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4 BIO CONTENT BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

COVER
DESIGN BY:
DOMINIX STRATEGIC
DESIGN PVT. LTD.
NEHA METHA

COVERSTORY......................................................................................................................................................... 23

CMOS- SUPPORTING
THE PHARMA INDUSTRY
The Indian pharma industry has shown tremendous progress on several indices such as
infrastructure, technology, product range, GMP, regulation compliant manufacturing facilities. Also,
the high quality standards of purity; stability and international safety; health and environmental
protection under which bulk active ingredients are manufactured and supplied by Indian
pharmaceutical companies ensure that they will pass through several rounds of stringent
assessment by various regulatory authorities. India has already gained a foothold in the global
arena of export due to its high proficiency in manufacturing fantastic quality of drug products.
Moreover due to the high number of CMOs available, Indian pharma is looking for better prospects.

STARTUPS ANALYSIS
30 34
Startups advancing women Is CRISPR Causing Concern?
health & hygiene through innovation!

Q&A
12 36
“Indian initiatives driving growth “KIHT to support indigenous
in translational research and research and manufacturing
biobanking are complementary capability to make India self-
to our company ethos” dependent”
Dr Jas Sanghera, Dr Jitendar Sharma,
Co-founder and senior partner, TTP Group; CEO of KIHT, India
Chairman of TTP Labtech
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com BIO CONTENT 5

Q&A TOPVIDEO
40
“Today, most local Dr Amod Nayak,
problems have global Medical Director,
solutions and vice-versa” Dr Agarwal’s
Prof Pankaj Chandra, Eye Hospital,
Vice-Chancellor, Bengaluru talks
Ahmedabad University about the latest
situation of eye
diseases and their
42 treatments in India.
“Collaborations are always
welcome as they expand the
strengths mutually”
Prof Pradeep K. Khosla,
Chancellor, University
of California San Diego

Scan the QR Code »

44
“Annual percentage of cancer
detected at awareness camps is 5%” Dr K R Balakrishnan,
Dr. Harsha Rajaram, Director, Cardiac
Vice President, Sciences, Fortis
Columbia Asia Hospitals
Hospital, Chennai
highlights the
challenges being
OPINION faced by the
field of organ
46 transplantation in
Indian pharma should India.
focus on quality
Sanjeev Gupta,
Managing Director,
Kusum Group of Companies, India

Scan the QR Code »

Tejbir Singh,
CEO & Co-Founder,
REGULARS AffordPlan gives
out solutions
BioEdit ........................................................................06 for affordable
BioMail .......................................................................08 healthcare in
Policy and Regulatory News.....................................09 the form of
new financial
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6 BIO EDIT
Implanting correct measures
T
he details coming out of the Johnson
& Johnson (J&J)’s Acetabular surface
replacement (ASR) hip implant controversy
raise more questions than answers. This metal-
on-metal type hip joint replacement device is
manufactured by J&J’s fully-owned subsidiary
DePuy Orthopedics Inc. It was withdrawn
globally by the company in August 2010 following
complications developed among some patients
fitted with the implant requiring many patients
to undergo revision surgery. As against the
permissible limit of 5% almost double the number
of patients developed the complications requiring
the product recall.
Like in case of many other faulty drugs and
medical devices ASR hip implant too has become
a big legal issue in the US with the company facing
lot many court cases and ending in paying millions
of dollars as compensation . The company agreed
to pay approximately $2.5 billion in 2013 covering
8,000 patients to settle thousands of law suits
emerging out of the faulty hip joint. But in India
the patients with post-operation complications
have not been paid any compensation. The reason
reported being that there is no provision for
compensation in case of approved products as per
the Act.
The hip joint was implanted in about 4700
patients in India before it was globally recalled in
2010. No ASR hip joint was implanted thereafter
in India. But it took two years to cancel the import
license of the company. Later a medical device alert
was issued to hospitals, surgeons and patients.
Then in 2014 the regulator started seeking
information on patients fitted with the implant.
Two MPs, Sanjay Jaiswal of BJP and Brinda Karat
of CPM, have severely criticised the regulator for
failing in its duty of safeguarding the patients.
A suffering patient informed media that he was
not aware of the alert. Only when a doctor saw
him limping in a conference which he attended
as he was working as medical representative and
asked him about his condition he came to know
from that doctor that such an alert was issued. If
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
that is the case with educated people and that too
from medical field one can imagine the situation of
uneducated patients and those from remote areas.
The government formed an 11-member
committee in February 2017 to go into the
issue which gave its report in February 2018.
The committee has indicted the company for
“suppressing” key facts on the harmful effects of the
implant. The committee could track only 1080 of
the 4700 patients fitted with the implant. Revision
surgery was conducted only on 275 of them. Over
3,600 patients remaining untraceable even after 8
years is a serious issue exposing the shortcoming
of the national joint registry, a common database
of all joint replacement surgeries.
The committee has recommended among
other things appointment of central and regional
committees for evaluating patients’ claims, the
company should be made liable to pay at least Rs 20
lakh to each patient, an independent registry should
be set up to track usage of medical devices and
provision for compensation should be included in
medical devices rules. Compared to US, minimum
compensation of Rs 20 lakh is too low.
It is a good development that the government
is using this opportunity to send a strong signal
to medical devices producing companies that they
cannot escape from paying damages to the Indian
patients. It has already initiated the process to
make a legal provision making companies pay
the compensation to patients. This incidence can
also be used to correct the shortcomings within
its regulatory system to initiate quick actions in
future.
The government has launched Ayushman
Bharat for providing medicines, healthcare
facilities, health insurance at reasonable rates to
the masses. But at the same time, tackling such
issues effectively with quick actions to safeguard
the interests of patients should also be considered
as an integral part of Ayushman Bharat.
Milind Kokje
Chief Editor
milind.kokje@mmactiv.com
8 BIO MAIL BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

Vol 16; Issue 09; September 2018

Attending to Alzheimer’s Vaccine Production

The lack of fundamental knowledge
about Alzheimer’s is the key reason why
we have not been successful or close to
preventing or slowing down the disease.
But of course worldwide efforts are being
made to validate existing therapeutics and
discover newer targets. Hoping to find a
solution soon.
- Dr Aravind Kishore, Mumbai
It is great to know that Indian companies
are doing well in giving a tough fight
to established players and acquiring
global market share in the vaccine R&D
domain. It would be best if the Indian
firms collaborate with the government and
expand their coverage of vaccines in India.
This will improve their market penetration.
- Ravi Verma, New Delhi

Cutting edge prosthetics Ban Effect

Although good prosthetics and With the recent call by the Health Ministry
replacements are gradually becoming on banning 328 combination drugs, a big
available, amputations are best preventable hole has been made in the pocket of many
by provision of health education, early pharma companies. But the government
presentation and appropriate management has made a rational decision by keeping
of the common indications. patient safety as the priority.
- Nihar Parambil, Bengaluru - Leena Paul, Nagpur

Vol 16; Issue 10; October 2018

Publisher & Managing Editor:
Ravindra Boratkar
Editorial:
Chief Editor: Milind Kokje
milind.kokje@mmactiv.com
Advisor - Content: Vijay Thombre
General Manager Content Creation
and Coordination: Narayan Kulkarni
Content Team:
Bengaluru: Dr Manbeena Chawla
Mumbai: Prapti Shah
Pune: Dr Sonali Wankhade
Social Media Editor: Ankit Kankar
ankit.kankar@mmactiv.com
Chief Financial Officer:
Manasee Kurlekar
Production & Design:
MM Activ Sci-Tech Communications
Anil Walunj
Product & Marketing
Ankit Kankar
ankit.kankar@mmactiv.com
Content Creation and
Coordination:
Dr Manbeena Chawla
Manbeena.chawla@mmactiv.com
Circulation, Subscription and
Media Enquiry:
Asmita Thakar
asmita.thakar@mmactiv.com
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BIOSPECTRUM | OCTOBER 2018 | WWW.BIOSPECTRUMINDIA.COM l POLICY AND REGULATORY NEWS 9

Cabinet approves
MoU between India
& Indonesia on health
cooperation
The Union Cabinet chaired by Prime
Minister Narendra Modi has approved
the signing of the Memorandum of
Understanding (MoU) between India
and Indonesia on health cooperation.

CAM signs pact The MoU covers the following

areas of cooperation- Research and
to implement development, active pharmaceutical
ingredients (API) and IT-based
Ayushman Bharat medical equipment; Human Resource
Development; Health services; and
Charutar Arogya Mandal (CAM) has signed a Memorandum any other area as may be mutually
of Understanding (MoU) with National Health Systems agreed upon. A Working Group will be
Resource Centre (NHSRC) of State Health Society, Gujarat set up to further elaborate the details
to provide technical support for implementing Ayushman of cooperation and to oversee the
Bharat programme in Dahod district. implementation of this MoU.
CAM’s chief executive officer (CEO) Sandeep Desai,
extension programme head Dr Shyamsundar Raithatha
and mission director of National Health Mission, Gujarat,
Dr Gaurav Dahiya were present during the signing of the
agreement.
Earlier, CAM was selected as an innovation and learning
centre for providing technical support to the government
at national and state level to roll out Ayushman Bharat
programme’s comprehensive health and wellness centre
initiative.

SJVN collaborates with HelpAge India

Himachal Pradesh
(HP) based Satluj
Jal Vidyut Nigam
(SJVN) has entered
into a Memorandum
of Understanding
(MoU) with HelpAge
India for health
camps in different states. SJVN
is joint venture, with the HP
government also having equity
share in the Central Public
Sector Unit. As per the MOU,
financial assistance of Rs 32 lakh
will be provided for conducting
20 health camps in the states
of HP, Uttarakhand, Bihar and
Maharashtra. The camps are
being organised in the areas of
Ophthalmology, gynaecology,
dental, ENT, general health
etc. During the camps health
awareness lectures will also be
delivered by health experts.
In the area of health, SJVN is
operating 14 mobile health vans
in the states of HP, Uttrakhand,
Bihar and
Maharashtra which
have benefitted more
than 5 lakh patients.
Besides 150 health
camps have been
organised benefitting
around over 50,000
patients.
Also, projects for disable
section of society like financial
assistance to Indian Association
of Muscular Dystrophy for
construction on integrated
muscular dystrophy center,
construction of special school at
Dhalli etc. are being implemented.
sample management
future-proof lab solutions

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store up to 140,000 2D barcoded tubes
high integrity, secure and traceable storage of:-
plasma, serum, urine, DNA, RNA,
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rapid cherry picking to enable HTS
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12 Q&A
“Indian initiatives driving growth in
translational research and biobanking are
complementary to our company ethos”
« our portfolio with complementary, including
Dr Jas Sanghera,
Co-founder and
senior partner,
TTP Group;
Chairman of
TTP Labtech
TTP Labtech, an employee-owned, global
leader in the design and development
of automated instrumentation and
consumables for life science applications,
based near Cambridge, UK has been
supplying products to the Life Science
industry in India for nearly 15 years.
TTP Labtech India is now establishing
a strong foothold in the genomic and
sample management markets, including
biobanking. The company is helping to
develop and nurture these markets in India
and have already installed several arktic
and comPOUND units within the area of
biobanking. Dr Jas Sanghera, Co-founder
and Chairman of TTP Labtech India got in
touch with BioSpectrum to share some of
his plans. Edited Excerpts;
Tell us about TTP Labtech India journey so far?
TTP Labtech has been selling products into the Life
Science market for 17 years. Over this period, India
has seen significant investment into this sector from
both private and government sources whilst the
global impact of Indian research has been increasing.
In recognition, TTP Labtech opened an
office in India, Faridabad (Delhi-NCR) in 2015
providing sales, engineering and application
support, complimented by a Pan Indian network of
distributors and a satellite office in Bengaluru.
Since 2015, TTP Labtech India has developed a
wealth of technical expertise within the structural
biology, sample management and biobanking
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
markets. By engaging with select manufacturers
in these areas we have been able to supplement
consumables and software, to offer a comprehensive
collection of market leading products. Our aim is
to make the customers buying experience seamless
through providing a complete solution.
Which of your products are dominating the Life
Sciences Industry in India?
The automation of protein crystallography screening
has made a significant contribution to the rapid
expansion of crystallography-based structural
biology. Obtaining crystals of a high enough
resolution for X-ray diffraction studies can be a time
and cost intensive process, as an extensive number of
screening and optimization experiments need to be
carried out in order to determine ideal conditions for
crystal growth.
Our mosquito protein crystallography liquid
handling range has been widely adopted within India,
the most popular products being mosquito xtal,
mosquito LCP and dragonfly crystal. Interestingly,
this correlates with global trends where the former
two instruments are considered market leading.
What advantage does India provide for your
protein crystallography products?
India has supported crystallography research from
the 1930’s, although it was in 1950’s when GN
Ramachandran was named as a founding father of
structural biology. GN Ramachandran was an Indian
physicist best known for his development of the
Ramachandran plot for validating protein structures
but he was also the first person to propose a triple-
helical model for the structure of collagen. Since
then, India has gone through turbulent times but has
excelled in bioinformatics. Thanks to the generous
support from a few individuals, funding from the
Department of Science and Technology (DST) and
other agencies; crystallographic research is on par
with leading research laboratories in the rest of the
world. In emerging areas, India has established itself
among the top publishing countries.
Our leadership position within this market
results from offering a robust portfolio of solutions-
based products, coupled with first rate service and
application support.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
What are some of the upcoming steps for TTP
Labtech in India this year?
With a history of innovation and being at the
forefront of new technology introduction, TTP
Labtech has become an industry leader within the
areas of biobanking and nanolitre liquid handling
applications, the latter of which includes; protein
crystallography and more recently genomics
(NGS, single cell sequencing and high-throughput
transcriptomics).
To showcase our solutions within these
applications, we will be participating in a plethora of
major global conferences, such as AGBT (Advances
in Genome Biology and Technology), where we will
be promoting our mosquito range of liquid handlers
for miniaturised genomics applications. Here we plan
to speak to researchers about miniaturising their
NGS (Next-Generation Sequencing), single cell and
transcriptomics workflows.
Within sample management this year, TTP
Labtech will proudly install an arktic biobanking
system into a leading Indian Institute and a
comPOUND into a private company for chemical
library storage, both of which will strengthen
our foothold in India and help to provide a solid
foundation for future growth.
What new scientific areas is TTP Labtech
exploring in the coming years for strengthening
its foothold in India, and why?
One of the primary reasons for establishing our
Indian entity, was to nurture and support the growth
of new initiatives in India. Short term within India,
we anticipate significant growth opportunities
within the application areas mentioned above,
however, looking to the future, we observe increased
market interest in emerging technologies such
as cryo-electron microscopy (CryoEM). To
further strengthen our foothold within the
structural biology market, we are developing
novel solutions that address current sample
preparation bottlenecks with the aim of
improving CryoEM productivity.
What are the main
challenges the Indian Life
Sciences Industry is
facing today?
India is one of the fastest
growing economies in
the world, however,
historically we have
seen a lag in the
adoption of new
technologies and
Q&A 13
innovations in India. To truly compete on the global
stage, this is something India needs to address.
What more can the existing Indian ecosystem
offer the Life Sciences Industry for making it a
leader?
Becoming a key global leader within Life Sciences will
require significant R&D investment from both the
Indian Government and private sectors, in conjunction
with polices that support and promote innovation.
Several initiatives designed to drive growth through
innovation are being implemented within Life Science,
including the translational research and biobanking
markets. To ensure their success, it is imperative that
such initiatives are implemented quickly and backed-
up by a stable cash-flow.
Why is TTP Labtech committed to supporting
growth in the life science research market in
India?
Indian initiatives driving growth in translational
research and biobanking are complementary to
our company ethos. We design and manufacture
robust, reliable and easy-to-use solutions for life
science research. Enabling life scientists through
collaboration, deep application knowledge and
leading engineering to accelerate research and make
a difference together. Many of our innovations have
been born out of the desire to create solutions to
existing customer problems; and it’s this ethos that
drives TTP Labtech’s R&D efforts. Our strengths
come from the trust our customers have with us to
develop truly unique, automated technologies to meet
their needs.
14 FINANCE NEWS l BIOSPECTRUM | OCTOBER 2018 | WWW.BIOSPECTRUMINDIA.COM

Online pharmacy NetMeds secures $35M

Online pharmacy NetMeds
Marketplace Pvt. Ltd has
raised $35 million in a Series C
funding round from Southeast
Asian business conglomerate
Daun Penh Cambodia Group
based in Singapore. Existing
investors Sistema Asia Fund, the
venture capital arm of Russian
conglomerate Sistema JSFC,
and Tanncam Investment, a
Cambodian investment holding
company, have also put in money
in this round. NetMeds intends to
use the funds to expand its reach
through marketing efforts and
enhance customer experience by
expediting delivery and increasing
its stock. NetMeds offers both
prescription drugs and over-
the-counter medications as well
as other health products. Users
can order their medicines via the
firm’s web portal or mobile app
by uploading their prescriptions.
A team of qualified pharmacists
verifies the prescription for validity
and prescribes the appropriate
dosage accordingly. The company
claims to have eight fulfilment
centres in Chennai, Bengaluru,
Hyderabad, Delhi, Pune,
Ahmedabad, Raipur and Kochi.

Cadila to acquire
majority stake in
Windlas Healthcare
Cadila Healthcare Ltd, which operates
under the Zydus Cadila brand, has
agreed to acquire a 51 per cent stake
in pharmaceuticals company Windlas
Healthcare Pvt. Ltd for Rs 155.5 crore.
The acquisition will help the company
expand its pharmaceutical manufacturing
footprint. Windlas Healthcare is a
subsidiary of Windlas Biotech Pvt. Ltd,
which is backed by private equity firm
Tano Capital. Tano had invested $12.96
million in Windlas Biotech in 2015.
Windlas Healthcare, which was
set up in February 2010, develops and IHH Healthcare to exit from
market pharmaceutical products and
formulations. The company clocked
Apollo Gleneagles Hospitals
revenue of Rs 33.31 crore in the year Malaysian hospital chain IHH Healthcare, which won the bid
ended 31 March 2018 compared with Rs for debt-ridden Fortis Healthcare, will sell its 50 per cent stake
27.67 crore and Rs 29.12 crore in 2016- in Apollo Gleneagles Hospitals in Kolkata and its radiology
17 and 2015-16, respectively. It recorded centre in Hyderabad to its joint venture partner, to abide with
a net profit of Rs 5.37 crore in the last a non-compete agreement.
financial year. Apollo Gleneagles is a joint venture between Apollo
Hospitals and Parkway Pantai, a subsidiary of IHH. Apollo
has begun to raise resources to fund the acquisition of IHH’s
stake. The company is in advanced talks to sell unit Apollo
Munich Health Insurance to HDFC Ltd., the country’s largest
mortgage lender, at a valuation of Rs 1,000 crore.
Apollo Munich is a joint venture between Chennai-based
Apollo Hospitals promoted by Prathap C Reddy and his
family and Munich Re. It is the second-largest standalone
health insurance provider in the country, with a 1.08 per
cent market share after Star Health, which was recently
sold to a consortium of Westbridge Capital, Madison
Capital and India’s ace stockbroker Rakesh Jhunjhunwala
for Rs 6,500 crore.
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16 COMPANY NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

AstraZeneca receives marketing permission for cancer drug

AstraZeneca Pharma India
Limited recently announced
that it has received Import &
Market permission for olaparib
(Lynparza)100 mg and 150 mg
tablets in India by the Drug
Controller General of India
(DCGI). The receipt of this
permission paves way for the
launch of olaparib in India,
subject to the receipt of further
related statutory approvals and
licenses.
For ovarian cancer, olaparib
is indicated for the maintenance
treatment of adult patients with
recurrent epithelial ovarian,
fallopian tube or primary
peritoneal cancer, who are in a
complete or partial response to
platinum-based chemotherapy. It
is also indicated for the treatment
of adult patients with deleterious
or suspected deleterious germline
BRCA-mutated advanced
ovarian cancer who have been
treated with three or
more prior lines of
chemotherapy.
For breast
cancer,
olaparib
is
indicated
for patients with deleterious or
suspected deleterious gBRCAm,
human epidermal growth factor
receptor 2 (HER2)-negative
metastatic breast cancer who
have previously been treated with
chemotherapy in the neoadjuvant,
adjuvant or metastatic setting.
Patients with hormone
receptor (HR)-positive
breast cancer should
have been treated with a
prior endocrine therapy
or be considered
inappropriate
for endocrine
treatment.

DNAtix, Mapmygenome Glenmark inks pact with True

to advance personalized North for pain management
preventive medicine portfolio in India and
Glenmark has formed a
Digital DNAtix Ltd, the blockchain joint venture with private Nepal.
genetics company, and Mapmygenome, equity firm True North The transaction is
a molecular diagnostics company, for its pain management expected to be completed
have announced their alliance to and orthopedic products in 2-3 months. As part of
advance cutting-edge, personalized and business in India and the deal, Sujesh Vasudevan,
preventive medicine using blockchain Nepal. President, India
technologies. The DNAtix genetics Under this Formulations, Middle East
ecosystem links individual users in search collaboration, Glenmark’s and Africa at Glenmark
of genetically-based health and lifestyle orthopaedic and pain will join the board of
solutions with products and services that management business, Integrace. Glenmark’s
fit their needs. Mapmygenome offers a valued at Rs 635 crore, will orthopaedic and pain
range of genetic tests and, as a provider be transferred to a new management business in
on DNAtix’s growing genetic ecosystem, entity to-be incorporated India, consisting of brands
this collaboration will allow users to by True North. The new such as Esoz, Bon K2,
explore their genetic makeup in entirely entity would be named as Collasmart, and Lizolid,
new ways, with security and anonymity ‘Integrace Private Ltd’ and clocked revenue of Rs 155.8
as a top priority. The DNAtix direct-to- will market the product crore in 2017-18.
consumer (D2C) platform provides full
genome testing and access to services
and solutions on the blockchain, and it
allows researchers to use anonymous
DNA stored on the DNAtix infrastructure
to create tests, do research, and design
new treatments. Mapmygenome will use
DNAtix’s breakthrough infrastructure
and working D2C genetic platform to
provide in-depth analysis of full genome
sequences with the speed, security and
anonymity of blockchain technology.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
Panacea
Biotec
collaborates
with Natco,
Breckenridge
Panacea Biotec
has entered into a
tripartite agreement
with Natco Pharma
Ltd. and Breckenridge
Pharmaceutical Inc. for
the manufacture and
supply of Azacitidine
injection for the
U.S. market under
Breckenridge’s already
approved ANDA.
Azacitidine is a generic
equivalent of Vidaza
which is marketed by
Celgene Corporateion,
U.S. As per the terms of
the agreement, Natco has
provided the technology
for manufacturing
Azacitidine to Panacea
Biotec’s facility located
at Baddi, Himachal
Pradesh, India. Panacea
Biotec will be responsible
for manufacture and
supply of the product,
which will be marketed,
sold and distributed by
Breckenridge in the U.S.
The application (Prior
Approval Supplement)
for qualifying Panacea
Biotec’s site has been filed
with US FDA and approval
is expected in due course
of time. Azacitidine is
a nucleoside metabolic
inhibitor indicated for
the treatment of patients
with the B myelodyplastic
syndrome (MDS), having
annual sales of about $
140 million as reported by
IMS, MAT, Dec 2017.
l COMPANY NEWS 17
Mankind Pharma launches
drug to prevent constipation
Mankind Pharma, a quality-
driven pharmaceutical company
in India has launched a new
over-the-counter (OTC) product,
‘KABZEND Natural Laxative
Granules’ to help relieve
constipation.
KABZEND is an Ayurvedic-
based formulation that will
help maintain regular bowel
movements and ensure proper
cleansing of the body which is
available in trendy 50g bottle good manufacturing guidelines to
packaging. ensure quality standards, making
KABZEND is a blend of time- it safe for consumption.
tested potent & quality herbs to Inspired by Pradhan Mantri
effectively pacify the problems Jan Aushadi Scheme to deliver
leading to gastrointestinal pharmaceuticals products at
disorders such as constipation, affordable prices, Mankind
indigestion, gas and irregular Pharma with its Make in India
bowel syndrome. Herbs used in approach has set up goals to
the formulation of KABZEND are sustain a balance in the healthcare
undertaken with intense care and of the country.
Sanofi introduces
Aubagio for MS treatment
Sanofi Genzyme, the specialty care global business unit of Sanofi,
brings to India Aubagio, from its international Multiple Sclerosis (MS)
portfolio. A chronic and debilitating disease of the nervous system,
Multiple Sclerosis has varied symptoms like weakness in the limbs, poor
vision, fatigue or slurred speech. Aubagio (Teriflunomide, 14 mg) is the
first original ‘once-daily’ oral ‘disease modifying therapy’ (DMT) for
Multiple Sclerosis to be approved
in India. It offers an effective, safe
and a convenient option that is
indicated as a first-line treatment
for relapsing forms of Multiple
Sclerosis that must be taken
once a day, with or without food.
First approved by the US FDA in
2012, Aubagio has a strong global
presence today with approvals
in more than 81 countries. It has
been extensively studied in more
than 5,500 patients with up to 13 years of clinical and follow-up studies
with proven clinical efficacy, safety and tolerability outcomes. Globally,
more than 85,000 patients with Multiple Sclerosis are benefitting from
the use of Aubagio.
18 START-UP NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

HoloSuit gets funding
from Singapore, India investors
HoloSuit, an augmented reality
startup, has raised an undisclosed
sum of funding from three
investors based in Singapore and
India. As part of the transaction,
the investors will advise HoloSuit
on its global strategy and growth.
The startup has developed a
full-body suit, which it recently
unveiled, using wireless motion
capture technology. The product
captures the user’s entire body
movement data and uses haptic
feedback to send information
CureFit
targets
500 fitness
centres by
2020
back to the user. The suit can be
applied in areas such as neuro-
rehab, sports, healthcare, among
others.
The HoloSuit can be operated Health and fitness startup
on the Android, iOS and Windows CureFit is looking to
operating systems and can also aggressively expand its
be used with the HTC Vive and CultFit fitness centres to
Oculus virtual reality headsets. at least 500 by 2020 and
It also offers developers a over 200 by next year-end,
wireless platform and a software supported by $120 million
developer’s kit (SDK) where funds raised recently.
they can create real and virtual The two-year-old startup
applications. currently has 60 CultFit
outlets across three cities
of Bengaluru, Gurgaon/

Startup India launches Delhi and Hyderabad

with over 100,000
academia alliance programme customers. The firm is
currently reporting a run
Startup India has launched Startup Academia Alliance Programme for rate of about Rs 25 crore
academic scholars and startups, aimed at bridging scientific research and a month. The startup has
its industrial applications gap, and increase the efficacy of technologies for so far raised around $160
wide impact. The Startup Academia Alliance programme by Startup India million and only less than
aims to fulfill the government’s 20 per cent of the funds
mission to promote the spirit of were utilised so far. The
entrepreneurship in the country. balance funds will be spent
It focuses on simplification, over the next few years
handling, funding support, towards developing fitness
incentives, industry-academia devices and technology
partnership, and incubation platform, apart from
for startups. The programme is expanding the footprint.
being organised in partnership The startup has last month
with The Regional Centre for raised $120 million in its
Biotechnology, The Energy and series C round of funding
Resources Institute (TERI), led by IDG Ventures,
The Council on Energy, Environment and Water, and The TERI School Accel Partners and Kalaari
of Advanced Studies. Startup Academia Alliance further strives to create Capital with participation
lasting connections between the stakeholders of the startup ecosystem and from Chiratae Ventures
implement the third pillar on which the Startup India Action Plan is based and Oaktree Capital.
— Industry Academia Partnerships and Incubation.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com l START-UP NEWS 19

Bugworks Research secures $9M in series A

Bengaluru and Delaware-based
drug discovery startup Bugworks
Research has raised $9 million
in series A funding led by
University of Tokyo Edge Capital
(UTEC). UTEC is an early-stage
technology-focused investment
firm. It invests in early-stage
startups helping the global
society through innovation. The
firm has around $500 million
under management.
Other investors that
participated in the round
include South Africa-based
Acquipharma Holdings,
3one4 Capital, along with
angels Marcus Schabacker,
former chief strategic officer of
Baxter Healthcare, Shrikumar
Suryanarayan, former head
of research and development,
Biocon.
The funds raised will be
used to boost its clinical trials
to test the efficiency of its
drugs. Bugworks Research
aims to combat drug-resistant
superbugs by inventing
antibiotics that will be effective
in combating the antimicrobial
resistance.

3Hcare
raises $1M
Healthcare portal 3Hcare has
raised $1 million in its second
round of funding, led by a
group of technology experts.
The startup will use these funds
to expand its team, upgrade
its tech infrastructure across
India. Founded in 2016, 3Hcare
has partnered with leading
laboratories and aims to bridge
the accessibility gap between
healthcare services and patients.
It provides access to labs
and hospitals with complete
MedCords receives information regarding tests. Its
portal also allows users to compare
Rs 2.64 Cr funding and book online treatment. Part
of the funds will be used to bolster
Early stage venture fund, WaterBridge Ventures, along with and upgrade the technology,
Infoedge has invested Rs.2.64 crore in MedCords, a startup based especially incorporation of
in Kota, Rajasthan with a technology centre in Pune. According to Artificial Intelligence (AI) and
the startup, the investment will diversify its presence into a new Machine Learning (ML), to
line of business within the internet services industry. MedCords is provide an enhanced value-added
a cloud-based, machine-learning powered platform that connects customer experience. 3Hcare
and enables various stakeholders of the healthcare ecosystem. has partnered with over 400
The startup, founded in 2016, facilitates remote and follow-up diagnostic centres and around 50
consultations with doctors and digitises users’ medical records hospitals (both NABL and JCI-
and makes them available on-demand. The firm aims to create accredited) in more than 1,500
intellectual property out of medical data and advanced analytics to locations across India to bridge
create efficient healthcare decision systems for doctors, hospitals the accessibility gap between
and the government. It currently has a web-app for doctors and healthcare services and patients.
Android apps for pharmacies and patients.
20 WORLD NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

Nepal to
Bangladesh approves
improve four new medical colleges
existing health Bangladesh government has
practices approved four state-run new
medical colleges in Naogaon,
Nepal Health Research Netrokona, Magura and Nilphamari
Council (NHRC) has amid quality concerns. A fifth in
urged the government to Chandpur is awaiting the Prime
formulate health policies Minister Sheikh Hasina’s approval.
based on scientific With those five, the number of
research data. In a government medical colleges would
recent event organized stand at 36 in Bangladesh. As many
by NHRC, Nepal Health as 250 students will be able to sign
and Population (NHP) up for the 2018-2019 academic
Minister Upendra session in all those five colleges.
Yadav stated that The number of private medical
excerpts from research colleges is 69 as the current
data will assist in government has been expanding the
formulating effective medical colleges since 2009. Hasina
laws and policies in the had earlier announced a plan to set
Nepali health sector. up one government medical college
Formulating policies in each district.
based on research In the coming weeks, Hasina
will help in aligning will lay the foundation stone
with the government’s of a 10-storey institute at the Sheikh Hasina Burn and Plastic
sustainable development Bangabandhu Sheikh Mujib Surgery Institute will also soon be
goals (SDG). Over Medical University. The 500-bed opening in Dhaka.
the time, NHRC has
been conducting
researches on various
aspects including,
Pakistan to work towards
communicable and
non-communicable
better healthcare education
diseases, environmental The Organization of Pakistani Entrepreneurs of North America (OPEN), the
pollution and global Aga Khan University (AKU) and a Pakistani multinational pharmaceutical
warming. But currently, company have recently signed a memorandum of understanding (MoU)
Nepal lacks quality to support start-ups of
research centres due to young entrepreneurs that
which it is dependent solve today’s challenges
on international in health care and medical
non-governmental education. The MoU
organizations. The has been signed by AKU
government intends President Firoz Rasul and
to develop more OPEN Karachi President
research centers so Dr Zakiuddin Ahmed,
that research can be who is also the director of
performed as per the Digital Health & Strategic
need of the government Projects at PharmEvo.
to implement proper The objective behind the
policies from the partnership is to support
gathered evidences of and promote new ideas and help start-ups so that new products based on
the research. technology and innovation can be introduced in the field of health care and
medical education.
22 WORLD NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

Pfizer, Exact Sciences to co-market

colorectal cancer diagnostic test
Molecular diagnostics company
Exact Sciences and Pfizer have
signed a multi-year agreement to
co-market the Cologuard test for
diagnosing colorectal cancer in the
US. Cologuard is one of the only
US Food and Drug Administration
(FDA) approved and non-invasive
stool DNA screening diagnostics
for cancer.By promoting the test,
Exact Sciences and Pfizer intend to
boost colorectal cancer screening
rates. Exact Science’s sales force,
the science of Cologuard and a
direct-to-consumer marketing
campaign will be combined with
Pfizer’s health systems network
and marketing expertise. Exact
Sciences will continue to carry out
all manufacturing and laboratory
operations of the test. Pfizer will
evenly share gross profits and
marketing costs above an agreed
baseline.

Stanford team
develops effective
imaging technique for TB
A research team at Stanford University School of
Medicine has developed an imaging technique that
can diagnose live tuberculosis (TB) in an hour and
help monitor the efficacy of treatments. The new
method is easier and cheaper to carry out than current
methods, meaning the technology could be useful in
cash-strapped healthcare systems. It requires the use
of fluorescent microscopes, which nearly all hospitals
have, and no special training. The technology relies on
a newly created two-piece fluorescent probe. The probe
is combined with the spit sample and is activated when
it comes in contact with TB bacteria. When one part of
the probe detects TB it then glows and the second part
localises the glow to the bacterium. This concentrated
fluorescence allows researchers to track the distribution
of the bacteria in infected host cells. The probe can
also determine the appropriate drug for a patient by
showing which bacteria are still alive in the patient
sample. The research team hopes that the technique
could help scientists develop new TB drugs for different
strains of the disease. The team is planning to test the
probe and obtain approval from the US Food and Drug
Administration (FDA).
Facebook,
NYU to initiate
fastMRI using AI
Facebook has partnered with New York
University (NYU) School of Medicine
to initiate a research project focused on
leveraging artificial intelligence (AI) to
make magnetic resonance imaging (MRI)
scans ten times faster. Under the fastMRI
collaboration, Facebook AI Research
(FAIR) group and the medical school’s
Radiology department will investigate the
use of AI in expediting the reconstruction of
MR images. As part of the collaboration, the
university will provide Facebook with access
to about three million images of MRI scans
of the knee, brain and liver. This data from
10,000 clinical cases will be used to train
the algorithms. According to Facebook and
NYU, patient names and all other critical
health information have been removed from
the images, as well as raw scanner data. The
partners intend to open-source their work
to enable other researchers to replicate and
build on their findings.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com COVER STORY 23

CMOS- SUPPORTING
THE PHARMA INDUSTRY
The Indian Pharma industry poised to grow to $100
T
he present pipeline of
pharmaceutical products
billion by 2025 has unfailingly been on a strong is increasingly complex
growth trajectory for many years now. But given and requires specialized facilities,
the very nature of its business, the pharmaceutical equipment and operational
expertise. Small molecule
industry is continuously faced with challenges such drugs account for nearly 90 per
as cost aspects and stricter regulations, to name cent of the therapeutics in the
a few. In this regard, the industry’s response has pharmaceutical market. Last
year, FDA’s Centre for Drug
always been towards creating novel approaches and Evaluation and Research approved
techniques to overcome the obstacles and move 34 small molecule drugs. This
forward. Outsourcing of various development and represents an annual growth of
nearly 56 per cent, signifying the
manufacturing operations to third party vendors is one growing importance of contract
such approach pharma companies have been seeking manufacturing in the overall
for quite some time. At present, with around 700 US pharmaceutical industry.
Over the years, the contract
Food and Drug Administration (USFDA) approved manufacturing market has
pharmaceutical manufacturing facilities, accounting grown into a prominent and
to close to 40 per cent of the total facilities, India has promising segment of the overall
pharmaceutical industry. Since
the highest number of such facilities outside the US. 2000, globally close to 150
But the very recent ban on 328 combination drugs new Contract Manufacturing
announced by the government has come across as Organisations (CMOs) have been
established, offering cost-efficient
a big blow for many domestic pharmaceutical firms. solutions to several stakeholders in
These fixed-dose combination (FDC) medicines, which the industry.
are a cocktail of two or more active drugs packed in The current global CMO
market is highly fragmented
a single dose, accounts for at least one-fourth of the but characterized by multiple
total pharma market which is valued at Rs 1.3 trillion. mergers and acquisitions (M&A)
What remains to be seen is that how this development as stakeholders strive to broaden
their respective service portfolios.
will impact the pharma sector in the long run. This has enabled several CMOs to
24 COVER STORY
“Multinational companies in India have
stopped manufacturing some of their
products and have outsourced to Indian
manufacturers. Products which are brand
leaders in its segments are also being
outsourced to many Indian companies
and yet retaining their market share. The
rising cost of manufacturing and some
of the ageing plants of Europe reaching
their life cycle conclusion may open
up enormous opportunities to India’s
companies in contract manufacturing as
European companies are also considering
to either relocate those units in cost
efficient centres like India or to outsource
to India manufacturers. The contract
manufacturing space in India is expected
to gain grounds in the near
future. The efficiency in
manufacturing and
maturity of business
models would
eventually lead to
containment of cost of
manufacturing to a
great extent.”
- Dr P V Appaji,
Director
General Emeritus,
PHARMEXCIL
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
start offering end-to-end services, ranging from drug
development, including preliminary R&D, preclinical
and clinical trials, to commercial scale production
and regulatory filings.
A continued high level of M&A activity is
expected over the next five years, leading to further
consolidation of the contract services market. The
key driver is the desire of contract manufacturers to
provide integrated service offerings across the entire
pharmaceutical development cycle from discovery
to commercialization (APIs and formulated drug
products) and lifecycle management. The number
of CMOs transforming themselves into contract
development and manufacturing organizations
(CDMOs) reflects this trend, as does the rise in
the number of primary contract manufacturers
that have expanded into secondary (finished dose)
manufacturing (and vice versa) through mergers or
acquisitions.
Understanding the Dynamics
As per the Mordor Intelligence 2017 report, the
dynamics of the global pharmaceutical contract
manufacturing market can be better understood
by means of two broad segmentations- Region and
Type. By region, the five market segments are North
America, Europe, Asia Pacific, Latin America and the
Middle East & Africa. North America holds a lion’s
share of the market, with an approximate share of
36 per cent, followed by Europe and Asia-Pacific.
The emerging markets of China, India and Japan are
spearheading the growth in the Asia-Pacific region.
By type, the three Pharma market segments are
active pharmaceutical ingredient (API), final dosage
formulation (FDF) and secondary manufacturing. The
growth in the API market is driven by several factors
such as the increase in development of biological
APIs, increase in demand for API packaging, upsurge
in demand for abbreviated new drug applications
(ANDA) and rise in drug master files (DMF)
from Indian companies. Also, API packaging is a
significantly revenue-generating sub-segment. Even
though captive manufacturers are currently leading
the API market, they are expected to eventually
partner with contract manufacturers to overcome
the challenges of complex and costly in-house API
manufacturing and increasing competition.
Due to restructuring of the pharmaceutical
industry, API CMOs are expected to witness a strong
surge in demand, particularly in the generics sector.
Additionally, regulatory developments in the markets
would let generic drug companies develop and
manufacture products for export, worldwide. However,
demand for specialized technologies and improvements
in pharmaceutical manufacturing capabilities, could
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26 COVER STORY
Key Drivers for
rise in Pharma CMOs
● Dwindling profit margins in highly competitive
global Pharma marketplace
● Growing demand for generic drugs
● Patent expiration of major therapeutic brands
● Demand for up-to-date processes
● Need for high-quality R & D facilities and cost-
effective production technologies that meet
global regulatory requirements
● Government initiatives in the healthcare sector
● Innovation in biologics and high potency API
● Escalation in the incidence and rate of growth
of diabetes, cancer, cardiovascular diseases
and psychological illnesses
“Earlier was the era of manufacturing
APIs, or finished products, or ready
to fill products like granules. But now
outsourcing of biopharma has also
started. Before it was considered difficult
due to complexities. Like any other
sector, complexities and challenges lie
in the contract manufacturing area as
well. Firstly there are expectations about
timelines. These are often not estimated
correctly and built into the plan as both
parties want to start as soon as possible.
For example, the regulatory lead time is
often underestimated and leads to delays
and a lot of heartburn. Often there are
also issue related to role clarity. It is
important to have a clarity about who is
responsible for each step in the process. It
could be a member of only one or
both parties. Not doing so
often leads to standoffs
and delays. Apart from
this, there are often
complexity with
respect to technology
transfer especially
in case of biological
products.”
- Dr Vishwas
Sovani, Founder
Director,
Pharmawisdom
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
steer some companies to return to sourcing their APIs
from suppliers. But contract manufacturing, like other
forms of shared services or outsourcing has two sides
to it. There are both benefits and risks associated with
it. The nature of possible risks that could possibly have
performance repercussions could range from direct
economic ones, such as poor contracting decisions and
expensive renegotiations; and the other contingency
factors such as quality risk arising out of the aging
manufacturing facility.
Indian Scenario
With more than 100 pharma companies and 500+
units involved in contract manufacturing, India is
the third largest pharma manufacturer in terms of
volume and thirteenth in terms of value, contributing
about 10 per cent to the global production. The
country is way ahead of its competitors in Drug
Master File (DMF) filings that is going up more than
three times for the last few years. India is the largest
exporter of formulations in terms of volume, with 14
per cent market share and 12th in terms of export
value. Drug formulation exports from India reached $
7.25 billion during April to November 2017.
The Indian pharma industry has shown
tremendous progress on several indices such as
infrastructure, technology, product range, GMP
(Good Manufacturing Practices), regulation
compliant manufacturing facilities. Also, the high
quality standards of purity; stability and international
safety; health and environmental protection under
which bulk active ingredients are manufactured and
supplied by Indian pharmaceutical companies ensure
that they will pass through several rounds of stringent
assessment by various regulatory authorities in the
importing countries of buyer companies.
With 600 to 700 US Food and Drug
Administration (USFDA) approved pharmaceutical
manufacturing facilities, accounting to close to 40
per cent of the total facilities, India has the highest
number of such facilities outside the US. USFDA
given drug approvals to Indian companies have
almost doubled to 201 in 2016 from the previous
year’s 109. India has an important role in the
production and supply of drugs at international
level, as, currently over 80 per cent of the USFDA-
approved antiretroviral drugs used globally to combat
AIDS (Acquired Immuno Deficiency Syndrome) are
supplied by Indian pharmaceutical firms.
The most important factors that are likely to
keep contract manufacturing in the Indian Drug &
Pharmaceuticals Industry in good stead in the global
market include: 1. Fast approaching patent expiries;
2. Availability of adequate compliant facilities in the
country to meet high magnitude of demand; 3. Rise in
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com COVER STORY 27

List of leading Indian CMOs with their manufacturing plants

Companies
Dr Reddy’s Laboratories
Aurobindo Pharma
Divis Laboratories
Akums Drugs & Pharmaceuticals Dosage Formulations
Kemwell Biopharma
Piramal Pharma Solutions
Innovexia Life Sciences
Natco Pharma
Logos Pharma
Ciron Drugs
Radico Remedies
BDR Pharmaceuticals
Ankur Drugs & Pharma
Synokem Pharmaceuticals
Arch Pharmalabs
Manufacturing
Location Total
Categories
Srikakulam District, Andhra Pradesh- 2,
API Nalgonda District, Telangana- 1, 7
Hyderabad- 4
Srikakulam District, Andhra Pradesh- 1
Yanam, Puducherry- 1, Hyderabad- 3
Dosage Formulations 9
Baddi, Himachal Pradesh- 2
Vizag, Andhra Pradesh- 2
Unit 8, 9- Medak District, Telangana
API Unit 11- Srikakulam District, Andhra Pradesh 3
Unit 5- Hyderabad
Unit 3, 4, 6,12- Hyderabad,
Dosage Formulations 2
Unit 7- District Mahbubnagar, Telangana
API Visakhapatnam, Hyderabad 2
Haridwar- 11, Guwahati-1 12
Drug Substance and
Bengaluru 1
product manufacturing
API Digwal, Telangana, Ennore, Tamil Nadu 2
Dosage Formulations Pithampur, Madhya Pradesh 1
Dosage Formulations Baddi, Himachal Pradesh 1
Rangareddy district, Telangana,
API 2
Manali, Tamil Nadu
Dosage Formulations Nagarjuna Sagar, Telangana, Dehradun 2
Dosage Formulations Nalagarh, Himachal Pradesh 1
Dosage Formulations Palghar, Maharashtra, Thane, Maharashtra 2
Dosage Formulations Baddi, Himachal Pradesh 1
API, Dosage
Vadodra, Gujarat 1
Formulations
Dosage Formulations Baddi, Himachal Pradesh, Daman 2
Dosage Formulations Haridwar 1
Vitalife, Gurugram, Oncology site, Tarapur,
API 3
Dombivli Site, New Mumbai
Merven Site, Hyderabad, Watsol Site,
Dosage Formulations Hyderabad, Badlapur Site, near Mumbai, T-86 5
Site, Tarapur, Taloja Site, near Mumbai

production approvals or licenses and supply contracts

with overseas companies; 4. Changing preferences in
regulated markets for generic compositions to keep
the rising health care costs under check.

Government’s Role
The draft pharmaceutical policy 2017, floated by the
ministry of chemicals and fertilizers for stakeholder
opinion last year, had pointed out Indian industry’s
increasing dependence on imported raw materials
- active pharmaceutical ingredients and key
starting materials - to manufacture finished dosage
formulations. The policy proposed to phase out loan
licensing which is a variant of contract manufacturing
that accounts for 40 per cent of total drugs
production in the country, to improve drugs quality.
Many pharma companies rely on loan licensing for
28 COVER STORY
Limitations of Contract Manufacturing
● Lack of Control – When a company signs the
contract allowing another company to produce
their product, they lose a significant amount of
control over that product. They can only suggest
strategies to the contract manufacturer; they
cannot force them to implement them.
● Relationships - It is basic that the organization
shapes a decent association with its agreement
maker. The organization must remember that
the maker has different clients. They cannot
constrain them to create their item before a
competitor’s. Most organizations alleviate this
hazard by working durably with the producer and
granting great execution with extra business.
● Quality concerns – When entering into a
contract, companies must make sure that the
manufacturer’s standards are congruent with
their own. They should evaluate the methods in
which they test products to make sure they are
of good quality. The company has to rely on the
contract manufacturer for having good suppliers
that also meet these standards.
● Intellectual property loss – When entering
into a contract, a company is divulging their
“Due to availability of idle capacities with
several small and medium enterprises
(SMEs), contract manufacturing has
increasingly grown in the Indian
pharmaceutical industry. The sector
will grow further as there are a lot of big
pharmaceutical companies in the national
level who show interest to do contract
manufacturing with SMEs. So many
multinational companies (MNCs)
opt for Indian contract
manufacturers to use
their idle capacities
instead of setting
up capital intensive
facilities in India.”
- S V Veermani,
Immediate past
president of
Indian Drugs
Manufacturers
Association (IDMA)
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
formulas or technologies. This is why it is
important that a company should not give
out any of its core competencies to contract
manufacturers.
● Outsourcing risks – Although outsourcing
to low-cost countries has become very popular,
it does bring along risks such as language
barriers, cultural differences and long lead times.
This could make the management of contract
manufacturers more difficult, expensive and
time-consuming.
● Capacity constraints – If an organization does
not make up an extensive bit of the agreement
producer’s business, they may find that they are
de-organized over different organizations amid
high creation periods. In this manner, they may
not acquire the item they require when they
require it.
● Loss of flexibility and responsiveness –
Without direct control over the manufacturing
facility, the company will lose some of its ability
to respond to disruptions in the supply chain. It
may also hurt their ability to respond to demand
fluctuations, risking their customer service levels.
manufacturing and focus on sales and marketing.
Thus, phasing out of loan licensing will force pharma
majors to develop in-house production capacities.
Through ‘Pharma vision 2020’, the Government
of India is aiming at making India a global leader in
end-to-end drug manufacture. Under this campaign,
the approval time for new facilities has been reduced
to encourage and boost investments. Plans by the
Government to incentivise bulk drug manufacturers,
including both state-run and private companies as a
part of its ‘Make in India’ programme is intended to
reduce dependence on imports of API, of which nearly
75-85 per cent is currently imported from China.
However, the recent ban on 328 combination
drugs by the government has raised few concerns
on the business of pharma contract manufacturers.
The final impact of this development is yet to
be seen. As of now, India has already gained a
foothold in the global arena of export due to its high
proficiency in manufacturing fantastic quality of
drug products. Moreover due to the high number
of Contract Manufacturers available in India there
is a wide spread growth of Indian pharmaceutical
industry making them a Building block of Indian
pharmaceutical industry.
Dr Manbeena Chawla
manbeena.chawla@mmactiv.com
30 STARTUPS BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

Startups advancing
women health & hygiene
through innovation!
Women’s hygiene in India has always been a topic that has raised a lot of controversy and hearsay.
Around 70 per cent of all reproductive diseases in India are caused by poor menstrual hygiene and
women continue to put their health, livelihood and dignity at risk. In a country where women have
reached the frontiers of space, basic necessities such as access to clean drinking water, toilets,
basic education, fundamental knowledge and products for feminine hygiene are still unavailable to
women in rural areas.

A
ccording to the
World Health
Organisation
(WHO), reproductive
tract infections (RTIs)
are extremely common
among women and
are reported to affect
one third of women
of reproductive age
around the world.
Sexually transmitted
infections, of which
RTI is a significant
contributor, are also
classified among
the ‘top five disease
categories’ by WHO.
The risk of women
contracting RTIs are
high in rural India,
where, in the absence
of toilets in villages,
access to sanitation is
still limited.
In this context
some entrepreneurs
have taken the lead
to make an impact. A
number of healthcare
based startups are
working towards
providing better
hygienic conditions for
women in India.
PeeBuddy
Another startup operating in the
women hygiene and wellness
space since 2015 is PeeBuddy
whose funnel-shaped female
urination device helps women
urinate while standing. The
startup has recently secured a
funding of Rs 2.96 crore from
Indian Angel Network.
“Women do multiple things to
avoid the menace of using public
toilets while men have it easy.
PeeBuddy, a simple urination
funnel-like device that enables
women to go while standing
has come as a merciful and
much-needed solution. Besides
PeeBuddy, our company has now
started making products like wet
wipes, underarm sweat
pads, menstrual
cups, tampons,
and herbal pain
relief patches.
All in all, these
products have
been created
keeping in
mind the
personal needs
of women”, shares
Deep Bajaj,
Co-Founder,
PeeBuddy.
PeeBuddy Private Limited
has reported a turnover of Rs 1
crore in 2016-2017 and is poised
to finish at around Rs 2.5 crore in
2017-2018. Though Indian retail
stores might need some more time
to come around, PeeBuddy got its
initial break online. E-commerce
websites, like Healthkart,
Snapdeal, and Amazon.in,
were more than willing to offer
it to their customers. Soon
retail stores like Modern trade,
WHSmith, and NewU in Delhi
also started selling the product.
This patent-protected,
portable, disposable product
has won multiple awards, made
headlines, and is recommended by
the medical fraternity. And 2018
began on yet another golden note,
with Deep Bajaj declared as
the winner at the Lufthansa
Runway to Success
Season 5. The grand prize
includes sponsorship to
a business programme
at the prestigious
Cambridge University
in the UK, as well as
a much sought-after
mentorship from
TiE (The Indus
Entrepreneurs).
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
L-R: Grace Kane Co-Founder, Amrita Saigal Co-Founder CFO,
Kristin Kagetsu Co-Founder CEO, Tarun Bothra Co-Founder,
CTO.
Saathi
Saathi began in 2015, when its co-founders came
together on a mission to create fully eco-friendly,
compostable sanitary napkins using locally sourced
banana fiber from the state of Gujarat, where
Saathi is based. Saathi pads are Biodegradable &
Compostable, using plant-based materials for the
leak-proof outer layers of the napkin. Saathi pads
are made with banana fibre because of its highly
absorbent properties, and the environmental and
social benefits of its supply chain.
“Our product can be used safely and responsibly
by women everywhere because it is sustainable.
It is an all-natural product that doesn’t cause any
irritation or rashes or have long term negative effects
on women’s health like the commercial chemical
filled plastic pads. In that way, it is a healthy option.
In addition to that, we are running our one million
pads campaign to provide pads to women in rural
Jharkhand through our partnership with Ekal
Vidyalaya and Arogya Foundation. This is the first
step towards being able to provide these to rural
women all over India”, shares Tarun Bothra and
Kristin Kagetsu, co-founders of Saathi.
“Now the government and other large
organizations are understanding the importance of
feminine hygiene and taking measures to improve
women’s health and hygiene. We believe it will take
time but it is definitely improving. It is not just an
issue about sanitary pad access and awareness but also
about access to toilets as well so women have a safe
place to use those products”, Bothra and Kagetsu add.
The startup has bagged a number of laurels in the
three years since its inception, including winning the
IP Start-Up of the Year - 2018, Expo Live 2020- 2018,
the Global Cleantech Innovation Program 2018, the
Asia Social Innovation Award 2017, National Bio
Entrepreneurship Competition 2017, the 3M Young
Innovators Challenge 2016 and the Harvard Business
School New Venture Competition, 2014.
STARTUPS 31
PeeSafe
Redcliffe Hygiene Pvt Ltd, which manufactures
toilet seat sanitiser spray PeeSafe, recently
raised Rs 6.3 crore in a fresh round of funding.
Founded in 2015 by the husband-wife duo
of Vikas and Srijana Bagaria, PeeSafe is an
isopropyl alcohol-based toilet seat sanitiser in
the form of a quick-drying aerosol.
“Women hygiene is crucial, as women
are considered to be the backbone of society.
Around 70 per cent of all reproductive
diseases in India are caused by poor
menstrual hygiene and women continue to
put their health, dignity and livelihood at
risk. The scenario has changed in the past
few years, even the Government of India
is taking initiative to aware masses about
the need of improved sanitation, daily and
personal hygiene with the help of both online
and offline media. Private companies are
also playing a major role in empowering
women. There is a lot of scope when it comes
to improving health and wellness industry.
Combining various elements like proper
education, awareness, easy availability of
affordable and user friendly hygiene products,
together will eventually create a huge impact
and will lead India towards a positive change”
points out Vikas Bagaria, Founder, Pee
Safe.
“In order to empower Indian women, we
need to tackle challenges such as fighting
against social taboos and myths related to
women during their menstruation period,
fighting against the invisible germs over a
clean toilet seat to reduce the risk of infection
and lack of knowledge about proper use of
product, its longevity and risk involved if used
in improper way”, adds Vikas Bagaria.
The brand PeeSafe is the
first in the category of daily
hygiene and aims at creating
an environment where
women can be helped to
reduce the risk of infections
with the use of daily
hygiene products. PeeSafe
is presently focusing on
improving hygiene habits
among women and
looks up to create a
cleaner and better
India where women
have good health
and life overall.
32 STARTUPS
Module Innovations
Module Innovations, which was founded in
2014, has developed USense, a credit card size
test designed to detect presence of 4 major
Uropathogens (E.coli,
S.aureus, Klebsiella and
Enterococci) causing
96 per cent cases of
Urinary Tract Infection
(UTI) in India. The
innovative design allows
for the detection of these
organisms by a simple
blue to red color change.
The compact dimensions
makes USense portable. USense boasts of
innovative and unique features of being rapid
with detection in only 30-60 minutes, affordable
with nanofibers technology, portable and simple
to use, making it reachable and usable in every
setting and intellectual depth.
“Hygiene is a big word in India. With 1 in 3
women under 24 contracting a UTI, and over
150 million cases globally, UTI continues to
deeply affect women in India. Poor menstrual
hygiene is the breeding ground for bacteria
and can lead to UTIs. Due to unavailability of
clean toilets on highways, many females either
do not drink water or tend to hold urine in
their bladder for increased duration severely
increasing the risk of catching a Urinary
Tract Infection”, points out Sachin Dubey,
CEO, Module Innovations, a healthcare
OmiX Labs
Last year, Omix Research and Diagnostics
Laboratories received Rs 49 lakh from Karnataka
Government for the
development of a novel tool
for detection and surveillance
of antimicrobial resistance
among UTI. Besides that, in
2015 after its inception, social
enterprise incubator Villgro
Innovations Foundation
invested Rs 50 lakh in this
Bengaluru based healthcare
startup. Over the years,
the startup has been focusing on setting up a tech
platform for DNA testing to diagnose a wide range of
diseases.
“Our journey started with looking at little girls
who get UTI, especially those below the age of 5. But
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
startup based out of National Chemical
Laboratory Innovation park, Pune.
He adds, “While our technology does
not build clean toilets or affordable sanitary
pads, it does much more to alleviate the pain
a women encounters when she is gripped by
UTI. USense in its current version will aid
doctors to ascertain UTI in females at the
clinic. Often many females cannot go to work
and lose daily wages further worsening their
financial condition. USense in its later version
would help females keep track of their wellness,
allowing them to check regularly for UTI. This
in turn is an indicator of good hygiene. Being
affordable, rapid and easily usable in normal
settings USense would mark the beginning of a
time where Indian women take charge of their
wellness.”
Module Innovations has so far raised funds
worth Rs 3.15 crore. Recently, USense emerged
as a winner along with few other startups at the
Design: Impact Awards (DIA) for Social Change
event organised by Titan in collaboration with
Tata Trusts.
The startup has received money from Grand
Challenges Canada (GCC), National Science &
Technology Entrepreneurship Development
Board (NSTEDB) CIIEI, Nesta, Unitus Seed
Fund and Indian Institute of Management (IIM)
Ahmedabad as product development support.
The startup has also secured funding from
BIRAC through its Biotechnology Ignition Grant
(BIG) scheme and SBIRI.
UTI today is a problem that affects 1 in 5 women
during their lifetime, with pregnant women being at a
much higher risk. With rising antibiotic resistance in
India, it is becoming an ever increasing need to have
rapid antibiotic resistance detection that can be easily
deployed in every lab. And that is what OmiX Labs
is bringing to the market”, highlights Dr Sudeshna
Adak, CEO & Director, OmiX Labs.
“At OmiX Labs, we started working on a platform
technology that is aimed to diagnose urinary tract
infection and provide antibiotic susceptibility in 3
hours instead of 3 days, and very easy to use. Today,
without doing culturing, we can test urine samples
for presence of bacteria, identify the organism and
provide an antibiotic susceptibility profile in 3 hours”,
she adds.
Dr Manbeena Chawla
manbeena.chawla@mmactiv.com
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34 ANALYSIS
IS CRISPR
CAUSING CONCERN?
S
ince its discovery in 2012,
the gene editing tool
CRISPR-Cas9 has generated
quite an excitement by making
the possibility of routine genome
editing a reality. A number of
biotech companies, including
CRISPR Therapeutics, Intellia
Therapeutics, Editas Medicine,
and eGenesis, are currently
developing medicines based on
this technology. In addition,
CRISPR-based technology is
already being used in the clinical
context in China. For example,
at Hangzhou Cancer Hospital,
immune cells of patients with
oesophageal cancer are being re-
engineered to fight the disease.
But lately an article published
in Nature Biotechnology has
led to a debate over the safety
of the potential CRISPR-
based therapies. Studies have
highlighted that CRISPR-Cas9
edited cells might trigger cancer.
It is likely that this finding can
drastically affect the accuracy of
gene editing and cause alterations
of non-target genes, leading to
concerns that if used clinically,
CRISPR-Cas9 gene editing could
result in unwanted damage
in humans, or worse, tumor
formation.
“CRISPR technology is a
powerful technology in gene
editing and could answer a lot
in the field of genetic disorders.
However, we do not yet fully
understand gene interactions
and that could only come with
new knowledge which is being
generated. We need to gather
enough evidence through
experiments before reaching
any conclusion”, shares Dr N
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
K Ganguly, Former DG, Indian
Council of Medical Research.
The major safety concern
is that, this field is moving so
quickly and some researchers
want to get into human clinical
trials right away, even before the
CRISPR technology paradigm has
been fully validated. Researchers
in China have actually proceeded
to human clinical trials using
CRISPR much faster than has
been possible in the United
States. Recent reports state that
somewhere between 80 and 100
people are already being tried,
or already being tested using
CRISPR.
“Much of the basic research
around the CRISPR-Cas9 system
has centered around two themes.
The first has been to ensure
specificity of the system so that
the modifications are made only
in the desired genomic region and
not anywhere else in the genome.
The second theme centres on the
nature of modification. Knocking
out a gene by causing double-
stranded DNA breaks is the most
common technique, but the
system is very versatile and it has
been used for everything from
gene editing to controlling gene
expression. These techniques
continue to be optimized and the
costs have reduced to a point that
has democratised research in the
field. However, the implications
of carrying out these changes in
humans are far from clear”, points
out Dr Vamsi Veeramachaneni,
Chief Scientific Officer, Strand
Life Sciences.
No matter which side wins,
it is evident that years will go
by before the CRISPR system is
ready for prime time and clinical
use. “Fully achieving the promise
of this technology will be achieved
with more knowledge and
understanding of the genome-
editing mechanism supported
by scientific peer review and the
rigor and regulations applied to
clinical trials”, mentions Supriya
Shivakumar, Head of strategy,
Gene Editing & Novel Modalities,
Merck.
However, the safety concerns
surrounding CRISPR-based gene
editing are less of a concern in
potential agricultural applications
in which the technology could
also have important implications.
“This technology has
tremendous potential in
agriculture and manipulations
in Synthetic Biology. Beneficial
effects in corn, potato and tomato
have already been shown. The
biggest problem could still be
regulation, especially in India.
India needs to move fast in
terms of ushering in a second
green revolution using such
technologies in a transparent
manner. It should not get into the
muddle being experienced with
the application of GM technology.
A pro-active initiative to draw
guidelines for use of CRISPR
and its commercialization in
agriculture is a priority. An early
success in producing Beta-
carotene-rich banana in India is
a distinct possibility”, highlights
Professor G. Padmanaban, NASI
Platinum Jubilee Senior Scientist,
Department of Biochemistry,
Indian Institute of Science (IISc).
Dr Manbeena Chawla
manbeena.chawla@mmactiv.com
36 Q&A BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

“KIHT to support indigenous research

and manufacturing capability to
make India self-dependent”
complement efforts on industrial promotion in the
medical devices segment.
So far, KIHT has facilitated convergence of
available technologies to bring increased access to
affordable health products to citizens and a thriving
medical devices manufacturing sector in India. The
« institution has created a knowledge repository for
Dr Jitendar Sharma, trade information, and has analysed emerging trends
CEO of KIHT, India in trade and investments and provided policy enabling
inputs to the government.
KIHT has been instrumental in launching a

I
ndian biomedical industry is undergoing a
positive transformation over the few years. The
change has been felt with Kalam Institute of
Health Technologies’ (KIHT) tremendous efforts.
India, a country which projects as being extremely
import-dependent for medical devices, is no more
the same. The efforts of KIHT has changed that
paradigm and in just one year since its formation,
significant MoUs and agreements have been inked
that aim at creating a more indigenous research
and manufacturing environment and capability
for India. Supporting biomedical startups, skilling
India’s young biomedical workforce, nurturing talent,
interacting with policy makers and most of all being
the face of India’s biomedical industry is serious
business for KIHT.
Celebrating its first birth anniversary and
its recent agreement with Cuban counterparts
has prompted BioSpectrum to interact with Dr
Jitendar Sharma, CEO of KIHT. Dr Sharma in an
interactive session reveals the goals of KIHT and its
accomplishments done so far. Edited excerpts;
pioneer initiative named NIPUN certificate, i.e. Non-
regulatory Innovation Potential Utility and Novelty
certificate, to act as a single point window for all non-
regulatory requirements of the medical technology
sector and provide a simplified approach to the current
process in the commercialization of a product. It takes
care of all the processes relating to regulatory filing for
a certified product in hand for gaining market access.
KIHT promulgated Health Technology as one of
the core component of market access, which adds value
to the product credibility by giving them comparative
overview of clinical and economic effectiveness of
the innovation with its systematic, transparent and
evidence based decision making process.
Following are few achievements in space of
Health Technology Assessment (HTA):

With what purpose was KIHT formed and so

far how has the institute kept in lines with its
objectives?
KIHT was formed to facilitate focused research on
critical components pertaining to medical devices
by supporting institutions involved with R&D,
industry, policy makers and knowledge repositories.
KIHT successfully created the world’s first e-auction
platform for transfer of Intellectual Property, material
and prototypes and bringing strategic and coherent
synergy of scientific facilities and institutions to
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
1) KIHT got collaborated with The Joanna Briggs
Institute (JBI), and Institute of the University of
Adelaide as JBI Affiliated group member for applying
international standard and methodology to conduct
systematic reviews & meta-analysis.
2) KIHT is now regional hub for conducting HTA
for Department of Health Research, Ministry of Health
and Family Welfare.
3) KIHT has organized two international fellowship
programme on HTA and has collaborated with Tata
Institute of Social Science (TISS), Mumbai for taking
fellowship programme to next level by converting it to
Executive programme on Health Technology Policy,
assessment and outcomes research. This programme
would give holistic approach in understanding public
health policies and how to utilize evidence based
research for decision making.
4) As part of NIPUN certification, KIHT is well
equipped to evaluate technologies with highest
international standards and provide recommendation
for innovations on the basis of evidences.
As part of its constant endeavour to cater to the
needs of the medical devices industry, KIHT has
come out with unique type of dossiers to disseminate
information specific to devices in healthcare which are
complex in technology and import dependent. These
dossiers capture key features of a product like design,
technology, market share, etc. and facilitates users like
startups, researchers, academicians, manufacturers
and other stakeholders in taking decisions on R&D,
investment, potential market, innovations etc. KIHT
periodically conducts training sessions and workshops
on medical devices and their functionality with hands
on session by experts on the actual device itself. Such
level of close proximity to actual operating medical
devices and in depth learning has been unprecedented.
Q&A 37
How does the Chandrababu Naidu-headed
Andhra Pradesh Government support
developments at KIHT?
The land and infrastructural support for KIHT has
been provided for within the Andhra Pradesh MedTech
Zone, which is an enterprise of AP Government. KIHT
was the knowledge partner for AP Health festival in
Visakhapatnam and are often consulted for essential
decisions in the health department.
What are the significant milestones
accomplished by the Institute so far?
KIHT has been recognized by the Principal Scientific
Advisor (PSA) to the Government of India as official
Project Analysis Unit for all Health Technology
Projects in the country. The PSA himself held a
consultative meeting at the KIHT campus, where a
host of institutions and organizations were called in
for an in depth discussion on the status of projects that
received government funding in the health technology
domain.
Apart from the NIPUN certification and HTA
initiative, KIHT takes pride in successfully launching
the first ever e-auction for medical technologies
on February 15, 2018, by Ananth Kumar, Union
Minister for Chemicals & Fertilizers on India Medical
Device 2018, the largest exhibition and conference
on the Indian Medical Devices Sector Organized by
Department of Pharmaceuticals, Ministry of Chemicals
and Fertilizers, Government of India in partnership
with Federation of Indian Chambers of Commerce &
Industry (FICCI). The e-Auction web portal hosts 22
technologies for technology transfer as on date. KIHT
has signed MoU with 12 institutes/ company for the
purpose of technology transfer so far and more in
progress to bring more technologies to market.
KIHT also participated in International Technology
Transfer Convention 2017, Beijing, China. China’s
largest technology transfer forum to streamline the
innovative healthcare technologies to India.
NIPUN Certification came as a boon to start-ups,
innovators and MSMEs of medical device industry for
commercializing their products. Since the industry
is still in its infancy stage, the exposure towards
standardization is limited and therefore the innovators
are finding difficulty in putting their product in the
market. Soon after the official launch of NIPUN by
PSA on April 30, 2018, an overwhelming response
from various people have been observed. The services
of NIPUN include: conformity testing, HTA, Market
Research, Patenting, Rapid Prototyping and other
related services in order for the product to conform
to a particular standard. As a part of the continuous
growth phase, KIHT has entered into 22 associations
with several institutions and organizations pan India
38 Q&A
and have offered trainings, workshops, conference
speech at many events in order to bring more open-
ended discussions in the MedTech space.
What is the USP of KIHT and how it is different
from other institutes?
No other organization, in any realm of any discipline
of science, has accomplished what KIHT has in this
short span of time. KIHT has mapped the core health
technology space, offered solutions and various aspects
of policy support, along with the parent organization,
Andhra Pradesh MedTech Zone Ltd (AMTZ) has
created a bandwidth of bench to bedside transition
and has opened up medical technology as a formidable
discipline to contribute to the Indian dream.
The institute has been instrumental in shaping
the biomedical skill sector of India. How,
according to you, has this been accomplished?
KIHT along with AMTZ, National Accreditation Board
for Certification Bodies (NABCB), Quality Council of
India (QCI) and Association of Indian Manufacturers
of Medical Devices (AIMED) joined hands to form
the Indian Biomedical Skill Consortium on February
16, 2018 with an objective to reinforce biomedical
skill sector in the country. Institutional Bio Safety
Committee (IBSC) brings an equivalence system
of value-based assessment covering educational
qualification, work experience and competency
possessed by practitioners of biomedical engineering
skills. To facilitate this, 50 assessment centres
with a total testing capacity of 14,000 to take load
of certification of more than 2 lakh biomedical
engineering practitioners is planned across several
states in India.
Could you elaborate on the recent collaboration
with BioCubaFarma? How is this collaboration
benefitting India and its relationship with Cuba?
The President of India visited Cuba from June 21-
23, 2018. An MoU on collaboration in the field of
Biotechnology was signed between the two countries
on June 22, 2018. It is to be emphasized that this is a
great opportunity for Indian startups and industries
in the field of Biotechnology to collaborate with their
Cuban counterparts and vice versa.
A delegation comprising experts from the
Biotechnology Industry Research Assistance Council
(BIRAC) and KIHT, participated in discussions with
‘BioCubaFarma’, the Cuban Industry promotion
institute for health sector for further potential
collaboration in areas of mutually interest.
It has been observed that owing to its limited
domestic production, Cuba is highly dependent on
medical device imports. More than 40 per cent of
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
medical devices are imported from Europe, primarily
Germany and nearly 30 per cent come from China and
Japan collectively. Indian startups/companies can
play a major role in providing better and cost-effective
solutions through mutual collaborations in the field
of medical devices and other biotechnology related
technologies/products. In view of the above a tripartite
MoU between KIHT, BIRAC and ‘BioCubaFarma’ was
signed to facilitate several stakeholders, including
industry, R&D Institutes and Technology Transfer
offices and pave the way for technological & industrial
progress in Biotechnology sector. Some of the
companies have been identified to interact with Cuban
technology enterprises for licensing, manufacturing,
R&D and program uptakes.
What is KIHT’s vision/goal for the next five
years?
KIHT has few set goals to accomplish in the next five
years.
a) Create a self-dependency module for Medical
Technologies.
b) Consolidate all government funded health
technology projects and facilitate their successful
completion.
c) Enable more and more health technology
innovations to reach out to their industry partners.
d) Create testing and validation bandwidth for all
innovators so that they can take their prototypes to the
next phase, thus enabling start-up’s in this technology
driven segment.
e) Make HTA a mandatory module for procurement
for medical devices.
f) Enable early researchers’ access to medical
devices so that further innovations can be carried out.
How do you see accomplishing those goals as a
boost to India’s biomedical industry?
The Indian biomedical industry is extremely import
dependent. The efforts of KIHT can potentially
motivate more indigenous research and manufacturing
capability and in turn make the nation come out of this
import dependency.
Besides BioCubaFarma are there any other
partnerships KIHT has entered into? If yes, how
have those partnerships supported the growth
of KIHT?
KIHT has so far partnered with 22 institutions
through which innovations can reach out to market
place for possible health and market access avenues.
The disease burden and trade deficit amalgamated
model by KIHT created the National Priority List
which was the first-of-its-kind need and trade-based
grant released for R&D in any sector of science.
40 Q&A
“Today, most local problems have
global solutions and vice-versa”
« complement each other to cater to the needs of the
Prof Pankaj Chandra,
Vice-Chancellor,
Ahmedabad University
R
ecently, Ahmedabad University in partnership
with University of California San Diego
launched Global Executive MBA program for
pharmaceutical industry professionals. With this
regards, BioSpectrum talks to Prof. Pankaj Chandra,
Vice Chancellor, Ahmedabad University. He was a
member of two Steering Committees constituted
by the Planning Commission of India for 12th Plan
Development, one on higher and technical education
and the other on industry. He has been involved
in several startups and has also been a consultant
to large Indian and multi-national firms. He also
serves on the Boards of several firms and institutions.
Edited experts;
Can you please throw some light on the strategic
collaboration?
Ahmedabad and San Diego are both very strong
centers of life sciences and pharmaceutical innovation
and production. Ahmedabad University is building
strong research and teaching programmes around the
sector that allows interdisciplinary enquiry – one that
can happen only at a multi-disciplinary university.
The University of California San Diego is one of the
prominent centres of research and development
in the pharmaceutical industry. The Rady School
of Management at the University of California San
Diego has exceptional examples of developing ethical
and entrepreneurial leaders and enhancing qualities
that demonstrate inspirational leadership. Moreover,
there is a need in the pharmaceutical industry to skill
employees to become innovative leaders in this very
rapidly changing industry. At Ahmedabad University,
we are focused on integrated problem solving and
innovative leadership by strategically bringing
together disciplines of management, engineering,
pharmaceutics, and arts & sciences on to a singular
learning platform. On the other hand, UC San Diego
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
brings in intellectual depth by harnessing high
quality education and interdisciplinary research.
The partnership between Ahmedabad University
and University of California San Diego is a natural
collaboration of capabilities and expertise that
pharmaceutical industry, not just in India, but across
the globe.
What are the fees of this program and how will
this course help working professionals?
The programme will enhance the leadership skills
of the working professionals, against the backdrop
of changing regulatory landscape and emerging
global trends in innovation and drug delivery. The
programme will be led by distinguished faculty from
India and abroad, who have deep understanding
and expertise in leadership and management, digital
and medical technology, biological and life sciences,
and the pharma quality and audit systems. The
programme will also help students develop excellence
in strategy and leadership; align R&D and technology
with commercial operations; build organizational
agility; and achieve competitive advantage through
sustainable growth. Most important, the programme
is modular in design and professionals can continue
to work and still complete the degree.
The fees for the programme is Rs 4.5 lakhs per year,
inclusive of hotel stay during the residency period but
exclusive of cost to travel to Ahmedabad for various
residencies of the programme. To encourage more
women to enhance their leadership capabilities in the
sector, we provide a discount of 10% on the total fees.
What is your opinion on the industry-academia
gap in the life sciences sector and what should
be done to reduce it?
There are two things to be kept in mind. One,
degree programmes must build on new theory while
teaching how to apply. And industry must take
advantage of this critical thinking
approach that universities
build. The problem
is that there
are too many
poor academic
institutions that
do not do their
teaching-learning
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
well and too many companies that do not use the
capabilities of their academically better trained
employees. And second, problems in industry or
society do not often come defined as disciplinary
problems – solving problems requires multiple
disciplinary skills and multiple perspectives as well as
experiences. Unfortunately, academia is built around
silos which does not help. Ahmedabad University, for
instance, has built relationships with a few select firms
in the sector to engage with them when thinking about
curriculum and its review, to develop programmes
for working professionals, to get students to do small
projects, for industry professionals to undertake
masters and doctoral degrees while they are
working, conduct joint research projects etc. These
help academia to understand industry issues and
problems more deeply and for industry to upgrade
the capabilities and retain their talent. This could be
a good model. One must remember that relationships
are built over time by taking many small steps.
In your opinion do corporate supporting
academic institutions help in students’ skill
development?
Definitely. As I mentioned, engaging with corporates
at the stage of curriculum design, bringing them to
class, getting students to do projects, internships etc.,
all make students aware of the real issues, understand
the processes and tools & techniques used – all of
which enhances capabilities and hence employability.
Internships that allow students to use state-of-art
equipment also help build enduring skills.
How collaborating with a foreign university is
advantageous?
Today, most local problems have global solutions and
vice-versa. Moreover, as India becomes a stronger
partner in global supply chains, both global companies
as well as local companies will seek skills and
perspectives that help them navigate the requirements
of the world. This requires creating a mindset amongst
students, faculty, and administrators which says
that my local solutions can have global impact and
that there are global best practices that can help me
do things better and more
effectively or simply
Q&A 41
allow me to do more. For educational institutions,
collaborations with universities abroad allow building
of such mindsets. It creates diversity amongst student
population which has tremendous benefits. It leads
to sharing of knowledge and doing things that each
individual institution would find difficult to do. It
teaches new things and builds new perspectives that
will help students navigate their careers better. It
also allows institutions to explore, jointly, frontiers
of research and solve knotty problems pooling of
intellectual resources.
Many students are moving to management
after studying pharmacy. In your opinion, are
management professionals required more
compared to technically sound people?
The Indian pharmaceutical industry is very vibrant
but is also facing strong headwinds from regulatory
and insurance industry globally. Moreover, the pool
of drugs coming out of patent is slowly declining in
the medium term. At the same time, new technologies
are starting to address areas that were intractable and
through different mechanisms. This calls for a different
kind of strategy at the organisational level. Firms in
India will have to invest more in R&D, partner more
with academic institutions for early stage research and
startups for quick translation while managing risks
and markets globally. This requires a very different set
of competencies. Domain knowledge in life sciences
including mathematics & pharmaceutics when
combined with managerial skills form a potent mix
of abilities that will help a young manager contribute
to the industry. Having said that, in a knowledge
industry like pharma, highly skilled technical experts
who are MD or PhD or both will be most valued as they
can pick up managerial skills on the job and through
various executive programmes and lead the industry.
Is Ahmedabad University in plans with
collaborations with other firms or institutions
apart from this?
Ahmedabad University has developed a partnership
with some of the finest pharmaceutical firms in
India for advancing knowledge creation especially in
STEM. The Executive Global MBA in Pharmaceutical
Management, is guided by an Advisory Board that
comprises senior leaders from industry and academia.
The initial industry members of the Board are from
Torrent, Biocon, Zydus, DRL, Sanofi, Lupin, and
SciVista IP. We have also developed a Pharma
Collaboratory that will drive our research agenda, our
programmes, and our engagement in the sector for the
benefit of all firms in the industry.
Prapti Shah
prapti.shah@mmactiv.com
42 Q&A
“Collaborations are always welcome
as they expand the strengths mutually”
« enhancing the student experience on a primarily
Prof
Pradeep K. Khosla,
Chancellor, University
of California San Diego
P
rof Pradeep K. Khosla, the eighth Chancellor of
University of California (UC), San Diego, leads
a campus that has more than 35,000 students.
He has initiated and led UC San Diego’s first ever
Strategic Plan aimed to identify and implement
unprecedented solutions necessary to address
pressing global challenges. With annual revenues of
$4.3 billion in fiscal year 2015, UC San Diego is an
academic and research powerhouse, with faculty,
researchers and staff attracting more than $1 billion
in research funding a year. The campus is the third
largest employer in San Diego County and one of
10 campuses in the world-renowned University of
California system. Recently UC San Diego entered
into a partnership with Ahmedabad University
and launched Global Executive MBA program for
pharmaceutical industry professionals. In this regard
BioSpectrum spoke to Prof Pradeep K. Khosla,
Chancellor, University of California San Diego about
the strategic plan and how this partnership will help
Indian students. Edited experts;
Tell us about how UC San Diego’s first-ever
Strategic Plan was created? Why did you
initiate it and how has it helped students?
UC San Diego’s Strategic Plan was initiated in 2014
when the University was at a critical juncture in
its evolution. We needed to think boldly, identify
and implement unprecedented solutions that were
necessary to ensure our continued level of excellence
and to advance our knowledge, in order to address
pressing global challenges.
We engaged more than 10,000 stakeholders
to gather ideas and insights about UC San Diego’s
challenges and opportunities. We coupled that
effort with a quantitative assessment, benchmarking
UC San Diego to peer institutions across multiple
dimensions. Based on the data we gathered, we
sharpened and framed our mission, values, goals, and
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
initial strategies to collectively map a framework for
sustainable excellence.
The Strategic Plan has refocused UC San
Diego to be a student-centered university. We are
residential campus. We are creating a more
connected campus. We are making UC San Diego
a destination for arts, culture and recreation. We
are creating an educational and overall experience
that develops students who are capable of solving
problems, leading, and innovating in a diverse and
interconnected world.
What are the driving factors of its success?
The Strategic Plan touches all aspects of the
university and has been instrumental in its holistic
transformation. Also, the fact that we engaged each
and every stakeholder category while gathering the
insights and made this plan highly inclusive is a
crucial factor in its success. The Strategic Plan is a
dynamic roadmap and is ever evolving, making it
highly relevant and contemporary, which is another
reason why it is thriving and succeeding.
Why did you choose Ahmedabad University as
a partner? What makes it stand apart from the
other universities?
In the universe of universities, both Ahmedabad
University and UC San Diego are relatively young
– and hence both are agile, aspiring and nimble to
move faster. Ahmedabad University with its stellar
leadership team driving an interdisciplinary paradigm,
well-trained research-oriented faculty, and a focus
on solving larger issues of the modern world, has all
the right credentials to emerge as a great university in
India. Their unique understanding of the context and
sense of the requirement of the times that we live in,
both, from the Indian as well as global perspectives,
have helped them design their academic models that
address complex problems faced by society, while
building deep disciplinary skills. In fact, the speed
at which our two teams conceived and designed
the Global Executive MBA in
Pharmaceutical Management
program is a testimonial of
our mutual understanding
and teamwork – that
bodes well for further
collaborations in specific
domains of interest.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
How will partnership with UC San Diego help
Indian students?
One of the goals of the Strategic Plan has been
to cultivate a diverse and inclusive university
community that encourages respectful open dialogue,
and challenges itself to take bold actions that will
ensure learning accessibility and affordability for all.
So Indian students choosing UC San Diego will find
a very supportive and multi-cultural environment
in which to study. We have also expanded the
number of students who receive scholarships and
boosted on-campus programming to further support
the scholars. Our partnership with Ahmedabad
University will explore innovative ways in which
Indian students would make their overseas study
feasible and highly engaging at UC San Diego.
Are there any plans to partner with other public
or private universities in India?
Collaborations are always welcome with other
universities as they expand the strengths and
enhance the learning curve, mutually. Our
association with the Ahmedabad University is an
important collaboration in India and we look forward
to a dynamic partnership that would make the
Global Executive MBA program in Pharmaceutical
Management to be the best in the world. We are open
to exploring new opportunities that might arise in the
future which would entail collaborating with public
or private universities in India.
How has this partnership helped UC San Diego?
First, we all know India’s
gigantic aspiration to
provide its citizens with
world class education.
Recent estimates
suggest that students
from India spend
more than $8 billion
in education abroad
– nearly half of
which is spent
in the United
States. Indian
students
are
Q&A 43
among the most meritorious globally. So access to this
huge pool of talent aspiring for cutting-edge education
in technology, sciences and policy is highly desirable
for UC Dan Diego. This partnership with Ahmedabad
University enables us to access that pool. Second, like
Ahmedabad in India, San Diego has emerged as an
American and global hub for cutting-edge research
and innovation in life-sciences and biotechnology.
Hence, it is a very attractive proposition for both UC
San Diego and Ahmedabad University to synergize
these biopharma and life sciences clusters to align
with each other and create a world-class ecosystem of
scientific and managerial expertise.
In your opinion, what should be done to reduce
the industry-academia gap in life sciences &
pharma sector?
As India becomes a global pharma hub, it is
imperative that the leaders, managers and
employees of companies in the sector sharpen
their technological, scientific, and management
acumen. There needs to be an ongoing collaborative
interaction and input mechanism between the
industry and academia to make the pharma courses
more industry ready and application oriented. The
Global Executive MBA degree in Pharmaceutical
Management is one step in that direction where
pharmaceutical professionals are engaged in intense
interaction with experienced colleagues and world-
class faculty on key issues affecting innovation and
drug delivery in pharmaceutical and life sciences
field.
How can Universities help in making students
equipped with the skills that are needed in the
industry?
First, it’s important that students are well-rounded
and able to think with both the left and right
brain. We must provide students with a strong
foundation of skills – like how to apply knowledge
with understanding and how to work collaboratively
– so they can then build advanced expertise and
work on multi-disciplinary teams to tackle and
address our society’s most complex and pressing
global challenges. It is also imperative that students
learn from faculty who have industry experience
and leadership. At UC San Diego, we actively
encourage student innovation, leadership,
entrepreneurship and nontraditional
thinking, as we want to prepare our
students for the ever-evolving job market
and economy, which requires creativity,
flexibility and adaptability.
Prapti Shah
prapti.shah@mmactiv.com
44 Q&A
“Annual percentage of cancer
detected at awareness camps is 5%”
«
Dr. Harsha Rajaram,
Vice President –
Columbia
Asia Hospitals
C
olumbia Asia Radiology group (CARG) has
been providing Tele radiology services since
2008. It has provided reporting services to
nearly 100 plus clients across 9 countries. CARG has
been extending this services to nearly 13 missionary
hospitals across India and institutes such as Indian
Cancer Society (ICS) through camps. Providing
services at subsidized price for centers such as ICS,
helps Columbia Asia (CA) play a role in creating
awareness about cancer, which is the need of the hour.
In addition, the remote patient base this institute
serves caters to diverse and unique disease profile, this
provides a great learning for urban based radiologist.
CA has reported nearly 40,000 cases over the last 4
years for ICS. This year the camp for Teleradiology
was headed by Dr. Harsha Rajaram, Vice President
– Columbia Asia Hospitals. Dr. Harsha Rajaram
shares his experience on the awareness drive and the
intensity of the camp. Edited experts;
How many locals showed up at the various
camps? What was the ratio of the cancer
detected to the participants?
The Preventive Screening Camps are always area
specific. Local partners ensure attendance. We try
and cover the whole sample of that particular area.
If it is full day screening, then ICS targets around
120 individuals and if the screening camp is of half
day then targeted sample size is 50-60. The annual
percentage the cancer detected to the participants is
4.77%.
What was learning from the camp? Would you
look forward to more such camps?
ICS has undertaken Mobile Camps since 1984. In early
years, Individuals were less aware of the risk factors
and symptoms of Cancer. Now, thanks to social media,
WhatsApp etc. Awareness levels are much improved.
Awareness speakers- Volunteers undertake field
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
visits to far flung villages and provide them general
awareness about Cancer. Yes, we always look forward
to conduct Preventive Cancer Screening Camp in
order to increase their health seeking behavior.
Do you feel Technology in medical field was an
added advantage in this situation?
Yes, Technology adds a great value to the medical field.
There is improvement in the cancer detection rate as
technology helps changes over time. We are thankful
to Columbia Asia Hospital Bangalore for helping us
providing tests reading. Receiving Reports within 24
hours is very encouraging, & impressive to Patients.
Technology is the leverage. Mobile bus mounted
with Digital X-ray and Mammography is connected
with Columbia Asia Center in Bangalore which
provides the reporting services, Tele-radiology
services on a moving platform/ bus, probably is one
of its kind in India. Technology can further help in
tracking of screened patient, better analytics and also
help in getting expert medical opinion from anywhere
in the world.
What is the importance of Tele- radiology and
AI in cancer screening, kindly elaborate on the
procedure?
Tele radiology has helped bridge and connect the
needy population at remote places with experts
from institutes such as CARG. Accurate reports from
experts in the domain can be provided in short span of
time with tele radiology. Artificial Intelligence can be
a game changer in cancer screening.
Imaging plays a vital role in cancer screening
and it is a proven fact that early detection has better
mortality benefit. Lot of efforts to improve screening
outcomes have mostly focused on intensifying resource
expenditures like double instead of single-reading,
more frequent screens, or supplemental imaging.
Imaging analysis by AI, can be accurate and efficient,
making it an ideal tool. The key though is the data on
which the algorithm has been built, it is essential that
AI should be mentored by expert clinician, build on
validated data and good quality assurance program
will ensure the good outcomes.
AI driven chatbots and virtual assistants can take
care of basic yet tedious tasks like registering, history
taking and also be a great engagement tool with the
identified population.
Narayan Kulkarni
narayan.kulkarni@mmactiv.com
 ADVERTORIAL

PROVEN SINGLE-USE
CONTAINER CLOSURE INTEGRITY
Single-use systems (SUS) are increasingly used for the storage, mixing,
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A problem in industry is the lack of understanding of defect sizes, causing
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In order to facilitate the implementation of SUS for sterile drug product
manufacturing, Sartorius Stedim decided to develop physical integrity tests
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Marc Hogreve, packaging integrity at the supplier as well as post shipping and post-installation
Senior Engineer at the manufacturing site
Integrity Testing, A consistent and reliable integrity control strategy must be based on an
Sartorius Stedim initial risk analysis, prior to the implementation of Quality by Design to ensure
Biotech the inherent and consistent robustness of SUS and the control of all stages of
the manufacturing process. In-depth knowledge of factors that may impact
Marc started his career their integrity under actual use-case conditions and the understanding of liquid
as a project lead in lab leakage mechanisms, as well as their correlation with microbial penetration
equipment development are essential in order to be able to define, on a scientific basis, the appropriate
for cell culture and detection thresholds.
microbiology. Marc Knowing the potential failure modes in each stage of a SUS lifecycle allows a
is a senior engineer systematic QbD (Quality by Design) approach for the development of single-use
for integrity testing technologies, starting with an understanding and control of the raw materials &
solutions with a focus components used up to the finished products.
on single-use system In addition, process qualification and product validation ensure mechanical
for fluid management. and microbial integrity of the complete SU assembly. A lot of different test
A subject matter methods like tensile strengths or burst test, are being used to qualify film
expert, Marc works on robustness, components, bag chamber manufacturing and finally complete bag
Sartorius’ global single- assemblies. Also packaging & shipping validation is part of this robust approach.
use container strategy. As a basis for developing physical integrity test methods, it is key to
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BPSA and PDA task material used for single-use systems. To establish the MALLs* for microbial
force and leader of the ingress & liquid leaks as leak detection target for physical non-destructive
new ASTM standard testing Sartorius decided to perform bacterial challenge and liquid leak studies
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of Single-Use Systems”. protocols can then be implemented, both at the supplier and at the end-user
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creation of standards, a physical, non-destructive test method allowing a detection of this MALL with
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* Maximum Allowable Leakage Limit, is the greatest leak size tolerable that poses no risk to product safety, USP<1207>
46 OPINION BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

Indian pharma
SHOULD FOCUS ON QUALITY
Indian population has been suffering from long
with lower standard cheap drugs with reduced
or no efficacy. It is only right that the best
« quality products is made available first to the
Sanjeev Gupta, nation and then be exported elsewhere. This will
Managing Director,
also help offshore companies to invest heavily
Kusum Group of
Companies, India in India, noting the volume that India drives.

I
f not that rampantly in the developed countries,
but definitely in the developing countries, and
especially in India, access to medicines comes
first, even earlier than the access to healthcare
facilities or doctors. This essentially means that come
illness, most likely one would swallow a pill first and
then visit a doctor, if at all felt necessary.
In a state where consumption of medicines takes
such precedence, the quality standard of drugs need
to be the primary focus area for the pharmaceutical
industry. Not that the industry encourages the
unregulated consumer habits of purchasing over the
counter drugs, but the onus of manufacturing high
quality medicines with fewer adverse effects has to be
the borne by the pharmaceutical industry.
When composing a medicinal drug, the most
important considerations invariably are identity
and purity. The slightest deviations from the
set norms complied by the originator can be
damaging to masses, if the same goes unchecked
during the research and development process.
The creation and accessibility of comprehensive
pharmacopoeias themselves is a matter of much care
and complexity. It is of the wider public knowledge
and understanding that export quality of products
nonexclusive to pharmaceutical drugs is different
to what is either imported or sold internally. In
products as essential as medicines, it becomes all the
more important to evaluate the quality standards of
the drugs exported to those being sold to one’s own
citizens.
Quality Standard of Drugs: Brief Context
It is estimated that 70 per cent of pharmaceutical
drugs in India is generic, with 9 per cent being
oriented and 21 per cent being over the counter
drugs. The entire generic drug industry is estimated
to be of around $ 30 billion. The pharmaceutical
industry is much export oriented; however in recent
years, various factors contributed to an export slump,
with export figures dropping from $ 6488 million in
2015 to $ 2082 million in 2016.
The dropping of export figures is reflective of
the various challenges faced by the industry in re-
establishing the Indian pharma brand and culture
as one which is quality oriented. In the otherwise
flourishing and growing industry, quality standard of
drugs remains the major burning area.
India has remained the largest supplier of
pharmaceutical drugs to United States. Till last year,
US Food and Drug Administration (FDA) had sent 42
warning letters to its global manufacturers of drugs.
Nine of those letters were directed towards Indian
facilities. In light of repeated concerns, US FDA
inspection in India has increased by over 20 per cent.
While the other developing countries including
CIS (Russian Commonwealth) nations, Latin
American nations, African Countries have favored
India for importing pharma products, keeping
the immediate competitor, China, fairly behind;
it is only fair that the reputation gained of being a
quality affordable drugs
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
provider be sustained with consistent quality
delivery, even though the quality assessment
procedures in these countries may not be as rigid as
US FDA.
Challenges and Solutions
It will only be beneficial to the credibility of the
industry in the longer run if the challenges are
identified and a roadmap be worked upon to address
these issues in a time bound manner. Some of
the common challenges that have been ailing the
industry include
Low Government investment in
healthcare. The government investment in
healthcare is still shying away to touch the 2 per cent
GDP mark, which is not only affecting the hospital
industry but the pharma industry as well. A 1 to
2 per cent increase of investment in healthcare,
and perhaps a minimum dedicated investment for
pharmaceutical industry, will give the industry the
required boost to strengthen its manufacturing
output and upgrade the quality standards across the
board.
Ensuring better level playing field. The
existing focus has been on promoting low-scale
indigenous manufacturing enterprises to push
unbranded generic medicines at a much cheaper rate.
While the same may seem beneficial for the poorer
masses, the same should be allowed only when the
domestic entities match the quality and uniform
standards those that export to a global consumers.
Lower quality standard is not only detrimental to
the credibility of the industry at large but also to the
health of the nation. A robust quality framework for
domestic markets also helps in creating larger and
better global impression of Indian pharmaceutical
industry as a reliable player, as exporters necessarily
face higher quality compliance requirements to
maintain export competitiveness and international
credibility. Regulatory authorities such as the Central
Drugs Standards Control Organization (CDSCO)
should be empowered more to ensure the compliance
of established law.
Another important benefit of ensuring level
playing field is that Indian population has been
suffering from long with lower standard cheap
drugs with reduced or no efficacy. It is only right
that the best quality products is made available first
to the nation and then be exported
OPINION 47
elsewhere. This will also help offshore companies to
invest heavily in India, noting the volume that India
drives.
Limit the range of medicines that
are subject to price control. Research
and development, coupled with the complete
manufacturing process, and added quality checking
mechanisms such as pharma covigilance is a high
manufacturing cost of the final product. Extending
the number of medicines, which is now 20 per cent
of drugs by sales volume, that are subjected to price
control will adversely affect the production of quality
products in order to maintain sustainability. High
margin combination drugs will also suffer from this.
Ensuring efficacy of Indian manufactured
drugs, data integrity, and hygiene factors.
These three form one of the strong pillars for
ensuring quality standards in Indian drugs. Stronger
guidelines for manufacturing drugs, due diligence in
maintaining data integrity, and implementation of
strong hygiene policy from the time of importing of
raw materials to the time of packaging and finalizing
batch for sales, are essential elements to ensure
quality standard.
The Good News
The government has recently provided much hope
and positivity to the entire industry and the world by
initiating the drafting of Pharmaceutical Policy 2017,
which gives significant focus on the quality concerns
challenging the industry today. The draft is yet to
mature, but the same will happen when the industry
leaders across the board, policy makers, healthcare
experts, government, domestic and private players,
all come on board to engage and debate severely in
order to resolve the quality challenges of the industry.
Recently, the announcement by Drug Controller
General of India (DCGI) to start the single window
facility for providing consent, approvals, and other
information will further ease the process for Indian
manufacturers, allowing them to focus their energy
on other matters. Digital integration of pharmacies
will not only ease the flow of drugs with a proper
track from one point to another but also help regulate
pharmacies.
More initiatives are required at a quicker pace for
India to dominate pharma industries of the world,
as countries like China are closing on our heels with
many aggressive measures.
48 SCIENCE NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

IIT-B to develop ILBS to design

effective TB treatment test for Severe
The Indian Institute of Technology-Bombay (IIT-B), along with three
other renowned national institutes, is running clinical trials of a Alcoholic
breakthrough medicine that aims at treating multi-drug resistance
(MDR) tuberculosis (TB) and killing the bacteria in the lungs more
Hepatitis
quickly, if taken along with regular medication. In a recent study led by
The research holds promise as it would significantly shorten the scientists at the New
current two-year treatment, and the Delhi-based Institute of
easy mode of administration would Liver and Biliary Sciences
persuade more patients to complete (ILBS), researchers have
their course of medication. Currently, identified a biomarker in
MDR-TB treatment involves 16 tablets a human urine that may
day and daily injections for the first six help develop a simple test
months. This research began last year to let clinicians predict
and the first phase of the trials has been response to treatment prior
completed at the National Institute of to starting therapy for
Tuberculosis and Respiratory Diseases, patients of Severe Alcoholic
New Delhi, which is also conducting the Hepatitis (SAH). SAH
study with the National Jalma Institute progresses fast and results
of Leprosy and Other Mycobacterial Diseases in Agra, and the Delhi- in death in 60 per cent of
based Indian Council of Medical Research (ICMR). The study is being cases. Unlike Hepatitis B
funded by Tata Trusts (Rs 2 crore) and the Ministry of Human Resource and C which are treatable
Development (Rs 2.5 crore). with drugs, therapeutic
options for SAH patients
are limited. Corticosteroid
Scientists create biosensor therapy is available but
not all patients respond
for detecting fungal infection to it. Those who do
not respond to steroid
A team of researchers from CSIR – therapy have high risk
Centre for Cellular and Molecular of infections and may
Biology (CCMB), Indian Institute die within three months.
of Technology Guwahati and Based on their study,
MNR Dental College & Hospital, researchers concluded
Hyderabad have developed an that one particular urinary
electrochemical nanobiosensor metabolite - acetyl-L-
that can efficiently diagnose carnitine – can be used
invasive aspergillosis. as a biomarker to predict
The researchers used gold non-response. This study
nanoparticles, a polysaccharide is the first demonstration
called chitosan, a gold of the utility of urine to
electrode and a chemical called determine treatment
1,6-Hexanedithiol (HDT) to responsiveness in
assemble the biosensor. It works SAH. According to the
by detecting gliP, a gene found researchers, the findings
exclusively in the Aspergillus hope that they can soon have could form the basis for
species. The biosensor developed a market-ready product. This the development of a cost-
by the researchers is quicker and study was supported by grants effective dipstick screening
cost-effective as compared to from the Department of Science test for restricting steroid
the existing methods, allowing and Technology (DST), Science use to patients with a good
early detection and affordability and Engineering Research Board likelihood of responding.
to patients. The researchers (SERB), Government of India.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
Novel clot buster to revolutionize treatment of strokes
A new Clot buster,
PEGylated Streptokinase
- a Novel Biological
Entity (NBE) developed
by Dr Girish Sahni,
Director General,
Council of Scientific
& Industrial Research
(CSIR) and Secretary,
Department of Scientific
and Industrial Research
(DSIR) and his team
of inventors at CSIR-
Institute of Microbial Technology
(CSIR-IMTECH), Chandigarh
is all set to revolutionize the
treatment of ischemic strokes.
Ischemic stroke is a condition
caused by a dysfunction in the
supply of blood to the brain
due to emboli, thrombus or
atherosclerosis occurring in
cerebral arteries. CSIR-IMTECH
and Epygen Biotech Pvt Ltd,
Mumbai, have entered into
an agreement for the latter to
develop PEGylated Streptokinase
for treatment of Ischemic Stroke.
Epygen is the first company
in India with exclusive license
of this NBE thrombolytic
protein for ischemic stroke.
PEGylated Streptokinase, the
novel recombinant protein
Thrombolytic molecule has been
l SCIENCE NEWS 49
precisely engineered
through decades of
research for enhanced
proteolytic stability and
extended plasma half-
life, fibrin-specificity
and associated clot
specificity, with reduced
immuno-reactivity
which would be
significant attributes
with unmistakable
clinical advantages
such as reduced probability
of hemorrhage over current
treatment regimens of
thrombolytic drugs for acute
stroke. These are huge advantages
with a potential to transform the
way ischemic stroke, deep-vein
thrombosis, pulmonary embolism
and acute myocardial infarction
are treated around the globe,
especially in the developing world.
50 SUPPLIER NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

J. Mitra, IIT-M launch Promega

iQuant analyzer
J. Mitra & Co., in collaboration with IIT Madras’ HTIC (Healthcare
Technology Innovation Centre), has launched India’s first portable
diagnostic solution–iQuant
immunoassay analyzer in
the Indian market. The
device is designed to read
multiple test kits, and reads
the calibration information
directly from the test kit
without the need for a
separate calibration chip.
The product is meant for
small to medium labs,
and is hence designed in
an aesthetic desktop form
factor, with an intuitive
touch screen display, battery back-up and capabilities for advanced
data storage, syncing and transmission capabilities. iQuant provides 8
separate diagnostic tests for TSH (Thyroid Stimulating Hormone), T3
(Tri-iodo thyronine), T4 (Thyroxin), Vitamin D, Dengue NS1 Antigen,
Dengue IgM, Dengue IgG and HbA1c test.
Measuring consistency
with ROTAVISC
Biotech
collaborates
with CORE
Diagnostics
Promega Biotech India Private
Ltd., a 100 per cent subsidiary
of Promega Corporation USA, a
leader in providing innovative
solutions and technical support
to the life sciences industry,
has entered into a technology
collaboration with CORE
Diagnostics. The collaboration
allows CORE Diagnostics to
leverage Automated Nucleic
Acid Purification with Promega
Integrated Quantitation systems.
The Maxwell Automated
Nucleic Acid Purification
Instrument offers benchtop
automation with worry-free,
walk-away purification of
B
DNA and RNA from a variety
of different sample types.
The collaboration agreement

b
focuses on the implementation
After it’s been produced, stirred and of the Promega Microsatellite
shaken, the viscosity of a sample can now Instability (MSI) technology
be measured with the new ROTAVISC for Immuno-Oncology.
series from IKA. This parameter The patent-protected MSI
indicates the fluidity of a substance and technology is considered the
is important for quality control in all gold standard molecular assay
manufacturing processes and even early on
in the application in the research laboratory.
for detecting DNA mismatch-
repair deficiency. Gurgaon-
D
ROTAVISC is the most functional viscometer based CORE Diagnostics brings
in its class. latest cutting edge testing
Four new models for different viscosity techniques in areas of definitive
ranges are part of the new product diagnosis and Molecular
series. They deliver extremely precise Diagnostics, Flow Cytometry,
measurements under different Immunohistochemistry,
conditions, so that chemical Histopathology, Cytogenetics
substances, cosmetic products, paints and Cytopathology for patients
or foodstuffs actually achieve the desired consistency and in India. These tests bring
reliably maintain them, even at different temperatures. targeted, customized treatment
The new ROTAVISC series viscometers are characterized by their one step closer to reality and can
infinite viscosity measurement ability. At the same time they are very help health practitioners provide
easy to handle. In addition, device control and the documentation the most actionable information
of the measurement process are possible using special software. to address the various treatment
ROTAVISC offers users the popular IKA laboratory equipment needs of patients in India to get
structure and can be tested in the IKA Application Centre. better outcomes.

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52 SUPPLIER NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

Roche receives FDA approval for cobas EGFR Mutation Test v2

Roche recently announced
approval from the U.S. Food and
Drug Administration (FDA) for the
cobas EGFR Mutation Test v2 as a
companion diagnostic test (CDx)
with IRESSA. A CDx test provides
information that is essential for
the safe and effective use of a
corresponding therapeutic product.
Clinical studies have demonstrated
that patients diagnosed with
NSCLC who test positive for defined mutations of the
epidermal growth factor receptor (EGFR) gene benefit
from tyrosine kinase inhibitor (TKI) therapies.
The cobas EGFR Mutation Test v2 is currently the
only FDA-approved diagnostic test for NSCLC using
liquid biopsy. EGFR testing in
plasma offers a non-invasive
option for patients using a simple
blood draw for those who are not
eligible for a tissue biopsy.
The cobas EGFR Mutation
Test v2 is a real-time polymerase
chain reaction (PCR) test for the
qualitative detection of 42 defined
mutations of the EGFR gene in
exons 18-21, including L858R,
exon 19 deletions, and T790M mutations. This in-
vitro diagnostic (IVD) test is the first and currently the
only FDA-approved EGFR test to include both tissue
and liquid biopsy (plasma) as patient sample types for
testing.

GE Healthcare to open Agilent receives

Innovation Centre in Uppsala
GE Healthcare has partnered with the government of Sweden to
open a $15.9 million centre in Uppsala that focuses on advancing
manufacturing capabilities and the commercialization of new
technologies in life sciences.
Testa Centre is a 2,500 square-meter facility that houses four
bioprocessing laboratories with GE Healthcare technologies for
testing new discoveries intended to enable the production of
biopharmaceuticals, including bioreactors with working volumes
up to 500 L for mammalian cell cultures, 50 L for bacterial and
chromatography equipment from lab to pilot scale.
Open to academia, startups, and industry, Testa Centre is
designed to help organizations achieve a more time and cost-
effective way to reduce the risks of securing industrial Proof-
of-Concept, in order to support the development of digital,
technical, and biological innovations.
approval for urothelial
carcinoma assay
Agilent Technologies Inc. has recently
announced that the U.S. Food and Drug
Administration (FDA) has approved its
Dako PD-L1 IHC 22C3 pharmDx assay for
expanded use in urothelial carcinoma. The
assay is now approved to identify patients
with urothelial carcinoma who may
benefit from KEYTRUDA, an anti-PD-1
therapy manufactured by Merck (known
as MSD outside the United States and
Canada), as a first-line treatment option.
KEYTRUDA is approved for patients with
locally advanced or metastatic urothelial
carcinoma who are not eligible for
cisplatin-containing chemotherapy and
whose tumors express PD-L1 [Combined
Positive Score (CPS) ≥ 10] as determined
by an FDA-approved test, or in patients
who are not eligible for any platinum-
containing chemotherapy regardless of
PD-L1 status. PD-L1 IHC 22C3 pharmDx
is the only FDA-approved companion
diagnostic to identify patients with
urothelial carcinoma for treatment with
KEYTRUDA. This follows previous FDA
approvals for PD-L1 IHC 22C3 pharmDx
in non-small cell lung cancer (NSCLC),
gastric or gastroesophageal junction (GEJ)
adenocarcinoma, and cervical cancer.
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54 ACADEMIC NEWS l BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com

SRI inks pact with

RCPS Glasgow
to train medical
graduates
Sri Ramachandra Institute of Higher
Education and Research in Chennai
has inked a pact with Royal College
of Physicians and Surgeons (RCPS),
Glasgow, UK, for training medical
graduates in preparatory courses and
examinations of MRCP, MRCS and
FRCS. With this, the Sri Ramchandra
University of Houston signs Institute (SRI) will become the centre for
the Royal College’s medical education
MoU with Indian Nursing Council and training activities in South India,
especially in Tamil Nadu, sources from
The University of Houston, College of Nursing and the Indian the Institute claimed. The MoU was
Nursing Council, a national regulatory body for nurses and signed by Prof. David J. Galloway,
nurse education in India, have signed a Memorandum of president of the Royal College and Dr
Understanding (MoU), for developing opportunities for nursing P V Vijayaraghavan, vice-chancellor
education in India through academic and leadership exchange. of the SRI. The tie-up will allow both
The Nurse Practitioner Critical Care programmes in institutions to support delivery of
India will support hospitals to increase the number of higher postgraduate healthcare training and
educated nurses trained to care for critically ill patients. The assessment in many disciplines in dental
nurse practitioners will work closely with physicians to provide and oral surgery, international travel
treatment and care for patients in intensive care units. medicine, specialist surgical and medical
Graduates of the Nurse Practitioner Critical Care programme assessment education, training in foot
will be eligible to pursue the doctoral programme. The Doctorate pathology and pediatric medicine. Both
of Nursing Practice (DNP) programme is a professional graduate the institutions will develop joint post-
degree which focuses on the clinical aspects of a disease process graduate education, training and clinical
and uses evidenced-based practice to improve patient outcomes. skills programs further to enhance
Nurses in India with a DNP will have completed the highest clinical standards through clinical
level of training in nursing practice. assessment and examinations.

IIT Mandi collaborates with RxDataScience for AI portal

Indian Institute of Technology
(IIT) Mandi has tied up with
RxDataScience Inc., a leading
healthcare manufacturer in the US,
to create a portal documentation
of Artificial Intelligence and
Machine Learning Research in the
Pharmaceutical Sector.
Further, IIT Mandi team is
also planning to work closely
with RxDataScience Inc, to
apply deep-learning methods
and cognitive algorithms for
discovering patterns among
patient journeys and social ties
among physicians. This is part of
a long-term collaboration focused
on performing machine-learning
on healthcare datasets concerning
patients and physicians and
developing novel web-based
visualizations.
According to Prof Varun
Dutt, Assistant Professor, School
of Computing and Electrical
Engineering, IIT Mandi, data
sciences in India are at a
very nascent stage yet but in
the US, most healthcare and
pharmaceutical companies have
moved onto the consulting stage
wherein live cases are debated
online by the doctors and medical
practitioners’ community.
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56 PEOPLE NEWS l
Dr R M Anjana
receives
felicitation from
Kerala Governor
Dr R M Anjana, Managing Director
and Senior Diabetologist of Dr.
Mohan’s Diabetes Specialties Centre
and Vice President of Madras
Diabetes Research Foundation
was awarded the Keshavdev JPEF
Award for Young Researcher in
Diabetes in India. Governor of
Kerala, P Sathasivam presented
the award recently in the presence
of the Tourism Minister of Kerala,
Kadakampally Surendran on the
occasion of the two-day convention
organised by Dr Jothydev and
Jothydev’s Diabetes and Research
Centre at Trivandrum. This is one
of the highest honours for young
diabetologists and is given to the
best conducted original research in
India. Dr R M Anjana was selected
for the award from among more than
100 entries. The award carries a cash
prize of Rs 1 lakh, a gold medal and
a citation. Dr Anjana has published
nearly 100 research papers including
original articles and chapters in
text books. Her contribution to the
field of epidemiology, particularly
the mega epidemiological study
called as ICMR INDIAB study which
involves a sample size of 1.24 lakh
people from 31 states and 2 union
territories, has been recognized
nationally and internationally.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
IIT-H Prof gets
recognition by NASI
Dr Aravind Kumar Rengan, research involving novel
Assistant Professor, nanomedicines synthesized
Plasmonic NAnoSpace in IIT Hyderabad
(P-NAS) Laboratory, laboratories and proceed
Department of Biomedical towards human clinical trials
Engineering, IIT Hyderabad, in collaboration with pharma
has been chosen for the industry. After his MBBS
NASI-Young Scientist degree from Thanjavur
Platinum Jubilee Awards Medical College, Tamil Nadu,
(2018) by the National Dr Rengan went on to do
Academy of Sciences,
India (NASI) this year.
his Masters in Nanomedical
Sciences from Amrita Centre
He has been chosen in the for Nanosciences (DST centre
Bio-medical, Molecular
Biology and Bio-technology
of Excellence) followed by
a PhD in the same field at
category. Dr Rengan heads IIT Bombay - Institute of
the Plasmonic NAnoSpace Eminence. His research
laboratory (P-NAS Lab) is focused on developing
at IIT Hyderabad and is affordable nanosystems to
working in the area of cancer achieve better outcome in
nanotechnology. The award cancer treatment. Some
was given in recognition of his earlier awards
of his work for developing include DST INSPIRE,
affordable nanomedicines DBT Innovative Young
towards cancer theranostics Biotechnologist Award, INSA
(combining diagnostics Young Scientist Medal, IIT
with therapeutics). He plans Bombay - Excellence in PhD
to perform translational Thesis.
Ajay Bhatt joins
Intas as Global HR President
Intas Pharmaceuticals has appointed Ajay Bhatt as President-
Global Human Resources to spearhead
HR for its complete global portfolio
consisting of India, Europe, US &
Emerging markets.
A pharma industry veteran, Bhatt
brings with him more than two
decades of HR leadership experience
with some of the most respected names
in Indian and global pharma. Prior to
this, he was Director HR-Innovation
& Development with Abbott Laboratories based out of Basel,
Switzerland. He has previously been associated with leading
Indian Pharmaceutical majors including Sun Pharma, Zydus
Cadila and Torrent Pharmaceuticals. Bhatt holds a Masters
in Social Work in the field of Personnel Management from
Maharaja Sayajirao University of Baroda.
 328 Ansal Chamber II
6 Bhikaji Cama Place, New Delhi-110066
Tel: 91-11-2610-1271 | 91-11-4984-6500
Info@BiotechIndia.com | TechSupport@BiotechIndia.com
www.BiotechIndia.com
58 BIOEVENT
FICCI HEAL 2018
Private Sector support critical
for Ayushman Bharat: J P Nadda
T
he Indian Health & Family Welfare Minister J
P Nadda said that the government was keen to
formalise a multi-stakeholder forum to arrive
at policy decisions and formulate implementable
strategies to make healthcare affordable and accessible
to all.
He was addressing FICCI HEAL 2018 with the
theme ‘Healthcare at Crossroads’, jointly organised by
FICCI and NITI Aayog.
“There is no formal structure for policy interaction
and very soon we will have a forum where multi-
stakeholders will join hands with the government for
policy decisions and program implementation plans,”
he said and added that such synergies would be
important to achieve a hepatitis-free India by 2030.
The Minister added that Ayushman Bharat
(Pradhan Mantri Jan Arogya Yojna) looks at health
holistically with twin pillars of Health and Wellness
Centres for comprehensive Primary health Care and
financial protection for secondary and tertiary care
hospitalisation.
“Ayushman Bharat is a historic decision and has
two pillars of preventive and promotive healthcare and
converting 1.5 lakh sub-centres and PHCs into health
and wellness centres. All support should be given to
health centres to ensure preventive care. For this we
are going for universal health screening at the age
of 30. This is a paradigm shift as far as healthcare is
concerned and this is one area where the private sector
can come in.”
He said that healthcare services should also be
credible accompanied by affordability, accessibility and
quality.
Dr V K Paul, Member (Health), NITI Aayog,
Government of India said that as course correction in
healthcare takes place, quality and ethics will be the
guiding force. He urged the private sector to engage with
the government in providing quality care at reasonable
rates, monitored by the government. He said, “PMJAY
is not possible without the engagement of the private
sector. We need to create a pipeline of specialists and
private sector can help in filling that gap.”
Sangita Reddy, Vice President, FICCI and Joint
MD, Apollo Hospitals Enterprise Ltd. in her welcome
address, said, “India is no longer at crossroads with the
launch of Ayushman Bharat. Healthcare has entered
the Universal Collective Super Highway.”
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumindia.com
Sangita Reddy, Vice President, FICCI and Joint MD, Apollo Hospitals
Enterprise Ltd is having word with J P Nadda, Health & Family Welfare
Minister, Government of India at FICCI HEAL 2018 in New Delhi.
Setting theme of the conference, (Hony) Brig. Dr
Arvind Lal, Chair, FICCI Health Services Committee
and CMD, Dr Lal PathLabs said that in order to
ensure appropriate costs for procedures covered under
the Pradhan Mantri Jan Arogya Abhiyaan, while
maintaining the quality of services, it is important to
derive rational and sustainable package rates. “There is
a strong need to understand costs from the perspective
of all relevant stakeholders, the government, the
providers and the consumer.”
Prof (Dr) Dinesh Bhugra, CBE, President, British
Medical Association said, “there is need to shift the
focus from secondary healthcare and hospitals to
primary care. There is also a need to change the way
we train the next generation of doctors and medical
students.”
The Health Minister also released the ‘FICCI Code
of Ethics for the Health Services Industry. A FICCI
White Paper ‘Demystifying Healthcare Costs’, was also
released during the session.
A major concern that the healthcare sector is
facing today is the rising trust deficit - between the
private sector and the government as well as between
the provider and the patient. Hence, the FICCI Task
Force on Accountability, along with the stakeholders
from the government and industry, has developed the
‘Code of Ethics for the health services industry’, which
encourages members to voluntarily and collectively
commit to ethical professional conduct for patient care.
Already, 7 other Associations, with more than 30,000
institutional and individual members and more than
15 healthcare organizations from across India, have
endorsed the FICCI Code of Ethics.
 Healthh ii
Better

Email us :- nutrition.ease@techie.com
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