Express Pharma (Vol.12, No.5) January 1-15, 2017

VOL. 12 NO. 5 PAGES 82

1-15 JANUARY 2017, ` 40

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CONTENTS MARKET

Vol.12 No.5 JANUARY 1-15, 2017 Chairman of the Board Viveck Goenka

13

Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury*

Biosimilars Digital Revolution Precision Medicine PatientCentric R&D Artificial Intelligence Advanced Analytics Speciality Pharma Medical Tourism| 20

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil

P11: INTERVIEW

'We still have a lot of headroom to grow'

MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

P22: INTERVIEW

Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal

P51: INTERVIEW

PRODUCTION General Manager BR Tipnis

Increasing access to medicines via collaboration and digitisation

52

FABTECH TECHNOLOGIES SIGNS CONTRACT WITH VACSERA (EGYVET)

53

OXFORD GENE TECHNOLOGY LAUNCHES SURESEQ MYPANEL NGS CUSTOM FH PANEL

54

ALBERT DAVID TO OPEN NEW DIVISION TO FOCUS ON GYNAECOLOGY AND ORTHOPAEDICS

Verayo chip has a huge opportunity in India

P74: INSIGHT

Manager Bhadresh Valia

Why talent crunch is derailing the pharma sector?

Scheduling & Coordination Ashish Anchan

P75: AWARD

CIRCULATION Circulation Team Mohan Varadkar

PHARMA ALLY

Moin Don, CEO, PVCON Consulting receives Pharma Ratan 2016

PV TRAINING PROGRAMME TO BE LAUNCHED SOON

RESEARCH

46

MOMENTA’S HUMIRA BIOSIMILAR SUCCEEDS IN KEY PSORIASIS STUDY

47

PROTEON THERAPEUTICS KIDNEY DRUG FAILS KEY STUDY

48

SYNERGY PHARMA’S IRRITABLE BOWEL DRUG SUCCEEDS IN KEY STUDY

49

ASTRAZENECA PILL SLASHES LUNG CANCER PROGRESSION IN STUDY

50

RENEURON SAYS STEM CELLS IMPROVED MOTOR FUNCTION IN STROKE STUDY

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

More pain before the gain

A

n ICRA quarter update on the

action, the biggest reform measure of the Modi

pharmaceutical sector does

government, demonetisation, is set to put

not have very encouraging

FY17earnings at risk, according to the latest

news for 2017. Growth from

report

the US market, once the sweet

implementation has not lived up to the intention

spot of many Indian companies, has come down

and it is anyone's guess how other factors like

to less than nine per cent in H1 FY2017 despite

the shortage of cash in rural and even semi-

consolidation and currency benefits. The report

urban areas, etc, will impact the sales of

predicts that there will be more pain, as going

medicines. As as of now, the pharma companies

forward the growth momentum is likely to face

are in a wait and watch mode. Online

Prabhudas

Lilladher.

The

pharmacies have no doubt benefitted from

further pressure.

Other markets like LATAM, CIS countries and South Africa are yet to bounce back.

Companies will take some time to gain the confidence to re-start serving these markets.

For instances, Glenmark had to effect sizeable write-offs in Venezuela and is still in dialogue with the government to repatriate their dues.

Remediation costs of product recalls and 483s from the US FDA

from

is also a drag on the

performance of some companies.

2017 promises to be yet another year of change, with more pain before the gain

demonetisation as well as the push towards a digital economy and this could have a positive impact on inventory control and tracing counterfeit medicines as well.

A sign of the maturity of leading pharma companies is that inspite of shrinking margins, R&D spends are increasing, not decreasing.

According to the ICRA report, pharma companies have increased their R&D budgets significantly, from six per cent of sales in FY2011

While there was some cheer on the domestic

to close to nine per cent now. Glenmark recently

formulations side, with companies in the ICRA

revealed their strategic blueprint for the next

sample registering double the growth, 14.1 per

decade, and R&D spends up to 11 per cent is

cent in Q2 FY2017 as against seven per cent in

clearly the company's intention. This is because

Q2 FY2016, future regulatory action on FDCs,

these companies have graduated from low-

expansion in the NLEM will see further erosion.

margin to high margin complex product

But some companies have used these

strategy,

such

as

injectables,

inhalers,

shrinking margins to take a closer and more

dermatology, controlled-release substances and

critical look at their business strategies.

biosimilars.

Companies have reworked their product mix as

All in all, 2017 promises to be yet another

well as introduced productivity improvement

year of change, with more pain before the gain.

measures which have reduced the stress on the

The cover story in the Jan 1-15, 2017 presents a

balance sheet. These measures will result in

round up of experts who analyse these trends

incremental savings over a period of time.

and make their predictions about the best

However, beyond sector-specific regulatory

strategies for the year ahead.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

10 EXPRESS PHARMA January 1-15, 2017

MARKET I N T E R V I E W

'We still have a lot of headroom to grow' Peter DeYoung, CEO, Piramal Critical Care, talks about its recent product acquisitions from Janssen, recent advancements in the inhalation anaesthesia, and his division’s growth plans, in an exclusive interaction with Sachin Jagdale Recently, Piramal Enterprises has acquired five anaesthesia and pain management injectable products from Janssen Pharmaceutical. Tell us more about this acquisition.

In line with our strategy to grow both organically and inorganically, this October, we acquired a portfolio of five injectable anaesthesia and pain management products from Janssen that include Sublimaze, Sufenta, Rapifen, Dipidolor and Hypnomidate.

These injectable anaesthesia and pain products are a terrific addition to our existing portfolio that will allow us to provide greater value to our customers by leveraging our existing organisation and distribution partners. Once the business is fully transitioned to us, our customers and business partners will benefit from our broader product basket, and in turn, we can grow the value of the acquired product portfolio through our team’s focused sales and marketing efforts.

This is in-line with our strategy to add generic hospital products and further leverage our sales and distribution capabilities.

Which are the other critical care products in Piramal's product portfolio? What percentage of the Piramal Enterprises' revenue comes from critical care division?

Piramal Critical Care is a global leader in the field of anaesthesia with a portfolio of inhaled and intravenous

anesthesia and pain solutions.

We are the world's third largest producer of inhaled anaesthetics with a global market share of 12 per cent and the only company with the complete inhalation anaesthetic product portfolio.

Our products are sold directly or through our network of distribution partners in over 110 countries across the world, with significant availability in the US, Europe, Japan, and a number of important emerging markets, including India.

The revenue of Piramal Critical Care during the last fiscal year was `876 crores.

How has inorganic growth helped the company to dominate the global inhalation anaesthesia market?

With 12 per cent market share in the inhalation anaesthetic market, we still have a lot of headroom to grow and thus it is premature to describe our market position as dominant.

However, as discussed earlier,

The Standard of Comparison

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Registered Office Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identification Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

EXPRESS PHARMA

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January 1-15, 2017

MARKET Piramal Critical Care’s strategy is to growth through a combination of organic and inorganic growth. If we look back at our performance since we entered into the critical care space, we have acquired products and capabilities and then used what we acquired as a platform to drive organic growth in subsequent years.

Our journey started in 2002 when we acquired Halothane from ICI India. We then acquired the Inhalation Anaesthetic business from Rhodia Organique in 2005, the Haemaccel plasma blood expander from Pharmaselect in 2008, and Inhalation Anaesthetic businesses from Minrad and Rxelite in 2009. In each case we were able to improve the performance of the acquired products post acquisition. While it is too early to show the results, we are on track to replicate this success with the recently closed acquisition of products from

12

EXPRESS PHARMA

January 1-15, 2017

Janssen in 2016.

anaesthesiologists and Certified Registered Nurse Anaesthetists. The products are used for both inpatient and outpatient procedures. Drivers such as more active ageing population and an increase in elective surgeries as the economy improves both bode well for this market.

What is the revenue target set for the next financial year? Any new developments on the acquisition front?

We look forward to continue expand our share through line extensions and further penetration in our focus markets across the world. We also look forward to launch our remaining inhalation anaesthetic product, Desflurane, in 2017. In addition, we are working hard to successfully integrate the recently acquired Janssen products and expect our expanded portfolio to drive the growth. Finally, we continue to look for additional generic hospital pharmaceutical products that can further strengthen our product portfolio.

What are the market drivers for inhalation anesthesia products?

Inhalation anaesthesia products are a trusted and well

established part of the armamentarium available to

What are the latest advancements in the inhalation anaesthesia segment?

The inhalation anaesthesia market is well established and although there are experiments underway with alternative gases, the four primary molecules - Sevoflurane, Isoflurane, Desflurane and Halothane dominate the market. Technological advancements with anaesthesia machines utilising lower fresh gas flow rates have led to more efficient use of the inhalation anaesthesia gases. sachin.jagdale@expressindia.com

MARKET PRE EVENT

Pv training programme to be launched soon The programme by MoHFW, NCC-PvPI will have a series of skill development programmes on basics and regulatory aspects of Pv AS PER the amended Drugs & Cosmetics (D&C) Rules 1945 Schedule Y, the Ministry of Health & Family Welfare, Government of India has made Pharmacovigilance (Pv) one of the legal obligations for marketing authorisation holders.

In order to build a talent pool of Pv professionals, the National Coordination

and union territories.

The course is targeted at existing and young pharmacy/ medical/ paramedical professionals in pharmaceutical companies as well as corporate hospitals. The programme aims at encouraging, initiating and creating a registry of skilled talent in Pv, and capacity building and

Centre for Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, MoHFW, GoI will be launching a series of skill development programmes on basics and regulatory aspects of Pv. The first edition of the programme will take place from January 16-25, for the states of Uttar Pradesh, Uttarakhand, Manipur, Chandigarh and Delhi. The last date for application for the January programme has been extended to December 30.

There will be five more such programmes during 2017 for other states

strengthening of Qualified Person for Pv (QPPv). Given the mandatory requirement for Pv under the amended Schedule Y Drugs and Cosmetics (D&C) Rules 1945, there will be an expanding need for a large number of healthcare professionals trained in Pv and it is hoped that such training programmes will help meet this demand.

It is hoped that these programmes will accomplish the Pradhan Mantri Kaushal Vikas Yojana by imparting training to the young healthcare professionals in the field of Pv. EP News Bureau

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EXPRESS PHARMA

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January 1-15, 2017

MARKET GROWTH TRACKER

IPM clocks ` 9,282 crores in Nov 2016 The anti-infectives was the largest therapy area for the month with a revenue of ` 1164 crores THE INDIAN Pharmaceutical Market (IPM) was valued at ` 9,282 crores in the month of November 2016. Base effect of November 2015 which affected on account of the festival of Diwali helped clock an eight per cent over same period last year (SPLY). Government of India’s well intentioned move to demonetise currency notes of ` 500 and ` 1000 disrupted the market to a certain extent rendering the growth in November lesser than that witnessed in October 2016. QuintilesIMS sales leads for November 2016 reflected a shrinkage by five per cent over previous month.

On a MAT basis, the industry was valued at ` 112,314 crores and reflected a 12 per cent growth with volumes contributing around 34 per cent of this growth and new introductions playing an important role with almost 41 per cent contribution to the overall growth.

IPM continued to remain fragmented with top 10 companies occupying 43 per cent share. Top 20 companies reflected 12 per cent growth for the month. Sun Pharma (14 per cent growth), Abbott (15 per cent growth), Lupin (16 per cent growth), Intas (10 per cent growth), Torrent (16 per cent growth), Glenmark (14 per cent growth) and USV (13 per cent growth) were the only companies among top 20 to reflect a double digit growth for the month.

The M&A story in IPM added a new dimension with Ahmedabad-based Eris Lifesciences acquiring Kinedex Healthcare a company specialising in pain, analgesics and orthopaedic segments.

Domestic companies continued to dominate the market with a 78 per cent share in November 2016 with a growth of 8.6 per cent. MNCs on the other hand reflected a growth of 7.8 per cent for the month on a SPLY basis. Both Indian and MNCs reflected a growth of -5

TABLE 1: PHARMA MARKET SIZE IN MILLION $ USD BY COUNTRY All values in Million USD Global pharma market US JAPAN GERMANY CHINA BRAZIL FRANCE INDIA ITALY VENEZUELA SPAIN UK CANADA AUSTRALIA RUSSIA

October Month 86981 35074 6948 6552 5184 3514 2806 2588 2367 2261 1775 1770 1660 1137 1134

Month Growth per cent -12.6 -20.5 2.4 -3.1 -24.1 -6.4 0.1 -5.1 -6.3 15 -33.1 -9.6 3.7 0.5 -8

MAT October 1043251 446862 80012 40377 68941 20117 31913 15234 27193 18352 20149 24542 19182 12657 10788

MAT growth per cent 3.3 6.3 10.6 1.5 -6.1 -0.8 -3 6.4 1.3 54.4 0 -3.1 -2 -14.7 -16.3

TABLE 2: INDIAN COMPANIES MARKET SIZE IN THE GLOBAL MARKETY All values in Million USD

October Month

Month Growth per cent

MAT October

Indian Pharma Market Globally

2587

-5.1

15234

6.4

SUN PHARMA

207

-3.9

1216

5.8

ABBOTT

166

-2.2

954

CIPLA

136

-3.5

792

6

MANKIND PHARMA

98

-6.2

581

11.7

LUPIN LAB

88

-0.9

489

6.1

● ● ●

4.9

ALKEM

86

-7.3

475

9.4

MACLEODS

85

-6.8

495

10.7

ZYDUS CADILA

85

-5.4

517

1.8

GLAXOSMITHKLINE

82

-1.6

498

1.4

INTAS

70

-3.4

475

9.4

TOP 150 COMPANY SNAPSHOT

●

MAT growth per cent

Top 10 companies constitute about 43% share of IPM on MAT and Month basis.

The top 150 companies continue to account for 97% of IPM on MAT and month basis.

For the month,Top 20 companies (contributing to 64%) have reflected growth of 12% For the month,Top 10 companies have reflected stronger performance over the next category of companies

Source: QuintilesIMS TSA & SSA, Nov'16

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per cent and -3 per cent respectively over October 2016 on account of demonetisation.

The demonetisation drive had limited impact on chronic therapy areas with the category reflecting 2 per cent growth over October 2016.

Anti-diabetics grew by 4 per cent and cardiac therapy area by 2 per cent in November over October 2016. Acute therapy areas on the other hand, grew by -8 per cent over October 2016 with anti-infectives reflecting -16 per cent, gastrointestinals (-7 per cent), vitaminsminerals-nutrients (-6 per cent), pain (-9 per cent) and respiratory (-1 per cent).

Anti-infectives was the largest therapy area for the month with a revenue of ` 1164

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January 1-15, 2017

MARKET crores reflecting a growth of -4 per cent over SPLY. Six out of the top 10 molecules reflected de-growth with large molecules like Amoxyclav solids (-2 per cent), Ceftriaxone injectable (-9 per cent), Cefixime OS (-7 per cent), Azithromycin OS (-5 per cent), Pip + Tazo (-6 per cent) and Amikacin (-5 per cent) reflecting negative trends.

Cardiac therapy area maintained its number two position in IPM missing the number one slot by a whisker with a value of ` 1120 crores growing at 13 per cent over SPLY. Rosuvastatin (22 per cent), Telmisartan + HCT (21 per cent), Amlodipine + Telmisartan (27 per cent),

Domestic companies continued to dominate the market with a 78 per cent share in November 2016 with a growth of 8.6 per cent Olmesartan (19 per cent) were some large molecules driving overall growth for the therapy area.

Gastrointestinals continued to be the third largest therapy area for the month garnering a revenue of ` 923 crores with a growth of nine per cent over SPLY. Proton Pump Inhibitors (PPIs) and their combination with Domperidone contributed around 18 per cent of the overall therapy area value, while most molecules reflected robust growth over SPLY on account of base effect, average growth of the top 10 molecules in gastrointestinals over previous month was to the tune of -3 per cent.

Anti-diabetics maintained its fourth position in IPM and emerged as the therapy area to reflect highest growth both on SPLY and previous month clocking a growth of 23 per

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January 1-15, 2017

INDIAN / MNC TRENDS

● ●

Indian companies registered growth of 8.6% during the month and continue to dominate IPM in value terms Indian companies constitutes ~78% of IPM during the month and MAT basis

Source: QuintilesIMS TSA & SSA, Nov'16

ACUTE / CHRONIC THERAPIES

cent and 4 per cent respectively. DPP4 inhibitors was the largest drug category in the anti-diabetic space with Teneligliptin contributing 19 per cent of the category by value. On a MAT basis, 50 per cent of growth in the anti-diabetics space was contributed by new introductions primarily in Teneligliptin.

Dermatology, one of the fastest growing therapy areas in IPM registered a growth of 16 per cent SPLY with a value of ` 675 crores, however, this therapy area also witnessed pressure of demonetisation with top molecules like Itraconazole and Clobetasole combinations growing at -10per cent and -6 per cent respectively over previous month.

Neurology reflected a 12 per cent growth for the month over SPLY, however, witnessed a -1 per cent growth over October 2016. Levetiracetam continued to be the largest molecule in the space clocking a value of ` 42 crore with a 21 per cent growth for the month. Sodium Valproate solids reflected a 14 per cent growth and emerged to be the second largest molecule in the central nervous system space.

Global (October 2016) Acute therapies continue to dominate the market constituting 65% of the IPM ● The top TC4 in the IPM is DPP4 Inhibitor & Comb with the a value growth of 32% ●

Source: QuintilesIMS TSA & SSA, Nov'16

THERAPY TRENDS

Anti-Infectives and Cardiac therapy continue to constitute the largest market share in IPM occupying 13% & 12% resp.

Anti Diabetics & Derma registered growth around 23% and 16% respectively for the same period last year. ● All therapies De grew compared to Prev.month except for Cardiac and Anti-Diabetic which showed positive GR. ● ●

Source: QuintilesIMS TSA & SSA, Nov'16

The global pharma market is valued at $1043 billion growing at 3.3 per cent. The US continues to dominate the market with 43 per cent market share with growth of 6.3 per cent.

Amongst the top market, India has moved two positions and is ranked seventh in the month of October 2016. Only market which has shown value growth more than 10 per cent in the month of October globally is Venezuela.

Indian companies hold 3 per cent share in the global market and growing faster than the global market as per October 2016 data. For the month of October 2016, the IPM showed degrowth and none of the Top 10 companies showed positive growth.

(QuintilesIMS is a leading global information and technology services company providing end-to-end solutions to the life sciences and healthcare industry)

EVENT BRIEF JANUARY TO SEPTEMBER-2017

6

BioAsia 2017

9

BIOASIA 2017 Date: February 6-8, 2017 Venue: Hyderabad International Convention Centre (HICC) Summary: BioAsia 2017 will be supported by Ministry of Science & Technology, Government of India and organised by Federation of Asian Biotech Associations (FABA). There will be participation from 50 countries with 100 speakers, 800 corporates and 1000 partnering meetings.

Technology Conferences of BioAsia is a science-business bridge, that aims to bring together a trans-disciplinary environment for driving innovation in the life sciences industry. The tech conferences have been structured in order to leverage technology trends for business relationships and help to put technology in the development relay across the world through codevelopment opportunities.

BioAsia’s tech conferences will cover contemporary developments in research and will assist in building capabilities to break the technology development resistors for smooth flow of technology and collaborations.

Contact details BioAsia Secretariat 301, Gayathri Nest, Telecom Nagar, Gachibowli, Hyderabad - 500032, Telangana Phone: +91 (40) 23000205/206 Fax: +91 (40) 2300 0207 Email: info@bioasia.in

INDIA PHARMA 2017 Date: February 9-11, 2017 Venue: Bangalore International Exhibition Centre, Bengaluru

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India Pharma 2017

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PharmaTech Expo 2017

25

Respiratory Drug Delivery (RDD) Europe 2017

3

PharmaTech Expo 2017

EVENT BRIEF Summary: India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the conference delegates and business visitors provided by the event. India Pharma 2017 will cover all the sectors of the pharma industry starting from finished formulations, APIs, bio-pharmaceuticals, fine chemicals and intermediates, natural extracts, excipients and many more.

Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will also be showcased.

Contact details Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ ficci.com Federation of Indian Chambers of Commerce & Industry (FICCI) Federation House, Tansen Marg, New Delhi 110001

PHARMATECH EXPO 2017 Date: April 11-13, 2017

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of high tech pharma machinery, lab and packaging equipment were on display.

Contact details PharmaTechnologyIndex. com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

INDIA LAB EXPO 2017/ANALYTICA ANACON INDIA Venue: Parade Ground, Sector – 17, Chandigarh Summary: The 5th Edition of PharmaTech Expo 2017, an international exhibition on pharma machinery, lab and packaging equipment, will see a common platform for suppliers, manufacturers, industrialists, buyers and consultants. This year the focus will be on nutraceutical, food and cosmeceuticals and ayurveda. The event will be concurrently held with LabTec expo 2017.

More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display. With more than 5000 trade visitors took part in last year's event.

Contact details PharmaTechnologyIndex.com A Division of KNS Group 701 - 702, Corporate House,

Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

workshops sessions.

Academics, industrial and regulatory scientists involved in the research, development, investigation will take part in the event.

RESPIRATORY DRUG DELIVERY (RDD) EUROPE 2017

Contact details Joanne Peart: info@rddonline.com

Date: April 25-28, 2017 Venue: Palais des Congrès d’Antibes, Nice, France Summary: RDD Online and Aptar Pharma will organise RDD Europe 2017, an event in the Respiratory Drug Delivery field in Europe. It will bring together pulmonary and nasal drug delivery experts from all around the world to exchange scientific knowledge and expertise, and also provide a dynamic forum for expanded opportunities for business networking. RDD Europe 2017 will feature podium sessions and debates, scientific poster sessions, technology exhibition and

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. This year, the focus will be on pharma machinery and equipment manufacturing sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event and varied kinds

Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India.

Contact details MMI India INIZIO 507 & 508, 5th Floor, Cardinal Gracias Road Opp P&G building, Chakala, Andheri (E), Mumbai 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 info@mmi-india.in

MARKET NEWS

Indian pharma industry facing growth headwinds: ICRA

Increasing penetration, accessibility and continued new launches will help Indian pharma industry to grow in the long term INDIAN pharmaceutical industry will grow at a slower pace due to sluggish growth in the US market, increased competition leading to price erosion in high single digits and generic adoption reaching saturation levels, according to rating agency ICRA. Growth from the US has come down to less than nine per cent in first half of 2016-17 despite consolidation and currency benefits and going for-

ward, the growth momentum is likely to face further pressure, it said.

Besides, increased regulatory scrutiny and consolidation of supply chain in the US market resulting in pricing pressure along with increased R&D expenses will have an impact on profitability of Indian pharmaceutical companies, it added.

“In spite of these ongoing challenges, several Indian

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pharma companies are increasing their R&D spend, targeting pipeline of speciality drugs, niche molecules and complex therapies,” ICRA said.

The domestic pharma industry has gained adequate scale and drug development capability over the last decade of growth, which will keep it in good stead to capture new opportunities in the US market, it said.

On overseas markets, the

rating agency said the operating environment in emerging markets (EMs) like Latin America, CIS countries and South Africa has been affected by confluence of factors, including devaluation of currency, a frequently evolving regulatory landscape and a weakening macro environment.

“Select pharma companies have taken sizeable write-offs in Venezuela due to currency

devaluation and have stopped despatches there on the back of repatriation issues,” it said.

On the domestic front, ICRA said continued regulatory interventions are expected to put some pressure in the near term though longterm growth prospects remain healthy, given increasing penetration, accessibility and continued new launches.

PTI

EXPRESS PHARMA

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cover )

INSIGHT

22 Increasing access to medicines via collaboration and digitisation

20 EXPRESS PHARMA January 1-15, 2017

24 Where the Mind is Without Fear‌

26 Pharma 2017: A year of opportunities and challenges

29 Business trends in 2017

(

W

hat will be the most dominant business trends in the pharmaceutical sector in the year ahead?

As the US, the world’s biggest pharma market gears up for a new President, companies in India are scrambling to figure if President Trump will be good or bad news. India’s Prime Minister’s bold move demonetisation initiative is but yet another variable that the sector has to cope with.

But in spite of these challenges, the pharma sector in India has strong longterm potential. Provided of course, pharma CEOs can change strategies in tune with the evolving global trends. For instance, how do pharma companies cope with increasing price controls? Is partnering with government affiliated agencies the answer to meet both access issues as well as increase reach? Does a company buy assets or go the organic route? Buy overseas companies for their manufacturing units to increase global footprint or for their brands to increase market presence? Will 2017 be a year of consolidation around core strengths? Or

30 Dominant business trends in 2017

32 Pharma cos need to realign biz models

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THE MAIN FOCUS

will the pendulum swing to the other end of diversification to spread risks?

Digitisation too will play a transformative role in these endeavours, with companies striving to convert big data into usable intelligence, especially in R&D, which is pegged to be the biggest differentiator between the leaders and the also-rans.

The future for will see the war for talent in R&D ramp up even higher, as the industry prepares for life after the patent cliff. Drug development will have to keep the patient at the centre, looking to anticipate clinical needs as the global population ages. The sector will have to look for ways to make not just increase life spans but also address quality of life issues.

The challenge of meeting increasing regulatory scrutiny coupled with higher patient expectations will squeeze profit margins but will also give rise to more opportunities for the forward looking corporates, who can anticipate the mood and moves of both policy makers and consumers. Express Pharma presents experts who analyse these trends and make their predictions.

34 Fixed dose combination drugs – to be banned or not to be banned

36 Trends in global and Indian pharma industry

37 Pharma cos brace up for a paradigm shift

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cover ) I N T E R V I E W

Increasing access to medicines via collaboration and digitisation A Vaidheesh, VP, South Asia and MD, India, GlaxoSmithKline Pharmaceuticals, in an exclusive interaction with Prathiba Raju mentions that in 2017 and beyond, the pharmaceutical sector will witness partnerships with governments to increase access to a broad range of innovative medicines, vaccines and foresees a transformational role of digital in the next few years

What will be the most dominant business trends in 2017 in the Indian pharmaceutical industry?

I foresee a trend of collaboration between government and pharma companies to further increase access to medicines and vaccines in the coming years.

The evolution of digital technologies will further aid this development. In fact, GSK India is already making big investments on the digital front, to deliver growth while remaining committed to serve patients with futuristic quality standards. Apart from partnerships, digitisation will see a major leap in the sector.

Digital disruption is transforming every industry globally. At GSK, we believe that the time has come for the pharma industry to leverage technology to improve realtime flow of information and ride the digital revolution to fast forward the future. With increased Internet penetration in India and more digital-savvy healthcare professionals (HCP’s) GSK is leading this transformation with a vision of an integrated solution that will increase the quality of in-clinic interactions. In fact, in a single quarter in 2016, GSK reached over 400,000 HCPs through the digital route. GSK is also investing in communications with the doctors and leveraging

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the power of emerging new technologies. We have digitised our entire field force of over 3000 sales reps with iPads for instant detailing and real-time reporting. We have invested in Veeva a CRM tool for our sales force with an integration of all the digital channels such as websites, emails, webinars, tele-detailing so that they can communicate easily with doctors and offer real-time information. This ensures a seamless and transformational customer experience and makes GSK future ready.

Titans of the pharma

industry are adjusting their sails to adapt to an increasingly VUCA world where volatility, uncertainty, complexity and ambiguity are the only constants. So, what defines the leadership in a VUCA pharma scenario?

It is not just the pharma industry but the entire world that is in VUCA right now. First and foremost, we need to recognise the fact that we are in a volatile ever-changing environment and one of the key factors that are likely to face more scrutiny in the pharma industry is the increasing role of regulators and policy

makers. For example, in a critical ecosystem of healthcare, industry is made up of 6Ps – Patients, Payers, Providers, Policy makers, Physicians and Play makers. In every country, VUCA is created by any one of them in some form or the other. For example, in India, this whole focus towards accessible and affordable medicine has created volatility. Now talking of volatility, I believe that the government is very much justified in stepping up and trying to find a way to reach healthcare to over 1.2 billion people in this country.

The pharma industry should also play a huge role as one unified voice and discuss with policy makers ways and means to drive the agenda of accessible and affordable medicine. Though the government and private players strategies might differ, a coalition is necessary. Even industry associations such as OPPI (Organisation of Pharmaceutical Producers of India) are working towards the same goal. Moreover, we as sensible business leaders, must recognise our own responsibility of ensuring the affordability and accessibility of medicines. For example, at GSK India, we have made our vaccines and medicines more accessible by voluntarily reducing the prices of our key

products such as pneumococcal conjugate vaccine (PCV) Synflorix vaccines and Seretide, our leading respiratory offering.

We do believe that a large number of people need to get these vaccines and medicines from the private market. If you want to play for the long term then you need to start looking at price volume equations.

There are some categories where you may not have volume headroom and that is where you need to seek government intervention. So, we need to develop an innovative method of engaging with the government on ways and means to subsidise our price decrease otherwise business becomes non-viable.

VUCA is all about how we engage with the entire ecosystem proactively.

How have pharma leaders and corporations in the established markets like the US, EU etc. changed their strategies?

From a GSK perspective, we have always been focussed on access to medicines to patients at large. We differentiate IP and pricing. IP has to get protected and pricing is a function of affordability of that particular country.

As far as the US is concerned, we know a new president has been elected. He,

( however, has not yet articulated what the healthcare reforms will look like.

Any new vaccines on the pipeline by GSK? We do have a wide range of vaccines. Last month, we launched Priorix Tetra vaccine, a paediatric vaccine for immunisation of children between one to twelve years of age against measles, mumps, rubella and varicella.

Over the next few years, we plan to launch three respiratory products and two vaccines from our global pipeline. We are in the process of looking at launching few India appropriate solutions.

How do you maintain the highest quality and goodwill of GSK products?

GSK remains committed to the highest quality standards in the pharma industry. We are committed to safeguard the patients who use our products, so it is of paramount importance that we have an effective quality management system (QMS). The quality team ensures that we comply with global and local regulations, assure product safety, quality and efficacy, maintain a state of control over our products and processes and support continuous improvement. We have a large team that continuously conducts quality audit for the value chain, not only in manufacturing, but also across our warehouse and distribution. Quality assurance is our backbone.

How will GST Bill impact the pharma sector?

As long as GST is about less than double digit, the pharma industry should be on a neutral basis, but anything above may affect the industry in terms of sustainability depending on the therapy areas. We are sure that concerned policy makers will do what is appropriate. GST will definitely bring efficiencies as it will improve the ease of doing business, removing the

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tax components and making warehouse optimisation possible. We should welcome GST with open arms if it means short-term inconveniences.

How important is India for

GSK? GSK has a rich 90-year legacy of operating in India with over 30 per cent of the global volume of worldwide pharma products manufactured and sold in India.

So, we are committed to India

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as a company and that is one of the reasons our parent company has agreed to invest in a new greenfield manufacturing project in India.

We are investing ` 1,000 crore to set up a new manufacturing

facility in Vemgal, Karnataka, which will be completed in 2018.

We are also upgrading our existing manufacturing facility in Nashik with an investment of ` 500 crore. prathiba.raju@expressindia.com

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cover ) INSIGHT

Where the mind is without fear…

TK Kanchana, Director-General, Organisation of Pharmaceutical Producers of India (OPPI) talks about the trends which are most likely to drive the industry’s fortunes and company strategies over 2017

A

review of the pharmaceutical industry landscape as we approach the end of 2016 highlights a few key developments. It also sets the stage for the issues that may well dominate the industry’s attention in 2017, impacting business trends, product strategies and regulatory actions. This could well be true for any year, but 2016 is special.

About 25 major drugs will be going off patent this year. According to estimates by Evaluate Pharma – a UK-based market intelligence and research firm that covers the pharma industry – about $120 billion in sales was lost to patent expirations between 2009 and 2014. The firm forecasts that $215 billion in sales will be at risk from patent expirations from 2015 to 2020.

A number of factors are coming together to impact the fortunes of research-based drug manufacturers and not all of them are benign. A quick review of some other numbers will underscore the big challenges that the industry faces. For example, 95 per cent of new medicines fail during development, and just two out of 10 recoup research and development (R&D) costs.

At the same time, new diseases and conditions call for greater innovation and drug discovery. Take biotechnology, that has given pharma firms exciting new pathways for new drug discovery; it sets the stage for targeted and specialised therapies that target rare diseases, but cost too much.

So what trend are most likely to drive the industry’s fortunes and company strategies over 2017 and perhaps until 2020?

Four principal ones come to mind: healthcare access and af-

24 EXPRESS PHARMA January 1-15, 2017

fordability, empowered patients, specialty drugs and personalised medicine, bio-similar and generics growth, and going digital.

In India, pricing issues are an important part of the discourse, particularly between researchbased companies and the policy makers. The overall ecosystem in India needs affordable medicines. However, as a 2013 IMS Health report showed, affordability ranks lower than physical proximity, functionality and access to appropriate care for even the poorest patients.

Access to healthcare and medicines has to emphasise patients’ needs. Public policy on healthcare is focussed on communicable rather than non-communicable diseases. This is despite studies that have shown that 53 per cent of the disease

In India, pricing issues are an important part of the discourse, particularly between researchbased companies and the policy makers

burden in rural India, where the bulk of the poor people live, can be attributed to diabetes, cardiovascular disease, pulmonary disease and cancer.

To improve the effectiveness of policy and implantation, the conversation about access to healthcare has to shift from affordability to the larger challenges of creating the necessary health infrastructure, having the appropriate level and availability of care and adequate public spending on healthcare.

Patients today are more empowered, as information is easily accessible. They learn about their health conditions online.

They have greater awareness of the various treatment alternatives and choose the one they prefer most. Doctors have less power to influence this choice. In other words, and often supported by regulatory changes, patients are becoming increasingly organised and influential.

Risk-benefit assessments involve greater patient involvement and input. Globally, drug companies are becoming more patient-centric, leveraging demographic changes. Advancements in genome technology, data science methodology and investments in public and private sector programmes are taking us closer to the ideal of personalised medicine.

Statistics reveal approximately 94 per cent of drug companies actively research specialised therapies. One reason is that individual responses to current therapies are not completely satisfactory. Research by Arthur D Little, a consulting firm, suggests that patient subgroups optimise treatment response and help better manage side effects and foster innova-

tion.

Innovation, however, is becoming more complex. Again, Arthur D Little’s research shows that despite a substantial increase in R&D spending – estimated at an annual compound growth rated of 8-9 per cent – the number of new, original drug approvals has stabilised. Biotech ventures also generate a large number of late-stage molecules.

What about the innovation in India? As a report by PhRMA supported by knowledge partner, PricewaterhouseCoopers (PwC) pointed out, India’s intentions are clear: We have started to recognise that developing an enabling ecosystem that supports investment, technology transfer and growth in innovative areas such as biosciences is possible. It is also in line with other government initiatives such as Make in India, Start-up India, National Education Policy, the National Health Policy and Digital India.

Creating an innovative ecosystem to foster growth and development in the pharma research sector requires four key pillars: infrastructure, financing, human resources, and a legal, IPR (Intellectual property rights) and regulatory framework.

An innovation-oriented industry will lead to generation and commercialisation of homegrown IP and help position India globally as a strong knowledgedriven economy with advanced capacities in science and medicine. However, as the PwC report points out, time-bound implementation of policy interventions is a prerequisite to realise India’s innovation potential and vision.

Going digital is a key compo-

( nent of innovation; big data, digital technology and the Internet are transforming lives on an almost daily basis, and drug companies are no exceptions. In 2014, four top pharmacompanies made it to Forbes magazine’s list of the Top 20 World’s Most Innovative Companies.

Then, there is mHealth; mobile and wearable devices that can track movement, take measurements and record information that is highly useful in postmarket studies. An mHealth app engages very large numbers of individuals in different locations.

By increasing the amount of data, the patient pool becomes more representative, and resulting in more accurate results.

In 1966, Isaac Asimov, physicist and science fiction novelist, novelised a film script called, Fantastic Voyage. In the film, a group of doctors are miniaturized along with a submarine, and injected into an injured scientist’s bloodstream. They navigate their way to his brain, and repair the damage to it.

Science fiction is reality today, with nanotechnology.

Nanoparticles can easily travel around the human body in the blood stream and assist in the delivery of anti-cancer drugs.

Researchers are also examining the potential use of nanobots, or microscopic robots, that can be preprogrammed to perform tasks inside the human body.

The next frontier in technology is what many call machine learning, or artificial intelligence.

Already, there are computers that can absorb and interpret millions of pages of scientific literature and data, like IBM Watson. Global pharma companies are teaching Watson to read and understand scientific papers that detail clinical trial outcomes used to develop and evaluate medications and other treatments. They are also exploring how it can speed up the discovery of alternative indications for their existing drugs.

Can India be part of such a vision? Yes, and to do that we have to strengthen our pharmaceutical innovation ecosystem across multiple dimensions. Such an environment needs close collab-

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oration between the government, academia and the pharma industry.

Learning from economies that have strong innovation systems and others that have moved up the value chain in recent times will help,

along with a policy framework aimed at the holistic development of the ecosystem for innovation.

Realising India’s potential as an incubator of pharma innovation will create more job oppor-

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tunities, increase local and foreign investment, and help the government collect higher tax and export revenues. This is separate from vastly improved health outcomes through access to newer medicines. An innova-

tion-oriented industry will lead to creating home grown IP, positioning India globally as a knowledge-driven economy with proven capacity in science and medicine. That is a worthwhile dream to pursue.

cover ) INSIGHT

Ayear of opportunities and challenges Vikas Bhadoria, Senior Partner, Mc Kinsey and Vivek Arora, Associate Partner, Mc Kinsey, talk about how the global industry is at the cusp of change in multiple ways and what factors will enable Indian pharma industry to unlock maximum value in the coming year

T

rends in the healthcare industry have always generated a lot of interest around the world, with only a few economic dialogues that are able to circumvent this topic. As different players across the healthcare eco-system develop their strategy and business plans for 2017, some key trends developments are expected to offer disproportionate opportunities for value creation. However, these will not come without a fair share of challenges.

One of the fundamental trends in today’s global pharmaceutical industry is the growing pricing pressure on drugs. The US, the world’s largest pharmaceutical market, is witnessing increased competition and control over medicare costs. Globally as well, government policies, along with consolidating stakeholders such as payors, Pharmacy Benefit Managers (PBMs), providers, wholesaler buyers, and pharmacy chains are seen flexing their muscles to challenge drug pricing and new drug access.

However, fundamental demand drivers are strong, and growth is shifting towards emerging markets. The global branded and generic pharmaceutical market is expected to be around $950 billion 1 by FYE2017, and is expected to grow further at about 5 percent to reach $1.2 trillion by 2022. While 70 per cent of the profit pool will still remain with the developed markets till 2018, the major share of future growth (up to 60 or 70 percent) is expected from developing markets. Driving the demand for pharma is the

26 EXPRESS PHARMA January 1-15, 2017

Vikas Bhadoria Senior Partner, Mc Kinsey

Vivek Arora, Associate Partner, Mc Kinsey

ever-increasing aging population (180 million people aged 70+, 550 million people aged 50+).

At the same time, customer centricity has never been more important. Customers are now more engaged and proactive in their healthcare choices. For instance, 90 million2 people discuss health online, 85 percent 3 of the US online population seeks health info on the web and there are over 16,000 health and wellness applications available for smartphones4. Patients are increasingly expecting personal health-related information and services from pharma companies. Industry players may have to factor this trend into their product and service offerings going forward.

The fundamental value driver for the industry will continue to be research and development. Increasing competition and shrinking LOE

(loss of exclusivity) opportunities are making differentiated products and ‘getting

early to the market’ critical for success. This will lead to blurring boundaries between innovator and generic pharma. Generics players worldwide are increasingly developing generic molecules with patented delivery mechanisms, complex generics, biologics/biosimilars, incremental innovation products and New Molecular Entities (NMEs). First-to-file generics products providing a 180-day exclusivity period to generics manufacturers also remain a rich source and reiterate the benefit of getting early to the high-value US market.

Increasing exposure to these high-value pools will not be without risk of intense regulatory scrutiny. Regulators such as US FDA, UK MHRA and others are continuously raising the bar on Quality sys-

tems and processes required to supply to these high value markets. This has resulted in an almost 200 per cent increase5 in the number of product recalls, import alerts, warning letters and non-compliance observations over the last five years. Regulators worldwide continue to collaborate with increased information sharing, and follow a riskbased inspection model wherein companies with high export volumes or compliance deviations continue to experience more regulatory scrutiny.

To respond to increasing consolidation and the changing landscape of opportunities, pharma players have also spent more effort on expanding their own scale through a wave of M&A and re-structuring or divestiture transactions

PATIENTS ARE MORE ENGAGED & PROACTIVE IN THEIR HEALTHCARE CHOICES

SOURCE: The Associated Press; http://www.symplur.com/healthcare-online-presence; https:// www.elsevier.com/__data/assets/pdf_file/0007/139903/Elsevier_WP_MobileApps5_21_15WEB.pdf

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DIGITAL CHANNELS WOULD BE A STRATEGIC PRIORITY FOR PHARMA PLAYERS

SOURCE: McKinsey with varied objectives such as scale/cost focus, corporate transformation, and access to new markets.

The ‘Pharmageddon’ surge in deals between April-2014 and March-2015 has resulted in around 500 deals with a total value of over $4006. Additionally, around 500 deals took place between April-2015 and March-2016.

The growth in digitisation and advanced analytics is also likely to have a transformational impact on the industry. This is driven by reduced costs of data acquisition, storage and advanced computation, and enhanced visualisation capabilities that generate better, faster, and more robust insights. If applied appropriately to decision making, this could drive competitive differentiation through faster approvals, better patient satisfaction, improved productivity and quality levels. This trend too will be accompanied by greater risks of data reliability, cybersecurity and the need for enhanced traceability. Technology advancement also gives rise to a new string of competitors with giants such as Google, Qualcomm, Samsung, Apple and IBM investing in Digital Health. Industry leaders may have to take a big leap forward to embrace change.

Given that the global industry is at a cusp of change in multiple ways, the big question is what will enable Indian pharma to unlock maximum value in the coming year.

Five crucial factors that could unlock the maximum value: (1) Improving efficiency of R&D to reduce development time and develop differentiated assets; (2) Developing

deeper customer insights to build brands/therapies, and adapt commercial models; (3) Improving operational efficiency and reducing the cost of poor quality; (4) Developing a digital and advanced analytic roadmap for the future; and (5) Building capabilities to embrace this change.

Indian pharma companies will need to increasingly invest in R&D to equip themselves with the right nextgeneration assets. India’s share of approvals in the 505b(2) and New Molecular Entity (NME) space can substantially go up from current levels7 (approx. 4 per cent for 505b (2) and 0 per cent for NMEs). While this will require the government to play a supporting role in funding a part of these investments, pharma companies will have to build new scientific capabilities to develop these products (e.g., drug-device combinations, biosimilars) and to introduce new manufacturing technologies. At the same time, organisations will need to improve R&D productivity, and hence time to market, through optimised development, regulatory and launch management capabilities. We will also see Indian companies acquiring more differentiated assets in India and globally. It will be imperative to identify assets which align with the broader business strategy and ensure substantial value creation.

Capturing deeper customer insights through various channels will help companies identify white spaces to shape their brands and therapies.

Disruptive commercial models will also become increasingly popular.

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cover ) Digitally enabled healthcare delivery, digital apps and platforms will emerge as important commercial models.

Telemedicine, healthcare apps, omni-channel communication will also become more prevalent in engaging today’s customers and physicians. In 2017, pharma companies could develop their commercial transformation roadmap and run smaller-scale pilots at select business units to build conviction and gather learnings.

Many Indian pharma companies will embark on the next wave of operational efficiencies through lean and cost excellence to counter pricing pressures. These will be driven through increased focus on improving productivity, equipment efficiencies and raw material and conversion costs. However, it is imperative to continue to resolve the quality and compliance issues which have had a significant impact on the profitability and reputation of the industry.

Companies will continue to invest in improving their fundamental Quality Management Systems. Six-Sigma in quality will emerge as the next frontier as pharmaceutical companies look to improve

APPLICATION OF ADVANCED ANALYTICS CAN DRIVE SUBSTANTIAL IMPROVEMENT IN OPERATIONS

Finally, pharma companies will have to equip themselves with the right set of capabilities to embrace these new trends and manage change.

They will need to attract and develop the right talent. Given that the Indian pharma industry has traditionally not been at the cutting edge of many advancements, the search for talent may have to extend to sectors such as advanced industries and to other geographies.

In the coming year, we expect to see India pharma companies take important steps towards adopting some of these best practices. How well the players respond to the head winds and shape up for the future will define their success going forward.

SOURCE: McKinsey

References

their product robustness and process capabilities, and reduce the cost of poor quality. This will require an integrated approach to operations excellence and change management at scale.

The availability of digital tools, real-time data and advanced analytics capabilities will create opportunities

across the value chain—in R&D (clinical trial productivity, predictive modelling, disease pattern analysis, etc.), manufacturing and quality (manufacturing processes, real-time quality monitoring, condition-based maintenance, etc.), and marketing and sales (customer insights, physician education, sales force productivity, etc.).

Indian pharma companies have a lagging starting position vis-à-vis their global peers on this front. In 2017, Indian companies could look to develop their digital foundations, drive select improvement initiatives and develop a multi-year roadmap to transform themselves into data and analytics-led enterprises.

1. Business Monitor International Database, 2015 2. The Associated Press 3. http://www.symplur.com/ healthcare-online-presence 4.https://www.elsevier.com/__ data/assets/pdf_file/0007/139 903/Elsevier_WP_MobileApps5_21_15WEB.pdf 5. US FDA Website 6. Pharma Deals Database 7. Evaluate database, US FDA Website

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INSIGHT

Business trends in 2017

Utkarsh Palnitkar, Partner, National Head – Infrastructure, Government & Healthcare and National Head – Life Sciences practice, KPMG India, elaborates on the emerging trends, which are further impacting pharma companies, leading to an intense need for an efficient and competitive business model

T

he last decade or so has seen exciting breakthroughs in the sector leading to discovery of novel therapeutics for unmet patient needs. However, as the focus is shifting from a ‘provider-dominated and product-focussed’ system to a ‘patient-centric and customer-focussed’ model, the pharmaceutical industry is also facing several challenges. The conventional strategy of pursuing blockbuster drugs is declining as patents for major drugs are expiring and the output of product pipelines is diminishing.

The emerging trends such as regulatory pressure, new technologies and patient centricity are further impacting pharma companies, leading to an intense need for an efficient and competitive business model. A few of the key trends impacting the global pharma industry are as follows:

Smarter and more focussed marketing strategies

◗ Digital advertising to increase patient engagement Although the pharma industry lags behind other industries in digital marketing, spend on digital advertising directed towards patients and healthcare professionals is expected to see an upward trend. Pharma marketers are forecast to spend $2.5 billion in 2019 on paid online and mobile advertising compared with $1.6 billion in 2015.1 The approach could be used to send personalised and relevant messages to patients. ◗ Value-based pricing to promote higher efficacy-driven treatments Considering that the new patient pool is well-informed about

the treatments and medicines they undergo and are prescribed, respectively, a majority of payers are looking forward to ink different healthcare plans with the outcome/value-based pricing model, especially for the high-priced and speciality drugs — oncology drugs, hepatitis C treatment, etc. Enhancing the patient experience via better efficacy of drugs drives valuebased pricing instead of volumebased pricing.

Increase in the adoption of technology-based care

◗ Implementing Big Data analytics for making precise decisions As the industry is realising the importance of applying Big Data to take informed decisions, pharma companies too are increasingly embracing the need to analyse Big Data. The analysis of real-time data collated from telehealth, mHealth, eHealth and digital health devices would enable making precise decisions for patients. ◗ Technocare for targeted therapy Augmented Reality (AR) and Virtual Reality (VR) via devices like digital contact lenses from a technology company (to measure blood glucose levels from tears), cognitive computers like IBM Watson (to help physicians make medical decision), 3D printed drugs, and all such disruptive technologies could help researchers contribute significantly to targeted breakthroughs within the healthcare industry. The latest emerging technology of brain-computer interface (BCI) technology would significantly contribute to breakthroughs within the pharma industry. Smart applica-

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tions such as spinal cord stimulators (for pain relief) and retinal implants (to restore sight) and are also under development.2 ◗ Increasing pharma–tech collaborations As the industry is progressing towards becoming digitised, more collaborations are expected in the near future between pharma manufacturers and tech companies. For example, a pharma company entered into an alliance with a tech company to enable in-house remote monitoring of clinical trial patients through smartphones. In fact non-traditional companies have expertise in collecting information from multiple platforms and can collaborate with researchers and pharma companies to develop and commercialise more effective treatments.

Patient-centricity in drug development

◗ Focus on patient centricity in the drug development process Patient centricity is an increasingly important element of the pharma business model, but it has been ignored by the industry as a whole. A French multinational pharma company took steps to this end in 2015, by adopting a three-pillar strategy for patient centricity and creating a new role of chief patient officer. In January 2016, the European Patients' Academy launched an Internet library to educate patient representatives on the drug development process, fostering greater understanding and increasing patient involvement in R&D process. Patients performing an active role in trial design can help reduce cost, increase re-

cruitment and thus accelerate road development to market drugs.

Shift towards biosimilars

◗ Increase in the adoption of biosimilars Several countries are adopting biosimilars to provide affordable care and increased access.

The regulatory pathways are evolving towards establishing more rigorous standards for safety and efficacy of biosimilars.

Patent expiries on major biologic products are also expected to push the growth of biosimilars globally.

Trends impacting the Indian pharma industry The last few decades have seen genericisation becoming the global arsenal to combat surging healthcare costs. The generic version of life sciences products emerged as a profitable business option for the Indian pharma industry. By taking advantage of low labour cost and high technology skills, domestic companies have already demonstrated their prowess in the global generic business. However, owing to the increasing complexities of the business environment, the need to evolve continuously has intensified.

The following business trends are expected to impact the Indian pharma industry in 2017:

Greater adoption of digital technology

◗ Increase in the adoption of digital technologies Indian pharma players are increasingly using digital technologies to market products to doctors, strengthen patient engagement and compliance, etc.

Marketing spend through digital platforms is estimated to soar by approximately 50 per cent in the next two years to reach `220 crore. An Indian pharma company has launched a mobile app in May 2016 to make patients aware about asthma and enhance adherence to its treatment. Similarly, a pharma MNC has introduced several tools like a single platform where physicians can access medical information, a heart and liver app and another one for vertigo exercises.

Regulatory changes

◗ GST implementation The Indian pharma and biotechnology industry, like others, is eyeing GST as a favourable tax regime that might eliminate the cascading effect of taxes and other anomalies of the current indirect tax structure.

The government is planning to implement GST from April 1, 2017. GST is expected to reduce the burden of taxes considerably by removing the anomalies of the current indirect tax structure, reduce compliance hassles, etc.3 Further, with the advent of GST, the supply chain of the pharma industry would be impacted by the availability of input tax credit of interstate trade GST (IGST) on inter-state transactions, eliminating the need for Carrying and Forwarding Agents (CFAs) in each state. The implementation of GST in 2017 is expected to propel the ease of doing business in India for pharma companies. ◗ Implementation of the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) The Department of Pharma-

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cover ) ceuticals (DoP) had launched voluntary UCPMP guidelines in 2015 for better adherence to ethical practices by the industry while promoting sales. The government is now planning to implement a mandatory code that is expected to replace the current voluntary UCPMP for increased adherence and governance. ◗ Regulation of online pharmacies The government is working on a policy governing the sale of medicines online by startups/online pharmacies that have disrupted the traditional business model. The e-pharmacy policy aims at establishing rules and regulations for the sale of medicines online and facilitating

access to quality medicines in a cost-effective manner.

A government panel has recommended the creation of a national portal as a nodal platform to monitor sales of medicines via the Internet. Further, as the industry policies evolve, along with increase in the adoption of technology, the market share of online pharmacies in India’s drug distribution market is likely to increase. ◗ Fixed Dose Combination (FDC) ban In March 2016, the Health Ministry banned 344 FDC drugs on grounds that it posed a risk to humans when alternative drugs were available.4 This has impacted the growth rate of Indian pharma industry and ease of do-

ing business environment in the country. In 2017, the pharma companies are expected to come up with new strategies and combination drugs to recover from this set back. ◗ Price control regime Under the current regime, the Drug Price Control Order (DPCO) continues to affect the growth of pharma companies at large. However, the government is planning to overhaul the drug pricing policy to delink it from the national list of essential medicines and enable investment opportunities in the industry.

Way forward The pharma industry in India has come a long way in the last few decades and has grown from

strength to strength in terms of R&D capabilities, infrastructure development and technical skills. The industry is facing several challenges regarding the price control regime, a complex regulatory regime and poor infrastructure, which continue to remain contentious in the market. On the brighter side, trends such as increased R&D investments, technology adoption and global expansion are positive signs for the future growth of pharma companies.

The industry has rightfully gained the epithet as ‘pharmacy to the world’ and with numerous strengths in areas aligned with current market trends, it is expected to remain an attractive investment destination.

References 1. “Pharma digital spending ticks upward slowly but surely”, FiercePharma, April 2016 2. “Brain computer interfacing: Applications and challenges”, ScienceDirect, July 2015, Volume 16, Issue 2, accessed 18 November 2016 3. “India-U.S. trade – a formidable economic force”, KPMG in India, June 2016 4. “Ban on sale of 344 drugs: Delhi HC to resume hearing pleas against Centre’s order”, Indian Express, MARCH 2016 (The views and opinions in this article are those of the author and do not represent the views and opinions of KPMG in India.

Dominant business trends in 2017 Ameesh Masurekar, Director, AIOCD Pharmasofttech AWACS, talks about the prevalence of online retail, therapeutic and regulatory measures to drive growth and stability in pharma sector

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he Indian pharmaceutical market can be broadly classified into three aspects namely retail, therapy and regulatory.

Retail Post GST there is an expected reduction in the number of distributors, due to fierce competition while expanding the reach of some large, dominating distributors. This is good news for consumers as it will result in better retail availability, less possibility of counterfeits entering the chain and possibility of higher discounts being passed on to them.

Distribution consolidation and large distributors going beyond their traditional sales geography is going to be a big challenge for the sales force of pharma companies. The field or sales team is given sales credit linked to distributor purchase (or sales) assuming that the distributor sells in finite geography in which the respective sales person or team is working. With distributors cross-selling across traditional geographies, the per-

30 EXPRESS PHARMA January 1-15, 2017

formance markers will become blurred and companies will have to innovate on how to recognise and reward field forces, so as to ensure justice for individuals as well as growth for the organisation.

Online retail is likely to get legal backing, however, it may not lead to success. In terms of reach, product availability and discounts there is already an intense competition among traditional retailers. So online retail in pharma is not adding much convenience unlike Uber or Ola. Till date, online retail has struggled financially and many have shut shop because of excessive discounts and burning investor's money in hope to develop a loyal customer. It seems to be the only strategy. Unless there is a commercially viable model, this trend is likely to continue.

Therapy Both acute and chronic therapies are likely to see a growth in the pharma market. Along with diabetes and cardiac, there have been rising incidences in anti-infectives, dermatology, respira-

ney, increase glucose excretion, and thereby lower blood glucose levels.

Regulatory

tory and gastroenteritis as well.

With air pollution rising exponentially, there has been a spurt in the consumption of asthma and allergy medicines.

There are newer drugs being launched across several therapies – Oncology (Cancer) treatment has seen the highest number of new drugs. In diabetes the new class of drugs called SGLT 2 Inhibitors (drugs like Canagliflozin, Dapagliflozin etc) are becoming an important additional tool for physicians and are likely to grow by leaps.

SGLT2 inhibitors block the reabsorption of glucose in the kid-

Regulatory aspects have witnessed an increased impact on the pharma industry in last three years. There have been several regulatory interventions such as price control under DPCO, banning of several fixed dose combinations, additional regulations in clinical trial management and regulatory framework for online retail. Among these measures, the most beneficial for consumers has been the DPCO or price reduction which has passed on a cumulative benefit of around ` 5,000 crores over the past three years. However, there is a thin line between regulating a drug versus making it less attractive for manufacturers. The market-based average pricing has been a good win-win proposition as it has not reduced prices to an extent where manufacturers suffer loss and discontinue the production of a drug, something that we saw over period of time with the 1995 DPCO.

India was expected to be the clinical trial capital of the world, yet we are far away and things are at a standstill for the want of clarity in policy. We have world class labs, huge patient population and talented pool of doctors, data scientists and healthcare workers to meet our potential and become the clinical trial capital. This will also encourage innovation and new drug discovery and hopefully 2017 will see a turnaround and rapid development of this sector.

Pharma has been a steady and high growth sector for several decades now. We have the cheapest and high quality medicines in the world and India is the global pharmacy. While we import bulk drugs from China, the formulation or finished dosage forms is one rare sector where we are ahead by leaps compared to China or any other country. Pharma is likely to maintain its consistency and double digit growth by generating revenue, tax income for government, employment to millions and most importantly by improving the health of India.

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Indian pharma landscape in 2017 Antal International takes a closer look at the business trends that could be game changers for India's growing pharmaceutical industry

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he Indian pharmaceutical industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of five per cent between the same period. The market is expected to grow to $55 billion by 2020, thereby emerging as the sixth largest pharma market globally by absolute size, as stated by Arun Singh, Indian Ambassador to the US. It is evident that a lot of internal factors are responsible for the gargantuan growth seen here. There are over 200 companies manufacturing medicines for the largest population in the world which adds to the prevailing competition on the domestic front. India has always been an important contributor to the global pharma industry with its large domestic market, impressive growth rate over last few years, and due to that it has become one of the sunrise sectors of the Indian economy.

There are various factors that have contributed to the growth of this sector ◗ Changing demographics ◗ Higher spending ◗ Rise of lifestyle diseases ◗ Easier access to medical facilities and health insurance ◗ MNC’s and Foreign brands adopting strategies that are more Indianised in terms of pricing, products etc ◗ Increase in exports to regulated and semi regulated markets ◗ Building partnership with MNC’s from emerging markets As 2016 comes to a close, we take a closer look at the industry and the business trends that could be game changers for this growing industry.

Boost in generic drug exports

India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume. 2017 sees a big opportunity for Indian firms to export generic drugs to countries like Japan and Latin America. India has been exporting drugs to the US for a while, however, pricing pressures and a host of other factors took a big toll on the overseas shipments and the pharma exports from India fell by over one per cent in the six months to September.

India is now shifting its’ attention toward countries like Japan that have a high number of ageing population along with a rise in demand for generic drugs, which gives Indian pharma firms a good opportunity for exporting generics in the Japanese market.

Increase in number of M&As The Indian pharma sector has seen a healthy year, driven by M&A’s and this trend will continue in 2017. The government’s decision to increase FDI to 74 per cent in existing pharma companies is expected to boost mergers and acquisitions and private equity investments in the sector. This move is a welcome change for global pharma companies who are looking at India as a lucrative market and are therefore looking for Indian pharma firms to partner with.

Government policy The government’s revamp plan for this sector such as winding off NPPA, drug price control, government-regulated prices, perpetuity of licenses to manufacture drugs will all bring more flexibility into the sector. These positive initiatives coming from the government will ease business operations and open doors for more investment within this sector.

The latest government initiative ‘Pharma Vision 2020’ is a

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platform that will attract global companies to invest in India and make India a global pharma leader. Other initiatives like ‘Make in India’ ‘Swachh Bharat Abhiyan’ are also proving to be beneficial and encouraging for this industry.

Medical tourism: A recent report by Nomura Financial Advisory and Securities (India) revealed that medical tourism in India is expected to grow at 2025 per cent over the next five years. The report cited various factors like rising internationally accredited healthcare facilities and lower costs of surgeries like bypass, hip/ knee replacement, neurosurgery, cosmetic surgeries, cancer treatments as well as dental treatments, which are boosting medical tourism in India. Hospitals across the country have observed an increase in patients coming from neighbouring countries as well as Europe, the Middle East, South Africa etc.

Trump win The Trump landslide in the US Presidential election seems to be a ‘win-win’ for the Indian pharma industry. Trump’s administration is expected to remove the restrictions on drug imports as he said this would give American patients greater access to drugs manufactured abroad. If Trump does lift export barriers for drugs manufactured outside the US, Indian Pharma companies will benefit the most.

Pharma sector going digital Mobile apps and social media are set to play a bigger role the growth story of the pharma industry in India. Indian pharma firms are now getting rid of old schools marketing methods and switching to new age technologies. Mobile apps, social media will play a bigger role; pharma companies will pay more attention on digital marketing strategies and spend. The industry is

at its best phase and global investors are eyeing India, therefore marketing will play a major role at this hour. This year we saw top pharma companies launch innovative and interactive mobile apps, increase use of webinars, live video chats and other digital platforms to keep clients engaged in the new age digital world.

Rising demand to acquire Indian health-tech startups We saw many examples of global pharma and biotech companies teaming up with Indian health startups which signal an opportunity to reach out to bigger and more competitive global markets. Optimism within this field has led to an increase in number of health tech startups and this trend will continue into the next year as well with more global pharma and bio tech giants looking to team up with startups in India.

R&D takes priority 2016 saw pharma companies prioritising R&D and 2017 will see the same trend. Companies have also increased their R&D budgets to boost productivity and launch differential and speciality products that will help the sector establish a stronghold in the global market. These companies are working towards creating niche and complex products through investments in R&D. Despite high risk of success, gestation periods and uncertainty regarding returns on investment, Indian companies are continuously investing higher funds toward R&D. These companies are entering new tie-ups with major international players, universities, academicians and absorbing new technologies. Indian pharma companies are engaged in contract manufacturing in a big way and R&D investments are offering necessary support for these activities. Even these com-

panies are taking up clinical trials for MNCs. Move to cloud services, attract tech giants The cloud services business has been gaining momentum in India. We are now seeing an increasing number of firms from various sectors moving to cloudbased services; which has in turn led to an increase in the popularity of cloud services within India and many more local players are now entering this domain. This market is becoming highly competitive with global cloud firms like Amazon, IBM, Google, Microsoft eyeing the smaller Indian players to tap on this opportunity and expanding their presence in the Indian market.

Hiring trends in the sector The business trends that we see above will boost hiring within this sector massively. There will be a steady rise in the need for skilled manpower in the pharma industry especially within R&D, analysis and testing, Quality Assurance (QA), Intellectual Property (IP), manufacturing and Sales & Marketing.

In the coming year, the industry will focus on women at senior and leadership roles. The pharma industry was for a long time dominated by male leaders.

However, 2017 may see more women being hired or mentored to manage more senior level roles. This sector is emerging as a popular choice amongst Gen Y, since the nature of work, primarily treating patients and research for new drug discoveries plays an integral role in meeting their key career aspirations.

Therefore the industry will now have to focus on training, developing, retaining and mentoring existing talent for future leadership roles. As recruiters, we do expect a lot more activity within this industry in 2017 and the years to follow.

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Pharma cos need to realign biz models Pharma companies should focus on high-performing therapeutic area and geographic markets and they need to realign their business models to be able to cope up going forward in 2017-18, writes Amit Varma, Managing Partner, Quadria Capital Expected trends factors in 2017-18 are:

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nnual global spending on drugs is expected to reach $1.2 trillion by the end 2016, as the contribution from pharmerging markets, generic penetration and biologics is continuously increasing. In the developed markets, including the US, Europe and Japan, spending is declining due to expiring patents for a number of significant brand-name drugs, slower increases in spending on branded products, and increased cost containment measures by payers. Alternatively, pharmerging markets share is increasing as ageing population and economic growth contribute to dramatically higher use of drugs in these markets. Majority of the spending is expected to be on speciality drugs, especially in the chronic care therapies such as oncology, autoimmune, respiratory, anti-virals and immunosuppressants therapy areas. Much of this growth is from drugs bringing new treatment options for patients, including breakthrough therapies or even cures, and often reduced complications or hospitalisation. The pharma market is also witnessing an increasing focus on biologics and biosimilar, as biologics are becoming central to the key therapies. This is demonstrated from the fact that five out of the top 10 drugs today belong to the biologics category.

Amidst the healthy growth, the market incumbents across the globe face a wide variety of challenges, ranging from a more diverse and globalised economy, stringent government regulations, increasing R&D cost, longer developmental timelines, downward price pressure, and increased demand for better healthcare. The dynamics re-

32 EXPRESS PHARMA January 1-15, 2017

◗ Increasing pricing pressures In the past few years, there have been increasing concerns over sky-high drug prices and sharp price rises for existing drugs.

Drug prices are rising faster than the budgets to pay for them. Premium-priced treatments for cancer, viral infections and high cholesterol create friction between concerns of access and drug costs, it remains an ongoing headwind, dragging on profitability in both Europe and Japan, where the use of generic drugs is rising. As a result, governments and payors are increasing pressure on pharma companies to manage the drug prices. A couple of governments have implemented price controls on critical drugs and are expected to further increase the drugs list that come under the purview of price controls.

Pharma companies will have to re-align their business model and cost structure, in order to be equipped with government and payor policies in the coming future sulting from changes in the role of drugs in healthcare systems and the associated level of spending are differing significantly across countries. Healthcare payers are also beginning to focus on measure outcomes much more carefully and emphasising the importance of prevention. Furthermore, the governments across the pharmerging markets are in the pursuit of universal health coverage that is effecting the pharma landscape in many significant ways. With spend on drugs expected to be over $1.3 trillion by 2018, the focus on the value provided by drugs as an in-

tegral part of prevention and treatment has never been more important—to patients, healthcare professionals and payers alike.

This creates challenges for pharma companies that need to realign their business models to be able to cope up going forward.

Pharma companies would need to adapt to current market dynamics and position themselves for growth through portfolio transformation, targeted makeor-buy strategy, cost-cutting measures, digitisation and sharpened focus on high-performing therapeutic area and geographic markets.

◗ Complex regulatory framework Development and commercialisation of a new drug and generics requires pharma companies to interact with complex and continually evolving regulatory environment across different countries. Most of the regulatory challenges are associated with slow review and approval process, increasing requirement around data integrity and clinical effectiveness and stringent adoption to process and protocols. Equally important, the challenges are different for each country and the penalties for

non-compliance with these regulations are becoming increasingly severe, including the revocation or suspension of business licence, imposition of fines and sanctions, hence requiring companies to equip themselves accordingly. ◗ Portfolio transformation Global companies will continue to evaluate portfolio realignment strategy with the objective of focussing on their core proposition, in terms of capabilities and products. This would entail divesting their non-strategic assets, using the proceeds to invest in a pipeline of new drugs that are core to their business. Various factors are driving the need to create competitive advantage in the core area. The big pharma companies have been shifting away from developing primary care and small-molecule drugs, and progressively tailoring their pipelines to speciality drugs and biologics targeted for high unmet medical needs. ◗ Make or buy strategy High R&D costs and increasing developmental timelines are forcing companies to look at inorganic opportunities for acquiring product portfolio as well as entering into portfolio transformation agreements with other pharmaceuticals. Given the pressure of patent cliff and increasing drug development cost, the deal making, will largely be dominated by ‘specialty pharma’ groups with strategy to grow through acquisitions rather than by in-house drug research.

Going forward the focus would remain on smaller biotech companies developing innovative drugs in segments such as oncology and neurodegenerative

( diseases and acquiring companies that would help optimise costs, especially in the wake of pharma pricing coming under scrutiny would remain in focus. ◗ Increasing penetration of biosimilars The global biologic market, primarily dominated by the US and the EU, is over $200 billion and growing at over 10 per cent annually. The top 10 biologics have an annual turnover of over $80 billion today and are expected to lose their exclusivity by 2020.

Patent expiry and high barriers to entry is leading to an increasing interest in biosimilars.

The market for biosimilars in the US has just opened up and with the approval of three biosimilars over the last one year. We are about to witness the big biosimilar wave in the world’s biggest market. ◗ Performance-based pricing models: With increasing focus on pricing pressures and resultoriented models, pharma companies are now transitioning to pay-for-performance deals with payors. Pharma companies are agreeing to be paid based on the drug’s result estimated through the spend on hospitalisations by patients on the drug or patient’s reaction to the drugs. ◗ Digitisation It is estimated that digitisation will account for almost one-third of the growth and approximately 40 per cent of the profitability in the pharma market by 2020. For those that partially digitise, their business models can drive improved profitability by as much as 27 per cent. But, the true prize will go to those who become ‘digital all-rounders’ and build new business models that address new markets. Changing consumer behaviour and proactive approach of consumers with new technology tools is changing how patients interact with pharma companies and payors. ◆ Personalised drugs: The global pharma industry is witnessing a rise in development of personalised drugs, with leading players such as AstraZeneca, Pfizer, and Roche investing in R&D. Through advances in ge-

nomics and Big Data, companies are striving to provide targeted therapies to patients by analysing their characteristics, needs, preferences and genetic makeup. ◆ Creating a digital-health ecosystem: Apps and wearables are set to transform the industry into a digital pharma space. The popularity of “beyond the pill” pharma services — namely apps and wearable’s — is expected to rise dramatically in 2017 and beyond. These apps and wearable

GlaxoSmithKline. GlaxoSmithKline has announced it will be using ResearchKit to conduct medical study on rheumatoid arthritis.

Given the stature and size of Indian pharma industry, it will be profoundly impacted by the global trends. Indian companies account for 10 per cent in terms of volume and approximately three per cent in value besides contributing 20 per cent of global generics exports. Given that India has the highest num-

THE MAIN FOCUS

cus on their R&D and manufacturing procedures, implement comprehensive action plans and even conduct risk assessment of products that are already in the market. Furthermore, with the growing healthcare costs and longer development timelines, we will see increased collaborations between regulators and pharma companies in an effort to ensure that they are able to bring quality lifesaving products to market faster and minimal regulatory bottlenecks.

Pharma companies needs to adapt current market dynamics and position themselves for growth through portfolio transformation, targeted makeor-buy strategy, cost-cutting measures, digitisation and sharpened focus on high-performing therapeutic area and geographic markets will help companies to track compliance of drugs by patients and consequently re-align their marketing strategy. Companies are increasingly focusing on offering consumers digital devices for monitoring health, as well as administering drugs. ◆ Big Data: Pharma companies are increasingly embracing the need for analysing big data to attain deeper insights and improve decision-making. The emergence of predictive and prescriptive analytics is moving data analysis toward anticipating trends that will drive efficiency, targeting cost-effectiveness and real-time validation in the R&D, sales, marketing and distribution of drugs. Companies are expected to focus on leveraging these insights to stay ahead in the increasingly competitive and demanding pharma marketplace. Big brands like Apple, Google and IBM are showing interest in the pharma sector because of the need for data-driven patient engagement, self-responsibility, and real-world results.

For example: In 2015-16 Apple unveiled ‘ResearchKit’— a medical platform designed to turn the iPhone into a diagnostic tool for clinical trials and studies.

Now, Apple has partnered with

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ber of FDA approved sites beyond US and that Indian companies contribute to 30 per cent of the ANDA approvals every year, the emerging trends in the US will contribute to the important trends in India.

The key dominating trends

◗ Regulatory overhang: Over the past few years, the Indian pharma industry has seen a proliferation change in the regulatory landscape and is expected to be increasingly challenging and uncertain going forward as well. Unlike the past, where the regulatory compliance management was a back office capability, it is now becoming the cornerstone of key business practices due to high repercussions in case of non-compliance.

For instance, over the past seven years, Indian pharma have received over 50 warning letters from the US FDA with nearly 40 per cent being converted into import alerts. During 2015 alone, US FDA issued 17 warning letters against companies such as Dr Reddy's Laboratories, Cadila Healthcare, Sun Pharmaceutical, Unimark Remedies, Micro Laboratories.

Pharma companies will need to align their business model to fo-

◗ Price control In its effort to increase transparency and affordability of critical drugs, the National Pharma Pricing Authority has put in place price control on essential drugs. Currently, the authority has placed over 450 formulations under price controls and plans to increase the list to 800 formulation molecules over the coming years. The impact on pharma companies is however differing based on the percentage coverage of products under the price control. However, as companies are increasing their resources toward compliance with various regulations, price controls impact the profit margin to quite an extent. Companies would need to re-align the business models that would help reduce their cost of commercialisation and maintain profitability. Additionally, companies would need to transform the portfolio to focus on few of the key specialities where the pharma company specialises, both in terms of manufacturing as well as sales and marketing. ◗ Injecting innovation in India Pharma India’s generic drug manufacturing industry constitutes over 10 per cent of the volume of the

global pharma industry, but only 1.5 per cent of the value. With increasing regulatory overhangs, limited differentiation in generics and price controls, the next stage of growth would be propelled through innovation. Companies would need to focus on moving up the value chain by leveraging the well-developed scientific database and large number of highly skilled researchers and scientists. Companies would need to invest a higher proportion of their revenue into R&D as compared to what they have in the past and increase their partnerships with universities and research organisations to increase the chances of a healthy development pipeline. Furthermore, the companies will need to innovate their business to increase accessibility of drugs to smaller towns and cities across the countries. ◗ ‘Make in India’ initiative Government is constantly working towards enabling Indian pharma industry to play a leading role in the global market and ensure abundant availability, at reasonable prices within the country, of good quality pharma for mass consumption. Through multiple initiatives such as ‘Pharma Vision 2020’ and ‘Make In India,’ the government is trying to attract investment to allow innovation, skill development, protect IP and build world class infrastructure and help Indian pharma become one of the leading destinations for end-toend drug discovery and innovation. There are incentive plans for the bulk drug manufacturers, including both state-run and private companies, to encourage ‘Make in India’ programme and reduce dependence on imports of Active Pharmaceutical Ingredients (API), nearly 85 per cent of which comes from China. A boost for public sector enterprises, tax-free status for manufacturers and cluster development are the highlights of the policy. The government will also offer zero duty for technology upgrades in the pharma sector through the Export Promotion Capital Goods (EPCG) Scheme.

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Fixed dose combination drugs – to be banned or not to be banned Ajay Bhargava, Vanita Bhargava and Aseem Chaturvedi explain how the FDC ban notification has adversely affected the pharma industry

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ith the advancement of science and technology, the pharmaceutical Industry has also grown and evolved. Various ailments, which could not be treated before, are easily diagnosed and medication is available for its treatment.

There are boons and banes to every field and science certainly is no exception .

Earlier, the only medication that was given as a cure for fever, cold, cough etc. was paracetamol. Paracetamol, till date, is considered a safe option for treating fever and flu.

However, with the advancement of science, various other medicines were developed for combating cold, flu, fever etc.

The pharma companies developed combination drugs also known as Fixed Dose Combination Drugs (FDC). FDCs are combinations of two or more active pharma ingredients in fixed ratios, given in the form of a single dose.

For example, a patient suffering from fever, cold, cough etc. would ideally have to take 3 medicines i.e. for fever, the patient is usually administered 500 mg of paracetamol and for cold and cough the patient is usually administered 10 mg of Phenylephrine Hydrochloride.

However, Phenylephrine Hydrochloride is known to cause drowsiness. In order to get rid of the side-effect of drowsiness, caffeine is added which is known to keep people awake.

Thus, when the companies added 500 mg of paracetamol + 10 mg of phenylephrine hydrochloride + 32 mg of anhy-

34 EXPRESS PHARMA January 1-15, 2017

The petitions were heard by Justice Rajiv Sahai Endlaw, over a period of nearly three months, with several days of back to back hearings.

Ajay Bhargava, Partner, Khaitan & Co

Vanita Bhargava, Partner, Khaitan & Co.

Aseem Chaturvedi, Principal Associate , Khaitan & Co.

drous caffeine, they formulated an FDC to treat common cold, cough, throat pain and fever, which in the common market is known and available as D-Cold Total. Similar combinations are available in the market under different trade names such as Ascoril-D, Wickoryl etc. manufactured by different companies. Some other popular examples of FDCs are Pfizer’s Corex, Piramal Healthcare’s Saridon, Merck India’s Nasivion, Glenmark’s Ascoril and Candibiotic, Lupin’s Gluconorm etc.

The Government of India, however, sought to ban this mushroom growth of FDCs. Exercising its powers under Section 26A of the Drugs & Cosmetics Act, 1940 (the Act), the Central Government, through its Department of Health & Family Welfare; issued a notification dated 10 March 2016, whereby 344 Fixed Dose Combination (FDC) Drugs were banned

with immediate effect. The notification purported to ban the FDCs for the reason that they involved risk to human beings and that safer alternatives to the same were available. Further, the notification was also purported to be based on the findings and recommendations of an Expert Committee appointed by the Central Government, which stated that the FDCs in question were found to have no ‘therapeutic justification’. Lastly, the notification was, of course, touted as an exercise in ‘public interest’. Hundreds of pharma companies were in for a shock when this notification was published.

Needless to say, the said notification adversely affected almost the entire pharma industry of the country; and had the notification gone unchallenged – it would have amounted to a loss of revenue of approximately `3,000 Crores, annually.

The pharma industry immediately proceeded to challenge the notification on various grounds.

Although, several writ petitions were filed before various High Courts of the country – the Delhi High Court, having passed the first interim order dated 14 March 2016 concerning the notification in WP (C) No. 2212 of 2016, directing that no coercive action will be taken by the government in furtherance of the notification, till further orders – became the hot-bed of the present litigation.

Soon, various other companies followed and flooded the court room with petitions challenging the ban; and a total of 455 writ petitions were filed before the Delhi High Court. To maintain decorum in such a circumstance the High Court, in an unprecedented measure, directed that only 1 lawyer per matter be allowed to enter the court room.

The companies challenged the ban on, inter-alia, the following grounds: ◗ Violation of Article 14 of the Constitution of India, in as much as the notification was issued in an arbitrary manner; in violation of the principles of natural justice; was unreasonable, harsh and unscientific. ◗ Violation of Article 19(1)g, in as much as the notification was an unreasonable restriction upon the business and trade of the petitioners. ◗ Violation of the procedure prescribed under the Act, for exercise of powers under Section 26A, in as much as the Notification was issued without the mandatory consultation with the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC), as constituted by virtue of sections 5 and 7 of the Act, respectively. ◗ The primary ground of challenge in most of the petitions was that there was a violation of the principles of natural justice, more particularly the principle of audi alteram partem – in as much as no Show-Cause Notice was issued to the petitioners, enabling them to empirically justify their production/ sale of the banned FDCs. It may be noted that a Show-Cause Notice was, in fact, duly issued to some of the petitioners; and the said petitioners, nonetheless, went

( on to challenge the notification, inter-alia, on the ground that no personal hearing was afforded to them. ◗ It was also stated that most of the affected drugs had been in production for several years (decades, in some cases); and had been successful in treating lakhs of patients across the country. Accordingly, it was submitted that the ban was unwarranted and the imposition of the same with immediate effect, was all the more arbitrary and unreasonable. ◗ More importantly, the court was apprised of the fact that the FDCs in question, in most of the petitions, had been under production, on the basis of the requisite licenses and approvals issued by the Drugs Controller General of India DCG (I) ITSELF and/ or the relevant state authorities. In this regard, it was submitted that the said licenses and approvals were given only after examining the efficacy and suitability of the relevant drug; and that it was astonishing that the government,

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The notification purported to ban the FDCs for the reason that they involved risk to human beings and that safer alternatives to the same were available. The pharma industry immediately proceeded to challenge the notification on various grounds would now, all of a sudden, brand the same drugs as unsafe.

Apart from the above, certain other grounds of challenge included perverse constitution of the expert committee; unscientific methods adopted to reach the conclusion that the FDCs in question did not have any therapeutic justification etc.

The judgment was reserved on 2 June, 2016.

With much respite to the pharma companies, the Delhi High Court, vide its landmark judgment passed on 1 Decem-

ber, 2016 allowed all the writ petitions and quashed the notification dated 10 March, 2016, issued by the central government.

It will now be interesting to see how the central government reacts to the decision of the Delhi High Court. The following three possibilities, in no order of likelihood, seem to be in the offing: ◗ The central government may accept the decision and give up the entire exercise concerning FDCs, altogether. ◗ It may accept the decision, but, go on to undertake the en-

tire exercise, afresh – removing the infirmities, as pointed out by the Delhi High Court. ◗ It may challenge the decision and file an appeal against the same.

The proceedings also assume importance as the impugned action of the central government was purportedly undertaken to further public interest and to protect public health, in particular. In such circumstances, the court was faced with a fairly vexed issue and was called upon to circumscribe the powers of the Central Government, within

the contours of the procedure prescribed under the specific law and the settled principles of common law. To that end, the court made it clear that an exercise affecting substantive rights, if undertaken in violation of the law, would not be permitted to prevail – notwithstanding the fact that it is seemingly peddled to be in furtherance of public interest.

Whether the FDCs are a boon or deserve a ban, only time will tell.

Khaitan & Co, New Delhi acted for several of the affected pharma companies, namely, Glenmark Pharma, GlaxoSmithKline Pharma, Lupin , Wockhardt , Unichem Laboratories , Ajanta Pharma, Centaur Pharma, Blue Cross Laboratories, Tablet India, Unichem Laboratories, Yash Pharma , Serum Institute, FDC India, Coral Laboratories, Ruby organic & Labs, Akums Drug and Pharma, Koye Pharma, Hema Laboratories amongst others; and filed over 50 writ petitions.

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cover ) Trends in global and Indian pharma industry Uttam Jain, Director, Neon Laboratories, elaborates on how the pharma industry will register positive growth trends in the next couple of years

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he pharmaceutical industry worldwide has been escalating steadily despite certain adversities. The global pharma revenue is expected to touch $1226 billion by 2018, registering positive growth trends over the next couple of years.

The Indian pharma industry is no exception and the market has grown at a CAGR of 17.46 per cent in 2015 to $30 billion from $6 billion in 2005 and is expected to grow at a CAGR of 15.92 per cent to $55 billion in 2020. With this speed India is expected to outperform the global pharma industry as the later may grow at an annual rate of five per cent over the next five years.

Going by the incremental growth, India is expected to be among the top three pharma markets and by volume it would be sixth largest market globally by 2020. The decision by the Union Cabinet for the amendment of existing FDI policy in the pharma sector to allow FDI of upto 100 per cent with certain conditions will certainly provide more oxygen to the industry in terms of fresh investments towards R&D activities, manufacturing and biotechnology.

The Department of Industrial Policy and Promotion has reported inflows of cumulative FDI worth $13.85 billion between April 2000 to March 2016. ‘Pharma Vision 2020’ by the Department of Pharmaceuticals, Government of India, will help the nation to get established as a prime location for R&D of drugs. As per the information available, the government has planned to set up a $640 million venture capital fund to improve pharma infrastructure and research. Factors like low cost clinical tri-

36 EXPRESS PHARMA January 1-15, 2017

als, skilled manpower, increased understanding and exercise of Intellectual Property Rights (IPR), already amended patent law, decision to review DPCO-related price controlling, favourable political support will speed up the growth of Indian pharma industry in times to come.

Contributing factors for the continued growth in pharma industry worldwide will include increase in chronic diseases across the globe, personalised medicines, approval and availability of bio-similar drugs in the US, steady growth of emerging markets, clinical and technological advances, digitalisation, increased investments in R&D by pharma giants, positive approach of US FDA towards new approvals, increased demand of generic drugs and positive role play by different governments worldwide. Besides, the broad scale activities on merger and acquisition is expected to accelerate further for capitalising the opportunities in emerging markets and to diversify focus to newer segments with deeper penetration approach. Actually, the traditional concept of focussing and promoting selective molecules are losing its ground due to price rises, availability of branded generics, decreased productivity of R&D and loss of huge revenue due to expiry of patents.

Moreover, the focus is getting shifted to prevention from treatment and discovering new molecules is appearing as a challenge to scientists and researchers.

By 2017, generics are expected to make stronger position in global scenario, accelerating from 27 per cent in 2012 ($261 billion) to 36 per cent

($421 billion). Demand for generics across the globe is on the rise due to reduced costs.

As per reports available, 70 per cent of the pharma market volume is controlled by generics in the US, which is 84 per cent in UK, 84 per cent in Mexico and 60 per cent in Japan. Major pharma companies globally are facing the challenges to regain their market share and revenue in developed as well as emerging markets due to stupendous growth of generics. The largest segment of the Indian pharma sector is represented by generic drugs with 71 per cent market share in terms of revenues and accounts for 20 per cent of global exports in terms of volume, making the country largest exporter of generic medicines globally. A tough competition is expected among the top generic manufacturers in the forthcoming years to earn sizeable share of the existing and emerging markets, as much of the activities in terms of setting up manufacturing units, fresh investments, mergers and partnerships are continuing.

2017 can expect acceleration in speciality medicines which are used to treat chronic, rare and genetic diseases, not only in global markets but also in our country.

As per the report of IMS Institute for Healthcare Informatics, speciality medicines are expected to account for 28 per cent of the total global medicine expenditures. Besides, the biopharmaceutical industry in India which ranks third as biotech destinations in the Asia – Pacific region has grown by 17 per cent and is expected to grow at an average rate of 25 per cent in the following years. Biopharma account for 64 per cent of the Indian biotech industry and is currently valued at $4 billion.

Revenue from biopharma exports is expected to reach to a new height in 2017 as many Indian companies are investing heavily in this segment and as per Harsh Vardhan, Union Minister of Science & Technology, the industry can touch $100 billion by 2025. Positive moves by the Indian government for e.g. relaxing norms in import and export of human biological samples, withdrawal of import license or export permits, planning to launch a venture capital fund of `1000 crore under the Department of Pharmaceuticals will motivate and boost the sector. Global giants have identified the enormous potential of Indian biotechnology sector and there is a noticeable surge in strategic alliances and investments since 2015, which is bound to grow henceforth.

The domestic pharma industry expects to benefit from the long awaited Goods and Services Tax (GST) in terms of simplified tax structures, supply chain efficiency and decrease in manufacturing cost. It will enable pharma manufactures to enjoy a level playing field. Besides, manufacturing houses can establish their warehouses at strategic locations as there will be no

necessity to maintain warehouses at certain states (for CST factor) only. Post GST, there may be increases in prices as expected rate of GST will be higher than the prevalent tax of five per cent in most of the states. The impact may also be there on free schemes, physician samples and return of expired medicines, but as per the opinion of experts, the effects may get neutralised gradually because of other factors involved and there will be a win-win situation for the drug manufacturers and customers in the long run.

With an aim to avail the benefits of growing markets both globally and within the country, pharma companies need to devise and implement new strategies, generate innovative ideas, and exercise well thought marketing activities.

Brighter days are ahead and the best is yet to come.

References a) Indian Pharmaceutical Industry : available at www.ibef.org b) Pharmaceutical Industry in India : available at www.en.m.wikipedia.org c) Global Lifesciences Outlook : available at www2.deloitte.com d) Global Pharma Industry in 2016 : available at www.thesmartcube.com e) Biotechnology Industry in India : available at www.ibef.org f) GST impact on Pharmaceuticals : available at www.dsij.in g) The Economic Times : available at m.economictimes.com h) Seven Pharma Trends for 2016 : available at www.pharmafile.com i) Strategies and Trends in Pharma. Industry, Pharma 2020 series : available at www.pwc.com

(

THE MAIN FOCUS

INSIGHT

Pharma cos brace up for a paradigm shift With vast and quick change in culture and various global platforms, the industry is to witness a growing trend of digitisation in the pharma industry. They need to be equipped with technology, as many healthcare services would be offered on digital platforms, writes Ketan Zota, Director, Zota Healthcare

D

igital platforms have helped the pharmaceutical industry stay connected with people globally and drives them effectively towards their products and services. The healthcare players have become more active on the social media to connect with the inclined demands and trends. With this concept as a core thought, there are online patient communities that help the industry gain crowd-sourced data, with rating systems for drugs and various health supplements.

Pharma companies have positioned themselves for improved growth through portfolio transformation, pursued deal-making, rate cutting procedures, and improved focus on high-performing therapeutic area (TA) and geographical markets.

AI in drug development The global industry will adapt to Artificial Intelligence for drug development. More and more new chemical entity would be studied using designed software to identify suitability and effectiveness of new chemical. Once these entities show favourable results, chemicals would be used further for drug development. AI would be of much help in pre clinical and clinical studies.

Pharma industry can see a revolution hitting in 2017, in terms of medical equipment and its usage. Advancement in nanotechnology helps to develop medical devices that are in the range of micrometers to nanometres. These devices would be easier to insert/ im-

plant in the body and can be useful to get real time drug release information and also help to destroy targeted pathogen or tumour cells. Use of electronic media is increasing to keep medical records.

This will help healthcare professionals in measuring pharma-economic performances of different medicines and its outcome based pricing.

One of the leading reports on global life sciences outlook read, “Amongst the latest developments with implications for 2016 and succeeding years is a rising trend in health authority findings: 483s and warning letters related to unreported adverse events (AEs) found within third parties and non-safety-related departments at pharma companies.

This increased enforcement is driving companies to examine the way they are assessing non-traditional sources of AEs, such as patient support programs, market research vendors, and insurance assistance centres.

Pharma companies are implementing ongoing AE reporting assurance and monitoring programs, leveraging technologies with natural language processing capabilities in order to constantly identify AEs in non-traditional informants and confirm that those AEs were properly and accurately reported to health authorities.�

Pharma companies have pursued targeted and specialised therapies to meet the global trends till date. Corporations have also invested their money and time in upto-date treatments known as

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roll out of improved health insurance and services, particularly in developing markets.

The Indian pharma industry witness significant growth in near future owing to rise in pharma outsourcing and consolidation of highly fragmented industry. India has acquired most number of US FDA-approved manufacturing facilities and in terms of technology, quality and vast range of medicines that are manufactured; it is ranked highest amongst all the third world countries.

Impact of demonetisation

precision or personalised medicine that rely on advances in genomics and big data to target very specific types of cancer or other diseases affecting small groups of patients. For example, a drug called Herceptin, approved in 2006, treats women whose breast cancer has too many copies of a specific gene that manufactures a protein that can stimulate out-of-control cell growth. Many companies might completely go virtual with their services and methods but yet certain research requires physical inputs for accurate results. Pertaining to this there might be certain processes that may be constant throughout. During 2017 and the coming years, both global health spending and pharma sales are expected to see an increased growth, driven by population ageing and expansion and the

The impact of the demonetisation will be seen on Indian pharma industries for short term as purchasing power of entire retail network will be affected by this drive. Also this will create requirement to have cashless mode of payment across all retail and hospital networks where majority of payments care done in cash. This would also reduce overall healthcare expenses and more would avail medical facilities creating huge requirement of medical services. According to the Indian Pharma 2015 report, the Indian pharma industry will roll in the next decade, and will position itself into the top 10 market places in the world by surpassing Mexico, Turkey and South Korea. The number of global acquisitions by Indian companies for strategic objectives like technical or manufacturing expertise, distribution facilities and market share has also increased in the recent past. The global

market continues to offer these opportunities for domestic companies pushing them to expand their international presence.

Awareness among people, side effects of drugs, and requirements of nutrition in the body will boost the use of nutraceutical supplements among youth in the country.

Talking about India’s global reach in terms of Ayurveda, roots of medicine culture is India, is likely to grow. Along with the changing trends, the Ayurveda world is regaining its importance too. It has also boost the use of herbal products. Many pharma companies have included Ayurveda into their products and services. This has given a different outlook to their market positions. Youth would be opting more for nutraceuticals and ayurvedic products for normal day to day requirements.

But the catch lies that the Indian companies will have to reconsider their business strategies on country to country. The core information of the survey should be considering individual value of the market, be it operating through strategic and marketing alliances or physically setting up operations in these countries.

Overall, the global and Indian pharma business models are witnessing a paradigm shift, moving from a completely integrated company structure towards a future where companies will use a wide range of digital platforms and outsourcing, contracting and partnerships to create use of digital platforms.

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cover ) REPORT

Outlook for global medicines through 2021 Growth in spending on medicines in major pharmerging markets has slowed from 2–10 percentage points over the past five years and is expected to slow further, according to a report by QuintilesIMS Institute. Excerpts from the report

T

he total volume of medicines consumed globally will increase by about 3 per cent annually through 2021, only modestly faster than population and demographic shifts, but driven by very different factors around the world. Spending on medicines will grow by 4–7 per cent, primarily driven by newer medicines in developed markets and increased volume in pharmerging markets.

Developed markets will offset increased costs from new medicines with the use of generics, and a greater focus on pricing and access measures, while pharmerging markets will struggle to live up to promised access expansions made when their economic outlooks were stronger.

By the numbers Global medicine spending will reach nearly $1.5 trillion by 2021 on an invoice price basis, up nearly $370 billion from the 2016 estimated spending level. Importantly for the outlook is that spending growth is slowing in 2016, declining from nearly 9 per cent growth in 2014 and 2015 to just 4–7 per cent CAGR over the next five years. The short-term rise in growth in 2014 and 2015 was driven by new medicines in hepatitis and cancer that contributed strongly to growth but will have a reduced impact through 2021.

Most global spending growth, particularly in developed markets, will be driven by oncology, auto-immune and diabetes treatments where significant innovations are expected. The US will continue as the world’s largest pharma-

38 EXPRESS PHARMA January 1-15, 2017

ceutical market and pharmerging markets will make up nine of the top 20 markets. China will continue as the #2 market, a rank it has held since 2012.

Developed market spending growth will be driven by original brands, while pharmerging markets will continue to be fueled by nonoriginal products that make up an average 91 per cent of pharmerging market volume and 78 per cent of spending.

New medicines increasingly are specialty in nature, and their share of global spending will continue to rise from less than 20 per cent ten years ago to 30 per cent in 2016 and to 35 per cent by 2021, approaching half of total spending in US and European markets. This rise primarily will be driven by the adoption of new breakthrough medicines, but also will be a key focus of payers and constrained by cost and access controls as well as a greater focus on assessments of value. Off-invoice discounts and rebates, particularly in the US market, will reduce invoice-price growth by about one per cent, resulting in a total global market of $1 trillion in 2021.

Transformations in disease treatment The number of new medicines reaching patients will be historically large with 2,240 drugs in the late-stage pipeline and an expected 45 new active substances (NAS) forecast to be launched on average per year through 2021.

The new medicines will address significant unmet needs in cancer, autoimmune dis-

GLOBAL MEDICINE VOLUME GROWTH 2006–2021, STANDARD UNITS BN

or by biomarkers the tumour expresses. The sheer number of cancer treatments, their potential combinations in treatment regimens, and the variety of companies involved in development will bring significant change to the landscape of cancer treatment over the next five years. Dramatic improvements in survival and tolerability are expected and will be accompanied by substantially greater levels of clinical trial and real-world information to support treatment decisions.

Payers and providers are developing tools to better assess value and will demand, or create on their own, the evidence to support spending, especially where new treatments would add to already expensive cancer treatment costs.

Trends in US Medicines

Source: QuintilesIMS Institute, Oct 2016 eases, diseases of the metabolism, nervous system and others. In addition to the continued research of mechanisms in use in existing drugs, there will be an ongoing flow of new mechanisms to target cell processes and diseases across the spectrum. Developments that go beyond specific ‘drugs’ are emerging in research that will challenge traditional regulatory approval and commercialisation approaches. These include completely new platforms that will see their first human uses in areas such as gene-editing technology CRISPR, which could transform personalised cancer

treatments while creating a plethora of ethical dilemmas.

Advances are expected to treat a range of diseases by harnessing the microbiome (a person’s own gut bacteria), as well as regenerative cell technologies that include stem cells harvested from one part of the body to use against a disease in another.

Cancer is by far the largest general category of research, including immunology, celltherapy and dozens of molecularly targeted agents. Treatment choices will be made based on the tumour diagnosis as much as by a patient’s family history, genetic marker

The US market growth will slow by half in 2016 to 6–7 per cent from 12 per cent in 2015, and is forecast to average 6–9 per cent through 2021. This decline is a key driver of the overall global slowdown and has similar causes—the end of Hepatitis C-driven growth and the greater impact of patent expiries after a period with fewer brand losses of exclusivity. The US growth also was lifted in 2014 and 2015 by historically high price increases for both brands and generics on an invoice-price basis before the impact of offinvoice discounts and rebates.

After adjusting for those price concessions by manufacturers, spending growth is estimated to be more than 4 percentage points lower in 2016 and 2 percentage points lower

( through 2021, growing at a 4–7 per cent CAGR. Pricing, and particularly the difference between invoice and net prices, will be a key political issue for the incoming administration but is unlikely to affect the forecast net growth rates.

Medicine costs will be driven by the use of transformative specialty brands and invoice price increases, offset by rebates and the use of lower-cost generics. Brand prices will increase at 8–11 per cent—more slowly than the 12–15 per cent in the past three years, and with fewer outlier major price increases as these have become unsustainable in light of high-profile media and political attention.

Net prices for protected brands are expected to increase, albeit at a slower 2–5 per cent rate, and including some declines for products facing greater competition and price transparency. Patient out-of-pocket costs are forecast to decline despite rising brand prescription costs as patients shift to newly available generics and receive copay assistance for brands.

More than one-third of prescriptions will have no out-ofpocket costs. Free prescriptions are a growing trend as some patients receive preventive services under the Affordable Care Act, under expanded eligibility for Medicaid, and through some insurance plans.

The reduction in overall spending as branded medicines lose exclusivity is expected to total $143.5 billion in the next five years—more than 1.5 times the impact as in the past five years. This includes the estimated impact of biosimilars, which will contribute between $27–58 billion, uncertainty based on multiple issues in litigation with originators, as well as regulatory, pricing and competitive dynamics.

Regardless of the uncertainty, biosimilars are expected to affect spending over the next five years, with 25–35 products in development across biologic molecules with

THE MAIN FOCUS

PHARMERGING COUNTRIES MEDICINES SPEND PER CAPITA IN 2021 CONSTANT US$

Source: IMS Market Prognosis, Sept 2016; QuintilesIMS Institute, Oct 2016 Note: Spending per capita, per capita growth and overall spending growth in Constant US$ the highest sales levels.

Pricing and growth in Europe Low pre-rebate and discount growth of 1–4 per cent in the EU5 countries through 2021 is partly driven by policymaker responses to unexpectedly high new drug spending growth in 2014 and 2015, and efforts to control future growth. The Hepatitis C drugs were surprising to stakeholders in their effectiveness, the extent to which patients and providers were willing to use them, and the budget impact that few were able to accurately predict.

Looking forward, these budgeting weaknesses are prompting European payers to redouble their efforts to bring predictability to their budgeting processes for drugs—especially given the wave of promising agents to treat a variety of diseases.

Mechanisms that control access based on clinical quality alone may not be sufficient in the face of the variety and number of breakthroughs expected.

Perhaps the most pressing question for European governments on issues outside pharma centre around BREXIT. The more than halfcentury of progressively

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greater integration of Europe including medicines-related institutions and practices will make disentangling the UK from Europe extremely complicated, not least because the UK government has yet to officially trigger the process.

While uncertainties remain, the impact on the UK pharma market is expected to be modest with a 1.5 per cent slower growth rate in the downside scenario, than the basecase outlook for 4–7 per cent growth to 2021, still the highest medicine spending growth in the EU5 in either case.

Relatively weak economic growth in the region, combined with budget concerns arising from adopting and paying for recent innovations, will encourage European payers to be more cautious in adopting newer medicines in the future. Mechanisms to control price and/or access to innovative drugs continue to be the main tools used by European governments to manage spending on medicines, and will limit spending growth through the forecast period.

As a result, fewer new launches in Europe are achieving price premiums, as few medicines are considered breakthroughs while the remainder are subject to more

stringent levels of price limitations at launch.

Medicine use in pharmerging markets Since 2011, the global expansion in the volume of medicines used essentially has been driven by pharmerging markets, where volume grew 37.5 per cent over five years, or 7 per cent annually, compared with 2 per cent in total over five years in all other markets.

In most developed markets, where access already was high and usage driven by demographic shifts to aging populations, volume grew an average of 0.4 per cent—less than half the rate of population growth in most markets.

In pharmerging markets a decade ago, many lacked basic healthcare infrastructure and patients often paid for medicines out-of-pocket without insurance coverage. As access expanded through government support of expanded infrastructure and either government or private insurance coverage, medicine usage expanded broadly.

More recently, as economic growth has slowed, medicine volume growth also has slowed, showing a direct correlation between medicine usage and affordability. Com-

pared to ten years ago with the start of their growth boom, leading pharmerging markets have seen real GDP growth slow from 1 to 4 percentage points, and their currencies’ value to the US dollar weaken by 15–35 per cent.

Medicine spending growth has slowed from 2–10 per centage points over the past five years in major pharmerging markets and is expected to slow further. Volume growth averaged 7 per cent for pharmerging markets over the past five years but is expected to slow to 4 per cent through 2021, as China declines from 17 per cent average annual volume growth in the past five years to 4 per cent CAGR in the five years through 2021. Broad economic issues have led to a range of derailed commitments and delayed, revamped or cancelled expansion programmes—initiatives that may be hard to restart even if economic conditions recover.

Overall, volume growth continues to be driven by nonoriginal products that account for 91 per cent of volume in pharmerging markets, and the outlook for spending growth across these markets is expected to be slower in the next five years and beyond.

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MANAGEMENT

P

ermeating all facets of the modern world, digitalisation is not only disrupting the way we conduct our business but also reshaping the way we lead our lives. The widespread adoption of digital technologies for even day-to-day activities as a means to tackle the cash crunch caused by demonetisation in India is a case in point.

Yet, the pharma industry has been cautious about going down this route to the point that it has often been labelled a laggard in this arena. Many external and internal factors such as ambiguous regulations, lack of universal standards, ignorance in grasping the true potential of digitalisation, and concerns about return on investments have contributed to the industry's reluctance when it comes to adopting newer forms of engagement and technology.

But, the need to improve manufacturing efficiency, tackle supply chain complexities,

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DIVING DIGITAL into

Pharma companies are embracing the power of digital to further their progress but there is a need for clear strategic direction to drive optimal value

By Lakshmipriya Nair

handle price and cost pressure, meet changing consumer demands, ensure compliance with global regulations and manage reputations etc. have made it imperative for pharma companies to get on to the digital highway and optimise the benefits of evolving technology trends.

A report from Accenture predicts, “digitisation will spur almost one-third of the growth and an estimated 40 per cent of the profitability in the pharma market by 2020.

For those that partially digitise, their business models can drive improved profitability by as much as 27 per cent.

But, the true prize will go to those who become ‘digital allrounders’ and build new business models that address new markets. Our research indicates digital all-rounders will not only grow revenues faster (by as much as 35 per cent), but could also improve today’s profitability baseline by as much as 61 per cent.” (Source:

Digitisation, e.g. online pharmacies, telemedicine platforms bring the probability of spurious medicines close to nil Nishi Gandotra Co-Founder, Saveonmedicals.com

It will help to have total process control across all stages: right from manufacturing, to the end of the packaging process, to the distribution channel and ultimately to end customer/consumer level Ettore Cucchetti CEO, ACG Inspection, ACG Value Links, ACG Pharmagents

https://www.accenture.com/usen/insight-highlights-life-sciences-pharmaceutical-grow)

Embarking on a digital journey Fortunately, the pharma sector is gradually shedding its inhibitions and designing digital strategies to achieve success through mediums like mobile phones, the cloud, advanced analytics, wearables, artificial intelligence and the Internet of Things.

‘Emerging Technologies Energizing the Future of the Pharmaceutical Sector’, a recent analysis from Frost & Sullivan’s TechVision, reveals, “Pharma companies are looking beyond sales of blockbuster drugs, and measuring success by care outcomes.

To facilitate this, they are focusing on innovation through emerging technologies.” It also points out that top pharma companies are already leading the way, collaborating with cross cluster tech-

nology companies in order to address unmet needs, get a disruptive advantage in industry, and gain diverse opportunities in the market.

To give a few pertinent examples: ◗ Novartis has signed a deal with Google (Alphabet) that allows it to license Google’s smart contact lens which can measure a wearer’s blood sugar levels. ◗ This year, Sanofi and Verily Life Sciences came together to form Onduo, a joint venture to develop a comprehensive diabetes management platform combining devices, software, medicine, and professional care. ◗ Pfizer has utilised digital platfroms to create patient engagement initiatives like Quitter's Circle, an online endeavour through an app and social media connection to aid smokers kick the habit; and HemMobile, an app to help haemophilia patients and

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their caregivers track treatment and history. ◗ Boehringer Ingelheim's social media strategies have garnered a lot of praise from different quarters. Active on eight out of the 10 popular social networks, their tweet chats with specific topics and hashtags, such as #COPDchat and #ChatAFib gained widespread attention. Twitter itself highlighted one of them as good business practice.

There are several instances on the homefront as well. ◗ Sun Pharma's RespiTrack, a mobile app to spread awareness on asthma and ensure patient adherence to treatment regimen. ◗ Qlik, a provider of visual analytics, and Lupin have signed a deal for data insights across across the latter's supply chain, finance, and research and development departments to drive rapid and factbased decisions for the business.

◗ Janssen, under Connect for Life, an HIV disease management programme launched in partnership with SAATHII, will support the development of m-Maitri, an initiative to educate pregnant women on techniques to prevent motherto-child HIV transmission. ◗ DocPlexus, an online venture, is helping pharma companies to connect with over 1,50,000 doctors with their proprietary clinical insights through articles, webinars, CMEs and interviews. These kind of ventures are ushering new means of marketing for the pharma segment. ◗ Online pharmacies like 1mg, Netmeds.com and Saveonmedicals.com etc are ushering new distribution models and improving supply chain efficiencies, thereby improving access to medicines considerably.

Thus, waking up to the value that can be derived through digital, pharma companies are experimenting

with a wide range of initiatives.

So, which are the areas where significant impact can be created through digitalisation? Let's examine.

Unlocking the power of data As improving manufacturing and operational efficiencies become paramount, investing in data analytics technologies is pivotal. Souma Das, MD, India, Qlik highlights, “Pharma companies sit on huge treasure troves of data, mostly stowed away in disparate organisational silos. Acquiring the ability to work and sweat that data to gather insights and drive more efficient decisions will help them unlock hitherto unknown potential.

Access to insights from one’s data and being able to make faster data-driven business decisions will help pharma companies become more agile and move at the speed of business. Digital enablement

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MANAGEMENT

A significant number of pharma’s future customers (doctors and patients) are going to be digital-natives. Consequently, a brand that is foremost in digital initiatives will gain the most recognition and engagement.

Phanish Chandra CEO, DocPlexus

helps pharma companies make better business and clinical decisions faster.”

He further explains, “Qlik helps to effectively address the key problem organisations face in determining how the influx of disparate, internal and external data can be managed to allow for real-time analysis. With an exponential growth in data and the value that collective data-driven intelligence brings to any business and organisation, the use of an analytics platform not only requires minimal training, but removes the guesswork needed by users.”

Similar views are echoed

by Ettore Cucchetti, CEO, ACG Inspection, ACG Value Links, ACG Pharmagents. He informs, “Digitalisation will help pharma companies capture market insights from consumers, providing actual information about changes in market trends and challenges in the market. We have used ACG Inspection’s cutting edge technology to develop equipment and data management solutions that not only meet regulatory requirements but also meet technological requirements of the global pharma industry. In fact, ACG Inspection is one of the few companies that offer full spectrum of data management from line level to the cloud level.

Phanish Chandra, CEO, DocPlexus, states, “As today’s organisations recognise the benefits of a customer-centric approach, they make attempts to understand the ways in which they can fulfil the needs of their customer

42 EXPRESS PHARMA January 1-15, 2017

groups. Digital technology equips pharma marketers with detailed data-driven insights into physicians’ behavior, brand perception and product impact, among other things.”

Enhancing quality standards Cloud and mobile technology, sensors, and business intelligence is ushering a wave of automation in business processes which in turn will play a pivotal role in ensuring quality and transparency in the pharma industry.

Ettore explains, “Digitalisation will play a strategic role to enhance and maintain quality in the pharma industry.

It will help to have total process control across all stages: right from manufacturing, to the end of the packaging process, to the distribution channel and ultimately to end customer/consumer level.

Through brand protection, supply chain optimisation, development of internet of things, digitalisation can offer better cost control, improved quality and better production yield.”

Das adds to this and states, “It helps shorten discovery-tocommercialisation product cycles, improve physician feedback to manufacturers, and reduce the time and cost of regulatory compliance.”

“It facilitates closed loop marketing wherein doctors’ feedback on a particular marketing initiative is obtained and analysed to assess its effectiveness. Using advanced tracking tools for a range of metrics, pharma can pinpoint

exactly what is required by the market and develop perfect solutions,” informs Chandra.

Nishi Gandotra, CoFounder, Saveonmedicals.com, offers a perspective on how the spread of spurious medicines can be curbed through online pharmacies and says, “As of now, pharma sector, especially retail, is largely unorganised. There is substantial share of spurious medicines in pharma, since many transactions are being done without the proper bills.

Digitisation, e.g. online pharmacies, telemedicine platforms bring the probability of spurious medicines close to nil. Every transaction is on record, and the entire chain of transaction from manufacturing to end user can be traced easily. Another big advantage is that digitisation can provide a big pool of data which will help healthcare policy makers to analyse the incidence of various diseases and take steps accordingly.”

Engaging the patients In Chandra's opinion, “Digitisation increases visibility and reach. It lays a foundation for long-term engagement with the target audience. ‘Social listening’ ensures that a company takes necessary action to stay relevant even under rapidly changing scenarios. A constant connect with customers equips brands to stay competitive in the event of new product launches.”

He further expounds, “Digital initiatives are set to play a key role in Indian pharma’s success story. Modern med-

ical practitioners favour online media to access latest medical information and network with peers. A significant number of pharma’s future customers (doctors and patients) are going to be digital-natives. Consequently, a brand that is foremost in digital initiatives will gain the most recognition and engagement.”

Thus, it is becoming very evident that at atime when the focus is shifting from blockbusters to personalised medicines, the pharma industry can no more depend on just the traditional means of marketing. Leveraging the potential of the digital would become imperative and hence pharma companies are developing a structured strategy to make it the primary approach for customer engagement can no longer be delayed.

Ettore shares his perspective, “Pharma companies will be using digitalisation to market their brands strongly and effectively to the target audience. Through digitalisation, the pharma companies will be able to provide genuine and authenticated information to their customers.

Pharma companies are also looking toward customer/consumer engagement through digitalisation.”

Das further elaborates on how digital techniques can be deployed by pharma firms to reach out to consumers and says, “Sales people can communicate on patterns they see in their customers and react to changes more rapidly on the ground, at the speed of business. The ability to see

and explore the whole story in your data is essential to understanding and improving your business.”

Chandra adds, “Digital initiatives increase the probability of a successful product launch by making a wide audience aware of the uses, advantages, side effects and contraindications of the new molecule. Even before the product is ready to be launched, digital media lend valuable insights into what exactly is needed by the market.

This leads to the development of the right kind of product and increases the probability of it being widely accepted.”

He further states, “Digital marketing makes possible a results-driven mindset, in which organisational focus lies firmly on the desired outcomes, and key performance indicators are set keeping these outcomes in mind. It keeps the marketing function flexible so as to swiftly adapt its activities to meet the desired outcomes. Marketers can take immediate steps to respond to customer demands.”

Dealing with VUCA Another significant advantage of going digital is that it helps pharma players to stay relevant in a world which is beset by volatility, uncertainty, complexity and ambiguity (VUCA). Ettore points out, “Digitalisation is a key factor to keep the variable of VUCA at minimum. Digitalisation helps in risk assessments, to minimise counterfeiting and minimise inventory costs by supply

MANAGEMENT

Pharma companies sit on huge treasure troves of data, mostly stowed away in disparate organisational silos. Acquiring the ability to work and sweat that data to gather insights and drive more efficient decisions will help them unlock hitherto unknown potential Souma Das MD-India, Qlik

chain optimisation. Secondly, digitalisation will help pharma companies capture market insights from consumer, providing actual information, changes in market trends, and provide the visibility about challenges in the market.”

“In a volatile and ambiguous environment, digitisation becomes all the more important and relevant, since it helps in tracking and monitoring each and every transaction. So, it leaves no scope for misuse of any system. In fact, digitisation can not only help to make healthcare facilities available in remote areas, but also take care of all the anomalies which are prevalent in current scenario.”

Chandra connects it with pertinent, real-time examples and explains, “At present there is a lot of ambiguity around what doctors want from pharma. Efforts made by pharma to understand doctors’ opinions and their latest prescription patterns have proved ineffective as they largely encompass one-way communication from pharma to doctors. This has left most drug developers shooting in the dark. Digital marketing tools offer analytics-based insights into the physicians’ mindsets which give clarity regarding the type of information that doctors are looking for. Pharma can then communicate only the most relevant content and rest assured that its marketing efforts are not misdirected. Moreover, content that is personalised at an individual level will improve the marketing campaign’s effec-

tiveness.”

He further elaborates, “The USFDA have created uncertainties in the pharma world. Making things worse is the Indian Department of Pharmaceuticals’ recently introduced Uniform Code of Pharmaceutical Marketing Practices (UCPMP). This code marks the government’s move towards ethical pharma marketing practices and is the first step in a larger goal to formulate a compulsory marketing policy. The UCPMP threatens to render most of pharma’s conventional marketing practices useless. Digitisation will ensure that marketing continues to deliver the desired outcomes for pharma even after the UCPMP is enforced. Companies that have embraced digitisation are cushioned from the volatility and uncertainty that could arise from the UCPMP Act. In this scenario, digitisation will enable pharma marketers to build a future-proof knowledge-based relationship through ethical means.”

Challenges to conquer Thus, pharma companies are utilising digital technologies to open up new vistas for marketing and information exchange between key stakeholders which include key opinion leaders, doctors, therapists, and patients. But, there are several obstacles that could derail Indian Pharma Inc's digital journey.

Chandra draws attention to some of the challenges and lists down a few: Lack of C-suite support: Digitisation calls for a cultural

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shift in an organisation. In pharma’s case, strategic commitment of top level executives towards digital marketing is largely absent. Pharma’s approach to digitisation is restricted to individual projects for a particular business unit. This limited adoption will not translate into longterm benefits. Only when top leadership gets serious about going the digital way, will real change occur.

Poor expertise in executing technological changes and digital marketing: Pharma’s core competence lies in R&D of drugs that improve patient outcomes. Digital marketing is a new field that requires huge commitment in terms of time and talent. It is difficult for pharma to put together a cross functional team having expertise in digital marketing, content marketing, multi-media, analytics and data science.

Pharma cannot assure unbiased content: Even if pharma manages to build its own team of digital experts, there will always be concerns over the authenticity and unbiased nature of the content provided on its proprietary apps. Doctors are more likely to opt for neutral platforms that deliver impartial and accurate information on drugs.

Gandotra feels that the biggest challenge is lack of clarity of government regulations. She states, “Most of Indian laws in the healthcare sector were enacted more than 50 years back and these laws have not been updated with changing times. Resis-

tance of new age technology by traditional players has dampened the sentiments of new players in the industry.

Government should be taking appropriate steps to promote new age technologies, keeping in mind the interests of consumers, rather than some vested interests.”

Ettore also reiterates, “The challenges include cost and time required for implementation, lack of dedicated and talented resources to understand, design, select and maintain the right digital architecture.”

Getting future-ready Thus, several roadblocks exist but it is equally evident that the pharma sector needs to devise strategies to tackle these challenges and cannot shy away from adopting digitalisation. Fortunately, the industry is aware of it.

Chandra advises, “Indian pharma must act fast to adapt to an era dominated by technology. A solid digital strategy will help the industry tide over tough times and continue to be a valued stakeholder in the healthcare ecosystem.”

Ettore also espouses similar views and avers, “Pharma companies need to first understand their digitalisation strategy and objectives. Accordingly, the implementation plan needs to be drafted and implemented in a phase wise manner.”

Ettore states, “Through brand protection, supply chain optimisation, development of internet of things, digitalisation can offer better cost control, improved quality

and better production yield.

Also, digitalisation can bring pharma companies closer to their consumers, bringing in valuable information which will be essential for future innovations.”

Das informs, “With pharma companies waking up to the inherent benefits of technology, it is only a matter of time before we see commoditisation entering the fray.

The time is now to adopt digital technologies that will help improve innovation and commercial models for pharma companies. This will help them gain competitive advantage or less risk losing out.

Furthermore, digitalisation can help pharma companies occupy the central position in the healthcare digital transformation. ” “From identifying operational inefficiencies to evaluating and enhancing critical functions such as manufacturing and procurement; from augmenting omni-channel communication and collaboration strategies to driving supply chain efficiencies, more pharma companies are investing in digital technologies than ever before,” he informs further.

A Gartner report also validates this and foretells that IT spending in the life sciences sector will reach $54 billion by 2019, growing at average of five per cent from 2015-2019 annually.

Digital technologies have transformed and disrupted many industries, it seems that now it is the pharma industry’s turn. lakshmipriya.nair@expressindia.com

EXPRESS PHARMA

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January 1-15, 2017

MANAGEMENT INSIGHT

Impact of demonetisation on pharma industry Amit Mookim, GM, South Asia, QuintilesIMS, explains how digital way will not only benefit the customers but also the overall economy in the long run OVER THE last few years digital revolution has penetrated across many industries in India and has aided in disruption of business models. Notably amongst the most benefitted industries from digital revolution are e-retailing and financial services. Although slow, the pharmaceutical industry too has been gradually adopting digitisation to offer better patient experience. The recent announcement of demonetisation by the Government of India is an effort towards having a ‘digital India’. The relevance of digitisation have a direct correlation with a progressive economy.

While the bold step taken

by the government is highly commendable, we have evaluated the direct effect of this announcement on the pharma industry. We took up a survey across 399 stockist across India post the development and made a qualitative and quantitative analysis. 78 per cent of stockist reflect decreased sales in November 2016 vis-à-vis October 2016 on account of demonetisation with sales getting impacted by 21 per cent in value terms. North Zone is impacted to the maximum followed by South. The pharma companies would have faced severe pressure on primary sales on account of 60 per cent of stockist reflecting no change

in stock holding for the month.

Demonetisation also has an impact on the therapy areas, with chronic therapies performing marginally better than acute therapies. In addition, online pharmacies have seen an upsurge during the month.

Despite the hit on the overall pharma market, we do see long-term benefits of demonetisation. We will gradually witness a decrease in cash flow, as most transactions will be done through banks and online.

There will be documented account of transactions at all steps. This will indirectly cause cheaper medicines followed by appropriate invoicing and billing, a process that is not

mandatorily followed in the pharma market. Increasing bank and digital transactions by stockist, wholesalers, distributors and retailers will also help in regulating the industry at higher extent enabling more control of drug department at every purchase and sale. The government will be able to track the sale of banned or illegal drugs and also have the ease of implementing new regulations.

Demonetisation is an effort to ensure that we conduct our business in a fair and transparent manner. We need to look at this development as an opportunity to expand reach, create new innovations,

DEMONETISATION IMPACTANALYSIS

399 stockist were sampled to undergo qualitative and qunatitive impact analysis of demonetization in Nov 2016 Stockist were categorized as ■ A+ Stockist (Monthly turnover of 1+ cr), ■ A Stockist (50L – 1cr turnover / month), ■ B Stockist (25 – 50L turnover / month), ■ C Stockist (Less than 25L turnover / month) ■ A+ stockist contribute to 38% of turnover (i.e. 95 cr),A stockist contribute to 37% of turnover (i.e. 91 cr), B stockist contribute to 20%, C stockist contribute to 5%.

■ As per Zone, North contributes to 30%, South 27%, East 14%,West 29% Source: QuintilesIMS Stockist Research, November 2016 ■ ■

44 EXPRESS PHARMA January 1-15, 2017

MANAGEMENT

STOCKIST BY COUNT

■ Though the sales impact for the 1st fortnight of Nov was marginal on account of Demonetisation, the impact is clearly large by Nov 25. Out of the sampled 399 stockist, only 42 stockist had an increased sales for the same period, whereas 312 stockist had a decrease in sales and another 45 stockist had no impact on account of demonetization.

■ Among the Stockist categories: ■ A+ Stockist: 63% of stockist had a reduced sales for Nov 1-25 vis-à-vis Oct 1-25 (North Zone: 94%) ■ A Stockist: 77% of stockist had a reduced sales for Nov 1-25 vis-à-vis Oct 1-25 (North & South Zone: 82%) ■ B Stockist: 84% of stockist had a reduced sales for Nov 1-25 vis-à-vis Oct 1-25 ■ C Stockist: 86% of stockist had a reduced sales for Nov 1-25 vis-à-vis Oct 1-25 Source: QuintilesIMS Stockist Research, November 2016

improve market share, and provide additional value to customers by incorporating

digitisation into our business models. It is necessary that we all understand as a

country that moving towards reduced usage of cash and going the digital way will not

only benefit the customers but also the overall economy in the long run. Hence, the

effort should be a joint one between the government, the industry and the customers.

REPORT

Neurodegenerative drugs mkt set to hit $45 bn by 2022

According to GBI Research, much of the growth is expected due to the approval of many products THE neurodegenerative disorders market, which covers Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), Huntington’s disease, and multiple sclerosis (MS), is set to grow from $27.2 billion in 2015 to $45 billion by 2022, at a compound annual growth rate of 7.42 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that much of this growth is expected to occur between 2018 and 2022, due to the approval of many pipeline prod-

ucts within these years. Indeed, several late-stage products are expected to be highly commercially successful, including ocrelizumab, ozanimod, solanezumab, ITI-007 and RG7412.

Qaisrah Khalid, Analyst, GBI Research, explains, “There is a large pharmaceutical pipeline for neurodegenerative disorders, consisting of approximately 1,494 products in active development. The majority of pipeline products are novel active pharma ingredients, with only a small proportion of products being either generics, or

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Several key market players are forecast to maintain their strong market shares throughout the forecast period

repositioned from other indications – most of which are at Phase I. This indicates progress in terms of different molecules being developed as therapeutic agents within the neurodegenerative pipeline.”

GBI Research also states that several key market players, such as Biogen, Novartis and Sanofi, are forecast to maintain their strong market shares throughout the forecast period, despite the fact that many of the impending patent expiries – especially that of Biogen’s Tysabri and Novartis’ Gilenya – will affect these com-

panies directly.

Khalid continues, “The revenue for the highest-selling product within the MS market – Copaxone (glatiramer acetate), marketed by Teva – is expected to decrease substantially following its 2014 patent expiry, from just over $4 billion in 2015 to $2.5 billion by 2022, due to competition from generics, such as Glatopa. Declining revenues from this and other drugs will lead to a significant drop in the neurodegenerative disorder market share for Teva.”

EP News Bureau

EXPRESS PHARMA

45

January 1-15, 2017

RESEARCH UPDATES

Momenta’s Humira biosimilar succeeds in key psoriasis study In Momenta’s trial, adult patients with moderate-to-severe chronic plaque psoriasis received up to 48 weeks of treatment with Momenta’s drug

U

S biotech Momenta Pharmaceuticals said its experimental biosimilar version of AbbVie’s top-selling autoimmune drug, Humira, met the main goal in a late-stage trial involving patients with a form of psoriasis.

Humira, considered the world’s biggest-selling medicine, generates $15 billion in annual sales and treats rheumatoid arthritis, Crohn’s disease and psoriasis, among other conditions.

Biologics including Humira are manufactured in living cells, then extracted and purified. As they are more complex than traditional medicines and cannot be copied with precision, their knock-off versions are called biosimilars, rather than generics.

Several companies are developing biosimilar versions of top-selling biotech medicines for rheumatoid arthritis and cancer.

In September, Amgen’s Humira biosimilar was approved

by the US Food and Drug Administration - the first one to win US regulatory nod for the drug. But AbbVie is trying to block its launch, contending that Humira's patents should protect it until at least 2022.

Humira, generates $15 bn in annual sales and treats rheumatoid arthritis, Crohn’s disease and psoriasis, among other conditions

In Momenta’s trial, adult patients with moderate-to-severe chronic plaque psoriasis received up to 48 weeks of treatment with Momenta's drug, called M923, Humira itself, or Humira alternating with M923.

The percentage of patients that achieved at least a 75 per cent reduction on an index of psoriasis severity was equivalent between M923 and Humira, meeting the main goal of the study.

Momenta developed M923 in collaboration with Baxalta which is now part of Shire — but in September, Shire decided to end its biosimilars programme, and is in the process of transitioning the drug to Momenta.

Reuters

FDA approves Pfizer ointment for chronic itchy skin condition The topical drug, crisaborole, will be sold under the brand name Eucrisa, the FDA said A PFIZER ointment to treat mild to moderate cases of the itchy skin condition eczema, or atopic dermatitis, won US approval for use in patients aged two years and older, the Food and Drug Administration said.

Atopic dermatitis, a chronic inflammatory skin disease, is the most common of the many types of eczema, typically beginning in childhood and possibly lasting through adulthood.

The condition causes red, scaly and crusted bumps on the skin that can be extremely itchy.

The topical drug, crisabo-

46 EXPRESS PHARMA January 1-15, 2017

role, will be sold under the brand name Eucrisa, the FDA said. Pfizer, which acquired the drug through its $5.2 billion purchase of Anacor Pharmaceuticals earlier this year, has estimated potential annual peak sales for Eucrisa of about $2 billion. Eucrisa will carry a wholesale price of $580 for a 60 gram (2 ounce) tube and be available by the end of January, Pfizer said. The wholesale cost does not take into account discounts or rebates the company may offer insurers and pharmacy benefit managers. Atopic

dermatitis is considered to be a large market and an unmet need.

Regeneron Pharmaceuticals and Sanofi are awaiting an approval decision for their injectable drug dupilumab for more severe cases of atopic dermatitis, which patients have described as being like having a permanent case of poison ivy that leads to intense scratching and skin damage.

While dupilumab appears to be more effective, BMO Capital Markets analyst Alex Arfaei said in a research note,

"Eucrisa will likely have a dosing, safety and price advantage; attractive attributes for dermatologists." He sees the treatment reaching annual peak sales of about $2 billion by 2023. In clinical trials that led to the drug's approval, many patients who received Eucrisa experienced clear or almost clear skin after 28 days of treatment. The most common side effect was application site pain, including burning or stinging, the agency said.

Reuters

Proteon Therapeutics kidney drug fails key study Proteon is also testing the drug in another ongoing late-stage study PROTEON THERAPEUTICS said that its experimental chronic kidney disease drug failed to meet the main goal in a late-stage study. The company’s sole drug, vonapanitase, is being tested against a placebo in patients on or expecting to undergo dialysis after the creation of a radiocephalic arteriovenous fistula.

Proteon is also testing the drug in another ongoing latestage study. The disappointing results do not bode well for data from the second latestage study, expected to be re-

encouraging, the company said. Vonapanitase is also be-

ing evaluated for use in peripheral artery disease, and

Proteon has another drug in the preclinical stage of

development.

Reuters

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vealed in the second quarter of 2018, Baird Equity Research analysts said, downgrading the stock to ‘neutral’ and slashing their price target to $3 from $20.

The two studies are designed to evaluate whether a single 30 microgram dose of vonapanitase can improve the period of time during which a fistula remains open with adequate blood flow to enable dialysis, Proteon said. Surgical intervention is necessary to create the fistula, typically in the wrist, to facilitate a direct connection between an artery and a vein. The vein enlarges over a period of time because arterial blood is now flowing through the vein at a higher pressure. When dialysis is required, needles are inserted into the vein and connected to a dialysis machine. Patients with a fistula have a better chance of surviving renal failure. Blood vessel blockages in a patient’s fistula are a leading cause of corrective procedures and death. Data from secondary and tertiary goals is

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January 1-15, 2017

RESEARCH

Synergy Pharma’s irritable bowel drug succeeds in key study The US FDA is reviewing plecanatide for the treatment of chronic idiopathic constipation SYNERGY Pharmaceuticals said its experimental once-daily tablet, plecanatide, met the main goal of a late-stage study on irritable bowel syndrome patients with constipation (IBS-C), according to an analysis of preliminary data. The two doses being tested outperformed a placebo in patients who were overall responders.

Overall responders are patients whose abdominal pain was reduced by 30 per cent or more and whose spontaneous bowel movements increased at least once in the same week, for at least half of the 12 treatment weeks, Synergy Pharma said.

The most common side effect across the 1,135 adult patients in the trial was diarrhoea. Data on a second late-stage IBS-C study is expected to come later this month.

The US Food and Drug Administration is reviewing plecanatide for the treatment of chronic idiopathic constipation, and is expected to reveal its decision by January 29. The company plans to submit an application to

Plecanatide consists of 16 amino acids and is designed to stimulate fluid secretion and promote stool consistency

market the drug for IBS-C patients in 2017, it said. Plecanatide, which consists of 16 amino acids, is designed to stimulate fluid secretion and promote stool consistency.

Irritable bowel syndrome is a chronic condition and has three forms: constipation (IBS-C), diarrhea (IBS-D), or mixed (IBS-M).

About 4-5 per cent of American adults suffer from IBS-C, though this number may vary as patients often fluctuate between the three subtypes.

Reuters

Israel's Bonus says lab-grown bones successfully transplanted The material, grown in a lab from each patient's own fat cells, was injected into problematic bones ISRAELI BIOTECH company Bonus Biogroup's lab-grown, semi-liquid bone graft was successfully injected into the jaws of 11 people to repair bone loss in an early stage clinical trial, it said.

The material, grown in a lab from each patient's own fat cells, was injected into and filled the voids of the problematic bones. Over a few months it hardened and merged with the existing bone to complete the jaw, it said.

The announcement was made

48 EXPRESS PHARMA January 1-15, 2017

in a statement to the Tel Aviv Stock Exchange and Bonus Biogroup is presenting its results at the International Conference on Oral and Maxillofacial Surgery in Spain.

“For the first time worldwide, reconstruction of deficient or damaged bone tissue is achievable by growing viable human bone graft in a laboratory, and transplanting it back to the patient in a minimally invasive surgery via injection,” said CEO Shai

Meretzki.

Meretzki previously founded Pluristem Therapeutics, which works with stem cells and is one of the more advanced Israeli biomed companies. Ora Burger, VP of regulation affairs at Bonus Biogroup, said the transplant ‘was 100 per cent successful in all 11 patients.’ “Now we are going to conduct a clinical study in the extremities, long bones,” she said.

Reuters

Further promising data seen with Biogen Alzheimer’s drug: Study GRADUALLY INCREASING the dose of Biogen’s experimental Alzheimer’s disease drug appeared to reduce the risk of brain swelling compared to higher fixed doses, interim 12-month results from a small study released showed. The closely watched drug, aducanumab, led to significant reductions in amyloid plaques in the brain compared with a placebo among the 31 early-stage Alzheimer’s patients given titrated, or gradually increased dosing, according to data from the Phase I study.

“These data appear solid to us, and if anything provide additional confidence in the programme and viability of the titration regimen,” Evercore ISI analyst John Scotti said in a research note. Any successful Alzheimer’s drug is expected to reap multi-billiondollar annual sales. In the group of trial patients given titrated dosing, 35 per cent experienced a side effect involving a fluid shift in the brain, compared with 55 per cent given a high fixed dose, Biogen said.

Biogen last year began enrollment in two Phase III trials of aducanumab using titrated dosing, but those results are still several years away, said Samantha Budd Haeberlein, the company's VP, clinical development.

The amyloid reduction and slowing of mental decline seen in patients in the titration portion of the Phase I study after 12 months of treatment were similar to what was reported earlier this year for patients who received fixed doses of aducanumab. Full details of the study were being presented at an Alzheimer's meeting in San Diego. Patients in the study had either mild or prodromal, meaning early pre-symptomatic, Alzheimer's disease, researchers said.

Aducanumab works by removing brain plaques largely made from a protein called beta amyloid.

Other companies have also tried to develop drugs that block beta amyloid, but all failed to significantly slow cognitive declines, and some were also associated with brain swelling. The most spectacular recent failure was Eli Lilly and Co's experimental solanezumab, designed to soak up beta amyloid from the bloodstream. Lilly last month said its infused drug failed to slow mental decline, compared with placebo, among patients with mild Alzheimer's. That largely dashed hopes for the drug and cast further doubt on whether beta amyloid is the right target for attacking the memory-robbing disease that affects millions of people.

Some Alzheimer’s experts have suggested the approach might work very early in the course of the disease. They said once brain plaques can be observed it may already be too late for the drugs to provide significant benefit.

Reuters

RESEARCH

AstraZeneca pill slashes lung cancer progression in study The medicine is designed to help cancer patients with certain genetic mutations that are very common in China and other parts of east Asia ASTRAZENECA'S PILL Tagrisso cut the risk of lung cancer progressing by 70 per cent compared to standard chemotherapy in a major clinical trial, lifting prospects for a drug that is key to the company's lofty long-term sales goals. The medicine is designed to help cancer patients with certain genetic mutations that are very common in China and other parts of east Asia. Tagrisso is already on the market, winning early approval

sus forecasts have now risen to $2.5 billion for 2022, according to Thomson Reuters data, helped by its strong launch and the failure of some rival products. Sean Bohen, AstraZeneca’s CMO, told Reuters the latest data showed ‘a pretty extraordinary benefit,’ especially as Tagrisso also produced better results than chemotherapy in patients whose cancer had spread to the brain.

The drug, already approved in major Western markets and Japan, is currently under fast track review in China, where nearly half of lung cancer patients are thought to have the EGFR mutation based on mid-stage studies and selling $276 million in the first nine months of 2016, but AstraZeneca was required to produce a confirmatory Phase III randomised study detailing its benefits.

Results released recently showed that Tagrisso, given as a second-line treatment, helped patients live a median 10.1 months before their cancer worsened, against 4.4 months for those on chemotherapy. Tagrisso patients also had fewer drug-related side effects. AstraZeneca said it would continue to monitor patients to see if the improvement in progression-free survival also translated over time into increased overall survival. The lung cancer pill is a key component of AstraZeneca’s target to lift sales to $45 billion by 2023. The company set that goal in response to a takeover attempt by Pfizer in 2014, with Tagrisso forecast to contribute $3 billion.

At the time, many analysts viewed the Tagrisso target as highly ambitious. Yet consen-

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Studyraises questions over benefit of Roche’s Gazyva cancer drug ROCHE'S GAZYVA cancer drug did not show a significant overall survival benefit and raised greater safety concerns than its predecessor Rituxan, a study showed, raising doubts over the Swiss pharmaceuticals group’s bid to replace a key blockbuster.

Gazyva is used with the chemotherapy drug bendamustine to treat follicular lymphoma (FL) and Roche is counting on it to help mitigate the impact of biosimilars on Rituxan, whose patents expired this year. Roche failed to find a follow-up drug to its Avastin blockbuster this year and faces competition from rivals including Novartis whose Sandoz generics unit is hot on Rituxan's heels.

An analysis released at the weekend meeting of the American Society of Hematology found that for patients with previously untreated FL, those getting Gazyva and bendamustine showed a 94 per cent overall survival rate at three years. That compares with 92 per cent overall survival among those getting

Roche failed to find a follow-up drug to its Avastin blockbuster this year and faces competition from rivals including Novartis whose Sandoz generics unit is hot on Rituxan's heels

Brain tumours are an important consideration in lung cancer, since 25 to 40 per cent of patients have brain metastases at some point in their disease. Results of the trial, involving 419 patients whose disease had progressed after using a so-called EGFR inhibitor drug such as AstraZeneca's Iressa or Roche's Tarceva, were presented at the World Conference on Lung Cancer and published online in the New England Journal of Medicine. AstraZeneca is also assessing Tagrisso as a first-line treatment in a non-small cell lung cancer clinical trial that will report results next year.

The drug, already approved in major Western markets and Japan, is currently under fast track review in China, where nearly half of lung cancer patients are thought to have the EGFR mutation.

By comparison, EGFR-mutated lung cancer accounts for only 10-15 per cent of cases in Europe and the US. Reuters

Rituxan and chemotherapy, raising concerns among analysts that Roche will have trouble differentiating Gazyva. "A few physicians we spoke to were unimpressed... which could make it more difficult to replace Rituxan with Gazyva," Jeffrey Holford at Jefferies said in a note to investors.

Roche said the trial had shown Gazyva to be superior to the current standard of care and the improvement was ‘meaningful.’ “People with this disease need better initial treatment options that delay their cancer getting worse, since the disease is incurable and becomes more difficult to treat with each relapse,” a Roche spokesman said.

In the more-detailed analysis released at the US meeting this weekend, Roche said Gazyva improved progression-free survival by 34 per cent among 1,202 patients in the study. But analysts said three-year-old Gazyva’s safety profile in combination with bendamustine was a concern, with the rate of severe, life-threatening and fatal adverse events 74.6 per cent with Gazyva, versus 67.8 per cent with Rituxan. “The data presented was critically perceived by haematologists, as the favoured combination with bendamustine appears relatively too toxic,” Bank Vontobel analyst Stefan Schneider said. “It will take a strong effort from Roche to achieve a broad switching.”

Reuters

EXPRESS PHARMA

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January 1-15, 2017

RESEARCH

ReNeuron says stem cells improved motor function in stroke study ReNeuron said that three out of the 21 patients achieved improvement in their motor function at three, six or twelve months after treatment BIOTECHNOLOGY COMPANY ReNeuron Group said its experimental stem cell therapy helped some patients improve motor functions in their arms in a mid-stage study after being disabled by stroke. ReNueron’s trial adds to a small but growing number of studies being conducted by a few publicly listed companies around the world that are testing stem cell therapies in various indications.

Stem cell therapy development has been stalled in the past by stricter regulations in US, and concerns over side effects in testing a field that experts believe is still in its nascent stages. US stem cell

therapy developer Asterias Biotherapeutics said in November that an early study of its treatment for complete spinal cord injury hit its efficacy target within three months. Fellow US

stem-cell therapy developer StemCells merged with Israeli company Microbot Medical in August, a week after it scrapped a mid-stage study on its treatment for spinal cord injury.

ReNeuron said that 15 out of 21 patients that were treated with the company’s CTX cell therapy showed statistically significant improvement on various scales in the study.

The company said that the data was encouraging despite the study failing to meet its main goal, as some of the responses to the treatment came after the study period of three months. The British biotech firm had set the main goal of the mid-stage study as a two-point improvement in the motor function at three months after treatment, in two patients out of the 21 who have suffered a stroke and participated in the study.

ReNeuron said that three out of the 21 patients achieved improvement in their motor function at three, six or twelve months after treatment. The company plans on testing the stem cell treatment in a larger study. ReNeuron had said in August that based on the results of the mid-stage study, it would apply to various health regulators to start a phase 2/3 study in the first quarter of 2017. The company is also testing its stem cells in early stage studies to treat patients with Critical Limb Ischaemia and a kind of vision problem called Retinitis Pigmentosa.

Reuters

Novo, Sanofi go head to head as FDA clears new diabetes drugs The two drugmakers hope they will boost revenue at a time when insulin prices are under intense pressure in the key US market RIVALS NOVO Nordisk and Sanofi have won US approval for new combination drugs to treat diabetes, sparking a fresh battle for sales in a fiercely competitive market.

Novo’s Xultophy and Sanofi's Soliqua both combine a longlasting insulin with a so-called GLP-1 medicine that stimulates insulin production in the pancreas.

Officials at the Danish and French companies said that the rival treatments would be sold at discounts to the combined price of the component ingredients.

The combination products are viewed by analysts as having substantial sales potential and the two drugmakers hope they will boost revenue at a time when insulin prices are under intense pressure in the key US market, the world's biggest.

Some 400 million people

50 EXPRESS PHARMA January 1-15, 2017

worldwide suffer from diabetes, with type II accounting for more than 90 per cent of the total, as rising obesity rates fuel the epidemic in the US and many other countries.

Jakob Riis, Novo’s head of North American operations, said millions of US diabetics were using insulin but around half were not getting satisfactory treatment, so there were lots of patients who could benefit.

Achieving Xultophy's full potential will take time, however, as Novo negotiates reimbursement terms with insurers.

“We will go for a focused launch of Xultophy, which will reflect the fact that not all patients will have access to this product through their insurance. That is something we will develop over time,” Riis told Reuters.

The timing of the approvals is broadly in line with expecta-

tions for Sanofi but a few weeks ahead of the scheduled decision date for Novo.

Following the green light from the US Food and Drug Administration (FDA), Sanofi said it planned to launch Soliqua in January, while Novo intends to launch Xultophy in the first half of next year.

Industry analysts expect Xultophy to generate annual sales of around $1.20 billion in 2021, while Soliqua is forecast to reach $550 million by then, according to Thomson Reuters.

Xultophy, approved in Europe since 2014, combines Novo's insulin drug Tresiba with its GLP-1 agonist Victoza. Soli-

qua is a mix of Sanofi’s Lantus and the GLP-1 Lyxumia.

Novo said Xultophy would be offered at a 20 per cent discount to the combined price of Tresiba and Victoza, while Sanofi said Soliqua would cost about same as a GLP-1 drug.

Both new drugs are given as once-daily injections and are designed to improve glycaemic control in adults with type II diabetes.

Jefferies analysts said the most notable aspect of the FDA decisions was that Sanofi had only been granted approval for a single pen device, with one fixed ratio between insulin and GLP-1.

The French drugmaker had originally filed for two devices with different ratios but FDA advisers considered this could cause confusion.

Reuters

PHARMA ALLY I N T E R V I E W

Verayo chip has a huge opportunity in India Datta Nadkarni, CMO, Verayo, explains the features of Verayo chip which can bring about revolutionary changes in the way drugs are protected from counterfeiting, in a discussion with Sachin Jagdale Explain the mechanism of Verayo chip.

The Verayo chip is an NFC/ISO14443-A highfrequency (HF) RFID Integrated Circuit (IC) device that incorporates Physical Unclonable Function (PUF) technology. The PUF technology enables true authentication of articles using the emerging NFC protocol in mobile phones.

Major features of the IC include: ◗ Passive RFID Tag – no external power required ◗ Contactless data transfer ◗ NFC/ISO14443-A RFID standard ◗ Physically Unclonable Function (PUF)-based True Authentication ◗ Near Field Communication (NFC) tag-compatible ◗ 13.56 MHz operational frequency ◗ 1024 bits of non-volatile memory (NVM) including: 96 bits factory-programmed unique ID & configuration 896 bits user memory (including 32 bits as user-programmable OTP) 32 bits of lock, reserved bits ◗ Simple reader access mode ◗ ISO 14443-3, Type A, Cascade Level 2 Anti-Collision• 106kb/s data transfer rate ◗ CRC and parity data integrity ◗ 50 pF resonant capacitor A data sheet is available from Verayo, for the IC, on request.

How is this chip superior to 2D barcode?

2D barcodes are vulnerable to counterfeit and replication attacks because of their static nature. Even the user of additional technology, such as block chain, cannot prevent product substitution attacks as 2D barcodes can be replicated

liquor company.

In which markets are you selling your chips? Can you name some of your major pharma clients?

Our chip technology is in use in the US with Dept of Defense, and only recently opened up for the consumer space. We have already deployed it in China for a liquor brand, Japan for Canon cameras etc. We saw a huge opportunity in India to save consumer lives by partnering with major drug companies and helping them deploy our chip technology. We have started talking with Indian companies only in the past three to four months. We now have a couple of pilot tests being implemented in the coming weeks.

and counterfeit drugs with replicated 2D barcodes can be substituted while the product is in transit. Existing 2D barcode approaches assume a chain of trust in the supply chain. PUFNFC approach allows one party to audit another through multiple dynamic authentication which is not possible with a static 2D barcode.

Embedded PUF technology makes each IC unique, with a large entropy space. This uniqueness in conjunction with a random challenge/response protocol provides for true authentication of articles.

Additionally, the Verayo IC utilises the growing/ubiquitous mobile phone NFC infrastructure. This enables true authentication at the enduser, without proprietary systems/hardware.

2D barcodes are vulnerable to counterfeit and replication

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attacks because of their static nature. This vulnerability cannot be designed out, rather only complimented with other mechanisms (Block Chain).

Embedded PUF technology makes each IC unique, with a large entropy space. This uniqueness in conjunction with a random challenge/response protocol provides for true authentication of articles.

Additionally, the Verayo IC utilises the growing/ubiquitous mobile phone NFC infrastructure. This enables true authentication at the enduser, without proprietary systems/hardware.

Do you have any case study to share?

We have used this chip in Canon: Anti-counterfeit of cameras, in the US: major tire company for tire tagging/inventory, geo-location tracking and in China: Major

With pharma companies already under huge pressure over drug pricing related issues, do you think using Verayo chips will further add to the cost of the medicine?

Yes, the incremental cost will be more; however, the benefits are much greater. Frankly speaking, What price can you put on saving human lives?

This chip offers the following key benefits: ◗ Prevention of supply chain substitution attacks ◗ Does not presume a chain of trust in supply chain; allows multiple parties to cross audit authenticity through dynamic challenge/response authentication (not possible with static ID that is the same every time) ◗ Consumer safety, saving lives ◗ True authentication to the end user ◗ Ubiquitous NFC deployment ◗ GPS location tracking of goods

◗ Direct marketing/sales ◗ User experience, dosage information ◗ Medicine reminders ◗ Back-end server software allows for applications not yet conceived How do you plan to promote Verayo chip in India? Has it already been launched in the country? If not what is the approximate time frame set for the same?

We have talked to 30+ pharma companies in India along with other industries where product authenticity is important from a safety point of view for consumers, as well as brand protection for the manufacturers. We are in a soft launch mode for the next three months and implement a few case studies in multiple industries. After that we will leverage the media in highly visible public interest platforms in news, PR and product promotions jointly with product manufacturers.

Besides pharma, which are the other industries where Verayo chip will have an application?

It can have applications in: ◗ Currency with track n trace geo-location capability ◗ Authentication of consumer identity for “one view of consumer” ◗ University certificates for authentification ◗ Aadhar card address change/update ◗ Marketing/branding for various FMCG products ◗ The list is endless limited only by ours and our partners’ creativity. sachin.jagdale@expressindia.com

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PHARMA ALLY VENDOR NEWS

Fabtech Technologies signs contract with Vacsera (Egyvet) The $19 million project will produce 400 million doses of the bird flu vaccine VACSERA (EGYVET), an Egyptian company for veterinary drugs and vaccines has recently signed a contract with Fabtech Technologies to establish the first vaccines facility for avian flu vaccines in Cairo, Egypt. Present on the occasion were Dr Khalid Mujahid, spokesperson for the Ministry of Health in Egypt and the Health Minister Dr Ahmed Imad Eddin.

The $19 million project will produce 400 million doses of the bird flu vaccine in the first year and over 800 million doses from the second year onwards. The project is scheduled to be completed in 18 months. The project is funded by a loan of $15 million from development partners

Hassan of the Islamic Development Bank and another loan of $4 million from the Saudi finance fund. Fabtech Technologies have gained a reputation of successfully implementing turnkey pharmaceutical, biotech and vaccine projects globally.

Fabtech, a global integrated engineering enabler, specialises in innovative turnkey solutions for pharmaceutical, biotechnology and healthcare segments.

With over 14 years of experience, and more than 700 installations in over 42 countries, they have grown into one of the leading engineering and construction partners for pharma and allied industries.

EP News Bureau

ERT launches multi-language diagnostic platform for respiratory trials Native language capabilities significantly improve site performance and clinical data quality ERT, PROVIDER of highquality patient data collection solutions for use in clinical drug development, announced a significant enhancement to MasterScope, the company’s flagship platform for centralised respiratory clinical trials, making it the industry’s first and only multi-language solution.

With multi-language capabilities, MasterScope enables sites to manage respiratory trials in their native language, which saves time, reduces the risk of protocol compliance errors, and improves overall data quality. Sponsors can

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With multi-language capabilities, MasterScope enables sites to manage respiratory trials in their native language, which saves time, reduces the risk of protocol compliance errors, and improves overall data quality now confidently expand the scope of countries in their trials, removing language as a barrier to site performance.

“Respiratory trials are highly complex, requiring in-

vestigative site personnel to guide patients through precise manoeuvrers in order to collect accurate data that supports drug efficacy and safety claims,” said Achim Schülke,

EVP, Respiratory Solutions at ERT. “Assuming all site personnel and patients can comprehend English well enough to accurately follow these workflows is impractical.

With these enhancements to MasterScope, sponsors running global cardiopulmonary trials can now add native language capabilities to reduce another level of risk while increasing site compliance.”

ERT’s MasterScope supports any clinical trial that requires spirometry measurements, including those that also collect Fractional exhaled Nitric Oxide (FeNO), electrocardiogram (ECG), home spirometry, and electronic Clinical Outcome Assessment (eCOA) data.

EP News Bureau

PHARMA ALLY

Oxford Gene Technology launches SureSeq myPanel NGS Custom FH Panel SureSeq myPanel NGS Custom FH Panels enable streamlined investigation of FH and customisation of content OXFORD GENE Technology (OGT), the molecular genetics company, has expanded its customisable SureSeq NGS panel range with the launch of the SureSeq myPanel NGS Custom FH Panel – allowing fast and cost-effective study of variants in familial hypercholesterolemia (FH). The new panel delivers both single nucleotide variation (SNV) and copy number variation (CNV) detection on a single small NGS panel assay and allows customisation by ‘mix and match’ of fully-tested and optimised gene and hotspot content. This includes all exons for LDLR, PCSK9, APOB, LDLRAP1, APOE, LIPA and STAP1 and a further 14 single-nucleotide polymorphisms (SNPs). This enables researchers to selectively sequence relevant regions, increasing throughput and saving on reagents.

FH is characterised by high LDL levels leading to early-onset coronary artery disease — treatable with statins. It is well characterised at the molecular level with various genes and multiple point mutations described. Analysis of mutations is often time-consuming when performed by multiple PCR or Sanger sequencing reactions and around 5-10 per cent of mutations are due to CNVs, requiring further detection by Multiplex Ligationdependent Probe Amplification (MLPA).

In order to cost-effectively streamline detection, OGT’s FH panel will allow sequencing of all relevant gene regions in one assay. In addition, hybridisation-based enrichment delivers unparalleled completeness and uniformity of coverage, removing the need for supplementary fill-in by Sanger sequencing

and enabling simultaneous detection of SNVs and CNVs. Detection of CNVs has shown complete concordance with microarray results (the gold standard for CNV detection) in all samples tested by OGT. This means that researchers can analyse CNVs with confidence, removing the need for additional MLPA testing, saving time and costs. OGT also has customisable CytoSure microarrays available for downstream CNV confirmation.

Dr Mafalda Bourbon, Head of the Cardiovascular Research Group at the National Health Institute Doutor

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Ricardo Jorge, Lisbon, Portugal, is using a custom FH panel and commented, “We were previously using another custom panel but found OGT’s custom FH panel much easier and more costeffective to work with. From the start we worked very closely with OGT on the design of the panel and were impressed by the support they gave us, especially with the bioinformatics. The ability to call CNV from the NGS data as well as point mutations is also extremely valuable to us.

The fact that the panel is preoptimised has reduced the need for in-house optimisa-

tion and decreased our assay development time.”

Emma Shipstone, EVP Marketing, OGT added, “Being able to confidently detect SNVs and CNVs on one panel is a big step forward. Our hybridisation methodology and bait design expertise make this possible by ensuring our panels deliver outstanding completeness and uniformity of coverage. Areas of CNV can be easily identified within each sample — delivering an increased understanding of the sample more rapidly and cost-effectively for our customers.”

EP News Bureau

Agilent Technologies and Transcriptic collaborate AGILENT TECHNOLOGIES and Transcriptic have agreed to partner their technologies to provide a solution for convenient, broad scale synthetic and discovery biology research.

Agilent continues its strong programme of fostering innovation using the Agilent portfolio by collaborating with rising companies such as Transcriptic to develop novel synthetic biology solutions. Transcriptic’s automated discovery biology platform enables scalable life science research through a convenient and simple web interface. Biologists who use the platform can control their science and generate data remotely via the cloud.

Transcriptic will add multiple Agilent Genomics product lines for mutagenesis and cloning to the protocol library within the Transcriptic robotic cloud laboratory.

The first in the series – QuikChange Lightning – will accelerate the generation of multiple mutants for large protein function projects. Providing cutting-edge Agilent bioreagents in a robotic laboratory setting will allow a global customer base to automate and optimise workflows for rapid and efficient research discoveries.

“We’re excited to combine our genome engineering tools with automated experimentation,” said Herman Verrelst, VP, Agilent and GM of the company’s Genomics Solutions Division and Clinical Applications Division. “Transcriptic’s services are validated, scalable, and accessible from anywhere in the world, which will enhance the market for our industry-leading reagents.”

“Agilent QuikChange site-directed mutagenesis kits have an unsurpassed reputation for being reliable and easy to use,” said Yvonne Linney, COO, Transcriptic. “By bringing these products to Transcriptic, we will make it extremely easy for customers to scale up their research, using many mutants to produce very large datasets for exploring protein function.”

EP News Bureau

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PHARMA ALLY

Albert David to open new division to focus on gynaecology and orthopaedics It is a move to help the company to expand the customer base, product basket and its presence in various segments and achieve its growth objectives of the next five years KOLKATA'S LEADING pharma company, Albert David, a unit of Kothari Group, has initiated the process of opening a new division which would focus primarily in the therapeutic segments of gynaecology and orthopaedics and help the company achieve the growth objectives of the next five years.

To maintain its competitive edge in low price common dosage forms and to maintain the vibrancy of its product portfolio several newer formulations are being outsourced in line with the growth strategy of

the company. Reportedly, this move would also help the company to expand the customer base, product basket and its presence in various segments.

Currently, Albert David manufactures pharma formulations, bulk drugs and injections.

It has manufacturing plants at Kolkata, Ghaziabad and Mandideep (Bhopal). The Kolkata factory produces tablets, powders, small volume parenterals, oral liquids and bulk drugs.

The Ghaziabad plant manufactures IV fluids in glass and polyethylene containers using Blow Fill Seal Technology

(BFS), small volume parenterals and capsules. Plant located at Mandideep is dedicated to produce disposable syringes and needles.

Technology upgradation and a fully revamped Research & Development (R&D) department would support the growth plans of the company with more in-line oral solids, liquids and sterile liquid dosage forms.

The company also has an active Export Division which is engaged in the process of developing specific dossiers for registration and future business in various countries.

The current export focus of Albert David Limited is restricted to the Rest of the World (ROW) markets.

In the last fiscal (2015-16), the company recorded a topline of ` 321.30 crores and is expecting to touch ` 345 crores by the end of March 2017.

The two launches, DHUP (Vitamin D3) and Inbalanse (Probiotic) would not only add to increase the net turnover of the company but will also open up newer therapeutic segment to ensure rapid growth and facilitate future launches.

Understanding the chal-

lenges which has risen due to various government policies, viz. FDC Ban, DPCO and stricter regulatory norms for both pharma formulations and FSSAI products, the company has put its strategies in place to tide over such hardships and sail through successfully to achieve its business goals.

EP News Bureau (In Dec 16-31, 2016 issue of Express Pharma, the write-up of Albert David was inadvertently missed out.

The error is regretted)

ASPA, MFI to organise ‘The Authentication Forum 2017' The conference,to be held on February 8-9,2017 will focus on authentication solutions and case studies AUTHENTICATION Solution Providers’ Association (ASPA) and Messe Frankfurt India (MFI) will organise India’s first international authentication conference, 'The Authentication Forum 2017' at The Taj Mahal Hotel, Man Singh Road, New Delhi from February 8-9, 2017.

The event had a two-day conference and an extensive display area, with more than over 120 delegates and leading anti-counterfeiting solutions companies demonstrating their latest offerings and discussing the latest generation authentication solutions.

UK Gupta, President, ASPA said, “We are delighted to announce the Authentication Forum 2017. Product counterfeiting in India resulted in loss of `39,239 crores to Indian economy in fiscal year 2013-14. This is a serious menace and we aim to create more awareness among the government, public and exhibitors about the problems created by counterfeiting, IPR infringement issues among

54 EXPRESS PHARMA January 1-15, 2017

Signing of MoU between Messe Frankfurt and ASPA

others. The initiative taken by our government of demonetisation have exposed the established link in between terrorism and counterfeiting. Our goal is to unite the industry and spread awareness on the impact and consequences against counterfeiting to provide consumers genuine and authentic goods which will ultimately lead to the economic growth of the country,

enhancement in revenue for brand owners and governments as well as consumer empowerment and satisfaction.”

Dr GN Singh, Drug Controller General (India), Central Drugs Standard Control Organization, CDSCO; Anil Rajput, Senior Chair - FICCI CASCADE and Vice President - Corporate Affairs, ITC, Arvind Gupta, National President, IT

Cell, Bhartiya Janta Party, Uday Devineni, ICE Representative, Department of Homeland Security-Homeland Security Investigations, US Embassy, New Delhi, India Enforcement (ICE) Homeland Security Investigations, Mark Davison, Founder & CEO, Blue Sphere Health, Ravi Mathur, CEO, GS1 India, Pramod Krishna, Director General, Confederation of Indian Alcoholic Beverage Companies (CIABC), Pradeep Shroff, Noted Anti-Counterfeiting Expert and Author & Former President, ASPA & Managing Director – PRS Permacel, UK Gupta, President, Authentication Solution Providers’ Association (India) and Manoj Kochar, Chairman, International Hologram Manufacturers Association (UK), are likely to take part in the event.

Raj Manek, Executive Director and Board Member, Messe Frankfurt Asia Holding said, “The seriousness in tackling the counterfeit issue is evident with the recent move of demonetisation and pertinent policies in the

country. However, this issue needs to be addressed with equal significance across multiple sectors and the authentication forum will be the driving force of this change. The forum aims to educate brand owners, government authorities and consumer about the importance of fighting counterfeits and bring forward authentication solutions that can help reduce its impact.”

The Authentication Forum conference is a part of ASPA ‘Make Sure India’ campaign running across India. To take this initiative forward, ASPA has found a strong partner in Messe Frankfurt India with its portfolio of 22 prestigious trade fair brands and over 35 conferences and across B2B markets of automotive, automation, lighting, technology and production, textiles, consumer goods, entertainment, media and creative industries and environment technology.

EP News Bureau

PHARMA ALLY PRODUCTS

Videojet boosts productivity and efficiency with new CO2 laser range IN RESPONSE to manufacturers’ needs for higher quality codes, Videojet Technologies, a global leader in coding, marking and printing solutions, has advanced its range of CO2 laser marking systems with the introduction of the Videojet 3340 and 3140 laser marking systems. This advanced CO2 laser range is designed to help deliver peak coding performance for mainstream applications, as well as a solution for manufacturers that require faster data processing speeds, high-speed coding up to 900m/min and large marking fields across a wide web application.

Recognising that high-quality codes are important for manufacturers, the new Videojet laser solutions offer speed improvements in data processing and communication over its predecessor lasers. This im-

provement provides benefits for a range of applications from food and beverage, to pharmaceutical and tobacco by providing more time to engage the product, more time to finish the required mark, and ultimately producing higher quality codes.

Marking speed enhancements of the new Videojet 3340 laser marking system are impressive, and manufacturers can now mark four lines of variable data, plus 2D codes at 400+

products per minute. With mark speeds of up to 2,000 characters per second, the Videojet 3340 offers the equivalent in speed and capability of one of the leading 60W lasers on the market today.

This has significant cost, space and power advantages for manufacturers, integrators and other machine builders.

These advanced CO2 laser solutions offer the largest marking field in the industry and are 20 per cent wider than the clos-

est equivalent on the market today. The Videojet 3340 can now cover up to 600 mm marking field width, allowing certain wide web applications to be addressed with one laser that previously would have required two lasers. The large marking window helps to increase throughput and productivity.

Complementing the 3340 and 3140 laser marking systems, Videojet also offers a range of fume extraction systems and fil-

ter options that can be tailored for the given application, helping to remove smoke and particulate debris and improving uptime by keeping the laser lens clean. Specifying the right laser solution supports easy integration, speeding up the installation and changeover process and ultimately increasing uptime. In addition to this, the detachable umbilical cable can be easily routed during set-up, helping to eliminate the need to move other machinery.

The Videojet 3340 and 3140 laser marking systems are one of a number of innovative new laser products being launched

by Videojet in 2016.

Contact details Call +91-7506345599 Visit: http://www.videojet.in Visit: www.videojet.in

Waters launches Torus SFC columns WATERS CORPORATION expanded its Torus SFC column line with the addition of four new preparative supercritical fluid chromatography (SFC) columns. The new achiral SFC columns are designed for purification laboratories scaling up their separations of investigatory drug compounds, natural products, or synthetic chemicals.

Dart Neuroscience, a San Diegobased speciality pharmaceutical and research firm recently evaluated the Torus columns for the purification of small molecule drug compounds.

Torus Columns for preparative SFC give scientists the resolving power they need to speed method development and scale up their separations from analytical to preparativescale achiral separations. Based on a new and proprietary bonding chemistry, the columns come in four differ-

ent phases to cover a range of selectivity while being stable and reproducible ensuring day-to-day and batch-tobatch consistency. Torus 1.7 and 5 micron columns are available in four chemistries: 2-picolylamine (PIC), diethylamine (DEA), high density diol (DIOL) and 1-aminoanthracene (1-AA) and in a variety of internal dimensions and lengths, and are sold with the Waters SFC 100 System and other commercial preparative SFC instruments.

Contact details Dayamani Santosh Sr Admin Officer Waters India 36A, II Phase, Peenya Industrial Area, Bangalore 560 058 [T] 080-49292200-03 [F] 080-49292204 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@waters.com

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PHARMA ALLY

Alfa Laval launches rotary jet head TRADITIONAL SPRAY balls in jet heads used for cleaning tanks in manufacturing facilities are static. Thus the majority of the tank cleaning energy comes from water cascading down over the tank wall at low wall shear stress. This way of cleaning requires more time, water and energy in order to compensate for the poor cleaning performance. Because of the unique design of Alfa Laval Rotary Jet Head, the first - out of eight - cleaning cycles hits the tank wall at an evenly dense cleaning pattern throughout the entire tank surface. The distance between the footprint tracks is relatively wide, but if the product is easy to clean off (e.g. milk or syrup) it only requires little wall shear stress to be removed. This means the pre-rinse cleaning of the tank is done using only one cleaning cycle, resulting in a saving of time, water and energy.

One cleaning cycle typically

terms of payback time, compared to a static spray ball, the Alfa Laval Rotary Jet Head is a higher initial investment, but its low operating cost gives a short payback time - often less than one year.

takes one to three minutes. and now that the product is effectively removed from the tank

wall, the jet will offset the second cleaning cycle, thereby minimising the distances be-

tween the jets. More cleaning cycles are needed for products that are harder to clean. In

Contact details: Alfa Laval Kolding Registration number: 30938011 http://www.alfalaval.com

PCI Analytics launches ultrapure laboratory gas generators PCI ULTRAPURE Digital Display Gas Generators manufactured using modern PSA technology, CE marked, eliminates the downtime, constant monitoring, and routine maintenance, availability and logistical issues associated with using cylinders. PCI Analytics Ultrapure Gas Generators produce gas continuously and reliably, without interruptions that can be experienced during cylinder changes or delays in delivery when using gas cylinders. An ultrapure and consistent gas supply is needed for reproducible analytical results, but gas purity can vary from cylinder to cylinder in a way that is difficult to control. Dirty or rusted cylinders can also introduce contaminants and particulates into your gas stream. PCI Analytics Ultrapure Gas Generators eliminate these problems by continuously generating clean

56 EXPRESS PHARMA January 1-15, 2017

PCI Gas Generators are so compact and aesthetic that these can be placed in the lab in close proximity to your instruments, eliminating the need for a remote, isolated storage area and pure gas.

PCI Gas Generators are a safe, compact, and minimal maintenance source of high-purity gas. Routine maintenance is minimal and since generators don’t store gas at high pressures, they are not as hazardous as high pressure gas cylinders specially for gases like Hydrogen. PCI Gas Generators are so compact and aesthetic that these can be placed in the lab in close proximity to your instruments, eliminating the need for a remote, isolated storage area. PCI Gas Generators are

less expensive than gas cylinders in the long term. PCI Gas generators offer an unlimited and uninterrupted source of high purity gas which is available on demand.

Nitrogen Gas Generators (NG): Nitrogen Gas generators produce ultrapure Nitrogen from compressed air using PSA technology. PCI Nitrogen Gas Generators (NG) produce ultrapure nitrogen for use as GC carrier gases, makeup gases, and low-flow sample concentrators.

Models are available to supply nitrogen at flows from 1 to 4

liters per minute at 5Kg/Cm2 pressure and for LCMS from 10 LPM to 30LPM at 60-100psig and for Turbo Evaporators from 50 LPM to 700LPM at 600psig pressure.

Zero Air Gas Generators (ZAG): High-purity air is essential as a fuel gas for flame ionization detectors (FID) in order to produce a stable baseline.

Zero air gas generators from PCI based on PSA technology can turn in-house compressed air into ultra-pure air with less than 0.1 ppm hydrocarbon (HC) levels. Varying models are avail-

able with flow rates from 1,000 mL/minute up to 4,000 mL/minute at 5Kg/Cm2 pressure.

Nitrogen-Air Combination Gas Generators (NAG): NAG is compact 2in1 generator that produces a continuous flow of Nitrogen and Zero Air from 200ml/m to 4000ml/min at 5Kg/Cm2 pressure.

Hydrogen Gas Generators (PGH/SGH): Hydrogen Gas Generators produce Hydrogen (H2) through the electrolysis of water. For operation, these generators require an electrical outlet and a source of deionised water. PCI offers various models of hydrogen generators that can produce flow rates from 300 mL/minute up to 2,000 mL/ minute at 0-60 psig pressure.

Contact details Tel: +91-22-40946946 marketing@pcianalytics.in

BUSINESS AVENUES

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BUSINESS AVENUES

EXPRESS PHARMA

Product List Humidity Chamber

Walk in Chambers I Humidity ( Stability) Chambers Cooling Chambers I BOD Incubators Bacteriological Incubators I Deep Freezers Ovens I Photo Stability Chambers I Vacuum Oven Muffle Furnace I Auto Clave I Water Chillers

Salient Features :

Walk in Chamber Cooling Chamber

Most Preferred Chambers for USFDA & UK-MHRA etc. approvals Accurate Controls & Uniform Conditions.

Alternative PLC with touch screen display with Ethernet with automatic change over facility.

Computer Interface with 21 CFR Compliance software.

Complete validation package comprising DQ, IQ, OQ & PQ. 24 x 7 Online service support.

B-8, Karma Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445 (Gujarat) INDIA. Tele : 079 - 25890727 Mobile : +91- 9427613646 Email : service@kesarcontrol.com Web : www.kesarcontrol.com

MFGRS. PHARMA AND LAB EQUIPMENTS

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HVAC System Modular Clean Room PUF/EPS WALL/CEILING Partitions-Thickness Range : 50-200 mm.

Reverse Laminar Air Flow (Dispensing & Sampling Booth)

Clean Room

Horizontal LAF Unit

Air Showers

Static Pass Box

Dynamic Pass Box

Garment Cubicle

The leading air management solution provider...

Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects.

Airtech undertakes complete project management comprisig of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems.

Airtech’s Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clan room applications.

EXPERTS IN HVAC & CLEAN ROOM SOLUTIONS 502 & 503, 5th Floor, Satellite Silver, Andheri - Kurla Road, Marol Naka, Andheri (East), Mumbai – 400 059.

Tel:+91 9322218023 / +91 9324644630 /+91 9699626434 /+912228592275 E-mail : sales@airtechsys.in, sunil.airtech@gmail.com • Website : www.airtechsys.in

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h ation services whic Airtech offers Valid ocols IQ, OQ & PQ prot l comply with DQ, wing Internationa follo to ing orm conf Field Projects) : Standards (Green

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Multiple Products Under One Roof for Food & Bio-Pharma Industries We are specialized in manufacturing Platinum Cured Silicone Tubes, Braided Hoses, Inflatable Seals / Gaskets and customized polymer solution for food, medical and pharmaceutical industries application.

Imavac™ - Silicone Hose reinforced with SS 316 helical wire

Imawrap™ - Silicone Hose reinforced with Polyester Fabric & SS 316 helical wire

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Silicone Inflatable Seals & Gaskets

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CORPORATE OFFICE : 319, Mahesh Indl. Estate, Opp. Silver Park, Mira‐Bhayander Rd., Mira Road (E), Thane ‐ 401104. Maharashtra. INDIA. Tel.: +91‐22‐28555 107/631/914. Cell : +91‐9223 411 447 / 9223 290 931 / 43.

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A BENCHMARK FOR

QUALITY SOLUTIONS

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An Enterprise Providing Professional Value of Optimized Technology Name Source : Advantage + Technology + Praxis + Practice

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Optimized Technology Osworld Scientific Equipments Pvt. Ltd.

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OSMOMETER 3250

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Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

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Shah Brothers introducing HIGH PURITY TUBINGS & HOSES u u

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Molded Manifold Assemblies & Bioclosure Systems

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Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India.

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Sight Glass Flange with LED

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PHARMA LIFE INSIGHT

Why talent crunch is derailing the pharma sector With the demand of skilled resources going up companies now need to look beyond just poaching talent from competition, to expanding their search across sectors and geographies.

By Thammaiah BN, MD, Kelly Services India THE INDIAN pharmaceutical industry is expected to outperform the global pharma industry and grow to $55 billion by 2020.

Bio-pharmaceuticals account for the largest share of the biotech industry revenues. Augmenting this boom is the demand for talent that is surging at every level.

While the country has a large pool of scientists and engineers who have the potential to steer the industry to an even higher level, the shortage of the talent pool is still a worrisome reality of today.

Traditionally for the last five to six decades, the Indian pharma has seen a very staid outlook in hiring. Resources hired have been mainly at two levels – graduates at entry level from pharma background and specialists at mid-level from the existing industry pool. There has been very little dynamism in the hiring outlook so far. This landscape is now seeing a drastic change. With the demand of skilled resources going up companies now need to look beyond just poaching talent from competition, to expanding their search across sectors and geographies.

India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume. With several biologics drugs coming off patent, India stands to gain immensely by the upsurge in opportunity in biosimilar manufacturing. Most of the pharma companies are riding this wave, while existing players are also increasing their efforts. By 2020, world emerging markets such as India, Mexico, Turkey, China, Brazil and Russia will represent one-fifth of the total pharma turnover in the world. As per industry projections, around 2.5

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million skilled people will be needed by 2022 to maintain this high growth rate.

Policy makers and organisations are beginning to realise that the pharma organisations in India are suffering from the apparent results of qualitative changes, that may include insecurity, low motivation, reduced engagement, loss of high talent employees etc which threaten industrial future development and its growth. Many feel that inefficient recruitment strategies and the lack of real forward planning are behind the shortage. This lack of talent in areas like analytics, quality, manufacturing, clone development is increasingly making Indian pharma and bio-pharma companies to look at talent outside the country.

It’s a wake-up call for Indian pharma industry policy makers.

These challenges would have to be addressed holistically by way

of clarity of organisation’s purpose, with a robust leadership pipeline and high quality leadership talents. These would be the most vital sources for successful growth and development of the organisations.

Hiring organisations should now look at the following parameters to retain and attract talent: Mapping a planned organizational structure: Talent acquisition, defining jobs and roles and the company’s business strategy go hand in hand. Even before setting out to acquire talent, companies should ensure that they have proper systems and processes are in place, while jobs and roles of each department and individuals are well defined and documented. Management should provide a healthy environment to employees to have a bird’s eye view of the company’s business goals, growth drivers, future strategies etc. It is suggested to go as granular as

possible for defining the jobs and roles which will ensure that the right person is picked for the right job.

Training and capacity building: Pharma companies should invest in systematic development programmes to keep their current talent pool engaged and effective. Training, therefore, becomes a mandate and should be a continuous process, given the change in regulatory policies, patent laws, technical training and understanding of global best practices. Companies should open up several avenues of development for their employees and engage with them to understand their skills and weaknesses.

Leadership Development: Going beyond traditional capacity building, companies should also be able to discover and invest in high performing individuals who have the potential for handling leadership roles. This will ensure continuity and a leadership pipeline at every level of the organisation. Leadership development should include focused training on understanding company’s business objectives, as well as honing managerial skills to support and develop teams of strong individuals.

Talent retention: Employee retention plays a crucial role to any company’s growth. The demand-supply imbalance has led to higher salary hikes in the pharma sector than most other sectors. This is clearly a challenge in an industry which is very knowledge and relationship driven. Retaining of talent by adopting best-in-class human resources practices, rewarding and re-training employees regularly and defining their career paths. It is also essential to clarify what the company’s competency needs will be in the future and

help the employees to acquire those skills.

Most important factor here, is to have an independent progress assessment method at every level, that would enable for subsequent development requirements or needs. Independent coaching platforms by internal mentors or from industry leaders which could deliver more results and also keeps their employees on continuous knowledge acquisition.

Thinking ahead The key to ensuring committed and engaged employees is to adapt organisational policies to create an enabling environment and meet the evolving needs of today’s workforce. In the long term, there needs to be an overhaul of pertinent education streams besides public-private partnership in large scale capacity building initiatives. In the short term, corporates and industry bodies should collaborate with academia and research institutes to develop training to reskill pharma and life sciences professionals. Creating a culture that fosters synergy between an employee’s expectations and an organisation’s objectives will set the ball rolling for India’s pharma growth story.

The pharma industry, by and large is recession proof and has been growing at a steady rate in India. As the industry takes strides towards innovation and new drug development from being a bulk drug and generics oriented market, the career opportunity is immense. In a corporate world that is more unpredictable than ever, the pharma companies that are agile and super-responsive, powered by an inspired work ecosystem, will be the successful organisations of the future.

CAMPUS BEAT

AWARD

Lloyd School of Pharmacy organises national conference Around 70 graduate and undergraduate students sent their abstracts for poster presentation

LLOYD SCHOOL of Pharmacy recently organised a national conference on ‘Industry expectations from Academia.’ The conference, which aimed to bridge the gap between industry and academia, had two different sessions. The first was a brainstorming interactive session with various eminent personalities from regulatory, industry and academia and second post lunch session was a poster presentation competition.

Dignitaries from CDSCO, IPC, PCI, Jubilant Pharma, Panacea Biotec, Belco Pharma, Arbro Pharmaceuticals, Nutrilife, Sesderma India, Zydus Cadila Healthcare

along with the students took part in the conference. The students interacted with the dignitaries to understand the need of industry and different job opportunities which a pharma graduate/postgraduate can avail as a profession. The event was organised under the mentorship and guidance of Dr GN Singh, Drug Controller General (India) and SL Nasa, Registrar, Delhi Pharmacy Council. The chief guest, Dr VG Somani, Joint Drug Controller, CDSCO, emphasised on training of students apart from their syllabus.

B Datwani, Owner, Pharma PMT, Rajiv Gulati, Ex President, Ranbaxy, Rajiv Duggal, Country Di-

rector, Sesderma India, Vinod Chabra, Director, Arbro Pharmaceuticals, Dr Jai Prakash, Sr Principal Scientific Officer, IPC, shared their experiences and answered the queries of many delegates.

Around 300 students from Delhi Institute of Pharmaceutical Sciences and Research, Jamia Hamdard, Galgotias University, SGT University, HIMT, Noida Institute of Engineering and Technology, Ram-Eesh Institute of Vocational & Technical Education, Raj Kumar Goel Institute of Technology, Subramania Bharati College of Science & Technology, participated in the interactive session.

Around 70 graduate and undergraduate students sent their abstracts for poster presentation.

The titles of the abstract were from research, industrial practices, nano-technology, biotechnology and on newer technological advancements such as biomarkers, QbD, DMPK etc. Certificates were given to all the participants of poster presentation.

EP News Bureau

APPOINTMENT

MSD in India appoints VivekVasudev Kamath as MD Kamath has over 25 years of experience Vivek Vasudev Kamath has assumed the role of MD Designate of MSD in India. Kamath joined MSD in India in July 2012 and is currently the Business Unit Director for Cardiovascular Metabolics and Market Access.

Kamath has over 25 years of experience across India, South Asia and ASEAN markets. He brings rich experience with leading Indian and Multinational healthcare organisations in marketing, sales and

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general management. He has managed portfolios in prescription, over-the counter (OTC) & Diagnostics segments, partnering with healthcare professionals, consumers, diverse trade channels and government/ non-government healthcare entities. MSD in India operates its business in India through three legal entities, MSD Pharmaceuticals, Organon (India), and Fulford (India).

EP News Bureau

Moin Don,CEO,PVCON Consulting receives Pharma Ratan 2016 Dr YK Gupta, Head of Pharmacology, AIIMS was also presented the Pharma Ratan Award DELHI-BASED NGO called RDM (an offshoot of Meher Pharma) recently felicitated various stakeholders from the healthcare industry at a function held in India International Centre, Delhi. The chief guest for the event was Dr GN Singh, DCG(I).

The awardees included pharmacovigilance (PV) professionals, academicians, regulators, importers, ex-

(L-R): Dr YK Gupta, Head of Pharmacology, AIIMS with Dr GN Singh, DCG(I)

(L-R) Moin Don, CEO, PVCON Consulting with Dr GN Singh, DCG(I)

porters, manufacturers, sales and marketing personnel from India, the UAE, Tanzania and Bangladesh.

The Life time Achievement Awards 'Pharma Ratan 2016’ were presented to Moin Don, CEO, PVCON Consulting for his contribution in Drug Safety & PV and Dr YK Gupta, Head of Pharmacology, AIIMS. Others who received the awards in various categories included Dr S Ansari, VC, Jamia Hamdard, Dr Kalaiselvan, Principal Scientific Officer, PVPI among others.

Dr Singh appreciated this initiative by RDM which brought all the healthcare stakeholders on a single platform, and hoped that such initiatives would inspire others to contribute more actively towards the pharma sector.

EP News Bureau

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