BioSpectrum India August 2022

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4 BIO CONTENT BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

COVER STORY 20

COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.

IMPROVING
AIR QUALITY
QUOTIENT WITH

TECH

Air quality affects all living organisms in diverse ways. Airborne pathogenic microbes are
associated with many infectious diseases such as tuberculosis, severe acute respiratory
syndrome (SARS), avian flu, anthrax, and SARS-CoV-2. In particular, the COVID-19 pandemic
has demonstrated the real need for mechanisms to control the spread of airborne respiratory
pathogens. Thus, preventing the spread of disease from pathogens has come to the forefront
of the public consciousness. And this has brought an increasing demand for novel technologies
to prioritise clean air by both big and small players. Startups are flaring up with innovations and
technology that have the potential to change the situation, providing methods to combat air

pollution and related infections sustainably, intelligently and in an affordable manner.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com Top Video BIO CONTENT 5

Corruption Darshit Patel,
Chief Scientific
26 Officer, Decode
Age explains how
How deep runs ‘The Rot’? biomarkers are
being explored
Neonatal Devices for developing
new disease
29 treatments.

Saving Newborns On Priority Scan the QR Code »

Speaking With Abhijeet Kaji,
Co-founder, Knya
33 Enterprise (Knya
Med) talks about
“To address talent supply crunch, how his startup
we should devise a ‘Buy & Build’ is supporting
pipeline for designer profiles” medical workers
Benjamin James, with useful
apparels.
HR Business Partner,
Asia-Pacific, Cytiva

Branded Vs Generics

35

Epic Battle of
Branded Vs Generics
Gauri Chaudhari,

Healthcare Marketing
and Branding Expert

Awards

44 Scan the QR Code »

MM Activ bags recognition Why is the
for exhibition excellence development
of vaccines for
Regulars infectious diseases
so challenging in
BioEdit .......................................................................... 06 India? Answers
BioMail ......................................................................... 08 Dr Neeraj Sood,
Policy and Regulatory News..................................... 10 Professor and Vice
Finance News.............................................................. 14 Dean for research
Company News.......................................................... 15 at the USC Price
Start-up News............................................................. 17 School of Public
WHO News................................................................... 19 Policy, US.
R&D News.................................................................... 37
Academia News.......................................................... 42 Scan the QR Code »
Supplier News............................................................. 46
Let’s Talk Health.......................................................... 50

6 BIO EDIT BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Pharma Vision 2047

The Indian pharmaceutical industry should move Germany 3 per cent and Brazil 1.3 per cent. Even if the
from volume leadership to value leadership. investment of private companies is considered, it is
That is the vision for 2047 and the roadmap little less than half in India. Top 10 pharma majors in
envisaged recently by Dr Mansukh Mandaviya, India spend 7.8 per cent of their revenue on research
Union Minister for Chemicals, Fertilisers, Health & when top 10 global pharma giants spend 16.5 per cent.
Family Welfare. He also expressed the government’s
commitment to support the sector with industry From the production perspective, becoming self-
friendly policies to achieve the goal. sufficient in Active Pharma Ingredients (API) is an
important step. Its importance was realised when
Being the third largest drug producer, India is China initiated lockdown in the initial phase of
already one of the leaders in volume. When it comes COVID-19 and also during the military faceoff with
to generic drugs, India is the largest producer with China, drying the supplies of APIs for Indian pharma
20 per cent market share. The country also has the due to its over dependence. Some steps were initiated
highest number of USFDA-approved manufacturing then to avoid such handicaps in future. Out of 53 APIs
plants outside the USA – 741 plants (as of August imported from China, production of 35 has begun
2021) set up by over 3,800 companies. under Production Linked Incentive (PLI) scheme at
32 plants by March 2022. This will need more boost
However, moving from volume to value leadership for total self-sufficiency.
is not an easy shift. In terms of value, Indian pharma is
13th largest globally. While the world leader, the USA, As the minister pointed out, developing our own
has a market value of $533.5 billion and the number models of production to accelerate general drug
two player, China, is worth $93 billion (2020), India’s production is also important. We should also meet
domestic pharma market stood at $45 billion in FY21. our entire domestic demand and increase exports to
This shows the huge gap that needs to be covered to achieve value leadership.
reach even the second or third position to assume a
leadership position in value. Achieving leadership in value will also require
stress on practising values in the operations and
The Indian domestic market is expected to grow good manufacturing practices (GMPs). The recent
rapidly and is estimated to reach $65 billion by 2024 and two incidences illustrate their requirement. Biocon
further $120 billion by 2030. But, the journey towards Biologics reportedly came up in a case of bribery for
the top three positions is full of several challenges allegedly waiving Phase III clinical trial of its insulin
requiring several steps in different directions from the injection. An executive of Biocon and its agency
government as well as by the industry. director were arrested. Joint Drug Controller was
arrested for allegedly accepting the bribe of Rs 4 lakh.
Our huge volume of generics production itself
underlines the need for basic research to produce In another incident, Securities and Exchange
original medicines, which is the first big challenge. Board of India (SEBI) has issued a warning letter to
In his ‘Vision 2047’ comments, the minister also Aurobindo Pharma for disclosing very limited and
stressed on accumulating knowledge from global best restricted information to the stock exchanges about
practices in research, manufacturing and innovation. the USFDA audit of its production facility.
A Brooking’s report has pointed out that we have
a mere 216 researchers per million population as Such incidences that bring ignominy to the industry
against 1200 in China, 4300 in the US and 7100 in at large must be addressed with conclusive resolution.
South Korea. This clearly shows the path we need to Brand value and acceptance achieved through value-
choose to fill this huge gap. based operations and GMPs are key to move from
volume leadership to value leadership.
Next is the paucity of funding for research. When
India invests only 0.7 per cent of its GDP on research, Dr Milind Kokje
Israel invests 4.6 per cent, South Korea 4.5 per cent, Chief Editor

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8 BIO MAIL BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Vol 20; Issue 7; July 2022

Acknowledgements/ Feedback

BioSpectrum has been doing a great job in bringing out all-important news and analysis
with great dexterity. Our congratulations for continuously maintaining a high standard.

- Dr M H Mehta, Vadodara

Many thanks for the story on drones titled- ‘Providing Succour with UAVs’. It was a
pleasure interacting with BioSpectrum. Looking forward to interacting with you in future
also.

- Shishir Kumar Upadhyaya, New Delhi

Hester Biosciences thanks BioSpectrum magazine for featuring Rajiv Gandhi’s views
on the animal vaccines market in India. BioSpectrum is an important platform in the
healthcare and biotech industry & we look forward to more such opportunities with them.

- Riddhima Basiya, Gandhinagar

The information captured in the cover story on drones was very well aligned with the
current industry trends. Including ongoing industry facts and figures supported by
industry experts’ quotes makes the story very crisp, informative and at the same time an
easy read for anyone who may not possess prior knowledge of the subject.

- Aarti Chitale, Mumbai

Vol 20; Issue 8; August 2022 MM Activ Sci-Tech Communications

Publisher & Managing Editor: South Region New Delhi INTERNATIONAL
Ravindra Boratkar Alok Srivastava Dr Manbeena Chawla Singapore
Editorial: National Business Head- Executive Editor MM Activ Singapore Pte. Ltd.
Chief Editor: Dr Milind Kokje Ad Sales & Marketing 103-104, Rohit House 3, Saradha Mani
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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Centre’s ambitious Autonomous Navigation
Facility to churn out UGVs-UAVs for healthcare

Dr Jitendra Singh, Union cars, driver-less self-driven in different shapes and sizes.
Minister of State (Independent bicycles etc, and unmanned Unmanned aircraft vehicles
Charge) Science & Technology aerial vehicles including drones including drones can be used
inaugurated first-of-its-kind, for various healthcare purposes.
state-of-the-art Autonomous Funded by the Union Ministry
Navigation Facility to develop of Science & Technology at a
unmanned ground and aerial budget of Rs 130 crore, the
vehicles (UGVs-UAVs) in the ‘Technology Innovation Hub
Indian Institute of Technology, on Autonomous Navigation’ is
Hyderabad (IIT-H) campus. The a multidisciplinary initiative,
minister also interacted with which will make India a global
startups developing unmanned player in the futuristic and
ground motor vehicles like next-generation Smart Mobility
driver-less self-driven motor technology.

India’s first mRNA Cabinet approves MoU
between India, Singapore
COVID-19 vaccine for tech innovations

gets Emergency The Union Cabinet chaired by Prime Minister Narendra
Modi was apprised of a Memorandum of Understanding
Use Authorisation (MoU) signed between the Department of Science and
Technology of the Republic of India and the Ministry of
Pune-based Gennova Trade and Industry of the Government of the Republic of
Biopharmaceuticals, a subsidiary Singapore on Cooperation in the fields of Science, Technology
of Emcure Pharmaceuticals, has and Innovation. The MoU was signed in February 2022.
announced that its mRNA vaccine The MoU will provide a mechanism and help in creating an
– GEMCOVAC-19 - has received ecosystem that will promote innovation and entrepreneurship
the Emergency Use Authorisation
(EUA) from the office of the Drugs in both countries leading to
Controller General of India (DCGI). new technology creation,
GEMCOVAC-19 is the very first manpower training and
mRNA vaccine developed in India IP generation through
and only third mRNA vaccine to collaboration. The new
be approved for COVID-19 in the knowledge and technology
world. Gennova’s GEMCOVAC-19 has development through
reached the primary endpoint of the activities implemented under
Phase III clinical trial. The clinical this cooperation will provide
data was evaluated by the Central impetus to Atmanirbhar
Drugs Standard Control Organisation Bharat. The MoU will provide a mechanism and help in
(CDSCO). The vaccine was found to be creating an ecosystem that will promote innovation and
safe, well-tolerated and immunogenic. entrepreneurship in both countries leading to new technology
Gennova Biopharmaceuticals aims creation, manpower training and IP generation through
to produce around 40 - 50 lakhs of collaboration. The activities envisaged in the MoU will involve
doses per month and this capacity can product development and technology exchange which may
be quickly doubled. Beyond India, lead to the generation of new enterprises and employment.
Gennova aims at providing sustainable The objective of this MoU is to encourage, develop and
access to low-and middle-income facilitate cooperation between India and Singapore in fields of
countries around the world to the common interest in science, technology and innovation.
vaccine to blunt the spread of pandemic.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com PARTNER CONTENT 11

Trace metal free centrifuge tubes: setting
“cleaner than clean” standard in research

Biological researchers and scientists are aware that choose their own method of analysis. Almost all laboratories
even the smallest contamination might undermine the opted to determine the heavy metal contents with ICP-MS or
research. Similarly, now the biochemists and biologists AAS following analysis.
are able to comprehend on how trace metals can ruin
important experiments and hinder the analysis tests. How Significant Is the Analysis of Trace Metals in
Your Specimen Samples?
Finding the ideal plastic consumables for your research
is a task in and of itself, as many scientists will agree. Abdos came to the realisation that sample collection and
High chemical resistance, the proper purity to prevent transportation must be planned in trace metal-free collecting
contamination, exact product design, and function are labware. Additionally, aberrant results or false positives will
only a few of the factors that must be taken into account. be recorded if a specimen is received in a non-metal-free
Because the requisite depth of environmental information, container. Abdos has therefore developed the Maxi RCF™
quality concerns like Product Leachability, presence of trace Trace metal-free centrifuge tubes, which are devoid of 18
metals were frequently neglected earlier. Similarly, now the distinct Trace metals lower as <1ppb.
biochemists and biologists are able to comprehend on how
trace metals can ruin important experiments and hinder the Applications & ABDOS Advantage-
analysis tests. 1. Medical-grade Resins- Abdos MaxiRCF™ Trace
Metal Free centrifuge tubes are manufactured using high
However, both major and small biomedical and research purity virgin USP Class VI Medical grade polypropylene,
organization are now starting to use Trace metal free conforming to US FDA 21 CFR, free from natural rubber &
products making this quick shift in mindset toward improved heavy metal.
labware. 2. Maximum RCF/RPM- Abdos MaxiRCF™ Trace
Metal Free Centrifuge Tubes withstand 20,000xg RCF and
What are Heavy Metals? comes with Pure, Additive Free, Natural Colour Cap for easy
Heavy metals such as cobalt (Co), copper (Cu), labelling.
chromium (Cr), iron (Fe), magnesium (Mg), manganese 3. Wide Ranging Applications- MaxiRCF™ withstands
(Mn), molybdenum (Mo), nickel (Ni), selenium (Se) and breakage, allows frozen storage at -80°C & work excellently
zinc (Zn) etc. are naturally occurring elements that are in high density gradient separation of samples.
found throughout the earth’s crust. Heavy metals are also 4. High Quality Standards- Abdos MaxiRCF™ Trace
considered as “trace elements” because of their presence Metal Free centrifuge tubes are specifically manufactured
in trace concentrations (ppb range to less than 10ppm) in to ensure that common trace metals and elements that can
various environmental matrices. Their bioavailability is interfere with experiments are below an ICP-MS detection
influenced by physical factors such as temperature, phase level of one part per billion (< 1ppb). Metals included in testing
association, adsorption and sequestration. are: Zinc, Iron, Copper, Manganese, Aluminium, Silicon,
Nickel, Vanadium, Phosphorous, Cobalt, Chromium, Lithium,
List of “Potentially Toxic Elements” Selenium, Cadmium, Mercury, Arsenic, Lead and Boron (18).

Why Trace Metal Free in Life Science? Author Name:
Since Trace elements can hamper the experiments Gaurav Sharda
by creating plastic toxicity, Sample toxicity & many other Assistant Manager –
implications. Researchers opt for Trace metal free products Product & Marketing
for analysis and critical applications. As there is no generally (International Business)
applicable or universal ISO standards for the determination Abdos Labtech Pvt ltd
of heavy metals in plastics, participants were at liberty to

12 POLICY AND REGULATORY NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Centre NHA announces milestone
allocates paving way for greater
Rs 404 Cr to adoption of digital health
TN for medical
infrastructure More than one lakh healthcare facilities across government and
advancement private sector have been successfully onboarded in the Health Facility
Registry (HFR) under the Ayushman Bharat Digital Mission (ABDM).
Dr Mansukh Mandaviya, Union This historic milestone paves the way for greater adoption of digital
Minister for Health and Family health platforms and services across the country. ABDM is the flagship
Welfare during his two-day scheme of the government being implemented by National Health
visit to Tamil Nadu (TN) and Authority (NHA). Health Facility Registry (HFR) which is being built
Puducherry, visited the Tamil under the ABDM is a comprehensive repository of health facilities of
Nadu Government Multi Super the country across modern and traditional systems of medicine. It
Speciality Hospital in Chennai. includes both public and private health facilities including hospitals,
Dr Mandaviya informed that clinics, diagnostic laboratories and imaging centres. The ABDM aims
the Central Government has to create a seamless online platform that will enable interoperability
allocated more than Rs 2600 within the digital healthcare ecosystem. ABDM has developed building
crore for the health of Tamil blocks and interoperable APIs (Application Programming Interface)
Nadu under National Health to offer a seamless digital healthcare experience for all stakeholders –
Mission and Rs 404 crore health facilities, patients and healthcare professionals. One of the key
for medical infrastructure building blocks is the Health Facility Registry.
advancement under the
Pradhan Mantri Ayushman NITI Aayog releases
Bharat Health Infrastructure compendium of Ayush-based
Mission. The minister virtually practices for COVID-19 management
laid the foundation stone of
CGHS Wellness Centre and NITI Aayog has released a compendium of Ayush-based practices
Lab at Avadi. Informing that from States and Union Territories detailing information about
the Central Government will various Ayush-based initiatives and practices adopted by the States
soon launch the ‘ One Nation, and Union Territories in India for containing and managing the
One Dialysis’ programme, COVID-19 outbreak. In preparing the compendium of Ayush-based
under the Pradhan Mantri practices, NITI Aayog reached out to all State Governments and
National Dialysis Programme, administrations of Union Territories, requesting them to share Ayush
Dr Mandaviya said through this
scheme, any patient can get a practices they have undertaken
dialysis facility from anywhere in for COVID-19 mitigation and
the country. management. The practices
in the compendium have
been disaggregated under
five sections: (i) Overview
and objectives of practices
adopted by the States/UTs
(ii) Ayush Human Resource
and infrastructure (iii)
Interventions and Initiatives
(iv) Digital Platform and Tele-medicine (v) Issues occurred or
addressed. The compendium has also included a summary of the
Ministry of Ayush, Government of India guidelines, and initiatives.
The report indicates that traditional healthcare systems in the
country should be strengthened further. The integration of evidence-
based Ayush services with the modern system has the potential to
significantly strengthen India’s healthcare system.



14 FINANCE NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Vieroots to invest Rs 100 Cr for nationwide expansion

Bengaluru-based startup by 2023. Vieroots also has plans Experiential Centres.
Vieroots Wellness to open another Experiential Vieroots has plans to
Solutions is set to invest Centre in Dubai. In India, the raise $10 million in a
Rs 100 crore to open 50 company will take franchise Series A funding round
Vieroots Experiential routes to expand its network of for expanding its core
Centres across metro businesses. Actor Suniel
and Tier – I cities in Shetty, an ardent believer
India by 2025. As part of preventive wellness,
of the expansion plan, had invested in Vieroots.
the firm backed by To drive expansion,
Bollywood actor Suniel Vieroots has set up
Shetty will open six first-of-its- Viegyan Academy in collaboration
kind interactive and immersive with the Indian Association of
tech-driven Experiential Centres Functional Medicine to introduce
in Delhi, Mumbai, Chennai, a certification programme in
Bengaluru, Hyderabad and Kochi lifestyle coaching.

Cipla buys 21% JB Pharma acquires
4 paediatric brands
stake in Achira from Dr. Reddy’s Labs

Labs for Rs 25 Cr Mumbai-based JB Pharma has announced its third
acquisition of four brands in the calendar year in
Mumbai-based pharmaceutical firm Cipla the paediatric segment – Z&D, Pedicloryl, Pecef
has signed definitive agreements for the and Ezinapi from Hyderabad-based Dr. Reddy’s
acquisition of 21.05 per cent stake (on a fully Laboratories. All the acquired four brands have their
diluted basis) for Rs 25 crore (approx.) in specification in their respective segments. Z&D DS
Achira Labs engaged in the development 20 Suspension is a market leader in the zinc sulphate
and commercialisation of point of care (PoC) molecule category, used as a nutritional supplement
medical test kits in India. The investment will for boosting immunity and for gut related disorders
facilitate a Cipla entity’s strategic participation in children, primarily
in the PoC diagnostics and AMR space through in diarrhoea; while
Pecef (Cefpodoxime
the design, development, Proxetil) and Pecef
and manufacturing of Duo (Cefpodoxime
microfluidics-based Proxetil + Clavulanic
technologies. A PoC Acid Potassium Salt)
that enables rapid acquired, have a wide
identification of the bug range of SKUs to cater
causing an infection to bacterial infections as well as RTIs (Respiratory
would be extremely Tract Infections) in children. Ezinapi Cream is a
helpful in choosing the perfect blend of Cetyl myristoleate, Zinc oxide,
and D-panthenol - a clinically tested formulation
appropriate antibiotic early in recommended for use as an emollient for diaper rashes
the treatment process. Achira is developing in infants; and Pedicloryl oral solution (Triclofosq) is
PoC immunoassays and molecular assays used in children in hospital settings for idiopathic pain
across the clinical areas of infectious diseases, management. All four brands are in the paediatric
antimicrobial resistance (AMR) and hormone segment with a total market size of Rs 1800 crore. The
analysis among others. Cipla has also recently combined sales as per internal estimates were Rs 33
acquired an additional stake of Rs 25.9 crore in crore for FY 2021-22.
digital tech company GoApptiv enabling wider
patient reach with affordable and quality drugs
and end-to-end brand marketing and channel
engagement across tier 2-6 towns in India.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com COMPANY NEWS 15

Novartis opens Lenovo & CSIR-
manufacturing IGIB accelerate
plant in Maharashtra cancer research
through genetic
Sandoz Technical Operations, global market and will play analysis
a Novartis division, has a key role in enabling the
recently unveiled its delivery of high-quality cancer Lenovo, the global technology
manufacturing plant for treatment. The manufacturing leader, is collaborating with the
medicines and therapies at facility is spread across CSIR- Institute of Genomics and
Kalwa in Mumbai. The plant, 32000 sq m, and houses Integrative Biology (CSIR-IGIB),
which marks a new chapter for state-of-the-art production New Delhi, in a unique partnership
Sandoz, will further strengthen technology. Additionally, to advance cancer research by
the company’s operations built on a brownfield, effluent digging deeper into the genetic
in India to support growing treatment units installed at roots of disease. This partnership
healthcare needs globally. The the plant shape a next-gen uses Lenovo’s high-performance
new facility will manufacture environmentally sustainable Genomics Optimisation and
oral cancer medicines for the manufacturing atmosphere. Scalability Tool (GOAST)
architecture, featuring 2nd Gen
GE Healthcare announces 5G Intel Xeon Scalable processors,
Innovation Lab in Bengaluru to power through ultra-intensive
genomic sequencing workloads
GE Healthcare has launched It provides expertise as well as and help researchers find insights
its 5G Innovation Lab in India, a platform for a collaborative faster. Lenovo’s GOAST is a high-
the first for GE Healthcare ecosystem for academia, performance computing (HPC)
across the globe. Situated at the healthcare industry, architecture engineered specifically
the John F. Welch Technology and startups, facilitating for demanding genomics workloads
Centre (JFWTC) Bengaluru, exploration and enabling that is a significant contributor
GE Healthcare’s largest R&D validation and qualification to this initiative. Working closely
centre outside of the US, the of 5G-enabled Precision with Lenovo’s high-performance
lab will serve as a testbed to Healthcare use cases. The GE computing services, CSIR-IGIB
develop future-ready products Healthcare 5G Innovation deployed a 28-node system—the
and solutions, turning a new Lab will serve as a conduit for largest GOAST installation in India
corner in innovation. It houses the interplay of exponential to date. By leveraging an optimised
state-of-the-art infrastructure, technologies like AI/ML, IoT, architecture and efficient open-
including a private 5G network Big Data, Edge Computing and source software, GOAST offers
for testing and development. Cybersecurity. GPU-level performance at CPU-
level costs, making it an attractive
proposition for a public sector body
such as CSIR-IGIB.

16 COMPANY NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

TCG Lifesciences unveils Pune R&D facility

TCG Lifesciences (TCGLS), build a major presence there. chemicals and polymer sciences
a global contract research It is taking up approximately activities in line with its parent
organisation (CRO) with 100,000 sq ft of space to build company, The Chatterjee
operations in Kolkata, a comprehensive discovery Group’s investments in those
Hyderabad, Richmond, VA, services centre. Starting with domains. The labs are equipped
and Princeton, NJ, has opened an efficient team of chemists with automation devices, safety
a new R&D facility in Pune, and support personnel in instrumentation, and regular
as part of a major expansion. July 2022, TCGLS foresees and walk-in fume hoods. It is
Pune with its proximity to the ability to accommodate supported by general access to
Mumbai and Gujarat offers a sizeable batch of chemists, scientific journals/databases,
a great ecosystem of talents, biologists, and formulation IT systems with secured
scientific institutions, and scientists in the coming networks, human resource
relevant industry players which years. It is also looking at officers, and best practices in
TCGLS plans to leverage to opportunities in speciality safety and supply chain.

Lupin collaborates Glenmark launches
with Accenture for
data-driven initiative Sitagliptin for adults with

Pharmaceutical firm Lupin has collaborated with Type 2 diabetes in India
Accenture to enable its data-driven transformation
journey for improved business agility, performance, Glenmark Pharmaceuticals has launched Sitagliptin
and operational efficiency. Accenture has deployed and its Fixed Dose Combinations (FDCs), at an
a digital platform based on SAP S/4HANA, affordable price for adults with Type 2 diabetes in
providing decision-makers with real-time visibility India. The company has introduced eight different
into integrated data from multiple sources combinations of sitagliptin-based drugs under
including supply chain, people and sales networks the brand name SITAZIT and its variants at an
spread across 100+ countries and its fifteen affordable price. The medicines will be available
manufacturing and research facilities in India, the under the brand name SITAZIT, SITAZIT- M,
US, Brazil and Mexico. The consolidated view of SITAZIT- M ER and SITAZIT D. Each of these
global business operations and performance has brands will have two different variants – SITAZIT
enabled informed decision-making. SAP Fiori apps (sitagliptin) will be available in 50 mg and 100 mg
have also helped enhance the user experience for variants; SITAZIT M will have sitagliptin (50 mg)
Lupin employees with simple and easy-to-access + metformin (500 mg/ 1000 mg); SITAZIT M ER
data models and analytical reports. Through this will have sitagliptin (100 mg) + metformin SR (500
collaboration with Accenture, Lupin plans to mg/ 1000 mg). The brand SITAZIT D is a new
unlock the value of enterprise data to increase combination with two variants SITAZIT D 100/10,
efficiencies and accelerate innovation across all which will have sitagliptin (100 mg) + dapagliflozin
functions and processes, including manufacturing, (10 mg) and SITAZIT D 50/5 which will have
testing, supply chain, and finance and accounting. sitagliptin (50 mg) + dapagliflozin (5 mg).

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com START UP NEWS 17

GOQii partners with Medicfibers
SRL Diagnostics for disease
management programmes develops

Mumbai-based startup GOQii, will also offer GOQii’s diabetes antimicrobial
a leading smart-tech-enabled care programme visibility across
preventive healthcare company that their centres pan India for walk-in solution
is focusing on digital therapeutics, patients. As per GOQii’s latest India
has entered into a strategic Fit Report 2022, people suffering Viroclog
partnership with SRL, one of the from lifestyle diseases namely
leading diagnostic companies for diabetes have seen an increase from against HAIs
disease and lifestyle management 7.9 per cent in 2017 to 13.2 per cent
programmes. The strategic in 2021 over the past five years. Medicfibers, an Indian
partnership between GOQii & Institute of Technology-
SRL Diagnostics will extend to Delhi (IIT-D) incubated
where SRL Diagnostics will be startup, in collaboration
the diagnostic partner for all tests with AIIMS New Delhi,
booked by the patient through the has developed an
GOQii App & specifically the HbA1c antimicrobial solution
tests for the GOQii Diabetes Care Viroclog that when
programme. GOQii in association applied as a coating
with SRL Diagnostics offers a on textiles, provides
two-way partnership where SRL long-lasting protection
against hospital acquired
Mylab’s COVID-19 test infections (HAIs)
detects all variants in 20 seconds by reducing viruses,
bacteria, fungi survival
Pune-based startup Mylab Discovery Solutions and US-based Hemex on fabric. Coating the
Health, a medical diagnostic device company focussed on creating Viroclog on textiles
diagnostics to transform frontline healthcare, have announced the official lowers the surface
launch of the Gazelle PathoCatch COVID-19 FIA test, their collaborative energy preventing
diagnostic solution for point-of-care (POC) testing in India. This portable, adhesion of microbes
lightweight test detects all COVID-19 variants in 20 seconds with 99.4 and destroying the
per cent accuracy compared to the gold standard, PCR. The diagnostic is membrane integrity of
microbes. Destruction of
currently under review with the lipid-based membrane
US FDA for Emergency Use barrier makes the
Authorisation and will launch microbes inactive, thus
in Africa and the Middle East preventing infection
later this summer. The Gazelle transmission. The
PathoCatch test includes basic significance of
a fluorescent lateral flow this technology is to
immunoassay (FIA) and a save lives and reduce
reader that utilises image- healthcare-associated
recognition software for the costs by integrating
detection of nucleocapsid antimicrobial technology
protein from SARS-CoV-2. with hospital clothing
The reader uses AI imaging that provides a layer
of protection against
and signal-to-noise enhancement microbial pathogens.
techniques to achieve near-PCR The tests show that
accuracy. Specimens are collected Viroclog technology
using a nasal swab. contributes significantly
to reducing infections
through antimicrobial
hospital clothing.

18 START UP NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

BioNEST Immuneel Therapeutics commences
incubator at trials for CAR-T cancer therapies
Dr Moopen’s
Medical College Biotech startup Immuneel Therapeutics has begun patient dosing
to support in a CAR-T trial named IMAGINE. This phase II trial is the first
health startups industry sponsored CAR-T trial in India and is now actively enrolling
patients at Narayana Hrudayalaya, Bengaluru. The IMAGINE trial is
Dr Moopen’s Medical College funded by Immuneel and will include up to 24 paediatric and adult
(DMMC) has received approval cancer patients. Immuneel has exclusive rights to ARI-0001/IMN-
from Biotechnology Industry
Research Assistance Council 003A (a CD-19 CAR-T cell therapy)
(BIRAC) to set up an incubation from Hospital Clínic de Barcelona
facility under Bioincubators and Institut d’Investigacions
Nurturing Entrepreneurship for Biomèdiques August Pi i Sunyer in
Scaling Technologies (BioNest) Spain to develop, manufacture and
Scheme. The incubator is commercialise in India via technology
equipped with a Biomedical transfer. ARI-0001 is approved by
Research Laboratory with the Spanish Drug Agency (AEMPS)
specialised facilities and a and the data available compares very
small animal laboratory and favourably with the US FDA-approved
is supported by a hospital products. CAR-T therapies, previously not available in India, have
information system, laboratory shown promising results for patients who have exhausted all other
information system, Digital means of treatment in a range of blood cancers. These therapies are
Health Databank and Clinical available internationally at $350K+ per dose, making the IMAGINE
Simulation Lab. A space of trial the first step towards bringing affordable treatments to patients in
11,000 square feet has been India that are on par with global quality benchmarks and clinical data.
dedicated for incubation. The
expected project cost is Rs MyHealthcare,
6.5 crore. In Phase 1 (3 years) Ashoka University to
DMMC BioNEST plans to enhance evidence-based
support 10 startups as physical clinical research
incubates, 5-10 startups as virtual
incubatees and three startups Gurugram-based startup MyHealthcare has partnered with
from the BIRAC network for Ashoka University to build evidence-based, clinical research across
field validation every year in the hypertension, cardiovascular diseases and diabetes. With the growing
areas of digital health, healthcare need for chronic care management in India, the partnership aims to
and biomedical technology
development. It is anticipated research and build clinical models
that at least 30 startups will that will help deliver better care
get successfully incubated in outcomes. MyHealthcare will
the BioNEST and few of them work with Ashoka University to
graduate as successful exits improve clinical data collection,
with indigenously developed curation, and analytics and
innovative technologies help develop evidence-based
at the end of Phase 1. The clinical decision support systems
current industry partners for across key chronic diseases
this initiative are Aster DM such as cardiovascular disease,
Healthcare, Agappe Diagnostics, hypertension and diabetes. As a part of this engagement, Ashoka
Applied Materials, Motherson, University will provide its expertise in data analysis, biomedical
Intel Pixel – Fuji Film and research and public health expertise in data collection and will further
CARPL. ensure access to scientists, academicians, data analysts, public health
experts etc. for accelerating this joint research initiative.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com WHO NEWS 19

WHO, I-DAIR ink MoU for international research in digital health

The World Health Organisation and governance of the digital collaboration and implementing
(WHO) and the International health and AI space, with particular innovative digital health long-
Digital Health and AI Research focus on the inclusion of young term solutions, consistent with
Collaborative (I-DAIR) have signed researchers and entrepreneurs. WHO recommendations and
a Memorandum of Understanding The partnership will focus on interoperability standards. The
(MoU) outlining their joint efforts achieving these common goals joint activities include, inter
to advance the use of digital through a multi-faceted approach alia, the promotion and the
technologies for personal and focusing on promoting scientific development of new norms and
public health globally. Through cross-domain/cross-border guidelines for the governance of
this agreement, WHO and I-DAIR health data as a public good, the
will work together to harness building of evidence cases for
the digital revolution towards thoughtful investments in digital
urgent health challenges, while health globally, & the strengthening
emphasising equity and greater of stakeholders’ capacities -
participation from Low and for instance via the common
Middle-Income Countries (LMIC) elaboration of the WHO digital
in the research and development health competency framework.

WHO strengthens WHO releases
collaboration for HIV, viral
hepatitis and STIs treatment COVID-19 critical

Dr Meg Doherty, Director of WHO’s Global HIV, Hepatitis care course for
and Sexually Transmitted Infections (STI) Programmes
(WHO/HHS), and Professor Yazdan Yazdanpanah, Director nurses, doctors
of ANRS | Emerging infectious diseases, have signed a
memorandum of understanding aimed at supporting and With support of the European Union early
strengthening their collaboration in research and knowledge in the COVID-19 pandemic, the European
sharing to support global health policy development and Society ofIntensiveCareMedicine (ESICM)
implementation in low- and middle-income countries developed the C19 Skills Preparation
(LMICs). They will jointly review research priorities for Course (C19_SPACE) to orientate and
improving the prevention, treatment and care of HIV, supplement clinical learning for nurses
hepatitis, and STIs and develop and doctors not regularly or newly engaged
research programmes and in intensive care units (ICUs). C19_SPACE
innovative approaches on provides the most recent evidence-based
identified priorities; facilitate the information, video lectures and clinical
implementation and adaptation case videos delivered by critical care
of priority research programmes experts. It is based on WHO normative
and innovative approaches by guidelines (Health Care Readiness). In a
providing technical support new collaboration with WHO and ESICM
and strengthening human and the C19_SPACE interactive programme is
technical capacities across now available in English, French, Arabic,
ANRS-MIE networks, in particular in LMICs where research Chinese, Spanish, and Russian to ensure
programmes are implemented. ANRS | Emerging Infectious the course can reach a wider global health
Diseases, founded on January 1, 2021, is an autonomous care audience. Along with multiple hours
agency of Inserm whose missions are to facilitate, evaluate, of training, the course includes a series of
coordinate and fund research into HIV/AIDS, viral downloadable checklists to guide health
hepatitis, sexually transmitted infections, tuberculosis, and professionals through decision-making at
emerging and re-emerging infectious diseases (emerging the patient’s bedside. WHO and ESICM
respiratory diseases, including COVID-19, viral hemorrhagic are working closely to identify and enrol
fevers, arboviruses etc.). the first participants in the new multi-
language learning platform.

20 COVER STORY BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

IMPROVING
AIR QUALITY
QUOTIENT WITH

TECH

Air quality affects all living organisms in diverse ways. Airborne pathogenic microbes are
associated with many infectious diseases such as tuberculosis, severe acute respiratory
syndrome (SARS), avian flu, anthrax, and SARS-CoV-2. In particular, the COVID-19 pandemic
has demonstrated the real need for mechanisms to control the spread of airborne respiratory
pathogens. Thus, preventing the spread of disease from pathogens has come to the forefront
of the public consciousness. And this has brought an increasing demand for novel technologies
to prioritise clean air by both big and small players. Startups are flaring up with innovations and
technology that have the potential to change the situation, providing methods to combat air

pollution and related infections sustainably, intelligently and in an affordable manner.

Over the years, there have been a number of in response to the COVID-19 pandemic, there has
novel filters introduced to try and prevent the been an increase in demand for novel antimicrobial
spread of air-borne pathogens and pollutants technologies to prevent transmission.
through heating, ventilation and air conditioning
(HVAC) systems. For example, in aerospace cabins With advancements in nanotechnology, many
HVAC systems are designed to be used with high- researchers across the globe are employing the
efficiency particulate air (HEPA) filters. HEPA are unique properties of nanomaterials to develop
extremely efficacious at screening out airborne efficient and sensitive detection methods.
viruses and bacteria due to their small particulate Nanomaterials have enabled miniaturisation of
size. However, a significantly higher level of energy is sensing devices, leading to rapid, portable, and
required to push air through HEPA filters compared sensitive pathogen diagnostic systems that can
to basic HVAC filters. detect airborne pathogens in hospitals, air vents, and
aeroplanes and anticipate bioterrorism attacks in
While these air filtration systems can effectively public spaces.
remove pathogenic microorganisms from the indoor
air environment, the organisms are not destroyed The incorporation of silver nanoparticles into
and can remain viable, or even proliferate, within meshes for filters has also been tested in a range
the air filtration system and on the filter media. of forms. Studies have reported the development
Therefore, the filter itself can behave as a source for of a nano-fibrous air filter with incorporated silver
contamination of the air environment with airborne nanoparticles to impart an antimicrobial effect. The
pathogenic microorganisms. inclusion of silver nanoparticles demonstrates an
effect on survival of both gram-positive and gram-
Due to the risk of filters acting as a reservoir for negative bacteria on the filters.
contamination of the indoor air environment, and
Further, carbon nanotube filters have

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com COVER STORY 21

demonstrated a 90 per cent reduction in virus such as COVID-19 and influenza indoors, and
survival downstream of the filter, which is lowering the risk of the next pandemic.
significantly more effective than the silver
nanoparticle technology. A direct approach to limit airborne pathogenic
transmissions is to inactivate them within a short
“Children who breathe in polluted air are time of their production. Germicidal ultraviolet light,
more likely to develop asthma or other breathing
conditions that will affect them throughout their typically at 254 nm, is effective in this context but,
lives. Adults and elderly who regularly breathe when used directly, can be a health hazard to skin
in polluted air can develop acute infections like and eyes. By contrast, far-UVC light (207–222 nm)
pneumonia or chronic diseases like chronic efficiently kills pathogens potentially without harm to
obstructive pulmonary disease (COPD) or chronic exposed human tissues.
bronchitis. All of these ailments have been on the
rise over the last decade as air has become dirtier. Sharing her thoughts on the new technologies
Thus, many industry leaders in the life sciences sector being developed to tackle air-borne pathogenesis
are focusing on treating the cause of these diseases and pollution, Dr Rajvi Mehta, Microbiologist and
by highlighting the importance of clean air”, says Scientific consultant, Trivector Biomed says, “The
Amarpreet Rai, Co-Founder & Director of Operations pandemic has made people realise the importance
and Development, Sanrai Med India. of air quality and search for effective means for air
purification. Many new technologies which were
Recent studies have revealed that far-UVC light available even before the pandemic are now getting
from lamps installed in the ceiling could be a highly more exposure. However, at the same time, many
effective passive technology for reducing person-to- products are coming into the market making tall
person transmission of airborne-mediated diseases claims and mis-leading vulnerable customers. With
the launch of far-UVC light disinfection devices

22 COVER STORY BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

“Many industry leaders in “With the launch of far-UVC
the life sciences sector are light disinfection devices
which can be safely used
focusing on treating the around human beings, it
cause of air-borne diseases by
highlighting the importance is certainly going to have a
paradigm shift in the practices
of clean air.”
- Amarpreet Rai, of infection control.”
Co-Founder & Director of - Dr Rajvi Mehta,
Operations and Development,
Sanrai Med India Microbiologist and Scientific
consultant, Trivector Biomed
“Air purifiers today have
moved from being just a which can be safely used around human beings, it
seasonal product to a year- is certainly going to have a paradigm shift in the
practices of infection control and our company would
long necessity.” certainly play a major role in it by offering the latest
- Gulbahar Taurani, technologies at affordable costs.”
Managing Director & Chief
Executive Officer, Philips Marketing purified air
Domestic Appliance, India
According to the report by ResearchAndMarkets,
Subcontinent the Indian air purifier market stood at over $85.08
million in FY 20-21 and is projected to cross over
“While air purifiers can $569.07 million by FY 26-27. Some of the major
eliminate indoor air pollutants, players operating in the Indian air purifier market
the urgent need of the hour is a include Philips, Eureka Forbes, Sharp Business
device that not only purifies air, System, Panasonic, Honeywell, Daikin, Kent RO,
Xiaomi Technology, Crusaders Technologies, Dyson
but also disinfects it.” Technology, to name a few.
- Sumit Joshi,
With rising pollution levels, rising incidences
Chief Executive Officer and of respiratory diseases, and lack of proper
Managing Director, Signify ventilation systems, a majority of these companies
have increased their spending to raise consumer
Innovations – South Asia awareness in order to increase the demand for air
purifiers in the private and public sector.
“We forecast explosive growth
in the area of personal air For instance, Kent has launched Alps+ UV
air purifier with LED technology at a price of Rs
purification and protection over 30,000 with a three stage mechanism of purification
the next few years. Wearable air consisting of a primary filter, activated carbon filter,
purifiers will become ubiquitous and HEPA filter. On the other hand, Dyson has
launched two new air purifiers with HEPA filtration
in the near future.” at a price range of Rs 45,900.
- Mukund Rajukumar,
Chief Executive Officer, Aerion Similarly, Philips has introduced a multi-
functional air purifier that is equipped with a three-
Technology Labs layer HEPA filtration system which claims to remove
99.95 per cent of particles as small as 0.003 µm
(micrometre), available for Rs 32,995. Joining the
list is Sharp Business system that has developed a
smart air purifier using its patented Plasmacluster
Ion Technology (PCI) with proven efficacy in
obliterating SARS-CoV-2 by 91.3 per cent within 30
seconds. Priced at Rs 43,670, SmartAir is equipped
with Sharp’s original HAZE Mode for superior and
efficient cleaning during smog and high impurity
conditions.

According to Gulbahar Taurani, Managing

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com COVER STORY 23

“We need to understand the “We have introduced a bipolar
effects of something called ionisation technology-based

the sick-building syndrome, a system that is considered the
situation in which occupants first of its kind in India and
is also believed to be a rare
of a building experience technology globally.”
one or more adverse health - Dr Kasu Prasad Reddy,

symptoms.” Co-Chairman, Jaitra Devices &
- Kartik Singhal, Systems & Co-Chairman & Founder
Founder- O2 Cure and Director- of MaxiVision Eye Hospitals Group

Zeco Aircon

Director & Chief Executive Officer, Philips Domestic various pathogens such as viruses, bacteria, and
Appliance, India Subcontinent, “Air purifiers today fungus. Available at a starting price of Rs 9,000, it
have moved from being just a seasonal product to a is the first-ever Make in India product to adopt the
year-long necessity. With the advent of COVID-19 bipolar ionisation technology, which works against
pandemic, the consciousness to breathe healthy air harmful microbes by starting a chemical reaction on
and to keep families safe from the impact of bacteria the cell membrane surface of the viruses and bacteria
and viruses has spiked up”. making them dead.

Netherlands headquartered Signify has recently Dr Kasu Prasad Reddy, Co-Chairman, Jaitra
launched its EcoLink Air Purifier with UV-C Devices & Systems & Co-Chairman & Founder
technology in India. This air purifier is designed of MaxiVision Eye Hospitals Group says, “Due
to purify and disinfect air at the same time and to the large influx of visitors at hospitals, the
is equipped with a HEPA filter and UV-C lamps. healthcare industry must ensure that intense
The products are priced between Rs 25000 and Rs care is administered to sanitise the surfaces and
60,000. have a clean environment. For the past 20 years,
bipolar ionisation technology has been used and
Sumit Joshi, Chief Executive Officer and implemented across various countries in the world.
Managing Director, Signify Innovations – South Asia, This technology generates both positive and negative
says, “With growing evidence about the air-borne ions in the air and neutralises the glycoproteins and
transmission of COVID-19, we need to pay close makes the air safe-to-breathe. We have introduced
attention to the quality of the air we breathe. While this system that is considered to be the first of its kind
air purifiers can eliminate indoor air pollutants, the in India and is also believed to be a rare technology
need of the hour is a device that not only purifies air, globally. This technology will also be useful for many
but also disinfects it. We have leveraged our 35 years more hospitals, airports, cinema theatres, malls, bus
of expertise in UV technology to develop this device stations, hotels and areas where the quality of air can
that addresses the growing need for air purification get endangered through multiplying bacteria.”
and disinfection in a world that is still reeling under
the pressure of COVID-19.” Promoting another new technology, Bengaluru-
based startup Shycocan Corporation has developed
Startups with a mission Scalene Hypercharge Corona Canon air-purifier
that is intended to disable air and surface-borne
In the expanding scenario of air purifiers, startups coronaviruses. Costing around Rs 20,000, this device
are flaring up across the country with innovations exhibits electron-mediated virus deactivation.
and technology that have the potential to change the
situation, providing methods to combat air pollution Aerion Technology Labs, a Coimbatore-based
and related infections sustainably, intelligently and in startup, has developed a wearable active air-purifying
an affordable manner. face shield that employs a patented reusable filtration
technology to reduce the total cost of ownership,
The Indian Institute of Technology (IIT) Delhi thereby making it affordable to the masses. The
startup Nanoclean Global has launched the world’s product is priced at Rs 7,000. Alongside, the startup
smallest wearable air purifier. Priced at Rs 500, is also developing wearable air purifiers integrated
Naso95 is an N95 grade nasal filter that sticks to into 2-wheeler helmets and hard hats for use in
the user’s nasal orifice and prevents bacteria, viral factories.
infection, pollen and air pollution.
“We forecast explosive growth in the area of
Hyderabad-based Jaitra Devices & Systems has personal air purification and protection over the next
recently launched bipolar air disinfectant and purifier few years because of the widespread awakening that
in the country that has been testified effective against

24 COVER STORY BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

LIST OF STARTUPS DOMINATING THE AIR-PURIFICATION SPACE IN INDIA

Startup Technology/ Product Price (Rs)
Nasal filter 500
NanoClean Global,
New Delhi Bipolar Ionisation 9,000

Jaitra Devices & Systems, Electron-mediated virus deactivation 20,000
Hyderabad
Air purifying face shield 7,000
Shycocan Corporation,
Bengaluru Ultraviolet germicidal irradiation NA

Aerion Technology Labs, Sanitiser for Airborne Virus Elimination (SAVE) NA
Coimbatore
Photohydroionisation 42,000
Airific system, Noida
Pure Skies- green technology NA
AiRTH, New Delhi
Photoelectrochemical oxidation 38,000
O2Cure, Gurugram
Airific Car Cabin Filter 2,000
Devic Earth, Bengaluru
Graphene-based AC Filters 2,000
Molekule, US
Plant-based air purifier NA
Nirvana Being, New Delhi
Ultraviolet Germicidal Irradiation NA
Nanomatrix Materials,
Jaipur IoT-based device 15,000-50,000

Urban Air Laboratory,
Ropar

Magneto CleanTech,
New Delhi

Aura Air, Israel

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com COVER STORY 25

COVID-19 has created regarding the huge health risk Source: https://www.sciencedirect.com/science/article/
posed by airborne pathogens. In addition, outdoor pii/S0160412020321383#f0065)
air pollution is getting worse every day and causing
widespread respiratory illnesses. In India alone, more Major players operating in the
than 15 million new two-wheelers hit the road every Indian Air Purifier Market
year and there are more than 20 crore 2-wheelers in
India. Wearable air purifiers will become ubiquitous ● Philips India
in the near future and Aerion is well-poised to tap ● Eureka Forbes
into this greenfield opportunity with its robust ● Sharp Business System India
product roadmap”, says Mukund Rajukumar, Chief ● Panasonic India
Executive Officer, Aerion Technology Labs. ● Honeywell
● Daikin Air-conditioning India
Ultraviolet germicidal irradiation (UVGI) ● Kent RO Systems
technology is another tool being deployed by Noida- ● Xiaomi Technology India
based startup Airific System to improve air quality. ● Crusaders Technologies India
The startup has developed India’s first UVGI systems, ● Dyson Technology India
tested and certified by Indian Council of Medical
Research (ICMR) for 99 per cent disinfection against Adding on, US-based startup Molekule has also
SARS-COV2 virus. launched its air purifying products in India last year
at a price of Rs 38,000. In fact, the company has
New Delhi-based AiRTH is another player rapidly partnered with Panjab University in Chandigarh
making its mark in the air purification space. The to assemble and optimise its air purifiers in
startup has developed an antimicrobial air purifier about 10 hospitals. Molekule’s core technology,
referred to as ‘Air Doctor’ that also protects against Photoelectrochemical oxidation (PECO), is designed
Black Fungus, using proprietary SAVE (Sanitiser for to destroy airborne pollutants like viruses, bacteria,
Airborne Virus Elimination) technology developed by moulds or chemicals in the air known as volatile
IIT Bombay. organic compounds (VOCs).

On the other hand, Gurugram-based startup Israeli startup Aura Air has also launched its
O2Cure has launched a Plug&Play air purifier that is smart air management platform in India recently.
equipped with US-based firm RGF Environmental Priced between Rs 15,000 and Rs 50,000, these
Group’s photohydroionisation (PHI)-Cell technology IoT-enabled devices connect to a mobile phone and
which has been successfully tested under the ICMR deliver real-time updates on the overall indoor and
to neutralise the COVID-19 virus by 97.48 per cent. outdoor Air Quality Index based on volatile organic
It is available at a cost of Rs 42,000. The startup has compounds, carbon dioxide, carbon monoxide, and
also launched REME LED- portable air purifier in the fine particulate matter levels.
market recently, priced at Rs 22,000.
With technology advancement at the forefront for
“India is home to 22 of the world’s 30 most air purification in India, efforts might still be required
polluted cities. To combat the threat of rising air for the mass production and easy availability of these
pollution, government and non-governmental solutions in the coming years.
organisations have devised novel solutions such as
switching to cleaner and greener technologies. The Sakura Koner
use of room air purifiers has grown in popularity
in recent years due to their effectiveness. Also, we
need to understand the effects of something called
as the sick-building syndrome, a situation in which
occupants of a building experience one or more
adverse health symptoms that seem to be related to
the time spent indoors without necessarily resulting
in any specific illnesses”, says Kartik Singhal,
Founder- O2 Cure and Director- Zeco Aircon.

Introducing a disruptive green revolutionary
technology, Bengaluru-based startup Devic Earth has
developed Pure Skies technology as an air pollution
control equipment. With indoor plans starting from
20,000 sq ft at Rs 1.99/sq ft/month, it is the world’s
first-ever ‘Clean-Air-as-a-Service’ to help improve
ambient air quality in India.

26 CORRUPTION BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

HOW DEEP RUNS

‘THE ROT’?
While weeding out corruption is a tall order, especially in the pharma industry, there needs to be a
will to implement the ‘checks and balances’ already in place. Corruption in the pharma industry is
nothing new and the recent reportage of unethical, illegal and fraudulent activities in India have, in
effect, tarnished the image of the industry in the global sphere. Let’s pick up a few recent threads
of corruption and find out what industry insiders have to say.

Public health is in limbo and the ‘Pharmacy of Dinesh Thakur, Founder, Thakur Family
the World’ tag for India is in real distress with Foundation, a pharma crusader and a whistleblower,
the latest happenings in India’s pharma sector. who worked with Ranbaxy and eventually exposed
Things unfolded recently with the Central Bureau of frauds within the company, says, “Regulatory capture,
Investigation (CBI) arresting a top executive of Biocon when it comes to the pharma industry, is not a new
Biologics, a drugs inspector and a joint drug controller phenomenon. It exists both in India and worldwide.
for alleged corruption. According to media reports, However, the level of capture is by far an order of
several people have been booked over alleged bribes to magnitude worse in India compared to elsewhere.”
get approval for insulin injections for diabetes patients
developed by Biocon. Some pharma companies indulge in giving
gifts, cash, and paying for trips to attend medical
Biocon, however, came up with clarifications to conferences. This is done to potentially influence
protect itself and tried to come out clean. The National a doctor to be favourably inclined to prescribe the
Stock Exchange (NSE) has sought clarification from company’s products.
Biocon concerning the firm’s subsidiary being caught
by the CBI for allegedly offering bribes to waive-off a Says Girdhar Balwani, Professional Mentor &
trial of a new drug, according to media reports. Independent Director, Cadila Pharmaceuticals said,
“All companies and doctors have to operate within the
Recently, Micro Labs’ offices were raided by the legal domain of the country. While various laws and
Income Tax Department for tax evasion. It is notable codes exist, it is important to look at the best way to
that it is the same company which provided life-saving ensure compliance. The Prevention of Corruption Act
Dolo-650 during the COVID-19 pandemic. In this case, prescribes that corporate entities have compliance
however, there was no reaction from the company. procedures in place to prevent their employees
from engaging in any act which may be categorised
All these happenings have put to question how the as corruption or bribery. Subsidiaries of foreign
regulatory body works and the in-depth corruption companies have to also adhere to the applicable
that is happening across the pharma sector. laws of the jurisdiction where the parent company is
located.”
Corruption in the pharma sector is nothing new
and the recent episode has opened a can of worms Instances
where pharma regulatory agencies are hand in glove
with pharma companies on various occasions. Recently the Supreme Court has asked the
Centre to file an affidavit on a plea alleging unethical
It may be noted that nine years ago, in 2013, the marketing practices by pharmaceutical companies in
Parliamentary Standing Committee on Health in its their dealings with healthcare professionals resulting
118-page report found lapses in the way Central Drugs in the prescription of excessive or irrational drugs
Standard Control Organisation (CDSCO) functions and a push for high-cost or over-priced brands.
and blamed the department citing incidences of lapses, The plea was filed by the Federation of Medical &
irregularities, and opaqueness. According to the Sales Representatives Association of India (FMRAI)
committee, it is of the firm opinion that most of the seeking a Uniform Code of Pharmaceutical Marketing
ills besetting the system of drug regulation in India are Practices (UCPMP) and making it effective by
mainly due to the skewed priorities and perceptions of
CDSCO.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com CORRUPTION 27

providing a monitoring mechanism, transparency, “Elimination of intermediaries
accountability as well as consequences of violations.
by extensive use of digitisation
The Hisar vigilance department recently arrested
the deputy President of the Haryana State Pharmacy is one way to reduce corruption
Council (HSPC) for bribing officials related to some
registration-related activities. as we have seen in the success

An article published in Frontiers in Research of the centre’s ‘ Direct Benefit
Metrics and Analytics talks about ghost-management
of medical research, a process by which industry Transfer’ scheme. The Right to
representatives craft and publish research in the
names of doctors and psychiatrists. There have been Information Act & Whistleblower
instances where the pharma industry’s sponsorship
of clinical trials have influenced the results, putting a policy are also other tools to
question mark on evidence-based medicine.
reduce corruption.” - Dr Ajit Dangi,
The Pharma City in Telangana was also in the news
when a Member of Parliament from the state met the President & CEO,
Prime Minister of India regarding the cancellation of
the permission granted for setting up of Pharma City Danssen Consulting
due to some corruption.
“Regulatory capture, when it
Take for instance Ranbaxy. A few years back,
the company, a pioneer in India’s generic medicines comes to the pharma industry,
revolution, had to pay damages to the tune of $500
million to settle corporate fraud related to unethical is not a new phenomenon.
production of medicines that compromised on quality.
It exists both in India and
Global corruption in pharma
worldwide. However, the
A few years back US-based China focussed
SciClone Pharma had to cough out more than $12 level of capture is an order
million in fines, penalised by US prosecutors after
violating the Foreign Corrupt Practices Act. Many of magnitude worse in India
years back, US-based Purdue Pharma was fined $600
million for misbranding its blockbuster painkiller compared to elsewhere.” - Dinesh Thakur,
drug, OxyContin. The recent one is the corruption
charges against GlaxoSmithKline in China. The Founder,
UK-based pharma giant was prosecuted by local
authorities and was found guilty of bribing physicians Thakur Family Foundation
and hospitals to promote products and subsequently
the company paid $490 million in fines. “All companies and doctors
have to operate within
The recent opioid crisis in the US where over the legal domain of the
50,000 people died due to overdose of drugs country. While various
like oxycodone, fentanyl etc. as these were often laws and codes exist, it
overprescribed by giving inducement to doctors, is a is important to look at
classic example. Off-label promotion of a drug for an the best way to ensure
indication not approved by the US FDA is also another compliance.”
form of corruption. - Girdhar Balwani,
Professional Mentor & Independent Director,
Similarly in the UK, the National Health Service Cadila Pharmaceuticals
(NHS) which is often touted as a model healthcare
system in Europe, reported losses due to frauds in “Blockchain integration
2016-17 to the tune of £ 1.25 billion per annum. in the pharma industry
will lead to lower drug
The way out development costs and
efficient clinical trials.”
Technology can play a huge role in preventing
corruption in the pharma sector. Technologies - Gunjan Bhardwaj,
such as Artificial Intelligence (AI) and blockchain, Founder and CEO,
can help eliminate the loopholes which can lead to
Innoplexus

28 CORRUPTION BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

GLIMPSES OF PHARMA CORRUPTION bribery/corruption and improve transparency and
accountability within the industry. The faster AI and
Year Company Form of corruption blockchain are implemented across the industry the
more we can prevent certain corruption in the sector.
2022 Biocon Bribery
Says Dr Ajit Dangi, President & CEO, Danssen
2022 Micro Labs Tax Evasion Consulting, “Elimination of intermediaries by
extensive use of digitisation is one way to reduce
2022 Teva Pharma Unapproved promotion corruption as we have seen in the success of the
of medical products centre’s ‘Direct Benefit Transfer scheme. The Right
to Information Act and Whistleblower policy are
2021 Sandoz False Claims Act and also other tools to reduce corruption. If the new drug
related approval process was fully digitised there would have
been fewer chances of the recent example of approval
2021 Johnson & Johnson Unapproved promotion of a new drug of Biocon by allegedly waving phase
of medical products three trial by the Deputy DCGI (Drugs Controller
General of India) for consideration, may not have
2020 Purdue Pharma Fraud happened.”

2020 Novartis False Claims Act and The UCPMP guidelines and newly enacted the
National Medical Commission Act 2019 may usher
Pharmaceuticals Corp related into a new era to clean up the rot in the healthcare
industry.
2017 Mylan False Claims Act and
related According to Gunjan Bhardwaj, Founder and
CEO, Innoplexus, blockchain integration in the
2015 Takeda Pharmaceutical Drug or medical pharma industry will lead to lower drug development
equipment safety costs, efficient clinical trials and an effective and
violation efficient system of secure spending, transparent data
and more medicines for patients and consumers
2014 Boehringer Ingelheim Medical equipment throughout the world.
International safety violation
Need for clampdown
2013 Ranbaxy Medical equipment
safety violation There is much more to this menace and only
strict regulations by the government will help
2012 Abbott Laboratories Unapproved promotion to weed out the corruption. As it is known that
of medical products officials from CDSCO, DCGI and some members
of the pharma fraternity are well involved in these
2012 Amgen Unapproved promotion activities, more stringent laws may help in the long
of medical products run. Putting the culprits behind bars will send a
strong message to those who plan to indulge in such
2011 Merck, Sharp & Dohme Unapproved promotion activities.
of medical products
The Union Health Ministry is learnt to have
Source: https://violationtracker.goodjobsfirst.org/industry/pharmaceuticals been taking steps to improve compliance and crack
down on corruption. There is news that the Centre
Omissions, Commissions and Frauds has decided to introduce QR codes for ensuring
authenticity and traceability for 300 common drug
India’s drug regulator had granted emergency brands including analgesics, vitamins, diabetes
use authorisation (EUA) for Biological E’s COVID-19 and hypertension medicines etc. This step is aimed
vaccine Corbevax for children between 5 and 12 at preventing spurious drugs from getting into
years and Bharat Biotech’s Covaxin for children circulation. The health ministry has made necessary
between 6 and 12 years. However, the National amendments to the Drugs Rules, 1945, to implement
Technical Advisory Group on Immunisation (NTAGI) the rule. While weeding out corruption is a tall order,
found that the study by Christian Medical College especially in the pharma industry, there needs to be a
(CMC), Vellore lacked uniformity in results upon will to implement the ‘checks and balances’ already in
mixing jabs for booster shots. In this case, it is place.
not clear why the drug regulator gave a go-ahead
whereas NTAGI raised certain questions. Experts Sanjiv Das
have raised concerns over the vaccine’s efficacy and [email protected]
safety data which are not in the public domain.Last
year, Brazil suspended its deal with Bharat Biotech
for 20 million Covaxin doses amid an ongoing
investigation into alleged irregularities and corruption.
The country’s health regulator also suspended
the vaccine’s emergency use application, citing
incomplete paperwork provided by the intermediary.
Among other points raised, the pricing issue of
vaccine doses has been a point of contention. Bharat
Biotech, however, denied any wrongdoing.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com NEONATAL DEVICES 29

SAVING NEWBORNS
ON PRIORITY

With a high number of neonates dying every year in the country, there is a need for quality medical
devices to save the little ones. Having a majority of global players catering to the demand for this
sector, Indian companies are slowly entering this space to provide the much-needed relief.

The demand for neonatal monitoring and care The neonatal critical care market
equipment is seeing an upward trend in India.
India, with its huge population base, has the According to ResearchAndMarkets.com, the
most neonatal deaths, 75 per cent, occurring during global neonatal critical care equipment market size
the first week of life. Preterm birth, childbirth-related is expected to reach $1.36 billion in 2030, expanding
complications, infections, and birth defects cause at a CAGR of 8.7 per cent. The rising number of
most of these deaths. In 2021 India had an infant preterm births, increasing incidence of newborn
mortality rate of 28 deaths per 1000 live births, jaundice, and launch of new products are some of the
representing sustained progress over the past couple of factors responsible for market growth. Another report
decades. The United Nations International Children’s published by Allied Market Research mentions that
Emergency Fund (UNICEF)’s report states that “80 the global newborn screening market was estimated at
per cent of all newborn deaths result from three $1.1 billion in 2021 and is expected to hit $2.0 billion
preventable and treatable conditions: complications by 2031, registering a CAGR of 6.8 per cent from
due to prematurity, intrapartum related deaths 2022 to 2031. Some of the equipment used as medical
(including birth asphyxia) and neonatal infections. The devices to cure neonates heart or cardiorespiratory
report also suggests that Australia, Japan, Singapore, monitor, blood pressure monitor, pulse oximeter,
Korea, and China have reported around 2 deaths per X-Ray, CT scan, MRI nasogastric tube etc.
1,000 live births. Although the death rate in the US
is less than that in developing economies, it is still Indian context
significant, with 47 per cent of 2.4 million newborn
deaths (112,800) in 2019 recorded during the neonatal In a developing country like India, where there is
period. This is where the role of the medical devices for a high number of newborn deaths, both the domestic
neonates comes to the fore. and the global neonatal medical devices industry, has
seen a huge demand for their products. The rising
birth rate in the nation is additionally contributing to

30 NEONATAL DEVICES BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Innovations and The Central Drug Standard
transformations in technology Control Organisation
have tremendously helped in
providing advanced treatment (CDSCO) has brought up
the Indian Medical Device
and care to neonates Rules (MDR) which is also
improving their intact survival
posing challenges in the
especially, these last three Regulatory Affairs of Medical
decades.
- Dr Karthik Nagesh, Devices.
- Wilson Ponnian,
Chairman & HOD - Neonatal ICUs, Founder and MD,
Manipal Hospitals
nice Neotech Medical Systems

New technologies in the the growth of the neonatal medical devices sector.
respiratory support space Key factors driving the neonatal critical care
have already saved over 10,000
babies in India alone babies equipment market growth include growth in the
that would have had very poor incidence of neonatal jaundice, an increasing number
outcomes if such technologies of preterm births, and the introduction of innovative
had not been developed and equipment for use in the neonatal intensive care units
(NICU).
deployed in India.
- Nitesh Kumar Jangir, As per a report in Technavio, the neonatal and
prenatal devices market size in India is to grow by $4
Co-founder, InnAccel and Director, Critical Care billion. The report “Neonatal and Prenatal Devices
Market in India by Product and End-user - Forecast
We are passionate and Analysis 2022-2026” suggests that the market will
witness a YOY growth of 4.01 per cent in 2022 and a
about developing CAGR of 5.21 per cent during the forecast period.

life-changing The neonatal devices market in India is
fragmented, and the vendors are deploying growth
technologies strategies such as offering innovations and high-
quality products to compete in the market.
to help people,
According to the Technavio report, the rising
including incidence of preterm births is driving the neonatal
and prenatal devices market growth in India.
vulnerable infants, Premature babies are often associated with high
neonatal mortality, short- or long-term morbidity,
live better lives. - Payal Agrawal, and disabilities such as cerebral palsy, sensory
impairments, and others. According to the National
GM, Abbott’s Structural Heart Business in Neonatology Forum (NNF), 13 per cent of births in
India are premature births.
India and the Subcontinent
Nitesh Kumar Jangir, Co-founder, InnAccel and
The lack of skilled human Director, Critical Care opines, “Private companies are
resources, service delivery contributing to this sector by specialising in child and
maternal care and paving a path for the localisation
challenges, insufficient of medical devices for the Indian market. New-age
financial resources, and a lack startups with innovative technologies are entering the
pregnancy and labour monitoring space with highly
of community ownership differentiated products. Remote monitoring and
are the most significant cloud-enabled solutions from companies are helping
universalise ICU-grade physiological monitoring.
impediments to effective scale- Finally, new technologies in the respiratory support
up of neonatal interventions in space have already saved over 10,000 babies in India
alone, babies that would have had very poor outcomes
reducing NMRs. if such technologies had not been developed and
- Prof Dr R Kishore Kumar, deployed in India.”

Founder and Chairman, Cloudnine Group of Hospitals,
India and Senior Consultant Neonatologist at
Cloudnine Hospital, Bengaluru

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com NEONATAL DEVICES 31

Abbott, the global healthcare company, has Source: Technavio
launched its Amplatzer Piccolo Occluder in India,
the world’s first medical device that can be implanted wheelchairs. The company has a presence across 32
in the tiniest babies (weighing as little as 700 gms) countries in Africa, Europe, the Asia Pacific region,
using a minimally invasive procedure to treat patent South America and the Middle East.
ductus arteriosus or PDA. The Amplatzer Piccolo,
a device even smaller than a small pea, now offers The company recently launched Brilliance Pro, a
hope to premature infants and newborns who need phototherapy device to treat infants with jaundice.
corrective treatment, and who may be non-responsive The device has features to provide consistent intensity
to medicine and are at high risk to undergo corrective across the baby’s skin, regardless of the angle at which
surgery. the light head is oriented.

Says Payal Agrawal, GM, Abbott’s Structural Mumbai-based Zeal Medical, an ISO 13485
Heart Business in India and the Subcontinent, certified organisation, provides neonatal and
“We are passionate about developing life-changing paediatric intensive care equipment like radiant heat
technologies to help people, including vulnerable warmers, neonatal resuscitation units, intensive care
infants, live better lives. It is gratifying to know that infant incubators, high-intensity LED phototherapy
through our devices, these children have a chance at a systems, and non-invasive ventilation systems, smart
normal life and can live their fullest lives.” interfaces and consumables, resuscitation equipment,
resuscitation accessories and kits.
Researchers from the Indian Institute of
Technology (IIT) Jodhpur and Western Michigan Ernakulam-based Ibis Medical Equipment &
University, USA, have identified significant neonatal Systems is an Indian organisation established in the
and infant mortality predictors using multiple machine year 2008 and has been engaged in manufacturing
learning (ML) techniques. The study uses nationwide high-quality neonatology-focussed equipment.
household survey data from India. The primary The company has an R&D tie-up with the National
objective of this research was to identify early warning Institute of Technology, Calicut (NIT-Calicut). One
signs of child mortality that community health workers of the major products is LED Phototherapy machines
can use. which the company exports primarily to South Asia
and Africa.
Bengaluru-based Centre for Cellular and Molecular
Platforms (C-CAMP) has joined hands with SELCO Chennai-based Trivitron Healthcare was recently
Foundation, a sustainable technology foundation, conferred with the prestigious India Medical Device
to launch the pilot deployment of a long-supported Award under the India Medical Device Company of
portfolio technology in maternal and neonatal health the Year category at the 7th India Pharma and India
monitoring. The technology’s USP is non-invasive Medical Device Awards 2022, by the Department of
diagnosis and management of neonatal sepsis. The Pharmaceuticals under the Ministry of Chemicals &
deployment of this technology developed by C-CAMP Fertilizers, Government of India. The company is also
startup and former incubator Spotsense in the into the manufacturing of medical devices for neonates
tribal majority Sargur, Mysore district, Karnataka is and provides a wide range of newborn screening
expected to significantly improve these numbers and instruments, including modular and fully automated
make quality healthcare accessible to socially and NBS instrumentation, manual and automated
economically vulnerable communities. equipment and reagent kits.

Coeo Labs, an Indian medtech startup, designed Delhi-based startup iNICU Medical is on a mission
a neonatal CPAP system that can help reduce for early diagnosis of critical diseases and to improve
deaths due to Respiratory Distress Syndrome (RDS) the overall quality of healthcare being provided to
during neonatal transportation. Moreover, financial neonates. The team of Dr Harpreet Singh, Ravneet
assistance is being provided to local manufacturers Kaur and Dr Gautam Yadav have created a solution
in India as part of the government’s ‘Make in India’ that captures data from diversified devices connected
programme.

Chennai-based Phoenix Medical Systems is a
manufacturer of infant and maternal care products
and assistive devices. The Phoenix range of
maternal and infant care products includes warming
systems, jaundice management units, respiratory
care equipment and obstetric and gynaecological
tables. Phoenix also makes Smartcane, an electronic
travel aid, refreshable Braille readers and standing

32 NEONATAL DEVICES BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

LEADING PLAYERS OF to be ‘Notified’ while there are over 1000 medical
devices in the market yet to be added to the list. The
THE NEONATAL DEVICES MARKET delay and the initial phases of trial and error in the
process of perfecting the Indian regulatory system
Company Location for medical devices pose challenges to manufacturers
in more aspects rather than financial aspects in
Becton Dickinson and Co New Jersey, US particular.”

Cardinal Health Ohio, US Affordability issues are challenging the neonatal
and prenatal devices market growth in India. The cost
Dragerwerk AG and Co. KGaA Lübeck, Germany of NICU care per patient per day is $125 (Rs 5,450)
in India. Middle-class families find it difficult to bear
Fisher and Paykel Healthcare Auckland, New Zealand this cost. Hence, such devices are inaccessible and
Corp unaffordable in hospitals and primary healthcare
centres, especially in remote locations of the country.
General Electric Co New York, US
Despite the COVID-19 pandemic, the neonatal
Getinge Sweden medical sector was not that impacted. Though there
were delays and unreliability at the screening centres
Koninklijke Philips Amsterdam, Netherlands that hindered the market, the sector continued to
thrive at a high rate even with all the difficulties during
Masimo Corp California, United States the outbreak.

Medtronic Dublin, Ireland Says Prof. Dr R Kishore Kumar, Founder and
Chairman, Cloudnine Group of Hospitals, India
Vyaire Medical US and Senior Consultant Neonatologist at Cloudnine
Hospital, Bengaluru, “The lack of skilled human
Ibis Medical Equipment Ernakulam, Kerala resources, service delivery challenges, insufficient
& Systems financial resources, and a lack of community
ownership are the most significant impediments
Zeal Medical Mumbai, Maharashtra to effective scale-up of neonatal interventions in
reducing NMRs. Due to gaps in the public health
Trivitron Healthcare Chennai, Tamil Nadu sector’s coverage and quality of services, the rural
population still seeks healthcare from informal health
iNICU Medical New Delhi care providers (IHCPs). Not only this, but there are
numerous medical errors due to which neonatal care
Medical devices used in neonatal care is affected. For instance, the amount of drug dosage is
different for babies and children, since the babies are
● Heart or cardiorespiratory monitor given their doses according to their weight.”
● Blood pressure monitor
● Pulse oximeter The way forward
● X Ray
● CT scan Dr Karthik Nagesh, Chairman & HOD - Neonatal
● MRI nasogastric tube ICUs, Manipal Hospitals & Manipal Advanced
● Nasogastric tube or orogastric tube Children’s Centre, Manipal Hospital Old Airport
● Endotracheal tube Road, Bangalore mentions, “Innovations and
● Respirator or mechanical ventilator transformations in technology have tremendously
helped in providing advanced treatment and care to
to the preterm infant and provides a well-structured neonates improving their intact survival especially,
user interface for the medical staff to perform these last three decades.”
calculations for prescriptions, nutrition, and neonatal
scores. The iNICU cloud platform also integrates According to Grand View Research, increasing
laboratory results, and bedside clinical observations. government initiatives in developing countries such
as India are favouring the growth of the market in the
Challenges Asia Pacific. Opportunities are more for medical device
companies in a country like India, however, the pricing
India imports more than 70 per cent of medical of these devices can be a deterrent for many as the
devices, which are not only too expensive to buy and question of affordability comes into our minds.
operate but also misaligned with the infrastructure
and HR availability in low-resource settings. The Sanjiv Das
situation is even worse in the neonatal care space, due [email protected]
to the super-specialised nature of the field, which has
restricted the product offerings available to the Indian
market. This has led to the non-availability of essential
diagnostic and treatment interventions for newborns,
in resource-constrained settings in India and globally.

Wilson Ponnian, Founder and MD, nice Neotech
Medical Systems said, “The Central Drug Standard
Control Organisation (CDSCO) has brought up the
Indian Medical Device Rules (MDR) which is also
posing challenges in the Regulatory Affairs of Medical
Devices. Only very few devices have been announced

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com SPEAKING WITH 33

“To address talent supply crunch,

we should devise a ‘Buy & Build’

pipeline for designer profiles”

As an industry leader and ecosystem builder, «
Cytiva has been supporting the Indian
biotechnology industry for more than 30 Benjamin James,
years by forging close collaborations between the
industry, government and academia. In a follow HR Business Partner,
up to the comprehensive Cytiva Global Biopharma
Resilience Index launched last year, this year’s Asia-Pacific,
study, which focuses on government policy and
regulation and its impact on the resilience of the Cytiva
global biopharma system, reveals a bright spot in
India. BioSpectrum India spoke to Benjamin James, means export of talent is limited by geographical
HR Business Partner, Asia-Pacific, Cytiva to unearth location. The exposure of talent to manufacturing
what’s happening in the Indian biopharma sector in processes has limited reach. On the contrary, today’s
terms of newer job opportunities. Edited excerpts; biopharma industry gains significantly from talent
who have Goods Manufacturing Process (GMP)
What is the current ‘Talent Crunch’ scenario experience. This poses a real issue of manufacturing
in the biopharma sector in India? exposure and ecosystem crunch.

According to Cytiva’s 2021 Global Biopharma The ones who sell and service are part of the
Resilience Index, the talent pool is the weakest pillar commercial arm of the company. This group is
globally in the biopharma industry. In the same generally a tenured one, and show a lot of longevity
vein, India scored 6.15 out of 10 in the talent pool with their current company. Talent exchange here is
pillar, making it one of the weakest results in Asia limited.
compared to Singapore, South Korea, China, Japan
and Australia. 65 per cent of respondents in India With the rising demand in the biopharma
have pointed out that it is challenging to find R&D sector, how can we manage this talent crunch
and manufacturing talent in the country, with only 35 in India?
per cent & 41 per cent of them respectively thinking
that it’s not a challenge to recruit in those areas. In summary, we have three different types of
talent crunch in the biopharma sector a) talent supply
When we dissect the talent into three categories, crunch b) manufacturing exposure and ecosystem
we will be able to see the issue closer. The three talent crunch and c) diversified talent pool crunch. To
categories would include a) the ones who design address the talent supply crunch, we should devise a
solutions b) the ones who make solutions and c) “Buy & Build” pipeline for the designer profiles. To
the ones who sell and service. Additionally, we have tackle exposure and ecosystem crunch, we should
two groups of companies - a) manufactures and b) apply a “Collaborate & Exchange” strategy between
suppliers. industries. To address “diversification crunch”, we
should scale partnership with academia to “Promote
The ones who design solutions are part of the & Prepare” science, technology, engineering, and
Research / Engineering / Digital arm of the company mathematics (STEM) enthusiasts towards the
and the competition for talent here is enormous. We industry.
often need to apply the “BUY” strategy as “BUILD”
from within takes time. We also need to look at two ways of approaching
this strategy – what we can do externally for the
The ones who make the solutions are part of the industry as an ecosystem builder, and what we can do
manufacturing arm of the company. This is clearly internally as an employer to attract and retain talent.
an area where we lack exposure and capability.
The manufacturing hubs of India’s biopharma India’s biotechnology industry, estimated to reach
industry exist in concentrated pockets today. This

34 SPEAKING WITH BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

To manage the talent crunch in India, the
biopharma industry needs diversified talent – not
only Chemistry and Biology graduates
– but also graduates specialising
in digital transformation and
automation. Another area where the
talent inflow can be supplemented
is through R&D and innovation. As
the Biopharma industry continues
to evolve, it increases the demand
to develop a pool of skilled workers.

$150 billion by 2025, expects to see the number of world-class institution that now has 100+ scientists
emerging biotech companies boom from 3,475 to and 110 patents. This is a flagship facility for
more than 10,000. attracting world-class talent.

To manage the talent crunch in India, the Our associates in India are all working on global
biopharma industry needs diversified talent – not projects. For example, in 2020, our India R&D centre
only Chemistry and Biology graduates – but also contributed to our global technology innovation - the
graduates specialising in digital transformation and Xcellerex Automated Perfusion System for a more
automation. Another area where the talent inflow can efficient manufacture of biotherapeutics.
be supplemented is through R&D and innovation.
Cytiva brings a strong focus on people through
As the Biopharma industry continues to evolve, process. There are several in-house learning and
it increases the demand to develop a pool of skilled development programmes to coach, train, mentor,
workers. Process development and manufacturing and ultimately develop talent with opportunities that
operations are two major areas of skill development vary from on-the-job, classroom and community
in India. There is a growing focus on niche drugs for learning.
smaller patient populations. The industry is moving
from making one antibody with huge investment in How are you deploying AI technology to train
one plant to multi-product facilities.
the workforce in India?
This change brings the need for new skills. They
include, but are not limited to: Training personnel creates fundamental
 Technical support operations for both upstream challenges in bioprocessing. These challenges include
limitations in access to the equipment and trainers,
and downstream manufacturing as well as global and regional barriers. In search of
 People who can facilitate both design and transfer a solution, experts at Cytiva have turned to virtual
reality. This virtual training platform reduces costs
process and provides a more flexible training schedule and
 Large / Small scale column packing learning environment to the workforce in India.
 Cell and Gene therapy technology
 Automation and digital Although this example of how we leverage new
 Working GMP (Good Manufacturing Process) technology is not exclusive to India, this virtual-
reality system can train our customers in India
knowledge without having them shut down commercial
 System Integration production or maintain equipment used only for
training.
How are you ensuring that the right talent
Besides training, another example of how we
is being onboarded, as per international use technology to engage with incoming staff is
through the Enboarder onboarding app. The pilot
standards within India? was launched in India to engage new joiners prior
to their start date. Bite-size onboarding activities
Cytiva India is a microcosm of global Cytiva. include introducing the new joiner to their manager,
India houses talent across all functions – R&D, introducing them to the company culture and asking
Digital, Marketing, Sales, and Services. This gives them about their concerns and what they like.
India Cytiva the unique advantage of hiring diverse
talent groups. Most of these talents work with Dr Manbeena Chawla
global stakeholders, hence the hiring standards [email protected]
automatically level play with international standards.

Cytiva India’s R&D centre, founded in 2008, is a

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com BRANDED VS GENERICS 35

Epic Battle of Branded Vs Generics

It is commonly understood that every issue «
has two sides, and the truth lies somewhere in the
middle. When it comes to healthcare, we typically Gauri Chaudhari,
hear one side of the narrative: branded generics are
blamed for higher costs of medicines and unethical Healthcare Marketing
pharma practices. On May 23, the National Medical
Council (NMC) proposed draft guidelines to doctors. and Branding Expert
The guidelines insist that the doctors must prescribe
medicines ONLY by generic names and encourage get kickbacks from pharma companies? It is essential
patients to buy medicines from JanAushadhi stores. to understand that doctors’ source of income is
They’ll be penalised if they don’t. patients and not pharma companies. If patients were
unhappy, doctors would see empty waiting rooms,
About 90 per cent of India’s Rs 1,83,000 crore and pharma companies would stop meeting them. So,
pharma market comprises branded generics. the patient is always the priority of the doctors.
Numerous branded generics, such as Dolo, Limcee,
Human Mixtard, or Razo, are now household Another common notion is that all generics of
names. There is a growing belief that branded the same medicines are the same. Branded Generics
generics are the reason behind higher healthcare differ in many ways: Source of the API, its form,
costs in India, and forcing doctors to prescribe adjuvants, dosage form, manufacturing process,
generics is the solution. Let’s dig deeper. packaging, offers on the brand, unit price, supply
chain SOPs, quality checks, beyond pill services,
Are branded generics the healthcare industry’s so on and so forth. Clearly, the value provided is
villains? If this is the case, why have branded different for each brand.
generics been around for decades in India and
dozens of other countries? Patients, too, have different requirements
depending on their psychographic, occupational, and
In my opinion, generics, branded generics and financial needs. Doctors look at the value offered by
patented brands must co-exist in the country to keep brands and match them to the requirements of the
India healthy. To know why let’s focus on the other patients.
side of the story and the prevalent narratives.
Doctors trust some brands more than others
Branded generics drive up based on experience. When prescribing generic
the cost of Indian medications drugs, they don’t know which company’s generic
will be given to the patient. How can they take
Medicine prices in India are amongst the lowest in responsibility for the outcome? Would that not put a
the world. The most recent data shows that roughly strain on patient-doctor relationships?
11 per cent of India’s medicines cost less than Rs 6.
India’s average cost of pharmaceuticals is 70 per cent Branded generics are expensive because
less than the global average. However, medications they are marketed with high promotional
are expensive for Indians because, in contrast to expenses
other countries, medicines are an out-of-pocket
expense for Indians. The other factor is that Indians One of the arguments against branded generics is
spend about 28 per cent of their healthcare expense that they spend huge money on promoting branded
on medications, compared to the global average generics. This amount is similar to every other
of 15 per cent. Do the doctors overprescribe in industry: around five to 20 per cent of revenue.
India? This is a debatable topic. Experts must come
together to create treatment algorithms specific to Many believe that brands spend money sending
Indian patients. But, banning branded generics is no doctors on foreign trips or giving them heavy
solution to over-prescription if it exists. incentives. This is a sweeping generalisation.
Neither all brands nor all companies indulge in these
Even when cheaper alternatives exist, practices. Yet those who indulge in these practices
doctors prescribe expensive medicines must stop them STAT. Stringent implementation
of Uniform Code for Pharmaceuticals Marketing
Why can’t doctors prescribe generics from
JanAushadhi? Do they prescribe branded generics to

36 BRANDED VS GENERICS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Medicine prices in India are amongst the New scenario
lowest in the world. The most recent data
shows that roughly 11 per cent of India’s Let’s assume NMC and the policymakers ban the
medicines cost less than Rs 6. India’s prescription of branded generics. What impact will it
average cost of pharmaceuticals is 70 have on the healthcare ecosystem?
per cent less than the global average.
However, medications are expensive for Pharma companies: It will not change
Indians because, in contrast to other anything for pharma companies. Instead of selling
countries, medicines are an out-of-pocket medicines as an individual brand, they will promote
expense for Indians. The other factor is them under the corporate brand. Instead of calling
that Indians spend about 28 per cent of the insulin brand, Mixtard, they will call it Insulin by
their healthcare expense on medications, Novo Nordisk. They will continue to price it higher to
compared to the global average of 15 support their investments to create brand value. So
per cent. Do the doctors overprescribe in technically, nothing much would change.
India? This is a debatable topic.
Yes, one will see many pharma corporate ads in
Practices (UCPMP) and not banning branded the media to win doctors’ and patients’ trust for the
generics is the need of the hour. generics from the corporate house. This will further
increase promotional expenses leaving lesser money
Take Human Mixtard, a brand of insulin for for R &D and innovation.
diabetics, which is the No. 1 selling branded generic
in India. The brand has been investing heavily to Physicians: In India, there is a strain on patient-
improve patient outcomes. Insulin is a temperature- doctor relations, who are solely held responsible for
sensitive medicine. To ensure Mixtard remains patient outcomes. Now doctors would need to bear
effective despite soaring temperatures in the country, responsibility for the generic whose manufacturer
the company invested heavily in cold chains from they wouldn’t know. To avoid this issue, physicians
manufacturing plants to last-mile delivery. The brand may prescribe a generic and orally recommend the
invested significantly in color-coding packaging company whose generic the patient should buy.
to ensure that neither boy at the chemist shop nor
the caregiver at home would mix up the doses. In India, we don’t have electronic medical
The brand Mixtard supports counseling diabetics records. Doctors rely on patients to understand their
through human and AI-based counselors. Would treatment history. Compared to brand names, generic
JanAushadhi generic manufacturer of insulin, make names are tongue-twisting and expecting patients to
such investments? remember them without any mistake is too much of
an ask.
Branded generics invest in patient outcomes. Free
patient camps, disease awareness initiatives, patient Chemists: The responsibility of the chemist
education etc., have improved the country’s diagnosis increases many folds in the generic prescription
and treatment of many chronic diseases. world. We do not have an adequate number of
qualified chemists. The impact on the healthcare
Branded generics also contribute to doctors’ environment is easy to foresee.
continuous medical education (CMEs). Patients are
the ultimate beneficiaries of these activities. Quality inspectors: The burden on the quality
inspectors would increase immensely. There must
Of course, these promotional initiatives help the constantly be checks on the quality. Is the quality of
pharma companies get prescriptions, but they create the generic consistent with every batch? Is a good
an ultimate win-win for all the stakeholders. manufacturing process (GMP) being followed? India
has a considerable burden of counterfeit medicines.
How will the scenarios unfold? A larger debate is
needed on this issue.

Patients: Consumers all over the world are
switching from commodities to brands. Be it clothes,
food or education. Why should this trend be reversed
in healthcare? Will patients accept the new norms?

So instead of depriving Indians of branded
generics, the policymakers should empower patients
by giving them a choice. Patients can make their own
decisions depending on their needs and priorities.

Branded generics exist for a reason in India and
several other developing countries. We would throw
the baby out with the bath water if we eliminated
branded generics from the country.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com R&D NEWS 37

Study analyses IIT Guwahati designs
affordable prosthetic leg
movement of
Researchers at the Indian Institute of Technology (IIT)
speech aerosols for Guwahati have developed a prosthetic leg specifically
designed for Indian conditions. It is suitable for uneven
virus transmission terrain and supports Indian needs such as cross-legged
sitting, and deep squatting. It is also adjustable for the
When a person sneezes or coughs, they different age groups and multiple stages of prosthesis use.
can potentially transmit droplets carrying This research was funded by the Ministry of Education,
viruses like SARS-CoV-2 to others in Government of India and the Department of Biotechnology,
their vicinity. Does talking to an infected Government of India. IIT Guwahati researchers collaborated
person also carry an increased risk of with 151 Army Base Hospital, Guwahati, Tolaram Bafna
infection? To answer such questions, a Kamrup District Civil Hospital, Guwahati, Guwahati
research team has carried out computer Neurological Research Centre (GNRC), North Guwahati,
simulations to analyse the movement of and North Eastern Indira Gandhi Regional Institute of
the speech aerosols. The team includes Health and Medical Sciences (NEIGHRIMS), Shillong.
researchers from the Department of Prototypes of models developed by this research team
Aerospace Engineering, Indian Institute are currently undergoing trials. A methodology is being
of Science (IISc), along with collaborators developed to fit a 3D-printed test socket which is verified
from the Nordic Institute for Theoretical using computer analysis.
Physics (NORDITA) in Stockholm and
the International Centre for Theoretical
Sciences (ICTS) in Bengaluru. The
team visualised scenarios in which two
maskless people are standing two, four
or six feet apart and talking to each other
for about a minute, and then estimated
the rate and extent of spread of the
speech aerosols from one to another.
Their simulations showed that the risk
of getting infected was higher when one
person acted as a passive listener and
didn’t engage in a two-way conversation.

IIT-D reveals mechanisms driving
SARS-CoV-2 evolution in humans

A team of researchers at the (and other RNA viruses) and host immune response, thus
Indian Institute of Technology- recruits other host proteins to allowing better virus replication
Delhi (IIT-D) has discovered the degrade the viral RNA. Several and survival. The team analysed
existence of temporal variations in viruses including HIV-1, Influenza over 1.4 million full-length SARS-
selection pressures during SARS- A virus and SARS-CoV-2 prefer CoV-2 sequences from across the
CoV-2 evolution and adaptation to to reduce their CpG content (by world. They found that the rate of
the human host. CpG (or CG; i.e. losing CpGs) to minimise the CpG depletion from SARS-CoV-2
a cytosine followed by a guanine) genomes rapidly decreases after
numbers in virus genomes has the first few months of evolution
been linked to host-switching, in humans. Furthermore, most
efficiency of virus replication, SARS-CoV-2 variants of concern
immune evasion and the ability had lower CpG content. This
of a virus to cause disease. Zinc- work highlights the existence of
finger antiviral protein (ZAP), selection pressures apart from ZAP
a host protein that can bind to that may lead to CpG depletion in
CpG-rich regions in SARS-CoV-2 SARS-CoV-2 genomes.

38 R&D NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

IIT-M’s AI tool Indo-US team deploys 3D-printing
for nanoparticle coated N95 mask
identifies
Researchers from Amity University Haryana (AUH) and the University
cancer-causing of Nebraska, US, have developed a reusable, recyclable, washable,
odourless, non-allergic and anti-microbial N95 mask by using 3D
genes using printing technology. The four-layer mask whose outer layer is made
up of silicon has a shelf life of more than five years depending upon
‘supervised the use. The mask can be modified according to the requirement by
changing the filter configuration according to the place in which it will
learning’
be used and can help prevent
Indian Institute of Technology severe lung diseases such as
-Madras (IIT-M) researchers SILICOSIS. A trademark and
have developed an Artificial a patent have also been filed
Intelligence (AI) based tool, for the mask called Nano
‘PIVOT’, that can predict cancer- Breath. A 4-layer filtration
causing genes in an individual. mechanism has been provided
This tool will ultimately help in in the mask wherein the outer
devising personalised cancer and first layer of the filter is
treatment strategies. PIVOT is coated with nanoparticles. The
designed to predict genes that second layer is a high-efficiency
are responsible for causing particulate absorbing (HEPA)
cancer in an individual. The filter, the third layer is a 100
prediction is based on a model µm filter and the fourth layer is a moisture absorbent filter. A Zetasizer
that utilises information on Nano ZS, a facility supported by the ‘Fund for Improvement of Science
mutations, expression of genes, & Technology Infrastructure’ (FIST) project of the Department of
and copy number variation Science & Technology (DST), Government of India which enables
in genes and perturbations in high-temperature thermal analysis for ceramic materials and
the biological network due to catalysis applications, has been used to carry out this work. It is a
an altered gene expression. high-performance, versatile system for measuring particle size, zeta
The tool is based on a machine potential, molecular weight, particle mobility and micro-rheology.
learning model that classifies
genes as tumour suppressor IISc uses GPUs to study
genes, oncogenes or neutral human brain connectivity
genes. The tool was able to
successfully predict both A new graphics processing unit (GPU)-based machine learning
the existing oncogenes and algorithm developed by researchers at the Indian Institute of Science
tumour-suppressor genes like (IISc), Bengaluru can help scientists better understand and predict
TP53, and PIK3CA, among connectivity between different regions of the brain. The algorithm,
others, and new cancer-related called Regularised, Accelerated, Linear Fascicle Evaluation, or ReAl-
genes such as PRKCA, SOX9 LiFE, can rapidly analyse the enormous amounts of data generated from
and PSMD4. Although there diffusion Magnetic Resonance Imaging (dMRI) scans of the human
are tools available to identify brain. Using ReAL-LiFE, the team was able to evaluate dMRI data over
personalised cancer genes, they 150 times faster than existing state-of-the-art algorithms. The improved
use unsupervised learning and algorithm, ReAl-LiFE, was also able to predict how a human test subject
predict based on presence and would behave or carry out a specific task. In other words, using the
absence of mutations in cancer- connection strengths estimated by the algorithm for each individual,
related genes. the team was able to explain variations in behavioural and cognitive
test scores across a group of 200 participants. Such analysis can have
medical applications too. Data processing on large scales is becoming
increasingly necessary for big-data neuroscience applications, especially
for understanding healthy brain function and brain pathology.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com PARTNER CONTENT 39

UPES School of Health Sciences
designated as ADR Monitoring Centre

Adverse Drug Reaction (ADR) is one of the leading

causes of mortality and morbidity across the globe

and a particular health risk in a diverse country
like India which has different disease patterns and
practising systems of medicine

World Health Organisation defines Adverse Drug Pharmacovigilance Programme of India plays a vital role in
Reactions (ADR) as “any response to a drug ADR data collection and follow-up of ADR reports from the
which is noxious and unintended which occur patients. They are responsible for collecting information
at doses normally used in humans for prophylaxis, related to ADR from patients, performing follow-ups with
diagnosis and treatment of the disease or the modification them, checking the completeness of the ADR reports as
of physiological functions”. It is one of the leading causes per Standard Operating Procedures (SOPs), entering the
of mortality and morbidity across the globe. The severity ADR information in the recommended software ‘Vigiflow’
and incidence of ADR vary by patient characteristics (like and providing the information to the NCC-PvPI with the
age, sex, genetic or environmental factors) and by drug- same software. AMCs also provide training and technical
related factors (like dosage form, route of administration, support as well as pharmacovigilance education to create
treatment duration, and bioavailability). awareness related to patient safety and improve ADR
reporting culture in India.
India is a diverse country with different disease
patterns and practising systems of medicines. Because School of Health Sciences and Technology, UPES, was
of this Indian population encounters ADRs that could be designated as Adverse Drug Reaction Monitoring Centre
entirely different from other parts of the world. Therefore, by National Coordinating Centre-Pharmacovigilance
it is imperative to evaluate drug safety scientifically by a Programme of India (NCC-PvPI) on December 7, 2021.
highly specialized system known as “Pharmacovigilance”. The objectives of UPES-AMC centre are:
• To be a part of a nationwide system for patient safety
The Central Drugs Standard Control Organisation
(CDSCO), New Delhi, under the aegis of Ministry of reporting.
Health & Family Welfare, Government of India has • To collect, detect and analyze ADR reports.
initiated a nation-wide pharmacovigilance programme in • To provide training to the healthcare professionals
July, 2010, with the All India Institute of Medical Sciences
(AIIMS), New Delhi as the National Coordinating Centre about ADR reporting and monitoring.
(NCC) for monitoring ADR in the country to safe-guard • To create awareness among people about safety
Public Health. In year 2010, 22 ADR monitoring centres
(AMCs) including AIIMS, New Delhi had been set up reporting of ADR.
under this Programme. To ensure implementation of • To assess causality of each adverse event reported at
this programme in a more effective way, the National
Coordinating Centre was then shifted from the All India our AMC centre.
Institute of Medical Sciences (AIIMS), New Delhi to the • To investigate the benefit-risk ratio of marketed
Indian Pharmacopoeia Commission (IPC), Ghaziabad,
(U.P.) in April, 2011. medications and create evidence-based information
on medicine safety.
The mission of PvPI is to safeguard the health of the • To perform follow up with the complainant to check
Indian population by ensuring that the benefit of use of completeness as per SOPs (standard operating
medicine outweighs the risks associated with its use. procedures) given by NCC-PvPI.
Since there exist considerable social and economic • To perform ADR data entry into Vigiflow database with
consequences of adverse drug reactions and the the source data (original) attached with each ADR
positive benefit/cost ratio of implementing appropriate case.
risk management, there is a need to engage healthcare • To develop as centre of excellence for
professionals and the public at large, in a well-structured Pharmacovigilance events and collaborate with other
programme to build synergies for monitoring adverse centres (national) for the exchange of information and
drug reactions in the country. data management.

Pharmacovigilance (PV) plays an important role in the
healthcare system through assessment, monitoring and
discovery of interactions amongst drugs and their effects
on humans. The Adverse Drug Monitoring Centre under the

40 PARTNER CONTENT BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Leading Specific
Protein Testing in India

« equipment, the semi-automated nephelometry cum
photometry device, Mispa i2, with new channel
Thomas John, shifting technology, was launched. In terms of quality,
Managing Director, the system is on par with comparable automatic
Agappe Diagnostics nephelometry machines thanks to its 26 parameter
testing procedures. The Mispa i2 machine has
Agappe takes pleasure in its innovations and an innovative and sophisticated smart card pre-
introduces the most cutting-edge technology while calibration system with built-in controls for stable
retaining economy in prices. The purpose of Agappe open vials.
is to contribute significantly to national efforts to
achieve the millennium goals of “Health for All” by The classic latex method was superseded by the
offering diagnostic tools that are state-of-the-art in Mispa i-Series by Agappe with the combination of
terms of technology, excellent, and affordable, under Nephelometry & Immunoturbidimetry Technology,
true Atma Nirbhar Initiative of our Government. offering a broad measurement range with great
sensitivity and superior linearity at an affordable
Adecade ago, the conventional visual latex price. The dual measuring technology (rate based
approach was used to estimate particular nephelometry and immunoturbidimetry) with
proteins in close to 35 per cent of cases, the unique patented technology -UCS (Unique
with all its limitations. The tests used in latex are Channel Shifting) makes Mispa i2 different from
qualitative and semi-quantitative. There was always other conventional nephelometers. With this, most
a degree of ambiguity in the results in the borderline medium-sized labs and many lower-end labs in
regions of the reference ranges because of this rural India could own protein testing equipment
latex testing limitation. Rural residents could afford with smaller reagent pack sizes, which is apt and
these tests, but because of their low specificity affordable and appropriate for their lower daily
and sensitivity, the tests’ intended purposes were workload. With its novel channel shifting method,
frequently missed. Previously, over 35 per cent of Mispa i2 has developed a patented technology with
protein estimations were carried out in completely or more than 10,000 successful installations across the
partially automated turbidimetry tests at a relatively world as on today.
high cost of the automated instruments, reagents,
and consumables. Nephelometry, the best methods Mispa-i2
for protein testing, was unreachable to the common
laboratories because of the very high cost of the
automated instruments, reagents, and consumables.

With the motive to provide high quality protein
estimation at affordable cost Agappe introduced
i-series of nephelometry instruments, starting with the
Mispa-I in 2011 and using a highly aggressive pricing
strategy for protein analysis. Then, at a price that
was 1/10th of the price of then-current automated

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com PARTNER CONTENT 41

Mispa-i2, the semi-automated specific protein osteoporosis screen profile, etc. The use of many
analyser offers high precision and quick turnaround test profiles enables clinicians to detect disease
results, for all protein assays in blood testing, very relatively quickly and track patients’ progress. Mispa
easy to operate. Mispa i2 offers a wide assay i3 nephelometry equipment is relatively affordable for
panel of 26 parameters and supports the clinical medium- or lower-end labs with light workloads.
management of variety of diseases such as diabetes,
Cardiovascular risk, Inflammation, etc. Mispa i2 Cystatin C is a better marker than enzymatic
is a purely Indian made product, which helps in creatinine, which helps to find early kidney failures.
quantitative specific protein estimation using a Cardiovascular risk profile includes high-sensitivity
combination of the gold standard nephelometry and C-reactive protein (hs-CRP), lipoprotein (a), D
turbidimetry methodologies. Hence the analyser Dimer, Apo A1, Apo B. Diabetic Profile includes
has 2 detectors namely, nephelometry detector and HbA1c and Microalbumin tests which can be easily
turbidimetry detector. Rate based nephelometry estimated without any calibration at an affordable
method offers high sensitivity and immunoturbidimetry cost. Increased or decreased levels of CRP, RF,
method offers high linearity. Thus, the dual measuring ASO, Ferritin, PCT, C3, C4 due to infections or
technique offers wide measuring range and ensures inflammation, by dint of viral or bacterial responses
accurate results at all protein concentrations, providing can be easily estimated with the advanced UCS
best sensitivity and high linearity which ensures quality Technology used in Mispa i3. Due to the Immune
results, with minimal interferences. responses in the body, elevated levels of IgG, IGA,
IgE and IgM can be performed in Mispa i3 with zero
In 2015, Agappe released cartridge-based reagent wastage and least reporting time.
revolutionary technology in the nephelometry device
Mispa i3, and the Indian market has received 2500 New generation instrument automation with
successful installations of Mispa i3, while the global an affordable cost and convenient pack sizes for
market has received another 2500 installations. all special parameters differentiate Mispa i3 from
This intelligent system is again built on smart cards, other instruments. Mispa i3 distinguishes itself from
and each cartridge pack includes a pre-calibrated other instruments with new generation instrument
smart card. Total, there are currently 70 countries automation, with an inexpensive price, and simple
and 15,000 Mispa i-series (Mispa-i, Mispa-i2, and pack sizes for all unique reagent parameters, suitable
Mispa-i3) devices operating across the Indian for our medium and low workload labs.
continent.
With automation decreasing manual errors and
Agappe introduced numerous special parameters reporting in 5 minutes, Mispa i3 quickly became
in protein testing with Mispa i3 as a strategy to the market leader in particular protein testing and
disseminate testing of advanced parameters in the clients’ top choice for protein estimate. Agappe
medium and lower end labs, including Vitamin-D, intends to release Mispa i3 Plus with cloud-based
cardiovascular risk profile, allergy profile, COVID technology so that we may get calibration data from
profile, diabetic profile, rheumatology profile, the cloud and execute various application-level
modifications online. Agappe can provide improved
Mispa-i3 online support for optimal equipment maintenance
thanks to cloud-based technology. Let’s work
together to help humanity by offering high-quality
goods that will guarantee precise and trustworthy
outcomes for quicker diagnosis and treatment.

Agappe would prefer to provide access to high-
quality healthcare at affordable prices for Indians
living in rural areas and in neighbouring developing
countries by putting a priority on technology
improvement, without diluting quality, an inch. Thanks
to scaled-up manufacturing capabilities, Agappe
takes pleasure in its innovations and introduces
the most cutting-edge technology while retaining
economy in prices. The purpose of Agappe is to
contribute significantly to national efforts to achieve
the millennium goals of “Health for All” by offering
diagnostic tools that are state-of-the-art in terms of
technology, excellent, and affordable, under true
Atma Nirbhar Initiative of our Government.

42 ACADEMIA NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Apollo Hospitals Group introduces
International Clinical Fellowship Programme

Apollo Education UK (AEUK) will clinical learning. At the same a Master of Surgery or Master
launch the Apollo International time as gaining this international of Medicine degree at Edge Hill
Clinical Fellowship Programme work experience in an area of University. The Apollo ICFP is
(ICFP) 2022, as a part of its speciality, doctors will study for carefully structured to ensure
Global Workforce Development that doctors get mentorship,
(GWD) initiative. Over the world-class specialist clinical
three-year ICFP programme, exposure and hands-on
doctors (MS/MD/DnB) can experience in providing the
‘earn as they learn’, receiving highest standards of healthcare.
mentorship from senior doctors The programme is a collaboration
at Apollo Hospitals, India, in a between AEUK, Global Training
preparatory year to aid transition and Education Centre (GTEC)
into NHS clinical practice before at Wrightington, Wigan and
being placed in a UK hospital Leigh Teaching Hospitals NHS
for the next two or more years, Foundation Trust, and Edge Hill
where they can complete their University, UK.

IIT Jodhpur, IIT-H, LVPEI
announce MTech in
iHub Drishti ophthalmic engineering

Foundation offer Centre for Interdisciplinary Program (CIP), Indian
Institute of Technology, Hyderabad (IIT-H), in
MTech in AR & VR collaboration with the LV Prasad Eye Institute
(LVPEI), is launching a blended Master of Technology
The Indian Institute of Technology (IIT) (MTech) programme in Ophthalmic Engineering
Jodhpur, in collaboration with iHub Drishti through their combined expertise in ophthalmic care
Foundation, the Technology Innovation Hub and engineering and technology from this academic
(TIH) at IIT Jodhpur, is starting a new part-
time online MTech programme with campus year (August 2022). The
immersions for working professionals in collaborative MTech
Augmented Reality (AR) and Virtual Reality programme aims to
(VR) for the semester commencing 2022- bridge the gap between
23. Students will be provided hands-on clinicians and medical
experience in the latest, state-of-the-art AR/ practitioners working in
VR tools available at the institute. At the end eye care with qualified
of the programme, a student is expected to technologists from
have a knowledge of working principles of related engineering
game design, medical applications, amongst streams. The programme
others. The main objectives of the programme intends to create a pool of qualified ophthalmic
are to produce competent engineers who can engineers who could take up the pressing challenges
design and develop AR and VR applications; to in eye care and develop technology products. This
impart in-depth knowledge, and analytical and unique, promising programme is expected to create
experimental research skills to solve AR and professionals who can take up technology challenges
VR systems problems; to provide knowledge in ophthalmology as a startup. The programme is
of several tools for the design and modelling ideal for medical school graduates, ophthalmologists,
of AR and VR applications and immersive optometrists, and engineers interested in advancing
experiences; and to develop the ability to their careers in areas of technology-enabled eye care
cultivate technological solutions for addressing and vision science.
the growing demands of AR and VR systems.

Corning Life Sciences provides
a full range of innovative solutions

Cell Culture • Drug Discovery • Genomics • Microbiology • Chemistry

India t 91 124 4604000 f 91 124 4604099 [email protected]

44 AWCAADREDMSICS NEWS BIOSPECTRUM | AUGUST 20221 | www.biospectrumindia.com

2

1 3

1. Ravindra Boratkar, Managing Director, MM Activ Sci-Tech Communications
Private Limited receiving the Runner-up award in the category “The
Knowledge Hub” for organising the Bengaluru Tech Summit.

2. Ravindra Boratkar, Managing Director, MM Activ Sci-Tech
Communications Private Limited receiving winner’s award in the ‘The Big
Show’ category for organising Agrovision India.

3. MM Activ Group company Asian Convention & Exposition Private
Limited’s team receiving Runner-up award in Merit- Corporate Category
for ‘CIDCO Exhibition & Convention Centre’.

MM Activ bags recognition for exhibition excellence

MM Activ Sci-Tech Communications Private a common platform for the farmers, industry, and
Limited received 3 outstanding awards at the 6th government and bring together every important
edition of Exhibition Excellence Awards (EEA) entity in agriculture to create a better future for the
ceremony held on July 8, 2022 at the India Expo farmers. The vision of Agrovision is to create a more
Mart, Greater Noida. After a gap of two years, the knowledgeable, practical and a smart famer.
EEA came back in physical format in 2022. Over
500 exhibition organisers, trade & professional Another Runner-up award was bagged by MM
associations, trade bodies, corporate heads, venues Activ Group company Asian Convention & Exposition
and meeting, incentive, convention, and exhibition Private Limited in Merit- Corporate Category for
(MICE) stakeholders attend the event. ‘CIDCO Exhibition & Convention Centre’ during
the ceremony. Built on a sprawling 2,00,000 sq.ft.
MM Activ won a Runner-up award in the area, the centre has two large halls for exhibition and
category “The Knowledge Hub” for organising the 1,50,000 sq.ft. convention centre. Both the exhibition
Bengaluru Tech Summit, on the basis of a number and business centres are connected by a bridge.
of conference sessions held at the exhibition Innovatively designed at par with international
between January 2020 and March 2022. Bengaluru standards, the centre sports an aesthetic and
Tech Summit is an initiative by the Department of attractive view.
Information Technology, Biotechnology and Science
& Technology, Government of Karnataka, Software The award was accepted by Ravindra
Technology Parks of India (STPI) Bengaluru. Boratkar, Managing Director, MM Activ Sci-Tech
Jagdish Patankar, Executive Chairman, MM Activ Communications Private Limited. He said, “These
Sci-Tech Communications has been playing a key awards serve as a recognition for hard work that goes
role in curating this event along with the Karnataka into organising and planning large-scale events. Our
government. Currently, in its 25th year, Bengaluru commitment to continue producing high-caliber work
Tech Summit has emerged as Asia’s most prestigious has increased as a result of receiving three awards.”
and sought-after technology event.
In the last 20 years, since its inception, MM
Adding more feathers to its cap, MM Activ Activ has curated over 100 national & international
emerged as a winner in the ‘The Big Show’ category technology conventions with special focus on agri-
for organising Agrovision India, a physical exhibition food and biotechnology. MM Activ is the publisher of
with the greatest number of participating exhibitors. leading B2B digital and print media- BioSpectrum,
Agrovision was conceived in the year 2007 to create nuFFooDS Spectrum and AgroSpectrum from India
and Singapore catering to the APAC region.

BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com PARTNER CONTENT 45

EVENT Merck India’s 3rd Annual Pharma Forum 2022 in
HYDERABAD ON AUGUST 10, 2022
ANNOUNCEMENT
RELEASE

Shaping the next gen processing
of pharma manufacturing

The Process Solutions division of Merck India in India to discuss the latest trends by bringing
has announced its 3rd Annual Pharma Forum in together eminent leaders from the industry and
Hyderabad on August 10, 2022. the subject matter experts across the globe.
Merck has a vision where innovations in products
The focus of the event is “Shaping the next and services as well digital offerings help create
gen processing of pharma manufacturing”. solutions for people globally and a sustainable
The forum creates a platform for a deep dive future for generations to come. We also take an
discussions with the industry experts on the future active role in shaping the future enabling brilliant
of the BioPharma manufacturing, providing the people to solve global challenges.
latest insights on the process trends and quality
approach in aseptic processing and discuss the This thought leadership platform Pharma
regulations around it. Forum is a flagship event of Merck India, hosted
annually with a focus on the Bio-Pharmaceutical
Renowned industry experts like Dr Ranjit industry to dive into a deeper discussion with the
Barshikar, CEO QbD International, QbD / cGMP industry experts.
Consulting, United Nations Adviser, Geneva,
Somasundaram G., Senior Consultant, Asia The Pharma Forum is a very diversified
Pacific, Process Solutions, Merck KGaA, Ramesh forum that takes the advantage of dynamism
Raju, Head of Operations, Validation Services lab, and interactivity. The platform motivates industry
Merck KGaA amongst others. These experts will associates to not only learn from eminent speakers
share their views from their respective areas of but equally clarify the queries and engage
expertise, followed by a panel discussion on the themselves in debates and discussions. Industry
most discussed topics in sterile pharmaceutical associates are encouraged to attend and share
manufacturing. their knowledge acquired from past experiences.

Merck India has been creating various Don’t forget to register here! https://forms.
platforms for the Bio-Pharmaceutical industry gle/qvtES1DmDqZK6Du1A

46 SUPPLIERS NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Agilent improves PerkinElmer introduces
next-gen automated gas
analysis speeds chromatography platform

of genomics PerkinElmer, Inc., has launched the GC 2400 Platform, an
advanced, automated gas chromatography (GC), headspace
bioinformatics sampler and GC/mass spectrometry (GC/MS) solution
designed to help lab teams simplify lab operations, drive
pipelines precise results, and perform more flexible monitoring.
Created with productivity in mind for pharmaceutical,
Agilent Technologies Inc. will use Amazon food, environmental and industrial analyses, the new
Elastic Compute Cloud (Amazon EC2) platform brings together systems, software and a wide
G5g instances powered by Amazon Web range of columns and consumables to meet customers’
Services (AWS) Graviton2 processors
and featuring NVIDIA T4G Tensor Core varied workflow needs. For high throughput lab
GPUs, in combination with NVIDIA Clara environments and complex applications, the
Parabricks’ advanced genomics analysis GC automated sampling capabilities reduces
capabilities, to significantly improve hands-on time and human error, and the
processing speeds for variant calling industry-unique automated
workflows on Agilent’s cloud-native Alissa headspace/pneumatics
Reporter software. This collaboration technology delivers superior
enables Agilent to offer streamlined precision. Monitoring single or
workflow solutions for its SureSelect multiple GC 2400 systems, inside
family of next-generation sequencing or outside the lab, is simple, using
(NGS) assays comprising a wide range of the wireless, touchscreen tablet
custom and catalogue panels, including interface running the PerkinElmer
SureSelect Human Exome reagents. The
integration of NVIDIA Clara Parabricks Simplicity Vision app. The platform’s icon-driven, 21
platform with the Alissa secondary CFR Part 11 compliant PerkinElmer SimplicityChrom
analysis pipelines enables clinical labs Chromatography Data System (CDS) software reduces user
and researchers to benefit from fast training and guides teams through their entire GC workflow.
panel-specific data analysis solutions in The software interface is also customisable to address user’s
a secure and user-friendly cloud software unique data, notification and diagnostic needs.
environment.

Illumina, Merck unveil research
test for insights into tumour genome

Illumina has launched a research assay. It will be available globally, technology and validated HRD
test, co-developed with Merck excluding the US and Japan, and technology from Myriad Genetics,
that builds upon Illumina’s will enable researchers to unlock enabling labs to accurately
commitment to broadly enable deeper insights into the tumour detect genomic instability and
comprehensive genomic profiling genome by identifying genetic analyse more than 500 genes
and enhance research critical mutations used in the evaluation simultaneously, including those
to realising precision medicine of homologous recombination relevant to HRD status. HRD
in oncology. The is a genomic signature used to
test adds an deficiency (HRD). The describe when cells are unable to
assessment of Research Use Only effectively repair double-stranded
a new genomic TruSight Oncology DNA breaks. When this occurs,
signature to cells rely on alternative, error-
the distributed, 500 HRD test is a prone DNA repair mechanisms,
market-leading next-generation which may lead to genomic
TruSight sequencing (NGS)– instability and, eventually,
Oncology 500 based assay that tumour formation.
harnesses the power
of Illumina NGS



48 SUPPLIERS NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Bio-Rad launches EconoFit chromatography column packs

Bio-Rad Laboratories, Inc. has and disposable column format
is fully compatible with Bio-
announced the launch of EconoFit Rad’s NGC Chromatography
Systems and other commonly
Low-Pressure Prepacked used chromatography systems.
Columns are available in 1 ml
Chromatography Column Packs and 5 ml sizes. Similar resins can
give different results for different
to support resin screening target molecules, and with Bio-
Rad’s EconoFit Column Packs,
experiments in the development the customers can easily perform
resin scouting to identify the one
of protein purification workflows. which yields the best outcome for
their chromatography application.
Bio-Rad’s range of EconoFit

Columns provides a wide selection

of resins in a prepacked format, include mixed-mode, cation, and
anion exchange resin columns,
allowing customers to simply as well as a pack designed for
His-tag protein purification.
screen resins and select the The convenient, easy-to-use

optimal chemistry for different

target molecules. The new packs

Avantor brings BD offers combination test for
COVID-19, Influenza & RSV
custom hydrated
BD (Becton, Dickinson and Company) has announced that
solutions & cell the BD MAX Respiratory Viral Panel (RVP), a new molecular
diagnostic combination test for SARS-CoV-2, Influenza A + B
culture media and Respiratory Syncytial Virus (RSV), has been CE marked
to the IVD directive 98/79/EC. The test uses a single nasal
Avantor, Inc. has entered into an swab or a single nasopharyngeal swab sample to determine if
agreement with GeminiBio to deliver a patient has COVID-19 or the flu or RSV. It helps eliminate
custom hydrated solutions and cell the need for multiple tests or doctor visits and can help
culture media to the biopharma industry. clinicians to implement the right treatment plan quickly. The
Custom hydrated solutions and cell co-testing approach also helps to increase testing capacity
culture media are critical components of
the bioproduction workflow, especially during the busy
for emerging modalities such as flu season and
gene therapy. This collaboration will speeds the time
complement Avantor’s proven ability to diagnosis. The
to serve manufacturing platforms with BD MAX System,
GeminiBio’s small-to-medium scale a molecular
offering, enabling customers to utilise diagnostic
custom cGMP products through the platform, is already
full development lifecycle – including in use at thousands
early-stage research, scale-up and of laboratories
commercialisation. This new capability worldwide, and
along with Avantor’s recent acquisitions each unit is capable
and site investments, support a growing of analysing
portfolio of proprietary offerings, hundreds of
demonstrating its commitment to samples over a
supporting customer workflows in both 24-hour period. The BD MAX RVP assay is an RT- PCR assay
upstream and downstream processing for that detects and differentiates the mRNA of SARS-CoV-2, flu
the biopharma industry. A, flu B and RSV in approximately two hours, with the easy-
to-use and automated workflow of the BD MAX System. The
BD RVP assay for BD MAX System is an important addition
to the extensive number of assays available on the system
across respiratory, STI, gastrointestinal, women’s health and
health care associated infections.

Corning® Immune
Cell Therapy Solutions

Corning can provide a diverse range of the products required for immune cell therapy, spanning the
upstream and downstream processes. This includes all the supplies, reagents, and equipment
required to perform cell separation, cell culture, quality control, and cryopreservation.

Patient Functional Antibodies
peripheral Cytokines
Serum-free Medium
blood

Obtain
PBMCs

Lymphocyte Separation Medium Ex vivo
General Lab Supplies proliferation
Universal Small Equipment
and
differentiation Cell Culture Bags
Cell Culture Flasks

Cell quality Universal
control Equipment

Patient reinfusion Cryopreservation

Cell Culture Freezing Medium
Cell Freezing and Storage Bags, Tubes

India t 91 124 4604000 f 91 124 4604099 [email protected]

50 LET’S TALK HEALTH BIOSPECTRUM | AUGUST 2022 | www.biospectrumindia.com

Betting on Self-amplifying
RNA Shots

India has recently approved its first mRNA the limited protection being offered by the mRNA
vaccine against COVID-19, developed by Gennova vaccines. To avoid loss of efficacy, periodically updated
Biopharmaceuticals, a subsidiary of Emcure vaccine boosters that compensate for antibody waning
Pharmaceuticals. GEMCOVAC-19 is the first mRNA and viral evolution will be needed, especially in high-
vaccine developed in India and the third mRNA risk groups. So, how to address this requirement?
vaccine to be approved for COVID-19 in the world.
The pandemic has undoubtedly brought tremendous Here comes the concept of self-amplifying RNA
momentum to the field of nucleic acid vaccines, in (saRNA) to the rescue. Since saRNA is a much larger
particular messenger RNA or mRNA vaccines, since molecule as it encodes four extra proteins in addition
it offers advantages such as rapid development. to the vaccine antigen or gene of interest.
Because mRNA can be produced quickly and
synthetically, this greatly minimises the time It is a newer type of RNA vaccine with high
required to manufacture these vaccines. immunogenicity. Derived from alphaviruses or
flaviviruses, it contains the viral replicase enzyme
Over the years, studies have focused heavily that allows it to amplify itself. Since saRNA is already
on developing DNA rather than RNA candidates, more immunogenic than other RNA molecules,
because there were concerns about stability of RNA- activating several Toll-like receptors, for instance,
based therapeutics. But we saw that DNA vaccines this elevated expression of viral antigen in vivo causes
have generally performed poorly in human clinical extremely robust immune responses. The saRNA
trials, which has led to a renewed interest in RNA packaged in lipid nanoparticles expresses the antigen
vaccinology for infectious diseases. for much longer than mRNA.

However, a big hurdle in the field of the mRNA The first-in-human clinical trial for a saRNA
vaccines has been the efficient delivery of mRNA. vaccine was performed in 2020 for a COVID-19
While many delivery vehicles have been investigated, vaccine by a team at Imperial College London, which
lipid nanoparticles (LNP) consisting of an ionisable concluded the combined phase I/II clinical trial in
lipid, phospholipid, cholesterol and PEGylated lipid January 2021. The doses used in the trial, much
are the most clinically advanced and are used in less in comparison to the Pfizer/BioNTech vaccine
both the Pfizer/BioNTech and Moderna vaccines. and Moderna vaccine, illustrate the benefits of this
The combination of these advances has enabled the platform.
approved COVID-19 vaccines and set the stage for
future mRNA technologies. Also, COVID-19 is not the only pathogen that’s
been explored for this platform. Other applications
Another challenge is lowering the dose of RNA have included infectious diseases such as influenza,
in order to avoid side effects associated with high rabies, HIV-1, malaria, Chlamydia trachomatis,
doses of RNA. The data from the clinical trial shows Ebola, RSV and Zika viruses, as well as oncology
that approximately 50 per cent of participants had applications such as melanoma and colon carcinoma.
side effects even though the RNA was prepared with
modified nucleotides in the vaccine. This is caused Future research will likely include optimising
by innate sensing and detection of foreign RNA that both the molecular design of saRNA (sequence and
humans have evolved to fight infections from RNA structural elements), the delivery vehicle, as well as
viruses. These side effects are directly proportional the manufacturing and quality control processes used
to the total administered dose of RNA. Therefore, for these vaccines. Self-amplifying RNAs have shown
minimising the dose of RNA required for vaccines enhanced antigen expression at lower doses compared
will not only lessen side effects, but also the cost and to conventional mRNA, suggesting this technology
time required to produce doses. may improve immunisation in the future.

Another hurdle that is now coming into light is Dr Manbeena Chawla
Executive Editor

[email protected]