Express Pharma July 1-15, 2013

VOL .8 NO.17 PAGES 70

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Market ‘Monsoons are closely linked to uptake of medicines’ Management B(LO)w and behold!

Research Genetic testing of breast cancer: The widening horizon 1-15 JULY, 2013, ` 40

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Join pharma professionals from all over the world to network and do business with pharma machinery, equipment and technology suppliers @ P-MEC India 2013!

Pharma Machinery, Equipment & Technology

3-5 December 2013 Bombay Exhibition Centre, Mumbai, India P-MEC India is part of the largest and most comprehensive pharmaceutical industry event in South Asia. Focused on pharmaceutical machinery, equipment, ingredients, outsourcing and bio-solutions, this is your ultimate one stop pharma shop!

As the pharma industry is increasingly looking towards India to source low cost, high quality pharma solutions, P-MEC India and co-located events provide the perfect place to initiate and explore partnerships with key pharma companies from India and abroad.

www.pmec-india.com

Co-located with:

P-MEC is an excellent platform to see the latest products in action. Most of us would like to see the machine performance live and P-MEC is the best place to see the product and thus facilitates the decision making process.

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This event is an excellent opportunity to keep abreast with new developments in the pharma industry.

Dr Prakash U.Tahiliani, Prime Ever Ayurvedic Research Laboratories

Organised By:

V O L 8 . N O . 1 7 J U LY 1 - 1 5 , 2 0 1 3

CONTENTS

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

RESEARCH Genetic testing of breast

BUREAUS

cancer: The widening horizon

Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

PAGE 32

PHARMA ALLY

Bangalore Neelam M Kachhap

‘Water treatment accounts for 72% of

Delhi Shalini Gupta

water and wastewater treatment

MARKETING

equipment’

PAGE 34

Deputy General Manager Harit Mohanty

DHL brings together industry leaders to

Senior Manager Rajesh Bhatkal

discuss key supply chain issues

Phenomenex introduces Kinetex C8

PRODUCTION

5-micron core-shell HPLC column

General Manager B R Tipnis

PAGE 36

Thermo Fisher Scientific unveils

Manager Bhadresh Valia

LC-MS software

Asst. Manager - Scheduling & Coordination Arvind Mane

PAGE 37

Choosing Ultrasonic Flowmeters: The latest

Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

MANAGEMENT

technology for your application

B(LO)w and behold! PAGE 25

Enhancing compliance for oral liquid

Insights in data science and its

medications

applications

A stitch in time saves nine -

Layout Rakesh Sharma

Publication of non-worked patents

PAGE 38

PAGE 39

PAGE 28

Photo Editor Sandeep Patil

PHARMA LIFE Positive sentiments continue in pharma

PAGE 30

C I R C U L AT I O N

sector

Circulation Team Mohan Varadkar

PAGE 63

Abbott receives Golden Peacock Award for Global Business Excellence

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15 RNI Regn. No.MAHENG/2005/21398 Printed for the proprietors,The Indian Express Limited by Ms.Vaidehi Thakar at The Indian Express Press, Plot No. EL-208,TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021.

(Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act.

MARKET

Copyright @ 2011 The Indian Express Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

IPM grows at 9.9 per cent in May 2013 PAGE 20 IPA to organise 6th Symposium on Nasal and Pulmonary

‘Monsoons are closely linked to uptake of medicines’

‘Our members worldwide want to engage with their counterparts in India’

PAGE 64

Indegene launches iAcademy

PAGE 13

PAGE 64

PAGE 15

USP hosts international exchange on public quality standards for medicines and foods

PAGE 17

MoHFW to set up four member committee to regulate stem cell and other cell-based therapies

PAGE 18

Clariant Chemicals (India) invests `38 crores

Drug Delivery in Mumbai

PAGE 19

PAGE 21

Parenteral Drug Association inaugurates its Indian chapter

July 1-15, 2013

PAGE 35

PAGE 24

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9

EDITOR’S NOTE Standing up to Big Brother

THE RECENTLY-FORMED ALLIANCE FOR FAIR TRADE WITH INDIA (AFTI) IS THE LATEST ATTEMPT TO PRESSURE INDIA ON THE IP FRONT. AT STAKE IS INDIA'S RIGHT TO BALANCE PATIENTS AND PATENTS

Bilateral economics and border security issues top the agenda of any India-US strategic dialogue and the recent negotiations co-chaired by US Secretary of State John Kerry in late June were no different.

India got a forewarning of the mood of the US business community when Kerry's visit was preceded by a strong letter to President Obama from the National Association of Manufacturers (NAM), urging him to take strong action against what NAM calls ‘discriminatory’ trade practices, and an ‘erosion’ of IP rights in India.

NAM's June 18 letter was followed by further posturing in the US. Senators representing committees like the Senate Finance Committee, the House Ways and Means Committee, and the Trade Subcommittee, put their weight behind the anti-India rhetoric by sending similar letters to the Obama administration.

The movement culminated with 15 industry associations coming together to form the Alliance for Fair Trade with India (AFTI) co-chaired by NAM and the US Chamber of Commerce’s Global Intellectual Property Center. On June 25, the last day of Kerry's three-day India trip, Pharmaceutical Research and Manufacturers of America (PhRMA) and its counterpart in the biotechnology space, Biotechnology Industry Organization (BIO), together representing most research-driven lifesciences companies, joined the AFTI, a clear indication that the pressure on the pharma IP front will only mount in the coming days.

Given that a fair number of judgments have gone against MNC pharma in India, the pharma industry was closely watching the moves of the US Secretary of State for hints on how the situation was developing.

As the US tries to redefine its relevance in a changing world order, analysts say that it must step back and understand new realities. The reality is that the legal systems of not just India, but other countries like Thailand, are issuing judgments on pharma patents which put the interests of their populations first. Whether it’s the Supreme Court of India's judgment on Novartis' Glivec, or the Bayer-Natco case, this is the 'new normal'. US-based or for that matter, MNC pharma companies, have termed these as unfair business practices, echoing the backlash to Indian IT companies in the US. In a bid to outsource less jobs, the US imposed more stringent visa rules and this too is a sore point between the two nations. If these IP and trade issues are not dealt with soon, they threaten to disturb the uneasy balance between the two nations.

In fact, pressure on the pharma IP front has been mounting from early March, when Roy Waldron, Pfizer's Chief IP Counsel accused India of "routinely flouted trade rules" to benefit domestic companies,

denying IP rights (citing India's revocation of Pfizer’s patent for Sutent), abusing the compulsory license system and ignoring obligations to prevent unfair commercial use of data to grant generic marketing approval.

In May, the Indian Pharmaceutical Alliance (IPA) put out a statement objecting to Waldron's testimony, clarifying that Indian patent law does not discriminate between the domestic and foreign companies. The letter goes on to state that India's laws “distinguish only between innovation and discovery of new forms of known substances that do not result in the enhancement of efficacy”. Pfizer replied to the IPA's letter defending its stance and with this backdrop, the pharma industry was not all surprised when the rhetoric started building up before Kerry's visit.

Given that Waldron's testimony was given days before the Supreme Court's decision rejecting Novartis' plea for a patent on Glivec, it is clear that this campaign is not a knee jerk reaction to one judgment, but a considered move to influence policy in the long term.

As we analyse the outcomes of the US Secretary of State John Kerry's visit, both sides are no doubt preparing the grounds for the next level of talks scheduled for late July, during US Vice President Joe Biden's visit.

Against this backdrop, the Indian government needs to take a firm stand and prepare for a long drawn out battle. In fact, in a clear warning, the June 18 NAM statement also urged the US government "to coordinate closely with the European Union and other like-minded economies," a sign that the US will seek to isolate India on this front in the hopes that if it succeeds in restraining India, other nations will also fall in line.

The US is clearly cracking the whip. If US President Barrack Obama's visit in 2010 included photo ops of the US First Lady interacting with school children, the focus of Kerry's visit was strictly business. Biden's impending visit will be not different in tone, unless both sides decide to explore a middle path.

If Pfizer's IP chief makes a case for the US government by saying that India's actions on the IP front "diminish our market share abroad, which hinders US exports, and ultimately harms US jobs", then industry associations like the IPA need to work in a similar manner. If AFTI is all about 'pursuing public policy options that help create a level playing field for US exporters and innovative companies operating in India', can we counter this move with an alliance to protect the rights of patients in India, and the world, to affordable medicines?

Viveka Roychowdhury viveka.r@expressindia.com

10 EXPRESS PHARMA

www.expresspharmaonline.com

July 1-15, 2013

MARKET

W H AT ’ S INSIDE

THE BUSINESS OF PHARMACEUTICALS

‘Monsoons are closely linked to uptake of medicines’ With the onset of the monsoon, diseases prevalent in this season are also going to up their ante. Kumar Hinduja, Sr Director, Strategy Planning, Business Development, Pharma and Payer Solutions, IMS Health India, talks about the effects of monsoon on the drug market, in discussion with Sachin Jagdale How is the onset of monsoon going to shuffle the Indian drug market?

If you look at the IMS Health market report, it clearly indicates that monsoons are closely linked to uptake of medicines. In the Q3 i.e from July to September, when monsoons are at their peak across the country, it is also the highest contributing quarter for the market. For the last four years, this quarter has contributed at an average of 27 per cent to the market.

As far as chronic therapy drugs are concerned, they remain fairly stable across seasons, whereas, acute therapies show the maximum uptake during monsoons.

The linkage is even more evident as in 2012, when there was a shift in the peak sales of acute drugs, on account of delayed monsoons.

What is the current size of the market for drugs that are mainly used to treat diseases which are more

AVG MARKET CONTRIBUTION % (2009-2012)

INTERVIEW

prevalent during monsoon?

Therapies which are broadly used to treat monsoon related ailments and which generally spurt during this period total up to `33113 crores (MAT April 2013), and contribute ~45 per cent of the total market.

Anti-infectives (antibiotics), gastro intestinals, pain/analgesics and respiratory drugs are the main categories that comprise this group.

How has the market for

THERAPIES PEAKING IN MONSOON

‘Our members worldwide want to engage with their counterparts in India’ PG 15 USP hosts international exchange on public quality standards for medicines and foods PG 17 MoHFW to set up four member committee to regulate stem cell and other cell-based therapies PG 18 Clariant Chemicals (India) invests `38 crores PG 19 IPM grows at 9.9 per cent in May 2013 PG 20 IPA to organise 6th Symposium on Nasal and Pulmonary Drug Delivery in Mumbai PG 21 Parenteral Drug Association inaugurates its Indian chapter PG 24

MANAGEMENT 25 RESEARCH 32 PHARMA ALLY 34 PHARMA LIFE 63 Source: IMS Health TSA, April 2013

July 1-15, 2013

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MAT April 2019 Rs Crore Anti-infectives

11968

Gastro Intestinal

7715

Pain/ Analgesics

6010

Respiratory

5810

Hepatoprotectives

740

Anti malarials

550

Anti Parasitic

319

Total Market

73718 Source: IMS Health TSA, April 2013

Source: IMS Health TSA, April 2013

Rs Crore

2009

2010

2011

2012

CAGR% 09-12

Acute Therapies

34705

40305

46192

51061

13.7

Chronic Therapies

12180

14575

17757

20452

18.9

Total market

46885

54880

63950

71513

15.1

Source: IMS Health TSA, April 2013

Source: IMS Health TSA, April 2013

such drugs evolved over the years in India?

Acute therapies (which constitute ~70 per cent of the total market) have posted a double digit compounded annual growth rate of 13.7 per cent over the past four years. Though this is an impressive performance, chronic therapies in comparison have posted a significantly higher CAGR of 18.9 per cent over the same period.

Besides the monsoon, which other factors decide the diseases patterns?

The India market is still dominated by acute therapies and this is likely to continue for some time.

Monsoon season does contribute to different disease patterns; however, improving literacy and hygiene conditions along with growing urbanisation is also affecting

Source: IMS Health TSA, April 2013

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www.expresspharmaonline.com

disease patterns and gradually expanding the prevalence of lifestyle related chronic conditions (cardiac, diabetes, CNS, etc). As a result besides acute therapies, we are seeing increasing contribution trend from chronic therapies to the overall market.

Since the last few years, monsoon pattern has changed considerably. Has this made pharma companies change their strategies and also modify their product categories?

The table shows the top 20 companies by their acute / chronic portfolio. As can be seen, most companies are skewed towards acute therapies, with Glaxo Smithkline, Alkem, Aristo Pharma, Pfizer and Mankind having more than 80 per cent contribution from this segment. On the other hand we also see companies like USV, Sun Pharma and Torrent who have more than 60 per cent contribution from their chronic portfolio.

Companies with higher contribution from acute therapies may see relatively higher seasonal fluctuations in performance on account of high dependence on acute therapy areas and varying demand for such therapies. Also as mentioned above, these therapies are growing slower than the overall market.

Will pharma companies continue to lean more towards chronic therapies?

Over the years we do see companies consciously shifting their focus towards the faster growing chronic therapies, that promise long-duration treatment, and can to some extent ensure that performance is more stable and predictable. Lupin is a good example which clearly illustrates the successful implementation of this strategy. sachin.jagdale@expressindia.com July 1-15, 2013

M|A|R|K|E|T

‘Our members worldwide want to engage with their counterparts in India’ Richard Johnson, President and Chief Executive Officer, Parenteral Drug Association (PDA), reveals his plans for the Indian pharmaceutical industry, in discussion with Sachin Jagdale Why did it take such a long time for PDA to enter the Indian market? Why is India now a preferred destination for PDA? PDA is a member-based organisation that has been in existence since 1946. There have been members from India for many years. In the last three years we have been working to establish a firm core of supporters and volunteers to assure that a PDA India Chapter will be sustainable. India is recognised as an important player in the global pharma community, and PDA wants to support this community.

July 1-15, 2013

What do you think of recent increased scrutiny of parenteral plants by FDA and global regulatory agencies?

How would the industry get affected by this? What role would PDA play?

Worldwide there has been increased regulatory focus on pharma manufacturers, especially as the supply chain and global sourcing have become more complex. Sterile product manufacturing is among the most sophisticated types of processes, and regulators have always focussed on these facilities. PDA works to bring best practices to the industry, and provides expertise, technical guidance and training to the industry and regulators to promote sterile manufacturing.

INTERVIEW

What are the current challenges for the Indian pharma and biologics indus-

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tries in the global market?

How is PDA going to address these challenges?

All manufacturers worldwide are trying to balance higher expectations for quality and compliance with cost and competitiveness pressures.

This is very true in India as well. PDA is an important venue for bringing all parties (manufacturers, technical experts, regulators, academics and suppliers) together to identify the best ways to advance these goals. Through our many activities (conferences, training, technical guidance) we promote harmonisation of these practices.

What role does PDA play in the biologics and pharma industry and how does it interact with the global regulatory bodies?

PDA is a leading international association that works to ‘Connect People, Science and Regulation’. Our activities are focussed on sterile manufacturing of pharma and biopharma products via conferences, training and the development of science-based technical guidance. In these efforts, we often engage with regulators from around the world. PDA has been holding joint conferences with regulators on important topics for more than 25 years, and we have provided training with, and for regulators from many countries and multinational organisations such as US FDA, PIC/S and WHO. What are PDA’s future plans, globally and specifically for India? Which are the pharma and biologics companies in India that you are currently engaging with?

PDA has a strategic plan whose focus is to advance science-based improvement in the supply of safe and effective healthcare products worldwide. PDA is committed to working with and through our members in India to expand these activities in India. We have met with members from many Indiabased biologics and pharma companies including Biocon, CIPLA, Dr Reddy’s, and Aurobindo, allied industry partners like Sartorius-stedim, pharma-consulting organisations like Vienni, as well as multinational companies and Central and State Health Authorities. Our chapter board includes members from a diverse group of companies.

Currently, Interim Chapter President is Sanjay Singh, who

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www.expresspharmaonline.com

PDA IS A LEADING INTERNATIONAL ASSOCIATION THAT WORKS TO ‘CONNECT PEOPLE, SCIENCE AND REGULATION’. OUR ACTIVITIES ARE FOCUSSED ON STERILE MANUFACTURING OF PHARMA AND BIOPHARMA PRODUCTS VIA CONFERENCES,TRAINING AND THE DEVELOPMENT OF SCIENCEBASED TECHNICAL GUIDANCE is from Aurobindo Pharma, Interim President Elect is Sanjit Lamba from Eisai, Interim Secretary Amit Sharma from Sartorius, and Interim Treasurer, Ivy Louis from Vienni.

Which are some of the projects that PDA is currently working/will work on, in India?

PDA has several areas of focus that are pertinent to India. Our leadership, guidance, and training in sterile manufacturing is applicable.

Our focus on quality systems, biologics, drug delivery technology and supply chain integrity are also areas that can be very applicable in India.

How would you describe the response of Indian pharma and biologics companies to PDA? I have been impressed by the response we have received. Members, industry leaders and regulators see the need for PDA to be a participant in helping the Indian industry rise to these new challenges, and through that energy and commitment, I am confident that we can be a good partner with the industry in India. Our members worldwide want to engage with their counterparts in India to advance our common goals, safe and effective healthcare products. Every patient, in every country deserves this commitment. sachin.jagdale@expressindia.com July 1-15, 2013

M|A|R|K|E|T

COMPANY WATCH USP hosts international exchange on public quality standards for medicines and foods Delegations from countries in the Middle East, Africa, Russia and the former Soviet Republics gained knowledge about USP processes and standards

the globe,” Ibrahim

said Fahad Al-Jenoobi,

Executive Director for the Product Evaluation and

Standards Setting division of the Saudi Food and Drug

Authority.

EP News Bureau–Mumbai

he US Pharmacopeial Convention (USP) has welcomed representatives from 17 international regulatory and enforcement agencies and national reference laboratories to its International Training Programme (ITP).

Delegations from countries in the Middle East, Africa, Russia and the former Soviet Republics gained knowledge about USP processes and standards-setting activities for chemical and biological medicines, as well for herbal medicines, dietary supplements and foods.

“Public standards are critically important to help ensure the quality of all medicines,” said Roger L Williams, Chief Executive Officer, USP. “The international training programme is a unique opportunity not only for countries interested in improving their health systems and regulatory framework, but also for USP to expand its understanding of regulatory and compendial issues from an international perspective.”

The programme includes speakers from the US Food and Drug Administration, the National Institutes of Health Office of Dietary Supplements, and USP. Speakers will address enforcement and scientific aspects of implementing public standards, and how the global market is influencing the regulation of medicines and dietary supplements, as well as healthcare quality and safety, quality assurance, and global health programmes.

“With manufacture and commercialisation increasingly crossing borders in the international landscape, it is important to consider the need to exchange information with other regulatory and scientific organisations around

T

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MoHFW to set up four member committee to regulate stem cell and other cell-based therapies Committee to submit report within the next two months of its formation Usha Sharma - Mumbai he Ministry of Health and Family Welfare, Government of India, has decided to set up a fourmember high-powered committee in order to formulate regulation of stem cell and other cell-based therapies in India. The committee will review the existing therapies and finalise the parameters of stem cell regulation guidelines. It is expected that the report will be presented to the Ministry of Health and Family Welfare in the next three months.

The new proposed committee will be monitored by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

Prof Lalji Singh, Vice Chancellor, Banaras Hindu University, who has been nominated as the Chairman of the high powered committee said, “So far I have not received any official communication from the Ministry of Health and Family Welfare. Some time back I had put a proposal to the Government of India and suggested that they form a separate committee for stem cell and other cell-based therapies. I am happy to know that the Government of India accepted my

T

proposal and has taken a step forward.”

Commenting on the need for such a committee, Singh said, “Since ages there has been a hue and cry to make guidelines in order to regulate stem cell and other cellbased therapy industry.

However, the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT) were both wary of accepting stem cell regulation under their respective umbrellas.”

The primary area of functioning of the proposed high-powered committee of stem cell and other cellbased therapies is to review the status of the stem cell research therapy in India.

We will be identifying the different types of stem cell therapies to come under the regulation. For eg. live cell

transplant, organ transplant will not come under these stem cell regulation guidelines. Something like bone marrow (autologous stem cell) will certainly come under the format.

Autologous stem cells will be strictly regulated and will need to follow quality parameters. Besides this invitro and multiple in-vitro will certainly come under regulatory control with strict quality control parameters, revealed Singh.

As per an order issued by the Ministry of Health and Family Welfare, Dr Gopal Pande, Chief Scientist, CCMB Hyderabad will also be a member of the proposed committee. Two more experts, one each from the stem cell industry and from academia, need to be nominated.

THE COMMITTEE WILL REVIEW THE EXISTING THERAPIES AND FINALISE THE PARAMETERS OF STEM CELL REGULATION GUIDELINES.THE NEW PROPOSED COMMITTEE WILL BE MONITORED BY THE CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO), DIRECTORATE GENERAL OF HEALTH SERVICES, MINISTRY OF HEALTH AND FAMILY WELFARE, GOVERNMENT OF INDIA

As required by the Ministry, the committee will submit its report within two months after the formation of the proposed committee.

The committee will be reviewing the existing draft guidance documents and modify / replace it with CDSCO's regulatory documents.

It will suggest the future scope and points of action which need to be included in the CDSCO activities to make it an effective regulator of stem cell therapy in India and also to indicate the role of other bodies.

The terms of reference of the committee’s report also include suggestions on the prerequisites which need to be fulfilled for the approval of proposed indications for the stem cell product or therapy with specific differentiation of who will control the claims mentioned under therapy (which may fall out of domain of CDSCO). A road map to establish collaboration and training programme with international regulatory agencies will also be part of the committee's suggestions.

Singh also mentioned, “We will be having a separate testing laboratory as per international GLP (good laboratory practice) standards.

All cells can be tested and certified and then sold and used by patients. If we find it necessary, we will set up a separate committee for monitoring this activity.” u.sharma@expressindia.com

Intas Pharmaceuticals files DRHP for IPO The IPO will be made through a public issue of equity shares of face value of `10 each ntas Pharmaceuticals has filed a draft red herring prospectus (DRHP) with the Securities and Exchange Board of India (SEBI) and the stock exchanges for an initial public offering (IPO). The IPO will be made through a public issue of equity shares of face value of Rs`10 each (equity shares) including a share premium, which will be determined on a later

I

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date, aggregating ` 2,250 million (fresh issue) and an offer for sale of 11,621,100 equity shares by Mozart (the ‘Offer for Sale’ and together with the Fresh Issue, the ‘Issue’).

The issue is being made through the book building process, wherein not more than 50 per cent of the issue shall be allocated on a proportionate basis to qualified institutional buyers (as defined in the SEBI (issue of capital and disclosure requirements), Regulations, www.expresspharmaonline.com

2009, as amended. The company may, in consultation with the book running lead managers, allocate up to 30 per cent of the QIB Portion to anchor investors at the anchor investor allocation price, on a discretionary basis, out of which at least one-third will be available for allocation to domestic mutual funds only.

The promoters of the company are Hasmukh Chudgar, Binish Hasmukh Chudgar, Nimish

Hasmukhbhai Chudgar, Dr Urmish Hasmukh Chudgar, Kusum Chudgar, Bina Chudgar, Bindi Chudgar, Parul Chudgar, Shail Chudgar, Intas Enterprise, Equatorial, and Cytas Research.

Kotak Mahindra Capital Company and Morgan Stanley India Company are the book running lead managers to the issue and Link Intime India is the registrar to the issue.

EP News Bureau–Mumbai July 1-15, 2013

M|A|R|K|E|T

Clariant Chemicals (India) invests `38 crores Invests in its pigments business at its Roha site in Maharashtra lariant Chemicals (India) has announced an investment of `38 crores in its pigments business, at its Roha site in Maharashtra to support the strong market growth in the country. This step has been taken as an initiative to help accelerate Clariant’s business and support R&D to respond faster to local product development needs.

The announcement marks another step in Clariant’s significant commitment to support customers in emerging markets like India with high quality products that are sus-

C

tainable, sharing the principles of Performance, People and Planet.

The investments also

include the construction of a new pigment plant at Roha that will double the plant’s capacity. During the course of the past few months, an upgraded, new technical service laboratory for pigments also commenced its opera-

tions in Cuddalore site (Tamil Nadu).

Dr Deepak Parikh, Managing Director and Vice Chairman, Clariant Chemicals (India) said, “These initial steps are the first in a broader strategy to invest and develop

our capabilities in India in order to better serve our customers and provide them with the high quality products and superior technical support they need to be successful in growing their business.”

EP News Bureau–Mumbai

Glenmark Generics receives final ANDA approval for Riluzole tablets Is indicated for the treatment of amyotrophic lateral sclerosis lenmark Generics, USA the subsidiary of Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Riluzole tablets, 50 mg. The company will commence shipping immediately.

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis. Based on IMS Health sales data for the 12 month period ending March 2013, Riluzole garnered sales of $64 million.

Glenmark’s current portfolio consists of 86 products authorised for distribution in the US marketplace and 52 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

EP News Bureau–Mumbai

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GROWTH TRACKER

IPM grows at 9.9 per cent in May 2013 Valued at ` 6100 crores With Bonus Units at Full Value

Sun Pharma

1

1

3608

5.03

20.9

327

5.39

21.2

Cipla

2

2

3576

4.98

6.0

307

5.06

12.1

Glaxo

3

5

3201

4.46

6.7

248

4.08

-5.1

Ranbaxy

4

3

2983

4.16

7.9

256

4.21

20.2

Zydus Cadila

5

4

2961

4.13

23.3

253

4.17

25.3

Abbott HC

6

6

2732

3.81

7.6

222

3.66

11.0

Mankind

7

7

2597

3.62

20.2

215

3.55

8.2

Lupin

8

8

2210

3.08

14.2

189

3.11

14.4

Alkem

9

9

2190

3.05

11.8

185

3.05

15.8

Macleods

10

10

1846

2.57

18.1

156

2.57

12.8

Intas

11

11

1781

2.48

18.8

154

2.54

15.7

Pfizer

12

13

1714

2.39

12.1

136

2.25

-0.3

Aristo

13

12

1651

2.30

9.8

139

2.28

7.4

Dr. Reddys

14

14

1583

2.20

12.1

136

2.24

13.0

Sanofi-Aventis

15

15

1436

2.00

9.0

120

1.98

4.0

Glenmark

16

18

1430

1.99

17.0

116

1.91

14.5

Abbott

17

16

1418

1.98

6.9

117

1.93

1.7

IPCA

18

19

1298

1.81

15.8

112

1.84

15.8

USV

19

17

1284

1.79

20.9

116

1.91

18.8

he Indian Pharma Market (IPM) has been valued at `6100 crores in May 2013. It has seen a growth of 9.9 per cent during May. For the month of May 2013, amongst the top 10 corporates, Zydus has seen a growth of 24.3 per cent, followed by Sun Pharma at 21.2 per cent and Ranbaxy at 20.2 per cent. 23 corporates have crossed the growth of IPM for the month of May amongst the top 50.

Amongst the top 50 corporates, Bharat Serums has the highest growth of 52.8 per cent followed by AstraZeneca at 39.9 per cent and Eris at 28.5 per cent. Amongst the 11-20 ranked companies USV has shown high growth at 18.8 per cent followed by Ipca at 15.8 per cent and Intas at 15.7 per cent.

Akumentis breaks into top 50 amongst the corporates. Amongst the upcoming corporates Corona Remedies has seen a growth of 171.6 per cent, Eris at 28.5 per cent and Akumentis at 24.2 per cent. Astra comes to positive growth during May with 39.9 per cent. Centaur has entered the `200 crores club and Micro has crossed `1300 crores on MAT basis.

From therapy perspective nine therapies have outgrown the IPM growth. The antiinfective market has a growth of 8.7 per cent whereas respiratory market is at 10.4 per cent growth. The anti-diabetic market has seen a growth at 12.5 per cent and Cardiac at 12.9 per cent in chronic business. Amongst the top 10 therapies, Neuro/CNS market has shown the highest growth at 13.2 per cent.

Micro Lab

20

21

1271

1.77

5.7

106

1.74

9.0

About PharmaTrac

Val in Crs COMPANY

Rank MAT

MAT May -13

MTH

IPM

Val in Crs Super Group

May-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

71774

100.00

10.6

6069

100.00

9.8

RANK MAT SV

AV

With Bonus in Crs

BV MAT May13 GR% Mth May13 GR%

IPM

71774

10.6

6069

9.8

ANTI-INFECTIVES

1

1

1

12666

8.5

996

8.7

CARDIAC

2

2

10

8839

13.1

776

12.9

GASTRO INTESTINAL

3

3

3

8178

11.8

756

9.0

VITAMINS / MINERALS / NUTRIENTS

4

4

7

6344

11.2

554

7.1

RESPIRATORY

5

5

4

5429

7.5

382

9.7

PAIN / ANALGESICS

6

6

5

5309

7.9

440

6.8

ANTI DIABETIC

7

7

16

4671

14.6

414

12.5

GYNAECOLOGICAL

8

9

2

4658

8.0

400

5.1

NEURO / CNS

9

8

12

4383

11.4

382

13.2

DERMA

10

10

9

3770

11.5

322

11.7

OPHTHAL / OTOLOGICALS

11

11

15

1286

11.3

114

5.8

HORMONES

12

12

14

1242

16.3

104

12.2

T

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 in AIOCD AWACS stands for Advanced Working, Action & Correction System – reflecting 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. Accurate and faster information flows from the market will help clients grow topline and bottom-line.

Terminologies used

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www.expresspharmaonline.com

MAT – Moving Annual TotalMTH – MonthVal(Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage For more information, visit http://www.aiocd.net

July 1-15, 2013

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PRE EVENT IPA to organise 6th Symposium on Nasal and Pulmonary Drug Delivery in Mumbai Event to be held on October 24 and 25, to have a theme on ‘Global Regulatory Trends’

Patient Choice and Improving Compliance’ – David Harris,

Team Consulting; Global Bioequivalence Expectations

for Orally Inhaled and Nasal Drug Products' – Dr Julie

Suman, Nextbreath; ‘Challenges and Opportunities

he Indian Pharmaceutical Association (IPA) will organise a Symposium on Nasal and Pulmonary Drug Delivery in Mumbai from October 24 to 25, 2013. The event is the sixth in the series of similar programmes organised over the last decade. This year the theme of the symposium is ‘Global Regulatory Trends.’

The USP of the symposium will be the workshops organised on day two, which will give the participants an opportunity for closer interaction and hands-on experience.

The symposium will have an exhibition by sponsors and poster presentations by leading researchers from India and abroad, working in the area of nasal and pulmonary drug delivery.

Aptar Pharma has continued to be the platinum partner and co-organiser for the event since the beginning.

Mexichem Fluor, DH Industries, Presspart, Malvern AIMIL, Innova Systems, Copley Scientific have been the gold partners. This year, IPA has added two more gold partners, Team Consulting and DFE Pharma for the event.

Experts would share their knowledge in this field with topics like: ‘Overview of the Ph. Eur’ – Dr Steven Nichols; ‘Methodologies for In-Vitro Bioequivalence Testing of Generic Inhaled Products in the Emerging Markets’ – Mark Copley, Copley Scientific; ‘The HFA Challenge: The Safe, Effective Containment and Delivery of pMDI Respiratory Medicines’ – Richard Turner, Presspart; ‘pMDI Filling and Control Equipment Solutions to Meet the Ever Increasing Demands of the Global Regulatory Authorities’ – Paul Sullivan, DH Industries; ‘Automated Testing of Nasal Sprays and Metered Dose Inhalers and FDA Regulatory Requirements’ – HenrikKrarup, Innova Systems; ‘Time for Change:

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in Dry Powder Inhalers’ – Dr Kapileshwar Swain, Wockhardt; ‘Utilising QbD Analytical Method Development in Nasal Spray Droplet Size Characterisation’ – Stuart Wakefield, Malvern AIMIL; ‘Medical Propellants: Regulatory Update and Other News’ – Dr Tim Noakes, Mexichem; ‘Inhaled Therapies for Tuberculosis in the Russian Regulatory Landscape’ – Dr

Amit Misra, CDRI. Three parallel workshops will be conducted in the first half of day two by Malvern AIMIL, Innova Systems and Aptar Pharma.

IPA plans to bring in experts from US FDA, EDQM and DCGI office to participate in this programme. The media partner for the event is Express Pharma.

The first edition of the

symposium was organised way back in 1999, followed by the next one in 2004, the third in 2007, fourth in 2009 and the fifth in 2011. The earlier editions of the symposium were focussed on discussing the basics of formulation technology and manufacture of nasal and pulmonary drug delivery systems. Keeping in view the interest shown by the Indian pharma companies

for making forays into the regulated markets, in 2009, IPA had decided to focus on the basics of regulatory filing concerning these delivery systems. In 2011, IPA took the theme a step forward by focussing on the regulatory challenges faced by the pharma companies working on nasal and pulmonary drug delivery systems.

EP News Bureau-Mumbai

EVENT BRIEF Seminar on ‘Widening the Horizons for Practicing Pharmacists in Industries and Hospitals’

4th Annual Pharma Supply Chain Summit

Pharmac India 2013

Date: July 11-12, 2013

Date: September 5-7, 2013

Venue: Mumbai

Venue: Hitex, Hyderabad

Summary: Now in its 4th year, CPhI’s Annual Pharma Supply Chain Summit would be focusing on practical case studies and open discussions on important topics like Government Policies GST Act, extensive use of IT for visibility and automation of supply chain, optimising international logistics and the critical debate on 3PL for effective outsourcing of supply chain.The topics will be discussed in innovative networking formats like speed geeking, i3 centre, clash of the titans.

Summary: Pharmac India 2013 is 4th International pharma machinery, equipment, bulk drugs, API and material exhibition is going to be held in Hyderabad, Hitex. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry.

Pharmac India 2013 is jointly organised by Orbit Exhibitions and IDMA (GSB) and actively supported by BDMA and CIPI.

Contact details: Tel: (022) 61727001 Email: Conferencesindia@ubm.com Website url: http://www.pharmasupplychainindia.com?utm_campaign=MEDIAPARTNER&utm_ medium=EVENTLISTING&utm _source=EXPRESSPHARMA

Contact details: Varsha Surve Manager - Exhibitions Orbitz Exhibitions 101, Navyug Industrial Estate, TJ Road, Siwree (W) Mumbai - 400015 Mob: 9322037955 Email: info@pharmacindia.com

Date: July 5-6, 2013 Venue: PSG College of Pharmacy, Peelamedu, Coimbatore-641004, Tamil Nadu Summary: PSG College of Pharmacy will organise a national level seminar on 'Widening the Horizons for Practising Pharmacists in Industries and Hospitals'.The seminar will be co-sponsored by Department of Science and Technology (DST), New Delhi and The Tamilnadu Dr MGR Medical University, Chennai.

The seminar will highlight the concept of practising pharmacist services in community and the opportunities/role for pharmacist in the healthcare industry.

Contact details: Tel: 0422-4345841 Email:principalsgcp@ gmail.com Website: www.psgpharma.ac.in

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Clinical Trials Asia Summit Date: September 26-27, 2013 Venue: Hyderabad

www.expresspharmaonline.com

Summary: Clinical trials are being conducted globally however outsourcing them to emerging economies like India provides competitive advantages in terms of lower operational costs and faster conduction of clinical trials.

India has a steady supply of patients and medical facilities for conducting clinical trials at very competitive proposition. The Indian pharma industry is growing at the annual rate of 11 per cent while the clinical research industry is growing an annual rate of whopping 84 per cent.

Clinical Trials Asia Summit is a platform for key stake holders to engage and critically analyse the road map for further growth towards establishing sustainable leadership of India in global clinical trials scenario.

Contact details: Tikenderjit Singh Makkar Dy. Mktg. Manager - India Fleming Gulf 605, City Tower Boat Club Road Pune - 411001 Maharashtra (India) Tel: (020) 67276403 Fax: (020) 6607 0061 Email: tikenderjit.singh@fleminggulf.com Website: www.fleminggulf.com URL: http://www.fleminggulf.com/c onferenceview/Clinical-TrialsAsia-Summit-/485

16th PAC-2013 Date: September 27 - 28, 2013 Venue: Hotel Hyatt Regency, Sahar Airport Road, Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and Association of

July 1-15, 2013

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Pharmaceutical Analysts (APA) have announced the 16th Pharmaceutical Analysts’ Convention (PAC) 2013. The main theme for this year’s convention is ‘Generics The Game Changer’. Dr B Suresh, Vice Chancellor, JSS University, Mysore and President, Pharmacy Council of India New Delhi will be the Chief Guest.

Experts in analysis, research, academia and regulatory spheres from the Indian pharmaceutical industry, will converge and get-together to interact on various recent developments. The convention will be held in order to update and exceed the current regulatory requirement and science-based systems approach in pharma

es are likely to attend the convention.

Contact details: Prachi Sr Manager - Publications & PR IDMA 102-B, 'A' Wing, Poonam Chambers Dr Annie Besant Road, Worli Mumbai - 400018 Tel: (022) 24944624/ 24974308 (Extn. 103) Mob: 9867634383 Email: ppr@idmaindia.com / prach17@gmail.com Website: www.idmaassn.org

CPhI India Date: December 3-5, 2013 Venue: Bombay Exhibition Centre, Mumbai

industry.

The convention is designed to cater to all those involved in: pharma industry; biopharmaceutical industry; biotechnology industry; nutraceutical industry; microbiological industry; Government laboratories; research institutions; academic institutions; business consulting companies; contract manufacturing organisations; contract research organisations; R&D equipment / machine manufacturers; supply chain management; API, excipients and intermediates manufacturers and CROs. Heads of strategy and business development, R&D, regulatory affairs; analytical development laboratory; quality control / assurance; production; packaging; purchase; exports; medical affairs; pharmacology and toxicology; outsourcing; supply chain; pharma product development; logistics and clinical research servic-

July 1-15, 2013

Summary: Reflecting the continued growth in the API, generics, fine chemicals and bio-pharmaceuticals industries on the Indian sub-continent, CPhI India and related pharma services events saw an increase in visitors and exhibitors. CPhI India will bring pharma professionals from all over the world to Mumbai and facilitates initiating and closing business deals. Take this opportunity to showcase your products and services while enhancing your brand at South Asia’s leading pharma industry event.

Contact details: Chaitali Patil UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol,Andheri (East) Mumbai - 400 059 T +91 22 61727162 F +91 22 61727273 E chaitali.patil@ubm.com

www.expresspharmaonline.com

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POST EVENT Parenteral Drug Association inaugurates its Indian chapter Event held in Mumbai was attended by over 70 delegates from parenteral manufacturing and allied industry ith the increase in emphasis by the regulators on sterility assurance, representatives of the Indian parenteral drug manufacturing industry came together to establish Parenteral Drug Association (PDA) India chapter. This platform will be used to connect people, science and regulations. The inaugural convention of PDA India chapter was recently held in Mumbai and Hyderabad. The convention in Mumbai was attended by approximately 70 delegates from parenteral manufacturing and allied industry.

The convention held in Mumbai started with written message and best wishes, which was read to the participants by Mahesh Zagade, Commissioner, Food & Drug Administration Maharashtra to PDA India Chapter. The Guest of Honour was Farhana Khan, Assistant Director (Medicines) US FDA. Richard Johnson, President and Chief Executive Officer, PDA, elaborated the role which PDA plays in connecting people, science and regulations, the plans of PDA in near and distant future and benefits of volunteering with PDA. Sanjay Singh, President, PDA India Chapter explained the need of PDA chapter in India, the story behind the efforts to convince PDA. Sanjit S Lamba, President elect, PDA India chapter, elaborated the plans of PDA India chapter and the role it envisages to play in becoming voice of India on global platforms.

The convention proceeded with technical discussions on latest advancements in chemical sterilization, pharmaceutical water, specific emphases to Indian needs and latest on isolation technologies. There were open

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panel discussions, addressed by industry experts and Peter Baker, Assistant Country Director, US Food and Drug Administration India Office.

The programme ended with the vote of thanks to all the guests and participants

by Ivy Louis, Treasurer PDA

India Chapter.

A similar convention was also held in Hyderabad.

PDA is the leading global provider of science, technology and regulatory information and education for the pharma and biopharmaceutical community. Founded in 1946 as a

non-profit organisation, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide.

EP News Bureau-Mumbai

(L-R) Ivy Louis, Treasurer PDA India Chapter; Michele Arduini, IMA Life; Peter Baker, Assistant Country Director, US Food and Drug Administration India Office; Richard Johnson, President and Chief Executive Officer, PDA

Sanjay Singh, President, PDA India Chapter; Richard Johnson, President and Chief Executive Officer, PDA; Farhana Khan, Assistant Director (Medicines) Office of International Programme, US FDA India Office; Sanjit Lamba, President Elect, PDA India Chapter during the inaugural convention in Mumbai www.expresspharmaonline.com

July 1-15, 2013

MANAGEMENT INSIGHT FOR MANAGING PHARMA

W H AT ’ S INSIDE

Insights in data science and its applications PG 28 A stitch in time saves nine - Publication of non-worked patents PG 30

RESEARCH 32 PHARMA ALLY 34 PHARMA LIFE 63

July 1-15, 2013

www.expresspharmaonline.com

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I In 2001, Sherron Watkins, the then Vice-President of the corporate development department at Enron wrote an anonymous letter detailing aberrations in the company's financial statement to the CEO, Kenneth Lay, turning whistleblower in the process. Not only did Enron go bankrupt because of fraudulent earnings reports and embezzlement, many employees lost entire retirement portfolios filled with company’s stocks as their value turned to zilch. The scandal is remembered as one of the biggest in the US till date. It was then that Senator Paul Sarbanes and Representative Michael Oxley drafted the SarbanesOxley Act or 'SOX' to rein in corporate fraud. That is in the financial domain.

However, such cases can have serious implications when pharmaceutical companies are involved, since the lives of innumerable patients are at stake and the damage is irrevocable.

The revelation by Dinesh Thakur, then Director and Global Head of Research Information and Portfolio Management at Ranbaxy Laboratories (2003-2005) has not only made Ranbaxy the first Indian company to come under the scanner for misrepresenting data in one of the biggest settlement by a

generic pharma company ($500 million) but it also serves as a warning for others to be careful and diligent about data reporting and others such frauds. The case which dragged on for the past eight years could not have made a roaring impact had Thakur’s identity not been protected under the Whistleblower Protection Act. It was in 2005, when he first reported falsified data from Ranbaxy’s Paonta Sahib and Dewas plants to the management. Their failure to take any action, led him to knock the doors of the US FDA over falsified records and violations of US Drug manufacturing rules.

The Indian scenario Figures indicate that in the US alone, of all the whistleblower suits filed, 10 per cent involve drugmakers, which is significant given that 2011 saw 900 such suits in total. The stream of allegations continues even as the lawyers from US Justice Department dish out hefty penalties, one after the other.

So much so that pharma biggies including GSK, Johnson & Johnson and Abbott to name a few, paid $6.6 billion as fraud penalties in 2012, double that of previous year, suggest estimates. However, the Indian scenario is completely different. Unlike the US, where the Whistleblower Protection Act is two decades old, India does not have any law to protect whistleblowers, though a bill for the purpose is in the pipeline. The Union Cabinet passed The Public Interest Disclosure and Protection of Persons Making Disclosure Bill, 2010 in order to implement an effective whistle blowing policy. This bill was passed by the Lok Sabha on December 27, 2011 but the Rajya Sabha is still to pass

THE UNION CABINET PASSED THE PUBLIC INTEREST DISCLOSURE AND PROTECTION OF PERSONS MAKING DISCLOSURE BILL, 2010 IN ORDER TO IMPLEMENT AN EFFECTIVE WHISTLE BLOWING POLICY.THIS BILL WAS PASSED

BY THE LOK SABHA ON DECEMBER 27, 2011 BUT THE RAJYA SABHA IS STILL TO PASS THE BILL 26

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www.expresspharmaonline.com

NANDITA GERA

DINESH ANAND

Partner Titus & Co

Partner and Head, Forensic Services, KPMG India

The major loophole in our administration lies in the fact that Indian Companies Act, 1956 as well as SEBI Act, 2002/ Guidelines do not contain any statutory provision regarding whistle blowing policy and there exists only a non-mandatory provision under Clause 49 of the Listing Agreement under SEBI guidelines

US also recently introduced the Dodd Frank Act which provides for a whistle blower bounty programme, beyond just protection of identity with the provision for the whistle blower to report directly to the regulators.

The US laws are quite stringent in terms of quantum of penalties and settlement of criminal matters

the Bill. At present, the Chief Vigilance Commissioner and the Central Vigilance Commission have the same powers as that of a criminal court in matters related to whistleblowing.

“The major loophole in our administration lies in the fact that Indian Companies Act, 1956 as well as SEBI Act, 2002/ Guidelines do not contain any statutory provision regarding whistle blowing policy and there exists only a non-mandatory provision under Clause 49 of the Listing Agreement under SEBI guidelines(which deals with the various measures of corporate governance that companies should follow),” elaborates Nandita Gera, Partner, Titus & Co. Under this policy, if a company is involved in any kind of malpractices, persons aware of it do carry an option to report higher official or rather appropriate Governmental authorities so that the investigation procedure can begin at the very onset, and the responsible persons/company could be penalised.

“Since, there are no specific statutory provisions regarding whistleblower policy, people in our country do

not report such instances out of the fear of retaliation, rejection, lack of personal security and risk of loosing their jobs in absence of any provisions of reward/ compensation for reporting any unethical acts in their organisations,” she says further.

Corporate India has been slow to respond to the nonmandatory requirements of Clause 49 in general, and the clause relating to the whistleblower policy in particular, she opines.

Chips in Dinesh Anand, Partner and Head, Forensic Services, KPMG India, “US also recently introduced the Dodd Frank Act which provides for a whistleblower bounty programme, beyond just protection of identity with the provision for the whistleblower to report directly to the regulators.

The US laws are quite stringent in terms of quantum of penalties and settlement of criminal matters. Further, they also have provisions for voluntary self disclosures of problems by companies.”

The Indian Ministry of Health and Family Affairs devised a reward scheme for whistleblowers who provide specific information to the July 1-15, 2013

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THE INDIAN MINISTRY OF HEALTH AND FAMILY AFFAIRS DEVISED A REWARD SCHEME FOR WHISTLEBLOWERS WHO PROVIDE SPECIFIC INFORMATION TO THE DESIGNATED AUTHORITIES LEADING TO THE SEIZURES OF SPURIOUS, ADULTERATED, MISBRANDED AND NOT OF STANDARD QUALITY DRUGS, COSMETICS AND MEDICAL DEVICES BY THE DESIGNATED OFFICERS OF THE CENTRAL DRUGS STANDARD CONTROL ORGANISATION [CDSCO].THE INFORMER IS ENTITLED UPTO 20 PER CENT OF THE TOTAL COST OF CONSIGNMENTS SEIZED WHICH SHOULD NOT IN ANY CASE EXCEED `25 LAKH IN EACH CASE designated authorities leading to the seizures of spurious, adulterated, misbranded and not of standard quality drugs, cosmetics and medical devices by the designated officers of the Central Drugs Standard Control Organisation [CDSCO]. The informer is entitled upto 20 per cent of the total cost of consignments seized which should not in any case exceed `25 lakh in each case.

While it keeps the identity of the whistle blower a secret, the fact that he/she is required to file an FIR for CDSCO to take any action, is responsible for the little or no impact of the scheme.

Discretion is essential Both Anand and Gera agree that the policy can go either way. “While whistleblowing reinforces the idea

of social justice by exposing fraud, deceit, corporate inequity etc. to protect the public, colleagues or others from risk, its misuse can't be ruled out. A person might blow a whistle in order to pursue a personal grudge or for other malicious reasons even when the concerned person is not directly responsible,” says Gera. Moreover, many of the employees look for opportunities to come in to the limelight so that their seniors can recognise them as a responsible person. This may engage the company into unnecessary investigations which would result in substantial loss of the company, she adds.

However, whenever there

is a debate with regard to the pros and cons of whistle blowing, academia has always tilted the balance in favour of whistle blowing despite the awareness that a law which is completely in favour of the whistle blowers may lead to frivolous complaints without merits, she reinforces.

Anand stresses, “If companies want to know whether unethical practices exist in a work place, one of the best ways to unearth these are through appropri-

ate whistleblower mechanisms.

These provide a safe and secure means to stakeholders to report ethical violations and concerns in a non-threatening environment. It is necessary that any such measures are supplemented by strong training and triage processes that result in the correct identification and remediation of ethical complaints as regards general grievances.”

Enactment of new laws in India will go a long way in terms of vastly improving governance cultures in companies and prompt companies to identify, address and report shortfalls to regulators in the future, he adds. This along with an increasing number of companies realising the need to pay heed to non-mandatory requirements might help the situation. Till then, the probability of any malpractices in an Indian pharma company being reported are very low.

However, the subsidiaries of the Indian pharma company outside India will always stand a better chance of being exposed on account of the specific legislations on whistle blowing in such countries, which may ultimately expose the parent Indian company like in Ranbaxy’s case, concludes Gera. shalini.g@expressindia.com

Origin of the term he term `whistle blowing' was first discussed by Doggett, J, in the case of Winters v. Houston Publishing Company (781 S.W.2d 408 (1989). The word is derived from the practice of the English Police, who would blow their whistles when they noticed the commission of a crime. Whistle blowing is when a worker reports suspected wrongdoing at work. Officially this is called ‘making a disclosure in the public interest’. The whistle would alert both law enforcement officers and the general public of danger. It can be invoked in case of danger to health and safety of an individ-

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July 1-15, 2013

ual, damage to the environment, occurrence of a criminal offence etc.

Various international conventions recognise whistle blowing as an effective tool for detecting and fighting corruption, fraud and mismanagement, and commit signatory countries to implement appropriate legislation.

to a number of corporate accounting scandals

AUSTRALIA: the Public Interest Disclosure Act, 1994, enacted for Employees in the public sector and those who disclose information of public concern, to provide protection to such persons from any retaliation or reprisal.

UNITED STATES: First to pio-

CHINA: Article 41 of the Chinese

neer the formulation of a policy, the American Senate and House passed Whistle Blowers Protection Bill in 1988, but it was vetoed by President Reagan.

Later, the Sarbanes - Oxley Act was enacted in 2002 in response

Constitution enshrines the whistle blower protection as a constitutional right for all citizens. It empowers all citizens to report any kind of misconduct and forbids retaliation against such citizens.

www.expresspharmaonline.com

UNITED KINGDOM: Public Interest Disclosure Act, 1998 protects employees in all sectors from dismissal and other forms of retaliation. The Sarbanes Oxley Act lays emphasis on the fact that the public sector must follow the highest norms of corporate governance including having a whistle blowers mechanism in place. The statute ensures that the whistle blowers are not subjected to victimisation or retaliation in any manner.

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INSIGHT Insights in data science and its applications Data science will contribute more to reducing costs and increasing effectiveness than the drugs themselves, says Reenita Das, Partner, Frost & Sullivan he global healthcare industry is in the middle of an era of ‘re-imagination’. Disruptive and transformative forces are colliding with one another and creating a massive remix. With technology intruding into biology and society, boundaries are changing and often disappearing. More change is expected to be driven from markets/industries outside the healthcare industry than from within the field. Due to these developments, progressive healthcare business models are evolving to focus on personalisation, communication, decentralisation and collaboration. In order to remain ahead of these changes and continue on the growth path, traditional healthcare companies are rethinking their 'value.' In fact, definitions of 'value' have changed as well in this new era. The following chart shows the shift in the system as the focus of healthcare moves from sick care to wellness and prevention. It is from this model that companies will need to identify their value and core offerings.

With the goals of making healthcare more affordable and cost effective, there will be a seismic shift from public to private sector financing of healthcare services and solutions. Frost & Sullivan expects this to be a trillion dollar opportunity in the next five years. A recent study conducted by a team of analysts across Asia Pacific (APAC) found that approximately 180 million new beds are necessary over the next decade to meet the healthcare demand in Asia; more than 40 per cent of that is expected to come from the private sector. Several bigger hospital groups from within and outside APAC are acquiring smaller hospitals in the region due to tremendous market potential. Revenues from the hospital sector in APAC are projected to account for more

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Reenita Das, Partner, Frost & Sullivan

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than one-third of the global market by 2015.

The second transformation is the re-engineering of healthcare. The industrial revolution has arrived for our industry at last. Connectivity and smaller, cheaper testing solutions will reduce dependence on large, expensive facilities and give individuals greater control over their health and well being.

www.expresspharmaonline.com

This patient-centric health system opens the door to new market participants from industries such as mass retail, telecommunications, health/ wellness/spa, automotive, travel and tourism.

In the next 10 years, data science will contribute more to improving medicine than anything learned in medical school or researched in the laboratory. This system of

collecting and analysing billions and billions of patient records, understanding protocols and pathways, and identifying the highest success factors and best practices lead to overall success rates being increased and cost lowered. Physicians will need to rely on big data to predict outcomes. With the current model of reimbursement changing soon,

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physicians will need to be incentivised to utilise big data to predict these outcomes. Insurance companies will also need access to this data as well to determine payments. By using electronic medical records (EMRs) and advanced analytics, companies will be able to develop appropriate pathways for treatment and diagnosis. This will lead to a shift in control and responsi-

bility from the clinician to the patient.

The consumer will take on the role of the CEO of their own health through increased engagement, access and empowerment.

This will lead to the concept of 'care anywhere,' 'care customisation,' and 'care coordination,' in which healthcare will evolve to become a team sport using the support of not only clini-

cians and the medical community, but also family, support groups, fitness and diet counsellors, and therapists, among several others.

The healthcare industry will also become more focused on preventing sickness rather than providing treatment. In 2012, the segment of global healthcare expenditure on treatment was 60 per cent, which will significantly decrease to 35 per cent by 2025.

Currently the elderly population of 60 years or older is approximately 25 per cent of the world’s global population. Frost & Sullivan research also shows that 75 per cent of people above the age of 60 years have one chronic condition.

By the time this elderly population reaches 70 years, they will have at least two chronic conditions.

By spending more dollars on diagnosis, monitoring and prevention, this will accelerate reduction of healthcare costs in the long term and create a more wellness and preventative culture. This along with big data analytics will drive the change and reduce overall costs.

What are the implications today for a company to survive and grow with so many disruptions and transformations? The healthcare

industry is moving from a system of being a volume business to a value business – identifying ahead of time what that value is. That is the roughest part of the market today and the hardest lesson for any company to realise, as it most probably implies the need for a change in business model.

The industry is already embracing the shared risk model as is seen in so many cases in the recent months.

Currently, pharma companies are forced to pay some portion of costs for treatment, taking on this burden along with the healthcare system. By moving the focus to outcomes and more bundled services, pharma companies will have to compete with all the other products and services that are part of the outcome value, while demonstrating their portion of it in terms of reducing cost and increasing efficacy.

There is definitely a need for companies to start investing and looking at products beyond the pill in terms of service along the continuum of care, or related to maintenance and wellness. This is also a great time to start initiating patient engagement programmes, which will pave the way to increasing this dialogue and interactivity.

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LEGAL EAGLE A stitch in time saves nine - Publication of non-worked patents Publication of list of non-worked patents by Patent Office is not prohibited by TRIPs but is a globally neglected phenomenon- intentionally or unintentionally. Such publication is of critical importance to developing economies. There is a global need to take this issue on the anvil in every nation for the benefit of subject population and to ensure alignment of patents and patent system to national priorities, as patents are territorial in nature, primarily. Milind V Sathe, Founder of Compulsory Licensing Group, an online discussion group, discusses this issue he topic is of great relevance to all categories of nations i.e. developed countries, developing countries (DCs) and least developed countries (LDCs) but of more importance to later two categories. Is subject population and industry in these countries aware of quantum and quality of non-worked patents? Are they aware of qualitative and financial implication of their unawareness? Is there any provision in their patent enactment that categorically prohibits IP wings or patent office (PO) from publishing list of non-worked patents? Can the law be interpreted to mean that publication of non-worked patents is expected from POs? What is the utility, significance and relevance of publication of non-worked patents to the economy, industrial capabilities and materialistic achievements of these countries? Are prevailing provisions being effectively used? What more can be done so as to make better use of existing provisions to achieve objective of publication of non-worked patents?

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Publication of details of non-worked patents Although POs in all nations publish some details about patent applications and granted patents, they seldom publish the list of non worked patents. At least, date of the patent application, grant and number of years it is not worked after the grant should be published along with contact details of patentee.

Note that patent offices in developed world publish the data in a more user-friendly manner than POs in DCs and LDCs. The prosecution history is accessible on the net in developed world to an extent

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to which it is not accessible in DCs and LDCs. Besides these striking differences, efficiency and transparency is another issue that distinguishes developed world from DCs and LDCs.

Reasons for the difference is transparency, quality and quantity of data published The striking difference as referred above indicates that a developed nation uses patent information better to boost their economy, to create new industries and provide certain and sure comfort to subject population. Whereas DCs and LDCs have uplifted their IP offices and infrastructure not by their internal drive but because of external thrust imposed by being signatory to TRIPs and other FTAs or bilateral agreements.

Forced transparency provided by DCs and LDCs is result of designing inadequate policies / systems and their lopsided implementation which do not benefit entities and the subject population of that country albeit it benefits the foreign patentees. To benefit domestic population and the industry, IP wings of the nation should publish such data that will clarify intellectual dilemma and guide domestic industry to gain an edge so as to lift their top lines, bottom lines, expand economy and provide comfort to consumers.

In knowledge economy (KE), IP wings have a major role to play in this regard in DCs and LDCs, than ever. IP wings should publish all such information which is not prohibited by international agreement and which will allow domestic industry or industrial activities run by foreign entrepreneurs in their land. This understanding is going to allow a sovereign to reign www.expresspharmaonline.com

supreme within its territorial limits. One such neglected area is publication of non worked patents.

What are non-worked patents?

Albeit literal meaning of the phrase 'non-worked patent' would mean a patent that is not worked, this article presumes non-worked patents to be the patents that are not worked for the period of three years after the grant or for the period of four years after the application. Patents protecting trivial invention or those blocking competitors or those which protect practically useless invention are some of the categories of non-worked patents.

What is significance of publishing list of non-worked patents?

As per Pars convention which is internalised by TRIPs agreement, non-working of patent for a period of three years after the grant throws open the said patent for compulsory licensing (CL).

Invoking CL is an internationally acknowledged authentic way of internalising protected non-worked technologies.

Non-worked patents systematically kill competing technologies and ensure that competitive products are not provided to market.

Non-worked patents are intellectual barriers in the development of industry, trade and distribution of wealth in DCs and LDCs which economies of these nations cannot afford.

Non-worked patents are intentional negative acts of patentee or genuine cases of useless or neglected sparks of alleged intelligence or genuine cases of inability of the patentee to work the patent. Intentional non-working is anticompeti-

tive and against the betterment of consumers, nation, economy and industry. Nonworking of patent whether intentional or unintentional is cost to nation. As public pays the cost for enforcement of patents, patents must be worked.

However, if IP wings or POs of any nation are not taking steps to declare the nonworked patents or not providing the facility to allow patentee to declare his willingness to license the patent, then PO has lot of scope to improve its function to align to national priorities and interests of the domestic industry. PO can encourage individual patentee to license out his patent and allow good products to reach market by publishing the list of patents open for licensing.

No international agreement prohibits IP wings of any nation from publishing list of patents which are not worked in the country for the period of three years after the grant.

How many nations are publishing it? Is your nation publishing it?

Utility and significance of publication of non-worked patents Consenting to be a part of KE necessitates designing of concrete policies and their execution by signatories to ensure that industry realises the freedom of space to operate, as well as areas where their inherent freedom to operate is restricted. This restriction of freedom of operation is to be viewed as shrinking of domains. This shrinkage is more serious because some wings of apex institute, which are part of administrative machinery, propagate this shrinkage for some reasons may be unknowingly.

Publication of non-worked inventions enables various players, manufacturer companies in diverse industry segments to understand how they can make use of unused technology which may be more efficient and cost effective than the one used by them.

Similarly alternative/ July 1-15, 2013

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versatile uses of the protected but unused technology provide potent possibility of supply of novel articles to provide consumer comfort.

Non-working of patents is primarily used as barrier by patentee to stop nation and its industry from producing either competitive products which may be better then or inferior to his products. Knowledge of non-worked patents avenues to augment industrial activity within the nation by legal and authentic means to use it by domestic industry to produce user friendly articles.

Publication of non-worked patents is a unashamed manifestation of political will and live sovereign. IP educated leadership can steer the nation in KE when IP based trade frame is bent on restricting sovereign domains. It is an indicator of ability of IP wings and legal ministry of the nation to construe international agreements in sane manner for the benefit of subject population. It demonstrates the sovereign’s concern for the domestic industry and its uninterrupted development and for the promise to provide better future to subjects. By publishing list of non-worked patents, sovereign fearlessly expresses his undisputable concern for the economy of the nation, its continuous efforts to get rid of the intellectual barriers diplomatically placed by international agreements.

It is a fearless expression of inherently capable nation to remain undeterred from external influences.

It opens avenues for fast internalisation of new technologies which positively impact consumption of scarce resources and ensure its prolonged use. It provides guidance for import substitution and helps nation to be more competitive in global trade.

It certainly augments licensing activity and aligns patentees to national priorities. It neutralises unilateral lopsided interpretation of IPR and patents in specific and propagates realistic version of IPR. It neutralises negative aspects of IPR.

Possible reasons for non publication and their hollow nature 1)Although clauses of international agreements adequately describe the objectives of IPR, these agreements do not specifically prescribe for publication of non-worked patents. It must be noted that July 1-15, 2013

these agreements do not specifically prohibit the publication of non-worked patents as well. On the contrary objectives and preamble of these agreements reinforce sovereign identity and measures taken by it to identify situations of emergency and provide freedom to define the same. Fact of protecting sovereign identities and their measures empower signatories to publish the list of non-worked patents.

2)Albeit signatories are free to publish the list of nonworked inventions, may be inadequate understanding of IPR and its potent canines capable of inflicting long lasting and at times irrecoverable damage to the economy and development of industry primarily in DCs and LDCs leads to apathetic administration and indifferent processing of IPR information such as patent applications, designing of rules to govern patents, publication of non-worked patents, use of user unfriendly packages by IP wings, publication of real time data giving www.expresspharmaonline.com

patterns of monopolisation of industry and their classification into domestic and foreign patentees, prosecution history and other measures imparting transparency.

3)Inadequate trained and educated manpower resources.

4)Inadequate infrastructure.

5)Inability of the nation to prioritise administration of IP wings and provide financial resources due to pressing needs of other priorities.

6)Unconcerned or unorganised industry sector.

7)Industry associations prioritising other issues over pressing IP wings and apex institution for publication of non-worked patents.

8)Educational institutes imparting superficial education of IPR without giving deserving and due emphasis on origin, history and development of IPR and patent system in specific. Inability of the IPR teaching institutes to understand and align objectives of IPR and patent system with the nation and its priori-

ties. This inability results into echoing those IPR versions which are propagated by developed world which is more concerned about protecting their economic interests than strengthening economies of their trade partner nations and hence industries therein.

9)Exclusion of introduction to IPR from the syllabus of high school and undergraduate college courses. Shortage of IPR educated teaching staff further complicates the problems by resorting to ready made IPR versions which are irrelevant for the nation.

10) Refer to the reasons sited by article published in Express Pharma, Thursday, 01 November 2012 titled ‘Nonworking of patent a blot on knowledge economy.’ Besides these there are few other reasons which are more of macro nature and related inabilities of sovereign signatories to form a cohesive international to generate counter pressure and hence making them more vulnerable to remain intellectual slaves.

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RESEARCH EXPERTISE FOR DRUG DEVELOPMENT

Genetic testing of breast cancer: The widening horizon A bird’s eye view of breast cancer prevalence, diagnosis and the role of BRCA1 and BRCA2 gene testing, from Dr Faisal Khan, Sr Research Officer-Knowledge Management, R&D, SRL

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This story is of a beautiful girl who has almost everything it takes to make life complete and fulfilling. She is a successful career woman. She has a loving family. She is a doting mother to her kids. She is physically fit and is blessed with good health. But fate wanted to throw an unpleasant surprise at her when she underwent a medical examination, a gene sequencing test. The results of her BRCA1 and BRCA2 gene testing projected an exponentially high risk of developing breast cancer in the near future. This was further complicated by her discouraging family history of breast tumours. Her scenario changed dramatically.

She was scared of the impending doom.

However, a ray of hope ushered in when she learned that preventive measures can be exercised. But, the choice was tough. She was told that the only panacea to avert her risk of breast cancer was prophylactic surgical removal of the breasts, also known as mastectomy. This presented a huge personal dilemma to her. She had to choose between her own physical appearance and her health, future and family. The benefits certainly outweighed the drawbacks of the procedure; she thought of it pragmatically, futuristically and like a modern woman before she opted to go under the surgeon’s knife for excision of her breasts. She is none other

than the one and only heartthrob of millions and millions of fans across the globe, Angelina Jolie.

Angelina’s story speaks volumes about the phenomenal impact of the advancements in medical diagnostics; on the lives of people, all over the world.

“Nevertheless, it is ironical that though tremendous progress has been made in the realm of breast cancer diagnostics; direct benefits of these diagnostic advancements have touched the lives of very few women, particularly in developing nations like India,” said Dr BR Das, President, Research and Innovation, SRL. “It is time that we made an effort to reach out to all women with a family history of breast cancer and at least spoke about the availability of such a test,” he added.

Breast cancer epidemiology: Emerging trends Epidemiological data presented in the 2006-2008 report of the Population Based Cancer Registry (PBCR) which is a subset of the National Cancer Registry Program, reveals a dismal picture1. The report shows that

Dr Faisal Khan, Sr Research Officer-Knowledge Management, R&D, SRL www.expresspharmaonline.com

almost half of India’s breast cancer cases are below the age of 50 years. The analysis revealed that breast cancer comprised 22 per cent to 32 per cent of all female cancer cases in major Indian cities with the most alarming incidence reported in Mumbai. Globally, breast cancer accounted for 23 per cent (1.38 million) of the total new cancer cases and 14 per cent (458,400) of the total cancer deaths in 2008. About half the breast cancer cases and 60 per cent of related deaths are estimated to occur in economically developing countries like India2. As per recent data published by the WHO, the five-year survival rate of moderately advanced breast cancer cases in India was 48 per cent3. This is notably low as compared to the robust 89 per cent fiveyear survival rate in the US, as revealed by the American Society of Clinical Oncology (ASCO) in 20094. These figures compel us to introspect on the low five-year survival rates of Indian breast cancer patients in comparison to their Western counterparts.

The answer lies in the degree of robustness of 'breast cancer awareness campaigns and routine diagnostic surveillance.'

The Western world has succeeded in reducing the burden of this disease and in escalating survival rates; primarily due to stringent and meticulous large scale routine screening of breast cancer and huge mass awareness campaigns. This diligent effort seems lacking in the Indian healthcare system.

Negligence in routine screening leads to breast cancer being undiagnosed in its initial stages. As a result, most patients are diagnosed only when the aggressive metastatic Stage 3 or 4 cancers develop. In fact, what makes us really uneasy and apprehen-

sive is the PBCR report’s finding that the most aggressive forms of breast cancer, (HER2 positive, ER/PR negative or the worst variety HER2/ER/ PR negative) are much more rampant among the young age group in India1.

Low incidence but high mortality: Indian irony With respect to breast cancer incidence and mortality figures; a comparison of India with other countries of the world, elucidates some interesting facts. The reported incidence of breast cancer is much higher in countries like the US and UK than that in India (101 in the US and 87 in the UK versus 19.1 in India per 100000 women)5. This is primarily because most cases of breast cancer are diagnosed during routine screening, documented and reported while calculating incidence rates, in the Western world. The converse is true for India. Due to relatively less stringent community surveillance of breast cancer, innumerable Indian cases remain undiagnosed and thereby unreported.

These cases are missed out while accounting for Indian incidence rates and are identified only when progressive symptomatic disease strikes.

Thus, though the incidence rates are lower, India’s breast cancer mortality figures are ironically higher than the western world. The overall percentage of breast cancer deaths at India stood at about 50 per cent a decade ago while similar mortality figures for China and the US were a meagre 30 per cent and 18 per cent respectively5.

The 'Diagnostic Mix' with a special focus on BRCA1/BRCA2 testing To alleviate the burgeoning burden of breast cancer cases, the Indian healthcare system should exercise potent measures to ensure regular July 1-15, 2013

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Chemoprophylaxis is yet another potent weapon in the armoury of breast cancer risk reduction. Clinical studies have shown that administering anti-cancer agents like tamoxifen and raloxifene to high risk subgroups of women can significantly reduce the risk of developing breast cancer or its recurrence. These agents have been approved by the US FDA for chemoprevention of breast cancer in known high risk subgroups5.

screening, early diagnosis and risk forecasting for breast cancer. Hence, a 'diagnostic mix' of routine mammograms and clinical examinations; along with gene testing for high risk candidates (testing for BRCA1 and BRCA2 mutations) seems the most pragmatic solution.

Within this diagnostic mix, BRCA1 and BRCA2 gene testing for high risk group of women offers clinical advantages which are very distinct from those of routine mammography and clinical examination. BRCA1 and BRCA2 gene testing provides the benefit of forecasting the genetic tendency of a healthy individual to develop breast cancer in the future; an advantage not available through other surveillance methods6.

Cancer genetic testing: A peek into the future

Identifying the right candidates for BRCA1 and BRCA2 gene testing A detailed family and personal history can prove very instrumental in deciding whether a woman is a suitable candidate for BRCA1 and BRCA2 testing. Women with a pronounced family history of breast cancer involving first and second degree relatives, a familial history of ovarian cancer, a family history positive for BRCA1 and BRCA2 mutations or BRCA1 and BRCA2 positive tumours seem to be ideal candidates for BRCA1 and BRCA2 gene testing6.

Besides these, certain known high risk subgroups, like women with a history of late pregnancies, those with early menarche and late menopause, those with a history of past long term hormone replacement

DR BR DAS President, Research and Innovation, SRL

“It is ironical that though tremendous progress has been made in the realm of breast cancer diagnostics; direct benefits of these diagnostic advancements have touched the lives of very few women, particularly in developing nations like India. It is time that we made an effort to reach out to all women with a family history of breast cancer and at least spoke about the availability of such a test”

References 1.Consolidated report of the Population Based Cancer Registry (PBCR) report (2006-2008). Accessed at http://www.breastcancerindia.net/bc/statistics/trends.htm on 1st June 2013 2.Jamal, B. Freddie, M Melissa, Jacques F,

July 1-15, 2013

E Ward and Forman D; GLOBOCAN 2008.

Global cancer statistics. Ca Cancer J Clin 2011;61:69–90 3.Cancer Survival in Africa, Asia, the Caribbean and Central America. WHO’s IARC publication number 162. IARCSurvCan, Lyon 2011 4.American Society of Clinical Oncology

therapy (HRT) or currently ongoing HRT, obese women with a physically inactive lifestyle and those with a history of chronic or regular alcohol consumption; can also be considered for BRCA1 and BRCA2 testing5. In case of these high risk subgroups, clinician’s judgement on a case-to-case basis and individual patient choices would drive the decision to undergo the gene test.

Women for whom the BRCA1 and BRCA2 test reveals a positive result, several precautionary and prophylactic measures can be exercised. In cases wherein the percentage of risk projected by the BRCA1 and BRCA2 test is too high, prophylactic mastectomy can be resorted to, after thorough oncological consultation. This procedure involves bilateral surgical removal of the breast tissue. As much of the 'at-risk' breast tissue as is possible is removed during this procedure. This minimises the possibility of developing breast cancer in the future to very negligible levels. Presently, there are no clear cut universally accepted clinical guidelines or recommendation criteria to judge the eligibility of

a woman to undergo prophylactic mastectomy based upon BRCA1 and BRCA2 test results. Therefore, decisions to opt for prophylactic mastectomy post BRCA1 and BRCA2 testing are purely made upon a case-to-case basis6.

Risk-mitigation plans would typically involve prophylactic control of factors that are known triggers of breast cancer. This would include a precautionary regimen comprising of reduction of obesity, avoidance of alcohol, indulgence in strenuous physical activity, avoiding the use of hormone replacement therapy, avoiding late pregnancies, breast feeding, using birth control pills for contraception and opting for oophorectomy in consultation with a qualified medical specialist, if needed.6,7 These changes can help women with BRCA1 and BRCA2 mutations to significantly reduce the risk of developing breast cancer.

One could counter argue that most of these generic lifestyle changes can be recommended to any woman as a safeguard against breast cancer, regardless of BRCA1 and BRCA2 status. However, for BRCA1 and BRCA2 mutation positive high-risk women, these lifestyle changes are not just recommended but are almost mandatory and warranted.

data accessed on 1st June 2013 at http://www.breastcancerindia.net/bc/statistics/stati.htm 5.J. Fertay, F. Bray et al; GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide, IARC Cancer Base No. 5, Version 2.0; IARC Press, Lyon 2004 6.National Cancer Institute fact sheet on

‘BRCA1 and BRCA2: Cancer Risk and Genetic Testing’. Accessed at http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA on 1st June 2013 7.Rebbeck T, Levin A, Eisen A, Snyder C, Watson P, Cannon-Albright L et al. Breast cancer risk after bilateral prophylactic oophorectomy in brca1 mutation carriers.

BRCA1/BRCA2 mutation positive cases: Prophylactic and preventive measures

www.expresspharmaonline.com

A market research report

by RNCOS revealed that the global genetic testing market which stood at $1.5 billion in 2010 is expected to touch the $4 billion mark by 2015.8 According to this report, the oncology segment will predominate the realm of genetic testing worldwide.

However, the realm of genetic testing is faced with multiple ethical concerns. The bioethics of genetic testing revolves around issues like the social stigma attached to an abnormal genetic status, the panic created by abnormal gene test results, the financial and personal implications of gene test results on the lives of patients, the need for precise and sensitive genetic counselling and deciding the therapeutic options to be chosen based on gene test results.

These are a few examples of the ethical issues involved which can not be ignored.

There are umpteen other ethical dilemmas associated with genetic testing, beyond the scope of this write up, which need to be addressed prior to and after testing. Besides, affordability of genetic testing remains a major concern especially in a country like India; though the costs of several gene tests have now reduced dramatically, making them more affordable to patients. However, in spite of the ethical dilemmas and other obstacles, genetic testing is considered as a promising diagnostic tool. The clinical utility of genetic testing continues to captivate the attention of patients and the healthcare fraternity worldwide.

JNCI J Natl Cancer Inst (1999) 91 (17): 1475-1479 8.RNCOS. Global genetic testing market analysis. Accessed at http://www.rncos.com/Report/IM352.htm

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W H AT ’ S INSIDE

DHL brings together industry leaders to discuss key supply chain issues PG 35 Phenomenex introduces Kinetex C8 5-micron core-shell HPLC column PG 36 Thermo Fisher Scientific unveils LC-MS software PG 37 Choosing Ultrasonic Flowmeters: The latest technology for your application PG 38 Enhancing compliance for oral liquid medications PG 39

Pharma Life PG 63 34

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PHARMA ALLY ‘Water treatment accounts for 72% of water and wastewater treatment equipment’ A new report indicates that the water and wastewater management treatment market in India is all set to be fuelled further by the growing demand from the pharmaceutical industry. Shalini Gupta finds out more in an interview with Sasidhar Chidanamarri, Industry Manager, Environment & Building Technologies Practice, Frost & Sullivan How do you define the water and wastewater treatment market in the Indian pharma context? Does it include pure wastewater treatment or even water recycling and reuse? Explain.

The pharma industry uses purified water in process applications for drug manufacturing, sterilisation of equipment, captive power plant commissioned in a pharma plant etc. Different water treatment technologies deployed include filtration (multi media/activated carbon/cartridge), ion exchange, distillation, reverse osmosis and softening and disinfection systems.

Depending upon the water purity requirement, one technology or a combination of these technologies is used.

Wastewater generated by the companies undergo conventional treatment such as aeration and activated sludge process and the treated effluent is discharged into the nearby lakes, river, sea etc.

Penetration of recycle and reuse applications is very low and the recycled water is only used for landscaping purpose.

Recycled water is not used for process water applications because of the fear of contamination.

Water treatment accounts for 72 per cent of the water and wastewater treatment equipment in pharma industry and the remaining 28 per cent of the market is accounted for wastewater treatment.

How huge is this market in India? What percentage of the current demand for water and wastewater treatment comes from the pharma industry? What are its growth drivers and who are the main players?

The water and wastewater treatment equipment sold to the Indian pharma industry was worth `5.8 billion in 2012.

The pharma industry accounts for approximately 10 per cent of the total water and wastewater treatment equipment market in India.

The water and wastewater treatment equipment demand from pharma industry is growing due to the following factors: ■ High growth witnessed in pharma segment because of the low production costs observed in India and increasing domestic demand ■ Supportive government policies are driving the entry of multi-national companies (MNCs) in the pharma segment which bring in the global best practices that further drive the demand for high purity water treatment systems and advanced wastewater treatment systems ■ Stringent regulations adopted for wastewater treatment by the Central Pollution Control Board (CPCB) These factors are anticipated to drive the market at a CAGR of 13 per cent for the period 2011 – 2016. Major companies providing water and wastewater treatment systems to the pharma segment are Ion Exchange, Neela Systems, CN Tech, Nilsan Nishotech, Triveni Engineering, UEM India, GE Water, and Doshion among others. The Indian market is dominated by domestic companies.

What effluents from pharma firms rank on the alert list of regulators?

Wastewater is generated www.expresspharmaonline.com

INTERVIEW

from various sources and the major source is the wastewater generated from production process (drug manufacturing), which is high in Biological Oxygen Demand (BOD) and Total Suspended Solids (TSS). Other sources include cooling towers, boilers, and fire prevention systems. The various contaminants covered by CPCB regulations are BOD, Chemical Oxygen Demand (COD), pH, TSS, oil and grease, mercury, arsenic, lead, sulfides and phosphates. Among these contaminants, pH, BOD, TSS, and oil and grease are the major ones.

What are some of the latest technologies and equipment’s employed for treatment?

Traditionally, Indian industries have been using chemical treatment and demineralisation (DM) systems for water treatment. A demineralisation(DM) plant is a low cost option available for water treatment and is a time-tested technology. Cost of consumables to run it is high as large volumes of chemicals are required for regeneration.

With the advent of membrane technologies, usage of chemicals reduced significantly, so membrane systems are preferred because of low requirement of consumables.

Another reason for the growth of membrane systems is the Good Manufacturing Practices (GMP) adopted by all major companies in the pharma industry. Indian companies are adopting global standards for drug manufacturing,

which is creating demand for high purity water.

This is driving the sales of RO systems along with MF/UF/NF systems as pre-filtration or final filtration in a water treatment system.

Activated sludge process is the commonly used wastewater treatment method in India.

Membrane Bioreactor (MBR) and Zero Liquid Discharge (ZLD) are other technologies which are being adopted by chemical and pharma companies, although the penetration rates are very low. High capital investment and energy requirement deters the growth of such advanced ZLD systems. The pharma industry in India has many Small and Medium Enterprises (SMEs), who are not financially strong to build an individual effluent treatment plant. Hence, all the SMEs in a particular region would come together and build a Common Effluent Treatment Plant (CETP).

Companies operating from a Special Economic Zone (SEZ), divert their wastewater to the CETP which is managed by the SEZ. Which segments do you see are growing and why?

Recycling systems seem to be the trend in the US. What about India?

Key areas of growth within water and wastewater treatment include RO systems for water treatment and MBR, ZLD and conventional treatment systems for wastewater treatment.

Increasing demand for high purity water for process applications would drive the demand for RO systems. Many pharma companies in India export their products and hence the products have to meet global standards. So, pharma companies are deploying advanced water treatment systems such as membrane-based systems.

Recycling and reuse market is in a very nascent stage in India and Frost & Sullivan estimates that it would take a few years for the market to develop. shalini.g@expressindia.com July 1-15, 2013

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VENDOR NEWS DHL brings together industry leaders to discuss key supply chain issues in pharma sector DHL Supply Chain is capitalising on the opportunity in the life sciences and healthcare industry in India, which is estimated to reach $100 billion by 2015 HL Supply Chain, the global market leader for contract logistics solutions, recently concluded a successful customer event, ‘Unlocking Supply Chain in Healthcare and Life Science Logistics’ in Mumbai. Well attended by key professionals from the healthcare industry, the event deliberated on relevant topics related to challenges and opportunities in the overall supply chain in the pharmaceutical industry.

These included distribution and channel management, benefits of collaborated and integrated supply chains, current regulatory issues facing the life sciences and healthcare sector along with new insights and opportunities for clinical research in India.

Prakash Rochlani, Vice President Business Development, South & South East Asia, DHL Supply Chain said, “Targeting the life sciences and healthcare industry, this event provided an ideal opportunity for collaboration, discussion and networking between sector experts and the pharma industry. To stay ahead in today’s dynamic environment it is paramount to understand the industry’s issues and challenges, skill-

D

fully adapt and respond with increasing flexibility to changes and embrace new trends.”

He further added, “At DHL, we work closely with our customers to ensure that we offer a comprehensive range of services across the entire supply chain, from initial consultancy and design, to the last mile delivery along with reverse logistics.”

Speakers included Pratin Vete, Associate Director – Business Advisory Services, Ernst & Young, TR Prasad, Associate Director – Operations, Abbott India, and Dr Sofi Joseph, Head – Regulatory Operations, Pfizer attended the event.

Speaker presentations highlighted the expected growth in the Indian pharma industry at 1.5 to 2 times the GDP growth of India due to several factors which include increased literacy, higher per capita income, improved healthcare access and greater

market penetration. It was estimated that distribution and channel management initiatives can improve sales by atleast 4-5 per cent per annum, thereby extending the life cycle of a product.

With distribution being highly unorganised in India and its complexity increasing over the years, especially in Tier-II cities, it was felt that supply chain managers have an excellent opportunity to penetrate the market and increase distribution efficiencies through smart logistics.

As the global leader in healthcare logistics, DHL Supply Chain is capitalising on the opportunity in the life sciences and healthcare industry in India, which is estimated to reach $100 billion by 2015, growing at 20 per cent every year to touch $280 billion by 2020, on the back of increasing demand for specialized and quality healthcare facilities.

DHL Supply Chain recog-

DHL SUPPLY CHAIN IS CAPITALISING ON THE OPPORTUNITY IN THE LIFE SCIENCES AND HEALTHCARE INDUSTRY IN INDIA,WHICH IS ESTIMATED TO REACH $100 BILLION BY 2015, GROWING AT 20 PER CENT EVERY YEAR

nises the need to drive value and competitive advantage through integrated and optimised logistics solutions which will help transform the industry. The company operates over 150 life sciences facilities worldwide to support its global life sciences and healthcare strategy. Last year DHL Supply Chain introduced its first state-of-the-art life sciences facility in India, located within its newly constructed 56.000 square metre multi-customer distribution centre in Mumbai. This world class infrastructure assists in meeting the industry’s increasing logistics and warehousing needs with capabilities to distribute to wholesalers, pharmacists and hospitals based on customer demands.

This includes innovative services to manufacturers of pharma products from order management to warehousing and distribution. Additionally, DHL’s services are customised to the needs of the medical devices and pharma industry, including very specific solutions such as postponement services, clinical trials logistics and order-to-cash.

DHL Supply Chain provides unrivalled experience and capability in compliant, specialist supply chain solutions to the global healthcare industry, to help their customers succeed.

EP News Bureau-Mumbai

Quintiles Infosario wins 2013 Informatica Innovation Award Bags recognition for its enterprise data integration uintiles has received the 2013 Informatica Innovation Award for Enterprise Data Integration recognising its pioneering efforts, through the Quintiles Infosario solution, to integrate and master both clinical research and healthcare data across numerous institutions.

Quintiles Infosario seamlessly integrates data, systems, processes and Quintiles’ therapeutic expertise to unlock faster, better-

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informed decisions from clinical trial planning and design to trial execution services, through post-market outcome studies. It uniquely allows for scientific and operational design to inform and optimise operations based on real-time alerts and data insights, mitigating risk, while improving patient safety, productivity and time to market.

The Informatica Innovation Awards honour organisations that have demonstrated leadership www.expresspharmaonline.com

through the application of Informatica technologies that yielded significant business results. Out of more than 5,000 companies and organisations, winners in 12 categories were announced at the annual Informatica user conference, Informatica World 2013.

“We are honoured to have Quintiles Infosario recognised as one of the world’s leading data integration solutions,” said Richard Thomas, Chief Information Officer, Quintiles.

“At the core of Quintiles Infosario is our data factory which integrates a wide variety of clinical, healthcare and operational data across a significant number of sources ranging from pharma companies to hospital and care provider networks. Being able to combine this data and add context / meaning results in highly actionable analytics which our customers really appreciate,” Thomas concluded.

EP News Bureau-Mumbai EXPRESS PHARMA

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PRODUCT Phenomenex introduces Kinetex C8 5-micron core-shell HPLC column henomenex, a global leader in the research and manufacture of advanced technologies for the separation sciences, has introduced the Kinetex C8 5-micron coreshell HPLC column. The widely used C8 phase delivers optimum retention for the analysis of hydrophobic and 'sticky' compounds. In combination with Kinetex CoreShell Technology, this phase gives analysts an excellent high-performance reversed phase alternative for HPLC methods. As with the existing Kinetex 5-micron C18 and XB-C18 phases, the new 5-

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micron C8 core-shell column can be easily substituted into methods that meet United States Pharmacopeia (USP)

and European Pharmacopoeia (Ph. Eur.) requirements.

Specifically the Kinetex 5-micron C8 meets USP specifications for Classification Code L7, enabling laboratories using 5-micron L7 columns to realise the performance benefits of Kinetex Core-Shell Technology without adjusting their USP methodology.

The largest diameter particle in the family, Kinetex 5micron core-shell media delivers better performance than 3 and 5-micron fully porous offerings, with no

increase in backpressure. In fact, the new 5-micron media provides 90 per cent higher average efficiencies compared to the same size fully porous columns with little to no method development.

Kinetex 5-micron C8 columns are fully scalable to or from the 1.7- and 2.6-micron particles, enabling easy method transferability.

Contacts details: Simon Lomas, Phenomenex Phone: (310) 212-0555 Ext. 2267 E-mail: simonl@phenomenex.com

SAW Instruments enhances protein interaction analysis with the samX acoustic biosensor

AW Instruments, developer of the innovative sam family of biosensors for realtime, label-free biomolecular interaction assays, is continuing to advance acoustic wave biosensor technology with the samX platform.

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Based on SAW’s Surface Acoustic Wave technology, the biosensors measure changes in mass and viscoelasticity at the chip surface based on changes in the high frequency acoustic oscillations running across the chip surface. This innovative approach is complementary to other biophysical techniques, such as SPR and QCM for measuring protein interactions, and can also be sed for samples and applications that are difficult to analyse by these other methods, thus providing additional information and insights.

The samX platform is ideally suited to the study of native membrane proteins and protein complexes such as the 7TM G-Protein Coupled Receptors (GPCRs),

either as membrane fragments or within liposome or vesicle particles. Such complexes can be very challenging to analyse by traditional biosensor platforms. For these therapeutically relevant targets, samX technology represents a new potential tool for drug discovery programmes.

Closely coupled to this, many drug companies are also interested in looking at the separate conformational data from the samX platform (i.e. measuring the change in the acoustic wave amplitude) when using small molecule candidates against protein targets or vesicles. This can provide very valuable information on compounds whose binding induces structural changes in their targets.

In terms of practical workflow improvement and benefits, the eight channels of the dual-chip samX system provide more sensors for a higher throughput, and perhaps even more importantly, provide flexible fluidic channel routing which allows different samples or reagents to be delivered to discrete channels or combinations of channels on the chip.

Different proteins can also be immobilised at separate sensor position while the chip is on-line, enabling loading of the surface to full capacity, and allowing for a degree of quantification, which vastly improves data quality and assists interpretation.

Contact details: www.saw-instruments.com.

Lonza introduces Lonzagard RCS products onza’s Hygiene and Preservation business has to introduced a new disinfecting line of products designed for hard surface cleaning applications. The new EPA registered Lonzagard RCS and RCS Plus products offer fast contact times in an easy to use dilutable disinfectant spray form. Fast acting Lonzagard RCS and RCS Plus products have a broad effica-

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cy claim set, including Norovirus, along with superior cost-performance benefits.

Healthcare, janitorial, and other customers will benefit from the multiple formulations available for use in the US. Lonzagard RCS dilutable hospital disinfectant spray products are Lonzagard RCS Plus Series offers three minute kill time for hospital disinfection and five minute www.expresspharmaonline.com

kill time specifically for Norovirus. Lonzagard RCS Series offers five minute kill time for hospital disinfection and five minute kill time specifically for Norovirus.

The Lonzagard RCS family of EPA registered products have an extensive claims set for hard surface disinfection approved for use in a wide variety of markets including but not limited to healthcare,

institutional and janitorial.

Lonza provides RCS products through key suppliers of surface hygiene products who directly serve these markets.

Contact details: Lonza Inc Hygiene & Preservation, N.A Ray Fahmy Tel +1 201 316 9265 Fax +1 201 696 3533 ray.fahmy@lonza.com July 1-15, 2013

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Thermo Fisher Scientific unveils LC-MS software hermo Fisher Scientific has introduced 10 new or updated software packages to help customers harness the power of its new-generation liquid chromatographymass spectrometry (LC-MS) instruments and turn data into knowledge in a wide range of discovery and quantitation experiments.

The software packages made their debut at the ASMS Conference on Mass Spectrometry and Allied Topics, which was held recently at the Minneapolis Convention Centre.

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The new software introduced at ASMS includes: Thermo Scientific FreeStyle 1.0, has highly flexible data visualisation software that enhances users’ ability to interrogate and display both low and high resolution MS data. It facilitates rapid method development by providing high-quality data and quick report writing capabilities. It integrates seamlessly with new method editor software for new-generation Thermo Scientific LC-MS instruments.

Thermo Scientific TraceFinder 3.1, an easy-touse, workflow-driven application for routine quantitation and targeted GC-MS and LC-MS screening.

Intelligent sequencing is designed to protect precious samples by checking instrument performance before making injections.

TraceFinder 3.1 enhances productivity with new method development tools, simplified data acquisition protocol and comprehensive data review that features customised visualisation and reports.

Lipid search automates comprehensive analysis of lipids from raw mass spectra generated by a variety of instruments. It supports a number of acquisition modes, including precursor scanning, neutral loss scanning and product ion scanning. It helps identify lipids and determine relative quantitation in different sample groups.

Thermo Scientific Proteome Discoverer 1.4 is a full-featured data analysis platform for qualitative and quantitative proteomics research. It now includes multi-threaded SEQUEST July 1-15, 2013

and library searching tools for fast data processing.

Other tools, Percolator and Byonic, help extract maximum information from MS/MS data.

Thermo Scientific SIEVE 2.1 automates differential analysis of proteins, peptides, and metabolites.

Version 2.1 includes a new, advanced algorithm for small molecule peak detection designed to facilitate large-scale data reduction, reduce false positives and generate elemental composition information. It also displays pathway mapping for metabolomics applications.

ProSight 3.0 helps scientists perform top-down and bottom-up protein identification and characterisation.

New algorithms enhance performance for intact protein analysis.

Thermo Scientific Pinpoint 1.3 is a comprehensive, targeted proteomics www.expresspharmaonline.com

quantitation platform supporting targeted discovery through routine quantitation. Automated workflows help streamline experiments, from method development and acquisition, through data verification and reporting.

Thermo Scientific LCQuan 2.9 is designed to help regulated laboratories harness the performance of new-generation Thermo Scientific Quantiva and Endura triplestage quadrupole mass spectrometers within a 21 CFR Part 11 environment. mzCloud is a novel mass spectral database that helps scientists identify unknowns, even when the spectra are not present in libraries. It features libraries of annotated high resolution, accurate mass spectral ion trees to facilitate identification of compounds, using a new-generation spectra correlation algo-

rithm. It is designed to improve research results in fields such as metabolomics, toxicology, and environmental analysis.

The company also previewed Thermo Scientific Compound Discoverer 1.0, a new application designed to help users confidently detect and identify small molecule compounds in a wide range of experiments. User-assembled workflows allow for flexibility and workflowaligned data processing.

Contact details: Stuart Matlow Public Relations Manager Chromatography and Mass Spectrometry Thermo Fisher Scientific 355 River Oaks Parkway San Jose, CA 95134 (408) 965-6408 office (415) 407-5474 mobile email: stu.matlow@thermofisher.com www.thermofisher.com EXPRESS PHARMA

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VALUE ADD Choosing Ultrasonic Flowmeters: The latest technology for your application In the last decade, ultrasonic flowmeters have grown in popularity in laboratory and process areas as a cost-effective, non-invasive alternative for measuring the velocity and flow rates of liquids and gases. An outlook by Cole Parmer ith highly accurate and flexible ultrasonic flowmeters, users can choose from various electronics packages, and also use the devices in areas that require explosion-proof devices. These value-added benefits provide a striking contrast to turbine or variable-area flowmeters, which are less accurate, offer fewer output capabilities, and are invasive to the process media.

While ultrasonic flowmeters are now cost effective, their most significant benefit may be their ability to measure flow without interfering with any process liquids or gases. The non-invasive measurement is taken from two or more transducers attached to the piping exterior. The frequency shift of an ultrasonic signal that is sent through the fluid or gas is measured; then a signal is sent via cable to the electronics housed in the flow computer.

Other advantages of using ultrasonic flowmeters include: ● Improved accuracies ● No pressure drop ● High turn-down ratio ● No moving parts ● Minimum maintenance ● Long-term cost savings According to a 2006 Frost and Sullivan report1, the replacement rate for ultrasonic flowmeters is 12 to 15 years, producing a solid return on investment. This longevity may account for an expanding market for ultrasonic flowmeters when many other flow technologies are shrinking. By 2012, the report projected, the market is expected to grow to an estimated $1 billion in sales.

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Ultrasonic measurement: Doppler and transit-time Two main technologies distinguish ultrasonic meas-

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urement: Doppler technology uses particles or aeration in the fluid as a reflective mechanism to gauge the velocity of the fluid. Transit-time technology relies on a frequency difference in forward and reverse signals sent through a clean liquid to gauge the velocity of the fluid; this fluid must not contain solids or aeration as they will distort the sonic pulses.

Both of these technologies are ideal in creating flow profiles through an existing process when modification of piping or a process line is not possible.

Selecting a ultrasonic flowmeter style To determine what style of ultrasonic flowmeter will be most effective for any specific application, consider how it will be used. The three primary styles are handheld, portable, and dedicated.

Handheld ultrasonic flowmeters are exactly what they seem to be. They generally include a case for transporting the meter between locations within a factory, process area, or facility.

While they are priced lower as compared to other ultrasonic flowmeters, their functionality is limited to basic flow rate measurement.

Typical accuracies are ±2 per cent full-scale or better.

On an average, the handheld models are battery powered or rechargeable. Most will have a four- or five-digit display and will show flow in GPM or LPM. The unit is easy to use—simply turn on the flowmeter and hold the transducer (which sends and receives radar signals) to the pipe to take a reading. Most handheld ultrasonic flowmeters use Doppler technology.

Some are now capable of datalogging and employ RS-232 output for recordkeeping needs (if required for ISO compliance).

Handheld flowmeters are most commonly used to measure slurries and dirty fluids in the chemical industry, food processing, and water treatment plants where www.expresspharmaonline.com

basic flow measurement is required from time to time.

Facility engineers working in office buildings or smallscale process plants fre-

quently need to monitor HVAC-R systems. Typically, these engineers will use a handheld unit to accomplish this task.

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Portable ultrasonic flowmeter Portable ultrasonic flowmeters are more advanced than the handheld models and also more expensive. These larger units use both doppler and transit-time technologies to measure flow and velocity.

Most high-end portable doppler and transit-time ultrasonic flowmeters employ digital signal processing (DSP), digital cross-correlation, and a proprietary time expansion algorithm—producing outstanding accuracy as compared to handheld models. The design of the transducer set enables the flow to be measured in a broad range of pipe sizes and materials. Transducers used with ultrasonic doppler flowmeters do not operate well with concrete, clay, or fiberglass pipes as the transducers don’t have the capability to “see” through such dense materials.

Many portable systems are suitable for survey work in remote locations. For example, fisheries need to monitor the input and output of water flow on a daily basis to confirm filtration is at ade-

quate levels. Large petrochemical facilities also measure and monitor flow regularly. These facilities can extend over a wide area, requiring an engineer to employ a portable system if dozens of locations are measured.

A waterproof enclosure can protect the transmitter from accidental immersion or splashes. When wired power is not available, most portable meters will operate from eight to 24 hours on an integrated, rechargeable battery. If operating in a wired installation, a 4 to 20 mA or voltage output can be used for continuous monitoring of flow rate.

Several portable models are available with a datalogger that can be unplugged for data downloading without disrupting the operation of the meter. Proprietary software is usually included with these flowmeters. A portable unit can be programmed through its integrated keypad allowing control of operating parameters. Many portables can also be programmed via a PC or laptop.

Dedicated ultrasonic flowmeter The displays on portable

ultrasonic flowmeters are usually much larger than handheld meters, enabling the user to see more data at a glance. Because the flowmeter cases are NEMA 4X rated or better, these units are suitable for continuous outdoor use. Also, they can be used in wide temperature range applications. Dynasonics, GE Sensing, and Thermo Scientific are the leading manufacturers for portable ultrasonic flowmeters.

Dedicated ultrasonic flowmeters are designed to be installed and operated in one location. They are used almost exclusively in plants and process areas. These flowmeters operate well in HVAC-R, potable water, ultrapure water, petroleum products, sludge and slurries, and liquefied gases applications.

As with portable units, dedicated ultrasonic flowmeters use both doppler and transit-time technologies.

Unlike portable units, though, dedicated units deliver unique benefits and options. Many manufacturers (including GE Sensing and Thermo Scientific) offer intrinsically safe and ATEXrated units for the petro-

chemical markets. They also have units that are DC or AC powered and operate with digital communications.

Dedicated units have electronics housed in enclosures rated NEMA 4X and contain NEMA 6-rated transducers.

They are typically waterproof, preventing damage in case of accidental immersion.

Some manufacturers offer 30,000-point datalogging and accuracies to ±0.5 per cent full-scale. Easily installed, the transducers clamp onto pipes that range in size from 1 to 200 inches and offer bidirectional flow measurement.

Conclusion In summary, with prices dropping and benefits increasing, it may be an optimal time for users to upgrade from older technologies and invest in an ultrasonic flowmeter. It just makes sense to buy an instrument with high accuracy and flexibility.

References 1 Frost & Sullivan, World Flow Sensors and Transmitters Markets (Palo Alto, California: Report, 2006), Section 5-3, 5-7.

VALUE ADD Enhancing compliance for oral liquid medications Günter Nadler, Matthias Birkhoff, Degenhard Marx Aptar Pharma, Consumer Healthcare Division, Radolfzell, Germany expounds on up to date dosing systems for multi-dose bottles o increase patient compliance while at the same time ensuring correct dosing is an ongoing task for the OTC industry when it comes to liquid medications.

Administration of medicines in liquid form is very common for self medication of medical conditions in adults, as well as in infants.

Preferable over tablets, liquid medications are easy to swallow, an important point for children and elderly people. They provide a distinct benefit to these consumers.

Liquid formulations should provide a more rapid onset than solid dosage forms with the same active ingredient. From a marketing per-

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spective, liquid formulations provide a wide range of options to differentiate products: appealing to the senses of patients, marketing people understood to create products e.g. cough syrups with different colours and flavours to meet their sensitive taste and other consumer’s preferences. This should be enough for a story of success.

On the other hand, liquids are not easy to handle and to dose, which often means that the medication is not taken as prescribed by the physician or as recommended by the manufacturer. The challenging issue with all these products is the preciseness of the dose.

Inconvenient packaging and complicated dosing procedures contribute here. As of today, liquid medications are commonly packed in conventional glass or openmouth plastic bottles www.expresspharmaonline.com

equipped with dosing devices like measuring cups or spoons. But patients are often not able to follow the instructions provided by the manufacturer, and drug products are not always fully compatible with the dosing system they are equipped with. Confusing symbols and measuring units result in over or underdosages. Apart from the limited if not erased efficacy following under dosing, numerous reports of accidental overdoses are of more serious concern. In an US study, 120 deaths in infants from 1969 to 2006 were attributed to the overdose of unprescribed antihistamines or decongestants1.

Consequently, in 2009 the FDA issued a draft guidance “Dosage Delivery Devices for OTC Liquid Products” to address existing safety concerns.

However, there is still

Figure 1: Typical in-use appearance of standard bottle: the content may cover the bottle and depending on the ingredients the screw may be blocked by dried medication space for improvements.

Shonna Yin et al of NYU School of Medicine published a study2, showing that top-selling paediatric OTC liquid medications in the US contained highly variable and inconsistent EXPRESS PHARMA

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dosing directions and measuring devices. Intelligent and well designed packaging can help to provide a save product as well as a cutting edge to meet patients’ and consumers’ preferences. As tee- and tablespoons are certainly an inappropriate choice, this article tries to provide an overview on up to date dosing systems for multi-dose bottles.

Major problem is simple dosing

Figure 2: When using a measuring cup with a standard bottle it is hard to hit the mark

Figure 3: SimpliSqueeze® is a unique silicone valve system enabling clean dispensing out of flexible bottles and precise dosing into dosing caps or spoons

Figure 4: Examples of vitamin supplements using metering dispensers which ensure easy handling and precise dosing

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Since ages, liquid medications are dosed by numbers of drops dispensed.

Alternatively, auxiliary devices such as cups or spoons are utilised. Such dosing procedures in general do not establish any risks for well tolerated drugs with a high safety margin. But many drugs do require exact dosing in order to be effective and to prevent side effects caused by overdosing. For the drug manufacturer easy administration is obviously an important selling argument. Under dosing will result in poor and slow symptom relief, overdosing in more or less severe side effects. Such negative experiences made with a particular drug product will certainly influence the next purchase the consumer may undertake when in the same or a similar condition.

The problem is well known and in discussion for quite some time.

Consequently, a range of more or less sophisticated solutions is available. The simplest solution and still widely used for dosing of liquid medications is a measuring spoon or cup with appropriate markings.

Manufacturers only need to make sure that the appropriate spoon is packed with the drug product it is designed for. The advantages of such spoons or measuring cups are obviously very low costs, and any consumer knows how to deal with it.

At least in theory it can be concluded that people know even without consulting the packaging information that a certain amount of liquid needs to be poured onto the spoon or into the cup.

However, the interaction between liquid properties, the bottle and the dispensing closure can sometimes turn this into a very challenging task. Not only that sticky medication with sometimes alarming colours

will be found all over furniture and clothing, serious dosing issues may occur when the spoon is lost or confused with one for another medication bearing different markings. (See Figure 2) A step forward is also provided by dosing syringes and recently developed sipping devices. An individual locking system can prevent confusion between different medications while enabling precise dosing. These solutions also prevent contamination of hands or waste of product during handling.

However, the use of these systems is not intuitive, comparably complex and requires additional information provided to the consumer. After use and certainly if there are longer intervals of non-use (e.g. cough and cold medication used seasonally), these dosing devices must be cleaned carefully to avoid clogging or microbial growth inside.

New technologies for liquid medications A very simple but highly efficient technology to enable precise dosing into measuring spoons or cups was recently introduced: Aptar Pharma’s SimpliSqueeze closure system. This is a successful technology, originally developed for the food and beverage sector and consequently adapted to the needs of pharma applications.

SimpliSqueeze is a unique silicone valve system enabling clean dispensing out of flexible containers.

The system does not provide any metering, so dosing caps or spoons are still required.

But SimpliSqueeze facilitates convenient and precise dosing significantly. It keeps the neck of the bottle clean of medication and will prevent clogging (see picture). The valve will prevent dripping and spoiling of product even if the bottle is held in top down position. To dispense the medication, the bottle must be squeezed; the applied pressure controls the product flow. The viscosity of the product may range from water to syrup. As the system is plugged into the bottleneck, the protection cap can be screwed on, using the outer thread of existing containers with or without child-protection features.

Plenty of suitable bottles are available on the market www.expresspharmaonline.com

using polyethylene terephthalate (PET) as preferred material. The advantages of such bottles are a low weight and high resistance to fracture. (See Figure 3) SimplySqueeze is, as of today, widely marketed for a broad range of products in the food & beverage (F&B) industry for e.g. honey, mustard or ketchup. Its features make the patented SimpliSqueeze technology the choice for any liquid medications such as cough and cold syrups, decongestants or other liquid medications.

Multi-dose pumps Another proven but more costly technology is the use of metering pumps for exact dosing and convenient handling (see picture: example Simetocin (Lefax).

Such pumps are available at different sizes for a wide range of dosing volumes.

Packaging designers need to spend some time to select an appropriate pump, because dosing volume is just one property that requires consideration. The pump must be fully compatible with the targeted formulation. An important consideration is viscosity. Not all pumps can reliably dispense high viscous products. If the medication is of higher viscosity, the force required to deliver the dose (actuation force) may increase to an unacceptable value, certainly decreasing consumer compliance. Dosing problems may occur because of trapped air bubbles, especially when the bottle is shaken before use. If the pump is not used for a longer time, the outlet channels in the actuator may be subject to clogging as a result of crystallisation, in particular if a medication contains a lot of sugar. To overcome such hurdles, some pumps incorporate sealing features at the orifice. Alternatively, flexible caps which have to be reattached after use are available. Another important point to consider is that some pumps have metal parts in the fluid path (e.g. springs or balls) which may be incompatible with the drug. Oxidation (rusty metal parts) and discoloration of the drug product are problems reported in such cases.

New pump generations with metal free fluid paths and special design for high vis-

cous products can help addressing such issues.

Metering pumps will normally fit standard glass bottles with screw or snap on closures, so the switch from a simple cap to a metering pump is not that complicated from a manufacturing point of view. If such a change is considered, the package must clearly inform about the new dosing technology to avoid habitual use and consequent wrong dosing. (See Figure 4)

Summary According to a recent market research, consumers reduced their spending on OTC drugs and start to prefer private label products3.

This development of consumer behaviour within the triangle of prices, costs, and perceived value will certainly continue throughout the next future. However, innovations in delivery mechanisms or ingredients will help manufacturers in differentiating their products and defend higher price positions. In order to maintain margins and competitive advantages, companies must think about novel products or features appreciated by consumers. If consumers do not perceive value, they will maintain a level of loyalty to a product which is mandatory to keep them from considering private label alternatives.

Packaging suppliers can contribute substantially here to balance convenient handling and patients expectations with manufacturing costs. Last but not least, recent findings and consequent expectations concerning dosing accuracy raised by agencies such as the US Food and Drug Administration (FDA) can be tackled more appropriately with up-to-date technologies.

References 1Dart RC et al. Paediatric fatalities associated with over the counter (non-prescription) cough and cold medications.

Ann Emerg Med. 2009; 53(4):411-7 2Yin HS et al. Evaluation of consistency in dosing directions and measuring devices for paediatric non-prescription liquid medications. JAMA. 2010;304(23); E1-8 3Chmelik S. Balancing Value and Safety: Drivers for Consumer Purchasing Decisions. OTC Perspectives, May 2010, 23-5 July 1-15, 2013

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NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical.

Recognized by Bureau of Indian Standards.

Drugs Control Administration (A.P).

Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC).

NABL for ISO/IEC 17025:2005.

!"! $!%!&'('%" )*!+",+'- ,% ./012 324. !*' 5'-,&%'5 "6 '%-7*' "6"!8 ,%"'&*,"9: -'+7*,"9 !%5 ;!-"'-" *'"*,'<!8=

ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com July 1-15, 2013

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Business Avenues Please Contact: ■ Mumbai: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Vijay Kulkarni 09940047667 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: A K Shukla 09849297724 ■ Kolkata: Ajanta / Prasenjit Basu 09831182580 / 09830130965 ■ Ahmedabad: Rajesh Bhatkal 09821313017

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AAS, ICP, ICPMS Sample Preparation for Pharmaceutical Industry 110 0 °C op e Max ra t i im ng t e mp um e ra t ur e

AAF ASHING & BURN-OFF FURNACES ■ 3, 7 & 18 litre models available ■ Specifically designed for ashing purposes ■ Elements are protected from carbon build-up by a hard wearing alumina liner ■ Large floor & optional racking system in the AAF 11/18 for large sample numbers ■ Preheated airflow for complete combustion ■ Optional over-temperature protection for unattended use www.carbolite.in RETSCH INDIA PVT LTD | 1-2-45/1, 2nd Floor, Street No: 2, Kakatiya Nagar Colony, Habsiguda | 500 007 Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: info@carbolite.in | Web: www.carbolite.in

July 1-15, 2013

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JOB TRENDS Positive sentiments continue in pharma sector Hiring increases by 25 per cent in May 13’ over May 12’

he pharmaceutical sector continues to hire experienced talent.

Overall the pharma sector has shown a 25 per cent increase in jobs when compared to last year, while if we see the hiring trends, professionals from the same sector have been in demand with 12 per cent increase as compared to previous month and 38 per cent as compared to year before.

Pharma, besides ITES is the only sector

T

showing double digit growth in hiring professionals this month. Thus jobseekers in this sector can look forward to some good job opportunities ahead.

About Naukri.com Naukri.com, India’s No 1 job site and the flagship brand of Info Edge revolutionised the concept of recruitment in India. Since its inception in 1997, Naukri.com has seen continued

growth while outperforming its competitors in every sphere. Info Edge was the first Internet company to list in India. The site enjoys a traffic share of around 61 per cent as per the Sept Comscore data.

Naukri.com is a recruitment platform that provides hiring-related services to corporates/ recruiters, placement agencies and to job seekers in India and overseas. It offers multiple products

like Resume Database Access, and Response Management tools and its services include Job Postings, and recruiter branding solutions on the site.

The site has a database of over 29 million resumes and has serviced over 46000 clients in FY-2012. The company has over 2000 people operating through 48 offices in 31 cities in India and overseas offices in Dubai, Abu Dhabi, Riyadh and Bahrain.

Jobs from Naukri.com Executive -Maintenance Mechanical Company: Exp: Location: Job Id:

Gland Pharma Ltd. 3-8 Hyderabad / Secunderabad 030613001464

Production Manager Company: Exp: Location: Job Id:

Biogenetic Drugs Pvt.Ltd. 15-20 Baddi 030613001408

Medical Writer Company: Exp: Location: Job Id:

Quintiles 2-7 Bengaluru/Bangalore 030613000954

Client Servicing Manager Company: Exp: Location: Job Id:

Sorento Healthcare Communications 3-7 Mumbai 020513001333

Factory Manager/ Works Unit Head Company: Saurav chemicas limited Exp: 10-20 Location: Chandigarh Job Id: 070113003105

Junior Research Scientist - Formulation Company: Exp: Location: Job Id:

Piramal Enterprises Ltd 3-5 Mumbai 200513001988

Regional Sales Manager Area Sales Manager Company: Exp: Location: Job Id:

Yasham Speciality Ingredients Pvt Ltd 10-15 Mumbai 030613001411

Network & Hardware Engineer Company: Parenteral Drugs (India) Ltd Exp: 1-3 Location: Baddi Job Id: 030613001044

July 1-15, 2013

Company: Exp: Location: Job Id:

Sapat & CO (Bombay) Ltd 7-10 Bengaluru/Bangalore 070113001819

ITI - Maintenance Engineer - Nigeria Company: Exp: Location: Job Id:

Meyer Organics Pvt. Ltd. 4-7 Mumbai 250413003723

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P|H|A|R|M|A| L|I|F|E

AWARD Abbott receives Golden Peacock Award for Global Business Excellence Award acknowledges Abbott’s outstanding management practices and stakeholder engagement bbott was honoured with the Golden Peacock Global Business Excellence Award for 2013 at the recent Global Convention on Business Excellence in Dubai. The Golden Peacock Global Business Excellence Award recognises Abbott’s strong foundation of stakeholder engagement, a commitment

A

to transparency, a workplace environment that enables its employees to achieve their greatest potential, high standards of ethics and compliance for the company and its partners, and the quality of its involvement with communities. It also recognises Abbott’s broader economic, social and environmental performance.

“Abbott is committed to advancing healthcare and improving the lives of millions of patients and cus-

tomers by partnering with healthcare professionals, governments, non-governmental organisations and other stakeholders,” said Bhaskar Iyer, Divisional Vice President, Established Pharmaceuticals, Abbott in India. “Being a responsible corporate citizen involves more than health care innovation and outreach. Good citizenship also extends to the way we run our business in a sustainable manner to benefit our many

stakeholders.”

The Golden Peacock Global Business Excellence Award was created by the Institute of Directors to encourage Business Excellence achievements in both manufacturing as well as service organisations globally. This category of award recognises companies in areas such as leadership, vision, financial performance, managing risk and corporate sustainability.

EP News Bureau-Mumbai

INITIATIVE Indegene launches iAcademy Will train every employee competently and effectively to meet the changing needs of the global pharma industry ndegene has opened its iAcademy, the company’s learning and development institute to ensure that every employee is trained to competently and effectively meet the changing needs of the global pharmaceutical industry.

Manish Gupta, Chief Executive Officer, Indegene,

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said, “We foresee these transformational changes as important opportunities for Indegene, and for our employees in their learning and growth. iAcademy provides a sophisticated and predictable system for training and developing employees across all functional and domain areas that tie very closely with real changes in the marketplace. The primary benefactor of this initiative will be our clients who will continue to gain access to our

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highly specialised and multiskilled talent pool as they continue to traverse this changing global landscape.” iAcademy is built on an integrated curriculum of interactive courses that are linked with the current positions employees hold in the organisation (entry-level, team leaders, middle management, senior management); and functionally across content/medical writing, research, analytics, clinical sciences, regulatory &

safety, scientific multimedia, multi-channel marketing, technology, and medical affairs.

Gupta said, “iAcademy incorporates L&D best practices, including proprietary technology and instructional systems design (ISD), making this probably the most sophisticated and relevant pharmaceutical services learning and development employee academy in the Asia-Pacific region.”

EP News Bureau-Mumbai

July 1-15, 2013

IT’S HOW WE WORK. IT’S HOW WE SUCCEED.

IDENTIFY TOGETHER WITH AGILENT BIOPHARMA SOLUTIONS Confidence means having tools designed specifically for the task at hand.

Agilent has characterization solutions made for biopharma scientists, enabling high-quality methods that help you get more information from every characterization.

Agilent 1260 Infinity Bio-inert LC ensures nothing interferes with your biomolecule characterization and QA/QC, and Agilent’s AdvanceBio Peptide Mapping and ZORBAX RRHD 300Å, 1.8 µm columns deliver essential resolution.

The Agilent MassHunter BioConfirm LC/MS software and high mass accuracy Agilent TOF/Q-TOF allow easy mapping of intact proteins and peptides.

IDENTIFY MORE – see more biopharma solutions and request the Biopharma Applications Compendium at agilent.com/chem/togetherbiopharma. © Agilent Technologies, Inc. 2013

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