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#MAKEINDIACOVID-19FREE

Multiplying efforts to beat COVID-19

The government along with the industry is exploring every other possibility to combat the COVID-19 pandemic whether in the form of vaccines, drugs, diagnostic tests, medical equipment or therapeutic interventions. The major objective is to develop a long term solution by pooling proper resources, sharing knowledge and collaboration.

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Published by MMA Media, 2020-04-30 11:56:38

BioSpectrum India May 2020

#MAKEINDIACOVID-19FREE

Multiplying efforts to beat COVID-19

The government along with the industry is exploring every other possibility to combat the COVID-19 pandemic whether in the form of vaccines, drugs, diagnostic tests, medical equipment or therapeutic interventions. The major objective is to develop a long term solution by pooling proper resources, sharing knowledge and collaboration.

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

COVER STORY 18................................................................................................................ COVER
DESIGN BY:
MULTIPLYING DOMINIX STRATEGIC
EFFORTS TO BEAT DESIGN PVT. LTD.

DRUG
REPURPOSING

VACCINES EQUIPMMENETD&ICGAELARS

DIAGNOSTICS ITNHTEERRAVPEENUTITOICNS

The government along with the industry is exploring every other possibility to combat the
COVID-19 pandemic whether in the form of vaccines, drugs, diagnostic tests, medical
equipment or therapeutic interventions. The major objective is to develop a long term
solution by pooling proper resources, sharing knowledge and collaboration.

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com TOPVIDEO BIO CONTENT 5

COVID-19 Dr Suresh Jadhav,
29 Executive Director
(ED), Serum
A relief or aded threat for India? Institute of India,
Pune shares his
views on the
economic impact
of COVID-19.

33 Scan the QR Code »

Emerging stronger: Bioscience businesses Dr. Priti V. Warke,
Director- Cell Culture,
in and beyond the war on COVID-19 Head- Regulatory
Affairs, HiMedia
36 Laboratories,
Mumbai talks about
BioSpectrum webinar on the challenges
“Exploring various aspects of COVID-19” associated with
mass testing in India.
“Indian economy will take
2-3 years to come back to normal position” Scan the QR Code »

39 Dr Taslimarif Saiyed,
CEO & Director,
Time to build Centre for Cellular
Indian Medtech industry and Molecular
to global reckoning Platforms (C-CAMP),
Dr Satya Prakash Dash, Bengaluru reflects
on how to be more
Industry Thought Leader, New Delhi prepared for a future
pandemic.
REGULARS
Scan the QR Code »
BioEdit........................................................................06
BioMail........................................................................08
Policy and Regulatory News.....................................10
Company News..........................................................12
Start-up News............................................................15
WHO News.................................................................17
Supplier News............................................................44
R&D News...................................................................46
People News..............................................................48

6 BIO CONTENT BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

Fast Tracking Solutions

COVID-19 outbreak scene is changing but speeding up the production and taking it to
every day, globally and also in India. At massive scale is the key. Lockdown and increasing
many places in the country the situation is supply of test kits are after all local actions and
turning from bad to worse with growing number with limited effect.
of patients detected with the virus. At several
others, it is improving with number of affected The real lasting solution will have to be in
people going down or even coming to zero. finding a vaccine and/or medicine. News columns
Wherever situation is improving relaxation in are flooded each day with various actions going
some economic activities with lot of restrictions is on at various places globally for the development
being allowed. Still, it appears to be too early for of a vaccine. Several scientists, institutes are
relaxation even in green zones. Wherever situation engaged in these efforts. For example, Hyderabad
is not improving lockdown periods have not only based Indian immunological Limited (IIL) has
been extended but even more restrictions are being joined hands with Griffith University in Australia
imposed rightly so as an important step to control to develop vaccine for COVID-19. Efforts are on
and subsequently reduce the effects. at almost 70 places to find out solution in the
form of vaccine or medicine to cure COVID-19. At
However, there are limits as to how much some places the work is in advanced stage and has
period such lockdown can be continued and even already reached to clinical trials stage.
if it is continued how to implement it effectively.
Though it has been proved to be effective to a Various existing medicines, like for ebola,
certain extent, it cannot be a long time solution for malaria etc, are also being tested. Some
the whole country. It also seems to be not enough. combinations of medicines are also being tested.
The country will have to look at models which have Some of them have shown encouraging results.
managed to control the outbreak. Plasma from the blood of recovered patients
is also being tested hoping that antibodies in
South Korea’s example is constantly quoted. the blood will help, to build immunity in other
When it comes to the ratio of affected people and patients. News reports claim of all these different
deaths Germany is quoted often as it has managed treatments working positively at different places.
to restrict deaths to less percentage. In India itself, But due to emergency situation the tests are not
Kerala state and Bhilwada district in Rajasthan being conducted in 100 per cent scientific way and
have shown examples of controlling the outbreak. hence their results are not yet fully acceptable.
The affected states will have to pick up suitable There are issues like smaller sample sizes or not
factors from these models for fast implementation. conducting tests following all the accepted norms
and rules. Researchers will have to overcome this
It appears that two things will be needed to gap fast to come out with completely tested specific
be done on war footing. Increasing the number remedies as early as possible considering the fast
of testing and speeding up the efforts to find spread.
vaccine and medicine to fight the disease. The first
is of course domestic action while the second is Whatever efforts are done even in an expediting
globally. way, still, it is going to take some time. So, till then
gearing up tests and increasing them to maximum
For increasing the number of testing, as level is the only solution. India is currently one
Germany did, testing kits will be needed in large among those countries having the lowest percentage
number. It is good that a Pune based company’s of tests. This needs to change fast.
testing kit is approved and it has started its
production. Two prominent investors have Milind Kokje
invested funds in it for more production. Few more Chief Editor
companies have also come forward with new kits,
[email protected]



8 BIO MMAAILIL BIBOISOPSEPCETCRTURMUM | | APMRAILY 22002200 || wwwwww..bbiioossppeeccttrruummiinnddiiaa..ccoomm

VVooll 1188;; IIssssuuee 43;; AMparriclh20220020

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CfeOatVuIrDin-g19BohuatrbarteBaikoitsecahn. interesting Prashanth Reddy, Founder & Director,

read. Trivitron Healthcare is committed Anv-ayMaauKrainliCdahraer, aHny,dHeryadbeardabhads come

to combating this crisis. Thank you for out well.

your support. - Rolly Agarwal, Bengaluru

Thank you for- tGhaeulorvaevlyJcaoivne,raNgeewinDtehlheiMarch edition celebrating womanhood.

- Subhadra Dravida, Hyderabad

Thank you so much for covering the

The feature on Syngene International interaction with Luca Visini, Managing

lIotoisksa gmreaatte. rTohfapnrkidyeouto. figure in the top 10 ofDthireeLcitfoer,SEcileinLciellsyianncdubCaotmorpsainyth(Iendia)

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- Prof. Appa- ARmaobPuojadKilea,sHhyadepr,aGbaudrugram

The interaction with BaselArea.swiss has come out very well in the March edition.
- Krishna Bhatia, Mumbai

Vol 18; Isssuuee45;; AMparyil 220020 MM Activ Sci-Tech Communications

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

ICMR approves Govt sanctions Rs 15000 Cr for
plasma COVID-19 response package
therapy trials
for COVID-19 Government of India has the development of diagnostics
announced significant and COVID-19 dedicated
The Indian Council of investments to the tune of treatment facilities, centralized
Medical Research (ICMR) has Rs15000 crore for ‘India procurement of essential
sought letters of intent from COVID-19 Emergency medical equipment and drugs
institutions with necessary Response and Health System required for treatment of
equipment and infrastructure Preparedness Package’. The infected patients, strengthen
to participate in a clinical trial funds sanctioned will be utilized and build resilient National and
to study safety and efficacy of for immediate COVID-19 State health systems to support
therapeutic plasma exchange in Emergency Response (amount prevention and preparedness
COVID-19 patients, subsequent of Rs 7774 crore) and rest for for future disease outbreaks,
to necessary approvals and medium-term support (1-4 setting up of laboratories
clearances. The project is years) to be provided under and bolster surveillance
named ‘Multi-center, Phase mission mode approach. The activities, bio-security
II, Open Label, Randomized key objectives of the package preparedness, pandemic
Controlled Study of include mounting emergency research and proactively engage
Therapeutic Plasma Exchange response to slow and limit communities and conduct risk
in COVID-19’. The Therapeutic COVID-19 in India through communication activities.
Plasma Exchange (TPE) is an
experimental procedure for AYUSH Ministry
critically ill COVID-19 patients. works on scientific
The primary objective of the solutions for COVID-19
study is to assess the efficacy of
TPE in improving the clinical AYUSH Ministry has initiated action on the Prime Minister’s advice
status of COVID-19 patients to work for scientific evidence based solutions from the AYUSH
and to evaluate the safety of systems to restrain the spread of the
treatment with anti SARS- pandemic by setting up a channel
CoV-2 plasma in patients with to enlist various suggestions and
COVID-19. proposals from AYUSH practitioners
and AYUSH institutions, and having
them examined for viability through a
group of scientists. The Ministry is to
set up an online channel on its website
for receiving suggestions based on
scientific explanations and proposals
on therapies and procedures prepared based on standard scientific
guidelines that could restrain the spread of the COVID -19 pandemic.

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com POLICY AND REGULATORY NEWS 11

Cabinet approves development DBT sets
of 3 mega bulk drug parks
up Indian
The Union Cabinet chaired by drug intermediates and active
the Prime Minister, Narendra pharmaceutical ingredients (APIs) Biological
Modi has approved the scheme on in the country with financial
promotion of bulk drug parks for implications of Rs 6,940 crore for Data Centre
financing common infrastructure next eight years. The decision has
facilities in 3 bulk drug parks been made to develop 3 mega Bulk The Department of
with financial implication of Rs Drug parks in India in partnership Biotechnology (DBT)
3,000 crore for next five years. with states. The parks will have has established the
The Cabinet has also approved common facilities such as solvent country’s first national
the production linked incentive recovery plant, distillation plant, Indian Biological Data
(PLI) scheme for promotion of power and steam units, common Centre (IBDC) for
domestic manufacturing of critical effluent treatment plant etc. deposition, storage,
annotation and
DST sets up COVID-19 task force sharing of biological
data generated in
The Department of Science and these solutions include masks and the country through
Technology (DST) is coordinating other protective gear, sanitizers, extensive funding from
an effort to upscale appropriate affordable kits for screening, various government
technologies and manufacturing ventilators and oxygenators, data organizations. The
available in India for addressing a analytics for tracking, monitoring, IBDC will enable life
plethora of issues related science researchers
to COVID-19, as well and controlling the spread of to deposit biological
as scout for new and outbreak through artificial data in a central
developing solutions intelligence (AI) and Internet of repository and thus
more relevant to the things (IoT) based solutions, to safeguard data
country to help prepare name a few. generated using public
the country for exigencies resources from loss.
arising out of COVID-19 It will perform quality
pandemic. DST has set control, curation, and
up a COVID 19 Task annotation of data.
Force for mapping These efforts will help
of technologies from establish benchmarks
R&D labs, academic for the quality of data
institutions, startups, and MSMEs to deposited and thus
fund nearly market-ready solutions improve the quality of
in the area of diagnostics, testing, experimental research
health care delivery solutions, conducted in the
and equipment supplies. Some of country. It will also
facilitate distribution
of biological data
to researchers for
further analysis and
the discovery of
emergent properties
in biological systems.
IBDC will also conduct
training programmes
on data storage and
analytics to help
increase the number
of manpower skilled
in data science in the
country.

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

Stempeutics Research explores
stem cell therapy for COVID-19 treatment

Bengaluru based treating critically ill COVID-19 the product on a
Stempeutics Research, patients with lung disease. First regular basis. In this
a group company of the product will be clinically connection it is signing
Manipal Education tested and upon successful up an alliance with
and Medical Group outcomes, it intends to export Educell Ltd, Slovenia.
(MEMG), announced Stempeucel is an
that it has partnered allogeneic, off the shelf,
with Global pooled mesenchymal
Consortium of cell stromal cells having
therapy companies antiinflammatory and
seeking European immune-modulatory
Commission Funding properties which
to Fight Against Corona prevents the over
(FAC). Under this partnership, activation of the immune system.
Stempeutics will export its stem Stempeucel product exhibits a
cell product Stempeucel (subject wide range of potent therapeutic
to regulatory approvals) for properties.

DCGI approves Excelra releases
Roche’s Atezolizumab for COVID-19 drug
breast cancer treatment repurposing database

Roche India has announced the launch of Hyderabad based Excelra, a leading global
Atezolizumab for the treatment of metastatic data and analytics company has announced
triple-negative breast cancer (TNBC) in India. the release of the COVID-19 Drug Repurposing
Atezolizumab (cancer immunotherapy drug) in Database. The open-access database presents
combination with nab-Paclitaxel (chemotherapy) a compilation of previously approved small
can now be used as a first-line treatment for TNBC molecules and biologics with known preclinical,
patients. This approval from the Drug Controller pharmacokinetic, pharmacodynamic, and
General of India (DCGI) is based on the data from toxicity profiles that can rapidly enter either
phase III IMpassion130 study according to which Phase 2 or 3 clinical trials on fast track basis
Atezolizumab is proven to significantly reduce the for COVID-19. In addition, the database also
risk of disease worsening or death (PFS) in the includes information on promising drug
intention-to-treat and PD-L1 positive population candidates that are in various ‘clinical, pre-
with metastatic or unresectable locally advanced clinical and experimental’ stages of drug
triple-negative breast cancer (TNBC). discovery and development for COVID-19.

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COMPANY NEWS 13

IIL to lead research collaboration Bharat Biotech
for COVID-19 vaccine to develop one
drop COVID-19
Hyderabad based Indian Attenuated SARS – CoV-2 vaccine’ nasal vaccine
Immunologicals Limited (IIL), or COVID-19 vaccine using the
has announced that the company latest codon de-optimization Hyderabad based Bharat
is going to commence research technology. The technology Biotech has announced that
for developing a vaccine for looks promising for developing a a unique intranasal vaccine
COVID-19. The vaccine maker vaccine for prophylactic, active, for coronavirus CoroFlu
has joined hands with Griffith single dose immunization against is under development. An
University of Australia by coronavirus in humans, with international collaboration of
entering into an agreement for an enhanced safety profile. The virologists at the University
research collaboration to conduct vaccine is expected to provide of Wisconsin–Madison and
exploratory research to develop long-lasting protection with a the vaccine companies FluGen
a lead vaccine candidate for single dose administration with along with Bharat Biotech has
coronavirus. In this significant an anticipated safety profile begun the development and
cross-continental collaboration, similar to other licensed vaccines testing of a unique vaccine
scientists will develop a ‘Live for active immunization. Upon against COVID-19 called
completion of the research, the CoroFlu. CoroFlu will build on
vaccine strain will be transferred the backbone of FluGen’s flu
to IIL and the company will vaccine candidate known as
work accordingly with the M2SR. Based on an invention
Central Drugs Standard Control by UW­–Madison virologists
Organisation (CDSCO) to further and FluGen co-founders
conduct clinical trials which will Yoshihiro Kawaoka and
be taken up in a phased manner. Gabriele Neumann, M2SR is
IIL intends to use its existing Vero a self-limiting version of the
cell platform technology for mass influenza virus that induces an
production of the virus. immune response against the
flu. Kawaoka’s lab will insert
Premas Biotech gene sequences from SARS-
steps up to fight COVID-19 CoV-2, the novel coronavirus
that causes the disease
US based Akers Biosciences, Inc., a developer of rapid health information COVID-19, into M2SR so
technologies, has announced that it has acquired a licensing agreement that the new vaccine will also
with Gurugram based Premas Biotech, under which Akers will in- induce immunity against the
license a novel coronavirus vaccine candidate under development coronavirus.
by Premas using Premas’
genetically engineered S.
cerevisiae platform, D-Crypt,
and partner with Premas to
ultimately seek FDA approval.
Premas is utilizing its D-Crypt
platform to recombinantly
express the major structural
proteins of the coronavirus.
Based on genetically
engineered baker’s yeast S.
cerevisiae, D-Crypt is highly
scalable into commercial production quantities and has been previously
utilized for the production of multiple human and animal health vaccines
candidates during its 10-year development track record.

14 COMPANY NEWS BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

Dr. Reddy’s launches leukemia drug in India

Dr. Reddy’s Laboratories has launch of Invista is a significant Dr. Reddy’s Invista is available
announced the launch of Invista, step forward in improving access in strengths of 50, 70 and 100
a formulation of Dasatinib that to medicines at an affordable mg tablets. Chronic Myeloid
is bioequivalent to the innovator price for CML patients in India. Leukemia is a type of blood-cell
brand. It is indicated for the cancer that begins in the bone
treatment of chronic accelerated marrow. The median age of the
or myeloid or lymphoid blast patients in India is a decade
phase and newly diagnosed in earlier than the west, and every
chronic phase adult patients with year about nine thousand new
Chronic Myeloid Leukemia (CML) patients are diagnosed in the
in India. The development and country.

Mapmygenome launches Syngene opens
Genomepatri Immunity COVID-19
RT-PCR test centre
Hyderabad based improving patient in Bengaluru
Mapmygenome announces outcomes. Doctors can
the launch of a new report identify patients at risk for Syngene International, a global
called Genomepatri cytokine storms and use research and development services
Immunity. It contains the pharmacogenomics company, has announced the opening
genetic risk factors for an information to devise of a COVID-19 testing laboratory at
array of immune system personalised treatment its Bengaluru site. In less than six
diseases along with some plans. Mapmygenome’s weeks, the company used its expertise
lifestyle diseases like current Genomepatri in clinical trial management, human
diabetes, heart disease customers have clinical sample testing procedures,
and other comorbidities already received a free molecular biology and viral testing
that affect overall health COVID-19 immunity to gain the additional approvals,
status and immune and risk panel report. including ICMR approval, necessary
function and thus, the This report contains to open the facility to support
severity of symptoms/ SARS-CoV susceptibility hospitals in the city. Syngene has
infection. The report also and severity (cytokine repurposed one of its laboratories
includes a person’s genetic storm) and predicts to conduct the RT-PCR tests. A
response to a variety of genetic predisposition dedicated team of scientists has been
drugs including antivirals to immunity associated trained to perform these tests as per
and antifungals, and levels disease risk factors, the guidelines prescribed by national
of various vitamins and nutrition elements such and global regulatory authorities.
minerals.This is not a as zinc and vitamin levels Necessary processes have been
diagnostic test but it has as well as response to established for safe handling of the
a potential in prevention, medications such as samples and testing kits have been
early screening, and chloroquine and abacavir. sourced and validated.

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

C-CAMP, UNHIE and Social Alpha
seek innovative ways to fight COVID-19

Bengaluru based Centre for Cellular and Molecular pilot scale deployment, scaling through industry
Platforms or C-CAMP in partnership with United partnership, facilitating regulatory pathway as well as
Nations Health Innovation Exchange (UNHIE) and connecting with investors.
Social Alpha is interacting with innovators, startups
and entrepreneurs for breakthrough innovations that
are ready to deploy immediately or in the near future.
The special COVID-19 focused accelerator named as
COVID-19 Innovations Deployment Accelerator or
CIDA has been established to align near deployment-
ready innovations with unmet needs and help them
overcome last-mile gaps wherever and howsoever
possible. Based on a case-by-case assessment, CIDA
will help in fast-tracking promising innovations for

Marico calls for Aerobiosys
innovations to address builds emergency
COVID-19 crisis use ventilator

In response to the from across the nation to Indian Institute of Technology, Hyderabad,
growing seriousness of meaningfully contribute Center for Healthcare Entrepreneurship
the COVID-19 pandemic towards mitigating the (CfHE) incubated startup Aerobiosys
that has engulfed the risk of the outbreak. Innovations has developed a low-cost,
world and now threatens The purpose of the portable, emergency-use ventilator. Called
the Indian healthcare grand challenge is to Jeevan Lite, this device offers protection to
systems and economy combat short-supply healthcare providers as well as it is Internet
alike, the Marico of ventilators, personal of Things-enabled and can be operated
Innovation Foundation protective equipment through a phone app. It can also be battery-
has launched the first of and other respiratory operated, enabling its deployment in areas
its kind grand challenge solutions that can aid the without assured power supply. Jeevan Lite
#Innovate2BeatCOVID. medical fraternity. They can perform both the invasive and non-
With this dynamic format, are looking for existing invasive ventilation across a comprehensive
Marico Innovation innovative solutions that set of modes and settings. It can be used for
Foundation and A.T.E can be modified and pediatric and adult patients and will work
Chandra Foundation scaled immediately. As on rechargeable lithium-ion batteries in an
have come together to the pandemic progresses, uninterrupted manner for five hours without
offer a total grant value the grand challenge power supply.
of Rs 2.5 crore. The may expand to other
programme calls out items of critical need in
medtech entrepreneurs, consultation with medical
corporates and innovators experts.

16 START UP NEWS BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

JClean develops novel disinfectant technology

Pune based startup JClean of them will soon be ready for & fungal infections in a closed
Weather Technologies is offering installation in various hospitals environment, could clean up the air
an effective solution for India’s in Maharashtra. The negative ion & disinfect areas which are exposed
fight against COVID-19 by reducing generator titled ScitechAiron, which to the infection through COVID-19
the viral load of infected areas helps to control the virus, bacteria, positive cases & suspects.
within a room significantly in an
hour. The technology has been
developed under the NIDHI
PRAYAS programme initiated
by the Department of Science
and Technology (DST). DST has
released Rs 1 crore to manufacture
and scale up the product, & 1000

Bione unveils Seagull BioSolutions
home screening test gears up for
kit for COVID-19 COVID-19 vaccine

Bengaluru based startup Bione has launched a rapid Seagull BioSolutions, a Pune based startup
COVID-19 at-home screening test kit. The easy-to- working on new biological technologies, is
use kit displays accurate results within minutes, being funded by the Department of Science
instrumental in the timely screening of the deadly and Technology (DST), to undertake the
virus. The at-home screening kit is available for development of Active Virosome (AV)-Vaccine
sale on company’s platform after approval from the and Immunodiagnostic kits for COVID-19
requisite medical regulatory authorities. The kit is emergency. Active Virosome Technology (AVT)
priced between Rs 2000 and Rs 3000 depending is useful for the
upon the global supply, to increase its affordability production of
for the masses. Under normal circumstances, the vaccines and
ready-to-use kits can be received within 2-3 days immunotherapeutic
of placing the order at their platform. An effective agents. The
screening tool for mass screening, the organisation is AVT platform
also in talks to provide bulk orders for early detection. is useful for
COVID-19 screening test kit is an IgG & IgM based producing novel,
tool which takes 5-10 minutes to deliver the results. non-hazardous
Upon receiving the kit, the users are required to clean & economical
their finger with an alcohol swab and use the lancet active virosome
provided to finger-prick. The cartridge provided reads agents expressing
the results from the blood sample thus obtained, desired antigens from the target pathogen.
within 5-10 minutes. These will be used to develop a novel vaccine for
the prevention of COVID-19 infection and also
immunodiagnostic ELISA kits for COVID-19.
The Immunodiagnostic kits are expected to be
ready for field trials by the end of August 2020
and expected to get approval in the next 10-11
months. On the other hand, the AV vaccine is
expected to take a longer time. However, given
the emergency situation, the startup aims to
complete the proof of concept in 80 days and
complete preclinical development and start
Phase I trial in the next 18-20 months.

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com WHO NEWS 17

WHO and WHO issues new
UNICEF partner on recommendations
pandemic response for TB prevention

World Health Organisation (WHO) and WHO has recommended a scale-up of tuberculosis (TB)
United Nations Children’s Fund (UNICEF) preventive treatment among populations at highest risk
have announced an agreement to work including household contacts of TB patients, people
together on COVID-19 response, through the living with HIV and other people at risk with lowered
historic COVID-19 Solidarity Response Fund immunity or living in crowded settings. There should be
powered by the United Nations Foundation an integration of TB preventive treatment services into
and Swiss Philanthropy Foundation. The ongoing case finding efforts for active TB. All household
money collected through the fund will be used, contacts of TB patients and people living with HIV are
among others, to train and equip communities recommended to be screened for active TB. If active TB
and health-care workers to prevent, detect and is ruled out, they should be initiated on TB preventive
treat COVID-19. It will help countries expand treatment. Either a tuberculin skin test or interferon-
their healthcare capacity and mitigate its social gamma release assay (IGRA) should be used to test for
impact, especially on women, children and TB infection. Both tests are helpful to find people more
vulnerable social groups. And it will accelerate likely to benefit from TB preventive treatment but should
research and development of treatments and not become a barrier to scale-up access. Testing for TB
preventive vaccines. As a key partner in this infection is not required before starting TB preventive
joined-up effort, UNICEF will lead emergency treatment in people living with HIV, and children under
efforts to ensure families and communities 5 years who are contacts of people with active TB.
in the most vulnerable countries are fully
engaged in the response and have access
to water, sanitation and hygiene and other
infection prevention and control measures.

WHO, UN launch COVID-19 Solidarity Response Fund

World Health Organisation to global response efforts, and all countries, particularly those
(WHO), UN Foundation and has been created by the United most vulnerable and at-risk, and
partners have launched first-of- Nations Foundation and the with the weakest health systems
its-kind COVID-19 Solidarity Swiss Philanthropy Foundation, to prepare for and respond to
Response Fund. It will raise money together with WHO. Funds will the COVID-19 crisis including
from a wide range of donors to go towards actions outlined in the rapidly detecting cases, stopping
support the work of the World COVID-19 Strategic Preparedness transmission of the virus, and
Health Organization (WHO) and and Response Plan to enable caring for those affected.
partners to help countries respond
to the COVID-19 pandemic. The
fund enables private individuals,
corporations and institutions
anywhere in the world to come
together to directly contribute

18 COVER STORY BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

MULTIPLYING

EFFORTS TO BEAT

DRUG
REPURPOSING

VACCINES

DIAGNOSTICS

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

The government along The unprecedented COVID-19 pandemic has
with the industry is thrown a new set of challenges and opportunities
to the entire world. This pandemic is a wakeup
exploring every other call on how fast a contagion can spread in a globalised
possibility to combat world and the damage it could do to a civilization.
the COVID-19 pandemic The spillover effects of COVID-19 are seeping into a
multitude of industries, by disrupting supply chains and
whether in the form crippling many business sectors globally.
of vaccines, drugs,
diagnostic tests, medical It has not only posed a risk to the health of people
equipment or therapeutic but has also brought forward an imminent threat to
interventions. The major the health of economies across the globe. Although the
objective is to develop number of cases in India are far less than some of the
a long term solution by majorly affected countries, India is no exception to the
pooling proper resources, current exigency.
sharing knowledge and
The government along with the industry is exploring
collaboration. every other possibility to combat this pandemic whether
in the form of vaccines, drugs, diagnostic tests, medical
EQUIPMMENETD&ICGAELARS equipment or therapeutic interventions. The major
objective is to develop a long term solution by pooling
ITNHTEERRAVPEENUTITOICNS proper resources, sharing knowledge and collaboration.

“The Central Government has provisioned Rs
15000 crore for treating coronavirus patients and
strengthening the medical infrastructure of the
country. This will allow for rapidly ramping up
the number of corona testing facilities, Personal
Protective Equipment (PPE), isolation beds, ICU
beds, ventilators and other essential equipment.
Simultaneously, training of medical and paramedical
manpower will also be undertaken. I have requested
the State Governments to ensure that only healthcare
is treated as their first and topmost priority now,”
states Prime Minister Narendra Modi.

Diagnostics

In response to the growing COVID-19 pandemic, the
scientific community and the industry are developing
rapid and easy-to-use diagnostic devices. One such
example is of ChitraGeneLAMP-N test developed
by Thiruvananthapuram based Sree Chitra Tirunal
Institute for Medical Sciences and Technology
(SCTIMST). The confirmatory diagnostic test, which
detects the N Gene of SARS- CoV-2 using reverse
transcriptase loop-mediated amplification of viral
nucleic acid (RT-LAMP), is one of the world’s first few if
not the first of its kinds in the world.

The test kit, funded by the Department of Science
& Technology (DST) is highly specific for SARS-CoV-2
N-gene and can detect two regions of the gene, which
will ensure that the test does not fail even if one region
of the viral gene undergoes mutation during its current
spread. The detection time is 10 minutes, and the
sample to result time is less than 2 hours.

Similarly, Pune based startup FastSense Diagnostics
has rolled out a modified polymerase chain reaction
(PCR) based detection kit for confirmatory analysis in

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

“The Central Government has lesser time compared to existing detection methods.
provisioned Rs 15000 crore for The kit can test approximately 50 samples in an hour.
treating coronavirus patients The startup has also developed a portable chip based
and strengthening the medical module for rapid screening of target population based
infrastructure of the country. This on the on-chip sensing technology that can provide on
will allow for rapidly ramping up the the spot results in less than 15 minutes per sample. The
number of corona testing facilities, sample size for confirmatory tests can also be increased
Personal Protective Equipment (PPE), in the future to 100 samples/ hour.
isolation beds, ICU beds, ventilators
and other essential equipment. Now although Reverse Transcription Quantitative
Simultaneously, training of medical Polymerase Chain Reaction (RT-qPCR) based assayis
and paramedical manpower will also a highly sensitive test for detecting SARS-CoV-2, it has
be undertaken. I have requested the its limitations. The test can be used for early diagnosis
State Governments to ensure that only of the disease but the situation today demands
healthcare is treated as their first and surveillance along with diagnosis.

top most priority now”. As a result, the attention has now shifted to
- NARENDRA MODI serological immunoassays that detect viral-specific
antibodies (IgM and IgG) or antigens. These serological
Prime Minister of India assays can be tested on seemingly healthy people who
may have been infected with COVID-19 in the past
but recovered without showing any symptoms. This is
done by measuring the amount of antibodies from their
blood samples.

Till date, 16 antibody based rapid tests for
COVID-19 have been validated at the Indian Council of
Medical Research- National Institute of Virology (NIV)
Pune, and 13 have been found to be satisfactory.

Understanding this need of the hour, Module
Innovations, based in Pune, is currently developing
a testing device called nCoVSENSe for detection
of antibodies that have been generated against the
COVID-19 in the human body. The test is aimed at
detecting the IgG and IgM antibodies generated in the
human body upon the onset of viral infection and is
targeted against the spike proteins making it specific for
COVID-19. The startup is planning to deploy the test in
a time of 2 months after due validation with national
agencies.

“Upon infection with the SARS-CoV-2 virus, the
patient’s immune system tries to fight the virus by
producing blood-circulating molecules known as
antibodies. IgM is a class of antibodies that appears
early after an infection (as early as 3-5 days). IgG is
another class of antibodies that appears later and
gradually replaces the IgM antibodies. Usually, IgG
antibodies appear in the blood circulation after 7-10
daysof the exposure. The presence of SARS-CoV-2-
specific IgM and/or IgG antibodies in the blood of a
patient is a strong indication that the patient has been
infected with the SARS-CoV-2 virus”, explains Sachin
Dubey, CEO & Co-Founder, Module Innovations, Pune.

Another startup in Pune, Seagull BioSolutions based
out of Entrepreneurship Development Center (Venture
Center) and supported under the Seed Support System
of the Technology Development Board (TDB), DST,
is developing immunodiagnostic kits- IgM capturing

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

ELISA kits, IgG type antibody detecting ELISA kits, “After evaluating various options
and a Lateral flow (LFA) immunodiagnostic test, being followed across the world, we
for COVID-19 detection. The startup expects the decided to develop a live attenuated
immunodiagnostic kits to be ready for field trials by the COVID-19 vaccine based on codon
end of August 2020. de-optimization technology. With our
dedicated research and development
Amongst the many other attempts being made by capabilities supported with excellent
the industry in the diagnostic space, Bengaluru based team of scientists and engineers, IIL
startup Bione has developed a rapid COVID-19 at- is committed to developing high-
home screening test kit which is an IgG & IgM based quality vaccines that are affordable.
tool which takes 5-10 minutes to deliver the results. We are confident that this new cross-
The kit is approved by theIndian Council of Medical continental collaboration will yield the
Research(ICMR) and will be deployed in the market desired results”.
after proper quality checks and assurance. - DR PRASANNA DESHPANDE
Deputy Managing Director, Indian
Vaccines Immunologicals Limited, Hyderabad

More than 60 candidate vaccines are currently in “From the clinical data using
development, worldwide, and several have entered Stempeucel in different clinical
early clinical trials in human volunteers, according to trials in other indications it may be
the World Health Organization (WHO). Few Indian postulated that the product has the
companies have also joined this fight by opting for potential capability for treating COVID
innovative approaches. 19 infection. Together with the safety
profile observed from DCGI approved
Pune based Serum Institute of India (SII) and clinical trials involving more than 350
Ahmedabad based ZydusCadila were the first to patients injected with Stempeucel
announce their plans for developing vaccine candidates by different routes of injection, this
against COVID-19. At present, the Department of therapy may help in mitigating the
Biotechnology (DBT) is providing funding support to lung tissue damaging effects of COVID
SII to carry out Phase III human clinical trials study of 19 infection”.
recombinant BCG vaccine (VPM1002) for COVID-19 - BN MANOHAR
treatment. Cadila Healthcare has also received support CEO, Stempeutics, Bengaluru
from DBT for advancing the development of its DNA
Vaccine candidate.

A recent announcement in this space came from
Hyderabad based company Bharat Biotech for the
development of a novel nasal vaccine. The unique
intranasal vaccine called CoroFlu is under development
with an international collaboration of virologists at
the University of Wisconsin–Madison and the vaccine
company FluGen in the US.

“We will manufacture the vaccine, conduct clinical
trials, and prepare to produce almost 300 million
doses of vaccine for global distribution. Under the
collaboration agreement, FluGen will transfer its
existing manufacturing processes to Bharat Biotech to
enable the company to scale up production and produce
the vaccine for clinical trials”, shares Dr Raches Ella,
Head of Business Development, Bharat Biotech,
Hyderabad.

In collaboration with US based Akers Biosciences,
Gurugram based Premas Biotech has also stepped
into the process of vaccine development to tackle this
outbreak. Premas is utilizing its D-Crypt platform to
recombinantly express the major structural proteins
of the coronavirus. Based on genetically engineered
baker’s yeast S. cerevisiae, D-Crypt is highly scalable
into commercial production quantities.

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

“Upon infection with the SARS-CoV-2 C-CAMP PICKS
virus, the patient’s immune system 25 NEAR DEPLOYMENT-READY
tries to fight the virus by producing COVID-19 SOLUTIONS

blood-circulating molecules known as Bengaluru based Centre for Cellular and Molecular
antibodies. IgM is a class of antibodies Platforms (C-CAMP) in partnership with United Nations
that appears early after an infection (as Health Innovation Exchange (UNHIE) and Social Alpha
early as 3-5 days). IgG is another class has developed a special COVID-19 focused accelerator
named as ‘COVID-19 Innovations Deployment
of antibodies that appears later and Accelerator’ (CIDA). So far, the accelerator has picked
gradually replaces the IgM antibodies. 25 near deployment-ready COVID-19 products, to help
tackle this outbreak. And the search continues. CIDA
Usually, IgG antibodies appear in the will help in fast-tracking promising innovations for pilot
blood circulation after 7-10 days of the scale deployment, scaling through industry partnership,
exposure. The presence of SARS-CoV- facilitating regulatory pathway as well as connecting
with investors. Selected innovations will also get fast
2-specific IgM and/or IgG antibodies track technology assessment and an opportunity for
in the blood of a patient is a strong scale-up investment and implementation support as
facilitated by UNHIE. Such an opportunity could be a
indication that the patient has been potential ticket to expand beyond India.
infected with the SARS-CoV-2 virus”. ● Biodesign Innovation Labs (Bengaluru) – Respiraid

- SACHIN DUBEY ventilation system
CEO & Co-Founder, ● Aerobiosys Innovations (Hyderabad)- Low-cost
Module Innovations, Pune
portable ventilator Jeevan Lite
“CDRI has inked a memorandum ● MedIoTek (Chennai)- Wireless health monitoring
of understanding (MoU) with King
George’s Medical University (KGMU) system
for the drug repurposing strategy. ● Cardiac Design Labs (Bengaluru)- Health monitoring
The m-protease, CL-proteinase, RNA-
dependent RNA polymerase, Spike system
● Nemocare (Hyderabad)- Comprehensive patient
protein-ACE2 system, and other
targets are presently being worked monitoring system
● Dozee (Bengaluru)- Health monitoring system
on. Their binding or inhibition will ● Leafbox Technologies (Bengaluru)- Air purifier
also be evaluated in in vitro and in ● Biomoneta (Bengaluru)- Decontamination technology
vivo systems with the help of sister ● Clensta Technologies (New Delhi)- Antimicrobial rub
● Blackfrog (Manipal)- Medical grade cold chain
laboratories and KGMU”.
- PROF. TAPAS KUMAR systems
Director, CDRI, Lucknow ● Tessol (Navi Mumbai)- Cold Chain logistics’ solution
● Omicsgen (Kerala)- Smart wipe gadget
● OMG Innovations LLP (New Delhi)- Herbal antiviral

spray
● CoSara Diagnostics (Ahmedabad)- Diagnostic test
● Ampligene Diagnostics (Ahmedabad)- Diagnostic

test
● Coeo Labs (Bengaluru)- Non-invasive ventilator
● Avyantra (Hyderabad)- Assisted respiratory device
● Anabio Technologies (Bengaluru)- Anti-viral spray
● Docturnal (Hyderabad)- Screening technology
● Salcit (Hyderabad)- Screening technology
● Predible (Bengaluru)- Screening technology
● AIkenist (Bengaluru)- Screening technology
● Stempeutics (Bengaluru)- Stem cell based therapy
● Huwel Life Sciences (Hyderabad)- Diagnostic test
● Ubiqare Health (Bengaluru)- Telemedicine support

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

Revealing more details, Prabuddha Kundu, Co- “The country needs to brace for a
Founder and Managing Director, Premas Biotech, dual war, one against COVID-19 and
Gurugram says, “We believe our platform has three key the other on the economy front. Due
advantages which will set our potential vaccine apart to COVID19, the demand of medical
in the industry. First, it has successfully expressed items like ventilator, PPE kits, masks
more than 30 proteins of similar profile to those in the and sanitizers have increased suddenly
structure of COVID-19. Second, the technology platform over the last one month. MSME is
is highly scalable with a robust process, which should playing an important role in filling
represent significant cost savings compared to other the gap by increasing the production
similar vaccine platforms. Third, the current global of these items. MSME Technology
pandemic might allow for an expedited FDA review Centres (TCs) are engaged in the
timeline based on recent pronouncements regarding manufacturing of sanitizers, masks,
other COVID-19 vaccine and treatment candidates. gowns, face shields and hospital
furniture and are ramping up the in
Hyderabad based Indian Immunologicals Limited house manufacturing. But this has to
(IIL) is also ramping up efforts to fight the pandemic. be done very quickly because of the
The company has joined hands with Australia based bulk requirements of these items”.
Griffith University to develop a vaccine using the latest - NITIN GADKARI
codon de-optimization technology. Upon completion of Union Minister of Micro, Small and
the research by Griffith University, the vaccine strain Medium Enterprises,
will be transferred to IIL to further conduct clinical Government of India, New Delhi
trials which will be taken up in a phased manner. IIL
intends to use its existing Vero cell platform technology “CCMB is using the epithelial cell line
for mass production of the virus. from African green monkey grown
in Petri dish to artificially culture and
“After evaluating various options being followed harvest the deadly virus. A few more
across the world, we decided to develop a live options of cell lines will be explored
attenuated COVID-19 vaccine based on codon de- to find the right one on which the
optimization technology. With our dedicated research novel coronavirus can infect, grow and
and development capabilities supported with excellent multiply.”
team of scientists and engineers, IIL is committed to - DR RAKESH MISHRA
developing high-quality vaccines that are affordable. Director, CCMB, Hyderabad
We are confident that this new cross-continental
collaboration will yield the desired results”, mentions
Dr Prasanna Deshpande, Deputy Managing Director,
Indian Immunologicals Limited, Hyderabad.

Bengaluru based Indian Institute of Science (IISc)
is also contributing to the vaccine space through its
startup Mynvax, founded by Dr Raghavan Varadarajan
and Dr Gautham Nadig. The team is trying to design
and test variants of the spike glycoprotein as vaccine
candidates against COVID-19. For this effort, the
startup is seeking a funding support of Rs15 crore.

“With critical, catalytic funding and support from
the Bill and Melinda Gates Foundation, a number
of spike protein derivatives have been designed and
characterized at IISc. These are being tested in animal
models. The design which shows the best results in
animals will be advanced to development of production
technology, safety and toxicity testing, followed by
GMP manufacturing for use in Phase-1 clinical trials.
We estimate that atleast 100 million doses will be
required to meet India’s requirement if the SARS-
CoV-2 infection persists for the medium to long-term”,
reveals Dr Raghavan Varadarajan, Professor, Molecular
Biophysics Unit, IISc, Bengaluru.

The government is equally geared up to fight this

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

“With critical, catalytic funding and outbreak by launching novel solutions. DST is funding
support from the Bill and Melinda Pune based Seagull BioSolutions to undertake the
development of an active virosome (AV) vaccine against
Gates Foundation, a number of COVID-19.
spike protein derivatives have been
designed and characterized at IISc. “Accurate diagnostics, breaking the chain of
transmission, therapy and preventive measures
These are being tested in animal including safe and effective vaccines are the
models. The design which shows foundational pillars of addressing the challenges of
COVID-19. Of these, developing vaccines has the
the best results in animals will longest timeline and so it is essential to fast track that
be advanced to development of activity now,” says Prof. Ashutosh Sharma, Secretary,
production technology, safety and DST, New Delhi.
toxicity testing, followed by GMP
manufacturing for use in Phase-1 On the other side, researchers from Hyderabad
clinical trials. We estimate that at least based Centre for Cellular and Molecular Biology
100 million doses will be required (CCMB) have embarked upon developing an inactivated
to meet India’s requirement if the virus vaccine for the dreaded novel coronavirus.
SARS-CoV-2 infection persists for the
Providing more information in this regard, Dr
medium to long-term”. Rakesh Mishra, Director, CCMB, Hyderabad says, “If
- DR RAGHAVAN VARADARAJAN we grow a large amount of virus and we can inactivate
Professor, Molecular Biophysics Unit, it that will be material for candidate vaccine to be
injected. Now the virus will not be active but the
IISc, Bengaluru human body will recognise the proteins of the virus
and start making antibodies against it. The important
“Accurate diagnostics, breaking technological challenge is culturing the virus outside of
the chain of transmission, therapy the human host. As the novel coronavirus has evolved
and preventive measures including to life on human cells, especially in cells with active
safe and effective vaccines are the ACE2 receptors, locating the right source of the cell
foundational pillars of addressing line to culture the virus outside of the human body is
the challenges of COVID-19. Of these, key to this technology. CCMB is using the epithelial cell
developing vaccines has the longest line from African green monkey grown in Petri dish to
timeline and so it is essential to fast artificially culture and harvest the deadly virus. A few
more options of cell lines will be explored to find the
track that activity now”. right one on which the novel coronavirus can infect,
- PROF. ASHUTOSH SHARMA grow and multiply.”

Secretary, DST, New Delhi But of course the process of developing a new
vaccine is a long one. Thus, an alternative strategy is
being employed for treating COVID-19 in the form an
already developed vaccine against leprosy. The Drug
Controller General of India (DCGI) has approved the
Mw vaccine to be tested and the trials have just begun.

Drug Repurposing

Knowing the fact that developing a new drug is
a lengthy process, few companies have started
investigating existing drugs in order to find a cure for
COVID-19. This strategy of drug repurposing offers
advantages over developing an entirely new drug for a
given indication.

Hyderabad based Excelra, a leading global data
and analytics company has released a COVID-19 drug
repurposing database that presents a compilation
of previously approved small molecules and
biologics with known preclinical, pharmacokinetic,
pharmacodynamic, and toxicity profiles that can
rapidly enter either phase 2 or 3 clinical trials on fast

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

track basis for COVID-19 treatment. In addition, the ANTIBODY BASED RAPID
database also includes information on promising drug TESTS APPROVED BY ICMR
candidates that are in various clinical, pre-clinical and
experimental stages of drug discovery and development S. Company Test
for COVID-19. No

NovaLead Pharma, a Pune based pioneer in the 1 BioMedomics COVID-19 IgM
field of drug repurposing, has deployed its proprietary (US) IgG Rapid Test
computational technology for identifying existing
drugs which may be potentially effective against the 2 Guangzhou Wondfo SARS-CoV-2
coronavirus as well as for minimizing its impact on Biotech (China), Antibody test
human body. Mylan Laboratories (Lateral flow
(Hyderabad) method)
“Use of existing drugs already approved by the
regulators can offer a huge relief in the short to medium 3 Zhuhai Livzon COVID-19 IgM/
term, if found effective against COVID-19. The major Diagnostics IgG Antibody
advantage with this approach is that the drugs being (China) Rapid Test
approved are already proved to be safe for humans,
are being actively manufactured and therefore can 4 Voxtur Bio New
be immediately put to use in a very short time. If (Gujarat) Coronavirus
successful, we can save lives and also prevent early (COVID-19) IgG/
infections from turning critical. The fight against IgM Rapid Test
COVID-19 is a race against time and we are deploying
whole of our computational infrastructure and 5 Vanguard COVID-19 IgM/
technology platform armed with Artificial Intelligence Diagnostics IgG Antibody
(AI) and Machine Learning (ML) techniques, along with (New Delhi) Detection Card
intensive statistical modeling and simulations”, says Test
Supreet Deshpande, CEO, NovaLead Pharma, Pune.
6 HLL Lifecare Makesure
On the academic front, a team of researchers at
the Lucknow based Central Drug Research Institute (Thiruvananthapuram) COVID-19 Rapid
(CDRI) are trying to repurpose some already existing
drugs that have been used by clinicians. The institution Test
has a diverse library of molecules and these have been
screened using in silico approaches against a panel of 7 CPC Diagnostics YHLO SARS-
drug targets from SARS-CoV-2 under the third vertical, (Chennai) CoV-2 IgM and
target-based screening systems. The identified hits will IgG detection
be evaluated in a preliminary drug-target-based screen. kit (additional
equipment
Providing more information on this development, required)
Prof. Tapas Kumar, Director, CDRI, Lucknow
shares,“CDRI has inked a memorandum of 8 Lab-Care Diagnostics ACCUCARE
understanding (MoU) with King George’s Medical
University (KGMU) for the drug repurposing strategy. (Mumbai) IgM/IgG Lateral
The m-protease, CL-proteinase, RNA-dependent RNA
polymerase, Spike protein-ACE2 system, and other Flow Assay kit
targets are presently being worked on. Their binding or
inhibition will also be evaluated in in vitro and in vivo 9 Alpine Biomedicals One Step
systems with the help of sister laboratories and KGMU.” (Ambala) Corona Virus
(COVID-19) IgM/
Medical equipment & gears IgG Antibody
Test
India with its fragile healthcare infrastructure is
struggling to cope up with the increasing number of 10 NuLifecare Abchek
cases every day. On one hand, there is a shortage of (New Delhi) COVID-19 IgM/
vital equipment such as face masks, personal protective IgG Antibody
equipment (PPE) etc. needed to protect healthcare staff Rapid Test
from catching infections, while on the other, the urgent
need for ventilators is at the heart of the demand. 11 SD Biosensor Standard Q
(South Korea) Covid -19 IgM/
The government is working round the clock to IgG Duo test –
One Step Rapid
Antibody test

12 Immunoscience India Immuno Quick

(Pune) Rapid Test for

Detection of

COVID-19 IgM/

IgG Antibodies

13 Medsource Ozone COVID 19 IgM/
Biomedicals IgG Rapid Test
(Faridabad) Kit

Source: ICMR

26 COVER STORY BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

“Use of existing drugs already approved meet these demands through innovative solutions.
by the regulators can offer a huge The Defence Research and Development Organisation
(DRDO) is taking a lead by coming up with a number of
relief in the short to medium term, if products such as a full body disinfection chamber, face
found effective against COVID-19. The protection mask, a portable sanitisation equipment and
major advantage with this approach a bio suit with seam sealing glue.
is that the drugs being approved are
already proved to be safe for humans, The Ministry of Micro, Small and Medium
are being actively manufactured and Enterprises (MSME) is also playing a role in
therefore can be immediately put to contributing to the fight against COVID-19. For
use in a very short time. If successful, example, MSME Technology Centre in Hyderabad
we can save lives and also prevent early is developing a prototype of an electro mechanical
ventilator based on sensors. Alongside, Mumbai
infections from turning critical. The based Institute for Design of Electrical Measuring
fight against COVID-19 is a race against Instruments (IDEMI) is developing an ion based
sanitizer. These are some of the many other activities
time and we are deploying whole of taken up by the MSME sector.
our computational infrastructure and
technology platform armed with AI and “The country needs to brace for a dual war, one
against COVID-19 and the other on the economy
ML techniques, along with intensive front. Due to COVID19, the demand of medical
statistical modeling and simulations”. items like ventilator, PPE kits, masks and sanitizers
have increased suddenly over the last one month.
- SUPREET DESHPANDE MSME is playing an important role in filling the
CEO, NovaLead Pharma, Pune gap by increasing the production of these items.
MSME Technology Centres (TCs) are engaged in the
“We will manufacture the vaccine, manufacturing of sanitizers, masks, gowns, face shields
conduct clinical trials, and prepare to and hospital furniture and are ramping up the in house
produce almost 300 million doses of manufacturing. But this has to be done very quickly
vaccine for global distribution. Under because of the bulk requirements of these items”, says
the collaboration agreement, FluGen Nitin Gadkari, Union Minister of Micro, Small and
will transfer its existing manufacturing Medium Enterprises, Government of India, New Delhi.
processes to Bharat Biotech to enable
the company to scale up production and Simultaneous efforts are being made by the
produce the vaccine for clinical trials”. Department of Science & Technology (DST) in ensuring
availability of sufficient equipment and gears to fight
- Dr Raches Ella this pandemic. Scientists at Thiruvananthapuram based
Head of Business Development, SCTIMST have developed a number of novel products
such as a disinfection gateway, facemask disposal
Bharat Biotech, Hyderabad bin, a super absorbent material for safe management
of infected respiratory secretions and a disinfected
barrier-examination booth for examining COVID-19
patients. As a recent development, the institute has tied
up with Wipro 3D, Bengaluru to jointly build up on a
prototype of an emergency ventilator system based on
Artificial Manual Breathing Unit.

The DST is also supporting a team of scientists from
the Indian Institute of Technology (IIT) Kanpur for
developing a protective coating that would greatly help
in making medicated masks and PPE. Another project
being funded by DST involves Pune based startup
Green Pyramid Biotech that has developed a natural,
alcohol-free sanitizer for hands and surfaces with long-
lasting antibacterial and antiviral effect.

Scientists associated with Council of Scientific
and Industrial Research (CSIR) are equally engaged
in devising a variety of protective equipment.
Bengaluru based National Aerospace Laboratories,

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COVER STORY 27

along with MAF Clothing, Bengaluru has developed “SCTIMST is the first to receive approval
polyproplylene spun laminated multi-layered non- from ICMR for carrying out plasma
woven fabric based coveralls for healthcare workers. therapy. Initially we will try in a small
In addition, Pune based National Chemical Laboratory number of patients. At present it is
(NCL) has partnered with Bharat Electronics for mass permitted as an experimental therapy
manufacturing of its recently developed hand held for restricted use for severely affected
digital infer red thermometer and oxygen enrichment patients only. Potential donor would
unit. Joining in these efforts, researchers at Durgapur be examined before the blood serum
based Central Mechanical Engineering Research is extracted and given to a sick person”.
Institute have designed disinfection walkways and road - DR ASHA KISHORE
sanitizer units to help in countering the menacing virus. Director, SCTIMST, Thiruvananthapuram
On behalf of the Ministry of Chemicals and Fertilizers,
researchers at the National Institute of Pharmaceutical “We believe our platform has three
Education and Research (NIPER) in Guwahati have key advantages which will set our
developed a novel 3D-printed hands-free object and potential vaccine apart in the industry.
a 3D-printed antimicrobial face-shield to control the First, it has successfully expressed
spread of the coronavirus. more than 30 proteins of similar profile
to those in the structure of COVID-19.
Therapeutic interventions Second, the technology platform is
highly scalable with a robust process,
As a potential treatment for the dreaded disease, which should represent significant
plasma therapy is likely to bring a ray of hope. cost savings compared to other similar
Technically called the convalescent-plasma therapy, the vaccine platforms. Third, the current
treatment aims at using the immune power gained by a global pandemic might allow for an
recovered person to treat a sick person. SCTIMST is the expedited FDA review timeline based
first to receive approval from ICMR for carrying out the on recent pronouncements regarding
novel treatment. other COVID-19 vaccine and treatment
candidates.
“Initially we will try in a small number of patients. - PRABUDDHA KUNDU
At present it is permitted as an experimental therapy Co-Founder and Managing Director,
for restricted use for severely affected patients only. Premas Biotech, Gurugram
Potential donor would be examined before the blood
serum is extracted and given to a sick person. First,
the swab test must be negative and the potential donor
has to be declared as cured. Then the recovered person
has to wait for two weeks. Or else the potential donor
should be asymptomatic for at least 28 days. Either
of the two is mandatory”, explains Dr Asha Kishore
Director, SCTIMST, Thiruvananthapuram.

Reports from the US and China indicate that the
beneficial effect of transfusion plasma is obtained in
the first three to four days and not later. Though this
solution might prove to be effective, it has its set of
challenges.

“Convalescent plasma therapy with high
neutralizing antibody titres will be an effective and
cheaper option for COVID-19 provided it is given to the
patients before he/she develops severe symptoms. It
should be noted that passive antibody therapy may be
effective only if sufficient antibody is administered. We
also need to understand the risks associated with this
therapy that are known and theoretical. Known risks
are those associated with transfer of blood fractions
like hypersensitivity, donor should be free from other
disease causing agents. The theoretical risk involves
the phenomenon of antibody-dependent enhancement
of infection (ADE). ADE has been reported in several

28 COVER STORY BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

“Convalescent plasma therapy with viral diseases and involves an enhancement of disease
high neutralizing antibody titres will in the presence of certain antibodies”, elaborates Dr
Sunit Maity, Director, Product Development, Zumutor
be an effective and cheaper option Biologics, Bengaluru.
for COVID-19 provided it is given to
the patients before he/she develops Recently, the DCGI has given its approval to the
severe symptoms. It should be noted New Delhi-based Institute of Liver and Biliary Sciences
that passive antibody therapy may (ILBS) to conduct trials to test the effectiveness of the
be effective only if sufficient antibody convalescent plasma therapy for serious coronavirus
disease patients. Ludhiana based SPS Hospital has also
is administered. We also need to decided to go for plasma therapy after receiving the
understand the risks associated with required approval.

this therapy that are known and Sharing his thoughts on the sustainability of
theoretical. Known risks are those this therapy, Dr Prasanna Deshpande says, “Plasma
associated with transfer of blood therapy alone is unlikely to be sufficient to contain
fractions like hypersensitivity, donor the pandemic. To obtain convalescent plasma, a very
should be free from other disease large number of donors would be required. These
causing agents. The theoretical risk would be the donors who have recovered from a
involves the phenomenon of antibody- COVID-19 infection. Currently, these numbers are
dependent enhancement of infection comparatively small. Also, to be an effective large-
(ADE). ADE has been reported in scale option, infrastructure to collect and screen the
several viral diseases and involves plasma, fractionate it and harvest the antibodies will be
an enhancement of disease in the required. It will be a challenging process.”

presence of certain antibodies”. Bengaluru based Stempeutics Research, a group
- DR SUNIT MAITY company of Manipal Education and Medical Group
(MEMG) has brought about another therapeutic
Director, Product Development, option for COVID-19 treatment in the form of stem cell
Zumutor Biologics, Bengaluru. therapy. The company has put forward its stem cell
product Stempeucel for treating critically ill COVID-19
patients with lung disease.

“The product exhibits potent immunomodulatory
and anti-inflammatory properties which could help in
reducing the inflammation caused due to the cytokine
storm elicited by the body’s immune cells in response
to COVID-19 related infection in the lungs. Also, the
growth factor, Angiopoietin-1 is effective in reducing
alveolar epithelium permeability in the lung. From
the clinical data using Stempeucel in different clinical
trials in other indications it may be postulated that
the product has the potential capability for treating
COVID 19 infection. Together with the safety profile
observed from DCGI approved clinical trials involving
more than 350 patients injected with Stempeucel by
different routes of injection, this therapy may help in
mitigating the lung tissue damaging effects of COVID
19 infection”, reveals BN Manohar, CEO, Stempeutics,
Bengaluru.

Nevertheless, behind these dark clouds, a silver
lining is being brought about by the collaborative efforts
of the government and industry in finding numerous
solutions to fight this global enemy. The presence of
this conducive environment is all set to invigorate the
operations of the government and the industry to help
them emerge out as winners.

Dr Manbeena Chawla
[email protected]

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

A RELIEF OR ADDED
THREAT FOR INDIA?

Researchers across the globe have observed that there may be a unique mutation in the viral strain infecting
the Indian population. And may be that is the reason why few countries are suffering large numbers of
fatalities as compared to India.

In December 2019, several cases of pneumonia protein via its receptor binding domain.
of unknown etiology were reported in Wuhan, Simultaneously, researchers across the globe
Hubei Province, China. The disease which
is now called COVID-19 is caused by a novel started conducting similar studies to understand
coronavirus, severe acute respiratory syndrome how exactly this virus is attacking the humans.
coronavirus 2 (SARS-CoV-2), which was discovered Researchers also started studying the infection
through whole-genome sequencing, polymerase pattern of this virus in different countries and came
chain reaction (PCR) and culture of bronchoalveolar out with the finding that there may be a unique
lavage fluid obtained from affected patients. mutation in the viral strain infecting the Indian
population. And may be that is the reason why few
Soon after, Chinese researchers revealed that countries are suffering large numbers of fatalities as
the virus is 96 per cent identical at the whole- compared to India.
genome level to a bat coronavirus. The researchers
also announced that the virus uses a same cell Researchers from Taiwan and Australia have
entry receptor, angiotensin converting enzyme apparently found a coronavirus strain isolated in
2 (ACE2), for its entry into the host.A spike India carrying mutations in the spike protein’s
glycoprotein found on the surface of SARS-CoV-2 receptor-binding domain (RBD) of the virus. A
is a class I fusion protein which helps the virus in computer simulation shows that the RBD mutation
its initial attachment with human ACE2 receptor that was not found in any other variants across the
and its consecutive fusion with the host cells. The world, could remove a hydrogen bond from the
attachment is mediated by the S1 subunit of the spike protein. In the absence of this bond, the virus
is less likely to bind to ACE2 that is found in the

“There are three different
types (Type A, B and C) of
COVID strains infecting people
across the globe. While Type
A strain is the most prevalent
one in Australia, Type B is the
dominant strain across large
parts of the United Kingdom
and Europe. Type C is an
offshoot of Type B, mutating
from the secondary strain
and spreading to Europe and
Australia via Singapore. It has
also been observed that it was
the Type B strain that was in

circulation in China.”
Dr Peter Forster

Fellow in Genetics, University of Cambridge

30 COVID-19 BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

“A report published on April 6, experiments to understand the virulence of the
2020, announced the successful viral strain infecting India in comparison to other
countries.
genome sequencing of SARS-
CoV-2 that caused COVID-19 Dr Himanshu Vashistha, Assistant Director
(Molecular Biology), National Center for Disease
in South Africa by researchers Control (NCDC), New Delhi, reveals some more
from NICD and SANBI. The observations in this context and says, “Our team
at NCDC has also sequenced some of the isolated
sequencing results showed six strains and found a change of two amino acids
differenced in its 29,000 RNA from the sequence of Wuhan strain. These changes
letters compared to the virus are identified as providing significant contribution
in China. According to the in the transmission of the disease and found
researchers, difference of six is somewhat less virulent than the Wuhan strain. This
very nonsignificant and it has research article is submitted for publication and in
no effect on how the virus is communication with a peer reviewed international
journal.”
changing or producing protein.
The virus found in South Africa As more and more researchers are working
towards understanding the behavior and
is similar to the ones found in background of this virus, several speculations and
Europe and the US”. hypothesis are emerging consequently.At present,
Dr Parveen Sobia New Delhi based International Centre for Genetic
Engineering and Biotechnology (ICGEB) is using a
Post-Doctoral Fellow, CAPRISA, Durban, South Africa bioinformatics approach to perform comparative
analyses of SARS-CoV2 genomes from different
lungs and other organs. geographical locations with genomes of other
“Without much data if you make any conclusion coronaviruses to monitor SARS-CoV2 transmission
and its sequence variations, with a particular
that may not be right. We need to understand emphasis on looking for variants that may have
the evolution of the virus, how dynamic is it and different degrees of pathogenesis. Analysis so far
how fast it imitates. Two institutes of Centre for has revealed a unique mutation in the Indian SARS-
Scientific and Industrial Research (CSIR) Centre for CoV2 strain. The Group intends to continue further
Cellular and Molecular Biology (CCMB), Hyderabad computational analyses involving more genomes as
and Institute of Genomics and Integrative Biology they become available.
(IGIB), New Delhi have started working together
on the whole genome sequencing of the novel “Right now, there’s very little evidence available
coronavirus. At the moment we are accumulating as to say that the COVID-19 strain is less virulent in
many sequencings as we can and once we have few India. It may appear less virulent because very less
hundred sequencing with us then we will be able to number of tests are being done right now. As we
make many inferences from many biological aspects reach a considerable amount of tests, a statistically
of this virus”, says Dr Rakesh Mishra, Director, relevant comment can be made with better
CCMB, Hyderabad.
“We are in discussions with
Three to four people from both institutes are pharma partners to advance
currently working on the whole genome sequencing. their drug development work
In few weeks, researchers would be able to get with genomics insights and
at least 200-300 isolates and this information capabilities, in particular in the
would help them to make some further conclusion context of this COVID-19 crisis. I
about the behaviour of this virus. For this purpose, think we have a potential drug
National Institute of Virology (NIV), Pune has also solution that should work and
been requested to give virus that has been isolated can be developed quickly with
from different places. This will help the scientists to the right pharma or biotech
cover the whole country to get a bigger and clearer
picture. partner”.
Sam Santhosh
Alongside CCMB and IGIB, another CSIR
associated lab in theInstitute of Microbial Chairman, MedGenome
Technology (IMTECH), Chandigarh has initiated
the whole-genome sequencing of the novel
coronavirus. There are few other prestigious
institutes in Indiaalso carrying out sequencing

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COVID-19 31

“Right now, there’s very little have discovered three new mutations.
evidence available to say that Another study conducted by a group of

the COVID-19 strain is less researchers from Bengaluru based MedGenome
virulent in India. It may appear and Kerala based SciGenom Research Foundation
less virulent because very less (SGRF) has identified variations in the ACE-2
protein gene that are predicted to make individuals
number of tests are being more susceptible to the virus. The group analyzed
done right now. As we reach a ACE2 protein altering variants from over 300,000
considerable amount of tests, a individuals’ variant data from across the world and
statistically relevant comment have found variants that are predicted to bind to
the virus less tightly and hence make individuals
can be made with better less susceptible, giving these individuals natural
correlations”. protection against the invading virus.
Pranav Anam
Founder, The Gene Box, Mumbai “We are in discussions with pharma partners
to advance their drug development work with
correlations”, observes Pranav Anam, Founder, The genomics insights and capabilities, in particular
Gene Box, Mumbai. in the context of this COVID-19 crisis. I think we
have a potential drug solution that should work and
In a bid to offer more answers to these can be developed quickly with the right pharma
hypotheses, New Delhi based diagnostic company or biotech partner,” mentions Sam Santhosh,
Redcliffe Lifesciences is using its proprietary Chairman, MedGenome.
computational pipeline that can automatically
analyze the sequences and identify various viral Across the Globe
strains based on patient samples.
The speculations on mutations and variations
Explaining the approach being taken by the within the viral strain are not only restricted to
company on this front, Ashish Dubey, Co-Founder, India. The Institute of Human Virology (IHV) at
Redcliffe Life Sciences says, “Our aim is three- the University of Maryland School of Medicine in
fold: understand the various strains of COVID-19 the US and scientists from Trieste, Italy have also
if any, found in the Indian public; evaluate the announced the characterization of a novel mutation
spread patterns of thesemutations in different in the RNA polymerase of certain viral strains of
geographic areas, and predict the response of drugs SARS-CoV-2 carried by patients located in Europe
on each such viral strain. We are positive about the and North America.
opportunity offered by whole genome sequencing
in taking quick treatment decisions for combating With highest number of diagnosed COVID-19
COVID-19.” cases on the African continent, South Africa has
also announced the successful genome sequencing
Meanwhile, a team of researchers at Gujarat of a local sample of SARS-CoV-2.
Biotechnology Research Centre(GBRC) have
successfully completed the whole genome “One report that was published on April 6, 2020,
sequencing of the novel coronavirus claiming to
“Our aim is three-fold:

understand the various

strains of COVID-19 if any,

found in the Indian public;

evaluate the spread patterns

of these mutations in different

geographic areas, and predict

the response of drugs on each

such viral strain. We are positive

about the opportunity offered

by whole genome sequencing

in taking quick treatment

decisions for combating

COVID-19.” Ashish Dubey

Co-Founder, Redcliffe Life Sciences

32 COVID-19 BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

announced the successful genome sequencing of “Our team at NCDC has
SARS-CoV-2 that caused COVID-19 in South Africa sequenced some of the
by researchers from the National Institute for isolated strains and found
Communicable Diseases (NICD) and South African a change of two amino
National Bioinformatics Institute (SANBI). The acids from the sequence of
virus sample was collected from the nose and throat Wuhan strain. These changes
of a patient in KwaZulu-Natal province. The patient are identified as providing
had returned from Italy at the beginning of March. significant contribution in the
The sequencing results showed six differenced in its transmission of the disease
29,000 RNA letters compared to the virus in China. and found somewhat less
According to the researchers, difference of six is virulent than the Wuhan
very nonsignificant and it has no effect on how the strain. This research article is
virus is changing or producing protein. The virus submitted for publication and
found in South Africa is similar to the ones found in in communication with a peer
Europe and the US”, reveals DrParveen Sobia, Post- reviewed international journal.”
Doctoral Fellow, Centre for the AIDS Programme
of Research in South Africa (CAPRISA), Durban, Dr Himanshu Vashistha
South Africa. Assistant Director (Molecular Biology),

Simultaneously, the UK government has NCDC, New Delhi
launched a new alliance to sequence the genomes
of SARS-CoV-2. Samples from patients with strains infecting people across the globe. While
confirmed COVID-19 in the UK are being sent to Type A strain is the most prevalent one in Australia,
sequencing centres across the country, including Type B is the dominant strain across large parts
in Belfast, Birmingham, Cambridge, Cardiff, of the United Kingdom and Europe. Type C is an
Edinburgh, Exeter, Glasgow, Liverpool, London, offshoot of Type B, mutating from the secondary
Norwich, Nottingham, Oxford and Sheffield; and strain and spreading to Europe and Australia via
the Wellcome Sanger Institute is coordinating data Singapore. It has also been observed that it was the
analysis. Type B strain that was in circulation in China.

Interestingly, researchers from UK based “Versions of type A were seen in Chinese
Cambridge University have revealed that there are individuals, and Americans reported to have lived in
three different types (Type A, B and C) of COVID Wuhan, and mutated versions of type A were found
in patients from the USA and Australia. Wuhan’s
“Without much data if you major virus type B was prevalent in patients from
make any conclusion that across East Asia. However, the variant didn’t travel
may not be right. We need much beyond the region without further mutations,
to understand the evolution implying a founder event in Wuhan, or resistance
of the virus, how dynamic is against this type of COVID-19 outside East Asia.
it and how fast it imitates. The ‘C’ variant is the major European type, found
Two institutes of CSIR- CCMB, in early patients from France, Italy, Sweden and
Hyderabad and IGIB, New England. It is absent from the study’s Chinese
Delhi have started working mainland sample, but seen in Singapore, Hong
Kong and South Korea”, shares Dr Peter Forster,
together on the whole Fellow in Genetics, University of Cambridge.
genome sequencing of the
Although these observations are intriguing
novel coronavirus.At the and fascinating, it does raise concerns towards the
moment we are accumulating industry that is working hard to develop drugs and
vaccines for combating the killer COVID-19. The
as many sequencings as we discovery of various mutations indicate that the
can and once we have few ongoing vaccine development may become futile in
future epidemic if more mutations were identified.
hundred sequencing with us Or on the other hand, these revelations might help
then we will be able to make in developing the right cure.
many inferences from many
biological aspects of this virus”. Dr Manbeena Chawla
[email protected]
Dr Rakesh Mishra
Director, CCMB, Hyderabad

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COVID-19 33

Emerging stronger:

Bioscience businesses in and
beyond the war on COVID-19

Despite the COVID crises, according to AIOCD AWACS the Indian Pharma Market registered a surprising
growth of 8.9 per cent in March 2020 with some evidence of panic buying in chronic medicines. In the stock
market too, pharma stocks have managed to retain investor interest amid deep fall in nearly every other
sector. Nifty Pharma, at well over 7400 levels, is up by 20 per cent over the last month, and is showing the
promise of crossing its 52-week high in the coming months.

The entire last year, we all were talking about Recession
the reduction in growth rate of the Indian
economy. Yet, each industry and each company International Monetary Fund (IMF) has already
in turn, hoped for and tried to beat the slowdown revised its growth estimates for India for the year,
and aimed for growth projections at a rate invariably from 4.8 per cent to 1.9 per cent and for the world as
higher than the GDP growth figures, till well into the a whole, to predict negative growth of -3 per cent, i.e.
new year 2020. Then the world started screeching recession, in coming months. According to the IMF’s
to a halt in February and stopped nearly completely chief economist Gita Gopinath, in the World Economic
in March. Even the countries most reluctant to stop Outlook report of April 14, 2020, “It is very likely that
economic activity were forced to do so with the this year the global economy will experience its worst
high numbers of infected people and much-higher- recession since the Great Depression, surpassing that
than-anticipated percentages of death among those seen during the global financial crisis a decade ago”.
infected and symptomatic. Amid severe lockdowns The WTO has expressed fears of trade plummeting
across continents, the world scrambles to find and by nearly a third, calling the numbers ‘ugly’. The
create more ventilators, more Personal Protective estimates put forth by World Bank, Organization
Equipment (PPE) kits and more healthcare resources of the Petroleum Exporting Countries (OPEC), and
to take care of the unprecedentedly overwhelming other global finance and commerce monitoring
load of COVID-19 patients. organisations are in tandem with the prediction of a
world-wide recession.
Estimates of the loss of production during the
months of lockdown vary from industry to industry. The sectors most affected are,
The only sectors that are buzzing with activity, obviously, the ones requiring
though with a different focus than usual, are the most social contact and / or
Biotech, Clinical Research Organisations (CROs), travel. The luxury goods sector
Diagnostics, some part of Pharma and Medical and industries dependent on
Equipment industry, and some Healthcare facilities. ‘discretionary spends’ e.g. car sales,
However, even in the industries allowed to function have already ground to a complete
in this pandemic, like food and pharmaceuticals, halt and are likely to see
the production and distribution has suffered due to the situation continue
movement and transport restrictions. World Trade for some time even
Organisation (WTO) estimates the decline in trade after
due to transport restrictions to be anywhere between
13 per cent and 32 per cent.

34 COVID-19 BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

IPM REGISTERS 8.9% GROWTH

Indian Pharma Market (IPM) registered a
surprising growth of 8.9 per cent in March 2020
with some evidence of panic buying in chronic
medicines.Cardiac registered a monthly growth
of 19.8 per cent compared to 11.0 per cent in
February 2020, Anti-Diabetic registered growth
of 18.2 per cent compared to 11.0 per cent in
February 2020 and Respiratory medicines grew
at 22.9 per cent compared to 11.5 per cent in
February 2020. Considering the lockdown period
for one week plus in March 2020, there was
struggle for Gastro 6.4 per cent, Vitamins 3.7 per
cent, Pain & Analgesics 4.8 per cent and Derma
-1.7 per cent.

Source: AIOCD AWACS

lockdowns are lifted, due to the fear factor and or would emerge stronger, e.g. Biotech, CROs and
recession that would have taken hold by that time. On pharmaceutical companies producing (and exporting)
the other hand, most digital meeting platforms are generic drugs, active pharmaceutical ingredients
witnessing unimaginable growth in usage, and media, (APIs), bulk drugs, respiratory system medicines and
especially news channels, are enjoying unprecedented others like e.g. even small companies producing APIs
viewership. The stock market is favouring pharma and common drugs like Hydrochloroquine (HCQ).
and biotech stocks amidst a wide fall in the broader
indices, and there are reports of bulk value-picking in The restrictions on transport resulted in
these sectors. disruptions in the supply of APIs in January and
February of 2020, most of which come from China.
Growth via reverse integration in pharma? The production losses resulting due to this were
however not severe since the industry had sufficient
If one is looking at the bioscience spectrum of inventory to last before China lifted curbs on its cargo
industries and sub-sectors, the picture is quite movements. This has in fact had a beneficial effect
similar though with a different scale and with a by giving a sharp wake-up call to Indian pharma
twist. Even here, everything that is ‘discretionary sector, showing the importance to going back to
spending’ is unlikely to witness much volume going greater self-reliance for at least the critical APIs. The
forward - including, for example, in healthcare, knee central government has shown clear inclination to
replacement surgeries and such. The hospitals, while urge more and wider API production domestically.
having a critically important role in the present crisis, In a strange yet definite further boost to this is the
are going to feel the pressure from two sides: on one current favourable sentiment for India, created
hand, they are having to allocate all their available because of the prompt response of exporting HCQ
resources to fighting the war against COVID-19, to nations suffering in the COVID-19 pandemic
and have to do so at their own cost since most of when called upon. Irrespective of the occasional
the patients suffering in the pandemic cannot even comments and adverse remarks by the US Food and
be asked to pay for the fight on their behalf. The Drug Administration (FDA), there are a number of
laboratories doing COVID tests have even sought manufacturing facilities in India that are already
judicial help for making government reimburse them approved by them and other international authorities
for the expenses on the tests. On the other hand, like European Medicines Agency (EMEA)and UK’s
since all non-emergency and elective medical care / Medicines and Healthcare products Regulatory
surgeries are on hold for the period, the income of Agency (MHRA). Therefore, it is certainly possible
most of the hospital sector has suffered drastically.
The medical tourism industry has already come down
to zero, and would see severe restrictions in growth
going forward, at least for this year.

Quite a large part of the biosciences sector,
however, would either directly benefit from the crisis

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COVID-19 35

“India has a large number of
start-ups that are thinking

creatively and using cutting-
edge technology to develop

world class bio-medical
products. Yet, many of them
are stuck at the stage of taking

‘ideas’ to ‘proof of concept’
in the absence of sufficient
and longer term investment
availability. If the government

creates better regulatory
framework to encourage
investment in this sector, it
could be the start of a new

Biotech era for India”.
- Dr Kiran Mazumdar-Shaw

Chairperson and Managing Director, Biocon

to predict a distinct trend of growth in that sector, to invest $2 billion in debt and equity in Alnylam,
which should, ceteris peribus, continue forward even and TPG Capital agreed to invest in LifeStance
beyond 2021. The story in formulations and branded Health Partners, at a $1.2 billion valuation. Two
medicines might not be as buoyant, yet it would large biotech venture capital firms - ARCH Venture
certainly be spared of the severity of the recessionary Partners and Flagship Pioneering – have announced
pressures of the rest of the economy. the combined raise of $2.6 billion for their respective
biotech funds and VenBio of San Francisco has raised
Dawn of biotech age $394 million, scheduled to be invested in cutting-
edge biotech stories. In Asia, while there are no
The capital flows into the biotech and research billion-dollar biotech deals yet, in the last few weeks
organisations in India, both from domestic and the biotech VC deals in China alone have topped
foreign venture capitalists (VC) and angel investors, $500 million in investments, the largest among the
have traditionally been rather subdued compared latest being Hualan Bio’s vaccine unit raising $292
to the deal-flow seen in USA, Europe or even China. million from Hillhouse and Liu Xiaodan.
This will likely change quickly in the coming months
given an upsurge in the interest in Indian biotech and In the stock market too, pharma stocks have
pharma research. managed to retain investor interest amid deep fall in
nearly every other sector. Nifty Pharma, at well over
As aptly put by Dr Kiran Mazumdar-Shaw, 9400 levels, is up by 35 per cent over the last month,
Chairperson and Managing Director, Biocon, India and is showing the promise of crossing its 52-week
has a large number of start-ups that are thinking high any time now.
creatively and using cutting-edge technology to
develop world class bio-medical products. Yet, The one distinct benefit to emerge out of any war,
many of them are stuck at the stage of taking ‘ideas’ has been the tremendous scientific and technological
to ‘proof of concept’ in the absence of sufficient progress that was spurred by the extraordinary sense
and longer term investment availability. If the of urgency. This too is quite obviously happening
government creates better regulatory framework to at frenetic pace now, as we fight the war against
encourage investment in this sector, it could be the COVID-19, as companies and scientific community
start of a new Biotech era for India. race to find solutions and defences - this time in
the biology arena. As we go to print, it is becoming
Internationally, some billion-dollar deals have increasingly apparent that the effects of the attack
already been concluded for biotech/ healthcare of COVID-19 on the world are exactly like the war
start-ups during this month: Blackstone has agreed and post-war effects, especially in changing the
priorities in the minds of people worldwide and in the
economic arena.

Manasee Kurlekar
[email protected]

36 COVID-19 BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

BIOSPECTRUM WEBINAR ON “EXPLORING VARIOUS ASPECTS OF COVID-19”

“Indian economy will
take 2-3 years to come
back to normal position”

As the number of COVID-19 cases continue to rise all across the globe, healthcare authorities and experts
are coming together to identify gaps and work together to accelerate and fund priority research needed to
help stop this outbreak and prepare for any future outbreaks. With an aim of exploring the various aspects
associated with the COVID-19 pandemic, BioSpectrum India conducted a webinar on April 16,which saw
participation of industry experts sharing their views on how can India tackle this outbreak.

Hailing the government’s efforts and initiatives Dr Taslimarif Saiyed, CEO & Director, Centre
in controlling the spread of pandemic for Cellular and Molecular Platforms (C-CAMP),
COVID-19 in India industry experts suggest Bengaluru; Dr Priti V. Warke, Director- Cell Culture,
few measures to move to normal daily life and bring Head- Regulatory Affairs, HiMedia Laboratories,
cheer among the daily wagers who have been the Mumbai and Satyaki Banarjee, CEO- Medical
most affected. The suggestions include Fast-Track Imaging, Trivitron Healthcare, Mumbai shared their
Approval of Innovations; Scaling-up the number of views on various crucial aspects of this pandemic
testing labs and Manufacturing set-ups; More Public- such as What are the current challenges facing India
Private Partnerships; Developing Rapid-Tests and in countering this fight?What are the resources
Proper Functioning of Logistics and Transportation. available and what more is required?What needs to
be done so that India is more prepared for a future
The above suggestions were made during pandemic situation? And what is the impact on the
a webinar organised by BioSpectrum India on Indian economy?
“Exploring Various Aspects of COVID-19” on April
16. Participating in the webinar Dr Rajeev M. Dhere, Challenges
Executive Director & Dr Suresh Jadhav, Executive
Director, Serum Institute of India Pvt Ltd, Pune; Healthcare system all over the world is facing number
of challenges in the current pandemic situation.
“There is almost 45000 tons of Talking about the challenges, Dr Taslimarif Saiyed
fleet material which has come said, “It’s a worldwide health challenge now. Some
into the country and sitting on of the challenges includes early stage diagnosis for
the tarmac in Delhi, Mumbai people who are symptomatic carrier or asymptomatic
and other areas. Unless it is
cleared, we cannot get raw
material inside. Also, even if the
material is ready, we cannot
export it. All this is causing the
choking of storage. This will
create a very several problems
in coming months for pharma
industry as well”.
Dr Suresh Jadhav
Executive Director,
Serum Institute of India Pvt Ltd, Pune

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COVID-19 37

carrier, which is going to be a very crucial thing “The biggest challenge that
and very important aspect. At the same time, we our country is facing right now
are facing the availability issues of diagnostic kits,
personal protection equipment (PPEs) for healthcare is the skewed ratio between
professionals and therapeutic aids like ventilators. population and limited
Having said that, India due to lockdown have
gotten some time to prepare itself to tackle these resources. Since we are not self-
challenges where spread of infection has possibly sufficient and need to import
shifted bit further away giving the time to prepare for lot of critical raw materials,
availability of diagnostics, PPEs and other resources.
Now, India needs to work bit more to tackle these customs and airports should be
challenges.” opened for next two months at

Pointing out the skewed ratio between population least for the critical goods.”
and limited resources, Dr Priti V. Warke added, “The Dr Priti V. Warke
biggest challenge that our country is facing right now
is the skewed ratio between population and limited Director- Cell Culture, Head- Regulatory Affairs,
resources. We have doctor ratio of eight doctors HiMedia Laboratories, Mumbai
per thousand people as opposed to seventy-one in
Korea and eighty-one in Italy. We have one state-run Talking about public-private partnership in
hospital for fifty-five thousand people. The biggest ensuring the resources, Satyaki Banarjee said,
challenge that we are facing is the limited resources “The government is actively working with medical
that we have in terms of our testing capabilities and device manufacturers across the country to scale
healthcare system.” up the manufacturing of ventilators. It is created a
consortium bringing in the expertise of automobile
Resources manufacturers, other electronic manufacturers
and have asked them to work very closely with
Availability of proper resources is crucial for medical device manufacturers to help them develop
the smooth functioning of healthcare system. ventilators rapidly and scale-up the manufacturing.
Highlighting the role of resources, Dr Rajeev M. That’s a prudent step that has been taken. The
Dhere added, “Today, the number of tests we are regulatory agencies, the medical fraternity and
carrying out is significantly low so we are missing the manufacturers of medical equipment’s have
out on many asymptomatic carriers which eventually collaborated in this time of need and has come up
could transmit this and make a hotspot or a cluster. with specifications and a roadmap to scale up the
So, what is must today is the number of tests that manufacturing of ventilators.”
we should carry out. There is also a concept of the
pool testing which proved to be successful during “Efforts are being made to manufacture
earlier pandemic. A group of ten people tested ventilators that can operate in multitude of
simultaneously could reduce the number of test and environment even in places where access to
then if you find in them ten positives, you can go on compressed air is not available. These ventilators will
testing ten. I think increasing the number of tests either have built-in turbine or a mechanical system
with some innovative approach will be a better thing to generate air in the absence of compressors”, he
to do.” added.

“We need to scale-up the number of testing labs
and manufacturing set-ups involved in the sampling

“India is possibly getting
towards right direction. Post
COVID there should be larger
investments in infrastructure,
regulatory approvals, science
& innovation so that we are
much better in our position to

respond.”
Dr Taslimarif Saiyed

CEO & Director, Centre for Cellular and Molecular
Platforms (C-CAMP), Bengaluru

38 COVID-19 BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

KEY TAKEAWAYS “The regulatory agencies, the
medical fraternity and the
● Fast-Track Approval of Innovations manufacturers of medical
● Scaling-up the number of testing labs &
equipment’s have collaborated
manufacturing set-ups in this time of need and has
● More Public-Private Partnerships come up with specifications
● Developing Rapid-Tests
● Proper Functioning of Logistics & and a roadmap to scale up the
manufacturing of ventilators.”
Transportation
Satyaki Banarjee
and testing kits. The entire workforce involved in CEO- Medical Imaging, Trivitron Healthcare, Mumbai
the healthcare system, testing labs, manufacturing
set-ups involved in making of testing kits, PPEs, may be the time where in-built innovation, local
sanitisers should be fully operational. Since we are innovations may be able to at least to some extent be
not self-sufficient and need to import lot of critical able to address the challenge but that exactly would
raw materials, customs and airports should be open allow us to how we can prepare ourselves to future
for next two months at least for the critical goods. pandemic and what we require is: Infrastructure,
Apart from this, supply chain and logistics is a very right healthcare system which can approve
important part of this chain and it needs to be agile innovations in speedy manner so when such kind of
and seamless”, Dr Priti added. challenges come, it just needs to gear up one notch
and not necessarily many notches. This is something
Preparing for a future pandemic situation India is possibly getting towards but post this there
should be larger investments in infrastructure,
Highlighting the role of innovations and innovators regulatory approvals, science & innovation so that we
in pandemic situations, Dr Saiyed said, “Because are much better in our position to respond.”
of the availability of indigenous innovation which
were being built over last 8-10 years, innovators Impact on the Indian economy
have been able to make a small shift in their plan
and worked towards addressing the need of such Talking about the impact of COVID-19 on Indian
resources in COVID-19 situation and that has been economy & pharma sector, Dr Suresh Jadhav said,
a very important aspect where you have what you “On Indian economy, this is really going to impact
call it a infrastructure, the talent and innovation in a big way and it will take another two-three year
temperament built over 8-10 years. This now possibly for India to come back to normal position. All the
would allow us to address the issue of availability businesses are closed down except for maybe the
which conventionally we were looking at in terms of small shop owners. It has impacted tremendously
importing and currently importing is not an option daily wage people. To be honest, even government
and rather it’s not sufficient. I think this possibly was also not really prepared at this time to take a
decision on what to do with these people. Although so
“There is also a concept of the many NGOs and government have come out to help
pool testing which proved to such people but they have suffered the maximum.
Apart from that, almost all people working in big
be successful during earlier industries are now operating from home or they have
pandemic. A group of ten closed down except few like pharma which is working
but with no sales. The reason being that there is no
people tested simultaneously transportation, no drugs available.”
could reduce the number
of test and then if you find “There is almost 45000 tons of fleet material
in them ten positives, you which has come into the country and sitting on the
tarmac in Delhi, Mumbai and other areas. Unless it is
can go on testing ten. I think cleared, we cannot get raw material inside. Also, even
increasing the number of tests if the material is ready, we cannot export it. All this
with some innovative approach is causing the choking of storage. This will create a
very several problems in coming months for pharma
will be a better thing to do.” industry as well”, Dr Jadhav concluded.
Dr Rajeev M. Dhere
Executive Director, Kalyani Sharma
[email protected]
Serum Institute of India Pvt Ltd, Pune

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COVID-19 39

Time to build Indian
Medtech industry to
global reckoning

« Over the last decade there has been a major
push to develop home grown medtech
Dr Satya product startups in healthcare and other areas
Prakash Dash, of biotech. Several agencies notably Department
Industry Thought of Science & Technology (DST), Department of
Leader, New Delhi Biotechnology- Biotechnology Industry Research
Assistance Council (DBT-BIRAC), Millennium
India has built amazing infrastructure of Alliance, Indo-U.S. Science and Technology Forum
science especially interdisciplinary and (IUSSTF), Atal Innovation Mission (AIM)-Niti Aayog
translational aspects of biology in the last 15 and others have contributed to injecting funding
years despite history of low level of investments and other support mechanisms to build 3000-
both in R&D (0.8 per cent of the GDP) as well as 4000 biotech/medtechstartups as well as 200 S&T
healthcare (1.3 per cent of the GDP). This needs incubators in the country.
to change not just as a stopgap measure but
greater investment, consistently over a longer- This arguably is a national portfolio that has been
range horizon, is important. And there is need built through tax payers money and painstaking
to leverage the strengths and find strategic efforts of various stakeholders, most notably the
responses to the gaps in a mission mode. leadership shown by incubators. The incubators
housing them are analogous to an “asset house”.

The innovation community has responded with
a can-do attitude and have scrambled to kick start
COVID-19 focused solutions. The Principal Scientific
Adviser’s (PSA) Office has constituted several task

40 COVID-19 BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

forces that are co-ordinating different aspects of the products such as testing kits or vaccines or re-orient
response with speed and precision. their product platforms to build COVID-19 related
products. Pune based MyLab was able to build a
COVID-19 Funding: Fast decisions RT-PCR diagnostics kit for COVID-19 that received
certification from Indian Council of Medical Research
Most Science & Technology arms of the Government (ICMR) and approval from Drugs Controller General
of India have launched COVID-19 specific funding of India in a quick turnaround time.
calls, be it CAWACH by DST, Council of Scientific
and Industrial Research (CSIR) labs, DBT-BIRAC Several other startups have also strategized
(a special COVID-19 call), Technology Development to ramp up productions of antibody testing kits,
Board (TDB) and Invest India as well as big defibrillators, touch free standalone hand sanitising
incubators such as IKP Knowledge Park (IKP), stations, ventilators, cardiac and vital monitoring
Venture Center, SINE-IIT Bombay, Centre for systems, oxygen enrichment systems, vaccine carriers
Cellular and Molecular Platforms (C-CAMP), SIIC- and imaging systems amongst others. Indeed, this
IIT Kanpur, AIC-CCMB and FITT-IIT Delhi amongst is indicative of the immense depth that the country
others. now possesses in terms of innovators for building
appropriate and relevant products for healthcare.
Incubators such as IKP and Venture Center
launched their COVID-19 action plan to not just Connect of incubators and
provide funding but also pro-actively provide support startups to local communities
in connecting startups with mature products to
scale them by connecting them to manufacturers, One of the defining features of the response of
procurement agencies and hospitals that are at the incubators has been the immediate connect to the
forefront of the frontline of care. local communities especially providing safety and
sanitising kits, digital non-contact thermometers
Another feature noticeable in the strategy is for healthcare staff and other essential services.
rapid turnaround time for decisions. For example, in Additionally, it was seen that innovator groups
IKP’s COVID fund from the launch of call to decision nucleated organically to connect with local
to fund a cohort (I-CO fund selected 11 relevant communities. Venture Center based in Pune has
products) was a mere 10 working days and similarly formed the Pune Faceshield Action Group that
Venture Center’s NIDHI Prayas call for COVID-19 3D-printed and delivered 30000 faceshields to
had extremely fast turnaround times. Additionally, essential services such as police and healthcare
these incubators have resourced dedicated staff to workers. It aims to build 100,000 faceshields.
push and co-ordinate in accelerating the support Similarly, IKP centres in Mangalore and Belgaum
extended to selected startups. have designed essential products such as foot-
operated sanitiser dispensers to install at local
Venture Center is driving the Drug Repurposing communities.
Taskforce (under the aegis of PSA’s Office) and has
looked at different aspects of 19 drugs that can then Gaps & Future Issues
inform about strategies for India to conduct clinical
trials for re-purposed drugs. All severe crises lead to a change and COVID-19
will create a new normal. India has built amazing
Startups ramping up product manufacturing infrastructure of science especially interdisciplinary
and translational aspects of biology in the last 15
Medtech startups have responded with amazing years despite history of low level of investments
speed and have either strategized to ramp up both in R&D (0.8 per cent of the GDP) as well as
manufacturing of their existing products, build new healthcare (1.3 per cent of the GDP). This needs to
change not just as a stopgap measure but greater
investment, consistently over a longer-range horizon,
is important. We have defined the COVID-19 crisis as
a national emergency and this should also make us
ready to take measures with taking into account short
range, medium range and long-range strategies-

A.Boost National Capacity
This crisis has shown that while we are perhaps
still the ‘pharmacy of the world’ (though our
dependencies on China for APIs is high), however
when it comes to medtech products including masks,

BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com COVID-19 41

INDICATIVE LIST OF MEDTECH ORGANISATIONS

Category Companies (Startups, SMEs & Large)

Diagnostics MolBio, Strand Lifesciences, Medgenome, Transasia, J Mitra & Co, Robonik,
MyLab, Huwel LifeTechnology, Omix, Achira Labs, Pandorum, PathShodh,
Module Innovations, Prantae, Valetude Primus, MicroX, VidCare, Affigenix,
Healthcubed, Exoscan Heathcare, Fastsense Diagnostics, Diagnorite,
BioAptagen, Oncosimis, BioArtis, BioLine Diagnostics, Core Diagnostics, VNIR
Biotechnologies, Neuome Technologies, XE3 Edubioskills, Truspectra

Personal Protective Equipment Mallcom, Ontex Medical Devices, AxioBiosolutions, Sure Safety, Butterfly
&, Surgical Materials, Assistive Edufields, Aarna Biomedical, Parishodhna, ZeroPlast Labs, Newndra
Innovation, Advanced MedTech Solutions, Lifecare Surgicals, HLL, Lotus
Surgical, Angiplast

Care, Critical Care & monitoring Skanray, Erkadi, Trivitron, Sahajanand Medical Technologies, JyotiCNC,
Jeevtronics, Inaccel-Coeo Labs, AtmenTechnovention, Windmill Health, Nocca
Robotics, BioDesign Innovation Labs, Renalyx, Axxonet System Technologies,
Monitra, Cardea Biomedicals, Ayu Devices, Genrich Membranes, Nemocare,
Janitri, Bempu, SattavaMedtech, Sensivision, Yostra Labs, Biosense, Cephas,
Dynasense, Embryyo, Agatsa, Nemocare, Pluss Tech/Miracradle, Perfint
Health, Forus, Remidio, Aindra, Sohum Innovation Labs

Sanitisers, Sterilization MicroGo, WeInnovateBiosolutions, PadCare Labs, Green Pyramid Biotech,
machines and Disinfectants Fuma Labs, Incredible Devices, Biomoneta Research, Anabio Technologies

AI & Predictive Qure Ai, Predible Health, Niramai, Docturnal, Salcit

Data Mining, and Trend Analysis Attentive AI, BMeK LLP, WadhwaniAI

Telemedicine, Home & Remote Turtle Shell Technologies, Periwinkle Technologies, Ubiqare, Neurosynaptic

Monitoring Communication, Erkadi, Accuster

Mental health Tick Talk, ToStreben Healthcare,PushD, Juno Clinic, Wysa, Edupysche,
InnerHour

Other Technologies including Embryyo Technologies, BlackFrog Technologies, Divish Mobility, Flytbase
Plasma Separation, vaccine Labs, Zipline, Skylark Drones
carriers, drone,

Designers, Manufacturers, Tiffinbox, Futuring Design, Phoenix, Skanray, Vinyas Innovative Technologies,
Testing & others Cyient, Imaginirium, SFO Technologies, Trivitron, Axxonet System
Technologies, Caremont, Veol Medical Technologies, Df3D, Alfa Corpuscles,
Tata Elxsi , Wipro, Astute

PPEs, ventilators, our capacity is low and we are net when we need them in emergencies. India has to
importers. The silver lining from this crisis is that it create a method for demand generation especially for
could be the “Y2K moment” for the Indian Medtech “Make in India” products leveraging its recent push
Industry. into Ayushman Bharat and State public procurement
policy initiatives.
Our national assets of translational organisations
should be expanded and local manufacturing should C. Build a National Bio-Innovation Grid
be deepened. This is a unique opportunity for India It is essential that “knowledge transfer”
to re-charge its “Make in India” mantra in medtech mechanisms be established amongst our translational
especially linking innovators to manufacturers. institutions and incubators. Translational
Instead of one AMTZ in Andhra Pradesh, we need organisations such as Translational Health Science
at least four to five more- that should be made and Technology Institute (THSTI), Shri Chitra
functional sooner. The mantra is to “localise, localise, Tirunal Institute of Medical Sciences & Technology
localise”. (SCTIMST), Centre for Nanoscience and Engineering
(CeNSE) and CSIR-National Chemical Laboratory
B. Create a National Stockpile (NCL) should be massively strengthenedfurther.
We do not mind, and rightly so, having a stockpile We need fast acting Technology Transfer Offices
of armaments and food, it is time we build a stockpile and translational institutions and dense connect
of essential medtech products that have long shelf to industry. This is still in nascent stages and must
life or increase capacity for ramping up production

42 COVID-19 BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

be accelerated. The existing efforts however well- crores to our small and medium-sized enterprises
meaning still look piecemeal. This crisis has shown sector. A New Millennium Indian Technology
how orchestration and clear directions help build a Leadership Initiative-TDB kind of instrument that is
national response. The role of Accelerating Growth fast, transparent and responsive is required urgently.
of New India’s Innovations or AGNIi (the initiative of This will need co-ordinated efforts involving the
the office of PSA) and National Biopharma Mission aforementioned points.
(NBM) will need to be scaled up. Indeed, we need
to make a Bio-Innovation Grid that is dynamic and A missing link in the product journey in India is
networked. The role of PSA’s office as an integrative the connect between innovator and manufacturing
platform is paramount here. vendors and therefore we are highly dependent on
vendors in China which is currently the epicenter
D. Create National Standards of global medtech supply chains. It is therefore
India must create specific standards for all highly critical that we build an ecosystem of cutting-
medtech products that are clear and take into edge vendors in manufacturing who can work in
account global standards. Whilst we have Bureau tandem with innovators. Our hubs of small but
of Indian Standards (BIS), we need to have proper growing medtech manufacturing clusters should be
standards for categories of medtech products that are strengthened.
well defined. We also need a responsive standards
organisation in the lines of National Institute of F. Create another BIRAC especially for
Standards & Technology of USA. Additionally, Translation of Medtech Innovation
there is a need for “testing and validation centres”-
especially biomed and material testing centres. DBT-BIRAC was created in 2012 to build
Indeed, we have South India Textile Research the biotech startup ecosystem which it has
Association (SITRA) but we need to expand such done wonderfully over the last 7-8 years but it
infrastructures. Further the Indian medtech encompasses a wide gamut of areas in biotech and
regulations which have been streamlined should have medtech. Now is the time to build another BIRAC-
more clarity. like organisation focused specifically on medtech
E. From Prototypes to Products innovation and its translation under the aegis of
E. From Prototypes to Products Over the last ICMR. ICMR & Ministry of Health & Family Welfare
decade, we have established, through a wide range of should be playing a leading role in this as they have
funding tools, close to 3000-4000 biotech startups- the connect with testing beds and extensive clinical
many of them are in prototypes (Technology infrastructure, primary healthcare and healthcare
Readiness Level 3) or validation stages (Technology infrastructure of Indian States. DBT, AIM and
Readiness Levels 4-7) and hence India is indeed Ministry of Electronics and Information Technology
a “land of prototypes”. It is now the time to push (MeitY) can play a supportive role in launching of
forward and let India become a land of cutting-edge this organisation. There has to be a sense of urgency
products. We also have to start providing elevated in establishment of such an organization. The new
levels of funding. A grant of Rs 50 lakhs to Rs 3 organization should be given a well-defined mandate
crores will only take us this far and no further. We and a timeline to develop and scale medtech
need to be able to invest in the scale of Rs 50-200 products with clear and specific target product
profiles.

G. Injection of Support to Stressed Assets
The COVID-19 crisis is a severe stress to the
fledgling startups and incubators, many of which
possibly may disappear. It is imperative that the
government should quickly understand the new
stress that startups are facing and formulate
strategies to keep this nascent national asset afloat- a
framework should be designed, in consultation with
stakeholders, and support should be extended- not
carte blanche but identify important assets and
support them to tide this turbulence.
COVID-19 has allowed India to see where her
strengths lie as well as where the gaps are in the
medtech innovation ecosystem. We need to leverage
the strengths and find strategic responses to the gaps
in a mission mode. It is time to build this industry to
a global reckoning.

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44 SUPPLIER NEWS BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

SCIEX, Intabio to accelerate biopharma drug development

SCIEX, a global leader in life systems provides imaged capillary
isoelectric focusing with mass
science analytical technologies, spectrometry (iCIEF-MS) in order
to simultaneously characterize
and Intabio, a developer of and identify intact protein
charge variants. The successful
innovative instrumentation integration of iCIEF-MS workflows
will streamline current laborious
systems for biotherapeutic and time-consuming approaches
in the biopharma environment to
precision analysis and quality identify, monitor and characterize
critical quality attributes in
assessment, have announced a intact protein samples for the
development and manufacture of
collaboration to couple Intabio’s next-gen therapeutics.

Blaze system with SCIEX high

resolution accurate mass (HRAM)

systems. This collaboration is

geared to accelerate and transform

biotherapeutic development and

biomanufacturing. The integration

between Blaze and SCIEX HRAM

Agilent introduces Eurofins launches
new device for SARS-CoV-2 testing of
pharma manufacturers environmental surfaces

Agilent Technologies Inc. has announced the launch Eurofins Technologies, a fast growing provider of
of the newest instrument in its Raman technology diagnostic technologies in the field of immunoassays
portfolio. The new Agilent Vaya Raman raw and molecular detection methods, has launched
material identity verification system is a handheld GeneScanVIRSeek SARS-CoV-2 RT-PCR, an
instrument that accelerates quality control testing integrated solution including RNA extraction and test
in the pharmaceutical and biopharmaceutical kits based on real-time RT-PCR (reverse transcription
industries. Vaya verifies raw material identity polymerase chain reaction) for the detection of SARS-
through unopened transparent and non-transparent CoV-2 in swabs of environmental surfaces. Recently
packaging, testing more containers for the same published studies suggest that SARS-CoV-2 may
cost by reducing the need for sampling. Vaya is remain viable on different surfaces for up to 72 hours.
the first true through-barrier handheld Raman The comprehensive VIRSeek suite of test kits and
instrument, incorporating Agilent’s Spatially Offset workflows provides customers with fast tests to broadly
Raman Spectroscopy (SORS) technology for fast ID screen for the presence of SARS-CoV-2, as well as
of incoming goods through opaque containers in verification of results with an independent test. This will
a GMP ready package. Vaya combines SORS with enable organisations in diverse industries, as well as in
conventional Raman spectroscopy for maximum healthcare, transport and many other environments to
compatibility with a wide range of packaging from help test, determine, monitor and eventually strengthen
clear glass vials and plastic bags to opaque plastics the effectiveness of sanitation measures put in place,
and paper sacks. ultimately contributing to increased health and safety
in these respective environments.



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

IIT-G brings NCBS preparing
antimicrobial solutions to fight COVID-19
spray-based
coating for PPE Bengaluru based National country and worldwide, a
Centre for Biological Sciences rapid compressed sensing
A team of researchers (NCBS) and Institute for technology for COVID-19
of Indian Institute of Stem Cell Science and pooled testing is being
Technology Guwahati (IIT-G) Regenerative Medicine developed. Mathematical
has developed affordable (inStem) have received models of COVID-19
antimicrobial (antiviral/ approval to immediately spread are being developed,
antibacterial) spray- undertake projects that aim including detailed agent-
based coating for Personal to develop affordable, field- based models and coarse-
Protective Equipment deployable actions in the fight grained epidemiological
(PPE) and 3D printed Ear against COVID-19. Given the models. These will be fit to
Guard for comfortable use acute shortage of reagents national-level quantitative
of face masks by healthcare for the manufacture and data on COVID-19 spread, to
workers. The innovation procurement of COVID-19 provide recommendations on
is affordable and readily diagnostic test kits in the outbreak suppression.
deployable using existing
infrastructure available with JNCASR builds novel
PPE manufacturers. It can anti-microbial coating
be spray/dip-coated onto
any kind of surface including Bengaluru based Jawaharlal
textiles and other medical Nehru Centre for Advanced
device surfaces to get rid of Scientific Research (JNCASR),
microbial load. This will allow an autonomous institution
reusability of PPEs and easy under the Department of
containment of the microbes. Science and Technology
The research team has (DST), has developed a one-
developed the prototype of the step curable anti-microbial
technology. Further validation coating which, when coated
of product safety is ongoing on different surfaces such
and antimicrobial action as textile, plastic and so on
specifically against coronavirus could kill a range of virus
will be done at a government types including COVID 19.
facility. The team has filed for Considering the current
a provisional patent for the coronavirus outbreak, if shown
technology. to be active, the molecules can
be synthesized in large scale
through Contract Research coated on various personal
Organization and can be protective tools such as
masks, gloves, gowns, etc. in
collaboration with the private
organizations. The molecules
can also be coated on other
medical devices and tools to
avoid hospital-acquired or
nosocomial infections.

BBIOIOSSPPEECCTTRRUUMM || MAAPYRI2L0220020 | | wwwww.bwi.obsiopsepcetrcutmruimndiniad.icao.cmom SUPRPL&IEDRNNEEWWSS 4475

IIT-R creates CCRAS signs
low-cost MoU with
face shields JNU and ILBS

The Indian Institute of Central Council for Research in

Technology (IIT), Roorkee Ayurvedic Sciences (CCRAS) under
Ministry of AYUSH, Government of
researchers have used a 3D
printer to create low-cost face IIT-M working onIndia has entered a Memorandum
shields to protect the frontline algorithms for genetic studiesof Understanding (MoU) with
health workers fighting against
JawaharLal Nehru University
Indian Institute of Technology, (JNiUm)parnodveIdnsstyistutetme otfhLaitvearchieved
Madras (IIT M) is working with and5B0iliapryerSciecnecnets (ILpeBrSfo) rfmorance
IMTECH partners with IIT-BCovid-19 at All India Institute

of Medical Sciences (AIIMS)
Rishikesh. The face shields researchers across the world and cooipmerpartoivoenminentht e fienld oifdRenetsiefyairncgh

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ITITecRhnoorlokgeye (cIoMstTaEsCliHtt)l,e as Rs 45 betweenaltghoerirtehsmeasrchteors link diseases Ayuerxviesdtiang& aTprapdroitaiochneasl.MTehdeictineaem.
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CkOnoVwIDle-d1g9epaantidenentsh.ance high other. algorithms and developed an disebaisoelo(gNyA. FLD).

48 PEOPLE NEWS BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

Lupin hands over new task Dr Renu Swarup
to Ramesh Swaminathan
gets 1 year
Pharma major Lupin Limited has
announced the appointment of extension as
Ramesh Swaminathan as Chief
Financial Officer and Head Corporate DBT Secretary
Affairs. He will also join the board
as Executive Director. Swaminathan Dr Renu Swarup has been
will lead Lupin’s finance, investor given one-year extension as the
relations, strategic planning, Secretary of the Department of
information technology, corporate Biotechnology (DBT), according
communications and administration to a Personnel Ministry order.
functions. He brings to Lupin rich The move assumes significance
experience of over 30 years. In as the country is working upon
addition to having worked with Lupin containing the spread of corona
for more than a decade, he has also virus. She took over as the
worked with reputed organizations Secretary of the department on
in diverse industry sectors such as April 10, 2018, for a two-year
VST Industries Ltd, SPIC Group, term. A PhD in Genetics and Plant
Standard Chartered Bank, Henkel Breeding, Dr Swarup completed
and L&T. Swaminathan is a her post-doctoral studies at The
qualified Chartered Accountant, John Innes Centre, Norwich
Cost Accountant and Company UK, under Commonwealth
Secretary and recipient of Scholarship and returned to
the prestigious Chevening India to take up the assignment
Scholarship (UK). He also has of a Science Manager in the
an MBA from INSEAD. DBT, Ministry of Science and
Technology, in 1989.

Takeda appoints new
country head for India

Takeda India has announced company’s India business.
the appointment of Koki Sato In his current capacity, he
as the Country Head for the will lead the company’s
operations with a focus on the
expansion of patient access
to Takeda’s highly innovative
portfolio in the country. Koki
joined Takeda in 2003 and,
since then, grew within the
company to hold various
senior international roles
across multiple functions,
including commercial
operations, finance, and HR.
Prior to this role, Koki was the
General Manager of Ukraine,
Belarus, and Moldova (UBM)
Cluster in Takeda’s ICMEA
Area (India, C.I.S., Middle
East, Turkey, and Africa).



50 PEOPLE NEWS BIOSPECTRUM | MAY 2020 | www.biospectrumindia.com

MedGenome labs Fortis Healthcare
announces its new CEO ropes in Anil
Vinayak as GCOO
Bengaluru based MedGenome, the leading South
Asia Genetic Diagnostics, Research and data com- Fortis Healthcare Limited has announced the
pany has announced the appointment of Dr Vedam appointment of Anil Vinayak as its new Group
Ramprasad as its India Chief Executive Officer Chief Operating Officer (GCOO). He will lead
(CEO). A genetic scientist with several peer-re- operations for Fortis at a group level. He will
viewed publications to his credit, Dr Ramprasad be based out of the Corporate Office of Fortis
believes in harnessing the power of genomics for in Gurugram, Haryana. Vinayak is a seasoned
providing better outlook to patients. With MedGe- professional with a career spanning 32 and
nome, he has contributed significantly in carving has held
and developing an evidence-based market for ge- senior roles
netics in India. He has been with MedGenome since in global as
inception and spearheads operations and strategy well as Indian
for the organisation. Dr Ramprasad will focus on organizations
expanding to other markets in Asia and Africa. He and is a well-
was previously associated with Vision Research respected
Foundation, Sankara Nethralaya, Spinco Biotech, leader in the
and SciGenom labs over his two decade long career. industry. He
has strong
experience
in operations
management,
team building,
organizational
transformation, product development, business
development and partnerships, which will
undoubtedly enable him to be effective in
this role. Vinayak has previously worked with
Asian Paints (India), American Express Bank,
Mastercard International and Europe Assistance
India. His last assignment was with Max
Healthcare Institute Limited as Senior Director
& Chief Operating Officer – Cluster 1.

Dr Niti Kumar receives SERB excellence award

Dr Niti Kumar, Senior women researchers will be
Scientist from Division of supported by research grant
Molecular Parasitology and of Rs 5 lakh per annum for 3
Immunology, CSIR-CDRI, years by SERB, Department
Lucknow has received of Science & Technology,
Science and Engineering Government of India (SERB-
Research Board (SERB) DST). Dr Niti’s research
Women Excellence group is trying to understand
Award-2020. This award the protein quality control
is given to women scientist machinery in human malaria
below 40 years of age who parasite for exploration of
have received recognition alternative drug targets for
from national academies. The malaria intervention.


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