Express Pharma (Vol.11, No.21) September 1-15, 2016

VOL. 11 NO. 21 PAGES 70

www.expresspharmaonline.com

Pharma Ally PharmaLytica 2016 concludes successfully in Mumbai

Research It’s personal

1-15 SEPTEMBER 2016,` 40

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CONTENTS MANAGEMENT

Vol.11 No.21 SEPTEMBER 1-15, 2016 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

29

BALANCING GROWTH WITH OPERATIONS

31

CYSTIC FIBROSIS THERAPIES WILL PUSH VERTEX AHEAD OF GSK IN $46.6 BN RESPIRATORY MKT BY 2022: GBI

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap

RESEARCH

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 MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar Arun J Debnarayan Dutta E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager B R Tipnis

It’s personal Though personalised medicines have shown potential in revolutionising medical treatment by making them patient-specific, there is still a long way to go before it makes inroads into the Indian healthcare system| 32

PHARMA ALLY

INTERVIEWS P26: GST likely to bring down total cost as a percentage of sales by 1- 1.5%

P28: The pharma industry is looking to emerging markets for growth

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

P37: ‘We would like to spend the next few years concentrating on primary glass packaging’

38

PHARMALYTICA 2016 CONCLUDES SUCCESSFULLY IN MUMBAI

39

IPEC INDIA HOSTS CONFERENCE ON ‘THE NEED FOR TOTAL EXCIPIENT CONTROL’

40

VICAM’S AFLA-V AQUA STRIP TEST RECEIVES USDA-GIPSA CERTIFICATION

41

36

STUDY IN MICE SHOWS ZIKA VIRUS ALSO ATTACKS ADULT BRAIN CELLS

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CIPLA APPOINTS UMANG VOHRA AS MD & GLOBAL CEO; SAMINA VAZIRALLI AS EXECUTIVE VC

63

HK COLLEGE OF PHARMACY ORGANISES MENTOR-MENTEE PROGRAMME

LMT GROUP OPENS ACADEMY IN GOA

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. 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

Thriving through change

A

recently released analysis of the global courier industry from 2010-2021, shows that the pharmaceutical sector accounts for just seven per cent of the sector's global revenue stream, which was an estimated $3.55 billion in 2010. Though currently the sixth largest client sector, the NgenKo Investments report, ‘Global Couriers Industry Analysis 2010 – 2021-Application in the Pharmaceutical Sector’, points out that demand from the pharma segment has seen an increasing demand over the latter half of the past decade primarily due to the advanced tracking, real time monitoring and cold chain delivery capabilities that have been made available by the courier industry. The big four of the courier industry namely, DHL, FedEx, UPS, TNT, are all expected to further develop and improve logistics services that they offer to the pharma and health sector, by focussing on resolving key challenges such as supply chain visibility, IT integration and dynamic containment environment maintenance, which have a crucial impact on these sectors. In fact, the report projects an estimated growth potential amounting to a CAGR of 3.3 per cent, and may very well be worth $4.95 billion by 2021.

As supply chains become more global, pharma logistics will have to keep up with the latest SCM trends as well as view all enhancements from the patient security lens. However, while pharma companies are upgrading their logistics arrangements, India's retail pharma logistics has remained stuck in the dark ages, for the most part.

With a highly fragmented industry, around 170,000 stock keeping units (SKUs) to be delivered across geographically diverse terrain, the logistics challenges in pharma retail are humongous. But online pharmacies have catalysed a long overdue overhaul. As new kids on the block, they currently face resentment from conventional pharmacies who allege that selling medicines online violates existing guidelines.

While that is another debate (which Express Pharma has already covered: http://www.financialexpress.com/pharma/marketpharma/sparks-fly-at-express-pharma-debate-ononline-pharmacies-2/198050/), the cover story of the current issue focuses on how online pharmacies are adding a much needed dose of high tech to pharma logistics. They are introducing e-commerce concepts like traceability, audit trail and validation of actual delivery. These concepts will also improve supply-demand

10 EXPRESS PHARMA September 1-15, 2016

Most pharmacies, like the pharma industry, are family-driven concerns, and the younger tech savvy generation, would like to embrace the change

forecasting, the benefits of which will flow back to pharma companies, who will be able to tighten their manufacturing schedules. (See story: Going high tech, pages 18-25, issue dated September 1-15, 2016) Operational efficiencies across the supply chain will also mean better profit margins, and for the patient, less chances of getting fake/spurious drugs.

Online pharmacies are awaiting the release of guidelines specifically designed for the online sale of medicines. Regulators too stand to gain by implementation of these guidelines because traceability will allow faster recall of spurious products and a tighter leash on the black sheep in the sector. With online pharmacies projected to increase their market share to almost a quarter of the retail pharma trade by FY2020, it is crucial that this segment is regulated before it proliferates beyond control.

With fund flow into online pharmacies in India crossing $92 billion, investors are clearly betting on and not against this sector. Some pharma retail chains, flush with funds, are already showing the results of growing too fast, without an adequate tech infrastructure.

For instance, in another story in the same issue, a case study details how SynCore Consulting had to step in to help a fast growing pharma retail chain balance growth with operations. After building a robust supply chain and IT-business alignment to support existing operations, stock accuracy improved from 60 per cent to more than 99 per cent. (See story: Balancing growth with operations, pages 29-30, issue dated September 1-15, 2016) In fact, though associations of conventional pharmacy stores publicly oppose their online siblings vehemently, some of their members are reportedly as eagerly awaiting these guidelines.

Most pharmacies, like the pharma industry, are family-driven concerns, and the younger tech savvy generation, would like to embrace the inevitable. Rather than remain confined to their geographical reach, who wouldn't want to expand their business? In this clash of the conventional with the new age, both sides would do well to keep the patient's long-term needs at the centre of all decisions.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET GROWTH TRACKER

IPM crosses ` 10,000-crore mark in July 2016 Anti-infective was the largest therapy area for the month with a revenue of ` 1469 crores

12

EXPRESS PHARMA

September 1-15, 2016

Company

No. of brands in top 300 (July 2016)

Value of brands in top 300 (July 2016) (Rs crores)

2015

2016

2015

2016

SUN

27

29

215

273

27 per cent

ABBOTT

26

28

267

308

15 per cent

CIPLA

22

23

167

205

23 per cent

PFIZER

17

16

170

184

8 per cent

GLAXOSMITHKLINE

14

15

159

204

28 per cent

ALKEM

14

15

140

182

29 per cent

ARISTO PHARMA

10

11

93

141

51 per cent

SANOFI

12

11

108

114

6 per cent

MANKIND

9

11

68

98

43 per cent

ZYDUS CADILA

12

11

80

82

2 per cent

Note: Companies have been ranked as per number of brands which feature in top 300 brands in IPM

IPM Overview Month Growth %

T

he Indian Pharmaceutical Market (IPM) was valued at ` 10,025 crores in the month of July 2016 clocking a 14.7 per cent growth over same period last year (SPLY).

This was the first time ever the market crossed the ` 10,000crore mark in a single month.

The robust performance was aided by a strong monsoon witnessed across the country. On a MAT July basis, the industry was valued at ` 108,362 crores and reflected a 13 per cent growth with volumes contributing to 37 per cent of the growth.

The retail channel remained the largest channel in IPM contributing 84 per cent of the overall sales and reflected a 13 per cent growth. The hospital and doctor channel contributed to 16 per cent of the overall sales and reflected a growth of 17 per cent on a MAT July basis. It is expected that the hospital channel will continue to report robust growth rates due to rapid capacity expansion in this space. As per IMS Health data which captures sales from trade stockists more than 10 Therapy Areas in the IPM have already crossed a sale of ` 500 crores in the hospital segment viz. anti infectives, cardiac, gastrointestinals, pain, neuro, vmn, gynaecology, antidiabetics, vaccines and respiratory.

IPM has witnessed consolidation over the last few years, the industry however remains fragmented with top 10 players contributing 43 per cent of overall sales and reflecting a robust 17 per cent growth for the month. Among top 10 companies, Mankind, Alkem, GSK, Macleods & Lupin registered a growth higher than IPM. Companies ranked 11-20 contributed 21 per cent of total revenues for the month reflecting a growth of 15 per cent aided by strong growth posted by Aristo (34 per cent), Glenmark (22 per cent), Alembic (17 per cent) and Micro (16 per cent).

25

25

20

2016

15

2015

10

2014

5 0

20 15 10 5 0

Aug

Sep

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

TSA IPM Trends

Dec

Jan

Feb

Mar

+15%

Jun

Jul

+15% MAT

108,362

+13%

Month

90,934

Value Rs. crores 80,719

95,628

Growth SPLY

83,692 76,133

2013

May

SSA IPM Trends

+13%

7,010

Apr

70,601 63,894

7,749 2014

8,736 2015

10,025

2016

5,881 2013

6,567 2014

7,348 2015

8,451

2016

Source: IMS Health TSA & SSA,July 2016

Amongst top 25 companies, GSK reflected a robust performance for the month climbing back to sixth rank. Aristo, Emcure and Glenmark gained two ranks each and moved to 12th, 14th and 16th respectively while Pfizer, Alembic, Ipca gained one rank each and moved to 10th, 20th & 21st

rank respectively in comparison to previous month.

Domestic companies continued to dominate the market with a 78 per cent share in July 2016 with a growth of 16.3 per cent.

MNCs reflected an improvement in growth, clocking a 9.3 per cent growth vis-Ă -vis a 5.3

per cent in June 2016. Large MNCs like Abbott, GSK and Pfizer who contribute to ~56 per cent of the total MNC share in the month reflected a growth of 10 per cent, 18 per cent and 7 per cent respectively which was a marked improvement over previous months.

Acute therapies continued to dominate the IPM with a 68 per cent contribution to the total market. After a gap of five months, acute therapy areas (16.2 per cent) have outpaced chronic therapy areas (11.9 per cent) in terms of growth with anti-infectives and cough prepa-

Snapshot of Top 150 Companies IPM value – Rs. 10,025 crores (15 % Growth) Month July 2016 Value (Rs. Crs)

% MS

4,264

Rank #1 - 10

Rank #21 - 30

% Gwth

Value (Rs. Crs)

558

6

Rank #41 - 60

660

7

Rank #61 - 100

663

7

13

13

22

15

11

11,418

19

4

357

% Gwth

43

23,561

15

11

1,061

% MS

46,071

17

21

Rank #31 - 40

Rank #101 - 150

IPM value – Rs. 108,362 crores (13 % Growth) MAT July 2016

43

2,144

Rank #11 - 20

9

5,829

5

15

11

7,150

7

15

13

7,279

7

14

18

4

3,834

20

Source: IMS Health TSA & SSA,July 2016

Indian Cos. vis-à-vis MNCs % Growth over same month last year

Month Growth

25

IPM Indian

20

MNC

15 10 5 0 Aug’15

Sep’15

Oct’15

Nov’15

Dec’15

Jan’16

Feb’16

Mar’16

Apr’16

May’16

Jun’16

Jul’16

Value (Rs. Crs)

12,000 IPM

Value

rations spearheading growth for acute therapies.

Anti-infective was the largest therapy area for the month with a revenue of ` 1469 crores reflecting a 29 per cent growth on the back of a good monsoon witnessed by the country. This was an impressive performance considering 14 per cent of the portfolio impacted by the FDC ban comprised anti-infectives while it was also one of the largest therapy to be affected by the NLEM notification. Amoxyclav solids and liquids reflected a strong growth of 32 per cent and 47 per cent respectively while Cefpodoxime solids and Ceftriaxone injectables were among the fastest growing anti-infectives registering a 58 per cent and 43 per cent growth for the month respectively.

Gastrointestinals surpassed cardiac therapy to be the second largest therapy area for the month garnering a revenue of ` 1117 crores with a growth of 11 per cent. PPIs and their combination with Domperidone reflected strong double digit growth. Omeprazole + Domperidone and ranitidine were the fastest growing molecules among top 10 with a growth of 23 per cent and 19 per cent respectively. Digestive enzymatic liquids reflected a 17 per cent growth driven primarily by the east zone.

Cardiac was the third largest therapy area for the month of July 2016 clocking a revenue of ` 1115 crores growing at eight per cent driven by Rosuvastatin (14 per cent growth), Amlodipine + Telmisartan (18 per cent growth), Telmisartan being affected by NLEM reflected a growth of -3 per cent for the month while largest statin Atorvastatin reflected a growth of -5 per cent.

Respiratory, though the seventh largest therapy area for the month, was the fastest growing clocking a growth of 35 per cent.

Cough preparations, Levosalbutamol combinations and cold preparations (liquids and solids) were among the fastest growing categories in the respiratory space reflecting growth of 70 per cent, 152 per cent, 46 per cent and 47 per cent respectively.

Among chronic therapy ar-

10,000

Indian

8,000

MNC

6,000 4,000 2,000 0 Aug’15

Sep’15

Oct’15

Nov’15

Dec’15

Jan’16

Feb’16

Mar’16

Apr’16

May’16

Jun’16

Jul’16

• Indian companies registered growth of 16.3% during the month and continue to dominate IPM in terms of value • Indian companies constitute ~78% of IPM during the month and MAT basis

Source:Source: IMS Health TSA &TSA SSA,July 2016 IMS Health & SSA, July 2016

eas, anti-diabetic and neurology were the fastest growing therapy areas, growing at 16 per cent and 10 per cent for the month respectively. DPP4 inhibitors and Glim + Met formulations spearheaded growth for the anti-diabetic market owing to rising prevalence, diagnostic and treatment rates of diabetes.

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In the neurology space, Levetiracetam continued to be the fastest growing molecule in neuro psychiatry for the month clocking a value of ` 42 crores with a growth of 25 per cent in July 2016. Escitalopram plain and its combination with Clonazepam found place among the fastest growing CNS molecules

for the month with a growth of 13 per cent and 15 per cent respectively.

Brand building efforts across top companies continued to be evident with seven out of top 10 companies driving robust double digit growth for their portfolio falling under top 300 brands with only Sanofi, Zydus and

Pfizer reflecting single digit growth. Calpol propelled GSK performance for the month while Aristo was driven by Monocef.

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

EXPRESS PHARMA

13

September 1-15, 2016

EVENT BRIEF SEPTEMBER TO NOVEMBER - 2016 01

7th Annual Pharma SCM

7TH ANNUAL PHARMA SCM Date: September 1 - 2 Venue: Mumbai Description: 7th Annual SCM Pharma Confex will be the biggest conglomerate of supply chain experts from leading Indian pharma companies and supply chain and logistics solution providers to create avenues for better pharma supply chain solutions and infrastructure for the pharma industry.

08

Facility Design

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

19

cGMP Workshop

ing facilities.

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

FACILITY DESIGN Date: September 8 - 9, 2016 Venue: Hyderabad Description: A industry workshop crafted for understanding and identifying the factors necessary to build efficient pharmaceutical biopharmaceutical manufactur-

CGMP WORKSHOP Date: September 19 - 20, 2016 Venue: Mumbai Description: CPhI is announcing for the first time ever a ‘cGMP workshop’, a

22

Healthcare senate

two-day practical training to be conducted by a former US FDA drug investigator.

The workshop will guide companies prevent instances of contamination, mix-ups, deviations, failures and errors to successfully meet the desired quality standards.

Contact details: E: Purvai.gupta@ubm.com T: 91-22-61727077

22

2nd Edition of Asia Labex

HEALTHCARE SENATE Date: September 22-24, 2016 Venue: Hyderabad Summary: Healthcare Senate, the national private healthcare business summit will host the game changers, path finders and and opinion leaders of the healthcare industry, to facilitate sharing of innovative ideas and experiences, and convert them into reality.

The event will see a largest

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EXPRESS PHARMA

September 1-15, 2016

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

EVENT BRIEF gathering of India’s most influential healthcare practitioners; CEO/CFO/MDs of hospital chains, medical superintendents, hospitals owners and decision makers, owners of single specialty hospitals, owners of diagnostic and other healthcare centres, hospital administrators, HoD of medical and bio-medical departments, HoD of engineering and operations, medical directors, purchase managers, healthcare consultants, project heads, biomedical engineers, dealers and distributors, thought leaders, industry stalwarts and domain experts Contact details: For delegate registrations Vinita Hassija Mobile: +91 9820590053 Email: vinita.hassija @expressindia.com Shilpa Chaurasia Mobile: +919892170209 Email: shilpa.chaurasia @expressindia.com For awards Raelene Kambli raelene.expressindia @gmail.com

2ND EDITION OF ASIA LABEX Date: September 22-24, 2016 Venue: Gujarat University Convention & Exhibition Centre, Ahmedabad Summary: Asia Labex is a premiere exhibition and conference on laboratory, analytical, scientific, diagnostic, biotech, research and testing instruments and consumables. The exhibition will be organised by Fenza Exhibitons.

Contact Fenza Exhibitions Plot No 1, 2nd Floor, GT Karnal Road, Opposite PNB Bank, New Delhi – 110033

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

Metrics a case study- led two-day workshop will cover the latest draft guideline on quality metrics and critical topics related to overcoming data integrity issues.

BIOSIMILARS CONGRESS INDIA 2016

Contact details: E: Purvai.gupta@ubm.com T: 91-22-61727077

integrity, CSV metrics, network validation and cloud validation.

Date: October 13 – 14, 2016 Venue: Hyderabad Description: Biosimilars Congress India 2016 will aim to provide strategic solutions to key issues faced by the manufacturers around the regulatory guidelines of FDA, EMA, upstream, downstream processing, identifying critical quality attributes and statistical approaches to demonstrate biosimilarity.

Contact details: E: Drashti.shah@ubm.com T: 91-22-61727381

CSV WORKSHOP

PHARMA DATA INTEGRITY, REGULATORY AND QUALITY CONFERENCE

Date: October 6 - 7, 2016 Venue: Mumbai Description: A two-day in depth workshop designed to provide unique insights and authoritative debate into CSV models, validating data

Date: October 18 - 19, 2016 Venue: Mumbai Date: October 20 - 21, 2016 Venue: Hyderabad Description: CPhI's 3rd Annual Data Integrity, Reliability and Quality

16

EXPRESS PHARMA

September 1-15, 2016

ANALYTICA ANACON INDIA AND INDIALAB EXPO 2016 Date: October 20-22, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: analytica Anacon India and India Lab Expo happens to be India's largest trade fair for the analysis, laboratorytechnology and biotechnology sectors. As the industry's leading marketplace, it brings together scientists, entrepreneurs and users from around the subcontinent.

At the analytica Anacon India and India Lab Expo Conference, scientists from around the world will present their innovative analysis solutions.

Contact Email: info@analyticaindia.com

PHARMA CONFERENCE SERIES Date: November 3-4, 2016 November, 2016 Venue: Mumbai Description: A strategic conference series that will address the most critical issues in pharmaceutical and biopharmaceutical manufacturing in India Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

CPHI PRECONNECT- DAY ZERO Date: November 17, 2016 Venue: Mumbai Description: CPhI's Pre Connect Congress will bring together thought leaders under one roof to discuss on the latest trends and advancements in the Indian pharma industry.

Discussions will be held on key topics such as M&A, regulatory challenges, drug discovery and other critical topics which are a burning issue in the pharma industry.

Contact details: E: sean.palanna@ubm.com T: 91-22-61727072

CPHI AND P-MEC INDIA Date: November 21 – 23, 2016

Venue: Bombay Exhibition Centre & MMRDA Grounds, BKC, Mumbai Summary: The event will be an ideal congregation for companies to pick up on the latest trends and innovations the market has to offer. CPhI India is also co-located with P-MEC India, the pharma machinery show in Asia. This year, the expo has grown from a three-day exhibition to a show spanning a week, Pharma Week, (November 17 to 23, 2016). The Pharma Week will hold more than 12 events that will take place across the city of Mumbai focusing on business, knowledge, leadership, innovation and recognition in the field of pharma. With two venues this year, Bombay Exhibition Centre and Bandra Kurla Complex in Mumbai, CPhI & P-MEC 2016 will include exhibitor showcase, innovation gallery, speed meetings, live entertainment and much more.

Contact details UBM India TIMES SQUARE Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

EVENT BRIEF IPC EXPO 2016 Date: December 16-18, 2016 Venue: Visakhapatnam The 68th Indian Pharmaceutical Congress (IPC) will host IPC Expo 2016, which will be jointly organised by the Indian Pharmaceutical Association (IPA) and Orbit Exhibitions. The expo will see a congregation of business delegates from all parts of the world. Visakhapatnam, the upcoming pharma hub will host the fair under the patronage of N Chandrababu Naidu, Chief Minister, Andhra Pradesh. With India’s new initiative of ‘Make in India’ campaign, the show will witness a huge boost with national and international participation.

natural extracts, excipients and many more.

Latest pharmaceutical machinery, plants, laboratory equipment, analytical

instrument and cleanroom equipment will 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

Contact details University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh-530003 Ph: 0891 2526143 Mob: 7036164555 Email: loc@68ipc.com Website: www.68ipc.com

INDIA PHARMA 2017 Date: February 9-11, 2017 Venue: Bangalore International Exhibition Centre, Bengaluru 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 pharmaceutical industry starting from finished formulations, APIs, biopharmaveuticals, fine chemicals and intermediates,

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EXPRESS PHARMA

17

September 1-15, 2016

cover )

Online pharmacies are streamlining India’s fragmented retail pharma supply chain with a much needed dose of technology

BY USHA SHARMA

18

EXPRESS PHARMA

September 1-15, 2016

(

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THE MAIN FOCUS

EXPRESS PHARMA

19

September 1-15, 2016

cover )

O

nline pharmacies in India have gained significant attention over the last one and half years. The concept of buying medicines online might seem new today, but users are well aware of its implications. The online pharmacy space in India features small as well as big players like Bigchemist, mChemist, Pharmaeasy, 1mg.com, Bookmeds, Medidart, Medlife, Medstar, Nedmeds, SaveOnMedicals, Zigy.com, and Savemymedsa. Most of these players ventured into this space less than two years back but in this short period, managed to establish themselves considerably largely due to technology.

However, the sector is seen to be in violation of norms and has faced a backlash due to the lack of regulatory guidelines. Today, the biggest challenge to these players is that in the absence of guidelines specific to online sale of medicines, they need to follow existing guidelines applicable to traditional brick and mortar chemist stores as well as maintain a good distribution

supply chain. Therefore it is only to be expected that these players are reportedly eagerly awaiting guidelines designed for online sale of medicines as these might give them relief and address the perception of both regulators and patients that they are violating norms.

Potential of e PHARMACYAT A GLANCE

Pharma logistics: The missing link Unlike developed markets like the US and UK, India does not have a set of guidelines for online sale of medicines but is set to follow in the footsteps of these countries.

As Pradeep Dadha, Founder and CEO,

Nedmed.com explains, “I think everyone first looks to the US, for good reason, since national chains like Walgreens and CVS have been perfecting the mail order business for more than a decade now, and where there are about 400 licensed “e-pharmacies”. UK, Canada, many EU countries

Expected to reach

Indian pharma retail market is about

have all demonstrated that the e-pharma business is safe and convenient and benefits the consumer and the overall health picture.”

The regulatory environment in these countries is different, may be due to clearly articulated guidelines or the trust levels built up by both pharma as well as logistic providers. It is to be noted that online pharmacies in these countries have also gained the trust of patients, by proving that getting a medicine through online platforms is safe and has minimal risk to life. However, the situation is completely different in India as there is still a huge possibility that the patient/consumer receives adulterated/spurious/fake/expired medicines and is unsure about the authenticity of these products.

This could be due to many reasons, the primary one being a lack of supply chain management. Drug distribution in India has witnessed a paradigm shift. Before 1990, pharma companies established their own depots and warehouses. Now they have been replaced by clearing and forwarding agents (CFAs). As

Projected current e-pharmacy market in India: Upto 15 per cent of retail pharma

20 55 1.1 92.6 e-pharmacy market in China(2014)

$

$

BILLION

BILLION

by FY 2020

Projected market share of e-pharmacy by FY 2020: About 25 per cent of retail pharma

$

BILLION

20 EXPRESS PHARMA September 1-15, 2016

Funds invested in online pharmacies in India

$

MILLION

(

THE MAIN FOCUS

Siddharth Singhal, CEO, Vibcare and official spokesperson of India Internet Pharmacy Association (IIPA) informs, “Until now, the pharmacy supply chain has been devoid of high-end technology. Distribution (of medicines) has been through the traditional way, with no accountability and efficiency in the processes. A pharmacy or a hospital works with close to 21-35 distributors to stock all their requirements, which in itself poses a lot of operational inefficiencies including higher manpower costs.”

Dealing with multiple distributors, each having their own payment terms and credit charges, poses a big problem for the retailer.

Challenges in pharma distribution channels Listing the challenges plaguing the entire pharma distribution chain, Dadha says, “The challenges include receiving, vetting and digitising the prescriptions, stocking and picking from the vast number of SKUs, the fact that most orders include multiple items, and a mix of medicine and OTC products, and the delivery area is a huge expanse of country, served by a multiplicity of last mile couriers.”

Secondly, the easy access to medicines poses its own set of problems as self medication is a big challenge and one of the most common case of abuse/misuse in the pharma space in countries like India. Patients have easy access to any drugs without having a valid prescription.

At times, the easy access to medicine also results in over consumption of medicines.

The presence of counterfeit drugs in the market is also a huge issue for the industry.

To counter this, online pharmacies deploy an intelligent combination of data analytics to ensure safety and transparency in the system by redefining end-to-end solutions

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EXPRESS PHARMA

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cover ) and strengthening the logistics and supply chain pan India.

The unavailability of records for dispensed medicines poses yet another challenge. Since India still follows the traditional methods for dispensing medicines, maintaining records is almost nil.

As Dharmil Sheth, Founder, Pharmeasy, reveals, “Digital records and tracking is the biggest challenge in the pharma distribution channel today. In case of any drug recall or spurious drugs entering the chain, it would be difficult to track it down to the last mile. A major chunk of retailers do not use digital platforms for invoicing or maintaining inventory. This makes it difficult to maintain sales records of patients consuming medicines.”

Today, very few physical pharmacy stores follow the set rules and regulations specified in the law. If online pharmacies get guidelines specific to their sector, then a major factor is that each player would need to maintain e-records. Sheth emphaises, “The online channel is at a very nascent stage and has a potential to grow 50 times in the coming five years. In the e-pharmacy model, every transaction is recorded and tracked. There is no possibility of medicines being sold without prescriptions, and this can easily be audited and verified. Also, dispensation is done by a licensed pharmacist, under his license and from licensed pharmacy premises – significantly positive compared to the prevailing model in the market where medicines are commonly available without a tracking and record of prescriptions.”

Bringing in good distribution practices So what are the fundamentals of good distribution practices that online pharmacies need

22 EXPRESS PHARMA September 1-15, 2016

A pharmacy or a hospital works with close to 2135 distributors to stock all their requirements, which in itself poses a lot of operational inefficiencies including higher manpower costs Siddharth Singhal CEO of Vibcare and official spokesperson of India Internet Pharmacy Association (IIPA)

Today most online pharmacies are technology companies which have, over a period of time, acquired expertise in the pharma domain Anoop Sharma Co-Founder and CEO, drbean.com

PUNEET KAPOOR, Director, BigChemist.com

RECOMMENDATIONS FROM E-PHARMACIES FOR E-PHARMACIES ➤ The online pharmacy should carry the license details which should have a link to the regulator site through a logo / redirection to verify the credentials

to follow? Are there global standards which can be adopted by online pharmacies in India? Most developed countries have already established an eco-system for safe and secure pharma distribution via e-pharmacies. Singhal informs, “(The business model of ) E-pharmacy has gained prominence in many parts of the world including the US, the UK, Canada and Brazil. Most of these countries have a centralised electronic health record (EHR)based method which helps them operate under clearer guidelines. Unfortunately in India no such systems exists and it will be quite some time till the concept of EHR and eprescription takes off.”

Explaining the requirements of good distribution practices for e-pharmacies, Dadha spells out, “Good prac-

➤ Doctors and institutions should be encouraged to write digital prescriptions with digital signatures which can be verified through technology mechanism. This should be for both online ordering and walk-in take away. ➤ There should be a negative list of medicines which should only be sold through walk-in with proper stamping of the original prescription ➤ The online orders should capture the IP address of the user for any audit trail and traceability ➤ In-case, where the prescription is found to be false, the same should be reported to the regulator for further action like sharing the list with all other epharmacy platforms. Both preventive and corrective measure should be used to avoid the misuse and abuse of the system. ➤ The proof-of-delivery should be digitised and kept in record in-link with the invoice ➤ The invoice should carry the name of patient, buyer and doctor as standard format ➤ The prescription should be standardised for format and details it carries pan-India ➤ Like we have MRP, to create a level playing field there should be a concept of MSP (Minimum Selling price as % of MRP). This will protect both the small pharmacy livelihood and also ensure that substandard drugs and counterfeits are not pushed in market at unrealistic prices to gain market share ➤ Lastly, the delivery should only happen through a registered and licensed physical pharmacy store as per the acts and guidelines irrespective of the business model

tices start at the point of prescription receipt where a large team of certified pharmacists, working round the clock, examine each prescription for validity. At the fulfillment level, additional pharmacists and pharma technicians oversee the selection of products aligning proper drugs, dosages, expiration dates with the dictates of the prescription. The process is further supported by technology, barcode scanning, digital video capture of each order being processed.”

While informing about the situation in India, Singhal highlights, “Given that the percentage of e-prescriptions in India is not even 0.01 per cent, this poses a whole new challenge for e-pharmacies to cater to consumers as doctors are neither tech savvy enough to issue eprescription nor do they feel any need to shift from hand-

written prescription to e-prescription. e-pharmacies in India are now being forced to face another hurdle by the recent announcement by a government subcommittee that e-pharmacies can only operate and dispense drugs on e-prescriptions and cannot accept offline prescriptions. Given the limited amount of takers in the market to this new amendment, this clause has the potential to grossly affect consumers and online players alike.”

Given the way global markets like the US and the UK have evolved, Sheth feels that, “The only way to connect and get all the stakeholders of the healthcare eco-system on a common platform is to go digital.”

Tech-enabled pharma logistics Comparing good distribution

( practices for online pharmacies and current practices used by retail pharmacies, Bhavik Kumar, Co-Founder, Medibox Technologies points out the shortcomings of the latter saying, “The existing system lacks tracability, audit trail and validation of actual delivery. These issues are efficiently and effectively addressed through the practices followed by online pharmacies. A good distribution will also help control abuse and misuse to a large extent. This delivery mechanism should be adapted for all forms of distribution.”

India still follows the traditional method of dispensing medicines to patients/ consumers. The unfortunate situation is that patients in India are still not sure if the medicines they consume are genuine or fake. And this is the situation not just in rural areas of the country but also in metros like Mumbai and Delhi.

So what could be a solution? Can technology be a saviour? Kumar believes it can, explaining, “Technology not only can help e-pharmacy players ensure good distribution network but could help the entire supply chain including the distributors and retailers. Proper implementation and use of technology will bring information to the fingertips to all stakeholders.

It will help plan production, keep a tab on real-time inventory at all levels of supply chain and provide insights for pro-active decision making.

The best outcomes will be in making medicines available where there is a necessity and reduce expiries.”

Agreeing to Kumar's view, Anoop Sharma, Co-Founder and CEO, drbean.com says, “Technology can help right from design to delivery, and can complete the entire value chain. And today most online pharmacies are technology companies which have, over a

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EXPRESS PHARMA

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cover ) period of time, acquired expertise in the pharma domain.”

Further explaining the benefits he says, “One of the key problems today is (that) nobody cares about (buying medicines against) the prescription. There are people who buy medicines for years with the same prescription.

(Once there is) full fledged technology implementation in this space, customers will have to buy medicines with valid prescriptions. This helps the enforcement of law in reality and not just on paper.”

The government is presently preparing guidelines for online pharmacies and once they are released, India's online pharmacy market is expected to open up even further and at a faster pace. “The Indian pharmacy industry is expected to be a $55 billion market by 2020.

However, due to the adoption of e-commerce among Indian consumers and rising spends on healthcare, this category is likely to grow and is fast attracting high traction from investors in the past couple of years who have already invested $92.6 million of funding in the business of online pharmacy so far,” informs Singhal.

Thus, over the past couple of years, with the advent of technology, online pharmacies have helped simplify the pharma supply chain by creating an efficient workflow using technology and are slowly streamlining an otherwise disorganised market.

Commenting on operational excellence which can be maintained or achieved by different technologies Kumar specifies, “The value proposition in every part of India is different for different stakeholders when it comes to serving the ailing population.

Hence, operational excellence is varied and mixed. However, to generalise, GPS tracking of shipments, bar coding, NFCs, ERPs, accounting software,

24 EXPRESS PHARMA September 1-15, 2016

UK, Canada, many EU countries have all demonstrated that the e-pharma business is safe and convenient and benefits the consumer and the overall health picture

DHARMIL SHETH, Founder,Pharmeasy

Pradeep Dadha Founder and CEO, Nedmed.com

A good distribution will help control abuse and misuse to a large extent.

This delivery mechanism should be adapted for all forms of distribution Bhavik Kumar

RECOMMENDATIONS FROM E-PHARMACIES FOR E-PHARMACIES ➤ Registry of e pharmacies: Provide for the creation of a registry of e pharmacies; which includes a list of all persons who should be required to obtain a specific license to operate an online pharmacy.It is also recommended,that the appropriate authority prescribe a specific logo for the purposes of identifying a licensed online pharmacy (logo),which is required to be displayed on every page of the Internet portal and the mobile application.The user with a click on the logo will be directed to the registry of online pharmacies, which would authenticate the factum of the online pharmacy holding a valid license. ➤Define obligations of the portal ◗ Only the owner of the portal,who is selling or facilitating the online sale of medicines and healthcare devices,should get a license for online business and an authenticated seal which should be displayed to the

public prominently on the website/portal/app. ◗ Portal should comply with the ITact. ◗ Licensee portal to be audited in periodic intervals with powers to cancel the license resting with the DCG(I). ◗ Portal should disclose complete transaction details to the licensing authority on request. ◗As soon as a vendor pharmacy is enrolled by the portal,it must be notified to the licensing authority ◗ Portal should disclose the name of the dispensing pharmacy prior to dispatch of medicines ◗ Portal should not entertain Schedule X(habit forming drugs) orders,till further detailed guidelines are in place to handle Schedule Xdrugs separately ◗ Portal should employ registered pharmacists to provide an additional layer of checks and balances to ensure the suitability of the prescribed medication and ensure that there is no misuse of prescriptions. ◗ License for e pharmacies be given only to serious operators and renewed only if pharmacy related operations comprise more than 25 per cent of the value transacted through the platform to ensure top management focus ◗ Portal must allow users to interact with their pharmacists for routine clarifications and counselling ◗ Portal’s pharmacist should check the veracity of the prescription before handing it down to the retailervendor. ◗The e pharmacy should maintain confidentiality of patient records should fully comply with the provisions of the ITAct read with the RSP Rules regarding the handling and transfer of personal information regarding the end-customer Pharmacy should pack,transport and deliver medicines in such a way that their integrity,quality and effectiveness are preserved.The delivery mechanism must provide a verifiable audit trail for the medicine from the time it leaves the pharmacy to the time it is handed over to the end-customer ➤ Define responsibilities of retailer/vendor ◗ Liability regarding the dispensing and sale of medicines rests on retailer,wholesaler or the manufacturer as per the current prevailing laws ◗ Interstate transactions to be suitably accounted as per existing rules ◗ Couriers,transport agencies,delivery agents to be out of the purview of the licensing agency as per current laws as long as there is no tampering

Co-Founder, Medibox Technologies

integration tools, digital solutions, cloud technologies, mobile applications, analytics and relevant algorithms can improve operational efficiencies significantly.

Operational excellence therefore could bring standardisations; provide inventory planning and replenishment solutions;

go-to-market strategies will give optimum results and reduce supply chain costs significantly.”

A key enabler of this trend has been the evolving role of the mobile phone, which is now not restricted to making calls. Today, the smart phone helps users remain connected

to other devices or networks via different wireless protocols. Kumar signifies the benefits of app-enabled technologies in pharma e-distribution channel network and explains how it simplify the entire supply chain. He says, “The distribution industry is fragmented in India with too

many players serving the same customers. Hence there are challenges of bullwhip effects of inventory, pilferages, breakages and expiries. Mobile app enabled technologies could benefit the entire gamut of stakeholders including medical representatives, booking agents, distributors

(

THE MAIN FOCUS

and manufacturers. It could reduce manufacturing leadtime, cost of holding inventory, reduce shortages, distribute medicines evenly as needed, remove issues of stock-pile up and much more.”

A bright future The Indian online pharmacy segment is at nascent stage and regulators are working to frame guidelines for such operations. Signing off, Singhal says, “All online pharmacies are currently strictly abiding by the laws and are very careful while screening

The Indian online pharmacy segment is at nascent stage and regulators are working to frame guidelines for such operations prescriptions for authenticity. A lot of online players like Pharmeasy have recorded declining almost 45 to 50 per cent of orders daily due to flawed prescriptions only because they want to adhere to a process and curb the flow of fake prescriptions. This has impacted the business of online pharmacies and if the government imposes clauses like e-prescriptions and restrict intra-state sales it will not allow this industry to evolve and grow at the pace that it is poised to.” u.sharma@expressindia.com

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cover ) I N T E R V I E W

GST is likely to bring down total cost as a percentage of sales by 1 - 1.5% India’s Logistics Performance Index (LPI) rank improved 19 places as per the LPI 2016 World Bank report and is set to improve further as the Goods and Service Tax (GST) bill is implemented. Vidhyasagar L, Asst General Manager, Corporate Ratings, Credit Analysis & Research (CARE Ratings), gives highlights of the impact of GST on the pharmaceutical industry and the interest of PE players in India's overall logistics sector, to Viveka Roychowdhury

As per the CARE report, 'Indian Logistics Industry gaining the traction', India’s logistic performance index (LPI) rank has improved by 19 places to 35th position from 54th position as per LPI 2016 report by World Bank. What have been the factors behind this increase?

A country’s competitiveness is measured by the ease of doing business. India stands at 35th (improved from 54th position as per LPI 2014 report by World Bank) position in the Logistics Performance Index (LPI) amongst 160 countries around the world, with Germany on the top, Singapore, China and US in 5th, 9th, and 10th positions, respectively, as per the World Bank report 2016.

India’s logistics performance has seen a rise in all the six key performance indicators used to compute international LPI. The factors which led to growth in improvement of LPI includes increase in infrastructure (especially road, railways and ports) spending along with their successful commissioning, growth in investments and participation of international logistics players in Indian firms which attracted better technology along with rise in international shipments coupled with leveraging the established network of the investor and implementation of

26 EXPRESS PHARMA September 1-15, 2016

effective IT systems used for tracking and tracing of goods.

Has there been a corresponding improvement in pharma logistics like cold chain facilities, warehousing, etc?

Instead of using ‘cold chain’, it would be more appropriate to use ‘temperature-controlled logistics’ which covers more broader segments. The industry pertaining to temperature-controlled logistics is estimated to be about ` 1,50, 000 crore and is expected to grow at a CAGR of about 20 per cent during next three to five years as per industry experts. The major contributors for the growth in the aforesaid logistic segment would be larger use of goods falling under the categories such as pharmaceutical and perishable goods. The Indian pharma industry during FY12~FY16 has shown a significant change in the trend of operations by paying more attention to introduction of quality products in the market and part of that initiative is increase in preference towards temperaturecontrolled logistics.

Thus, in an overall sense, the prospects of temperaturecontrolled logistics segment has been favourable and expected to improve going forward.

would pass on the partial benefit to the downstream, which remains to be seen.

As per the CARE report, the Indian logistics industry is projected to grow at a CAGR of 15-20 per cent during FY16~FY20. What percentage of the sector could be attributed to pharma/life sciences logistics?

The Indian pharma industry has shown consistent growth during the past decade and has marked its presence having ranked third globally in terms of volume and 13th in terms of value. As per CARE estimates, the pharma industry attributes to about 15 per cent towards the entire Indian logistics industry.

The implementation of Goods and Service Tax (GST) bill is expected to trim the logistic costs upto 20 per cent from the current levels. What will be the impact of the roll out of GST on pharma logistics?

The implementation of GST, in the longer run, is likely to bring down total cost as a percentage of sales somewhere between 1 to 1.5 per cent, depending on the company’s total logistics cost, which is determined by the product portfolio. However, there is a market expectation that the pharma industry

India’s logistics sector has seen interest from PE players during FY15 and FY16, with two PE players, Mandela Capital and Asia Climate Partners investing into cold chain logistics (` 120 crore in GATI and ` 250 crore in Cold Ex respectively) But India still is fairly low, at 35th position, in the LPI. What are the government’s initiatives to improve this ranking?

During the last five years, the Government of India has been taking various initiatives in order to develop road infrastructure. The net road projects awarded by National Highways Authority of India

(NHAI) during FY16 have increased to 4368 km in comparison with 3250 km level of FY12. NHAI plans to increase both awards and execution of road projects in FY17 by four times over FY16 levels, i.e., with target execution of 8000 km (@21.92 km/day) and target awards at 15,000 km.

Furthermore, on account of various government initiatives, focus on hybrid annuity as well as engineering, procurement and construction (EPC) contract and structural changes in the concession agreement, CARE expects substantial increase in pace of award and execution of road projects during FY17 over FY16.

As per the Railway Budget for the year 2016-17, the capital plan has been pegged at ` 1.21 lakh crore. The railway ministry has given emphasis on rapid expansion of freight business to take up freight corridors: North-South connecting Delhi to Chennai, East-West connecting Kharagpur to Mumbai and East Coast connecting Kharagpur to Vijayawada.

Apart from above, various initiatives such as setting up the broad gauge lines, capacity building plans and to improve the customer interface through IT systems to provide better quality of services have been taken up.

( As a part of reviving the existing ports of the country, the Indian government has developed 10 coastal economic regions, which led to improvement in the capacity of all the major ports to 892.92 MMT as on January 31, 2016 (871.52 MMT as on March 31, 2015). Furthermore, the government is taking up various initiatives such as investing ` 70,000 crore under ‘Sagarmala project’ in 12 major ports in the next five years, allowing upto 100 per cent FDI under automatic route for port development projects and providing income tax incentives.

India, although gearing towards (being0 logistic friendly on its performance index, has been facing inhibitions that primarily include higher logistic costs and complex tax structure. The implementation of GST Bill is expected to trim the logistic costs upto 20 per cent from the current levels, however, the persisting high logistic costs could only be resolved by development of logistics infrastructure. Transportation alone holds 60 per cent share of the logistic industry and rest 40 per cent is contributed by warehousing, freight forwarding, value-added logistics, etc. Thus, the growth in logistics sector to a large extent depends upon successful implementation of the aforesaid initiatives taken by the government.

industry has raised the FDI for brownfield projects to 74 per cent under automatic route.

This initiative by the government is expected to enthuse the global pharma

THE MAIN FOCUS

players to invest in domestic companies leading to JVs, mergers or acquisitions, which

in turn would benefit the entire stratum of pharma industry. viveka.r@expressindia.com

Any specific measures that will impact/ improve life sciences logistics ?

It would be difficult to specifically pin down the impact of the measures taken by the government to improve the selective segment of life sciences logistics, however, there are other initiatives apart from the aforementioned which would help the industry grow.

Indian pharma companies already have 100 per cent FDI under automatic route for greenfield projects, however, the same has not encouraged many investors in the past.

Therefore the government in order to benefit the pharma

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cover ) I N T E R V I E W

The pharma industry is looking to emerging markets for growth Agarwal Packers and Movers Ltd (APML), a globally recognised logistics company, recently ventured into the pharma logistics segment. Ramesh Agarwal, Chairman, Agarwal Packers and Movers, in an interaction with Sachin Jagdale, reveals more about his company’s growth strategies and future prospects APML is a well known name for shifting household goods.

What prompted you to get into pharma logistics?

In almost three decades, APML has emerged as India’s largest mover of household goods. It has been recognised by Limca Book of Records for four consecutive years, from 2012-2015.

Transport is one sector where no changes in work pattern have been observed.

Same old methods have been followed for ages, but with changing lifestyle and technology, we have to keep pace with other sectors. APML has always been ready to accept changes and our R&D team has been highly innovative in estimating the needs of its clients. We, as a logistics partner, ensure that the processes and technologies being implemented adhere to quality assurance standards.

What kind of research did you conduct before venturing into the pharma segment?

A study conducted by BITS –Pilani found out that according to logistics industry standards, approximately three to four per cent of the vehicles breakdown during transit. As a result, goods need to be transhipped in another vehicle.

Also, there have been instances where due to pressure of timebound deliveries, transporters carried pharma or FMCG products, in vehicles which

28 EXPRESS PHARMA September 1-15, 2016

require special training. How have you overcome these challenges?

As mentioned above, all the procedures have been designed to provide shipper confidence in end-to-end shipping process for pharma products. A testament to the success of this multi-layered, high-visibility approach is that customers who started the journey with us as a pilot programme have continued to use 'Trucking Cube' for their temperaturecontrolled shipments.

might have been previously used to transport urea or any other hazardous chemicals.

Health hazards may arise when an unaware customer, without the knowledge of how the products have been transhipped, consume these products. The study confirmed that due to the above reasons, products lose their effectiveness.

Hence, zero transhipment during transit ensured that if food, pharma products and FMCG being transported are untouched and unseen then quality assurance yardsticks abided by companies remain intact. Hence, we thought of making 'Trucking Cube.'

How much do you plan to

invest in 'Trucking Cubes’?

In 'Trucking Cubes', we will invest `100 crores in a phased manner in the next three years.

How will you use 'Trucking Cubes' in pharma logistics?

At 'Trucking Cube,' we have implemented a multi-layered, high-visibility system that combines state-of-the-art cubes with accredited, highlytrained cargo personnel in major cities across India. Our cubes are fitted with Air Circulation System (ACS) which maintains the air temperature in the cubes.

Pharma products have specific temperature requirements. Even the handlers of these products

Have you received any specific inputs from pharma operators?

Both domestic and global pharma companies follow stringent regulations and hygiene while manufacturing and packaging medicines at their respective units, yet sometimes we come across cases where medicines transhipped are not being effective.

"Potency/virulence/viability goes down if and when bio-pharma goods are subjected to temperature excursion and 'Trucking Cube' will help to resolve supply chain issues. It will go a long way in a country like India, which has different climate and weather conditions," said Arumugam Muruganandam, Managing Director and Chief Scientific Officer, Affigenix, a Bengaluru-based lifesciences company.

Will you be taking care of reverse logistics as well?

At present, we have no plans to do reverse logistics. We will think of it two years from now.

Where do you see your pharma logistics business in the next five years?

Developed countries are considered mature in terms of pharma logistics. For growth, the pharma industry is looking to emerging markets like Southeast Asia, the Middle East etc. As these emerging nations have become more affluent, demand is increasing for modern medical treatments and healthcare products.

Lifesciences companies who were previously reliant on the developed countries are moving into unfamiliar territories and cultures, and discovering the accompanying supply chain challenges.

The shift in pharma growth, away from the established drivers towards high–potential 'pharma emerging' markets, offer tremendous opportunities for pharma manufacturers who face pressures in more mature markets.

In a developing country like ours, I think it will be a challenge due to unstable regulatory environment and less developed logistics infrastructure, but if we are able to innovate and read the necessities beforehand then it can be a smooth ride. sachin.jagdale@expressindia.com

MANAGEMENT CASE STUDY

Balancing growth with operations SynCore Consulting helped a fast growing pharma retail chain, bogged down by snags in its distribution model, improve stock accuracy from 60 per cent to 99 per cent+ as well as move from selling products to being a true healthcare partner, by adopting a service based business model.

In this case study, Javin Bhinde, MD and CEO and Vivek Acharya, Principal Consultant, SynCore Consulting illustrate the importance of balancing rapid growth with building a robust supply chain and IT-business alignment to support existing operations

X

YZ is a pharmaceutical retail chain operating around different metros around the country. They have a traditional distribution model consisting of one mother warehouse, regional warehouses and 14 pharmacies, dealing with an average of 2,500 SKUs on a daily basis. After meeting with success in the initial periods, XYZ is now facing a challenging phase with slow growth and a myriad of operational issues.

JAVIN BHINDE, Managing Director and CEO, SynCore Consulting

Pain points ◗ Scaled too fast, processes unable to support ongoing operations ◗ IT-Business alignment lacking ◗ Large scale stock mismatches

Project objectives ◗ Put the company firmly back on the growth trajectory ◗ Improve process efficiency and effectiveness ◗ Improve performance in key measurements ◗ Increase customer loyalty and share of spending ◗ Moving from selling products to being a true healthcare partner

VIVEK ACHARYA, Associate Consultant, SynCore Consulting

Analysis of problem In the first few periods of the business, the emphasis was purely on growth and adding more number of stores and product range, without much attention to demand estimation and operational efficiency. Problems with respect to unavailability, customer dissatisfaction and high staffing costs did not receive much attention of the management and these were addressed by increasing resources (manpower and inventory and

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MANAGEMENT warehouse space) thus increasing costs.

As the business matured and consolidated, attention was focused on key business success factors like inventory and working capital management which had a direct impact on profitability and cash flow. This focus brought to light a myriad of issues. Addressing these problems would involve conceptualising, designing and implementing new solutions, business processes that would not only be able to create sustained growth, but also deliver tangible business results i.e. profit and cash while minimising business risk.

Engagement details Due diligence At the start of the engagement, a holistic view was adopted and SynCore performed exhaustive due diligence across the value chain, geographies and business processes to highlight to the management the following: ◗ Weaknesses in the existing process ◗ Root cause analysis ◗ Identification of key levers to address the weaknesses The team performed primary interviews with a carefully chosen representative sample set across the company.

Inputs obtained were anonymously verified through data as well as subsequent interviews with different stakeholders.

Designing the change intervention It was evident during the research process that managing the change from legacy

30 EXPRESS PHARMA September 1-15, 2016

Quantifiable benefit drawn from engagement

Benefit (INR Lakhs / month)

Inventory shrinkage

1.1

Reduced inventory in the system (interest savings on capital only)

0.9

Increased sales from repeat business from existing customers

1.8

Increased sales from reduced lost sales

13

processes to rigorous new ones would require extensive change management. With this in mind, the team analysed the formal and informal power structures existing in the company. The team also developed cross-functional task forces and leadership teams to demonstrate seriousness and break down the communication and decision barriers within the company.

Priming up for change The team developed a series of workshops intended to educate the team on the problems faced and their solution using a Socratic method. These sessions were designed to educate the participants in business problem solving and solution development and were guided towards arriving at the proposed processes on their own rather than issuing a series of pre-designed SOPs. Implementing the change Some of the principles that SynCore employs in most of its engagements are as follows: ◗ Organisations are complex systems, but even complex systems can be significantly influenced by relatively few key levers. ◗ Individuals and all that they

bring with them, profoundly influence organisational performance. ◗ Resources, processes and values are increasingly difficult to change in that order and influence organisations in the same increasing order.

In SynCore's experience, the successful change efforts are the ones which are able to visualise the human nature hidden behind behaviours and are able to leverage them to achieve the following: ◗ Buy-in to the proposed change ◗ Remove conflicts across departments, people, measurements, targets and forecasts ◗ Empower people to drive the change Keeping this in mind, SynCore recast XYZ from being a retailer of pharmaceuticals to being a caring partner in healthcare for its customers.

This was achieved through the “We help people live better lives” campaign. The senior management highlighted (through multiple interactions with team members) the renewed focus on “helping people live better lives through better health”. Factors like very high availability of medicines, range of products and quality of services and use of IT to deliver all these points of value led from

the core objective “We help people live better lives.”

SynCore also revised the roles and responsibilities and KRAs to enable rapid change as well as a smoother transition: ◗ Removal of conflicting measures for different departments/people and their replacement with simple measurements directly relating to organisational goals ◗ Clear decision making responsibility allocated to reduce decision paralysis as well as the other extreme i.e. decision apathy SynCore rolled out the implementation in keeping with a plan to choose the functions having minimum dependency on other functions (i.e. related changes in other functions were at a minimum) and had the potential to deliver some quick wins. In the case of XYZ this was found to be the stock accuracy problem and the digitisation of all information consistently across all points in the value chain. ◗ The stock accuracy was improved from 60-70 per cent to 99 per cent while simultaneously implementing digitisation and streamlining of the entire upstream process. This set the stage for subsequent improvements like rapid replenishment,

improved availability and reduced shortages. ◗ Manpower capacity planning was taken up simultaneously to ensure staffing was in lock-step with the new processes. ◗ Finally a series of dashboards were developed at different levels of the organisation for management to assess and take superior decisions in the fastest possible time.

Results delivered ◗ XYZ was able to improve the stock accuracy across all touch points to beyond 99 per cent consistently. ◗ Availability (both in warehouse and stores) which was not measured previously was deployed as a key measurement and was able to achieve the target of 98 per cent within eight weeks of the implementation. ◗ The number of inventory turns achieved by XYZ improved by 60 per cent. The average age of the inventory also dropped sharply. ◗ Customer satisfaction feedback study conducted from week 16 to week 20 of the engagement showed significant improvement over the feedback received before the start of the engagement. ◗ Employee morale improved as both attrition and absenteeism at the stores as well as offices were seen to reduce.

Disclaimer All names have been disguised to protect the identity of the client in keeping with client requests.

All numbers have been scaled to protect client interests.

MANAGEMENT REPORT

Cystic fibrosis therapies will push Vertex ahead of GSK in $46.6 billion respiratory market by 2022: GBI It will grow at a CAGR of 7.5 per cent

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International Quality Standards THE MARKET size for respiratory therapeutics, covering asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), and cystic fibrosis, is expected to rise considerably from $28.1 billion in 2015 to $46.6 billion by 2022, at a compound annual growth rate (CAGR) of 7.5 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that although the patent expirations of

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Although GSK is currently the leading company in terms of revenue generated from respiratory disorder products, GBI Research expects Vertex, which specialises in the cystic fibrosis segment, to overtake GSK by 2022.

Mushtaq continues, “The emergence of transmembrane conductance regulator modulating therapies, which are considered disease-modifying therapies for cystic fibrosis, an indication which has traditionally only had symptomatic

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The approvals of novel biologics in the asthma market, including interleukin (IL)-targeting Nucala (mepolizumab) and Cinqair (reslizumab), marketed by GSK and Novartis, respectively, are also forecast to have a strong commercial impact on the market the commercially successful Advair, Symbicort, Ventolin and Spiriva will allow generics to enter the market, the impact of these expirations will be offset by the approval of new products.

Yasser Mushtaq, Senior Analyst, GBI Research, explains, “Recently approved products in COPD include multiple long-acting beta-2 agonist/long-acting muscarinic antagonist (LAMA) fixed-dose combinations, some of which are forecast to generate over $1 billion by 2022, and include GlaxoSmithKline’s (GSK’s) Anoro, Novartis’ Ultibro and Boehringer Ingelheim’s Stiolto.

“The approvals of novel biologics in the asthma market, including interleukin (IL)-targeting Nucala (mepolizumab) and Cinqair (reslizumab), marketed by GSK and Novartis, respectively, are also forecast to have a strong commercial impact on the market.”

treatments, is set to have a substantial clinical and commercial impact.

“There are only two of these products on the market – Kalydeco and Orkambi – both of which were developed by Vertex. They are forecast to generate $2.8 billion and $6.8 billion, respectively, by 2022, driven by strong demand for disease-modifying therapies.

Vertex also has a phase III candidate of the same class, which is expected to achieve blockbuster status during the forecast period.

“These factors, combined with the limited or negative growth forecast for other key players in the market, including GSK, Boehringer Ingelheim and AstraZeneca, will allow Vertex to become the leading company in the respiratory disorders landscape in terms of revenue generated by 2022.”

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EP News Bureau-Mumbai

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RESEARCH

It’s personal Though personalised medicines have shown potential in revolutionising medical treatment by making them patient-specific, there is still a long way to go before it makes inroads into the Indian healthcare system. By Sachin Jagdale

F

rom generalised to personalised, medicines have evolved in a big way over the last few years.

Target-oriented approach of personalised medicines has not just promised to make the treatments more precise and accurate but at the same time it is going to reduce the duration of medication as well. As evidence of the benefits offered by this new form of healthcare mounts, medical community has also gradually started rooting for it. However, there are always two sides to a coin. There is a mixed reaction over the cost involved in the use of personalised medicines. Diseases that would be effectively covered under it is also a subject of discussion. As far as India is concerned, besides lagging behind in research, we will have to start with spread awareness about its potential.

Why personalised medicines?

As the term itself indicates, personalised medicines are person-specific. When it comes to the benefits offered by them, till now, this concept has proved beneficial mainly in the treatment of cancer where genetic mutation is the norm. It is always said that repeated chemotherapy kills the whole body by degrees.

This therapy cannot distinguish between what is good and bad. Healthy immune cells and cancerous cells, both multiply rapidly and chemotherapy kills both. Experts sarcastically say that

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chemotherapy is to kill and not to cure the patient. This scenario can be changed with the help of personalised medicines.

Arunima Patel, Founder and MD, iGenetic Diagnostics, explains, “Personalised medicine has been extremely beneficial in disease categories like cancer. Cancer arises due to a genetic mutation and thus it is important to understand the particular mutation that ails the person. For example, there are more than 50 different types of mutations within the same type of cancer. Thus, it is important for the treating doctor to know the exact character of the disease they are treating and then prescribe medication. The effectiveness of the medicine sig-

nificantly improves if it is targeted towards a particular genetic mutation. Traditional chemotherapies target every fast growing cell in the body, thus disrupting the immune system and leading to high mortality rates. Personalised medicine targets specific cancerous mutations and hence are more efficacious with limited side effects.”

However, though oncology would be the biggest gainer from personalised medicines, treatment of several other diseases will also enjoy the benefits offered by it. Patel adds, “Other areas where personalised medicines are being used are transplant cases, infection, neurological disorders and paediatric segments.”

Today, global pharma companies are investing significant resources towards developing these target-specific drugs. However, currently very few of these are commercially launched in India, making them unaffordable for the general population. Patel is optimistic that this scenario will change in the future, leading to a significant decrease in the cost of personalised medication.

“One more important application is for diagnosis of diseases. This could be for confirmation of a diagnosis or differential diagnosis for diseases with overlapping symptoms. Genetic testing could help to conclusively identify the disease. There are instances where genetic

testing provided additional information that changed the initial diagnosis by the physician,” informs Satish Sankaran, Lab Director, Strand Center for Genomics and Personalised Medicine, Strand Life Sciences.

Challenges to conquer Personalised medicines hold the potential to revamp the way medicines are being administered, it has few limitations as well. With the progression of the disease personalised medicines come less handy. Like, in cancer, more the delay more it will be difficult to decide the targeted treatment.

Kapil Mehta, Director R&D, MolQ-Personalised Medicine, explains, “In

patients with active or advanced disease, these treatments may have minimal impact on overall survival and quality of life. For example; in case of cancer, genome is highly unstable and mutations are continuously added making it hard to target specific genetic alterations. Moreover, in addition to genetic changes, epigenetic changes and tumour microenvironments have significant impact on disease progression. This would make it even harder to target changes detected by this approach for effective control and treatment.”

Is cost an obstacle?

The concept of personalised medicines is still at a nascent stage in India.

So, despite a significant number of cancer patients and those with other serious ailments in the country, personalised medicines haven't really offered spectacular results. As is the case with a lot of new inventions, this particular form of treatment has its origin in the overseas countries. A good amount of research has been taking place over there. With our limited expertise in this field, if we need to borrow something from our foreign counterparts, it makes the entire process very expensive.

Anu Acharya, CEO, Mapmygenome, India, sheds more light on the topic. She says, “While India has a great genepool of IT and biotech talent, there are some challenges to development of personalised medicine.

Machinery and software used are expensive. Moreover, shipping costs and import tariffs add to these costs. Globally, governments are focused on this developing science and are allocating budgets for R&D. We have to see this happening in India too. The Startup India initiative earlier in the year was a good start, but we need more to keep up with the advances in science. Regulations too need to be revamped to allow technology to breathe and grow.”

“It would require exuberant amount of resources, well regulated oversight processes and labs as well as a tightly controlled review process to validate and approve tests before implementation into the clinic,” insists Mehta. Mehta also considers cost as one of the major challenges. He says, “Importantly, due to high cost factor, very few patients in developing countries like India will be able to afford and benefit from genetically-based individualised treatments that are likely to offer only marginal benefit in terms of overall survival and quality of life.”

Sankaran says, “Adoption of the

concept of precision medicine is in its infancy in India. There are some physicians who are abreast with the latest scientific developments and see great potential for genetic testing, while others are sceptical about the utility of the test due to the high cost of genetic tests and unavailability of drugs for identified diseases in the local market. Even though certain service providers in India send samples outside the country for testing, certain others like Strand does testing in-house, adopting stringent quality control measures as recommended for such complex tests by national and international regulatory agencies like CAP, ACMG and NABL. This helps in lowering the cost to an extent. However, all the reagents are still imported from companies in the US and Europe. R&D efforts to develop tests with generic reagents would further bring down the cost for testing.”

R&D for personalised medicines is a very expensive proposition and hence only large global pharma companies are undertaking this type of research currently. As mentioned before, normally such medicines are launched in developed countries. Patel informs that in the developed countries affordability is higher and also can get reimbursed under insurance schemes.

With our limited strength in the field of personalised medicine it is imperative for Indian operators to have tie-ups with established players from overseas countries. Unless efforts are made to be self-sufficient in this regard the cost factor will always remain a deterrent for the patients.

But there is a silver lining to the cloud as well. Companies such as iGenetic are collaborating with global providers of personalised diagnostics to make these tests available at affordable rates in India.

Patel states, “Cross-border collaboration should largely be in the R&D space. Indian biotech companies can collaborate with global peers in developing indigenous drugs in this space at lower costs in order to cater to Indian and developing world population.”

Acharya also believes in the same theory and informs that Mapmygenome is on the right track.

She says, “Cross-border agreements are a rapid-expansion strategy that can be of immense value – introducing tests and services to the Indian market can be economically viable. Mapmygenome has several such strategic partnerships – with Brain Resource, and other diagnostic companies.” She

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September 1-15, 2016

RESEARCH informed that they also have organisations that offer their personal genomics services in Latin America, Asia, etc.

While pointing out that collaborations with drug companies conducting clinical trials and accessibility of patients from India to these drug trials would really help patients to try out experimental drugs, Sankaran echoes what Patel said before. He says, “Efforts by government agencies to facilitate import and sale of approved drugs and mandate insurance companies to provide coverage for treatment of genetic disorders would considerably help in better adoption of personalised medicine.”

a cautious approach. He says, “The field of personalised medicine will help pharma companies. It is very essential we understand that with the right data, they will be able to make better targeted drugs for people with various conditions. Having said that it is a long way away.”

Need for awareness

Pharma perspective New discovery is the norm in the pharma industry. The survival and growth of any pharma company depends on its ability and willingness to accept the latest advances in the market. Though the concept of personalised medicines has not yet gained significant ground in India, it will happen sooner or later. Pharma companies will be left with no option but to accept this new form of healthcare. Till now personalised medicines have showed potential in the treatment of diseases like cancer. A lot of research is still going on in the overseas market. As far as India is concerned, there are a few developments taking place, but nothing noteworthy has been achieved yet.

Sankaran feels that advances in the field of genetics have pharma companies more opportunities to develop new drugs. “The pharma industry is driven by market requirement. There is a huge requirement for discovery of new drugs for cancer and rare diseases. Data from genetic profiling would definitely be a rich source for discovery of new drug targets. Drug re-purposing, yet another outcome of genetic profiling, has opened the doors for pharma companies to conduct trials of drugs in nonapproved diseases and get approvals from FDA and EPA,” says Sankaran.

However, is it easy for

34 EXPRESS PHARMA September 1-15, 2016

Today, global pharma companies are investing significant resources towards developing these target-specific drugs. However, currently very few of these are commercially launched in India, making them unaffordable for the general population

pharma companies to achieve Sankaran’s expectations? Perhaps not. Mehta explains, “High costs and high failure rates in drug development are major impediments in bringing effective therapies to the clinic. So far, the general approach by pharma manufacturers has been to develop inhibitors against single target (targeted therapies), which have sky-rocketed the costs with minimal survival benefits. Cancer is a multigene disease and only few drugs are available to target selected mutations. It will required to develop many more drugs against remaining tar-

get genes to reap potential benefits of personalised medicine (for example in lung cancer 8-10 driver genes have been identified whereas only two genes can be targeted by available drugs). It will take enormous effort, time and resources to develop effective drugs against remainder targets before this technology can be applied for identifying right drugs for right patients, that too implying that epigenetic and micro-environmental changes do not have significant impact in disease progression.”

Despite having done considerable work in the field of

personalised medicines, overseas researchers too have a lot of ground to cover. So, India lags way behind in this sphere. As mentioned before

by Mehta, even today there is a very limited success and a lot of time and efforts needed to be devoted to take a real leap.

In comparison with their overseas counterparts, Indian researchers' work and achievements are miniscule.

So, in the near future, Indian pharma companies are less likely to have strategies/business plans developed around personalised medicines.

Pranav Anam, Co-Founder and CEO, The Gene Box, takes

India has one of the largest patient pools in the world but lack of awareness is going to affect the growth of personalised medicines in the country. However, according to Sankaran, Internet savvy population is keeping themselves updated with the latest development. Sankaran narrates, “It is interesting to mention here that I was asked by a cancer patient about a year back as to why we do not use liquid biopsy instead of tumour blocks for testing; the test was not even being offered in the US at that time!

The utility of personalised medicine in diagnosis of rare inherited diseases is steadily being recognised and accepted by physicians. They are excited about new non-invasive technologies like liquid biopsy and its utility in testing tumours that are inaccessible and tracking disease progression and recurrence.”

When it comes to patient awareness, the physician's role proves detrimental. He is the connect between the patient and the medicine producer. Educating general population is important but educating the physician is perhaps more important. As Acharya opines, “One factor that holds sway here is the medical fraternity’s opinion.

There is a need to educate doctors about the clinical value of this service.”

Patel sums up saying, “There are early adopters, especially in metros; however the pick up is slow. Also, there is a thought process on changing treatment protocols to incorporate personalised medicines. As soon as prices reduce, clinicians and patients will shift towards personalised medicine.” sachin.jagdale@expressindia.com

RESEARCH UPDATES

Study in mice shows Zika virus also attacks adult brain cells Experts cautioned that the findings are preliminary and may not have any correlation to how Zika impacts human brain function US RESEARCHERS have found that Zika can attack special populations of brain cells in adult mice in the part of the brain involved in learning and memory, raising new questions about how the virus may be impacting millions of adults who have been infected with the virus. The findings, published in the journal Cell Stem Cell, are the first to look at whether Zika can attack the same kinds of cells in adult mice that they do in fetal mice.

Experts cautioned that the findings are preliminary and may not have any correlation to how Zika impacts human brain function, but they suggest the need for follow-up research. “This is one potential consequence we need to look at,” said Dr Joseph Gleeson, an expert in paediatric brain disease at The Rockefeller University in New York, who led the study. Zika has already been shown to attack foetal brain cells known as neural progenitor cells - a type of stem cell that gives rise to various kinds of brain cells.

The death of these cells is what disrupts brain development and leads to the severe birth defects seen in babies whose mothers were infected with Zika during pregnancy.

US health officials have concluded that Zika infections in pregnant women can cause microcephaly, a birth defect marked by small head size that can lead to severe developmental problems in babies. The connection between Zika and microcephaly first came to light last fall in Brazil, which has now confirmed more than 1,600 cases of microcephaly that it con-

36 EXPRESS PHARMA September 1-15, 2016

US health officials have concluded that Zika infections in pregnant women can cause microcephaly, a birth defect marked by small head size that can lead to severe developmental problems in babies siders to be related to Zika infections in the mothers. Fetal brains are chock full of neural progenitor cells, which are responsible for making cells that form key brain structures. Adults, whose brains are fully formed, have far fewer and there are some pockets remaining - including in the hippocampus, a part of the brain involved in memory and learning. Gleeson wanted to see if Zika could attack

these cells in adult mice. To find out, his team injected the virus into lab mice and examined their brains for Zika infection.

In the hippocampus, Gleeson said, “It lit up like a Christmas tree and wiped out the stem cell population.”

“Based on our findings, getting infected with Zika as an adult may not be as innocuous as people think,” he said.

There have already been

signs that Zika affects adult nerve cells. Several teams have published papers showing that in some patients, Zika can cause serious brain and spinal cord infections - including encephalitis, meningitis and myelitis - in people exposed to Zika. In rare cases, Zika has also been linked with Guillain-Barre Syndrome, a post-infectious autoimmune disorder that can cause temporary paralysis in adults.

“It's really unclear if this translates to human Zika infections,” said Dr Daniel Pastula, a neurologist and medical epidemiologist at the University of Colorado Denver.

But if it does, it is not clear whether the effect is temporary or lasting. “Detailed neurological studies are needed in infected humans to describe the effects of Zika virus infection on the brains of adults,” said Dr Anna Checkley of the Hospital for Tropical Diseases, part of University College London Hospitals. Gleeson said the study needs to be replicated by other scientists, and he wants to test other strains of Zika on adult mice at other times during an infection to see if those viruses have the same effect. Since 2015, 66 countries and territories have reported evidence of vectorborne Zika virus transmission, according to the World Health Organization. Earlier this month, researchers at Notre Dame University estimated as many as 93 million people across Latin America and the Caribbean could become infected with Zika in the current outbreak.

Reuters

Compound found to treat three parasitic tropical diseases SCIENTISTS HAVE found a single class of drugs that can kill the parasites responsible for three tropical diseases that affect millions in Africa, Asia and Latin America - Chagas disease, leishmaniasis and sleeping sickness. In a study published in the journal Nature, scientists at the Genomics Institute of the Novartis Research Foundation found the compound can cure all three diseases in mice, and does not harm normal human cells in laboratory tests. This provides a strong starting point for developing new drugs to replace existing treatments that are expensive, sometimes not very effective, and can also have side effects. Chagas, leishmaniasis and sleeping sickness kill more than 50,000 people a year, but receive relatively little funding for research and drug development.

They have different symptoms but are all caused by parasites called kinteoplastids with similar biology and genetics.

Hoping to find a shared weak spot in that biology, the scientists tested around 3 million chemicals on them. They identified a compound, called GNF6702, that worked against the parasites, and then refined it to make it more potent before testing in it mice. "We found that these parasites harbor a common weakness. We hope to exploit this weakness to discover and develop a single class of drugs for all three diseases," said Frantisek Supek, who led the work. The fact that GNF6702 seems to have no adverse effects in mice suggests it might have fewer side-effects than existing drugs, the researchers said, although this will need to be tested in human studies.

Reuters

PHARMA ALLY I N T E R V I E W

‘We would like to spend the next few years concentrating on primary glass packaging’ Shreevar Kheruka, Managing Director, Borosil Glass Works, in an interaction with Sanjiv Das, talks about Borosil’s recent acquisition of Klasspack, its plans to leverage opportunities in pharma glass packaging and strategies to become India’s most customercentric company

By upgrading Klasspack's manufacturing facilities, we will deliver to the increasingly stringent norms required by the pharma industry. Our vision is to be a partner which provides reliable, high quality, on time primary glass packaging to our customers To subscribe: bpd.subscription@expressindia.com

Recently, Borosil announced the acquisition of 60.3 per cent shares in Klasspack. Why did you go in for the acquisition?

At Borosil, our endeavour is to be India’s most customercentric company. Borosil has been a trusted supplier of high quality products for the Indian pharma industry for the past 50+ years. In feedback sessions, our customers have indicated to us that there is an opportunity to supply them high quality pharma glass packaging products owing to an increased requirement of compliance in the industry.

Based on this input, we looked at various options for entering this sector including a greenfield project. However, when we came across Klasspack, a company that has many of the same value systems as Borosil, it seemed a natural point of entry into this space.

With compliance becoming increasingly stringent in the Indian pharma sector, what made Borosil Glass Works enter the primary pharma glass packaging business?

We see compliance stringency

as an opportunity. Borosil currently provides glassware to pharma laboratories. We pride ourselves on accuracy and traceability, with some of our products delivering an accuracy of 0.006 ml. We have always worked to provide products that far exceed compliance demands and we are confident that by upgrading Klasspack’s manufacturing facilities, we will deliver to the increasingly stringent norms required by the pharma industry.

Klasspack already had a strong reputation for service and product development. Our vision is to be a partner which provides reliable, high quality, on time primary glass packaging to our customers.

Do you also plan to enter the secondary and tertiary pharma packaging business in future?

Primary packaging is a large market with a huge opportunity for us. We would like to spend the next few years concentrating on primary glass packaging.

Why do you think pharma companies will be keen to use your packaging products?

As with all customers, pharma companies will accept us if we provide value. Borosil stands for trust, and we will upgrade the manufacturing facilities with clean rooms, world class machines, automatic lines and automated vision inspection systems. If we execute these plans well, there is no doubt that our customers will support us.

Are there plans to set up any new facilities besides the one located in Bharuch, Gujarat?

Borosil group already has large facilities in Jaipur, Bharuch and Tarapur.

However, for the primary glass packaging space, Klasspack’s Nashik facility has significant capacity to accommodate our immediate and near future plans.

Any additions to the core team after the acquisition?

While our existing team is very competent to execute immediate growth plans, Borosil is always on the look out for motivated and competent individuals who can contribute during this exciting phase of the company’s growth. sanjiv.das@expressindia.com

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PHARMA ALLY POST EVENT

PharmaLytica 2016 concludes successfully in Mumbai It brought the pharma fraternity under one roof to witness the latest industry trends, innovations and conduct business with analytical, bio tech, lab, pharma machinery and outsourcing services THE THIRD edition of PharmaLytica, hosted by UBM India, successfully concluded at the Hitex Exhibition Centre, Hyderabad. This year, PharmaLytica witnessed a good turnout from exhibitors and visitors from the pharma industry.

A comprehensive analytical and contract service event, PharmaLytica 2016, brought the pharma fraternity under one roof to witness the latest industry trends, innovations and conduct business with analytical, bio tech, lab, pharma machinery and outsourcing services.

The Innovation Gallery was the key highlight of the show.

Companies like Biopharmax India, Galaxy Sivtek, Gandhi Automations, Scientific Research Instruments Company, POLMON INSTRUMENTS, SK Pharma Machinery, Landsky Engineers and Orbit Technologies showcased their innovative product offerings as part of the gallery. These cuttingedge offerings were evaluated both by an esteemed panel of jury as well as by popular choice voted by the visiting participants. The selected companies were then felicitated by UBM India as part of the event.

The Visitor’s Choice Award was awarded to Polmon Instruments for the launch of innovative MP98 Automated Melting Point Apparatus. MP98 is a specifically designed apparatus that automatically identifies the melting points and melting ranges of three test samples simultaneously. With the advantage of the colour touch screen

38 EXPRESS PHARMA September 1-15, 2016

The Innovation Gallery was the key highlight of the show

The Jury’s Choice Award was bagged by Biopharmax Group for introducing the Biopharmax: The Next Generation of Pharmaceutical Pre-treatment Water Systems

The Visitor’s Choice Award was awarded to Polmon Instruments for the launch of innovative MP98 Automated Melting Point Apparatus

to display all melting operations, the apparatus can be independently operated without the need of an external PC or keyboard.

The Jury’s Choice Award was bagged by Biopharmax Group for introducing Biopharmax: The Next Generation of Pharmaceutical Pre-treatment Water Systems. The Pre-treatment process reportedly ensures an environment friendly, clean, reliable and effective way of supplying chemical-free and hardness-reduced water for use as RO feed water, without the need of any additional treatment.

Yogesh Mudras, Managing Director, UBM India said, “I am delighted that PharmaLytica 2016 has witnessed such a great participation from Indian and global firms. I would also like to congratulate the winners of the Innovation Awards.

At UBM India, we are committed to encourage novelty in products and an exchange of ideas within the framework of our exhibitions. We are looking forward to taking this prestigious platform to the next level in the coming years.

EP News Bureau – Mumbai

PHARMA ALLY VENDOR NEWS

IPEC India hosts conference on ‘The need for total excipient control’ A host of reputed speakers spoke on various subjects that impact the excipients industry THE INTERNATIONAL Pharmaceutical Excipients Council of India (IPEC India) hosted its first ever annual conference in Mumbai recently to focus on the theme ‘The need for total excipient control.’ The conference was chaired by Ajit Singh, Chairman, IPEC India and ACG Worldwide. The guest of honour during the conference was Sudhanshu Pandey, IAS, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry, who inaugurated the event. He was joined by Dave Schoneker, Global Expansion Controller, IPEC Federation and Subhodh Priolkar, Vice Chairman, IPEC India, Peter Salazar and SM Mudda, Managing Committee Member, IPEC India.

Singh said, “Today, excipients are an important part of the formulation for optimal drug delivery system. IPEC India is the foremost body that is taking concrete steps to ensure

(L-R) Peter Salazar, Managing Committee Member, IPEC India; Subhodh Priolkar, Vice Chairman, IPEC India; Ajit Singh, Chairman – IPEC India; Sudhanshu Pandey, IAS, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry; Dave Schoneker, Global Expansion Controller, IPEC Federation and SM Mudda, Treasurer, IPEC India

total patient safety in this country through such conferences wherein key stakeholders get a common platform to meet and deliberate on areas that concern them the most.”

Schoneker during his presentation stated that IPEC is all about science and using this science to drive what is ultimately good to businesses across the world. IPEC Feder-

ation is the regional voice with a global influence. IPEC is the largest organisation in the world that focusses on excipients and excipient safety.

A host of other speakers spoke on various subjects that impact the excipients industry.

They were Dr Sameer Navalgund, VP, USP-India; Seema Kamath, Manager, Global Regulatory Management Life Sciences, Merck; Vishakha Metkar, Manager, Regulatory Affairs, Colorcon South Asia and TS Shadagopan, Product Manager, SGS India and Kedar Chikhalikar, Associate Head – Technical Services, Lubrizol Advanced Materials.

Kamath stressed that poor quality excipients can hamper a drug batch or the final drug product. Therefore, it is critical only to use components in drug formulation from high quality reliable suppliers who have good change notification programmes in place.

Shadagopan gave an overview of EXCiPACT and other certifications. He said that IPEC is doing a very good job of education. He appealed that IPEC India should approach all excipient manufacturers in India and ask them to be members of the council.

Shadagopan also announced that ‘ACG Associated Capsules’ (manufacturer of Gelatin and Cellulose Capsules) have received the EXCiPACT Certification on this very day.”

The event was attended by representatives from the pharma industry such as Merck, Unichem, Sun Pharma, Dr Reddy’s Laboratories, Micro Labs and Cipla. Key players in the excipients industry including BASF, Colorcon Asia, Dow Corning as well as ACG Worldwide also ttok part in the event.

EP News Bureau – Mumbai

Lonza to acquire InterHealth Nutraceuticals The acquisition will strengthen Lonza’s specialty nutritional ingredients portfolio LONZA HAS agreed to acquire InterHealth Nutraceuticals, a leader in research, development, manufacture and marketing of value-added nutritional ingredients for use in dietary supplements, based in Benicia, CA (USA). InterHealth is a portfolio company of Kainos Capital.

“With this acquisition, Lonza is taking a further step along our strategic path as a high-value supplier to the

healthcare continuum,” said Richard Ridinger, CEO, Lonza. “Lonza will leverage the successful product portfolio of InterHealth on a global level and in turn will be able to benefit from InterHealth’s proven management and branding capabilities to promote Lonza’s existing product portfolio. We see significant positive synergies from this combination.”

InterHealth offers more

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Lonza will acquire InterHealth for a total transaction price of up to $300 million

than 15 branded ingredients, including its cornerstone ingredient, UC-II, which is revolutionising the joint-health segment; and it complements Lonza’s existing nutritional portfolio in the area of sports nutrition, weight management, immune health and pet health. The acquisition will also expand Lonza’s offerings into new areas such as cognitive and diabetic health.

Lonza will acquire Inter-

Health for a total transaction price of up to $300 million, representing a multiple of approximately ten times InterHealth’s EBITDA for the twelve months ended July 2016, split into an upfront payment and an earn-out payment. Closing is expected to take place in September 2016 following customary closing conditions.

EP News Bureau – Mumbai

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September 1-15, 2016

PHARMA ALLY

VICAM’s Afla-VAQUAStrip Test receives USDA-GIPSAcertification Eco-friendly Aflatoxin detection method is now verified by the US Official Grain Inspection System VICAM, A Waters Business, has received USDA-GIPSA (Grain Inspection, Packers & Stockyards Administration) certification for its Afla-V AQUA strip test for the quantitative analysis of total aflatoxins in grains.

“Aflatoxin detection is critical to global food cultivation and trade. USDA-GIPSA approval provides official verification of method performance, giving our customers even greater confidence in their aflatoxin testing data,” said Marjorie Radlo-Zandi, MD, VICAM. “In addition, the Afla-V AQUA strip test is an ecofriendly and sustainable alternative to traditional solvent based methods – improving safety and reducing the overall

costs of aflatoxin testing.”

The Afla-V AQUA strip test provides fully quantitative

data for the determination of total aflatoxins. Results are displayed on the digital screen

in just five minutes (following extraction and sample preparation) with

a range of 5-300 parts per billion for total aflatoxins, and was designed to be used virtually anywhere, requiring little to no training or expertise.

Traditional methods for the detection of aflatoxins have required the use of methanol, ethanol and other solvents for the extraction step, costly chemicals which require specialised and often costly shipping, handling and storage facilities. The Afla-V AQUA strip test replaces chemical solvents with a water-based extraction solution which is both environmentally friendly and safe for use in the field, process or laboratory environment.

EP News Bureau – Mumbai

Eric Kaneps joins Pharma Tech Industries as VP of Business Development Kaneps’ primary role will be to develop and maintain new supply chain relationships with both current and potential customers PHARMA TECH Industries has hired Eric Kaneps as its new VP of Business Development. As the newest member of Pharma Tech’s leadership team, Kaneps’ primary role will be to develop and maintain new supply chain relationships with both current and potential customers. He will also be responsible for evaluating and assessing new technology capability platforms in the health and wellness space as the company looks to expand its core offerings to its

40 EXPRESS PHARMA September 1-15, 2016

customers.

Kaneps comes to Pharma Tech with more than 20 years of sales and business development experience serving the pharmaceutical and consumer healthcare markets. Most recently, he served as the director of business development for DPT Laboratories. Prior to that, he was global account manager for Alcan Flexible Packaging.

“Eric’s sales and business development experience will help Pharma Tech continue its

growth trend,” said Tee Noland, Chairman and CEO, Pharma Tech Industries. “His proven ability to develop and maintain strong client relationships will be invaluable as we build upon our excellent record of exemplary quality, expedient turnaround, and overall customer satisfaction.”

Kaneps earned his BSBA in Economics and International Business Administration from The Ohio State University.

EP News Bureau – Mumbai

PHARMA ALLY

LMTGroup opens academy in Goa The facility offers ongoing training and courses for employees of LMT Group GERMANY-BASED LMT Group has recently inaugurated an academy in Goa. The LMT Group Academy is the international training institution of the business group. Following the same model, the group had just opened an academy in Nanjing, China, in 2015.

The foundation of the LMT

Group in India. Its core mission is to continuously develop technical, functional and managerial capabilities amongst the employees for their holistic development.

“The LMT Group is increasingly becoming a knowledgeoriented company,” said Olaf J Müller, CEO, LMT Group, at the

(L-R) Olaf J Müller, CEO, LMT Group, Sandeep Sood, MD, Fette Compacting India, Siva Venkatasubramanian, MD, LMT Tools India and Sameer Kulkarni, Deputy GM of Human Resources, LMT Group India at the opening of the LMT Group Academy in Goa

Group Academy India takes account of the worldwide growing importance of knowledge-based services. The new facility offers ongoing training and courses for employees of the LMT

opening ceremony in Goa. “That is why investments in the skills and expertise of our employees are a major part of our strategy for the future. In Goa, we opened the second LMT

Group Academy outside Germany. In all three facilities, we provide extensive training and skills development for our employees and customers. This will make us even more reliable and faster.”

Siva Venkatasubramanian, MD, LMT Tools India and member of the LMT Group’s

India, he emphasised on the critical role of an academy in developing employee’s capabilities to achieve ambitious business objectives.

In addition, Sameer Kulkarni, Deputy GM of Human Resources, LMT Group India, emphasised, “The new academy has a strategic focus aiming at

product innovation and community engagement in ways that make the world a better, more sustainable place to live.”

FTSE Group confirms that Ingersoll Rand has been independently assessed according to the FTSE4Good criteria and has satisfied the requirements to become a constituent of the index.

EP News Bureau – Mumbai

EP News Bureau – Mumbai

the holistic development of people as individuals, of their performance as a team and of the organisation as a whole.”

EP News Bureau – Mumbai

Ingersoll Rand listed on FTSE4Good Index Series for second consecutive year Index series measures environmental, social and governance performance INGERSOLL RAND, a leader in creating comfortable, sustainable and efficient environments, has been listed on the FTSE4Good Index Series. Created by the global index company FTSE Group, FTSE4Good is an equity index series designed to measure the performance of companies demonstrating strong environmental, social and governance (ESG) practices.

Companies in the series have met stringent ESG criteria. Ratings are designed to measure the ESG risk and performance of companies worldwide and provide market participants with a tool to be used in portfolio design and management against ESG criteria, or as a framework for corporate engagement and stewardship.

“Inclusion on the FTSE4Good index two years

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running is further verification that our performance matches the commitment of our employees to integrating sustainability in ways that are valuable to customers and to the vision and purpose of Ingersoll Rand,” said Paul Camuti, Senior VP of innovation and CTO, Ingersoll Rand.

“While we are pleased with the FTSE4Good listing, we realise that we must continue to improve our business practices,

The certificate was received for its plant in Dahanu, Maharashtra ACG WORLDWIDE announce that ACG Associated Capsules Pvt Ltd (ACG ACPL) has received EXCiPACT certification for its plant at Dahanu, Maharashtra. ACG ACPL is the first empty hard capsule manufacturing company in Asia to receive EXCiPACT certification. The certificate provides independent validation that ACG ACPL maintains excipient Good Manufacturing Practices and complies with current European Union regulation and US FDA regulation.

“We give paramount importance to maintain the highest quality whilst adhering to necessary compliance at ACG ACPL. This has been the key driver for helping us achieve market leadership and create a long term relation with our global customers,” said Quateel Ahmed, CMO, ACG Worldwide.

“ACG ACPL endeavours to maintain company’s quality and compliance policies that surpass the current regulatory norms. We are delighted to become the first empty hard capsule manufacturing company in Asia to receive the prominent EXCiPACT certification,” he further added.

EXCiPACT was created by IPEC Europe, IPEC Americas, FECC, EFCG and PQG as a rigorous, independent, third-party audit system to respond to regulatory requirements and reduce the audit burden of pharmaceutical companies as well as audit authorities.

As third LMT Group Academy, the new facility offers trainings and courses for all employees of the LMT Group in India

Global Executive Committee, appreciated the decision of the management to start an academy in India at an appropriate time. Together with Sandeep Sood, MD, Fette Compacting

ACG ACPL receives EXCiPACT Certification

EXPRESS PHARMA

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September 1-15, 2016

PHARMA ALLY PRODUCTS

Dock levellers by Gandhi Automations GANDHI AUTOMATIONS, an entrance automation and loading bay equipment company, is ISO 9001 : 2008 certified. Since its inception in 1996, the company has manufactured, imported, distributed and installed products that are problem free and easy to operate. The company offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses.

Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only a bridge to connect a vehicle, but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimise the energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.

Efficient loading and unloading of goods The importance of efficient loading of goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently, lesser qualified manpower is being utilised which leads to damage of goods.

The cost of loading and unloading of goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into the process. Gandhi Automations has always designed solutions based on such scientific

42 EXPRESS PHARMA September 1-15, 2016

approach and feedback from clients. The dock levellers offered by the company ensure loading and unloading with lesser effort and minimal cost.

It is possible to load and unload products in a safe way and in the process obtain remarkable energy savings. The loading bay remains with the dock leveller in rest position and the sectional overhead door closed, until the vehicle is positioned. The driver drives back centering to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers.

The sectional overhead door is then opened only when

the vehicle is positioned, brakes applied and engines shut off. This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveller connects to the truck bed for loading / unloading to take place.

At the end of the loading/unloading, the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process.

Following are the two types of dock levellers Radius lip dock levellers Radius lip dock levellers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc.

The self-cleaning lip hinging system does not retain rubbish with automatic end-ofrun, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349.

Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting vehicles unable to drive near

dock i.e. sea containers, side loading railway wagons etc.

These types can be supplied with a lip extending up to 1 m.

Gandhi Automation’s dock levellers are equipped with the most secure safety devices and accessories.

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email: sales@geapl.co.in http://www.geapl.co.in/docklevelers.html

PHARMA ALLY

MarkVi Systems launches new products MARK VI Systems was founded by a team of people having vast experience in packaging and printing industry and has been supported by a group of technically qualified engineers with a vast experience in the machinery maintenance.

MARKIPRINT X1JET HP MARKIPRINT X1JET HP is based on reliable MARKIPRINT X4JET technology. This compact and powerful system is available in different, upgradable system versions. MARKIPRINT X1JET HP is designed for different range of applications i.e. Food and beverage, chemical, coated/uncoated materials, timber and the pharmaceuticals industry.

The small and compact integrated controller/printer comes in a single unit. The innovation system codes smooth absorbent and semiabsorbent surfaces – quickly, accurately and reliable. ◗ Innovation technology for printing information directly onto cartons ◗ High availability through cartridge technology, tested and proven a million of times ◗ High quality, high resolution printing

Easy to use No training is necessary. printing with MARKIPRINT X1JET HP is simple, due to 3logic intuitive operation with LED status light, data transmission is initialised with USB stick/interface. ◗ User friendly due to 3-logic ◗ Select and printing directly upto 9 layouts/labels

Universal and flexible use MARKIPRINT X1JET HP uses true type fonts for printing. All conventional 1- and 2dimensional codes can be printed. The controller is fully integrated into the print module. ◗ Highly compact design and also has simple integration

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into packaging systems and conveyors for printing from the side or top. ◗ Printing height upto 12.5mm

Control The system X1JET HP PRO allows data transmission via USB stick. Each controller has a network connection (LAN) or a standard ETA-232 interface. Print layouts are created with iDesigns software. ◗ Data transfer using USB stick ◗ Data transfer connecting Ethernet ETA -232 ◗ Data transfer connecting to option interface ◗ (Printing communication from PLC or external photosensor) ◗ Data transfer enabling web interface Contact details MARK VI TRAC SYSTEMS Office No 11, ‘GIRNAR’ SV Road, Opp Police Station Dahisar (East) Mumbai 400 068 Tel: +91 -07738536663

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Phenomenex launches Yarra 1.8μm PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, has launched Yarra 1.8μm SEC-X300 – a high-resolution gel filtration (GFC)/aqueous size-exclusion (SEC) column for the separation of high molecular weight (HMW) biomolecules on HPLC and UHPLC systems.

With a wide separation range of 10K to 700KDa and high efficiency, SEC-X300 is ideal for separating and characterising monoclonal antibody (mAb) aggregates, antibody drug conjugates (ADCs) and biosimilars in drug discovery and development research.

The HMW focus of the SECX300 complements the low molecular weight range (1K450KDa) of the existing Yarra 1.8μm SEC-X150 column, providing two versatile separation tools for biopharmaceutical

operate at backpressures below 3,500 psi on traditional HPLC and UHPLC systems, they can deliver improved performance (greater resolution, better peak shape and faster analysis time) compared to existing 3μm and 5μm GFC/SEC column methods. Designed and manufactured for stability, reproducibility and long product life, all Yarra phases are supported by a superior product quality and performance guarantee.

research. The proprietary Yarra surface chemistry, combined with bio-inert column hardware, reduces sample adsorption compared to other GFC/SEC columns currently

on the market, providing improved recovery and more accurate quantitation of biomolecules at a lower price point.

The SEC-X150 and -X300 media are both now available in

150 and 300 mm column lengths, for analytical flexibility to increase speed or further increase resolution.

Because Yarra SEC-X150 and -X300 columns typically

Contact details Jennifer Dahlgren, Dahlgren Communications Phone: (530) 263-6817 E-mail: dahlgrenpr@comcast.net Simon Lomas, Phenomenex, Inc. Phone: (310) 212-0555, Ext. 2267 E-mail: simonl@phenomenex.com

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

Board line: 0120-6651500.

Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com Our Associate: Dinesh Sharma Mobile: 09810264368 E-mail: 4pdesigno@gmail.com CHENNAI Arun J The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 91 9940058412

Fax: 044- 28543035 Email id: arun.j@expressindia.com BANGALORE Mathen Mathew The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Mobile: +91 9840826366 Fax: 080- 22231925 Email id: mathen.mathew@expressindia.com HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936, Fax: 040 23418675

Email Id: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015, Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

44 EXPRESS PHARMA September 1-15, 2016

PHARMA ALLY VALUE ADD

Differentiation and characterisation of subvisible particulates in therapeutic protein products Michael Caves, India Business Development Manager, Malvern Instruments, in this article elaborates how Archimedes can be used to detect and quantify the formation of protein sub-visible particles and the introduction of silicone oil droplets, in response to shear stress

THE FORMATION of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to the potential for increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life. While immunogenicity can be induced by a variety of mechanisms, contamination by non-protein material is known to be a potential cause.

The presence of silicone oil in parenterals has attracted considerable interest, due to its use in syringe-based administration systems and the difficulty in distinguishing oil droplets from protein aggregates. In addition to protein aggregates, non-biological contaminants may act as nucleation points for aggregate growth. Consequently, particle sizing alone is not sufficient.

Guidance from the FDA for the biopharmaceutical indus-

try states, “Naturally sourced products should be evaluated for other components, protein and non-protein� (1). Resonant Mass Measurement (RMM) technology in the Archimedes system measures the buoyant mass of particles passing through a cantilever, allowing detection of particles with a density different to that of the buffer solution. Consequently, the Archimedes provides the ability to distinguish between negatively buoyant particles, such as proteins, and positively buoyant particles, such

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as silicone oil.

Results The impact of shear stress of the formation of protein aggregates and the introduction of silicone oil was determined using the Archimedes system.

Formation of sub-visible Protein Aggregates in Response to Shear Stress Understanding the impact of bioprocessing on protein characteristics is an important aspect of product knowl-

edge and design of manufacturing parameters. To ensure compliance with regulatory requirements, the impact of materials used in the manufacturing process stream should be evaluated to ensure no impact on product quality (2) . Biopharmaceuticals may have different compatibilities to materials used in the construction of product contact components, based on individual protein and formulation characteristics, as well as the leachables and extractables. Therefore, the impact of

product contact components may need to be compared.

Sub-visible particles induced by shear stress of two different syringe manufacturers were compared using RMM. These data are shown in Figure 2A. 1 mL syringes from two different manufacturers were used to induce shear-stress.

From the data in Figure 2A, the number of sub-visible particles formed by the syringe from manufacturer 1 (red bars) is much higher than the syringe from manufacturer 2

EXPRESS PHARMA

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September 1-15, 2016

PHARMA ALLY (blue bars). These data would suggest that the protein is more compatible with syringes from manufacturer 1 than those from manufacturer 2.

Detection and quantification of silicone oil from two different syringes manufacturers The ability to distinguish silicone from protein aggregates based on buoyant mass is a significant benefit for the Archimedes RMM system.

The positive mass data from the previous experiment is shown in Figure 2B, and demonstrates the presence of silicone oil from the two syringes tested. While protein aggregates produce a negative frequency shift, silicone which has a positive buoyant mass in water, produces a positive frequency shift. This technology enables quantification of silicone oil content, which can have a detrimental impact on the protein itself, and / or an increase in immunogenicity following administration.

From the data shown in Figure 2, the syringes from manufacturer 1 (red bars) introduces significantly higher levels of silicone oil into the protein sample, following repeated shear-stress. The increased levels of silicone oil may be the cause of the higher levels of protein aggregates detected with this syringe. However, the ability to detect and quantify silicone oil content provides a more detailed insight into the product, and therefore more knowledge concerning the relevant degradation pathways.

the ability to distinguish protein aggregates and silicone oil can enable more efficient resolution of product investigations. By quickly ruling in or out silicone oil as a potential root cause (3), efforts can be focused on finding the most likely causes. Importantly, the Archimedes is able to quantify protein particles in a size range that is currently poorly served by analytical instruments, between 0.2-5 Îźm, that has been identified as an important size range for understanding immunogenicity (1).

In conclusion, the Archimedes RMM system is able to provide highly valuable information about biopharma products, in terms of both formation of sub-visible particle formation and the presence of non-protein contaminants, such as silicone oil.

References 1. Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (2014): FDA 2. Code of Federal Regulations; CFR21, Part211.65 3. Characterization and Quanti-

Figure 1. Archimedes can distinguish between silicone oil and protein aggregates.

Conclusion As recommended by the FDA, the ability to distinguish protein aggregates from non-protein material is an important aspect of monitoring and studying biopharmaceutical stability. This article demonstrates the ability of the Archimedes system to quantify protein aggregates and silicone oil in response to shear-stress. Such data is greatly beneficial when understanding product stability, immunogenicity and bioprocessing impact. In addition,

46 EXPRESS PHARMA September 1-15, 2016

Figure 2. Quantification of protein aggregates (A) and silicone oil (B) from syringe manufacturer 1 (red) and 2 (blue)

tation of Aggregates and Particles in Interferon-Ă&#x; Products: Potential Links Between Product Quality Attributes and Im-

munogenicity (2013): J. Pharm.

Sci. (102) p.915 Contact details Malvern Aimil Instruments

Naimex House, A-8 Mohan Co-operative Industrial Estate, Mathura Road,

New Delhi – 110044 Tel : 011-30810244 Fax : 011-26950011 Email : delhi@aimil.com

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State-of-the-art optical particle analyzers with patented dual camera technology, based on Dynamic Image Analysis. n Reliable detection of oversized and undersized particles down to 0.01% Vol n Particle shape analysis n Unique, almost 100% agreement with sieve results (option) n Fast, time-saving, easy to operate

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Subvisible Particles Satisfying Regulatory Demands Subvisible particles are a cause of regulatory concern due to their immunogenic and difficult to characterize nature. Regulatory bodies increasingly insist on not only detecting and sizing sub-visible particles, but also on counting them and differentiating protein from non-protein.

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56 September 1-15, 2016

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PHARMA LIFE APPOINTMENT

Cipla appoints Umang Vohra as MD & Global CEO; Samina Vaziralli as Executive VC Both will take charge of their new positions from September 1, 2016

C

ipla announced the appointment of Umang Vohra as the MD and Global Chief Executive Officer of the company effective September 1, 2016. The current incumbent, Subhanu Saxena will step down from his position on August 31, 2016 to attend to emergent family priorities. Subhanu joined Cipla in February 2013 as the CEO.

Umang Vohra

Samina Vaziralli

Vohra joined the company in October 2015 as the Global Chief Financial & Strategy Officer and was elevated as the Global COO, early this year as part of a planned progression.

Samina Vaziralli, Executive Director and the Global Head-Strategy, M&A and Cipla New Ventures will be the Executive Vice-Chairman of Cipla effective September

1, 2016. She will move on from her current responsibilities to focus on board and governance issues, in addition to growing Cipla’s strategic priorities through key global partnerships, corporate brand building and public advocacy.

MK Hamied will continue to serve on the Board as the Nonexecutive Vice-Chairman.

EP News Bureau-Mumbai

CAMPUS BEAT

HK College of Pharmacy organises Mentor-Mentee Programme It aims at providing continuous practical guidance to current HKCP students (mentees) by experienced alumni from the pharma sector who would act as mentors HK COLLEGE of Pharmacy (HKCP) recently organised the second Mentor-Mentee Meet in the HK campus. The occasion was graced by alumni from different batches of HKCP. The Mentor-Mentee, ‘Involve to Evolve’ programme was introduced by the institution in 2015. It aims to provide continuous practical guidance to current HKCP students (mentees) by experienced alumni from the pharma sector who would act as mentors.

The programme was welcomed by HKCP’s student council. Speaking on the occasion, Dr Anubha Khale, Principal,

HKCP presented the achievements of the institution to the alumni. She also expressed pride in the fact that many of the institution’s alumni hold responsible positions in the pharma indus-

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try. She praised their contribution towards the growth of their alma mater and emphasised the need to further strengthen the linkage between the alumni and HKCP’s current students.

The alumni enlightened students about the diverse options available to pharmacy students after graduation and the wide scope for pharma graduates in various fields. They also ad-

vised students not to get disheartened by the initial struggles in their career and focus on long-term results, which are very promising.

Mentees discussed varied topics with the mentors such as the difference between pharmcovigilance and clinical trials, problems/difficulties faced in a marketing job, difference between sales and marketing, opting for work experience first or going for further studies, etc.

Mentors also emphasised on the need for timely studies and participation in college activities for overall personality development.

EP News Bureau-Mumbai

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