Express Pharma (Vol.10, No.9) March 01-15, 2015

VOL. 10 NO. 9 PAGES 60

www.expresspharmaonline.com

Cover Story Moving over the contraceptive PHARMA LIFE SL Nasa: Hospital pharmacist par excellence 1-15 MARCH 2015,` 40

CONTENTS MARKET Vol.10 No.9 MARCH 1-15, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

In part three of the Express Pharma 20th Anniversary series, two experts review how the current regulatory overhaul, spanning clinical research, drug pricing, FDI norms etc,will pave the way for safer medicines and faster growth of the industry | P30

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

8

US FDA RAISES CONCERNS OVER LUPIN'S PLANT AT PITHAMPUR

9

INTAS PHARMA LAUNCHES BIOSIMILAR IN EUROPE

10

ELDER PHARMA LAUNCHES ‘SOLO’ INHALERS

11

MYLAN SIGNS EXCLUSIVE AGREEMENT WITH GILEAD SCIENCES

RESEARCH P14: PRE EVENT PHARMA Pro&Pack Expo 2015 to host more than 150 international buyers

MANAGEMENT

31

STATUS OF CLINICAL RESEARCH IN INDIA

33

ART AND SCIENCE OF PHARMA MARKETING

35

HUMAN INSULIN MARKET WILL REACH $49,197.3 MILLION IN 2020 GLOBALLY: PERSISTENCE MARKET RESEARCH

P15: POST EVENT ISCR celebrates a decade of existence

P16: POST EVENT Govt to release policy to improve bulk drug capacity: Subburaj

P55: PROFILE SL Nasa: Hospital pharmacist par excellence

P56: AWARD Glenmark’s facilities conferred with Greentech Environment Gold Award – 2015

36

‘INDIA HAS NO DEARTH OF TALENT IN BIOLOGICS’

37

LEVELS OF THE AMINO ACID MORE STRONGLY ASSOCIATED WITH INCREASED DIABETES RISK IN SOUTH ASIAN MEN

PHARMA ALLY

41

TUV RHEINLAND INDIA APPOINTS THOMAS FUHRMANN AS CEO AND MD

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited 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 @ 2011. The Indian Express 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

Policy pinings

A

s in previous years, we mark this Women's Day with a cover story section devoted to women's health issue. The cover story, (Moving Over the Contraceptive, pages 18-22) takes a critical look at whether pharmaceutical companies in India are willing to expand their women's healthcare portfolio to uncharted territory, like the OTC feminine intimate care market, for example.

India is far from debating issues like the pros and cons of taking oral contraceptives OTC or the US FDA’s refusal to approve the world's first ‘female Viagra’, which claims to increase female libido. Both topics have become women’s rights issues, with women groups arguing that the regulator's lack of faith in Flibanserin, Sprout Pharmaceuticals' 'little pink pill', is an indication that the agency does not feel that women’s sexual health issues are as important as men's. On the other side of the fence, critics, including some women health advocacy groups, say the agency’s caution, citing ‘not very robust effectiveness and ... a safety profile (that) had not been really characterised very well at all’, befits a new drug application and even question the pharma industry's drive to invent a pill for every ill.

India Pharma Inc’s engagement with women’s rights issues seem far down the priority list, when one considers the existential issues staring them in the face. At the recent Pharma Summit organised by ASSOCHAM, one got the sense that PM Modi's urgency for change has filtered down to the ministries and there will be no further delay

Will January 30, Mahatma Gandhi's death anniversary, also become the death anniversary of clinical research in India?

on the policies which are already under review.

(See report: ‘Govt to release policy to improve bulk drug capacity: Subburaj', on page 16).

The frustration and worry can be gauged by two comments. The first was the sign off quote in the keynote address presented by Nishant Berlia, Member, Management Board, Apeejay Stya Group and Svran Group. Referring to the former US President Ronald Reagan’s pithy views of the economy; ‘If it moves, tax it. If it keeps moving, regulate it. And if it stops moving, subsidise it,’ he seemed to be warning the government that if remedial measures were not implemented, we would soon have to adopt drastic measures.

Dr Surinder Kher, CEO, Acron Acunova's comment was also in the same vein of dark humour, who asked if January 30, Mahatma Gandhi’s death anniversary, also become the death anniversary of clinical research in India. He was referring to the now infamous gazette notification released on January 30, 2013 mandating new compensation guidelines and other changes in clinical trial regulations.

Beyond the budget, will the policies be truly or merely play lip service to the consultative process? Will the cautious optimism and waitand-watch stance finally break? The industry is on tenterhooks on many counts, and meeting these expectations will be a tall task. This is truly a make or break year for India Pharma Inc.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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March 1-15, 2015

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MARKET COMPANY WATCH

US FDAraises concerns over Lupin's plant at Pithampur FDA inspected the plant in January this year and listed six observations on the manufacturing processes at the plant THE US Food and Drug Administration (FDA) has raised concerns over production processes at a plant that makes oral contraceptives operated by Lupin.

The FDA inspected the plant in January this year, after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, Lupin said in a statement.

Lupin didn't disclose the nature of the observations.

Once a Form 483 is issued by the FDA, a company has 15 days to respond before the FDA takes further action.

The FDA's concerns come as India's generic drugmakers continue to face close regulatory scrutiny on their products. In recent months, local plants of firms including Sun Pharmaceutical Industries, Dr Reddy's Laboratories, and

Cadila Healthcare have all come under the FDA's scanner due to production quality issues.

The Lupin plant, at Pithampur in Madhya Pradesh, produces both oral contraceptives and treatments for eye

diseases for sale in the US. The US oral contraceptives market, in which Lupin is a leading supplier, is valued at about $5 billion and the firm has filed for approval of close to 36 products in that segment so far.

Lupin, which started selling oral contraceptives in the US in 2011, said that since the FDA audit it has won US approvals to launch one new drug and transfer production of two existing medicines to the same plant. The company

LUPIN AND CELON IN AGREEMENT LUPIN AND Celon Pharma have entered into a definitive agreement under which the companies will jointly develop fluticasone/salmeterol dry powder inhaler (DPI) product which is a generic version of GlaxoSmithKline’s Advair Diskus. Lupin will be responsible for commercialisation of the product. Celon will supply the product to Lupin for its commercialisation in the US, Canada, Mexico, and other key markets. GlaxoSmithKline’s Advair Diskus had global sales of over $7 billion as of last fiscal.

Vinita Gupta, Chief Executive Officer, Lupin said, “This collaboration is an important milestone in Lupin’s efforts to evolve its global

inhalation pipeline. We are pleased to partner with Celon given their experience in the development and manufacturing of fluticasone/salmeterol DPI in Europe. This coupled with Lupin’s expertise in inhalation product development and commercialisation in the US and other markets will accelerate the development of generic Advair Diskus for global markets.

We look forward to providing access to high quality, affordable fluticasone/salmeterol DPI as part of our strategy to deliver inhaled products to key markets.”

also said it had received FDA approval for a generic version of Allergan Inc's Lumigan opthalmic solution, which was filed from its Pithampur plant.

The FDA regularly audits plants that export products to the US. When it issues a Form 483, it outlines conditions or practices at the plant that it believes may cause the products made there to be in violation of its standards.

The Pithampur plant is Lupin's second-largest manufacturing facility exporting to its largest market, the US. The FDA letter could impact approvals of new drugs made at the plant, analysts at brokerage Motilal Oswal said in a note.

Lupin said the FDA in November inspected its plant in Pune in western India and did not outline any concerns.

EP News Bureau-Mumbai Reuters

Zydus completes phase I studies for its oral HIF inhibitor The multiple dosing studies are expected to be completed by Q2 2015 ZYDUS CADILA has completed the single ascending dose (SAD) range finding studies of ZYAN1 in healthy human volunteers as a part of the phase I study currently ongoing in Australia. The molecule, ZYAN1 is an orally bioavailable hypoxia-inducible factorprolyl hydroxylase (HIF-PH) inhibitor being developed for the treatment of anaemia. ZYAN1 has been designed to increase the

8

EXPRESS PHARMA

March 1-15, 2015

natural production of erythropoietin (EPO) in anemic patients.

“This is an important innovation that will radically change the treatment paradigm in anaemia,” said Pankaj R Patel, Chairman and Managing Director, Zydus Cadila.

“ZYAN1 has the potential to become an oral therapy for treating patients with anaemia with significant advantages

ZYAN1 is an orally bioavailable hypoxiainducible factorprolyl hydroxylase

over currently available injectable EPO stimulating agents (ESAs),” he added.

The phase I study was designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of ZYAN1 in healthy volunteers.

During the dose ranging study, ZYAN1 was administered up to 150 mg orally, once-a-day to healthy human volunteers as part of single ascending dose

finding studies. Pharmacokinetics, erythropoietin and other biomarker responses were also measured in the healthy volunteers as part of this study. Now the multiple ascending doses of ZYAN1 in healthy human volunteers have been initiated. In addition, the effect of food and gender on the pharmacokinetics of ZYAN1 will also be studied.

EP News Bureau-Mumbai

Intas Pharmaceuticals launches biosimilar in Europe The product has recently been introduced under the brand Accofil INTAS PHARMACEUTICALS has launched their first biosimilar, filgrastim, in Europe, through their whollyowned subsidiary Accord Healthcare. The product has recently been introduced under the brand Accofil and has already won two tenders, in Netherlands and the UK respectively. In addition, Intas is also the only company from India to have two of its products, filgrastim and peg-filgrastim filed for registration in the US, through its collaboration partner.

According to the company release, Accofil is a biosimilar product of Neupogen (filgrastim) and will offer patients cost effective therapy that is comparable in quality, safety and efficacy.

Accofil is indicated for the treatment of reduction in the duration of neutropenia and the incidence of febrile neutropenia, mobilisation of peripheral blood progenitor cells, severe congenital, cyclic, or idiopathic neutropenia and persistent neutropenia in patients with advanced HIV infection.

Binish Chudgar, ViceChairman, Intas Pharmaceuticals said, “The launch of our filgrastim in Europe is another demonstration of our commitment to global healthcare at affordable prices. Accofil (filgrastim), which was developed at our own laboratories and manufactured at our own cGMP approved site in Ahmedabad, showcases our expertise in biopharmaceutical development and its manufacture.

This is only the first of many biological products that we will launch in EU and other regulated markets over the next few years.”

EP News Bureau-Mumbai

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March 1-15, 2015

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MARKET

Elder Pharma launches ‘Solo’inhalers Glenmark gets US Forays into the ` 800-crore nasal inhaler segment approval for Ashlyna extended-cycle oral Elder foresees contraceptive tablets an eight to 10 ELDER Pharmaceuticals has expanded its Solo range of OTC products with the launch of Solo range of inhalers for nasal congestion. The Solo basket consists of Solo Rub, a pain balm, Solo cough drops and Solo lozenges for throat soothing. With an eye on the rural markets, the company is also launching these products in smaller sizes and has earmarked a budget of ` 25 crore for promotional activities.

Elder foresees an eight to 10 per cent annual growth in the nasal decongestion market and is banking on substan-

per cent annual growth in the nasal decongestion market tial growth from category B&C towns.

Alok Saxena, Managing Di-

rector, Elder Pharmaceuticals said, “Over the counter inhalers are the first level treatment for nasal congestion and doctors / specialists are consulted only if the condition worsens. Rising cost of raw materials, competitive market conditions and over dependency on the urban markets had affected the sales of the company’s OTC products in the recent years. With focus on price, product mix and penetration, Elder is set to regain its prime position in the OTC sector.”

EP News Bureau-Mumbai

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Date : 1/3/2015

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sd/VAIDEHI THAKAR Publisher

The company plans to commence shipping of Ashlyna immediately GLENMARK GENERICS, US, the subsidiary of Glenmark Generics announced the US market approval and introduction of Ashlyna (levonorgestrel/ethinyl estradiol and ethinyl estradiol) extended-cycle oral contraceptive tablets, the generic equivalent of Seasonique by Teva Women’s Health.

Seasonique is indicated for use by women to prevent pregnancy. According to IMS Health sales data for the 12 month period ending December 2014, the Seasonique market achieved annual sales of approximately $159.1 million.

The approval marks Glenmark’s 10th oral contraceptive and first extended-cycle oral contraceptive authorised for distribution by the US FDA. Glenmark plans to commence shipping of Ashlyna immediately.

Seasonique is indicated for use by women to prevent pregnancy.

Glenmark plans to commence shipping of Ashlyna immediately Glenmark’s current portfolio consists of 94 products authorised for distribution in the US marketplace and 75 ANDA’s pending approval with the US FDA. EP News Bureau – Mumbai

Cipla wins $ 189 m global tender CIPLA HAS been awarded US $188.95 million of Global Fund ARV tender. Cipla has been selected as a ‘Panel Supplier’ for a Supplier Partnership Agreement. The contract is effective from the 1st of January 2015 and will run for a period of three years. The supplies will begin from Q4 FY 2015.

Subhanu Saxena, Managing Director and Global CEO, Cipla said, “We are extremely proud to have won this tender from Global Fund. Cipla has been committed to the cause of HIV/AIDS for over two decades and this tender offers us a great opportunity to make HIV/AIDS

treatment accessible to more than 140 countries through Global Fund.

Cipla has a long-term association with Global Fund since 2002. Last year, Cipla has been one of the suppliers who has been awarded with a long-term contract for supplying antimalarial drugs.

The anti-retrovirals drugs will be manufactured in Cipla’s state-of-the-art manufacturing facilities in India, which has been approved by various international regulatory agencies.

EP News Bureau – Mumbai

MARKET

Mylan signs exclusive agreement with Gilead Sciences Under the agreement Mylan will distribute Sovaldi and Harvoni in India MYLAN INC. announced that its Indian subsidiary, Mylan Pharmaceuticals has entered into an agreement with Gilead Sciences, under which Mylan has been appointed as the exclusive distributor of Sovaldi (sofosbuvir 400mg tablets) and Harvoni (ledipasvir 90mg/sofosbuvir 400 mg tablets) for the treatment of chronic hepatitis C, in India.

As Gilead’s exclusive branded medicine distribution partner, Mylan expects to begin distribution of Sovaldi in India in Q2 2015. Sovaldi received regulatory approval in India in Janu-

Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDSin India and other developing countries ary 2015 – the first country in Asia to approve the medicine.

Rajiv Malik, Mylan President said, “Hepatitis C is a growing

public health concern, particularly in developing countries such as India where access to high quality, effective and afford-

able treatment remains a challenge. Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India.”

This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead, which grants Mylan the non-exclusive rights to manufacture and distribute generic sofosbuvir, ledipasvir/sofosbuvir and, upon approval, the investigational NS5A inhibitor GS-5816 and single

tablet regimen of sofosbuvir/GS5816 in 91 developing countries.

Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.

Sovaldi is the latest addition to Mylan India’s new gastrointestinal segment called Hepato Care. The company also offers four additional unique and innovative segments – Critical Care, HIV Care, Women's Care and Oncology.

EP News Bureau-Mumbai

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MARKET GROWTH TRACKER

IPM clocks `7294 crores revenue in January 2015 31 corporates have shown growth more than 10 per cent amongst the top 50 IN JANUARY 2015, the Indian Pharma Market (IPM) has clocked ` 7294 crores in January 2015. It has grown at 12.7 per cent in the said month.

Amongst the top 10, Ranbaxy grew by 28 per cent followed by Pfizer at 25.8 per cent and Abbott at 15.1 per cent. 24 corporate have crossed the growth of IPM for the month of January 2015 amongst top 50. Amongst the top 50 corporate, Akumentis has the highest growth of 68.6 per cent followed by Ranbaxy at 28 per cent and JBCPL at 27.3 per cent. 31 corporates have shown growths more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporate, Sanofi has the highest growth of 25.1 per cent followed by Macleods and Torrent at 25 per cent and Glenmark at 21.3 per cent. Amongst the 5160 ranked corporates, Panacea grows at 32.5 per cent followed

by Systopic at 20.1 per cent and Centaur at 15.1 per cent.

Amongst the 61-70 ranked corporates, Boehringer grew by 70.4 per cent followed by TTK at 25.4 per cent and Tablets India at 18.9 per cent.

Mankind and Alkem have entered the ` 3000 crore club, Wockhardt has entered the ` 1000-crore club, Himalaya entered the ` 500-crore club, Fresenius Kabi, Serdia and Charak Pharma entered the ` 150 crore-club as on MAT Jan 2015.

Indian companies have grown at 11 per cent versus 17.7 per cent for MNCs in January 2015. Amongst the top 50 in MNCs, Ranbaxy grew by 28 per cent followed by Pfizer at 25.8 per cent and Sanofi & Merck at 25.1 per cent. Under the nonNLEM category Indian companies grew at 12.7 per cent whereas MNCs grew at 17.8 per cent.

The DPCO containing molecules market grew at 6.9 per cent whereas the non-DPCO market grew by 14 per cent resulting in an overall growth of

12

EXPRESS PHARMA

March 1-15, 2015

With Bonus Units at Full Value Val in Crs CORPORATE

(Val in Crs)

Rank

MAT Jan -15

MAT

MTH

Abbott + Abbott HC + Novo

1

1

Sun Pharma

2

2

IPM

Jan-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

84018

100.00

10.8

7294

100.00

12.7

5199

6.19

7.4

475

6.51

15.1

4574

5.44

14.7

430

5.89

13.5

Cipla

3

3

4187

4.98

12.2

374

5.13

13.0

Zydus + Biochem

4

4

3625

4.32

8.4

316

4.33

7.0

Ranbaxy

5

5

3124

3.72

12.6

293

4.01

28.0

Mankind

6

7

3020

3.59

13.0

243

3.33

13.4

Alkem + Cachet + Indchemie

7

8

3005

3.58

13.2

241

3.30

10.5

Glaxo

8

10

2786

3.32

-2.7

225

3.08

2.8

Lupin

9

9

2778

3.31

11.3

237

3.24

5.0

Pfizer

10

6

2523

3.00

14.2

243

3.34

25.8

Macleods

11

11

2449

2.91

26.9

215

2.95

25.0

Emcure + Zuventus

12

14

2269

2.70

12.4

196

2.69

6.2

Intas

13

12

2210

2.63

16.0

200

2.74

17.5

Sanofi India

14

13

2106

2.51

8.0

200

2.74

25.1

Aristo

15

17

2087

2.48

17.6

164

2.24

12.5

Torrent

16

15

1898

2.26

12.3

178

2.44

25.0

Glenmark

17

16

1851

2.20

15.6

175

2.40

21.3

Dr. Reddys

18

18

1772

2.11

9.6

151

2.07

12.4

Micro + Bal

19

20

1638

1.95

7.5

129

1.76

0.7

USV

20

19

1634

1.95

17.1

150

2.06

19.7

Ipca

21

21

1480

1.76

16.3

112

1.53

1.3

Novartis

22

23

1161

1.38

1.7

98

1.34

1.1

Alembic

23

24

1133

1.35

10.8

97

1.34

6.6

Wockhardt

24

22

1000

1.19

2.8

100

1.37

19.0

FDC

25

27

840

1.00

4.9

66

0.91

9.3

MSD + Fulford + Organon

26

25

837

1.00

15.6

78

1.07

22.6

Unichem

27

26

807

0.96

6.3

72

0.98

6.6

Cadila

28

30

670

0.80

4.7

51

0.70

-5.4

12.7 per cent for January 2015.

The NLEM and Non - NLEM category showed unit growth at 1.8 per cent and 3.7 per cent respectively. The DPCO 2013 portfolio for Pfizer grew at 18.6 per cent, Ranbaxy 53.7 per cent and Abbott 21.2 per cent.

From therapy perspective. eight therapies have outgrown the IPM growth and 13 therapies have double digit growths.

The respiratory market grew at 11.2 per cent, gastrointestinal market grew at 12.6 per cent,

pain and analgesics market grew at 11.4 per cent whereas the anti-infectives grew at 7.6 per cent. The anti-diabetic market grew at 25.4 per cent and cardiac at 13.2 per cent in chronic business. The derma market grew by 18 per cent and the urology market at 51.5 per cent.

From regional perspective, 11 regions have outgrown the IPM growth. The Telangana market grew the highest at 23.6 per cent followed by Tamil

Nadu and UP East market at 19.2 per cent and Rajasthan market at 18.7 per cent ◗ No regions had negative growth in January 2015 ◗ Molecules: ◗ Amoxycillin + Clavulanic Acid Market grew at 9.4 per cent whereas Glimepiride + Metformin grows at 12.9 per cent at No 2. ◗ The markets of Paracetamol grew at 10.3 per cent, Atorvastatin 14.9 per cent, Probiotic Microbes at 16.2 per cent, Ce-

fixime 4.2 per cent, Pantoprazole 10.1 per cent, Montelukast + Levocetrizine at 18.0 per cent, Glimepiride + Metformin + Pioglitazone at 26.6 per cent, Vitamin-D at 29.9 per cent, Hydroquinone + Mometasone + Tretinoin at 23.7 per cent, Voglibose + Metformin + Glimepiride at 55.3 per cent, Rosuvastatin at 29.1 per cent, Protein Supplements at 15.7 per cent Brands ◗ Mixtard continues to lead the

MARKET pack with 38 crores for the Month of Jan -15 ◗ Glycomet-GP grew at 23.2 per cent, Monocef at 32.8 per cent, Volini at 21.0 per cent and Lantus at 30.6 per cent amongst the top 10 brands Few brands who have gained ranks include Januvia (+66), Shelcal (+63), Magnex (+60), Janumet (+59), Panderm Plus and Istamet (+44), Jalra M (+41), Rosuvas (+40), Clexane (+35), Storvas (+32), Thyronorm (+18), Allegra (+17), Taxim (+14), Dolo and Pantocid DSR(+12), Pan D (+11), Novomix (+7) amongst top 100 brands over January 13 New launches in IPM ◗ Total 337 SKUs and 174 brands launched in January 2015 ◗ Novo Nordisk also launches full-fledged its diabetic drug Ryzodeg in India in Jan 2015 ◗ Top new brands for January are Ketoadd, Abstet, Ketoplast

Val in Crs

MAT Jan 15

Month Jan-15

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR% 12.7

IPM

84018

10.8

7294

ANTI-INFECTIVES

13394

6.7

1069

7.6

CARDIAC

10485

11.3

965

13.2

GASTRO INTESTINAL

9652

12.0

794

12.6

VITAMINS / MINERALS / NUTRIENTS

7635

10.9

625

10.8

RESPIRATORY

6561

11.1

622

11.2

ANTI DIABETIC

6406

22.0

614

25.4

PAIN / ANALGESICS

5973

9.7

493

11.4

NEURO / CNS

5107

8.2

457

9.0 18.0

DERMA

4843

16.1

434

GYNAECOLOGICAL

4237

5.9

361

7.8

OPHTHAL / OTOLOGICALS

1543

12.5

124

8.7

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

HORMONES

1414

5.2

124

8.7

Terminologies used

ANTI-NEOPLASTICS

1380

26.0

125

22.4

VACCINES

1181

-5.6

109

3.2

BLOOD RELATED

943

2.6

76

1.4

OTHERS

929

16.1

103

51.5

UROLOGY

896

22.9

82

31.2 28.9

MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

ANTI MALARIALS

606

5.4

39

SEX STIMULANTS / REJUVENATORS

466

4.8

47

13.5

STOMATOLOGICALS

366

12.4

31

12.6

For more information, visit http://www.aiocd.net

MARKET PRE EVENTS

PHARMAPro&Pack Expo 2015 to host more than 150 international buyers Above 20,000 potential buyers including 1,400 international buyers from 180 countries are anticipated THE THREE-DAY long international Buyers Seller Meet (BSM) at PHARMA Pro&Pack Expo 2015 is expected to host more than 150 international buyers towards promoting the exports of pharma engineering products. Jointly organised by IPMMA – Indian Pharma Machinery Manufacturer’s Association and GPE EXPO, PHARMA Pro&Pack Expo 2015 will be held at Mumbai Exhibition Centre, from May 13 to 15, 2015. The BSM at PHARMA Pro&Pack Expo 2015, Mumbai Exhibition is being initiated and organised in association with the EEPC India (formally known as Engineering Export Promotion Council of India, set up by Ministry of Industry andCommerce, Government of India).

The fundamental aspect in organising the BSM is to promote Brand INDIA pharma machinery and engineering to worldwide pharma markets.

The hosted buyers will be representing the countries which have a pharma manufacturing

base. At the same time, another BSM, will be organised in association with the PHARMEXCIL at iPHEX 2015. The co-located exhibition will promote the Brand INDIA API, bulk actives and formulations across the world.

The third edition of PHARMA Pro&Pack Expo 2015 on total pharma manufacturing technologies will offer a common business platform for the pharma industry. The first and second editions of the exhibition received an excellent response from the industry and so the expectation is very high from the third edition of PHARMA Pro&Pack Expo 2015. iPHEX organised by PHARMEXCIL is a co-located exhibition which will feature the exhibitor’s profile of the complete range of pharma and biochemicals, API and finished products. PHARMA Pro&Pack Expo 2015, along with the co-located exhibitions, PharmaLAB Expo 2015 will feature a complete range of analytical and biotech lab instruments. Vari-

PHARMA Pro&Pack Expo 2015, along with the co-located exhibitions, PharmaLAB Expo 2015 will feature a complete range of analytical and biotech lab instruments. Various trade associations have extended their non-financial support to the exhibition ous trade associations have extended their non-financial support to the exhibition which includes Indian Pharmaceutical Association (IPA), Indian Drug Manufacturer’s Association (IDMA), Indian Pharmacy Graduates’ Association (IPGA), Confederation of Indian Pharmaceutical Industry (CIPI), Indian Analytical Instruments Association (IAIA), Ambala

Scientific Instruments Manufacturers Association (ASIMA), Federation of East African Pharmaceutical Manufacturers (FEAPM), Bangladesh Associaiton of Pharmaceutical Industries (BAPI), Hologram Manufacturer’s Association of India (HOMAI), Association of Pharmaceutical Producers of Nepal (APPON), Pharmaceutical Manufacturers Group of Manu-

facturers Association of Nigeria (PMG-MAN), Institute of Packaging Machinery Manufacturers of India (IPMMI), and Indo African Chamber of Commerce and Industries (IACCI).

At PHARMA Pro&Pack Expo 2015, PharmaLAB Expo 2015 and iPHEX 2015, more than 523 exhibiting companies from 18 countries are expected to participate to showcase their latest products /services. Above 20,000 potential buyers including 1,400 international buyers from 180 countries are anticipated, will reportedly mark their presence in these twin exhibitions (PHARMA Pro&Pack Expo 2015 and iPHEX 2015).

Exhibitors' profile range from pharma processing and packaging machineries and materials, analytical lab instruments, consumables and glasswear, environment control equipment and services, water management products and services and turnkey contractors.

EP News Bureau-Mumbai

10 Nutra India Summit to be held in Mumbai th

NuFFooDS Expo will be organised concurrently TH

10 NUTRA India Summit is scheduled to be held during March 18 -19, 2015 in Mumbai.

The Nutra India Summit will see a congregation of nutrition,

14

EXPRESS PHARMA

March 1-15, 2015

nutraceuticals, dietary supplements, functional foods and health foods industry in India.

The event will be organised

by Council of Scientific and Industrial Research (CSIR), International Society for Nutraceuticals, Nutritionals and Naturals (ISNNaN) and MM ACTIV Sci-Tech Communications and supported by International Organisations and

leading industry. Dr V Prakash, FRSC, Distinguished Scientist of CSIR-INDIA; Vice President, International Union of Nutritional Science (IUNS) is the Chairman of the Summit.

The key highlights of the 10th Nutra India Summit will be international conference, NuFFooDS Expo, highlight talks, Nutra Excellence Awards, doc-

tors and nutritionists forum and poster session 'Walkway of Discovery'.

The summit is expected to attract international participation. The NuFFooDS Expo will witness participants from the best of private sector companies, R&D institutions from India and abroad and over 3000 business visitors.

Nutra India Summit will be

attended by leading researchers and medical professionals, distributors and sourcing organisations, nutritionists and regulatory policy makers, heads of research organisations along with financial institutions focusing on sectors such as food, pharma and formulation business.

EP News Bureau-Mumbai

MARKET POST EVENTS

ISCR celebrates a decade of existence Emphasises on the fact that clinical research needs to be built on a quality and ethical framework THE 8TH Annual Clinical Research Conference was recently organised by ISCR at Gurgaon.

Against a background of positive winds of change in the regulatory environment, ISCR has themed its conference, Clinical Research in India – Towards Achche Din. where over two days, multiple stakeholders deliberated on what constitutes Achche Din for the clinical research fraternity in India and how that can become a reality.

“India cannot afford not to do research in new drug discovery.

Have confidence in the new rules and regulations, take advantage of them and bring clinical trials back to India,” said Prof Ranjit Roy Chaudhury while delivering the keynote address at the inauguration of the conference.

Suneela Thatte, President, ISCR, in her inaugural address said, “Given the fact that India as a country has the highest disease burden in the world, it seems only logical that we as a country should have a clinical research agenda of our own. On the contrary, in spite of being home to 17 per cent of the population of the world and having a fifth of the world’s disease burden, our contribution to global drug trials is around 1.5 per cent and this has probably dropped even lower over the last couple of years.”

EP News Bureau-Mumbai

EXPRESS PHARMA

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March 1-15, 2015

MARKET

Govt to release policy to improve bulk drug capacity: Subburaj Other topics at the ASSOCHAM Pharma Summit included changes in drug pricing, the impending revision of NLEM-2011, and amendments in compensation guidelines and clinical trial approval process

Viveka Roychowdhury New Delhi EXPRESSING CONCERN over the nation’s dependency on other countries for bulk drugs, Dr VK Subburaj, Secretary, Department of Pharmaceuticals (DoP) said that the government is currently studying the proposals submitted by a committee headed by Dr VM Katoch, Secretary, Health Research based on suggestions from industry.

He indicated that after processing the details, the government will come out with a policy in two months time, to ensure that bulk drug capacity will improve in the next decade.

He declined to share details as the policy would first have to go to the Cabinet for perusal and approval. He was speaking at a Pharma Summit recently organised by the Associated Chambers of Commerce and Industry of India (ASSOCHAM) in Delhi.

“More than 80 per cent of bulk drugs come from one source — China — so we want to reduce this dependency,” said Subburaj. Similarly, as much as 75-80 per cent of medical devices are imported and here too, the secretary indicated that all concerned departments are working in tandem to reduce India’s dependence on imports in the medical devices sector.

The secretary further said that there is a need to boost the sector’s manpower to improve drug quality in India. “We are trying to institute a study very shortly to assess the manpower requirement in the pharma sector for the next 20-25 years.”

Commenting on the decreasing growth rate of pharma exports, he pointed out that though

16

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March 1-15, 2015

total exports has increased, the growth rate has dropped to a mere five per cent (versus 18-20 per cent in previous years) due to procedural delays in product approvals and other factors.

With the theme, ‘Changing Dynamics & The Road Ahead’, the summit was supported by Organization of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers’ Association (IDMA), Confederation of Indian Pharmaceutical Industry (CIPI) and Indian Pharmaceutical Association (IPA).

Dr Jagdish Prasad, Director General of Health Services, Ministry of Health & Family Welfare presided as Guest of Honour while Subburaj was the Chief Guest at the day-long well attended meet.

Changing dynamics Nishant Berlia, Member, Management Board, Apeejay Stya Group and Svran Group, gave the keynote address where he outlined the changing dynamics and resulting challenges of both the healthcare and pharma sectors.

For instance, while India is on track to achieve the Millenium Development Goals (MDGs), India’s non-communicable diseases (NCD) burden, present in rural areas as well, will require a change in healthcare delivery architecture while on the pharma front, Indian companies are struggling with the dichotomy of earning in rupees, but spending in dollars as they have to take their trials outside the country.

Speaking during a session focusing on drug price control related issues and revision of the National List of Essential Medicines (NLEM) -2011, Injeti

Srinivas, Chairman, National Pharmaceutical Pricing Authority (NPPA) made the point that efforts to fix the systemic issues in the country’s public healthcare system needed to be buttressed by measures like drug price control and periodic revision of the NLEM. Industry views were presented by AH Khan, Vice President, Corporate Relations, Sun Pharma, Sundeep Kumar, Head, Corporate and Public Affairs, Novartis India, C Venkataraman, Director, Corporate Services, Lupin and Dr Ghulam Moinuddin, Head, Regulatory Affairs, LG Lifesciences India.

Dr VK Subbburaj, Secretary, Departmetn of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India addresses the ASSOCHAM Pharma Summit

Inaugural session of the ASSOCHAM Pharma Summit

Release of the ASSOCHAM-YES Bank Knowledge Report

Towards consensus, not conflict The following session on clinical trials unfortunately did not have a regulator present to respond to the industry perspectives presented by Suneela Thatte, VP, global operations, Quintiles India, Anil Seth, General Secretary, Indian Society for Clinical Research and Surinder Kher, CEO, Ecron Acunova. The sentiment was that while the past two years have seen wide pendulum swings, there were signs of moderation in the past few months. They expressed hope that this process of consultation with industry would continue.

Prof YK Gupta, Head, Department of Pharmacology, AIIMS, New Delhi and Vice Chairman, Core Committee on revision of NLEM 2011 in his special address on the ongoing review of the NLEM-2011 took the audience through a detailed analysis of the issues being considered and parameters being used for the revision.

India’s pharma sector has seen considerable regulatory

Technical session on drug price control related issues and revision of NLEM

Panel discussion on cilnical trials, focussing on amendments in compensation guidelines and approval process

review in the past two years, with industry sometimes lamenting the lack of transparency and arbitrary nature of the resultant policies. Industry associations have tried to bridge the gap between regulators by organising regular in-

dustry-regulator meets in order to promote consensus rather than conflict. One hopes that the action points aired during the sessions of the Summit will help balance the policies currently under review. viveka.r @expressindia.com

EVENT BRIEF MARCH - APRIL - MAY 2015 13

th

10 Nutra India Summit

19

International conference on regulatory in emerging markets

05

Respiratory Drug Delivery (RDD) Europe 2015

13

PHARMA Pro & Pack Expo 2015

10TH NUTRA INDIA SUMMIT Date: March 18 -19, 2015 Venue: Mumbai Summary: The event will be organised by Council of Scientific & Industrial Research (CSIR), International Society for Nutraceuticals, Nutritionals and Naturals (ISNNaN) and MM ACTIV Sci-Tech Communications and supported by International Organisations and leading industry. Dr V Prakash, FRSC, Distinguished Scientist of CSIR-INDIA; Vice President, International Union of Nutritional Science (IUNS) is the chairman of the summit.

The Nutra India Summit will see a congregation of nutrition, nutraceuticals, dietary supplements, functional foods and health foods industry in India.

The key highlights of the 10th Nutra India Summit will be international conference, NuFFooDS Expo, highlight talks, Nutra Excellence Awards, doctors and nutritionists forum and poster session 'Walkway of Discovery'.

Contact details: Niket Donde MM Activ, 160, Kaliandas Udyog Bhavan, Babasaheb Woralikar Marg, Near Century Bazaar, Mumbai 400 025, India Tel: +91 22 2438 5007 – 9, Fax: +91 22 2437 9882 Cell: +91 098208 59902 Email: enquiry@nutrain diasummit.in

INTERNATIONAL CONFERENCE ON REGULATORY IN EMERGING MARKETS Date: April 9-10, 2015 Venue: Hotel Westin, Mumbai Organiser: Alliance India Summary: Asia has a

13

iPHEX 2015

their technologies/ services.

Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services and purchase officers.

population of around 4.3 billion and is home to about 60 per cent of the world’s population. China alone has a population of approximately 1.3 billion, which is three- to fourfold bigger than Europe or the US. Adding in the other developing markets, such as those in Latin America, this makes for a huge potential market for the pharmaceutical industry.

The growth markets popularly include Brazil, Russia, India, China – the BRICs however Mexico, South Korea, and Turkey are now added to BRICs to be known as the BRIC-MST countries.

In terms of the submission format, countries are beginning to move closer to the international submission template (eCTD — electronic common technical document).

Similarly, the trend is toward more harmonisation in legal frameworks among the countries. For example, China’s regulatory processes are evolving, creating a framework that is more closely aligned to the US and European legislation and in both South Korea and China, the regulatory agency has been raised to the

To subscribe: bpd.subscription@expressindia.com

ministry level.

Contact details: Mob: +91 9619633320Email: admin@allianceindia.co.in

RESPIRATORY DRUG DELIVERY (RDD) EUROPE 2015 Date: May 5-8, 2015 Venue: Antibes, France Summary: RDD Europe 2015 will welcome pulmonary and nasal drug delivery experts from around the world. The joint organisers of the event, RDD Online and Aptar Pharma, will celebrate RDD Europe’s 10th anniversary and announce the opening of registration at www.rddonline.com/ rddeurope2015.

RDD Europe 2015 will host high-level academic, industry and government experts who specialise in research, development and marketing in the field of pulmonary and nasal drug delivery. The conference will start with a plenary lecture presented by Dr Bruce K Rubin, Professor and Chair, Department of Peadiatrics, Virginia Commonwealth University, entitled “Delivering drugs to

paediatric airways: Unhelpful myths and future directions”.

The symposium will also focus on aerosol delivery in paediatrics, personalised medicine, global patent practice, nasal drug delivery, stretching the OINDP boundaries: Exploring alternative technologies, particle engineering and QbD, alternative distribution practices for inhalers.

As part of the symposium, RDD Europe 2015 will highlight innovative research contributions in podium and scientific poster sessions, and will also host 12 interactive workshops led by device experts and service providers.

Contact details:Elisa Eschylle,Events & Press Relations ManagerTel.: + 33 (0)1 39 17 20 41Email: elisa.eschylle@aptar.com

Contact details: Indian Pharma Machinery Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg, Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

IPHEX 2015

PHARMA PRO & PACK EXPO 2015

Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: Pharmexcil with Ministry of Commerce and Industry, Department of Commerce, Government of India will organise iPHEX 2015. Over 400 overseas buyers from focus areas are being invited to participate in the exhibition.

Co-located with PHARMA Pro&Pack Expo 2015, a show for pharmaceutical machinery manufacturers, iPHEX 2015 will offer the industry majors from India and all across the world a great platform to connect and do business.

Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit

Contact details: Pharmaceuticals Export Promotion Council of India TV Indl. Estate, Unit No. 211, 2nd Floor, 248-ASK Ahire Marg, WorliMumbai – 400030 Tel: 91 22 24938750 Fax: 91 22 24938822

EXPRESS PHARMA

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March 1-15, 2015

cover )

MOVING OVER THE CONTRACEPTIVE 18

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March 1-15, 2015

WO M E N ' S DAY S P EC I A L

As the Indian woman becomes more aware and vocal about her health, are pharma companies gearing up to meet her aspirations? For instance, India’s OTC women’s health market has huge potential, but growth is slow as companies figure their way beyond the tried and tested, trying to win over women reluctant to voice their needs. Of late, a savvy few companies are breaking through into this under-served territory

BY SHALINI GUPTA

E

ven as the US debates the inclusion of the oral contraceptive pill as an Over The Counter (OTC) product, OTC products for women globally have taken a huge leap. Gone are the days when they began

Laboratories, which, recently signed a definitive agreement to acquire certain female health care businesses from Famy Care, a specialty women’s health-care company with global leadership in generic oral contraceptive products (OCPs) for $750 million in cash plus additional contingent payments of up to $50 million.

Huge potential, slow growth

and ended with contraception.

Today they span across menstrual cycle regulators, antifibronoytics, haematinics, antifungal, nutrition supplements etc. Women are getting more discerning and aware about their health needs. Companies too are not shy of expanding their offerings in this segment as they come up with newer products or even acquire another company to add value to their basket. Like Mylan

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However, the women’s health market in India is at a very nascent stage and captures 32 per cent (valued at $662 million) sales of the total Indian OTC market which is estimated at $2 billion, says Sangeeta Barde, Managing Partner, Sorento Health. She further adds that the market for prescription medicines for women stands at around `5200 crores (AWACS Nov 2014) growing at a rate of nine per cent. This mainly comprises gynaecologicals, hormones and urology products used by women. Data from IMS Health pegs the market at `4,927 crores as of MAT (Moving Annual Total) December 2014.

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March 1-15, 2015

cover ) Figures are in a flux since OTC as a category remains undefined and within that what constitutes women's health is expanding as well, however, there is no denying that it is growing.

HLL Lifecare is credited with the launch of Saheli (Ormeloxifene), the world’s only non hormonal contraceptive pill (with one week dosage) which has been empowering Indian women for the past 25 years in taking the decision to space their family. The company also launched Novex DS (Ormeloxifene 60mg Tablets) an effective Dysfunctional Uterine Management pill with 90 per cent efficacy that occupies 70 per cent of the market share in its category. No wonder then that their women’s health division has registered a growth of 35 per cent over last year. The ethical subdivision of it consists of contraceptives viz., Oral Contraceptive Pills (OCPs), Intra Uterine Contraceptive Devices (IUCD), injectables contraceptives, emergency contraceptives and hormone releasing intra uterine systems like Emily. The other categories include, ovulation inducers, anti emetics, ante natal’s, menstrual cycle regulators, anti fibronoytics, MTP Pills, haematinics, anti spasmodic, anti fungal, DUB management pills, nutrition supplements, galactagogue, pregnancy test kits and sanitary napkins.

The institution business team of WHD focusses on the needs of State and Central Governments and has facilitated large scale supply of iron and folic acid tablets and sanitary napkins to Tamil Nadu, Karnataka, Maharashtra, AP, UP and Bihar to the tune of more than 300 million each. “Products which cater to everyday needs and are specifically positioned for women can drive significant volumes.

Among women, decision of consuming supplements is need and evidence-based. Hence, creating awareness regarding preventive health and showcasing brand differentiation will create the desired impact,” chips in M Ayyyapan, Chairman and Managing Director, HLL. The past few few years have seen several brands catering to women's health rise to the top.

“Revital Woman, Calcium

20 EXPRESS PHARMA March 1-15, 2015

TABLE 1: YEAR-ON-YEAR INCREASE (VALUE IN ` CRS) MAT Dec'11

MAT Dec'12

MAT Dec'13

MAT Dec'14

Women’s Health Products

3829

4186

4509

4927

Indian Pharmaceutical Market

63976

71522

78603

87235

YoY Growth (%)

17.3

9.3

7.7

9.3

Source: IMS Health

TABLE 2: TOP 10 BRANDS THE TOP-5 BRANDS CAPTURE 15 PER CENT MARKET SHARE OF THE WOMEN’S HEALTH PRODUCTS THE TOP-10 BRANDS RANKED BY VALUE (` CRORE) ARE AS UNDER Brands

Company

Therapeutic Group

MAT Dec’14 (Value ` Crs)

Dexorange

Franco Indian

Haematinics-Iron combinations

244.6

Duphaston

Abbott

Progestogen and similar combinations

148

Orofer-XT

Emcure

Haematinics-Iron combinations

126.5

Mifegest-Kit

Zydus Cadila

Antiprogestogens

109.1

Susten

Sun

Progestogen and similar combinations

109.1

Unwanted-Kit

Mankind

Antiprogestogens

90.5

R.B.Tone

Medley Pharma

Haematinics-Iron combinations

57.9

Gestapro

Emcure

Antiprogestogens

54.6

Hepatoglobine

Raptakos Brett

Haematinics-Iron combinations

54.4

Ovral-L

Pfizer

Hormone contraceptive nontopical

52.3

Source: IMS Health

WO M E N ' S DAY S P EC I A L

Sandoz Woman and Supractiv Complete Woman have significant potential, but need aggressive brand building to make an impact. Some of the major introductions have also been in the area of birth control category like i-pill and Unwanted-72,” observes Barde.

Even though the women's health market is nascent, data from IMS Health reveals positive findings. Talking on the same, Amit Mookim, Head of South Asia Consulting at IMS Health, elaborates, “There were around 861 New Introductions (NI) in the last five years in this segment as of December 2014. Over the last two years, NIs in gynaecology segment contributed `323 crores to overall Indian pharmaceutical market. 70 per cent of the NIs came from haematinics, gonadotrophins and antiprogestogens categories with haematinics alone contributing one-third.”

Scope for improvement Mookim notes the increase in consumption of haematinics

and hormones due to changing lifestyles as one of the major drivers of growth alongwith increasing health awareness and rising disposable income especially in metro and Class I regions. He also observes that health supplements market has steadily grown over the years triggered by the iron and folic acid supplementation initiative under the national RMNCH+A programme.

HLL which is setting up generic pharmacy outlets in the entire state of Karnataka sees an increase in the healthcare spend by the government to leverage greater opportunity.

Growth in medical infrastructure, changing lifestyles resulting in higher incidence of lifestyle diseases, greater penetration in rural markets, and a nascent, yet fast growing health insurance industry will fuel the growth in future, adds Ayyyapan.

“Women of today are more economically inde-

The area of reproductive health especially in PMS relief, sexual dysfunction in women, painful intercourse due to menopause, menopausal health, should be explored to market these brands OTC in India Sangeeta Barde, Managing Partner, Sorento Health

pendent thus increasing their purchasing ability which in turn influences their consumption decisions. They enjoy an active and diverse role in the family, increasingly digitally involved, talking and interacting with physicians and friends, take active interest in their health and lifestyle,” reiterates Barde outlining the women consumer.

While product opportunities lie across a woman’s life cycle spanning adolescence, reproductive age and post menopause, most of the products target the reproductive stage. Barde thinks that sexual health category in women is a very interesting space, although it is a very hush-hush topic.

Feminine intimate care, like vaginal wash, prescriptions to OTC switches of some of the potential products, innovations in formulations, dosage, formats etc present other viable opportu-

nities.

Mulling on the white spaces that currently do not address women’s needs directly through the OTC route, Ayyyapan notes, “None of the iron supplements are promoted OTC, despite the glaring necessity. Analgesics present an interesting opportunity, considering studies that report that women are more sensitive to intense pain than men (Source: Journal of Pain, January 2012).

Vaginal yeast infections (VYI) treatments too are still largely prescription-driven or based on home remedies. Introducing effective products in convenient and non-messy formats will drive OTC consumption. With the launch of vaginal wash and anionbased sanitary napkins catching up, mild herbal remedies, that can relax the tense muscles and nerves and keep anxiety levels low, would be much welcome by many women.”

These areas can open doors to marketers who are looking for new avenues of growth. Besides, catering to

TABLE 3: NEW INTRODUCTIONS LAUNCHED IN DEC ’14 (GYNAECOLOGY THERAPEUTICS) Brands

Therapeutic Group

Company

Roseus

Haematinics-Iron combinations

Akumentis Health

Coehb

Haematinics-Iron combinations

Koye Pharma

Clingen Wash

Other gynaeco preparation

Aristo Pharma

Coehb Plus

Haematinics-Iron combinations

Koye Pharma

Grofer-SR

Progestogen and Similar combinations

Wanbury

Migrate Q10

Other urological preparation

Icarus Healthcare

Migrate

Other urological preparation

Icarus Healthcare

Ormetect

Hormone contraceptive nontopical

Akumentis Health

Lexifer

Haematinics-iron combinations

Icarus Healthcare

Drospy

Hormone contraceptive nontopical

MSD Pharmaceutical

Femovan

Hormone contraceptive nontopical

Bayer Zydus Pharma

Source: IMS Health

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EXPRESS PHARMA

21

March 1-15, 2015

cover ) INNOVATIVE MARKETING AND R&D P

iramal Healthcare has used offbeat marketing to reach out to its women consumers. More than two thirds of the company’s portfolio is generated from - skin care and intimate space targeting females and it hopes to increase this to 50 per cent in the next five years. Elaborates Kedar Rajadnye, President and Chief Operating Officer – Consumer Products, Piramal Enterprises,“We developed an application for women wanting to conceive to track their periods, advertised in female washrooms of movie theatres to educate consumers about the intimate categories and created awareness about misconceptions in

the emergency contraception space through twitter campaigns.”

The company’s i-sure brand which detects the two most fertile days of a women and helps her conceive faster, has been priced at `100 since its launch, to avoid women spending more time at the cash counter. 10 lakh CDs were distributed across one lakh pharmacy outlets in India to create awareness about ovulation and educate women about their fertility.

Supractive, a multivitamin supplement was designed differentlyby the R&D team, since the calcium and iron receptors in the body are similar.

None of the iron supplements are promoted OTC, despite the glaring necessity.

Analgesics present an interesting opportunity, considering studies that report that women are more sensitive to intense pain than men M Ayyyapan,

these needs can create first mover advantage, he adds. The vitamin and nutritional category seems to have evolved but there is still a long way to go.

Same applies to the feminine intimate care products, however, the change will only come when women talk on this subject more comfortably.

Addressing unmet needs Companies have for long been operating in predictable categories, but some are diving into unchartered waters, given the huge opportunity it represents. HLL Pharma plans to achieve `1600 crores by 2020 in which WHD Ethical business will contribute `100 crores.

The company’s R&D team will be developing osteoporosis as a new indication for Ormeloxifene, projected to revolutionise the treatment modality. Bone mineral density is a major problem in Indian women nearing menopausal age with 20 per cent of them suffering from osteoporosis, for which there is no effective medication apart from calcium supplements. It is also focusing its

22 EXPRESS PHARMA March 1-15, 2015

The women’s health category is poised for a revolution, and why should it not. The US FDA has recognised female sexual health as a top 20 focus area to address unmet needs. With more companies researching and developing novel products for women’s health needs, empowerment is not far energy to develop an effective and affordable prophylaxis for breast cancer which accounts for 25 to 31 per cent of all cancers in women in metros.

Barde stresses further, “The area of reproductive health especially in PMS relief, sexual dysfunction in women, painful intercourse due to menopause, menopausal health, should be explored to market these brands OTC in India. With OTC feminine intimate care opening up in a big way internationally, products such as Lactacyd, Clean & Dry inti-

mate wash and 18 (vaginal tightening cream) have entered the Indian market.

There is a need to create awareness among women about the need for such products, as their intimate needs are largely unspoken. Women’s needs such in urinary incontinence and UTI prevention are largely underserved and require serious attention.”

HLL has been instrumental in breaking new ground.

Its hormone releasing intra uterine device – Emily released in FY 2013-14 has created a buzz amongst the gy-

naecological fraternity, because of the easier insertion mechanism. It works as a contraceptive for five years and is mostly used by the doctors to control heavy menstrual bleeding. Uncontrolled heavy menstrual bleeding can even lead to removal of uterus. The company tied up with Kottakal Arya Vaidya for an ayurvedic medicine to increase breast milk secretion for nursing mothers called Lactohil which contains 23 natural herbs.

The women's health category is poised for a revolution, and why should it not.

The US FDA has recognised female sexual health as a top 20 focus area to address unmet needs. With more companies researching and developing novel products for women's health needs, empowerment is not far.

It is time for holistic empowerment, one that is just not centered around education and financial inclusion, but focusses on the most important aspect, the health of women, for the health of a nation depends on it. shalini.g@expressindia.com

Chairman and Managing Director, HLL

There were around 861 New Introductions in the last five years in this segment as of December 2014.

Over the last two years,NIs in gynaecology segment contributed ` 323 cr to overall Indian Pharmaceutical Market Amit Mookim, Head of South Asia Consulting at IMS Health

WO M E N ' S DAY S P EC I A L

Woman on a mission An entrepreneur producing quality medicines, Leena Gandhi-Tewari, Chairperson, USV, is also a humanitarian striving towards the well being of under-privileged women in the society

BY SACHIN JAGDALE

D

esmond Tutu, a South African social rights activist had once said, “If we are going to see real development in the world then our best investment is women.” Leena GandhiTewari, Chairperson, USV, may well be known as a pharma entrepreneur; in line with Tutu’s thought, she has been taking keen interest in women empowerment for last many years. Today, GandhiTewari is not just known for her entrepreneurial skills but also for a sense of social responsibility.

USV supports the Dr Sushila Gandhi Centre for Underprivileged Women since 2008. Young girls (from 8 - 18) are mentored through academic instruction, dance and computers. Their overall confidence, emotional needs, values and aspirations are shaped and guided. They are financially supported through college and remain with the centre until they are capable of being independent. Their mothers are also mentored in several ways to enhance the life of their daughters and the rest of their family. The centre has made a significant difference to the lives of the families it supports.

According to Gandhi-Tewari, culturally in India, we are taught to revere our 'mother'. 'Didi' or 'bhabhi' are endearing terms

men use to hail younger women.

Yet, the presence of Indian women in the workplace and the respect they command is highly variable. She says, “We take for granted the capability of a female nurse, doctor, and beautician; however, as a manager, machine operator or travelling sales person she faces many a bias, and often, an impenetrable glass ceiling. Despite many measures towards the growth of women, our progress could gain further momentum. The issue of working women should be looked at in a broader perspective of societal perceptions, family limitations, corporate policies, ease and safety. A more holistic approach will result in better progress.”

Good work starts at home Apart from her work for women

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empowerment in the social arena, Gandhi-Tewari has not shied away from offering top posts to deserving women candidates in her company as well.

Today, USV is one of the largest and among the most successful pharma companies in India, and its women staff has played a significant role in this achievement.

“Since USV was founded in 1961 the culture has been one that respects and acknowledges the competence of women at work. With women in both manufacturing and Head office, from 1960s till today, as a policy all hiring is not gender-specific. Some of our departments are populated more by a majority of women. To mention just a few, HR, biotech research labs, analytical research labs, supply chain, accounts, domestic marketing. Some of these are not

traditional careers for women,” says Gandhi-Tewari.

She adds, “The absence of a glass ceiling is evident here with women confidently occupying the following top positions, Chairperson, President, Vice President, several AGMs and numerous managers. The work environment is consciously tailored to be friendly, informal, transparent and one which encourages learning. A beautiful garden surrounds the USV office, a bright cheerful cafeteria, a spacious and calm work place are additional touches that appeal to the female psyche more than their male colleagues.”

Reservations against reservation The idea of keeping 33 per cent seats reserved for women candidates in Loksabha also led the

foundation for a debate over whether private sectors should also follow suit. Gandhi-Tewari, however, is not in favour of this idea.

She explains her point of view, “I do not believe that reservation is an optimum solution as it is forced and one-sided. Yes, corporates do need to have more focus on the development of women but primarily this change requires a change in many mindsets. As we know, changing mindsets is a longer and difficult process but it is a more sustaining and complete process. I believe the government should facilitate and provide incentives for corporate houses to have initiatives that empower women.”

Gandhi-Tewari feels that through media and initiatives it is possible to do good work in bringing about this change.

“Look at how we are all aware of the need to educate the girl child, similarly we can all learn to play a role in being more supportive to women who have the desire and ambition for a career. Facilities such as creches, flexibility in work hours, safety go a long way but this is greatly enhanced by a supportive mother-in-law, an understanding husband and an admiring circle of family and friends,” she opines.

Gandhi-Tewari's endeavours towards women empowerment is an exemplar for others. More such entrepreneurs who take women empowerment as a moral responsibility is needed to usher development among women in the country. sachin.jagdale@expressindia.com

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cover )

BREAKING THROUGH As women all across the world grapple with cancer, the oncology space is getting competitive with companies coming up with new breakthrough treatments to usurp the other

BY SHALINI GUPTA

24 EXPRESS PHARMA March 1-15, 2015

WO M E N ' S DAY S P EC I A L

T

FDA

he past two months have seen the US FDA approve two new breakthrough treatments for cancer in women.

First being Lynparza, marketed

by Astra Zeneca, used to treat advanced ovarian cancer with the genetic BRCA mutation and in women in whom three or more lines of therapy do not work.

Pfizer’s breast cancer drug Inbrance is the latest in line, released in February, marketed along with Letrozole to treat postmenopausal women for a certain type of breast cancer that has spread. Both Lynparza and Inbrance were

granted accelerated approvals as a step to release a ‘breakthrough therapy’ sooner into the market than expected. The oncology market is sure to heat up with both these developments. Two analysts help understand the dynamics of the breast cancer and ovarian cancer market from their individual perspectives.

Ovarian cancer: Japan rules; India and China to lead the future Japan accounts for more than half of the APAC market, with its high Annual Cost of Therapy (ACoT), good healthcare access, and high treatment rates. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 2.5 per cent by 2020 driven predominately by the approval of potential pipeline candidates such as Amgen’s Trebananib and AstraZeneca’s

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cover ) The collective sales from CDK4/6 and PI3K inhibitors will account for $3.6 billion clocking 79 per cent of the global sales in the HR+ setting in 2023.

Contextually, the APAC prevalence population will increase by approximately 27,000 ovarian cancer patients by the end of 2020, 95 per cent of which will come from India and China

Shabaaz Ali

Sravanthi Addapally

Analyst, GlobalData

Associate Analyst, GBI

Olaparib, which has recently already gained approval in the US and EU. The country’s incidence rate stands at 8.1 cases per 100,000 population and has become increasingly stable over the past two decades, a trend expected to continue throughout the forecast period and reflected in the stabilised prevalence population.

The effect of drug-price inflation rates is minimal in Japan as the inflation rate for pharmaceuticals is almost equal to the consumer price index, which itself is very low due to strong controls on drug pricing. The factors driving the market have not changed drastically, with the key factor being the approval of potential pipeline drug candidates.

However, even as Japan rules, India and China, are expected to post higher growth rates between 2013 and 2020 despite the modest cumulative growth rate of the ovarian cancer therapeutics market in APAC. Says Sravanthi Addapally, Associate Analyst, GBI Research, “This is largely due to their growing prevalence populations and drug-price inflation rates. Contextually, the APAC prevalence population will increase by approximately 27,000 ovarian cancer patients by the end of 2020, 95 per cent of which will come from India and China.”

China has the second-highest market share due to a larger prevalence population

26 EXPRESS PHARMA March 1-15, 2015

HIGHEST GROWTH TREATMENTS BY 2023 (BREAST CANCER) Drug

Treatment stage

Year of launch

Countries

1.Palbociclib

First-line hormonal metastatic setting

2015

US, EU, and Japan

2. Palbociclib

Second-line hormonal metastatic setting

2016

US, EU, and Japan)

3. Buparlisib

Second-line hormonal metastatic setting

2018

US, EU,Japan, and China)

4. Lynparza

Adjuvant chemotherapy triple-negative breast cancer

2021

US, EU,Japan, and China)

Source: GlobalData

although the actual cost of treatment is lower than that of Japan. “While the prevalence rate in India is 5.4–8.0 cases per 100,000 population (according to location), China stands at 7.73 cases per 100,000 population and 5.19 cases per 100,000 population (in urban and rural areas respectively). However, currently India has the smallest share, accounting for only 10.4 per cent of the APAC market revenue which is contributed by its lowest actual cost of treatment coupled by a low treatment rate,” Addapally adds.

The Asia Pacific market shows a lower incidence rate as compared to developed countries.

However, unlike developed western countries, the incidence rate is not expected to decrease during the forecast period, except in Australia which has a high ACoT and low prevalence rate of 10.4

cases per 100,000 of its population. All said and done, however, North America dominates the global market for ovarian cancer due to a large number of aging population.

Asia is the dark horse of the future, expected to show high growth rates in the next five years.

Breast cancer: Newer treatments, first to market approach GlobalData in their latest report estimates that the global breast cancer market for HER 2 (excluding APAC) is set to increase to $6.12 billion by 2023 growing at a rate of 15.5 per cent. US would lead the pack occupying close to $4 billion of the projected market followed closely by five EU countries combined (France, Germany, Italy, Spain and the UK) with $2 billion. This would be led by newer treatment options coming in the market namely, the CDK4/6,

PI3K inhibitors in the HR (hormone receptor) positive setting, and the PARP inhibitors in the niche and highly underserved triplenegative breast cancer (TNBC) setting.

According to Shabaaz Ali, GlobalData’s analyst covering oncology, “Sales from these drug classes alone are expected to account for $5.1 billion (84 per cent) of the global HER2-negative breast cancer sales in 2023. The collective sales from CDK4/6 and PI3K inhibitors will account for $3.6 billion clocking 79 per cent of the global sales in the HR+ setting in 2023. The collective sales from all of the PARP inhibitors will account for $1.02 billion i.e 94 per cent of the global sales in the TNBC setting.”

Implementation of nationwide breast cancer screening programmes in several countries will contribute to an increase in the diagnosis of

early-stage disease. This along with increasing worldwide aging population remains the biggest driver. This is especially the case in urban China, where, over the forecast period, the incident cases are expected to increase faster than in any other market, at an Annual Growth Rate (AGR) of 6.4 per cent.

Adjuvant setting is a lucrative space for companies given the sheer size of the adjuvant population and the high number of treatment cycles that can be administered in this setting. “By 2023, Lynparza sales across the 8MM in TNBC are expected to reach $926 million, with 79 per cent from sales in the adjuvant TNBC setting at $731 million.

NeuVax (nelipepimut-S/E75) is also set to enter the adjuvant setting (HR+) in the US and 5EU, and even with relatively low patient shares (<10 per cent), it will score comparatively high global sales of

WO M E N ' S DAY S P EC I A L

$567million,” adds Ali. However, it will remain relatively untapped, even after the forecast period.

While hormonal agents such as CDK 4/6 and PI3K inhibitors will be more in demand in the HR+ setting extending the time patients spend on these agents, PARP inhibitors will stand out in the TNBC setting. However, these can only be used in the subgroup of patients who are BRCA mutation positive (around 30 per cent). For these BRCA+ patients, the PARP inhibitors will create a new treatment paradigm altogether. However, this does not apply for the majority of TNBC patients (who don’t have a BRCA mutation).

To sum up, the oncology market is getting crowded and competitive taking away the luxury of time from companies

TOPMOST COMPANIES BY TREATMENT (BREAST CANCER) Company

Drug

Setting

AstraZeneca

Lynparza

TNBC

Bristol Myers Squibb

Nivolumab

—

EliLilly

Abemacicilib

HR+

Pfizer

Palbocicilib

HR+

Novartis/GSK

Buparlisib/LEE011

HR+

Galena Biopharma

Neuvax

HR+

Source: GlobalData

when it comes to their drug gaining approval. There is no approach but the first to market approach. GlobalData believes that when it comes to some of the drugs that demonstrate extraordinary efficacy, such as Palbociclib, special regulatory pathways (such as the FDA’s breakthrough desig-

nation pathway), are greatly accelerating the time needed for those drugs to reach the market. Ali adds that the oncology space is going to experience a trend towards filing on Phase II data.

“We are now seeing very large Phase II trials with over 150 patients which are also

adopting surrogate endpoints such as PFS (progression free survival).

Another tactic is to jump straight from Phase I to Phase III (as exemplified by Abemaciclib).

The tell-tale signs of such strategies are the sheer size of these early stage trails, which are often multi-centre

and multinational,” concludes Ali. Overall the breast cancer therapeutics market in the four Asia-Pacific (APAC) countries of India, Australia, China and Japan is expected to grow at a CAGR of 7.6 per cent to $2.5 billion by 2020.

Japan had the largest market in 2013 with a value of $872 million, or a share of 58 per cent, followed by China with $320 million or 21 per cent, and Australia with $234 million or 16 per cent. India had the lowest market share and value at five per cent and $81 million, but is expected to witness the fastest growth over the forecast period with a CAGR of 13.8 per cent, compared to Australia at 7.8 per cent and China and Japan both at 7.7 per cent. shalini.g@expressindia.com

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cover ) INSIGHT

‘Gender diversity and corporate boards’— Pharma leads the way!

DEBABRAT MISHRA Director, Hay Group India

SUDAKSHINA TYAGI Senior Consultant, Hay Group India

Debabrat Mishra, Director, Hay Group India and Sudakshina Tyagi, Senior Consultant, Hay Group India elaborate on the need for more women in leadership positions, including corporate boards PICK UP any financial newspaper on any given day and scan through its pages, and you are likely to stumble upon an article which focuses on the merits of gender diversity within the organisations of today. The issue of ‘including’ women has gained a considerable amount of prominence in recent times.

While putting in place statistical indicators/ dictates to drive gender diversity is a good step, the true essence of gender diversity in an organisation can only be driven through a change in mindset across the organisation. Needless to say, in a corporate set up, while this change needs to be all pervasive and percolate across levels, it definitely needs to be driven from the top itself. Hence, clearly there is a need for more women in leadership positions, including corporate boards. Also, Hay Group’s research and numerous others studies have pointed out that embracing diversity in the workplace – especially encouraging women to succeed in senior roles - flows through to the bottom line.

The present — We lag far behind Let’s analyse the current scenario with respect to our corporate boards. As per PRIME database, there are just 488 women presently occupying

28 EXPRESS PHARMA March 1-15, 2015

PHARMASECTOR LEADING THE WAY: FEMALE REPRESENTATION ON CORPORATE BOARD PHARMA SECTOR WOMAN REPRESENTATION 80

76

Out of the 58 women directors, the split in termsof the appointment date

70 60

51

50 40 30 20 10 0 No of listed pharma companies

Listed pharma companies with women directors

Source: PRIME Database

597 directorship positions across all NSE-listed companies. And, if the requirement for boards as per the Indian Parliament’s Companies Act, 2013 mandate was to have independent women directors, as many as 1240 companies (or 85 per cent of companies) still need to meet the norm. Clearly a law/ tokenism can only go so far.

There is a need to move towards embracing the spirit or essence behind the law. We need to truly recognise the value that a woman director

■ Appointmed before 2014 ■ Appointmed during and after 2014

Source: PRIME Database

brings to the board. There is now significant research to show the considerable value that women add to the decision making processes within the top echelons of organisations.

While a lot of research has gone towards statistically trying to prove the significant business benefits of having women directors on corporate boards, we would like to look beyond to some reasons why women directors may be adding significant value in their own unique ways.

An indispensable contribution A company’s board signifies its capability, integrity and veracity to say the least. The board member is the dispassionate individual who is looking out for the interest of the shareholders at all times and enables the organisation to have an unwavering focus on performance with a strong command on the company’s governance. Recently, Hay Group conducted its annual ‘India’s Best Boards’ study. This was underpinned on our Board Evalua-

tion Framework which has been developed using the learnings from our comprehensive studies of more than 100 Indian corporate boards over the past two years. The study involved a rigorous process of detailed onsite audits where our team validated documents, interviewed independent directors and chairman/CEOs to get a deeper understanding/ assessment of governance processes and principles. The study also drew insights in terms of the effectiveness of women as board

(

TH WOMEN ' SE DMAAYI N S PFEOCCI U AS L

members.

Through our study, we found strong evidence to support the fact that the contribution of women board members is significant, in terms of the following:◗ Being more consistent in bringing in a focused approach to board discussions ◗ Being more diligent in their level of preparedness, as well as being relatively more participative in those sessions ◗ Having higher self-awareness and an ability to objectively look at , and contribute to board discussions as well as handle conflicts

Pharmaceuticals industry’s step forward If you look at the pharma industry, through the lens of gender diversity; the sector has, either by design or by chance, managed to show a relatively impressive women representation across the top brass of the organisation including corporate boards. As per PRIME Database, out of the 76 listed pharma companies, 51 of them already have a woman director on the board, with a sum total of 58 women directors.

Of these, 32 directors have been appointed prior to the mandate of ‘atleast one woman on the board of directors’ got rolled out, which is noteworthy.

The crucial ‘emotional intelligence’ factor Women of the likes of Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon; Dr Preetha Reddy, Managing Director, Apollo Hospitals Enterprise; Dr Swati A Piramal, Vice Chairman Piramal Enterprises testify that the Indian healthcare sector has had successful precedents of women in leadership positions.

While technical expertise is something they definitely bring to the table, but more so their leadership ability to manage and steer people stands out. A critical component of managing people as Hay Group’s research shows is the individual’s emotional intelligence. As Daniel Goleman wrote on Emotional Intelligence, “Emotions guide everything we do.” Indeed, emotional intelligence is regarded as

While the government needs to help through legislative actions, companies need to go the extra mile through efforts like focused and customised recruitment initiatives and tailor-made training and development programmes.At the same time women too must take the initiative to assert themselves

a far stronger predictor of success – in work, love and life – than traditional measures of intelligence, with 90 per cent of leadership success being attributed to a high EQ. While there is no research definitively pointing to women having or consistently demonstrating higher levels of emotional intelligence than men, it is fair to say that men and women bring forth different facets of emotional intelligence which are beneficial in their own

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unique ways. Thus, women representation on boards would definitely provide a more comprehensive perspective on decision making.

Strive towards ‘real change’ However, the question which rankles in our minds is that by just having women directors on the board, would one be able to have gender diversity in the true sense of the term? Also, would this gender diversity really lead

to enhanced business outcomes, which in turn, as a virtuous cycle, would fuel the gender diversity cause? It may not be so in the current ways of work. We would need to break free from stereotypes to realise this vision in entirety.

Consider the following facts:◗ Is there genuine intent to onboard effective women board members? As we mentioned earlier, 51 of the listed pharma companies have female repre-

sentation on board with a total of 58 directors in all. The fact is 30 per cent of these women are from promoter families, which makes one wonder if this is a mere fulfilment of a law and not a genuine attempt to focus on building diversity, which would lead to intended business benefits. The ideal scenario that we must all aim for is one wherein women are included on boards to plug an essential skill gap or enhance the group’s overall capability quotient, instead of just meeting a diversity target for the organisation ◗ Has age got something to do with being effective as a board member? Here’s fact two.

Of the listed pharma companies, with non-promoter women directors, approximately 65 per cent-70 per cent of them are in the age group of around 50+. Is this a norm to go by or are we willing to take chances in terms of bringing in younger female board members too? Yes, age brings in wisdom and experience, but there is enough evidence to show that the representation of younger members on board enables an organization to build its risk appetite and take on transformational changes.

Having said all this, one needs to remember that gender diversity is a fine balance that can only be achieved if everyone does their bit. While the government needs to help through legislative actions, companies need to go the extra mile through efforts like focused and customised recruitment initiatives and tailor-made training and development programmes. At the same time women too must take the initiative to assert themselves. Women should volunteer confidently and not hesitate from promoting themselves. Organisations must work persistently towards getting the right mix of gender representation within the board, so as to ensure an optimal output. We certainly hope that more and more industries take a cue from the pharma sector, and drive gender diversity in its true spirit, rather than just mere symbolism.

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MANAGEMENT

In part three of the Express Pharma 20th Anniversary series, two experts review how the current regulatory overhaul, spanning clinical research, drug pricing, FDI norms etc, will pave the way for safer medicines and faster growth of the industry

30 EXPRESS PHARMA March 1-15, 2015

INSIGHT

Current status of clinical research in India Dr YK GUPTA, Professor and Head, Department of Pharmacology, AIIMS, New Delhi expounds on the measures taken to revive clinical research in India and shares his recommendations to better the situation CLINICAL RESEARCH has grown exponentially over the past decade in India because of cost advantage, treatment naïve patient, qualified doctors conversant in English etc. India was the second most preferred country to conduct clinical trials outside the US in 2009. However, recent years have witnessed a decline in number of trials in India (529 in 2010; 253 in 2012). The number of drugs entering the Indian markets had been gradually reducing even before the current slump in clinical research activity (270 in 2008;140 in 2011; 44 in 2012 and 25 in 2013). This necessitates a relook on the strategy so as to optimise clinical research in Indian context. The problems and possibilities around the clinical research arena can be broadly grouped as capacity building issues and ethico - regulatory ones.

In India, Drug Controller General (India) (DCGI) is the competent authority for approving clinical trials as well as manufacturing and marketing drugs.

DCGI grants approval after appropriate clinical trials are conducted in India with adequate number of trial subjects.

To begin with, there are scant training resources to train adequate number of researchers so as to carry out research activities as per the international standards. There is a need to build dynamic training modules and platforms which confirm to international regulations and best practices while addressing peculiar national needs. The training infrastructure needs to be flexible enough to accommodate ever changing regulatory landscape. We have a

DR YK GUPTA, Professor and Head, Department of Pharmacology, AIIMS, New Delhi

thriving knowledge base of traditional medicine systems which cater to a large segment of the population are regulated by a separate Department of AYUSH. There is a requirement of involving AYUSH practitioners in collaborative research and reorient the research regulations so as to effectively monitor research in AYUSH. Recent draft notification regarding regulations for ‘Phytopharmaceuticals’ is a step in this direction.

Though India has a robust regulatory apparatus, it is perceived that Indian patients being poor and less informed are vulnerable. While isolated instances of unethical clinical trials cannot be ignored, a more informed debate and perception management is the need of the hour. The confidence building amongst all stake holders has now assumed paramount importance.

The Govt of India has taken a lot of steps to ensure participant safety by introducing major changes in regulatory landscape of clinical research. Some such changes are as follows.

Registration of all clinical trials with Clinical Trial Registry India (CTRI) is mandatory w.e.f Feb 01, 2013. The

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MANAGEMENT protocol, enrollment and the final report also need to be uploaded at the registry. This is a welcome step aimed at putting trial related information in the public domain. However, there is a case for broadening the ambit of CTRI by capturing the subsequent trial results (positive, negative or inconclusive termination) too in the national database. This step shall go a long way in ensuring optimum publicity of trial results thereby mitigating publication bias.

W.e.f. Jun 07, 2013, audio-visual recording of the informed consent process is now mandatory to make the process more transparent and maintaining confidentiality. Reservations on logistics of this notification has been expressed by stakeholders, however amendments are awaited.

Registration of Institutional ethics committees (IECs) is mandatory w.e.f. Feb 08, 2013.

IECs have been empowered and made more accountable.

Now, they are required to actively monitor and participate in reporting of SAEs. Strict timelines for reporting of Serious Adverse Events (SAEs) have been mandated in which IEC has to give their report including opinion on compensation within a fixed time frame.

Investigators are required to report SAEs to the IEC within 24 hours followed by a detailed report within 14 calendar days.

Within next 30 days, IECs have to analyse and forward these reports to national expert committee with opinion on financial compensation. In order to fulfill their responsibility, IEC should be competent. Therefore training of IECs needs to be undertaken so as to empower them about their roles and responsibilities.

For the first time in the world, the financial compensation based on no - fault principle calculated as per defined formula has been made the mandatory responsibility of the sponsor for trial related injuries or death. This comprehensive and dynamic formula has been so devised that younger participants get more compensation as compared to older participants. The final order regarding compensation is

32 EXPRESS PHARMA March 1-15, 2015

For the first time in the world, the financial compensation based on no - fault principle calculated as per defined formula has been made the mandatory responsibility of the sponsor for trial related injuries or death. This comprehensive and dynamic formula has been so devised that younger participants get more compensation as compared to older participants given by the DCGI which has to be complied within 30 days. If the trial related injury is discerned after the completion of trial, still the compensation has to be given. The financial compensation to be paid is over and above free medical management of injury that has to be provided to the participant. In addition, trial participants have to be provided ancillary care if they suffer from for any other illness during the trial. The calculation of compensation for trial related injury is derived from the one applicable in case of trial related deaths. It is based on the assumption that death is the maximum injury possible to an individual and the amount in case of injury has to be less than the amount that would have been applicable in case of death in similar circumstances. According to this formula, the trial related SAEs for deciding the amount of compensation have been di-

vided into following four categories - permanent disability; congenital anomaly or birth defect, chronic life-threatening disease; or reversible SAE in case it is resolved. The compensation applicable in all these scenarios has to be calculated differently.

Accreditation of principal investigators (PIs), IECs and the trial sites has been recommended to ensure competence of investigator(s), IEC members and the capacity of the site. For drafting the principles of accreditation, a committee, steered by Dr Ranjit Roy Chaudhury and Dr YK Gupta has been formed. To ensure adequate trial supervision, the number of trials per investigator has been restricted to three.

This spate of well intended regulatory overhaul has also made pharma companies apprehensive and skeptical about doing trials in India.

Once the grey areas and contentious issues are addressed, it is envisaged that clinical research in our country will quickly scale up in a much safer, regulated and enabling environment.

Besides the regulatory action, patient, the most important stake holder, needs to be sensitised too. There is a need to generate informed and balanced debate in electronic and print media. The entire spectrum of clinical research needs to be made transparent with seamless knowledge sharing and information exchange.

Regulators also need to act more as facilitators of research and not merely as law enforcers. The regulations have been made after detailed deliberations, consultations and analysis of the situation. These steps were essential to fill the gaps in the regulations, in absence of which there can be potential harm to the trial

participants, who are relatively less informed as compared to their counterparts in the developed world. However, it is perceived that at few points, there is some over-correction which needs to be adjusted based on the evidence and detailed discussion with all the stakeholders, so that the progress of science is also not affected.

While the arena of clinical trials is under close watch, other types of clinical research such as observational studies, population based studies, outcomes research etc. also deserve equal emphasis. We need to formulate standardised protocols and SOPs for these activities and train adequate manpower. In the country of our size and magnitude, this is where the clues and leads are likely to emerge from.

Another important issue is to align the clinical research activity in our country as per our national health needs.

Research in India specific problems (such as JE, Dengue, malaria, MDR TB) should be incentivised by way of faster approvals, liberal funding and extended marketing rights. It is good to have a vaccine against HPV but one against JE may be needed more and sooner.

Clinical research is essential not only for developing medicines for emerging health concerns (such as XDR TB, antibiotic resistant pathogens, H1N1, Ebola virus, etc) but also for finding safer and better medicines for entrenched diseases such as HIV, malaria, diabetes, hypertension etc. India, with its large patient population, unmet health needs, and limited resources, needs to make newer and better treatment options available to its population in a quick, economical and dependable manner. For this, India must take proactive part in clinical research and assume leadership role globally. We must ensure that clinical research in our country is carried out as per global scientific standard, is moored in sound ethical foundations befitting a liberal democracy but is optimally oriented towards addressing national medical and health needs.

MANAGEMENT INSIGHT

Art and science of pharma marketing Pawan Chaudhary, CMD, Venus Remedies, gives an overview on the evolution of pharma marketing and the need to 'think out of the box' to propel growth in the industry RISING COMPETITION, stringent laws, new drug guidelines, changing FDI policy, compulsory licensing, price control and so many other factors have made most Indian pharmaceutical companies think ‘out of the box’ marketing strategies to survive in the race of the fittest.

The pharma industry in India and around the globe is one of the fastest growing industries, accounting for a total revenue of $3 trillion. The revenue of the Indian pharma industry stood at $12 billion in 2013. The Indian pharma industry is projected to be among the top three global markets in terms of incremental growth by 2020.

Globally, the pharma sector in India ranks third in terms of volume and 14th in terms of value. It is primarily driven by exports in regulated and emerging markets. The Indian pharma market is highly attractive despite fragmentation and crowding. The country has more than 20,000 pharma firms, 60,000 distributors and a significantly larger retailer base.

Key changes in the market The rapidly changing environment due to strict drug guidelines and policies have made pharma companies around the world adopt unconventional ideas of marketing to reach to the top. The rising competition where only the fittest can survive requires proper positioning to establish a product and make it grow. In the pharma industry, it is all about positioning the product properly. This is the reason why marketing and promotion hold immense significance in the pharma industry.

Since the introduction of the Patent Act, 2005 in India, the approach of pharma companies has changed a lot with a majority of the companies opting for transition (by switching over from generics to branded generics) for survival. Medical representatives and

PAWAN CHAUDHARY, CMD, Venus Remedies

the field force now play an important role in helping pharma companies know the details of doctors’ prescription slips. Networking has always been the key to success in reaching out to chemists, pharmacists, distributors and doctors. In today's competitive world when medical representatives from various companies do not get much time from doctors for appointment to explain them the details of a particular product, it becomes imperative for every pharma company to come up with an innovative marketing model to ensure growth.

Pharma marketing and promotions have become a necessity in today's date. Ideally, every pharma company spends eight-10 per cent of its total sales in marketing activities to properly promote and position its brands in the market. For an R&D-driven company like Venus, it becomes a bit more difficult as we do not have the option of advertisement. Our products are highly specialised and used in healthcare units/ICUs, so companies like ours depend on the following tools to market their products: Key Opinion Leaders (KOLs): Key Opinion Leaders (KOLs) have always been considered as the ‘thought leaders’ who play an important role in the advisory committee of pharma companies. As KOLs are capable of influencing other clinicians through their professional status and updated scientific knowledge, they also play a vital role in the drug development stage and the

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MANAGEMENT pre and post launch phase by providing valuable suggestions and merging the gap between clinical needs and research. Pharma industries have been and will be relying heavily on KOLs in future too.

Be it developing a new research product, targeting a unique segment of clinicians for drug promotion through symposiums and conferences, taking first-hand clinical inputs to upgrade the scientific information of the drug or conducting training and education programnes, KOLs have a crucial role to play. They also help in publication of clinical data, thereby apprising the medical community about the scientific worth of the drug.

Webinars: It is a latest means of communication where pharma companies invite several doctors to participate in online/live interactions to introduce and discuss a product.

It is one of the most powerful modes of communication among the medical fraternity, which provides a platform to industry experts to share their views about the subject.

Expositions: Participating in expos like Microcon is another way of positioning your product and educating the healthcare and pharma fraternity about your product kit. For in-

Since the introduction of the Patent Act, 2005 in India, the approach of pharma companies has changed a lot with a majority of the companies opting for transition (by switching over from generics to branded generics) for survival stance, we have been participating in Microcons for the past two years. It serves as a good platform for companies like us to introduce their research products to microbiologists and speciality doctors whose opinion and recommendation about a particular drug decides its acceptance and promotion in speciality hospitals.

Conferences/seminars: Another useful marketing technique is participation in seminars and conferences where you can introduce your products, ideas and research innovations and convey your unmet needs and opinions. We, at Venus, have been part of many conferences and programmes where we have introduced our research products and got appreciation for them. The DSTLockheed Martin India Innovation Programme is one of the most prestigious platforms we used to present our three

research products and received appreciation for them in the form of awards.

Social media: Social media is the latest rage these days. It is hard to ignore it. With a single click, you get to introduce your products to the masses and educate all stakeholders about it, including pharmacists, stockists, investors, distributors, doctors and the general public. It is the best way to penetrate into various regions around the globe and promote a brand.

Continuing Medical Education (CME) programmes: It is a technique used by pharma companies to influence the prescriptions of physicians.

CMEs are utilised by pharmaceutical companies as a platform to introduce their innovations and educate doctors about how their discoveries will help patients.

These are some of the techniques which almost every research-driven pharma company around the world is practising to excel in the business.

Challenges ahead Despite the market growth, the industry is still facing a number of challenges, which includes funding for new technologies/drug development, an increase in co-morbidities associated with chronic diseases and human factors such as the administration of drug delivery in home and regulatory interventions. The cost of research and developing new products is becoming challenge day-by-day due to increased input costs and regulatory hurdles. It takes a time of eight to 10 years and an average investment of $8001,000 million to successfully develop a new chemical entity.

Even after the product launch

in the market, the regulatory requirements are comprehensive in terms of pharmacovigilance and reporting.

The drug pricing policy poses another big challenge.

The Government of India has adopted the National Pharmaceutical Pricing Policy (NPPA) to strike a balance between the pharma industry’s growth and availability of reasonably priced medicines for patients, particularly the poor. In the NPPA list, the number of essential medicines that come under direct price control of the government has been increased from 74 to 348 to cap their prices based on the average price of these medicines in that particular therapeutic segment.

In a nutshell, the confluence of research education and pharma marketing is leading to the emergence of a new marketing model that promotes the idea of smaller, more agile and smarter marketing teams/field staff. The time of incremental innovation or branded generics has long gone. In today's date, the growth and sustenance of a pharma company depends solely on the revolutionary package of the product in terms of the value it offers to patients without burdening their pockets, and effective results in a shorter time span.

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph.

Preferably in colour, postcard size and with a good contrast.

34 EXPRESS PHARMA March 1-15, 2015

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Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

MANAGEMENT REPORT

Human insulin market will reach $49,197.3 million in 2020 globally: Persistence Market Research Asia Pacific to show fast growth rates in the next five years ACCORDING TO a new market report published by Persistence Market Research â&#x20AC;&#x2DC;Global Market Study on Human Insulin: Asia Pacific to Witness fastest Growth by 2020,â&#x20AC;&#x2122; the global human insulin market was valued at $24,332.6 million in 2014 and was expected to grow at a CAGR of 12.4 per cent from 2014 to 2020, to reach an estimated value of $49,197.3 million in 2020.

The report provides indepth analysis and estimation of the human insulin market for the period 2014 to 2020, considering 2013 as the base year for calculation. In addition, data pertaining to current market dynamics, including market drivers, restraints, trends, and recent developments, has been provided in the report. The human insulin market is categorised on the basis of the type of insulin, diseases and geography.

China and India are expected to be the fastestgrowing human insulin markets in the Asia Pacific region. In addition, the human insulin market in Japan is also growing due to rising number of R&D investment and availability of large number of drug manufacturing companies Based on the type of human insulin, the market comprises traditional and modern human insulin. Traditional human insulin is further categorised into short acting, intermediate acting and premixed human insulin. Modern human insulin is further categorised into rapid acting, long acting and premixed insulin.

On the basis of diseases, the market comprises type I and type II diabetes. On the basis of geography, the report identi-

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fies and analyses the market size and predictions for North America, Europe, Asia-Pacific, and Rest of the World (RoW).

Globally, the human insulin market is witnessing a significant growth due to increasing prevalence of diabetes and increasing awareness among people about diabetes care. In addition, technological advancements in insulin delivery devices and increasing prevalence of lifestyle related disor-

ders such as obesity are also driving the growth of the market. However, uneven pricing and limited access to human insulin in emerging countries such as Brazil, India, and China are inhibiting the growth of the human insulin market. In addition, strict regulatory requirements for drug approval are also restraining the growth of the market.

North America dominates the global market for human insulin due to large number of

aging the population, increasing prevalence of diabetes and diabetes-related disorders. In addition, availability of technological advanced human insulin infusion devices is also boosting the growth of the market. Asia Pacific is expected to show fast growth rates in the next five years in the global human insulin market. China and India are expected to be the fastest-growing human insulin markets in the Asia Pacific region. In addition, the human insulin market in Japan is also growing due to rising number of R&D investment and availability of large number of drug manufacturing companies. Some of the key driving forces for human insulin market in emerging countries are rise in disposable income, large pool of patients and increasing awareness about diabetes and diabetes-related disorders.

EP News Bureau-Mumbai

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RESEARCH I N T E R V I E W

‘India has no dearth of talent in biologics’ Dr Surendra Chavan, Founder and CTO, Accutest Biologics, shares his views with Sachin Jagdale on India’s strength in the field of biologics

You have spent more than two decades working in the global biotech environment? What are the major differences observed by you between the global and Indian biotech industry?

The global biotechnology industry is well established and rebounded strongly in the recent time. The Indian biotechnology sector has emerging market characteristics and is one of the fastest growing knowledge- based sectors, and is expected to play a key role in shaping India's rapidly developing economy.

The biotechnology industry in India is one of the most significant sectors building on technological advancements and leading to new discoveries to meet the rising demands from the pharma sector.

While the global biotechnology industry is focused on new drug discovery and novel technology platforms, the Indian biotech industry focuses mainly on biosimilars. In India, we have many assets and a strong pool of expertise where real collaboration between the industry and the academic institutes is key. In addition, the efforts and support from the government will further create opportunities for small and middle sized companies in the sector. With a huge base of talented, skilled and cost-competitive manpower and a well developed scientific infrastructure, India has great potential to become a leading global player in the biotechnology industry.

36 EXPRESS PHARMA March 1-15, 2015

How is Accutest Biologics working towards removing/ minimising this gap/differences?

Accutest Biologics, a leading CRO in the field of biosimilars, offers a complete package required for the characterisation of the product. We are very well poised to offer complete physico-chemical characterisation of the product as per the relevant guidelines to meet the applicable regulatory requirements. By offering end-to-end, customised and cost effective solutions, we also invest significant resources in educating our scientific staff while establishing a network with academic institutes.

India is still at nascent stage as far as biologics are concerned. What are the key changes that you would recommend to Indian biopharmaceutical companies?

India has no dearth of talent in this sector. Thus, I would recommend Indian pharma companies to develop expertise in all the sectors of biotechnology and especially in protein chemistry, molecular biology, and bioinformatics to participate in the growth potential. Also, they must exploit the scope provided by the Government of India for research and development (R&D) in the field of biotechnology.

Companies should cultivate novel technology platforms in biotherapeutics too (e.g. biologics, cell therapy, vaccines, regenerative, genomic,

nanotechnology, and molecular devices), diagnostics, agriculture, food biotechnology and bioenergy which are affordable to India and other developing countries.

I would recommend Indian pharma companies to develop expertise in all the sectors of biotechnology and especially in protein chemistry, molecular biology, and bioinformatics to participate in the growth potential

What type of cross talk you would expect between global and Indian biotech industry experts?

Both global and Indian biotech players can contribute in their respective way, leveraging on each other’s strengths, assets, know how and network. We at Accutest Biologics are actively engaging in this dialogue, which will all allow us to accelerate progress for the benefit of all.

Indian regulatory structure is often blamed for the slow growth of the Indian biotech industry.

What is your take on this?

The regulatory structure needs enhancements to expedite the approval process. We already witnessed some favourable changes in the Indian regulatory agency, thanks to which the industry is on the way back to normal, contributing again to the growth of the Indian biotech industry.

How do you wish to see Accutest Biologics and the Indian biotech industry grow in the future?

Accutest Biologics will be a leading bioanalytical service provider for the global biotech industry, providing one-stop-solutions for innovations.

Our bio-analytical services include bio-assay

(i.e. potency determination) and immunological properties. Together with our sponsors, we can perform customised studies therefore enabling preclinical in vitro comparability testing, pharmacokinetic (PK) and pharmacodynamic (PD) assess-ments in animal and human samples and immunogen-icity testing during clinical studies. We provide end to end solutions for the analytical characterisation of novel biologics and comparability solutions for biosimilars, covering from early stage product characterisation/ comparability to late stage preclinical and clinical characterisation/ comparability.

We also present ourselves as an ideal cost-effective partner for a biologics development organisation in its clinical phases. We offer both the clinical set-up (through the Accutest Clinical Development Group) for patient/volunteer/data management and the analytical setup (Accutest Biologics) for developing and executing the analytical testing protocols that are required for determining the PK, PD, immunogenicity and other safety/efficacy parameters for an investigational biopharmaceutical drug.

The Indian biotech industry has a strong future, it will be a leader in many sectors such as biotherapeutics, diagnostics, food, agriculture and many more. Accutest is part of this. sachin.jagdale@expressindia.com

RESEARCH UPDATES

Levels of the amino acid more strongly associated with increased diabetes risk in South Asian men Tyrosine was a particularly, and significantly, stronger predictor of incident diabetes in South Asians than in Europeans A STUDY of white European and South Asian men in the UK has found that levels of the amino acid tyrosine, and several other amino acids, are more strongly associated with increased diabetes risk in the South Asian men. The study is published in Diabetologia (the journal of the European Association for the Study of Diabetes), and is by Dr Therese Tillin, UCL Institute of Cardiovascular Science, University College London, UK, and colleagues.

South Asians, both in their home countries and as migrant populations, experience a markedly greater burden of diabetes compared with Europeanorigin populations. The Indian subcontinent is expected to contribute the greatest increase in the number of people with diabetes in the world over the next 15 years. The reasons for the excess risk in South Asians are poorly understood and are not solely due to increased waistlevel obesity or other established risk factors.

Amino acids (AAs) are the building blocks of proteins, and, in European origin populations, AA disturbances have been shown to predict development of insulin resistance and diabetes.

However, until now, no studies have looked at whether AAs would predict development of diabetes in South Asians to the same extent as in Europeans. In a unique cohort of European and South Asian men, the authors compared cross-sectional associations between AAs, metabolic and obesity traits, and associations with development of dia-

betes over a 20-year period.

Nuclear magnetic spectroscopy was used to measure baseline (1988-1991) levels of nine amino acids in serum samples from a London population-based cohort. The participants consisted of 1279 European and 1007 South Asian non-diabetic men, aged 40-69 years from the SABRE (Southall And Brent REvisited) cohort. 801 Europeans and 643 South Asians were followed up for over 19 years.

The data showed that blood concentrations of the amino acids isoleucine, phenylalanine, tyrosine and alanine were significantly higher in South Asian men. Diabetes developed in 227(35 per cent) South Asians and 113(14 per cent) Europeans.

Tyrosine was a particularly, and significantly, stronger predictor of incident diabetes in South Asians than in Europeans, even after adjustment for other risk factors, including obesity and insulin resistance. A given (one standard deviation) increase in tyrosine increased dia-

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Until now, no studies have looked at whether AAs would predict development of diabetes in South Asians to the same extent as in Europeans betes risk by just 10 per cent in Europeans, while in South Asians this increase in risk was 47 per cent. A similar pattern was seen for several other AAs including phenylalanine, isoleucine, leucine and valine. Interestingly, most amino acids correlated with obesity measures to a lesser extent in the South Asian men. Taken to-

gether with the fact that obesity measures did not explain the links between tyrosine and some other AAs and diabetes in South Asians, this may suggest that the way we measure obesity, and perhaps other risk factors, may not capture the best indicators of future risk for developing diabetes in South Asian individuals.

Although this study was not in a position to explore the mechanisms by which tyrosine and other AAs may contribute to the extra risk of diabetes in South Asians, these are likely to involve altered AA metabolism in the liver, kidneys, muscle or adipose tissue. Further study is needed to tease out the underlying mechanisms.

The authors conclude, â&#x20AC;&#x153;These findings suggest that higher branched chain and aromatic AAs, particularly tyrosine, may be a focus for identifying novel mechanisms and potential treatment targets for diabetes in South Asian individuals and may contribute to their excess risk of diabetes.â&#x20AC;?

EP News Bureau-Mumbai

Europe okays first stemcell therapy for rare eye condition EUROPE HAS approved the Western world's first medicine containing stem cells to treat a rare condition caused by burns to the eye, marking a milestone in the use of the technology. Holoclar, from privately held Italian company Chiesi, was given a marketing green light by the European Commission for treating so-called limbal stem cell deficiency due to physical or chemical burns. Left untreated, the condition can result in blindness.

The stem-cell therapy is a living-tissue product. It resembles a contact lens and is made from a biopsy taken from a small undamaged area of a patientâ&#x20AC;&#x2122;s cornea and grown in the laboratory using cell culture. The conditional marketing authorisation had been expected, following a positive recommendation by the European Medicines Agency in December.

Chiesi said the approval meant that Holoclar would be available 'in the near future' to all suitable patients in Europe, including people who have suffered eye injuries caused by solvents, acids, abrasive and chemical agents."

Reuters

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RESEARCH

US FDAapproves 23andMeâ&#x20AC;&#x2122;s genetic screening test for rare disorder The test is intended for post-natal carrier screening in adults GOOGLE-BACKED 23andMe won US approval to market the first direct-to-consumer genetic test for a mutation that can cause children to inherit Bloom syndrome, a rare disorder that leads to short height, an increased risk of cancer and unusual facial features. The Food and Drug Administration said it plans to issue a notice to exempt this and other carrier screening tests from the need to win FDA review before being sold. There will be a 30-day period for public comment.

"This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market," the agency said, referring to genetic mutations carried by two unaffected

parents.

The FDA previously barred Mountain View, California-based 23andMe from marketing a saliva collection kit and personal genome service designed to identify a range of health risks including cancer and heart dis-

ease, saying it had not received marketing clearance. The current approval is for a much narrower slice of the genetic testing market.

"The FDA believes that in many circumstances it is not necessary for consumers to go

through a licensed practitioner to have direct access to their personal genetic information," Alberto Gutierrez, director of the FDA's office of in vitro diagnostics and radiological health said. "These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children," he added.

The company conducted two studies to show that the test is accurate in detecting Bloom syndrome carrier status, the agency said. The test is intended for post-natal carrier screening in adults.

"No test is perfect," the FDA said. "Given the probability of erroneous results and the rarity of these mutations, professional so-

cieties typically recommend that only prospective parents with a family history of a genetic disorder undergo carrier screening."

Company co-founder Anne Wojcicki said that 23andMe has not yet decided how much the test will cost or exactly when it will be available though she expects it will be "some time this year."

She said the company has 40 more screening tests of this type that it hopes gradually to introduce. The company has not given up hope that it can win FDA approval for other types of genetic tests for which the agency currently requires premarket approval, she said. "This is the first step in what we hope will continue to be an evolving journey, she said.

Reuters

FDA approves new use for Celgeneâ&#x20AC;&#x2122;s cancer drug Revlimid The drug is approved in 70 countries for previously treated patients THE US Food and Drug Administration has expanded the authorised use of Celgene Corp's cancer drug Revlimid to include newly diagnosed patients with multiple myeloma, the company said.

Previously the drug was only approved for patients who had received at least one previous therapy. Physicians in the US have long been prescribing Revlimid for new patients on an "off-label" basis, but the company had not been allowed to promote its use in this population. The FDA's action means Celgene can market Revlimid, in combination with a different drug, dexamethasone, as a

38 EXPRESS PHARMA March 1-15, 2015

treatment for all multiple myeloma patients and helps validate the company's premise that treating patients earlier and for a longer period of time increases progression-free survival. The approval is expected to only modestly increase sales in the US since doctors are already prescribing the drug for newly diagnosed patients.

In Europe, where physicians are not allowed to prescribe offlabel, the situation is different.

Celgene expects European regulators to also approve the drug for newly-diagnosed patients within the next few weeks. If they do, the move could add meaningfully to sales. About 50

until now, no studies have looked at whether AAs would predict development of diabetes in South Asians to the same extent as in Europeans per cent of patients with multiple myeloma are newly diagnosed. The remainder have received one or more prior therapies.

Revlimid generated total sales in 2014 of $2.92 billion in the US and $2.06 billion in the

rest of the world. The drug is approved in 70 countries for previously treated patients. The company hopes approvals in the US and Europe will pave the way for other countries to also approve the drug for newly diagnosed patients. John New-

man, an analyst at Canaccord Genuity, said in a research note that he expects sales of Revlimid to reach $10 billion by 2020. About 93,600 patients are living with multiple myeloma in Europe and about 88,499 patients are living with it in the US, Celgene said.

Revlimid is also approved in the US and some other countries for a group of blood disorders known as myelodysplastic syndromes. It is also approved in the US for patients with mantle cell lymphoma whose disease has progressed after two prior therapies.

Reuters

RESEARCH

WHO approves breakthrough 15-minute Ebola test The so-called ReEBOV Antigen Rapid Test involves putting a drop of blood on a small paper strip THE WORLD Health Organization (WHO) has approved the first rapid test for Ebola in a potential breakthrough for ending an epidemic that has killed almost 10,000 people in West Africa, it said. The test, developed by US firm Corgenix Medical Corp, is less accurate than the standard test but is easy to perform, does not require electricity, and can give results within 15 minutes, WHO spokesman Tarik Jasarevic said.

"It's a first rapid test. It's definitely a breakthrough," he said. The standard laboratory test has a turnaround time of 12-24 hours. While the Corgenix test is not failsafe, it could quickly identify patients who need quarantine and make it much easier to verify rapidly any new outbreaks.

Procurement and roll-out of the test kits will not begin immediately because the company is still working out costing and needs a week or two

more to finish administrative procedures with the US Food and Drug Administration, Jasarevic said. The health charity Medecins Sans Frontieres, which has been at the forefront of the fight against Ebola, had expressed an interest, he said.

The so-called ReEBOV Antigen Rapid Test involves putting a drop of blood on a small paper strip and waiting 15 minutes for a reaction in a test tube. It is able to correctly identify about 92 per cent of Ebola infected patients and 85 per cent of those not

infected with the virus, the WHO said. Knowing that margin of error is a major help, said Robyn Meurant, from the WHO's department of essential medicines and health products.

"The big fear has been that the market gets flooded with

tests of unknown quality, or unknown performance, and with Ebola you need to know what are the limitations. A false negative has enormous implications. So does a false positive," she said.

"So this is not a perfect test but for a rapid test, (it is) not too bad at all." It would be especially useful if a cluster of suspected cases flared up, she said. "If you had five patients with suspected symptoms and you went ahead and tested them and they were all positive you'd have a high degree of confidence that you've got Ebola." Because of the margin of error, the Corgenix test would then need to be followed up by the standard laboratory test. The WHO is still assessing four or five other rapid test candidates, but Meurant said it was not possible to say when the next approval might be.

Reuters

High energy breakfast with low energy dinner helps control blood sugar with type II diabetes Adjusting diet could help optimise metabolic control and prevent complications of type II diabetes A SMALL new study published in Diabetologia (the journal of the European Association for the Study of Diabetes) shows that, in people with type II diabetes, those who consume a high energy breakfast and a low energy dinner have better blood sugar control than those who eat a low energy breakfast and a high energy dinner. The authors of the study include Professor Daniela Jakubowicz and Professor Julio Wainstein, Wolfson Medical Center, Tel Aviv University, Israel, Professor Bo Ahren, Lund University, Sweden and Professor Oren Froy Hebrew Univer-

40 EXPRESS PHARMA March 1-15, 2015

sity of Jerusalem, Israel.

Previous work by this group has shown that high energy breakfast with low energy dinner (the B diet) reduced postmeal blood glucose spikes (postprandial glycaemia) in obese non-diabetic individuals, when compared with a low energy breakfast and high energy dinner diet (the D diet). This new randomised study included 18 individuals (eight men, 10 women), with type II diabetes of less than 10 years duration, an age range 30-70 years, body mass index (BMI) 22-35 kg/m2, and treated with metformin and/or dietary

advice (eight patients with diet alone and 10 with diet and metformin). Patients were randomised to either the B diet or the D diet daily for one week.

The B diet contained 2946 kilojoule (kj) breakfast, 2523 kj lunch, and 858kj dinner. The D diet contained the same total energy but arranged differently: 858 kj breakfast, 2523 kj lunch, and 2946 kj dinner. The larger of the two meals included milk, tuna, a granola bar, scrambled egg, yoghurt and cereal, while the smaller meal contained sliced turkey breast, mozzarella, salad and coffee.

Breakfast was taken at 0800H AM, lunch at 1300H PM, and dinner at 1900H PM. Patients consumed their diets at home for six days before the sampling day. On the 7th day (sampling day), each group consumed their assigned meal plan in the clinic, and blood samples were collected just before breakfast (0 min) and at 15, 30, 60, 90, 120, 150 and 180 min after eating commenced. Post-meal levels of glucose were measured in each participant, as well as levels of insulin, c-peptide, and glucagonlike-peptide 1 hormone. Two weeks later, patients were

crossed over to the other diet plan, and the tests repeated.

The results showed that post-meal glucose levels were 20 per cent lower and levels of insulin, C-peptide and GLP-1 were 20 per cent higher in participants on the B diet compared with the D diet. Despite the diets containing the same total energy and same calories during lunch, lunch in the B diet resulted in lower blood glucose (by 21â&#x20AC;&#x201C;25 per cent) and higher insulin (by 23 per cent) compared with the lunch in the D diet.

EP News Bureau-Mumbai

PHARMA ALLY VENDOR NEWS

TUVRheinland India appoints Thomas Fuhrmann as CEO and MD Fuhrmann has been associated with TÜV Rheinland Group for the past 18 years TÜV RHEINLAND India, a subsidiary of the Germany based TÜV Rheinland Group, a leader in testing, training, inspection, consulting and certification, has announced the appointment of Thomas Fuhrmann as its Chief Executive Officer and Managing Director. In his new position, Fuhrmann will lead the management team in consolidating current operations of TUV Rheinland India and oversee speedy growth and expansion in the Indian market.

Fuhrmann has been associated with TÜV Rheinland Group for the past 18 years.

Prior to taking on his current position, Thomas Fuhrmann was based in China, where he had been serving as the Director Industrial Services of TÜV Rheinland Group Greater

China and Asia Pacific. In this role, Fuhrmann was mainly responsible for the business development of industrial services as environmental and energy efficiency service, renewable energy service, material testing service, pressure equipment safety, elevator, conveyor, and machinery technology testing, explosion-protection equipment testing, functional safety service and supply chain service in Greater China and AsiaPacific.

Fuhrmann brings with him more than three decades of rich and diverse international experience in the energy efficiency industry as well as from the manufacturing industry. In his earlier assignments, he has served in various senior managerial and top leadership roles not only in TÜV Rheinland

Group but also in other companies spread across boundaries.

Fuhrmann said, “It’s been a very warm welcome for me in India and looking forward to work with the team. I strongly believe that India is a very diverse and potential market; in fact we have invested more than ` 100 crores in the past

three years and will continue to do so. With the new government in place, which is taking numerous initiatives to boost the manufacturing and energy sector, I feel we can make a significant contribution towards the industry.”

"We are delighted to have Thomas Fuhrmann as our new Chief Executive Offiecr and Managing Director. As a technical inspection company, we need leaders with excellent technical expertise as well as managerial capability and Fuhrmann brings in his vast international experience with him. We are confident that his unique blend of skills will play a critical part in the growth and sustainability of our organisation," said M Bhaskar, Director, TÜV Rheinland India.

EP News Bureau-Mumbai

Signet partners with Galactic Partnership will help its customers respond to the growing needs of the pharmaceutical industry for safe and cost-effective products SIGNET CHEMICAL Corporation has extended its distribution channel through a new partnership with Galactic for their product range of lactic acid and lactates. This partnership will exemplify the commitment of the two companies to help its customers respond to the growing needs of the pharmaceutical industry for safe and cost-effective products.

Galactic, headquartered in Belgium is a leader in pharmaceuticals, healthcare applica-

The new partnership is for the distribution of Signet’s product range of lactic acis and lactates

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tions and biotechnology and Signet is the leading excipient distributor in India.

“A diverse application range of products in mineral fortification, electrolyte replenishment, antacid category etc. pooled with an efficient and renowned partner, Signet, will help us leverage our position in the Indian pharma industry. We are confident of a long term growth and partnership with this esteemed organisation” said Wang Feng, Regional Sales Manager,

Galactic.

Harish Shah, Managing Director, Signet commented on this new tie-up saying, “We are looking forward to this vibrant partnership with Galactic which will enhance our existing product portfolio with their niche application. With a constant focus on enhancing the quality, performance and value of their products, Galactic can be perceived as a steadfast partner in the industry.”

EP News Bureau-Mumbai

Excel Gas & Equipments receives contracts EXCEL GAS & Equipments, India’s leading project management company that operates in the field of gas piping installation for all research laboratories has recently received huge contracts from IOCL, Novartis, GVK Bioscience, Syngenta and Indian Institute of Science Education & Research.

Located at Mahape, Navi Mumbai, Excel Gas and Equipments from the last 13 years of its inception, has now turned out to become one of the leaders and major players in turnkey installation of gas handling systems.

Besides, their operations are not just spread across India, but they have expanded their wings in the Middle East market.

Catering to the requirements of over 15 major industrial sectors and while talking about the pharmaceutical industry in particular, the company has got the opportunities to execute projects of most of the multinational companies as well. In the pharma industry, the company has executed projects from concept to commissioning for major players like Cipla, Dr Reddy’s, Biocon, Novartis, Mylan, Pfizer, GVK, Syngenta, Hikal and many more.

After successful completion of over 400 plus projects spread all over India and in the Middle East, Excel Gas and Equipments is the single point solution for design, procurement, installation and ensuring continued performance of gas handling systems.

Elaborating on the contract work, Nitin Godse, Managing Director, Excel Gas & Equipments said, “The contract includes understanding client requirement, design, procurement, installation and of gas handling systems.”

EP News Bureau-Mumbai

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Q A &

PHARMA ALLY

WITH SCHOTT GLASS INDIA

TiGenix,Lonza pact To manufacture stem cell-based treatment of complex perianal fistulas in crohn’s disease LONZA AND TiGenix entered into an agreement for the supply of TiGenix’s eASC product, Cx601. Under the agreement, Lonza will manufacture material for the phase III trial of Cx601 in the US at Lonza’s cell therapy production facility in Walkersville, Maryland.

Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn’s disease patients, currently in phase III of clinical development in

Europe.

Following the positive feedback received at a meeting with the Centre for Biologics Evaluation and Research within the US Food and Drug Administration (FDA), TiGenix is moving ahead with the development of Cx601 for the US market. To supply Cx601 for a phase III trial in the US, and potentially for the US market when the product has been fully approved, TiGenix has chosen to partner with Lonza as its contract manufacturing organisation (CMO).

TiGenix will begin the process of technology transfer to Lonza in the coming weeks.

In December 2014, TiGenix submitted to the FDA the required documentation for a Special Protocol Assessment (SPA) of its pivotal phase III trial design for Cx601 in the treatment of complex perianal fistulas in patients with Crohn’s disease in the US. Agreement with the FDA on the SPA will ensure that the trial design is aligned with the FDA’s requirements for the future approval of Cx601.

EP News Bureau-Mumbai

Q

Is glass permeable against gases and water vapour?

A

Glass has been in use for pharmaceutical packaging since decades. It was always first choice not least for its inertness, its transparency and its impermeability. Due to the dense structure of the glass gases and water vapour are not capable of migrating through the glass. There has been a study on ampoules with OPC that showed that even if there is a cut in the constriction of the ampoule not even helium gas (which is much smaller than oxygen and water vapour) can migrate inside the ampoule.

This is important especially when it comes to biological products which often are oxygen and or water vapour sensitive and would be degraded.

Q

Does glass contain any organic substances, like BSE or Pthalates?

PRODUCT

Aptar Stelmi unveils PremiumCoat APTAR STELMI has introduced a novel range of coated stoppers called PremiumCoat, designed for the protection of sensitive and highvalue drugs, including biopharmaceuticals.

Sensitive and high-value injectables encompass complex and potent drugs manufactured by chemical synthesis and biological agents engineered in a living system such as a microorganism, plant or animal cell. They include cytotoxic drugs used in cancer therapies, novel vaccines, blood derivatives, hormones and many compounds used to treat auto-immune diseases, including monoclonal antibodies.

The market for biologics represents 20 per cent of the global drug market with growth at a CAGR of 10 per cent in 2010-2015, twice that

42 EXPRESS PHARMA March 1-15, 2015

of the global drug market.

Sensitive and high-value injectables are fragile by nature. Therefore maintaining the integrity of the container closure while minimising interaction between the drug compound(s) and the component constituents is a challenge. Conventional elastomeric closure systems may not be an optimal solution for these fragile drugs.

PremiumCoat is a novel range of elastomeric stoppers developed by Aptar Stelmi. The surface of the elastomer is coated during

manufacturing with a thin fluoropolymer film. This coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer and contaminate the drug. As a result, compatibility of the drug and the closure is significantly superior with PremiumCoat stoppers.

Contact details Anne Bailly, Product Communication Manager Tel.: + 33 (0)1 48 63 56 71 E-mail: anne.bailly@aptar.com

A

Certain organic materials can interact with the drugs or alter the inner surface of the glass packaging. In some case e.g. the meniscus of the solution would appear more flat than without any organic materials. These particular containers are then rejected in the filling line due to improper filling even if they are properly filled. BSE bears the risk for the Creutzfeld-Jakob disease. These are only a few of the reasons why this information is requested by regulatories. For the production of glass temperatures of around 1600°C are needed. At this temperature all organic substances like BSE, Pthalates and others are decomposed. Also bacteria and other living organisms cannot survive these temperatures. When the tubing comes out of the melting tank it is absolutely pure and clean and free of any organic material.

(To feature in this column, email your queries to Dr Bettine Boltres , SCHOTT AG: bettine.boltres@schott.com)

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PHARMA LIFE PROFILE

SL NASA:

HOSPITAL PHARMACIST PAR EXCELLENCE For more than six decades, Sham Lal Nasa has borne witness to many changes in India's pharmaceutical industry and pharmacy education, but feels a lot more needs to be done

By Usha Sharma

O

ne of the founder members of the Indian Pharmacy Graduates’ Association (IPGA) and Indian Hospital Pharmacists Association, Sham Lal Nasa has contributed in no small measure to the present day stature of India's pharmaceutical industry. By helping to shape pharmacy education policy, he has tried to ensure that academia keeps pace with industry needs.

Born in December 1935 in Jhallari village, in present day Pakistan, he recalls moving to and settling in India post partition along with family members.

His father Atma Ram Nasa wanted him to join the medical profession and hence he enrolled in the Government Medical College Amritsar in 1953. Two years later, on receiving a diploma in pharmacy, he started his career as a hospital pharmacist in Lady Hardinge Hospital (Kalawati

Saran Children Hospital) and three years later, followed this up with a similar position in Safdarjang Hospital from 1958 to 1964.

There was no looking back.

He decided to delve deeper into the pharmacy profession, by juggling both job and further studies in order to enhance his capabilities with a B Pharma from Delhi University. Expressing gratitude to his role model he says, “My role model is Dr BD Miglani, under whom I started my career as a hospital pharmacist in Lady Harding Hospital and later Safdarjang Hospital. He became a real eye opener for me in each and every sphere.” Besides Miglani, SL Nasa also counts Dr GK Naraynan, Principal, College of Pharmacy and Dr JS Qadry, Principal, Jamia Hamdard as strong motivational forces in his professional journey.

In turn, SL Nasa has passed

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on his respect for the pharmacy profession to the next generation, with both his children deciding to follow in his path. Ever the proud father, he shares that his son, Sandeep did an M.Pharm in pharmacognosy and phytochemistry and is currently with JB Chemicals as Head of Exports, posted in Moscow for the last 15 years. His daughter, Monica Madan did an M.Pharm in pharmaceutical chemistry and worked as a scientist in the R&D department of Ranbaxy Laboratories, Gurgaon before she decided to focus on her family. His wife Sneh Prabha was a librarian in the Pusa Polytechnic, New Delhi before she retired.

Looking back Recalling the evolution of the pharma industry in India, he says , “After a long period of a negative balance of trade in

pharma products, India started enjoying a positive balance of trade from the late ‘80's. By the late ‘90's the pharma industry of India had reached a position of near self-sufficiency in formulations. In terms of production volume, India today accounts for eight per cent of world’s pharma production and is the fifth largest country in the world after the US, Japan, Europe and China.”

In terms of manufacturing facilities too, he underlines the growth trajectory saying, “The number of pharma manufacturers increased from a mere 200 in 1950-1951 to more than 6000 in the ‘80's, which reached a phenomenal figure of 23,790 in 199899. Of this, a sizable percentage of firms belong to the small-scale sector. It is estimated that out of the 28.6 million strong workforce employed in the pharma sector, about 4.6 million are employed in

organised units while the rest are engaged in the distribution and ancillary segments.”

This characteristic of the pharma industry in India has strategic importance, because as he says, “These units produce drugs that are not under patent protection and are analogous to products that are already present in the market. Hence competition is severe among pharma units in India, which is one of the important reasons for the relatively lower prices of medicines in India. At present there are around 16000 manufacturing units in the country of which 300 are in the organised sector.”

Another parameter to gauge the success of any industry is volume of exports. As he points out, “The export value of the pharma sector is today approx. ` 56000 crores while at the time the country achieved independence, the country was importing

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March 1-15, 2015

PHARMA LIFE pharma products. Today, the country exports to many developed countries; indeed exports to the US alone stand at $ 4.23 billion.”

SL Nasa is clear that this growth of the Indian pharma industry prior to the new intellectual property regime was due to a favourable patent policy, i.e. the Patent Act, 1970 which provided ample opportunities for the growth of domestic pharma companies.

His contribution lies is helping to shape the pharmacy education policy in India. Recalling a pivotal milestone, he says, “We wanted to amend the Pharmacy Act, 1948 and we were able to press the Pharmacy Council of India (PCI) to introduce the 12th grade as a minimum qualification to enter pharmacy courses leading to the framing of ER-91

by PCI.”

Way forward Like any other industry, the pharma sector too has many challenges which require strategic shifts. The amendment of the Drugs & Cosmetics Act, 1940 tops his wishlist of changes which he would like to see in the pharma sector as he believes that there are certain loop holes in the Act when it was notified in

1940. There were only a handful of pharmacy colleges offering diploma-level courses and very few degree colleges offering graduate level pharmacist qualifications. However the situation today is vastly different, with more than 40,000 D.Pharm and 50,000 graduates in pharmacy.

Hence he opines that rule 71 & 76 of the Drugs & Cosmetic Act should be omitted and a B.Sc. qualification should be replaced with a B.Pharm qualification as the minimum requirement In the same vein, he opines that a B.Pharm should be made a minimum qualification for registration as a pharmacist. Last December, the PCI released a notification in the official gazette that stating that D Pharm students can undergo a two year B.Pharm practice course so that they can be at par with the B.Pharm students. In this way D.Pharm students too will be trained to offer patient counseling on drug–drug and drug–food interactions which is vital from a patient safety perspective.

His third suggestion is that pharmacy education should be under the sole purview of the PCI rather than the present scenario where it is divided into many parts: i.e. undergraduate pharmacy courses are under

ROLL OF HONOUR ◗ 1990: Best Pharmacist

by Railway Pharmacists Association ◗ 1993: .LSchroff Memorial National Award

by IHPA ◗ 1994: Best Teacher Award in Pharmacy by the Govt. of Delhi ◗ 1998: Best Pharmacist Award by C.G.H.S. Pharmacists Association ◗ 1988: Fellowship Award

by Institute of Chemists ◗ 2003: Fellowship Award

by Indian Pharmaceutical Association (IPA) ◗ 2009: Life Time Achievement Award from the Indian Hospital Pharmacists Association, UP State Branch : Best alumni award by the College of Pharmacy (DIPSAR), Delhi

the AICTE, where as higher education and research is under the Ministry of Chemical and Fertilisers i.e. NIPERs in our country.

Many miles to go Presently, Nasa serves as a registrar of Delhi Pharmacy Council.

Beside this he is an Ambasador of the Indian Pharmacopoeia Commission, one of the Directors of the Indian Confederation of Health Accreditation, President of the Indian Hospital Pharmacists Association, Executive Member of APTI, a Visiting Professor at DIPSAR and Jamia Hamdard, an advisor of IPGA, Inspector at the PCI and also looks after various activities of these professional associations as their advisor. As if this were not enough, he also lectures and presents papers at national and international level meets and seminars. He also finds time to guide M.Pharm students of hospital pharmacy in DIPSAR. He was also President of the Indian Pharmaceutical Congress (2010).

Unveiling his likes and hobbies Nasa reveals that he loves to travel and counts Moscow, Pittsburg, Switzerland, Thailand, Bangkok, Lisbon, Italy, and France as memorable mile-

stones in his globe-trotting avatar. Playing badminton was a hobby in his younger days while today he counts reading books and watching movies as his key leisure time activities.

He is the managing trustee of Hospital Pharmacy Foundation, Managing Trustee of Delhi Pharmacy Council, Regd. Pharmacists Welfare Trust & Trustee of IPGA Welfare Trust. He is Advisor for various journals viz IPGA TODAY, Indian Pharmacist, Pharma Review, and Pharma Paramarsh, & Associate Editor of Indian Journal of Hospital Pharmacy since 1964. He got him self commissioned in the National Cadet Corp. from NCC Officer’s School Kamtee (Nagpur) and he served as NCC officer for more than two decade in College of Pharmacy.

While signing off, he exhorts young and upcoming pharma professionals “To work in unity, to raise the standards of pharmacy profession advising pharmacists to look after patient safety by patient counseling and more interaction with patients in order to guide them on administration of proper dosage form at appropriate times, as prescribed by the doctors.” u.sharma@expressindia.com

AWARD

Glenmark’s facilities bags award Greentech Environment Gold Award – 2015 conferred to Goa and Nashik facilities for their commitment to environmental management across different sectors TWO MANUFACTURING facilities of Glenmark located in Goa and Nashik, India bagged the prestigious ‘Greentech Environment Gold Award – 2015 for Excellence in Environment Management at a ceremony in Kolkata recently. Greentech Environment Awards are presented every year to companies/units in India demonstrating the highest level of commitment to environmental management across different

56 EXPRESS PHARMA March 1-15, 2015

sectors.

“The coveted Gold Accolade from Greentech Foundation is a testament of our commitment towards Environment Protection. At our Goa and Nashik plants we have taken a number of steps in conserving natural resources, preventing pollution and minimising environmental impact which has resulted into this award,” said Cheryl Pinto, Director Corporate Affairs – Glenmark.

Greentech Foundation, established in the year 2000 and based at New Delhi, is a nonprofit organisation committed to recognise and celebrate ethos of outstanding performance in Environment Protection, Fire andSafety, HR and CSR. Glenmark’s manufacturing facility in Goa manufactures oral solids, semi solids and hormones. It is approved by regulatory bodies like US FDA, TPD (Canada), MCC (South Africa),

Cheryl Pinto, Director Corporate Affairs – Glenmark

WHO-GMP, ANVISA (Brazil) and MHRA (UK).

The Nashik facility which began operations in the year 1983 is Glenmark’s first manufacturing facility. Today the facility manufactures more than 200

products catering to the bulk of the demand for solid orals, liquid orals, and external creams and powders in over 70 markets in Asia [including India], Africa, CIS/Russia and Latin America.

EP News Bureau-Mumbai

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.