BioSpectrum India June 2021

Defined solutions for cell cultures.

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

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

COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.

COVERSTORY 24.........................................................................................................................................................

MALARIA DENGUE TB
PLAY SECOND FIDDLE TO COVID-19

Although India has worked relentlessly towards developing innovative testing solutions for COVID-19
throughout last year, the timely detection of a number of other infectious diseases has been sidelined. In
India, the range and burden of infectious diseases such as tuberculosis, malaria, filariasis, leprosy, HIV
infection, typhoid, hepatitis etc., are enormous. In fact, inadequate containment of the vector has resulted
in recurrent outbreaks of dengue fever and re-emergence of chikungunya virus disease and typhus fever. If
India can develop more than 20 different diagnostic tests or devices in a single year to fight COVID-19, many
more such innovations can be brought to effectively detect other infections looming in our country.

ANALYSIS PRECISION MEDICINE

20 32

Rare diseases policy outlines Precision Medicine to
challenges sans solutions reshape healthcare delivery

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com TOPVIDEO BIO CONTENT 5

PRECISION MEDICINE Dr Vedant Kabra,
HOD, Surgical
35 Oncology, Manipal
Hospitals, Dwarka,
Is the stage set for Precision New Delhi
Medicine to take off in Asia? recommends
COVID-19
SPEAKING WITH vaccination to
37 cancer patients &
care-givers.
“India should have
a vibrant clinical research Scan the QR Code »
community who can advise
drug developers” Ratna Mehta,
Dr Sanish Davis, Executive Vice
President,
President, Indian Society for Wadhwani
Clinical Research (ISCR), Mumbai Foundation,
Mumbai shares
39 her thoughts on
the future funding
“Digitally skilled scenario of health-
employees need to tech startups.
increase 9-fold by 2025”
Vivek Kanade, Scan the QR Code »

Managing Director, Kiran Gadela,
Siemens Healthcare, Mumbai Co-Founder &
Managing Director,
DIGITAL ADOPTION Oasis Fertility,
41 Hyderabad
highlights the
Will the second COVID-19 technological
wave overwhelm the challenges facing
pharma companies? the Indian IVF
Dr Sandeep Narula, market.

Associate Professor, Assistant Dean, Scan the QR Code »
School of Pharmaceutical,
IIHMR University, Jaipur

REGULARS

BioEdit ............................................................................... 06
BioMail .............................................................................. 08
Policy and Regulatory News.......................................... 10
Company News............................................................... 14
Finance News................................................................... 17
Start-up News.................................................................. 18
People News..................................................................... 43
Academics News............................................................. 45
R&D News......................................................................... 46
Supplier News.................................................................. 48
Let’s Talk Health & Science.....................................50

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

No foresight, No jabs

The devastating second wave of COVID-19 vaccine development of different companies. As
has exposed the total lack of preparation of August 2020 itself the United States paid $11
on part of the government, more so by the billion to eight companies to develop vaccines.
Union government and to varying extents by State Some companies were assured that a specific
governments. The Union government has mainly number of their vials will be purchased by the
failed in vaccinating a large number of people due government, with some even paid in advance.
to its tardy decision making, despite being aware As AstraZeneca worked with Oxford to develop a
that the only solution to fight COVID-19 currently vaccine, it had entered into an agreement with the
is large scale vaccination, something that’s been Serum Institute of India (SII), Pune in May 2020
accepted worldwide. for the production of 100 crore vials in a year,
once the vaccine was developed by Oxford.
Like various other factors related to
COVID-19, the powers for vaccine procurement, When all vaccine manufacturers are, presently,
too, were concentrated with the Centre. It has busy fulfilling their commitments made from
launched a phased vaccination programme since August to November last year to different
mid-January with the youngest group (18-45) countries, the Indian government suddenly woke
added since May 1. As the number of patients and up to demand for vaccines in January. Without
deaths and their gory stories of non-availability bothering to fully vaccinate Indian citizens, it
of beds, medicines, medical oxygen (causing thought wise to first export vaccines to other
deaths in many cases) across the country started countries. In the resultant chaos, it nonchalantly
coming out, people’s willingness and rush to get handed over vaccine procurement to states also.
vaccinated grew since the beginning of April. To States like Maharashtra urgently require the
that was added the second age group of 45-60, vaccine and are willing to spend (Maharashtra
followed by 18-45. But, the total lack of vision and Chief Minister Uddhav Thackeray expressed
decision making of the centre, leading to failure willingness to buy 12 crore doses in one go
in procuring the required number of vaccine vials for 6 crore people in the 18-44 age group) but
for such a huge population, has led to a miserable the vaccines are not available. Vaccine import
situation of non-availability of vaccines. proposals of states like Maharashtra were
pending with the centre for a long time despite
As a result, when 60 crore doses were required the emergency situation. This is an utter failure in
to cover the priority categories as announced foreseeing the situation and taking remedial steps.
by the government, only 25 per cent were
administered by April 30. Vaccination of the 18-45 Russia’s Sputnik vaccine has landed in India
group has not started with the speed it is required and its local production has commenced. Also,
to be done as the adequate quantity of vaccine is more vials are being churned out by SII and
not available and the priority is to give the second Bharat Biotech. In addition, vaccine technologies
dose within 70 days to 9.94 crore people who are being transferred to other companies to
have taken the first dose. This has resulted in long increase the production quantity and reduce the
queues and crowds at vaccination centres and delivery time frame of the same. Still, large scale
people waiting since very early morning just to vaccination appears to be a distant target. The
obtain a token number. loss of precious time due to delayed decisions
could have been avoided, mitigating the people’s
A glaring revelation for India is that countries sufferings to some extent.
like the USA, UK and several in Europe, despite
having much less population, have already placed Dr Milind Kokje
the order for vaccines from May to November Chief Editor
2020 itself after reviewing the possible success in
[email protected]

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

Vol 19; Issue 5; May 2021

Acknowledgements Thank you for the interview feature on
Agappe Diagnostics. Looking forward
Infinita Biotech is really grateful to the to a very productive association with
continuous support by BioSpectrum. BioSpectrum.
The ranking special edition on industrial
enzymes looks good. - Girish Menon, Ernakulam

- Adarsh Desai, Vadodara

The interaction with Boehringer- Appreciate Syngene’s coverage
Ingelheim India reads very well. Thank in the BioServices industry
you for the coverage. ranking edition.

- Magline Rufina, Mumbai - Sneha Ashok, Bengaluru

Vol 19; Issue 6; June 2021 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
Ravindra Boratkar Alok Srivastava Dr Manbeena Chawla Singapore
Editorial: National Business Head- Executive Editor MM Activ Singapore Pte. Ltd.
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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

PSA launches community mental-health digital platform

The Principal Scientific of Indian citizens. MANAS App research institutions.
Adviser (PSA) to the integrates the health and wellness MANAS was initiated by
Government of India efforts of various government the Office of the Principal
Prof. K VijayRaghavan ministries, scientifically validated Scientific Adviser to the
has virtually launched indigenous tools with gamified Government of India.
‘MANAS’ App to promote interfaces developed/researched It was jointly executed
wellbeing across age by various national bodies and by National Institute
groups. MANAS, which of Mental Health
stands for Mental and Neurosciences
Health and Normalcy (NIMHANS) Bengaluru,
Augmentation System, Armed Forces Medical
was endorsed as a national College (AFMC) Pune and
programme by the Prime Centre for Development
Minister’s Science, Technology, of Advanced Computing, (C-DAC)
and Innovation Advisory Bengaluru. The app is intended
Council (PM-STIAC). MANAS to be integrated with the public
is a comprehensive, scalable, health schemes like the National
and national digital wellbeing Health Mission, Poshan Abhiyan,
platform and an app developed e-Sanjeevani and others so that it
to augment mental well-being is used widely.

Telangana to try Health Minister
drone delivery of
COVID-19 vaccines unveils special issue

The Ministry of Civil Aviation (MoCA) and Directorate General of ‘Indian Journal of
of Civil Aviation (DGCA) have granted conditional exemption for
drone deployment to the Government of Telangana. The drone Medical Research’
usage permission has been granted for conducting experimental
delivery of COVID-19 vaccines within Visual Line of Sight (VLOS) Dr Harsh Vardhan, Union Minister
Range using drones. The permission exemption is valid for a for Health and Family Welfare chaired
period of one year or until further orders. These exemptions ICMR’s International Symposium
shall be valid only if all conditions and limitations as stated for titled ‘One Health in India: Research
the respective entities are strictly adhered to. Trials will also assist informing biosafety, preparedness and
in assessing conditions such as population, degree of isolation, response’ through video conference
geography etc. to identify regions that specifically require drone recently. He launched a special issue
deliveries. Similar permission has also been granted to the Indian of ICMR’s Indian Journal of Medical
Council of Medical Research (ICMR) for conducting feasibility Research which discusses the One
study of Covid-19 vaccine delivery using drones in collaboration Health approach, corroborating multi
with IIT Kanpur. sectoral research informing regarding
biosafety, preparedness and response
and has original articles, viewpoints,
perspectives and reviews from the
eminent experts in the field. The
commencement of the constitution
of a high-level steering committee
for Eco Health Initiatives in India
was also announced. This committee
will have its secretariat hosted at the
ICMR, and will also be supported by
the upcoming National Institute of
One Health which is planned to be
set-up in Nagpur.



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

DCGI gives Centre disallows export of C
nod to anti- Remdesivir injection & API M
COVID-19 drug Y
made by DRDO As India is witnessing a recent surge in COVID-19 cases, there has CM
been a sudden spike in demand for Injection Remdesivir used in the MY
An anti-COVID-19 therapeutic treatment of COVID-19 patients. There is a potential for a further CY
application of the drug 2-deoxy- increase in this demand in the coming days. Seven Indian companies CMY
D-glucose (2-DG) has been are producing Injection Remdesivir under a voluntary licensing K
developed by the Institute agreement with Gilead Sciences, USA. They have an installed
of Nuclear Medicine and capacity of about 38.80 lakh units per month. In light of the above,
Allied Sciences (INMAS), a the Government of India has prohibited the exports of Injection
lab of Defence Research and Remdesivir and Remdesivir Active Pharmaceutical Ingredients (API)
Development Organisation till the situation improves. In addition, the government has taken
(DRDO), in collaboration the required steps to ensure easy access of hospital and patients
with Dr. Reddy’s Laboratories to Remdesivir. All domestic manufactures of Remdesivir have
(DRL), Hyderabad. On May been advised to display on their website, details of their stockists/
1, 2021, the Drugs Controller distributors to facilitate access to the drug. Drugs inspectors and
General of India (DCGI) granted other officers have been directed to verify stocks and check their
permission for Emergency malpractices and also take other effective actions to curb hoarding
Use of this drug as adjunct and black marketing. The State Health Secretaries will review
therapy in moderate to severe this with the Drug Inspectors of the respective States/UTs. The
COVID-19 patients. Being a Department of Pharmaceuticals has been in contact with domestic
generic molecule and analogue manufacturers to ramp up the production of Remdesivir.
of glucose, it can be easily
produced and made available in Govt fast-tracks emergency
plenty in the country. Clinical approvals for foreign-made
trial results have shown that COVID-19 vaccines
this molecule helps in faster
recovery of hospitalised patients The matter of augmenting the basket of vaccines available for
and reduces supplemental fighting the pandemic as well as accelerating the pace and coverage of
oxygen dependence. A higher domestic vaccination programmes was discussed recently at the 23rd
proportion of patients treated meeting of the National Expert Group on Vaccine Administration
with 2-DG showed RT-PCR for COVID-19 (NEGVAC). The NEGVAC, after comprehensive
negative conversion in COVID
patients. The drug comes in deliberation, recommended that vaccines
powder form in sachet, which for COVID-19, which have been developed &
is taken orally by dissolving are being manufactured in foreign countries
in water. It accumulates in and which have been granted emergency
the virus infected cells and approval for restricted use by USFDA,
prevents virus growth by EMA, UK MHRA, PMDA Japan or which
stopping viral synthesis and are listed in WHO (Emergency Use Listing)
energy production. Its selective may be granted emergency use approval
accumulation in virally infected in India, mandating the requirement of
cells makes this drug unique. post-approval parallel bridging clinical
trial in place of conduct of local clinical
trial as per the provisions prescribed under
Second Schedule of the New Drugs &
Clinical Trials Rules 2019. Further, the first 100 beneficiaries of such
foreign vaccines shall be assessed for seven days for safety outcomes
before it is rolled out for further immunisation programmes within
the country. The Union Government, after due consideration, has
accepted the recommendation of NEGVAC.



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

Dr. Reddy’s launches Sputnik V vaccine in India

Dr. Reddy’s Laboratories supply of the Sputnik V vaccine are presently priced at Rs 995
announced that the first will commence from Indian per dose, with the possibility of
consignment of imported doses of manufacturing partners. The a lower price point when local
the Sputnik V vaccine that landed imported doses of the vaccine supply begins. The company
in India on May 1, 2021, received is working closely with its six
regulatory clearance from the manufacturing partners in India
Central Drugs Laboratory, Kasauli, to fulfill regulatory requirements
on May 13, 2021. As part of a limited to ensure smooth and timely
pilot, the soft launch of the vaccine supply. Dr. Reddy’s will work
has commenced and the first dose closely with stakeholders in the
of the vaccine was administered government and private sector in
in Hyderabad on May 14, 2021. India to ensure the widest possible
Further consignments of imported reach of the Sputnik V vaccine as
doses are expected over the part of the national inoculation
upcoming months. Subsequently, effort.

Glenmark launches Wipro focuses on
transforming vaccine
nasal spray for safety assessment

allergic rhinitis Bengaluru -based IT firm Wipro has announced a partnership

Glenmark Pharmaceuticals has with Hyderabad-based Transcell Oncologics to transform
announced the launch of Ryaltris-
AZ Nasal Spray for the treatment of vaccine safety assessment using augmented intelligence
moderate to severe allergic rhinitis,
in India. Glenmark, being one of the (AI). This partnership combines Transcell’s innovative stem
leaders in the respiratory segment, has
been the first to launch the branded cell technology with the advanced augmented intelligence
generic version at an affordable
capabilities of Wipro HOLMES to improve the safety of
cost for the treatment of
allergic rhinitis in India. global vaccine immunisation programs. By applying AI to
This will provide patients a
far more convenient, cost- the vaccine development
effective treatment option
in the country. Mumbai- process, the solution is
based Glenmark is the first
company in the world to capable of predicting
launch Ryaltris-AZ, as a
novel fixed dose combination adverse neurovirulent
of Mometasone furoate 50
impacts resulting from
mcg + Azelastine 140 mcg.
Ryaltris-AZ nasal spray is a vaccinations. Currently,
novel fixed-dose combination
nasal spray of an antihistamine vaccine safety assessment
and a steroid, indicated for treatment
of symptoms associated with allergic often includes testing
rhinitis in patients over 12 years of age.
It relieves symptoms of allergic rhinitis, on animals to measure
including stuffy nose, runny nose, nasal
itching, sneezing, as well as itchy, red adverse impacts. Using
and watery eyes.
Wipro HOLMES

instead, researchers

and biopharmaceutical

companies have a new and fully viable solution and

alternative. Wipro HOLMES can also be integrated into any

existing workflow, including quality control tests in vaccine

production, batch-wise release and other safety evaluation

assays. This partnership will also expand the Wipro HOLMES

solutions available to life science companies. The solution

applies AI for drug repurposing and Messenger Ribonucleic

Acid (mRNA) based platform for biodefense. It enables the

testing of new vaccines by applying augmented intelligence to

stem cell research and measuring safety and potency.

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com 15

Cutting edge Lab Facilities for
Biotech Pharma and IT / ITES Companies

at TICEL BIOPARK, Coimbatore

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

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

TICEL BIO PARK LIMITED – III

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

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

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

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

16 COMPANY NEWS BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

J B Chemicals Voxtur Bio to setup pan-India
forays into IVD kit distribution network
nephrology
segment Voxtur Bio, a Mumbai-based on the outskirts of Mumbai
In-vitro diagnostics (IVD) with a production capacity of
J.B. Chemicals & company, has rolled out a pan- 12 million tests per month.
Pharmaceuticals (JBCPL), India plan to expand its IVD kit As the IVD market in India
based in Mumbai, has distribution network. As a part is growing at a rapid pace,
announced its foray into of the strategy, the company Voxtur Bio aims to capture
the area of Nephrology with will onboard more than 100 the larger market share with
a new dedicated division marketing professionals across its affordable world-class IVD
called ‘RENOVA’ which will key metros and cities in India to test kits and reagents. In line
endeavour to serve patients strengthen its order procurement with the government’s Make
who are under treatment for and supply capability. To ramp In India mission, the company
Chronic Kidney Disease (CKD). up its manufacturing strength, is bolstering its manufacturing
The new division will focus the company has set up a and distribution wherewithal to
exclusively on comprehensive 40,000 sq. ft. state-of-the-art reduce dependence on imports
renal care ranging from the manufacturing facility in Vasai from countries like China.
management of hypertension
in Chronic Kidney Disease Kemwell Biopharma augments
to End-stage renal disease. existing CDMO infrastructure
After successfully becoming
one of the leading players in Bengaluru-based Kemwell enhancing in-lab productivity.
Hypertension with brands like Biopharma, a biologics contract In addition to Ambr 250, three
Cilacar and Nicardi, JBCPL development and manufacturing more 5L scale glass bioreactors
has now begun to also focus organization (CDMO), has are installed and now houses
on patients with CKD. With recently augmented its existing a total of 12 bioreactors of 5L
the introduction of this new infrastructure. As part of this and 10L scale. The company is
division and patient-centric expansion strategy, the company also looking forward to meeting
initiatives, JBCPL can help has installed Ambr 250, a the demand of its customers by
address the medical needs of high throughput equipment expanding its manufacturing
patients with CKD. The launch with 12 fully automated mini capacity further by adding three
of this division will also enable bioreactors at a 250 ml scale to Single-Use Bioreactors (SUBs)
nephrologists and physicians accelerate process development. this month. It plans to install
to provide patients with Ambr 250 enables setting of 100L (R&D), 200L and 1000L
different treatment options 12 different media conditions, SUBs in its existing cGMP plant
and ultimately improve the temperatures and gases, helping to support process scale-up and
quality of life in these patients. the client projects identify the preclinical toxicology batch and
JBCPL will continue to launch most optimal process leading to early clinical trial supplies, which
products under this division higher titer while reducing the are expected to be operational by
to achieve its objective of cost per experiment and thereby October 2021.
providing holistic support to
CKD patients at every stage.

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com FINANCE NEWS 17

Morepen Group seals Rs 750 Cr investment to expand diagnostic biz

The Board of Directors of approval, Corinth would be would be in the promoter group
Morepen Laboratories, based allotted 58.50 million new companies. The funds would be
in New Delhi, has approved equity shares on a preferential used in the expansion or scaling
the investment proposed by basis. This shareholding would up of the company’s R&D centre,
Corinth Group, a global private equate to a 9.41 per cent equity facilities to meet the significantly
investment Group, headquartered stake in the Company on a enhanced Active Pharmaceutical
in Switzerland, to the extent fully expanded capital base. Ingredient (API) demand, a
of $32.5 million in the parent The balance of $67.50 million market size of $40 billion, that
company, Morepen Laboratories, Morepen has in the pipeline for
out of a total $100 million (Rs the next 3 years. The investment
750 crore approx) investment in will also be used in world-class
the promoter group, subject to the diagnostics facilities including the
approval of the shareholders and manufacture of critical inputs/
other regulatory bodies. Following components/enzymes to meet
shareholder and regulatory regulated market standards.

Manipal Hospitals IvyCap Ventures
completes acquisition
of Columbia Asia sells stake in

Manipal Hospitals has announced the successful Leixir Dental Group
completion of acquiring 100 per cent stake in Columbia
Asia Hospitals. The transfer of ownership has taken IvyCap Ventures, one of the leading
place post the completion of all regulatory approvals. homegrown venture capital funds based in
With this acquisition, Manipal Hospitals becomes Mumbai, has announced the sale of its stake in
India’s second-largest multi-speciality hospital chain. Leixir Dental Group with 4x returns. Leixir is
Today, the integrated organisation with the strong a technology-enabled provider of outsourced
clinical expertise and breadth of services of Manipal dental solutions serving both the independent
Hospitals, complemented by the strengths of Columbia dentists and dental service organisations
Asia in clinical and service quality, is uniquely placed (DSOs) as well as technology and distribution
to enhance access and address the growing demand companies. The company operates five dental
for high quality tertiary and quaternary healthcare in laboratories across the US in addition to a
the country. The acquisition helps Manipal Hospitals digital design and manufacturing facility in
with a remarkable geographical and cultural fit that Gurugram, India. Harmeet Bindra, founder
Columbia Asia offers to reach a larger national footprint. of Leixir, will continue in his role as CEO and
Together, the combined entity now has 26 hospitals Executive Chairman. IvyCap was the first
across 14 cities with 7,000+ beds, and a talented pool of institutional investor in Leixir in 2015. The core
4,000+ doctors and 10,000+ employees. Treating over strategy was to build a cross border integrated
4 million patients annually, the hospital chain today dental lab network using digital technology to
ranks amongst the largest healthcare provider networks disrupt the sector. Leixir has since, acquired
in the country. several leading labs in various geographies in
North America and build an offshore centre for
design and 3D printing in India.

18 START UP NEWS BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

Sarathi Healthcare raises Rs 1 Cr in seed funding

Agetech startup, Jodhpur-based deliver holistic care for the elderly is a premium healthcare provider
Sarathi Healthcare has raised by providing them well-rounded with top-notch services that
a funding of Rs 1 crore in seed preventive and emergency brings 24X7 medical services at
funding from a clutch of investors. healthcare. ‘Sarathi Healthcare’, the doorsteps at times of need.
The angels who participated in the Sarathi Healthcare will use the
round seasoned entrepreneurs funds to support its 20x growth,
and investors Nitin Sethi, Vishal with geography expansion, adding
Dhikale, Swapnil Bagul, Gaurav new towns, medical specialties in
Satbhai and Jayshree Harak from turn bolstering their team and tech
Jodhpur, Nasik, Surat and Pune. product. Saarthi Healthcare has
Sarathi Healthcare is currently already impacted around 5000+
being accelerated by India’s lives including patients suffering
fastest-growing startup accelerator from chronic diseases, since its
Marwari Catalysts Ventures. incorporation in the middle of the
Sarathi aims to prioritise and pandemic.

iCreate unveils Crediwatch helps
critical health-
tech devices to validate medical
fight COVID-19
services to combat fraud
International Centre for Entrepreneurship and
Technology (iCreate), an autonomous centre of Crediwatch (CW), a digital trust platform backed by
excellence of the Government of Gujarat, has leading investors from Silicon Valley, has developed
announced the launch of critical health-tech tools to help validate medical service providers for
devices developed by three respective startups COVID-19 relief across India, in a bid to combat
incubated with the institution. The devices will fraud in relief efforts. CW aims to enable COVID-19
help in altering ICU ventilators to host multiple relief workers, doctors, hospitals and resource teams
patients at the same time and augmenting to quickly ascertain the bonafides of a supplier of
large scale oxygen supply chains. Developed by medical supplies such as liquid oxygen, medicines,
Social Hardware, 3D printed splitter is a unique surgical masks and so on. Unfortunately, this crisis
has seen bad actors take advantage of relief work.
ventilator expansion device For example, bogus suppliers have not delivered
that allows a single ventilator to medical oxygen that they were paid for by aid
support up to two or four patients organisations. Many fraudsters have emerged
during a time of acute equipment who claim to offer a service and fail to deliver
shortage. The startup also has after collecting premium payments for it. CW’s
developed a second device; web platform or APIs (application programming
Venturi Valve Respirator that interface) enables relief networks to instantly run
can be used for airflow control checks on businesses claiming to offer a service.
through varying its annular orifice CW’s bot infrastructure and proprietary scores will
to modulate the flow of air. On the other hand, the identify any potential risks with a business entity.
IoT-enabled solution Chief Beta (Industrial IoT Only validated businesses can be retained by various
Gateway) developed by Limelight IT solutions, relief networks providing critical care across India.
is an industrial gateway that can easily plug into
the oxygen supply lines of hospitals and allied
healthcare institutions to monitor, perform
audits, detect and send leakage alerts, and Oxyter
developed by RedCarbon TechnoHub is a portable
Oxygen Generator that works on Electrolysis.

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

PinkTech launches digital Fitterfly
system for germ detection bags $3.1M
in pre-Series
New Delhi-based startup PinkTech Designs has recently launched Digital A round
Sanitisation Audit System (DSAS), supported by the Government of India,
that can detect whether your hands are really clean and germ free, which was Fitterfly, a Mumbai-
ideated and developed by an eight year old student Meer, with the help of based healthtech startup
his sister Mira and father Dr Kanav Kahol. DSAS is an innovative technology working in the field of
Digital Therapeutics
that helps in identifying whether (DTx), has raised $3.1
we are adhering to the hygiene million in Pre-Series A
protocols or not. DSAS innovation, round. The round was
supported by Biotechnology led by Fireside Ventures
Industry Research Assistance and also saw participation
Council (BIRAC), Department from 9Unicorns – the
of Biotechnology, Government accelerator fund of
of India with the funding of Rs Venture Catalysts, Venture
50 lakh, partnered by NU Verse, Catalysts and a clutch of
can now predict if the hands are angel investors from India,
germs free and properly sanitised, the US and Singapore.
ensuring the breakage of COVID-19 Funds will be primarily
chain. The DSAS innovation comprises three major systems, namely Radio- used for improving the
frequency identification (RFID) Attendance system, AI/IoT-based hand solution to deliver better
sanitisation detection system and sanitiser dispenser. It has a cloud based patient outcomes at scale
sanitisation audit where all the records are stored. This technology can be and impacting a large
integrated anywhere and everywhere due to its user friendly nature. number of people by
creating better awareness
Ahammune Biosciences secures and reach. Kanwaljit
funds to develop vitiligo drug Singh, Managing Partner
at Fireside Ventures also
Pune-based biotech startup, Ahammune Biosciences has raised an joins as a board member.
undisclosed amount in a Pre-Series A round led by Ideaspring Capital and Fitterfly DTx programmes
Indian Angel Network. Kotak Private Equity, Legacy Assets LLP (Baldota offer 360-degree guidance
family fund), and Dr Ajith Kamath (ex-Pfizer) have also participated in around nutrition, exercise,
the round along with existing investors, including Dr Anand Deshpande sleep, stress and other
and Suman Kant Munjal. The company also has Dr Ganesh Natarajan factors which affect
as an existing investor and has been in receipt of funding grant from health outcomes. More
Government of India’s body, BIRAC. The freshly infused than 10,000 people
capital will be used for ‘first-in-human’ studies have subscribed and
with Ahammune’s new drug candidate AB1001 benefited from Fitterfly’s
for vitiligo, a debilitating skin depigmentation programmes.
disorder. The study will comprise Phase-I safety
studies in healthy human volunteers and Phase-II
efficacy studies in vitiligo patients. The biotech
company will also deploy the funds in building
the patent portfolio to further the research
and development efforts. Ahammune,
founded in May 2016, has filed its
first Investigational New Drug (IND)
Application with the Drug Controller
General of India (DCGI) for approval to
conduct human studies with its lead
drug candidate for vitiligo.

20 ANALYSIS BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

Rare diseases policy outlines
challenges sans solutions

There is no substantial data on the number of people suffering from rare diseases in India and
the data that is available is from tertiary care hospitals. The lack of epidemiological data on rare
diseases makes it a herculean task to determine the prevalence and burden of rare diseases,
hence hampering the definition of rare diseases in the Indian context.

The National Policy for Treatment of Rare cent have therapies available to treat them. About 95
Diseases (NPTRD) was formulated by the per cent rare diseases have no approved treatment
Ministry of Health and Family Welfare and less than 1 in 10 patients receive disease specific
(MoH&FW), Government of India in July, 2017. treatment. Where drugs are available, they are
The policy, however, has faced challenges with prohibitively expensive, placing immense strain on
implementation. One of them was bringing the states the resources.
on board and the lack of clarity on the quantum of
support for the states from the Centre in terms of Rampant delayed diagnosis
tertiary care.
There are also varying definitions of rare diseases.
Due to these challenges, an Expert Committee The World Health Organisation (WHO) defines rare
was constituted by MoH&FW in November, 2018 disease as a debilitating lifelong disease or disorder
to review the NPTRD, 2017. The Expert Committee, with a prevalence of 1 or less, per 1000 population.
along with the approval of the competent authority, The US defines rare diseases as a disease or condition
finalised a draft of the National Policy for Rare that affects fewer than 200,000 patients in the
Diseases and placed it in the public domain on country (6.4 in 10,000 people). The European Union
January 13, 2020 for all stake holders to review and (EU) defines rare diseases as a life-threatening
recommend. Reviews and recommendations were or chronically debilitating condition affecting no
examined by an Expert Committee set up by the more than 5 in 10,000 people. Japan identifies
Directorate General of Health Services (DGHS). It rare diseases as diseases with fewer than 50,000
has finalised the policy after further deliberations, prevalent cases (0.04 per cent) in the country.
examination of recommendations. There are between
7000 and 8000 rare diseases, but less than 5 per According to the ‘Rare Disease Impact Report:
Insights from patients and the medical community’
(a report commissioned by Shire and developed in
collaboration with an external advisory board), it
takes patients in the US an average of 7.6 years and

patients in the UK an average of 5.6 years
to receive an accurate diagnosis, typically
involving as many as eight physicians,
four primary care and four specialists.
In addition, two to three misdiagnoses
are typical before arriving at a final
diagnosis. Delay in diagnosis or a wrong
diagnosis increases the suffering of
the patients exponentially. There is an
immediate need to create awareness
amongst the general public, patients,
their families and doctors. Training
of doctors to facilitate early and accurate
diagnosis, standardisation of diagnostic
modalities and development of newer

diagnostic and therapeutic tools is an
urgent requirement.

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com ANALYSIS 21

Lack of ‘Orphan Drugs’ “The lack of foresight and
grounding in the rare
Despite the progress that life sciences has made
in the last few decades, availability of medicines disease community’s reality
and therapy related to rare diseases to prevent shines through the cold
morbidity and mortality has remained low. As per a and thoughtless drafting
paper published in the Lancet, there is no approved of the NPRD 2021. A truly
treatment for 95 per cent of rare diseases. The
number of people suffering from rare diseases also shocking thing, given the
termed as ‘orphan diseases’ are comparatively small, hundreds of High Court cases,
hence they do not constitute a significant market
for pharma companies. Drugs to treat rare diseases individual representations,
are also called ‘orphan drugs’ and very few pharma and representations spanning
companies make these drugs as the cost of R&D is almost two decades by patient
monumental.
advocacy groups. But we will
Whither data? continue to fight on - till every
person living with a rare disease,
There is no substantial data on the number of irrespective of age, or any socio-
people suffering from rare diseases in India and economic factors, has the right
the data that is available is from tertiary care
hospitals. The lack of epidemiological data on rare to health.’’
diseases makes it a herculean task to determine - Prasanna Shirol,
the prevalence and burden of rare diseases, hence
hampering the definition of rare diseases in the Founder Director, ORDI, Bengaluru
Indian context. The most commonly reported
diseases are primary immunodeficiency disorders, “The announcement of
lysosomal storage disorders (Gaucher’s disease, the rare diseases policy is a
Mucopolysaccharidoses, Pompe disease, fabry disease comprehensive step forward by
etc., small molecule inborn errors of metabolism the government that will further
(Maple Syrup urine disease, organic acidemias etc), add impetus to the rare diseases
cystic fibrosis, osteogenesis imperfecta, certain ecosystem, thus ensuring
forms of muscular dystrophies and spinal muscular timely access to therapy and
atrophy, etc.
treatment.”
Problems without solutions - Gopal Agrawal,

NPTRD 2021, even though it is a welcome move, Head of Market Access and
has not been accepted well by the rare diseases Pricing- Takeda India, Gurugram
community as the policy itself is severely flawed,
leaving a massive void that needs to be filled. “Efforts should be made for
Organisation for Rare Diseases India (ORDI) is of regional medical institutes
the opinion that the government has taken a rather to act as ‘collection centres’
cavalier approach to the issue of affordability of the for blood or tissue samples.
care needed to sustain a life of dignity for persons
living with rare diseases as the policy suggests These samples can be
that a patient should rely on crowdfunding for sent to higher centres or
treatment. Prasanna Shirol, Founder Director, ORDI,
Bengaluru states, “The NPTRD policy 2021 is simply other apex laboratories
a draft compilation of a few existing initiatives and for diagnosis. Unless,
a policy directive for the future but without any
funding, timeline, relation, and actionable. This diagnosis is done, treatment
policy has only listed the challenges of the rare cannot be initiated. Once
disease community without focusing on sustainable
solutions; no concrete action plans have been diagnosis is confirmed, the
mentioned.” government should take full
responsibility of the patient
Shirol in a statement exclaimed, “The NPRD,
2021, is a mockery of the right to health each for further medical and
other logistics care of the

patient.”
- Dr Ajoy Kishore Ravi,

Consultant, UNICEF, Ranchi

22 ANALYSIS BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

“Appropriate definitions DEFINITIONS OF RARE DISEASE
IN DIFFERENT COUNTRIES
need to be in place so that
Sr. Country Prevalence less than
potential drug developers are No. per 10,000 population

aligned with policy makers 1 USA 6.4

and prioritise their research. 2 Europe 5.0

Another important issue is the 3 Canada 5.0

need for waiver of local clinical 4 Japan 4.0

trial requirements based on 5 South Korea 4.0

the safety and efficacy data 6 Australia 1.0

submitted to other regulatory 7 Taiwan 1.0

agencies such as US FDA, EMEA Source: The 1.C. Vermo Sub-Committee Report ‘Guidelines for Therapy and Management’

etc. This will enable access masses, other important factors are availability/
affordability of treatment drugs, correct diagnosis
to these lifesaving drugs to and timely treatment.

patients with unmet needs There are a lot of inroads that have to be made if
this policy truly has succeed in catering to all those
earlier.” who are in desperate need of this. Gopal Agrawal,
- Dr Sanish Davis, Head of Market Access and Pricing- Takeda India,
Gurugram comments, “The announcement of the rare
President, ISCR, Mumbai diseases policy is a comprehensive step forward by
the government that will further add impetus to the
person in India enjoys, because it ignores the true rare diseases ecosystem, thus ensuring timely access
needs of the rare disease community in India. to therapy and treatment. With the policy now in
The lack of foresight and grounding in the rare place, there is considerable ground work that will be
disease community’s reality shines through the required for successful implementation of the policy.
cold and thoughtless drafting of the NPRD 2021. It will be instrumental to build innovative access
A truly shocking thing, given the hundreds of initiatives and strategic partnerships across the
High Court cases, individual representations, and rare disease landscape to bring customised solution
representations spanning almost two decades by for patients with targeted education, awareness,
patient advocacy groups. But we will continue to diagnosis and treatment.”
fight on - till every person living with a rare disease,
irrespective of age, or any socio-economic factors, has The Centre and states need to come to a
the right to health.” consensus to address issues related to rare diseases
as there isn’t enough data and infrastructure
Even after being in the works for four years this available to ascertain what should be considered a
policy doesn’t address the immediate need of the rare rare disease and what doesn’t fall into the category
disease community, which is estimated to 70 million of rare diseases. The funds allocated for the National
in India, as the policy neither addresses the major Health Policy for Rare Diseases currently stands at
current issues nor does it have a robust plan for the Rs 25 crore for the year 2021-22 and an additional
future. sum of Rs 4.10 crore has been remitted to the All
India Institute of Medical Sciences (AIIMS) under
India currently has two definitions of rare the rare disease component of the umbrella scheme
diseases: ICMR defines rare disease as 1: 2500. This of Rashtriya Arogya Nidhi (RAN) for 2020-21. The
is based on comprehensive consultation from genetic amount isn’t enough as treatment, research and drug
doctors across India; New Drug and Clinical Trials development costs are going to be monumental.
Rules of Orphan Drug under Rule 2(1)(x) states that
an -“Orphan drug means a drug intended to treat Dr Ajoy Kishore Ravi, Consultant, United
a condition which affects not more than five lakh Nations Children’s Emergency Fund (UNICEF),
persons in India.” The policy not only fails to define Ranchi opines, “Efforts should be made for regional
rare diseases, but also is simply a draft compilation medical institutes to act as ‘collection centres’ for
of a few existing initiatives and a policy directive for blood or tissue samples. These samples can be
the future but without any funding, timeline, relation, sent to higher centres or other apex laboratories
and actionable. This policy only lists the challenges
of the rare disease community with no focus on
sustainable solutions and no concrete action plans.

It isn’t only NPTRD 2021 that requires immediate
attention, as there are not enough labs that conduct
tests for rare diseases, awareness about rare diseases
is another prominent issue, even amongst educated

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com ANALYSIS 23

for diagnosis. Unless, diagnosis is done, treatment Issues related to
cannot be initiated. Once diagnosis is confirmed, classification of diseases
the government should take full responsibility of the
patient for further medical and other logistics care of Group I disease
the patient. Dedicated personnel should be involved Rs 20 lakh one time only under Rashtriya
for implementation of this sensitive missionary job. Arogya Nidhi (RAN) scheme is not made exclusively
Procedures should be performed on priority basis, for rare diseases, it is a part of an existing scheme
with waiting periods minimised. Hospital beds extended; there is nothing new about it.
should be ear-marked for such diseases, R&D should Generally, those requiring lung or kidney
be encouraged. Doctors should be encouraged to opt transplantation have lifetime management
for these research oriented specialities by offering of huge expenditure with pre and post
them financial and promotional incentives in their transplantation. This amount is not sufficient to
professional career.” address such needs. How will the family Below
Poverty Line (BPL) get to this stage without the
The policy is flawed, but has been envisioned basic infrastructure to diagnose in government
with good intent. There needs to be specific funds healthcare centres?
allocation for treatment of diseases in Group II & Group II disease
III categories instead of relying on crowd funding This responsibility of Group II disease patients
as the solution. Responding the policy initiatives, is transferred to the state. Unfortunately, the
The Indian Society for Clinical Research (ISCR), an majority of state governments have done little for
association of clinical research professionals is of these patients. There should have been a support
the opinion that the funding allocated for Group II system for state governments to manage these
& III diseases isn’t adequate as they require long- conditions in terms of funding, proper protocol
term treatments. The other major issue that ISCR and guidance, etc.
highlights is to get research priorities correct and Group III disease
the need to align the definition of ‘rare disease’ with The whole idea of the rare disease advocacy
that of ‘orphan drug’ under the New Drugs & Clinical movement started only for such conditions where
Trials Rules 2019. no one could afford it. In fact, if the government
says that the treatment is expensive, how can one
“Appropriate definitions need to be in place expect aam aadmi to bear this burden? In this case,
so that potential drug developers are aligned with the government has suggested ‘crowd funding’.
policy makers and prioritise their research. Another Central government clarification
important issue is the need for waiver of local clinical Beneficiaries for such financial assistance
trial requirements based on the safety and efficacy would not be limited to BPL families, but the
data submitted to other regulatory agencies such as benefit would be extended to about 40 per cent of
US FDA, EMEA etc. This will enable access to these the population, who are eligible under Ayushman
lifesaving drugs to patients with unmet needs earlier. Bharat- Pradhan Mantri Jan Arogya Yojana
This will also open up India for participation in (PMJAY). This financial support for treatment
both early and late stage global clinical development of rare diseases is proposed under the Umbrella
programmes thereby also enabling the generation of Scheme of Rastriya Arogya Nidhi (RAN) and not
safety and efficacy data in the local population,” adds under Ayushman Bharat PMJAY.

Source: ORDI

Dr Sanish Davis, President, ISCR, Mumbai.
The policy immediately needs to urgently define

what is a ‘rare disease’ and develop a robust, long
term plan. States need directives and support from
the central government to tackle Group II disorders.
Woefully, there are, presently, only eight Centres of
Excellence for management of rare diseases which
aren’t enough considering the population of the
nation.

Prabhat Prakash
[email protected]

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

MALARIA DENGUE TB PLAY

SECOND FIDDLE
to

Although India has worked Like the previous year, 2021 is expected
relentlessly towards developing to be dominated by the coronavirus
innovative testing solutions for pandemic. Apart from the difficulties it
COVID-19 throughout last year, has imposed on the healthcare system, it has
the timely detection of a number made India realise the importance of biomedical
resources. It has pushed India to optimise the
of other infectious diseases latent capabilities which the country possesses,
has been sidelined. In India, the across the public and private sector to promote
range and burden of infectious indigenous development and manufacturing.
diseases such as tuberculosis,
2020 saw many innovative solutions
malaria, filariasis, leprosy, HIV entering the market within the diagnostic space
infection, typhoid, hepatitis etc., particularly for COVID-19 testing. A majority
are enormous. In fact, inadequate of them came from the academic sector, after

containment of the vector has
resulted in recurrent outbreaks of

dengue fever and re-emergence
of chikungunya virus disease and
typhus fever. If India can develop
more than 20 different diagnostic
tests or devices in a single year to
fight COVID-19, many more such

innovations can be brought to
effectively detect other infections

looming in our country.

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

receiving timely regulatory approvals and “We are currently funding projects at the
commercialisation. AIIMS, THSTI, PGIMER and University of

Although India worked relentlessly towards Delhi-South Campus, for developing rapid
developing innovative testing solutions for detection kits for tuberculosis and COVID-19,
COVID-19 throughout last year, the timely
detection of a number of other infectious diseases amid many others.”
got sidelined. A recent example is the rise of a - DR RENU SWARUP
rare fungal infection mucormycosis. Secretary, Department of Biotechnology,
Government of India, New Delhi
In India, the range and burden of infectious
diseases are enormous such as tuberculosis, “In diagnostics, Indian scientists, engineers, and
malaria, filariasis, leprosy, HIV infection, data experts are rapidly innovating new products
typhoid, hepatitis etc. In fact, inadequate that can help humanity to identify and overcome
containment of the vector has resulted in
recurrent outbreaks of dengue fever and re- many diseases expeditiously.”
emergence of chikungunya virus disease and - AJIT RANGNEKAR
typhus fever.
Director General, Research and
For instance, India is home to approximately Innovation Circle of Hyderabad
2.8 million tuberculosis patients, making it the
largest number in a single country. On the other
hand, more than a decade after India eliminated
leprosy, the disease continues to linger on.
Adding on, India’s malaria surveillance system
ranks among the worst in the world according
to the World Health Organization (WHO).
According to a study published in The Lancet in
2020, diarrheal diseases, tuberculosis and lower
respiratory infections were among the leading
causes of deaths in India in 2019.

Thus, after witnessing a range of novel
diagnostic tests stepping into the market for
rapid detection of COVID-19, India should lay
focus on developing and commercializing similar
point-of-care tests for other infectious diseases

“Thanks to the introduction of the PLI scheme,
a large number of manufacturers will be able to

bolster their production capacity of diagnostic
solutions. This will significantly enhance India’s
share in the global diagnostic device exports.”

- DR VEERAL GANDHI
Founder & Chairman,

Voxtur Bio, Mumbai

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

“Early diagnosis of dengue is the key to prevent »
deterioration of a patient’s health. However,
conventional diagnostic tools like nucleic acid Sushil Mehta,
detection using Reverse Transcriptase Polymerase Chairman,
Chain Reaction (RT-PCR) is a time taking process
and it also requires expensive equipment and NextGen Invitro
reagents for the diagnosis of dengue.” Diagnostics, Gurugram
- DR J P SINGH
Professor, Department of Physics, shares his views on
Indian Institute of Technology, Delhi the current challenges

too, for their timely detection and subsequent facing the diagnostic
elimination. If India can develop more than space for infectious
20 different diagnostic tests or devices in a
single year against COVID-19, many more such diseases in India.
innovations can be brought out to effectively
detect other infections looming in our country. “Diagnostics
solutions in
Translating ideas in lab the infectious
disease domain
Amidst the ongoing pandemic, the need for are not available
devices that can rapidly detect and diagnose to the needy
infectious bugs is evident within our scientific population”
community. Resultantly, a number of researchers
are finding out numerous ways to develop novel, There are some diseases which are of
inexpensive and easy-to-use devices to combat national importance - HIV being first. We
these diseases. have rapid kits which are good such as
Tridot. Then we have good immunoassay CD4,
A recent example comes from the Indian CD8 which are available in semi point of care
Institute of Technology, Delhi (IIT-D) where a (POC) format, and then the reference labs and
group of researchers has developed a handheld hospitals use flow cytometry or Molecular Dx
Surface Enhanced Raman Spectroscopy (SERS) for accurate diagnosis in labs. Here, the sample
based platform for early diagnosis of dengue is blood which makes it so easy for sample
virus. It gives dengue test results within one collection and diagnosis. HIV is an exception as
hour. The handheld device has been successfully there was a very concerted, sustainable effort.
tested on the clinical blood samples collected
from hundreds of individuals in collaboration However, for other diseases like TB, an
with the National Institute of Malaria Research accurate point of care test is the need of the
(NIMR), New Delhi. hour. However sample collection itself is a
challenge. We have good molecular and culture
The detection and distinction of human tests suitable for a medium to a large lab setting.
immunodeficiency virus (HIV-1) was also carried TruNat gives that additional advantage of
out in collaboration with the National AIDS peripheral setting usage but throughput is very
Research Institute (NARI), Pune through the less. Hence upfront investment is high. That’s
handheld SERS based platform. It gives HIV-1 why there is a need for a solution - where sample
test results also within an hour. This research collection is easy, throughput is also good and
work has been funded by IMPRINT India can be adopted in POC settings.
programme of the Ministry of Education with

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

Diagnostic solutions in the infectious “High-sensitivity rapid tests for HBsAg are
disease domain except for SARS-CoV-2 in the necessary with the effective vaccination
Indian scenario are not available to the needy programme to eliminate Hepatitis B.”
population. There is a dearth of quality serology - KIM PETTERSSON
and/or molecular diagnostics-based tests except
a few imported but not cost-effective solutions Research Director, Molecular Biotechnology
in the Indian context for e.g., GeneXpert and Diagnostics, University of Turku, Finland
cartridge-based test for TB, ID Now by Abbott
for COVID-19. “TB is the deadliest infectious disease today and
India has the largest number of TB-related deaths
Before the implementation of the new
medical device rule (MD-2017) by the Central among all countries in the world. Through our
Drug Standard Control Organization (CDSCO), device, we have tried to address the challenges of
only notified test/devices (HIV, Hep-B, Hep-C
and blood grouping antigen) were regulated in affordability, accessibility and user-friendliness.”
India, hence most non-notified IVD kits and - DR BHUSHAN TOLEY
reagents lacked the required quality standard.
Assistant Professor, Department of
After the implementation of MD-2017, Chemical Engineering, Indian Institute
Indian manufacturers have improved their
quality system and CDSCO have helped with of Science, Bengaluru
the notifications issued from time to time to
provide clarity on the manufacturing process “With our malaria detection test, results can be
and quality standards. There is a need to fast read after 20 minutes from sample addition,
track regulatory approvals to service the gap of with a simple photoluminescence reader. It
accurate, accessible and economical infectious has potential for diagnostic testing of both
disease diagnostic solutions symptomatic and asymptomatic individuals.”
- DR GAURAV BATRA
Also, for better industry-academia
collaboration, there needs to be greater Assistant Professor, Translational Health Science
visibility into areas of research being pursued and Technology Institute, Faridabad
by institutions. The industry will rapidly adopt
and even scale up once they see the clinical and
commercial benefit. Institutions can collaborate
with the industry at early stages, with a very
clear orientation towards making a clinically
acceptable product.

A fair economical model can be also put in
place which fosters transparent and attractive
partnership. Institutions are flushed with high
tech capability, they use it for basic research
and for publications. Often such research is lab
focused and proof of science. We need to take it
further from proof of concept to a viable product.

There are examples of Academia and
Industry having participated in offering new
solutions to market both pre and post COVID.
MD Check (Feluda) developed by Delhi-based
Institute of Genomics and Integrative Biology
(IGIB), commercialized by Tata Medical &
Diagnostics is one such case. An early-stage
collaboration between Academia and Industry
would improve efficiency in ensuring that proof
of concept graduates to a market required
solution backed with clinical validation and
quality standards.

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

FACT-CHECK Gurugram-based New Age Instruments and
Materials as the industry partner.
● Tuberculosis (TB) affected 2.64 million Indians
in 2019 and killed nearly 450,000 people in “Dengue is a serious global health concern
the country. The government is calling for with a large population around the world facing
the elimination of TB by 2025, and there is the risk of getting infected. Early diagnosis
a National Strategic Plan 2020-2025 with of dengue is the key to prevent deterioration
ambitious ideas in place. of a patient’s health. However, conventional
diagnostic tools like nucleic acid detection
● The World Malaria Report (WMR) 2020 using Reverse Transcriptase Polymerase Chain
released by WHO, which gives the estimated Reaction (RT-PCR) is a time taking process
cases for malaria across the world, based on and it also requires expensive equipment and
mathematical projections, indicates that India reagents for the diagnosis of dengue. Our
has made considerable progress in reducing its ultrasensitive and handy device has a wide
malaria burden. India has a vision of a malaria range of applications in the early-stage on-site
free country by 2027 and elimination by 2030. detection of viral diseases and can produce the
final report of investigation within an hour”, says
● India has the third largest HIV epidemic in the Dr J P Singh, Professor, Department of Physics,
world, with 2.1 million people living with HIV. As Indian Institute of Technology, Delhi.
a signatory to the United Nations declaration
on Sustainable Development Goals (SDGs), Keeping a focus on rapid detection of
India is committed to achieving the “End of tuberculosis (TB), engineers at the Indian
AIDS” as a public health threat by 2030. Institute of Science (IISc) in Bengaluru have
designed a low-cost paper-and-plastic device
that can detect the presence of TB DNA in liquid
samples. An untrained user can perform a TB
test by simply adding liquid samples to the paper
reaction zones and placing the device in an
incubator for 60-80 minutes. The results of the
test are read using a cell phone camera installed
within a small plastic box. The material cost of
fabricating the device is only Rs 61 and the cost
of reagents per reaction zone is Rs 41.

“TB is the deadliest infectious disease today
and India has the largest number of TB-related
deaths among all countries in the world.
Through our device, we have tried to address
the challenges of affordability, accessibility
and user-friendliness. The technology is called
Fluorescent Isothermal Paper-and-Plastic
Nucleic Acid Amplification Test (FLIPP-NAAT).
A pilot clinical trial done in collaboration with
Christian Medical College (CMC) Vellore has
achieved 100 per cent sensitivity for the detection
of TB. Besides its application for the diagnosis of
TB, it could be modified to detect other diseases
as well”, says Dr Bhushan Toley, Assistant
Professor, Department of Chemical Engineering,
Indian Institute of Science, Bengaluru.

Adding on, a recent collaborative study
between Faridabad-based Translational Health
Science and Technology Institute (THSTI) and
University of Turku, Finland has led to the
development of a highly sensitive and robust
point-of-care test that can detect malaria
infection. The test has been validated by
running samples containing different strains of

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

Plasmodium falciparum, the causal organism, “Diagnosing a drug resistant urinary tract
from different geographical areas. infection can take days. The most used method

While microscopy is the historical standard of microbial culture, requires 2-3 days’ time, a
method of malaria diagnosis, rapid diagnostic laboratory and highly trained manpower. With
tests (RDTs) are currently the most popular our test ASTSENSe, the results would be available
method of diagnosis in resource-poor areas.
RDTs are easier to use than microscopy, do not within 2 hours rather than 2 days.”
require skilled workers, and produce results - SACHIN DUBEY
quickly. However, most currently available
RDTs do not have sufficient sensitivity to detect Chief Executive Officer & Co-founder,
asymptomatic or submicroscopic infections. Module Innovations, Pune

“Results can be read after 20 minutes “Bengaluru based SpotSense is working on building
from sample addition, with a simple a diagnostic pacifier platform for saliva-based
photoluminescence reader. In the absence of a screening of various neonatal health ailments
reader device at the testing site, the strips after
running the test can be transported and read at a including a rapid diagnostic test for neonatal sepsis,
central location with access to a reader. We have and Pune based Module Innovations is developing
found that the test and control line signals are
stable for at least 10 months after running the colour changing nanofiber strips for selective
test. It has potential for diagnostic testing of both detection of the entero-haemorrhagic bacterial
symptomatic and asymptomatic individuals”,
explains Dr Gaurav Batra, Assistant Professor, strains, to combat AMR”.
Translational Health Science and Technology - DR TASLIMARIF SAIYED
Institute, Faridabad. Chief Executive Officer & Director,

A similar collaboration between the scientists C-CAMP, Bengaluru
of THSTI, the International Centre for Genetic
Engineering and Biotechnology (ICGEB), and the
University of Turku, Finland has resulted in the
development of a highly sensitive rapid testing
device for hepatitis B. The team has built a lateral
flow immunoassay (LFIA) for hepatitis B Virus
surface antigen (HBsAg) utilising up-converting
nanoparticle (UCNP) reporter. The assay can use
whole blood, serum, or plasma and the results
can be read in 30 minutes using a reader device.
Scientists plan to use clinical settings, with
freshly drawn patient samples, using a battery-
operated reader device feasible for point-of-care
use to further evaluate the true performance of
the test.

“Detection of hepatitis B Virus surface
antigen (HBsAg) is an established method for
diagnosing both acute and chronic hepatitis B
virus (HBV) infection. In addition to enzyme
immunoassays (EIAs), rapid diagnostic tests
(RDTs) are available for the detection of
HBsAg in resource-poor settings. However,
the available RDTs have inadequate sensitivity
and therefore are not suitable for diagnosis of
patients with low levels of HBsAg and for blood
screening. High-sensitivity rapid tests for HBsAg
are necessary with the effective vaccination
programme to eliminate Hepatitis B”, points out
Kim Pettersson, Research Director, Molecular
Biotechnology and Diagnostics, University of

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

UPCOMING DIAGNOSTIC TESTS FOR INFECTIOUS DISEASES

Organisation Product Diseases
Handheld spectroscopy- Dengue, HIV
Indian Institute of Technology (IIT), Delhi based device Tuberculosis
Paper-based device Malaria
Indian Institute of Science (IISc), Bengaluru Strips-based test
Translational Health Science and Hepatitis B
Technology Institute (THSTI), Faridabad Lateral flow immunoassay
International Centre for Genetic Engineering Malaria
and Biotechnology (ICGEB), New Delhi Point-of-care test
Translational Health Science and Enterococcus infection
Technology Institute (THSTI), Faridabad Detection kit
National Institute of Ocean E.coli infection
Technology (NIOT), Port Blair Probe-based assay Neonatal sepsis
National Agri-Food Biotechnology Saliva-based screening Urinary tract infections
Institute (NABI), Mohali Rapid test- ASTSENSe Urinary tract infections
SpotSense, Bengaluru Rapid molecular platform
Module Innovations , Pune
Achira Labs, Bengaluru

Turku, Finland. Government of India, New Delhi.
Delving further into the world of Even though scientists across the country

microorganisms that are responsible for are being provided with public and private
different parts of the human body, a team of funding opportunities and a comprehensive set
researchers at the National Institute of Ocean of resources to support their discovery, research,
Technology (NIOT), Port Blair, has developed pre-clinical development, and clinical evaluation,
a highly effective kit to detect multi drug- the important part is to fast-track the entry of
resistant (MDR) strains of the gram positive these products into the market with suitable
bacteria Enterococcus faecalis. This organism industry partnerships.
is a common cause of morbidity and motility
across the world infecting the urinary tract, Startups reinforcing the need
bloodstream, endocardium, abdomen, biliary
tract, burn wounds, and indwelling foreign Over the past few years, many biotech and
devices. healthcare startups have carved a niche for
themselves in the Indian diagnostic market with
Likewise, scientists at the Mohali-based novel ideas and technologies. India is also home
National Agri-Food Biotechnology Institute to a number of accelerators and incubators that
(NABI) have developed a probe-based assay to are nurturing these startups to deliver beyond
detect the presence of Escherichia coli, the most their capacity.
common cause of diarrhoea.
A common example of such an accelerator
“Despite India’s rapid economic growth and for startups is Bengaluru-based Centre for
growing technological prowess, it continues to Cellular and Molecular Platforms (C-CAMP)
face a heavy burden of infectious diseases. Under that is currently encouraging startups to develop
our Infectious Disease Biology Programme, solutions against antimicrobial resistance (AMR).
currently we are funding projects at the All AMR has become a serious global challenge for
India Institute of Medical Sciences (AIIMS), public health as bacteria, fungi and viruses are
Translational Health Science and Technology increasingly becoming resistant to antimicrobial
Institute (THSTI), Postgraduate Institute of drugs that were previously effective against them,
Medical Education and Research (PGIMER) making it more difficult to treat infections.
and University of Delhi-South Campus, for
developing rapid detection kits for tuberculosis “C-CAMP has recognized the significance
and COVID-19, amid many others”, says Dr Renu of AMR and is working towards fostering and
Swarup, Secretary, Department of Biotechnology, amplifying R&D efforts in this space. C-CAMP
startups and individuals currently working

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

MAJOR INFECTIOUS
DISEASES IN INDIA

● Tuberculosis ● Pneumonia
● Malaria ● Dengue
● HIV/AIDS ● Lymphatic
● Influenza
● Cholera Filariasis
● Hepatitis ● Kala-azar
● Typhoid ● Trachoma
● Leprosy ● Urinary tract

infections

on innovations tackling AMR are under three scientists, inventors, and innovators; supported
verticals: Preventatives, Diagnostics and New by the Centre for Cellular and Molecular Biology
Drugs. In particular, Bengaluru based SpotSense (CCMB), Hyderabad, this programme is expected
is working on building a diagnostic pacifier to help startups overcome all hurdles, both
platform for saliva based screening of various conceptual and infrastructural, to realise their
neonatal health ailments including a rapid full potential in the diagnostics space.
diagnostic test for neonatal sepsis, and Pune
based Module Innovations is developing colour “Innovation in science has demonstrated its
changing nanofiber strips for selective detection ability to transform the world. In diagnostics,
of the entero-haemorrhagic bacterial strains”, Indian scientists, engineers, and data experts
says Dr Taslimarif Saiyed, Chief Executive Officer are rapidly innovating new products that can
& Director, C-CAMP, Bengaluru. help humanity to identify and overcome many
diseases expeditiously,” says Ajit Rangnekar,
On the other hand, another startup associated Director General, RICH, Hyderabad.
with C-CAMP, Achira Labs has recently received
recognition by US based organization CARB-X, On the whole, the diagnostic industry in
for developing a rapid molecular diagnostic India encompasses a number of established and
platform for urinary tract related infections. In experienced players that are capable of bringing
addition, Module Innovations has received up to multiple innovations on the table. But there
$3.2 million funding from CARB-X to develop are certain challenges that have limited the
a rapid and easy urinary tract infection (UTI) manufacturing potential of the industry all this
diagnostic test giving antibiotic resistance results while.
in two hours.
“In India, the approach to healthcare is
“UTI is the one of the most common transforming from curative to preventive with the
infections in the human body affecting 150 concept of preventive healthcare gaining ground.
million people globally. While there have On the manufacturing front, thanks to the
been significant advances towards bacterial introduction of the production linked incentive
diagnosis, UTIs largely are still treated on the (PLI) scheme, a large number of manufacturers
basis of empirical broad-spectrum antibiotic. will be able to bolster their production capacity
This practice fails in many situations when the of diagnostic solutions. This will significantly
infectious bacteria are drug resistant. Diagnosing enhance India’s share in the global diagnostic
a drug resistant UTI can take days. The most device exports”, says Dr Veeral Gandhi, Founder
used method of microbial culture, requires & Chairman, Voxtur Bio, Mumbai.
2-3 days’ time, a laboratory and highly trained
manpower. With our test ASTSENSe, the results Besides developing affordable and accessible
would be available within 2 hours rather than diagnostic solutions, we also need to pay
2 days”, shares Sachin Dubey, Chief Executive attention to specimen collection. Thus, it is
Officer & Co-founder, Module Innovations, Pune. essential to train the healthcare workers in our
country on phlebotomy for specimen collection
Research and Innovation Circle of Hyderabad as well as improve our infrastructure to transport
(RICH), set-up by Telangana government, has specimens to diagnostic centers. These measures
recently started a new accelerator programme are critical in controlling infectious diseases in
for startups in the in vitro diagnostics sector. India.
Mentored by an expert panel of entrepreneurs,
Dr Manbeena Chawla
[email protected]

32 PRECISION MEDICINE BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

Precision Medicine to
reshape healthcare delivery

As an emerging approach for disease treatment and prevention, Precision Medicine takes into
account individual variability in genes, environment, and lifestyle of every patient. It aids doctors
and researchers in predicting, more accurately, which treatment and prevention strategies will
work for a particular disease and in which groups of people. Although the terminology is relatively
new, the concept of Precision Medicine had been a part of healthcare for years.

Precision medicine has been all the rage over the populace, yet the need is urgent to collect data
years. Imagine individuals receiving treatments correctly in a standardised manner and efficiently
specially customised for them. Over the years store it. If data analysis isn’t done correctly it will
there has been tremendous progress when it comes to prematurely kill precision medicine even before
advancements in precision medicine. The healthcare it takes flight. Dr Gaur further adds, “Educating
industry worldwide has come to a unanimous clinicians on the actual meaning and various factors
consensus that one size just doesn’t fit all. A dream of precision medicine are paramount. Our medical
at one point in time is now a reality. All this progress education system needs to include genetics. If
can vastly be credited to a better understanding of precision medicine approaches are to become part
human genomic makeup. of routine healthcare, then healthcare providers will
need to know more about molecular genetics and
Currently, precision medicine in India is in the biochemistry and interpret the results of genetic
early adoption stage but there is no denying that it tests, understand how that information is relevant to
has penetrated into almost every form of healthcare treatment or prevention and convey this knowledge
delivery over the years. With the Genome India to patients.”
Project, India aims to map its diverse genetic pool,
which will help in boosting vast clinical research that The groundwork in India has already begun which
will help make better inroads into precision medicine. has given precision medicine in India the much-
It will also be decisive in projecting a better picture needed wind to take flight. Indian Council of Medical
of rare, genetic diseases which will help those in need Research (ICMR) released ‘National Guidelines for
with better diagnosis and treatment. Gene Therapy Product Development and Clinical
Trials”. The guidelines will ensure the development
Huge scope, less awareness and launch of innovative gene therapies in India
following an ethical, safe, and scientific pathway.
India accounts for roughly 17.7 per cent of the There are also over 2000 biotech firms in India, with
world population (www.worldometers.info) with the majority being startups aimed at developing
a population group of roughly 4000. Dr Ravi Gaur cutting edge drug development technologies and
MD, Director & Chair Medical Advisory Committee, therapies for these genetic and rare conditions.
Oncquest Laboratories Ltd, New Delhi, states, “With
1.4 billion people, the absolute number of patients Aarti Natu Chitale, Project Manager, Cetas
suffering from diseases in which genetics play a Healthcare, Mumbai is of the opinion that India’s
role is significantly large. However, the challenge is pharma industry is taking the leap towards a more
about creating awareness for widespread adoption. patient-centric approach, precision medicine will
India is still an emerging market for genomics. be key to achieve this goal. Moreover, funding from
Precision medicine aims at offering the possibility venture capitalists will further ensure consistent
to tailor the diagnosis and treatment of cancer, growth of these therapies, hence making precision
lifestyle diseases, psychiatry diseases, and infectious medicine the ultimate medical panacea. She
diseases according to the best possible evidence mentions, “Players such as 4baseCare, an Illumina
of effectiveness and tolerability for each subject. Accelerator backed precision oncology startup, raised
However, implementation is going to be a big an investment of $2 million through Mount Judi
challenge.” Ventures, growX Ventures, Season Two Ventures,
First In Ventures and other angel investors. The
With the vast population that resides in India, company aims to make precision oncology a standard
it is a daunting task to map the genes of the entire

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com PRECISION MEDICINE 33

of care in Asia by means of promoting the usage of “Immuneel’s facility
genomic testing in oncology. inauguration is a significant
milestone for India as it enables
A major breakthrough India to have an integrated
facility that develops advanced
Considering the progress that precision medicine has
made, it indeed seems to be the future of healthcare. technologies and delivers
Indian Department of Biotechnology has allocated cutting edge therapies.
$33 million for the Genome India Project, the entire
project is a collaboration of 20 Indian research Immuneel will play a role as the
institutes including the Indian Institute of Science’s central anchor for cell & gene
Centre for Brain Research. therapy in India.”
- Dr Renu Swarup
Recently Immuneel Therapeutics Private Secretary, Department of Biotechnology,
Limited, a research-led, fully integrated cell and Government of India, New Delhi
gene therapy company committed to bringing
breakthrough cancer treatments to India, affordably “With 1.4 billion people, the
and build a portfolio of next-generation cell
therapies announced the inauguration of India’s absolute number of patients
first Integrated Cell Therapy Development and
Manufacturing Facility in Bengaluru. The facility suffering from diseases in
focuses on autologous cell therapies including
CAR-T cell therapy for lymphomas and leukaemia which genetics play a role is
(hematologic malignancies) and in the future, it
will concentrate on other forms of solid tumours, significantly large. However,
allogeneic cell therapy and beyond cell therapy
and oncology in future. The Centre of Excellence the challenge is about creating
for cell manufacturing will ensure reproducibility,
scalability, data integration for optimising efficiency awareness for widespread
and monitoring performance which will bring in
high-quality, world-class, cost-effective cell therapy adoption. India is still an
manufacturing capability.
emerging market for genomics.
Sharing her views on this development Dr Renu
Swarup, Secretary of, Department of Biotechnology, Precision medicine aims at
Government of India, New Delhi said, “Immuneel’s
facility inauguration is a significant milestone for offering the possibility to tailor
India as it enables India to have an integrated facility
that develops advanced technologies and delivers the diagnosis and treatment
cutting edge therapies. Immuneel will play a role as
the central anchor for cell and gene therapy in India.” of cancer, lifestyle diseases,

Being an emerging approach for disease psychiatry diseases, and
treatment, prevention it takes into account individual
variability in genes, environment, and lifestyle of infectious diseases according
each individual. It assists doctors and researchers
to predict more accurately which treatment and to the best possible evidence
prevention strategies for a particular disease will
work in which groups of people. Precision medicine of effectiveness and tolerability
terminology is relatively new, but the concept has
been a part of healthcare for years. For example, a for each subject. However,
patient that requires blood transfusion is not given
blood from a randomly selected donor; instead, the implementation is going to be a
donor’s blood type is matched to the recipient to
reduce the risk of complications. The current role big challenge.” - Dr Ravi Gaur
of precision medicine in day-to-day healthcare is
limited, with the current progress it is bound to MD, Director & Chair Medical Advisory Committee,
expand into many areas of healthcare in the coming
years. Oncquest Laboratories Ltd, New Delhi

“Players such as 4baseCare, an
Illumina Accelerator backed
precision oncology startup,
raised an investment of $2
million through Mount Judi
Ventures, growX Ventures,
Season Two Ventures, First
In Ventures and other angel
investors. The company aims
to make precision oncology
a standard of care in Asia by

means of promoting the usage
of genomic testing in oncology.”

- Aarti Natu Chitale
Project Manager, Cetas Healthcare, Mumbai

34 PRECISION MEDICINE BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

“Precision care is impacting individual needs and reducing the subjectivity of
operators and physicians.
implants, ensuring these
Enhancing therapy precision lies in the
devices and the corresponding integration of imaging and treatment delivery.
Therapeutic procedures from surgery to radiation
procedures are tailored to oncology rely on integrated real-time or multimodal
image guidance and robotic assistance. This
the needs of individuals. The facilitates minimally and non-invasive interventions
that support faster recovery and create fewer
use of artificial intelligence to complications. This enables healthcare providers to
advance therapy outcomes and make treatment safer,
drive automation, analyse vast faster and less costly. Automation, assisted decision-
making is used to create consistent diagnostic results,
amounts of data, and optimise diagnostic tests are crucial in medical decision-
making, impacting costs directly, about 75 per cent of
operations is growing rapidly clinical decisions are based on diagnostic tests.

and its potential remains largely Addressing challenges

untapped. These advances in India is still an emerging market for genomics.
Precision medicine aims at offering the possibility
diagnostics and personalised to tailor diagnosis, treatment of cancer, lifestyle
diseases, psychiatry diseases, and infectious
therapies, in conjunction with diseases according to the best possible evidence
of effectiveness and tolerability for each subject.
powerful artificial intelligence, However, implementation is going to be a big
challenge. Remote areas of the nation are lacking
are the key elements to primary healthcare delivery systems. Precision
medicine is a relatively young and growing field,
expanding precision medicine the technologies required to meet the goals of
precision medicine are ever-evolving. Genomics
enabling consistent delivery of isn’t the only tool to advance precision medicine, it
is much beyond genomics. Genetic tests are usually
high-value care.” 100 per cent sensitive and 100 per cent specific for
- Dileep Mangsuli identifying a genetic disorder. However, the test
is only a marker associated with only a risk of the
Head, Development Centre, development of a disease or a differential response
to drugs.
Siemens Healthineers, Bengaluru
Even though precision medicine does seem to
Reducing risks, enhancing therapies be the future, there are certain scenarios that need
immediate attention. It raises concerns about ethical,
Dileep Mangsuli, Head, Development Centre, social, and legal issues. There has also been a rising
Siemens Healthineers, Bengaluru is of the view that concern on the confidentiality of health information
precision medicine is very exciting and holds a lot worldwide. Another factor that has been the Achilles
of promise. He says, “Precision medicine is already heel in precision medicine becoming dominant
making targeted treatments possible in many clinical in mainstream healthcare delivery are the costs
conditions. The advances in healthcare with risk involved, although advancements in gene sequencing
prediction tools and more personalised therapies such as CRISPR Cas9, are developing orphan drugs,
will guide the medical decision making to improve higher cost of development, lack of reimbursements,
clinical outcomes.” severely impact their accessibility for a large chunk of
the population. Especially in countries across the Asia
Mangsuli further adds, “Precision care is Pacific, a severely impaired reimbursement landscape
impacting implants, ensuring these devices and the is a major barrier in the low acceptability of these
corresponding procedures are tailored to the needs therapies.
of individuals. The use of artificial intelligence to
drive automation, analyse vast amounts of data, Prabhat Prakash
and optimise operations is growing rapidly and its [email protected]
potential remains largely untapped. These advances
in diagnostics and personalised therapies, in
conjunction with powerful artificial intelligence, are
the key elements to expanding precision medicine
enabling consistent delivery of high-value care.”

The current ongoing pandemic has further
exposed healthcare delivery limitations based on the
ability to make precise, data-driven diagnoses: low-
quality data, non-comprehensive data ‘snapshots’,
non-actionable information, and a siloed approach.
This requires immediate attention to strengthen the
healthcare infrastructure for overall advancements
in healthcare, this will further assist in advancing
precision medicine.

As precision medicine involves reducing
unwarranted variations by adapting to patients’

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com PRECISION MEDICINE 35

Is the stage set for Precision
Medicine to take off in Asia?

Driven by an array of technological advancements and coupled with genomic breakthroughs,
precision medicine has become an established modality in the regular healthcare routine, particularly
in the US and the European Union (EU). However, it does not hold true for Asia. BioSpectrum delves
into the state of precision medicine in Asia and the promise it holds for the continent.

Even though precision medicine has many increasing cases of cancer and other diseases along
advantages when compared with the with the health awareness among people. This
traditional healthcare system, the Asia region presents a lot of opportunities for the players in the
is currently witnessing limited adoption of the same precision medicine space.
due to various underlying reasons. These include
high cost, lack of awareness among the public, “Asian countries with a growing middle class that
regulatory challenges, etc. is more affluent and better educated is likely to have
increased demand for better healthcare including
“There are many factors to consider. Precision precision medicine. This will drive the need for
medicine involves testing for specific genetic or diagnostic assays and drugs which in turn will push
protein alterations and this can be expensive if for the expansion of local infrastructure and training
a large number of alterations need to be tested of relevant personnel to meet the need,” opined Dr
such as in lung cancer. The extent to which Tay.
precision medicine can be practised in the clinic,
therefore, depends on the model of reimbursement At the national level, some Asian countries
of healthcare costs including the availability of have also initiated national genomics programmes,
government subsidies, not just for drugs but also for building their own population genomic databases
genomic tests”, said Dr Timothy Tay, Consultant, by sequencing the DNA from healthy individuals.
Department of Anatomical Pathology, Singapore Thailand, for example, recently approved a $150
General Hospital, Singapore. million five-year Genomics Thailand Initiative
to characterise the genomes of 50,000 citizens.
He added that high throughput sequencing Singapore, also has its own National Precision
technologies, such as next-generation sequencing Medicine Strategy which includes the collection of
required to test for multiple genetic alterations in genetic material from 10,000 healthy Singaporeans
a more cost-effective manner. It also requires a of different ethnicities. Such projects to build local
specialised laboratory set up and local infrastructure genetic data banks help serve as a reference for
to store the sequencing data. genetic normality that is more relevant to local/
Asian populations compared to databases derived
Dr Tay maintains that trained personnel are then from Western populations. As Singapore moves into
needed to perform and interpret the sequencing the second phase of its National Precision Medicine
data and they include people with a diverse range
of expertise such as laboratory scientists, clinicians, “Trained personnel are then
bioinformaticians and genetic counsellors. Such
expertise is in short supply in many countries in needed to perform and
Asia. The growth of precision medicine therefore
also depends on whether such high-end precision interpret the sequencing data
medicine assays are readily accessible to fuel the use
of targeted therapy. and they include people with

Evolving opportunities a diverse range of expertise

According to Precedence Research, the global such as laboratory scientists,
precision medicine market value surpassed $59.16
billion in 2019 and is expected to reach $141.33 clinicians, bioinformaticians and
billion by 2027. Asia Pacific seems to be the most
opportunistic region in this space owing to the genetic counsellors.”
- Dr Timothy Tay,

Consultant, Department of Anatomical Pathology,

Singapore General Hospital, Singapore

36 PRECISION MEDICINE BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

“Data that is being generated Shift to non-oncology areas
As genomic research has increased, there are
through the increasing genome signals that the focus of precision medicine may shift
beyond just oncology and towards non-oncology
sequencing activities in Asia has areas.
“According to the Diaceutics Group, two-thirds of
necessitated stringent policies phase three pipelines are focused on non-oncology
areas. This provides strong motivation for precision
for data sharing and data medicine researchers to find applications outside
of oncology areas. Examples of areas where such
security.” - Nitish Singh, applications may be found are infectious diseases,
central nervous system diseases, and cardiovascular
Principal Analyst at BIS Research, India diseases. Alzheimer’s and Parkinson’s, which have
strong genetic correlations, have been posited as
Strategy in 2021, there are plans to further enlarge possible candidates for further research in the
the data bank to 100,000 healthy individuals and precision medicine industry,” said Singh.
expand the use of precision medicine in clinical
practice. Emphasis on Blockchain

China’s Precision Medicine Initiative (PMI) The Asia region is anticipated to lead the adoption of
has made it possible to acquire and access data blockchain in healthcare. This is majorly attributed
for millions of people in order to enable better to various countries such as China, South Korea,
healthcare provisions, particularly for oncology. and Singapore, taking a significant lead in the
With the 13th Five-Year Plan (2016-2020) coming implementation of this advanced technology in
into action, China has confirmed its prioritisation regular healthcare practices. Singh added, “China,
of precision medicine as a strategy to enable better with the endorsement of blockchain technology, is
healthcare outcomes. PMI is expected to be funded expected to contribute heavily to the region taking
with $9.2 billion by 2030. Nearly every country has the lead in the adoption of this technology. With
a precision medicine initiative of its own, and China genomic data being massively extracted from various
has the largest and the well-funded initiative in research initiatives, the incorporation of blockchain
place. The introduction of China’s PMI is expected has become evident”. As per Singh, initiatives such
to offer lucrative opportunities to the domestic as as China’s PMI clubbed with massive government
well as international players to consolidate their support, are expected to contribute to the emerging
respective footprint in China and Asia. trend to adopt blockchain in precision medicine,
particularly for genomics.
Dr Tay believes that such government initiatives
provide ample opportunities for pharmaceutical and Growing demand for health security
biotechnology companies, as industry partnerships
are essential to make precision medicine a reality. Owing to the consequent genome sequencing
boom in Asia, the region’s enormous population
“Further, due to the shift from traditional poses a genetic goldmine. “However, an increasing
healthcare to precision medicine-based healthcare concern among the population and the governments
on account of the uptake of funding and initiatives, has fostered an environment wherein there is a
the stakeholders in this ecosystem are actively massive demand for health security. Data that is
adopting strategies to offer advanced diagnostics being generated through the increasing genome
and targeted therapeutics to patients suffering from sequencing activities in Asia has necessitated
cancer,” said Nitish Singh, Principal Analyst at BIS stringent policies for data sharing and data security,”
Research, India. said Singh.

Trends Collaboration among all the stakeholders
across academia, pharmaceutical and biotech,
Precision medicine is likely to grow in Asia for the clinical settings, governments and policy making
coming years and personalised oncologic treatments is important in advancing precision medicine.
will continue to be a key component of precision Increasing access to tests available, improving
medicine. awareness among healthcare providers, enhancing
the quality will all help in boosting the personalised
According to Dr Tay,”The prevalence of cancer medicine market in the region.
is unlikely to decrease and with scientific research
constantly yielding new insights into cancer Ayesha Siddiqui
genomics and bringing about the development of
novel targeted therapies with survival benefit, it is
inevitable that there will be a push towards increased
testing of cancers in order to match patients to the
right drug”.

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

“India should have a vibrant

clinical research community

who can advise drug developers”
The Indian Society for Clinical Research
(ISCR), an association of clinical research «
professionals, has announced the appointment
of Dr Sanish Davis as its President for the term 2021- Dr Sanish Davis,
23. Dr Davis holds a degree in Clinical Pharmacology
and has 15 years of experience in the clinical research President, Indian
industry. Currently serving as the R&D Director,
Global Commercial Operations (GCO)-India at Society for Clinical
Johnson & Johnson, he has taken over from Dr
Chirag Trivedi who was the President of ISCR for two Research (ISCR),
terms from 2017-2021. BioSpectrum reaches out to
Dr Sanish Davis, President, Indian Society for Clinical Mumbai
Research (ISCR), Mumbai to talk about the growth
and challenges in store for the clinical research to seek the best possible way for consenting either
sector in the post-COVID world. Edited excerpts; by reading out the form and/or audio-video taping
the same with the patient or their Legally Acceptable
What new initiatives have been taken to Representative or using an impartial witness.
protect the rights of clinical trial subjects Sponsors also communicated the implementation
during and post COVID world? process to the regulators.

During the initial stages of the lockdown in 2020, The regulators were quick to respond in ensuring
we faced challenges in ensuring the continuity of the quick implementation of digital measures to
clinical trials due to the several restrictions that were streamline processes and approvals in a pandemic
in place which led to delayed or no hospital visits, world. We are hopeful that these changes will not
difficulties in of investigational medicinal products just continue after the pandemic but that we will see
(IMP) reaching patients and so on. However, this an enhancement of more digital measures. Patient
was soon resolved as stakeholders came together protection and safety are at the core of any clinical
to collaborate in ensuring that clinical trials could trial and that is the tenet of any clinical trial whether
continue uninterrupted without impacting the quality we are in the midst of a pandemic or not.
and integrity of clinical trial data or patient safety.
Some of the routes to ensure this included: Direct Going forward how beneficial will be the
to participant shipment of IMP so that the patient academic and pharmaceutical industry
received IMP at their homes; Home nursing care collaboration for clinical trials in terms of
visits for the administration of IMPs and collection increasing participation and awareness?
of biological samples; Video/teleconsultation
(telemedicine) of trial participants by investigators The academic partnership is extremely important
as per the protocol; and implementation of remote and intrinsic to the growth and success of clinical
monitoring of patient data. Investigators worked research which is why a few years ago, we established
with Ethics Committees to best manage ongoing the Academic Consortium for Clinical Research in
patients and drug supplies, report SAEs, manage India (ACCRI) as part of ISCR. The ACCRI initiative
study visits, and so on. In the case of studies with was conceived to enhance clinical research in India
an new chemical entity (NCE)/ new biological through collaboration in areas of learning and
entity (NBE), new patients underwent audio-video development, capacity building and knowledge
consenting of the informed consent process especially enhancement which would benefit academic
in non-COVID-19 studies. In the case of COVID-19 institutions and researchers. As part of the initiative
studies, investigators worked with ethics committees we have done several research capacity building
programmes, including one in North East India,
initiated a Remote Clinical Research Mentorship
programme aimed at junior/mid-level faculty in

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

We strongly believe that if India has Stakeholders across the spectrum were also quick to
to be able to develop new drugs, implement digital interventions be it the regulators,
biologicals/vaccines, medical devices, ethics committees, investigators or sites. Digital
AYUSH products etc. then we should technologies that leverage algorithms, data science,
have an equally vibrant clinical research and health information can play a substantial
community that can advise developers role in drug development by reducing timelines
on the best clinical development plan. for approvals and ensuring better collaboration,
Hence ISCR’s strategy for developing thus enabling institutions to bring drugs to the
clinical researchers of the future is market faster. However, incorporating technology
with an aim to contribute to drug in clinical research requires a steep learning curve
development for the country for diseases by investigators, sponsors, participants, and other
that have unmet medical needs. stakeholders. As we move into the second half of
2021, we must make transformative use of digital
medical institutions who would like to build their platforms for better utilization of resources and
career as a clinical researcher etc. We also have an building capabilities.
annual best Academic Researcher Prizes for original
research work across senior, junior and mid-level What are your views on the approval of the
faculty positions for which ACCRI solicits original
work from researchers in medical institutions from vaccine taking place in India, particularly
the length and breadth of the country.
the fast-tracking of approvals for foreign
We strongly believe that if India has to be able
to develop new drugs, biologicals/vaccines, medical vaccines?
devices, AYUSH products etc. then we should have an
equally vibrant clinical research community that can A greater need for immunisation and protection has
advise developers on the best clinical development never been felt as much as during the pandemic. The
plan. Hence ISCR’s strategy for developing clinical world has watched as scientists, medics and clinical
researchers of the future is with an aim to contribute researchers from the industry, academia and research
to drug development for the country for diseases institutes collaborated and created new pathways to
that have unmet medical needs. The collaboration expedite the clinical development of vaccines that
between academia and industry, as the pandemic will help save lives and end the pandemic. We now
too has shown, is highly synergistic and mutually need to ensure better and faster access to vaccines,
beneficial to both. while also focusing on how we can use learnings from
vaccine development during the pandemic to advance
Due to the pandemic, clinical trials have the development of vaccines for other diseases. Fair
shifted to remote operation. How, do you and equitable access to immunisation, globally, is
think, we have fared upon the reliance on vital as it is a key element of primary healthcare and
digital technologies? And what are the future brings us closer to a healthier world.
opportunities for digital adoption?
Bringing safe and effective COVID-19 vaccines to
The pandemic has not just catalysed the India required bridging clinical studies in compliance
implementation of digital technology in clinical with local regulations. As there are several vaccines
trials but also demonstrated their efficiency in that have been developed in the west that have
ensuring shorter timelines and greater reliability Emergency Use Authorization (EUA) based on the
of data without compromising on patient safety. interim Phase III data, it becomes easy for India,
being a part of the ICH (International Council for
Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use) deliberations, to
provide the possibility of EUA for vaccines which
have EUA in major ICH countries. The government
has shown flexibility in its approach of accepting
efficacy and safety data generated till date globally,
and then following it up with a parallel local bridging
study. The local bridging study as well as the
proposed initial 100 beneficiary safety monitoring
during the rollout of the vaccine programme with any
foreign vaccine will allow the collection of safety and
effectiveness data in Indian participants.

Dr Manbeena Chawla
[email protected]

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

“Digitally skilled employees

need to increase 9-fold by 2025”
Vivek Kanade has recently stepped in as the
Managing Director of Siemens Healthcare, «
India, the wholly-owned subsidiary of German
medtech company, Siemens Healthineers which Vivek Kanade,
clocked in a global revenue of €14.5 billion during
the FY2020. After being associated with Siemens Managing Director,
for over 27 years, Kanade will continue to lead the
business for Siemens Healthineers India including Siemens Healthcare,
manufacturing, sales and distribution, strategy for
‘Zone India’, comprising neighbouring countries Mumbai
like Bangladesh, Nepal, Sri Lanka and the Maldives.
In conversation with BioSpectrum, Vivek Kanade, customers and their patients by making the chronic
Managing Director, Siemens Healthcare, Mumbai illness manageable and eliminating the fear of cancer.
talks about the company’s growth plans in India.
Edited excerpts; What are the major plans in store for 2021,
particularly in terms of investments and
What new strategies are you bringing to the product launches in India?
table to strengthen the company’s growth in
the long run? To advance the digitalisation of healthcare and
better serve the needs of emerging markets, we have
At Siemens Healthineers, we are on the second phase recently announced our plans to invest Rs 1,300
of our ‘Strategy 2025’ that is the ‘Upgrading’ phase. crore over the next five years in an innovation hub
The pressure of increasing cost and consolidation on in Bengaluru. The investment is part of Siemens
the customer side, as well as increasing digitalisation Healthineers’ strategy 2025, in which India plays an
are the key trends in the years to come. With our important role as a growth market for the company.
strong technological base, extensive clinical expertise Currently, we are manufacturing C-Arms and
and our global network, we are helping make Computed Tomography systems out of our Bengaluru
healthcare more efficient and further improving manufacturing facility and biochemistry reagents and
access to healthcare, coupled with our digital and urine strips from the Vadodara facility.
AI-based offerings. As a part of the upgrading phase
of our strategy 2025, India is identified as one of the Cios Fit, a multidisciplinary mobile c-arm ready
growth markets. In the Imaging segment, the focus for demanding environments with powerful state-
is on continuously innovating the core business, of-the-art imaging technology and an innovative
expanding its diagnostic offerings as well as on taking touch-and-play concept. Cios Fit is designed to help
a leading role in supporting clinical decision-making improve the quality of care and achieve efficient
based on artificial intelligence. workflows. It is designed, developed, and made in
India and sold in South-East Asia, Africa, Eastern
In the Diagnostics segment, the main task is to Europe, and South America apart from India. More
exploit the opportunities arising from the market than 250 Cios Fit C-Arms have been delivered
trend towards automated workflows in laboratory since January 2019. SOMATOM go. CT scanners
diagnostics. On top of this, it is planned to further from our Bengaluru facility are developed in close
expand the point-of-care business. One focus of collaboration with our customers to meet the demand
the Advanced Therapies segment is on combining of emerging markets and is one of the best possible
the technologies of the robotics company Corindus routine and beyond CT scanner. The manufacturing
Vascular Robotics, with the existing portfolio to facility in Bengaluru has already produced over 200
achieve additional growth and make new markets. units of CT machines since the start of the facility in
January 2020. Our teams have also played a huge
Recent combination of Siemens Healthineers role in developing Smart Remote Services (SRS),
and Varian Medical Systems is one of the biggest which provides a fast, secure, and powerful data link
developments in recent times. We are now well that connects medical equipment to service experts.
poised to provide even better support to our

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

While India has availability of the is high, which makes the market very price sensitive.
skilled human capital in the healthcare With stronger focus by the government on healthcare
sector, it is mainly concentrated in infrastructure and government healthcare spending
the big cities or the metros. Rising of nearly 3 per cent of India’s Gross Domestic Product
healthcare costs and increasing (GDP) by 2022 will give fillip to the MedTech industry.
expectations for quality outcomes is Tier II and Tier III cities have emerged as growth
creating increasing pressure on the centers of Indian healthcare sector over the past few
healthcare providers especially in the years. However, expansion of private players to these
Tier II and Tier III cities, which have cities is limited by resources, capex, low paying capacity
developed as growth centers of the of target population and low insurance penetration.
Indian healthcare sector over the past
few years. Increasing digitalization, High influx of Foreign Direct Investment (FDI)
automation, robotics and use of more in the hospitals and diagnostics centers is a positive
and more AI in the field of medicine sign for the Indian healthcare sector, which has
will require completely different also witnessed increasing mergers and acquisitions
skillsets in the years to come. (M&A) activities in the hospitals space. Production
linked incentives proposed by government of India
With data transfer via SRS, the performance and will boost local manufacturing of high-end diagnostic
condition of your equipment can be monitored in real equipment. Scarcity of healthcare related human
time. For us innovation is the key. Depending on the and infrastructural resources coupled with growing
opportunities, new medical imaging and laboratory non-communicable disease (NCD) load is yet another
diagnostics products would be added in the future. challenge that Indian healthcare sector will have to
overcome in the years to come.
How was the FY20-21 for the company’s
business in India? How did the pandemic How can we increase skilled workforce within
impact the business?
the MedTech industry in India?
It has been a mixed bag. The business was impacted
due to drastic reduction in the elective procedures While India has availability of the skilled human
and decrease in routine lab tests during the pandemic. capital in the healthcare sector, it is mainly
However, with the unlock process at the latter half concentrated in the big cities or the metros. Rising
of the year, showed some gradual improvement. healthcare costs and increasing expectations for
Due to the direct relevance to the pandemic, we quality outcomes is creating increasing pressure on the
have seen a reasonable surge in the demand for healthcare providers especially in the Tier II and Tier
Computed Tomography machines and tests related III cities, which have developed as growth centers of
to COVID-19. We were one of the early movers the Indian healthcare sector over the past few years.
to respond to COVID-19 related market needs by Increasing digitalization, automation, robotics and
launching and making the global tests (SARS-CoV-2 use of more and more Artificial Intelligence (AI) in
antibody, RT PCR, antigen) available in India after the field of medicine will require completely different
relevant approvals and expanding our test menu. skillsets in the years to come. Government’s push
However, testing and examination volumes are further for Electronic Medical Records (EMRs) adoption
stabilizing despite volatility in COVID-19 incidence. In will pave the way for Data Mining using AI/Machine
India, we delivered millions of tests over the last year Learning (ML) for better diagnosis and treatment.
and expect an increasing demand in the next year(s). COVID-19 pandemic has accelerated the journey for
digitization to a great extent for organisations as well
What are your views on the growth and as individuals. Telemedicine has been a fast-emerging
challenges of the Indian MedTech industry? trend in India over the past few years.

India faces a shortage of healthcare infrastructure and According to a report commissioned by Amazon
trained staff. The gap between what people need and Web Services (AWS), India’s present workforce
what they have is driving growth of about 10-12 per comprises only 12 per cent digitally skilled
cent yearly. However, insurance covers less than 25 employees, and the number of employees requiring
per cent of the population and out-of-pocket spending digital skills in the country will need to increase nine-
fold by 2025. We will be able to address this only
through close collaboration between industry and
academia, and build necessary capabilities that will
ensure industry ready skilled human capital.

Dr Manbeena Chawla
[email protected]

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com DIGITAL ADOPTION 41

Will the second COVID-19 wave
overwhelm the pharma companies?

It’s been more than a year that we are surviving «
under the constant threat of COVID-19. The
same is the case with business organisations. Dr Sandeep Narula,
Business is not at its usual. With first giving
respite around November-December 2020, and Associate Professor,
healthcare and pharma business trying to make
and cover the grounds, but only for the second Assistant Dean, School
wave to reckon back this with more power and
brutality. The second wave has created severe of Pharmaceutical,
havoc on the lives of the people, with deaths per
million population in India crossing the 180 IIHMR University,
mark and bringing the entire healthcare system
to collapse. Jaipur

With experts predicting the third wave of Accepting ‘change’
the pandemic, how will the businesses,
economy and social life cope up? The biggest challenge with the pharmaceutical
Are we really prepared for the new social and companies is not of Digital Transformation, but
business ecosystem? Will the government help of ‘Transformation’. Today the major challenge
businesses combat the huge losses? Will the pharmaceutical companies are facing is from
employment issues can be addressed? Especially their own domain companies, but from the
with respect to the pharma business, how the tech-driven domain companies like Apple,
pharma companies will make their transitions Microsoft, Google, Amazon and many others.
from the existing business model to the new As these tech-driven companies already have a
digital business model. Is the top leadership readymade ecosystem with strong customer data
(barring big MNC pharma giants) really equipped (Demographic and Psychographic) and details
for future digital challenges? that includes Healthcare professionals (HCPs)
and Patients, hence it is very easy for them to
As per BloombergQuint opinion survey of offer the desired solutions. The recent rise of
2018, the digital literacy of India was only 1.67 companies like Fitbit, GoogleFit, MIFit, Apple
per cent, if I extrapolate further by the same Health, Samsung Health apps in the wellness
growth rate then also by December 2020, it will domain is a clear example that pharma is set to
barely touch 2 per cent. As per Hootsuite January lose its share to these tech-driven companies.
2021 stats, individual internet users are 20.1 per These tech-driven companies have already made
cent, 32.3 per cent of the population on Social a paradigm shift from “illness” to “Wellness”.
media, with YouTube leading from the front The pharmaceutical companies to date are
followed by Facebook, WhatsApp and Instagram. focusing on illness and treating a sick person as
their customer, but these tech-driven companies
As per Gartner, healthcare, companies are don’t talk about any disease but they are focusing
experiencing ‘unprecedented levels of disruption’, on ‘fitness’, ‘staying fit and healthy’ and by
among the major reasons for disruption this definition, the entire universe is now their
mentioned are internal organisation changes and customer. Now, this is known as Transformation,
cost pressure followed by regulation, compliance. where, from a small percentage or a fraction
It is estimated by Gartner, that only 20 per cent of the population, you start targeting a bigger
of the “fit” healthcare organizations are going to mass or may universe, then this scale is known
thrive and the remaining will be left behind. It is as transformation. And when you want to reach/
already a proven fact that the companies which address this scale, this magnitude of customers,
are currently operating on digital platforms, then your traditional business model will not
their CAGR is 12 -15 per cent higher than the work and for this, then you need a model which
traditional business organizations. allows you to reach lakhs and crores of the
customers with ease and convenience and this
scale is offered by digital platforms.

42 DIGITAL ADOPTION BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

As on date, the pharmaceutical for product promotion, but they are looking
companies barring few big pharma beyond the products. The HCPs, they are not
companies, the so-called digital using one channel of promotion, rather there
transformation is beyond their realm. are multiple channels through which they are
To go for Digital Transformation the getting exposure to their product/services. So,
companies need to invest heavily pharmaceutical companies instead of going for
on IT , starting cloud computing, as Multichannel marketing, they need to design
investing in cloud computing will the concept of Omnichannel marketing and
offer them a competitive advantage, this itself is a big challenge for the Indian
as it is this investment only which pharmaceutical companies.
will offer them suitable platforms
to operationalise their business Todays’ HCPs they are more used to
strategies. Needless to say, here, in Omnichannel marketing and this experience
place of the traditional IT manager, they are already getting in their daily
companies need to hire a CIO or CTO. routine product/services which is offered
by the companies like Amazon and Netflix.
No recourse to digitalisation Pharmaceutical companies need to design
and think for their product promotion in
One thing is certain that for pharmaceutical this manner or on these lines and they have
companies, the pre-COVID period, in terms of created an ecosystem through which they can
HCP physical coverage and interaction, is not offer their product/services to HCPs. In other
going to come back. The pharma companies words, they have created an EXPERIENCE in
have to adopt the digital route to reach HCPs such a manner that the HCP is fully engrossed
as HCPs are finding digital platform a better or immersed in the company brand promotion
option, as Digital is the perfect route for ecosystem. And to create this ecosystem/
recovery and growth. experience, pharmaceutical companies need to
hire a Chief Experience Officer (CEO).
As on date, the pharmaceutical companies
barring few big pharma companies, the so- Apart from above three challenges, the
called digital transformation is beyond their fourth challenge which the pharmaceutical
realm. To go for Digital Transformation companies will have to face is the emergence
the companies need to invest heavily on of ’Substitution power of pharmacist’. Due to
Information Technology (IT) , starting cloud the pandemic, the supply chain of majority of
computing, as investing in cloud computing the pharmaceutical business organisation was/
will offer them a competitive advantage, as is interrupted due to the shortage of active
it is this investment only which will offer pharmaceutical ingredients (APIs) and raw
them suitable platforms to operationalise material. During this period, even the HCPs
their business strategies. Needless to say, also have given the consent and acceptance
here, in place of the traditional IT manager, of the substitution. Today this prescription
companies need to hire a chief information substitution is more than 40 per cent, as this
officer (CIO) or chief technology officer is a paradigm shift in the pharmaceutical
(CTO). Keeping in view the volumes of data, business selling. Pharmaceutical companies
the digital adoption and application offer, have to think about these pharmacists also as
pharmaceutical companies not only need to their customer, and they have to offer ‘desired’
hire chief data officer (CDO) but also they customer services to these pharmacist as well.
need to change their operating model too Also, these local pharmacists have stepped up
keeping the disruptions occurring frequently their services in the local community and are
at the marketplace. Hence, it is certain that now offering various form of extended services
minor or fringe changes or changes occurring like blood pressure monitoring, blood testing
at the edges, are not going to yield the desired and even Video Calling services to the HCPs
response and it will yield the investment below apart from free home deliveries of medicines.
the cost of capital.
In days to comes, if pharmaceutical
Also, today HCPs, they are not looking companies need to grow and sustain then they
have embrace the above mentioned challenges
and have to think of digital adoption first and
then transformation which will eventually give
them scale and magnitude both.

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

Dr Pramod Kabra takes charge DIVOC Health
as CEO of CPC Diagnostics brings
Prof. Rajesh
CPC Diagnostics, a Chennai-based provider of In-Vitro Diagnostics Chandwani
(IVD) products and services in India, Sri Lanka, Nepal and on Board
Bangladesh and the Indian subsidiary of Everlife Asia, has
announced the appointment of Dr Pramod Kabra as the company’s DIVOC Health, a New Delhi
Chief Executive Officer (CEO). Dr Kabra will be working closely based startup dedicated to
with the Everlife team and local management to accelerate growth bringing innovation in the
of the company by expanding reach and product offering, delivering Indian healthcare sector, has
announced the appointment
superior performance to the partners and of Prof. Rajesh Chandwani
improving customer experience. He brings as their Board Member. With
with him over 20 years of valuable and rich knowledge of the industry,
diverse industry experience notably in the Prof. Chandwani comes with
Pharmaceutical, Diagnostic, and Clinical an incredible expertise in the
Research segments. Prior to joining CPC, areas of healthcare management,
he led the Specialty Diagnostics Group at human resource management
Thermo Fisher Scientific. Throughout his and information technology. Prof.
career, Dr Kabra has demonstrated a proven Chandwani is a faculty at Indian
track record of growing businesses, driving Institute of Management (IIM),
productivity and improving overall business Ahmedabad. He is trained as a
performance. He is a trained physician Medical Practitioner (Paediatrics)
and is frequently invited to share his and Researcher at Baroda Medical
expertise at industry conferences. College and IIM Bangalore. He
completed his PhD from the
Himalaya Drug Company Indian Institute of Management
picks Rahul Kapoor as CPO Bangalore. He has worked as a
Paediatrician in Public Sector
The Himalaya Drug Company has announced the appointment of hospitals in Gujarat, Telangana
Rahul Kapoor as the Chief People Officer (CPO). Kapoor has over and Andhra Pradesh. He has been
20 years of experience working with Fortune 500 organisations awarded with multiple accolades
in Asian business sectors including India, Japan and Korea, and including the Best Innovation
South-East Asia. Before joining The Himalaya Drug Company, award in 2014, best paper award
he was the VP-HR with Dr. from the Indian Society of
Reddy’s Laboratories for one Training and Development (ISTD)
year, where he was driving Paper in 2013 to name a few.
the People and Culture plan
across 25 nations in Emerging
Markets. Prior to that, Kapoor
was with the GlaxoSmithKline
(GSK) for over 12 years. He
joined GSK India in 2008
and later in July 2014, he
became the HR Business Lead
for Consumer Healthcare
Asia. Before that he was the
Executive Vice President HR,
India Subcontinent at GSK
Consumer Healthcare, and was based out of Gurugram. He was a
pivotal part of the ISC Leadership Team. After the Novartis Joint
Venture (JV), he was selected HR Business Lead for Southeast Asia
and Japan/Korea.

44 PEOPLE NEWS BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com

Dr Boudhankar starts second innings as CEO of Bhatia Hospital

Dr Rajeev Boudhankar has been He has led the team to deliver
re-appointed as Chief Executive seminal operations clinically
Officer (CEO) of Mumbai-based and strategically, demonstrating
multi-specialty hospital, Bhatia great resilience. With over
Hospital for a second innings. 30 years of experience in
Dr Boudhankar will continue to healthcare, Dr Boudhankar is an
be responsible for spearheading acknowledged business leader
and overseeing the development and a seasoned professional and
and execution of the hospital’s has held various senior roles
strategy, patient relationship in hospital and health systems
management, quality distinction management. He has worked
and leadership development. with government as well as
Until now, as CEO, Dr international health bodies to
Boudhankar has played a set up public health programmes
significant role in the brand and has a strong track record
repositioning of the 89-year- of building great teams while
old iconic Bhatia Hospital. delivering excellent results.

Dr Trust appoints Fermenta Biotech
names Prashant
Rohit Saini as Nagre as MD

Vice President- Krishna Datla, Promoter and Managing Director,
Fermenta Biotech Limited (FBL) has announced
Sales & Marketing the appointment of Prashant Nagre, Chief Executive
Officer, FBL as the new Managing Director with
Nureca Limited, the owner of the leading effect from May 9, 2021. Datla will continue as a
healthcare and wellness brand Dr Trust, has Board member and the Executive Vice Chairman.
announced the appointment of Rohit Saini as its Prashant Nagre joined Thane-based FBL in 2010
new Vice President of Sales and Marketing. Saini as the Chief Operating Officer and in two years,
brings to the position a wealth of knowledge was elevated to the position of Chief Executive
Officer. Since then, he has led corporate strategy,
and an array of business operations and demand-driven innovation
experiences in the for FBL’s three business verticals viz,
consumer healthcare Vitamin D and other APIs, Integrated
industry. Prior to his Biotechnology and Environmental
current role, Saini Solutions. Under the leadership
was the General of Datla, during Nagre’s tenure,
Manager Sales and FBL has expanded from a solely
Marketing (India domestic-focused business to a
and Sri Lanka) at global vitamin player, with more
Omron Healthcare than 70 per cent of revenues now
India. During arising from exports. Nagre will
his tenure, Saini also be responsible for steering the
successfully led a team of Sales and Marketing company’s efforts to foray into
professionals across the Indian market. He was the nutrition segment by
responsible for India Subcontinent P&L growth developing a future-
strategy with the distribution of the KPIs, he ready organisation
also devised ‘Above the Line’ and ‘Below the with a value-added
Line’ marketing strategies along with a 360 portfolio.
degrees integrated marketing approach for
Omron Healthcare. He brings over 19 years of
experience. He has also served Coca Cola, Barry
Callebaut and Ferrero India.

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com ACADEMICS NEWS 45

Chitkara University receives $4K Academicians
grant for pharma toxicology studies call to improve
BME in India
In a major boost to Chitkara a safer and healthier world
School of Pharmacy’s global by advancing the science Academics from top
initiative to create a safer and and increasing the impact of educational institutions in the
healthier world, the Society of toxicology. The grant will help country have come out with
Toxicology (SOT) has sanctioned students of Chitkara School a whitepaper on Biomedical
a grant of $4,000 under SOT of Pharmacy in Punjab to Engineering (BME) education
Global Initiative Funding 2021. experiment activities consistent for the first time in India.
SOT is a US-based professional with the Society’s global Titled ‘Future of Biomedical
and scholarly organisation of priorities. SOT encourages Engineering programs in
scientists dedicated to creating proposals to represent India,’ the whitepaper aims
collaborations between the to help improve the quality
Society, SOT Component Groups, of BME programs in India by
SOT Committees, and other identifying and addressing
toxicology organisations. SOT many challenges and bringing
serves the needs of the scientific together all the stakeholders.
discipline to enhance human, The top recommendations
animal, and environmental of the whitepaper include
health; life-long learning and that engineers should teach
intellectual scientific stimulation; in medical colleges, while
diversity of representation in doctors and industrialists
all activities of the society and should teach BME in
integrity. engineering colleges. Every
Biomedical Engineering
Intuitive India brings college should partner
educational programme with Medical colleges
on robotic-assisted surgery for All India Council for
Technical Education
Intuitive India, the Indian arm of US-based Intuitive Surgical has recently (AICTE) accreditation and
collaborated with top government medical institutions in India as a part for developing medical
of their initiative to expose next generation surgeons to robotic-assisted devices. There is a need to
surgery. Intuitive India together with AIIMS Delhi, has developed this establish a ‘National BME
educational programme called Development Committee’
the Intuitive Robotic Onboarding with representatives from the
Programme and Education (I-ROPE). Medical Devices Industry.
Through this initiative, Intuitive BME education in India is to
aims to familiarise resident surgeons be revamped with outcome-
with robotic-assisted surgery, its based education. In addition,
technology, clinical applications and a ‘Medical Device Corridor,’
its benefits. Currently, Intuitive is similar to the ‘Defence
driving this programme in renowned Corridor,’ should be designed
government medical institutions in for achieving self-reliance in
the country, which includes the likes medical devices.
of AIIMS Delhi, AIIMS Bhubaneswar,
Dr Ram Manohar Lohia Hospital-
Delhi and Armed Forces Medical College, Pune. As a pilot, AIIMS Delhi
ran this programme in their oncology divisions. Based on the surgical
students’ feedback, Intuitive extended this programme to other specialities
and institutions across India.

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

IIT Mandi fine- N-protein of coronavirus critical
tunes diagnosis to transmission: IISER Bhopal
of neurological
problems Researchers from the Indian thereby increasing the chances
Institute of Science Education for each viral particle to bind to
Innovators at the Indian and Research (IISER) Bhopal the target cell. This discovery
Institute of Technology (IIT) have shown that proteins from opens up an exciting host of
Mandi have invented a method the COVID-19 virus other than questions for related research in
to simultaneously study the the well-known ‘spike protein’ this area. The researchers found
variations in nerve functions can play a critical role in the that pseudovirus produced with
and brain blood flow associated infectivity of the virus. The the nucleocapsid (N) protein
with brain disorders such as SARS-CoV-2 virus has an RNA had higher infectivity than those
Ischemic stroke. The invented genome, surrounded by a sphere- containing other proteins.
method helps in locating and shaped structure. This structure
classifying damaged sites comprises various types of
(lesions) in the brain, brought proteins, with one of them being
about, or leading to neurological the ‘spike protein’ that gives the
diseases. The IIT Mandi team’s virus its characteristic spiked
invention is based on the look or ‘crown’. Since the virus
intricate interactions between is highly infectious, most studies
nerve cells (neurons) and blood do not use the live virus but
vessels (vasculature), called the use a similar protein capsule
NeuroVascular Coupling (NVC) made up of spike that has been
that regulates blood flow in the filled with another viral core, in
brain. Diseases such as Ischemic a process called pseudotyping.
stroke adversely affect the NVC. The researchers believe that
NeuroVascular Uncoupling the N-protein promotes the
results in such cases, wherein, incorporation of the spike
the nerve impulses do not trigger protein into viral particles,
the required blood flow. Timely
detection of NVC is critical for IIT-B’s tech-hack
the prevention, diagnosis, and could end ‘oxygen crisis’
treatment of such diseases. The
invention by the IIT Mandi The Indian Institute of Technology, Bombay (IIT-B) has come up
team takes the diagnosis of with a creative and ingenious solution to addressing the shortage of
neurological problems one step medical oxygen for the treatment of COVID-19 patients in the country.
further and will help in better
detection and treatment of these The pilot project which has been
diseases. tested successfully, relies on a simple
technological hack- conversion of
PSA (Pressure Swing Adsorption)
Nitrogen Unit to PSA Oxygen Unit.
Initial tests done at IIT Bombay have
shown promising results. Oxygen
production could be achieved at 3.5
atm pressure, with a purity level of
93 – 96 per cent. This gaseous oxygen
can be utilised for COVID-related
needs across existing hospitals and
upcoming COVID-19-specific facilities by providing a continuous
supply of oxygen. The pilot project is a collaborative effort between
IIT Bombay, Tata Consulting Engineers and Spantech Engineers,
Mumbai, who deal with PSA Nitrogen & Oxygen plant production.

BIOSPECTRUM | JUNE 2021 | www.biospectrumindia.com 47

West’s Ready Pack™ System -
the Right Containment System
for Your Sensitive Biologic

There is no doubt biologics and biosimilars will remain hot topics in 2021. This is due to the pandemic period
of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed.
Several questions arise frequently regarding selection of the proper primary package system for a biologic/
biosimilar, including:

1. If the biologic is very sensitive - can the system provide enough protection?
2. If the molecules are very complex - can the system maintain stability?
3. If the timeline for approval is very tight - will the system be approved?

These questions are especially challenging for a company that may have expertise in drug development, but not
primary package systems.

West can help. Based on extensive knowledge and a history of market leadership, West offers primary
packaging systems that can address these and other questions.

The Ready Pack™ system comprises NovaPure® stoppers, Flip-Off® CCS (clean, certified, sterilized) seals, and
Schott adaptiQ® glass vials. NovaPure stoppers offer a FluroTec™ barrier film in areas that contact drug product,
which can reduce:

■ migration of leachables from elastomer into drug product; and
■ interaction of drug products with stoppers.

Each NovaPure stopper is vision inspected using the Envision™ verification process to ensure low and
controlled particle levels. Ready Pack system components are offered in quantities that support every
development stage – from concept through commercialization. The Ready Pack system provides you with a
flexible solution at any stage of your drug development, with small quantities delivered when you need them.
Components are suitable for small-scale filling of high value drugs and meet regulatory requirements from
R&D through commercialization. West seamlessly supports your scale up to commercial production with larger
volumes, while shortening your time to market with a proven containment system for your drug product.

Ready Pack™ system benefits include:
■ Integrated closure system proven to assure CCI, reducing your risks and testing efforts
■ Provides a solution for risk mitigation and change control, assuring your drug product and its packaging
maintain a consistent profile from clinical stages through commercial development
■ Components are supplied sterile and can be directly introduced into your filling operations, eliminating
component preparation from your process
■ Supports scale up and allows you to transition from early-stage pilot manufacturing to larger commercial
scale operations
■ Available in small quantities, with the flexibility to buy the full system or only the components that you
need, reducing waste associated with commercial volumes
■ Dedicated technical support and access to scientific resources and content, aimed at helping you move
your drug product to market

For more information, please visit www.westpharma.com/readypack or
contact Kriti Kotian ([email protected])

West and the diamond logo, By your side for a healthier world, Ready Pack, NovaPure, FluroTec and Flip-Off are trademarks or registered trademarks of West Pharmaceutical
Services, Inc., in the United States and other jurisdictions. FluroTec technology is licensed from Daikyo Seiko, Ltd.
adaptiQ is a registered trademark of SCHOTT AG.
© 2021 West Pharmaceutical Services, Inc.

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

Thermo Fisher unveils high-performance CO2 incubator

Thermo Fisher Scientific has Consistent with Thermo Fisher’s
history of proven incubator
launched a CO2 incubator that technology, the new system
provides optimal cell growth for
combines optimal cell growth even the most sensitive high-value
cell cultures. This new Vios CR CO2
capabilities with certified incubator boasts a fully enclosed
casing and electronics, minimising
cleanroom compatibility, particle emissions in sync with
critical particulate control in a
effectively addressing the growing Grade A/B cleanroom. Operating
on the patented Thermo Scientific
need among biotechnology, THRIVE active airflow technology,
which delivers homogenous cell
biopharmaceutical and clinical growth conditions and rapid
parameter recovery in less than 10
laboratories for high-performance minutes, the system prioritizes cell
culture protection.
incubation systems that meet

stringent cleanroom and cGMP

standards. The Thermo Scientific

Heracell Vios CR CO2 Incubator

expands the Thermo Scientific

Cell Therapy Systems (CTS) Series

laboratory equipment portfolio

with a solution specifically designed

for use in GMP environments.

Qiagen brings Eppendorf introduces
multipurpose
economical sequencing centrifuge 5910 Ri

solution for COVID-19 Eppendorf has introduced a new centrifuge designed
to increase efficiency in the laboratory, Centrifuge
Qiagen has announced the launch of QIAseq DIRECT 5910 Ri. The new centrifuge is the successor to
SARS-CoV-2 Kit, a viral genome enrichment and the popular Centrifuge 5910 R, the flagship of the
library preparation solution that significantly Eppendorf multipurpose centrifuge portfolio that
reduces library turnaround times and plastics use has been providing customers worldwide with
compared with ARTIC project protocols (primer- outstanding versatility and ease of use since its launch
based approaches for next-generation sequencing in 2018. With the introduction of Centrifuge 5910 Ri,
(NGS)). The lab and bioinformatic protocols of Eppendorf now offers scientists advanced features to
the ARTIC network, an initiative funded by the simplify and accelerate the centrifugation steps of their
Wellcome Trust, are considered the gold standard workflow. An innovative touchscreen interface allows
in NGS-based characterisation of SARS-CoV-2 for the quick setting of desired parameters while three
genomes. QIAseq DIRECT SARS-CoV-2 supports levels of user management and new documentation
sample multiplexing with up to 768 Dual Molecular options provide enhanced security and traceability.
Indices - unique markers tagged to molecules in The optional connection to the new VisioNize Digital
a sample to eliminate errors from downstream Lab Suite enables remote monitoring of the device,
analysis - in a library preparation workflow from notification of alarms and events, and convenient
extracted viral RNA that reduces turnaround time to access to important documents such as certificates
as little as four hours. This also increases the amount and operating manuals.
of samples per sequencer to over 6,000 samples
on the highest-throughput instruments. The kit
also cuts plastics usage by 50 per cent, drastically
reduces hands-on time, requires no fragmentation
or ligation reactions and can be readily automated
with robotic liquid handlers. The viral enrichment
approach delivers superior uniformity of coverage
across the SARS-CoV-2 genome as well as deeper
sequencing performance compared with the most
widely used amplicon-based options.

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

West Pharma, VAV Lifesciences to supply
Venus Remedies to phospholipids for mRNA-
launch safe syringes in India based COVID-19 vaccines

West Pharmaceutical Services has recently announced VAV Lifesciences, through its subsidiary
its partnership with Haryana based pharma company VAV Lipids, has agreed with a US-based
Venus Remedies Ltd. whose brand Cloti-Xa has made multinational contract development and
its introduction in the growing low molecular weight manufacturing organisation (CDMO), to
heparin market and has adopted the NovaGuard SA manufacture and supply highly purified
Pro safety system, a single-use accessory for prefilled synthetic phospholipids suitable for vaccine
ISO standard 1mL long staked-needle syringes. The manufacturing. The CDMO will use lipids
NovaGuard SA Pro safety system is a product with made by VAV to produce gene-based lipid
innovative safety features that help protect healthcare nanoparticles (LNPs) on behalf of brand
workers and patients from accidental needlestick owners namely Pfizer-BioNTech and Moderna.
injuries. Several biopharmaceutical manufacturers have VAV Lifesciences, which is headquartered
commented that this product delivers a compelling total in Mumbai, is the only Indian company
cost of ownership in that it prevents pre-activation, whose lipids will be used in the mRNA-
offers a lower syringe snap-in force and a lower LNP technology-based vaccines. It will thus
activation force for end-user comfort, and mitigates the play a vital role in the global vaccine supply
practice of recapping which helps to provide tamper chain. The company has already initiated a
evidence to customers. commercial supply of phospholipids for large-
scale vaccine manufacturing through its EU
cGMP certified facility under its subsidiary
company, VAV Lipids, based at Ratnagiri in
Maharashtra.

Bioscience Solutions India contact information:
Tel : +91 22 4342 4000
PyroTec™ PRO Email : [email protected]
An Automated Robotic
Solution for Endotoxin
Detection Integrated
within WinKQCL™ Software

2014 Lonza Walkersville, Inc.

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

Curious case of black fungus!

Adevastating and invasive fungal infection mucormycosis. Firstly, diabetes renders the phagocytic
called mucormycosis, dubbed ‘black fungus’ cells or white blood cells dysfunctional. Both neutrophils
is spreading in India lately. It is likely and macrophages exhibit defective killing by both
being triggered by the use of steroids in severe and oxidative and non-oxidative pathways under such
critically ill COVID-19 patients. Although an upsurge conditions, although the precise mechanisms mediating
of mucormycosis has been reported throughout these remain to be elucidated. Secondly, patients with
the world over the past two decades, the rise of diabetes have an acidic serum pH with elevated levels of
this infection in developing countries, including free iron, which is a major nutrient element governing
India, has been phenomenal. And now due to the susceptibility to the infection-causing organism. In
immuno-compromised conditions as an aftermath fact, a considerable number of patients are ignorant of
of the pandemic, an increasingly high incidence of diabetes status till they acquire mucormycosis. Other
mucormycosis is fast becoming a cause for concern. emerging risk factors of mucormycosis are pulmonary
tuberculosis, chronic kidney disease and critically ill
Mucormycosis is a serious, but rare, fungal infection patients, as in the case of COVID-19. Additionally,
caused by a group of moulds called mucormycetes isolated renal mucormycosis in an immunocompetent
or zygomycetes. These moulds gain entry into the host is now developing as a unique clinical entity.
human body via the respiratory tract or skin, and less
commonly through the gastrointestinal tract, eliciting On the whole, the major reasons for the high
an acute inflammatory response. Under favourable prevalence of mucormycosis are the abundant presence
conditions such as those in immune-compromised of mucorales in the community and the hospital
hosts, they invade the blood vessels, causing extensive environment, large number of susceptible hosts
vessel thrombosis and ischaemic tissue necrosis. Most especially diabetics, and the lack of regular health
of these infections are rapidly progressive and exhibit check-ups within the Indian population.
high mortality even after active management.
On the treatment front, drugs such as amphotericin
The infection rarely occurs in a person with an intact B, posaconazole, and isavuconazole are active against
immune system because macrophages phagocytise the most mucormycetes while surgical debridement
spores. However, an immunocompromised individual or resection of infected tissue is often necessary,
is unable to mount an effective immune response particularly for rhinocerebral, cutaneous, and
against the inhaled spores; thus, germination and gastrointestinal infections. First-line treatment with
hyphae formation occur and infection develops. high-dose liposomal amphotericin B is strongly
recommended, and intravenous isavuconazole and
It can affect the brain, sinus, lungs, skin and even the intravenous or delayed release tablet posaconazole are
heart. The optic nerve may also be affected, resulting recommended with moderate strength.
in vision loss. Pulmonary or lung mucormycosis is the
most common type of mucormycosis in people with However, the main challenge lies on the diagnostic
cancer and in people who have had an organ transplant front. Routine serologic tests for mucormycosis are
or a stem cell transplant. In addition, uncontrolled currently not available, and blood tests such as beta-
diabetes mellitus is the most common underlying D-glucan or Aspergillus galactomannan do not detect
disease associated with mucormycosis in India. mucormycetes. DNA-based techniques for detection
are promising but are not yet fully standardised or
Amongst diabetics, poorly controlled Type II diabetes commercially available. Thus, there is a dire need for
is the most common risk factor for mucormycosis. As a early diagnosis of infectious diseases in our country in
result, rhinocerebral or sinus and brain mucormycosis order to deliver better outcomes.
is most common in people with uncontrolled diabetes
and in people who have had a kidney transplant. Dr Manbeena Chawla
Executive Editor
Studies have revealed several factors relating
to the unique predisposition of diabetic patients to [email protected]