’s motive of Pergoveris Pen is a breakthrough therapy option for recombinant
fulfilling unmet medical needs combination of a freeze-dried gonadotropins, demonstrating the
by providing an improved, powder and solvent, reducing efficacy, safety, and combinability
convenient, and ready-to-use the probability of reconstitution of recombinant follitropin alfa
combination treatment option errors. As a result, Pergoveris with recombinant lutropin
for women with a severe follicle- delivers with more precision and, alfa, in a single ready to inject
stimulating hormone (FSH) hence, is more accessible to self-
and luteinizing device, using Filled-By-Mass
hormone (LH) Technology,
deficiency. The for infertile
new Pergoveris women in a
Pen allows an physiological
ratio of 2:1.

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

Roche brings oral therapy to treat Biocon
Spinal Muscular Atrophy in India Biologics adds
novel antibody
Swiss firm Roche has announced the launch of Evrysdi (risdiplam), to its COVID-19
the first and only approved treatment in India for a rare disease called portfolio
Spinal Muscular Atrophy (SMA). Evrysdi was first approved by the US
Bengaluru-based Biocon
FDA in August 2020 and is available Biologics has announced
in India within 11 months of US that the US-based Adagio
approval. Since its launch, over 4,000 Therapeutics has granted an
SMA patients across 50+ countries exclusive license to Biocon
have benefitted from Evrysdi. Evrysdi Biologics to manufacture
is administered daily at home orally and commercialise an
(it is supplied as a powder which is antibody treatment based on
constituted into a liquid solution and ADG20 for India and select
taken once daily by mouth or feeding emerging markets. ADG20,
tube if required) and is designed to a novel monoclonal antibody
treat SMA by increasing production targeting the spike protein
of the Survival Motor Neuron (SMN) of SARS-CoV-2 and related
protein. It is approved for the treatment of spinal muscular atrophy coronaviruses, is in global
(SMA) in adults and children 2 months of age and older. Evrysdi was clinical development by Adagio
approved by Indian health authorities after reviewing its efficacy and as a single agent for both the
safety data from three global clinical studies designed to represent a treatment and prevention
broad spectrum of people living with SMA. of COVID-19, the disease
caused by the SARS-CoV-2
Glenmark ties up with virus, its variants, as well
SaNOtize to commercialise as future variants that may
COVID-19 nasal spray emerge. Initial data indicate
that ADG20, Adagio’s lead
Mumbai-based Glenmark Pharmaceuticals and Canadian biotech firm clinical development candidate,
SaNOtize Research & Development Corp have announced an exclusive could provide both rapid and
long term strategic partnership to manufacture, market and distribute its durable protection against
breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment COVID-19 for up to one year.
in India and other Asian markets including Singapore, Malaysia, Hong This could make it an ideal
Kong, Taiwan, Nepal, Brunei, Cambodia, agent to prevent infections and
Laos, Myanmar, Sri Lanka, Timor-Leste significantly reduce COVID-19
and Vietnam. Available in the form of a related hospitalisations and
simple nasal spray, NONS is designed death.
to kill the virus in the upper airways,
preventing it from incubating and
spreading to the lungs. It is based on nitric
oxide (NO), a natural nano-molecule with
proven anti-microbial properties, and
which has a direct effect on SARS-CoV-2,
the virus causing COVID-19. In early July
2021, Glenmark presented a proposal to
the government for emergency approval for the import and marketing of
nasal spray. The committee has recommended a Phase III clinical trial
to be conducted in Indian patients in the weeks to follow. The Phase
III clinical trial for NONS is expected to be completed, followed by a
commercial launch under the brand name FabiSpray in India, by the
fourth quarter of the calendar year 2021.

16 START UP NEWS BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

Bihar-based startup develops decentralised biomedical waste incinerator

Buxar-based startup Ganesh installed in Buxar is a portable, waste made of cotton, plastic, or
Engineering Works has developed forced draft incinerator capable similar materials per hour (5kg
a decentralised biomedical waste to handle 50 kg of biomedical per batch), with the provision
incinerator. This technology was of waste heat recovery. The unit
selected through the Biomedical requires a two square meter
Waste Treatment Innovation area and requires only 0.6 kWh
Challenge launched in June 2020 electricity for initial ignition of
by the Waste to Wealth Mission. the waste with an option of auto
Principal Scientific Adviser to the electricity turn off. The startup
Government of India Prof. K Vijay plans to use insights from the
Raghavan virtually inaugurated operational phase and further
the decentralised biomedical refine the technology and explore
waste incinerator at Buxar manufacturing partnerships for
Municipality, Bihar. The pilot scale-up.

Mylab, Hemex Health US-based Startup
ink tech partnership
for PoC diagnostics Genome partners

Pune-based startup Mylab Discovery Solutions has joined with Karnataka Govt
forces with the US-based Hemex Health, a medical diagnostic
device company focused on creating life-changing global US-based Startup Genome and the
health products, to develop next-generation diagnostic Government of Karnataka have announced
solutions for the Point-of-Care (POC) testing of coronavirus a collaboration to further accelerate growth
and other diseases. Under the technology partnership, in Karnataka’s startup ecosystems. The two
Mylab will develop test assays and Hemex will provide its entities will work closely to support and
Gazelle POC testing platform and expertise. The portable promote startup ecosystems not only in fast-
diagnostic device and tests assays will help in testing at any growing cities such as Bangalore, Mangalore
location, in a wide range of environmental conditions, and and Mysore but also cities in North Karnataka.
without the need to transport the sample, enabling quick With more than 100 clients across six
results for the patients. Together, the companies will develop continents in 40+ countries to date, Startup
Fluorescence Immunoassay (FIA) and Electrophoresis- Genome is the leading research and policy
based diagnostic solutions. These tests are more sensitive advisory organisation for governments and
than the normal rapid antigen tests and have fewer false private institutions committed to advancing
negatives. The diagnostic solution will be jointly introduced startup ecosystems. Startup Genome’s Global
in the international markets including the US, Europe and Startup Ecosystem Report (GSER), the
Asia. The companies expect the first product from this world’s most comprehensive and widely-read
technology partnership to be launched by November 2021. research on startups, will include notable
startups in Karnataka in the next edition of
the report. Additionally, Startup Genome
will also interface with Karnataka Innovation
& Technology Society (KITS) in order to
better collaborate with industry, academia,
incubators, accelerators, and corporates to
promote the startup ecosystem in Karnataka.

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com START UP NEWS 17

Mynvax offers ‘warm 4baseCare
vaccine’ for COVID-19
teams up
Biotech startup Mynvax, minutes. Most vaccines require
incubated at the Indian Institute refrigeration to remain effective, with Wipro for
of Science (IISc) in Bengaluru, like Oxford-AstraZeneca which
has developed heat-tolerant must be kept between 2 and personalised
COVID-19 vaccine formulations. 8 degrees and Pfizer which
Published in the peer-reviewed requires specialised cold oncology
ACS Infectious Diseases storage at -70 degrees. The data
journal, researchers showed the shows that all formulations solutions
vaccine formulations triggered of Mynvax tested result in
a strong immune response in antibodies capable of consistent Bengaluru-based startup
mice, protected hamsters from and effective neutralisation of 4baseCare has partnered with
the virus, and remained stable the Alpha, Beta, Gamma and Wipro to develop precision
at 37 degrees up to a month Delta SARS-CoV-2 variants of oncology solutions that will
and at 100 degrees for up to 90 concern. improve the affordability and
timely availability of gene testing
Focelite brings curative reports for cancer patients.
therapy for COVID-19 patients 4baseCare and Wipro will jointly
pave the way for cancer patients
Focelite, a startup at Bangalore Bioinnovation Centre (BBC), plans to gain access to advanced
to launch ‘Welblu’, an innovative solution to treat COVID-19, in genomic testing at an affordable
collaboration with the US partner. It is a curative therapy for COVID-19 cost and reduce the turnaround
time (TAT) on test results to
positive patients. A clinical almost half from the current
study with this innovative market average of 30 days. The
solution has been performed partners will build a framework
in the US. This study has of efficient, streamlined, and
shown that COVID-19 well-regulated workflows for the
positive patients who have development of advanced gene
undergone treatment using panels. Through this partnership,
Welblu effectively recovered oncologists, cancer hospitals and
from cytokine storm and cancer clinics can tap diagnostics
respiratory distress in the and prognostics cancer gene
lesser meantime than the panels at an economical price
control group. Welblu has point. It can help them identify
unique therapeutic action and understand the genetic
that simultaneously impacts several mechanisms related to COVID -19 mutation of cancer, and design
complications such as severe hypoxia, hyperinflammatory reactions treatments to specifically target
and the increased death signalling leading to an immunosuppressive these mutations. The 4baseCare-
state. Likewise, it is seen to be re-adjusting cellular metabolism to a Wipro partnership will help
mitochondrion–centred condition that is depriving the COVID-19 with patient recovery and create
virus of energetic and structural supplies. economic dividends for the nation
at large.

18 WORLD NEWS BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

ADB lends Pakistan $500M loan for COVID-19 vax programme

The Asian Development Bank to ADB developing member prioritising frontline health care
(ADB) has approved a $500 million countries. The government is workers, the elderly, marginalised
loan to help the Government aiming to vaccinate the entire groups including refugees and
of Pakistan procure and deploy eligible population, around internally displaced persons,
safe and effective coronavirus 119 million people comprising and people with comorbidities.
disease (COVID-19) vaccines and all those aged 18 and over, ADB’s COVID-19 Vaccine Support
strengthen the country’s capacity Project will provide financing to
to implement its vaccination vaccinate over 18 million people
programme. The project will from priority groups or about 15
support Pakistan’s National per cent of the eligible population.
Deployment and Vaccination Plan ADB’s assistance will also help
by purchasing and delivering an to strengthen the capacity
estimated 39.8 million doses of of the Ministry of National
COVID-19 vaccine, safety boxes, Health Services, Regulations
and syringes. It is financed through and Coordination, and the
ADB’s $9 billion Asia Pacific Federal Expanded Programme
Vaccine Access Facility launched in on Immunisation to effectively
December 2020 to offer rapid and implement the COVID-19
equitable vaccine-related support vaccination programme.

Nepal to improve US donates
medical waste management
500,000 rapid
The Government of the People’s Republic of China and
the United Nations Development Programme (UNDP) diagnostic COVID-19
have jointly launched a new initiative in Nepal to
support the country in COVID-19 response by improving tests to Sri Lanka
the healthcare waste management system, under
the framework of China’s South-South Cooperation The United States (US) has donated
Assistance Fund (SSCAF). UNDP will work closely with 500,000 Rapid Diagnostic Tests (RDTs)
the Department of Health Services under the Ministry of as part of its commitment to support Sri
Health and Population of Government of Nepal and with Lanka’s fight against COVID-19. These tests,
seven COVID designated worth 300 million Sri Lankan rupees ($1.5
hospitals across the million), were delivered to the Sri Lanka
country, including Koshi Ministry of Health through the United
Hospital, Biratnagar; States Government’s development arm, the
Narayani Hospital, US Agency for International Development
Birgunj; Janakpur (USAID). These RDTs come in addition
Hospital, Janakpurdham; to over 1.5 million Moderna vaccines
Shree Birendra Hospital, donated to Sri Lanka in July. These antigen-
Chhauni; Rapti detecting rapid diagnostic tests directly
Provincial Hospital, detect the presence of the COVID-19 virus.
Tulsipur; and Bheri The tests are simple to use and enable fast,
Hospital, Nepalgunj. The joint effort will support the decentralised access to direct testing. They
upgrading of hospital waste management systems by do not require additional equipment or
providing support in the form of autoclaves, setting specialised laboratory access, which helps
up waste treatment areas, and training the healthcare achieve high testing coverage. The United
workers on their use as well as proper means to manage States has worked closely with Sri Lanka
medical waste. It is anticipated that 350 healthcare since the outset of the pandemic to protect
professionals will be provided with the required technical public health, providing over $8 million in
skill-set on the proper management of healthcare waste. emergency supplies and critical services,
plus an in-kind donation of 200 ventilators
and over 1.5 million Moderna vaccines.

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com WORLD NEWS 19

CEPI prioritises NIH studies
Rift Valley fever vax
third COVID-19
Norway-based Coalition for Epidemic Preparedness Innovations
(CEPI) has signed an implementing partner agreement with Integrum vaccine dose in
Scientific (US) as part of its ongoing efforts to combat Rift Valley fever
(RVF)—one of its priority diseases with epidemic potential. Under kidney transplant
the new partnership, serum material
donated from patients recovered from recipients
RVF will support the development of
an International Antibody Standard, A pilot study has begun to
a reference tool used when assessing assess the antibody response
the immune response induced by RVF to a third dose of an authorised
vaccines undergoing clinical trials. COVID-19 mRNA vaccine in
The programme of work will also kidney transplant recipients who
enable the calibration and validation did not respond to two doses of
of vaccine tests or assays so that the Moderna or Pfizer-BioNTech
accurate and standardised results on COVID-19 vaccine. The Phase 2
the immunogenicity of different RVF trial is sponsored and funded by
vaccines can be produced. Integrum the National Institute of Allergy
Scientific is now collecting serum from RVF survivors’ across sites and Infectious Diseases (NIAID),
in Uganda through a partnership with the Uganda Virus Research part of the National Institutes
Institute (UVRI) and will continue through to September 2021. of Health (NIH). The lifelong
immunosuppressive therapy that
Global health partnership organ transplant recipients must
to tackle hepatitis C in LMIC take to prevent organ rejection
blunts their immune response
The Drugs for Neglected PACT, will foster an enabling to both pathogens and vaccines.
Diseases initiative (DNDi), environment for testing and Research has shown that many
Médecins Sans Frontières treatment for HCV in LMICs by organ transplant recipients do
(MSF), FIND, the global rolling out all-oral cures, scaling not develop antibodies against
alliance for diagnostics, and the up community-based testing SARS-CoV-2, the virus that
Treatment Action Group are to find the missing millions causes COVID-19, after receiving
joining forces to tackle a ‘silent’ of undiagnosed people, and an authorised COVID-19 vaccine
public health injustice: the addressing domestic financial regimen. The purpose of the new
continuing disparities in access challenges that prevent the study is to determine whether a
to diagnostics and treatment launch of national programmes. third dose of one of the mRNA
for the hepatitis C virus (HCV) It will also tackle patent and COVID-19 vaccines could
in low-and middle-income access barriers that stand in the overcome this problem for at least
countries (LMICs), home to way of reaching World Health some kidney transplant recipients.
75 per cent of those living with Organisation (WHO) goals This is particularly important
this viral illness. The Hepatitis of controlling hepatitis C by because this population has a high
C Partnership for Control and 2030. Through its cumulative prevalence of conditions that are
Treatment, or Hepatitis C expertise and independence, risk factors for severe COVID-19,
the new partnership will build such as cardiovascular disease and
collaborations with countries diabetes.
and community and civil society
groups and develop evidence
to support ambitious test-
and-treat programmes while
addressing HCV financing
obstacles.

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

GUNG-HO
PHARMA R&D
INVESTMENTS
SURPASS $3B

While the pharmaceutical industry helped combat COVID-19, from R&D actions on potential treatment strategies
to balancing the medicines supply chain in the time of crisis, it struggled to maintain the natural market flow. As a
result, many pharma companies had to abort some of their ongoing R&D investment plans. However for FY20-21, the
average R&D expenses constituted 7.2 per cent of the total revenues of the pharma companies, with Lupin, Alembic
Pharma and Dr. Reddy’s spending more than others. The cumulative R&D expenditure of the leading 10 pharma
companies has been around Rs 10,627 crore ($1.43 billion) in the previous fiscal. This figure eventually reaches an
approximate amount of Rs 22,500 crore ($3.03 billion) after considering the cumulative expenditure by other small
and medium players of the India pharma industry.

Globally, India ranks third in pharmaceutical development and this momentum is likely to continue.
production by volume and 14th by The FY20-21 saw pharma companies like Sun
value. The country has an established
pharmaceutical industry, with a strong Pharma, Dr. Reddy’s Labs, Cipla and Cadila Healthcare
network of 3,000 drug companies and at the forefront in providing therapeutic drugs for
approximately 10,500 manufacturing units. According to treating patients afflicted with COVID-19 in India. In
the Indian Economic Survey, 2021, the domestic market addition, the R&D team at Cipla and Cadila Healthcare
is expected to grow threefold in the next decade. India’s
pharmaceutical market is estimated at $42 billion in worked towards developing indigenous
2021 and likely to reach $65 billion by 2024 and diagnostic solutions to combat the
further expand to reach around $120-130 raging disease.
billion by 2030. Simultaneously, FY20-21 saw many
leading pharma companies such
Over the last year, the Indian as Aurobindo Pharma, Cadila
pharmaceutical industry played a Healthcare, Dr. Reddy’s invest
crucial role in developing diagnostic heavily in R&D and manufacturing
tests and manufacturing of different COVID-19 vaccine
therapeutic drugs for COVID-19 technologies, either in
treatment. The pandemic has partnership with the
pushed India to expedite government, with global
focus on pharma research counterparts or on their
and development (R&D) to own.
become more independent. While the pharmaceutical
The aim of developing industry helped combat
indigenous COVID-19 vaccines COVID-19, from R&D actions on
has boosted the country’s potential treatment strategies
confidence towards to balancing the medicines
indigenous research and supply chain in the time

of crisis, it struggled to maintain

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

Total R&D expenditure of top 10 pharma companies in FY20-21

Company R&D R&D Focus Areas of Research
Expenditure Expenditure

(Rs in Cr) in % of
Revenue

Sun Pharmaceutical Industries Ltd, Mumbai 2149 Cardiology, Diabetology,
6.5 Gastroenterology, Ophthalmology,

Urology, Dermatology, Respiratory

Dr Reddy’s Laboratories Ltd, Hyderabad 1654 Oncology, Gastroenterology, Pain
8.7 Management, Cardiovascular,

Diabetes, Dermatology

Aurobindo Pharma Ltd, Hyderabad 1510 6 Oncology, Opthalmology and
Immunology

Lupin Ltd, Mumbai 1432 9.6 Cardiology, Anti-Diabetes, Respiratory,
Anti-Infective & Gastrointestinal

Cadila Healthcare Ltd., Ahmedabad 1132 7.5 Pain Management, Neurology, Liver
Diseases

Cipla Limited, Mumbai 924 4.82 Respiratory, Anti-Retroviral, Urology,
Cardiology, Anti-Infective

Alembic Pharmaceuticals Ltd, Vadodara 670 Cardiology, Anti-Diabetic,
12.4 Gynaecology, Dermatology,

Ophthalmology

Alkem Laboratories Limited, Mumbai 530 6 Anti-Infectives, Cardiology, Neurology,
Pain Management, Dermatology

Torrent Pharmaceuticals Ltd, Ahmedabad 487 Cardiovascular, Central Nervous
6 System, Gastro-Intestinal, Women

Healthcare

Ajanta Pharma Ltd, Mumbai 139 5 Ophthalmology, Cardiology,
Total 10627 7.252 Dermatology and Pain Management

Source: Annual Reports of the Companies

the natural market flow. As a result, many pharma scheme to promote domestic manufacturing by setting
companies had to abort some of their ongoing R&D up greenfield plants with a cumulative outlay of Rs
investment plans. 6,940 crore from FY21 to FY30.

For FY20-21, the average R&D expenses constituted Although the average R&D expenditure of the
7.2 per cent of the total revenues of the pharma pharma industry during FY 20-21 was considerably
companies, with Lupin, Alembic Pharma and Dr. lower than the previous years, owing to the pandemic,
Reddy’s spending more than others. The cumulative an innovative streak has surely settled in within the
R&D expenditure of the leading 10 pharma companies industry. Notably, India is expected to unveil a new
has been around Rs 10,627 crore ($1.43 billion) in the pharma R&D policy soon to incentivise scientists based
previous fiscal. This figure eventually reaches an on the monetisation of their innovations. According to
approximate amount of Rs 22,500 crore ($3.03 billion) the Global Innovation Index, India has moved up four
after considering the cumulative expenditure by other places to 48 in the overall ranking across sectors in 2020.
small and medium players of the India pharma industry.
Moreover, the government is willing to focus
The efforts of the pharma industry have been further on industry-academia linkage to facilitate research
supplemented by the government’s announcement in the development and the commercialisation of
of the Production-Linked Incentive (PLI) scheme technologies while promoting research towards new
recently. To achieve self-reliance and minimise import drug discovery for a self-reliant India.
dependency in the country’s essential bulk drugs, the
Department of Pharmaceuticals has initiated a PLI Let’s take a look at the R&D investment details of the
top 10 pharma companies during FY20-21.

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

AUROBINDO PHARMA LIMITED Key Highlights of FY20-21
■ Received approval from the Government of India
Hyderabad-based Aurobindo Pharma spent
6 per cent of its total revenue generated for setting up capacities for three fermentation-
during FY20-21 for R&D, amounting to Rs based products under the Production Linked
1510 crore. Driving up the R&D engine of Incentive (PLI) Scheme.
the company, this is the highest ever R&D ■ Completed the Phase II clinical trials for
investment made by Aurobindo Pharma. The company Pneumococcal Conjugate Vaccine (PCV)
has five R&D centres in Hyderabad with over 1,600 ■ Entered into license agreement with US-based
scientists and analysts; one R&D centre in Dayton, Vaxxinity for peptide-based vaccine for COVID-19.
New Jersey, US with over 25 scientists and analysts; Vaxxinity has also applied for Phase II/III clinical
one R&D centre in Raleigh, North Carolina, US with trials to be conducted in India.
over 40 scientists and analysts; and one R&D centre in ■ Collaborated with the Council of Scientific and
Pearl River, New York, US with over 40 scientists and Industrial Research (CSIR) to develop multiple other
analysts. With core focus on oncology, ophthalmology vaccine candidates for COVID-19.
and immunology, the company develops products ■ Acquired controlling stake in joint venture Eugia
for patients suffering from debilitating, painful and Pharma Specialities, making it wholly owned
chronic rheumatology and dermatology diseases. subsidiary.
Another area the company has initiated work on is ■ Signed a definitive agreement with New Mountain
immuno-oncology which ensures a strategic continuity Capital and its affiliate Jarrow Formulas to divest
of the products portfolio in a critical therapeutic the ‘Natrol’ business.
segment.

TORRENT PHARMACEUTICALS LTD.

Around 85 per cent of Torrent Pharma’s revenue is Ahmedabad-based Torrent Pharmaceuticals
derived from four core markets, namely India, United spent 6 per cent of its total revenue during
States, Germany and Brazil. India continues to be the the FY20-21, amounting to Rs 487 crore.
largest market, contributing to over 45 per cent of The company’s state-of-the art R&D Centre
revenue. The underlying growth in our core markets at Bhat near Ahmedabad has one of the
of India, Brazil and Germany has been strong and most advanced infrastructure for both basic and
continues to outperform the market. The growth in applied research to support all activities related to
the US was impacted due to lack of new approvals, generic, new drug discovery, API process development,
pending re-inspection of facilities by USFDA. Also, we formulation development and value-added generics.
are building a comprehensive pipeline for its liquids Torrent’s Research Centre houses 700+ inquisitive
and oncology facilities. minds that have identified potentially transformative
therapy areas for the New Chemical Entities (NCE) and
- SAMIR MEHTA Novel Drug Delivery Systems (NDDS) pipeline as R&D
priority areas. Besides cardiovascular, central nervous
Executive Chairman, Torrent Pharmaceuticals Limited system, gastro-intestinal and women healthcare, the
company also has significant presence in diabetology,
pain management, gynaecology, oncology and anti-
infective segments.

Key Highlights of FY20-21
■ Partnered with Eli Lilly and Company to

manufacture and commercialise ‘Baricitinib’
(an emergency use approved drug given in
combination with Remdesivir for COVID-19) in India.
■ Filed 12 Abbreviated New Drug Applications
(ANDAs) with USFDA.

■ Started shifting the production of several drugs from
the flagship Indrad facility to Dahej and Baddi units.

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

■ In biosimilars, completed the Phase I trials for the ■ Built a specialised characterisation centre with
lead molecule and initiated Phase III studies while state-of-the-art equipment at Hyderabad research
clinical trials for three more molecules were also centre.
initiated.
■ Completed the construction of an injectable
■ Received final approval for 42 Abbreviated New facility in the US, which will be a dedicated unit to
Drug Applications (ANDAs) including 17 injectables manufacture high-value and low-volume products.
and launched 53 products including 21 injectables.

We are now targeting products with higher complexity, making - K. NITHYANANDA REDDY
inroads into the specialty segment in the US and have firm plans
to expand in the second largest pharma market (China). We are Vice Chairman,
also reinforcing our prominence in the EU market and other key
growth markets (Canada and South Africa) and Brazil. We see the Aurobindo Pharma Limited
injectables business as one of our key growth levers. We are setting
up an injectables facility in Visakhapatnam for Europe and Growth
Markets, which is expected to be ready for commercial production
in the coming months. We are expanding capacities to further
increase supplies to external parties. Moreover, we are strengthening
our capabilities to develop and commercialise more complex APIs.

ALKEM LABORATORIES LIMITED The company invested Rs 532 crore
or 6 per cent of its revenues in R&D
For FY20-21, Mumbai-based Alkem Laboratories invested during FY 2020-21 as compared to Rs
6 per cent of its total revenue into R&D, amounting to Rs 472 crore or 5.7 per cent of its revenues
530 crore. Equipped with state-of-the-art infrastructure, in FY 2019-20. For the full year, our
all six R&D facilities of Alkem Labs have been accredited India business recorded a revenue
by international regulatory authorities. To further growth of 4.5 per cent YoY, which is
bioequivalence and bioavailability studies essential to prove the commendable considering
efficacy and effectiveness of dosage forms, the company has a our slow start. Overall,
clinical research facility comprising more than 100 beds. Through the slowdown was
its subsidiary Enzene Biosciences, a biotech-focused R&D company more severe in acute
based in Pune, the company has also made substantial investments therapies like anti-
in the biosimilars segment. Alkem is one of the prominent names infectives, owing to
in the acute therapy areas of anti-infective, gastro-intestinal, pain the heightened focus
management and vitamins/ minerals/ nutrients products. Moreover, on personal hygiene
the company has been expanding its footprint in the chronic and sanitisation. Usage
therapy areas of neurology, cardiac, anti-diabetes, and dermatology. of masks and sanitisers
also helped to bring down the
Key Highlights of FY20-21 infection rates. This had a significant
■ Entered into a partnership with Tata Memorial Centre to set up bearing on the company, which derives
more than 80 per cent of its domestic
a state-of-the-art cancer care facility in Muzaffarpur, Bihar and revenues from acute therapies, with
also to establish three mini cancer units in Buxar, Jehanabad anti-infective contributing close to 40
and Bhagalpur. per cent.
■ Started new formulation manufacturing facility in Indore
(awaiting US FDA approval) and biologic / biosimilar - SANDEEP SINGH
manufacturing facility in Pune.
■ Led 9 Abbreviated New Drug Applications (ANDAs) with the US Managing Director
FDA and received 25 approvals (including 6 tentative approvals). Alkem Laboratories Limited
■ Introduced its telemedicine or tele-consultation platform, called
‘Connect2Clinic’.

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

Through the quarters of FY21, we improved operational LUPIN LIMITED
performance and our margins by maximising revenues and
delivering on our cost optimisation efforts. As a company Amounting to Rs 1432 crore, Mumbai-
committed to innovation, we invested 9.6 per cent of our based Lupin invested 9.6 per cent
revenues in R&D during FY21. We have a clear research of its total revenue during FY20-21
strategy in place to maintain our core generic position, into R&D work. With R&D centers
deliver on complex generics, and build out our innovation in seven locations across the globe,
portfolio. As we progress into FY22, we see the ramp up employing over 1,400 personnel, the company
of Albuterol in the US, growth in our inline products as is continuously innovating by utilising advanced
well as new inhalation product launches like Brovana technologies, superior competencies and
driving growth. We also expect to hit multiple milestones strategic alliances. The state-of-the-art R&D
in our complex generic pipeline in all three of our lead Lupin Research Park (LRP) at Pune functions
platforms – inhalation, biosimilars and injectables. We see as the hub of its global research activity. The
our inhalation portfolio starting to go global with the UK campus houses the generic research unit
marketing authorisation for Fostair, for which we are the encompassing API and finished product
first generic to be approved. We also see our biosimilar research, and the Novel Drug Discovery and
portfolio starting to evolve with the ongoing review of Development (NDDD) unit. During FY20-21,
our first BLA ling in the US for Peg-filgrastim. Our growth the company conducted 36 in-vivo pivotal
markets strategy is focused on introducing new products bioequivalence (BE) studies, 69 in-vivo pilot BE
from our global pipeline to expand into newer segments studies and 11 in-vitro BE studies in FY21 at the
while improving market share in our legacy segments Lupin Bioresearch Centre (LBC) located in Pune.
and products. We will bring our complex inhalation and
injectables assets to most of the markets in the coming Key Highlights of FY20-21
years. The growth markets are now focused on crafting an ■ Launched 15 new products in the US.
entry strategy into China. Our India business continues to ■ Received USFDA approval for 19 Abbreviated
be a robust driver of revenue and profitability backed by a
strong pipeline of products, both from our external partners New Drug Applications (ANDAs).
and increasingly from our internal development. Our ■ Launched Albuterol in the US, which is
sustained efforts to enhance our product portfolio to meet
patient needs will continue to propel our India business indicated for the treatment of COPD and
towards newer milestones. asthma and has been used as a key rescue
product for COVID-19 treatment in the US.
- VINITA GUPTA ■ Filed Biologics License Application (BLA)
for Peg-filgrastim in the US, aiming to
Chief Executive Officer successfully commercialise in FY23.
Lupin Limited ■ Launched LegalRx, a medico- legal guidance
platform where doctors can get their queries
answered by a team of qualified lawyers.
■ Introduced BeOne, an ayurvedic energy and
immunity supplement.
■ Secured 36 patents.
■ Completed project work for the multi-fold
expansion of Biotech Drug Substance facility
in Pune.
■ Finished setting up a new facility for High
Potent products at Indore.
■ Finished setting up a new state-of-the-art
facility for inhalation products at Indore.
■ Completed Ranibizumab Indian Phase III
clinical study with product launch targeted
for FY22. The Global Phase III study is
ongoing, with sites in India, the EU and the
US.
■ Aflibercept biosimilar development picked
up pace.

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

DR. REDDY’S Two of our key promises have been addressing
LABORATORIES LIMITED unmet patient needs, and helping patients to
manage disease better. Nothing has underscored
During FY20-21, Hyderabad-based Dr. Reddy’s the importance of these promises as the COVID-19
Labs invested 8.7 per cent of its total revenue pandemic. During the year, we launched 20 brands
into R&D, amounting to Rs 1654 crore. At in India, including Invista, Redyx, Avigan which aided
the heart of the company’s research and growth. Thirteen of our brands — Omez , Omez -D,
development organisation is its state-of-the Atarax , Redyx, Bro- Zedex , Razo-D , Ketorol, Nise
art R&D Centre in Hyderabad, spread over 300,000 sq ft. , Stamlo, Zedex , Practin , Mintop and Econorm
The centre houses more than 70 laboratories and has — are among the top 300 brands of the Indian
more than 800 research scientists working on various pharmaceuticals market. The R&D expenses for
projects. This R&D Centre works in close conjunction FY2021 were Rs 1654 crore, or 8.7 per cent of revenue,
with other centres across the U.K. and the Netherlands. versus 8.8 per cent in FY2020. The R&D spends in
The work at the R&D centres result in a wide-ranging FY2021 increased by 7 per cent over FY2020, due to
suite of capabilities and services—from synthetic an increase in the development activities pertaining
organic chemistry to formulations development; to generics segment, including COVID-19 related
from intellectual property management to regulatory products development. Within manufacturing, we
science; from polymorphism to biopharmaceutics. are building Digital Lighthouse plants to increase
plant productivity, while in R&D, multiple digital
Key Highlights of FY20-21 solutions are being deployed to drive reduction
■ Partnered with The Russian Direct Investment in cycle time of drug development. The pricing
pressures in the US, Europe and certain emerging
Fund (RDIF), Russia’s sovereign wealth fund, for markets have continued. However, our strong
conducting clinical trials and distribution of Sputnik performance was led by volume growth and new
V vaccine in India. product launches across these markets. Having said
■ Completed Phase III trial for Sputnik V vaccine, that, some delays in launch of a few key products
which demonstrated efficacy at 91.6 per cent, hampered further growth. We have enough levers of
following its launch in the Indian market. growth in terms of expanding our market share, new
■ Created a partnership with the Biotechnology product launches, scale up of several businesses and
Industry Research Assistance Council (BIRAC) for opportunities arising from COVID-19 products. These
advisory support on Sputnik V vaccine. should enable us to deliver satisfactory performance
■ Signed a licensing agreement with Gilead Sciences, in FY2022.
Inc. for right to register, manufacture and sell
Remdesivir - K SATISH REDDY
■ Launched Remdesivir under the brand name Redyx
in India. Chairman
■ Entered into a licensing agreement with Fujifilm Dr. Reddy’s Laboratories Limited
Toyama Chemical for Avigan (Favipiravir) in all
countries other than Japan, China and Russia.
■ Launched Avigan 200 mg tablets in India and few
other markets.
■ Conducting Phase III trials of Avigan 200mg in
North America for outpatient setting with mild to
moderate symptoms.
■ Developed 2-DG in collaboration with by Defence
Research and Development Organisation (DRDO)
laboratories, as adjunct therapy for moderate to
severe hospitalised COVID-19 patients.
■ Working on Molnupiravir, Baricitinib and other
COVID-19 drugs for treatment ranging from mild to
severe conditions.
■ Filed 20 new Abbreviated New Drug Applications
(ANDAs) and one New Drug Application (NDA) with
USFDA.

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

We continued to enhance our ALEMBIC
manufacturing capabilities PHARMACEUTICALS LIMITED
during
the year and spent about 12.4
per cent of
our revenue towards R&D Vadodara-based Alembic Pharmaceuticals invested 12.4 per
activities to take complex generics cent of its total revenue into R&D during FY20-21, amounting
to the maximum number of people to Rs 670 crore. The company offers a suite of quality products
worldwide. We saw significant catering to 10 therapeutic areas namely cardiology, anti-
growth along with a substantial diabetes, dermatology etc., in the domestic market. Alembic’s
enriched portfolio is owing to unparalleled research and development
market share gain
for strengths, concentrated across R&D facilities in Vadodara (Gujarat),
Azithral OSD and we Hyderabad (Telangana) and New Jersey (USA). The company houses
stood
as a formidable 1,200+ R&D employees with diverse skill sets. Alembic Research Centre at
player globally as Vadodara is focused on novel chemistry including new polymorphs, salts,
Azithromycin was process for a possible first to file opportunity, while Alembic’s R&D unit in
a key molecule Hyderabad is majorly focused on Formulation Development, Analytical
for the treatment Development & Peptide (API) Lab Development.
of COVID-19. We
currently have 200+ Key Highlights of FY20-21
products in our R&D ■ Expanded manufacturing capacity
by adding three new plants
pipeline, and we plan
for oncology oral solids and injectables, general injectables,
to file 25-30 new filings per ophthalmic and oral solids.
year. With injectables and complex ■ Filed 29 Abbreviated New Drug Applications (ANDAs) with USFDA.
generics in the pipeline, our R&D ■ Launched 16 new products in the US and will be ramping up new
investments are expected to start product launches in the future.
yielding dividends from 2021-22. ■ Rhizen’s out-licenced, novel molecule Umbralicib (UKONIQ) launched by
TG Therapeutics USA for Marginal Zone Lymphoma (MZL) and Follicular
- CHIRAYU AMIN lymphoma (FL)- company’s first product to be developed in India.
■ Ramped up production capacity for Azithromycin in the domestic
Chairman & Chief Executive Officer as well as international markets.
Alembic Pharmaceuticals Limited

SUN PHARMACEUTICAL INDUSTRIES LIMITED

Sun Pharma spent 6.5 per cent of its total Key Highlights of FY20-21
revenue generated during the FY20-21 ■ Entered into an exclusive licencing and
for R&D, amounting to Rs 2149 crore. The
Mumbai-based company has three R&D distribution agreement for ILUMYA with Hikma
centres in India spread across Vadodara Pharmaceuticals PLC (Hikma) for the Middle East &
(Gujarat), Mumbai (Maharashtra) and Gurugram North Africa (MENA) region.
(Haryana). A critical catalyst to the business, R&D ■ Introduced ILUMYA Subcutaneous Injection 100
investments help build a strong pipeline of branded mg Syringe in Japan for the treatment of plaque
generics, pure generics and specialty products for psoriasis in adults, who have an inadequate
India and international markets. Sun Pharma’s R&D response to conventional therapies.
capabilities include expertise in the development of ■ Initiated Phase II clinical trials of SCD-044 for a
products across dosage forms, such as injectables, potential oral treatment for atopic dermatitis and
orals, liquids, ointments, gels, sprays, hormones and moderate to severe plaque psoriasis.
oral products. The R&D team is actively supported ■ Concluded a worldwide in-licencing agreement
by strong intellectual property capability. Sun with Sun Pharma Advanced Research Company
Pharma’s global team has 37,000+ people from over Ltd. (SPARC) for SCD-044, a potential oral
50 nationalities, collaborating across cultures and treatment for atopic dermatitis, psoriasis and other
locations to develop, manufacture and distribute auto-immune disorders.
pharmaceutical products to patients/customers across ■ Commenced Phase II trials of MM-II for a
over 100 geographical markets. potential treatment for knee pain in patients with
symptomatic knee osteoarthritis.

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

AJANTA PHARMA LIMITED The R&D cost came down to 5 per cent
of revenue from operations in FY 2021.
Mumbai-based Ajanta Pharma spent 5 per cent of its In absolute terms, it stood at Rs 139
total revenue generated during the FY20-21 in research crore in FY 2021 against Rs 164 crore
and development (R&D), amounting to Rs 139 crore. in FY 2020. Our R&D activities suffered
The company operates an advanced R&D centre for the maximum impact of
finished formulations and active pharmaceutical the lockdowns. Delays in
ingredient (API) synthesis of different dosage forms. The R&D centre completion of projects
has a team of over 650 scientists working on innovative products for resulted in us missing
various markets across the globe. The facility has a range of state-of- out on many targets
the-art equipment for formulation development, working on different for product filings
dosage forms such as topical creams, ophthalmological preparations, across global
nasal sprays, solid orals, liquids and dry powder inhalers. Ajanta also markets. However,
operates eight state-of-the-art manufacturing facilities in India our team geared up
and Mauritius. Two of the facilities in India have been successfully after the operations
approved by USFDA. The company employs over 7,000 people were allowed. The year
worldwide and its products are sold in over 30 countries. witnessed our determination
to complete the first in-house
Key Highlights of FY20-21 production line for sterile ophthalmic
■ Completed the first in-house production line for sterile products at our Guwahati facility,
despite the challenges.
ophthalmic products at Guwahati facility.
■ Developed 23 Active Pharmaceutical Ingredients (APIs). - YOGESH M. AGRAWAL
■ Commercialised 20 products for the domestic market.
■ Commercialised 10 products in rest-of-the-world (ROW) markets. Managing Director
■ Received 9 approvals for Abbreviated New Drug Applications Ajanta Pharma Limited

(ANDAs).
■ Filed 2 New Abbreviated New Drug Applications (ANDAs) with

USFDA.
■ Launched 8 new products & commercialised in the US market.

■ Initiated Phase I clinical trials of GLP-1R (Glucagon- ■ Introduced Brivaracetam at an affordable price for
Like Peptide-1 Receptor) agonist for treating epilepsy treatment in India.
diabetes.
■ Supplied drugs like Remdesivir, Itolizumab,
■ Launched FluGuard (Favipiravir 200 mg) in India Hydroxychloroquine (HCQ), Favipiravir and
at Rs 35 per tablet, for the treatment of mild to Liposomal Amphotericin B in the Indian market for
moderate cases of COVID-19. treatment of COVID-19 and associated ailments.

Most of our businesses have recorded growth for FY21 despite the challenges related to
the global COVID-19 pandemic. Our India business outperformed the average industry
growth. The R&D investments for the year were approximately Rs 2100 crore at 6.5
per cent of overall sales. During the year, we continued our R&D efforts to develop
complex generics and innovative specialty products. Some of the clinical trials for
our specialty products witnessed a delay of a few months during the year due to the
pandemic, and have gained momentum after the lockdowns were lifted gradually.
During the year, we launched 96 products in the domestic market, including Brevipil
(Brivaracetam) and FluGuard (Favipiravir). Investments for developing the long-term
specialty pipeline are expected to continue. We continue to invest in R&D related to
our global generic business, for developing and filing products across markets.

- DILIP S. SHANGHVI

Managing Director, Sun Pharmaceutical Industries Limited

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

CADILA HEALTHCARE From diagnostics
LIMITED (ZYDUS CADILA) to therapeutics and
preventives, Zydus has
During FY20-21, Ahmedabad-based Cadila Healthcare (popularly known been leading the way
as Zydus Cadila) spent approximately 7.5 per cent of its total revenue with a mission to do all
into R&D, amounting to Rs 1132 crore. More than 1400 scientists across that it can to fight this
its eight state-of-the-art R&D facilities focus on New Chemical Entity challenge. We leveraged
(NCE) and New Biological Entity (NBE) research, development of our manufacturing
biosimilars and vaccines, generic product development covering various dosage capabilities to provide
forms such as oral solids, having both immediate release and modified release required quantities of
pattern, injectables, topicals, transdermals and nasal products and API process Hydroxychloroquine
development. The Zydus Research Centre (ZRC) is the dedicated research arm and other therapies like
of the Zydus Group with its team of over 400 research professionals. In addition, Dexamethasone and other
Zydus Biotech Park houses the Zydus VTEC (Vaccine Technology Excellence medicines, to help patients
Centre) which is the new manufacturing hub for the world’s first DNA plasmid fight the infection. ZyCoV-D,
vaccine. The Vaccine Technology Centre (VTC) has two state-of-the-art R & D our plasmid DNA vaccine,
centres, one located in Catania, Italy and the other in Ahmedabad. has shown promising
results. No severe cases of
Key Highlights of FY20-21 COVID-19 or deaths have
■ Developed world’s first Plasmid DNA vaccine, to combat the COVID-19 been observed after the
third dose of ZyCoV-D till
pandemic date. Also, no moderate
■ Launched Virafin (Pegylated Interferon alpha- 2b) for treating moderate case of COVID-19 disease
was observed in the vaccine
COVID-19 infection in adults.
arm post administration of
■ Zydus and TLC of Taiwan, signed a license,
supply and commercialisation the third dose suggesting
100 per cent efficacy for
agreement to commercialise AmphoTLC (Amphotericin B Liposome for moderate disease. ZyCoV-D
Injection 50mg)- to treat Mucormycosis or Black Fungus in India. received approvals for
■ Launched Viroshield mouth spray, a unique scientifically tested enzyme based emergency use from the
formulation DCGI & is the first vaccine
■ Made Remdac, its brand of Remdesivir, at Rs 899 for a 100 mg lyophilised to be made available for
injection. adolescents in the age
■ Announced Phase I trials of ZYIL1, a novel oral small molecule NLRP3 group of 12-18 years, besides
inflammasome inhibitor for COVID-19 the adult population.
■ Completed Phase I clinical trials for an anti-malarial drug candidate

■ Completed the recruitment of patients for Phase III clinical trials in India for - PANKAJ R. PATEL
another Investigational New Drug (IND), Desidustat, targeted at treating
anemia both in dialysis and non-dialysis dependent CKD patients.
Chairman
■ Received an approval from the USFDA to initiate Phase II (b) clinical trials of Cadila Healthcare Limited
Saroglitazar Magnesium for NASH and F2/F3 Fibrosis in the US.

■ Received an approval from the DCGI for a New Drug Application (NDA)
of Saroglitazar Magnesium for the treatment of Non- Alcoholic Fatty Liver
Disease (NAFLD) in India. The molecule became the first medicine for the
treatment of NAFLD in India.

■ Successfully completed Phase III clinical trials in India for Rituximab.
■ Launched first biosimilar - Pegfilgrastim in Russia

■ Received marketing authorisation in India for Hepatitis B Vaccine (rDNA) I.P.
and Pentavalent Vaccine.

■ Completed Phase II/ III clinical trials in adults and adolescents in India for
Tetanus Diphtheria (Td) vaccine and submitted the marketing authorisation
application to DCGI.

■ Filed 22 additional abbreviated new drug applications (ANDAs) with the
USFDA

■ Sets-up a new manufacturing facility to produce DNA based vaccine ZyCov-D

■ Seeks DCGI approval to undertake clinical trials for ZRC-3308 (Covimabs), a
cocktail of two anti-SARS-CoV-2 monoclonal antibodies to combat COVID-19.

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

CIPLA LIMITED In FY 2020-21, the total R&D investments
stood at Rs 924 crores or 4.8 per cent of
For FY20-21, Mumbai-based Cipla spent 4.8 per cent of its total revenue. The Y-o-Y moderation in R&D
revenue in R&D, amounting to Rs 924 crore. With six state-of- as a per cent of revenue was on account
the-art R&D facilities located in New York (USA), Maharashtra of higher revenue and lower R&D spends
and Karnataka, the company’s product portfolio spans led by completion of large-scale gAdvair
complex generics as well as drugs in the respiratory, anti- trials in FY 2019-20 as well as lower
retroviral, urology, cardiology, anti-infective, CNS, and various other clinical trials and other developmental
key therapeutic segments. The company also has a collaborative activities in wake of the pandemic and
programme with the Indian Institute of Chemical Technology impact of the lockdown in FY 2020-21.
(IICT) to enroll Cipla R&D scientists for PhD in Chemistry under the The Company plans to enhance its API
guidance of IICT scientists. This helps in improving the skillset of R&D and manufacturing capacities in
scientists at Cipla. During the first wave of the COVID-19 pandemic, therapeutic areas such as Respiratory,
Cipla R&D had done a fast-track development of API Remdesivir, Gastrointestinal and Oncology, and
Favipiravir and other pipeline drugs targeted for COVID-19 patients. conduct backward integration for
manufacturing of Key Starting Material
Key Highlights of FY20-21 and critical API intermediates to have
■ Filed two partnered peptide injectable products including one a tighter control on the supply chain.
Our investments in ABCD Technologies
new drug application in US will help add to the digital channel
■ Expanded biosimilar partnerships with global pharmaceutical transformation in India. In FY 21-22, our
strong economic engine will enhance
companies for platform play across key geographies like Australia, our capabilities and digital evolution
New Zealand and Algeria will fuel our passion for patient care.
■ Partnered with Alvotech for marketing and distribution of We plan to continue to partner with
oncology products in South Africa e-pharmacy and point- of-care devices
■ Forged partnerships and forayed into the diagnostics space with to enable patient care continuum. We
the launch of ELIFAST (antibody detection kit), CIPtest (rapid will leverage digital assets to move
antigen test) and ViraGen (RT-PCR) test in India. closer towards patients for delivering
■ Collaborated with a Belgium-based firm Multi G, for integrated care and also build more
commercialisation of rapid antibody testing kits. digital assets.
■ Emerged as a partner of choice for Roche for their antibody
cocktail (Casirivimab and Imdevimab) and Tocilizumab, Eli Lily for - UMANG VOHRA
Baricitinib, MSD for Molnupiravir, and Gilead for Remdesivir.
■ Significant unlocking of respiratory portfolio with the launch and Managing Director &
ramp-up of Albuterol HFA in the US. Group Chief Executive Officer
■ Launched ‘Breathefree Virtual Educators’ – India’s 1st digital Cipla Limited
educator for inhaler devices available in 3 languages.
■ Launched Glycohale-FB in India: World’s first triple-drug
combination
of Glycopyrronium, Formoterol, and Budesonide in a
DPI form – for COPD management.
■ Launched generic Nintedanib in India for the treatment of
Idiopathic Pulmonary Fibrosis (IPF), a rare respiratory disease.
■ Received USFDA approval for Sumatriptan 20mg nasal spray: AB-
rated generic therapeutic equivalent of GSK’s Imitrex.
■ Received marketing approval in India for the therapeutic use
of Stempeutics stem cell product in Buerguer’s disease and
Peripheral Arterial Disease. The trials in Diabetes Foot Ulcer are
progressing slowly due to the pandemic.
■ Partnership with Boehringer Ingelheim to co-market three new
oral anti-diabetics drugs – Oboravo (Empagliflozin), Oboravo
Met (Empagliflozin + Metformin), Tiptengio (Empagliflozin +
Linagliptin).
■ Agreement with Roche for marketing and distribution of
Oncology drugs – Herclon (Trastuzumab), Avastin (Bevacizumab)
and Ristova (Rituximab).

30 CARDIAC CARE BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

How tech innovations
impact cardiac care

Cardiac care has seen a transformation over the years with technology playing an important
role. Armed with Artificial intelligence (AI) and machine learning (ML), cardiac care providers,
with the right technology, have received the right impetus to revolutionise treatment
mechanisms. Let us delve into the new technologies which the industry is offering to mankind
and decipher the way forward.

Cardiovascular diseases (CVD) have been on the more global companies are expected to penetrate the
rise across the globe and have seen exponential market in the coming years.
growth due to lifestyle disorders. To address
this growing concern, the World Heart Federation New age technological advancements
observes September 29 as ‘World Heart Day’, every
year. This year the primary goal for World Heart Healthcare across the world has witnessed transition
Day 2021 is ‘Globally harnessing the power of to new business models in order to improve patient
digital health to improve awareness, prevention and care and operating efficiencies. Some of the recent
management of CVD’. advancements include Artificial intelligence (AI),
advanced algorithms, and predictive analytics
Cardiovascular diseases such as ischemic heart facilitating early detection and treatment of critically
disease and stroke account for 17.7 million deaths ill patients, in improving outcomes and providing
in India and a significant patient pool involves value-based care. Then comes remote connected care
younger population, according to the World Health that allows electrocardiogram (ECG) diagnosis using
Organisation (WHO). COVID-19 pandemic has cloud technology and bluetooth-enabled cardiac
added fuel to fire as it has been found that the virus devices which measure the parameters and transmit
can act as an independent driver for heart attack. them back to healthcare providers without physically
Having said that, the world is witnessing a plethora visiting the clinic.
of technological innovations in this space, saving
numerous lives. India is not far behind and the American medical device firm Abbott has recently
country has witnessed significant improvements in launched its Amplatzer Piccolo Occluder in India,
heart care in the past decade. the world’s first medical device that can be implanted
in tiniest babies (weighing as little as 700 gms)
According to a recent report by Mordor using a minimally invasive procedure to treat patent
Intelligence, the market for cardiovascular devices in ductus arteriosus, or PDA. The Amplatzer Piccolo,
India consists of several global players along with the a device even smaller than a pea, now offers hope to
local players. However, the number of local players premature infants and newborns who need corrective
in the country is less and the market is dominated by treatment, and who may be non-responsive to
global companies such as Abbott, Boston Scientific, medicine and are at high risk to undergo corrective
Medtronic, etc. Since India is a growing economy, surgery.

“With advancement in
medical technology, we
now have procedures such
as Intravascular Ultrasound
(IVUS) which uses less dye
but still helps in visualising
the blocked artery even

more precisely.”
- Dr Sundeep Mishra,

Professor of Cardiology, AIIMS, New Delhi

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com CARDIAC CARE 31

Last year, Abbott also launched clip delivery Emerging trends to address CVDs
system, a minimally invasive heart valve repair
device to treat mitral regurgitation in India. The clip ● eHealth
device repairs leaky mitral valves without open-heart ● mHealth
surgery and is delivered to the heart through a vein in ● Wearable technology
the leg. ● Robotic assisted surgeries

Apart from this, the company has introduced “Abnormalities of the heart’s
implantable cardioverter defibrillator (ICD) and
cardiac resynchronisation therapy defibrillator valves and chambers, known
(CRT-D) devices in India, bringing the most
advanced heart rhythm management capabilities. as structural heart conditions,

“Abnormalities of the heart’s valves and affect millions of lives around
chambers, known as structural heart conditions,
affect millions of lives around the world. We believe the world. We believe that
that innovative heart treatments have the potential
to change the standard of care for patients. Our innovative heart treatments
transcatheter clip-based therapy can help make a
difference as it is associated with less trauma for have the potential to change
a patient. Further, we have developed Piccolo as a
critical advancement in the standard of care for the the standard of care for
most vulnerable of premature babies who may not be
able to undergo surgery to repair their hearts”, says patients.” - Payal Agrawal,
Payal Agrawal, General Manager, Abbott, Structural
Heart business- India and the Subcontinent, General Manager, Abbott, Structural Heart Business,
Mumbai.
India and the Subcontinent, Mumbai
Similarly, Ireland-headquartered Medtronic has
been at the forefront when it comes to transform Cardiac care evolution in India
healthcare especially in the cardiac sector. The
company has recently launched the world’s smallest In particular, treatment of coronary artery disease
pacemaker to treat heart block in India. Micra AV (CAD) has evolved over the years and innovation in
is a miniaturised, fully self-contained pacemaker the cardiovascular space across the value chain in the
that delivers advanced pacing technology to areas of product, process, health systems, will help
atrioventricular (AV) block patients via a minimally in expanding access to healthcare to more people.
invasive approach. This will eventually result in better clinical outcomes,
less invasive procedures, lesser complications, and
While the market is dominated by global players, shorter recovery times, thus improving overall health
one prominent domestic stent specialist Sahajanand of people.
Technologies (SMT), based in Surat, has recently
entered into the structural heart segment with an “In India, 272 people / 1 lakh population (higher
acquisition of medical device firm Vascular Concepts. than the global average of 235 per 1 lakh) suffer from
Vascular Concepts Group, comprising of two entities coronary artery disease. With the advancement in
based in India and Thailand, has developed and medical technology, we now have procedures such
launched the Hydra transcatheter aortic valve system, as Intravascular Ultrasound (IVUS) which uses less
which received Indian regulatory approval in 2020. It dye but still helps in visualising the blocked artery
is used for the treatment of high-risk patients suffering even more precisely and in a more complete manner,
from severe and symptomatic aortic valve stenosis. further even allowing even identification of early
(not as yet occlusive) plaque and other complications
Adding on, Chennai-based heart surgeon, Dr which might be otherwise missed in plain coronary
Sanjay Cherian has designed and developed India’s angiography”, says Dr Sundeep Mishra, Professor of
first 3D printed heart valve. According to Dr Cherian, Cardiology, All India Institute of Medical Sciences
the new 3D printed heart valve could be the future (AIIMS), New Delhi.
of cardiac surgery, since it overcomes most of the
disadvantages/ complications associated with the Adding his opinion Ganesh Sabat, CEO, SMT,
currently available artificial heart valves that are Mumbai says, “Angioplasty has become a standard
in use today. The list is long and there are various care of practice with substantial investment over
research being conducted in technology-assisted the last 20 years. There is a huge scope for further
cardiac care. improvement as cardiac death still remains the
number one reason for death in India. Other high
end medical devices in cardiac care are yet to be
developed and minimally invasive procedure for
transcatheter aortic valve replacement (TAVI) is
at infant stage. The government’s reimbursement

32 CARDIAC CARE BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

“There is a huge - Ganesh Sabat,
scope for further CEO, SMT, Mumbai
improvement as cardiac
death still remains the
number one reason for

death in India.”

“We need partnerships

with different

stakeholders i.e.,

government, hospitals,

doctors, and the industry

to address the existing

challenges as the market

is under-penetrated.” - Nitin Wadhwa,

Director, Coronary and Renal Denervation (CRDN),

Aortic Peripheral Vascular (APV) & cardiovascular community must familiarise itself
with the wearable technologies on the market and
Endovenous, Medtronic India, New Delhi their wide range of clinical applications.

programme will play a major role for faster The way forward
adoption.”
According to a 2021 report in Invest India, the
Advancements in the era of COVID-19 market size of the medical devices industry as a
whole is estimated to be nearly $10 billion in India.
The SARS-CoV-2 virus can directly impact the heart, With a huge population base, there remains a
causing myocarditis and pericarditis — inflammation huge opportunity for the cardiac care market and
of the heart muscle or outer lining of the heart. technology innovations are likely to boost the market.
Besides, it can cause abnormal heart rhythms, blood The India Cardiovascular Devices Market is growing
clots in the legs and lungs, and heart failure. To at a CAGR of 5.9 per cent over the next five years
counter these issues, companies launched a new (2021-2026), as per Mordor Intelligence report.
range of products. The evolution of telemedicine
during COVID-19 pandemic is worthwhile. Like Wadhwa states, “We need partnerships with
any other specialty, the Outpatient Department different stakeholders i.e., government, hospitals,
(OPD)’s/follow-ups in cardiac care has also moved doctors, and the industry to address the existing
to tele-medicine, with patients utilising telephonic or challenges as the market is under-penetrated with
video conferencing services. Only when a procedure inadequate access, low insurance penetration and
(tertiary care) is required on the basis proper perusal an ever-increasing cardiac disease burden coupled
of symptoms, a patient is called to the hospital. with lack of disease awareness and timely diagnosis.
Through initiatives like Ayushman Bharat, the
Remarks Nitin Wadhwa, Director, Coronary government is taking strong strides in making
and Renal Denervation (CRDN), Aortic Peripheral healthcare affordable and accessible to all and
Vascular (APV) & Endovenous, Medtronic India, New medical technologies will have a huge role to play in
Delhi, “Connected, and remote monitoring healthcare improving clinical outcomes.”
enables physicians to get timely notifications of
changes in their patient’s heart condition to make In the future, the world is going to witness more
necessary interventions, thus adding value by research in this arena. An array of new launches in
ensuring patient safety and reduced healthcare costs cardiac care is imminent with technology evolving at
while reducing the risk associated with COVID-19 a faster pace. How these devices will be able to reach
exposure.” the rural hinterlands and how cost effective these
products can be, is what needs to be looked into. Only
According to ResearchGate, in the era of remote, then can we have a healthy and hearty nation.
decentralised and increasingly personalised patient
care, catalysed by the COVID-19 pandemic, the Sanjiv Das
[email protected]

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com 3D PRINTING 33

3D printing moulds
healthcare innovations

Pharmaceuticals, bio-medicine, aviation, and automobiles industries have rapidly adopted 3D
printing over the years, worldwide, to develop new solutions and prototypes. It is also helping
many industries, healthcare, in particular, increase productivity. Despite all its advantages, 3D
printing technology is currently posing a number of challenges in the market such as initial costs,
limitation to the metals and plastics used for 3D printing, lack of policy standardisation, etc.

3D printing has made tremendous contributions manufactured component or additively fabricated
throughout healthcare. It has been able to step. The European Union has specific legislation for
improve clinical outcomes, reduce operation 3D printing in the manufacturing of medical devices.
duration and also reduce overall treatment cost. 3D During the onset of the COVID-19 pandemic, special
printing has been serving major applications across guidelines were issued for 3D printing for COVID-19
the globe such as replacing human organ transplants, relief.
producing cheaper versions of required surgical tools,
speeding up surgical procedures, and improving the On the other hand, India’s National Policy on
lives of patients on prosthetic limbs. Newer tools, Electronics, 2019 promotes R&D and startups in
advanced technologies are helping in delivering emerging areas of technology including additive
better treatments and devices that are customised to manufacturing. However, domestic manufacturing is
better serve the patient. yet to realise the full potential of 3D printing. India
has some sector-specific laws, such as in medicine,
As per a recent report by Markets and Research, which can be interpreted to include 3D printing.
the global automated 3D printing market was valued Even India’s Drugs and Cosmetics Act, 1940 does
at $507.8 million in 2020 and is expected to grow at not specifically address 3D printed objects but the
a compound annual growth rate (CAGR) of around Ministry of Health and Family Welfare expanded
37.14 per cent over the forecast period (2021 - 2026). its definition of ‘drugs’ under the Act in February
Although the additive printing market has witnessed 2020, which include appliances used for diagnosis,
growth in India as well, there is still a lot of untapped prevention, or treatment of a disease. There is still a
potential. lack of clarity on the applicability of this legislation to
3D printed devices.
Policy standardisation
3D printing pioneers
Despite the potential of 3D printing technology,
there is no global policy on the same. Globally The global market is dominated by 3D Systems, Inc,
industries are looking at 3D printing technology as GE Healthcare, Electro-Optical Systems, Stratasys,
the technology of the future, governments need to Renishaw plc. Major manufacturers are focusing on
take this into account and try and regulate the sector the development of intermediates by offering a wide
as and when the need arises. It would be helpful as range of 3D bioprinting.
different countries currently are in different phases
of 3D printing technology adoption across industries. India, as well, has its own homegrown companies
For instance, in 2018, China issued guidelines for
regulation and registration of 3D printed medical
devices which included custom-built additive-
produced medical devices. China further issued
several guidelines for different 3D printed medical
devices including a 2020 technical guidance for 3D
printed artificial vertebrae and acetabular cups.

In the US in 2017, Food and Drug Administration
(FDA) issued guidelines for additive manufactured
medical devices, including recommendations for
testing of devices that include at least one additively

34 3D PRINTING BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

“India has much to establish Hospital 3D printing labs in India for
potential in drug and 3D-printed implants that would enable doctors to
medicine development visualise and print implants for complicated cases.
The first of these would be launched at Apollo Health
and requires more City, Jubilee Hills, Hyderabad.
specialised technologies
Hospital’s 3D-printing labs would provide medical
to deliver the future 3D printing services for better healthcare, through
services in life science the creation of anatomical models for pre-surgical
planning and education, patient-specific cutting and
and healthcare.” drilling guides, and customised implants and implant
- Sharath Chandra, moulds.

Co-founding Director, Altem Technologies, Bengaluru Dr Prathap C Reddy, Chairman, Apollo Hospitals
Group, Chennai noted, “3D printing technology is
“The recent advances in transforming the medical environment providing
3D printing technology a fast, accurate, and economical solution to take
and word-class process medical care to the next level! As healthcare evolves,
3D printing will play an important part of this future
optimisation allows transformation.”
us to provide these
innovative implant Bengaluru-based Altem Technologies has
solutions at affordable partnered with CELLINK, the world’s first bioink
company, to accelerate Life-Science research with 3D
prices.” bioprinting in the Indian market. Altem intends to
- Dr Pranav Sapkal, establish a strong presence of bioprinting in the field
of medical research and life science applications.
Founder and Director, LUCID Implants, Nagpur
Commenting on the partnership with CELLINK,
that have channelised 3D printing technology. Indian Sharath Chandra, Co-founding Director, Altem
pioneers include Wipro, Bengaluru-based Intech Technologies, Bengaluru, said, “India has much
Additive Solutions, Surat-based STPL3D, Hyderabad- potential in drug and medicine development and
based T-Works, Hyderabad-headquartered think3D, requires more specialised technologies to deliver the
Mumbai-based Imaginarium, Anatomiz3D, future services in life science and healthcare. Through
headquartered in Mumbai, Pune-based Incredible this partnership, we invest in making strategic efforts
AM, and Divide By Zero-based in Navi Mumbai. in identifying and nurturing the 3D bioprinting
development opportunities for India. The outcome
Recently GE Additive collaborated with of this partnership will be to engage and respond
Imaginarium to join its global sales partner network to future trends of medicine and healthcare with
as an official sales partner in India. Imaginarium bioconvergence solutions”.
will resell GE Additive’s portfolio of metal additive
manufacturing machines and metal powders which Changing lives for the better
includes Direct Metal Laser Melting (DMLM) and
Electron Beam Melting (EBM) technologies. Indian doctors may soon have a novel and affordable
3D robotic motion phantom to simulate the lung
The products are aimed at manufacturers across motion of a cancer patient to help deliver focused
a wide range of industries, including medical and radiation in the upper abdomen or thoracic region.
dental in the form of customised implants, crowns, Developed by Prof. Ashish Dutta, Indian Institutes of
bridges, etc. GE Additive will leverage Imaginarium’s Technology (IIT), Kanpur, and Prof. KJ Maria Das,
network in the Indian market to drive the adoption Sanjay Gandhi Postgraduate Institute of Medical
of its state-of-the-art metal additive manufacturing Sciences (SGPGIMS), Lucknow, the 3D robotic motion
machines. phantom can reproduce the lung motion of a human
during breathing. It is part of a platform that not
Kamlesh Parekh, CEO, Imaginarium, Mumbai, only emulates the human lung motion as a patient is
said, “Metal additive manufacturing technology breathing but can also be used to check if the radiation
has the potential to disrupt the industry by is being correctly focused on a moving target.
catalysing innovation and enabling the production
of indigenous, Made-in-India, made-for-the-world The major part of the phantom is a dynamic
products.” platform over which any dosimetric or imaging
quality assurance devices can be placed, and the
The Apollo Hospitals Group and Anatomiz3D platform can mimic 3D tumour motion by using three
Medtech have also announced a collaboration for
the design and printing of complex implants. The
partners would take the lead in a pioneering initiative

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com 3D PRINTING 35

independent stepper-motor systems. As it emulates “Metal additive
the lung movement, a moving or gating window manufacturing technology
is used to focus the radiation from the radiation has the potential to disrupt
machine on the moving tumour. Detectors placed
in the phantom help detect whether the radiation is the industry by catalysing
localised on the tumour. innovation and enabling the

To aid and protect our healthcare workers, production of indigenous,
Tvasta Manufacturing Solutions, founded by IIT ‘Made-in-India’, made-for-
Madras Alumni, has collaborated with Saint-Gobain,
to develop a 3D-printed doffing (procedure of the-world products.”
‘effective and safe’ removal and proper disposal of - Kamlesh Parekh,
personal protective equipment (PPE) unit to protect
India’s healthcare workers in the frontlines against CEO, Imaginarium, Mumbai,
COVID-19. Two doffing units have already been
launched with the third one under construction. “3D printing technology is
transforming the medical
The first unit has already been deployed at environment providing a fast,
a Government Hospital in Kancheepuram near accurate, and economical
Chennai, Tamil Nadu, while the second unit has solution to take medical care
been established at Omandurar Medical College to the next level! As healthcare
and Hospital, Chennai. The Foundation Stone for evolves, 3D printing will play an
the third Doffing Unit has been laid at Government important part of this future
Medical College and Hospital, Thiruvalluvar.
transformation.”
Recently the orthopaedics team at Fortis - Dr Prathap C Reddy,
Memorial Research Institute, Gurugram implanted
the largest (in India) custom-made 3D printed hip Chairman, Apollo Hospitals Group, Chennai
implant (printed by Incredible AM) in a 60-year-old
Tanzanian patient. Such a customised implant was Trigonocephaly. A rare condition in which the shape
required as the patient’s pelvic bone had been badly of the front of the head is triangular, causing aesthetic
damaged due to three previous hip surgeries. and neuropsychological development defects. Digital
data from the patient’s 3DCT scan was fed into the
With the ongoing second wave of COVID-19 3D printer to print two rapid prototype skull and
in India, cases of Mucormycosis (black fungus) upper face models, which were exact replicas of the
have been on the rise, and by the end of June patient’s skull. A craniofacial surgery was performed
2021, India had reported over 40,854 cases. The to correct the deformity.
medical community is trying to get to the core of
this epidemic that is on the rise. Since black fungus Hurdles on the way
mostly affects the sinus region, surgeons remove
the infected tissues to prevent the spread, leading to With all its advantages, 3D printing technology is
facial deformities in several cases. still not used extensively. One of the most prominent
reasons being the initial costs involved in obtaining
Nagpur-based LUCID Implants has become the printers, and raw materials involved. There is a
the first Indian company to produce Polyether limitation to metals and plastics used for 3D printing
ether ketone (PEEK)-based customised implants of as not all metals and plastics can be 3D printed. Lack
patient’s facial anatomy with advanced 3D printing of knowledge widely available makes the printing
technologies and virtual surgical planning. process complex. Impact, in the long run, is yet to be
determined.
“The recent advances in 3D printing technology
and word-class process optimisation allows us Scaling up 3D printing will make the technology
to provide these innovative implant solutions at available to the masses, reducing costs. Global
affordable prices. Facial anatomy involves complex organisations can consider collaborations to bring
shapes, and reconstruction cannot be practically further innovation in the field of additive printing.
achieved by autogenous grafts. Patient-specific Policy standardisation will propel further growth,
implants help reduce the surgery time, which is boosting the technology which could lead to global
required in the case of patients suffering from adaptation of 3D printing. Faster adaptability will
COVID-19”, said Dr Pranav Sapkal, Founder and help boost the confidence of patients opting for 3D
Director, LUCID Implants, Nagpur. procedures, implants, and medical devices.

Fortis Hospital Shalimar Bagh in February Prabhat Prakash
2021 treated an 18-month infant suffering from [email protected]

36 SARS-CoV-2 BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

SARS-CoV-2: A Biochemical Treatise
on its Past, Present & Future

« in China between 2002 and 2004, also provided a
clear understanding about the nature and mechanism
Dr Ashok Kumar, by which SARS-CoV-2 spikes bind with Angiotensin-
President, Centre Converting Enzyme-2 (ACE-2), 10-20 times more
for Research and effective than its predecessor, and how it gets quickly
Development, Ipca detached with the help of a protease allowing the lipid
Laboratories Ltd, layer to fuse with the cell membrane and releasing
Mumbai its RNA into the host cell. Once inside, the virus
replicates by simply hijacking the machinery of the
The SARS-CoV-2 pandemic is unprecedented host cells, thus spreading further and infecting more
but equally unprecedented is the contribution of cells and eventually other organs, the transmission
scientists who have helped us in understanding the contaminating the environment and thus infecting
mechanisms by which it infects human beings and more people. It’s again the understanding of the spike
also, developing a variety of vaccines to protect the glycoproteins, which formed the basis for developing
masses, in a year’s time, which can be called truly novel vaccines, in record times.
groundbreaking. This article gives an overview
of the progress made by scientists around the The reasons for loss of smell and neurological
world working round the clock in developing an problems associated with COVID-19, NRP-1, a
understanding of the SARS-CoV-2 evolution and protein receptor in the host, not only helps SARS-
COVID-19 disease pathogenesis, and also makes an CoV-2 to attach to a host cell but also invading
attempt to suggest the possible ways of coping with the nervous system resulting in the loss of taste
this pandemic if we have to co-exist with it forever! and smell, as generally experienced by most of
the COVID-19 patients. TMPSSR2 and Furin, two
As per the figures disclosed by the National proteases present in the host cells, activate and
Health Ministry (NHM), India has witnessed facilitate the cleavage of spikes after they get bounded
400,000 excess deaths in April and May, to ACE-2. This activation is key to the fusion and
2021 in comparison with April and May 2020. And subsequent entry of the virus into the cell.
the surge in COVID-19, cases in Europe, the US and
neighbouring countries reveals that the coronavirus
is still amidst us and is thriving well! Since December
2019, with more than 188 million confirmed cases
and more than 4.0 million deaths worldwide, as
recorded on July 16, 2021, COVID-19 has severely
disrupted human life, and we still don’t know for
sure. The reasons why COVID-19 drastically affects
some people, but the majority recovers whilst
remaining largely asymptomatic. ‘How long will the
immunity acquired after infection or the vaccination
driven adaptive immunity be able to save us from re-
infection?’ is a million-dollar question.

Why is SARS-CoV-2 so contagious?

Expedited sequencing of the viral genome, which
proved that SAR-CoV-2 is similar to SARS (Severe
Acute Respiratory Syndrome), the infection broke out

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com SARS-CoV-2 37

Breaking of young hearts! It becomes pretty clear from the understanding
developed so far, that once the SARS-CoV-2 affects
The recent studies carried out by Kory. J. Lavine et the targeted organs the only option left with doctors
al. at Washington University School of Medicine have is to symptomatically handle the damage. Since
shown that SARS-CoV-2 infects heart muscle cells the extent of the damage appears to be directly
and fibres directly, causing heart failure or cardiac proportional to the overall weakness of the immune
injury in generally healthy people. It is important to system and/or a particular organ affected with co-
note that this effect is independent of inflammation morbidities, it unveils the mystery why COVID-19
level, which means that inflammation is not the is non-symptomatic in many but deadly in some
initial cause for this damage. isolated patients.

Previous studies have already demonstrated that There is nothing new about the speed with which
apart from wreaking havoc on the respiratory system, most of the RNA viruses mutate but the way SARS-
heart, brain and kidneys, SARS-CoV-2 impairs CoV-2 is mutating to evolve into more transmissible
insulin-producing beta cells of the Pancreas, leading and infectious versions and spreading across the
to diabetes in COVID-19 patients and thus ensuring globe, it is difficult to believe that it could soon be
that nothing remains unaffected by this deadly possible to eradicate it completely.
virus, as far as the vital organs of a human body, are
concerned, provided they are susceptible. It may be possible to keep people safe by timely
providing vaccines, capable of inducing required
The way forward antibodies, to protect masses from infection and the
studies carried out by researchers at Washington
The damaging effects of COVID-19, discussed above University confirming the presence of antibody
are mainly due to the presence of ACE-2 guarded producing cells against the virus in the bone marrow
multiple entry gates, available in high numbers on of COVID-19 patients gives hope that the SARS-
the cells in upper airways as well as in all the vital CoV-2 induced immune response may be robust
organs of our body including lungs, heart, kidney, enough to provide long-lasting protection against the
digestive system and brain. The efficient transmission virus.
and spread of the virus is further facilitated by NRP-1
and two proteases, namely TMPRSS2 and Furin, The findings that vaccines may elicit a similar
as discussed above. The Furin cleavage site in the immunological response further increase hopes to
spike protein of SARS-CoV-2 responsible for high contain the virus. However, one has to wait and
infectivity, transmissibility and disease pathogenesis see how these vaccines will tackle SARS-CoV-2 and
is absent in other lineage B beta coronaviruses, such also the continuously emerging novel variants in
as SARS-CoV. the long run. A recent study, published in Lancet
on July 15, 2021 finds that vaccine antibody levels
drop substantially over the course of 2-3 months
and can reduce by more than 50 per cent over 10
weeks. If the levels continue dropping at this rate,
it is very likely that current vaccines may not be
able to provide desired protection against future
variants.

Wearing masks appears to help a bit in keeping
SARS-CoV-2 infections at bay and the strength of an
individual’s immunity in avoiding the severity due
to COVID-19, but believing and feeling confident
that someone will not get the infection, is as good
as living in delusion. Also, knowing the facts that
even those who had taken vaccines have succumbed
to COVID-19, it is important for scientists to find
out a method to detect the infection soon after it
sets in, rather than after few days or a week, so as to
handle the COVID-19 well before it travels down and
infects vital organs of a person. Further, a foolproof
treatment to immediately restrict and neutralise
the virus before it travels down from the upper
respiratory to the lower respiratory system and other
vital organs is highly warranted.

38 SPEAKING WITH BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com

“R&D outsourcing has
become a ‘must have’
than ‘good-to have’ strategy”

« internal and external stakeholders is a testimony to the
liking of our new identity. This new brand identity is
Manni Kantipudi, well poised to launch Aragen into this exciting future.
Chief Executive Officer,
Aragen Life Sciences, What are the plans in store following the
Hyderabad recent investment by Goldman Sachs?

Aragen Life Sciences (formerly GVK BIO), a We believe this new investment at this important
leading contract research and development juncture in our company’s development underscores
organisation headquartered in Hyderabad, the tremendous opportunity ahead. We are incredibly
is marking its transition to a new brand identity excited by the opportunity to work with the global
in its 20th year. Established in 2001, the company Goldman team, harness their intellectual horsepower,
is poised for growth in the outsourced discovery, leverage their strategic thinking and global network,
development, and manufacturing services sector and judiciously invest our new access to significant
across both large and small molecule platforms with capital. We have some big ideas that we will pursue
new investments and collaborations. In conversation over the next 12 months, but what will not change
with BioSpectrum, Manni Kantipudi, Chief Executive is our fundamental intent: invest in solutions that
Officer, Aragen Life Sciences, Hyderabad reveals will accelerate our customer’s journey to market.
more about the company’s recent rebranding and We will continue to be only a company offering
growth plans. Edited excerpts; solutions to our customers with no conflict of
interests via internal investments on programmes
GVK Bio is now known as Aragen. How is the etc. The outsourcing market is an exciting one for
name change going to have an impact on the us, and there are more than enough opportunities
brand? there to propel our long-term growth. Working
with Goldman Sachs, we are well-positioned to
The re-branding exercise has given us an opportunity address the opportunities in front of us to become a
to re-discover ourselves as an organisation and build leading, global player with comprehensive end-to-
upon it. The company has grown from strength-to- end solutions for drug discovery, development and
strength over the last 20 years. While our values manufacturing in small and large molecules.
remain the same, it is now aligned to the new brand
promise and purpose, something that is imbibed What will the recent tie-up with Skyhawk
by each and every employee of the organisation. Therapeutics entail?
This rebranding initiative enabled us to streamline
and bring in a clear focus to our vision for success.
Aragen is a name known for its scientific expertise
and customer-centric culture in the West. We are now
investing in branding around the name – our initial
feedback from both current and prospective customers
has been very positive. They love our new identity
and our renewed purpose and promise. The number
of positive responses in the social media from all our

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com SPEAKING WITH 39

Skyhawk Therapeutics is a leader in the development India is now on par with China on key
of small molecule therapeutics that correct RNA infrastructure and offers an attractive cost-
expression, and through this collaboration, Aragen benefit option. India is also benefiting from
will drive both discovery chemistry and biology the risk mitigation strategy that a number
research to accelerate Skyhawk’s research pipeline, of our customers are implementing, as they
with the goal of advancing this novel concept into want to now have a significant footprint in
game-changing medicines. India, along with China. Some of the recent
trade wars due to pandemic between the
How much revenue was generated during western countries and China is also a key
FY20-21? How much growth is expected this driver behind these diversification plans.
year?
than ‘good-to have’ strategy over the past few years.
FY ’20-21 was our best year ever with Aragen clocking More and more companies have understood the
circa Rs 1200 crore of revenues. We currently work importance of working with CROs to advance their
with 450+ clients globally in accelerating their R&D R&D programmes. Every company, whether a large
programmes and keeping them ahead in the race pharma or a young biotech, has externalisation as a
for better health. With the industry-wide tailwinds, key element of their core growth plan.
the buoyant capital markets for our customers, the
continued interest in externalisation, the increased  Significant capital is still flowing into the life
focus in India as a desirable outsourcing destination, sciences industry, with 2020 attracting over $23
and the strength of the Aragen brand, we are billion in venture investments. Access to this capital
confident in our growth prospects for the next 3-5 will drive R&D spend and fuel outsourcing to CROs/
years. As we look ahead, we are investing and adding CDMOs.
to our discovery footprint both in Hyderabad and
Bengaluru, as our customers’ discovery needs are  The demand for R&D outsourcing is
growing rapidly. In development and manufacturing, outstripping supply. There are now a handful of
we recently invested significantly in expansions, and CROs /CDMOs in Asia with world-class capabilities,
now have the capacity to meet our customers’ near infrastructure that will surely benefit from these
and long-term future needs. In biologics, we are emerging outsourcing trends.
advancing downstream capabilities, and investing
in a manufacturing facility in the US to offer a single The COVID-19 pandemic has accelerated the
seamless solution to our customers who want to growth and consolidation of the CDMO market. Many
develop and manufacture from a single site. of the pharma companies’ R&D /manufacturing sites
were shut down for an extended period and this only
What are the current trends to look out reinforced this outsourcing trend. The situation has
for in the contract research, development also resulted in the migration of some clinical and
and manufacturing (CRO/CDMO) market, commercial supplies of APIs moving back into the
particularly with regards to the pandemic? West. Nevertheless, the CDMOs in the West just do
not have enough capacity to manufacture all steps of
The CDMO market is poised to grow consistently in these APIs. So, we expect to see a number of Starting
the coming years due to the following drivers: Materials, Intermediates, Advanced Intermediates,
and Regulated Starting Materials being supplied from
 R&D Outsourcing has become a ‘must have’ the East even as the final steps are carried out in the
West. We expect India to grow and benefit from the
expected growth in needs for API and Drug Product
manufacturing. India is now on par with China on
key infrastructure and offers an attractive cost-
benefit option. India is also benefiting from the risk
mitigation strategy that a number of our customers
are implementing, as they want to now have a
significant footprint in India, along with China. Some
of the recent trade wars due to pandemic between
the western countries and China is also a key driver
behind these diversification plans.

Sanjiv Das
[email protected]

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

“Truenat diagnostic tests
will be available for 30 more
diseases in next 2 years”

« TB has also begun through various international
agencies including United Nations, Global Funds,
Sriram Natarajan, Global Drug Facility, and the United States Agency
Director & Chief for International Development (USAID) etc. On the
Executive Officer, other hand, Truenat Dengue is being used by the
Molbio Diagnostics, state governments and the private sector effectively
Goa for early and timely diagnosis of Dengue. A study
in Sri Lanka has shown the superiority of Truenat
Established in 2000, Molbio Diagnostics Dengue over NS1 antigen ELISA in early and
is working aggressively to strengthen its accurate diagnosis of the infection.
presence in the molecular diagnostics space
in India. The company has recently opened a new How can your molecular diagnostics
manufacturing unit for its innovative molecular platform make an impact on India’s
diagnostic platform - Truenat Real-Time PCR, overburdened healthcare system?
spread across 1,35,000 sq ft, in Verna, Goa, in
the backdrop of increasing demand for point- With a turnaround time of one hour from sample
of-care molecular testing, in India and across to result, Truenat ensures early and accurate
the world. Sriram Natarajan, Director & Chief diagnosis and appropriate initiation of treatment
Executive Officer, Molbio Diagnostics, Goa spoke on the same day of presentation. This not only
to BioSpectrum in detail about the company’s helps in better patient outcomes but also prevents
growth plans and new launches in-store. Edited the further spread of the disease. The portable,
excerpts; battery-operated, rugged machines, the ready to
use room temperature stable reagents and the fully
How is the Truenat Real-Time PCR making automated protocols ensures that testing can be
a difference in diagnosing infectious done by minimally trained technicians. The in-built
diseases such as tuberculosis (TB) and data transfer capability further enables remote
dengue? interventions and remote monitoring. Truenat tests
are priced very affordably and cost much lower
Truenat MTB is the only World Health than conventional reagents. However, the overall
Organisation (WHO) and Indian Council of Medical cost-benefit of the early point of care diagnosis
Research, (ICMR) approved point-of-care platform and the resulting impact on reduced morbidity
for Tuberculosis (TB) detection recommended as and mortality, improved disease management and
a replacement to smear microscopy. It has been consequently reduced burden on the health care
adopted by the Indian National Tuberculosis system far outweighs the cost of testing.
Elimination Programme (NTEP) as a frontline tool
for the diagnosis of TB and Rifampicin resistance. What is so unique about the technology
The Government of India has already deployed used in the molecular diagnostics platform?
over 1,760 Truenat machines at a sub-district level
across all states and Union Territories and its Understanding the limitations of conventional
introduction by the National Programme is already molecular platforms, Molbio Diagnostics and its
showing a huge impact by a significantly increased R&D subsidiary Bigtec Labs had to completely
rate of case detection. Global rollout of Truenat for re-engineer the conventional Real-Time PCR
technology into a point of care solution. It was done
through leveraging on technologies such as Micro
Electro Mechanical Systems (MEMS), micro and
meso fluidic cartridges, nanotechnology, low power
thermal cycling using disposable intelligent ceramic
chips, lyophilisation and other drying techniques

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

and special sealing techniques. The platform There is also a much larger and growing global
was made rugged by minimising moving parts, demand for high quality molecular diagnostic
miniaturised to occupy little floor space, enabled tools that can be specially deployed at the point of
for portability and battery operation, with onboard care. We expect to establish ourselves as a major
memory, touchscreen interface and wireless data player in the global molecular diagnostics market
transfer capability. The reagents were designed for in the coming years. At the same time, we are
single testing capability, ready to use and stable at also working on other ‘point of care’ technologies
room temperature (up to 30°C) for two years and for providing better solutions for Antimicrobial
the intelligent chip carries a lot of information and resistance (AMR) and non-infectious disease
standard curve values for generating quantitative testing applications.
results. The intelligent chip also ensures that wrong
chips, previously run chips and expired chips are How do you view the evolution and growth
not run again. The system requires no special
environmental conditions, no specific maintenance of the molecular diagnostics market in
or calibration requirements has inbuilt diagnostic
features and error reporting features. India?

Are you planning to launch more diagnostic Molecular diagnostics was an underserved
tests for other infectious diseases, segment in the Indian scenario for a very long
following the opening of your new facility? time despite being regarded as the most reliable
for infectious diseases testing, especially Real-
Truenat tests for over 30 infectious diseases Time PCR that was invented several decades
are already available on the Truenat platform, ago and is considered the gold standard for
while tests for another 30 new diseases are in diagnosing many diseases. The primary reason
development, expected to be launched over the next for this was due to the highly centralised nature
two years. A range of open format reagents by the of molecular diagnostic platforms owing to a high
name Truemix are also planned, again in ready- to- level of infrastructure and skill dependence, high
use, room temperature stable format. capex and opex costs, the need for batch testing,
logistics issues of sample transportation and the
The new facility of Molbio was conceptualised consequent long turnaround time for results.
due to the increasing demand for point of care Delayed diagnosis denies access to appropriate
testing in India, partially driven by COVID-19 and timely medical aid resulting in deterioration
and partially by the growing awareness of the of patient health, thus increasing the risk of
importance and efficacy of this model for other complications and mortality. Their usage was
diseases like TB, Dengue etc. also limited to confirmatory testing which was
available at only a few centralised laboratories
This new facility will be used to increase the and hospitals in major Indian cities. The outbreak
manufacturing capacity of existing and upcoming of COVID-19 dramatically increased the need for
Truenat kits and reagents in addition to the RT PCR tests that have resulted in the market size
Truemix range. The manufacturing capacity has suddenly growing many folds.
been increased 5-fold, from the existing 80,000
tests per day to 3.5 lakh tests per day. Over 700 With the growing awareness, the demand
employees are currently working in Molbio for early diagnosis of infectious diseases is high,
Diagnostics and Bigtec Labs. and various public and private organisations are
investing funds to accelerate R&D in the field of
What are your plans for the next five years molecular diagnostics. Recently, the infectious
both for the domestic and the global disease application segment accounted for the
market? largest market share and will grow in the coming
years.
Truenat is already being viewed as a multi-disease
platform and in addition to the TB programme, The increasing prevalence of infectious diseases
we expect other programmes such as the Viral such as tuberculosis, hepatitis B, and hepatitis
Hepatitis programme, National AIDS Control C, coupled with tests for sexually transmitted
Organisation (NACO) and vector-borne diseases diseases/infections like HIV and HPV will propel
programme to add to the wider deployment and the segment’s growth. Molecular testing is expected
usage of the technology at the grass-root level. The to become more of a routine clinical diagnostics
Indian private sector is also able to use the Truenat tool not only for COVID-19 but for a wide range of
platform for delivering high-quality diagnostics for infectious diseases in the near future.
the full range of tests available.
Sanjiv Das
[email protected]

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

“Virology, epidemiology and biochemistry
research need governmental push”

« mix of in-house development, owned manufacturing,
CMO partnerships, and acquisitions of media
Amit Sharma, developers and manufacturers such as Xell. We aim
Head of Sales, to help India and other countries reach their goals of
Bioprocess Solutions- fully inoculating their population as early as possible
Asia, Sartorius, to bring an end to this pandemic.
Singapore
How do you foresee new trends shaping up in
To expand its current media offering, specifically
by specialised media for manufacturing vaccine R&D and manufacturing space in the
viral vectors and, additionally, in the area of
media analytics, Germany-headquartered Sartorius, post-COVID-19 era?
through its subgroup Sartorius Stedim Biotech, has
recently acquired cell culture specialist Xell AG. Vaccine manufacturers turned to vaccine platforms
Sartorius is, also, helping the industry across the that had been studied for decades but had not yet
globe during all stages of vaccine development, reached the clinic, namely, mRNA and viral vectors.
which is the need of the hour. In conversation
with BioSpectrum, Amit Sharma, Head of Sales, Viral vector vaccines use genetically engineered
Bioprocess Solutions- Asia, Sartorius, Singapore talks viruses to coerce patient’s cells into expressing the
about the company’s latest developments. antigen, while mRNA-vaccines are developed by
Edited excerpts; inserting an mRNA sequence encoding an antigen into
a lipid nanoparticle that grants the mRNA access to
How is Sartorius currently serving the one’s cells. Since mRNA is produced using enzymes
vaccine requirements in Asian countries? rather than via cell culture, the process of developing
these vaccines is simpler and more straightforward
We serve all the major vaccine players in Asia than traditional vaccine manufacturing.
who have developed their own vaccines or are
manufacturing vaccine doses on behalf of other Both mRNA and viral vectors are true platforms
companies for local distribution. Particularly in because all a manufacturer needs to do is synthesise
India, there is undoubtedly an urgent need for the correct genetic sequence. The rest of the process
local vaccine production and distribution to serve can be transferred easily from one indication to the
the huge population. Sartorius is working with all next, leading to an extremely rapid process that yields
manufacturers in India to develop and produce vaccines that reach the clinic much sooner. Given the
vaccines using both traditional techniques and savings they offer in terms of cost and time, flexible
emerging technologies. Our end-to-end solutions process platforms such as these enable vaccine
span cell culture technologies, filtration and manufacturers of all sizes to respond to novel viruses.
purification technologies, fluid management
technologies, data analytics solutions, and bioprocess Vaccine manufacturers should continue investing
development and engineering services. These in tools and expertise that can accelerate vaccine
solutions can help vaccine manufacturers quickly development and production. They must reinforce
ramp up production. and expand their vaccine pipelines, de-risk raw
material and equipment supply chains with dual
How is the recent acquisition of Xell helping? sourcing to prevent shortages and further invest in
technologies such as mRNA to boost flexibility.
For Xell media, like the rest of our portfolio, all
countries in Asia are our focus. To increase the Manufacturers also need to source the required
availability of critical raw materials and consumables, knowledge to develop these vaccines. Finally,
Sartorius has maximised its media supply through a governments and academic institutions must invest
more resources into virology, epidemiology and
biochemistry research to catalyse vaccine discovery
and development.

With the right government support and by
increasing their commitment to scientific knowledge,
flexibility and agility, vaccine manufacturers can
potentially counter the next viral outbreak more
effectively before it becomes a pandemic.

Dr Manbeena Chawla
[email protected]

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

Aarti Dharmadhikari Dr Aradhana Sarin steps
in as CFO at AstraZeneca
joins Rediffusion
British-Swedish multinational pharmaceutical firm
Healthcare as AstraZeneca has announced the appointment of Dr
Aradhana Sarin as an Executive Director and Chief
Marketing Head Financial Officer (CFO), following the closing of
AstraZeneca’s acquisition of Alexion Pharmaceuticals,
Rediffusion Healthcare has announced Inc. Dr Aradhana was serving as the Executive Vice-
the setting up of a Market Research President, Chief Financial Officer of Alexion. She will
division which will be headed by Aarti relocate from the US and be based in the UK. She will
Dharmadhikari. She will report to Sujata report to AstraZeneca’s Chief Executive Officer, Pascal
Mahadik, the Chief Executive Officer of Soriot. Dr Aradhana will succeed Marc Dunoyer who will
Rediffusion Healthcare. She will be based step down as CFO and retire from AstraZeneca’s Board,
out of having served as CFO for over seven years. She has
Mumbai. more than 20 years of professional
Aarti comes experience spanning operating
with an roles at Alexion and advisory
experience roles at global financial
of more institutions, gaining
than 18 extensive knowledge of
years in the global healthcare systems,
healthcare capital markets and
industry, strategic transactions. Prior
the major to joining Alexion, she
part of was Managing Director,
which has Healthcare Corporate &
been in market research, working with Ipsos Investment Banking,
and IQVIA. She is a trained exploratory and Citi Global Banking
analytical researcher and has conducted in New York
usage and attitude studies, pricing studies where she advised
and concept testing for brands and products clients in the
in the healthcare, pharma and medical life sciences and
domains. She has also been involved in biopharmaceutical
many due diligence exercises for multiple sectors.
clients, as also with brand and product
launch studies.

Cipla Quality Chemical picks new CEO

The Board of Directors of Cipla Pal holds a Master of Business
Quality Chemical Industries Administration in Management and
Limited (QCIL) has announced the Leadership from Nelson Mandela
appointment of Ajay Kumar Pal University - South Africa and a
as Chief Executive Officer (CEO)/ Bachelor of Pharmacy from the
Executive Director. Pal joined the Rajiv Gandhi University of Health
company in February 2020 as Chief Sciences (RGUHS) - India. He has
over 15 years of experience in the
Operating Officer (COO). Prior pharmaceutical industry spreading
to that he was Senior Director, across South Africa and India. Pal
Head of Manufacturing Cipla takes over from Nevin Bradford who
South Africa. Cipla Quality will be retiring from the company
Chemical Industries is the effective September 30, 2021.
Uganda-based plant of Bradford has been with CiplaQCIL
the pharmaceutical since 2013.
company Cipla.

44 ARC&ADDNEEMWICSS NEWS BIOSBPIOECSTPRECUTMRUM| S|EPTAEUMGBUESRT 2021 | www.biospectrumindia.com

THSTI develops BRICS scientists to
human-based carry out mathematical
models to study modelling of COVID-19
neurodevelopmental
disorders Indian scientists, in partnership with scientists from China,
Russia and Brazil, will carry out genomic sequencing
A group of researchers at the of SARS-CoV-2 and studies on the epidemiology and
Translational Health Science and mathematical modelling of the COVID-19 pandemic. This
Technology Institute (THSTI), Faridabad will help trace genetic mutations, recombinations as well
has developed human-based models as distribution of the virus and also make projections about
to study neuron development and the future of its spread. A research plan has been made by
neurodevelopmental disorders such as including the expertise of scientists and engineers from
autism which can help design treatment diverse backgrounds. Under this research supported by the
strategies for such brain disorders. They Department of Science and Technology, India and Brazil sides
have established a protocol from India will assess the distribution of SARS-CoV-2 in environmental
for the first time by generating and samples through metagenome analysis for wastewater-based
producing induced pluripotent stem epidemiology (WBE) surveillance. Chinese and Russian
cells (iPSCs) from human peripheral scientists will carry out the Real-Time PCR detection of
blood. They have further refined the SARS-CoV-2 in biological material (nasopharyngeal swabs)
protocol of differentiation of iPSCs into from patients with symptoms of respiratory diseases and
the brain-specific stem cells, i.e., neural investigate the genomic variability, comparative genomics
stem cells (NSCs). A human-based model and phylogenetic analysis.
thus developed could help study how the
brain develops, particularly the neurons, IIT-G invents biodegradable low-
and what goes awry during brain cost composite wound dressing film
development leading to cognitive decline,
impairment in language, and social A team of researchers at the Indian Institute of Technology,
interaction. This research can contribute Guwahati (IIT-G) has invented a biodegradable low-cost
to expanding the knowledge of neuron composite transparent wound dressing film. The material,
development and neurodevelopmental based on the integration of a synthetic polymer, is non-
disorders such as autism and the role of toxic and will create a moist environment that would enable
small non-coding micro RNA in brain- the body to heal on its own through the endogenous
specific stem cells fate. enzymes, according to recent research. IIT-G has created
the knowledge framework and associated protocols for

successful identification
and optimisation of
polymer hydrogel films
for the probable wound
dressing applications. Such
customised and effectively
designed novel materials
provide the necessary
hope to address issues
such as biodegradability of
synthetic polymer-based
materials, cost of raw materials and processes, utilisation of
expensive natural polymers to achieve functional materials,
and biocompatibility of developed products, among others.
The laboratory scale-based retail cost of the optimised
composite hydrogel film has been about Rs 0.188/sq cm,
which is about 66 per cent inexpensive in comparison with
similar commercial materials that costs Rs 0.565 /sq cm.

BIOSPECTRUM | SEPTEMBER 2021 | www.biospectrumindia.com 45

Cutting edge Lab Facilities for
Biotech Pharma and IT / ITES
Companies at TICEL BIOPARK, Coimbatore

Tamilnadu Industrial Development Corporation Ltd (TIDCO) has been formulating and developing self-sustained
Bio parks. The facilities feature robust infrastructure that minimizes investment of individual companies. TICEL BIO
PARK is a highly recognized and successful name on the commercial infrastructure landscape of Chennai. TICEL
BIO PARK I and II stand tall as a testimony to the concept’s acceptance across the Biotechnology industry.

After developing a comprehensive functional ecosystem for Biotech firms in Chennai, the game changing
concept is now all set to enrich the landscape of Coimbatore in the form of TICEL BIO PARK Ill. This cradle of life
science enterprise is a joint venture of TIDCO and TIDEL Park which spreads across a sprawling 10 acres and is
strategically located right next to Anna University. The ambitious project is spread across G+13 floors and offers
cutting edge facilities for Biotech Pharma and IT / ITES Companies. High end lab spaces stand out as unique value
propositions of the facility.

TICEL BIO PARK LIMITED – III

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

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

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

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

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

IIT-M, WIA to commercialise point-of-care
diagnostic device for ovarian cancer

The Indian Institute of Technology, to identify proteins that can be Centre (IGSTC), DST- Science
Madras (IIT-M) is collaborating detected in the blood which can and Engineering Research Board
with the Cancer Institute (WIA) help in the diagnosis of epithelial (SERB) and Indo-US Science and
at Adyar in Chennai to develop a ovarian cancers, which accounts Technology Forum (IUSSTF) to
point-of-care device for the early for over 90 per cent of the ovarian develop point-of-care diagnostic
diagnosis of ovarian cancer. The cancers. On the other hand, IIT-M platforms for pathogen detection
two institutions have entered has received funding from Indo- and disease diagnosis. Novel
into an MoU to further develop German Science and Technology diagnostic device technologies
and validate this technology and for important diseases specific to
transfer it to a suitable industrial India, in particular, tuberculosis
partner to manufacture and and COVID-19 are at the preclinical
market the kit to the general validation stage. Both institutions
public. Funded by the Department will establish a review board and
of Science and Technology (DST), will obtain the necessary ethical
the Department of Molecular clearances to evaluate and review
Oncology at the Cancer Institute the progress arising from this
[WIA] has undertaken research collaboration.

IIT-D, AIIMS IIT-H develops AI-
co-develop Telerobotic
Ultrasound System powered COVID-19 test

A research collaboration between the Indian Indian Institute of Technology, Hyderabad
(IIT-H) research team has developed an Artificial
Institute of Technology, Delhi (IIT-D) and the Intelligence (AI)-powered COVID-19 test that can
be performed at an affordable cost at home after
All India Institute of Medical Sciences (AIIMS), commercialisation and required approval from the
Indian Council of Medical Research (ICMR). The test
New Delhi has jointly developed a Telerobotic kit can produce results within 30 minutes for both
symptomatic and asymptomatic patients. The major
Ultrasound System. The system allows remote benefit of this testing kit is that it does not require
RT-PCR (Reverse
ultrasound access through a robotic arm. In the Transcription
Polymerase Chain
routine ultrasound setting, the doctor (Radiologist) Reaction), an expert
human resource, and
stands in close contact with the patient for a BSL 2 lab facility
for the extraction of
the entire scan duration. RNA, so it has the
potential for one to
However, cross-sectional take the test at home
without expert supervision. The Centre for Cellular
imaging is preferred instead in & Molecular Biology (CCMB), Hyderabad has
performed the validation of the rapid RNA electronic
the current pandemic scenario diagnostic device for detection of SARS-Cov-2 virus
in the swab samples independently with the in-house
with stringent social distancing samples and hospital samples as advised by ICMR.
Each test costs around Rs 400 now. However, mass
requirements – a more production of the testing kit will help to reduce the
cost to around Rs 300 per test.
expensive and less dynamic

technique. Ultrasonography is

a non-invasive, non-ionising,

cost-effective, rapid, bedside,

and readily available modality with immense use

in point-of-care and follow-up examinations.

The control architecture of the newly developed

ultrasound system had been developed to tele-

operate the ultrasound probe attached to the

robotic arm while ensuring the patient’s safety and

the quality of ultrasound images. Besides its role

in the pandemic, it will allow a better outreach of

ultrasound imaging to remote rural areas of India.



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

Berry Global Group to establish healthcare CoE in Bengaluru

US-based supplier of plastic some of the fastest growing the new facility will also house
packaging products Berry Global a dedicated R&D Center of
Group plans to establish a second healthcare market geographies. Excellence. In addition to ensuring
manufacturing facility and global the dosing and administering
healthcare centre of excellence Alongside precision high-quality of medicines are both easy and
(CoE) in Bengaluru. Planned for comfortable for the user, another
development near Berry’s existing manufacturing equipment, critical design criterion will be to
Bengaluru operation, the new support customers’ sustainability
facility will enable the company goals, with the existing Bengaluru
to extend its R&D expertise and facility already International
scale up production in several key Sustainability and Carbon
healthcare sectors: ophthalmic, Certificate (ISCC) Plus accredited.
nasal pumps, inhalation, and Construction of the new facility is
injectable administrations. The expected to begin later this year,
increased capacity will also with the site validated and ready
enhance supply in India and for production by the summer of
throughout South Asia, addressing 2023.

HiMedia gets patent for
sample collection devices

ACG enters The molecular biology the same. It has become
into strategic business of Mumbai-based exceedingly important that
partnership with supplier HiMedia, HiGenoMB clinical samples be collected
Danapak Flexibles has announced the issuance in the right manner and
of patents for its sample are transported intact for
Mumbai-based pharmaceutical collection devices, Salivol and maintaining good sample
Stoocol. Amongst the newest health so as to not affect the
supplier ACG has announced its innovations are Salivol and quality of testing negatively.
Stoocol devices that are used HiGenoMB realises the
strategic partnership with Danapak for the collection of saliva and important technicalities
stool samples respectively. involved in this process and
Flexibles A/S, the Denmark In the present day, various has come up with distinctive
facets of the diagnostics designs which not only
headquartered firm in packaging workflow in a clinical lab enables one to conveniently
set up have been brought collect and transport samples
for high barrier Transdermal Drug to light. One such aspect is to labs, but can also be
the specimen collection and directly processed for nucleic
Delivery Systems. The partnership plastic ware associated with acid extraction.

will translate into better services

to existing and new customers of

Danapak Flexibles in India. ACG

Films & Foils and Danapak Flexibles’s

collective product offerings will

now include a broad range of high

barrier quality laminates and flexible

packaging laminates, including

a broad spectrum of suitable

alternatives to Barex specifications

used for Rivastigmine, Nicotine,

Rotigotine, Lidocaine, Fentanyl,

Buprenorphine and other API’s.

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

Elanpro picks stake Thermo Fisher
in Icold Refrigeration
updates system to
Gurugram-based Elanpro (Elan Professionals) has
recently invested in New Delhi-based startup Icold detect Delta and
Refrigeration, a company specialising in cold storage.
Elanpro has taken a majority stake in the company. Lambda variants
With this investment, Elanpro strengthens its business
objective and forays into the cold chain storage segment Thermo Fisher Scientific has updated its
across India. The move will not only streamline the Applied Biosystems TaqMan SARS-CoV-2
vaccine storage issue but also minimise pharmaceutical Mutation Panel to detect the Delta and
product loss. Additionally, this will allow Elanpro to Lambda strains. First launched in March 2021,
significantly add value to its business partner and the research panel features a customisable
establish itself as a true comprehensive refrigeration menu of verified real-time PCR assays for
player in India. Elanpro has made an investment to the identification
not only expand its business outreach in India but of SARS-CoV-2
also paves way to penetrate its presence in the Middle mutations. The panel
East market. The new reforms and policies and huge enables laboratories
traction of tourism have reshaped the Middle East to track known
market drawing huge attention of foreign investors. For mutations by selecting
efficient cold storage, there is a need for reliable, safe from a menu of over
and potential products that are embedded with best-in- 50 assays designed to
class technology and upgraded features. screen for different
variants. The TaqMan
SARS-CoV-2 Mutation
Panel is highly scalable, allowing up to
hundreds of samples to be run to identify one
or multiple mutations so labs can scale their
surveillance operations based on testing needs.
The TaqMan SARS-CoV-2 Mutation Panel
provides results in about an hour and is based
on gold standard TaqMan SNP genotyping
assay technology, which helps detect and
distinguish mutations efficiently. The panel
can be used with real-time PCR instruments
and technology widely used in labs globally.

Sartorius Stedim Biotech
acquires cell culture specialist Xell

Sartorius Stedim Biotech has around 35 people, and is expected
acquired the cell culture specialist to generate sales revenue of
Xell, headquartered in Germany. approximately 5 million euros at
Xell develops, produces, and markets strong growth rates and a substantial
media and feed supplements for cell two-digit EBITDA margin for the
cultures, especially for manufacturing full year of 2021. Recently, a major
viral vectors that are used in state-of-the-art capacity expansion
gene therapeutics and vaccines. was completed at the company’s
The company also offers various headquarters. The contractual parties
analytical services for characterising, agreed on a purchase price of around
screening and quantifying media 50 million euros in addition to two
components, as well as for optimising earn-out components contingent
media composition. Xell has so upon the achievement of defined
far been privately owned, employs revenue targets from 2022 to 2025.

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

Routing Alzheimer’s disease

Abrain disorder that slowly destroys memory disease. This is in addition to the recent US FDA
and thinking skills and, eventually, the ability approval of aducanumab, which has the potential to
to carry out the simplest tasks is dreaded treat Alzheimer’s disease.
by all. Commonly known as Alzheimer’s disease,
the damage initially appears to take place in the Further, a new study has reported an association
hippocampus, the part of the brain essential in between a particular class of drugs used to treat
forming memories. Type 2 diabetes and decreased Alzheimer’s disease
biomarkers. Exactly how these diabetes drugs could
Damage to the brain begins years before exert neuroprotective effects is unclear, but experts
symptoms appear. The hardest fact of this disease are calling for large-scale clinical trials to explore this
is that it is impossible to diagnose Alzheimer’s in non-diabetic groups.
with complete accuracy while a person is alive. The
diagnosis can only be confirmed when the brain is This new research looked at a particular class of
examined under a microscope during an autopsy. diabetes drugs called dipeptidyl peptidase 4 inhibitors
However, specialists are able to make the correct (DPP-4i), also known as gliptins. During their
diagnosis up to 90 per cent of the time. experiments, scientists observed that people taking
DPP-4i to lower blood sugar levels had less amyloid in
The long standing theory suggests that the brain their brains overall, and it also showed lower levels in
of those afflicted with Alzheimer’s disease bear two areas of the brain involved in Alzheimer’s disease.
cellular hallmarks: clumps of amyloid-β, known as
plaques, which form outside the cells, and strings of a An Australian observational study has seen
protein called ‘tau’, known as neurofibrillary tangles, significantly slower rates of cognitive decline in
that form inside the cells. older diabetic patients on a drug called metformin,
compared to rates of decline seen in non-diabetic
Unless Alzheimer’s can be effectively treated or patients not taking the drug.
prevented, the number of afflicted will significantly
rise since the most important risk factor of Riluzole, a drug that has been used for more than
Alzheimer’s disease is advancing age. Estimates 20 years to slow the progression of motor neurone
vary, but experts suggest that the number of cases of affliction, Lou Gehrig’s disease seems promising.
Alzheimer’s in senior citizens across India in 2050 is A phase 2 study found that the drug slowed brain
projected to be about 4.6 million. metabolic decline and had a positive effect on
cognition in people with mild Alzheimer’s.
Currently there is no cure for Alzheimer’s
disease, but a number of drugs are available that Moreover, an international research team led by
can temporarily reduce the symptoms. For instance, scientists at the Hong Kong University of Science
acetylcholinesterase (AChE) inhibitors such as and Technology has developed a genome-editing
donepezil, galantamine and rivastigmine can be technology that could become a ‘once-and-for-
prescribed for people with early- to mid-stage all’ treatment for people with a family history of
Alzheimer’s disease. While memantine is used for Alzheimer’s disease. As the first demonstration of
moderate or severe Alzheimer’s disease. It is suitable efficient brain-wide genome editing to alleviate
for those who cannot take or are unable to tolerate Alzheimer’s disease pathology throughout the whole
AChE inhibitors. brain, this is really an exciting development.

However, an exciting turn in Alzheimer’s research As we observe World Alzheimer’s Day on
has recently been brought about by two pharma September 21, we look forward to more exciting and
companies in the US (Biogen) and Japan (Eisai) after fruitful developments that could help us get rid of this
their new drug candidate received breakthrough neurodegenerative condition in the years to come.
therapy designation by the US Food and Drug
Administration (FDA) for treating Alzheimer’s Dr Manbeena Chawla
Executive Editor

[email protected]