Express Pharma (Vol.11, No.7) February 1-15, 2016

VOL. 11 NO. 7 PAGES 60

www.expresspharmaonline.com

Market ‘We are in the process of setting up a $100-million venture capital fund’

1-15 FEBRUARY 2016,` 40

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CONTENTS MARKET Vol.11 No.7 FEBRUARY 1-15, 2016 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

09

REVITALISING INDIAN BIOTECH

RESEARCH

Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka 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 Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

Awakening to the need for a healthy workforce to build successful businesses, pharma firms are introducing a slew of measures to ensure their employees' fitness | P52

22

ELEVEN BIO'S EYE DRUG FAILS ANOTHER LATE-STAGE STUDY

23

TAKING DRUGS FOR DEPRESSION LINKED TO BETTER DIABETES CONTROL

25

HEARTBURN PILLS LINKED TO INCREASED RISK OF KIDNEY DISEASE

MANAGEMENT P8: INTERVIEW ‘We are in the process of setting up a $100-million venture capital fund’

19

SOCIAL MEDIA FOR DOCTORS, THE MOST AWAITED IMPETUS FOR INDIAN HEALTHCARE

P26: INTERVIEW

21

GLIOBLASTOMA TREATMENT MARKET WILL EXPAND FIVEFOLD TO $3.3 BILLION BY 2024: GLOBALDATA

‘We have an unrelenting commitment to quality and delivering results in everything we make and do’

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

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

EDITOR’S NOTE

Acche Din Kab Aayenge?

A

ll eyes are once again on India's Finance Minister Arun Jaitley as he prepares to present the Modi Government's second full budget.

He has hinted that it will focus on reforms and growth but will this intention filter down to the pharmaceutical sector?

Once again Express Pharma asked pharma leaders to come up with their laundry list of demands. Once again, the list had quite a few demands from the previous years, pointing to the fact that these are long standing demands. The plea for increasing government spend on public health and tax incentives for R&D top the list.

(See cover story in the Feb 1-15, 2016 issue: Wish list for budget 2016, pages:18-22) Some of the long standing demands have been met but these remain half done. For instance, policy changes in the clinical trial sector over the past two years have introduced some rationale and science into the regulatory framework but the sector is making the case for more incentives like tax exemptions to CROs involved in biomedical research.

Similarly, on the API side, nothing substantial was done besides naming 2015 the ‘Year of APIs’.

While the government announced a policy to spur manufacture of APIs and reduce dependence on China, we are yet to see this materialise. Besides an API policy, the industry's wish list has Special Economic Zones (SEZs) and rationalisation of the inverted duty structure which would make the sector more competitive and see more entrants.

The ruling government is facing its own test, with the opposition digging its heels on key reforms like GST. The impact of GST on the pharma sector will be substantial so companies are looking for clarity on the finer nuances. The sector will also be hit by global tax rationalisation moves like OECD's BEPS (base erosion and

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February 1-15,2016

If the Modi government wants a good shot at a second term, they will have to bring back some of the euphoria of their first 100 days in office

profit shifting) initiative aimed at curtailing the negative impact of multinational companies' tax avoidance strategies on national tax bases. As these measures will eat into the profitability, so will the increasing span of price control.

Industry analysts have always made the case that the potential of the pharma sector cannot be fully tapped unless the peculiarities of the sector are addressed. The latest salary survey

by HR consultancy Mercer supports the claim to fame with a prediction that the life sciences sector in India will see the highest projected salary increase for 2016 for the second year in a row. In terms of jobs creation, one in two companies are planning to increase headcount with hi-tech, shared services and lifesciences in the lead. Salary hikes and head count increases are a sure shot sign of positive sentiment and steady growth. Obviously, the sector is straining at the leash. It remains to be seen if the Union Budget 2016 will ease some of the pain.

After two years of deliberations and suggestions from over 300 industry representatives, India finally got an updated National Biotechnology Development Strategy 2015-2020 and going by initial reactions, most of the sector's recommendations have been accepted. (See story: Revitalising Indian biotech, pages: 9-11) This could be a hopeful sign that the consultative approach will work in the case of the API and bulk drug policies but unfortunately, the sense is that time is slowly running out for the Modi government. If they want a good shot at a second term, they will have to bring back some of the euphoria of their first 100 days in office.

Let's hope the Finance Minister hits the right note on February 29.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

'We are in the process of setting up a $100-million venture capital fund' Canbank Venture, a wholly-owned subsidiary of Canara Bank, has a good portfolio of investments in several promising sectors. It has recently invested ` 25 crores in clinical research firm Bioneeds. S Thiruvadi, Managing Director, Canbank Venture Capital Fund talks about the company's future prospects to Usha Sharma

Recently, Canbank invested ` 25 crores in Bangalore-based firm Bioneeds India.

Apparently, this deal has been under discussion since the last three years.

Why did it take so long and what were the reasons behind this delay?

The deal has not taken three years. The deal involved about a year of negotiations and concluded in June 2015. Thereafter, on due completion of investment procedures and compliance as per investment agreement, the investment was made in November 2015.

Tell us more about Emerging India Growth Fund. Reportedly, it has a corpus fund of ` 435 crores. In which areas will the company invest?

How important is the life sciences vertical in its growth strategy?

Emerging India Growth Fund is a sector agnostic fund and essentially invests in brownfield companies through equity and quasi equity instruments. It has already invested in several companies in sectors like engineering, healthcare, it, manufacturing, chemicals and consultancy etc. The life sciences vertical is seen

8

EXPRESS PHARMA

February 1-15,2016

as the growth vertical by the fund. Hence, we have some investments in companies operating in healthcare and clinical research organisation (CRO) segment. The commitment period of the Emerging India Growth Fund has already concluded and the fund is fully committed for investments as on date.

help you in doing so?

We are in the process of setting up a $100-million venture capital fund. This is envisaged to be a sector agnostic fund similar to emerging India Fund. The Bioneeds investment experience will enable us to look at profitable investment opportunities in CRO segment from the fund.

What are the unique opportunities and challenges of India's CRO Industry?

We believe that the CRO industry in India is poised for a major take off. Several global multinational companies are looking at India to outsource their research requirements.

Besides, abundant availability of skilled resources, lower labour cost and strong infrastructure make India a favoured destination for outsourcing CRO. The industry is facing the challenge of global players squeezing out mid-sized CROs. A maturity of the industry is expected to result in some consolidation in the sector.

Are you in talks with any other pharma/biopharma/biote ch companies? Are there any more deals in the offering?

We have been approached by some companies in the above space for investment.

However, as the commitment period of Emerging India Growth Fund has concluded and the fund is fully committed, we propose to look at fresh investments in the sector once the new fund of $100 million is set up.

How do you plan to leverage the existing potential of this industry and how would Bioneeds

Who are the contributors in your fifth fund? What stakes do each of them hold?

We have 18 contributors in the fifth fund. This includes leading nationalised banks, SIDBI, IFCI and an insurance company. u.sharma@expressindia.com

MARKET TREND STORY

Revitalising Indian biotech The recently launched National Biotechnology Development Strategy (NBDS) 2015-20 is expected to propel India's biotech industry on an accelerated growth path and help achieve its true potential. By Sachin Jagdale

W

ith the objective of giving an impetus to Indian biotech industry, Government of India established the Department of Biotechnology (DBT) under the Ministry of Science and Technology in 1986. Almost three decades later, the Indian biotech sector has not reached its full potential and not received its due in the international market.

The biotech industry in India, comprising about 800 companies, is growing at an average rate of about 20 per cent. The

Indian biotechnology sector is expected to grow from the current $ 5-7 billion to $100 billion by 2025, growing at an average rate of 30 per cent, as per Dr Harsh Vardhan, Union Minister for Science and Technology.

(Source: http://www.ibef.org/industry/biotechnology-india.aspx).

To boost India's chances of becoming world's biotech hub, Harsh Vardhan recently unveiled The National Biotechnology Development Strategy (NBDS) 2015-20. The industry is optimistic that NBDS will surely put the biotech sector on the growth track.

Hurdles to overcome Former Prime Minister of India, Atal Bihari Vajpayee, had once said that BT (biotechnology) stands for 'Bharat Tomorrow'.

Though NBDS can be considered as an important step in this direction, reasons behind the sluggish growth of the biotech industry in India should also be discussed.

Sharad Dahatonde, Biotechnology Consultant, Elder Pharmaceuticals says, “DBT is very supportive and there have been a number of dispensations offered by both the central government and various states to

encourage the growth of the biotech industry. However, inspite of these steps, Indian biotech industry's global share is just around two per cent.”

Giving reasons for the slow progress, he adds, “We failed to develop and launch patented bio products in international market. We are challenging European and US companies only in the generic bio space. We will have to set up EU/US FDA approvable manufacturing facilities for biologicals. This not only needs finance but also skills to run large bioreactors and processing plants as well as strong

There have been a number of dispensations offered by both the central government and various states to encourage the growth of the biotech industry.

However, inspite of these steps, Indian biotech industry's global share is just around two per cent Sharad Dahatonde Biotechnology Consultant, Elder Pharmaceuticals

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In India, we had to start biotechnology from scratch. The first phase was building the infrastructure. This took a number of years Dr PM Murali President, Association of Biotechnology Led Enterprises (ABLE) India

Increasing the number of trained manpower oriented towards biotech took a significant time Sachin Purohit Managing Director, Genome Biotechnologies

The NBDS involves establishment of a technology development and translation network across India with global partnership Shakthi Nagappan CEO, BioAsia

10

EXPRESS PHARMA

February 1-15,2016

research and development capabilities. Indian biotech companies have to focus on innovation, especially in the biopharma product space. The Indian biopharma regulatory system has seen a lot of changes and structure over the last 10 years, but there seems to be room to shape it further to take on global challenges and face tough competition to achieve global recognition. A clear regulatory framework would also be able to address the inventions and discoveries in the area of biotechnology in a more inclusive manner.”

India is taking time to emerge as a biotech power because we were completely new to this field, feels, Dr PM Murali, President, Association of Biotechnology Led Enterprises (ABLE) India. “In India, we had to start biotechnology from scratch. The first phase was building the infrastructure.

This took a number of years with little money being allocated by the government. The whole sector was built incrementally,” he elaborates. He quips, “The gains of setting up this science will slowly start emerging as tangible benefits.

Every second child uses an Indian vaccine. Is this not credible proof? It would not be wise to be dismissive of the achievement of biotechnology or the department.”

According to Sachin Purohit, Managing Director, Genome Biotechnologies, increasing the number of trained manpower oriented towards biotech took a significant time, as there were lesser career opportunities in biotech as compared to IT etc. “Biotech sector unlike IT, demands lot of capital investment and hence typical investment return period is more. This is a major reason why formation of biotech research facilities in government and private sectors is at a slower rate. Also as compared to the international industry, our spend on biotech R&D is way too minuscule, similar to pharma R&D,” informs Purohit.

Despite all scepticism surrounding the Indian biotech industry, Purohit feels that there is a silver lining to the cloud as well. He says, “However, many

research projects are on the threshold of amazing breakthroughs and hence though late, biotech sector shall certainly come up with major developments from India, in the areas of agriculture, food, clinical research etc.”

NBDS to the rescue?

NBDS was launched twice in November 2007, while its improved version came into being recently in December 2015.

Both these versions aim at promoting bioscience research, education and entrepreneurship.

The latest format of NBDS is the result of formal and informal consultations over the past two years with more than 300 stakeholders. These stakeholders include scientists, educationists, policy makers, leaders of industry and civil society, voluntary and non-government organisations, regulators and international experts. This development has been hailed as the most genuine attempt ever by any Indian Government to make the country a biotech hub of the world.

Murali says, “The whole ecosystem now is on nurturing start-ups. There are several initiatives being taken simultaneously, starting from grants to putting up incubators. We should invest close to $3-5 billion year-on-year.”

The DBT has successfully launched and implemented several schemes mentioned in NBDS. According to Purohit, the start-ups especially have benefitted from the above programmes, directly or indirectly due to the availability of trained

manpower, availability of incubation centres in various cities in India and research schemes for start-ups.

NBDS' major achievement is the strong base of indigenous capabilities it has created, which was hardly evident before. Though big biotech players were always in a position to back themselves in difficult circumstances, NBDS has provided small and medium size biotech companies a platform to grow and sustain themselves in the competition.

Dahatonde narrates the key benefits offered by NBDS. He informs, “PPP models have been successfully implemented and a new section 25 company a Public Sector Undertaking, Biotechnology Industry Research Assistance Council (BIRAC), has been established to exclusively work on PPP programs in biotechnology. BIRAC has a financial assistance scheme called Biotechnology Industry Partnership Programme (BIPP) which is a unique initiative with industry for support on a cost sharing basis for a development of novel and high-risk futuristic technologies in key areas of national importance and public good.

The DBT is operating this scheme to promote and nurture innovation in research in biotech enterprises, specially start-ups and SMEs.” He adds, “Most of the new initiatives announced in the 2007 strategy are in place.

Biotechnology Industry Research Assistance Council (BIRAC) has identified and supported many innovative, na-

tionally relevant ideas/products/processes for further development and commercialisation. A network of technology centres and promotion of startups by Small Industries Development Bank of India (SIDBI) are among the steps taken by the Government of India to promote innovation and entrepreneurship in the agro industry proposed by the Ministry of Micro, Small and Medium Enterprises in a new scheme.”

Shakthi Nagappan, CEO, BioAsia says, “The NBDS involves establishment of a technology development and translation network across India with global partnership, including five new clusters and 40 biotech incubators. These initiatives promise to be largest impact generators and are sure to benefit many healthcare startups. In this context there is a startup showcase being organised with the support of Government of India in the upcoming BioAsia 2016, which will offer a platform for the startups with disruptive ideas in Healthcare, Biotech and Life sciences sector; and mentor them. Startups will benefit from a combined effort that involves government, industry and academia at BioAsia.”

Retaining the biotech talent For the last many years lack of infrastructure and technological facilities have made many Indian researchers shift their base overseas where there are enough opportunities waiting for them. Has losing talent this way hampered the growth of

MARKET the Indian biotechnology sector?

Should bringing back talent also be one of motives of NBDS? Dahatonde says, “Yes. As per recent National Biotechnology Development Strategy, to keep abreast with the latest developments and meet the needs of trained manpower in the rapidly advancing field of biotechnology, it is important to attract talent.

In this context, opportunities for overseas scientists to work in India would be created. Also, skilled post doctorates and scientists should be encouraged to pursue their research activity in India through attractive remuneration. Provisions such as Science Chair would be created to attract the best brains.”

However, Murali feels that red tapism is still a problem in India. Unless such problems are taken care of, convincing overseas biotech talent to come back to India would be difficult..

Murali explains his point of view, “We have been sending mixed messages to the world. On one hand we want people to come and invest and then on the other hand we will not give approvals and bash GMO. How can anybody work if the basic confidence that their hard work will not be translated into a product in the country they have invented it? This could be a strong reason for scientists to move to more liberal locations. Bringing back trained talent will help India to quickly skill a lot of people.

This is one of the effective ways.”

“The aim is to grow the sector to $100 billion. There has to be an ecosystem that needs to be created and also all the enablers including transparent regulatory processes has to be in place.

This would mean good investments to back the convictions.

For this to happen, we have to regularise the ease of doing business, simplify taxation and R&D incentives as well as the treatment of capital and gains by investors. So all these in my opin-

ion are currently going on which has to supplement the NBD strategies,” opines Murali.

While taking a dig at past political bosses for not helping the industry, Murali feels that the current political leadership has kept the industry on the right track. “To Make in India, we need to invent in India,” he stresses.

Conclusion There may not have been a bet-

ter time than this to launch NBDS. Recently, to promote the culture of entrepreneurship the government has announced a slew of incentives including a `10,000-crore corpus for innovation-driven enterprises, a three-year break from paying income tax on profits, a ` 500crore per year credit guarantee mechanism, and exemption from capital gains tax for startups. Initiatives mentioned in NBDS, coupled with incentives

by the government are surely going to boost the morale of biotech companies, specially small and medium sized ones.

Since the Indian biotech industry has shown patience for decades before it received the much needed push by the government, we as a beneficiary of their services should also give them enough time to rearrange themselves. sachin.jagdale@expressindia.com

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Expecting more NBDS is undoubtedly a very effective step towards making India a biotech hub. Indian Government should be applauded for the way they have framed NBDS. It will surely help cover the backlog of the Indian biotech industry. However, experts do feel that future strategies will have a scope to add few more things for the industry.

Purohit expects more focus on applied research when strategy will be underway. He wants foreign collaborations to bring research grants even at individual researcher level, rather than depending only on in house grants. Facilitating implementation of research at the earliest and helping commercialisation through PPP will help the industry, feels Purohit.

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MARKET GROWTH TRACKER

IPM clocks ` 8349 crores in December 2015 The market in Bihar grew the highest at 25 per cent followed by Punjab at 22 per cent

With Bonus Units at Full Value Val in Crs

Rank

CORPORATE

MAT

MAT Dec-15

MTH

IPM

THE INDIAN pharmaceutical market (IPM) has clocked ` 8349 crores in December 2015 and has grown at 11.9 per cent.

Amongst the top 10, Mankind grew by 18.1 per cent, Alkem by 18 per cent and Lupin at 15 per cent. 21 corporates have crossed the growth of IPM for the month of December 2015 amongst top 50. Amongst the top 50 corporate, Hetero had the highest growth of 33.3 per cent followed by Wockhardt at 29.7 per cent and Bharat Serums at 27.8 per cent. 28 corporates have shown growths of more than 10 per cent amongst the top 50.

Amongst the 11-20 ranked corporates, Alembic had the highest growth of 24 per cent followed by Micro at 20.4 per cent and Intas at 20.2 per cent.

Amongst the 21-30 ranked corporates, Wockhardt has the highest growth at 29.7 per cent followed by Cadila at 22.2 per cent and FDC at 16.8 per cent.

Amongst the 31-40 ranked corporates, Hetero grew at 33.3 per cent followed by Bharat Serums at 27.8 per cent and AstraZeneca at 14.5 per cent.

Amongst the 41-50 ranked corporates, Troikaa had the highest growth at 16.8 per cent followed by Wallace at 15.4 per cent and Win-Medicare at 11.2 per cent.

Amongst the 51-60 ranked corporates, Boehringer grew at 60.6 per cent followed by Corona at 39.8 per cent and Centaur at 30.6 per cent.

Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 27 per cent followed by RPG which grew at 23.9 per cent and East India at 19.7 per cent.

Amongst the 71-80 ranked corporates, Samarth grew at 35.3 per cent followed by Walter Bushnell at 21.5 per cent and Roche at 20.1 per cent.

Amongst the 81 -90 ranked cor-

12

EXPRESS PHARMA

February 1-15,2016

porates, Galpha grew at 41.2 per cent followed by Med Manor, which grew at 35.6 per cent followed by Jagsonpal at 17.9 per cent.

Amongst the 91- 100 ranked corporates, Ozone grew at 47 per cent followed by Veritaz at 29.5 .per cent and Dey’s Medical at 28 per cent. The 100th biggest corporate is Gland Pharma and 150th biggest corporate is Claris in the IPM. Mercury entered the top 150 corporate as on MAT Dec 2015.

Indian companies have grown at 13.4 per cent versus 7.1 per cent for MNCs in December 2015. Amongst the top 50 in MNCs, AstraZeneca by 14.5 per cent followed by MSD at 11.5 per cent and Janssen at 8.8 per cent.

Under the non-NLEM category, Indian companies grew at 14.5 per cent whereas MNCs grew at 6.8 per cent. The NLEM containing molecules market grew at 7.5 per cent whereas the non-DPCO market grew by 12.7 per cent and NonSch Para 19 market at 2.9 per cent resulting in an overall growth of 11.9 per cent for December 2015.

NLEM and mon-NLEM category showed unit growth at 4.7 per cent and 3.8 per cent respectively. The non-Sch Para 19 market grew at 2.9 per cent from units perspective.

From therapy perspective, 10 therapies have outgrown the IPM growth. The respiratory market grew at 18.1 per cent, gastrointestinal market grew at 13.2 per cent, pain and analgesics market grew at 11.3 per cent whereas anti-infectives grew at 14.4 per cent. The antidiabetics market grew at 15.1 per cent and cardiac at 9.4 per cent in chronic business. The derma market grew by 11.4 per cent and the urology market at 12.7 per cent. The cardiac mar-

Dec-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

96289

100.00

14.4

8349

100.00

11.9

Sun + Ranbaxy

1

1

8472

8.80

14.0

737

8.82

9.2

Abbott + Abbott HC + Novo

2

2

5975

6.21

14.7

510

6.11

7.3

Cipla

3

3

4804

4.99

16.3

438

5.24

16.7

Zydus + Biochem

4

4

4013

4.17

11.6

342

4.09

8.6

Mankind

5

5

3522

3.66

18.1

310

3.71

18.1

Alkem + Cachet + Indchemie

6

7

3334

3.46

11.8

286

3.43

18.0

Lupin

7

6

3329

3.46

18.0

290

3.48

15.0

Glaxo

8

8

3174

3.30

6.1

275

3.29

8.2

Pfizer

9

9

2868

2.98

14.2

245

2.93

0.9

Macleods

10

10

2782

2.89

15.6

243

2.91

13.2

Intas

11

11

2699

2.80

23.8

242

2.90

20.2

Emcure + Zuventus

12

13

2541

2.64

10.1

213

2.55

6.9

Aristo

13

16

2391

2.48

17.4

194

2.32

16.4

Sanofi India

14

14

2373

2.46

15.1

210

2.51

4.0

Glenmark

15

12

2285

2.37

25.5

216

2.59

18.6

Torrent

16

17

2241

2.33

20.4

187

2.24

3.7

Val in Crs

MAT Dec 15

Month Dec-15

Super Group

MAT Dec 15

Gr%

Month Dec-15

Gr%

IPM

96289

14.4

8349

11.9

ANTI-INFECTIVES

14736

9.9

1261

14.4

CARDIAC

12022

15.0

1060

9.4

GASTRO INTESTINAL

11276

16.3

917

13.2

VITAMINS / MINERALS / NUTRIENTS

8603

11.3

696

4.9

ANTI DIABETIC

7759

24.2

694

15.1

RESPIRATORY

7572

14.6

783

18.1

PAIN / ANALGESICS

6651

12.6

563

11.3

NEURO / CNS

5906

14.9

526

12.5

DERMA

5759

17.7

516

11.4

GYNAECOLOGICAL

4707

11.5

386

8.5

VACCINES

1682

17.6

141

16.2

HORMONES

1631

12.2

144

12.2

ANTI-NEOPLASTICS

1571

12.5

128

4.4

OPHTHAL

1394

13.6

115

6.1

BLOOD RELATED

1117

14.4

91

8.5

UROLOGY

1048

19.6

88

12.7

OTHERS

1039

24.1

96

27.3

ANTI MALARIALS

554

2.9

34

-6.3

SEX STIMULANTS / REJUVENATORS

535

14.4

49

3.2

STOMATOLOGICALS

393

7.9

33

4.6

OPHTHAL / OTOLOGICALS

221

-1.9

17

-0.1

OTOLOGICALS

112

8.2

10

29.6

MARKET ket have crossed ` 12k crores and the difference between cardiac and GI market now stands at ` 746 crores.

From regional perspective, 15 regions have outgrown the IPM growth. The Bihar market grew the highest at 25 per cent followed by Punjab at 22 per cent and Jharkhand at 21.1 per cent. The Tamil Nadu market grew at 8.1 per cent and two regions had negative growth.

Amoxycillin + clavulanic acid market grew at 16.4 per cent and glimepiride + metformin market grew at 10.9 per cent.

The markets of paracetamol grew at 37.4 per cent, atorvastatin 3.7 per cent, probiotic microbes at 22.9 per cent, cefixime 10.8 per cent, pantoprazole 13.2 per cent, montelukast + levocetrizine at 13.9 per cent, glimepiride +

metformin + pioglitazone at 14.5 per cent, Vitamin-D at 20.2 per cent, hydroquinone + mometasone + tretinoin at -9.1 per cent, voglibose + metformin + glimepiride at 30.9 per cent, rosuvastatin at 16.2 per cent, protein supplements at 5.2 per cent, azithromycin at 19.4 per cent, calcium carbonate + Vit D3 market at -1.8 per cent, paracetamol + phenylephrine + chlorpheniramine at 16.3 per cent.

Mixtard leads the pack with ` 34 crores followed by Corex at ` 30 crores, glycomet GP and augmentin at ` 28 crores.

Few brands who have gained ranks include Meronem (+94), Unwanted Kit (+56), Rotarix (+52), Trajenta (+35), Spasmoproxyvon Plus, Januvia (+27), Betnovate C (+26), Vertin (+23), Azithral (+22), Panderm Plus (+21), Rantac, Telma H

(+19), Ultracet, Gluconorm G, Jalra M (+18), Mucain (+17), Ascoril Plus (+16), Calpol, Budecort, Betnesol (+15), Orofer XT, Betnovate N (+14), Telma, Zifi, Rosuvas, Levipil (+13), Dolo (+12), Pan D, Eltroxin (+11), Galvusmet (+10), Pantop, Allegra (+9), Jalra (+5), Sinarest (+4) amongst top 100 brands. Few brands that have moved up ranks fastest into Top 300 vrands for the month of December 2015 are Havrix, Ocid, Anafortan, Vaxigrip, Grafeel. The 300th biggest brand is Bio D3 Plus from Macleods.

A total of 234 brands and 396 SKUs were launched in December 2015. The top new brands were Dacihep, Loftair, Vilamid and Osmopres.

Two Teneligliptin brands were launched. They were Tenlimac and Teneza. Within the VMS

category, Ultra CO-Q (Meyer), Nervijen NP (Jenburkt), BD and D3 (Delvin), Theloxin C (Sundyota) and Gemshell (Mankind) were launched followed by Riax & Riaxm XR launch in Saxagliptin market from DRL in the anti-diabetic category. In the respiratory segment, Albutamol Plus (Centaur), Macbery DX (Macleods), Derisal (Zydus), Viscodyne LS Plus (Wockhardt), Lesafe (Saffron) were launched. There were three launches in Carica Papaya market. They were Caripap, Minmin PB and Platimax. Ledihep was the biggest launch in Sofosbuvir + Ledipasvir Market and Dacihep in Daclatasvir market and by an MNC was Lobun in December 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.aiocdawacs.com/

Partikelmess- und Analysesysteme

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cover )

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THE MAIN FOCUS

The Union Budget for FY17 should provide taxincentives for R&D activities in the country

RANJANASMETACEK Director General, OPPI

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015 has been a mixed bag!

Prime Minister Modi’s 'Make in India' vision, to transform India into a global manufacturing hub, presents huge potential for the pharmaceutical sector.

The pharma and healthcare industries in India are expected to grow to $45 billion and $250 billion respectively by 2020, with patented drugs expected to grow at an aggressive CAGR of 20 per cent.

In 2016, our foremost expec-

tation is an increase in the government expenditure on public health. We request that the government increase the healthcare budget from the current one per cent to at least 2.5 per cent over the next two years.

Implementing the promised Universal Health Assurance programme will benefit patients and increase access. We would also like to see the Union Budget for FY17 provide tax incentives for R&D activities in the country, either by way of a tax holiday or by extending the sunset clause on weighted deductions. This will go a long way in transforming India into an innovation hub for pharma products.

On APIs In order to avoid over dependence on China for import of Active Pharmaceutical Ingredients (APIs), we expect a robust policy to boost the manufacture of APIs. Secondly, steps need to be taken to create adequate infrastructure. From a tax point of view, investmentbased tax incentives such as

Special Zones for manufacture and export of APIs and Special Package Schemes similar to Modified Special Incentive Package Scheme (M-SIPS) or Electronics Manufacturing Cluster Scheme could be declared.

On direct tax While the government plans to phase out weighted deductions in light of the proposed lower corporate tax rates, it is important to provide an impetus and incentives for R&D activities to be carried out in India. Providing for a tax holiday or a lower rate of tax for income derived from R&D activities and benefits in the form of research tax credits which can be used to offset future tax liability (similar to those given in developed economies) could also be introduced. This could be introduced with a sunset clause of at least five years in order to ensure growth of R&D activity in India.

On indirect tax Under the current excise regime, inputs i.e. APIs attract

higher rate of excise at 12.5 per cent whereas the output is taxed at six per cent. Given the inverted duty structure, credit of excise duty paid on procurement of APIs used in the manufacture of finished formulations has typically resulted in accumulation of CENVAT credit, a cost to manufacturing entities, as the complete amount of duty paid on inputs cannot be set off against the output tax liability. Further there is no provision to recover the accumulated tax credit. The excise duty rate of APIs should be rationalised and made at par with pharma goods i.e. GST on the inputs (APIs) should be reduced from 12.5 per cent to six per cent. The same should also be rationalised in the proposed GST regime where the inputs are eligible for a credit of 10 per cent whereas the output CGST rate is six per cent.

Under the Central Excise Act, 1944, an abatement of 35 per cent is allowed for the purpose of levying excise duty on pharma. An abatement of 45 per cent to 50 per cent is nec-

essary to enable the industry to cover its costs while calculating the excise duty payable. Moreover, there are other industries such as clocks (43 per cent), mineral water (50 per cent), glazed tiles and vitrified tiles (45 per cent) that enjoy a higher abatement percentage. There are increased expenses that need to be incurred by pharma companies. Further, the rate of excise duty (as well as proposed GST) has also increased from five per cent to six per cent.

Therefore, this abatement on pharma should be increased 45 per cent to 50 per cent as the current 35 per cent abatement does not even cover the trade margins and the value of R&D costs and other costs associated with the pharma industry such as distribution of many medicines through the cold chain (e.g. vaccines). There remains ambiguity between customs and transfer pricing on pricing of imports. It is imperative that uniformity be brought between the methods and results of both these critical components.

‘Taxexemption/incentives for pharma and biotech manufacturers as part of Make in India initiative’ ■ Tax benefits should be given on manufacture and sale of medical devices/equipment manufactured in India. Since medical device manufacturing is one of important sectors as a part of the Make in India initiative, giving tax incentives or a tax holiday would boost this sector and lead to provision of economical devices to the patients in India.

■ Tax exemption should be given to CROs involved in preclinical research. This is a long standing demand and would enable more companies to do research and development that may increase India’s visibility in this sector.

■ Reduction in customs duty on medical devices/equipment that are not manufactured in India

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would lead to reduction in price that would ultimately benefit patients.

■ Tax exemption/incentives for pharma and biotech manufacturing companies as part of Make in India initiative will be a welcome step to boost the sector ■ Tax incentives/exemptions to e-health service providers/ telemedicine companies. These

companies provide access to healthcare services. We need more such companies to cover areas that do not have access to healthcare or even semi urban areas that don’t have access to speciality expert care.

■ Weighted deduction under Section 35 (2AB) to atleast 250 per cent. It will help boost research

DR MILIND ANTANI Nishith Desai Associates, Legal & Tax Counseling Worldwide

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cover ) ‘We hope that healthcare R&D will be Govt to set-up pharma clusters to encourage given an impetus in the budget’ production of APIs

SUNEELATHATTE President, ISCR

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015 saw the introduction of a more rational, balanced and scientific regulatory framework being built for the conduct of clinical research in

India with amendments in several rules and guidances.

We need to ensure that we continue on the trajectory to build an enabling environment in India to encourage a scientific temperament and research.

Given the fact that a sixth of the world’s population lives in India and we have the highest disease burden in the world, we need to foster an environment and ecosystem that encourages clinical research. We hope that healthcare research and development will be given an impetus in the budget. This will encourage local innovation and ensure that ‘Make in India’ and ‘Make for India’ becomes a reality in our sector. There is

path-breaking research being done in our academic institutions. We need to ensure that this is recognised and encouraged so that our patients can benefit from the access to better, safer and more affordable healthcare such research makes possible.

We also hope that there will be a rethink on the withdrawal of exemption on service tax for clinical trials which was introduced two years ago. The withdrawal of the service tax exemption makes the process of drug development more expensive and acts as a deterrent to the culture of research and innovation that needs to be encouraged, in the domestic industry in particular.

DR PVAPPAJI

There is hardlyanyfavourable expectation from the budget this year

TS JAISHANKAR Managing Director, Quest Life Sciences

T

here is hardly any favourable expectation from the budget this year for the pharma industry.

With GST around the corner, it will be an additional exercise in costing for every molecule and this is not expected to

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bring in any benefit to the pharma sector other than simplifying tax returns. Initiatives like Make in India, Digital India, and Skill India, introduced by our Prime Minister are yet to have any visible impact in the country. In the past, we have seen increased budgetary allocations for healthcare schemes with little or no allocations for pharma companies.

There have been repeated demands for incentives on R&D expenditure. The pharma industry is getting crippled with erratic price control, there is hardly any incentive for R&D, even for generic drugs, leave alone R&D for drug discovery.

Unless the pharma industry capitalises on the number one position achieved so far globally, the industry will have to face severe competition from China.

The government is contemplating a disproportionate increase in fees by almost 200 to 500 per cent. The sector cannot withstand such high regulatory fees.

The trade margins are also being reviewed. The government should try to control the retail sector rather than penalise the manufacturers. The uniform code for pharma marketing should be reviewed practically in consultation with the industry associations. The government is further tightening the good manufacturing practices (GMP) but is not willing to liberalise price control. The pharma sector is one of the biggest exporting industries in the country; so it is high time that the government formed a separate Ministry of Pharmaceuticals rather than clubbing it with the Ministry of Chemicals and Fertilizers.

Director General, Pharmexcil

I

ndia’s pharma industry today plays a pivotal role as a global pharmacy. India is able to make all its formulations requirement from the domestic industry as well as exports. We are also fairly strong in the API sector, but we are now importing intermediates mostly, early stages of it and then taking over the further process.

To enable more selfsufficiency which ensures smoother supply as well as full control of quality, both for domestic requirements and exports, we need to invest more in this sector. Besides, we have an opportunity as many of European units are now being retired and the companies running them, are looking at both China and India as alternatives. To derive maximum mileage from the present global scenario and to support the industry to go to the next level we may need modifications as suggested below in the existing laws. FIPB route to be

exempted for companies primarily deriving revenues from intermediates/APIs /biotech APIs business which are less than five years old and have net revenues of less than `1500 crores.

Loans advanced to API/ intermediates or biotech API industries should be treated as loans advanced to priority sector. Government to set-up pharma clusters to encourage production of APIs and intermediates, especially of fermentation units. This would encourage many MSME sectors to scale up their quality and production levels by accessing these facilities and compete better in international markets. Formulations, which are referred under ‘Listed Drugs’, are imported for the purpose of demonstrating bioequivalence of generics before obtaining market authorisations. The industry requires these studies to be bracketed along with clinical trials for the purpose of exemption of import duties.

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THE MAIN FOCUS

‘The Government of India needs to establish a policy frameworkfor the Indian clinical trial industry’

VIJAYPATEL ACRO India Chairman.

I

ndia has yet to cover a lot of ground. Clinical trials are the need of the hour because they allow access to better medicines in the future, thus resulting in significant medical advances.

Ensuring proper compliance with regulatory norms will ensure that India continues to reap the benefits of clinical trials and the poor and vulnerable population is protected against exploitation for the purpose of research.

However, it is yet to be seen whether or not the new regulations will deter the clinical trials industry from continuing its operations in the long run. How can India benefit technologically as well as build capacity for future R&D and innovation in the pharma sector?

There is an expectation that India could gain financially and scientifically through clinical trials. The Government of India needs to establish a policy framework for the Indian clinical trials industry to provide easy access to affordable drugs developed through adaptive clinical trials in India.

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cover ) 'Rolling out the long pending GSTprovisions is the need of the hour'

HITESH SHARMA Partner and National leader – Life Sciences, EY

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he pharma sector is one of the more crucial sectors to the Indian growth story. Being the third largest market on the globe in terms of volume and thirteenth in terms of value, the Indian industry has grown from strength to strength and continues to contribute heavily to

the country’s economy.

Through the last budget, the Finance Minister announced a slew of long-term measures, including the reduction in corporate tax rates, though at the same time reducing the incentives (with the rationale of reducing tax disputes and uncertainty). The industry in itself is highly competitive and research driven. In such an industry, innovation is the key to success and growth. This was coupled with the revision in National List of Essential Medicines 2015, benchmarking the prices of key medicines has led to impact on industry profitability. Further, in the healthcare space, there is a tremendous need and scope for large investment to provide access to basic healthcare to all. Accordingly, there is a case for the Government to consider providing the requisite impetus to the industry to attract investment and enable it to scale up to meet the deficient requirements of the coun-

try. Hence, it would be vital for the FM to strike a fine balance between doing away with incentives and incentivising capital outlay and research to generate needed economic activity in this industry.

The industry’s demands from this budget are: ■ Incentives for expenditure incurred on R&D activities ■ Incentives for setting-up and operating entities in backward areas ■ Detailed guidelines for transfer pricing aspects of key transactions (including intangibles) ■ Incentives for investment in healthcare infrastructure/ setting up of hospitals ■ Address concerns on inverted duty structure and roll out of GST Changes in the international tax arena, in view of Base Erosion and Profit Shifting (BEPS) project, will provide a new angle to Budget 2016. With the pharma industry characterised by centralised manufacturing,

R&D, intellectual property, etc., the FM has the tough task to ensure a balanced approach of implementing the proposals under BEPS. On this front, he will have to consider the valuedrivers of the industry and carefully role out provisions (including country-by-country reporting), provide practical examples/guidelines, ensuring that it does not result in disruption in the industry.

The transfer pricing arena has seen much unwarranted litigation. With several companies being multinational conglomerates there is a dire need to frame clear guidelines for benchmarking of key transactions around manufacturing, R&D, IP, marketing spend, etc. Further, companies face a dichotomy for the price of their import of APIs and raw materials, with customs (Special Valuation Branch), demanding higher import prices.

On the indirect tax front, rolling out the long pending GST provisions is the need of the

hour. While the government is taking efforts to bring in the law, attention is also required on impact of provisions on the industry, given the peculiarity of business model and existing duty structure. In the interim, the government may consider addressing issues surrounding the ‘inverted duty structure’.

There is little doubt on the dynamic potential of the Indian pharma sector, which is projected to scale upto $100 billion by 2025. However, considering the state of the fiscal deficit and the slurry of changes in the tax environment like BEPS and GST, it seems that the FM will be walking a tight rope. While the ‘list of wants’ by the industry will be enormous, it will be interesting to see how many of them find their way into the Finance Bill, and more importantly, in what form!

(With inputs from Himanshu Tanna, Director, International Taxation Services, E&Y)

There should be a reduction in import duties of med devices

T

RANJITSHAHANI Vice Chairman & Managing Director Novartis India

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here is a great desire to develop India as a drug discovery and innovation hub. Benefits by way of research tax credits which can be used to offset future tax liabilities need to be speedily put in place. For those who are already in the business of R&D tax benefits should be granted as deduction from profits linked to these investments.

The service tax exemption which was earlier available for clinical trials on newly developed drugs should continue so that India remains competitive in this field. Neighbouring countries such as Bangladesh, Malaysia and even Singapore are emerging as new hubs for such trials

and this will hurt us in the long run. Alternately, necessary amendments should be made in the place of Provision of Service Rules, 2012 so that clinical trials or R&D services conducted for foreign service recipients should qualify as export of services and not attract service tax in India.

With the rising cost of healthcare, the limits for deduction of health insurance for individuals and senior citizens need to be further increased. It would be a big boon to patients who suffer from critical illnesses if life-saving drugs are made available to them at reduced prices through reduction in duties applicable to these drugs. Similarly, there should be a reduction in import

duties and levies on medical devices and diagnostic equipment and consumables for detecting life-threatening illnesses as these will also be to the benefit of patients. The recommendations of the Chelliah Committee are yet to be implemented in spirit and rationalisation of customs duty for formulations needs to be done as a first step.

The pharma industry receives an abatement of 35 per cent on medicines while calculating the assessable value for the purpose of excise duty.

Industries such as clocks and glazed and mineral tiles and even mineral water receive a higher abatement. This is certainly an anomaly that needs

to be corrected. It would be in order for the pharma industry to receive abatement in the region of 45 to 50 percent.

These are but some of the steps the Finance Minister needs to take if the promise of Universal Healthcare for all is to be achieved. These together with creative policies will go a long way in creating an ecosystem that will not only encourage innovation but one that will actually serve to deliver top notch healthcare in the country.

The time has come to act and Budget 2016 presents the government and its Finance Minister this opportunity.

Compiled by Usha Sharma

MANAGEMENT INSIGHT

Social media for doctors,the most awaited impetus for Indian healthcare Phanish Chandra, CEO and Co-founder, Docplexus Online Services in this insight article gives an overview of about the relevance of social media in pharma and healthcare sector

PHANISH CHANDRA, CEO and Co-founder, Docplexus Online Services

EVER EVOLVING landscape in information technology has brought about innovative ways of engagement for communities.

An effective social media platform caters to the needs of its users as a community. While in return, extensive valuable insights are available for the stakeholders, which interact with the community.

The digital age has transformed how information is shared amongst humans. The Internet initially started providing means to obtain information.

Now the Internet is not only a huge database for information but has evolved as an essential tool for communication that spreads across the edges and corners of the world. This shift in technology has taken all the aspects of life in its strides. This emerging trend is now set to bring about revolution in the

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MANAGEMENT healthcare sector too.

The explosion in the social media began in 2000 with LinkedIn being launched in 2002, MySpace in 2003, Facebook in 2004, YouTube in 2005 and Twitter in 2006. Each of these platforms initially started as a person-to-person communication channel. These social media channels have penetrated our lives in such way that we find them imperative for communicating between us. These new platforms also brought about different and innovative ways of interactions for person-to-person and community-to-community communications.

tantly, the insights from such platforms provide ethical ways of facilitating each other.

What our knowledge tells us From our knowledge at Docplexus, we have gained very vital discernments regarding the healthcare sector in India. The platform recognises various factors related to users which are beneficial to pharma companies.

These benefits are now helping to devise more efficient, controllable and targeted approach of marketing.

Social media and its relevance in healthcare sector The boom in social media has encouraged many to find innovative ways in order to position themselves. Businesses needed new approaches to adapt to these platforms so innovative ways of marketing can be utilised. Somewhat static marketing approach has now been changed to much more responsive dynamic approach.

Even though various sectors are moving to multi-channel marketing, the healthcare sector is still a laggard. It was assumed that the use of Internet is only for acquiring the information which mattered in research. But the notion is slowly changing but positively. Many pharma companies, one of the larger stakeholders in healthcare industry, are trying to brace themselves for this emerging trend. But they are finding themselves in a very tight spot due to various reasons such as: 1. Tight external and internal regulations for marketing 2. Inadequate knowledge and experience 3. Fear of damaging the established brand Pharma companies missed the first boat due to the anxiety regarding social media. However, new innovative options are raising up from the horizon. The most significant of them is contributed by a closed-community of the doctors.

As we already know, the healthcare sector has three most important stakeholders: 1. Patients 2. Doctors 3. Pharma and healthcare

20 EXPRESS PHARMA February 1-15,2016

product companies The doctors are considered as the most important stakeholder in the healthcare ecosystem and also for patients for their well being. Similarly, doctors are most important contributors for pharma companies in order to market their products.

Even though regulations from Medical Council of India(MCI) and guidelines for International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) prohibit pharma companies to market their products directly to the patients, doctors remain most important participant in the healthcare ecosystem.

Docplexus recognised these insights and built social media platform exclusively for the doctors in India. Larger social media platforms such as Facebook show some really interesting intrinsic characteristics which can be incorporated in parts, in a highly specific social media platforms for doctors.

Features of best social media platform It is important that social media platform which specially caters to doctors, must have a benchmark that suits the interests and expertise of the doctors. It is important that the platform abides to the strict rules regarding the participation. Features which distinguish such platform are:

1. Stricter rules for registration: Rules for registration on these platforms need to be stricter than conventional social media platform like Facebook, where mere email address can grant an access to the user. However, for the platform catering to the doctors the registration is slightly more stringent and doctors need to provide their credentials in order to register 2. Well-gated access to the members: The platform needs to be well-gated to ensure only qualifying participants are contributing to the highly specialised community.

3. Adequate control on the content: As the platform is for professionals, there needs to be quality control regarding the content which has been posted.

Time-to-time irrelevant content needs to be taken care of.

4. Generating suitable content: Social media platforms are dynamic and need continuous flow of relevant content. At Docplexus, highly relevant content is generated regularly to stimulate community contribution.

Pharma and healthcare companies benefit from such platform. The attributes mentioned above are in line to help both doctors and pharma companies equally. A mutually beneficial relationship between the patients, doctors and pharma companies is bound to provide a win-win outcome for all. Most impor-

Some of these features and benefits are: Aggregates huge community of doctors at one virtual place. Historically, the doctors had limited connection with other doctors across India. The new social media approach is bringing them at one virtual site, empowering the community. We have also seen that doctors have now begun setting collective goals with respect to their practice, issues and concerns. Anyone who genuinely has an interest to help them in these is very well appreciated.

Associates the doctors of specific speciality and interests with each other. These doctors spanning pan-India can be easily identified as per their speciality by pharma companies and their needs can be adequately addressed.

Assists in collaboration between the doctors. Doctors often stumble across difficulty in clinical treatment of patients. A large number of doctors have started sharing their advices and views regarding clinical difficulties which other doctors face. As the platform also actively protects patient identity, essential knowledge is shared between the doctors without any hesitation.

Pharma companies have a great potential to collaborate with doctors in this particular area. It is possible to identify the areas of concerns for the doctors which pharma companies can address.

The symbiotic relationship thus helps doctors’ community as they are provided with additional knowledge resources.

Attention to the best practices and therapies. Doctors are very much aware about their online presence. While on other

communities, they remain dormant regarding in their area, on Docplexus they strive to promote best practices and therapies they feel are suitable for their peers. Often these practices are specific to a particular drug regimen or a device that left a good impression on them.

Thus the platform provides an additional opportunity for pharma companies to identify and promote these practices.

Most importantly, online reputation is very crucial for doctors.

Hence, they only recommend the practice and the drug they have tried, tested and have benefited from. Pharma companies can assist these doctors ethically in their clinical endeavours, by addressing clinical problems they face.

Assists in knowledge sharing amongst the doctors. Most of the doctors are satisfied when their professional, practice-related and educational issues are resolved. Continuously generated relevant content assists doctors in remaining informed and up to date with the knowledge. This provides an opportunity for not only pharma companies but other knowledge providers too, to deliver the content on demand.

This is how we play our game By aiding the doctors in their specific needs, pharma companies can now build their brand more effectively and ethically.

Docplexus offers an exclusive access to unique and genuine customer insights on perceptions, attitudes and behaviours of the medical community. Healthcare and pharma companies' profit from exceptional innovative communicational opportunities that can drive best-in-class relationship-oriented customer and KOL interaction, communication and insight. Our business mission is to help companies to transform their version of the new commercial model into actionable programmes that create results.

By Phanish Chandra CEO and Co-founder Docplexus Online Services Pvt. Ltd. Pune, India www.docplexus.in Email: sales@docplexus.in

MANAGEMENT REPORT

Glioblastoma treatment market will expand fivefold to $3.3 billion by 2024: GlobalData Japan will see the most impressive relative growth, with sales expanding from $47 million in 2014 to $268 million in 2024 THE GLIOBLASTOMA treatment market will increase fivefold from $659 million in 2014 to $3.3 billion by 2024, representing a rapid Compound Annual Growth Rate (CAGR) of 17.4 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this meteoric rise, which will occur across the seven major markets (7MM) of the US, Spain, France, the UK, Italy, Germany and Japan, will primarily be due to the launch of new therapies for glioblastoma patients with high unmet needs.

Maxime Bourgognon, Analyst, GlobalData covering oncology and haematology, says, “Adults with glioblastoma have some of the highest levels of unmet need of any cancer patients. Despite progress having been made in treating the disease, survival rates remain low. Although glioblastoma is a rare disease, such high levels of unmet need in the market have created ample opportunities for players with effective therapies. However, developing drugs which effectively treat glioblastoma has proved exceedingly challenging to date, predominantly due to the presence of the blood-brain barrier, which prevents many drugs from entering the brain and attacking the tumour.”

GlobalData believes that current pipeline drugs offer potential solutions to this complex obstacle, and has identified Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) as a particular contender to become the primary standard of care by 2024.

Bourgognon explains, “Immunotherapies have shown significant efficacy in other oncology indications, and as they affect the tumour microen-

Of the 7MM, Japan will see the most impressive relative growth, with sales expanding from $47 million in 2014 to $268 million in 2024, representing a CAGR of 19.7 per cent vironment rather than directly targeting the tumour, they make attractive candidates for glioblastoma treatments. Currently, Avastin dominates the market, working by inhibiting angiogenesis and disrupting the bloodbrain barrier, which in turn leads to tumour starvation. Patients refractory to the drug, however, have scant treatment options, and Opdivo addresses this.”

Of the 7MM, Japan will see the most impressive relative growth, with sales expanding from $47 million in 2014 to $268 million in 2024, representing a CAGR of 19.7 per cent.

As with the rest of the 7MM, growth will be driven by the introduction of new drugs such as Opdivo.

However, higher pricing of the drug in Japan will result in the country’s even faster growth rate, according to GlobalData.

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EP News Bureau-Mumbai

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RESEARCH RESEARCH UPDATES

Eleven Bio's eye drug fails another late-stage study Eleven Bio said it does not see an immediate path ahead for the drug ELEVEN BIOTHERAPEUTICS said its lead eye drug failed in a late-stage trial in treating patients with severe allergic conjunctivitis. The drug, codenamed EBI-005, failed to show statistically significant difference in treating ocular itching, compared with the vehicle arm, the company said.

Eleven Bio said it does not see an immediate path ahead for the drug, now named isunakinra, in allergic conjunctivitis. The company in May pulled the plug on developing the drug to treat dry eye disease after a failed

late-stage study. Eleven Bio said it would focus on testing EBI-031 in patients with diabetic macu-

lar edema (DME), a type of eye disease that could lead to blindness. The company said it plans to submit in the first half of 2016 an application with the US FDA to start clinical trials for DME. Allergic conjunctivitis, commonly called "pinkeye", is an acute infection of the eye. It might be viral or bacterial, or may be caused by allergies or chemical irritation. The infection is usually spread through contact with infected secretions from the eye, nose or throat.

Merck, BioLineRX to study drug combo to fight pancreatic cancer BL-8040 acts against CXCR4 receptors

Reuters

ISRAELI biopharmaceutical company BioLineRX said it would collaborate with US industry heavyweight Merck to test a combination of drugs for the treatment of pancreatic cancer. The companies will partner in a mid-stage study to evaluate the safety and efficacy of the combination of BioLineRx's BL-8040 and Merck's Keytruda in patients with metastatic pancreatic adenocarcinoma. "Because certain tumors exhibit only a modest

shown in several clinical trials to mobilize immune cells and to be effective at inducing direct tumor cell death. Keytruda, an antibody, works by increasing the ability of the body's immune system to help detect and fight tumour cells, said Merck, which is known as MSD outside the US and Canada.

Pancreatic adenocarcinoma accounts for most cases of pancreatic cancer, according to the American Cancer Soci-

has two other experimental drugs aimed at treating chronic pain.

Reuters

response to existing immunotherapies, we are increasingly seeing clinical studies involving combinations of immuno-oncology agents with other classes of drugs," said Kinneret Savitsky, BioLineRx's chief executive.

BL-8040 acts against CXCR4 receptors that are involved in tumor progression, the company said. It has been

ety. Specific symptoms often do not develop until the disease has reached an advanced stage, which is reflected in a low fiveyear survival rate. The study is due to start by mid-2016 and both companies will have the option to expand the collaboration to include a pivotal registration study, BioLineRX said.

FDA delays decision on Heron's nausea drug The FDA is now expected to decide on Sustol by late February HERON THERAPEUTICS said the US Food and Drug Administration had postponed a decision on its injectable drug to treat chemotherapy-induced nausea. The FDA is now expected to decide on Sustol by late February instead of the earlier deadline, Heron said.

Sustol succeeded in a latestage study that tested the drug against GlaxoSmithKline Plc's anti-nausea drug, Zofran.

Both the drugs were tested in combination with two standard-of-care nausea treatments.

Chemotherapy-induced nausea and vomiting (CINV), considered one of the most acute side effects of cancer therapy, occurs in up to 80 per cent of

22 EXPRESS PHARMA February 1-15, 2016

patients, according to the National Institute of Health.

Heron is testing another drug for CINV. The company

Reuters

Taking drugs for depression linked to better diabetes control Scientists are also exploring whether there’s a physiologic connection between the two diseases PEOPLE WHO have both diabetes and depression may have an easier time keeping their blood sugar levels under control if they also take medication to address their mental health symptoms, a US study suggests. Diabetics can be more prone to depression and stress than other individuals, and these mental health problems are linked to increased risks of dangerously high blood sugar levels and other serious complications, previous research has found. When diabetics do get depressed, however, taking antidepressants is linked to 95 per cent higher odds that their blood sugar will be well controlled, the current study found.

“We don’t know the mechanism by which the use of antidepressants is associated with better blood sugars in those patients with both conditions,” said lead study author Dr Jay Brieler of Saint Louis University School of Medicine. It’s possible that

when depression improves, people may be more likely to follow a healthy diet, exercise, check their blood sugars and keep up with medications for diabetes, Brieler said. Scientists are also exploring whether there’s a physiologic connection between the two diseases, which might mean shifts in stress hormones tied to antidepressant use might also affect blood sugars. “Regardless of the mechanism, I think that our study adds to the evidence that it is important to properly diagnose and treat depression in diabetics,” Brieler added.

Brieler and colleagues reviewed electronic medical records for about 1,400 diabetics, including lab tests for blood sugar and prescription data on antidepressant use, from 2008 to 2013. On average, patients were around 62 years old. Most were obese.

All of them had type 2, or adult-onset, diabetes, which happens when the body can't properly use or make enough of the hormone insulin to convert blood sugar into energy. Many had other health problems, too, such as high blood pressure or cholesterol.

Most – 1,134 of them – didn’t suffer from depression, but the study included 225 people being treated for depression and 40 individuals who were diagnosed with depression but were not taking medication for it. Researchers estimated average blood sugar levels over the course of several months by measuring the percentage of hemoglobin – the protein in red blood cells that carries oxygen – that is coated with sugar. This sugar-coated form of hemoglobin is known as hemoglobin A1c, or HbA1c. With diabetes, keeping HbA1c test results below 7 per cent is generally considered to be good blood sugar control.

Overall, only 44 per cent of diabetics in the study had their blood sugar under control, or below 7 per cent, and average HbA1c levels were 7.7 per cent. About 51 per cent of people with treated depression had their blood sugar under control, compared to only 35 per cent of those with untreated depression.

One limitation of the study is that researchers couldn’t determine whether treating depression led to better blood sugar control or whether lowering blood sugar eases depression symptoms, the authors acknowledge in family practice. Both scenarios are possible. It’s also important for patients to know that certain antidepressants and antipsychotics can be associated with weight gain and poor blood sugar control, noted Dr Robert Cohen, a researcher at the University of Cincinnati College of Medicine and the Cincinnati VA Medical Center who wasn’t involved in the study.

These risks shouldn’t deter diabetics from seeking depression treatment, however. “From my experience, getting depression under control by whatever means can help people overcome their inertia that prevents them from making their best efforts to deal with their diabetes,” Cohen added.

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Reuters Health

EXPRESS PHARMA

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February 1-15, 2016

RESEARCH

Morphine for back pain tied to rapid changes in brain Significant volume loss was also seen in the amygdala PATIENTS WHO take morphine pills for lower back pain may experience changes in the volume of the brain's gray matter in as little as a month, a small study suggests. In the 30-day experiment, researchers gave 11 patients daily morphine pills and 10 people placebos and then took magnetic resonance imaging (MRI) scans to see if treatment impacted the brain. The morphine group had gray matter volume declines of about three per cent in regions of the brain thought to regulate emotions, cravings and responses to pain and volume increases in areas believed to be responsible for learning, memory and executive function. No changes occurred with the placebo.

“Because we are seeing that opioids rapidly change the brain, our take-home message is that opioids should be reserved for cases when most other treatment options have failed,” said lead study author Dr Joanne Lin, a researcher at the University of Alabama at Birmingham. While more research is still needed to understand how opioids may alter the brain and whether these shifts in gray matter are harmful, caution is still warranted be-

cause the medicines can be addictive and lead to abuse and overdose deaths, Lin added. “We know that some people become addicted, but we don’t really know why – or how to stop it,” Lin said. “By examining brain changes, we may be able to identify targets to prevent adverse opioid events.”

While animal research has linked long-term opioid use to changes in the brain, the current study offers fresh insight into how even short-term use of the

drugs may alter the human brain, Lin and colleagues note in the journal Pain Medicine.

Patients in the current study had been suffering from chronic back pain for around eight years on average, and none of them had a history of drug abuse or opioid use. The patients experienced similar rates of pain reduction whether they got morphine or a placebo, though all of them were allowed to take overthe-counter pain drugs during the study period. Among people

in the morphine group, gray matter volume decreased in several reward-processing regions, such as the gyrus rectus, which regulates learning and memory, and the insula, an area involved in cravings.

Shrinkage in the left dorsal posterior cingulate, involved in pain processing, was significantly associated with morphine consumption, and higher doses of the opioid pill were tied to larger volume changes in this part of the brain. Significant volume loss was also seen in the amygdala, an area central to emotional responses such as fear, anger, pleasure and pain, as well as being involved in impulse control, addiction and tolerance.

For morphine users, gray matter volume also increased in regions located outside reward-processing networks, such as in the cingulate cortex, which is involved many functions, including pain responses and learning.

In addition to the study’s small size, another limitation is that the age and gender makeup was markedly different between the two groups, the authors note.

Researchers also didn’t ask people on placebo if they thought they were taking morphine, so

they cannot know if the participants’ beliefs affected shifts in brain volume. While doctors should still weigh the potential negative consequences of opioid use before prescribing these drugs, the study findings on their own don’t provide enough evidence to suggest physicians should change how they treat pain, said Laura Stone, a researcher at McGill University in Montreal who wasn’t involved in the new research.

Often, a combination of physical therapy and medication may be best for back pain, Stone added by email. Exercise, yoga, meditation and a healthy diet may ease discomfort and also have the potential to address problems that can accompany back pain such as depression and anxiety. “Morphine and other similar opioid drugs provide excellent pain relief in many individuals, especially for short treatment periods, and can result in real improvements in quality of life,” Stone said. “Concerns about the negative consequences of long-term use must be balanced for each individual against the potential therapeutic benefits.”

Reuters Health

FDA staff unconvinced by Sarepta's muscle wasting drug The negative review of Sarepta's data was not entirely unexpected US FOOD and Drug Administration staff said they were unconvinced about the effectiveness of Sarepta Therapeutics' drug for a rare muscle wasting disorder, dealing another blow to the quest for a drug to treat the fatal disease. More than half of Sarepta's market value evaporated after the report, which comes a day after the FDA rejected BioMarin Pharmaceutical's rival drug Kyndrisa.

Sarepta's drug, eteplirsen, is designed to treat a subset of patients with Duchenne mus-

24 EXPRESS PHARMA February 1-15, 2016

cular dystrophy (DMD), which hampers muscle movement and affects one in 3,600 newborn boys, with most patients dying by the age of 30. There are no FDA-approved drugs for DMD, and pressure has been mounting on the US regulator to swiftly approve treatments.

The negative review of Sarepta's data was not entirely unexpected, given the unfavorable response to BioMarin's application.

"We expected it to be bad, but not this bad," Wedbush Securities analyst Heather Be-

hanna said. However, it's not the end of the road for the treatment yet - the situation will become clearer after a panel to the FDA makes its recommendation on the drug on Jan. 22. Sarepta's eteplirsen, like Kyndrisa, skips a faulty section of the gene to produce dystrophin, the lack of which is believed to cause DMD. FDA staff reviewers brought up concerns about Sarepta's trial design, efficacy, dystrophin measurement methods, and statistical analysis. Differences in DMD pro-

gression between eteplirsen patients and the natural course of the disease were "too small and variable ... to be reliably attributed to drug treatment", they said. Still, reviewers did not raise concerns with the safety profile of the drug.

"I'm not writing the Sarepta drug off yet," WBB Securities analyst Stephen Brozak told, highlighting previous FDA staff concerns about potentially fatal long-term side effects with BioMarin's Kyndrisa.

Both drugs target the same subset of DMD patients, which

translates into an addressable population of about 1,800 boys in the US and about 5,000 outside, according to Behanna.

Recent documents only questioned the conclusiveness of Sarepta's data but didn't really question whether eteplirsen works, Behanna said, adding that in BioMarin's case reviewers were unconvinced of Kyndrisa's effectiveness. "I think there's still a chance (of approval), but a small chance," the analyst said.

Reuters

RESEARCH

Heartburn pills linked to increased risk of kidney disease PPIs stop cells in the stomach lining from producing too much acid PEOPLE WHO take popular heartburn pills known as proton pump inhibitors (PPIs) may be more likely to develop chronic kidney disease than individuals who don’t use these drugs, a study suggests.

The side effect is rare, and the study doesn't prove the drugs cause kidney failure. But earlier studies have also linked the pills to this side effect, and the association is worrisome because tens of millions of people a year take these pills, sold by prescription and over-the-counter in some countries, with brand names including Prilosec, Prevacid and Zegerid. “There appears to be mounting observational evidence that PPIs – historically a class thought to be extremely safe – have some adverse effects,” said lead author Dr Morgan Grams of Johns Hopkins University in Baltimore. “Given the widespread use of PPIs, even relatively rare adverse effects can impact large numbers of people,” Grams added. “Thus, I think it wise to be judicious in the use of PPIs.” PPIs stop cells in the stomach lining from producing too much acid. In that way, they help prevent ulcers and reduce reflux symptoms such as heartburn. While scientists aren’t certain how the drugs affect the kidneys, prior research has tied PPIs to a form of kidney inflammation known as interstitial nephritis. For the study, Grams and colleagues analysed two large sets of data to examine the connection between PPI use and kidney disease in the general population.

The analysis linked PPI use to an increased risk of chronic kidney disease in both data sets, although PPI users were also more likely than non-users to be overweight or on medication to lower blood pressure or cholesterol. High blood pressure can also increase the risk for kidney disease. First, the researchers reviewed data on 10,482 people who were part of a study on atherosclerosis, or hardening of the arteries, tracking half of them for more than 14 years.

They found 56 incidents of chronic kidney disease among 322 people taking PPIs,

compared with 1,382 incidents among 10,160 individuals who didn’t use the pills. In other words, if 1,000 PPI users were tracked for one year, researchers would see 14.2 new cases of chronic kidney disease, compared to a rate of 10.7 new cases if 1,000 non-PPIusers were followed for a year. Researchers estimated that over 10 years, the absolute risk of chronic kidney disease was 11.8 per cent among PPI users, versus 8.5 percent among nonusers.

In a second analysis, researchers examined data on 248,751 patients in the Geisinger Health System in Pennsylvania, with half of participants followed for at least six years. This time, there were 1,921 incidents of chronic kidney disease among 16,900 PPI users, compared with 28,226 incidents among 231,851 non-users. The incident rate for PPIs was 20.1 per 1,000 person-years, compared with 18.3 per 1,000 personyears without the medication.

Researchers estimated that over 10 years, the absolute risk of chronic kidney disease among the Geisinger patients was 15.6 per cent among PPI users, but just 13.9 per cent if they didn’t take the pills.

It’s possible that the PPI users had other risk factors for kidney disease that were unrelated to the medications, the authors acknowledge in JAMA Internal Medicine. Even so, the findings add to growing evidence suggesting that some patients may experience dangerous side effects from PPIs, Dr Adam Schoenfeld and Dr Deborah Grady of the University of California, San Francisco, note in an editorial.

Earlier research has linked the pills to kidney damage, heart problems, infections and fractures, they said. “Doctors must weigh the risks and benefits before recommending PPIs and this study adds chronic kidney disease to the risk of rare, but serious side effects associated with PPI use,” Schoenfeld said. Many patients with heartburn and indigestion don’t need PPIs.

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Reuters Health

EXPRESS PHARMA

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February 1-15, 2016

PHARMA ALLY I N T E R V I E W

'We have an unrelenting commitment to quality and delivering results in everything we make and do' Scott Gaddis, Global Business Leader, Healthcare Products, Honeywell in an interview with Usha Sharma talk about Honeywell's contribution to Indian pharma packaging market Tell us about the ongoing activities of Honeywell PMT’s pharmaceutical packaging materials business Honeywell invents and manufactures technologies to address some of the world’s toughest challenges initiated by revolutionary macrotrends in science, technology and society. With approximately 127,000 employees worldwide, including more than 22,000 technologists, we have an unrelenting commitment to quality and delivering results in everything we make and do.

Honeywell Performance Materials and Technologies (PMT) is a global leader in developing advanced materials, process technologies and automation solutions. PMT’s advanced materials businesses manufacture a wide variety of high-performance products, including environmentally friendlier refrigerants and materials used to manufacture end products such as bulletresistant armor, nylon, computer chips and pharma packaging.

Honeywell’s healthcare and packaging business produces Honeywell Aclar

26 EXPRESS PHARMA February 1-15,2016

barrier films. Aclar helps pharma packaging professionals lower their packaging costs, improve the flexibility of their operations, and increase overall profitability. Aclar films are based on poly-chloro-trifluoro-ethylene (PCTFE) fluoropolymer technology and have excellent moisture barrier and chemical stability properties. Our films are available in a variety of gauges and barrier levels and protect some of the world’s most important medications in all climates and environments. Aclar film can also reduce overall pack size and is crystal clear, enabling the customer to uniquely brand their products and bring them to market in the next generation of cost effective patient-centric packaging.

For more than 40 years, Honeywell and Aclar have been the trusted choice for pharma packaging. Today, Aclar thermoformable films are used in a broad range of markets including originator and generic pharma, overthe-counter (OTC) pharma and animal health packaging.

Not only does Honeywell’s Aclar barrier film have an impeccable track record for quality and protection, Aclar

also comes with a dedicated service and pack design team that ensures seamlessly fitment with the end user’s process.

Recently, Honeywell announced the launch of Safyr (pronounced: sapphire), a high-moisture barrier thermoformable film designed specifically to meet the requirements of India’s pharma packaging market.

The company has recently launched Safyr, a highmoisture barrier thermoformable film. Tell us more about the product We have recently launched Safyr, specifically to meet the requirements of India’s domestic pharma packaging market.

Safyr is a CTFE-based polymer with excellent moisture barrier properties and has been designed specifically for the domestic market. Safyr affords manufacturers with design flexibility and performs better than its alternatives.

Honeywell has optimised Safyr to meet regulatory requirements specific to the domestic pharma pushthrough packaging market in India. That, and the fact that Continued on Page 29

PHARMA ALLY WHITE PAPER

Encapsulation: raising the bar

SHAIKH CHAND, DGM - Technical Service explains in detail

A case study from ACG Worldwide on tackling a customer's problem arising from a particularly challenging sticky formulation, Shaikh Chand DGM Technical Service explains in detail

EVOLUTION OF the encapsulation process, from manual and semi-automatic machines has now reached a stage of complete automation. Encapsulation today, is at a stage where, machines are being customised to suit varying and dynamic applications. Incremental advancements in technology to realise the 99 per cent yield potential is the requirement of the industry.

The expectation from efficient encapsulation still remains high yield and ultimately ‘value delivered’ to all stakeholders, justifying the substantial capital equipment investment.

Encapsulation today, is at a stage where, machines are being customised to suit varying and dynamic applications. Incremental advancements in technology to realise the 99 per cent yield potential is the requirement of the industry

TOTAL POWDER LOSS (IN KG) 36.4

Conservation of energy The law of physics states, that energy in one form has to transform into another for balance to be maintained. A similar phenomena needs to be realised in the technologyintensive encapsulation industry. Any incremental advancement in technology or customisation, ideally should translate into “value” to the stakeholder. This value can embody cost savings, a larger top line and/or a healthier bottom line.

ACG Worldwide embarked on this journey of technological evolution, way back in time. For years, ACG has been committed to improving productivity, yield, and cost efficiencies for our partners. The ACG Technical Services team accomplishes this in their regular interactions with their partners. The years of domain expertise enables them to expertly identify, analyse and exploit otherwise, inconspicuous opportunities of improvement.

28 EXPRESS PHARMA February 1-15,2016

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Maximising results

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BEFORE

A sticky situation A case in point of this expertise are the solutions provided by the ACG Technical Services team to one of our customers to help tackle problems arising from a particularly challenging sticky formulation. To add to the challenge were the rigorous standards of the regulated market, the customer was operating in.

thus, restricted to the design of the machine. Customised parts, training of personnel and additional technical support were few of the many improvements incorporated to improve yield and productivity. These changes addressed all machine related complexities arising from the use of that particular sticky formulation. The solutions provided to the customer were for longterm impact. The post change validation ensured that the customised parts were sustainable and integrative in nature. These intangible benefits to the customer made the implementation of changes extremely operator-friendly, thus ensuring sustainability of the optimisation.

AFTER

A problem well-stated is half solved The ACG Technical Services team approached this case with defining as clearly as possible the problem. More apparent consequences of this situation were low yield, drop in productivity, excessive machine downtime, heavy product loss along the process and excessive wear and tear of the components.

To get to the root of the

problem, ACG Technical Services team studied the formulation across multiple batches, machines and in capsules from different suppliers. ACG’s Technical Services team strength lies in process efficiencies thus is able to improve yield in parameters other than those that are process related.

Thinking made visual The corrective action was

The result of this exercise was beneficial multi-fold. Increase in yield to a 98 per cent+ and improved productivity coupled with reduced machine downtime translated into costs saved and profits earned.

On an average, an additional 7 million capsules could be filled per machine after this change.

Ceteris Paribus i.e. all other factors remaining unchanged, this led to an increase in top line by half a million dollars annually, and naturally a much healthier bottom line. In the current industry trends, where continuous technological advancement is a pre-requisite, the one constant that ACG strives for, is adding value to its customers and it is ACG’s Technical Services team that ensures that it is able to deliver this benefit throughout the customer engagement with ACG.

PHARMA ALLY Continued from Page 26

'We have an unrelenting...

Safyr has a standardisation of SKU, all help in process and cost optimisation.

Some of the product’s key benefits include: ◆ Safyr gives flexibility: Cold form foil or foil strip packs no longer need to be the primarily chosen package formats to pass stability. Safyr film, available in a 2 mil (51μ) thickness, will likely pass stability for most of the commonly prescribed drugs in India. By utilising a thermoforming platform, pharma companies can decrease their pack size versus foil formats and increase pack density, while improving patient 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 preconditioning prior to operational use; and will not corrode tooling and equipment.

Today, several companies are offering similar services to pharma companies. How can Safyr be differentiated from the rest?

Safyr is a thermoformable material, thus providing all the benefits of a thermoforming packaging platform versus cold form foil. These benefits include, but aren’t limited to, smaller pack size, increased pack density, faster processing, and improved patient acceptance.In addition, Safyr is transparent, allowing the drug to be seen, which aids in identifying and accessing the drug in the pack.

Over and above the product’s benefits already detailed, Safyr is

priced competitively against the next best alternative product in the Indian market – a price more suited to the purchase trends of the domestic market. In addition, Safyr is not bound to the production process designed specifically for Aclar. Safyr will also be offered in only one thickness, in one width, and in one length – with no exceptions, allowing Honeywell to further maximise efficiencies in the manufacturing process and control costs.

What regulatory requirements does Safyr follow and how it helps pharma companies in reducing the cost as well as productivity?

Currently, Safyr is designed to meet the regulatory requirements specific to the Indian domestic pharma packaging market. Safyr will also be offered in only one thickness, in one width, and in one length – with no exceptions, allowing Honeywell to further maximise efficiencies in the manufacturing process and control costs. Safyr thus allows for a more efficient manufacturing process, allowing us greater flexibility in pricing it to the market it will serve.

What are your expectations from Safyr in its first year of launch?

Our focus in our first year is on making our customers aware of this exciting new offering which will give them an alternative to existing packaging platforms.

Why do you think pharma companies should opt for Safyr?

As a thermoformable material, Safyr provides all the benefits of a thermoforming packaging platform versus cold form foil – smaller pack size, increased pack density, faster processing, and improved patient acceptance. Safyr is also priced competitively against the next best alternative product in the Indian market, a price more suited to the purchase trends of the domestic market. In addition, since Safyr is offered in only one thickness, in one width, and in one length, with no exceptions, companies will be able to leverage Honeywell’s maximised efficiencies in the manufacturing process, leading to eventually controlling costs.

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u.sharma@expressindia.com

EXPRESS PHARMA

29

Febuary 1-15, 2016

PHARMA ALLY VENDOR NEWS

Algor launches temperature controlled logistics and supply chain services Plans to expand its footprints in India ALGOR SUPPLY Chain Solutions has introduced temperature controlled logistics and supply chain services targeted at the enterprise-class customers. With its professionally managed and top-notch quality service offerings, Algor is all set to expand its business footprint in India.

Starting with Mumbai and Gujarat, the company will extend its services to clients from Nagpur, Raipur, Hyderabad, Bengaluru and Chennai. It plans to expand its operations pan-India in the next two years.

The specialist service provider Algor combines its SOP-driven quality-focused offerings combined with international best practices to meet the customised logistical requirements of its enterprise clients’. Apart from logistics, the fastest growing service provider in the country will also offer refrigerated warehousing and transportation for small consignments (less than a truckload).

Right from the primary movement from the manufacturing or processing units to local distribution in its own fleet of reefer vans, Algor provides end-to-end temperature-controlled warehousing and distribution for export, import and domestic cargo movements.

The traditional logistics services with hub-and-spoke model are challenged with safety of goods and time-cost overruns as consignment changes hands multiple times before reaching the destination. This poses a serious challenge for companies from pharma and healthcare sector.

The difficulties are accentuated when goods are shipped

30 EXPRESS PHARMA February 1-15,2016

with passive cooling agents.

Temperature-controlled logistics is critically important in the pharma and healthcare sectors where the material being shipped can become unstable if temperature is altered.

Algor, with its emphasis on active, heavy-duty precision cooling inside the reefer vans and speedy, direct connectivity between origin and destination ensures safety and security of the material at all times.

Algor addresses the specific quick-transportation needs of corporates when it comes to shipping small consignments.

With a world-class fleet management system, satellite navigation and online temperature monitoring in real time, Algor addresses the organisations’ critical requirement of just-intime quality logistics with high visibility.

Algor knows that temperature-controlled specialised logistics and supply chain services are not just about moving goods from one place to other.

With a clear focus on global standards in service quality, its promise to the clients is fundamentally different.

Algor’s team of professional ensure that there is no damage to the goods. The company offers a range of specialised services including packaging support, pelletisation and bulk transportation.

Algor has invested in HACCP-certified quality cold storages, operating in five temperature zones in order to meet the requirements of handling various products with ease.

The temperatures that can be maintained range from +25 ºC to -25 ºC, and be changed as per customer-requirement.

The right level of humidity can also be maintained along with temperature as deemed necessary.

Algor’s custom-bonded facility within the cold store allows for cargo storage under bond and seeks partial releases, helping clients with a phased-out payment of customs duty. Using Algor’s services, customers can save ground rent charges to CFS for eight to 10 days, refrigerated plug-in charges for eight to 10 days, container detention charges to shipping line for eight to 10 days, as well as transportation charges to the cold store.

A strong emphasis on standard operating procedures (SOP) and cutting-edge technology tools are some of the focus areas of Algor. Backed by over 25 years of rich industry

experience of the founding team, the company invests heavily in internal training programmes to ensure its professionals surpass the global industry standards in terms of domain knowledge and technical expertise. From its R&D team members to reefer van pilots, every professional it hires is rigorously trained and qualified to excel in the job assigned.

For instance, Algor conducts refresher courses for its reefer van pilots every six months, educating them about relevant transportation rules and regulations, understanding of technology, maintenance of vehicle and on-vehicle equipment, and remedial course of action to save time when any urgent repairs are required.

Besides the job-specific skill-sets, Algor’s pilots are trained in soft skills and the right attitude towards hygiene.

The pilots also undergo for physical fitness tests and vision check-up regularly.

The refrigerator systems inside the van are maintained and the air conditioning systems well-calibrated to maintain controlled temperatures as required. The inside walls of the reefer vans are adequately protected via a layer of insulated material so that the cargo inside remains safe and secure. Algor’s spill-kits is yet another innovation that makes sure that liquid items are contained within the units of casing they are packed in. The company has several years of experience to carry out the transportation of hazardous chemicals or other dangerous goods.

EP News Bureau-Mumbai

PHARMA ALLY

PDP Couriers gets WDAlicence PDP Couriers continues to focus on delivering value added services for its customers COUNTERFEITING IS an issue worldwide the WDA also provides PDP’s customers with added peace of mind as they know their product never leaves the supply chain and therefore cannot be compromised.

PDP Couriers, the leader in clinical trial drug distribution and biological sample transportation has achieved its Wholesale Distribution Authorisation

stores or supplies medicines. Confirming that PDP’s offering provides secure, temperature-controlled premises for the storage of medicines and has developed a set of Standard Operating Procedures (SOPs) that comply with Good Distribution Practice (GDP) guidelines.

The added benefit of being able to offer storage of customer’s products in a compliant environment is yet another

(WDA) licence, awarded by the UK Medicines and Healthcare Products Regulatory Agency (MHRA).

Achieving its WDA licence, PDP Couriers continues to focus on delivering value added services for its customers. Susan Lewis, Global Quality Manager and Responsible Person explained, “A WDA shows our customers that we take Good Distribution Practice seriously and provides assurance that products are safe and secure because they stay in one supply chain.

“Initial feedback from our customers has been really positive and as a company we are ready to embark on new challenges within the pharmaceutical industry.”

A WDA is a requirement for any company in the UK that procures,

contingency measure that the company can call upon should there be regulatory or transportation issues at origin or destination. As counterfeiting is an issue worldwide the WDA also provides PDP’s customers with added peace of mind as they know their product never leaves the supply chain and therefore cannot be compromised.

The WDA has been the culmination of a yearlong project, which was put in place to ensure PDP is continuing to develop its customer offering. This further reassures customers that PDP is continuing to maintain its already high level of Good Distribution Practice with the safety of patients always uppermost in the minds of its employees.

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EP News Bureau- Mumbai

EXPRESS PHARMA

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February 1-15,2016

PHARMA ALLY

Multisorb to showcase optimal sorbent technology at Pharmapack Europe 2016 To help pharma and healthcare companies drive their success and quality MULTISORB Technologies will highlight its ability to help pharmaceutical and healthcare companies drive their success and quality through the optimal use of sorbent technology at Pharmapack Europe in Paris from February 10-11, 2016.

"With the high cost of pharma product development, companies need to consider how to best protect and maximise their investment,"

said Adrian Possumato, Vice President, Healthcare Packaging Group, Multisorb Technologies . "Optimising the use of sorbent technology with our success through efficiency programme can help companies assure drug stability while increasing operational efficiencies to reduce costs."

Multisorb's success through efficiency programme offers a comprehensive approach to help companies

quickly identify, select and dispense the optimal sorbent solution for market success: ◗ Simulations for product stability and faster market access: The SimulSorb and SimulOx simulations use QbD-based modelling to quickly identify the optimal sorbent for desired shelf life.

By eliminating costly sorbent ranging studies, the simulations can help get the product to market six to12 months

faster. ◗ Sorbent platforms for all requirements and complex issues: The technical team can help select the best platform for packaging presentation to deliver the lowest possible net packaging cost.

Multisorb's IntelliSorb moisture regulating packets, canisters, and compressed sorbents provide solutions for complex moisture management issues in pharmaceuti-

cals, gel capsules, and respiratory drug delivery products. ◗ Dispensing systems for cost effective and turnkey operations: By engineering sorbent platforms with their respective dispensers, the MultiPacket and MultiCanister systems deliver maximum efficiency. The result is an industry leading dispenser output efficiency of >99.997 per cent and the lowest total cost of ownership.

VALUE ADD

Thermolab receives UBM Indian Pharma Awards 2015 The company is a third generation company with over 48 years of experience THERMOLAB GROUP, a third generation company with over 48 years of experience, is most trusted and preferred brand in the pharmaceutical industry. The company had grown under the proficient leadership of Sandip Mhatre, Managing Director, Thermolab Group.

With constant new developments, Thermolab has designed a sustainable walk in type stability system. This chamber has been awarded as the ‘Leader in sustainable stability chamber’ by UBM Indian Pharma Awards 2015. Taking an initiative towards the sustainability of the environment, Thermolab has designed a system which can reduce 95 per cent of water consumption along with 60 per cent reduced power consumption in the

32 EXPRESS PHARMA February 1-15,2016

Thermolab Group are a one stop solution to all the stability requirements

walk stability chamber.

Thermolab’s stability chamber has evolved as the true leaders in stability with more than 5000 installations spread over 50 countries.

These stability chambers have also been awarded with the India Design Mark by the Gov-

ernment of India.

Thermolab Group are a one stop solution to all the stability requirements. Thermolab Analyticals, a stability storage and analytical testing laboratory, provides stability solutions for pharma products and drug substances at all stages of the registration process.

Thermolab testing services offer calibration, validation and third party solutions testing services to all industries with an NABL accredited laboratory.

Thermolab sales and services offer after sales services and AMC to all Thermolab products.

Thermolab Healthcare, is a WHO cGMP approved formulation manufacturing company, with separate facility for granulation and solid oral dosage.

PHARMA ALLY PRODUCTS

Gandhi Automations launches cleanroom doors in PMEC-2015 GANDHI AUTOMATIONS had displayed high-speed doors, cleanroom doors, dock levelers, dock shelters, motorised rolling shutters, motorised gates and boom barriers, at P-MEC India.

Cleanroom doors will help pharmaceutical companies boost quality in their plant. One of the most important aspects of cleanrooms is the doors choosen for cleanroom facility. Time for which the door is open will play a critical factor in avoiding

◗ Operating speed and superior sealing properties improve traffic flows and provide environmental control and savings on energy costs ◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ High door efficiency and low permeability values EN 12426 EN 12427 : < 12m3 / m2h ? 50 PA ◗ High leak tightness is due to curtain be-

dust, outside temperature, humidity etc.

Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Cleanroom high speed doors are best suited for facilities where one needs controlled environment.

The opening and closing of door is quick enough to separate outside environment and internal facility.

Clean room doors designed by Gandhi Automations are engineered carefully with feature below:◗Cleanroom high-speed doors are designed for inside applications and protects the environment against humidity, dust and dirt.

ing tightly integrated in special SS 316 matt finish side guides ◗ Bottom safety edges and photocells combine to ensure operator safety at all times ◗ Heavy duty motor: 400V three phase, opening speed upto 1.5 m / s with inverter system ◗ Size upto: 4000 mm (W) X 4000 mm (H) Contact details Gandhi Automations Chawda Commercial Centre, Link Road,Malad (West), Mumbai - 400064 Tel: +91-22-66720200 / +91-22-66720300 (200 lines) Fax: +91-22-66720201

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February 1-15,2016

PHARMA ALLY

Testo automates temperature & humidity monitoring in cold chain BE IT food products such as dairy, fruits, vegetables, frozen food or pharmaceutical goods such as vaccines, the cold chain between the manufacturer and the final consumer may under no circumstances be interrupted. Quality deficits, financial losses or even serious damage to the health of the consumer or patient can be the consequence.

The measurement technology manufacturer Testo offers cold chain management professionals an efficient solution for automatic monitoring and documentation of temperatures and humidity values in all refrigerated rooms and across the cold chain. The innovative monitoring system testo Saveris 2 saves staff the work of reading out and documenting the individual measurement data, simplifying the assurance of high product quality.

In order to guarantee the quality and shelf-life, and to comply with legal hygiene standards, perishable products such as food or also pharma products needs to be stored and processed under constantly perfect climatic conditions. Thanks to a cloud-based application, the Wi-Fi data logger system- testo Saveris 2 allows to keep the temperatures and humidity values in all refrigerated rooms and displays under control everywhere and at all times - without any ongoing work procedures. Once the system is installed, it monitors and documents the ambient temperatures fully independently. The measurement data are directly transmitted to the online data store – the Testo Cloud – by wireless LAN, where they can be called up, managed and analysed online by the user via smartphone, tablet or PC absolutely anywhere and anytime. This uninterrupted and exact documentation allows the stringent HACCP standards to be ad-

34 EXPRESS PHARMA February 1-15,2016

hered to. Another important advantage of the system: if an upper or lower temperature or humidity limit is exceeded, the user is immediately provided with an alarm by e-mail, or optionally by SMS. The system can be easily and quickly installed. For the use of the cloud, customers can choose between the free basic or the more comprehensive advanced functionality, depending on their requirements.

This NEW WiFi data logger system – Testo Saveris 2 has replaced time-consuming manual data monitoring and documentation.

Reliable cold chain monitoring during transport Testo also offers a solution for reliable cold chain monitoring during transport.

With the new data loggers

testo 184, you can monitor every step of the cold chain.

The loggers travel on your behalf in freight and loading rooms, monitoring temperatures during the transport of sensitive goods on rail, in the air or on the road. At their destination, your see at a glance whether the configured limit values have been adhered to. In order to obtain detailed information, it is sufficient to connect the logger to a PC – a PDF report is immediately generated with all relevant data.

These loggers are preconfigured and operated with just a "Start" and a "Stop" button.

No measurement experts are required for their operation. A simple logistic operator can also manage the start and stop of a measurement cycle.

Furthermore, it requires no software download, no installa-

tion for accessing the data. The sender of the package is geographically somewhere different than the receiver of the package. In such cases, just plug in any USB cable to the computer and the data can be accessed. A PDF/A report with the transport data is created immediately on connection of the testo 184 data logger to the USB interface of a computer.

All testo 184 data loggers can be read out on site also with an NFC-capable Android smartphone. Use and throw version of these loggers further eliminate the trouble of sending the logger back to the sender, especially during exports.

Testo also offers a special data logger for dry ice applications - testo 184 T4. Dry ice (-80 ° C) is used for transport especially in the pharmaceutical industry, for example when trans-

porting blood plasma, organs, virus, scientific material, etc. testo 184 T4 logger housings are made out of a special ABS polymer that can survive in such low temperatures. The extremely cold conditions are also very harsh for the batteries.

Nevertheless testo 184 T4 batteries can hold for 100 days at 80 °C. Testo 184 data loggers are compliant to the most important standards for the transport of pharmaceuticals and food products, namely, GxP (GMP, GLP & GDP), 21 CFR Part 11, HACCP and EN 12830.

Contact details Testo India Pvt. Ltd. Plot No. 23, Sind Society,Baner Road, Aundh, Pune - 411007 Tel: +91 20 6560 0203 Fax: +91 20 2585 0080 Email: info@testoindia.com

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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

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PHARMA LIFE

Awakening to the need for a healthy workforce to build successful businesses, pharma firms are introducing a slew of measures to ensure their employees' fitness

BY USHA SHARMA

52 EXPRESS PHARMA February 1-15,2016

A

healthy employee is a more productive employee. Health thus plays a significant role in helping companies grow and remain competitive in the market. In the next two to three years' many medicines are going off patent and there will be a huge business opportunity for Indian pharma companies, both in the domestic as well as global markets. MNC pharma firms are also poised to grow their footprint across India and other geographies. But in order to tap these opportunities, pharma companies must also invest in their employees' and their family members' well-being.

So, are pharma companies taking note of this fact and implementing steps towards ensuring their employees' well being?

Dr Chandrasekhar Sripada, President and Global Head of HR, Dr Reddy's Laboratories says that his company is completely aware of the need to ensure this and informs, “Investing in employee health is, for us, the first step towards gaining credibility around our philosophy of 'Patients First'. Only with healthy employees can we serve patients better. Therefore, for Dr Reddy’s, employee well-being is business critical.”

Roche, a multinational pharma company, also holds a vision of fostering a culture of health and well-being at work.

Nilesh Kulkarni, Director Human Resources, Roche Products informs, “We offers flexible working arrangements which helps our employees balance life and work and are, therefore, an important element in meeting the individual needs of our increasingly diverse workforce. Wherever possible, we meet employees' requests for special working conditions, offering arrangements that include flexi-time, working from home and parental leave for men and women.”

Well, these efforts are laudable but a lot more steps are needed to ensure that the workforce in an organisation is fit and healthy.

DR CHANDRASEKHAR SRIPADA President and Global Head of HR, Dr Reddy's Laboratories

challenge. The GCC is an effective way to get employees more active by motivating them to walk over 10,000 steps per day – and ultimately makes them more productive and engaged. It also offers International SOS, a complimentary service, to all the employees (and their dependents) to help keep them safe and healthy if an emergency situation arises when they are traveling or living outside their home country. Kulkarni also informs, “We organise ‘Live Well. Find your balance,’ a well-being week held across Roche sites once a year, to promote awareness of and education about healthy lifestyles, nutrition and emotional wellbeing.”

“We introduced a comprehensive mediclaim policy with enhanced benefits and additional flexibility as compared to current industry standards. Our policy includes a substantial family floater and also allows employees the additional benefit of enrolling either their parents or parents-in-law,” says Kulkarni. “As a leader in developing innovative solutions for cancer care globally, we recognise the multiple barriers that are associated with providing quality and affordable cancer care in India. Therefore, our employee policy exclusively covers all types of cancer for the enrolled members with an aim to reduce the burden on employees and their family,” adds Kulkarni.

DRL's endeavours

K Hariram, Retired Managing Director - Galderma India opines that pharma companies should consider providing health insurance policies to employees and their family members. He also raises some pertinent questions such as: What percentage of the turnover is set aside for employee health schemes? Does the company look at such initiatives as talent attraction/ retention strategies? If so, any indication of its impact on attrition rates? Does it impact any section of the company's cur-

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rent/prospective employee demographic profile more than the others? A self-evaluation by the pharma firms on these areas might lead to improved implementation of schemes /plans to improve the health and well-being of employees.

Express Pharma also spoke to two well known pharma firms to know about their investments in this arena. While, none of the pharma companies shared their financial figures with us, they did share details about their various programmes and initiatives.

Roche's route to good health Roche informs that it offers a range of programmes to its employees, which include medical services (e.g., medical checkups, screenings), workplace ergonomic evaluations, and counselling services. For instance, this year, employees at Roche Pharma India participated in the 100-day Global Corporate Challenge during which employees supported each other to boost their daily levels of physical activity and exercise to meet the 10,000 steps per day

DRL believes that its employees are the driving force of the organisation, therefore it endeavours to provide employees a safe, inclusive and empowering workplace with freedom to act, innovate and grow, not just as professionals but also as individuals. Sripada says, “We believe that health and wellness form an important aspect of one’s life. We are focused on ensuring that employees are both healthy and satisfied at work and lead enriching lives where they can balance work with their personal/family lives. Employees facing major health issues can opt for sabbaticals or opt for 'exceptional leaves' over and above

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PHARMA LIFE NILESH KULKARNI

K HARIRAM

Director – Human Resources, Roche Products

Retired Managing Director Galderma India

their normal leave balance. Both these policies have been already explained above. As a preventive measure, we also educate our employees continuously on the importance of health and support them with free medical checkups. We also have a bouquet of other benefits like health insurance, gym at office, health talks by doctors, doctor at campus, etc.”

They also provide certain benefits to the family members of the employees. Sripada elaborates, “Since health of the family members is a huge priority for the employees, we provide a number of benefits which takes care of the health and well-being of

54 EXPRESS PHARMA February 1-15,2016

the whole family. We offer free-of-cost annual health check-up for our employees. Employees can pay a discounted price and avail the benefits for their family members as well. Each employee has the option of covering his/her immediate family members and also his dependent parents/in-laws. We also have an additional buffer fund for funding the medical expenditures in case the overall cost exceeds the coverage.

Employees also have an option of buying additional cover for their family members and pay extra premium for buying additional critical illness coverage.”

Impact on talent retention/attraction Commenting on whether companies are looking at such initiatives as talent attraction/ retention strategies, Kulkarni emphasises, “We are a force of over 80,000 people working together across more than 150 countries. As a researchbased company, Roche encourages each employee to always strive to improve the lives of those around us. Roche Pharma India’s mediclaim policy is a testimony of its commitment to addressing healthcare needs and employee welfare at large. The benefits offered by the policy are the same, irrespective of the

tenure, age or management level within the organisation.

We believe that if each company in India starts thinking collectively about the well-being of their employees by putting the right healthcare plan in place in the organisation, not only will employees feel valued and engaged, even the issue of access to healthcare could be addressed significantly.”

Most recently, DRL also launched a series of health and wellness programmes, across all its India locations where they have two weeks dedicated to Wellness. In the first week which commenced on January 4, 2016, it conducted various programmes such as health camps, health quiz, health tips, health talks and app launches.

Subsequently, in the second week, which commenced on January 18, they had programmes organised by its Health Circle Volunteers in

various domains like yoga, dance fitness, and cycling etc.

Sripada informs, “We believe that this is just the beginning and the tip of the iceberg, in the future we plan to have various other initiatives aimed at the overall health and wellness of our employees and their families.”

Thus, these pharma companies have already adopted innovative health policies which have become an integral part of their organisation's structure. It would be a good idea for the rest of the pharma firms to follow suit and adopt such steps to help their employees stay fit and healthy.

Such measures would play a significant role in helping organisations achieve better outcomes and sustain their growth momentum in a world which is becoming increasingly competitive. u.sharma@expressindia.com

PHARMA LIFE I N T E R V I E W

â&#x20AC;&#x2DC;Our trainees consist of mainly students, teachers and industry chemistsâ&#x20AC;&#x2122; Dr G Ramakrishnan, Director, SIES Institute of Chromatography and Spectroscopy, discusses the features of training offered at his institute, with Sachin Jagdale

Describe the circumstances that led to the formation of SIES Institute of Chromatography and Spectroscopy?

While chromatographic and spectroscopic techniques hold a very important place in both research and industry, only a limited part of theoretical knowledge of these techniques is imparted to students during their graduate and postgraduate studies. The students neither see these instruments in real nor get the practical exposure to these instrumental techniques, as such facilities are not found in most of the colleges. It was also noted that quite a few teachers teaching these techniques needed in depth practical training in order to teach these techniques effectively to students. This visible gap in our educational system led us to the idea of creating an institute for training of students and teachers. Initially, we set up a small chromatography laboratory in the SIES college premises in Sion. Once we found that this is helping the graduate students and teachers, we decided to make an expanded facility in Nerul, Navi Mumbai, where our SIES Institute of Chromatography and Spectroscopy is situated.

Setting up a chromatography and spectroscopy lab is a very expensive process. How did you manage this? What was the role of Chromatographic Society of India to facilitate the same?

Yes, setting up a modern lab with good instruments is a

very expensive proposition.

But South Indian Education Society ( SIES) being a primary education institution believed that it is important that it takes a lead in setting up such an institute for providing such skill development among students and teachers. The instrument company Perkin Elmer need to be complimented in sharing our thought and agreeing to be our partner in this effort and to provide us with their instruments at an affordable price that SIES was ready to invest .Chromatographic Society of India, which does not have its own lab, agreed to support this idea by bringing the necessary people resources to conduct various courses, seminars and conferences. CSI is also associating with this institute in bringing in some of the instruments from its corporate members as donations.

What is your staff strength?

The institute has at present only four members including the Director, laboratory Manger and two students, who want to pursue their Ph.D. How many students and teachers have been trained by the institute till now?

Our trainees consist of mainly students, teachers and industry chemists. We believe that we have trained almost 50 college teachers in the last 18 months and nearly 250 students. Besides we have had almost 100 chemists from the industries who have come to our institute for focused

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seminars combined with instrumental training in the last 18 months.

Our institute can provide the initial theoretical and practical training on the chromatograp hic and spectroscopic instruments to the newly hired chemists of the pharma industry

What role can the pharma industry play to ensure that a maximum number of students and industry people get practical training in chromatography and spectroscopy?

The participation of pharma industry is very important for our success. For example, Cipla has helped us by donating to us some of their older instruments and software, especially in the initial stages. They also have sent their junior chemists for our training courses. Our courses will help the fresh and junior chemists in a pharmaceutical company to understand the theory behind chromatographic and spectroscopic techniques and instrumentation besides getting practical hands on experience on some of the techniques. In addition, if a chemist already working in a pharma industry knows the operation of GC, the use of Head Space accessory along with GC or Mass Spectrometer combined with GC can be learnt in our institute. Our institute can provide the initial theoretical and practical training on the chromatographic and spectroscopic instruments to the newly hired chemists of the pharma industry at a minimal cost so that they do not have to invest their time and money to do the training internally in their facilities. As we have two fully loaded HPLC instruments with Quaternary Pump, DAD, etc

we should be in a position to offer special training modules for method development, impurity profiling, etc. the pharma industry will be interested in. Pharma companies or their associations can also collaborate with our institute in conducting various training programs that will be useful to the students , who want to make a career in the pharma industry and also provide this opportunity to the chemists from various other industries, who want to shift their career path in to the pharma industry.

Do you provide placement assistance to the students as well?

Once we plan to do the 6 months / one year courses to students, we will be in a position to monitor the performance of the trainees and provide placements to them accordingly to various industries. However, we have not yet reached that stage as of now.

Besides training students and industry people, does this lab also take up commercial assignments?

We are not taking up any commercial testing on a large scale as we do not have an infrastructure to do that.

However, if some customers need our services especially with technical interpretation of the results, we are positioned very well for that.

We do have a few regular customers who come to us for analysis of essential oils and Continued on Page 56

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February 1-15,2016

PHARMA LIFE APPOINTMENT

Axol Bioscience appoints Xianmin Zeng as CSO Zeng has over 15 years of academic expertise in the development of stem cell technologies and its applications AXOL BIOSCIENCE, a biotechnology company, specialising in the use of stem cell technology to manufacture disease relevant cell based assay systems to the drug discovery industry, has appointed Xianmin Zeng as the Chief Scientific Officer. Zeng has over 15 years of academic expertise in the development of stem cell technologies and its applica-

tions. She is a well-established and internationally-recognised leader in the creation of disease models for drug discovery.

With Zeng as Axol’s CSO, the company will be able to continue to offer highly-validated products and further improve upon their current processes under her expert guidance. As a key opinion

leader in the field, she will offer strategic direction to help drive Axol’s product development, so as to address some of the vital challenges in the drug discovery industry.

Yichen Shi, PhD, CEO, Axol Bioscience said, ‘Prof Zeng is recognised globally for her wealth of experience working with both human ESCs and iPSCs. Her insight and expertise

Themis Bioscience appoints Dr Philippe Dro and Dr Christian Mandl The appointment follows in the wake of the successful completion of a phase I clinical trial of the company's Chikungunya vaccine THEMIS BIOSCIENCE, a company developing prophylactic vaccines against emerging tropical infectious diseases, has announced the appointment of two new leadership members, Dr Philippe Dro and Dr Christian Mandl.

Dro will join the board of directors while Mandl will be the chairman of the company's scientific advisory board.

Welcoming his new colleagues, Dr Erich Tauber, CEO and Founder, Themis said, "Themis is heading towards exciting times with our lead project, a Chikungunya vaccine candidate entering clinical trials phase II this year. The combined industry and vaccine development expertise of Dr Dro and Dr Mandl creates a fantastic asset for the company during its growth and continued partnering efforts."

Reportedly, in the last 20 years Dro initiated and executed several strategic transactions.

56 EXPRESS PHARMA February 1-15,2016

Mandl is a renowned expert in flaviviruses and co-inventor on several patents related to the marketed vaccine for tick-born encephalitis.

Prior to its acquisition by GSK, he served at the vaccine developer GlycoVaxyn AG as CEO and member of the Supervisory Board. Before that, he was leading Endoart, a medtech company, in the position of CEO and Chairman of the board through a

successful sale process of the company to Allergan. When Actelion acquired Axovan AG, he was acting CFO and Head of Business Development. Prior to that, he served at Novartis, SkyePharma and Antares Pharma in a number of responsible functions.

Mandl has served as head of Novartis Vaccines' US research and as global head for all viral vaccine research projects. Reportedly, he directed a team of 300 scientists working on over 15 viral and bacterial vaccine pipeline projects and platform technologies. Prior to this he acted as deputy head of the department of virology at the Medical University of Vienna.

He is an internationally renowned expert in flaviviruses and co-inventor on several patents related to the marketed vaccine for tick-born encephalitis.

EP News Bureau- Mumbai

in stem cell technologies, drug discovery and neurodegenerative disease modelling will be of enormous value to the innovative work we do here at Axol.

We are delighted to have Prof Zeng on board as our CSO and look forward to expanding our portfolio of highly-validated stem cells and services.”

EP News Bureau-Mumbai

Continued from Page 55

‘Our trainees consist...

APIs. Our emphasis is to keep the confidentiality of the customers and samples and provide them with excellent technical support.

What are your expansion plans? Have you identified locations to open more such institutes?

Presently we have most of the required instruments for research and training. The one major instrument that we need is LC/MS/MS and we are hopeful that some reputed manufacturer would come forward to collaborate with us in the near future.

Running such an institute at an optimum level in itself is a big feat; therefore, at present there is no plan to open more such institutes by SIES. Can you share case studies to show how students trained at SIES Institute of Chromatography and Spectroscopy have been benefited?

We do have a few cases in our short time of existence. A senior pharma chemist, who was working abroad came back to India and was assisting us with our courses

and research for a short period of time. During this period, he came across with one of the companies who have been collaborating and he was absorbed by that company in a senior position.

One of the B.Tech. biotechnolgy students from one of the Navi Mumbai colleges carries out her instrumental experiments of her project work and after completion of her degree is pursuing her M.Tech.; she is very thankful to our institute for providing all the help for her project. One of the colleges in Navi Mumbai brought their 30 B.Sc. students to our lab for an educational visit and we were pleasantly surprised to hear from the Professor -incharge that 10 out of 30 students joined for M.Sc. course and she credits our institute for this experience, which has happened for the first time in their college history. There may be a few more cases such as these, we shall make some conscious effort to keep a record of such instances. sachin.jagdale@expressindia.com

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