BioSpectrum India 20th Anniversary Special

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

ANNIVERSARY

20 LUMINARIES 16 18

THEN, NOW Saga of Growth &
& Boom of Indian life
AFTER Sciences Industry

The Journey that started on a small note has achieved milestones, KIRAN
with a promise to deliver more in the coming years MAZUMDAR SHAW
Executive Chairperson,
20 24 26 28 30 Biocon & Biocon
Biologics
Combatready Investing in Biopharma Where’s The Evolution and Gujarat to Bolster
For Future Can improve Access to Indian Pharma Developments in Biomanufacturing 34
Pandemics Life-saving Medicines Sector Headed? Pharma Industry & Innovation
Twenty Prolific Years
of Life Sciences
Startup Ecosystem

DR KRISHNA ELLA RAGHAVENDRA SAMIR MEHTA KV GARGI JAIN DR A N DEEPANWITA
Scientist, Serial GOUD VAGGU President, Indian SUBRAMANIAM BHADALKAR CHATTOPADHYAY
Entrepreneur and General Manager, Pharmaceutical Alliance President, IAS, Mission Director, Chairman & CEO,
Chairman and Cytiva South Asia (IPA) and Chairman, Reliance Life Sciences Gujarat State Bio Technology Joint Director (BD), IKP Knowledge Park
Managing Director, Torrent Group Mission (GSBTM) & Dy Secretary GSBTM and Director,
Bharat Biotech (BT), Government of Gujarat Savli Technology & Business
for Department of Science & Incubator (STBI) – both of DST,
Technology (DST) Government of Gujarat

38 40 43 46 48 50

From Genomics How Indian How AI can help Futureproofing Labs Burgeoning Scope of How Genome
to Age of MedTech is Soar Lab Productivity through Automation and Enhanced Imaging Sequencing & Mass
Living Machines Metamorphosing & Profitability Immersive Technologies Technologies Spectroscopy Improve
Lab Medicine

SATYA DASH DR VIJAY CHANDRU ARNAB BASUMALLIK YOSHIYUKI FUJINO AMIT CHOPRA T ANIL KUMAR DR SURESH
Board Member, Managing Director, Managing Director, President, THAKUR
Venture Center Executive Advisor, Co-Chair MTaI Policy Shimadzu Analytical India and South Asia, Waters India President, IVD, India,
ARTPark, Indian Institute Research Wing and India Thermo Fisher Trivitron Healthcare
52 of Science (IISc) and Director- Government Scientific
adjunct Professor, IISc Affairs and Market Access,
Why Point-of-care and BITS Pilani Edwards Lifesciences India 66
Diagnostics is
Booming 54 56 61 Will India Shine 70 74
Brighter in Healthcare
How Promising What’s How VC Funding for Delivery Sector? How Automation Can A Digital
is India’s Medical Propelling Indian Life Sciences Transform Enterprise & Future for
Devices Industry? Indian IVD Industry grew phenomenally Patient Journey Healthcare

HASMUKH RAWAL RAJIV NATH SURESH VAZIRANI NITIN DESHMUKH SAMEER AGARWAL AMIT MOOKIM DR K HARIPRASAD
Managing Director, Forum Coordinator, Founder Chairman, Sr Advisor, Group CFO, Managing Director, President,
Mylab Discovery Association of Indian Transasia-Erba Kotak Investment Manipal Hospitals IQVIA South Asia Apollo Hospitals
Solutions Medical Device Industry International Advisors
(AiMeD) Group of Companies

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com BIO CONTENT 5

Top Video ANNIVERSARY

Uthaman Kirill Dmitriev,
Bakthikrishnan, Chief Executive
Executive Director, Officer, Russian
ClearTouch shares Direct Investment
his views on how Fund talks
cloud technology about the recent
is driving intelligent approval of
customer Sputnik Light
experience in the vaccine in India for
medtech space. COVID-19.

Scan the QR Code » Scan the QR Code » COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.

Women Special 78 79
Dr Bharati Pravin Pawar Dr Aradhana Sarin
Women Special
PPaattAhhNNIVERbfSARiY rnedaekresrs Minister of State for Health and Chief Financial Officer,
Of Family Welfare, Government of India AstraZeneca
and
Dr Nita Patel Dr Shobhana Kapoor
ScGi-TeCenacdlhel rt&oDIAnivncetorivsoianttyifooinnr
FDoMrmirDneiesrRptSraeyerctomrnfeeStnauctriyeonftSocBeGiwo&otveTetcacohhfnrnoIunolodlopgiagy,y, Executive Director- Immunology, Assistant Professor,
Vaccine development- Novavax Indian Institute of Technology (IIT)
Bombay
Dr Priya Abraham
Priya Gandhi
Director, National Institute of Virology
Executive Director, Hester Biosciences
Dr Gagandeep Kang
Dr Parul Ganju
Professor, Department of
Gastrointestinal Co-founder & Chief Executive Officer,
Sciences, Christian Medical College Ahammune Biosciences

80 81 82
Dr Neetu Singh Ashvini Danigond Dr Priti V Warke

Associate Professor, Chief Executive Officer, Director - Cell Biology,
Indian Institute of Technology, Delhi Manorama Infosolutions Head - Regulatory Affairs,
HiMedia Laboratories
Runam Mehta Divya Sriram
Dr Tanushree
Chief Executive Officer, Co-Founder, Devi Laishram
HealthCube D-NOME
Co-Founder, CyGen HealthTech
Nidhi Jain Dr Prakriti Tayalia
Dr Mamta Murthi
Founder & Chief Executive Officer, Assistant Professor,
KareXpert Indian Institute of Technology (IIT) Vice President-Human Development,
Bombay World Bank
Sumita Mitra
Khushboo Sandhu Anuradha Gupta
Partner,
Mitra Chemical Consulting Customer Experience Manager, Janani Deputy Chief Executive Officer-
Gavi, the Vaccine Alliance

84 86

Call to Action for “Women must believe in their
Gender Diversity in ideas and the surrounding
Sci-Tech & Innovation environment must be supportive”

Dr Renu Swarup, Prof. P M Murali,

Former Secretary to Govt of India, Chairman,
Department of Biotechnology, Golden Jubilee
Biotech Park for Women
Ministry of Science &Technology

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

DR MILIND KOKJE ANNIVERSARY
Chief Editor
MOMENTOUS MILESTONE
[email protected]
Even in the face of numerous challenges, India’s $42 billion worth
pharma sector - ranked third in the world in terms of volume and
13th in value - could attract foreign investors, evident from the
Foreign Direct Investment flow (FDI) of the last two years.

The inflow of FDI, just in the first half of the current financial year –
April to September 2021 – was Rs 4,413 crore, 53 per cent more than the
same period of the previous year. Between April and September 2020,
the inflow was Rs 3,039 crore. The entire year of 2020-21 witnessed
even greater growth of 200 per cent FDI over 2019-20, according to
the Economic Survey of India presented by Finance Minister Nirmala
Sitharaman, a day prior to the presentation of the Union Budget 2022-23.

Obvious reasons for attracting FDI are the growth potential of India’s
pharma sector as estimated by market researchers and further increase
in the scope due to the pandemic. The $42 billion Indian pharma sector
is expected to reach $65 billion by 2024 & $120 billion by 2030. Added to
this is the COVID related demands of therapeutics and vaccines. Investors
might have also seen the potential due to the growth estimates of the
healthcare industry which is expected to reach $372 billion this year.
Expansion of the healthcare sector naturally aids expansion of pharma too.
Our strong pool of talent and human resource is also helping in receiving
investments.

But figures are only estimates and to make it a reality various steps
from the industry as well from the government are required. Our
large population, healthcare programmes, medtech and innovations
are, no doubt, helping to fuel the growth of pharma. But, as a parallel
step, development of R&D is also required. A large portion of the new
investments should be diverted to more focussed research in developing
new drugs. Incentivisation announced in the budget for sunrise industries,
which include genomics & pharma R&D will certainly help the industry. But
the opinion on incentives is a bit divided as everyone’s expectations were
not met. Some experts feel that not enough encouragement is being given
to contract research and innovative R&D projects with heavy investment.

Another hindrance to growth is our dependence on imports of bulk
drugs that are used in the formulations of medicines. Though we are a trade
surplus in drugs due to our exports of $24 billion in 2020-21, our imports
are $7 billion. More importantly, in some cases, our dependence on imports
of bulk drugs and Active Pharma Ingredients (APIs) is as high as 80 to
100 per cent, which can cause a major obstacle in production at times. The
Centre has initiated some steps to encourage indigenous production for
imports substitution when the imports were affected at the beginning of
the pandemic in China in January 2020. Recently it launched a Production
Linked Incentive (PLI) scheme for boosting API production.

It is hoped that Indian pharma will enter a new phase of growth, as it
had already passed through various such phases in the last two decades.
BioSpectrum has remained with the industry in all its ups and down,
challenges and success. As all our readers must have noticed from the
cover, this is the 20th Anniversary Issue of the BioSpectrum. We extend
greetings to all on this occasion and also express our sincere gratitude to
all our writers, contributors, advertisers and readers. Without your active
support and cooperation we wouldn’t have reached this milestone. Once
again greetings from BioSpectrum.



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

ANNIVERSARY

February 2022 the whole issue in a lucid and concise
Acknowledgements manner. It is an extremely pertinent topic in
Thank you so much for the publication on today’s world, and it is important to have an
the industrial enzymes ranking featuring active discussion and understanding around
Tex Biosciences in the recent edition. it. Also, I would like to extend my gratitude
- Aravindha Krishnamachari, Chennai for including my inputs on behalf of SIRO
Clinpharm in your article and I look forward
Thanks a lot for the feature on Infinita to partnering with you on any future writing
Biotech in the industrial enzymes ranking projects or collaborations related to the
special issue. I highly appreciate your healthcare and life sciences industry.
continuous support given to Infinita Biotech.
- Akshay Daftary, Mumbai
- Adarsh Desai, Vadodara

I read the article titled ‘Drug Wars The article on anti-ageing was good and it
Intensifies’ in your reputed magazine and placed lots of recent findings in context of
I would like to congratulate your team for global trend. Enjoyed reading the same.
some commendable work in writing about
- Dr Deepak Saini, Bengaluru

Vol 20; Issue 1; March 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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‘Biospectrum’ monthly publication is owned by MM Activ Sci-Tech Communications Pvt. Ltd.,
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Printed at Spectrum Offset, D2/4, Satyam Industrial Estate, Behind CDSS, Erandawana, Pune - 411 038. and
Published at ‘Ashirwad’, 36/A/s, S. No. 270, Pallod Farms, Baner Road, Near Bank of Baroda, Pune - 411 045.
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Website: www.biospectrumindia.com

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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

Russia’s one-shot Sputnik Light vaccine gets DCGI nod

The Russian Direct Investment increases virus-neutralizing Laboratories, a major partner
Fund (RDIF, Russia’s sovereign of RDIF in India, has conducted
wealth fund) has announced that activity against Omicron, which local clinical trials of Sputnik
the Russian one-shot Sputnik Light in India. Positive data from
Light vaccine against coronavirus is comparable to titers observed these trials have been presented to
has been authorised by the Drug India’s regulator and contributed
Controller General of India (DCGI). after Sputnik V against wild-type to the positive decision by DCGI.
Sputnik Light has been registered Clinical studies and the real-
in more than 30 countries with a viruses, associated with high world data in many countries have
total population of over 2.5 billion demonstrated Sputnik Light is a
people. A number of countries, levels of protection. Dr Reddy’s safe and effective vaccine when
including Argentina, Bahrain, used both on a standalone basis
UAE, San Marino and Philippines, and as a booster. Sputnik Light
have already authorized Sputnik will add to India’s national vaccine
Light as a universal booster. A portfolio and join Sputnik V,
preliminary study of the Gamaleya which was approved in the country
Center has found that Sputnik in April 2021. India is the leading
Light as a booster significantly production hub for Sputnik V.

DCGI grants market Dr Mandaviya
authorisation for
Covaxin, Covishield launches IMI 4.0

The Director Controller General of India (DCGI) has given nod for immunisation
to market authorisation of two COVID-19 vaccines- Covaxin
and Covishield, subject to certain conditions. The Subject Dr Mansukh Mandaviya, Union
Expert Committee (SEC) of the Central Drugs Standard Control Minister of Health and Family Welfare
Organisation (CDSCO) had recommended for upgradation of recently launched Intensified Mission
Indradhanush (IMI) 4.0 virtually in
status for the vaccines from restricted use in emergency presence of health officials of States
situations to grant of new drug permission and Union Territories. Intensified
with conditions in the adult population on Mission Indradhanush 4.0 will have
January 19, 2022. The market authorisation three rounds and will be conducted
is subject to the conditions that firms shall in 416 districts (including 75 districts
submit data of overseas ongoing clinical identified for Azadi ka Amrit Mahotsav)
trials of the product with due analysis on across 33 States/UTs in the country. In
six monthly basis or as and when available, the first round (February - April 2022),
whichever is earlier. The vaccines shall be 11 states will conduct IMI 4.0. These
supplied for programmatic setting and all are Assam, Uttarakhand, Gujarat,
vaccinations done within the country to be Jammu & Kashmir, Meghalaya,
recorded on CoWIN platform and Adverse Mizoram, Nagaland, Rajasthan,
Event Following Immunization (AEFI), Sikkim, Tripura and Chhattisgarh.
Adverse Event of Special Interest (AESI) shall The others (22 states) will conduct the
rounds from April to May 2022. These
continue to be monitored. The firms shall submit the safety states/UTs include Himachal Pradesh,
data including AEFI and AESI with due analysis on six monthly Maharashtra, Andhra Pradesh,
basis or as and when available, whichever is earlier as per Manipur, Arunachal Pradesh, Odisha,
NDCT Rules, 2019. ‘Conditional Market Authorisation’ is a new Bihar, Puducherry, Delhi, Punjab, Goa,
category of market authorisation that has emerged during the Tamil Nadu, Haryana, Telangana,
current global pandemic of COVID-19. The approval pathways Jharkhand, Dadra & Nagar Haveli
through this route are fast-tracked with certain conditions to and Daman & Diu, Karnataka, Uttar
enhance the access to certain pharmaceuticals for meeting the Pradesh, Kerala, West Bengal, Madhya
emerging needs of drugs or vaccines. Pradesh, Adman & Nicobar Islands.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com POLICY AND REGULATORY NEWS 11

ANNIVERSARY

Gujarat unveils new ‘Biotechnology Policy 2022-27’

Chief Minister Bhupendra Patel RT-PCR tests, vaccines, etc,” the a maximum of Rs 200 crore. This
has unveiled the new ‘Gujarat CM added. According to the new assistance will be provided in the
Biotechnology Policy 2022-27’ policy, MSMEs with a capital form of 20 quarterly installments
with a commitment to promote investment of less than Rs 200 over a period of 5 years. The new
rapid and inclusive growth in crore will be given maximum policy will further strengthen the
the biotechnology industry assistance of Rs 40 crore and ecosystem by providing support
in Gujarat. Bhupendra Patel mega/large projects with a capital to the special projects such as
said, “being a policy driven and investment of more than Rs 200 pre-clinical testing, genome
business-friendly state, Gujarat crore as well as special projects sequencing in private sector, plug
has remained at the industry like ecosystem empowerment, and play facilities, private sector
forefront in the country. New emerging technologies in BSL-3 lab-vaccine development,
forms of entrepreneurship have challenging areas and of strategic and manufacturing, testing
emerged with the adoption importance will be given and certification laboratories.
of science and technology in assistance of up to 25 per cent of Gujarat’s Biotechnology sector
the state.” “Biotechnology has the total capital expenditure up to has more than 200 biotechnology
made significant contributions companies and a thriving startup
in solving new-age problems, ecosystem. In order to provide
especially in the field of health further support to the sector,
and agriculture. The science- Government of Gujarat has
driven industry has been announced plans to establish
instrumental in understanding a Bulk Drug Industrial Park in
and fighting the global Jambusar Taluka of Bharuch
COVID19 pandemic. It was due District and a Medical Device
to biotechnology that we got Industrial Park at Viramgam/
effective rapid antigen tests, Rajkot.

Form IV (See Rule 8)

Statement about ownership and other particulars about newspaper (BioSpectrum) to be published in the first issue every year after the
last day of February.

1. Name of the Periodical : BioSpectrum

2. Place of Publication : ‘Ashirwad’ , 36/A/2, S. No. 270, Pallod Farms, Baner Road, Near Bank of Baroda, Pune–411 045.

3. Periodicity : Monthly

4. Printer’s Name : Ravindra Boratkar

Nationality : Indian

Address : Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune-411045.

5. Publisher’s Name : Ravindra Boratkar

Nationality : Indian

Address : Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune-411045.

6. Editor’s Name : Mr. Narayan Kulkarni

Nationality : Indian

Address : Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune-411045.

7. Name & Address of Printing Press : Spectrum Offset, D - 2/4 , Satyam Estate, Behind CDSS, Erandwane, Pune-411 004.

Owner Name and address : MM Activ Sci-Tech Communications Pvt. Ltd.,

‘Ashirwad’ , 36/A/2, S. No. 270, Pallod Farms, Baner Road, Near Bank of Baroda, Pune – 411 045

Names and addresses of individuals who own the newspaper and partners or shareholders holding More than one per cent of the total capital.

Name : Mr. Ravindra Vidyadhar Boratkar

Address : 402, Siddhivinayak Apartment, Khare Town, Dharam Peth, Nagpur–440010.

Name : Mr. Jagdish Balkrishna Patankar

Address : B-55, Mahavir Park Society, Pune - Satara Road, Pune–411037.

Name : Mr. Vijay Padmakar Thombre

Address : 1, Sagar Apartment, 6 Mahaganesh Society Paud Road, Kothrud, Pune–411038.

Office Address : Ashirwad, 36/A/2, S.No. 270, Pallod Farms, Near Bank of Baroda, Baner Road, Pune-411045.

I Ravindra Boratkar hereby declare that the particulars given above are true to the best of my knowledge and belief.

Sd/-

Date: 1st March 2022 Signature of Publisher

12 COMPANY NEWS BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

Piramal Pharma ANNIVERSARY

Solutions invests Glenmark launches FabiSpray
for COVID-19 treatment
£55M in UK
Glenmark Pharmaceuticals and Canadian pharmaceutical company
The Pharma Solutions division SaNOtize Research & Development Corp have launched its nitric
of Piramal Pharma, Mumbai-
based contract development oxide nasal spray (NONS) under the brand name FabiSpray in
and manufacturing company India. The nasal spray will be used for
(CDMO), has announced the the treatment of adult patients with
expansion of its antibody-drug COVID-19 who have a high risk of
conjugate (ADC) manufacturing progression of the disease. Glenmark
capabilities at the Grangemouth earlier received manufacturing and
facility in Scotland and investment marketing approval from the Drugs
in new Active Pharmaceutical Controller General of India (DCGI)
Ingredients (API) infrastructure for NONS as part of the accelerated
at the Morpeth facility in approval process. FabiSpray, Nitric
England. Taken together, these Oxide Nasal Spray, is designed to
expansions and modernizations kill the COVID-19 virus in the upper
represent a total investment of airways. It has proven anti-microbial
approximately £55 million in the properties with a direct virucidal effect
company’s UK drug development on SARS-CoV-2. NONS when sprayed
and manufacturing operations over nasal mucosa acts as a physical
and provide new employment and chemical barrier against the virus,
opportunities for technical and
operational staff. The first phase of preventing it from incubating and spreading to the lungs. A Phase
the expansion of the Grangemouth 3 clinical trial was conducted in adult COVID-19 patients across 20
site will add two additional clinical sites in India.
ADC production facilities to
the existing three, which will Dr. Reddy’s bets on medical
be operational by the third cannabis-based drugs
quarter of 2023. This extension
represents an investment of Hyderabad-based Dr. Reddy’s Laboratories has entered into a
£45 million including a £2.4 definitive agreement to acquire Nimbus Health GmbH, a licensed and
million grant from Scottish privately owned pharmaceutical distributor from Germany, focusing
Enterprise, Scotland’s national on medical cannabis. Dr. Reddy’s will acquire Nimbus Health for an
business development agency. upfront payment plus performance-based earnings and milestones
The investment in API capacity over the next four years. Founded in 2018, Nimbus Health is one of the
at the Morpeth site, valued at pioneering medical cannabis companies in
approximately £10 million, Germany. The acquisition will allow Dr.
includes new plant, infrastructure Reddy’s to build on Nimbus Health’s
and utility systems. Piramal is strengths and introduce medical
investing £8 million directly cannabis-based drugs as a promising
while the UK Government is treatment option for patients. The
contributing £2 million to the company will operate under the
project. Nimbus Health brand and as a wholly
owned subsidiary of Dr. Reddy’s. Demand for medical cannabis has
increased in recent years with the legalisation of medical cannabis by
the German Parliament (Bundestag) in 2017. The medical cannabis
market in Germany is already valued at approximately €122 million,
with growth of around 25 per cent in 2021 compared to 2020 and a
compound annual growth rate (CAGR) of approximately 55 per cent
since 2017, making Germany one of the biggest markets in Europe.
Around 150,000 German patients benefit from medical cannabis to
address unmet health needs.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com COMPANY NEWS 13

ANNIVERSARY

HLM acquires Panacea Biotec sells
100% stake in Care24
pharma formulations
Care24, a leading home healthcare platform operating
in Mumbai and Delhi, has been acquired by Human Life for Rs 1908 Cr
Management (HLM), a leading Japanese home medical
support corporation. Care24 will extend its robust service New Delhi-based Panacea Biotec has
delivery and agile technology platform for HLM and will announced that its wholly-owned
cater to the evolving healthcare subsidiary Panacea Biotec Pharma has sold
needs of the customers. Post the its domestic business assets constituting
acquisition, HLM and Care24 its pharmaceutical formulations brands in
will closely work together to scale India and Nepal to Mankind Pharma for
and strengthen medical service Rs 1908 crore. In the last financial year,
offerings in India and additionally the domestic business assets generated
expand to other southeast a turnover of Rs 219.85 crore which is
countries like Thailand, Vietnam, more than 63.75 per cent of the revenue
Indonesia using HLM’s deep of Panacea Biotec. As per IQVIA, with the
medical expertise and Care24’s Mankind Pharma acquisition of Panacea
superior software development and technology capabilities. Biotec, Mankind Pharma reached Rs
HLM will also play a pivotal role in launching new medical 8000 crore. Post the acquisition, Mankind
offerings for Care24 in the Indian market, like end of life Pharma maintains its rank of No 4 in the
care, critical care at home, family doctor subscription service, Indian Pharma market. Though the top 5
doctor on call, implementation of the care plan and Training therapies of Mankind Pharma remain the
of doctors along with training materials same, the acquisition provides an entry
of Mankind Pharma in the vaccines and
antineoplastic segments.

BIOKART INDIA PVT. LTD. In
Bringing Biotech Closer conversation

www.biokart.com A pioneer Genomics Company with
entrusted by multitudes of researchers
across the globe for the past 10 years. MR. VIKRAM S.,

l How did Biokart start? Founder,
Biokart India Pvt. Ltd. was started primarily as a distribution organization, later pivoting into the Biokart
services sector to provide sequencing services from 2013 onwards. We might be one of the few companies India
to own a sanger sequencing and an illumina MiSeq sequencer without raising funds – this itself we Pvt. Ltd.
consider as a testament to the efforts and services provided by us coupled with our client’s trust on us.

l What type of services do you provide?
We currently offer a plethora of services ranging from Sanger Sequencing to complicated offerings
such as ATAC seq or Degradome Seq along with Single cell genomics. Our routine offerings fall under
these categories of Whole Genome Sequencing, Transcriptome Sequencing, Metagenomics to name a few.

l What would you consider as a differentiator?
We ensure that every single client’s project is given individualized attention as well as providing our
inputs and technical service to stand by the researcher’s goal upto publication. The major differentiator
would be understanding and empathizing of each project as our own.

l Any innovative developments or offerings being offered from you?
Innovation is the driving force for any organization – we continuously update our technologies and
incorporate any new innovations. Recently we were also involved in the setting up of Covid Sequencing
Facilities for a Medical Institute in Bihar. We proudly do say that we can provide the fastest TAT and the
most economical costs for any screening-based sequencing for Covid Genomes currently. We have also
developed our custom proprietary amplicon sequencing panels which can be tailor made for a wide range
of applications. By using AI and ML we are in the process of developing robust analysis pipelines which can
provide results from raw data at a fraction of the time incurred using conventional methods

l Views about the current genomics market and growth in India?
India is one of the most technically growing market with a lot of researchers adapting the use of
Genomics for a host of solutions or insights. The future of genomics is not only going to be limited to
academic oriented aspects, rather the shift towards personalized genomics diagnostics.

14 START UP NEWS BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

Azooka launches indigenous bio-sample collection kit

Azooka Labs, a startup and faecal tubes. It is the only RNALater from Thermofisher,
incubated by the Society for molecular transport medium Zymo Sample Collection Kits,
Innovation and Development to be manufactured in India, UTM from BD Biosciences. With
at the Indian Institute of that competes with sample the market deployment of the
Science (IISc), Bengaluru has stabilisation and transport media, COVID-19 diagnostic series and
launched mWRAPR, India’s such as Paxgene from Qiagen, research use only product series,
first indigenous biological iLabKart Technologies will be its
transport and storage medium for authorised Partner for the states
research use, focused on genomic of Maharashtra and Gujarat.
sequencing labs, biobanks, and Azooka is expanding its partner
research labs handling biological network across the APAC regions
samples for molecular analysis. and rolling out easy payment
Azooka’s mWRAPR helps in options via Credit Card or UPI. As
preserving genetic content in an Azooka Distributor for the past
all types of biological samples year, iLabKart Technologies will
including, microbiomes, saliva, be clocking One Million Units of
cells, tissues, blood, body fluids, Azooka products by Q1, 2022.

HaystackAnalytics Mylab steps into vaccine
& therapeutics segment
develops UID
Pune-based startup Mylab Discovery Solutions has announced its
genomic test foray into the vaccine and therapeutics segment with its strategic
tie-up with Shilpa Biologicals, a 100 per cent subsidiary of Shilpa
HaystackAnalytics, a Mumbai-based Medicare, a specialist manufacturer of vaccine and wide variety
health-tech startup, has developed the of biologicals. Starting with COVID-19 vaccine manufacturing
first of its kind Universal Infectious opportunity, the parties plan to strengthen the relationship by
Diseases (UID) Test in the country, that expanding the product portfolio in various other areas including
deploys Next-Generation Sequencing various biosimilars, other vaccines & diagnostics. Mylab plans
(NGS) technology to identify existing to develop world-class diagnostics, vaccines and therapeutics
and emerging infections, while to augment its presence in the healthcare market. The company
providing information on drug will leverage the technical expertise of Shilpa Biologicals in
resistance to support and identify development and manufacture of biopharmaceuticals through
correct treatment options for patients. its world class facility at Dharwad. Shilpa Biologicals will utilise
HaystackAnalytics has partnered with its integrated R&D cum manufacturing facility in Dharwad,
various diagnostic centers such as spanning over 11 acres, to cater to these requirements. This
Unipath, Anderson, Sterling Accuris, collaboration will also be developing novel technologies that can
Apollo Hospitals and over 20+ hospitals enable production of safe, efficacious and cost effective vaccines
including AIIMS, to introduce their and therapeutics. The first vaccine project under this long-term
Sequencing based clinical products partnership is currently under final evaluation phase and the
for TB and COVID-19 in the past. The manufacturing is expected to start by March 2022.
new Universal Infectious Diseases test
developed by HaystackAnalytics will be
rolled out with their current partners
in a phased manner over the next three
months, and will be initially targeted
at identifying and treating sepsis in
Intensive Care Unit (ICU) patients, but
gradually be made available to anyone
suffering from a fever of unknown
origin, by eradicating the need to
conduct multiple tests.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com START UP NEWS 15

Bugworks secures $18M ANNIVERSARY
to advance work in AMR
West, IIT Palakkad
Bengaluru-based startup Bugworks Research, with
operations in US and Australia, has announced the partner for
financing of $18 million Series B1. This round will
support the clinical development of BWC0977, a novel medtech research
broad spectrum antibacterial agent available in both
IV and oral forms, and the pre-clinical development West Pharmaceutical Services, Inc. has recently
of its best-in-class Adenosine immuno-oncology asset. announced its partnership with TECHNIC – a
Bugworks will continue to invest in its proprietary Technology Innovation Foundation of the Indian
drug discovery platforms GYROX (for antimicrobial Institute of Technology (IIT) Palakkad which
resistance) and DARE (for immune-oncology), focuses on assisting innovation and incubation
and identify new drugs for serious, underserved for budding entrepreneurs, to build a Medtech
indications. Bugworks’ lead Antibacterial asset Research Center of Excellence. The aim of
BWC0977 continues to be supported by CARB-X, the building a distinctive Medtech Research Center
global non-profit partnership dedicated to accelerating of Excellence is to enable access to healthcare and
antibacterial research to tackle the global threat of medical technology by developing an ecosystem of
drug-resistant bacteria. The Series B1 financing was academia, hospitals, and the industry to promote
led by Lightrock India and included existing investors local entrepreneurship. To achieve this objective,
the University of Tokyo Edge Capital (UTEC) Japan, West’s medical expertise with IIT’s unique
Global Brain Corporation in Japan, 3ONE4Capital incubation model will be combined to advance
India, Acquipharma Holdings S.A, I.M Holdings B.V. research and development in medical technology.
and Featherlite Group India. West will work with IIT Palakkad’s TECHIN in the
area of medical technology. The engagement will
be carried out by West’s Digital Technology Centre
(DTC) in Bengaluru which will be directly working
with TECHIN’s team throughout this partnership.

The life science and biotech research industry in India is growing at an XPLOREGEN
extraordinary rate where a lot of researchers are plagued by dependencies of kits DISCOVERIES PVT. LTD.
imported from abroad, even for the basic yet most crucial aspects of DNA and
RNA extractions. DISCOVERY BEGINS WITH US

Xploregen Discoveries Pvt. Ltd. has been started to specifically address
these bottlenecks. Backed by a team of well renowned scientists and chemists , at
Xploregen we are dedicated to not only manufacture but rather innovate and provide
researchers with kits which are economical, and have an unmatched performance.

How it all began?
The above mentioned bottle necks which are faced by many researchers alike
was faced by us as well coupled due to disruption of logistics in the Covid period –
we were seeing wait times of more than 6 to 8 weeks for a basic DNA extraction kit.
This was an inspiration for us to address the issue and overcome it by getting into
manufacturing Indian made products. Thus the idea of Xploregen was born.

Range of products:
The first product ever developed and tested by us is a Gel and PCR
purification kit. From here on we have expanded into manufacturing a Universal
DNA Extraction kit suitable for any type of starting materials. Another product
being provided by us currently is the Bio beads (magnetic beads) which can
be used for wide range of DNA / RNA purifications and size selection for NGS
libraries. We also have an EtBr replacement in the form of our Firefly Dye which
is a combined gel loading and staining dye and doesn’t require the gels to be
stained prior and is completely EtBr free.

MRS. ANKITA KUMARI
Co-Founder, Xploregen Discoveries Pvt. Ltd.

About Mrs. Ankita Kumari:
Majoring in the field of Biotechnology, having completed her education from Haldia
Institute of Technology she brings with her the dedicated expertise and work experience
of having worked in Darbhanga Medical College and Hospital, Bihar, Chittaranjan
National Cancer Institute, Kolkata, Chromous Biotech, Bangalore and finally at Biokart
India Pvt. Ltd., Bangalore where she is still a crucial part in heading the operations.

16 20 LUMINARIES BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

THEN, NOW
&
AFTER
The Journey that started on a small note has achieved milestones,
with a promise to deliver more in the coming years

BY TEAM BIOSPECTRUM
Then, Now and After are words used very
often in English to refer to time. Then just how Time has changed the face of the life
is used as an adverb and an adjective. sciences industry in the last two decades and how
Now is used as an adverb. After is used it will emerge strongly amidst many challenges
as preposition, conjunction and an and issues, with the support of state and central
governments, working together.

adverb. The common factor among all is an adverb. The editorial team identified the industry

According to Cambridge Dictionary, as an captains, leaders and experts in their domain

adverb ‘then’ has been used to refer to the next such as biopharmaceutical, vaccines, medical

or after that, in addition, as a result. Then, as an devices, in-vitro diagnostics, investments, Bio-IT,

adjective means (at) that time (in the past or in the pharmaceutical, healthcare, contract research,

future). Now, as an adverb means at the present service and solution providers, regulators, who

time, not in the past or future, immediately, any have been part of the successful Journey of

minute/moment/second/time now. After, as a BioSpectrum and approached to share their views

preposition and conjunction means ‘later than’ and on the theme ‘Then, Now & After’.

‘next in time or place’. Here we are taking Then, To commemorate the occasion of completing

Now and After to mean at that time, present time 20 years, we are publishing the viewpoints of these

and next in time. 20 luminaries encapsulating how their fields have

The editorial team of BioSpectrum, when changed over the two decades and what the near

looking for a theme for its 20th Anniversary Issue, future holds, with the promise to deliver more in

has arrived at ‘Then, Now & After’ to express the coming years.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com 20 LUMINARIES 17

ANNIVERSARY

Kiran Mazumdar Shaw Deepanwita Chattopadhyay Hasmukh Rawal
Executive Chairperson, Chairman & CEO, Managing Director,
Biocon & Biocon Biologics IKP Knowledge Park Mylab Discovery Solutions

Dr Krishna Ella Satya Dash Rajiv Nath
Scientist, Board Member, Forum Coordinator
Serial Entrepreneur and Venture Center Association of Indian Medical
Chairman and Managing Director, Device Industry (AiMeD)
Bharat Biotech Dr Vijay Chandru
Executive Advisor, Suresh Vazirani
Raghavendra Goud Vaggu ARTPark, Indian Institute of Founder Chairman,
General Manager, Science (IISc) and adjunct Transasia-Erba
Cytiva South Asia Professor, IISc and BITS Pilani International
Group of Companies
Samir Mehta Arnab Basumallik
President, Co-Chair MTaI Policy Research Nitin Deshmukh
Indian Pharmaceutical Alliance Wing and Director- Government Sr Advisor,
(IPA) and Chairman, Torrent Group Affairs and Market Access, Kotak Investment Advisors
Edwards Lifesciences India
KV Subramaniam Sameer Agarwal
President, Yoshiyuki Fujino Group CFO,
Reliance Life Sciences Managing Director, Manipal Hospitals
Shimadzu Analytical India
Gargi Jain Amit Mookim
IAS, Mission Director, Amit Chopra Managing Director,
Gujarat State Bio Technology Managing Director, IQVIA South Asia
Mission (GSBTM) & Dy Secretary India and South Asia,
(BT), Government of Gujarat Thermo Fisher Scientific Dr K Hariprasad
for Department of Science & President,
Technology (DST) T Anil Kumar Apollo Hospitals
President,
Dr A N Bhadalkar Waters India
Joint Director (BD),
GSBTM and Director, Dr Suresh Thakur
Savli Technology & Business President, IVD, India,
Incubator (STBI) – both of DST, Trivitron Healthcare
Government of Gujarat

BROUGHT TO YOU BY

18 LIFE SCIENCES BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY SAGA OF
GROWTH &
KIRAN MAZUMDAR SHAW BOOM OF
Executive Chairperson, INDIAN LIFE
SCIENCES
Biocon & Biocon Biologics INDUSTRY

As one of the fastest growing Over the last 20 years, life sciences in
knowledge industries in the India has gone from being a nascent
sector to a sunrise industry. When I
country, India’s biotechnology began my own entrepreneurial journey
sector is poised to become a major in 1978, little did I know that I was
sowing the seeds of the country’s biotechnology
driver of the Indian economy. revolution. Up until the mid-1980s, I was the lone
Its benefits are overarching – it entrepreneur in the Indian biotech landscape.
My challenge was to get the market to accept
has the potential to increase biotechnology, which was a new concept back then.
food production and thus reduce An unreliable power supply situation in Bangalore
poverty and hunger. It has a key and the limited resources that I had at that time were
a serious challenge as biotech processes demanded
role in improving the health of uninterrupted power supply and precision process
the nation with next-generation, control. To top the constraints imposed by red tape
and inadequate infrastructure, I needed to import
personalised, affordable every research consumable to pursue critical R&D. As
medicines. Biofuels and industrial I built Biocon step by painful step, the sector evolved
in India around me and the business environment
enzymes have a powerful role became more biotechnology-friendly.
to play in preparing India to be
Government plays a crucial role
a low carbon emitting nation.
The power of biotechnology is Recognising the need to support biotechnology in
both transformational and far India, the government set up a National Biotechnology
Board in 1982 with Dr S Ramachandran as member
reaching and it is for us as a secretary with a mandate to identify areas of priority
nation to invest judiciously and development areas. As the need for a separate
pragmatically in order to derive Department grew, the government established the
the benefits of this technology of Department of Biotechnology (DBT) in 1986 with D
hope for its billion-plus people. S Ramachandran as founder secretary. As a pioneer
Let’s take a look back in history in the industry, I was privileged to be invited to the
and also chart the future, using DBT’s launch. The focus in this phase, through Dr S
the present day potential of this Ramachandran’s nearly seven-year-long tenure, was
on creating an academic ecosystem for biotechnology
vibrant sector. and thereby start generating the required human

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com LIFE SCIENCES 19

capital to support this emerging sector through a ANNIVERSARY
number of Departments of Biotechnology at select
universities, including Anna University, Madurai Eli Lilly and Sanofi had enjoyed for decades over
Kamaraj University, Jawaharlal Nehru University, MS insulins. Biocon has not only been instrumental in
University, Centre for Cellular & Molecular Biology increasing affordable access for people with diabetes
(CCMB), and Institute of Microbial Technology in India but also in serving patients the world over.
(IMTECH) Chandigarh. The DBT was also focusing
on helping the sector overcome the type of challenges To augment R&D efforts and entrepreneurship
faced by Biocon during its formative years – the in life sciences, the DBT created the Biotechnology
dire need for infrastructure for both research and Industry Research Assistance Council (BIRAC) in
development and manufacturing, along with a 2011. As the largest source of early-stage funding,
conducive regulatory environment. BIRAC supported thousands of first-time startups
as well as existing biotechnology entrepreneurs
By the 1990s, the sector started growing in depth in its effort to build the biotechnology innovation
and scope; several biotech companies sprung up ecosystem in the country. Dr Renu Swarup, who
across the country and a cluster effect was seen in played a crucial role in the foundation of BIRAC
Bangalore which soon became India’s pre-eminent and led it for six years, contributed to the industry’s
biotech city. Economic liberalisation in 1991 also success in accelerating and translating breakthrough
brought a sea change in the Indian life sciences scientific ideas into products and services. A role she
industry. Exponential investments were made by continued to play when she took over as Secretary,
leading Indian pharma companies to become global DBT in 2018 after Prof. K Vijay Raghavan’s
players through a combination of rapid indigenous illustrious 5-year stint at the department. At
expansion and overseas collaborations. It was the DBT, she was instrumental in promoting several
start of a new phase for the sector, speeding up the Atmanirbhar Bharat initiatives, which have led
growth of the Indian biopharma industry. India to take a leading role in the manufacture of
diagnostics, medical equipment and vaccines.
As the industry grew, DBT’s focus expanded to
include the building of industry-academia linkages Fighting the pandemic
that were critical to enhancing the sector’s value.
The phase, which spanned Dr Manju Sharma’s When the COVID-19 crisis broke in 2020, the
nine-year stint as DBT secretary, saw the birth of Indian biotech industry drew on its significant
Hyderabad startups Shantha Biotech and Bharat strengths in research, innovation and manufacturing
Biotech which developed India’s vaccine sector scale. It developed and manufactured diagnostics,
based on seed technology developed at CCMB and therapies and vaccines at speed and scale to save
Indian Institute of Science (IISc). In time, India countless lives. In the face of the biggest health
grew to be a biotechnology and pharmaceuticals hot calamity faced by humanity in a century, India’s
spot and a hub for manufacturing small molecule bioeconomy grew over 12 per cent annually to
generics, vaccines and insulins. After Dr M K Bhan reach $70 billion in 2020. The Atmanirbhar
took charge as the secretary of DBT in 2004, he Bharat framework is encouraging the Indian life
steered the biotech sector through his visionary sciences industry to build on its inherent strengths
leadership during his decade at the helm. Among while collaborating internationally to make a
other things, he played a key role in bringing the global impact. The government, through the
rotavirus vaccine to India. DBT, has made tremendous efforts in promoting
bioscience research, translational education and
Realising the Biopharma promise entrepreneurship. This, coupled with a burgeoning
start-up ecosystem, is unleashing biotech innovation
Biotechnology has already delivered several in the country. India needs to build on this
societal and economic benefits to India which in momentum by putting in place a comprehensive
turn have been shared with other global economies. biotech strategy encompassing investment, R&D,
Today, India’s vaccine industry led by the Serum exports and a strong start-up culture.
Institute of India, Bharat Biotech, Biological E and
others accounts for 50 per cent of the global vaccine The next level
capacity. By 2006, Shantha Biotechnics and Bharat
Biotech had disrupted the MNC monopoly for To capture the huge opportunity, India will have
Hepatitis B vaccines not only in India but throughout to act expeditiously, and the government will have
the developing world with the help of the World to play an enabling role by creating a conducive
Health Organisation (WHO). Likewise, Biocon and physical, financial, legislative and regulatory
Wockhardt broke the domination that Novo Nordisk, ecosystem. By aligning their goals, the scientific
community, the industry and the government will be
able to take Indian biotechnology to the next level.

20 VACCINE BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

DR KRISHNA ELLA COMBAT-
Scientist, READY FOR
FUTURE
Serial Entrepreneur and PANDEMICS
Chairman and Managing Director,
India had the advantage of two good vaccines
Bharat Biotech to fight the SARS-COV-2 virus and both
vaccine companies have to be commended
Several facets of our great nation for their contributions during this pandemic.
were brought forth by the sudden India has placed itself in the upper tier of
countries such as the United States and China,
impact of COVID-19. For one, where more than two COVID-19 vaccines were
healthcare infrastructure and manufactured and supplied at scale. Most
diagnostics need fundamental importantly, Covishield and Covaxin were available
changes and strategic direction in the quantities required to vaccinate our large
nation.
for future improvement.
Vaccinology has, however, ‘Necessity is the mother of all inventions’, and
written success stories in both adversity can bring out the best or worst in us.
development and manufacturing.
It also highlighted how public- During the early days of the pandemic (January-
private partnership can succeed, March 2020), while the nation was grappling
building on the nation’s earlier to deal with the pandemic, scientists at Bharat
success with developing and Biotech were chalking out its product development
manufacturing world-class strategies towards a self-reliant indigenous vaccine.
Rotavirus vaccine ROTAVAC, The company had the option of deploying multiple
TYPBAR TCV, the innovator platforms and vaccine manufacturing technologies
Typhoid Conjugate Vaccine such as inactivated, recombinant, viral vectored, etc.
among other world-leading Bharat Biotech had invested in these technologies
vaccines. These challenging times with a significant amount of prior knowledge and
also reaffirmed the growing need expertise in all these platforms including research
to nurture startups in areas of and development.
vaccine development and the ever-
increasing need for the industry Evolution of vaccine
and academia to participate in research in India

advancing science. The primary prerequisite for any new vaccine
is always safety, safety, safety !. The whole virion
inactivated platform technology provided us with
the required assurance of safety, with deep expertise
to rapidly deploy the technologies required for
manufacturing and testing. India was always ahead
in its pursuit to research, develop novel vaccines
such as the Rotavirus, Typhoid Conjugate, Hepatitis,
Zika, Chikungunya, Rabies, among others. Bharat
Biotech had existing BSL3 facilities and a vero cell
manufacturing platform to manufacture inactivated

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com VACCINE 21

vaccines. We received the SARS-COV2 strains ANNIVERSARY
from Indian Council of Medical Research (ICMR)-
National Institute of Virology (NIV)-Pune, and were Covaxin has created an ecosystem
immediately able to start product development for vaccine development,
activities. In fact, several developmental activities manufacturing not just at Bharat
had already commenced prior to the receipt of Biotech, but also around the country.
strains. This will surely improve the scientific
focus required for a country like ours.
The significant aspect of India’s vaccine was its We need to have positive examples
ability to complete all the preclinical studies and of Indian industry and academic
clinical trials required for emergency use approvals. institutions showcasing their ability
The knowledge on inactivated vaccine platforms to rise to the challenges during a
led to extensive pre-clinical studies and to conduct pandemic.
safety, immunogenicity, toxicology, and live viral
challenges, in multiple animal models including used as an adjuvant in Covaxin. The IMDG molecule
hamsters and primates for the vaccine. licensed from a company in the United States, and
the ICMR, both receive royalties as per industry
Clinical Trials knowledge is another significant standards. In the process, these institutions have
aspect of India’s advancement in vaccine science received a rare glimpse and understanding of the
and establishing its position as a world-leading R&D and product development process of vaccines,
vaccine developer and manufacturer. Covaxin has and they will be geared-up for future challenges.
been tested in more than 30,000 subjects (adults &
children), for safety, immunogenicity, and efficacy, The trail of knowledge does not end at
including, detailed immunogenicity evaluation that development and licensure, the manufacturing
was conducted for both humoral and cell-mediated process for Covaxin is being shared with four
immune responses. companies in India and one in the United States.
One of the companies has already absorbed
Covaxin is the most highly studied vaccine the technology, and started manufacturing and
in India, in the Indian population, providing a supplies. The IMDG adjuvant molecule is, also,
great level of confidence on the safety, efficacy, fully manufactured in India - the first adjuvant
effectiveness, and duration of immune responses. to be manufactured within India. Hence Covaxin
These detailed clinical evaluation studies have manufacturing has been 100 per cent indigenised,
defined Covaxin as a Universal Vaccine with providing a great amount of vaccine security to our
the versatility of the same dosage, that can be country.
administered to adults, and children, for the
two-dose primary and booster dose schedules. This initiative will result in the manufacturing
With approvals from India, 25 other countries, ecosystem also being activated for vaccines and
and World Health Organisation (WHO), Covaxin associated technologies and improve our readiness
has become a global vaccine with significant for future pandemics. Both the biotechnology and
demand from foreign countries. It is one of chemical-pharmaceutical manufacturing industries
the few vaccines that have an excellent safety have been involved in the manufacture of Covaxin,
profile, followed by efficacy and cellular immune both playing their roles.
responses.
Covaxin has created an ecosystem for vaccine
Need for self-reliance development, manufacturing not just at Bharat
Biotech, but also around the country. This will
The development of Covaxin was based on surely improve the scientific focus required for a
knowledge and technologies available in India. country like ours.
Its development has also been instrumental in
developing a sustainable ecosystem for vaccine We need to have positive examples of Indian
development and R&D in the country. industry and academic institutions showcasing their
ability to rise to the challenges during a pandemic.
It leaves behind a sense of accomplishment and
self-reliance that the country needs. Institutions Most importantly, the financial resources,
such as the NIV-ICMR and Indian Institute of taxpayers’ money, must remain within our country
Chemical Technology (IICT), Hyderabad, were to strengthen our GDP and reduce the drain on our
instrumental in developing Covaxin. economy.

While NIV-ICMR provided the strains for the
manufacture of Covaxin, IICT developed the process
for synthesis and manufacture for the IMDG molecule

22 BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

CASE STUDY Protein Sciences Corporation Chooses FlowCam for Quality Analysis

WHY CHOOSE THE FLOWCAM?

After doing some research on the available instruments on the Day One FlowCam Stability Study Data
market, Rhodes determined that the FlowCam imaging particle
analyzer would provide the assessment of product quality he Week Four
was looking for. The FlowCam provides information on particle
size, concentration and appearance, and it also can characterize
agglomerates that are transparent and therefore not detected
by light obscuration devices.

“We demoed a couple particle analyzers and we decided on

theCFAloSwECaSmTbUeDcaYuse of the flexibility in choosing objectives, Note: Overall particle count decreased after 4 weeks, and
particle size increased overall when looking at mean and max.
ability to detect particles in the 5 µm range or less, and it
provided real-time data analysis including particle count and

Protein Sciences Corporationshape,”saidRhodes.
Chooses FlowCam for“With the FlowCam, we
PRODUCT QUALITY WITH THE FLOWCAM
get to see the particle
With its
VisualSpreadsheet®
morphology instead

Quality Analysisof just counts, and that

really helps facilitate the
software, the FlowCam can Protein Sciences Corporation has improved overall product
debugging process if record over 40 different quality with the FlowCam. Their prior particle analysis
measured properties per methods of light obscuration and manual microscopy failed
particle and can capture to provide them with enough accurate information and were

particle images at up to 60 too time consuming. By incorporating the FlowCam into their

we encounter any issues frames per second allowing formulation development, quality analysis, and stability studies,

during the development for high sampling efficiency they have created a methodology that not only saves time and
of new products.” and fast analysis times. It money, but results in superior products.
sorts and filters particle
FlowCam® allows for easier, data and immTedHiaEteClyLIENT
- DmavoidreRahcocdueraste, and more dpiasrptilcalyessa. “llTshimePrtiloeastret-itinnygpSeciences Corporation, a Sanofi company, is a biotech firm based in Meriden,
eUaSsPpiine<arf,7roq8trui8mci>clektaeetarsi,tvnainneagdl,sy”muasdobisrdv.esiisRnihfboolrdemeas.ti“vIte’,sianpqsrouomecseetsisowniasyoasf,wttacTChhkhhoaoiaennnlenygntglhepo1iecrn5totgidcwuutco.erTlvhdaetcihrcrmionueissgs,hiothtnheiresactporee“uasttaiivcoesn, laoivnfedisnganenondveaimttihvpeerrovaavpceychpinereoasldtahuncbdtysbfroeiorsppchloiaenrndmtisnaagcnetduottichaels.”

minutes compared to taking a better part of a day.” Rphaordtneesrs, and supply product development and manufacturing services to the
est“imWaetdesemthoaet dthaiscporuopvliedepsarati1c0le-fold savings in laborsactoiernytcifoicstcsommunity.
foraPnraoltyezienrSscainedncwese. decided on the

FlowCam because of the flexibility FLOWCAMTHE CHALLENGE

STiAn BchILooITsiYngSoTbUjecDtiIvEeSs, aWbiIliTtyHtoTHE

detect particles in the 5 µm range or Prior to the FlowCam, David Rhodes, a member of the formulation and analytical
TdtehrsuealteginFnsalpsgol,rywoafsondCirsduasicmnuittcbspil.vsurWiodnsiviohbniwedlgeneuppdtsahaerrreedttyiaiccalhl-lteetaiPscmvroeioneutabnednituanetalkawSncddfiroeunrgmcesuuslbafotsirtoarnnocouerttdispnheareevonescdtleoasbpsimliteynatngdrosuupbvaitsiPbrloetpeianrtSicclieenccoenst,eanntdinhtisheteiradmruugsse:dligtwhtoomAimbbesaoctgvhueeord:adPwtrsiooittthnoeitnaahnnpedaaFlrlytoizcweleCsaams on
andshwaapnet”t-oDdaoviadsRthaboidlietys study, they include the instrmumaneunatl microscopy. Light obscuration inaccurately counts and sdizaeysoanme.orphous and
as pFoartmoufltahtieotneastnindgAantaelyatcihcapl oGirnotu. Tph, is analysis charatcratenrsipzeasrent particles, and manual microscopy is time-consumingLime. f“atNg: Peerdiothwteeiitnrhoatghf gethrFeelgosaweteCsamas

thePprootteeintSiacliednecgersadCaotripoonrpaatitohnway of a product. “Wem’ll emthoonditsorare very informative,” said Rhodes. “For example, whenafwteer fcohuarrwaeceteksri.zed
[the drug] at one week, two weeks, or a month [in stosraamgep]les known to contain particles, we weren’t able to adequatSeilzyecbhaarr=ac2t0eµrmizein both
sptoiazerdt,e”ictsleearimmd iRonhrepothdhoeelsop.g“rWyogiintrheststeshaioednFolooffjwupCsatarctmioc,ulewncetosg,uaennttdtsoathsneadetprttkeahhnareeotlliwsyculhehbeo-lvpwissimblaenpy,ahrtoicwulbaitge.thWeeykwneerwe,[osur banviystibhilnegpaerlsteic.”leRsh] wodeeres
there but we didn’t
was anxious to have

facilitate the debugging process if we encounter any sisosmueesthing that analyzed subvisible particles faster, captured more information, and
quantified more easily and accurately.
during the development of new products.”

YOKOGAWA FLUID IMAGING TECHNOLOGIES 207-289-3200
[email protected]
Yokogawa Fluid Imaging Technologies, Inc. www.fluidimaging.com

CASE STUDY CONTINUED ON REVERSE

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com 23

ANNIVERSARY

CASE STUDY Protein Sciences Corporation Chooses FlowCam for Quality Analysis

WHY CHOOSE THE FLOWCAM?

After doing some research on the available instruments on the Day One FlowCam Stability Study Data
market, Rhodes determined that the FlowCam imaging particle
analyzer would provide the assessment of product quality he Week Four
was looking for. The FlowCam provides information on particle
size, concentration and appearance, and it also can characterize
agglomerates that are transparent and therefore not detected
by light obscuration devices.

“We demoed a couple particle analyzers and we decided on Note: Overall particle count decreased after 4 weeks, and
the FlowCam because of the flexibility in choosing objectives, particle size increased overall when looking at mean and max.
ability to detect particles in the 5 µm range or less, and it
provided real-time data analysis including particle count and PRODUCT QUALITY WITH THE FLOWCAM

shape,” said Rhodes. Protein Sciences Corporation has improved overall product
quality with the FlowCam. Their prior particle analysis
“With the FlowCam, we With its methods of light obscuration and manual microscopy failed
get to see the particle VisualSpreadsheet® to provide them with enough accurate information and were
too time consuming. By incorporating the FlowCam into their
morphology instead software, the FlowCam can formulation development, quality analysis, and stability studies,
of just counts, and that record over 40 different they have created a methodology that not only saves time and
really helps facilitate the measured properties per money, but results in superior products.
debugging process if particle and can capture
particle images at up to 60

we encounter any issues frames per second allowing
during the development for high sampling efficiency
of new products.” and fast analysis times. It
sorts and filters particle

data and immediately

- David Rhodes displays all similar-type

particles. “The testing

process is a whole lot

easier, quicker, and more informative, in some ways, than the

USP <788> testing,” adds Rhodes. “It’s a question of taking 15

minutes compared to taking a better part of a day.” Rhodes

estimates that this provides a 10-fold savings in laboratory costs

for Protein Sciences.

STABILITY STUDIES WITH THE FLOWCAM

The FlowCam is now used at Protein Sciences for routine Above: Protein particles as
testing for subvisible particles in bulk drug substances and imaged with the FlowCam on
drug products. When they have a new formulation or process day one.
and want to do a stability study, they include the instrument Left: Protein aggregates as
as part of the testing at each point. This analysis characterizes imaged with the FlowCam
the potential degradation pathway of a product. “We’ll monitor after four weeks.
[the drug] at one week, two weeks, or a month [in storage] Size bar = 20 µm in both
to determine the progression of particle counts and particle
size,” said Rhodes. “With the FlowCam, we get to see the
particle morphology instead of just counts, and that really helps
facilitate the debugging process if we encounter any issues
during the development of new products.”

Yokogawa Fluid Imaging Technologies, Inc.

24 BCOIOVPEHRASRTMORAY BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY INVESTING IN
BIOPHARMA
RAGHAVENDRA GOUD VAGGU CAN IMPROVE
General Manager, ACCESS TO
Cytiva South Asia LIFE-SAVING
MEDICINES
In the last few decades, the
pharmaceutical industry has This is a challenging issue, because while
been expanding its reach; a PwC access to quality medical products
study had anticipated that by improves health conditions and saves
2018, over 30 per cent of global lives, one-third of the world’s population
pharmaceutical sales would stem lacks timely access to it. Studies suggest
from emerging markets. Another that at least 10 per cent of drugs on third-world
research indicated that from and second-world nations’ shelves are substandard
2015-2020, emerging markets’ or spurious. Regulatory authorities combating
expenditure on medicines was substandard remedies and promoting quality ones
supposed to touch $190 billion in find their efforts insufficient.
sales growth, while Africa alone
registered industry expansion to Implement VA regulatory practices
$20.8 billion in 2013 from $4.7
billion in 2003. These figures are One way to combat issues of lack and promote
clearly indicative of the soaring availability of necessary quality medicines is by
demand for pharma’s (hence applying value-added (VA) regulatory practices and
bio-pharma’s) supply, which utilising available resources such as by convergence
is growing exponentially and and reliance initiatives.
becoming increasingly pressing
Shaping new markets is dependent on
with every passing year. collaborative efforts between industries such as
pharma and food, a path also known as industry
convergence. Merging of these industries has
resulted in the medical nutrition industry. Following
knowledge diffusion and consolidation, subsequent
efforts are based on technological convergence.
While medical nutrition’s core domain remains
food, its technological development is driven chiefly
by pharma advancements. Hence, the success of
this nascent sector is completely dependent on the
degree of convergence of its parent industries.

Simultaneously, each parent market has
to continue to focus on its own path and
initiatives as an entity while converging on the
side. Only in this fashion, can it persist in its
own relevance and continue to contribute as
required to other sectors. By being self-reliant

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com CBOIVOEPRHASTROMRAY 25

and continuing its self-growth, will industries ANNIVERSARY
be equipped to drive newer industries.
The pandemic has once again put
Collaborative R&D ecosystem the spotlight on a relevant but
much ignored factor in biopharma,
In any environment, a collaborative habitat could and that’s manufacturing agility.
spell the difference between success and failure, Being able to produce the necessary
and India’s R&D ecosystem has always registered a quantum of drugs at the relevant
mixed performance. And yet, it managed to respond speed was crucial, and the industry
extremely well to COVID-19, as indicated by over responded with uncharacteristic
72 per cent of respondents in the Global Biopharma speed. While high-income countries
Resilience Index conducted by global industry did perform extremely well, even India
enabler Cytiva. They also indicated a satisfying R&D proved that we could keep pace.
collaborative environment, with the country ranking
a healthy 8th on this particular indicator. The study in order to expedite drug development and
by Cytiva identified collaboration as the unusual manufacturing. Only upon shifting biopharma’s
catalyst to this remarkable triumph. manufacturing gears into the fast lane can be truly
prepared.
With research scientists present through initial
stages and clinical trials alongside regulators Change in government policies
setting the rules for commercialisation, biopharma
is undergoing vast changes right from its initial Policymakers everywhere are recognising the
development processes. Even that can’t explain the value of home-grown R&D and manufacturing,
rare kind of R&D collaboration in the last year in especially of drugs. Governments are coming up
the race to end the pandemic. During the COVID-19 in support of local production and encouraging
Vaccines Global Access (COVAX) initiative, aimed regulators to support the industry’s commercial
at ensuring equal access to vaccines, 190 nations imperatives by way of lenient trade and tax
converged to expedite the immunisation drive. In a policies. In fact, in the Cytiva study, two-thirds
unique step, competing industry operators too set of executives responded in the affirmative about
aside differences to collaborate on the key challenge. their local laws being helpful in development and
manufacture of new drugs. However, now is the
If this unique first continues to be a time for regulators to go beyond simple policy
predominant factor in the industry, it could forge formulation. Public and private funding of startups
unmatched continual momentum and build a is extremely necessary, and should feature in the
vibrant R&D environment going forward. And this policies. The pandemic has already showcased
new approach could possibly remedy the challenges how regulators and companies can collaborate on
faced by the R&D arena. common grounds—this lesson has to be applied
overall, to support every relevant idea’s journey
The question of manufacturing agility from the lab to markets via the evolved models
that have been created during the pandemic.
The pandemic has once again put the spotlight Harmonisation of regulatory systems as one unit is
on a relevant but much ignored factor in biopharma, a great initiative, leading to the hope that one day a
and that’s manufacturing agility. Being able to “global, uniform regulatory system” could finally be
produce the necessary quantum of drugs at the forged. A common set of technical rules makes the
relevant speed was crucial, and the industry path easy for organisations to follow as well as an
responded with uncharacteristic speed. While high- easy approval window, if not a unified global one.
income countries did perform extremely well, even
India proved that we could keep pace. The future of Biopharma

There are still challenges to face in this sphere, Biopharma is an industry of the future. At
since domestic companies doubt their capacity to present, it’s dependent on many factors and
be able to meet their own nation’s needs for several contingencies to succeed and be relevant. This study
medicines. For example, even when it comes to shows the areas in which a little support to this
essential vaccines and insulin, respondents believed industry can pay back in a big way.
their capacity was only to be able to meet about 75
per cent of total local needs if the demand arose.

One of the main reasons cited for the same is a
lack of suppliers’ agility. In order to cure this lack,
transforming the entire manufacturing process is
necessary; as is employing innovative technologies

26 PHARMA BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY WHERE’S
THE INDIAN
SAMIR MEHTA PHARMA
President, SECTOR
HEADED?
Indian Pharmaceutical Alliance
(IPA) and Chairman, Torrent Group India exports pharmaceuticals to
approximately 206 destinations with the US
It has been a long journey for the being the largest export destination followed
Indian pharmaceutical industry by Africa and Europe. It is a leader in vaccine
manufacturing and supplies over 60 per
from being merely an import cent of global vaccine demand. With an export
dependent to emerging as a self- value of $24.44 billion (2020-21), the products of
reliant producer and now as one the Indian pharmaceutical industry continue to
of the main export countries in the improve health outcomes for patients worldwide.
global market. Today the Indian The policy initiatives by the Government of India
and entrepreneurship spirit of Indian industry have
pharmaceutical industry is the made it possible to achieve this.
world’s third largest by volume
and worth over $42 billion. Let’s In the recent Union Budget 2022, the Government
chart the future of this ‘sunrise’ of India recognised the pharmaceutical industry in
the sunrise sector of the economy which is expected
sector as it stands presently. to register a threefold growth in the next decade.
According to the Indian Economic Survey 2021-2022,
the pharmaceutical industry is estimated to reach $65
billion by 2024. The industry aspires to grow to $120-
130 billion by 2030. For this, the industry can embark
on a vision of establishing India’s global leadership
in life sciences, while driving deeper domestic access
and affordability.

Mettle of Indian pharma industry

“Crisis doesn’t create character, it reveals it”. The
pandemic posed unprecedented and new challenges
but it also offered opportunities and learning to the
Indian pharma industry. The pandemic demonstrated
the pharma industry’s commitment to be a reliable
supplier of high-quality, affordable medicines.

The urgency to understand the virus and develop
new medicines and vaccines provided unparalleled
learning opportunities. In India, the industry not only
supplied medicines continuously but also contributed
to preventive healthcare, sanitation and quarantine
facilities. It responded to the challenges of COVID-19
by evaluating the possible utilisation of available

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com PHARMA 27

drugs (repurposing drugs) and exploring innovative ANNIVERSARY
approaches to fight the pandemic. This coupled
with regulatory reforms, initiated by the Central Leading the post-pandemic world
Drugs Standard Control Organization (CDSCO), has
resulted in speedy permissions for clinical trials, and Having contributed significantly to the
encouraged approval of applications to manufacture generics, the industry is now poised to expand
or import drugs and vaccines for trials. its innovation and research and development
(R&D) capabilities to offer cutting-edge products
Over the last two years, collaboration and at affordable prices. It is time to move from
coordination between government, industry and ‘Make in India’ to ‘Discover and Make in India.
other stakeholders was instrumental to address The thrust would be on accelerating R&D and
challenges collectively by sharing best practices, innovation, smart manufacturing, foster policy
knowledge, technology, and experiences. reforms, expedite digital transformation, and
nurture valuable collaborations.
Several Indian companies forged strategic
alliances with global pharma to provide better Focus on R&D and innovation: Indian
access to essential drugs/new treatments for pharmaceutical industry would need to move up
COVID-19 such as Remdesivir, Molnupiravir the value chain and focus on innovation which
among others. Under the initiative of Vaccine accounts for 2/3rd of the global pharmaceutical
Maitri, the Indian government delivered over 14.68 market size. The Indian pharmaceutical industry
crores of doses of vaccine to 97 countries. A new needs to build a strong innovation pipeline
trend of joint development of vaccines by private (with 5-7 new molecular entities and 10–12
entrepreneurs and government laboratories has innovation launches per year by 2047). Towards
also been witnessed. For example, Bharat Biotech this, the industry is now venturing into complex
in collaboration with Indian Council for Medical generics and specialised drugs.
Research (ICMR) and National Institute of Virology
(NIV) manufactured Covaxin vaccine. Foster policy reforms: A fundamental
enabler for a vibrant innovation ecosystem is
Advantage India a strong and efficient regulatory setup e.g.,
having a ‘single window system’, elimination of
Under the ambit of ‘Ease of Doing Business’, the multiple regulatory bodies, establishing detailed
Government of India took initiatives to reduce the guidelines.
compliance burden and amended the Drug Rules.
Further Policy support such as the Production Digital transformation: Digital
Linked Incentive (PLI) scheme for Key Starting transformation is imperative for improved
Materials (KSMs)/ Drug Intermediates, Active patient care, cost-effectiveness, greater
Pharmaceutical Ingredients (APIs) and other transparency, improved production, and drug
pharma products by the government announced development. Supply chains are also becoming
in 2021, is a positive and significant step towards more patient-centric due to the increased
promoting domestic manufacturing thereby adoption of digital tools, telehealth, and app-
increasing not only self-reliance but also cater to based ecosystems.
the Make in India pharma products for the world.
India has the advantage of both scale and reach Nurture valuable collaborations: During
from the pharmaceutical sector perspective. The COVID 19 pandemic, cohesive collaboration
cost of manufacturing pharmaceutical goods in between the government, academia, and
India is relatively lower than advanced countries. industry to promote research initiatives has
India has a highly skilled workforce and enjoys been the key. Regular feedback, integrated
price advantage over other developed nations while efforts, sharing and consistent dialogue
providing best of quality medicines. between industry stakeholders and government
authorities has worked well during COVID-19
The road ahead pandemic and this dialogue should continue in
future too.
India has an advantage of technology and world-
class manufacturing capabilities that have been built Focus on exports: Going forward it will
over the years. This strength is critical in regulated be critical for the industry to consolidate the
and science driven industry as the rate of change existing large export markets and to explore new
is expected to be faster for the next two decades. ones. Indian missions abroad could be great
Agility to adapt will be crucial in sustaining the facilitators in this context. At the same time,
competition. the policies in India would need to focus on
supporting the industry to be competitive in the
export market through policy instruments.

28 PHARMA BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY EVOLUTION AND
DEVELOPMENTS IN
KV SUBRAMANIAM PHARMA INDUSTRY
President,
Today, the pharmaceutical industry
Reliance Life Sciences globally has revenues of about $1.2
trillion, with several large global players,
Apothecaries and Pharmacies which are innovation driven, and a large
sprang up in the middle ages number of generic companies. This
evolution has been influenced by technological
in various European countries progress, changes in regulatory oversight, research
offering traditional medicines. and development of new categories of products and
services, entry of generic products, changes in market
A more formalised way of dynamics & changes in consumer or patient choices.
pharmaceutical industrial
production started much later, Technological changes
probably in the 18th century,
aided by the industrial revolution Unlike some of the other industries like
which was taking place across automobiles, aerospace, information technology and
banking, to name a few, pharmaceutical companies
parts of Europe. Merck in have not been known to be leaders in adapting new
Germany was among the earliest technologies. The highly regulated nature of the
industry is said to be responsible for this inertia.
companies which started as a Pharmaceutical manufacturing processes are
pharmacy in 1668 and by 1817, mostly batch driven processes and not continuous
it had evolved into a formalised processes, as in the petrochemical and petroleum
refining industries. It is only in recent times that
industrial manufacturer of efforts are on to bring about continuous process
alkaloids. The pharmaceutical technologies in biopharmaceutical manufacturing.
industry has further evolved in Programmable Logic Controller-driven equipment,
various aspects in the last two networked through Distributed Control Systems,
centuries. We’ve to see just how evolved in pharmaceutical manufacturing as
the industry is expected to reshape operational efficiencies and quality compliances
itself in the future as technology, took centre stage. Over the last decade or so, further
regulations, therapies as well as automation in order to have better control on quality
compliances, driven by regulatory requirements,
market dynamics evolve. evolved. Laboratory Information Management
Systems (LIMS), Quality Assurance Management
Software (QAMS), electronic batch manufacturing
record (eBMR), Track and Trace system are
some of the information technology-enabled
technologies that have become standard features in
pharmaceutical manufacturing.

Products and markets

Initially, the pharmaceutical companies were
focused on developing products for infectious
diseases and alleviating acute conditions. However,
in the past few decades the focus has been on
developing products for treating lifestyle diseases
and chronic ailments. Over the years, although
relatively expensive, targeted therapies like

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com PHARMA 29

monoclonal antibodies, peptides and tyrosine ANNIVERSARY
kinase inhibitors (nibs) to cell and gene therapies
have come up. This has resulted in better tolerance Regulatory Environment
of therapies among patients and much better
outcomes. In the last three decades, the number It is important to recognise that the
of biologics, including recombinant proteins, pharmaceutical industry is one of the most
as a percentage of overall drugs have increased regulated industries globally. Be it in research
substantially. This trend is expected to sustain as and development of new products and
pharmaceutical companies continue to invest more therapies, development of generic products,
in the development of biological products. conduct of toxicity studies on animals, conduct
of clinical trials on patients or healthy volunteers
While the USA continues to have the lion’s share (for some generic products), manufacturing
of the global pharmaceutical market, emerging and distribution of products - all these aspects
markets of Brazil, China, India, and many of the ‘Rest are governed by stringent regulatory guidelines.
of the World’ countries are growing at a much faster The regulatory oversight has helped the industry
rate, although on a relatively low base. Two leading broadly standardise its product development
global therapy areas - oncology and immunology are pathway, improve safety and efficacy, and
expected to grow at 9-12 per cent and 6-9 per cent improve Good Manufacturing Practices. While
CAGR, respectively over the next five years. Oncology regulatory guidelines are quite evolved in the
is projected to add 100 new treatments and many small-molecule category, in many countries the
new therapies are expected in neurology, including guidelines for biosimilars, stem-cell therapies
novel migraine therapies, potential treatments for and gene therapies are still evolving.
rare neurological diseases and potential therapies
for Alzheimer’s and Parkinson’s diseases. One of The USA, which is the largest market
the areas that has been neglected by pharmaceutical for pharmaceuticals, is also the largest
companies is antibiotics development. This domain generics market. The introduction of ‘The
needs attention because of the increase in antibiotic Drug Price Competition and Patent Term
resistant organisms. Generic companies have Restoration Act’, better known as the Hatch-
increasingly started focussing on complex generics Waxman Act, enacted by the US Congress
and biosimilars because of lower competition. These in 1984, brought about a transformation in
two areas are expected to be the biggest growth the generic pharmaceuticals industry in the
drivers for generic companies over the next five years. USA. Today, about 90 per cent of prescription
pharmaceuticals in the USA are generics.
Consumer behaviour
Regulatory oversight, through review of
Unlike consumer products, patients generally generic dossiers filed for approvals, inspection
play a marginal role in choosing medicines & of clinical and manufacturing facilities and
therapies for their treatment. Those decisions review of post-approval changes, have become
are typically taken or influenced by the treating increasingly stringent over the years. USFDA
doctors or the hospital. However, in current times, has recently notified that, just like the un-notified
because of the proliferation of internet, social inspection of pharmaceutical manufacturing
media access & the resultant (mis)information facilities in the US that they conduct, they would
deluge, doctors & hospitals are made to justify their be conducting similar un-notified inspections of
selection of medicines or therapies more than ever foreign manufacturing facilities too from now
before. Regulators are getting more concerned on. This forces pharmaceutical companies to
with convenience of patients while evaluating a be audit ready on a 24X7 basis.
product, especially a delivery device associated
with the product; its ease of use, storage, clarity of The development data that needs to be
information provided along with the product, & a submitted at the time of filing application for
host of other associated aspects. generic product approvals have also gone
up substantially. Today, regulators insist on
Larger context Design of Experiments-based development to
ensure that critical process parameters and
The pharmaceutical Industry has evolved their allowable ranges are well defined during
significantly in the last few decades. As technology, product development itself. Process validation
regulations, therapies as well as market dynamics requirements too are evolving rapidly. The
evolve, the industry is expected to reshape itself in concept of continuous process validation
future. is now being encouraged to ensure that the
manufacturing processes are robust.

30 GUJARAT BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY GUJARAT TO
BOLSTER BIO-
GARGI JAIN DR A N MANUFACTURING
IAS, Mission BHADALKAR & INNOVATION
Joint Director
Director, (BD), GSBTM and Gujarat Biotechnology policy 2016-21
Gujarat State Director, Savli helped the State in realization of its
Bio Technology Technology & massive biotech exports potential that
Mission (GSBTM) Business Incubator it held and envisioned to increase
and Dy Secretary (STBI) – both of DST, that turnover resulting in enhanced
(BT), Government Government of productivity and growth of Gross State Domestic
of Gujarat for Product (GSDP).
Department Gujarat
of Science & During this policy period, State had enabled
Technology (DST) transformative changes in the industry by
establishing Research Infrastructures such
The development of the State as Gujarat Genomics, Virtual Institute of
specific biotechnology industry Bioinformatics, Marine Bioresource Centers,
occurs largely in regions which Savli Bioincubator, Network of Biotech Capacity
have skilled workforce to aid in Cells, Biotechnopreneur Programme, etc. Clinical
the development of the outputs. initiatives such as Stem Cell Training Programme
and Genetic Diagnostic Centre, etc. that eventually
The biotechnology industry is led to restructuring of Gujarat State Bio Technology
highly knowledge intensive and Mission (GSBTM) and formation of three newer
tends to agglomerate in regions organizations viz. Gujarat Biotechnology Research
Center (GBRC), which provides strong research
where academic institutes, infrastructure including shared lab facilities and
knowledge workers and employees instrumentation, Savli Technology & Business
Incubator (STBI), which focuses on a strong Start-
are available. Additionally, the Up Culture, and Gujarat Biotechnology University
presence of academic institutes (GBU), a dedicated University for Biotechnology.
caters not only to the development It has also augmented the equity-based venture
of the skilled workforce but also financing of Biotech Start-Ups & MSMEs by
partnerships with biotechnology formation of Gujarat Biotech Start-Up Venture
companies. Gujarat stands out with Fund (GBSVF).
a strong performance in all the
above three indicators as per the Further, the State produces above 10,000
Biotechnology Industry Research Graduates each year from above 60 educational
Assistance Council (BIRAC) Report institutions offering more than 55 PG & 45 UG
courses, providing a necessary work force for
on the subject. industry’s overall growth.

Leveraging on the strengths of these initiatives

Gujarat shall leverage on its
institutional strengths to make the
best of the Biotech opportunity.



32 GUJARAT BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

Public Private Partnership basis.

Policy ensures that diverse requirements of

Apart from the rise in ceiling; different Biotech subsectors are addressed through
With 25% subsidy on CapEx Incentives bundling approach, which does not
and 15% subsidy on OpEx; and impose individual ceiling for various CapEx & OpEx
various additional incentives like components.
Employment Generation Incentive,
Policy provides Capital Expenditure assistance
Interest Subsidy, etc.; Gujarat up to Rs 200 crore for ‘Mega, Special and

Ecosystem Strengthening Projects’ and up to Rs

undoubtedly offers best in Class, 40 crore for other BT Units/ projects. Components

amongst all states in India and also covered under Capital Expenditure assistance are
other emerging Biotech Destinations. Plant & Machinery, Building & Utilities, Technology
Acquisition, Registration & Stamp Duty and Green

Energy.

Policy provides Operational Expenditure

and to further strengthen the Biotechnology assistance up to Rs 25 crore per year for ‘Mega,

Ecosystem, Government of Gujarat has Special and Ecosystem Strengthening Projects’

announced ‘Biotechnology Policy 2022-27’ to and up to Rs 5 crore per year for BT Units/

help the State take a leadership role in National projects. Components covered under Operational

flagship programmes such as ‘Make in India’, Expenditure assistance for 5 years are Lease Rental,

‘AatmaNirbhar Bharat’, ‘Atal Jai Anusandhan Power Tariff, Quality Certification, Bandwidth,

Biotech Mission (UNaTI)’ and other National & Market Development and Patent Support.

International Programmes. Interest subsidy for Term Loan shall be at rate of

The policy targets creation of more than 1.2 7 per cent for borrowings up to Rs 100 crore within

lakh employment in the sector, support at least 500 a ceiling of Rs 7 crore per annum and at rate of 3

Business Units and attract investment of at least per cent for amount exceeding Rs 100 crore

Rs 20,000 crore. within an overall ceiling of Rs 20 crore per

Policy covers wide range of beneficiaries annum. In addition to these, Employment

including Business units developing Generation Incentive (EGI) upto Rs

infrastructure projects such as Pre- 60,000, for every local employee,

clinical Trial Facilities, Brownfield Support Upto 100 per cent reimbursement

spaces, Greenfield projects, etc., for Technology of employers’ contribution
Industrial Units venturing Acquisition, Green to EPF and 100 per cent
into challenging sectors such Energy Projects and reimbursement of Electricity
as vaccine production, 3D support for Ecosystem Duty shall be provided under
Bioprinting, Bioplastics, Strengthening is indeed very this policy.
etc. and Industrial Units The Government of
unique, apart from various
relocating from outside Gujarat, with this Policy,

State. other interesting provisions. reaffirms its commitment

Policy by recognizing -Dr Jayraj Doshi, to creating a globally
special projects, which Director, Zytex competitive ecosystem
covers Projects of strategic Biotech Pvt. Ltd., for Biotechnology in the
importance, in challenging Vadodara State by leveraging existing
areas, related to emerging infrastructure as well as building a

technologies, relocating from robust alliance between Government,

other countries/ states and Ecosystem Scientific establishments and Industries

Strengthening Projects such as PPP based in the sector.

projects, Pre-clinical trial facilities, Animal testing The way ahead for the Gujarat biotech industry

facilities, Shared instrumentation, Lab facilities, is to take advantage of the new policy to develop

Brownfield & Greenfield developments, clearly indigenous research processes, new and innovative

defined its focus areas and trust sectors. Policy with biotech products in tandem with international

this approach, has paved the way for development development programmes with international

of regional bio-clusters and industry infrastructure allies, since technology transfer and knowledge

in collaboration with other State & Central Agencies flow becomes a crucial component of overall sector

and private sector funded infrastructure projects on growth.

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34 STARTUP BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY TWENTY PROLIFIC
YEARS OF LIFE
DEEPANWITA CHATTOPADHYAY SCIENCES STARTUP
Chairman & CEO, ECOSYSTEM

IKP Knowledge Park When AstraZeneca’s R&D Centre
(erstwhile Astra Research
The new millennium was Centre India, ARCI) became
ushered in with the conviction operational in 1987 near the
that innovation in life sciences, Indian Institute of Science
especially biotechnology, will play (IISc) campus in Bangalore, it created an open
a transformative role in making innovation environment that helped bioscience
researchers gain industrial R&D exposure. ARCI
India a knowledge economy. could be called the first biotech incubator in India
The optimism was palpable and that helped spawn startups, like Bangalore Genie,
several ventures emerged during Xcyton and Gangagen, and later Aristogene,
Cellworks and Enzene. In 1993, when Dr
the period spanning 2000 and Varaprasad Reddy founded Shantha Biotechnics,
2002 to translate this dream. That it was briefly incubated at Osmania University,
Hyderabad and then at the Centre for Cellular &
was when I moved from Mumbai Molecular Biology (CCMB). Shantha Biotechnics
to Hyderabad to head the newly went on to produce India’s first domestically
developed rDNA product – Shanvac-B, a
formed ICICI Knowledge Park recombinant hepatitis B vaccine, at less than a
(later renamed as IKP Knowledge dollar a dose when the same was globally sold at
$23. Companies like Advanced Enzymes, Biocon,
Park, IKP), the first life science Biological E, Praj, Serum Institute of India (SII),
park in the country, founded by among others, were making their own mark in the
ICICI Bank with support from the biotech field. Bharat Biotech that indigenously
then State government of Andhra developed the COVID-19 vaccine, Covaxin,
Pradesh. But, before reminiscing started operations in Hyderabad in 1996. Two
institutions that funded technology innovations
about the evolution of the life during these times were TDICI (ICICI Ventures),
sciences startup ecosystem since the first Venture Capital Fund set up by ICICI and
UTI in 1988, and the Technology Development
that time, a few trendsetters Board, DST, Government of India (GoI) set up in
that created a fertile ground for 1996, to fund commercialisation of indigenous
technologies. Globally, the Human Genome
change, need to be recognised. Project was causing huge excitement regarding
advances in medicine and biotechnology.

This was the setting when a number of
startup icons began their entrepreneurial journey
between 2000 to 2002. Four Computer Science
faculty from IISc led by Prof. Vijay Chandru
started Strand Genomics (later Strand Life
Sciences), the first bioinformatics and medical
genomics company in India, in 2000. In the same
year, Anuradha Acharya co-founded Ocimum
Biosolutions, another trailblazing bioinformatics
startup. Prof J Ramachandran launched Gangagen

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com STARTUP 35

to develop novel therapeutic proteins targeting ANNIVERSARY
infectious diseases. Dr K K Narayanan and Dr
Gautham Nadig left their corporate research jobs Affordable Healthcare in India fund of Wellcome
to start Metahelix Life Sciences, focusing on crop Trust, UK, the Indo-US Endowment Fund, Grand
protection and productivity. Dr Villoo Morawala Challenges Explorations (GCE) of the Bill &
Patel founded Avesthagen and delved into the Melinda Gates Foundation (BMGF) and Grand
agbiotech and nutraceuticals opportunities. Dr Challenges Canada. A special GCE was launched
Ramanan Laxminarayan, founder, Healthcube, by BMGF in India in 2011 with IKP as the partner,
Bigtec co-founders Chandrasekhar Nair and GM which later on expanded as the DBT-BMGF Grand
Kini, and Dr Bala Manian of Reametrix focused Challenges-India initiative. With grant funding
on developing innovative, affordable point of care and guidance from Indian and global mentors,
medical diagnostics. Dr Sudhir Jain left Ranbaxy young engineers, clinicians and researchers found
to start Concord Biotech in fermentation based an alternate path to channelise their talent to
APIs. ChemBiotech, GVK Bio and Sai Life Sciences innovate for social impact.
augmented the CRO space where Syngene had
already started functioning. These entrepreneurs The growth of biotech startups in India
came with deep domain expertise and have however really began with the launch of the
been a guiding force for the next generation of Biotechnology Industry Research Assistance
startups. The journey of these iconic startups Council (BIRAC) in 2012. Pioneered by DBT
are rich with lessons. Many of these businesses under Dr M K Bhan’s vision, BIRAC became a
succeeded in developing unique scalable models. vehicle to both leverage government funding to
All of them raised capital at a time when biotech de-risk technology development and also develop
venture funding was rare in India. Some of them the ecosystem with partners. The Biotechnology
faltered, several pivoted, got acquired and the Ignition Grant (BIG) scheme with liberal grant
entrepreneurs went on to start one or more new funding drew innovators from across all fields
ventures. of biotechnology to develop the proof of concept
of their ideas. BIG has so far supported over 750
Several ecosystem level developments were startups and innovators from across India, many
simultaneously happening during this time. of whom went on to raise substantial follow-on
Andhra Pradesh (AP), Gujarat and Karnataka had private capital. Fig 1 shows that the number of
set up state level VC funds. AP, Karnataka and startups supported through BIG as a percentage of
Tamil Nadu came up with state biotech policies; the total number of biotech startups has decreased
biotech parks were set up, including the Jubilee from 23 per cent in 2015 to around 14 per cent in
Women’s Biotech Park in Chennai, focussing 2021.
on women entrepreneurs. BioSpectrum was
launched in 2002; the Association of Biotech Led This seems to point to the critical role BIG
Enterprises (ABLE) was launched in 2003. The played in reducing the risk perception of early-
New Millennium Indian Technology Leadership stage funding of biotech startups, thereby
Initiative (NMITLI) of the Department of Science attracting funding from other donors, friends and
& Industrial Research, Government of India (GoI) family, as well as angels and early stage VCs.
was launched in 2003 to fund innovation projects.
The Startup India action plan of 2015
The second wave of bio and medtech brought startups to the centre stage. NITI Aayog,
entrepreneurship came with the Department Central Government ministries as well as State
of Biotechnology (DBT), GoI setting up the Governments launched a plethora of initiatives
Small Business Innovation Research Initiative around incubation and seed stage funding. As
(SBIRI) scheme in 2005. The product IP regime per the Startup India website there are around
was introduced in India in the same year. Some 790 incubators in the country of which around
notable innovative companies founded during
this period are Stempeutics Research, VLife
Sciences, Anthem Bioscience, Inbiopro Solutions.
The Stanford India Biodesign (SIB) programme
of DBT, in partnership with AIIMS, IIT Delhi
and Stanford University in 2007 started clinical
immersion programmes for engineers and shook
up the medtech startup space. This got further
fillip from global partnership programmes like the

36 COVER STORY BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY and vaccines, the startup ecosystem walked in
step with regulators and industry to deliver. The
226 have biotechnology as one of their domains. investment community, incubators, corporates,
The total number of DPIIT registered startups donors and the government rolled out several
in February 2022 is around 63,800 and roughly funds at lightning pace. More than a dozen groups
one-tenth of that would be in the life sciences worked on non-invasive as well as ventilators for
space. ABLE puts the number of biotech startups ICUs. The story of the ICU ventilator developed
at around 5,400 at the end of December 2021. As at IIT Kanpur is well known. Huwel Life Sciences
of 2021, over 17 per cent biotech startups are from was quick to gauge the supply chain issue of its
outside the established clusters (Fig 2). imported reagents and started developing these
in their own labs along with the RtPCR test kit for
By 2010 e-commerce and SaaS platforms had COVID-19. Pune based Mylab, the first company
started revolutionising the technology startup to receive ICMR approval for COVID-19 testing
space with influx of huge global capital. Life and also developed a home based Rapid test is
sciences startups being IP /product driven largely supported by Adar Poonawala, Chairman, SII.
failed to attract the capital needed for scaling. Mylab acquired a majority stake in Sanskritech
Examples of biotech startups that succeeded in in September 2021 and entered into a strategic
raising substantial venture capital are Bugworks, tie-up with Shilpa Biologicals from Dharwad
MedGenome, Zumator, Sea6Energy, String for manufacturing of vaccines and therapeutics.
Bio. Several others like Remidio, Forus Health, I must hasten to add that these are just some
Niramai, Telluris and Tierra Bio Science could examples and there must be at least a hundred
provide a huge impact through early stage capital. startups that need special mention.

Since 2015 the country started witnessing the To judge the evolution and maturity of a
emergence of a large base of healthtech, agtech startup ecosystem my three indicators would be if:
and cleantech entrepreneurs leveraging data, AI ● Some startups from the ecosystem have grown
& ML. Technology convergence across domains
became a norm marked by the emergence of new enough to acquire new startups
age digital health and agtech startups offering ● Some employees from the matured startups
solutions to solve problems across the spectrum
of service delivery attracting several rounds of are becoming entrepreneurs
venture capital funding. The disruptions led by the ● The matured entrepreneurs are mentoring and
COVID-19 pandemic led to wide scale adoption of
digital healthcare services. Turtle Shell (Dozee), investing in new ideas
with its under-mattress wireless health monitoring A startup journey is akin to that of a river.
device could turn a hospital ward bed into a step It starts small and along its path gains strength
down ICU. It raised around $20 million as it through investments and acquisitions, very
went on to serve hospitals. Startups like Predible much like tributaries and at times hives off/or an
Health and Setu helped read CT scans and X-rays, employee quits to grow independently. This goes
providing quick decision support to doctors and on till it itself merges with a dominant river or the
healthcare staff. Predible recently got acquired. sea (IPO). Many streams also die before reaching
another river. Estimates are that 80 per cent of
The pandemic also tested the agility of the the streams on the planet are first to third order
Indian innovation ecosystem, and especially headwater streams. The story of Dr. Reddy’s and
the biotech ecosystem, and it passed the stress Biocon are well known as ecosystem creators.
test with aplomb. From breaking silos and Laurus Labs that started as a 3-member pharma
collaborating to solve problems, to shrinking API startup at IKP Incubator in 2006 has grown
development, validation and manufacturing to become a fully integrated pharmaceutical
timelines to meet the requirements of diagnostics company with a market cap of around $3.8
billion. In 2020 Laurus acquired Richcore Life
Sciences to foray into Biotech and in 2021 took
a minority stake in ImmunoAct, an advanced
cell and gene therapy startup from SINE, IIT
Bombay. This is a happy trend of a maturing
startup ecosystem. I look forward to many more
such examples in this decade of deep science
and deeptech innovations around digital health,
personalised medicine, sustainability, climate
resilience and one health.



38 BIO-IT BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY FROM
GENOMICS TO
SATYA DASH DR VIJAY AGE OF LIVING
Board Member, CHANDRU MACHINES
Venture Center
Executive “The future belongs to those who
Advisor, believe in the beauty of their
dreams” said Eleanor Roosevelt.
ARTPark, Indian At the start of the millennium, a
Institute of Science good decade after India opened
its economy, a few dreamers were quietly building
(IISc) and adjunct the foundations of enterprises anchored to global
Professor, IISc bioscience in a sparse ‘landscape of support’ for
innovations in India then. These founders and the
and BITS Pilani enterprises they led were bold and imagined an
India at the frontiers of global innovation. They
Congratulations to the aimed to leverage novel cutting edge science of
Biospectrum team for diligently early to mid-2000s be it in genomics, molecular
playing the role of an unofficial diagnostics, industrial biotechnology or agriculture.
scribe of the Indian biotechnology The perseverance of pioneering founders of
Strand Life Sciences, MolBio/Bigtec, Perfint, Praj,
ecosystem- painstakingly Metahelix and Neurosynaptics, to push through
capturing its trials and innovations despite the daunting challenges of
limited resources, laid early paths for others to
tribulations over the last two follow. Amongst the early pioneers, Strand was
decades. Where is the biotech the first example of faculty entrepreneurship as a
ecosystem in India headed? Can spin out from the Indian Institute of Science (IISc).
we predict its future? How would It pioneered the emerging synthesis of molecular
the ecosystem look in a decade’s biology and data science to build gold standard data
time? We assume that looking analytics platforms for gene expression, sequencing
at the past may inform us about and mass spectrometry in the realms of integrated
what we need to do to gain speed biology and precision medicine, while MolBio
to reach the high noon of the diligently built a point-of-care molecular diagnostics
product on a multiplex PCR platform that took rapid
Indian biotech industry. TB diagnosis and SARS-CoV2 testing all the way to
the primary healthcare (PHC) level.

Graveyard of prototypes & ecosystem
of translational experience

Today, we notice the growing pains of a semi-
mature ecosystem that we are now. While there is
an entrepreneurial effervescence, most startups
have stalled at the proof of concept (POC) or at early
validation stages- we term this as the ‘graveyard
of prototypes’ stage of ecosystem evolution.
There are multitudes of reasons for this inertia-
lack of infrastructure, inappropriate private and
public funds, regulatory hesitancy, procurement

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com BIO-IT 39

bureaucracy and tenuous linkages of academia ANNIVERSARY
and industry. There is a silver lining within this
phenomenon. It may well be that we have created a Two decades of
graveyard of POCs or even prototypes, but we have saltatory acceleration
also created an amazing pool of human capital of
several thousands of young professional scientists The Y2K phenomena provided a pivot to the
and engineers who have lived the journey of IT industry which took advantage of it as well
product development with a translational bent of as the support of Government of India (GoI)
mindset. This is what we refer to as an ‘ecosystem of to quickly gain market traction; much of that
translational experience’. We do not think that the was business process innovation. There was
‘graveyard of prototypes’ represents a failure but a no similar pivot for the biotech industry in the
stage in the evolution of the biotech ecosystem and early 2000s. The biotech ecosystem has evolved
the unique capacity of human capital that we have in a saltatory fashion anchoring itself to a few
built over the last decade to understand the eddies path breaking programmes by the GoI. By the
and hurdles of product development. This human mid 2000s, the S&T arms of GoI especially the
capital will play an important role in the next phase of Departments of S&T (DST), Biotechnology (DBT)
growth as the ecosystem starts to produce winners. and Council of Scientific and Industrial Research
(CSIR) had launched programmes, such as
Invigorating combinatorial NSTEDB, Technology Development Board (TDB),
Pasteur and Edison Quadrants in SBIRI and NMITLI, which were beginning to
Stokes’ framework create a nascent industry in the biotech and
medtech arenas. However, the density and
How would the Indian biotech ecosystem look frequency of entrepreneurs and new enterprises
in 2035? Building an ecosystem for rocket science being formed were still few and far between. A
is complex and this aphorism is true for biotech force multiplier in the entrepreneurial landscape
and medtech ecosystems. There is no silver bullet, was the establishment of DBT-BIRAC which
however, several parts of the scientific enterprise through its slew of programmes such as BIG
need to mature and come together for the innovation and SPARSH and National Biopharma Mission
puzzle to fit in place. Countries such as Israel, China, (NBM), helped unleash the entrepreneurial
South Korea and Taiwan have demonstrated that energy in the ecosystem which currently
it is possible to build a vibrant biotech ecosystem consists of five thousand biotech and medtech
within a generation. We must also learn from some startups. Most of these startups are at nascent
of their policy initiatives. The global winds of rapid or early technology readiness levels and some
technological change point to a convergence of have late-stage product development and a few
sciences utilizing the prowess of artificial intelligence. have products in the market.
Behold the AI resolution of protein folding (Alpha
Fold) and the shaping of fusion plasma (Deep Mind enterprise (through our startups and SMEs) to build
and EPFL). Our ability to modify genomes with breakthrough products by providing them with access
precision and program cells and living machines to significant public funds, private capital, routes
with greater control of their behaviour and outcome to public markets, clarity on regulation & markets.
is not far behind. The age of living machines defines Additionally, the cobwebs within academic research
the translation agenda for biotechnology to save the infrastructure & mindsets have to be removed,
planet in the Anthropocene. especially when it comes to providing clear routes for
technologies from the bench to market & space for our
Emerging from centuries of colonialism we have incubators & accelerators to expand their footprint.
come far and have achieved significant successes in
translational aspects of science but the status quo With political will and leadership, we are hopeful
speed would not deliver the envisaged future. Covid19 that the Indian biotech industry will become
showed us the inherent strengths that we have and a significant contributor to India’s knowledge
weaknesses that continue to hinder our progress. economy translating scientific knowledge to
Donald Stokes’ ‘Pasteur’s Quadrant’ provides a economic growth. German philosopher and
good framework for visualising the future state Indologist, Friedrich Von Schlegel once said, “The
of the biotech ecosystem. For revving the growth historian is a prophet looking backwards”. Based
engine of the Indian biotech innovation ecosystem, on our experiences of the last two decades we think
Pasteur’s Quadrant (use-inspired basic research) India should and will join the new era of the ‘age of
and Edison’s Quadrant (pure applied research) need living machines’ – it has to if it wishes to sit at the
more granular support. We need to accelerate private high table of global bio-innovation.

40 MEDTECH BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY HOW INDIAN
MEDTECH IS
ARNAB BASUMALLIK METAMORPHOSING
Co-Chair MTaI Policy Research
Wing and Director- Government According to reports from the
clinician conferences held in India
Affairs and Market Access, - global clinical guidelines issued by
Edwards Lifesciences India international bodies like American
Heart Association/ American College
Medical Technology is an ever- of Cardiology are getting accepted in India - like
evolving field whether it is the usage of long durable biological implants over
mechanical implants or shifting to non-invasive
technical specifications of a surgical procedures over open surgeries-all of which
device, operating procedure, aims to improve - Quality Added Life Years (QALY)
features, functions, maintenance and reduce hospital stay. Also, incorporation of
and servicing, or packaging. artificial intelligence and machine learning in
From having a wait time and routine procedures are now helping clinicians
visiting hospitals for a simple to even predict some critical parameters like
BP check to using wearables and hypotension, while treating critically ill patients. The
having health data access on our last two decades also witnessed more focus towards
fingertips, Medical Technology preventive healthcare, which led to significant
decrease in communicable diseases, reduced
has come a long way. We mortality rates, increased life expectancy and
have witnessed how much the enhanced well-being among geriatric population.
turnaround time of test results
has reduced, and how accurate However, with every technological advancement,
they have become. Diseases with there comes an accompanying need to update the
very high mortality rates which systems, regulations, infrastructure as well as the
were untreatable before, including ability to operate the technology. If we look at the
heart diseases or accidents with history of how the medical technology sector has
severe crippling complications travelled this journey in India, we will see all these
like loss of limb, etc., have now challenges and the correlating steps that were taken
become treatable with the help of to handhold and nurture the sector and to make it
future ready.
medical devices.
The policies and regulatory lifecycle saw multiple
amendments and updates to catch up to the speed
of requirements of the medical technology sector.
With the first medical device notification of syringes
and needles in 1989, the next notification of 10
more sterile devices took place in 2005. In 2012
the Central Drugs Standard Control Organisation
(CDSCO) released guidance document for the
import of medical devices and in 2018 with the
implementation of Medical Device Rules (MDR)
2017, the MedTech industry received their own
rules, harmonised with global best practices, which
then gave out the details of all regulatory processing,
filling and applicable statutes. Thereafter, more
devices were brought under regulation through
MDR 2017 and in Feb 2020, the definition of drugs
was further expanded to include all medical devices
under regulation in a phased manner. In future,

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ANNIVERSARY usage of new categories of medical devices. Hence
the PPO also needs to have provisions for necessary
Growth factors exemptions to innovative devices which are not made
in India. On Government Public Procurement, we
One of the most vital factors to determine also see the adoption of Transparent Quality criteria,
growth of a sector is to look at its economics. in the last Union Budget, which will lead to much-
The growth trend in India indicates that the needed value-based-procurement in healthcare.
healthcare sector grew up from $45 billion
from 2008 to $240 billion in 2020. The CAGR Another significant development in the recent
was particularly high in the year 2016-2020 years, is on the pricing regulation- which has shifted
where it remained at an average of 22 per cent, from cost-based price capping to market-based
which made the healthcare industry one of the price capping in 2012, with the introduction of
largest sectors of the Indian economy both National Pharmaceutical Pricing Policy 2012 and
in terms of revenue as well as employment. Drug Price Control Order 2013. The policy took
Similarly, the Government spending on a further shift to Trade Margin Rationalisation
healthcare has reached 1.6 per cent of GDP, (TMR), from first point of sales (price to the
from 1 per cent, but the same needs to be distributor). TMR was first introduced in February
increased to at least 2.5 per cent by 2024-25 2019 for 42 cancer drugs and then for 6 essential
as per the aspirations of our National Health medical devices required for COVID treatment,
Policy 2017. The Medical devices’ share in reducing the Maximum Retail Price (MRP), and thus
the entire healthcare market stands at around increasing patient affordability but without affecting
$11 billion. This is just 1.6 per cent of the innovation.
global medical device market, which is not in
proportion to India’s share of global population While the government is taking steps to ease
which is around 18 per cent. Comparing this the supply side issues, industry remains hopeful to
with the pharma sector, where India has a see more action to increase the demand side. The
market share of 14 per cent by volume clearly National Infrastructure Pipeline 2020 (NIP) created
indicates an opportunity of enormous growth by NITI Aayog and Ministry of Finance, aspires
for the Indian med-tech sector. to create 73 new tertiary medical centres and a
few state-of-the-art hospitals to enhance research
India can also look forward to being a member of activities. Budgetary provisions are already provided
International Medical Device Regulators Forum in 2020 and in 2021 to meet these aspirations.
(IMDRF) and to be a co-participant in the Medical Further a relook and revision of the Ayushman
Device Single Audit Programme to integrate our Bharat and CGHS package rates is required, to
regulatory system with global best practices. ensure that the critically ill patients get the right
treatment and also to undertake more patients into
To ensure a smooth sailing projected growth the ambit of reimbursement/ insurance, to achieve
trajectory, the government has brought in multiple Universal Health Care. This will help us to achieve
schemes recently - like – 100 per cent foreign the United Nations Sustainable Development Goal 3,
direct investment (FDI) to boost the sector, both of Good Health and Well Being, which is also a part
in green field and brown field since 2015. Make in of our National Health Policy 2017.
India campaign started in 2015; Ayushman Bharat
started in 2018, Production linked incentives were Furthermore, many other policies like draft
introduced for select categories of medical devices, R&D policy, emphasis of National Digital Health
starting 2020. Public Procurement Order (PPO) mission are also in the government’s pipeline which
which encourages procurement of locally made promises to take the sector to its envisioned heights.
medical devices was also introduced last year. Launch of Digital health mission will help in
However, as India imports around 86 per cent of unbiased patient data collection and its utilisation,
its medical devices and even more so for the high- in anonymous form, thus improving patient care
end high-risk devices, the policies need to be more and help in future R&D endeavours. Moreover, we
inclusive to ensure that the emphasis remains on see efforts for the adoption of a Circular Economy
patient safety and patient accessibility to quality with active public policies on regulation – this may
medical devices at all times. The Medical Device help Tier 2 and Tier 3 cities’ aspirational hospitals
industry is continuously innovating, and the latest in gaining refurbished medical devices. It will
generation of innovative medical devices needs to also be interesting to see how India formulates
be included, for improving patient outcomes and trade relationships with the countries it has good
to keep our medical fraternity updated about the relationships with, as friend-shoring has become the
need of the hour.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com ANALYTICAL INTELLIGENCE 43

YOSHIYUKI FUJINO ANNIVERSARY
Managing Director,
Shimadzu Analytical India HOW AI CAN
HELP SOAR LAB
Artificial intelligence (AI) is all PRODUCTIVITY &
around us. Every day, we see PROFITABILITY

new uses emerge to help make With an emerging wave of AI-
everyday tasks more efficient powered innovations, ideas about
what LC analysis should be, are
and solve problems across beginning to change. It calls for
multiple industries. From digital an analytical environment that
personal assistants like Alexa to can deliver identical results regardless of whether
self-driving trucks to automated the analyst is present in the laboratory or familiar
with the operating procedures, as long as the analyst
manufacturing facilities, AI performs the same operations and data analysis.
technologies are changing the way
Using new and exciting technologies to increase
we live, work and do business. throughput, improve accuracy and protect valuable
And now, this new technology columns, Shimadzu has developed the concept of
can also help analytical scientists Analytical Intelligence which is delivering what
is required for continued success. Analytical
maximise the accuracy and Intelligence is a smart analytical platform that
repeatability of their Liquid incorporates artificial intelligence (AI), Internet of
chromatography (LC) analysis. Things (IoT) and machine learning (ML) algorithms
with advanced monitoring, self-diagnostics and
auto-recovery capabilities.

This new analytical instrument concept consists
of systems and software that simulate expert
operators automatically determining whether
conditions and results are good or bad, providing
feedback to users, and resolving common problems.
It improves data reliability by compensating for
differences in instrument knowledge or experience
between users. This idea isn’t limited to automating
an analytical workflow or performing remote
operations. It enables anyone to obtain reliable data
and analytical results by aggregating and automating
the knowledge and skills of experienced analysts.

Analytical Intelligence goes hand in hand with
Shimadzu’s ‘Excellence in Science’ brand value
proposition. Numerous ‘world’s firsts’ which
meanwhile, have become industrial standards, as
well as increasingly sensitive measuring methods
substantiate this claim. With these technologies,
Shimadzu enables customers from the most diverse
industries to develop new products and solutions to
promote and support consumer, patient and product
safety as well as environmental protection.

At Shimadzu, all new products are obliged to
have less environmental impact than previous

44 ANALYTICAL INTELLIGENCE BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY supplements the market growth. Strict monitoring
and stringent rules set in the food and beverage
Significant progress has been industry by government authorities drive this
made in automating analytical growth further. The COVID-19 pandemic had a
operations in an effort to improve positive effect on the market due to high demand for
productivity and prevent human multiple spectrometers from the pharmaceutical and
errors. Nevertheless, differences biotechnology industries. However, the prolonged
in the functionality, performance, lockdown hampered the manufacturing activities,
and operability of instruments and disrupted the supply chain, and increased the prices
software; and also in the level of of raw materials.
analytical chemistry knowledge and
expertise, can affect the reliability Optical measurement technologies-
of results and the condition of Technological advancements have encouraged the
instruments. development of several industries, owing to these
advancements many industries are getting inclined
products, thereby contributing to reducing CO2 towards automation for providing high-quality
emissions. In particular, products at least 25 products. Many companies in diverse industries
per cent smaller or at least 25 per cent lower are using optical measurement instruments to
energy consumption than previous products are maintain the accuracy of their products during the
certified as “Eco-Products Plus,” promoting the manufacturing process. In the pharmaceuticals
commercialisation of instruments with excellent and chemical industry, the increasing focus on
environmental performance. the development of high purity grade products
is expected to increase the demand for optical
As a first step, selected system solutions measuring instruments. Lately, the demand for
incorporating Analytical Intelligence include video measuring machines (VMM) has been on a
the Nexera series of (U) HPLC systems, the new rise owing to their features such as high speed and
UV-i Selection spectrophotometers and the Nexis increased accuracy. The advancement in science
SCD-2030 sulfur chemiluminescence detection and technology is expected to propel market
system. The latest is the new, integrated i-Series growth in the next few years. Furthermore, an
LC system as it keeps the excellent performance increase in the number of patients having an eye-
of its predecessor but also addresses the demands related problem is further expected to increase the
of an increasingly varied range of users, locations, use of optical measuring instruments for diagnosis
and approaches to analysis while always delivering purposes apart from their other uses in the
highly reliable analytical results. healthcare industry.

Significant progress has been made in AI solutions- The AI in healthcare market has
automating analytical operations in an effort to historically been showcasing significant growth
improve productivity and prevent human errors. owing to the rapid adoption of AI and ML solutions
Nevertheless, differences in the functionality, in the healthcare sector. The onset of the COVID-19
performance, and operability of instruments and pandemic proved to be an opportunity to showcase
software and also in the level of analytical chemistry the prowess and sophistication AI can bring to the
knowledge and expertise can affect the reliability healthcare sector. During the second wave of the
of results and the condition of instruments. As a pandemic hospitals and clinics across the world
result core technologies such as mass spectrometry made use of AI-based virtual assistants, inpatient
and biotechnology, which are widely applied in care bots, and AI-assisted surgery robots to handle
drug discovery, medical research, and regenerative the continuous influx of patients, which would
medicine, as well as optical measurement have otherwise overwhelmed the entire hospital
technologies and AI solutions will have a significant operation cycle. With governments allocating funds
role to play in the coming years. to develop AI applications in the healthcare sector,
the market is expected to boom over the course of 5
Mass spectrometry- Technological to 10 years.
advancements in mass spectrometry have led
to increased applications of this procedure. In In today’s new normal, we wish that by
addition, rise in private funding and government combining our award-winning technologies along
grants for R&D activities of mass spectrometry with your expertise and experience, we could work
together and address the challenges that the pharma
industry faces and realise our wishes for the well-
being of mankind and the earth.



46 LABORATORY 4.0 BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY FUTURE-
PROOFING
AMIT CHOPRA LABS THROUGH
Managing Director, AUTOMATION
India and South Asia, AND IMMERSIVE
Thermo Fisher Scientific TECHNOLOGIES

The laboratory ecosystem, today, Now more than ever, there is an
is undergoing a massive change escalating need to provide a modern,
and transforming business and quality-driven digital approach
operating models by leveraging to laboratory operations that
digital technologies. In the last offer customers unprecedented
few years, the industry has convenience, impactful innovations, and reliability.
witnessed a gradual shift from It’s called Laboratory 4.0., which refers to the
physical experiences to digital complete automation of lab processes using
experiences in a steady manner. automation software, laboratory informatics,
However, the pandemic has robotics, interconnectivity, big data, analytics,
accelerated adoption of digital and machine learning to create a more holistic,
technologies, modernising better-connected, self-monitoring and smart
infrastructure to support lab environment. Automation delivers benefits
more automated, connected including increased productivity, scalability,
environments, and recruiting, enhanced safety for personnel, reliability, and
retaining, and upskilling a cost-effective operations. As a result, Laboratory
highly experienced workforce. Information Management Systems (LIMS) and the
Let’s see what the future holds Internet of Laboratory Things (IoLT) have emerged
for laboratories with respect to as solid pillars of lab automation.
automation and digitalisation.
Automation and LIMS

Over the last decade, laboratory automation
has proven to be critical, and its benefits, such
as increased throughput, standardisation,
and reproducibility, have been recognised by
organisations worldwide. The importance of
automation has especially come to light during
the COVID-19 pandemic, where it has enabled
laboratories to operate efficiently in a challenging
climate. Initially used to allow high throughput
screening in drug discovery, automation benefits
are now also being recognised in other areas, for
example in quality assurance (QA)/quality control
(QC), production environments and precision
medicine. It has many applications across different
stages of the pharmaceutical industry and most
recently, implementation has been rising in
diagnostic testing for COVID-19.

The COVID-19 pandemic has created huge

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com LABORATORY 4.0 47

challenges for laboratories worldwide. Achieving ANNIVERSARY
high throughput workflows, data integrity, and
traceability are game-changers in enabling diagnostic Over the last decade, laboratory
laboratories to scale up services and expand testing automation has proven to be critical,
capabilities in response to COVID-19. The need to and its benefits, such as increased
maintain continued operation with fewer people throughput, standardisation, and
on site, minimising errors and managing intense reproducibility, have been recognised
pressure for increased capacity and expanded services by organisations worldwide. The
has placed additional demands on data management importance of automation has
systems, automation, and technology. especially come to light during the
COVID-19 pandemic, where it has
Expanding high throughput testing capabilities enabled laboratories to operate
without scaling workflows in the digital space can efficiently in a challenging climate.
limit the efficiencies automation offers and potentially
compromise the integrity of results. Highly increasingly been viewed in a strategic way to assure
automated molecular diagnostic testing systems, such business continuity.
as the Thermo Fisher Scientific Amplitude solution,
have been developed and can analyse up to 8,000 Virtual Labs and Immersive Centres
COVID-19 specimens in 24 hours with minimal user
interaction. By using new systems such as this, which The pandemic has also compelled businesses
incorporate all three pillars of automation, including to adapt to changing market trends and customer
advanced data tracking via LIMS, laboratories can needs. As a result, companies are committed
rapidly scale their COVID-19 testing workflows to to fueling their digital transformation efforts,
the high volumes needed. This ultimately helps encompassing the Internet of Things (IoT), extended
reduce the spread of disease and restore economies reality, big data, AI, ML, and cybersecurity. Today,
and communities. LIMS have a key role to play virtual reality is also emerging as a key enabler in
in collecting, centralising, and managing data, ensuring an enhanced customer experience. Setting
automating processes, and delivering connectivity a benchmark, Thermo Fisher launched Labatar —
and data integrity to provide a strong foundation for the first virtual lab in India last year using these
artificial intelligence (AI) and machine learning (ML). digital drivers. Built on immersive technology,
Labatar supports the customers’ critical needs and
For example, LIMS manages Standard Operating offers an immersive online experience by helping
Processes for analytical instruments and collects them engage virtually with our state-of-the-art
large amounts of high-quality experimental and technologies while performing complex research.
operational data, storing it in a manageable way The platform seamlessly depicts a fully equipped lab
so that it can be analysed in deep learning. LIMS environment and walks the user through each step
software handles data securely and comprehensively of a workflow, using easy-to-understand instructions
to ensure data integrity and traceability, which that simulate the experiments performed in a
is crucial for complying with regulations and physical lab. The platform hosts several workflows
guaranteeing product/result quality that offer expediency, allowing customers to learn
from industry experts while performing experiments
LIMS also allows laboratories to automate with the click of a mouse and get a first-hand, virtual
processes, such as reagent re-stocking or flagging experience of handling them.
when instrument maintenance may be required.
Lab automation specific software solutions, such as The road ahead
Thermo Scientific Momentum workflow software,
enable connection to external applications such as At Thermo Fisher, we are future-proofing
LIMS, electronic laboratory notebook (ELNs) and laboratories with new and expanded capabilities in
other platforms to streamline data management automation and digitalisation. The pandemic has
and tracking. This connectivity also enables irreversibly changed the way people interact with
users to connect and synchronise applications technology. Our objective is to support researchers,
across multiple laboratory sites. Furthermore, industry, and society at large and remain steadfast
automation provides flexibility for laboratories in our mission to enable our customers to make the
to scale operations to meet current workflow and world healthier, cleaner, and safer.
future capacity needs. The higher quality data
generated can more easily be used for AI and ML
applications to drive further insights. In fact, during
the COVID-19 pandemic, laboratory automation has

48 IMAGING TECHNOLOGIES BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY BURGEONING
SCOPE OF
T ANIL KUMAR ENHANCED
President, IMAGING
TECHNOLOGIES
Waters India
Imaging has numerous potential applications
Imaging technologies save lives with ion mobility including: Health Sciences,
by helping to diagnose diseases Pharmaceutical – DMPK and Pre clinical
toxicology, histopathology, Clinical research
and aid the development of and pathology, Food industry, Cosmetics
new therapies. From Boston to industry, Forensics and Chemicals industry-
Bangalore, the demand for new coatings, paints, self-organising surfaces.

and life-saving therapies has India currently imports almost all major imaging
never been greater. Today, it’s equipment for diagnostics. This leads to a very high
the focus on both small and large cost burden to the medical practitioners and to
molecules. Tomorrow, there will the patients. National Biopharma Mission (NBM)
be more change. In the future, of Department of Biotechnology (DBT) supports
development of core technologies and subcomponents
advances in 3D imaging and of major diagnostic imaging equipment. According
improvements in the speed of to BIRAC four companies such as Healthcare
image acquisition are expected Technology Innovation Center, Chennai; Voxelgrids
to take off. The progress achieved Innovations Pvt. Ltd., Bangalore; Univ Labs
in imaging technology will assist Technologies, Delhi and Irillic Private Limited are
scientists in putting together a working on this area with grants from DBT.
more complete picture of diseases
and ultimately benefit patients Increasing interest and utilisation

worldwide. The field is also In the past few years, mass spectrometry imaging
expected to shift toward increased (MSI) has seen a rapid increase in interest and
utilisation in areas such as proteomics, biomarker
portability of medical imaging discovery and validation, drug distribution, and
instrumentation, with smaller clinical research. MSI was originally developed
ultrasound devices already on the using a matrix assisted laser desorption ionisation
market that can provide Colour- (MALDI) mass spectrometer, where the sample
flow Doppler imaging powered is prepared by first coating it with an ionisable
matrix. Then, the sample is placed under vacuum
solely by batteries. and a rastering laser is used to ionise molecules in
the sample for analysis by a Time-of-flight mass
spectrometer (TOF-MS).

More recently, an ambient ionisation technique
called desorption electrospray ionisation (DESI) was
introduced and applied to MSI to allow for the direct
analysis of surfaces at atmospheric pressure. DESI
imaging uses a charged jet of solvent to deposit
micro-droplets onto a surface where analytes
are extracted and desorbed into the gas phase at

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com IMAGING TECHNOLOGIES 49

ambient pressure and temperature. Subsequently, ANNIVERSARY
they are drawn into the MS inlet where they can be
analysed using a TOF-MS. Use of DESI imaging has the
advantages of requiring minimal
DESI imaging represents a significant sample preparation to collect a
enhancement in the capabilities of mass wealth of molecular information. DESI
spectrometers to analyse and determine spatial imaging has been shown to be very
localisation and molecular distribution of target effective in analysing small molecules
molecules within a variety of samples. Use of DESI such as lipids or other small molecule
imaging has the advantages of requiring minimal cellular metabolites. DESI imaging
sample preparation to collect a wealth of molecular provides effective and meaningful
information. When optimised, the technique allows molecular spatial localisation within
for either multiple analyses of a single sample a variety of samples with minimum
(with different MS polarities if desired) or enables sample preparation.
additional visualisation techniques (i.e. staining)
to be performed on the sample after DESI imaging benefit of larger society. Today, modern genomics
is complete. DESI imaging has been shown to be means it is possible to produce formulations for
very effective in analyzing small molecules such as individuals depending on the make up of their DNA.
lipids or other small molecule cellular metabolites. Understanding the role DNA plays in our health and
DESI imaging provides effective and meaningful our body’s ability to fight disease makes it simpler
molecular spatial localization within a variety of to predict segments of the population where illness
samples with minimum sample preparation. is likely to occur, make better diagnoses, and create
targeted treatments dependent on individual genetic
Waters is the sole source provider of Desorption factors.
Electrospray Ionisation (DESI) Imaging
technologies. Combined with MALDI Imaging Swift testing and approvals: Biotech data
and ion mobility mass spectrometry (IMS-MS) is being used to speed up this process by allowing
techniques, our Full Spectrum Molecular Imaging simulations of interactions between medicines and
capabilities allow the visualisation of a wider range the human body, rather than having to rely on costly
of molecular ions and provide key insights into the and time-consuming human trials for every stage of
underlying mechanisms of cancer, cardiovascular the process. Following the emergency development
and neuro-degenerative diseases. From Boston and approval of COVID-19 vaccinations, huge efforts
to Bangalore, the demand for new and life-saving have been made to speed up the process of testing
therapies has never been greater. Today, it’s the and approving new drugs. Much of this is reliant
focus on both small and large molecules. Tomorrow, on research and data originating in the field of
there will be more change. The change is constant biotechnology.
and all need to move with the change. Looking at
the current life sciences ecosystem the following will Sustainability and improved durability:
play a significant role in the next five – ten years. In the wake of increasing environmental awareness,
it is expected that in the coming decade green
Organoids: The progress made in the technologies will help accelerate the rate of change.
development of stem cell-derived organoids was Innovations predicted to take off in the future
a defining feature of the 2010s. Circumventing are varied, including regenerative and recyclable
the need for animal testing in the cosmetic and batteries. Further trends in the technological
pharmaceutical industries, organoids mimic human industry include finding new ways to capture and
organs to provide highly accurate results during store carbon waste and increasing efficiency to
drug R&D. Supported by advances in 3D cell culture reduce environmental toll.
techniques to further reduce expense and the need
for preclinical testing procedures, the market growth With clear understanding and foresight, together
for organoids is consequently predicted to surge we can take one step closer to achieving our visions
in the coming years. Organoids may even replace of the technological future. In this new decade as in
conventional research and drug discovery methods, all others, we are prepared to work with innovators
changing the face of R&D in the pharmaceutical to meet new challenges and grasp opportunities to
industry irrevocably. develop the next-generation technology the world
needs.
Personalised medicine: Traditionally
therapeutics have been recommended on a ‘one
size fits for all’ basis, and drug trials are used to
establish which formulations are best suited for the

50 LAB MEDICINE BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY Improved throughput with sample multiplexing,
higher sensitivity in finding low-frequency variations,
DR SURESH THAKUR the faster turnaround time for high sample numbers
President, and cost effectiveness are the advantages of NGS
over previous sequencing approaches. After Sanger
IVD, India, Trivitron Healthcare sequencing, NGS represents a true sequencing
technology revolution. Sanger sequencing took
HOW GENOME several years and billions of dollars to sequence
SEQUENCING the first human genome. However, with the advent
& MASS of NGS, a complete human genome can now be
SPECTROSCOPY sequenced in a few days at less expense.
IMPROVE LAB
MEDICINE NGS offers a wide range of applications in
laboratory medicine and has become an integral
When the outbreak of COVID-19 aspect of precision medicine. The technique has been
was first announced by the World used in diagnosis, prognosis, and therapy selection
Health Organisation, metagenomic for constitutional disorders, cancer, and infectious
next-generation sequencing diseases. At the same time, a growing body of
(NGS) was deployed to identify well-curated clinical and genomic data is becoming
and uncover SARS-CoV-2 infection caused by the available.
novel coronavirus. The quick development of reverse
transcription (RT) PCR techniques for detecting The breakthrough came when we understood
specific segments of the SARS-CoV-2 genome was the function of genes providing essential insights
aided by the early identification and sequencing into the human body and what happens when we get
of SARS-CoV-2. Major advancements in mass sick. This was the rationale for the Human Genome
spectrometry (MS) are providing complementing Project, which lasted 13 years and cost $2.7 billion.
data for the drive towards precision medicine, The world has progressed rapidly, and we can, now,
alongside advances in next-generation and whole- map a human genome in a matter of hours, at a
genome sequencing. fraction of the previous cost. Fast, large-scale, low-
cost DNA sequencing has catapulted genomics into
the mainstream of medicine, ushering-in a revolution
in precision medicine.

Gene therapy for cystic fibrosis has grown as
scientists have gained a better understanding of
the human genome. Because they contain defective
alleles, members of some families are more likely
to acquire specific forms of breast cancer. These
alleles have been identified as a result of the NGS.
People can now be tested to see if they carry these
alleles in their DNA; the procedure allows the
person to decide whether or not to have surgery
to remove breast tissue before cancer develops.
If both parents are checked for the alleles, it also
allows doctors to forecast the likelihood of any
offspring developing disease. The ability to sequence
the DNA in cancer cells is a huge breakthrough in
medicine. The treatment is extremely effective, and
it would not have been possible without an in-depth
understanding of DNA sequencing and the human
genome.

Now the human genome sequence has been
determined and it is hoped that the new treatments
can be developed in an easy manner. Modern
medicine will be transformed by the ability to target
diseases with specific drugs and the use of gene
therapy to treat diseases on a patient-by-patient
basis.