BSI_June 2016_Raj Gunashekar

1www.biospectrumindia.com | June 2016 | BioSpectrum

2 BioSpectrum | June 2016 | www.biospectrumindia.com
BioTalk

Biopreneur
The
fighters
FA
BIOSPECIAL
PRECISION
MEDICINE
INITIATIVE
DOES INDIA NEED
Volume 14  Issue 6  June 2016
3D PRINTING
revolutionizing healthcare
ARE THESE
PERFORMANCE
MATERIAL IN MEDICAL
DEVICES SAFE?
Cover
Design by:
Sareeta Sajjan
BioContents
32
COVERSTORY 24
Precision
Medicine
Does India need
Initiative
During his State of the Union address in January
2015 at the White House, American President
Barack Obama announced the launch of the most
ambitious healthcare initiative called the Precision
Medicine Initiative (PMI), with a mission to usher
the US into a new era of medicine where patients
will enjoy individualized and tailor-made treatment
for various ailments.
Both Dr Fathima Benazir and Alex Paul
were schoolmates and best childhood
buddies. She was a post doctoral research
fellow at Indian Institute of Science (IISc),
Bangalore, and was keenly looking out
for opportunities abroad. She approached
Alex and sent him her portfolio.
Alex D Paul,
Co-founder
President,
Azooka Life
Sciences
Dr Fathima,
Co-founder
CEO, Azooka
Life Sciences
A saga of the world’s
fastest DNA, RNA stain
Azooka Life Sciences

BioContents
Regulars
7BioEdit
08BioMail
12BioNews
50 BioPeople
52 BioSupplier News
64BookReview
Can India dominate the
biosimilar market?
BioTalk Biosimilars
‘We aim’ to make
biopharma more
affordable’
Racho Jordanov
President and CEO, JHL Biotech
‘India is a key
opportunity market’
A Narayanaswamy, Managing
Director, Essentra Packaging
‘There is a huge unmet
need for affordable
biologics in China’
Jan Mäkelä, GM, BioProcess business,
GE Healthcare’s Life Sciences business
09 36
46
34
48
20
40
Are these performance
material in medical
devices safe?
3D Printing
The Fat Fighters
Biospecial
Meet the Robotic Surgeons who conducted
nearly 4,000 procedures in 30 hospitals spread
across the country during 2015 to help cut flab.
After dominating generic drug
industry for decades, can India
become a leader in developing this
new class of drugs too?
‘Notification will
shut the door for
future licensing’
The recent notification of the Ministry of
Agriculture for compulsory licensing of
agriculture technologies is a major blow for
the responsible deployment of innovation
in the agriculture and food sector

C
hina’s 13th
five-year-plan
(2016-20) document, that
was released recently,
puts greater emphasis on
healthcare industry which is esti-
mated to be valued at eight trillion
yuan by the end of the plan period.
This will be an interesting and im-
portant period for the healthcare
sector as drugs worth of $250 bil-
lion are estimated to expire in next
five years and their market share
will be taken by generic drugs. And for this peri-
od China has emphasized on changing the mod-
el from research and development to innovation
with focus on making breakthroughs in biolog-
ics medicine and to facilitate better protection
of intellectual property rights. Its further plan is
to step up production for special APIs, improve
development of new drugs and speed up the reg-
istration process to expand export.
Interestingly, the plan document coincides with
the release of Thomson Reuters report describ-
ing China as the global leader of pharmaceutical
innovation. During 2015, five of the top 10 glob-
al organizations for filing pharma patents were
located in China and from 2005 to 2015, three
of the top 10 organizations for publishing papers
about drugs and disease were China institutes.
Both the reports need a careful watch and scru-
tiny from the Indian side as both the countries
had been in a race during the past few years in
faster economic development in general and
in biotech, pharmacy and healthcare sectors
in particular. India has to particularly take the
plan document seriously as China has been
relatively successful in achieving its broadly
outlined goals in previous five year plans. That
may continue with this plan document also.
An important development from the India’s
side is that it has announced its Intellectual
Property Right (IPR) policy, which is very cru-
cial in the pharma sector. The production of
cheap generic drugs in India is the only hope
for many poor patients and that is possible only
due toIndia’s IPR policy. Through this policy,
India has shown its independence and thus,
no wonder, the policy has come under severe
criticism from US and some other countries.
Apparently these countries are exerting pres-
sure on India to amend the policy to suit their
companies.
On this backdrop, India continues to closely
studyand scrutinize the Chinese plan docu-
ment and its likely impact in view of the race
between the two countries. But at the same
time both the countries can also explore pos-
sibilities of co-operation than racing with each
other. Not only bio and pharma industry lead-
ers from both the sides, but even independent
observers have been expressing similar opin-
ion.Both have their own strengths and weak-
nesses.Chinese industry feels India has speed-
ed up development of talent pool, registration
and certification process and its growth in ge-
neric business is phenomenal and impressive.
On the other hand a PWC report in 2010had
said that China was entering a ‘golden age’ of
the biopharmaceutical sector – facilitated by
substantial investment, patent protection and
strong regulation by the central government.
ThomsonReuters report adds over that at-
tributing China’s success to pharma industry
innovation,scientific research and fostered a
healthy mix of partnerships.
Indian industry feels that two-way trade be-
tween India and China in formulations and APIs,
in which each of the country is dominant respec-
tively, and contract manufacturing is possible.
There are some hurdles,but if efforts are made to
remove them, there could be a way for partner-
ship, making both the countries stronger.
Milind Kokje
Chief Editor
milind.kokje@mmactiv.in
Race or partnership?
Bioedit

Vol 14; Issue 6; June 2016
Shoolini University
I am happy to know that you highlighted Modi govern-
ment’s initiative to establish country’s first interdisciplin-
ary university for life sciences and biotechnology. Shoolini
University of Biotechnology and Management Sciences is
the first national-level interdisciplinary biotechnology uni-
versity established in 2009 as per the notification of the
Government of Himachal Pradesh and recognized by UGC.
In a short span of five years, Shoolini University of Biotech-
nology and Management Sciences has been ranked 66th
po-
sition in India by NIRF, MHRD, GoI survey, April 2016.
Also, our School of Pharmaceutical Sciences has been
ranked 19thamongst the pharmacy institutes in the coun-
try. As biotechnology is an interdisciplinary field, we offer
undergraduate, postgraduate, MPhil and PhD programs in
biotechnology, microbiology, food sciences, basic sciences
and pharmaceutical sciences.The established biotechnol-
ogy university was to harness the potential of Himalayan
flora and fauna for sustainable development and societal
benefits. Shoolini University is a research oriented Uni-
versity and envisions to be amongst top 200 global uni-
versities by 2022. We have made giant strides towards
our vision. To cite the key ones, we have published more
than 300 research papers in journals of national and in-
ternational repute, with h-index of 20, which is the high-
est amongst the same age public and private universities
including IITs and Central Universities. More than 60
students have completed PhD degree from this University
and of this, 50 are in biotechnology and related sciences.
Our PhD program utilizes rigorous standards, with one of
the thesis examiner being chosen from out of the country
and a rider of at least two publications for PhD thesis that
are indexed in Thomson and Reuter or Scopus database. Our
research has been endorsed by various government funding
agencies such as DAE, DST, DBT, DRDO, ICMR, and DAE.
We have been recognized by DST for FIST grants and by MoF-
PI for setting up food testing lab.
1An MM Activ Publication | www.biospectrumindia.com | May 2016 | BioSpectrum
Volume 14  Issue 5  May 2016 www.biospectrumindia.com
An Publication
`100
Totalpagesincludingcover68
EMERGING
NEW WAVE OF
THERANOSTICS
‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR ELECTRONIC WEARABLE INJECTOR A REALITY
BIOANALYSIS BIOSUPPLIERS
A COMBINATION OF DIAGNOSIS WITH
THERAPY GEARED TO REVOLUTIONIZE
THE WORLD OF HEALTHCARE.
Vol 14; Issue 6; June 2016
Publisher and Managing Editor:
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Contd.. on page 13

S
everal Asian companies have been increasing
their focus on biosimilars, terming it a long term
prospect. Although currently small and focused
on few diseases, the biosimilars’ opportunity is
all set to grow, thanks to the unprecedented patent cliff
and rising healthcare costs. Biosimilars are an affordable
option for Asia’s growing healthcare needs and this has
offered a clear potential for players in emerging Asian
countries to set up operations and leverage this lucrative
opportunity.
One such interesting company is a start-up in Taiwan –
JHL Biotech, which aims to build a biotech industry in
China. Founded in 2012, by two former Genentech col-
leagues, JHL Biotech has already received the EU ap-
proval to perform clinical trials for its biosimilar ritux-
imab and is planning to file an (Investigational New
Drug) IND for its upcoming orphan drug biosimilar by
the end of this year.
JHL is the first Chinese company to file a clinical trial for
biosimilar in Europe. The company has two factories, one
for clinical manufacturing and development in Hsinchu in
Taiwan, and one for commercial manufacturing and pro-
cess development in Wuhan. JHL is also the first to use
‘We aim' to make biopharma
more affordable’
Led by an experienced team of
Genentech and Amgen veterans, and
funded by top-tier venture capital firms
including Kleiner Perkins Caufield
Byers (KPCB), Sequoia Capital, Biomark
Capital and CDIB, JHL Biotech aims
to make biopharmaceuticals affordable
and accessible to all patients through
manufacturing innovation.
Racho Jordanov
President and CEO, JHL Biotech
Interview
Biotalk

GE Healthcare’s KuBio factory design, that can be built
and dispatched anywhere in the world in just 18 months.
Racho Jordanov, President and CEO, JHL Biotech, in an
interview with BioSpectrum Asia spoke at length on the
company.
When and how was JHL Biotech founded?
A JHL was founded in late 2012. Ms Rose Lin, general
manager, JHL Biotech, and I realized that there was
need in Asia for the kind of expertise we had acquired
throughout our careers at Genentech, and more impor-
tantly, we saw an opportunity to make biologics more af-
fordable. We put together a slide deck and quickly secured
KPCB as a cornerstone investor. After that, we attracted
more funding and set in motion our plans to construct a
pilot facility in Taiwan and a full scale plant in China.
Tell us about the biosimilars facility in China.
A Our campus is in a government-backed biotech
park in Wuhan. It is called ‘JHL-1’, with the ‘1’ indi-
cating that we have ambitious expansion plans. JHL-1
has space for utilities, two commercial scale API plants, a
fill-finish site, and an administration building that also
contains space for process development and analytical
work. We just celebrated the opening of our first API
plant and look forward to breaking ground on the second
API plant and fill-finish facilities in the near future.
Our newly opened JHL-1 API facility is built to compliance
with the highest standards. It is remarkable for a number of
reasons. We are the first to utilize a revolutionary GE mod-
ular construction technology called KUBio. It is the larg-
est single-use mammalian cell culture facility in Asia. Our
whole site was finished in about 18 months, and we spent
about 1/3 of what is typical for an mAb site of this scale. I
am excited to say that we will soon be starting production
in Wuhan. Our site is close to being fully operational and I
am very proud of the devotion of our team there.
How important are biosimilars for the Asian
market?
A Biosimilars are very important to the Asian phar-
maceutical market. This is due to population and
average income. Depending on how you define ‘Asia’,
nearly 1/4th
of the world's population lives in this part of
the world. This also means that the incidence of disease is
greater than in other regions; moreover, in the next two
decades, the number of new cancer cases here is expected
to rise 70 percent. So, we have this massive population,
but at the same time, many earn significantly less than
their counterparts in the West. Innovator drugs are
priced very high in many Asian markets, making it com-
paratively more difficult for locals to access these thera-
pies. Biosimilars will be priced much lower and will
therefore greatly increase options for patients.
What are the challenges you see in
commercializing biosimilars?
A There exist three big challenges. In order of impor-
tance: Regulatory, Economic, Manufacturing. Reg-
ulatory challenges are first and foremost, as biosimilars
are new and approval pathways are still in development.
We have a great regulatory team that has strong relation-
ships with relevant authorities. Each of our biosimilars
will be approved first in the EU and China, then later, in
the US. When our treatments are approved, the econom-
ics of biosimilars also dictate that, in markets where mul-
tiple biosimilars are competing for market share, success
will be driven by price, which means that we have to be
able to manufacture more efficiently than anyone else.
This plays to JHL's strengths and is at the core of why we
will be a dominant biosimilars player: we have world
class expertise in the manufacture of these molecules. We
also have our own manufacturing facilities. This vertical
integration allows us to focus on process innovation,
which leads to steep reductions in cost of goods.
Your thoughts on regulatory hurdles in
biosimilars space.
A The two biggest issues currently under debate are
interchangeability and extrapolation. We do not
believe that, in the near term, any regulators will allow
interchangeability. This said, after a significant body of
efficacy and safety data are available, which could take a
decade or longer, we think regulators will start to con-
sider interchangeability. Extrapolation is already allowed
in some markets for products that have shown safety and
efficacy in the indications most ‘difficult’ to treat. Long
term, we believe interchangeability and extrapolation will
become common due to the fact that regulators, doctors,
and payers will gain comfort with biosimilars.
Could you share with us the impact in China
from structural reforms?
A Sure. I shall focus on two groups: government and
consumers. On the government side, impact comes
from support for the biotech industry and overhauls to
the social security and drug administration systems. On
the consumer side, the biggest impacts from reform are
due to the effect rising wages and higher quality stan-
dards will have on demand for great medical products.
The Chinese government has made the biotech industry a
key focus of its 13th five-year plan and its ‘Made in China
2025’ plan. This was central to our decision to start JHL
in Asia and put our landmark facility in China. The Hubei
government, by way of the Biolake biotech development
zone, provided strong support to us. For example, aside
Biotalk

from our API facility, all buildings at JHL-1 were built for
us by the local government.
In addition to government incentives, the Chinese social
security and drug administration systems are undergoing
great change. In 2009, the government allocated $125 bil-
lion to various levels of government to upgrade hospitals,
reduce imbalance in medical care between rural and urban
areas, and decrease the burden of medical expenses to indi-
viduals. Likewise, since we started working in China three
years ago, we have begun to see changes in the tendering
process and means of getting on the reimbursable drug lists.
On the consumer side, reforms are underway to make the
Chinese economy one driven by consumption. We believe
that the growth of service industries and a gradual rise
in salaries will, over the long term, drive the new middle
and upper class to demand higher qualities of care than
currently available. Our biosimilars will make world class
therapies affordable to this population.
In your opinion which are the countries poised
to ride successfully in the biosimilars wave?
A We have seen great development in every Asian
country. Korean firms like Samsung and Celltrion
have invested massively in biologics and biosimilars de-
velopment. India has a mature generics industry and very
talented people, and we are watching the Indian market
closely. JHL has held conversations with Vietnamese au-
thorities regarding the possibility of operations in Viet-
nam. As you might also guess, we are especially bullish on
China. China's regulators have made huge steps towards
a biosimilars regulatory framework. The Chinese govern-
ment heavily supports development of the biotech indus-
try, and, finally, China has a deep and fast growing pool of
talented biotechnology experts.
What makes biosimilars an attractive
investment option?
A Biosimilars have a lower risk profile than innovator
compounds, lower capital costs, and great econom-
ic prospects. Risk in biosimilar development is inherently
lower than new entities because the compound has al-
ready been discovered and proven. In biosimilar develop-
ment, regulators place great value on analytical data and
PK/PD efficacy. Unlike a traditional drug development
process, in which risk increases with each development
phase, much of the risk in biosimilar development is
front-end loaded. Thus, investors have an idea of whether
a therapy and company are worth investing in much ear-
lier than is the case with new entities. Likewise, biosimi-
lars development takes about 7-8 years, while new enti-
ties can take 15-20 years. Additionally, innovator
compounds can cost billions to go from concept to prod-
uct. The capital required for us to go from concept to
product is an order of magnitude lower.
Finally, biosimilars are also attractive because of the eco-
nomics. We can sell at a sizable discount to innovator
compounds and still deliver 80-90% margins. To sweeten
the deal, barriers to entry are very high because biosimi-
lars are regulated drugs and the development of them re-
quires great technical expertise. From an investor's point
of view, this combination of lower risk, lower capital in-
tensity, and high margins is difficult to beat.
What are the key trends in Asia’s biotech space?
Without doubt, the key trend is the growth of world class
biotech firms in Asia. Along with this, another very impor-
tant trend is the growth of companies making therapies
specifically targeting Asian indications. JHL is develop-
ing biosimilars for the Chinese and global market, and we
also do CMO work for select domestic and international
partners. We are working on three projects for BeiGene,
China's premier drug discovery company. One of our
early investors from Sequoia started ZaiLabs, another
company focused on developing new molecular entities,
with a focus on entities targeting China and Asia-specific
ailments. Every day, we hold meetings with well-funded
entrepreneurs looking for assistance in the development
of their innovative biologics. We are honored to support
this new wave of companies and excited to play a role in
the growth of China's biopharma industry.
Could you talk about your product portfolio in
depth?
A I love discussing our products, but unfortunately, I
cannot say too much, as details of our pipeline are
confidential. Here is what I will tell you, though: our cor-
porate goal is to file two-to-three biosimilar INDs per
year (China, Europe, and US). At the end of 2015, we filed
an IND for our rituximab biosimilar with the UKMHRA,
and we have already received approval to perform human
clinical trials of it in Europe. We are on track to file an-
other IND at the end of this year for an orphan drug bio-
similar, and we believe the quality of that product will be
so great, it will go straight to Phase III trials. Stay tuned!
Can you elaborate your expansion plans?
A Our first concern is ensuring successful startup of
our new API plant. Once done, however, we will
soon start construction of our next API plant and our fill-
finish facility. We are also discussing possible locations
for our next JHL site, JHL-2. We have a strong product
pipeline and see great demand for our products, and we
will be expanding aggressively in this decade to ensure we
can meet the needs of global consumers. BS
Aishwarya Venkatesh
Biotalk

Monsanto rejects Bayer offer
Monsanto,the world’s largest seed company, has turned
down Bayer AG’s $62 billion acquisition bid as ‘incom-
plete and financially inadequate’ but said it was open to
engage further in negotiations.Earlier Bayer had made a
bid to acquire Monsanto for $62 billion.
The combination is expected to provide Bayer’s share-
holders with accretion to core EPS by a mid-single-digit
percentage in the first full year after closing and a dou-
ble-digit percentage thereafter.Initially, Bayer expects
annual earnings contributions from total synergies of ap-
proximately $1.5 billion after year three plus additional
integrated offer benefits in future years. “We have long
respected Monsanto’s business and share their vision to
create an integrated business that we believe is capable of
generating substantial value for both companies’ share-
holders,” said Werner Baumann, CEO of Bayer AG.
“Together we would draw on the collective expertise of
both companies to build a leading agriculture player with
exceptional innovation capabilities to the benefit of farm-
ers, consumers, our employees and the communities in
which we operate.” This transaction would bring together
leading Seeds Traits, Crop Protection, Biologics, and
Digital Farming platforms.
Specifically, the combined business would benefit from
Monsanto’s leadership in Seeds Traits and Bayer’s
broad Crop Protection product line across a comprehen-
sive range of indications and crops. The combination
would also be truly complementary from a geographic
perspective, significantly expanding Bayer’s long-stand-
ing presence in the Americas and its position in Europe
and Asia/Pacific.
Customers of both companies would benefit from the
broad product portfolio and the deep RD pipeline.
“Bayer is committed to enabling farmers to sustainably
produce enough healthy, safe and affordable food capa-
ble of feeding the world’s growing population,” said Liam
Condon, member of the Board of Management of Bayer
AG and head of the Crop Science Division.
BioNews
Dr Reddy’s acquires six OTC brands
Dr Reddy’s Laboratories has announced the acquisi-
tion of an eminent portfolio of over-the-counter (OTC)
brands in the cough-and-cold, pain, and dermatology
categories. The company acquired six OTC brands from
Ducere Pharma, including DOAN’S, BUFFERIN, NUP-
ERCAINAL Ointment, CRUEX Nail Gel, COMTREX, and
MYOFLEX.
“These legacy products enjoy strong brand equity built
over several decades,” explains Alok Sonig, executive vice
president and head of Dr Reddy’s in the US. “We are ex-
tremely excited to be entering the branded consumer
health arena through these brands and embarking upon
the next avenue of growth for our OTC business in the US.”
According to Sonig, Dr Reddy’s will build upon the sales
and marketing efforts for these brands and continue to
focus on their expansion into existing and new market
channels. Sonig commends the marketing and brand-
building efforts of Ducere Pharma, recognizing the or-
ganization’s role in successfully revitalizing the brands
through improved distribution and promotional efforts.
Aurobindo Pharma is pleased to
announce that the company has
received final approval from the
US Food Drug Administration
(USFDA) to manufacture and mar-
ket Fenofibrate Tablets, 48 mg and
145 mg. This product is expected to
be launched in Q1 FY16-17. The approved ANDA is bio-
equivalent and therapeutically equivalent to the refer-
ence listed drug product (RLD) Tricor Tablets of AbbVie.
Fenofibrate Tablet is used to treat high level of choles-
terol and triglyceride in the blood. The approved product
has an estimated market size of $412 million for the 12
months ending March 2016 according to IMS.
Aurobindo Pharma receives FDA
approval for Fenofibrate Tablets

Indian drug giant SunPharma has inked a deal with global non-profit Inter-
national Centre for Genetic Engineering and Biotechnology (ICGEB) to de-
velop a novel botanical drug that can combat the menace of dengue. The drug,
Cipa, has its roots in traditional Ayurvedic medicine. The project is backed
and supported by the Department of Biotechnology (DBT) and Ministry of
Science and Technology. The Cipa drug also aims to push towards traditional
medicine by the current government,as acknowledged by Dr Khanna and Dr
Altaf Lal, senior advisor with Sun Pharma. The eight year long research is led
by Dr Naveen Khanna of the ICGEB. Speaking to the media Khanna said, “It
is time India woke up and create these drugs with the help of modern science.
USFDA approved four botanical drugs from China last year. Four years from
now, India could have a pill for curative and even preventive dengue therapy.”
Nearly 10,000 cases of dengue were reported from the national capital last
year in one of the worst ever outbreaks of dengue in the country. The drug,
Khanna explained, is derived from the plant Cissampelos pareira Linn, com-
monly known as abuta, and laghu patha in ayurveda. Its extract has shown
to inhibit all four strains of dengue (DENVs). The team from both the ICGEB
and Sun Pharma lay much emphasis on supporting any ‘holistic’ medicine
with the clinical trials of modern science, so that, as Khanna said, such a drug
could be prescribed by all doctors, not just AYUSH practitioners.
India turns to Ayurveda to curb dengue
Shoolini University
Editorresponse
In order to take our research to the
end users, we have filed 26 patents in
the emerging areas of biotech, such
as drug resistance, nanotech, vac-
cine development, novel Enzymes,
water purification, therapeutics and
diagnostics. So in real sense, Shoolini
University of Biotechnology is the
first interdisciplinary university at
the national level. I,therefore, submit
you this note as letter to the editor in
claiming its right to be the first Bio-
technology University of the country,
not a footprint of Himachal Pradesh.
Prof PK Khosla, Vice Chancellor,
Shoolini University
Editor Response
(Shoolini has management courses too
whereas RCB will be a pureplay, interdisci-
plinary public university for biotech.)

Suven secures four product patents
Suven Life Sciences(Suven) an-
nounced that they secured product
patents in Australia(2012388383),
Eurasia (22746), Israel (228019) and
USA (9328092) to their New Chemi-
cal Entities (NCE’s) for CNS therapy
through mechanism of action - H3
Inverse agonist and these patents
are valid until 2032, 2030, 2031
and 2032 respectively. The granted
claims of the patent include the class
of selective H3 ligands discovered
by Suven and are being developed
as therapeutic agents and are useful
in the treatment of cognitive impair-
ment associated with neurodegen-
erative disorders.
With these new patents, Suven has a
total of24granted patents from Aus-
tralia, 17granted patents from Eur-
asia, Nine granted patents from Is-
rael and24granted patents from USA.
These granted patents are exclusive
intellectual property of Suven and are
achieved through the internal discov-
ery research efforts. Products out of
these inventions may be out-licensed
at various phases of clinical develop-
ment like at Phase-I or Phase-II.
Suven Life Science is a biopharma-
ceutical company focused on discov-
ering, developing and commercial-
izing novel pharmaceutical products,
which are first in class or best in class
CNS therapies through the use of
GPCR targets. Suven has 3 clinical
stage compounds, a Phase 2 under-
going candidate SUVN-502,Phase 1
completed candidate SUVN-G3031
and Phase 1 undergoing candidate
SUVN-D4010 for Alzheimer’s dis-
ease and Schizophrenia.
DBT launched indigenously developed
Stool Management Kit
Worldwide hundred mil-
lion bedridden patients suf-
fer from inadequate bowel
management. Impaired
bowel control and diarrhoea
in bedridden patients pose
significant challenges for
patients and care providers
alike. Patients with faecal
incontinence and diarrhoea have 22
times higher odds of developing facil-
ity acquired pressure ulcers (FAPU),
which increase to37.5 times higher
odds if they are also immobile.
Traditional bowel mismanagement
cannot even lead to an increased
length of stay but also an increase
in avoidable healthcare expenditure
due to complications such as pres-
sure ulcers and nosocomial infec-
tions
Till date only few measures are avail-
able for management of faecal in-
continence and diarrhoea includes
absorbent pads and adult diapers.
Though these methods are not so ex-
pensive, but obviously these methods
are time consuming, labour inten-
sive, and lead to costly complications,
such as incontinence associated der-
matitis (IAD), facility acquired pres-
sure ulcers (FAPU), and spread of
nosocomial infections.
Indwelling balloon cuf-based fae-
cal management systems have been
shown to reduce risk of complica-
tions such as infection and skin
breakdown. However, since these
devices anchor on the pressure-sen-
sitive anorectic junction, they put
patients at risk of new complications,
involving injury to the rectal mucosa
and sphincter dysfunction.
Qora is a closed-system stool
management kit that hygieni-
cally contains liquid to semi-
formed stool. It reduces the
risk of complications associ-
ated with traditional bowel
management. The kit mini-
mizes nursing time and effort spent
on stool management.It also opti-
mizes safety and comfort for bedrid-
den patients suffering from impaired
bowel control. It has proprietary lat-
tice diverter conforms to rectal wall
at rest and during peristalsis, divert-
ing faecal exudates while minimizing
leakage.
With this it has indwelling compo-
nent designed to function in patients
with all kinds of sphincter tone and
without inhibiting normal anorectic
physiology. Qora is innovative, pa-
tient-friendly applicator minimizes
exposure to effluents and contami-
nants during device insertion.
Bionews

Mapmygenome launches Babymap
carrier newborn screening
Recommended for newborns, expecting par-
ents, and people planning a pregnancy, this
test screens for 71+ metabolic conditions that
can be treated in newborns.
Ms Anu Acharya, CEO of Mapmygenome an-
nounced this news, adding, “Pregnancy and
parenthood are among the most joyful expe-
riences in a person’s life. We want to make
these experiences healthy and tension-free.
Babymap allows parents to make informed
choices to ensure their newborns and future children stay
healthy.”
Dr Radha Rama Devi, MD (Peds) at Rainbow Hospital,
who was instrumental in setting up the first Newborn
Screening for preventable causes of mental retardation in
India and published the first data on the prevalence of
these disorders in the Indian population, said, “Babymap
Piramal to acquire four brands from Pfizer
Piramal Enterprises’ Consumer Products Division has
entered into an agreement to acquire four brands from
Pfizer for a consideration of `110 crore. The acquisition
includes brands namely:Ferradol, Neko, Sloan’s and Wa-
terbury’s Compound. Additionally the agreement also in-
cludes the trademark rights for Ferradol and Waterbury’s
Compound in Bangladesh and Sri Lanka.
These brands hold a rich legacy and have a high consum-
er pull and are available in India for the past 30+ years
✓ Ferradol launched in 1982, is a leading nutritional
supplement for children and adults.
✓ Neko launched in 1967, is a medicated soap indicated
for body odor and minor skin infections.
✓ Sloan’s launched in 1982, is muscular pain reliever
that is available in balm and liniment forms.
✓ Waterbury’s Compound launched in 1970, is used for
building cough and cold immunity.
These products currently operate in a market which is cur-
rently estimated at `7000 crore. Completion of the deal is
subject to certain conditions including regulatory approvals.
Ms Nandini Piramal, executive director, Piramal En-
terprises said, “Our aim is to be a significant player in
every business under the healthcare vertical of Piramal
Enterprises Limited. We are one of the large custom
manufacturing companies and have manufacturing
bases in North America, European Union and Asia. Our
critical care business is the third largest player in the
global inhalation anesthesia market. The Consumer
Products Division of the company currently ranks 7th
in
India; but we aim to be a top 3 player in the OTC market
by 2020. Acquisition is one of the important routes to
help us achieve our goal and in the last 6 months we
have done two acquisitions in the consumer products
business. The first one was the Littles baby care range of
brands and second was the gastro-intestinal portfolio of
brands from MSD. We believe these brands from Pfizer
will fit our portfolio and also strategically help us move
closer towards our stated objective. The combination of
growing our existing core brands and strategically ac-
quiring accretive brands has helped us create a unique
business which has a powerful portfolio of OTC brands
in India.”
is an excellent idea and will replace
the newborn screening tests cur-
rently used”.
Babymap test requires blood
samples for genetic testing us-
ing the technology platform Next
Generation Sequencing for over
31,000 pathogenic single nucleo-
tide variants and minor insertions
and deletions. Following analysis,
a session with Mapmygenome’s genetic counsellors al-
lows parents to learn about their carrier status and future
course of action.
This test starts at `30,000 for individuals, with attrac-
tive pricing options for couples and parents of newborns.
Mapmygenome plans to market this test through their
healthcare partners.
Bionews

Dr Harsh Vardhan inaugurates
Biotech Infrastructure Facility
Union Minister for Science Technology
and Earth Sciences, Dr Harsh Vardhan in-
augurated the Department of Biotechnology
(DBT) funded Biotech Infrastructure Facil-
ity (BIF) at ICAR-National Research Cen-
tre on Mithun (ICAR-NRCM), Jharnapani,
Medziphema, Nagaland. Mithun is a unique
large semi-domesticated animal of the bo-
vine family, endemic to the North-Eastern
States of India.
The minister remarked that as Mithun touches every Naga household economi-
cally, socially and emotionally, it could not only become the symbol of the Naga
people but also exemplify India’s unity in diversity by strengthening the bond-
age between different communities. Dr Harsh Vardhan acknowledged that
ICAR-NRCM is the only institute of its kind in the world solely dedicated to
the conservation, propagation and development of Mithun which itself is geo-
graphically limited to Arunachal Pradesh, Nagaland, Manipur and Mizoram.
The ICAR-NRCM farm has established modern scientific facilities for the
rearing of Mithun under a semi-intensive system that comprises of various
farmer-friendly technologies developed by the institute namely feed block,
mineral block, area specific mineral mixture and low-cost feed formulation
using industrial by-products. Dr Harsh Vardhan, expressing strong convic-
tion said that this BIF facility will prove beneficial for young researchers of
the North-eastern region. During the interaction with scientific staff of the
institute he emphasized at working on research projects that are beneficial for
farmers and implementable at the grassroot level.
GE Healthcare partners with
Heritage Valley Health System
Heritage Valley Health System has
announced an innovative, strategic
alliance with GE Healthcare aimed to
propel the health system’s momen-
tum of obtaining advanced medical
equipment over the next 14 years.
Heritage Valley Health System and
GE Healthcare entered an agreement
that initially includes new, state-
of-the-art MRI and CT scanners for
Heritage Valley Beaver and Heritage
Valley Sewickley hospitals, new ul-
trasound equipment for Heritage
Valley’s hospital and medical neigh-
borhood locations, upgrades to an
existing GE CT scanner and the addi-
tion of nuclear imaging cameras.
This alliance marks GE Healthcare’s
first Managed Equipment Service
(MES) agreement in the US. The
company anticipates that, with this
announcement, it launches the first
of many MES solutions across the
country.
Infosys Foundation
inks pact
with IISER-Pune
Infosys Foundation, the philan-
thropic arm of Infosys, has signed
a Memorandum of Understand-
ing (MoU) with Indian Institute of
Science Education and Research
(IISER), Pune, a leading science
institute in the country, to provide
opportunities for economically
weaker students to pursue high
quality science education and re-
search through scholarships, fellow-
ships and travel awards.
As part of the MoU, the corpus fund
of `5 crore named as ‘The Infosys
Foundation Endowment Fund’, will
continue in perpetuity to benefit a
minimum of 50 students annually.
The grant will be used towards the
establishment of Infosys Foundation
Scholarships which will be awarded to
BS-MS students, Infosys Foundation
Fellowships endowed to integrated
PhD students and Infosys Founda-
tion Travel Awards to PhD students
who have excelled in their research
work. The grant is aimed at fulfilling
the Foundation’s objective of creating
equal opportunities for students from
poorer backgrounds and advancing
the quality of research done at Indian
institutions. The establishment of
scholarships, fellowships and travel
awards provides opportunities for
students at different academic levels
to gain from the grant.
Bionews

Bionews
Pharma exports growth heading for a sharp decline
CRISIL Research foresees exports growth in formula-
tions (in US dollar terms) decling sharply to 10-125 an-
nually over the next 5 years, compared with a growth of
19% seen in the last decade.
Exports of generics have been the growth engine of the
industry for a long while now, but the script is changing
because the value of drugs going off patent is declining
even as pricing pressures are increasing.
For example, annual sales growth of generic drugsin US
is seen slowing to 8-9% over the next five years, and de-
celerate even more after that. Therefore, for growth to
sustain beyond 2020, domestic companies will have to
step up investments in new molecules and draw up a
roadmap to deal with lower generics growth.
In the past decade and more, what came in handy was
process chemistry skills--which helped companies clone
drugs going off-patent by tweaking their molecules--and
low-cost manufacturing. But competition has been in-
tensfying, particularly for the large players, because of
the huge number of abbreviated new drug applications
(ANDAs) being filed with the USFDA, including by mid-
sized domestic ones looking to step up presence in the
biggest market.
Furthermore, consolidation of distribution channels in
the US could reduce the pricing power of domestic drug
makers. Says Ajay Srinivasan, Director CRISIL Research,
“Sharper focus on innovation and RD has become an
imperative. Our analysis of new drug applications ap-
proved by USFDA reveals that Indian companies got ap-
provals for just 26 products between January 2006 and
June 2015-a fraction of the 840 garnered by global phar-
ma companies. Their global generic competitors such as
Teva and Mylan has 48 and 33 NDAs to their credit as of
February 2016.”
To be sure, Indian companies have indeed increased their
RD spend; for the top 30, it has shot up to 6.5% of rev-
enue fiscal 2015 from 3.8% a decade back. However, this
pales in comparison with global majors, who spend close
to 16%.
WHO South-East Asia Region on track for
implementing polio endgame strategy
Implementing a monumental change
in vaccination that is expected to
bring the world closer to eradicat-
ing all types of polio, all 11 countries
in the WHO South-East Asia Region
have ‘switched’ from using the tra-
ditionally used trivalent oral polio
vaccine (tOPV) to bivalent oral polio
vaccine (bOPV) that protects against
the remaining wild poliovirus strains.
The vaccine switch removing ‘type 2’
component of the oral polio vaccine
follows global certification of eradi-
cation of type 2 wild poliovirus last
year.
The switch also aims at drastically
reducing the rare risk of children get-
ting paralysis by oral polio vaccine.
“The world is closer than ever before
to ending polio. The switch is a criti-
cal step in the Polio Endgame Strat-
egy towards achieving a world free
of all types of polioviruses,” said Dr
Poonam Singh, WHO Regional Di-
rector for South-East Asia.
The polio vaccine switch, which is
complemented with introduction of
injectable inactivated polio vaccine
(IPV), will boost the Region’s efforts
to protect children against polio un-
til the crippling disease is eradicated
globally.
“The Region was certified polio-free
in March 2014 and continues to
maintain the polio-free status, de-
spite the risk of importation from the
polio-endemic countries. Efforts are
ongoing to protect children with po-
lio vaccine,” she added.
Biocon to set up a
new manufacturing
facility
The Karnataka State government has
cleared biotechnology major Biocon’s
Rs1,060croreinvestment proposal
for setting up a new pharmaceutical
plant on the outskirts of Bangalore.
The new unit, that will come up on
leased plots at the new KIADB Indus-
trial Area in Jigani, few kilometers
from the Biocon Park in Bangalore,
will produce injectables, monoclonal
antibodies and oral solid dosage.
The facility is expected to generate at
least 750 jobs immediately. Biocon’s
investment proposal was approved
by the State High Level Clearance
Committee (SHLCC) chaired by Kar-
nataka Chief Minister Siddaramaiah
at a meeting on May 25, 2016.

I
n the manufacturing context, additive manufac-
turing for medical applications is significant when
compared to other popular industries such as elec-
trical and electronics, aerospace, automotive etc,
since there is the invaluable human element pres-
ent in all healthcare applications, where often cost takes
a backseat compared to a successful outcome that saves a
life or greatly improves the quality of health.
Today, 3D printing is an emerging technology to produce
cost effective, efficient and customized body parts and
medical devices such as dental implants, hearing aids,
prostheses, custom made knee and hip implants, and
surgical instruments. A 14-year-old boy from the United
States has become the first person to undergo a success-
ful nose transplant using 3D printing technology. Also
recently, 3D printing has helped surgeons to successfully
transplant a kidney to a toddler from Northern Ireland.
3D printing (3DP) technology has progressed rapidly
in recent years, and its medical applications are lead-
ing to some of the most significant deployments of the
technology.
3D printing and growing need for
right performance material
3D printing (3DP) is a term used to describe several dif-
ferent technologies and techniques used to create 3D ob-
jects. Currently there are several different technologies,
which perform this function in a variety of different ways
such as steriolithography, fused deposition modeling
(FDM), selective laser sintering (SLS), 3D microfabrica-
tion, and electron beam melting (EBM). These process-
es are substantial for creating prototypes and end-use
production parts using several polymeric and metallic
material.
The technology is emerging as a cost effective, efficient
solution and provides customized manufacturing option
for the medical devices industry. It promises to deliver on
various counts such as personalization according to pa-
tients or users, flexibility in design and manufacturing,
decreased material wastage, elimination of specialized
tooling, and low lifecycle costs.
Combined with the maturity of the 3D printing process
(in terms of better material, machines, and technologi-
cal innovations), the technology can be used to develop
many new medical devices that were earlier deemed dif-
ficult to create, expensive, or not patient friendly. The
advancements in additive manufacturing along with the
advancements in material evolutions have provided a
spring-board for increasing use of 3DP in healthcare in-
dustry.
Material selection is a critical step in any product devel-
opment cycle. The material selection criteria are always
derived from the requirements identified during the de-
sign stage of the component or end-product. For mate-
rial used in medical devices, mechanical performance
requirements combined with bio-compatibility, steriliza-
tion capabilities, fire retardency, smoke toxicity, chemical
resistance, etc., may be detrimental for safe performance
of medical devices. Therefore, when choosing a material
and the 3D printing process for the device, it is important
to ensure the material can deliver one or more of these
property requirements driven by the design, application
and function of the product.
Several thermoplastic material which are currently in use
with traditional manufacturing like injection molding or
extrusion can be modified to be used in 3DP applications
(ex., FDM, SLS). Polycarbonates (PC), PEI, ABS, ASA,
Polyamide, Polysulfide etc., are some of the thermoplas-
tic material types that are often used with FDM process.
These materials should also meet the bio-compatibility
needs along with the other safety needs that are demand-
ed by the function of 3DP parts.
Are these performance material in medical devices safe?
3D Printing
Biospecial

There are several safety standards that are currently
available to qualify these material for safety require-
ments. The ISO 10993 series of standards describe meth-
ods for evaluating material for biocompatibility in medi-
cal devices. There are other UL safety standards such as
UL 94 and UL 746A to evaluate material for flammability,
mechanical and electrical performances.
Current challenges
One of the key aspects affecting the industry has been the
safety associated with the performance material. This will
have maximum impact on the medical device sector, due to
the usage of a considerable volume of polymers. Safety has
also been an issue when it comes to polymer material se-
lection for a medical device. While high performance ma-
terial such as polyetheretherketone (PEEK) are rendered
safe compared to commodity thermoplastics, the high cost
of PEEK often pushes medical device manufacturers to use
cheaper material which has a good degree of biocompat-
ibility and regulatory compliance. Striking a balance be-
tween cost and performance is usually a challenge.
In spite of its state-of-the-art technology, 3D printing has
its own challenges. While it allows medical practitioners
to print their own devices, it provides a challenge to regu-
latory authorities in enforcing adherence to quality stan-
dards. This brings another challenge to the forefront - en-
suring traceability of the device throughout its lifecycle,
right from the patient-identification stage. This would re-
quire extension of the Unique Device Identification phi-
losophy to 3D printed devices. Unapproved devices that
need to be implanted into the patient’s body on an emer-
gency basis may have to go through emergency approval
processes. It is important for users to exercise extreme
caution to ensure there are no regulatory violations.
Mechanical testing and bio-compatibility questions may
arise with medical devices produced using 3DP tech-
nique. Therefore, Food and Drug Administration (FDA)
has been monitoring the mechanical and bio-compatibil-
ity requirements for the medical devices that are manu-
factured using this technology. Hence, crossing the strin-
gent regulatory barrier is a challenge for the performance
material industry. Further research is necessary to obtain
solutions for these challenges. Even though there are sev-
eral safety standards currently available, relevance of the
test methods to 3DP process needs further study. There-
fore, direct use of these safety standards for evaluating
material for 3DP application is still questionable.
Safety and regulations
What happens when entirely new material is subjected to
newer manufacturing and processing methods? With 3D
printing and such other newer technologies, such ques-
tions only seem to be scratching the surface. Given the
strict regulatory environment and lack of relevance of
existing standards for 3DP application, it is critical and
important that material considerations are thoroughly
examined when producing medical devices using 3DP.
A systematic material assessment that focuses on require-
ments, screening, manufacturability, and ranking will
help the manufacturer meet regulations and avoid poten-
tial liability while delivering innovative, safe, and effec-
tive medical devices to patients. While medical devices
in the US and EU are regulated by the Food and Drug
Administration (FDA) and the CE mark approval respec-
tively, in India, medical devices in general and those with
newer performance material face a tougher challenge.
This is largely due to sketchy regulatory framework and
the still to be implemented Drug and Cosmetic (Amend-
ment) Bill.
With the constantly evolving landscape in the medical de-
vices sector, new material, new processes and new equip-
ment are emerging at a dizzying pace. As with any new
or emerging technology like 3DP that has advantages like
reduction in manufacturing cost and faster time-to-mar-
ket, there are associated new challenges with respect to
selection of right material that meets both performance
and safety requirements. Lack of test methods to catego-
rize and rank material suitable for 3DP add more chal-
lenges in selecting right material for healthcare applica-
tion. Existence of such challenges does raise concerns on
the safety aspects of 3DP parts.
In spite of its state-of-the-art
technology, 3D printing has its own
challenges. While it allows medical
practitioners to print their own
devices, it provides a challenge to
regulatory authorities in enforcing
adherence to quality standards.
Prasad Shankarappa
Principal Engineer – Performance
Materials, UL South Asia
Biospecial

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Precision
Medicine
During his State of the Union
address in January 2015 at the
White House, American President
Barack Obama announced the
launch of the most ambitious
healthcare initiative called the
Precision Medicine Initiative (PMI),
with a mission to usher the US
into a new era of medicine where
patients will enjoy individualized
and tailor-made treatment for
various ailments.
Does India need
Initiative

Obama said, “Doctors have always recognized that every patient is
unique, and doctors have always tried to tailor their treatment as
best they can to individuals. You can match a blood transfusion to a
blood type — that was an important discovery. What if matching a
cancer cure to our genetic code was just as easy, just as standard?
What if figuring out the right dose of medicine was as simple as
taking our temperature?”
Coverstory

P
recision medicine is an
emerging approach of
medicine which looks at
the root cause of an illness,
rather than addressing the
symptoms alone. Precision medicine
may not be very well known as Per-
sonalized Medicine. But they are one
and the same. It takes into account
individual variability in genes, envi-
ronment, and lifestyle for each per-
son. The need and its potential in the
Indian healthcare scenario is high,
considering that the system is under
great pressure due to sheer numbers.
Precision Medicine in the country is
considered to be at an early adoption
stage. A diverse country like India,
with over 4,000 population groups,
and a significant percentage of con-
sanguineous marriages presents a
high-risk and prevalence of inherited
genetic disorders that require atten-
tion for early diagnosis, right treat-
ment, and management. India has a
heavy burden of inherited diseases
driven by the unique genetic charac-
teristics in the population. With 1.4
billion people, the absolute number
of patients suffering from diseases in
which genetics play a role is signifi-
cantly large.
It is reported that Indians witness a
loss of around $23 billion from their
annual income in treating or getting
tested for non-communicable diseases.
The global genomics industry is pre-
dicted to grow at around 18 percent in
the next 10 years, and India is expect-
ed to be a major stakeholder. Reve-
nue growth in molecular diagnostics
in 2013 was reported to be around 15
percent. Clinical diagnostics in one of
the fastest growing fields which may
cross $2 billion by 2018. Preventive
healthcare is growing at the rate of 25
percent, which will boost healthcare
revenue and the country’s Precision
Medicine scenario.
“Genetic testing is slowly getting ac-
ceptance among our clinicians. The
challenges are about creating the
awareness for wide-spread adoption.
It is not at all too early for the coun-
try to embrace precision medicine.
This is primarily because India is an
emerging market for genomics. A ris-
ing middle-class, state-of-art health-
care facilities and expert physicians
are driving the growth of the indus-
try in India…. I expect the industry to
attain double digit growth,” says Sam
Santhosh, Chairman Global CEO,
MedGenome.
Dr Saleem Mohammed, CEO
Founder, Xcode Life Sciences, agrees
that India has a strong need for Pre-
cision Medicine which will signifi-
cantly reduce its healthcare burden.
“It is estimated that only around 40
percent of the medicines we take are
effective and appropriate for us. To-
day, we practice trial-and-error med-
icine which does not consider in de-
tail the person-to-person variability,
which is a key source of variation for
the effectiveness of drugs. You can
imagine being dosed and prescribed
by taking into account various factors
such as age, gender, genetics, medical
conditions and usage of other drugs.
That is the promise of personalized
medicine, and India needs to take
leadership in this domain,” he adds.
In India, Precision Medicine is be-
ing practiced in several specialties
like oncology, cardiology, psychiatry
and diabetology. It is already being
embraced in India to a reasonable
extent, especially in cancer.
“Each individual is an island, and so
now that the molecular complexity
of disease has been deciphered, the
role of genetics, environment and
epigenetics are clearly telling us that
that we all need to receive treatment
designed for our physiology and body
type,” remarks Dr Villoo Morawala-
Patell, Founder CMD, Avesthagen.
Indian healthcare institutions are
fast adopting technologies that can
make them on par with the best in
the world. The need to modernize,
and be on par with global standards
can be seen amongst large hospitals
and private medical institutions.
Explains Dr Kalyanasundaram Sub-
ramanian, CSO, Strand Life Sciences,
“There are several targeted therapies
that work only on patients who have
a specific genotype or genomic varia-
tion. So, patients are tested before
the therapy is prescribed. Cancer is
probably the disease in which pre-
cision medicine is most advanced.
However, there are several other dis-
eases - cardiac, ophthalmic, and cer-
tain types of diabetes, where knowing
the genetic background of the disease
can help with disease management.
Here the field is not as advanced.”
Like most technologies, India is ex-
Precision Medicine in the country is considered to be at an
early adoption stage. A diverse country like India, with over
4,000 population groups, and a significant percentage of
consanguineous marriages presents a high-risk and preva-
lence of inherited genetic disorders that require attention
for early diagnosis, right treatment, and management. India
has a heavy burden of inherited diseases driven by the
unique genetic characteristics in the population.
Coverstory

pected to be a follower-market in
Precision Medicine. Doctors would
like approval from USFDA or the
American Medical Association
(AMA) for it to become mainstream
in their practice.
But the challenge is that the West is
going to fund studies in Caucasian
population and not the Indian. In
fact, most drugs are designed and
manufactured for Caucasian popu-
lation. Unless India accelerates re-
search in this space, validation in
the Indian context will always be
questionable.
“Precision Medicine is badly needed
to move towards personalized medi-
cine and personalized diagnostics,
which has a huge potential to reduce
the burden of national healthcare
costs,” points Dr Amit Kumar, CEO
CSO, BioAxis DNA Research Cen-
tre. “At several instances, this results
in patients selling assets or borrow-
ing money to pay incurring medi-
cal expenses. Precision medicine is
the best available tool and remedy
for combating this huge economic
burden.”
Cost of these tests are a concern
still, given India is largely a self-
paid economy. But as technologies
improve, the cost of sequencing is
seen to reduce. Precision Medicine
offers a possible answer by reducing
the costs of hospice stay, and reduc-
ing the overall financial, physical and
psychological costs of the try-and-
test approach of medicine.
“The infrastructure needed for pre-
cision medicine is taking shape in
India. There are certain issues to be
addressed for it to gain the needed
momentum,” opines Samarth, CEO
Founder, Positive Bioscience.
“The key is also the analysis of ge-
nomics data, which as we automate
will provide higher efficiency in the
entire data analysis process, thereby
making tests more affordable. We do
need more baseline genomics data of
Indian origin which will help us in re-
fining our analysis on clinical cases in
the country,” comments Sam.
Targeted therapies like Imatinib have
been around for 40 years. This has
changed the prognosis of Chronic
Myeloid Leukemia (CML) in children.
“People used to think that the role
of genetics ended with hereditary
disease. Today we know that every
response our body makes has a ge-
netic fingerprint to it. We can now
predict response to different thera-
pies, and thus avoid trial-and-error
medicine which is both costly, time
consuming, and puts an unnecessary
drug and hospitalization burden on
the patient,” comments Dr Sooraj
Ratnakumar, Founder Scientist,
Swagene.
The US and EU markets do have a
head start in Personalized Medicine
in terms of accessibility to resources
and raw material, government fund-
ing, and regulations.
“There is also greater awareness
among the people there about the
benefits of personalized medicine. In
India, we have an excellent gene pool
of biotech and IT professionals. With
government interest, we can easily
build India as the hub of personal-
ized medicine,” expresses Ms Anu
Acharya, CEO, Mapmygenome.
President, CEO Founder of Geno-
typic Technology Raja Mugasiman-
galam says that Precision Medicine
is too early for India at the moment.
“Precision Medicine is an emerging
field and sufficient success should be
shown by the western world for India
to embrace it. It is in its early phase,
and there is not sufficient govern-
ment support in the form of research
grants in this space,” he adds.
Overly hyped?
The way Precision Medicine can
help transform healthcare, especially
treatment and management of dead-
ly non-communicable diseases is tre-
mendous, and stalwarts opine that it
is not an overly hyped concept.
“The field of Precision Medicine is
“Each individual is an island, and so now that the mo-
lecular complexity of disease has been deciphered, the
role of genetics, environment and epigenetics are clearly
telling us that that we all need to receive treatment de-
signed for our physiology and body type,”
Dr Villoo Morawala-Patell,
Founder CMD, Avesthagen
Coverstory

still in a nascent stage in India, and
much needs to be done to create
awareness. So the concept cannot
be called as overly hyped, but rather
passionately acclaimed in the medi-
cal and scientific fraternity. Any de-
velopment in the science and medical
space that revolutionizes how medi-
cine will be practiced in the future
naturally generates a buzz around it.
Yes, the concept is quite novel at this
point of time but its scope is tremen-
dous. While we may lack the band-
width to carry out all the exceptional
research at this point in time, slowly
it will happen. And once it happens,
the impact will be more than just
overwhelming. However, there are
certain roadblocks that we cannot
ignore. But limitations and challenge
begets innovation and development,”
opines Samarth.
“I see Precision Medicine as a new
hope rather than a hype,” Dr Amit
states. “Some of our clients say that
research insights of the genomics da-
ta-related to lifestyle, diet, and clini-
cal methods have been very useful in
making a decision faster based on a
patient’s personalized genetic infor-
mation.”
More than hype, Precision Medicine
is said to be more of plain, pure com-
mon sense. For thousands of years,
humans have known that there is
inter-individual variability when it
comes to things ingested, be it medi-
cine or food. Why then patients pop
an over-the-counter pill? Or even
wonder whether it will work on them
or not?
In a recent study by Johns Hopkins
University (USA), medical error was
suspected to be the third leading
cause of death in the US. Many of
them are related to improper drugs
and improper drug dosages.
“It’s sort of like ‘death by medicine’.
Can you imagine what the statistics
are in India? asks Dr Saleem. “Today,
we don’t question why the outcome
was negative for a patient. We as-
sume that the medical establishment
did the best they can in good faith.
With increasing prevalence of clini-
cal decision support systems, and in-
surance insisting on good practices,
you will see things improve. Com-
mon sense dictates that precision
medicine is the only way medicine
should be practiced and not by trial-
and-error.”
Dr Binay Panda, Chief Officer
Head, Ganit Labs, also states that
the problem in India is that Precision
Medicine is hyped by people who un-
derstand little about it.
“Look around and you will find folks
who talk about Precision Medicine,
who understand little about it or
have very little practical and scien-
tific experience on developing preci-
sion medicine tests. We need rigor-
ous scientific minds to talk about the
utility of Precision Medicine, like in
the West, and not those who use the
term as a buzz word or a part of mar-
keting supplements only,” clarifies
Dr Binay.
India’s research scene
The research scene for Precision
Medicine in India is largely in the be-
ginning stage. Some studies are being
carried out in various translational
research centres across the country.
There are several Government labo-
ratories such as IGIB (Institute of
Genomics Integrative Biology),
CCMB (Centre for Cellular and Mo-
lecular Biology), hospitals such as
CMC Vellore, LV Prasad Eye Insti-
tute and other organizations, where
research is being conducted. “How-
ever, it would be fair to say that the
research is fragmented and indi-
vidual researcher-driven, and not
yet translated to patient care in a big
way,” points Dr Kalyanasundaram.
Research is also being carried out at
Sir Gangaram Hospital (Delhi), Ma-
dras Diabetes Research Foundation
(MDRF) (Chennai), Indian Council
of Medical Research (ICMR), Insti-
tute of Bioinformatics (IOB) (Banga-
lore), and Government institutions
such as National Institute of Biomed-
ical Genomics (NIBMG) and Center
for Genome Research.
Large government hospitals like Tata
Memorial Hospital, National Insti-
tute of Mental Health and Neurosci-
ences (NIMHANS), and All India In-
stitute of Medical Sciences (AIIMS)
are also involved in the identification
of new disease genes and biomarkers
by applying Genomics.
Dr Mallik Sundaram, Co-founder,
President CEO, Mitra Biotech,
says, “The western markets have em-
braced it quickly because healthcare
is more organized there with the pay-
ers being the government or insur-
ance companies, thereby translating
the benefits of decreased healthcare
costs while improving treatment suc-
cess rates using Precision Medicine.
In countries like India with frag-
mented healthcare, and the patient
It is estimated that only around 40 percent of the medi-
cines we take are effective and appropriate for us. To-
day, we practice trial-and-error medicine which does not
consider in detail the person-to-person variability, which
is a key source of variation for the effectiveness of drugs.
Dr Saleem Mohammed,
CEO Founder, Xcode Life Sciences
Coverstory

frequently being the payer, while the
benefits remain the same, but ac-
knowledging and translating them is
more piecemeal.”
India, like many other developing
countries, is following success stories
of the West.
“Success in Precision Medicine de-
pends on several factors includ-
ing availability of tests on Precision
Medicine, system on which medical
payment is made — out-of-pocket
versus insurance-based versus gov-
ernment-sponsored — overall posi-
tive atmosphere in the country to-
wards embracing new tests, previous
success stories, availability of skilled
manpower and the presence of the
right environment. On all these ac-
counts, we in India, have miles to
go. However, we have excellence in
pockets, which include brilliant peo-
ple who are capable of doing all that.
The trick is to encourage those few to
develop tests for the Indian popula-
tion,” Dr Binay explains.
Paradoxical elements
The use of Precision Medicine is a lit-
tle tricky and paradoxical, say experts.
“It has lot of social impact. But some-
one has to draw a line to the extent
one should use it. One single muta-
tion is responsible for more than one
medical condition and vice versa; it
may also create confusion and mis-
leading interpretations. Precision
Medicine may be only a corrobora-
tive aspect until we have more con-
fidence, and accurate outcomes get-
ting reported across the globe,” Dr
Amit reveals.
Dr Kalyanasundaram says that the
challenge is in marrying personaliza-
tion of medicine with reduced drug
costs to an individual patient.
“Currently, most of the best genome-
based medicines are expensive and
out-of-reach for the average Indian.
The other worrying aspect is that
none of these medicines are avail-
able in India. Imagine the plight of
a patient who realizes that there are
medicines that may work for him but
is unable to access it,” he observes.
Also, the discussion of paradoxes of
Precision Medicine often revolves
around the cost, i.e., spending more
and more to identify therapies that
applies to fewer and fewer.
Samarth adds, “This paradox can
be compared to the cost of any IT
initiative in the eighties era using
mainframe computers, and specially
created buildings for housing them
versus, even higher computational
processing being available today in a
mobile system; or 3D printing to give
a more recent example. As there is a
change in approach and increase in
use of the technologies, there will be
a reduction in costs.”
What Is needed?
In Precision Medicine, for success-
ful commercialization, many things
have to come together.
“There has to be a way of leveraging
all the information and insights that
is generated in other populations
from around the world. The Indian
government should be setting up
large genomic studies in various dis-
ease populations. Indian scientific
establishments need to view this as a
challenge, and work with physicians
to understand the diseases that are
most likely to have benefits quick-
ly, and work towards problems in
those areas. Indian funding agencies
should be funding large translation-
al projects with a clear clinical aim.
There should be clear frameworks
that allow industry to access these in-
sights to convert them to products,”
urges Dr Kalyanasundaram.
Both Sam and Samarth agree that in-
creasing the awareness levels of Pre-
cision Medicine among the general
population, clinicians and doctors is
much needed.
“In our country, the depth and width
of the healthcare system is very large,
often unorganized, and under tre-
mendous pressure. To bring in a new
approach to the practice of medicine
will need full participation and edu-
cation of patients, drug developing
pharma companies in pharmacoge-
nomics, change in the practices and
process of hospitals and clinics, good
regulatory framework and the sup-
port of the government in building
the research infrastructure. Further
in order to translate the bench re-
search to bedside care, it is important
for research academics and medical
market players join hands,” suggests
Samarth.
Collaboration of genetic testing labo-
ratories, hospitals, and medical doc-
tors may be the starting point, says
Dr Amit. “We require huge genetic,
clinical and lifestyle data from India,
and this can only be reached if gov-
ernmental programs backup such
kind of association and research.
With the fast decreasing cost of DNA
Precision Medicine is badly needed to move towards per-
sonalized medicine and personalized diagnostics, which
has a huge potential to reduce the burden of national
healthcare costs,
Dr Amit Kumar
CEO CSO, BioAxis DNA Research Centre
Coverstory

sequencing of a person’s genome, a
model shall be framed which should
have genetic medicine and precision
therapy as one of the most important
inclusion. Government may think
of including genetic tests under the
insurance coverage, starting with
critical illnesses. If we have enough
country data, it may offer a lot of very
important medical insights.”
According to Dr Binay, India needs 4
Ps to make Precision Medicine suc-
ceed. “They are people, processes,
protocols and pricing. People mean-
ing encouraging and aiding brilliant
minds to be involved in developing
new and innovative tests; processes
meaning developing the right clini-
cal and scientific processes or SOPs;
protocols meaning coming up with
the right regulatory…,” he lists.
Dr Saleem believes that the medical
community should actively collabo-
rate with genetic service providers
to validate concepts in the Indian
population.
“We operate in a highly cost-sensi-
tive environment. A key barrier to
adoption is cost of the test…. In the
long-term, genetics should become
a major part of the medical curricu-
lum. Genetics should get its due im-
portance given that we live in an era
where we are talking about actively
editing genes to cure major diseases,”
he notes.
Sam recommends public-private
partnerships (PPP) between aca-
demic institutes and the industry
to promote genomic research in the
country.
“Partnerships with private enterpris-
es that have already taken the leap
into genomics research and are pro-
viding solutions to address health-
care needs in India…. In addition to
this, initiatives like setting up of elec-
tronic medical records, and popula-
tion level genome sequencing will
go a long way in helping commercial
success. It will also be useful to chart
out a comprehensive plan to identify
key disease areas in India with un-
derlying genetic reasons that have
high unmet medical need and to al-
locate government funds to promote
education, research and innovation
in these areas,” he stresses.
Should India ape the US?
India may follow something similar
to PMI launched by Obama, but on a
pilot scale.
“The government can play a key role
by allocating research funding to
this area. Precision Medicine is go-
ing to have a tremendous impact on
our nation’s healthcare and will im-
prove health outcomes while mini-
mizing the costs. But someone has to
make the investment in accelerating
the creation of know-how, and the
knowledge base that is specific to In-
dia. Given the significance of health
for a nation’s economic and social de-
velopment, I would say that prioritiz-
ing of government grant funding to
this area will be highly useful. The US
again has taken leadership in this so
far with the Precision Medicine un-
der the Obamacare,” voices Samarth.
In an interview with BioSpectrum,
Dr Mandar Kulkarni, CTO, Cancer
Genetics India, states, “I think this
is a big challenge even in the US,
where most diagnostic testing is
paid through insurance reimburse-
ments, which are driven by FDA-
approvals.”
He further expresses, “Currently,
the FDA is reviewing the guidelines
and ensuring that the testing is not
wasteful. On the other hand, a major
advantage for such testing in the US
is the availability of well-curated da-
tabases that define the effect of mu-
tations on the disease-state in terms
of prognosis, clinical outcome and
treatment options. Unless we adopt
the tests and begin this exercise, we
will not be able to identify epidemio-
logical and etiological differences
that contribute to cancer in India.”
Though India’s limited studies in
this area show that while the Indian
genome has many similarities to the
Caucasian, there are significant dif-
ferences as well. “So it is absolutely
essential that a similar and large
PMI be launched in India given the
genomic diversity here,” justifies Dr
Kalyanasundaram.
Sam also agrees that a initiative like
PMI will be useful to India’s Health-
care. ‘‘If a similar program is initi-
ated, it has to be designed keeping in
mind the state of the economy, and
the public health issues of the Indian
population, and the diseases or disor-
ders plaguing our society. The Geno-
meAsia 100K consortium is one such
initiative in the region,” he urges.
Starting anything new is good, but
India needs to revive and encourage
what it already has, and have a long-
term vision for Personalized Medi-
cine.
“Science does not bear fruit over-
The western markets have embraced it quickly because
healthcare is more organized there with the payers being
the government or insurance companies, thereby translat-
ing the benefits of decreased healthcare costs while im-
proving treatment success rates using Precision Medicine.
Dr Mallik Sundaram
President CEO, Mitra Biotech
Coverstory

night,” Dr Binay adds. “One needs
to be patient and encourage fund-
ing the right talent in this direction.
First and foremost, we need to en-
courage young minds to pursue sci-
ence and be more meritocratic in our
institutions.”
Dr Amit emphasizes that both ICMR
(Indian Council of Medical Research)
and CSIR (Council of Scientific and
Industrial Research) need to play a
very important role in framing the in-
sights related to pharmacogenomics,
genetic variation-related drug stud-
ies, and population-wise human SNP
validation, if India wants a mean-
ingful outcomes from such a diverse
population.
Dr Raja says that India doesn’t have
to ape the West.
One might consider a PMI in India as
an overly zealous move for a country
where malnutrition and poverty collec-
tively kills more people than diseases.
“At the right time we can definitely
think of taking a step towards PMI
for our own country just like America.
India is already the diabetes capital
of the world and is slowly inching in
vying the top spot for heart ailments
and cancer too. I think we all have
come to appreciate the fact that all
these diseases are genetic-driven by a
combination of several mutations in
different genes. Precision Medicine
guided by genomics not only allows
us to diagnose and prevent these dis-
eases but also treat and manage them
effectively,” elaborates Samarth.
Regulatory woes
Genomic information is critical since
it not only affects an individual but
potentially their family as well. There
are legal, technical, social, and po-
litical hurdles which needs to be ad-
dressed.
Dr Kalyanasundaram stresses, “It
needs to be clear who owns this in-
formation, what are the limitations
under which researchers get access
to it, and how can this information be
used and misused. These issues are
all critical and need to be addressed
by the law.”
However, the current regulatory
frameworks are inadequate in terms
of providing guidelines for Precision
Medicine initiatives.
Information is required on how to
bring in a population level-approach
for genomics research. Also, policy
revisions to support the industry
from import duties on reagents are a
need of the hour.
“Intellectual property rights and pat-
ent policies are not very well defined
in the area of Precision Medicine and
predictive genomics. This could be a
challenge to further innovation. Also,
reimbursement from insurance com-
panies is another key factor that will
determine the growth of this indus-
try. In the western world, insurers
have started accepting genomic tests
in their formulary as it is expected
to reduce the cost of down-the-line
treatment. In India the option is to
bring the test at affordable prices
and foster innovation to reduce the
cost of genomic diagnosis,” Sam ex-
presses.
Precision Medicine is dependent on
the DNA study of an individual, and
India does not have a DNA usage
policy yet.
“We are hoping for the best since
this important master molecule has
caught the attention of our PM Na-
rendra Modi, and he has announced
to put all the efforts towards the DNA
Bill of India. Again, draft of this Bill
also needs to be concreted by includ-
ing insights from industry experts,
academicians, research organiza-
tions, laboratories and judiciaries,”
justifies Dr Amit.
Currently, most of the best genome-based medicines are
expensive and out-of-reach for the average Indian. The
other worrying aspect is that none of these medicines are
available in India. Imagine the plight of a patient who
realizes that there are medicines that may work for him
but is unable to access it,
Dr Kalyanasundaram Subramanian
CSO, Strand Life Sciences
Coverstory

Dr Binay strongly supports in having
strong ethical guidelines to practice
Precision Medicine.
Degree of impact
Just imagine a patient taking a sim-
ple blood or saliva test at a labora-
tory, and in the next meeting his or
her physician is very well prepared
with the patient’s genetic horoscope
including the information on chemi-
cal compounds, or combination of
drugs useful or harmful to him, based
on the tried-and-tested genetic test
report.
“We will be able to minimize side ef-
fects with very beautiful and faster
accurate therapies that too at af-
fordable costs if Precision Medicine
boosts up in India….. If used respon-
sibly, it can do wonders and contrib-
ute towards every individual’s good
health,” notes Dr Amit.
Precision Medicine can also trans-
form the national economy, espe-
cially in a population whose average
lifespan is increasing.
Sam explains, “From an individual’s
perspective, it has the potential to
make genetic diagnosis of diseases
more efficient and cost-effective, by
reducing genetic testing to a single
analysis, which informs individuals
throughout their life. Since it uses
state-of-the-art genomic technolo-
gies, rich medical record data, tissue
and blood banks, and clinical knowl-
edge that will allow clinicians and
payers to tailor treatments to individ-
uals, it can greatly reduce costs of in-
effective therapies incurred through
the current trial-and-error clinical
paradigm.”
The impact can be great, where pa-
tients get the right medications, have
better outcomes and lower side ef-
fects, feels Dr Kalyanasundaram.
“This would lead to healthier popula-
tions with better overall health eco-
nomics. To make this possible, lots
of information needs to be collected,
analyzed and translated. Medicines
that can exploit the genetic differ-
ences need to be present. So the task
is formidable but the payoffs are po-
tentially enormous.”
Precision Medicine will also allow
reduced morbidity, specifically in on-
cology cases, help in preventing high
burden of genetic diseases, and man-
aging high-risk cases with increased
surveillance.
It will also have a major impact on
the economy by reducing productiv-
ity losses, and decreasing costs of
treating disease, thereby reducing
overall costs on Indian healthcare.
“The internet will further accelerate
adoption of precision medicine by
empowering patients and doctors
who are already demanding more to
fight India’s unique challenges with
diabetes, heart disease and tobacco
use,” said Dr Sooraj.
In 2012, Futures Group predicted
a new perspective to healthcare by
2050, where gaps between medical
practice, healthcare, and personal
health will be bridged.
Another prediction is the predomi-
nance of preventive healthcare,
where individuals take charge of
their health by harnessing the power
of technology. Genomic tests – single
nucleotide polymorphism and whole
genome sequencing – will be the key
catalysts to this change.
“We have seen the beginning of this
change. Wellness was once a fancy
word. Today, it is part of every hos-
pital’s business strategy to engage a
new generation of customers, who
are actively pursuing wellness us-
ing social apps for various reasons –
right from fitness and diet to finding
the best doctor,” opines Ms Anu.
In India, diseases have a profound
physical, psychological and social
impact. Most of healthcare costs are
paid not out of insurance, but out of
pockets.
The impact of illness in one person in
the family has a domino effect on the
family and the community. “The cost
of treatment, for diseases like cancer,
cardiac diseases, diabetes, asthma,
and the impact of the side effects of
medication taken has often seen fam-
ilies, even amongst middle class and
higher middle class, needing to take
loans, or family members having to
leave jobs,” Samarth states. “Just the
simple factor of reducing treatment
time and side effects will have a sig-
nificant impact on the socio-econom-
ic situation of an individual.”
So, diseases that were previously a
death sentence will be manageable,
or even curable, because we will be
able to individualize therapy for each
patient. BS
People used to think that the role of genetics ended with
hereditary disease. Today we know that every response
our body makes has a genetic fingerprint to it, and thus
avoid trial-and-error medicine which is both costly, time
consuming, and puts an unnecessary drug and hospitaliza-
tion burden on the patient,
Dr Sooraj Ratnakumar
Founder Scientist, Swagene
Raj Gunashekar
Ayesha Siddiqui
Coverstory

Why India is not on the bio-
similars’ radar?
Over the last 15 years, Indian phar-
maceutical industry from having less
than 5 percent market share in the US
generic market, now has more than
25 percent. But we are yet to see the
same advancements in biosimilars.
The major bottleneck for developing
biosimilar molecules in India lies in
the regulatory challenges, says Dr
Sunit Maity, AVP, product develop-
ment, Theramyt Novobiologics.
He added, “Currently BioPharma com-
panies which are developing biosimi-
lars, must receive approval from multi-
ple government agencies, significantly
increasing the overall time it will take
to bring the product to market.A sin-
gle-window agency and streamlined
approval process will reduce the com-
plexity and encourage the players to
develop the biosimilar molecule.”
Cost and complexity of developing
biosimilars poses another challenge.
“Biosimilars are large and complex
molecules compared to generic phar-
maceuticals.Therefore, development
Can India dominate the
biosimilar market?
After dominating generic drug industry for decades,
can India become a leader in developing this new
class of drugs too? Read on to find out.
and manufacturing of biosimilars
is capital intensive and the overall
commercialization timelines are 5-7
years, even for launch in domestic
market,said Mr KVSubramaniam,
president, Reliance Life Sciences.
He further added,“Very few generic
pharmaceutical companies have ca-
pabilities and competencies in RD
and manufacturing of biosimilars.”
Dr Murtaza Khorakiwala, managing
director, Wockhardt, provides an-
other view, “The Biosimilar industry
even in the regulated markets is still
in a nascent infancy stage and ac-
counts for less than 5% of total bio-
technology market. However, there
are at least 8-10 corporates from In-
dia that have significant progress in
developing and launching biosimi-
lars in India and emerging markets.”
Challenges in development
of Biosimilars
Biosimilars manufacturing is capital
intensive. The development of bio-
similars requires extensive preclini-
cal and clinical trials.Thus, theinvest-
ments required for development and
commercialization of these products
is quite high.
“The investments in biogenerics are
very high when compared to conven-
tional generics. The development is
itself lengthy and expensive; a suc-
cessful biosimilar manufacturer has
to have good science and manufac-
turing technology, and the capability
to deal with complex regulations,”
said Rajiv Malik, president, Mylan.
The development of biosimilars is
also much more challenging due to
the greater complexity of biological
drugs and the complex manufactur-
ing process.
“The major challenges would be sig-
nificantly higher barriers to entry in
Indian biotech industry
is very well developed
otherwise we could not
become world leader in
vaccine industry.
Sunit Maity
AVP, product development,
Theramyt Novobiologics
Biosimilars

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11Start-ups…
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terms of – capital investments in sci-
entific/clinical development and man-
ufacturing capacities,evolving regula-
tory process and still to mature market
development strategies and also avail-
ability and accessibility of people capa-
bility and depth,” said Dr Khorakiwala.
Another big challenge is on the com-
petency front says Subramaniam. He
added, “Very few companies today
possess the competencies and capa-
bilities required for development and
manufacturing of biosimilars.”
Dr Maity pointed out that an in-
depth understanding of the product
and manufacturing process, as well
as highly specialized analytical tool
are required for development of bio-
similar molecule.
Cost and complexity
deterrent
The development of biosimilars is
much more challenging due togreater
complexity of biological drugs and the
high cost of development.Could these
be a deterrent for Indian companies?
“This is partially true. Small generic
pharma companies may not have
where withal to develop biosimilars
given the capital outlay for commer-
cialization of these molecules. For
large companies, it largely depends
on their overall strategy and capital
allocation for these new class of mol-
ecules,” said Subramaniam.
Cost of conducting clinical trial for
biosimilar is a huge burden on the
developers. “It has also been deliber-
ated that maybe it is better to develop
biobetters or novel biologics than bi-
osimilar. It is possible then to launch
a product with improved efficacy and
immunogenicity profile which can
get branded product pricing and it
can potentially replace the previous
product and will get a major market
share,” said Dr Maity.
Lack of biotech boom a
barrier?
Part of the problemthat India has not
made significant mark in biosimi-
lar is said to be that, biotechnology
is not as well developed in India as
chemistry. “It is partially true that ca-
pabilities in applied research in biol-
ogy limited India’s growth with regard
to biological drug development,” said
Subramaniam. He continues, “The
other key issue was that the generic
pharmaceutical industry was ‘behind
the curve’ on this front, as it was al-
ways focused on generic pharmaceu-
ticals development, which did not
require large capital and had shorter
commercialization timelines.”
However, Dr Maity absolutely dis-
agrees with this view. He said, “In-
dian biotech industry is very well
developed otherwise we could not
become world leader in vaccine in-
dustry.” Does India have the exper-
tise to dominate biosmilars industry?
“India does have the expertise in bio-
generics and recognises the poten-
tials with biosimilars, as was done in
the generics industry, and make bio-
generic manufacturing an important
part of the Make in India movement,”
Rajiv Malik, president, Mylan.
Biotech requires specialization and
is not as job intensive as compared
to pharmaceuticals. “State-of-the-art
production facility dedicated to manu-
facturing of only biotech products are
now available with many Indian com-
panies focusing on biosimilars. Indian
biotech industry is thriving resulting
in launch of more than 50 biosimilars
till the date,” said Dr Khorakiwala.
One of the major advantages we have
is the significant success and expe-
rience in pharmaceutical manufac-
turing that has been achieved over
the last 2 decades.That has brought
in rich experience in topics such as
GMP manufacturing, documentation
practices, scale up, technology trans-
fer and validation.
“Indian biopharma industry today
has all of the essential pre-requisites
that are essential for it to emerge as
a global manufacturer of economical,
safe and efficacious biotech thera-
peutic products,” said Dr Maity.
Can India dominate global
biosimilars market?
“Yes absolutely, if we can become
India does have the
expertise in biogenerics and
recognises the potentials with
biosimilars, as was done in the
generics industry, and make
bio-generic manufacturing an
important part of the Make in
India movement
India has immense potential
to become one of the key
players in the development
and manufacture of biosimilar
drugs
Rajiv Malik
president, Mylan
Dr Murtaza Khorakiwala
managing director, Wockhardt
Biosimilars

world leader in generics and vac-
cines then why not in biosimilar. We
need to make a concentrated effort
in every level to achieve this,” said
Dr Maity.
“India has immense potential to be-
come one of the key players in the
development and manufacture of
biosimilar drugs,” says Dr Khoraki-
wala. “There have been many Indian
companies who are developing this
portfolio have sold biosimilars in
emerging markets. Identifying port-
folio with well-laid strategy to devel-
op, manufacture and commercializa-
tion of the products in key markets is
very essential. The key is investing in
research development,” he added.
However, Indian companies would
have to overcome the challenges
mentioned to manufacture high-
quality, cost-competitive products.
“The companies also would need to
invest significantly in talent develop-
ment specifically in the area of mo-
lecular biology,process development
and manufacturing of biosimilars,”
said Subramaniam.
“Biosimilars are going to be the next
big growth driver in India, play-
ing a major role in offering quality
and affordable solutions for disease
management,” said Malik. New ‘Bio-
similar Guidelines’ of India provides
similarity in approach with those in
the USand Europe, certainly a step in
the right direction. In addition, DBT
has launched schemes to promote the
development of biosimilars. Given
this scenario, India is set to make its
mark in the biosimilars market. BS
Ayesha Siddiqui
Biocon’s Insulin Glargine receives regulatory
approval in Japan and is also gearing up for
the US launch.
Intas Pharmaceuticals launched INTACEPT, the
first etanercept biosimilar. It is also expecting
US approval of their Neulasta biosimilar soon.
Wockhardt is said to be the first in India to
launch recombinant human insulin “Wosulin,
recombinant insulin glargine‘Glaritus’ and
recombinant human Erythropoietin ‘Wepox’.
Hetero launched biosimilar ‘Rituximab’ under
the brand name ‘MABALL’.
Dr Reddy’s launched the first biosimilar
filgrastim (G-CSF) in India, first biosimilar MAb
(Rituximab) and biosmilar darbepoetinalfa-
Cresp.
Reliance Life Sciences markets, ReliFeron
(Recombinant Interferon α), ReliPoietin
(Recombinant Erythropoietin), ReliGrast
(Recombinant Granulocyte colony stimulating
factor) and MIRel (Recombinant Reteplase -
tissue plasminogen activator), among others
biosimilars in India and overseas market.
Some Indian companies in
biosimilar space
Biosimilars

B
elieve it or not India is the third fattest nation
in the world with over 30 million or 3.8 percent
of the adult population here grappling with obe-
sity. Globally a third of the world’s population
are overweight or obese with the United States leading
the charge.
Today it is a well recognized fact that obesity is not a mere
cosmetic problem, but is the mother of all important dis-
eases, including type 2 diabetes, high blood pressure,
ischemic heart disease, sleep apnea, and even some can-
cers. “There are over two dozen medical conditions that
are associated with obesity,” says Dr Arun Prasad, Ro-
botic Surgeon, Institute of Robotic Surgery at the Delhi-
based Indraprastha Apollo Hospitals.
While the ideal situation is to lose weight through physi-
cal fitness measures, often the morbidly obese are trapped
in a vicious cycle – their legs cannot support their weight
inhibiting them from prolonged exercise, which leads to
increased weight gain.
Take Chandrika Jayna, (name changed) who had severe
joint pain in her knees and unable to walk had been gain-
ing increasing weight. This led to a host of complications.
For people like Jayna bariatric surgery is a life-enhancing
procedure. There was a time when there was a lot of stig-
ma associated with opting for bariatric surgery, but today
as well known names go openly under the scalpel to trim
their flab, the benefits are becoming acknowledged.
Meet the Robotic Surgeons who conducted nearly
4,000 procedures in 30 hospitals spread across
the country during 2015 to help cut flab. Earlier
doctors were using laparoscopic techniques to
perform gastric bypass surgery. Today, robotic
surgery is the more preferred method.
The
fighters
FA
Biospecial

BSI_June 2016_Raj Gunashekar

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