Express Pharma (Vol.10, No.21) September 1-15, 2015

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Management Online pharmacies: Revolution in the making?

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CONTENTS MARKET Vol.10 No.21 SEPTEMBER 1-15, 2015

10

Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru 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

SOFTWARE SOLUTIONS: TRANSFORMING PHARMA Software is one of the most crucial Information Technology (IT)enabled services that the Indian pharma industry heavily relies on to improve and enhance its day-to-day operations | P34

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P16: PRE EVENT Pharma Tech Expo 2015 to be held in Indore

P36: VALUE ADD Sakar Healthcare: Getting technorich with lyophiliser

Scheduling & Coordination Mitesh Manjrekar

P40: VENDOR NEWS

CIRCULATION Circulation Team Mohan Varadkar

Perlen Packaging extends European coating capacity

11

NOVARTIS ACQUIRES FULL RIGHTS TO GSK’S OFATUMUMAB

12

YOGA CROSSES OVER FROM AYUSH TO DEPARTMENT OF SCIENCE

13

MYRIAD GENETICS PARTNERS WITH POSITIVE BIOSCIENCE

16

HYDERABAD TO HOST ANALYTICA ANACON INDIA, INDIA LAB EXPO

MANAGEMENT

RESEARCH

31

ASPIRIN LOWERS RISK OF CANCER IN OVERWEIGHT PEOPLE: STUDY

32

US FDA APPROVES ‘FEMALE VIAGRA’ WITH STRONG WARNING

P17: POST EVENT OPPI concludes 4th Healthcare Access Summit in Mumbai

GOVT LIKELY TO SET UP THINK TANK TO SOLVE PHARMA SECTOR ISSUES

26

ONLINE PHARMACIES: REVOLUTION IN THE MAKING?

PHARMA LIFE

66

DR SHIVANG SWAMINARAYAN NOMINATED AS MEMBER OF CCRH, MINISTRY OF AYUSH, GOI

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2015. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Mylan’s One Quality Standard a long way off

L

ike any highly competitive sector, most employees in the pharma industry in India are chained to key performance indicators but there is growing realisation that KPIs should make way for KBIs: key behavioural indicators. Mylan Laboratories’ August 6 warning letter (WL) from the US FDA, concerning inspections at three of its sites in Bengaluru, paint a picture of a work force unaware or unmindful of how they are expected to execute cGMP or ISO 5/6 procedures. Worse, the WL notes that some of these violations also featured in previous WLs over a period of almost two years, leading the US FDA to conclude that they were ‘recurrent and long-standing.’

The US FDA accepted that the three sites haven't been with Mylan long: they were acquired by the US-based MNC as the Agila Specialities injectables subsidiary from Strides Arcolab in December 2013.

But they also point out that Mylan was well aware of these violations when it acquired them. A change in ownership does not appear to have made too much of a difference, in spite of Mylan CEO Heather Bresch’s claim that they “have been taking extensive action to integrate the Agila business into Mylan’s One Quality Standard, and to ensure our leading position as a high quality, reliable source of injectables for the long term... We have been and will continue to work diligently to address all of the FDA’s observations and have made important progress."

Clearly, the US FDA remains unimpressed.

For example, at the first site, referred to as ‘Mylan Laboratories Limited, Onco Therapies Limited (OTL)’, the inspectors observed operators using torn gloves and frayed/torn gowns in the aseptic filling areas, during critical interventions, noting that these are a ‘direct risk to product sterility.’

Some cGMP violation practices noted in the US FDA’s WL dated September 9, 2013 reappear in the most recent WL. For instance, both letters mention inadequacy in process simulation (media fill practices and procedures) studies, environmental monitoring systems, controls of computer-based master production and control records at the second site, referred to as the Agila Specialities’ formulation

Some industry observers are surprised that ‘significant violations’of this nature have not warranted an import alert or ban.Is the US regulator giving the Mylan management the benefit of doubt?

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September 1-15, 2015

facility. The US FDA thus concludes that ‘several violations are recurrent and long-standing.’

Similarly, commenting on observations at the third facility, the Agila Specialities sterile products division, the WL says that a previous investigation into discoloration was ‘inadequate’, and that ‘enhanced detection (of discoloration) on its own does not resolve the root cause of the problem.’

The agency’s comments on operator movements are also damning from a GMP point of view.

Operators involved in the set-up and filling of batches were not ‘slow and deliberate …(Inspectors) often saw operators bump into each other during filling operations.’ Once again, this seems to be a recurrent problem as the August 2015 WL mentions that the firm was previously cited for ‘inadequate ISO 5 behaviours and procedures during the August 2013 inspection.’

Some industry observers are surprised that ‘significant violations’ of this nature have not warranted an import alert or ban. Is the US regulator giving the Mylan management the benefit of doubt?

To be fair, Mylan has voluntarily recalled batches from the OTL facility in March and April this year, when ‘foreign particulate matter’ were discovered in certain products. This was part of a product quality assessment protocol conducted in response to the previous US FDA inspection. But it is telling that this manufacturing issue was not completely sorted out even by June and the recall had to be expanded to some more lots.

Mylan CEO Bresch has often been quoted as a staunch supporter of increased regulatory scrutiny, and was in fact one of the key advocates of The Generic Drug User Fee Act of 2012, under which pharma companies would fund US FDA inspections of overseas plants exporting to the US market.

Her bet that regulatory compliance is Mylan’s differentiator could take some more time to play out in the India market. But if, nay, when it happens, it would make for an interesting case study, one that will help rebuild India’s reputation in the pharma fraternity in the long term.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

+91-22-6139-4444

1-800-266-1244 response@coleparmer.in

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MARKET COMPANY WATCH

Govt likely to set up think tank to solve pharma sector issues The think tank likely to be set up within the next two months THE COMMERCE Ministry intends to set up a think tank comprising CEOs of pharma companies, scientists, researchers and government officials to resolve issues arising both globally and domestically. The think tank, likely to be set up within the next two months, will have members identified from AYUSH, biotechnology, clinical research and from large, mid and small pharma companies. The move comes after India protested the ban of over 700 drugs of GVK Biosciences and postponed the scheduled talks on FTA with the EU. A meeting, headed by Nirmala Sitharaman, Commerce and Industry Minister in New Delhi recently, was attended by senior officials from ministries of health, pharma, and industry representatives,

to discuss the issues in the pharma sector, which saw exports worth $15.4 billion in 2014-15. It was decided to set up a platform to ‘identify bottle necks and resolve various issues for overcoming challenges and promoting hassle free trade.’

The meeting was led by Sudhanshu Pandey, Joint Secretary, Department of Commerce – Ministry of commerce and Industry and was attended by all concerned agencies of the Government of India, primarily related to the pharma sector. Dr Surinder Singh, DCG(I), KL Sharma, Joint Secretary, Ministry of Health and Family Welfare, Dr TS Rao, Additional Adviser, Department of Biotechnology, Dr M Ariz AhammedJoint Secretary, Department of Commerce, Dr S Eswara

Reddy, Joint Drugs Controller (India), Central Drugs Standard Control Organisation and Lanka Srinivas, International Pharma Consultant and Senior Adviser – Pharmexcil were also present.

In the meeting, the industry representatives said that

given the complexity of issues in the sector, there is a need for convergence among policies and programme of different departments.

“Since the scientific breakthroughs in chemistry, biology, microbiology, physics and biotechnology impact development of this sector directly or indirectly, it is important to have a platform where all these developments are shared between academia, industry and scientific community for the larger benefit of the society,” an official statement said.

The government has maintained that pharma industry is one of the flagship sectors of India and a think tank would help in pointing out the hurdles and overcoming challenges in the sector.

Commenting on the

meeting, Dr PV Appaji, Director General, Pharmexcil said, “We are happy with the initiative taken by the Ministry of Commerce and Industry under the chairmanship of Nirmala Sitharaman. Pharmexcil will give its full support in providing necessary information to the government required for the formation of the think tank and its objectives.”

While revealing the impact of the initiative on the pharma industry, Appaji said, “The think tank will allow experts from various segments related to the pharma sector help in bringing investments for the pharma sector in India.

Primarily, it will help in accelerating the growth of Indian pharma export.”

(With inputs from Usha Sharma)

PM nod for proposal to fortify drug regulatory system Strengthening/up-gradation of the system will be spread over a period of three years, both at the central and the state levels at a total cost of `1750 crores THE CABINET Committee on Economic Affairs, chaired by the Prime Minister Narendra Modi, has approved the proposal for strengthening the drug regulatory system both at the central and the state levels at a total cost of `1750 crores.

The strengthening/up-gradation of the system will be spread over a period of three years.

Out of the total amount of `1750 crores, an amount of `900 crores will be spent on

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EXPRESS PHARMA

September 1-15, 2015

strengthening central structures and `850 crores will be made available to the state governments, after signing a Memorandum of Understanding.

A report in PIB states that the upgradation will include provision of additional equipment and manpower in existing drug testing laboratories, setting up of new laboratories for testing drugs, medical devices and cosmetics, making mobile drug testing laboratories avail-

able, creation of additional manpower for regulatory structures, including for new and emerging areas such as stem cell, regenerative medicine, biologicals and medical devices in addition to drugs. The upgradation will also introduce organisation wide e-Governance and information technology-enabled/online services, and setting up a training academy for regulatory and drug testing officials, of both the central and

state governments.

Assistance will be provided to the states for strengthening their drug regulatory structures. The measure will help enhance quality, safety and efficacy of drugs and other medical products manufactured in the country, and thereby help mitigate the disease burden as also increase export of pharma products from India. Besides, it will also help trigger growth of the do-

mestic medical devices sector.

The implementation of the scheme is expected to facilitate domestic manufacture of quality medical products and help establish a robust industry in the field of medical devices, biologicals and other areas. The common training programmes for regulatory and laboratory staff will also help in evolving uniform practices throughout the country.

EP News Bureau-Mumbai

Novartis acquires full rights to GSK’s Ofatumumab Novartis will make an initial payment of $300 million to GSK for the acquisition of the compound NOVARTIS HAS entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra.

“Novartis is pleased to further reinforce our commitment to neuroscience and to add an exciting new treatment to our strong MS portfolio,” said David Epstein, Head of Novartis Pharmaceuticals. “Our vision for patients with MS is to develop treatments that improve on current standards of care, meeting patients’ needs at every stage of their disease with innovative and targeted drugs.”

Novartis will be responsible for the worldwide development, regulatory and commercialisation activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300 million to GSK for the acquisition of the compound and a further payment of $200 million payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534 million may be made. Novartis will also pay royalties of up to 12 per cent to GSK on any future net sales of Ofatumumab in auto-immune conditions.

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EP News Bureau-Mumbai

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September 1-15, 2015

MARKET

Yoga crosses over from US FDA issues AYUSH to Department warning letter to Mylan of Science Department of Science and Technology to fund research on impact of yoga.

IN FURTHER proof of the growing importance of yoga under the NDA government, the Department of Science and Technology (DST) has decided to fund research on the impact of yoga and meditation on human health — the first time the department has ventured into this area.

Research and studies on yoga have so far remained within the domain of AYUSH, a government department whose mandate is to promote traditional medicine, including ayurveda, unani and homeopathy.

Now, in tune with the government’s efforts to promote yoga internationally, the DST has called for research proposals from “scientists/academicians with prior research experience in yoga and meditation”.

“Yoga is already an international movement, and it has been adopted even by the United Nations. So, there is nothing unusual if the DST makes efforts in promoting research in yoga. We have already seen how popular yoga is,” Science and Technology Minister Harsh Vardhan told The Indian Express.

“The science and technology department funds a lot of high-end research in medicinal sciences and we have had good results. The decision to fund research in yoga and meditation should also be seen in this light.

The scientific advantages of practicing yoga are very well established,” he said.

The new research programme will be part of a longrunning Cognitive Science Research Initiative of the DST. “This programme is aimed at research on the effects of

12

EXPRESS PHARMA

September 1-15, 2015

Several premier medical institutions, including AIIMS and NIMHANS, have ongoing research programmes on yoga

yoga and meditation on mental health and cognitive functioning in healthy people as well as in patients with disorders,” the DST said in its call for proposals.

“Cognitive science as an interdisciplinary endeavour that interfaces with psychology, neuroscience, medicine, computer science and philosophy is well placed to address the different aspects of yoga and mediation research. An interdisciplinary approach based on cognitive science is needed to integrate different disciplines,

approaches and methods engaged in the study of yoga and meditation. The research on yoga and meditation would also help in solving fundamental problems in cognitive science,” it said.

It was not immediately clear how many research proposals the department would fund, or the amount of money it had kept for this purpose.

A number of premier medical institutions, including AIIMS in New Delhi and NIMHANS in Bengaluru, have ongoing research programmes on yoga.

The Central Council for Research in Yoga and Naturopathy, an autonomous organisation under AYUSH, is one of the nodal points for promoting research in this area. Delhibased Morarji Desai National Institute of Yoga, which is fully funded by AYUSH, offers degree and diploma courses in yoga, and also claims to conduct fundamental as well as clinical research related to yoga.

Even the Indian Institute of Science in Bengaluru runs a yoga and biomechanic laboratory. S N Omkar, one of the lead scientists at the laboratory, welcomed the DST move.

“Irrespective of which agency supports the research, there is a very important need to promote more research in yoga. Many other countries are also realising the benefits of yoga and promoting research.

The United States has been supporting several research projects on yoga. We must not be left behind,” he said.

(The story has been filed by Amitabh Sinha from New Delhi)

Inspectors found ‘significant violations’ in its three manufacturing facilities in Bengaluru THE US Food & Drug Administration (US FDA) has issued a warning letter to Mylan Laboratories for violation of current good manufacturing practice (CGMP) norms at its three plants in Karnataka.

According to a PTI report, the US regulator said its inspectors found ‘significant violations’ in the three manufacturing facilities in Bengaluru of the company, which is an arm of US-based Mylan.

Of the three units, two plants belonged to Agila Specialties, which Mylan had acquired from Strides

Of the three units, two belonged to Agila Specialties.

Mylan had acquired them in 2013 from Strides Arcolab Arcolab in 2013. The other unit is owned by Mylan Laboratories.

WARNING LETTER TO HAVE NO MATERIAL IMPACT ON MYLAN BUSINESS: CEO COMMENTING on a warning letter issued by the US Food and Drug Administration (FDA) on, relating to its Agila Specialty Formulation Facility (SFF), Sterile Product Division (SPD), and Onco Therapies Limited (OTL) sites in India, Heather Bresch, Chief Executive Officer, Mylan, said,“Since Mylan acquired the Agila injectables businesses in December 2013 to create a leading global injectables platform, we have been taking extensive action to integrate the Agila business into Mylan’s one quality standard, and to ensure our leading position as a high quality, reliable source of injectables for

the long term.”

Emphasising that this agency action has no material impact on Mylan’s business or its previously announced full year earnings guidance, the company quoted Bresch,“As part of this ongoing process, we have a deep and unwavering commitment to quality everywhere we operate.We have been and will continue to work diligently to address all of the FDA’s observations and have made important progress.”

This action follows inspections of the three sites by FDA in 2014 and February 2015, which the company has disclosed previously.

MARKET

Myriad Genetics partners with Positive Bioscience To offer molecular genetic testing in India US-BASED Myriad Genetics has signed a strategic partnership with Positive Bioscience to offer molecular genomic testing in India. These tests will help screen for cancer risks and enable families of cancer patients to take various preventive measures. All testing will be carried out at Myriad’s labs in the US and Germany.

Through this partnership, Positive Bioscience will provide molecular genetic testing for cancer patients and their families. The tests will provide physicians with information to personalise treatment for their cancer patients. Genomic tests are available for nine cancers: breast, pancreatic, ovarian, endometrial, melanoma, prostate, colon, lung and gastric.

Gary King, Executive VicePresident, International Operations, Myriad Genetics said, “We are pleased with our strategic partnership with Positive Bioscience through which Myriad can bring our 25 years of experience in clinical genetic testing to India. Indian patients can now access world leading tests such as BRACAnalysis to identify the risk of developing breast and ovarian cancer, colaris for hereditary colorectal cancer and the myRisk test, which assesses the risk of developing eight cancers.

Our prognostic tests such as EndoPredict for breast cancer and Prolaris for prostate cancer will help to avoid both the over treatment and under-treatment of patients and personalise patient care while reducing the economic burden of treatment.

We intend to work closely with Positive Bioscience to make these tests available to Indian clinicians and patients.”

Samarth Jain, Chief Executive Officer, Positive Bioscience said, “Positive Bioscience is pleased to work with Myriad to offer molecular genetic testing in India. These tests will help patients by providing insights into potential healthcare challenges they may encounter and improve the quality of their lives.”

EP News Bureau-Mumbai

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EXPRESS PHARMA

13

September 1-15, 2015

MARKET GROWTH TRACKER

IPM clocks ` 8328 crores in July 2015 Nine therapies have outgrown the IPM growth

WITH BONUS UNITS AT FULL VALUE Val in Crs CORPORATE

THE INDIAN Pharmaceutical Market clocked ` 8328 crores in July 2015. It has grown at 12.9 per cent in the same month. Amongst the top 10, Lupin grew by 25.1 per cent followed by Sun at 21.8 per cent and Pfizer at 17.2 per cent. 19 corporates have crossed the growth of IPM for July 2015 amongst top 50.

Amongst the top 50 corporates, AstraZeneca has the highest growth of 36.1 per cent followed by Bharat Serums at 34.6 per cent and Intas at 32.6 per cent. 25 corporates have shown growths more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporate Intas has the highest growth of 32.6 per cent followed by Glenmark at 30.9 per cent and USV at 21.7 per cent.

Amongst the 21-30 ranked corporates, MSD has the highest growth at 30.6 per cent followed by Wockhardt 30.2 per cent and Novartis at 14.1 per cent. Amongst the 31-40 ranked corporates, AstraZeneca has the highest growth at 36.1 per cent followed by Bharat Serums at 34.6 per cent and JBCPL at 22.8 per cent. Amongst the 4150 ranked corporates, Wallace has the highest growth at 17.8 per cent followed by WinMedicare at 9.8 per cent and Fourrts at 9.3 per cent.

Amongst the 51-60 ranked corporates, Boehringer grew at 84 per cent followed by Troikaa at 35.4 per cent and Eli Lilly at 32.3 per cent. Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 60.6 per cent followed by RPG at by 34.3 per cent followed by TTK at 21.6 per cent. Intas moves to number 11 and Novartis to number 21, Eris to 29th , Hetero to 40th rank in the IPM as on MAT July 2015. DRL has crossed the ` 2000-crore mark with the addition of UCB portfolio that had been acquired.

14

EXPRESS PHARMA

September 1-15, 2015

Rank MAT

MAT July-15

MTH

IPM

Wallace has entered the ` 400crore club on MAT basis.

For the month of July 2015, amongst the top 10, Lupin grew by 25.1 per cent followed

by Sun Pharma at 22.7 per cent and Ranbaxy at 20.4 per cent.

22 companies have crossed the growth of IPM for the month of July 2015 amongst top 50.

Amongst the 21-30 ranked companies, Wockhardt has the highest growth at 30.2 per cent followed by Novo Nordisk 25.5 per cent and Zuventus at 16 per cent.

Indian companies have grown at 12.6 per cent versus 13.8 per cent for MNCs in July 2015. Amongst the top 50 in MNCs, AstraZeneca grew at 36.1 per cent, MSD grew by 30.6 per cent followed by Pfizer at 17.2 per cent. Under the non-NLEM category, Indian companies grew at four per cent whereas MNCs grew at 8.4 per cent.

The DPCO containing molecules market grew at 5.1 per cent whereas the non-DPCO market grew by 14.2 per cent and Non Sch Para 19 Market at 11.8 per cent resulting in an overall growth of 12.9 per cent for July 2015. NLEM & Non - NLEM category showed unit growth at 0.6 per cent and 4.1 per cent respectively. The non-Sch Para 19 Market grew at 9.9 per cent from units perspective The DPCO 2013 portfolio for Pfizer grew at 13 per cent,

Jul-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

91230

100.00

14.5

8328

100.00

12.9

Sun + Ranbaxy

1

1

8199

8.99

15.9

783

9.40

21.8

Abbott + Abbott HC + Novo

2

2

5696

6.24

15.4

522

6.27

16.4

Cipla

3

3

4568

5.01

18.0

387

4.65

11.5

Zydus + Biochem

4

4

3782

4.15

8.9

333

3.99

8.5

Mankind

5

6

3237

3.55

16.0

282

3.39

3.6

Alkem + Cachet + Indchemie

6

7

3178

3.48

12.1

281

3.37

5.4 25.1

Lupin

7

5

3139

3.44

17.6

311

3.73

Glaxo

8

8

3071

3.37

5.4

259

3.10

-1.7

Pfizer

9

10

2735

3.00

19.0

247

2.97

17.2

Macleods

10

11

2654

2.91

23.4

234

2.81

5.2 32.6

Intas

11

9

2463

2.70

20.9

247

2.97

Emcure + Zuventus

12

12

2437

2.67

9.9

222

2.67

11.6

Sanofi India

13

13

2284

2.50

16.7

203

2.43

10.2

Aristo

14

14

2270

2.49

19.0

199

2.38

6.7

Torrent

15

16

2134

2.34

22.7

197

2.36

18.3

Glenmark

16

15

2098

2.30

23.2

197

2.36

30.9

Dr. Reddys

17

17

2094

2.30

15.3

193

2.32

19.0

USV

18

18

1807

1.98

20.3

169

2.03

21.7

Micro + Bal

19

19

1695

1.86

5.4

160

1.92

6.0

Alembic

20

22

1227

1.35

14.9

110

1.33

17.0

MAT July 15

Month July-15

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

91230

14.5

8328

12.9

ANTI-INFECTIVES

14152

10.4

1221

1.6

CARDIAC

11393

14.9

1050

17.1

GASTRO INTESTINAL

10592

16.5

1039

16.2

VITAMINS / MINERALS / NUTRIENTS

8245

13.8

782

12.5

ANTI DIABETIC

7244

26.2

684

25.4

RESPIRATORY

7136

15.5

539

9.6

PAIN / ANALGESICS

6323

12.4

587

9.6

NEURO / CNS

5568

12.9

519

16.0 19.4

DERMA

5364

18.3

497

GYNAECOLOGICAL

4504

9.8

420

10.1

VACCINES

1539

7.1

143

13.0 10.4

HORMONES

1533

10.1

134

ANTI-NEOPLASTICS

1524

17.3

147

19.7

OPHTHAL

1333

17.1

120

12.6

BLOOD RELATED

1029

8.7

99

8.8

OTHERS

995

21.5

103

35.0

UROLOGY

995

25.2

95

18.6

ANTI MALARIALS

546

3.5

46

-8.3

SEX STIMULANTS / REJUVENATORS

493

10.1

41

9.1

STOMATOLOGICALS

383

11.2

35

6.0

OPHTHAL / OTOLOGICALS

228

7.6

19

-2.5

OTOLOGICALS

109

12.5

11

8.1

MARKET Ranbaxy 20.5 per cent, GSK at -2.1 per cent and Abbott Healthcare 7.2 per cent.

From therapy perspective, nine therapies have outgrown the IPM growth. The respiratory market grew at 9.6 per cent, gastrointestinal market grew at 16.2 per cent , pain and analgesics market grew at 9.6 per cent whereas anti-infectives grew at 1.6 per cent.

The anti-diabetic market grows at 25.4 per cent and cardiac at 17.1 per cent in chronic business. The derma market grew by 19.4 per cent and urology market at 18.6 per cent.

From regional perspective, 15 regions have outgrown the IPM growth. The North AP market grew the highest at 21.6 per cent followed by Punjab market at 20.9 per cent and Mumbai City market at 19.6 per cent. No region had negative growth in July 2015.

Amoxycillin + Clavulanic acid market grew at -3.4 per cent whereas glimepiride+met-

per cent, azithromycin at -5.3 per cent, calcium Carbonate + Vit D3 market at 41.4 per cent.

Mixtard leads the pack with ` 42 crores followed by spas-

moproxyvon plus at ` 30 crores and glycomet-GP at ` 28 crores for July 15. phensedyl cough grew by 133.1 per cent followed by corex at 103.1, janu-

met at 93.4 per cent, spasmoproxyvon plus 70.4 per cent, mixtard at 37.4 per cent and glycomet-GP at 18.4 per cent amongst the top 10 brands.

Few brands who have gained ranks include betnesol (+108), Pantocid D SR (+77), Continued on Page 16

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Thermo Scientific Prima PRO process mass spectrometer

formin grows at 15.5 per cent at number two.

The markets of paracetamol grew at 2.2 per cent, atorvastatin 12 per cent, probiotic microbes at 36.7 per cent, cefixime -1.4 per cent, pantoprazole 16.8 per cent, montelukast + levocetrizine at 10.8 per cent, glimepiride + metformin + pioglitazone at 16.4 per cent, vitamin-D at 27.1 per cent, hydroquinone + mometasone + tretinoin at 18.3 per cent, voglibose + metformin + glimepiride at 56.8 per cent, rosuvastatin at 28.2 per cent, protein supplements at 13.9

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MARKET PRE EVENTS

Hyderabad to host analytica Anacon India,India Lab Expo More than 260 exhibitors and 8,500 visitors are likely to attend the event ANALYTICA ANACON India and India Lab Expo 2015, the most important platform for the analysis, laboratory-technology and biotechnology market, will be held in Hyderabad from October 8-10, 2015. More than 260 exhibitors and 8,500 visitors are likely to attend the event. Both the events will cover an entire value chain for industrial and research laboratories. International market leaders as well as local Indian manufacturers will participate in the trade shows.

The exhibition areas for analytica Anacon India are structured in accordance with the value chains for laboratories. It will have equipment for instrumental analysis, chromatography, spectroscopes, microscopy and optical image processing, industrial quality control, material testing, characterisation and properities of materials, quality control in pharmacology and industry, laboratory equipment and machines, laboratory data systems and documentation, laboratory apparatus, chemicals, reagents and consumables,

bioanalysis, biochemicals, bioinformatics, laboratory technology for biotech and life sciences, medicine and diagnostics. analytica Anacon India will address Indian users and decision makers of chemicals and petrochemicals industries, pharma industry, medical and diagnostics industries, environmental protection, electronics and electrical engineering, industrial research and development, public-sector research and development, public author-

Both events will cover the entire value chain for industrial and research laboratories.

International market leaders as well as local Indian manufacturers will participate in the trade shows ities / public facilities / universities / research institutions.

Express Pharma is the media partner for the event.

EP News Bureau-Mumbai

Pharma Tech Expo 2015 to be held in Indore The exhibition will showcase the cutting-edge technologies in industrial exposure in pharmaceutical industry THE THIRD edition of Pharma Tech Expo 2015 will be held at Brilliant Convention Centre Indore, Madhya Pradesh from October 30 to November 1, 2015.

PharmaTechnologyIndex.com, a KNS group company will jointly organise the exhibition with Indian Pharmaceutical Association (IPA).

The exhibition will showcase the cutting-edge technologies in industrial exposure in pharmaceutical industry.

The exhibition will be supported by Associations of Industries Madhya Pradesh, Ayush Drug Manufacturers Association, MP Small Scale Drug Manufacturers’ Association, MP Ayurvedic Medicine Mfg Association, Pithampur Audhyogik Sangathan, MP Pharmaceuticals Manufacturers' Organisation, The Indore Master Printers Association.

Express Pharma is the media partner for the event.

Exhibitor’s profile include processing plant and machineries, packaging materials and machineries, lab equipment, instruments and lab wares, water treatment, waste water treatment and waste management, biotechnology and clinical research organisations, bulk drugs, intermediates and formulations, excipients and additives, R&D, quality, control laboratories, healthcare products - ayurvedic and neutraceutical manufacturers, cosmetic and personal care, IPR standards and patent formulations bodies, environment and pollution control bodies, trade associations, trade promotion bodies, safety equipment and software for pharma industry and management.

EP News Bureau-Mumbai

Continued from Page 15

IPM clocks ` 8328 crores...

Eltroxin (+57), Phensedyl cough (+55), Chymoral Forte (+48), Istamet (+45), Janumet (+42), Jalra M (+41), Budecort & Huminsulin (+36), Pantocid & Omez (+33), Rosuvas (+28), Vertin (+26), Corex & Shelcal (+24), Magnex & Rantac (+22), Jalra (+20), Susten & Betnovate N (+19), Galvus (+17), Ascoril Plus (+16), Betnovate C & Aztor (+15), Levipil (+14),

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September 1-15, 2015

Telma (+12) amongst top 100 brands over July -14. Few brands that have moved up ranks fastest into top 300 brands for the month of July 15 are Biovac V, Brilinta, Oframax, Enteroquinol, Monocef SB, Bevon, Glycomet Trio, Primolut N Uprise D3 amongst others. 300th biggest brand is Livogen from Merck. A total of 291 brands and 545 SKUs were

launched in July 2015. Top new brands for July -15 were Cerebrolysin, Caripill & Kofarest PD. Biggest new launch by an MNC are Anzavir R, Sequadra & Daracept in July 2015.

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.

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

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

MARKET POST EVENT

OPPI concludes 4th Healthcare Access Summit in Mumbai Healthcare Access Award 2015 announced Usha Sharma Mumbai ORGANISATION OF Pharmaceutical Producers of India (OPPI) recently organised its fourth ‘Healthcare Access Summit’ in Mumbai. The daylong event registered key industry stakeholders and policy makers who discussed various measures which needs to be taken in order to improve healthcare access in India.

During the inauguration, Dr VK Subburaj, Secretary, Department of Pharmaceuti-

Hansraj Gangaram Ahir requested the healthcare industry to become self reliable on things which we are dependent to other countries cals spoke about the current state of healthcare scenario in India. He began his address by recalling the evolution of the global and Indian pharma industry and the importance of medicines. He talked about the growing disease burden worldwide, and especially in India. He went on to say, “India is becoming the capital for CVD, diabetes and cancer.

Globally, cancer cases are increasing and it is highly recommended that the Indian

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EXPRESS PHARMA

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September 1-15, 2015

MARKET population should go for routine check ups. The solution for all this lies in adopting the prevention approach.”

He also pointed out that India has several health days to commemorate, however, the advocacy for prevention and awareness about these disease remain constraint to only those days. He stressed upon the fact that India lags behind in addressing disease burden.

Highlighting the immunisation strategies, he went on to say, “I think there is a need to have a separate agency which will create awareness among the masses to prevent diseases.”

Speaking about the scarcity of doctors in our country, Subburaj pointed out that we have less medical colleges that can provide seats to the number of students applying for medical studies. He added that we need to make adequate arrangement to increase the number of doctors in India.

While speaking on Tamil Nadu government’s initiative towards healthcare, he encouraged the public private partnership model and mentioned that wherever good healthcare practices are available in the country, other states should adopt it as the sector needs innovation for the betterment of the society.

Hansraj Gangaram Ahir, Minister of State for Chemicals and Fertilisers, Government of India requested the healthcare industry to become self reliable on things which we are dependent to other countries. Ahir said that the core objective is to work for the betterment of the country’s population. He also mentioned that the government wants to increase the production capabilities of the industry and avail affordable medicines to the needy people of the country. “Our ministry is constantly working on this space and I request to the industry to work along with the government,” he said.

Speaking on the sidelines of the event, Ahir also expressed his views on the recent ban of 700 pharma products by EU, “I am confident that very soon this ban will be

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(L-R) Hansraj Gangaram Ahir, Minister of State for Chemicals and Fertilisers, Government of India, Ranjana Smetacek, Director General, OPPI and Ranjit Shahani, Vice Chairman and Managing Director, Novartis

revoked as Ministry of Commerce, Government of India is working on it.”

Dr K Srinath Reddy, President, PHFI, highlighted the need for technology-enabled public healthcare system and centralised government’s drug procurement systems.

Reddy also questioned the government’s will to successfully implement the National Health Policy. He suggested that to build an productive healthcare system, we need to approach states for more resources. “India needs a combination of investment, innovation and integrity to build a strong healthcare system,” he said.

During the event, OPPI also announced the Healthcare Access Award 2015 which was bagged by Narayana Health. Dr Devi Shetty, Chairman, Narayana Health, who spoke to the audience through a video call, urged the government to equalise UG and PG seats for medical colleges in India. He said, “The US has 19,000 undergraduate seats and 40,000 post graduate seats whereas here in India, we have 50,000 undergraduate seats and only 14,000 postgraduate seats.

Due to this, we are desperately falling short of specialists to tackle NCD and other conditions that need specialised care.”

Receiving the award on be-

half of Shetty, Arunesh Punetha, Zonal Director, Narayana Health spoke about their corporate plans, “We will soon establish our hospitals in Jammu, Lucknow, Bhubaneshwar and Mumbai.

Nitin Goel, MD, IMS Health Information and Consulting Services India presented the gaps in Indian healthcare infrastructure limits especially in rural areas.

He also released their latest report on the healthcare system. He informed that seeing the present scenario, we need three lakh qualified doctors in the system to provide quality healthcare to the Indian population. He also pointed out that no comprehensive survey has been done to know where the healthcare infrastructure has been created. There have been funds created but it’s not being used. Healthcare spend-

(L-R) Dr Shailesh Ayyangar, President, OPPI and Managing Director, India and Vice President, South Asia, Sanofi, Dr VK Subburaj, Secretary, Department of Pharmaceuticals and Ranjana Smetacek, Director General, OPPI

ing needs to be increased to six per cent of GDP, primarily driven by increase in public

spend, he added.

(With inputs from Raelene Kambli)

EVENT BRIEF SEPTEMBER-TO DECEMBER 2015 10

6th Annual SCM Pharma Summit

24

Training on IPR

9

Apticon 2015

13

CPhI Worldwide

6TH ANNUAL SCM PHARMA SUMMIT Date: September 10 - 11, 2015 Venue: Novotel Mumbai Juhu Beach Summary: SCM Confex, the biggest conglomerate of supply chain and logistics professionals from global pharmaceutical and chemical companies, will focus on creating a robust infrastructure for end-to-end supply chain solutions. The organiser for the event is UBM. Contact details UBM India E-mail: suvidha.shetty@ubm.com Web: http://globalformulation.com

TRAINING ON IPR Date: September 24, 2015 Venue: Rajiv Gandhi National Institute of Intellectual Property Management, Nagpur Summary: Rajiv Gandhi National Institute of Intellectual Property Management (Rajiv Gandhi NIIPM), a central government organisation under the Ministry of Commerce & Industry engaged in conducting training, awareness programmes on Intellectual Property Rights (IPR) i.e. patents, designs, trademarks and geographical indications, will conduct ‘Training on IPR’ to create awareness of IPRs. The training will be held in Rajiv Gandhi NIIPM, Nagpur.

The training programme will be attended by professors, lecturers, research scholars, students from perusing law or science or commerce, IPR attorney / Patent /TMR agents / Legal professionals, advisors, consultants etc, professionals from industries, research and development, and scientists, officials from IPR cell, knowledge process outsourcing / LPO attorneys, doctors, engineers, pharma

29

2nd Annual Data Integrity & Quality Metrics Workshop

all major suppliers of pharma ingredients, outsourcing, equipment and bio-solutions in one location. P-MEC, ICSE and BioPh will be co-located with CPhI event.

Contact details UBM India Times Square th Unit No. 1-2, 5 Floor, ‘B’ Wing, Andheri Kurla Road, Marol, Andheri (East) Mumbai – 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273 professionals, chartered accountants, company secretary, officers from management, insurance personnel.

Contact details Rajiv Gandhi National Institute of Intellectual Property Management 03, Hislop College Road, Civil lines, Near Nagpur University Nagpur, Maharashtra - 440001 Tel: 0712 –2542961 / 2542979 / 2540913 / 2540922 Fax : 0712 - 2542955 / 2540916 rgniipm.ipo@nic.in, niipm.ipo@nic.in www.ipindia.gov.in

APTICON 2015 Date: October 9 – 11, 2015 Venue: Devi Ahilya Vishwavidyalaya Auditorium, Takshashila Campus, Indore, MadhyaPradesh Summary: The 20th Annual National Convention of Association of Pharmaceutical Teachers of India will address the need of changes in pharmacy education in preview of industrial need of skilled professionals. The theme for the convention is strategic approaches to strengthen academic and industrial collaboration. The deliberations will provide a new vision to develop and strengthen the pharmacy profession for this millennium.

Further, it will provide an

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important platform to build a national network and a broader interaction amongst pharmacy fraternity, which includes students, researchers, industrial experts and teachers.

The organiser for the event is Association of Pharmaceutical Teachers of India along with pharmacy institutes of Madhya Pradesh.

Contact details Mob: +91 7354880836 Web: www.apticon2015.com Email: info@apticon2015.com

CPHI WORLDWIDE Date: October 13-15, 2015 Venue: IFEMA, Feria de Madrid, Spain Summary: CPhI Worldwide will host 2,500+ exhibitors and more than 36,000+ attendees from 150+ countries. Visitors will be able to meet face-to-face with international pharma companies, stay informed about the latest industry trends and remain one step ahead of a constantly changing pharma market. The event will be colocated with ICSE, P-MEC and InnoPack.

Through all CPhI channels, and live at CPhI Worldwide 2015 in Madrid, the Pharma Forum will open up both known and unknown business opportunities to all pharma professionals of the pharma industry, in one central place.

The forum will offer the chance

to connect with influential players in the pharma industry.

Contact details UBM India Kumudini Bodha Kumudini.Bodha@ubm.com

2ND ANNUAL DATA INTEGRITY & QUALITY METRICS WORKSHOP Date: October 29 - 30, 2015 Venue: The Westin Mumbai Garden City International Business Park, Oberoi Garden City, Mumbai Summary: CPhI conference’s workshop will focus on the issues related data integrity, reliability and also on quality metrics and pilot programmes in the US. Experts from Lachman Consultants will be conducting the workshop. The organiser for the event is UBM. Contact details UBM India E-mail: suvidha.shetty @ubm.com Web: http://globalformulation.com

CPHI INDIA Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai Summary: Key decision makers in the pharma industry from 92 countries, including India, China, the US, the UK, France and Italy will participate. Visitors can meet

ASIA PHARMA EXPO 2016 Date: January 28 to 30, 2016 Venue: Dhaka, Bangladesh Summary: Asia Pharma Expo 2016 (APE 2016) – the 8th international exhibition on complete pharma manufacturing technologies, will be beneficial to all participants from local business associates to international machinery manufacturers and API / bulk active manufacturers. through participation at the exhibition. During APE 2015, 492 exhibiting companies from 28 countries along with 8,500 square meters of floor space and 9,000 trade professionals visited the show.

The exhibitor’s profile includes pharma processing and packaging machinery & materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, lab. reagents – chemicals), environment control equipment and services, utility, and maintenance, R&D, biotechnology, CROs, contractors – turnkey, trade associations / trade publications, formulations and contract manufacturing.

Contact details Email: mail@AsiaPharma.org Website: www.AsiaPharma.org

EXPRESS PHARMA

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cover )

20 EXPRESS PHARMA September 1-15, 2015

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THE MAIN FOCUS

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“Companies that may previously have held back on doing a transaction or may have preferred a licensing event are today stepping up and acquiring biotechs to ensure access to the assets and technologies of interest” Laura Vitez, Senior deals analyst, Thomson Reuters

A

s the tug of war between Shire and Baxalta continues, those on the sidelines speculate that should the deal come through, it would make Shire the world’s biggest maker of rare disease drugs as it would enter the club of Top 20 global pharmaceutical companies. It would also bring the transaction value of global pharma deals announced so far to $284 billion, making 2015 the biggest year for pharma dealmaking (Source:Dealogic). If reports are to be believed, the spate of acquisitions is not going to die down any further and is only slated to gain momentum in the coming months with more deals in the pipeline. India is also gaining momentum in its own way.

PE ACTIVITY IN Q1 2015

Source: Grant & Thornton

M&A ACTIVITY IN Q1 2015

United States: On a high

“Companies are cash rich, banks are willing to lend, PEs are willing to invest, and so acquisition is a core part of the growth strategy of top 20 Indian pharma companies across the board” Sujay Shetty, India Leader, Pharma and Lifesciences, PwC

22 EXPRESS PHARMA September 1-15, 2015

According to data from Thomson Reuters analysed

by PricewaterhouseCoopers (PwC), the US saw 4,654 M&A deals worth a record $875 billion from the beginning of 2015 to May 31. The year is also speculated to be best for the US since 2007 for M&As. Pharma’megadeals’ — like AbbVie’s $21 billion deal for Pharmacyclis and Pfizer’s $17 billion deal for Hospira, together accounted for 17 per cent of the total deal value, coming in at $150 billion. Pharma acquisitions thus represent a highly significant portion of the aggregate dollars being spent on M&A. Informs Laura Vitez, Senior Deals Analyst, Thomson Reuters, “The numbers of deals and aggregate dollars spent have both increased in H1 2015 compared to H1 2014, with all of 2014 greater than 2013, and 2013 up over 2012.”

The key drivers include the accelerating progress being made scientifically and

Source: Grant & Thornton

( clinically combined with the still-open window for IPOs. “Companies that may previously have held back on doing a transaction or may have preferred a licensing event are today stepping up and acquiring biotechs to ensure access to the assets and technologies of interest. Also, with pharma past the bulk of the devastating patent cliff, the biggest companies have been able to re-strategise and are today heavily focused on dealmaking to fill out their pipelines,” she adds.

Companies are also not shy to divest businesses that no longer fit their updated strategies. Those which had previously inverted their tax status by acquiring companies in domiciles with lower corporate tax rates are now using their tax-advantaged status to win M&A auction processes and are driving acquisition prices ever higher, she notes.

According to Kalpana Jain, Senior Director, Deloitte India, “Pharma, medical and biotech together accounted for ~ $205 billion worth of deals, which is ~12 per cent of the total Global M&A deal value of ~ $1.7 trillion. In H1 2014, pharma accounted for ~$188 billion worth of deals, which was 12.2 per cent of the total global M&A deal value of ~$1.5 trillion.Value-wise, there has been an increase of ~ 10 per cent in deals in the pharma space in H1 2015 over H1 2014. Also, pharma deals have maintained their share in the overall M&A pie.”

Nearly all large pharma companies are interested in drugs for orphan and other rare diseases, with only GSK having stated a contrarian interest. However, the decision to be acquired is driven by the company's corporate strategy says Vitez. It depends on whether they want to continue to grow and develop products on their own, holding all the risk but potentially selling later for a larger price, or if they made a strategic choice to sell the company

now and let someone else harvest the upside.

This does not mean that smaller firms are at any disadvantage. Rather such companies in the novel drug space (unlike specialty/generic space) are in the catbird’s seat, meaning they have a variety of very appealing strategic alternatives available to them, points out Vitez.

“There is a great deal of money flowing now and strong funding is available, publicly and privately. The M&A market is hot. Licensing transaction activity and valuations are also seeing their strongest year ever thus far in 2015, for all kinds of novel molecules in a wide range of therapeutic arenas.” Even with larger specialty pharma, there

THE MAIN FOCUS

cheap money, consolidation, a market that rewards innovation and generic companies such as Mylan, Teva bulking up for size will lead to the emergence of a few large players eventually in both the innovator and generic space.

India: Crafting its own story

is not pressure to sell – shareholders are very happy with valuations right now and many wish to ride acquisition pricing up still further, she goes on to say further.

Sujay Shetty, India Leader, Pharma and Lifesciences, PwC is of the opinion that

Jain believes that what we are seeing in India now is the 'return of the outbound M&A' post the financial crisis (The financial crisis hit India in 2008, deepened in 2009, gained some stability from 2010-2011, slid back again 2012-2013 and finally recovered in 2014) which was a cooling period for such deals. In the pre-financial crisis era, driven by a strong rupee, the outbound acquisition

BIG PHARMA'S HUNT FOR BRANDED MOLECULES IN H1 2015 ◗ Pfizer’s acquisition of Redvax, which gave them access to a preclinical human cytomegalovirus (CMV) vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine programme

◗ Astra Zeneca’s acquisition of Actavis’ branded respiratory business in the US and Canada for ~$ 600 million ◗ Takeda’s acquisition of Neutec (~$ 122 million) for a portfolio of 13 products in GI, respiratory, metabolic and musculoskeletal therapeutic areas

“Indian pharma companies still do not have the ability to compete and win a global auction process of a major pharma player.

Their M&A strategy generally revolves around spotting a niche player in a particular therapeutic segment” Kalpana Jain, Senior Director, Deloitte India

“There has been no significant rise in deal value and volume not as much as last two years. Majority of the deals have been small ticket, only a few being $100 billion plus” Amit Mookim, Head of South Asia Consulting, IMS Health

Deal volume, value and classification

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cover ) ambition was visible with tierII pharma companies as well, to ensure low-cost production within India and marketing and distribution of the drug in the US, the largest pharma market globally. She points out that today most of the Top 10 pharma companies are scouting for acquisitions both in India and globally. The proof is in the pudding. Lupin’s recent acquisition of Novel and Gavis in the US for ~$ 880 million is one of the largest outbound acquisition by an Indian pharma company and its sixth acquisition since February 2014. Sun Pharma (six companies since 2012) and Cipla (five companies since 2013) follow close suit.

“Companies in India are closely watching developments globally. Sun has done a monumental deal. Lupins recent acquisition of Gavis is a step in that direction. Not everybody will be able to do such acquisitions. Given that global generic companies have gotten bigger, also consolidation among distributors on the downstream, the idea is do M&A to bulk up,” affirms Shetty. He concedes that balance sheets of Indian companies do not allow for big buys as those seen globally, a few companies being an exception. While there isn't much activity on the surface, a lot of companies are on a hunt.

However, the strategy of Indian companies differ from their US counterparts. “Indian pharma companies still do not have the ability to compete and win a global auction process of a major pharma player. Their M&A strategy generally revolves around spotting a niche player in a particular therapeutic segment and negotiating on a one-on-one basis with the potential seller. We are witnessing more of creeping acquisitions, wherein the Indian player would enter a new geography by acquiring a majority stake in the business and would ask the existing management team to continue running the day-today operations of the business,” says Jain.

The Indian company would slowly acquire 100 per cent stake in the business bringing the operations completely

24 EXPRESS PHARMA September 1-15, 2015

within its fold. She is quick to point out that even though domestic companies continue to be interested in inbound M&A, valuation expectations are still prohibitive. Also, US FDA’s latest stand on domestic manufacturing facilities (post the clampdown on Ranbaxy) has not helped in building confidence with MNC players.

Amit Mookim, Head of South Asia Consulting, IMS Health offers a realistic perspective. “2013 witnessed a total of 32 deals in the pharma space worth $6.5 billion, 2014 saw 40 transactions totalling $5 billion while so far 2015 has seen 19 transactions worth $1.2 billion. There has been no significant rise in deal value and volume not as much as last two years. Majority of the deals have been small ticket, only a few being $100 billion plus,” he says. However, he is buoyant

about companies in the M&A mode. “Almost all pharma companies are aggressively looking at acquisitions as a part of their growth strategy to either expand internationally or to bring a new technology to India. Specialty portfolios in dermatology, opthalmology, neurology are sought after while Latin America, Scandinivian countries, South East Asia especially

Indonesia continue to be attractive markets,” he adds. PE activity on the other hand has registered an increase in number terms. While the PE money flowing into pharma was 33 per cent of the aggregate in 2013, the figure stands at 60 per cent for 2015 so far.

The road ahead Vitez gives a global perspective.

“Commercialisation is very expensive so it will always behoove many small companies to access help in that arena. However, there are many, many ways to do this without selling the company. The developmentstage pipelines of the world’s top 20 pharma companies (none of these are Indian) range from 15-80 per cent externally sourced – that is, brought in via in-licensing or M&A.”

M&A - PHARMA & BIOTECH

BIGGEST DEALS SO FAR IN INDIA PRE-FINANCIAL CRISIS Company

Deals

Value

Announcement date

Completion date

Dr Reddys – Betapharm

Outbound

$572 million

16/02/2006

7/3/2006

Abott – Piramal

Inbound

$3.7 billion

21/05/2010

8/09/2010

Daichi – Ranbaxy

Inbound

$4.6 billion

11/6/2008

7/11/2008

POST-FINANCIAL CRISIS Sun – Ranbaxy

Domestic

$3.2 billion

7/4/2014

24/3/2015

Torrent – Elder Pharma

Domestic

$323 million

13/12/2013

29/6/2014

Lupin – Novel + Gavis

Outbound

$880 million

23/7/2015

Pending

Mylan – Agila

Inbound

$1.6 billion

27/02/2013

5/12/2013

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(

THE MAIN FOCUS

LUPIN’S ACQUISITION STRATEGY Lupin continues to lookout for meaningful acquisitions that would enable the company to build and consolidate its position as an emerging global speciality pharmaceutical powerhouse.

The company’s acquisition strategy is engineered to meet the aspirations of creating a meaningful global specialty business, bolstering its existing global brands business specifically in the US, acquiring technological capabilities, entering new markets where the company has no presence as it continues

Companies like Teva and Allergan, who do rely upon search, not research, and development stand at the top of that list . Big Pharma (Pfizer, J&J, Merck, etc.) is at the middle of that range at 30 to 50 per cent of their pipes externally sourced. Struck by the double whammy of the recession and the patent cliff, these companies still have powerful and robust internal R&D engines. At the low end are the smaller and more specialised companies such as Boehringer Ingelheim and Novo Nordisk who, presumably by strategic design, have lower portfolio needs. Niche biotech companies in India according to Jain are eager to participate in the upside of a successful research if the molecule actually becomes a drug.

“If an appropriate structure (one that captures the value of the molecule as on date, along with an upside sharing model if the research is successful) is agreed upon between the potential buyer and seller, then we do not see any road-blocks in such deals,” she says.

At the same time Jain doesn't mince words to say that smaller companies are facing a 'sell' pressure due to a levered balance sheet. “A lot of the listed / unlisted players have leveraged their balance sheets for setting up a US FDA approved plant (beyond optimum capacities) or spent the money on R&D of a new molecule. Without enough capacity utilisations / failed R&D, it is unsustainable to run these businesses,” she adds.

Shetty, however, does not see intra India deals as well as consolidation among generic makers owing to valuation issues between promoters, and says that a Torrent-Elder/ Reddy's UCB are a once a year phenomena.

“Companies are cash rich, banks are willing to lend, PEs are willing to invest, and so acquisition is a core part of the growth strategy of top 20 Indian pharma companies across the board. The primary focus is on marketing- good distribution channel, sales or a good brand. A lot of manufacturing

to make its presence as a world leader in the generics space. The company has a very balanced geographic spread right now of 60 per cent in regulated markets and 40 per cent in emerging markets. It is looking at acquisition in the US, Latin America (Brazil, Mexico), specific markets in Europe (Russia, Turkey etc.), Japan, China and India. Global targets would be specific to segments such as inhalation, complex injectables and dermatology.

is coming to Indian especially on the CRAMS side, and with the FDA getting stricter, there is interest in looking for facilities both on the API and formulations side.

Few companies are looking at going up the value chain by looking at targets with specific R&D or regulatory capabilities such as injectables and biologics,” he emphasises.

Sun-Ranbaxy deal is transformational, however, when asked if we can see more such in the future, analysts believe that they'll be far and few given the size and scale of Indian companies. In the last 10 years, there have been only four instances of over $ 1 billion deal size in India, out of which Ranbaxy changed hands twice. The other two were inbound acquisitions (Abott-Piramal; Mylan-Agila).

There is momentum on the ticket size of deals though as Mookim of IMS Health notes.

“In 2014-15, there were three $ 100 million plus deals, one $ 50 million plus, in 2013 there were two $ 100 billion deal, in 2012 there were none,” he says. It seems as if Indian companies are adopting a wait and watch approach, weighing up the pros and cons in a market that has always been dynamic and more so now. With companies such as Sun growing big in size and few others following suit, there is pressure to expand and grow to reach economies of scale. While some have openly declared their acquisition plans others are strategising since an aggressive M&A strategy could lead to loss in valuations over time.

Anand Bhageria, Partner, Singhi Advisors offers the final word and says, “The potential shareholder value of a merger is also 'destroyed' in many cases because companies fail to efficiently integrate their operations. The focus should be on good planning, solid integration, handling reputations, keeping an eye on valuations and just doing strategically those things that differentiate the company in the marketplace after the acquisition.” shalini.g@expressindia.com

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MANAGEMENT

26 EXPRESS PHARMA September 1-15, 2015

I

n the last few years, Ecommerce platform has picked up its pace globally as well as in India. However, online pharmacy concept in India is still at a very nascent stage because the Indian law does not permit it.

According to the Pharmacy Act subsection 1 of section 42 of Indian Pharmacy Act 1948, “No person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner.” Section 42 (2) also states, “Whoever contravenes the provisions of sub-section (1) shall be punishable with imprisonment for a

term which may extend to six months, or with fine not exceeding ` 1,000 or with both.”

Explaining the concept further, Ashutosh Garg, Chairman and Managing Director, Guardian Lifecare says, “With the growing use of Internet-based shopping, we are seeing a huge increase in sales via the Internet.

However, sales of medicines is not permitted since the law requires the sale to happen in a licensed store, sale to be effected by a pharmacist and sale to be effected based on a prescription. Some companies have already started to

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A regular supply of health maintenance drugs and supplies, affordably offered and conveniently delivered will prove to be an important weapon in the fight against the rise of chronic diseases Bruce Schwack Director, Marketing, Netmeds.com

find loopholes in the law and have started to sell medicines over the Internet, recognising the need for Internetbased sales of medicines.” He suggests, “Government of India (GoI) needs to proactively legislate this to manage unscrupulous elements while ensuring that the new medium of sales is available to all customers.”

According to a PTI report, considering the possibilities of misuse by E-commerce vendors, the Maharashtra FDA took the lead in examining details of major online pharmacies

such as Snapdeal, Flipkart and Amazon as well as issued showcause notices to them. A police case was also filed against Snapdeal by the Maharashtra FDA for selling prescribed drugs online. However, in the wake of information technology advancements and related smart phone-based applications, the importance of moving with the times and an in-depth assessment of online pharmacy practices was felt.

Realising the need for constituting guidelines for online pharmacies, Federation of Indian Chambers of Commerce and Industry (FICCI) recently

EXPRESS PHARMA

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MANAGEMENT

E-commerce or online retailing or m-commerce is still a very small fraction of the total retailing market in India. But it is making headlines because the customers and opinion leaders are seeing it as an efficient and effective channel of distribution of the future Hemant Bhardwaj CEO, Co-Founder and MD, PM Health and LifeCare

Over a period of time, the government should create a secure App which will be used by doctors to prescribe medicines.

Registered pharmacies can then deliver medicines on the basis of this App Ashutosh Garg, Chairman and Managing Director, Guardian Lifecare

28 EXPRESS PHARMA September 1-15, 2015

organised a meet on 'Pharma Guidelines for Reinforcing Due Diligence for Intermediaries (E-commerce Marketplace)' to ensure safety of consumers.

Dr GN Singh, Drugs Controller General (India) DCG(I) announced that the authority is in the process to formulate guidelines. He also informed that FICCI has been appointed as the nodal agency by the DCG(I) for consolidating the guidelines. A sub-committee has been formed by the DCG(I) under the chairmanship of Harshadeep Kamble, Commissioner Food and Drug's Administration & Food Safety Commissioner, Maharashtra, to assess the feasibility of online pharmacies. The committee also includes other members like the Karnataka Drugs Controller along with drugs controllers of Delhi and Odisha. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organisation, is also a member of the sub committee. It is seeking the views of Organisation of Pharmaceutical Producers of India (OPPI), All India Organisation of Chemists & Druggists, states chemists and druggists associations, Indian Medical Association, CIPI, BDMA, PHD Chamber of Commerce and Industry and consumer forums.

Highlighting the need for such guidelines, Dr KK Aggarwal, Secretary General, IMA points out, “There are no welldefined dedicated laws for online pharmacies. The laws applicable are Drug and Cosmetics Act 1940, Drugs and Cosmetic Rules 1945, Pharmacy Act 1948 and Indian Medical Act 1956. Laws related to E-commerce are defined under the Information Technology Act, 2000.”

Aggarwal further informs, “The Drugs and Cosmetics Act does not allow home delivery of drugs. The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have clear guidelines on the sale of Schedule H and Schedule X drugs, which are ‘restrictive drugs’ and can be sold only on the prescription of a registered medication practitioner. Schedule X drugs include narcotics and psy-

chotropic substances. Chances of drug abuse and addiction are higher with the Schedule X category. Schedule X drugs require meticulous storage and dispensing records. The prescription has to be in duplicate, one copy of which is to be retained by the licensed pharmacist for two years.”

Pharmacy, 1.MG, formerly Healthkart Plus, PM Healthcare, touted by former Igate CEO Phaneesh Murthy, and few others. Netmeds.com, the first-to-market pan-India, fully licensed and compliant Epharmacies, is a recent entrant in the space.”

Challenges Market potential According to FICCI's spokesperson, “Presently, online pharmacy is at its nascent stage in India, but like other categories, it has the potential to be a very large industry segment. It is expected that the online pharmacy model could account for five to 15 per cent of the total pharma sales in India, largely by enhancing adherence and access to the medicines for a lot of the under-served population.”

Hemant Bhardwaj, Chief Executive Officer, Co-Founder and MD, PM Health and LifeCare draws attention to the benefits of the model and says, “The icing on the cake is the concept of 'Marketplace', which is fuelling big dreams among thousands of small retailers. Now their business is no more constrained by the carpet area of their shops.

And, for a minute, if I ignore the massive discounts offered

by E-retailers, this channel still has a lot to offer to the customers in terms of convenience. Currently, 35 million Indians prefer buying products and services online. This tribe is going to cross 100 million mark by 2016 and is expected to continue to grow with a rapid rate. A smart businessman will not let go of an opportunity to cater to this next generation of buyers, whether he is in the business of selling needles or medicines. Best part is that he can leverage this new promising channel without junking his existing business or clientèle.”

The model has already found favour with many leading pharma players. Bruce Schwack, Director, Marketing, Netmeds.com informs, “Online availability of prescription medication has been discussed in a big way lately. Online pharma space currently has well-heeled players like Apollo

There are many players who have already stepped into the business or are intending to offer medicines online. However, several challenges are associated with the E-commerce platform, Aggarwal expresses his concern and says, “Online

pharmacies will promote drug abuse, drug misuse, self-medication etc. Any medication taken without the supervision of doctors may be dangerous and even potentially lifethreatening. There is every chance that the prescriptions submitted via fax/email may be fake and it could be difficult to verify their authenticity.”

Schwack also points out the pitfalls in the concept and says, “Selling mobile phones and T-shirts online is less problematic than selling prescription drugs. After all, getting the wrong prescription could ruin your health.” He further informs, “That is why both the DCG(I) and the Indian Pharmacist Association are calling for the strictest enforcement of the Drugs and Cosmetic Act, and the top tier players in the emerging space are all in lockstep with this philosophy. It is of critical importance that the prescription laws be followed to the letter.

And even more important is that patients see their doctors regularly and make sure that their prescribed medication is

still required and is causing no harmful side effects. Hence it is important to have a valid, current prescription.”

Aggarwal also indicates, “Online pharmacies may provide rebates and commissions to doctors to provide prescriptions on the basis of online information that has been filled by the patient. This way doctors will be vulnerable to malpractice suits. Regulation 6.4 of MCI Code of Ethics prohibits from giving or receiving any rebates or commissions.”

Operating an online pharmacy too has several challenges associated with it. As Bhardwaj highlights, “Technology is on the cusp of changing the dynamics of how patients get their medicines.

While cloud computing and electronic health records are changing the healthcare delivery paradigm, greatly benefiting the physicians and patients, likewise, E-commerce will change the accessibility paradigm for patients. A fresh perspective in our case is helping us as well.”

Garg shares his views on the measures that the government should consider, and says, “The government needs to ensure that only genuine medicines with proper expiry are dispatched by courier and pricing is done correctly. It should also ensure that medicines that need prescription are not sold online without a prescription.”

FICCI's spokesperson opines, “The sale of drugs and medicines online might lead to drug and substance abuse, incorrect dosage or administration, counterfeit drugs, etc.

However, with regulatory framework, the cases can be reduced. Also, generating awareness amongst the consumers could also help in overcoming these challenges.”

These are serious issues that need immediate attention, and the government should have provisions in the guidelines being drafted to tackle them effectively.

Will online pharmacies hit retail outlets?

Currently, online pharmacies are liable to violate various acts like Pharmacy Act, Drugs

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MANAGEMENT

Online pharmacies may provide rebates and commissions to the doctors, who will prescribe medicines on the basis of online information that has been filled by the patient Dr KK Aggarwal Honorary Secretary General, IMA

Medical shops and pharmacies need not fear for E-retailing which will only be additional and supplementary for enabling affordable access Dr Gopakumar G Nair Chief Executive Officer, Gopakumar Nair Associates

& Cosmetic Act and Violation of Human Rights. However, many E-commerce players have already ventured into the segment. Bhardwaj explains the phenomenon, “E-commerce or online retailing or M-commerce is still a very small fraction of the total retailing market in India. But it is making headlines because customers and opinion leaders are seeing it as an efficient and effective channel of distribution of the future. It offers quick massive reach, if backed by strong logistics network. This is accompanied with the fact that it gives assured access to medicines in the quickest possible time to the needy.”

The growth of online pharmacies have also given rise to a fear among the retail sellers that their business would be adversely affected. However, Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates, refutes this theory and opines, “The fear of all these physical distributors and suppliers that E-tailing/E-retailing such as Snapdeal, Flipkart, Amazon, Localbanya etc. will adversely affect the footfalls, has proved to be unfounded. As such, medical shops and pharmacies need not have fear for E-retailing which will only be additional and supplementary for enabling affordable access. Around 7590 per cent of the current customers of medicine shops and pharmacies will continue to access physically. Only the web-enabled or web-assisted community who don’t have proximity medicine shops will opt for E-retailing on the web.”

However, Schwack tries to balance

it out and says, “Although the 'brickand-mortar' pharmacy operators in India are voicing some concern about this shifting paradigm, at least a part of that concern seems to be unfounded.

While some of the opposition is based on a genuine concern for the public’s safety, since by and large the community of pharmacists is recognised as a group of dedicated healthcare professionals, another concern is probably the threat of a loss of business as their loyal customers migrate to the net or their smartphone to purchase their medications.”

He further elaborates, “In reality, industry analysts are predicting about a five to 10 per cent market share for the E-pharmacies as they emerge, jockey for position and settle in over the next few years. That means, that of the roughly 3,000,000 transactions that are going through local neighbourhood pharmacies and chemists each and every day, perhaps, as scant a number as 150,000 of those may be lost to 'the web', and in most cases, these pharmacies can actually enjoy an increase in business rather than a loss, by launching their own e-presence, extending their reach and appeal to their own customers and by enrolling in various “marketplace” engagements and providing fulfilment for some of the regional and national players.”

Though the mindset is changing and moving towards technology, the real challenge is how to strike a balance? Will providing certifications to chemist shops and online pharmacy be a solution?

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MANAGEMENT Accreditation According to the extraordinary gazette notification, “The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.”

FICCI spokesperson highlights the importance of certification and says, “We recommend a certification for online marketplace, so they register with the regulator and are certified as organised players within the purview of the regulator.

Online companies should clearly display the certificate on their home page and consumers should be made aware to only buy from certified online pharmacies.”

Agreeing about the measures needed to ensure safety and compliance, Bhardwaj suggests, “I completely agree that

medicines can’t be sold the same way someone sells books or vegetables. I am of the opinion that any retailing channel or a platform or a retail player, who keeps regulatory compliance at the heart of its operations and ensures safe delivery of medicines to the consumers, should be encouraged.”

Aggarwal again draws attention to the likelihood of malpractice by online pharmacies and says, “Many online pharmacies may be operating without the appropriate license. This increases the chances that drugs sold by such unlicensed pharmacies may be counterfeit, substandard, or adulterated and therefore risky to the patient. There are no checks in place to ensure that the drugs sold by online pharmacies are not spurious. Medicines have to be stored properly as recommended by the manufacturer.

Exposure of medicines to high temperatures in storage or in transit could diminish their

macies that have chosen to do so include retail giants like Walgreens and CVS, as well as hundreds of ‘mom-and-pop’ neighbourhood shops. As a result, they all have enjoyed an increase in business as a result.

Licensing is very much like in India, where issuance is predicated upon initial and on-going physical inspections, a review of Certified Pharmacist’s credentials, as well as a inspection of practices and procedures.”

Way forward efficacy and are a potential health risk. There is no way to check the storage conditions of drugs sold by the online pharmacies.”

Giving a rundown on the way, online pharmacies are operated in the US, Schwack says, “Even in the US, which is known as one of the most restrictive and regulated prescription drug marketplaces in the world, licensed pharmacies are permitted to offer their products online and those phar-

Garg suggests, “Over a period of time, the government should create a secure app which will be used by doctors to prescribe medicines. Registered pharmacies can then deliver medicines on the basis of this app. This will ensure complete transparency. Though there will be an initial resistance, customer push will drive doctors and pharmacies to have this implemented.”

Schwack opines, “The public not only wants it, but in

many cases, needs it. The population is ageing and with age comes greater dependence on health maintenance drugs. The incidence of chronic disease is on the rise as the emerging 'technocrat' class is setting new records not only in income levels, but also in areas of obesity, diabetes and heart disease. A regular supply of health maintenance drugs and supplies, affordably offered and conveniently delivered will prove to be an important weapon in the fight against the rise of chronic disease.”

Nair ponders, “Is it too much for me to look forward to seeing the E-dream of riding on ‘Digital India’ turn into a reality during my lifetime? I would eagerly wait to order at least my vitamin supplements through the E-way, even if it is the local speed-postman delivering it, with the government enabling the statutes to make the provisions legal and transparent, not prone to abuse.” u.sharma@expressindia.com

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RESEARCH RESEARCH UPDATES

Aspirin lowers risk of cancer in overweight people: Study Being overweight more than doubled the risk of bowel cancer in people with Lynch Syndrome, an inherited genetic disorder which affects genes responsible for detecting and repairing damage in the DNA A REGULAR dose of aspirin can reduce the long-term risk of cancer in those who are overweight, according to an international study of people with a family history of the disease. The study found that being overweight more than doubled the risk of bowel cancer in people with Lynch Syndrome, an inherited genetic disorder which affects genes responsible for detecting and repairing damage in the DNA. Around half of these people develop cancer, mainly in the bowel and womb.

Over the course of a ten year study, researchers from Newcastle University and the University of Leeds in UK found this risk could be counteracted by taking a regular dose of aspirin.

“This is important for people with Lynch Syndrome but affects the rest of us too,” said Professor Sir John Burn, Professor of Clinical Genetics, Newcastle University, who led the international research collaboration.

“Lots of people struggle with their weight and this suggests the extra cancer risk can be cancelled by taking an aspirin,” said Burn.

“This research adds to the growing body of evidence which links an increased inflammatory process to an increased risk of cancer. Obesity increases the inflammatory response.

One explanation for our findings is that the aspirin may be suppressing that inflammation which opens up new avenues of research into the cause of cancer,” Burn said.

The randomised controlled trial is part of a study involving scientists and clinicians from over 43 centres in 16 countries which followed nearly 1,000

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In the research, 937 people began either taking two aspirins (600 mg) every day for two years or a placebo. When they were followed up ten years later, 55 had developed bowel cancers and those who were obese were more than twice as likely to develop this cancer – in fact 2.75 times as likely. Following up on patients who were taking two aspirins a day showed that their risk was the same whether they were obese or not.

“What is surprising is that even in people with a genetic predisposition for cancer, obesity is also a driver of the disease. Indeed, the obesity-associated risk was twice as great for people with Lynch Syndrome as for the general population,” Mathers said.

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RESEARCH

US FDAapproves ‘female Viagra’with strong warning Warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol have been issued THE FIRST drug to treat low sexual desire in women recently won approval from the US health regulators, but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol.

The US Food and Drug Administration (FDA) said the pink pill, to be sold under the brand name Addyi and made by privately held Sprout Pharmaceuticals, will only be available through certified and specially trained health care professionals and pharmacies due to its safety issues.

Addyi, whose chemical name is flibanserin, is designed for premenopausal women whose lack of sexual desire causes distress. The condition is formally known as hypoactive sexual desire disorder, or HSDD. The drug needs to be taken daily. Addyi has been nicknamed the 'female Viagra' even though it does not work like Pfizer's blockbuster Viagra pill for men that in 1998 became the first approved drug for erectile dysfunction.

"This is the biggest breakthrough in women's sexual health since the advent of 'the pill'" for contraception, The National Consumers League said in a statement. "It validates (and) legitimises female sexuality as an important component of health."

But public citizen, a consumer watchdog group that testified against the drug earlier this year, predicted that Addyi will be pulled from the market within a few years because of “serious dangers to women, with little benefit” to them. “Unfortunately, we haven't heard the last of this drug.”

The FDA had twice re-

32 EXPRESS PHARMA September 1-15, 2015

US FDA approves use of opioid painkiller in 11-16 year olds The long-acting drug has been reformulated over the years to combat rising prescription drug abuse in the US

jected the Raleigh, North Carolina-based firm's drug. But the latest decision comes after an advisory panel concluded in June it should be approved with strict measures in place to ensure patients are fully aware of the risks.

Palatin's experimental treatment called bremelanotide is now in late-stage trials and works differently from Addyi. It attempts to activate certain brain pathways.

Palatin said its drug, if approved, would only be taken as needed, not on a daily basis like Addyi, thereby providing women 'greater control and flexibility in their treatment.'

Unlike Viagra, which affects blood flow to the genitals, Addyi is meant to activate sexual impulses in the brain. It is similar to a class of other drugs known as selective sero-

tonin reuptake inhibitors, or SSRI's, that include antidepressants such as Prozac. But those antidepressants, which raise levels of the neurotransmitter serotonin, are known to blunt libido. Addyi blocks certain cellular receptors from responding to serotonin. Women who took Addyi in a clinical study had an increase of about one sexually satisfying event per month compared with those taking a placebo. Advocates claim that increase is meaningful. Critics say the small benefit is outweighed by the drug’s risks.

Addyi will come with a prominent ‘boxed warning’ about side effects, including among people with liver impairment or who take Addyi with alcohol or with medicines known as CYP3A4 inhibitors that include certain steroids.

Originally developed by Germany's Boehringer Ingelheim under its chemical name flibanserin, it was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks. Sprout acquired the drug, conducted additional studies and resubmitted the application. In 2013, the FDA rejected it again.

The rejection sparked a lobbying campaign by Sprout, aided by some women's groups who accused the FDA of gender bias because it had approved Viagra for men - a charge the FDA vigorously rejected. The FDA approved Addyi despite a rocky relationship in recent years with the founders of Sprout.

Slate marketed an implantable testosterone pellet for men with low levels of the male sexual hormone, called Testopel. In one FDA warning letter, issued on March 24, 2010, the FDA said Slate had improperly inferred on its Testopel website and in a video that the testosterone product could help patients with depression, erectile dysfunction, diabetes and HIV.

THE US Food and Drug Administration (US FDA) has approved the use of opioid painkiller OxyContin in patients aged 11 to 16 who have not benefited enough from alternatives. The long-acting drug already treats adults suffering from around-the-clock pain, and has been reformulated over the years to combat rising prescription drug abuse in the US. Unlike adults, doctors are to prescribe the medicine only for children who can already tolerate a minimum dose of 20 milligrams of oxycodone, the active drug ingredient in OxyContin. The warnings and precautions for paediatric patients are the same as those for adults, the agency said.

OxyContin maker Purdue Pharma, which had been asked by the FDA to evaluate the drug's use in children, will also conduct postmarketing studies. The duragesic patch, which releases fentanyl, is the other long-acting opioid option for paediatric pain management. The original formulation of OxyContin, which was first approved nearly two decades ago, was withdrawn due to its potential for abuse.

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PHARMA ALLY

P

harmaceutical and biotechnology industries are always on the edge due to regulatory scrutinies, mergers and acquisitions, patent expiry and ever mounting cost-cutting pressures. At every stage of operations, starting from R&D, manufacturing and packaging to the distribution of the product, there is one sector that works hand-in-hand with the drug manufacturing industry i.e. information technology (IT). To be more specific, softwares manufactured by IT have given a considerable breathing space to the pharma sector. Use of softwares has allowed the industry to cut down on human intervention, reduced operation time, and as a result, adds considerable savings on overall investment.

Software, applications and challenges Today, various tailor-made or ready-to-use branded softwares and programmes are the backbone of pharma and biotech research and development. Without such cutting-edge platforms, R&D cannot move ahead. Starting from deriving to tentative structures of complex multithousand Dalton sized bioactive molecules, by scanning huge generated and fed data to multiple assaying of lakhs of samples through advanced high-throughput systems (HTS), several softwares are being developed and used.

“There are unique challenges in developing them for biological research and how the field of computational biology, as a whole, can move research agendas forward,” emphasises Dr Girish Mahajan, ConsultantMicrobiology.

Mahajan explains, “It is well reported that Basic Local Alignment Search Tool (BLAST) was the first program to assign rigorous statistics to useful scores of local sequence alignments.

Before then, people had derived many different scoring systems, and it wasn’t clear

34 EXPRESS PHARMA September 1-15, 2015

SOFTWARE SOLUTIONS

TRANSFORMING

PHARMA Software is one of the most crucial Information Technology (IT)-enabled services that the Indian pharma industry heavily relies on to improve and enhance its day-to-day operations

BY SACHIN JAGDALE

The BLAST or allied softwares available today are key drivers in phylogeny and genome mining in both prokaryotes and eukaryotes systems. Several factors have contributed to the usability of ImageJ Dr Girish Mahajan Consultant-Microbiology

why any should have a particular advantage. When MAQ came out, there was no other software that could do integrated mapping and single-nucleotide polymorphism (SNP) calling.”

He adds, “The BLAST or allied softwares available today are key drivers in phylogeny and genome mining in both prokaryotes and eukaryotes systems. Several factors have contributed to the usability of ImageJ. Primarily, it has a relatively simple graphical user interface, similar to popular desktop software, such as photoshop.

Scientific software often needs quite a strong insight—that is, algorithmic development. The algorithm implements original ideas, is based on deep scientific understanding of data and the problem, and takes a step ahead of what has been done previously.”

Thus, software development in pharma or biotech area is always very challenging involving diverse and multiple variables. The number of expertise available in such areas is very sparse compared to other commercial software development.

Why it is needed?

Indian pharma industry is a generic superpower and the next goal for it would be to transform itself into an innovation-driven industry. Another challenge is in enhancing the speed of bringing drugs to the market. Researchers will not be in a position to keep pace with the changing market demands unless they are aided by modern technologies. Softwares are going to play a key role in achieving this target.

Hence, it is important to know the IT company’s perspective in this regard.

Dr Abhay Jere, Associate Vice President and Head–Persistent Labs, Persistent Systems, informs, “Currently, the pharma industry is very much dependent on software solutions in its every department like production, QA/QC, packag-

ing, regulatory compliances and sales and marketing. In the production category currently all renowned pharma companies use ERP and LIMS solutions to ensure that various formulation batches are planned, scheduled and produces as per the protocol. Mobile apps are used to monitor critical formulation steps and control instrumentation.”

Persistent's life sciences group has combined science and technology to provide solutions to organisations across pharma, biotech, device manufacturers, clinical and cancer research institutes as well as universities and helps deliver services and solutions at reduced cost. The company has expertise across social, mobile, analytics and cloud technology platforms and in-depth knowledge of essential regulatory standards and compliances.

Jere provides a case study of how their software solutions helped their pharma clients. “At Persistent Systems, we have a big group of approximately 700 people who work on projects related to pharma companies, lab instrumentation companies and life science/healthcare companies. We work closely with companies like Agilent, Thermo Scientific, BD, etc. to build software for their instrumentation. They are 21CFR part 11 compliant which is very critical for pharma industries.

We have developed multiple apps for pharma industries.”

He gives the instance of an app they developed for a major pharma company in the US. The app was aimed at motorists and drivers, it sought to inform them about pollens and allergens as they drive across the US. It gives alerts to drivers as they drive from one province to another, based on their locations and also suggests drug and pharmacy stores in the vicinity so that they can purchase the suggested anti-allergic drug in case of allergy.

Clinical trial sector perspective Developing new therapies to treat various diseases is a very long, tedious and complex process, of which, the clinical

Persistent’s life sciences group has combined science and technology to provide solutions to organisations across pharma, biotech, device manufacturers, clinical and cancer research institutes trial sector is an integral part.

So, as for the pharma industry, use of softwares is an imperative for the clinical trial industry as well.

“Overall, advancements in technology are playing an increasingly important role in our understanding and management of healthcare and disease.

These advancements are also impacting the way clinical trials are being conducted and managed with technology driving end-to-end customer value, incorporating design, execution, engagement and commercialisation within the drug development process. The industry has seen a lot of innovation in the application of technology and will continue to do so with Quintiles playing a pioneering role in this development,” says Naz Haji, Senior Vice President & Head, Quintiles India.

Haji explains his point of view by giving two examples of how Quintiles has leveraged technology to deliver value in clinical trials. He explains, “With the Quintiles Infosario platform, Quintiles has developed the technology to take data from multiple source systems and integrate, synchronise and normalise and present this data in near real-time. The Infosario platform creates a seamless integration of data, therapeutic expertise and clinical trial processes in a system that provides data transparency, optimised workflows, and real time insights into patient, study/site and programme activities. Powering this is the Infosario Data Factory which is the clearing house and data hub for clinical and commercial data for the indus-

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try, supporting clinical development and integrated health analytics.”

The other example that Haji offers is of Risk-Based Monitoring (RBM). “With our Data Drive Trial Execution (DTE) led by RBM, we are using datadriven processes and insights to drive faster, more informed decisions that can improve a customer’s probability of success. We are currently engaged in more than 130 studies using RBM processes and policies, across more than 26,000 sites and 260,000 patients. We have seen our RBM model deliver value in several areas like ability to impact clinical monitoring costs, decreased time to analysis-ready data, increased quality/reduced risk and ability to impact medical monitoring,” he explains.

Quintiles recently announced two enhancements to its RBM. These enable study teams to identify the right signals and predict clinical trial site performance as well as potential patient safety issues before they occur. Called Predictive and Advanced Analytics, the capabilities combine advanced statistical monitoring and predictive analytics to improve precision in risk identification and are the first such model-based capabilities, fully integrated into an RBM solution in the market today.

Positive forecast India has a potential to build a $100 billion software product industry by 2025, according to Indian Software Product Industry Roundtable (iSPIRT).

The India IT-BPM industry intends to add $13-14 billion by FY-2015, according to National

Association of Software and Services Companies (NASSCOM). The current estimated size of the industry is about $2.91 billion and is expected to grow to $8.08 billion by 2016 (Source: http://www.financialexpress.com/article/pharma/management-pharma/impact-of-it-onindian-pharma-industry/56552/) The pharma industry is likely to be an important growth driver in enabling the software industry to touch the projected figure. As stated before, the Indian pharma industry is in a transition phase and the software industry is going to be a trump card in making this transition smoother and successful.

“Regulation of content and target audiences is key to sending relevant information to doctors and patients alike. Reporting the right information back to management to enable them to make right decisions and deliver the right products to the market is the road to success for all pharma companies. And with new age digital research and approach this puts a lot of responsibility back on the solutions providers to be accurate, fast and scalable,” says Aatish Shroff, Executive Director, Business Operations, Sunways (India).

According to Jere, in the future, the software industry will work very closely with pharma industry in each and every department. In R&D, software industry will have tools to study systems biology, genomic analysis, toxicity prediction and formulation development for predicting bioavailability. Software will become essential for vaccine design and predicting immunological responses.

Pharma industry has undoubtedly benefitted with the use of softwares. However, on the other hand, medicine consumers are also silent beneficiaries. To achieve the goal of scaling up drug production, with low cost and considerable reduction in delivery time, strengthening the bond between the pharma and IT sectors will become exigent.

Currently, the pharma industry is very much dependent on software solutions in its every department like production, QA/QC, packaging, regulatory compliances and sales and marketing Dr Abhay Jere Associate Vice President and Head–Persistent Labs Persistent Systems

Overall, advancements in technology are playing an increasingly important role in our understanding and management of healthcare and disease. These advancements are also impacting the way clinical trials are being conducted and managed Naz Haji Senior Vice President & Head, Quintiles India

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Sakar Healthcare: Getting technorich with lyophiliser Inclusion of lyophiliser with auto loading/unloading and orabs is an instance of Sakar Healthcare’s progress and its efforts to ensure quality on every front

LYOPHILISATION ALSO known as freeze drying, lyophilisation or cryodesiccation is a dehydration process typically used to preserve a perishable material or make the material more convenient for transport. Lyophilisation should be used when the product meets one or more of the following criteria: unstable; heat liable; minimum particulates required; accurate dosing needed; quick; complete rehydration needed; high value.

It uses a commonly known process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapour without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes.

Adoption of automated loading and unloading systems, clean-in-place systems, and controlling and monitoring systems in freeze drying systems in order to minimise manual errors, improve processing time, and reduce operating costs are expected to promote greater uptake of technologically advanced freeze drying systems in the global healthcare industry.

In recent years, the freeze drying equipment accounted for the largest share of the global freeze drying market; whereas, freeze drying accessories accounted for the remaining share of this market.

As in last year, Asia-pacific region accounted for the largest

36 EXPRESS PHARMA September 1-15, 2015

share of the global freeze drying market, followed by North America and Europe. Furthermore, in the forthcoming years, developing regions such as Asia-Pacific (China and India) and Latin America (Brazil, Mexico, Argentina) are expected to provide strong revenue growth opportunities for the market players. Economic developments, rising shift of pharmaceutical and biotech industries from developed countries to Asia-Pacific and Latin American regions, growing investments of foreign freeze drying market players in these regions, and increasing private investments and venture funding to support new biopharma product developments in these regions are the key factors driving the growth of the freeze drying market in developing regions.

New product launches and partnerships, agreements, and collaborations are the key strategies adopted by leading market players in the past three years to ensure their growth in the market.

Principle: The main principle involved in freeze drying is a phenomenon called sublimation, where water passes directly from solid state (ice) to the vapour state without passing through the liquid state.

Sublimation of water can take place at pressures and temperature below triple point. The material to be dried is first frozen and then subjected under a high vacuum to heat so that frozen liquid sublimes leaving only solid dried

Freeze dryer/lyophilliser

SR. #

MERITS

DEMERITS

1

Simplified aseptic handling due to ease in processing of liquid

Increased handling and processing time

2

In case of dry powder – enhanced stability

For reconstitution – Sterile diluents required

3

Without excessive exposure of heating of the product water can be removed

Equipment is expensive and complex

4

Enhanced product stability in a dry state

5

Dissolution of reconstituted product – Quick and easy

6

Porous, friable structure

PHARMA ALLY components of the original liquid. The concentration gradient of water vapour between the drying front and condenser is the driving force for removal of water during lyophilisation.

Equipment: There are mainly three types of freeze-dryers: the manifold freeze-dryer, the rotary freeze-dryer and the tray style freeze-dryer. Two basic parts are common to all types of freeze-dryers: a vacuum pump to reduce the ambient gas pressure in a vessel containing the substance to be dried and a condenser to remove the moisture by condensation on a surface cooled. The manifold, rotary and tray type freeze-dryers differ in the principle implied by which the dried substance is interfaced with a condenser. In manifold freeze-dryers a short usually circular tube is used to connect multiple containers with the dried product to a condenser.

The rotary and tray freeze-dryers have a single large reservoir for the dried substance.

Rotary freeze-dryers are usually used for drying pellets, cubes and other pourable substances. The rotary dryers have a cylindrical reservoir that is rotated during drying to achieve a more uniform drying throughout the substance.

Tray style freeze-dryers usually have rectangular reservoir with shelves on which products, such as pharma solutions and tissue extracts, can be placed in trays, vials and other containers.

Manifold freeze-dryers are usually used in a laboratory setting when drying liquid substances in small containers and when the product will be used in a short period of time. A manifold dryer will dry the product to less than five per cent moisture content. Without heat, only primary drying (removal of the unbound water) can be achieved. A heater must be added for secondary drying, which will remove the bound water and will produce lower moisture content.

Tray style freeze-dryers are typically larger than the manifold dryers and are more sophisticated. Tray style freezedryers are used to dry a variety of materials. A tray freezedryer is used to produce the

The design of a lyophilised formulation is dependent on the requirements of the active pharmaceutical ingredient (API) and intended route of administration. A formulation may consist of one or more excipients that perform one or more functions driest product for long-term storage. A tray freeze-dryer allows the product to be frozen in place and performs both primary (unbound water removal) and secondary (bound water removal) freeze-drying, thus producing the driest possible end-product. Tray freeze-dryers can dry products in bulk or in vials or other containers.

When drying in vials, the freeze-dryer is supplied with a stoppering mechanism that allows a stopper to be pressed into place, sealing the vial before it is exposed to the atmosphere. This is used for longterm storage, such as vaccines.

Improved freeze drying techniques are being developed to extend the range of products that can be freeze dried, to improve the quality of the product, and to produce the product faster with less labour.

requirements of the active pharmaceutical ingredient (API) and intended route of administration. A formulation may consist of one or more excipients that perform one or more functions. Excipients may be characterised as buffers and pH adjusters, bulking agents, stabilisers and tonicity modifiers.

Importance in pharma industry This technique is extensively being used in pharma industry in order to increase shelf life of products like vaccines and other injectables. Removal of water from the material and sealing in a vial, the final product can be stored and transported easily and finally

reconstituted to its original form for injection.

Sakar Healthcare has opted for this value added process of lyophilsation to cater as per industry needs.

The lyophiliser with auto loading / unloading and orabs would ensure benefits to esteemed clienteles both - domestic and international.

Sakar Healthcare is ready to manufacture and market brands with enhanced stability and shelf life – with ease in handling and transportation.

With transition to Sakar Healthcare, value added lyophiliser and increased marketing presence across the globe, the organisation is rightly placed at a platform to venture into developed markets with relevant approvals.

Excipients in lyophilised formulation The design of a lyophilised formulation is dependent on the

Open RABS

Row by row loading and unloading system

SR.

GENERIC NAME

DOSAGE FORM

THERAPEUTIC CATEGORY

1

Aceclofenac Injection 150mg

Lyophilised injection

NSAID

2

Aciclovir for injection USP 250mg/vial &500mg/vial

Lyophilised injection

Antiviral

3

Amphotericin-B for injection USP 50mg/vial &100mg/vial

Lyophilised injection

Antifungal antibiotic

4

Azithromycin for injection 500mg/vial

Lyophilised injection

Antibacterial antibiotic

5

Dobutamine for injection USP 250mg/vial

Lyophilised injection

Cardiac tonic

6

Esomeprazole sodium powder for injection 40mg/vial

Lyophilised injection

Proton pump inhibitor

7

Famotidine injection 20mg/vial &40mg/vial

Lyophilised injection

Anti-ulcer

8

Lansoprazole for injection 30mg/vial

Lyophilised injection

Proton pump inhibitor

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PHARMA ALLY VALUE ADD

Sub-visible particles: Satisfying regulatory demands Dr Michael Caves, India Business Development Manager, Malvern Instruments and Dr Namrata Jain, Product Technical Specialist — Nanometrics Bioscience, Malvern Aimil Instruments in this describes how Malvern Instruments provides the technology and expertise required for characterisation and regulatory satisfaction MOST MACROMOLECULAR drugs (proteins, peptides, DNA and RNA) are administered via intravenous (IV) injections and/or through a drug delivery system (DDS) because of their poor oral bioavailability. Development of a viable oral drug delivery system for proteins and peptides requires a careful consideration of their physico-chemical properties (molecular weight, pH stability, hydrophobicity, molecular size, and ionization constant). Therapeutic proteins such as antibodies play a prominent role in the treatment of numerous diseases including cancer and rheumatoid arthritis. However, these proteins have a propensity to degrade and aggregate during manufacture and storage. In addition to affecting the efficacy of a drug, protein aggregation has been implicated in numerous cases of dangerous drug-induced immunological responses, and is the main cause of increasing regulatory concern over protein therapeutics. In recent years, the regulatory spotlight has been shone on sub-visible particles, due to their potential immunogenicity and the difficulties involved in their characterisation. In order to comprehensively characterise biopharmaceutical aggregation, we must take an orthogonal approach and look at the problem from a number of different angles.

The solution SEC is regularly used to assess

38 EXPRESS PHARMA September 1-15, 2015

DR MICHAEL CAVES

DR NAMRATA JAIN Figure 2: Malvern Zetasizer Nano is the market leading technology for measurements of hydrodynamic size and electrophoretic mobility, its reliability and ease-of-use being highly valued by QC departments the world over

Figure 1: Viscotek SEC-MALS 20 is the most advanced multi-angle light scattering detector compatible with any GPC/SEC system

the aggregation state of protein samples throughout the drug development pipeline. Static light scattering (often referred to as multi angle light scattering (MALS)) is used to measure protein molecular weight (MW).

Malvern’s SEC-MALS 20 (Figure 1) is the most advanced multi-angle light scattering detector with 20 light scattering detectors arranged radially around a vertical flow cell. In addition to working in conjugation with Malvern’s Viscotek SEC systems, the MALS 20 detector

is also compatible with any third party SEC system.

Malvern Zetasizer range uses Dynamic Light Scattering (DLS) to detect early aggregates and also to monitor aggregate formation in response to stimuli such as time or raised incubation temperatures of biopharmaceutical formulations (Figure 2). Although this is a low resolution technique relative to SEC, the generation of accurate and consistent results in a short period of time makes DLS an essential

Figure 3: NanoSight Nanoparticle Tracking Analysis (NTA) is a particle-by-particle technique that gives high resolution particle size distribution and concentration analysis, with visual validation giving extra confidence

PHARMA ALLY biopharmaceutical characterisation tool. These two techniques used together provide a wealth of important information about the stability and aggregation profile of a sample.

The Zetasizer Nano ZSP is the premium member of the Zetasizer Nano series designed to provide exceptional sensitivity for enhanced protein characterisation, while the Automated Plate Sampler (APS) system is capable of performing efficient QC and compatibility analysis on a large number of samples without user-intervention. Since the particle size is determined from fluctuations in scattered light intensity due to the Brownian movement of the particles, the fact that the intensity of the scattered light is proportional to the sixth power of the particle diameter makes this technique very sensitive to the presence of large particles.

This can be an advantage where the purpose is to detect small amounts of large particles in relatively pure samples (during QC, for instance), though highly polydisperse samples are difficult to fully characterise using this technique. Moreover, immunogenicity is dependent not only on the particle size but also on level of sub-visible particles (0.1 to 10 Âľm) present in therapeutic protein products initially and over the course of shelf life.

NanoSight Nanoparticle tracking analysis (NTA) is an innovative system that combines laser light scattering microscopy with a high-sensitivity CMOS camera to track, visualise, count and size the particles individually but simultaneously using their light scattering signal (Figure 3).

NTA uses the same scientific principles as DLS, but applies them to individual particles rather than light scattered from many particles. Measurement of the scattering intensity of each particle allows differentiation of particles of different composition in complex mixtures. NTA can also be used in fluorescence mode enabling specific nano particles to be tracked even in complex formulation. The ability to monitor individual particles provides a high resolution size distribu-

Figure 4: (Left) Chromatogram of polyclonal IgG measured by SEC-MALS 20 detector shows the 90 degree MALS signal in orange and RI signal in red and the molecular weight is overlaid in black. (Right) Typical MALS data of IgG showing light scattering signal at 20 measurement angles

Figure 5. IgG aggregates (obtained by heat stress) measured with NTA and DLS. The size distribution (middle panel) with the corresponding NTA video frame (left panels) and 3D graph (size vs. intensity vs. concentration; right panels) are shown

tion profile, whilst visualisation gives additional confidence for process optimisation.

Proof of concept This article describes an IgG antibody formulation study using these Malvern technologies, IgG being the active ingredient in many commercially available biopharma. IgG has a very consistent molecular weight of about 150 kDa which was accurately measured using a SECMALS 20 detector (Figure 4).

This sample also contains a secondary peak of 308 kDa identified as a dimer and finally a third peak of 674 kDa which represents some larger and more polydisperse aggregates.

It can be seen that the molecular weight is stable across the monomer peak and also the dimer peak, with the polydispersity values, calculated using Malvern’s OMNISEC software, of 1.0 for each peak confirming their purity. The larger aggregate fraction formed a sloped molecular weight trace (in

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NanoSight Nanoparticle tracking analysis combines laser light scattering microscopy with a highsensitivity CMOS camera to track, visualise, count and size the particles individually

black) due to the higher polydispersity of this fraction. MALS data obtained from 20 detectors can also be displayed in a 3D plot as shown in Figure 4, showing the data collected for each of the 20 angles.

A heat-stressed IgG formulation was analysed using NanoSight NTA (Figure 5).

Given that the lower detection limit of NTA for proteins is about 30 nm, protein monomers and aggregates smaller than this are not detected by this technique, hence the lack of NTA data for the unstressed sample (DLS reliably sizing the IgG monomer). Figure 5 demonstrates that NTA enabled sizing (and concentration calculation) of a subset of sub-visible particles between 10 and 100 nm in size that DLS could not reliably detect. Contrary to DLS, high peak resolution and suitability for polydisperse samples with the possibility of visualisation and particle count makes NTA a very useful technique for sub-

visible particle quantification.

NTA has proven to be a very suitable characterisation tool for research areas like extracellular vesicles including exosomes, drug delivery and virus nanoparticles, vaccines and protein aggregates with the possibility of live monitoring for heat-induced aggregation, providing information about aggregation kinetics.

An orthogonal approach that gives true comparability The orthogonal approach described here gives confidence in sample purity and aggregate content, giving highly sensitive size and concentration characterisation of protein aggregates in biopharmaceutical formulations. Simple to implement, Malvern’s approach allows you to formulate and manufacture in a way that minimises the presence of aggregates in your final product and demonstrate your product purity to regulatory agencies.

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PHARMA ALLY VENDOR NEWS

Perlen Packaging extends European coating capacity To invest more than CHF 20 million in the extension of its global capacities for pharmaceutical films SWITZERLAND- BASED Perlen Packaging, a global leader in the area of high barrier PVdC films for blister packaging, has underlined their leading position in the PVdC barrier film market in Europe with the extension of their coating line in Perlen. Together with the construction of the manufacturing site in China, Perlen Packaging is investing more than CHF 20 million in the extension of its global capacities for pharmaceutical films.

The extension of the PVdC coating line in Perlen will allow for a more flexible and efficient production, as well as increasing the coating capacity. Jo-

hannes Giessler, Director Sales & Marketing, Perlen Packaging

said, “The pharma markets in Europe are continually grow-

ing and the demand for barrier films is increasing. Thanks to the continuous investments in our technology and our GMP standard production facilities in Germany and Switzerland, we can ensure the continued availability of our high-quality products for the European pharma market.”

“We want to extend this position, as this special market segment will grow above average because of the increasing complexity of molecular structures and global distribution.

As a consequence this requires additional coating capacity, which we are providing with this investment,” added Wolfgang Grimm, Chief Executive

Officer, Perlen Packaging.

“Perlen Packaging is setting up a production facility for the Asian market. The groundbreaking ceremony for the new site took place in Wujiang, China in spring 2015 and the plant will be ready to deliver the first products during 2016.

The Asian pharma markets are showing double-digit growth rates. As the first foreign company to set up a production facility in China, Perlen Packaging‘s aim is to cater to the expected growth in the region and to better serve the markets from a local site,” said Grimm.

EP News Bureau-Mumbai

Honeywell introduces Safyr film for pharma packaging market Safyr is a CTFE-based polymer film with excellent moisture barrier properties HONEYWELL HAS launched Safyr, a high-moisture barrier thermoformable film designed specifically to meet the requirements of India’s domestic pharmaceutical packaging market.

Safyr, pronounced sapphire, is a CTFE-based polymer film with excellent moisture barrier properties that is designed specifically to meet local packaging requirements while remaining cost-effective for the domestic India market. Safyr affords manufacturers with design flexibility, does not yellow over time, has a longer storage life compared to alternatives

40 EXPRESS PHARMA September 1-15, 2015

and requires no pre-conditioning prior to operational use, all while providing superior moisture barrier.

“As a world leader in pharma packaging materials, Honeywell is working to develop industry leading packaging solutions that can deliver increased competitive advantage. Honeywell optimised Safyr to meet regulatory requirements specific to the domestic pharma push through packaging market in India,” said Scott Gaddis, Global Business Leader for healthcare products, Honeywell Packaging

and Composites business.

“Safyr is standardised with one width, one length and one thickness, which helps in process and cost optimisation.”

Key benefits of Safyr Safyr gives flexibility: Safyr is available in a 2 mil (51µ) thickness, and provides an alternative option to cold form foil or foil strip packs as the package format to pass stability. By utilising a thermoforming platform, pharma companies can decrease their pack size versus foil formats and increase pack density, while improving pa-

tient acceptance.

Safyr lowers overall packaging costs: With Safyr films, packaging capacity can be increased with the same line speed, allowing significant reduction in capital expenditure for new or additional blister lines – thus increasing the manufacturer’s overall equipment efficiency (OEE). The reduced pack size means fewer raw materials, including primary packaging material, lid stock and secondary packaging, leading to reduced total cost of goods.

Safyr performs better than

alternatives: Other competitive thermoformable offerings on the market are brittle, require special storage conditions and have shelf-life limitations. In addition, these materials can corrode equipment and tooling during processing, resulting in higher maintenance and tooling costs.

Safyr does not yellow over time; has a longer storage life versus alternatives; requires no pre-conditioning prior to operational use; and will not corrode tooling and equipment.

EP News Bureau-Mumbai

PHARMA ALLY

Thermo Fisher Scientific opens TDC in Bangalore The newly-built centre will house more than 180 IT professionals THERMO FISHER Scientific has opened its new Technology Development Center (TDC) in Bangalore.

The facility will serve as an extension of Thermo Fisher’s information technology team while enhancing its responsiveness to the needs of customers worldwide.

“The newly-built centre will house more than 180 IT professionals who will help grow our technology and operational excellence and provide support to Thermo Fisher’s global IT services,” said Manoj Prasad, Vice President, Information Technology, Thermo Fisher Scientific.

Thermo Fisher continues to invest in India as an IT hub, both for highlyskilled professionals and innovative technology, and plans to expand the TDC to more than 250 employees over the next year. The TDC will leverage technology platforms such as cloud, J2EE, SAP, E1, Informatica, testing, web and database.

“The opening of the global technology centre in Bangalore marks a key milestone in Thermo Fisher’s journey to enhance what is already a world-class IT division,” said Amit Chopra, Managing Director and Vice President/General Manager, Thermo Fisher Scientific India.

“We have more than 50 technology experts who provide unique individual knowledge while maintaining their focus on Thermo Fisher’s mission of enabling our customers to make the world healthier, safer and cleaner,” said Ashish Shah, Leader, TDC IT India, Thermo Fisher Scientific.

EP News Bureau-Mumbai

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Alfa Laval launches rotary jet mixer ALFA LAVAL Rotary Jet Mixer effectively handles liquid and powder mixing, gas dispersion and Cleaning-in-Place (CIP) while reducing time, energy and costs.

In many applications the Alfa Laval Rotary Jet Mixer provides a faster and more efficient mixing than conventional methods. It combines high

blending precision with minimised mixing times and up to 50 per cent reduction in energy requirements. Based on rotary jet head technology, it can be used in tanks between 100 and 800,000 litres in size.

Equipped with two or four nozzles, the Rotary Jet Mixer is positioned below liquid level in the tank.

Liquid is withdrawn from

the tank outlet by a pump and circulated via an external loop to the mixer. It helps reduce operating expenses while achieving fast and efficient mixing. A single Rotary Jet Mixer can handle liquid mixing, gas dispersion and powder dispersion applications – plus tank cleaning – without requiring separate equipment for each process,

thereby delivering significant savings.

Contact details Søren Kragh Alfa Laval Kolding A/S Visit: 31, Albuen - DK6000 Kolding Registration number: 30938011 www.alfalaval.dk kolding.reception@ alfalaval.com

Phenomenex launches Lux Amylose-1 chiral stationary phase PHENOMENEX has added Amylose-1 chiral stationary phase to its high-efficiency Lux polysaccharide chiral column line. The affordable Amylose-1 adds valuable enantioselectivity to the Lux column family with the chiral selector amylose tris (3,5-dimethylphenylcarbamate), and is a guaranteed alternative to other phases with the same chiral selector. Offered in 5µm particles, the new media is available in analytical columns and Phenomenexpatented Axia preparative column hardware, both of which are stable in normal phase, reversed phase, polar organic and SFC conditions.

The Phenomenex Axia preparative format delivers longer column lifetime, higher efficiencies, improved performance and high reproducibility, compared with conventionally packedcolumns for lab-scale preparative HPLC and SFC chromatography.

The expanded Phenomenex Lux chiral column line of six amylose and cellulose chiral selectors comprises an affordable and complementary kit for chiral

42 EXPRESS PHARMA September 1-15, 2015

separations, featuring high efficiency, excellent loading capacity and pressure stability up to 300 bar in a wide range of conditions. Ideal applications for Lux columns include drug enantiomers from the pharma sector, chiral pesticide analysis in agrochemical settings, flavour analysis and production from the food industry, fragrance isolation and commercialisation in cosmetics and a range of other chiral-chemical raw materials such as intermediates and finished goods.

Phenomenex offers free chiral screening services with greater than 90 per cent suc-

cess rates from its PhenoLogix application development group, along with over 2,000 chiral applications online that are easily searchable by compound structure or name.

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

Clean room high speed doors by Gandhi Automations GANDHI AUTOMATIONS an entrance automation and loading bay equipment company is offering clean room high speed doors. Clean room high speed doors are designed for inside applications and protects the environment against draughts, humidity, dust and dirt.

The operating speed and superior sealing properties improve traffic flows and provide environmental control and savings on energy costs.

It has the concept of low air permeability in pressurised rooms with positive and negative air pressure. It has high door efficiency and low permeability values EN 12426 EN 12427 : < 12m3/m2h Δ 50 PA. The doors have high leak

tightness is due to curtain being tightly integrated in special SS 316 satin finish side guides, bottom safety edges and photocells combine to ensure operator safety at all times. It has heavy duty motor: 230V single phase, opening speed upto 1.5 m/s with inverter system and has size upto: 4000 mm (W) X 4000 mm (H).

Contact details Gandhi Automations 2nd Floor, Chawda Commercial Centre, Link Road, Malad (West) Mumbai – 400064 Off : +91 22 66720200 / 66720300 (200 lines) Fax : +91 22 66720201 Email : sales@geapl.co.in Website : www.geapl.co.in

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Optical Particle Analyzers

The CAMSIZER P4 is the new generation of the well-proven CAMSIZER system with patented Dual Camera Technology.

The new analyzer offers improved performance and extended functionalities. n Extended measuring range from 20 Îźm to 30 mm n Faster hard- and software record more particles per second n Particle library and 3D Scatter Plot Software

www.retsch-technology.com VERDER SCIENTIFIC PRIVATE LIMITED | 1-2-45/1, 2nd Floor, Street No: 2 Kakatiya Nagar Colony, Habsiguda | 500 007 Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: info@verder-scientific.co.in

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

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PHARMA LIFE APPOINTMENTS

Dr Shivang Swaminarayan nominated as Member of CCRH, Ministry of AYUSH,GoI He will hold the post for a period of three years DR SHIVANG Swaminarayan, Head – Healthcare Division, Sintex International (Gujarat) has been nominated as Member of Central Council for Research in Homoeopathy (CCRH), Ministry of AYUSH, Government of India for the period of three years. CCRH is the apex research body in homoeopathy of the Government of India.

Swaminarayan held honorary consulting homoeopath at Civil Hospital, Ahmedabad.

He graduated in Homoeopathy & Surgery (BHMS) from Pune (1991) and also pursued his PG studies in health & Family Welfare Management (NIHFW), Rural Development (IGNOU), MBA followed by PG Diploma in International Business from Symbiosis In-

stitute at Pune. He is conferred with MF Hom. (Malaysia).

Swaminarayan is on editorial Board of Asian Journal of Homoeopathy. He is the Chairman of Subcommittee for Ho-

moeopathy at IDMA (GSB) and National Secretary of Pharmacy wing of Homoeopathic Medicinal Association of India. He was Scientific Committee Member and Coordinator, Allied Life Sciences of 66th World Homoeopathic Congress LIGA 2011.

He is instrumental in developing wellness centres in several parts of Gujarat, which is on the way of getting adopted in Public Health as a tool for ‘Better Health at Lower Cost Without Side Effects.’ He has also developed variety of Homoeopathic Kits for domestic first aid and community healthcare.

In 2003, he initiated frugal home-based dairy animal health project for improving productivity using homoeo-

pathic veterinary kit in 20 villages Co-operative Milk Society that was successfully replicated in nearby tribal and rural belt of South Gujarat.

He has been member of mission and task force of various industry association, academic institute of repute and departments of Government of India that includes Information & Technology, Ministry of Commerce, AYUSH Ministry, Central Council For Research in Homoeopathy etc. He currently holds key executive posts on various professional bodies and active in industry associations. He has been Vice Chancellor nominee for Faculty of Homoeopathy in SP University.

EP News Bureau-Mumbai

Soumya Swaminathan appointed as DG,ICMR SCIENTIST SOUMYA Swaminathan has been appointed as Director General, Indian Council of Medical Research-cum-Secretary, Department of Health Research.

Swaminathan is presently Director, National Institute for Research in

Tuberculosis in Chennai.

According to a PTI report, she has been appointed for a period of three years, an order issued by Department of Personnel and Training said. The Indian Council of Medical Research is the apex body for the formulation, coordination and promotion of biomedical research in the country.

EP News Bureau-Mumbai

AWARD

Naveen Amar of Hilleman Laboratories bags awards Receives the ‘100 most influential CFO’s of India’ and Best CFO of the year -Pharmaceutical and Biotech award NAVEEN AMAR, Senior Vice President (Finance, Compliance) and Company Secretary of Hilleman Laboratories, has been honoured with ‘100 Most Influential CFO of India’ award presented by Chartered Institute of Management Accountants (CIMA). He was also awarded Best CFO of the Year

66 EXPRESS PHARMA September 1-15, 2015

(Pharmaceutical and Biotech) at a recently held event in Mumbai.

Speaking on this occasion, Amar said, “I am really blessed to have been honoured with two awards. It is a great privilege when your work is recognised on such a large platform. I am grateful to all those who

have been a part of my journey and to everybody at Hilleman Laboratories who are so supportive and believe in me.”

The award acknowledges CFOs with a proven track record of performance, achievements and contribution to the business. The nominees were judged on criteria such as

strategic perspective, business goal management, risk management, customer focus and business acumen. Hilleman Laboratories also received The Best Financial Reporting (Small Business) at the ‘Most Influential CFO’s of India’ award.

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.

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