Express Pharma April 16-30, 2014

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Cover Story Agenda for the next PM Management ‘Patient awareness on tuberculosis is a big gap’ Packaging Special Secure down to the primary pack 16-30 APRIL 2014,` 40

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CONTENTS MARKET Vol 9 No.12 APRIL 16-30, 2014

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

11

‘NEW PRODUCT DEVELOPMENT AND LAUNCH REMAINS A VERY CRITICAL AREA FOR PHARMA COMPANIES’

12

SUN PHARMA TO ACQUIRE RANBAXY IN $4-BILLION LANDMARK TRANSACTION

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

Indian political parties are busy wooing voters with myriad promises for the General Elections 2014.

Yet healthcare, a vital issue, once again fails to get its due in the campaigns and manifestos of the various parties | P38

Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P48: CLINICAL UPDATES USFDA advisory committee votes against approval of Novartis’ RLX030

P49: RESEARCH UPDATES

54

SECURE DOWN TO THE PRIMARY PACK

MANAGEMENT

41

Childhood flu shots could result in serious clinical outcomes in adults

P59: PACKAGING NEWS

PACKAGING SPECIAL

‘PATIENT AWARENESS ON TUBERCULOSIS IS A BIG GAP’

44

‘A DEMAND FOR NUTRITION SUPPLEMENTS HAS BEEN SEEN AMONGST THE INDIANS’

45

COMMERCIAL EXCELLENCE 2.0

Bosch to present new training concept at Interpack 2014

TURN TO PAGE 13 TO FIND SPECIAL DEALS

P89: APPOINTMENT Anders Malm appointed as Managing Director at Ecron Acunova

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

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

EDITOR’S NOTE

Three more cos face US FDA ire

L

ast month, the US FDA has reportedly issued 483s to at least three more pharmaceutical companies in India, one of them the Indian subsidiary of a US generics company. In parallel inspections at two sites in the same state, spanning March 24-28, the Agency issued 14 -15 inspectional observations per site, some related to data integrity issues.

Unconfirmed reports say that the local unit of the US generic major received nine observations; three of a critical nature, pertaining to contamination of manufacturing equipment.

As we go to press, Sun Pharma's takeover of Ranbaxy is being seen as a forerunner to a long overdue consolidation in the industry. There is hardly any doubt that the deal was a direct result of the Ranbaxy brand taking a beating in the past couple of years, due to import bans and product recalls triggered by US FDA inspections. Wilfully ignoring 483s or taking them too lightly can reverse years of brand building and therefore managements at all units facing 483s should take speedy action to rectify these problems lest they too lose credibility and become takeover targets.

But there is some good news as well. It's worth recording that some companies in India are already meeting US FDA's cGMP standards. Sources point out that of the five sites inspected by the US FDA in the same state as the above two units, from November 2013 to March this year, three sites did not trigger adverse observations. But 3/5 is not good enough for any industry and we need to improve this score.

While the nature of the 483s at the US generics plant could not be verified independently, state officials present during the two other inspections confirmed the news. But when quizzed on the seriousness of the observations, they seemed confident that none of the observations were critical and the respective managements were committed to rectify the lapses.

One recurring source of data integrity issues in past US FDA inspections of pharma plants in India is the lackadaisical approach to record keeping in key areas, especially quality control (QC) labs. As most pharma QC labs in India lack automated analysis equipment, readings are recorded manually and in most cases, this raw data is not archived adequately.

Shared login IDs for key QC lab equipment and work stations, disabled audit trail functions: all these are 'red flags'. As one Warning Letter (WL) states, 'the lack of reliability and accuracy of data generated by your firm is a serious cGMP deficiency that raises concern for all data generated by your firm.'

Moreover, this WL squarely put the onus on the management: 'Be advised that corporate management is responsible for ensuring the reliability of all

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The collaboration between Indian and US regulators,is in fact,upsetting crusadercommentators like Roger Bate who has accused the US FDA of suppressing concerns about Indian generics

data produced by your firm, including data submitted to FDA to support the safety, effectiveness, and quality of marketed products.'

Will the learnings from each inspection add to the collective know-how? Or will we keep repeating the same mistakes?

Post the March visit of the US FDA Commissioner, US and Indian drug authorities are working together on at least two fronts. Firstly, state or central inspectors are present as 'observers' during US FDA inspections. Secondly, the US FDA is conducting capacity building workshops. The third in the series of workshops is to be conducted on May 1213 at Ahmedabad and will focus on regulations for finished drug products as well as introductory concepts for the establishment of effective quality systems.

State regulators who have been included in such inspections concede that the US authority sees such inspections not as a means to punish, but as a chance for improvement; with a clear emphasis on the Corrective and Preventive Action (CAPA) approach. Indeed the WL cited above mentions seven steps that the erring company's data integrity consultant should follow to set things right and lays down clear timelines and punitive action.

The collaboration between Indian and US regulators, is in fact, upsetting crusader-commentators like Roger Bate, who on February 26, chaired a congressional briefing about the possibility that lowquality drugs from India are being sold in the US. Since then, Bates has accused the US FDA of suppressing concerns about Indian generics (http://bit.ly/1nb8Yot).

Irrespective of Bate's views, he does make a valid argument in an article exclusively written for Express Pharma (http://pharma.financialexpress.com/ latest-updates/3630-why-are-indian-generics-underattack-one-view-from-america). He points out that the laws overseeing drug production in India, date back to 1940 and I am sure that many in the country, including the DCGI himself, will agree with him when he advocates that the entire law needs to be rewritten to give the main regulator, the CDSCO, more status, funding and power.

Bate in fact puts the onus on the political machinery, urging the post-election Indian government to rewrite the laws, and properly fund a well constituted drug regulator. Industry leaders have a long list of recommendations for the next Prime Minister, which in fact form the cover story of this issue.

Let us hope that at least some of them actually make it to the PM's 100-day agenda.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

‘New product development and launch remains a very critical area for pharma companies’ In its latest report, Accenture outlines how innovation driven high performers are changing the landscape in the pharma industry. Sriram Shrinivasan, Managing Director, Lifesciences, Accenture in India in an interview with Shalini Gupta sheds some light on how far is this trend applicable in India Who would you say are the high performers in the Indian context and what percentage are these of the pharma industry and at what rate are they growing?

Majority of the large Indian pharma companies have done quite well in the last decade or so. They have moved from being primarily India focused to being significant players in the global generics markets especially in the US, RCIS and other emerging markets. Amongst these, firms like Lupin, Sun, DRL etc. are in the top quartile of performance. Top Indian companies have grown at a CAGR of 15+ percentage in last five to six years with Sun at ~27 per cent and Lupin at ~25 per cent.

What is the growth strategy of these high performers?

Is it the same as their global counterparts? In light of the recent challenges in term of pricing, regulatory, patents etc. how are companies changing their strategy? What business models are they looking at?

Most of the Indian companies are playing in the generics segment and hence their business strategy is mostly aligned with the global counterparts like Teva, Mylan, Actavis etc. The US

continues to be the largest market for the Indian companies followed by RCIS, Brazil, South Africa and other emerging markets. Western Europe remains an elusive market for Indian companies because of the need to adhere to country specific norms, low profitability on account of tender business in countries such as Germany etc. Companies are also making their presence felt in Japan and Australia.

As the patent cliff comes to an end with fewer drugs going off patent in the coming years, Indian companies are also trying to capture the 'hard to make' generics markets of sterile dosages, inhalers etc. In fact, quite a few of them have even tried the inorganic route to gain the necessary technical expertise for such products.

So far they have used various business models including partnerships, where Indian company supplies drugs to other companies in Western market for marketing and distribution. Cipla which has relied heavily on the partnership model so far, is now looking to go direct in few selected markets. Others include direct presence in the market with a large sales force (DRL in RCIS), use of pharmacies and wholesalers

to capture generics market – typically the US and local distributors led market growth e.g. in Southeast Asia.

There is a still a long way to go for Indian companies on the innovation front when compared to their Western and Japanese counterparts

Are companies bringing the right products along with value focused commercial models and the right level disease focus? How would Indian industry rank on Enterprise Value (EV), Future value (FV) and how much are recent and upcoming launches set to drive growth in absolute terms?

Success of Indian companies is a clear indication that companies are bringing the right products into the market. Few of the important parameters for generic companies are patent expiry schedule, global market size, competitive intensity, competitive medicines, pricing etc. to decide on the product portfolio. Indian companies have also used decades of reverse engineering skills to good use while developing the new drugs for the generics segment. Combination products have helped them to get ahead of the competition along with incremental innovation such as 505(b)(2) filings. Close to 45-50 per cent of the EV can be attributed to the future value of the Indian companies though this has reduced in the recent past (from

65 per cent at the end of FY11).

Are there any outliers in the Indian pharma industry breaking away with science-based innovation strategies?

Indian companies are spending five to six per cent of their revenues annually on R&D, however, none of them has succeeded in bringing new chemical entities (NCEs) or new biological entities (NBEs) to the market as yet.

There are early indications of success on that front. Firms such as DRL, Zydus, Biocon, Piramal Life Sciences, Glenmark etc. are pushing this agenda forward and may be able to commercialise one of the pipeline drugs in future.

Piramal Healthcare, despite selling off its domestic formulations business, continues to invest into innovative drug related R&D under Piramal Life Sciences and has several times stated the desire to launch innovative products globally. There is a still a long way to go for Indian companies on the innovation front when compared to their Western and Japanese counterparts.

What is the investor sentiment for Indian pharma industry? Are companies with

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MARKET diversified portfolios being rewarded less and those with niche portfolios more?

Investors continue to have a positive focus on the pharma market driven by a robust domestic market (though growth has slowed down in recent past to 10-12 per cent from 1516 per cent) and rise in exports markets. This is especially true for the large companies in the pharma market. Small and medium enterprises continue to struggle because of constant pressure on margins and slower growth in the low value add products in the global, Indian market. As far as the Indian market is concerned, most of the large players have started playing in multiple segments with

Investors continue to have a positive focus on the pharma market, driven by a robust domestic market and rise in exports markets. It is especially true for large pharma companies diversified portfolios while keeping their high focus on two to three target areas.

Cipla is a leader in respiratory segment whereas Lupin is a leader in the anti-TB market.

Overall the Indian market continues to be fragmented.

How do Indian companies fare on their launch capabilities, especially when it comes to launching their products in other markets?

Have they missed their pre-sales targets/achieved them/over-achieved?

New product development and launch remains a very critical area for pharma companies as it involves coordination with multiple departments – Sales and Marketing, Supply Chain, R&D, Regulatory Affairs etc. Few days’ delay from the launch date can lead to significant loss of revenues, market share for any generic company.

Hence, it is a high visibility, high focus area for any Indian company. In fact, in majority cases the owners and Managing Directors are directly involved in making sure that the launch happens on time. Indian companies have traditionally relied on low end project management techniques to monitor the

progress of new products but now they are slowly graduating to high end tools, bringing all the stakeholders, decision making on a common platform.

Like any forecast, there is always an uncertainty with new products and hence all scenarios of missing, achieving and over-achieving targets are possible and have taken place in the past. There are multiple internal and external factors which play a role in target achievement and not just adherence to launch time e.g. activity from innovators, competitive therapies/medicines, government actions etc. shalini.g@expressindia.com

COMPANY WATCH

Sun Pharma to acquire Ranbaxy in $4-billion landmark transaction To create world’s fifth largest specialty generic pharma company SUN PHARMACEUTICAL Industries and Ranbaxy Laboratories have entered into definitive agreements pursuant to which Sun Pharma will acquire 100 per cent of Ranbaxy in an all-stock transaction. Under these agreements, Ranbaxy shareholders will receive 0.8 share of Sun Pharma for each share of Ranbaxy.

The combination of Sun Pharma and Ranbaxy creates the fifth-largest speciality generics company in the world and the largest pharmaceutical company in India. The combined entity will have operations in 65 countries, 47 manufacturing facilities across five continents, and a significant platform of speciality and generic products marketed globally, including 629 ANDAs. On a pro forma basis, the combined entity’s revenues are es-

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April 16-30, 2014

timated at $4.2 billion with EBITDA of $1.2 billion for the twelve month period ended December 31, 2013. The transaction value implies a revenue multiple of 2.2 based on 12 months ended December 31, 2013.

Dilip Shanghvi, Managing Director, Sun Pharma said, “Ranbaxy has a significant presence in the Indian pharma market and in the US where it offers a broad portfolio of ANDAs and first-to-file opportunities. In high-growth emerging markets, it provides a strong platform which is highly complementary to Sun Pharma’s strengths. We see tremendous growth opportunities and are excited with the prospects to create lasting value for both our shareholders through a successful combination of our franchises.”

The combined entity will have operations in 65 countries, 47 manufacturing facilities across five continents, and a significant platform of speciality and generic products marketed globally, including 629 ANDAs “We believe this transaction brings significant value to all Ranbaxy shareholders.

Sun Pharma has a proven track record of creating significant long-term shareholder value and successfully integrating acquisitions into its growing portfolio of assets.

We are confident that Sun Pharma is the ideal partner to

help us realise our full potential and are excited to participate in future value creation opportunities,” stated Arun Sahwney, Managing Director and Chief Executive Officer, Ranbaxy.

Various industry leaders have given teh thumbs up to this buy out. GV Prasad, Chairman and Chief Executive Offi-

cer, Dr Reddys commented taht it was a great move by Sun Pharma and consistent with their strategy of acquiring distressed assets and turning them around.

V KrishnaKumar, Partner Transaction Advisory Services (Lifesciences & Healthcare), EY, said, “The deal will create a domestic powerhouse with a combined market share in excess of nine per cent in the domestic branded formulations space. In addition to size/ scale benefits, the domestic portfolios of the two companies complement each other well. Sun's domestic portfolio has a bias towards specialities (such as CVS, CNS and Oral Anti-diabetes), while Ranbaxy’s domestic portfolio has large primary-care and OTC segments as well.”

EP News Bureau – Mumbai

MARKET

Contaminated drug ingredient found at GSK plant US FDA said the company didn’t take sufficient action to resolve the problems at its Ireland facility THE US Food and Drug Administration (US FDA) found that a drug ingredient manufactured at a GlaxoSmithKline plant in Ireland was contaminated and said the company did not take sufficient action to resolve the problems. GSK said the ingredient was paroxetine, used to make its antidepressant drugs Paxil and Seroxat.

The company said it had proposed a recall of certain batches of the drugs from wholesalers but there was no risk of harm to patients taking these drugs.

In a warning letter dated March 18, the US FDA said GSK did not fully investigate a list of objectionable conditions the regulator sent after its inspection of the plant at Cork in October.

The company had proposed a recall of certain batches of the drugs from wholesalers but there was no risk of harm to patients taking these drugs Some batches of a drug or drugs using the contaminated ingredient were later shipped, the FDA said, and GSK did not notify its customers about the lapse.

The FDA said its investigator found that a certain drug ingredient was contaminated with material from the plant's pharmaceutical waste tank.

The FDA said it might withhold approval of any new drug applications that list GSK as the manufacturer of their drug ingredients until GSK corrected the issues.

According to a report in Reuters, the regulator said it also might refuse the import of

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drugs manufactured at the Cork facility into the US. The Cork plant is the company’s only drug ingredient manufacturing facil-

ity in Ireland. Over-the-counter medicines and oral care products are manufactured at a plant in Dungarvan, while consumer

products are made at Sligo, both in Ireland.

The investigator also raised concerns about the suitability of

the equipment used to manufacture the ingredients.

EP News Bureau – Mumbai

MARKET

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Aurobindo acquires select Western European business of Actavis Actavis and Aurobindo have also entered into a long-term commercial and supply arrangement AUROBINDO PHARMA has completed the previously announced acquisition of certain commercial operations in Western Europe from Actavis. The agreement to acquire the Actavis operations was announced in January 2014.

Aurobindo acquires personnel, commercial infrastructure, products, marketing authorisations and dossier licence rights in seven European countries. Actavis and Aurobindo have also entered into a long-term commercial and supply arrangement. Following receipt of clearances from competent authorities, Aurobindo now intends to combine the strength of both enter-

will enable Aurobindo to achieve critical mass in Western Europe with a top 10 position in several key markets. He further added, “I am delighted to welcome relevant Actavis customers, suppliers, partners and employees to Aurobindo.

We will continue to collaborate with Actavis to ensure business continuity and a smooth transition. In parallel, we will work closely with the acquired management teams to achieve a rapid and successful integration.”

Arvind Vasudeva, Chief Executive Officer, Aurobindo’s Formulations Business further stated, “We had carefully reviewed the Actavis

Aurobindo now intends to combine the strength of both enterprises (including its vertically integrated platform and existing commercial infrastructure) in these markets and to identify and maximise all opportunities to improve performance prises (including its vertically integrated platform and existing commercial infrastructure) in these markets and to identify and maximise all opportunities to improve performance.

The acquisition will make Aurobindo one of the leading Indian pharmaceutical companies in Europe said V Muralidharan, Senior Vice President, European Operations, Aurobindo. The acquisition

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European operations and concluded that with our cost competitiveness and group structure we could significantly capitalise Actavis’ strong market position in these Western European countries and improve profitability, thereby accelerating our strategy of becoming a significant Gx player in Europe.”

EP News Bureau – Mumbai

MARKET

Actavis acquires Silom Medical Company Enhances Actavis’ growth platform in Southeast Asia ACTAVIS, A global speciality pharmaceutical company, has acquired Silom Medical Company, a privately held generic pharma company focused on developing and marketing therapies in Thailand, for approximately $100 million in cash. The acquisition of Silom Medical immediately elevates Actavis into a top-five position in the Thai generic pharma market, with leading positions in the ophthalmic and respiratory therapeutic categories and a strong cardiovascular franchise. The transaction is expected to be immediately accretive to nonGAAP earnings in 2014.

“The acquisition of Silom Medical demonstrates our commitment to be a leading speciality pharma company in Southeast Asia, and will provide the combined business with an even more significant and united presence in the fast-growing Thai pharma market,” said Paul Bisaro, Chairman and Chief Executive Officer, Actavis.

“Silom Medical’s diverse product portfolio and fully integrated platform, when combined with Actavis’ current local commercial activities and world-class global generics infrastructure, will provide consumers in Thailand with expanded access to a combined, larger portfolio of affordable medicines and the increased opportunity to benefit from products in development for the market,” said Bisaro. Actavis markets approximately a dozen products through local distributors in Thailand, and has approximately nine additional products under registration.

The combination is anticipated to result in opportunities to expand the core therapeutic areas of cardiovascular, ophthalmology and respiratory with complementary and novel products, as well as the potential to use Silom Medical’s sales channels to create opportunities in new therapeutic categories including oncology, women’s health, CNS and others. Silom Medical offers more than 25 products in

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various dosage forms to more than 4,400 hospitals, clinics and drug stores throughout the

country. The company has an inhouse sales force and operates a 32,000 sq mt manufacturing fa-

cility in Ayutthaya with a production capacity of 660 million tablets/capsules and 47 million

sterile units per year.

EP News Bureau – Mumbai

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MARKET DEALTRACKER

March 2014 sees M&A activity decline in value Indian Pharma sector witnesses no deals in the month M&A ACTIVITY in the pharmaceutical sector recorded a fall, in value terms, across the globe.

North America witnessed the highest reduction, recording deals worth about $0.5 billion, a significant decrease of 94.3 per cent over the previous six month’s average of $8.2 billion.

In one of the key deals announced during the month of March, Vectura Group agreed to acquire Activaero, a Germanybased pharma company, for approximately $188.68 million. The acquisition will allow Vectura to strengthen its core capabilities and enable it to build a therapeutic specialty in respiratory diseases. This transaction supplements Vectura’s existing pipeline with a number of mid-and late-stage assets across a broad therapeutic scope, within the respiratory disease sector (seven clinical and several pre-clinical programmes).

In addition, Vectura will gain access to FAVORITE (Flow And VOlume Regulated Inhalation TEchnology), a nebulizerbased inhalation technology, and three devices, AKITA(R) JET, APIXNEB and FOX; along with an un-partnered, late-stage, asthma therapeutic: FAVOLIR, with peak sales potential exceeding the total deal consideration.

M&A activity in the pharma sector decreased in volume and value terms, when compared to the average of the previous six months (September 2013 – February 2014).

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FIGURE: M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

Source:

FIGURE: VENTURE FINANCING TREND ANALYSIS

Source:

TOP M&A DEALS (MAR 2014) RankDate

Date

Target

Acquirer

Deal value ($m)

1

03/20/14

Revive Pharmaceuticals - Donnatal (US)

Concordia Healthcare Corp. (CA)

265.3

2

03/13/14

Activaero GmbH (DE)

Vectura Group plc (GB)

188.68

3

03/31/14

Argenta Discovery, Ltd. (GB); BioFocus DPI plc (GB)

Charles River Laboratories International, Inc. (US)

185.9

4

03/31/14

Aptiv Solutions (US)

ICON Plc (IE)

143.5

5

03/11/14

GLYCOTOPE GmbH (DE)

ELSA Eckert Life Science Accelerator GmbH; Jossa Arznei GmbH

76.34

6

03/24/14

Cedarburg Pharmaceuticals, Inc. (US)

Albany Molecular Research, Inc. (US)

41

7

03/14/14

Agendia BV (NL)

Norgine Ventures; Undisclosed Investors

20.88

8

03/03/14

RainDance Technologies, Inc. (US)

GE Venture; Northgate Capital; Undisclosed Investors

16.5

9

03/04/14

Activiomics, Ltd. (GB)

Retroscreen Virology Group plc (GB)

6.68

Source:

TOP VENTURE FINANCING DEALS (MAR 2014) Rank

Date

Target

Investors

Deal value ($m)

KLP Enterprises; Undisclosed Investors; Deerfield Management Company; Franklin Berger; HBM Healthcare Investments Ltd; Purdue Pharma, L.P.; Osage University Partners

60

1

03/26/14 Kolltan Pharmaceuticals, Inc. (US)

2

03/05/14

ZS Pharma, Inc. (US)

Novo A/S; RA Capital Management, LLC; Adage Capital Management, L.P.; Sofinnova Ventures, Inc.; Alta Partners; Devon Park Bioventures; 3x5 Special Opportunity Partners; Salem Partners; RiverVest Venture Partners; Undisclosed Investors

55

3

03/11/14

Lumena Pharmaceuticals, Inc. (US)

New Enterprise Associates, Inc. (NEA); Adage Capital Management, L.P.; RA Capital Management, LLC; Pappas Ventures (formerly A.M. Pappas & Associates, LLC); RiverVest Venture Partners; Alta Partners

45

4

03/13/14

SAGE Therapeutics (US)

OrbiMed Advisors, LLC; EcoR1 Capital Management; Foresite Capital Management, LLC; Third Rock Ventures, LLC; ARCH Venture Partners; Undisclosed Investors

38

5

03/25/14 scPharmaceuticals, LLC (US)

5AM Ventures; Lundbeckfond Ventures (LFI Life Science Investments)

16

Source:

MARKET According to Datamonitor's Medtrack database, the pharma sector recorded 22 M&A transactions in March 2014, against the previous six months’ average of 31.1 transactions. In value terms, the sector recorded deals worth $0.9 billion, against the previous six months’ average of $9.3 billion.

The Indian pharma sector witnessed no deals during March 2014, against the average of 0.8 deals over the previous six months.

In one of the key deals announced in March, Vectura Group agreed to acquire Activaero, a Germanybased pharma company, for approximately $188.68 million. The acquisition will allow Vectura to strengthen its core capabilities and enable it to build a therapeutic specialty in respiratory diseases Companies in the pharma sector raised $246.4 million during March 2014, against the previous six months’ average of $257.3 million. In terms of volume, the sector recorded 12 venture funded deals, when compared to the

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April 16-30, 2014

previous six months’ average of 19 transactions.

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiol-

ogy. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a userfriendly, highly dynamic set of decision support tools and analytics. In-house analysts and researchers add key insights and conclusions to provide you with

the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

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MARKET PRE EVENTS

SPDS to conduct DISSO ASIA2014 convention in Mumbai To promote introduction of new technology, innovation and have deliberations on various issues faced related to dissolution SOCIETY FOR Pharmaceutical Dissolution Science (SPDS) will be conducting its 2nd Annual International Convention DISSO ASIA 2014 on May 5 and 6, 2014 in Mumbai. The event will promote introduction of new technology, innovation and have deliberations on various issues faced related to dissolution. Around 200-250 eminent professionals are expected to participate in this event. The event will be organised under the Chairmanship of Dr Nandakumar Chodankar, Chief Executive Officer and Promoter (Director on Board) at ASolution Pharmaceuticals and the Organising Secretary, Dr L Ramaswamy, Managing Director, Sotax India. The scientific sessions will be programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD and Professor of Pharmaceutics, Bombay College of Pharmacy, Mumbai.

The event will have plenary lectures, poster exhibits, panel discussion and exhibits. Vijay Kshirsagar, Director and Chief Executive Officer, TRAC Consulting, Mumbai will speak on the topic ‘Relevance of Current Batch Centric BE Studies’; Dr Vinod Shah, Ex US FDA, Pharmaceutical Consultant, USA will speak on ‘FDA/USP Perspectives on Dissolution Testing from Regulatory Filing Point of View’; Prof Dr Jean Michel Cardot, Professor, Department of Biopharmaceutics, and Pharmaceutical Technology, Auvergne University, France will deliver a lecture on ‘In-Vitro Dissolution as in Vivo Surrogate’; Samir Haddouchi, Managing Director, SPS Pharma Services, Clermont Ferrand – France will speak on ‘Overview of Challenges and Solutions to Dissolution Testing of Non-Oral Formulations’; Dr Umesh Banakar, Professor and President, Banakar Consultancy Services, USA will speak on 'Biosimilars The Emerging Frontier for Generics:

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Around 200250 eminent professionals are expected to participate in the event Role of Dissolution Testing’; Dr Sandip Tiwari, Technical Director: South Asia, Colorcon Asia will speak on ‘Future of Dissolution Testing’; Michel Magnier, Product Manager/Application Specialist, SOTAX will speak on ‘Automation for Dissolution Testing’; Bryan Crist, Manager, Scientific Affairs, Agilent technologies, USA will speak on ‘Validation of Components and data of Automated Dissolution Methods’; Prof Dr Sompol Prakongpan, Professor of Pharmacy, Burapha University, Thailand will speak on ‘Biowaiver of Biopharmaceutics Classification System Class III Drug Products’; Dr Sid Bhoopathy, Chief Operating Officer, Absorption Systems, USA will speak on ‘Strategies for Establishing Equivalence of Complex Drug Products’; Dr Flavian Stefan Radulescu, University of Medicine and Pharmacy ‘Carol Davila’ Bucharest, Romania will speak on ‘Correlation between rheology, in-vitro release and invivo performance of topical dosage forms.’

A panel discussion on ‘Handling dissolution Challenges’ will be held which has been specifically designed for all the professionals from R&D, QA and QC as well as the academia.

EP News Bureau-Mumbai

MARKET

IDMA to organise seminar on ‘Managing Risks for Quality Compliance 2014’ To be held in Mumbai on May 16, 2014 INDIAN DRUG Manufacturers’ Association (IDMA) and IDMA Technical Subcommittee will organise a seminar on Managing Risks for Quality Compliance 2014 on May 16, 2014 in Mumbai. Experts in technology, quality assurance, regulatory affairs, engineering,production,and packaging spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

Dr K Bangarurajan, Deputy

Drugs Controller (India), CDSCO West Zone (Mumbai) will give the keynote address on ‘QRM Requirements of WHO’; Bharat Doshi, Pharmaceutical Consultant, will speak on ‘Risk Free Facility Design for efficient QRM’; SM Mudda, Executive Director,Technical & Operations - Micro Labs will speak on Managing Operational Risks for Quality Products; R Raghunandanan, Pharmaceutical Consultant, will speak about ‘Managing Risks

The seminar will cater to those involved in pharma, bio-pharma industry, academic institutions; business consulting companies, facility design and materials management in Quality of Aseptic Operations’; RR Tuljapurkar, Vice President,Quality Assurance,

Zydus Cadila, will speak on ‘Controlling Risks in Quality Control’; R Dadich, Vice Presi-

dent, Corporate Quality, IPCA Laboratories will speak on Quality Materials for Quality Products-Controlling Risks.’

The seminar has been designed to cater to all those involved in pharmaceutical industry, bio-pharmaceutical industry, academic institutions; business consulting companies, facility design and materials management.

EP News Bureau – Mumbai

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MARKET POST EVENTS

DIAconference on pharmacovigilance well received by audience Two-day conference provided a platform to discuss and share insights on the global clinical research industry Usha Sharma Mumbai UPDATING THE industry about the global regulatory requirements of pharmacovigilance, DIA a neutral, global, non-profit association, recently organised a two-day conference in Mumbai on Pharmacovigilance & Drug Safety - A New Era. The conference provided a platform to discuss and share insights about the global clinical research industry.

Ganesh Parkar, Cluster Head of Pharma and Manufacturing, TCS welcomed all the delegates and participants and also delivered the keynote speech.

The conference registered a large number of participants from the industry and their active participation during the Q&A session created an inquisitive environment. The Q&A session raised various industry related issues, which were later discussed by different speakers.

Key speakers during the event were Professor Andy Stegachis, University of Washington, Prof YK Gupta and Head, Department of Pharmacology, All India Institute of Medical Sciences; Jyoti Joshi Jain, Senior Advisor, Immunisation Safety Surveillance Immunisation Technical Support Unit, MoHFW Public Health Foundation of India; Sudhakar BangeraProgramme Director, Clinical Development Services Agency (CDSA), an Extramural unit of THSTI, Department of

20 EXPRESS PHARMA April 16-30, 2014

Biotechnology Government of India; Ute Hoeffner- EU QPVV, Novartis Consumer Healthcare, Germany; Seema Jaitly, Chief Executive Officer, Essjay Solutions; Stewart Geary, Chief Medical Officer, Eisai Pharmaceuticals; CL Baklaji, Managing Director, Accenture Lifesciences; Aparna Patkar, Lead PV offering, TCS; Rajesh Kuppuswamy, Life Sciences Consulting Head, APAC; Dinesh Kasthuril, Director Service Delivery, Sciformix Corporation; Vineet Kacker, Managing Director and Global Technical Head, APCER Pharma Europe; Anish Desai, Director, Medical Affairs, Johnson and Johnson; Vishwas Sowani, Country Manager, Revogenex; Milind Sardesai, Assistant Director, Lupin and Mangesh KulkarniGroup Head, DS&E, Novartis.

Commenting on the recent direction on compensation in clinical trials in India, Gupta, stressed on the questions which were raised in the Parliament relating to clinical trial (CT) deaths. He emphasised that it is not necessary that the deaths have taken place due to the trials but it happened during the CT. Gupta highlighted various issues like compensation, 'who is the sponsor', 'what is called injury and its definition', 'who will give the compensation for negligence by sponsor or investigators?' and shared his perspective on the same. He also discussed quantum compensation formula and mentioned that

Delegates during the event

till the new formula arrives into the system this (For less than 16 years `73.59 lakhs is maximum compensation paid to for clinical trials related deaths) will remain as it is. He ended his speech with a message, 'Clarity evolves as we go along.'

Bangera talked about the importance of reporting adverse drug reactions (ADRs) and explained why there have been less number of ADRs reported.

He said that less number of reported ADRs in India that doesn’t mean that ADRs are not

happening in the country. When we have 2000+ pharmacy colleges, en numbers of nursing homes and various centres, it means that ADRs are happening but it is not being reported.

Bangera felt that the challenges in the public health programmes are basically disease management by the public health providers, not always well diagnosed clinically.

Treatments are often initiated in the absence of an adequate diagnosis and there are many insufficient follow

ups of patients.

Highlighting on fake drugs monitorisation, which can also play an important role in ADRs, Bangera said, “I feel if we monitor adverse events at the bottom level or grass root level, we will be able to gain more reports accurately and also gain confidence from various channels. We need to encourage patients to report the smallest side effects. Also 2D barcode, quick response codes and scratch off labels on medicines should be encouraged to stop counterfeit drugs.”

Dr Manoj Swaminathan, Global Safety Lead Global Pharmacovigilance Department, Sun Pharma said, “I was amongst the few participants who attended the two-day conference. This was my first ever participation at a DIA event. I was sceptical whether this would turn-out to be another networking platform with little or no learning.

However, I realised that my understanding was incorrect.

There were a lot of opportunities for networking. The best session on Day-one was the question and answer session with two EU-QPPVs and on Day-two was the panel discussion with big-five KPOs in India. These two sessions were the first-of-itskind in the pharmacovigilance arena and these sessions were well accepted by the audience as well.” u.sharma@expressindia.com

MARKET

CII hosts Agri Biotech conference in Chennai The event saw discussions on agriculture biotechnology’s role in enhancing productivity WITH A biotechnology policy, well-defined plans for agriculture biotechnology in the Chief Minister’s Vision 2023, and state-of-the-art infrastructure and research institutions, Tamil Nadu aims to be the hub of agriculture biotechnology R&D and the state government is seeking industry partnership for this. Addressing a conference on 'Agriculture Biotechnology’, organised by the Confederation of Indian Industry (CII) in Chennai recently HR Verma, Chairman, TIDCO Centre for Life Sciences (TICEL) Biotech Park, said, “The Chief Minister’s road map for Tamil Nadu Vision 2023 has clearly spelt out that biotechnology is going to be one of the sunrise sectors in the state and its economy.”

He said the Tamil Nadu

Industrial Development Corporation (TIDCO) and TICEL would co-operate with the Tamil Nadu Agriculture University and the Tamil Nadu Veterinary University and Forest College in various spheres of agriculture development. He said the industry could choose Tamil Nadu for biotechnology and agriculture biotechnology R&D with clear synergy with these institutions.

Verma said that Tamil Nadu, known as a 'Knowledge and Innovation hub,' would provide the infrastructure and necessary linkages as well as other support system to the industry.

The state also plan to move to the tier-II cities and partner with institutions there.

He said agriculture biotechnology research and product

Agri biotech research and product development offer opportunities for productive employment development offer big opportunities for the full and productive employment of the educated youth in the country.

S Chandramohan, President and Group CFO, Tractors and Farm Equipment and Vice Chairman, CII Chennai Zone

said that though the land availability in India to expand area under agriculture to increase production is limited there is tremendous scope to increase farm productivity. He mentioned that apart from biotechnology, we should address the constraints both from the supply side, as well as on the output side including farm extension services, credit, storage facilities bottleneck in the present APMC act etc. in a holistic manner.

While the agriculture biotechnology could play a big role in enhancing the productivity, our spending on agriculture research is very low compared to other countries and the farmers have apprehensions in use of this technology. Effort should be made at the grass root level to link the researchers, agri univer-

sities, farmers and the industry to inculcate confidence in the farming community in use of this technology.

Dr MD Nair, Consultant Biotechnology, Chennai, said that the growth of agriculture biotechnology worldwide has been much lower than that of the medical biotechnology mainly because of the lack of specific needs, inadequate knowledge on crops and pests, fear of adverse impact on environment and inability of the users who were mainly in the unorganised sector. The conference concluded that there is a need to have effective stakeholder engagement to address the various issues of the agribiotechnology sector.

EP News Bureau-Mumbai

MARKET

Shin-Etsu conducts technical seminars in Bangalore and Hyderabad First session focused on 'Solid Dispersion' and second session on 'Tableting and Coating

SHIN-ETSU recently conducted technical seminars in Bangalore and Hyderabad.

Around 106 delegates participated in the seminars.

Delegates from Dr Reddy's Lab, Aurobindo, Novartis, Strides, Himalaya, Biocon, Syngene and Micro Labs took part in the seminar. The audience comprised Presidents R&D, Senior Managers R&D, Managers R&D and Senior Scientists.

The seminar was divided in two sessions, where the first session focused on 'Solid dispersion' and second session on 'Tableting and Coating'. Dr Hiroyasu Kokubo, General Manager R&D, ShinEtsu Japan, gave a presentation on 'Aqoat in Solid Dispersion' and Dr Katrina Paulsen, Application Specalist Pharma from Thermofisher Germany discussed on 'Hot Melt Extrusion-Introduction and Formulation Development'. Academic lectures were presented

by Dr Vinay Rao in Bangalore and Dr Padma V Devarajan in Hyderabad. The first session saw participation from polymer, equipment and academic industry.

The second session was on 'Tableting and Coating.'

Miyuki Fukasawa, Technical Manager, Shin-Etsu Japan, gave a presentation on 'L-HPC a functional disintegrant' and 'Effect of Hypromellose parameters to the drug release in Matrix formulation using Metolose SR.' Under the LHPC presentation Smart EX, a new product was launched.

Quick disintegration of Smart EX tablets was also demonstrated to the audience, which was well appreciated by them. Under the Metolose SR presentation, Fukasawa covered QBD approach with

22 EXPRESS PHARMA April 16-30, 2014

Bangalore seminar

Hyderabad seminar

Metolose SR, which was well accepted by all the delegates.

Nitin Bhusane, Technical Sales Manager, Shin-Etsu India, spoke about 'Enteric coating using Shin-Etsu products. Bhusane mentioned that looking at the response

of these seminars and considering the overall situation of the Indian pharma industry, Shin-Etsu would like to have more such activities in the near future.

EP News Bureau-Mumbai

MARKET

NIPER’s conference on ‘Drugs for the Future: Infectious Diseases’held in Hyderabad Saw participation from 450 delegates and more than 50 members from the pharma industry

A CONFERENCE on 'Drugs for the Future: Infectious Diseases' was recently held at National Institute of Pharmaceutical Education and Research (NIPER), in Hyderabad. The theme for this year's conference was 'Antimicrobial Drug Discovery: Challenges and Perspectives'.

The conference saw participation from 450 delegates and more than 50 members from the pharma industry. They participated and presented their research papers through poster and oral presentations. Delegates from various renowned companies including Novartis, Daichi Sankyo, TCS, Suven Life Sciences, USP, Aurigene, Dr Reddy's Laboratories, GVK took part in the event. The conference had speakers and participants from all the inter disciplinary areas of infectious diseases research which included chemists, biologists and clinicians.

Dr Ahmed Kamal, Project Director, NIPER Hyderabad, initiated the proceedings of the conference. Talking about the conference, he emphasised on the unmet medical need in the area of infectious diseases like TB, malaria, AIDS, dengue and other bacterial infections due to widespread emergence of the resistance.

He thanked the distinguished key opinion leaders who had gathered to participate in the meeting and discuss the challenges and way forward.

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MARKET The Chief Guest, Dr A Venkateswarlu, Director, Dr Reddy’s Institute of Life Sciences, Hyderabad in his remarks has expressed concern for the decline in the interest of pharma majors to pursue research in these areas due to business challenges. Dr TS Balganesh, Distinguished Scientist, CSIR, in his keynote address, detailed the gathering about the trends in TB research in India. He also mentioned about the need for active participation of public research institutions and government agencies, in this area to overcome the current challenges.

Other eminent speakers in the conference included Prof V Nagaraja, Dept of Microbiology & Cell Biology, Indian Institute of Science, Bangalore; Dr JN Agrewala, Chief Scientist, Institute of Microbial Technology (CSIR), Chandigarh; Anu Acharya, Chief Executive Officer, MapmyGenome, Hyderabad; Dr D Srinivasa Reddy, Senior Scientist, NCL-Pune; Prof PP Singh, Department of Pharmacology and Toxicology, NIPER Mohali, SAS Naga; Dr SK Puri, Acting Director, Central Drug Research Institute (CSIR), Lucknow; Prof Diwan S Rawat, Department of Chemistry, University of Delhi, New Delhi; Dr Gopalakrishnan Bulusu, Principal Scientist, TCS Innovation Labs, Tata Consultancy Services, Hyderabad; Dr Cecilia Dayaraj, Scientist E, Deputy Director, National In-

24 EXPRESS PHARMA April 16-30, 2014

Dr A Venkateshwarlu addressing the august gathering

Welcome address by Dr Ahmed Kamal, Project Director, NIPER- Hyderabad

Distinguished invited speakers

stitute of Virology, Pune; Dr Ajith Vasudevan, Novartis Healthcare; Dr Mahesh Patel, Director, Wockhardt Research Centre, Aurangabad; Dr Sitaram Kumar, Former

Head, Biology, Panacea Biotech, Mohali; Dr Hoshahalli Subramanya, Senior Vice President, Aurigene Discovery Technologies; Dr Biswajit Das, Senior Director, Chem-

istry, Daiichi Sankyo India Pharma, Gurgaon, Haryana; Dr RS Paranjape, Director, National AIDS Research Institute, Pune; Prof Benu Dhawan, All India Institute of

Medical Sciences, Ansari Nagar, New Delhi; and Dr Rama Sivasubramanian, Novartis Healthcare, Hyderabad.

EP News Bureau-Mumbai

MARKET

Nutrition and Science 2014 concludes on a healthy note Attended by national and international nutrition experts, it focussed on nutritional requirements for all the age groups and possible impact of lack of nutrition on overall health

Sachin Jagdale Mumbai UNHEALTHY EATING habits can lead to the onset of some kind of disease.

Nutrition and Sciences 2014 conference, held in Mumbai recently, focussed on the nutritional requirements for all the age groups and possible impact of lack of nutrition on overall health. Many national and international experts in the field of nutrition revealed different aspects of nutrition and nutritional products at the conference.

The conference also had sessions dedicated to discuss regulatory compliance. In India, getting regulatory clearances has also always been a time consuming process.

Therefore experts debated on clarification of Food Safety and Standards Authority of India (FSSAI) policies and implementation guidelines to ensure regulatory compliance, harmonisation with the industry and smooth product approval process.

Speakers covered a wide

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MARKET range of topics during the conference. Dr Dilip Ghosh, Director, Nutriconnect, Sydney, Australia, revealed very important facts associated with antioxidants. He also talked about misconceptions associated with them. The overall market for antioxidants was valued at $86 billion in 2016. Ghosh talked about recent product developments in medical foods for metabolic disorders / nutritional insufficiency and neurodegeneration.

industry, government policies and consumer beliefs and behaviours about nutrition. A scientist’s point of view is largely governed by objective, peer reviewed science.”

Prabodh Halde, VP AFST(I), Head-Regulatory, discussed regulatory challenges related to global scientific developments in ingredients and nutrition categories. Halde stressed on the need for positive participation with the authorities for regulation making.

EVENT BRIEF MAY 2014 4

Respiratory Drug Delivery (RDD) USA 2014

RESPIRATORY DRUG DELIVERY (RDD) USA 2014 Date: May 4-8, 2014 Venue: El Conquistador Resort, Fajardo, Puerto Rico Summary: The symposium will present latest advancements in human genomics, drug design and delivery technologies, drug development, in Vitro and in Vivo testing methods, and regulatory science through podium sessions and debates; scientific poster sessions; technology exhibition and workshop sessions. Academic, industrial and regulatory scientists involved in the development, investigation, preparation and delivery of existing and therapeutic entities by inhalation will attend the symposium. RDD Online with support from Aptar Pharma will organise the event.

Contact details Joanne Peart E-mail : info@rddonline.com Website: www.rddonline.com

Dr K Madhavan Nair, Scientist-F, National Institute of Nutrition (ICMR), Hyderabad spoke about effectively incorporating science in policy making and implementation to promote the growth and sustainability of the nutrition industry. He said, “We eat what we buy and decisions about what we buy are heavily influenced by food

26 EXPRESS PHARMA April 16-30, 2014

As commonly assumed, microbes may not always be harmful to the human body.

Humans and bacteria have a symbiotic relationship.

Ravi Menon, The Bell Institute of Health & Nutrition, General Mills, Minneapolis, MN, USA, spoke about gut microbia and their role in nutrition. sachin.jagdale@expressindia.com

DISSO ASIA 2014 Date: May 5 - 6, 2014 Venue: Mumbai Summary: Society for Pharmaceutical Dissolution Science (SPDS) will be conducting its 2nd Annual International Convention DISSO ASIA 2014. The event will promote introduction of new technology, innovation and would have deliberations on

5

DISSO Asia 2014

various issues faced related to dissolution. DISSO ASIA 2014 event will witness eminent professionals from the pharmaceutical industry.

The event will have plenary lecture, poster exhibits and panel discussions. Around 200-250 delegates will participate in this event.

Contact details Society for Pharmaceutical Dissolution Science Dept of Pharmaceuticals Bombay College of Pharmacy Kalina, Santacruz (East) Mumbai – 400098 Tel: (022) 26670871 Email: scientific.committee @spds.in Website: www.spds.in

SEMINAR ON MANAGING RISKS FOR QUALITY COMPLIANCE 2014 Date: May 16, 2014 Venue: Mumbai Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Technical Subcommittee will organise a seminar on Managing Risks for Quality Compliance 2014.

Experts in technology, quality assurance, regulatory affairs, engineering, production and packaging spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

Dr K Bangarurajan, Deputy Drugs Controller (India), CDSCO West Zone (Mumbai) will give the keynote address on ‘QRM Requirements of WHO’; Bharat

16

Seminar on Managing Risks for Quality Compliance 2014

Doshi, Pharmaceutical Consultant, will peak on ‘Risk Free Facility Design for efficient QRM’; SM Mudda, Executive Director,Technical & Operations- Micro Labs will speak on Managing Operational Risks for Quality Products; R Raghunandanan, Pharmaceutical Consultant, will speak about ‘Managing Risks in Quality of Aseptic Operations’; RR Tuljapurkar, Vice President, Quality Assurance, Zydus Cadila, will speak on ‘Controlling Risks in Quality Control’; R Dadich, Vice President,Corporate Quality, IPCA Laboratories will speak on 'Quality Materials for Quality Products-Controlling Risks.’

The seminar is designed to cater to all those involved in pharmaceutical industry, bio-pharmaceutical industry, academic institutions; business consulting companies, facility design and materials management.

Contact details Indian Drug Manufacturers’ Association 102B, A Wing,Poonam Chambers, Dr Annie Besant Road, Worli, Mumbai – 400018 Tel: +91-22-24944624/ 24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Web: www.idma-assn.org

CONTRACT MANUFACTURING 2014 Date: July 11, 2014Venue: Hotel Hilton, Sahar, Mumbai

MARKET Summary: Indian Drug Manufacturers’ Association (IDMA) and IDMA Contract Manufacturing Subcommittee will organise the 1st conference on Contract Manufacturing 2014. The main theme of this conference is ‘360 degrees of Contract Manufacturing.’

Eminent experts in contract manufacturing, research, and regulatory spheres from the Indian pharmaceutical industry will converge and interact on various recent developments.

Contact details Indian Drug Manufacturers’ Association 102 - B, 'A' Wing, Poonam Chambers Dr Annie Besant Road, Worli Mumbai – 400018 Tel: +91-2224944624/24974308 Fax: +91-22-24950723 Email: ppr@idmaindia.com Website: www.idma-assn.org

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014Venue: Amrita Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference which aims to make a ‘industry-scientistsacademics’ collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including nobel laureates/ scientists/ researchers/ students and professionals from academia and industries from all over the country and abroad. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry,

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pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact details Dr P K Krishnan Namboori Asso. Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014

Computational Chemistry Group (CCG) Computational Engineering and Networking AMRITA Vishwa Vidyapeetham-Amrita UniversityAmritanagar, Coimbatore - 641 112 Tel: (0422) 2685000

(Extn: 5592) Email: aicadd_2014 @cb.amrita.edu / aicadd2014 @gmail.com Website: http://www.amritaccg.inConference URL: http://www.amritaccg.in /aicadd2014

cover )

What policy changes should be on the next Prime Minister's Agenda in order to re-vitalise the pharmaceutical industry in India? How can we as a country achieve the 3 As of healthcare: Affordability, Availability and Access? Express Pharma asks thought leaders to share their recommendations

30 I SHOBHA MISHRA GHOSH Sr Director, Federation of Indian Chambers of Commerce and Industry

31 I RANJANA SMETACEK Director General, Organisation of Pharmaceutical Producers of India

32 I D A PRASANNA Chairman, Association of Clinical Research Organizations

33 I GLENN SALDANHA Chairman & Managing Director, Glenmark Pharmaceuticals

34 I KIRAN MAZUMDAR-SHAW Chairman & Managing Director, Biocon

35 I RANJIT SHAHANI Vice Chairman & Managing Director, Novartis India

36 I DR ARUN GARG General Secretary, Indian Pharmacy Graduates’ Association

37 I SAKTHIVEL SELVARAJ Senior Health Economist, Public Health Foundation of India

28 EXPRESS PHARMA April 16-30, 2014

( (

T H E M A TI N H EF O MCAUI N S

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There is a need to develop a comprehensive vision for the pharma industry in sync with the healthcare delivery system Shobha Mishra Ghosh Sr Director, Federation of Indian Chambers of Commerce and Industry

I

ndia’s pharmaceutical industry, which is estimated to be approximately $26 billion, has made us all proud. We are the world leader in generic pharma production, supplying 20 per cent by value of the global market. Further, India accounts for eight per cent of global production and is exporting to over 200 countries. According to DIPP, Indian drugs and pharmaceutical industry has attracted $11.30 billion worth FDI in the period 2000-2013.

Access and availability of affordable quality medicines is the backbone of universal health coverage. As we all know, in the 12th Plan the government has moved towards implementing UHC and the pharma industry will play a critical role in achieving this ambitious goal.

The Indian pharma industry supported by the government has done well by establishing ourselves as the largest maker of finished generics, available at affordable prices. Today, more than 65-70 per cent medicines in the WHO-prequalified list of medicinal products belong to Indian manufacturers in the

30 EXPRESS PHARMA April 16-30, 2014

segments of HIV-AIDs, tuberculosis, malaria, reproductive health and other categories.

Both developed and developing countries import our drugs by virtue of which we are known as the ‘pharmacy of the world.’

Having said that, we still have the challenge of making drugs for chronic diseases and NCDs affordable for our own citizens for which innovation and R&D is crucial.

Hence to achieve the 3 A’s of healthcare, there is a need for developing a comprehensive vision for the pharma industry in sync with the healthcare delivery system. The three key areas that the country needs to focus on are:

Foster the quality agenda for API among manufacturers The quality of Indian medicines should meet the international standards including Global Manufacturing Practices (GMP) for the domestic as well as export markets. However, some of the recent events have bought to the attention the need for incentivising and promoting quality practices in the API

manufacturing in India. There is a need to foster the quality agenda for API among manufacturers including capacity building workshops and Government initiatives for incentivising API production. Some specific issues to be resolved are: ❑ The existing Indian GMP (schedule M + guidelines) should meet the international standards. ❑ The issue of shelf life requirement of minimum 60 per cent for API for Import under Advance Licence scheme ❑ Transfer of API to other Indian companies i.e. Finished formulation manufacturer for product development, solely for export As a beginning to build capacity and develop common understanding of standards amongst the regulators and Indian pharmaceutical manufacturers, the Department of Pharmaceutical (DoP), GoI in partnership with WHO Country Office for India and FICCI organised three Regional Good Manufacturing Practices (GMP) Strengthening Workshops,

focusing on GMP in production of Active Pharmaceutical Ingredients and Oral Solid Dosage forms at Hyderabad, Ahmedabad and Chandigarh.

Further, FICCI also organised an industry meet with the visiting US FDA Commissioner, Dr Margaret Hamburg to bring in common understanding between the US FDA, the Indian regulator and the industry. Many more such interactions are needed to keep the dialogue ongoing between the international and national regulators and the Indian pharma industry.

Create an ecosystem for spurring R&D and innovation in India India is facing the increasing burden of both communicable and non-communicable diseases. According to a global study, in 2010, non-communicable diseases account for 53 per cent of all deaths and 45 per cent of disability adjusted life years (DALYs). Affordable access to generic medicines would be needed for treating diseases like cardiovascular diseases, diabetes, asthma, cancer

both in India and around the world. The global industry is highly research intensive and spend around 15 per cent turnover in R&D, however, in India it’s still low with less than two per cent spending. Although the Indian private players have recently increased investments in R&D, however, the focus is on the thriving generics business instead of new drug discovery.

As a global player we need to remove this weakness in the system.

Some specific recommendations to spur R&D are: ❑ Set up a ‘National R&D Observatory’ in India: The Observatory will provide technical support to establish a system to monitor R&D investments and pipelines, recognising the considerable gaps that exist. ❑ Regulatory reforms for developing new drugs should be based on scientific knowledge, simplified and transparent procedures for speedy approvals ❑ To ensure flow of funds the weighted tax deduction needs be raised from 200 per cent-250 per cent and should be extended to clinical trials as well

( ❑ There should be grants

for advanced skill development programmes ❑ Exemption from excise/ custom duties on raw materials, capital goods and diagnostic kits should be extended

Create a common understanding of Clinical Trials landscape in India For the new drug discoveries, clinical trials are a must and there is an urgent need to revive the sector to address the burden of existing and new diseases.

India had been a favoured destination for clinical trials in the recent past due to large patient pools, trained physicians well versed in English language, hospitals with modern infrastructure and laboratories etc. However, as we all are aware, the recent Supreme Court rulings have reversed the trend. To address this, the Government has introduced several initiatives to streamline clinical research in the country viz. publication of Indian Good Clinical Practice Guidelines Bio Availability-Bio Equivalence (BA-BE studies) study guidelines, regulatory inspections, introduction of Clinical Trials Registry etc.

However, there are several issues pertaining to BA-BE studies, compensation packages, long processing time due for approvals etc. that needs to be streamlined for reviving clinical trials in the country. Also there is a need for a comprehensive industry-academia mechanism that would result in outcomes with patient benefits at the core of the drug research. And most importantly create awareness amongst judiciary, media and civil societies in order to enable them to take informed decisions.

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in the grant of patents.

he Organisation of Pharmaceutical Producers of India (OPPI) represents the research-driven pharmaceutical companies in India and is committed to working with the Indian Government to meet the nation’s healthcare challenges and find innovative solutions to address those challenges. OPPI looks forward to making a significant contribution by partnering with the Indian Government and other stakeholders to find sustainable solutions to increase healthcare access in India.

A holistic approach, that balances the need for innovation with the necessity for more accessible medicines within a robust IP environment, is needed to re-vitalise the Indian pharma industry. On behalf of the research-driven pharma industry, we would like to propose the following policy recommendations for the Government’s consideration.

c.Patent linkages OPPI believes that patent linkages will help India safeguard the rights of legitimate patentees. In India, marketing approval is sought from the Drug Controller under the Ministry of Health and patent approval is granted by Indian Patent Office. Currently, they are not interlinked which is detrimental in protecting the rights of a legitimate patentee and this has been used to violate patent rights.

The top five areas are: 1.Strong IPR protection OPPI believes that strong patent laws will encourage, stimulate and sustain innovation in the research-based and technology-intensive pharma industry. Adherence to and implementation of world-class patent laws will encourage foreign direct investment and technology transfer, stimulate local research by Indian and international companies and benefit the Indian pharma industry, as well as the people of India, leading to the availability of newer and better medicines. There is a huge unmet need in cancer, in diabetes, in mental illnesses, for which we need to continue research to bring in innovative drugs. a. Patentability OPPI believes that, apart from NCEs, all other forms should be patentable as long as they meet the criteria of patentability such as novelty, non-obviousness and commercial applicability. Section 3(d) of the Indian Patent Act restricts patents for incremental innovation unless there is

A healthier India will be a more productive India Ranjana Smetacek Director General, Organisation of Pharmaceutical Producers of India

therapeutic advantage and greater efficacy, but the Indian Patent Office does not define |efficacy. This section has been misused by the courts and the Indian patent office because it allows for a subjective interpretation. b. Pre and post grant opposition Opposition before and after filing of an application for a

patent have been introduced, allowing oral hearings.

Opposition can be filed any time after the date of publication of the patent application till the date of grant. OPPI does not approve of pre-grant opposition as this could result in several pre-grant oppositions being filed, causing delay in the patent granting process. In addition, serial pre-grant oppositions may cause further delay

d. Compulsory licensing Compulsory licencing should remain the exception, in order to preserve patent protection that would allow the development of additional innovative therapies for treatments.

While India should have the flexibilities available under TRIPS, including the compulsory licensing of innovative medicines, this flexibility should be used judiciously only for humanitarian, non-commercial use in treating HIV/AIDS, TB, malaria and similar diseases, and not for cancer which does not fall in the category of epidemic or communicable diseases. The Government should exercise a careful balance between encouraging continued pharma innovation and expanding access to the fruits of innovation for all patients in the country. e.Regulatory data protection (RDP) RDP is an integral part of IPR. Lack of RDP provision will be a disincentive to R&D-based companies and innovators. A committee chaired by Satwant Reddy, Secretary, Department of Chemicals and Petrochemicals, Government of India, has already submitted its report on Regulatory Data Protection.

The report is inconclusive and recommends a calibrated approach for RDP through a transition period.

OPPI has asked for a minimum of five years of RDP after grant of marketing approval in India.

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cover ) 2. Improved access to quality healthcare OPPI supports the Indian government’s quest for more accessible and affordable medicines and welcomes a more comprehensive dialogue between private and government stakeholders.

Access to medicine extends beyond the issue of cost to the proximity and functionality of the infrastructure that supports that access. More than affordability, the barrier to access is the inability to pay out-of-pocket and the lack of insurance cover. OPPI looks forward to jointly exploring with the government of India ways and means to build that infrastructure and ensure sustainable access to modern medicine at Indian healthcare centres.

We look forward to more collective CSR activity, bringing best practices and identifying and creating the critical infrastructure needed to achieve a good health development index.

This will also improve policy relationships with local, state and central government agencies through Public Private Partnerships for the long-term benefit of Indian patients and make a significant impact in India. A healthier India will be a more productive India. OPPI is committed to partnering with all relevant government agencies and regulators to help meet national healthcare challenges in the interest of patients.

3. Ethics – Uniform code of pharmaceutical marketing practices The DoP has issued the Revised Draft Uniform Code of Pharmaceutical Marketing Practices (UCPMP) on March 26, 2012 as a voluntary code of marketing practices for the Indian pharma industry, with the intent to review it six months from the date of its issue. If not implemented effectively by pharma companies, the Government was to consider making it a statutory code.

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OPPI has asked for a minimum of five years of RDP after grant of marketing approval in India We would like the Government to follow through on its intent, both to inspire confidence among patients and to demonstrate India’s commitment to a high level of ethics and compliance.

While it is important to achieve results, how we achieve them is equally important. Being a patient-focused industry, our members are committed to product safety and quality. In our interactions with the medical community, we are committed to following ethical promotional practices in our interaction with healthcare professionals and patients.

We believe there must always be confidence that prescription decisions are made ethically and to benefit the patients.

The OPPI Code of Pharmaceutical Practices 2012 is based on the model International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) code and lays down guidelines for ethical behaviour in pharma marketing. The implementation of a universal code across the industry can level the playing field and be meaningful only with the coordinated effort of all pharma companies, cooperation from the medical community and support from the Indian Government.

4. Clinical trials Clinical trials and the data they generate help doctors and pharma companies,

Indian and global, gain a better understanding of how India’s diversity responds to new therapies. Given that as the Indian economy grows, more and more people will have access to modern medicine, it is in India’s interest to encourage clinical trials, with adequate safeguards. This forms part of the research in the development of new medicines and thus a part of the intellectual property. We need policies and regulations that will build confidence among innovators (domestic and foreign) carrying out such research in India, because it will help leverage scientific talent in India and enable the country to benefit financially from its vast clinical material. We must have a robust and transparent process for the conduct of clinical trials to obtain regulatory approval for new drugs to benefit patients, while supporting the Government’s effort to create a compensation framework.

5.Adherence to regulatory guidelines on biosimilars The Government of India through its two agencies involved in the regulation of biological products viz.

Department of Biotechnology (DBT) and the Central Drugs Standard Control Organization (CDSCO) have prepared the ‘Guidelines on similar biologics: Regulatory requirements for market authorization in India.’ These guidelines clearly outline the data requirements for the production process, characterisation, preclinical studies and clinical trials of biosimilars.

Currently, pharma companies do not comply with the rules laid down in these guidelines. As an association of research based pharma companies, we seek full compliance with all applicable regulatory requirements before a company gets approval for marketing a drug in the country.

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ffordability, availability and access to healthcare requires: 1. Indian regulator to approve in a timely manner generics and biosimilars to cure, vaccines to prevent, diagnostics to identify early. Clinical trials are necessary to be conducted in India for pharma and biotech industry to bring to Indian and global market these medicines, vaccines and diagnostics. Last three years, the sector has been paralysed in the name of safety of participants in clinical trials.

While maintaining all measures to ensure global standards of

Attract highly qualified persons, offer sensible terms and conditions DA Prasanna Chairman, Association of Clinical Research Organizations participant safety, remove all hurdles for clinical research which are not in line with global practice. AIIMS-Harvard University recommendations to be adopted within 90 days.

2. Empower Drug Controller General (India) (DCGI) by making the position an independent regulator of the level of Secretary to Central Govt. Amend Drugs & Cosmetics Act to the effect. Like DBT has done, attract highly qualified persons and offer sensible terms and conditions.

3.

Responsible medical research requires MD’s Super Specialists who have deep understanding of disease and treatment. Double the capacity of PG seats in all Government Medical, pharmacy and biotech institu-

tions to have double the number of MD, M Pharm, PhD’s to become available within five years. Overcome clinical investigator shortage. MCI and UGC have come in the way of capacity creation in the last decade and prevent repetition of this mistake.

4. Invest in public health. Disease prevention will get a big boost if solid waste removal is brought to global standards to improve sanitation. Adopt Surat experiment.

5. Globally pharma industry is transforming from a chemical industry to a biologics industry. Incentivise Indian pharma to transform and build a significant biologics portfolio.

These are ACRO’s top five recommendations for clinical research.

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t is said that the wealth of a nation depends on the health of its citizens. But ironically, the healthcare and pharmaceutical sectors in India have not been given the level of importance it deserves by the government.

The result is: Healthcare in India is plagued with several challenges that need immediate attention. The most critical aspect among these is ensuring quality, affordability and accessibility of medicines and treatment to the patients at all times.

Despite improvements in the recent past, the healthcare sector continues to suffer because of poor policy implementation and underfunding.

The government will need to play a key role to drive India’s healthcare.

The first step to achieving the 3 A’s of healthcare (affordability, availability and access)

The Government needs to treat discovery R&D separately and incentivise organisations that are making progress in this area

is to increase the healthcare funding and reform the healthcare system for the optimum utilisation of resources.

India faces a major challenge in providing access to medicines for its 1.2 billion plus people. While the government has addressed the pricing issue through the new

pricing policy, the accessibility and quality aspects, especially for lower income groups in the country remains largely unanswered.

The solution to addressing the issue of affordability and accessibility lies in innovation coupled with collaboration between the government, industry, academia NGOs and other stakeholders.

As India unfortunately leads the world in terms of share of disease burden, innovation leading to new drugs is critical if we are to address unmet medical need in the country. Existing drugs will continue to be important in meeting the growing demand for healthcare, particularly with the increasing use of generic medication. At the same time, advances in disease understanding and the application of new technologies will be required to ensure the delivery of new medicines.

The Indian Government needs to implement favourable policies that enhance innovation and drive collaborations, besides addressing issues in critical building blocks like talent and infrastructure. The Government’s support for innovation R&D is required in the form of tax incentives, regulations and grants for various research projects in the sector.

The Government should work to make India the hub for discovery research and development, which can usher the same change that software brought to the country in the late 1990s and early 2000. This has the potential to create thousands of new jobs while discovering new cures for various diseases.

The Government needs to treat discovery R&D separately and incentivise organisations that are making progress in this area, as investment for taking a single molecule to market runs into millions of dollars; not to mention the high chances of failures.

The public-private partnership (PPP) model is the best way to harness India’s

THE MAIN FOCUS

The Indian Government needs to implement favourable policies that enhance innovation and drive collaborations Glenn Saldanha Chairman & Managing Director Glenmark Pharmaceuticals

innovation capability and the Government should take steps to promote PPP in innovative research projects.

The Government also needs to strengthen and increase capital outlay for academic institutions engaged in scientific research. R&D awards for scientific innovation would also be a major boost.

Contract manufacturing which is a key growth driver for the pharma industry should receive tax benefits by way of profit- linked incentives. Clearly, the time is now.

India has the potential to graduate from a cost-competitive destination to a land of innovation. Government intervention and support will play a huge role in making this aspiration a reality.

Pharma companies, Government and other stakeholders must understand that innovation calls for prolonged gestation periods and a longterm vision. At Glenmark, we strongly believe in innovation and have continued to invest aggressively in drug discovery research over the last 14 years. While Indian companies like Glenmark are making headway in innovation, but it is still a long way off to benchmark or set a global level. High capital investment is always a hindrance. This is where the Government needs to step in and provide significant incentive for innovative R&D and boost the efforts of research based pharma companies.

As pharma and healthcare are critical sectors and involves long gestation and capital intensive ventures, a long standing demand has been to accord ‘priority status’ to them just like infrastructure.

This will act as a catalyst for not only attracting funds, but will also provide gainful employment to millions of Indians. We hope that the new Government fulfills this aspiration of including pharma and healthcare in priority sectors.

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s India counts down to the start of the 2014 general elections, there is hope all around that these elections will usher in a stable majority government at the Centre. In keeping with the winds of change, the new Government that comes to power will be expected to articulate innovative solutions to tackle age-old challenges, especially in a critical area like healthcare.

In attempting to fulfil the needs of ‘affordability’, availability’ and ‘access’ for its citizens, the new government has an opportunity for creating a system of universal healthcare that can set a global benchmark.

The next Prime Minister needs to urgently address these following issues as part of his healthcare agenda: FDI in pharma: The FDI policy on pharma needs to revert to the previous regime that allowed automatic infusion

India should grant data exclusivity on all patented drugs for four years from the date of launch or until expiry of molecule patent, whichever is earlier

of foreign equity of up to 100 per cent in both greenfield and brownfield projects, so that it’s not left to the government’s discretion to introduce riders for clearing investment proposals.

IPR: India must clearly enunciate the rules governing patentability for pharmaceutical products. We should stick to our stand on IP laws that discourage

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ever-greening of patents.

Moreover, patent laws should establish the importance of practicing patents in India for seeking protection and not ‘squatting’ on patents e.g.

Bayer’s Nexavar case.

Also, India should grant data exclusivity on all patented drugs for four years from the date of launch or until expiry of molecule patent, whichever is earlier.

The government should not restrict drug substance or drug product development during the period a product is under active patent protection. Instead it should ensure that no marketing approvals are granted to copies until patent expiry.

Pricing policy: The government can’t expect the industry to bear the full burden of making medicines affordable, and should thus remove generic drugs from price control. In light of the healthcare challenges faced by developing countries with a large patient pool, innovator companies need to re-look at their business models for India. For imported patented drugs, MNCs need to evolve a pricing mechanism that is linked to purchasing parity and price their products at par with the lowest discounted price offered in global markets. The Indian Government, on its part, should raise its healthcare spending to three per cent of GDP so that it can fund schemes aimed at lowering the healthcare burden of the poor.

Clinical trials: The government should lift the prevailing moratorium on clinical trials. Moreover, it should re-look at some of the recent changes brought in to strengthen the monitoring of clinical trials as they could end up deterring drug innovation in India.

Mandatory video recording of free consent of patients to be part of a trial is one such requirement. Videography is doable for small clinical trials but impractical when there are thousands of patients involved like in vaccines trials. Similarly, guidelines should be rationalised to ensure that patients become eligible for compensation from the sponsor only when a direct link is established between an adverse event and the trial.

The new Government has an opportunity for creating a system of universal healthcare that can set a global benchmark Kiran Mazumdar-Shaw Chairman & Managing Director, Biocon

Irrational clinical trial guidelines will scare away innovators from India and irretrievably hurt India’s ability to partake in new drug development.

Incentives to spur R&D and SEZ benefits: To spur investment in research and development, the government should extend the current benefit of per cent weighted tax deduction on all in-house R&D spends to international patenting and overseas R&D expenditure. The government should grant a 100 per cent tax free status to biotech SEZs with an aim of incubating biotech companies and propagating R&D. In fact, in addition to the five-year tax-free status normally granted to SEZs, biotech SEZs deserve tax exemptions for two additional years to ensure that the time taken for obtaining regulatory approvals for products developed at the units is also accounted for.

International trade-related issues: As India is already one of the world’s leading manufacturers of generic drugs and vaccines at the lowest cost, all Government tenders should give preference to indigenously manufactured pharma products, like in the case of vaccines. In fact, the Government must exclude imported drugs from tenders except in cases of drug shortage.

This will improve the manufacturing efficiency through economies of scale as well as save the exchequer import dollars.

Import duty on pharma machinery: To provide a boost to local biotech and pharma companies, the Government should exempt all manufacturing and R&D equipment from import duty. The Government should also provide incentives to create large-scale pharma and bio-pharma manufacturing facilities, which in turn can attract large foreign investments.

Year 2014 can be a year of positive change if the new government can show the political will and provide effective administration to make healthcare accessible and affordable for millions of needy Indians.

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The first thing that should be done is to accord healthcare infrastructure status

Ranjit Shahani Vice Chairman & Managing Director, Novartis India

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f f o r d a b i l i t y, availability and access are becoming increasingly important particularly in the context of healthcare. The pharma industry is going through challenging times and with elections currently going on there is hope that the next Prime Minister and his/her Government will have healthcare high up on the agenda.

The first thing that should be done is to accord healthcare infrastructure status. Once that happens much else will fall into place.

India spends just 1.2 per cent of GDP on healthcare with scant attention paid to healthcare financing, infrastructure, environmental and societal factors that impact access. The new Government should increase healthcare

spend to at least three per cent of GDP to ensure universal health coverage.

We at the research -based pharma industry would certainly like to see a more predictable environment – one that encourages innovation. Over the past two years, there have been several IP decisions that have disproportionately impacted innovative pharma companies. This coupled with the constant threat of compulsory licensing needs to be addressed speedily.

Introducing research tax credits which can be used to offset future tax liability along the lines of existing systems in developed economies will be useful in spurring research by the local pharma industry.

According benefits to units engaged in R&D and

The Govt should coordinate better with industry and other stakeholders to ensure that the processes in place for approving and conducting clinical trials are robust

exempting income generated from utilisation of IP will also serve as an impetus. Recently, the Government moved away from 100 per cent FDI through the automatic route and the planned enabling of the Competition Commissions as the approving authority for pharma FDI remains pending.

Higher FDI will be to the longterm interest of the patient for funds are very much the need of the hour to provide a fillip to the healthcare sector.

Needless to say all life-saving drugs should be completely free of any import and other duties to help broaden access. Government should partner with industry to make medicines available to economically weaker sections of society while allowing market forces to influence pricing for

the rest of the population.

Clinical trials have all but come to a standstill with the limited understanding reflected by sections of society including the media.

We would like to see Government coordinate better with industry and other stakeholders to ensure that the processes in place for approving and conducting clinical trials are robust but not overly burdensome.

Also, clinical trials should be accorded priority status such that all expenses linked to trials at approved hospitals are eligible for weighted deduction.

All stakeholders in the realm of healthcare share a common goal of healthcare for all. We need to work together to make this happen.

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ntellectual Property Rights (IPR) in India enjoy a very good status altough it has been criticised a lot by the US officials. The US pharmaceutical companies have demanded that India should amend its patent laws by eradicating Section 3d altogether.

Also, pressure is being created on Indian Health Ministry to not consider drugs for compulsory licensing.

Through the decision of Gleevec case the Supreme Court and the Indian Government has clearly indicated that pharma companies cannot take Indian patent laws for granted. The public health advocates, charitable groups and NGO’s appreciate the decision.

Certain zones have been created in the country, as a result there has been enormous socio economic development of those regions.

More such tax free zones are required in the Northeastern states but the Government should keep in mind that they are in close proximity to research institutions

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companies to boost up their research facilities, India has failed to develop a good research environment in this sector. I believe the sole reason is lack of quality of higher education, as a result we are not generating good researchers in drug research. A complete overhaul is required in this. Industrial research should go hand-in-hand with institutional research and incentives should be given to such industrial-institutional collaborative programmes. Furthermore, there should be a separate agency exclusively for drug research on the line of DBT or DST, ICMR, CSIR where disbursement of funds will be processed to the institutions involved in pharma education exclusively.

Also, the Indian Supreme Court and IPAB takes decisions not only from industry perspective but also keeping in mind poor Indian patients. It is significant to note that many poor patients of underdeveloped nations rely on India for the supply of cheaper versions of latest treatments for HIV and other diseases.

On the contrary, after the decision, the pharma companies would not be very comfortable in launching new drugs in India.

They have become more concerned about the environment for innovation and investment in India. The general view point of the pharma companies is that the patent rulings in India have favoured generic producers.

If the Government continues to keep a unaffected image towards MNCs as seen with Gleevec and Nexavar (compulsory licensing) case, we are definitely going to lose intellectual uprgadation which these MNCs may provide by opening up their Drug Research Programme in India.

Incentives to spur R&D; and benefits of excise free zones Certain zones have already been created in some parts of the country in the past. As a result there has been an enormous socio economic development of those regions for eg. Baddi, Bhiwadi etc. More such tax free zones are required in the Northeastern states but the Government should keep in mind that they are in close proximity to some good research institution. India has no dearth of manpower and if policies of the Government are to promote production and export of drugs then there is no reason that we cannot think that we will be the number one supplier of generic drugs to the world market. But on the same side, we must ensure the quality of our products.

In order to ensure the quality, strict checks are required.

Unfortunately, we don’t have the required number of staff with our drug control department to ensure this. Despite of the huge initiative given to the pharma

Clinical trials

There should be a separate agency exclusively for drug research on the lines of DBT

Dr Arun Garg General Secretary, Indian Pharmacy Graduates’ Association

The clinical trials industry, which analysts have previously dubbed as the ‘sunshine sector’ and perceived as a potentially upcoming segment, is at a crossroads today. Among its many challenges is the lack of a standardised and balanced regulatory structure, along with an increasing number of datacompromise allegations.

Clinical-trial approvals have faced significant delays, which has led to a scenario where the very future of the industry is now uncertain.

Various factors contribute to this uncertainty. For instance, the Drug Controller General (India) (DCGI) usually takes 12 to 16 weeks to approve trials as against six to eight weeks in the US. The industry is also becoming progressively competitive, with countries such as China, Korea and Singapore emerging as fierce competitors. Meanwhile, MNCs are reportedly lowering their budgets while focusing on bringing drugs to the market quickly.

Manufacturing is becoming the key focus of most companies, and CROs (especially CMOs) could benefit from this development. The decline in clinical trials in the US has led to an increase in trials across emerging countries.

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Stringent regulatory measures are required to reign in inessential medicines

Sakthivel Selvaraj Senior Health Economist, Public Health Foundation of India

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he next Government in Delhi must ensure the following in order to realise the goals of access to affordable medicines in India. Being a ‘Global Pharmacy of the South’, the Government must put in place mechanisms to make sure our p u b l i c procurement is made efficient and effectively deliver rational, good quality generic medicines. Our key recommendations for the upcoming government are: 1. Both the Central and the State Governments in India must allocate 0.5 per cent of its GDP for procuring essential medicines. This is expected to reduce the household misery of paying out-of-pocket substantially.

2. Drug procurement and distribution should be modeled on the lines of TNMSC/RMSC (Tamil Nadu Medical Services Corporation/Rajasthan Medical Ser-

vices Corporation). This is based on ‘centralised procurement and decentralised distribution’ or ‘pooled procurement model.’

3. Scrap the new DPCO, 2013 (Drug Price Control Order). It should be replaced with a new DPCO, that must be based on a broad-based on an updated and a thoroughly revised National List of Essential Medicines. The new DPCO must anchor its price ceiling based on cost-plus based pricing rather than market based pricing. The cost-plus based pricing should be made transparent, non-intrusive and provide adequate incentives for continued investments.

4. India has a large-scale therapeutic jungle. Several banned, bannable and inessential medicines thrive in the market. Stringent regulatory measures are required to reign in these inessential medicines.

Almost 47 per cent of India’s

Future investment in pharmabrownfi eld should remain outside the ‘automatic’ route. Investors must be required to bring in matching grants of equal proportions to the value of the investment

market is composed of Fixed Dose Combinations, where only a handful of them are considered essential globally. The new Government must ensure that these are weeded out at the earliest, to make medicines safe, efficacious and cost effective.

5. Strengthen drug quality mechanisms in both central and state governments. This is required to eliminate sub-standard drugs from the market.

However, ensure that big pharma companies do not conflate the quality issues with IP regime, by labelling Indian generics as spurious.

6. Resist international pressure on revising India’s current patent regime. Safeguard and protect patients’ health by making medicines affordable. Liberal use of compulsory licensing provisions in the Indian Patents Act and stringent use of Clause 3 (D) which should disallow frivolous patents.

7. Revise foreign direct investment policies in pharma sector to stem the rising tide takeover of India’s topline pharma companies. Future investment in pharmabrownfield should remain outside the ‘automatic’ route. Investors must be required to bring in matching grants of equal proportions to the value of the investment.

The matching grant must be required to be invested in augmenting/expanding production capacities and research and development activities. Obligations for local manufacturing of finished products and investment in API production should be imposed. In several verticals, where the current market reflects a monopoly/ oligopoly scenario, where very few players exist, brownfield investment must be disallowed. And this list would include vaccines market, injectibles, API, rifampicin, erythromycin, ARVs, oncology market, biosimilars, etc.

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Indian political parties are busy wooing voters with myriad promises for the General Elections 2014. Yet healthcare, a vital issue, once again fails to get its due in the campaigns and manifestos of the various parties

BY SACHIN JAGDALE

orld’s largest democracy, India, is now in the midst of election fever. Political parties are going all out and decorating their manifestos with all kinds of promises. However, despite being a crucial sector, political parties haven’t given due priority to healthcare in their agenda. Yet, the industry has pinned a lot of hopes on the next Prime Minister as he is always at the helm of affairs.

India has more than a billion population, with different kinds of healthcare needs.

Moreover, a major portion of this population is constituted by sections of the society that cannot afford expensive healthcare. Yet, statistics reveal that Indian population consumes medicines worth a few billions rupees every year, most of it comprising out-of-pocket spending. So, politicians sidelining healthcare needs is likely to have a negative impact on the industry’s growth.

“Unlike in the developed world, health and education topics are the least debated.

Parties have namesake manifestos on these subjects. Affordability and accessibility of medicare should be debated. Citizens should be well informed about the initiatives and improvements that each party will undertake. The exclusion of health from debate will have no impact on the industry as it has been customary for politicians to not consider health as an important topic,” says Dr K Anand Kumar, Deputy Managing Director, Indian Immunologicals Limited (IIL).

Jayant Singh, Associate Director, Healthcare Practice, Frost & Sullivan, opines otherwise. He says, “Correlation between the health sector as a priority area in election and impact on pharma industry is a too far-fetched conclusion. Any intervention on health policy will have a lag time of around few years before its impact starts becoming visible on the pharma industry. What the pharma industry needs is clarity on policies rather than additional policies to the existing ones.

Ambiguity or lack of decisiveness on issues like pricing, M&As, threat of cheap imports from China in bulk drugs, nontrade barriers hurting our exports are some of the issues for which we don’t require new policies. Clarity on current policies along with some amendments in current policies should be able to take care of the immediate problems plaguing the pharma sector.”

Singh adds, “Long-term policy interventions like universal coverage, free

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cover ) medicine scheme, opening of new colleges should ideally have been a part of the election agenda, however, these schemes don’t provide instant gratification to voters and hence political parties also tend to just touch these issues in a very superficial manner in their agenda. This will though have an impact on the healthcare sector in terms of lesser funding and attention; however, I believe that a big section of the industry is in autopilot mode and will continue to grow provided some policy clarity and rectification is done in time.”

Separate budget for healthcare?

Singh has pointed out that political parties giving a cold shoulder to the healthcare industry may affect the inflow of funding and necessary attention for the industry. Over the last few years, America’s ‘Obama Care’ made headlines across all the leading global news papers. Besides being the second most populated country in the world, India is also a developing nation. The country has its own share of healthcare problems, which are perhaps even more severe than any developed nation. So, why are we lagging behind in devising schemes like ‘Obama Care’ with modifications made to suit India's needs? More than $1.50 trillion has been pumped into ‘Obama Care’. Has the time come to arrange for separate budget sessions to address healthcare needs in India? Government can have agreements with the pharma industry as well to reduce healthcare costs.

Dr SGA Rao, CMD, International Stem Cell Services, doubts whether separate budget sessions to address healthcare needs would really make the government more dedicated towards the healthcare needs of the country.

“Will it help focus government’s attention?,” questions Rao. According to Anand, should the expenditure exceed several times the current budget, a separate session may be necessary.

40 EXPRESS PHARMA April 16-30, 2014

Clinical trial industry, a victim of political unwillingness?

upon, leave alone comprehending the agreement.”

Another victim of lack of political will or government’s apathy has been the clinical trials sector. It is perhaps the most prominent example of what political neglect can do to an industry. To take the advantage of India’s costfriendly environment, many clinical trial operators used to flock India.

Once on the verge of becoming the clinical trial hub of the world, now clinical trial operators are giving a wide berth to India due to regulatory and bureaucratic issues. It is important to revive and regulate the clinical trials sector, since it is one of the most important sections of the Indian healthcare setup. This industry has the potential to bring in a lot of research activities, revenue and most importantly advanced healthcare solutions to India, which would be of great benefit to its populace.

“For the growth of this industry, political will is needed, which the government does not have. I am not confident whether the next PM would show some guts,” stresses Rao. A section of the industry is of the opinion that PM should intervene to address the grievances of clinical trials industry. “PM’s intervention is expected. India will end up in the dark ages if intervention is not immediate,” says Anand.

Singh says, “We believe that the government has sorted out this issue in an appropriate manner, though some provisions of the law may seem very stringent. However, the government has done a delicate balancing act of safeguarding the interest of the industry as well the common population, a chunk of whom are not even able to read the piece of paper which they sign

Accessibility, an issue?

What the pharma industry needs is the clarity on policies rather than additional policies to the existing one Jayant Singh Associate Director, Healthcare Practice, Frost & Sullivan

Unlike in the developed world, health and education topics are the least debated. Parties have namesake manifestos on these subjects Dr K Anand Kumar Deputy Managing Director, Indian Immunologicals Limited (IIL)

For the growth of the healthcare industry political will is needed, which the government does not have Dr SGA Rao CMD, International Stem Cell Services

Young Pharmacists Association in Pakistan had recently requested their PM to formulate laws in such a way that pharmacists in that country would be able to set up their own plants. Pakistan’s PM has promised to think over the request. Is the Indian PM easily accessible for the pharma industry and pharma associations in the same manner? If not what should be done to reduce or remove this communication gap?

Anand opines, “PM is hardly a name connected to the pharma industry. Yes, any measure to narrow the gap would be welcome.”

Rao criticises, “Babus are the main hurdles for any intervention by the PM. They create problems.

They should be disciplined first.”

Policy makeover Central government invests thousands of crores in different healthcare schemes. Its decisions regarding healthcare policies directly affect the entire population or to be more specific, a population that is largely dependent on government to fulfil its healthcare needs. No policy at the central government level can be framed or approved without the PM’s consent.

Hence, the new PM would have a huge challenge to face in this area.

However, according to Singh, it would be unrealistic to expect a policy makeover from the next PM as healthcare is a concurrent list subject and visible cooperation from state governments is required to implement these policies in a more effective manner.

Singh also suggests some policy changes in the drug industry which is also one of the key drivers of the Indian healthcare system.

He says, “There should not be flip flops on foreign investment in the pharma sector. Clear and long-term policy related to pricing, the science behind the pricing should be progressive and safeguarding the interests of both the consumer and manufacturer is required. The government should look at strengthening the inspection mechanism for drug manufacturers and making sure that the cost of violation is prohibitively expensive, this will ensure that our credibility as world generics supplier remains intact. It is also necessary to take a tough stand at bilateral forums in order to ensure that our manufacturers don’t face the heat of non-trade barriers.”

He adds, “Compulsory licensing related issues should be sorted out and it should be confirmed that a MNC is sure about the treatment its drug is going to face in India. Universal coverage scheme on a test pilot basis should be launched, say in 50 districts of India. Creating an ombudsman like authority for healthcare will also help.”

Anand stresses that there should be zero customs duty for import of materials used in vaccines. He says, “Complete overhaul of regulatory procedures to ensure early licensure of products is necessary. Adequate capital spend to modernise primary health centres is required. Government should try to make available adequate surveillance centres and ensure that data for various infectious diseases is reliable. Strict vigilance measures to ensure that prescription drugs (e.g. antibiotics) are not sold over the counter is also very important.”

Conclusion A nation deprived of basic healthcare facilities would find it very difficult to become developed. Hence, following Martin Luther King's maxim, 'Time is always right to do what is right', politicians should start realigning their agendas to include healthcare as a key factor and deliver on their promises. sachin.jagdale@expressindia.com

MANAGEMENT I N T E R V I E W

‘Patient awareness on tuberculosis is a big gap’ Tuberculosis is a focused area of diagnostic research at Mumbai’s Hinduja Hospital which performs 30,000 TB culture tests annually. The hospital has been committed to the cause of TB for over two decades, with large investments in state-of-the-art lab equipment. As we mark this year's World TB Day, Dr Camilla Rodrigues, Senior Consultant Microbiologist and the Chair of the Infection Control Committee at the PD Hinduja Hospital and Medical Research Centre, speaks to Viveka Roychowdhury on the recent advances in the diagnosis of TB In December 2012, Dr Zarir Udwadia and team published a report about 12 totally drug resistant (TDR) TB cases. It blew up into a controversy with the

Union Ministry later deciding that it was to be called XXDR-TB (extensively drug resistant TB). Today there is some good news that some of

those patients have tested negative after salvage treatment. In hindsight, was the controversy a wake up call - for policy makers as well as treating

clinicians?

In any eventuality, whatever helps patients is good. Yes the controversy did help drug resistant patients in Mumbai.

What are the trends in TB diagnostics in India?

Lack of diagnostics for TB has been a a crucial barrier in the past. Smear microscopy is rapid and cost

MANAGEMENT effective but requires a sufficient number of TB bacilli to flag as positive.

Much reliance was placed on chest X-ray but now India’s Revised National TB Control Programme: (RNTCP) has moved away from that.

In the last five years, the WHO has given a boost to validating TB diagnostics.

For one, the WHO has issued a negative policy recommendation on the use of serology that was being used rampantly in our country. We live in a TB endemic country and most of us are TB IgG positive. A positive serological test was used as a valid reason to prescribe TB drugs for any suspicious lesion on the lung or any patient who had a pyrexia of unknown origin.

The Government of India issued a Gazette notification in mid-2012 which banned the use of serology tests. The Government is vital in such situations because they have the wherewithal to stop the import of such kits. This has been a great step towards getting on the right track to diagnose TB. Secondly, there is another test known as the interferon

The gaps exist in terms of improving patient awareness about these tests and their availability.

Patients still want a blood test done rather than a test based on sputum

42 EXPRESS PHARMA April 16-30, 2014

gamma release assay This is a good test to diagnose latent TB. But again, most Indians are latently infected with TB. The problem with this test is that it can detect latent TB but cannot differentiate it from active TB. WHO has come out with a negative policy recommendation, for the use of these tests in the diagnosis of active TB in endemic countries In 2010, WHO advocated the use of GeneXpert MTB/RIF assay for MDR suspects. This molecular test diagnoses TB as well as accurately detects drug-resistance to rifampicin. The test takes two hours to give results and does not require any skilled manpower and is a game changer in TB diagnostics.

Currently in India, the cost of consumables for Xpert is being subsidised by the Foundation of Innovative New Diagnostics (FIND), in the public sector, as well as in the private sector via the Initiative for Promoting and Affordable Quality TB Tests (IPAQT). All accredited labs can become a part of IPAQT. Under this initiative, in the private sector, the effective reduction in cartridge cost is passed on to the consumer.

Two additional tests that WHO has approved are: ◗ MGIT automated liquid culture which allows for much faster detection of TB Liquid culture clearly enhances the rate of recovery and the time to detection. To have a TB culture facility, you require biosafety precautions in place. Expertise is required to avoid contamination issues . ◗ Another molecular test that is called the Hain Line Probe Assay (LPA). The National Programme is training personnel across the country to do these tests. These tests, in the last five years, have completely revolutionised TB diagnosis. In fact, sometimes at a molecular level, TB is detected faster than other routine infections!

We now require noninvasive, point-of-care tests,

One of the projects you are working on is testing biomarkers for immunity to Mycobaterium tuberculosis in exposed but uninfected healthcare workers, which is a collaborative project with Imperial College, London, UK. Could you tell us a little about this project?

This project is looking at why some healthcare workers, like nurses, paramedics etc., who though being continuously exposed to TB are not positive for latent TB. We are looking at biomarkers in their immune system that prevents the normal response. We are doing this in collaboration with Dr Ajit Lalwani in Oxford.

In the last five years, the WHO has given a boost to validating TB diagnostics. It has issued a negative policy recommend-ation on the use of serology that was being used rampantly in our country but we are at least two years away from such immunochromatic tests (ICTs) for detection of TB. What has been the response of policy makers in India and the RNTCP? Laboratory capacity building for TB in the nation will take time. I think the response of the programme has been good because you have public hospitals like JJ Hospital in Mumbai that also perform the LPA tests. The authorities have outlined certain areas in each state for upgradation.

Where are the gaps?

The gaps exist in terms of improving patient awareness about these tests and their availability. Patients still want a blood test done rather than a test based on sputum.

To convince patients that

these tests are actually better than a blood test needs a lot of awareness.

It is also important to create awareness about the fact that a cough persisting for over two weeks, weight loss, night sweats, low grade fever cannot be ignored and require a consultation.

If the person has had TB before, or is in contact with a person with drug resistant TB, then we need to quickly do a test to diagnose resistance. And the earlier testing is done, unnecessary treatment can be avoided.

If required, treatment too has to be rational. So, physicians need to be goaded into that direction. The situation is definitely improving. Role models, perhaps from Bollywood, may help to raise awareness about such issues!

A lot of imaging techniques are been investigated to diagnose TB in cases like bone TB. What are you views on that?

To be very honest, from a microbiology perspective, seeing is believing. I have to see the micro-organism. So, I do not think we can make judgement calls based on radiological examination alone. We need to have a sample from the patient and test it.

The 16th Annual L’OréalUNESCO for Women in Science Awards awarded five women scientists on International Women’s Day. Do you feel that women scientists in India get their due? What can be done to set this right?

They need better visibility within the scientific community. I also really believe in the power of the pen. If you publish good work, you get noticed.

What is the future of microbiology?

The sky is the limit as far as microbiology is concerned because everything starts with a diagnosis. There is so much that can be done and you need passionate and motivated people. viveka.r@expressindia.com

MANAGEMENT I N T E R V I E W

‘A demand for nutrition supplements has been seen amongst the Indians’ Haeri Roh-Schmidt, Head, Science & Innovation, HNH, APAC, DSM Nutritional Products, talks about the scope for nutritional products in the Indian market, in discussion with Sachin Jagdale

What are global and India specific nutritional trends?

Malnutrition is being referred to as India's silent emergency. According to the World Bank report, the rate of malnutrition cases among children in India is almost five times more than in China, and twice than in Sub-Saharan Africa.

India has long been the focus of under and malnutrition where Fe, VitA, Zn and VitD deficiencies, as well as malnutrition-driven stunting has been very prevalent.

However, what is important to note is that the global issue of over nutrition is also just as much an issue for India. Double burden of over and under nutrition is global as well as India concern.

India is said to be the diabetic capital of the world.

Is the lack of proper nutrition one of the reasons behind this? Diabetes has also made Indians prone to heart diseases. What kind of nutritional modifications/changes should be employed in the diet to counter these health problems?

India has the second highest number of people with diabetes in the world, which is expected to increase to 101.2 million by the year 2030. Nutrition is certainly a crucial reason for the rapid spread of this disease.

Juvenile diabetes and level 1 and level 2 diabetes amongst adults is on a high in India.

Much of age related chronic illness, metabolic syndrome (cardiovascular, obesity and

44 EXPRESS PHARMA April 16-30, 2014

diabetes) has a large contribution of diet, exercise and lifestyle management.

While there are multitude of lifestyle changes that can have a very positive impact on all of these, it appears that lifestyle changes aren’t as easy as it sounds. Sound diet choices in key essential nutrients that are important for aging consideration and related sugar management such as Vitamin B complexes, D, C, E, Omega 3 PUFA, as well as key minerals such as Mg, Cr, Zn can be considered.

How does developing nutritional science help in energy management?

Fatigue is one of the most frequent complaints amongst consumers (in fact energy has been a key trend in consumer food and beverage product for the past two to three years).

Complex lifestyle, abrupt working hours, stress, unhealthy eating habits contribute to rising fatigue amongst the youngsters.

Managing energy and vitality through good nutrition is a key market focus in global aging market. Developing nutritional science gives insights to the consumers on energy management and also helps them in choosing a healthy lifestyle.

Traditionally, Indian population is not inclined towards nutritional supplements.

So, what should be the way forward for the companies like yours that want to penetrate the Indian market?

Developing nutritional science gives insights to the consumers on energy management and also helps them in choosing a healthy lifestyle 'Dietary supplement' is just that, it is meant to supplement the diet. Where nutritional supplements in form of pills/capsules/tablets (historical dietary supplement format) is not conducive for consumer reception, supplementing via acceptable

form (food and/or beverage) should and could be considered.

This also means making supplementation easy and accessible to consumers and thus contributes to overall nutritional improvement in the population, especially to those who do not have access to sound nutrition. A demand for nutrition supplements has been seen amongst the Indians.

DSM as a life sciences and material sciences company is offering solutions for both vegetarian and non-vegetarian population in India in order to offer them a healthy life.

Genetic make-up of each country's population varies.

How challenging is it to manufacture nutritional products for Indian consumers?

While genetic variation contributes to how nutrition is metabolised and reacted upon (and science is still building), key nutritional need/consideration on population basis exists already and can be acted upon. This relates to above mentioned nutrients, especially relating to aging, sugar management, energy management, climate change etc. I think it is important to note that while we do not have all of the customisation/personalisation worked out, we have enough information for call to action/call to awareness on improving nutrition. A few challenges in manufacturing nutritional products in India are elimination of disparate solutions, standardising quality

management processes, availability of infrastructure and climatic conditions.

India is a cost-sensitive country and nutritional supplements are generally considered expensive. How are you going to resolve this?

This is an important consideration; however, it isn’t necessarily unique to India.

Making nutrition accessible at affordable cost is an important fact to remember for any market. And with key nutrient consideration, it is not cost prohibitive in most cases, in reality.

Any new products in the pipeline?

At DSM Nutritional Products, innovation is one pillar that bolsters our business. Innovation is not only through introducing new ingredients that address key health concerns but also through introducing ingredients forms that works in innovative application and delivery formats. With this is in mind, we are constantly innovating to bring new products to the market in the area that we discussed. Health concerns that address aging population, concerns such as cardiovascular health management, sugar health management, mobility management, and cognitive health management. We have several ingredients that we are launching this year in these areas. sachin.jagdale@expressindia.com

MANAGEMENT INSIGHT

Commercial Excellence 2.0 Bart Janssens, Partner and Director, BCG and Rahul Guha, Principal, BCG, in the third part of the article series, focus on people, ensuring that capabilities are build at the right level for business management and more importantly ensuring pockets of excellence in the organisation are deployed more broadly

THE PHARMACEUTICAL selling model has been established for decades. Much has been done on improving the model and squeezing the last bit of efficiency from the model using sales force effectiveness tools and IT-enabled solutions. In this three part article series, we challenge some of the fundamentals of the selling model and propose a new way to think about engaging with your customers as well as maximizing the return from your commercial spend.

We propose six tenets to Commercial Excellence 2.0 which we will elaborate in the third part article series. In brief, these six tenets are: 1. Move beyond share of voice: Engage with the customer to drive value in his business & ensure the messages delivered are differentiated, relevant and absorbed 2. Manage performance, not incentives: Understand the behavior of the sales force segments and then customise incentives and coaching to address specific patterns 3. Let the market drive marketing: Zero-base your marketing spend and then align your initiatives with where your brands are in the product lifecycle 4. Integrate to differentiate: Align the commercial model across sales and marketing and close the loop effectively 5. Middle managers manage a business: Equip Zonal / Regional managers with the right skills to manage a business vs. just managing sales 6. Sharing is caring: Pockets of excellence exist, but best prac-

tice sharing is rarely institutionalised, getting teams to learn from each other is key

Teach managers to manage a business, not sales For a long time, the linchpin in any pharma field force has been the front line sales manager. He (or she) has been identified as the node to drive change and many elements of coaching and guidance have been deployed to ensure the manager can manage his territory well.

This approach has been effective in driving change and has been the focus on numerous sales force effectiveness efforts. Yet, as this very same manager’s career progresses the focus still remains overwhelmingly on managing sales. A second line manager’s role is mainly to manage sales performance of the first line sales managers and to coach and provide leadership to the front line team.

However, if you look at the role they need to play, managing a zone or territory is a role that is much broader than simply just managing sales. At this level, companies should expect more from this resource in terms of delivering an overall business

management perspective of the zone / region. Companies need to start thinking of a second line business manager almost like a mini-CEO for a region balancing not just sales performance but also resource deployment and optimisation.

We define a Zonal Managers role at three levels.

1. Delivering results / targets: Supporting his (or her) front line sales managers in the field in terms of managing performance and ensuring committed sales volumes are delivered 2. People management: Providing leadership to the entire field force in the zone, ensuring front liners know the territory and the sales plan, building selling skills to deliver tailored messages, customising incentives to deliver performance and acting as a role model for the team 3. Business management: This involves communicating with Head Office and the field, planning tactics, coordinating with sales ops, marketing, medical as well as recruiting. Additionally a Zonal manager needs to drive key account management in the zone / region, co-

ordinate regional meetings and events, and manage administration and the zonal / regional costs.

However, the background of most of these managers is sales and they traditionally have their comfort zone in managing sales performance i.e. the first level and are too fragmented to focus on the people and business management aspects. The conundrum exists as to how a company enables the Zonal / Regional manager to think more broadly than month to month sales results.

We propose a senior management ‘Business Academy’ concept that is focused on building business acumen and not just selling / sales management skills. This is a focused effort deployed at the centre that builds the capability of the middle management. This is a long-term internal effort and not to be confused with executive education programmes which are just a point in time effort. The academy focuses on systematically deploying a set of tools into the hands of Zonal / Regional managers to help them become more effective in their roles. These tools are a combination of hard

Using business judgment to optimise the deployment at the bag level, mining customer relationship data, driving a coherent territory strategy, as well as effectively utilising sales effectiveness tools are skills that managers acquire over time

BART JANSSENS, Partner and Director, BCG

RAHUL GUHA, Principal, BCG

tools to support better business decision making, soft tools to ensure leadership competencies as well as capability building initiatives.

The academy is deployed through a combination of classroom training which includes structured training sessions, sales skills, coaching and motivating teams, as well as using analytical tools to enhance business judgement. This is combined with on-the-job training and coaching through dedicated coaches who train on coaching skills as well as day-today development of programme participants through interaction with internal light-houses. Our experience has shown a 10-15 per cent sales improvement in performance by deploying this targeted academy approach which is more scalable and can address a narrow part of the sales force, but have disproportionate impact on the ability of the on the ground sales team.

The ‘Business academy’ deploys the following kinds of tools: (summarised in the Exhibit I as well): 1. Analytical tools (Hard elements): These tools are simple analytical tools (typically based in excel or on a web-platform) and help simplify the major aspects of managing a territory. These tools automate analytics on the sales performance and deployment to highlight where the zonal manager should intervene in performance not just at the end of the month, but within the month itself. E.g. a tool which analyses weekly data and call logs to quickly alert a zonal manager of issues in a

EXPRESS PHARMA

45

April 16-30, 2014

MANAGEMENT

EXHIBIT I: COMMERCIAL EFFECTIVENESS TOOLS

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particular territory within the first two weeks of the month, can then help the zonal manager decide his travel schedule for the rest of the month so that he can focus where the issues are. Additionally, automated analytics on trends vs. previous months / weeks, sales rep segmentation in terms of performance and incentives are available and can be put in place relatively quickly.

2. Behavioral tools (Soft elements): These are behavioral coaching tools for a business team. In short capsules, essentially a zonal manager is trained to coordinate deployment efforts with marketing (an integrated approach to the territory), motivating the field force, codifying the ground level selling skills in an area and building a higher level relationship with senior doctors. Additionally, the softer elements address how to coach and mentor junior teams and manage people for performance.

These tools encompass leadership behaviours that zonal managers must demonstrate and drive consistency in the soft skill development as well.

46 EXPRESS PHARMA April 16-30, 2014

3. Business tools (capabilities): Typically, when people are promoted from the field, project management or planning is a commonly highlighted skill gap.

Additionally, using business judgment to optimise the deployment at the bag level, mining customer relationship data, driving a coherent territory strategy, as well as effectively utilising sales effectiveness tools are skills that managers acquire over time. Transmitting these skills to junior teams usually takes time and happens in an unstructured manner. However, by encompassing these tools into codified blue-prints, this can accelerate the learning curve and significantly move the needle in managing business performance at the territory level.

Sharing is caring Many companies believe they have done all they could in commercial effectiveness. Customer segmentation, calling plan alignment, sales training etc are all in place. Often times this will be true, but many would agree that while much has been done, they

still observe pockets of excellence and weak performance.

The difference between best performing and weak performing teams can be as much as 34x in terms of per capita per month. While policies, segmentation, deployment and brand spend are all aligned, it can be confounding to explain the differences in performances across territories and credibly address these differences with the sales teams in a way that they change their working and therefore brand position in the market.

Many times, companies review performance across these territories, but often the solutions designed are quite generic and ignore best practices that exist within the organisation itself. More importantly seeing solutions which work within the company and are accessible, help convince teams on the ground to do new things that they perhaps didnâ&#x20AC;&#x2122;t try in the past. However, mechanisms to share these best practices don't exist. Often when we suggest this is the right thing to do, we are met with skepticism

that this is a selfish world and people donâ&#x20AC;&#x2122;t want to share their secret sauce.

We would argue this may be true, but there are fewer more powerful incentives than peer recognition and appreciation in an organisation. A structured forum where people can stand up and share something new they are doing with their peers and get recognised for it is something that can break these barriers quite quickly. More importantly, hearing new ideas from peers which have worked in the organisation context can create great peer pressure to replicate new ideas.

It is important for companies to evaluate if they have the right mechanisms to ensure that the commercial model they have deployed is constantly improving and more importantly, these improvements are synthesised and shared so that the entire organisation can benefit. Continuous improvement on segmentation, beat planning, return on marketing investment are concepts that need to be relentlessly pursued, not just in

pockets, but across the company.

The way to do it is to â&#x20AC;&#x2DC;bubble upâ&#x20AC;&#x2122; great ideas and share them across the organisation using a core platform. These platforms could be a â&#x20AC;&#x2DC;Business Academyâ&#x20AC;&#x2122;, â&#x20AC;&#x2DC;Knowledge forumsâ&#x20AC;&#x2122;, â&#x20AC;&#x2DC;Learning sessionsâ&#x20AC;&#x2122; or however you want to call it, but itâ&#x20AC;&#x2122;s important that these ideas are found and shared. You will find not just pockets of excellence if you do so, but a broader more energised team working together to learn from each other.

This concludes our three part series on commercial excellence. Across the series we have walked through different elements of commercial excellence from effectively managing the field force, to driving an integrated zero-based approach to marketing as well as managing people more effectively to deliver. We hope you got some fresh ideas for your organisation and would encourage you to experiment with some of these concepts as only by challenging the status-quo will we find new ways of doing business and changing the game.

MANAGEMENT REPORTS

India,China key prospects for interventional cardiac device manufacturers: Frost & Sullivan Report says that manufacturers must expand capabilities and capacity through strategic partnerships in order to fulfill demand A HIGH degree of unmet clinical needs, the rising prevalence of ailments such as coronary artery diseases and hypertension, as well as increasing disposable incomes are creating robust opportunities for emerging interventional cardiac devices in emerging countries. Although the US and European markets will witness the highest growth, device manufacturers must focus on developing economies such as India and China, where the market is growing between 12 and 15 percent per annum.

New analysis from Frost & Sullivan’s analysis on The Global Emerging Interventional Cardiac Devices Market finds the market earned revenue of $1.49 billion in 2013 and estimates this

to reach $6.93 billion in 2020.

The analysis covers devices for the following segments: transcatheter heart valves, renal denervation, bronchial thermoplasty, bioresorbable stents, and fractional flow reserve.

“Cardiac disorders, including atrial septal aneurysm and patent foramen ovale that have been recognised as possible risk elements for ischemic stroke, are evolving into potential markets for interventional cardiac devices worldwide,” said Frost & Sullivan analyst. “Many companies have already forayed into this sector with products cleared under Food and Drug Administration humanitarian device exemptions.”

However, as with any emerg-

ing technology, the shortage of specialists restrains the use of interventional cardiac procedures. The current workforce in cardiology is insufficient to meet the escalating need across the globe. To resolve this challenge, official training programmes have been set-up by various academic institutions as well as companies like Edwards Lifesciences and Medtronic.

The development of these products will likely shape the overall interventional cardiology market, and the successful adoption of these emerging products will result in significant market growth rate.

Complex purchasing systems also hinder the adoption of interventional cardiac

devices, particularly in Asia-Pacific (APAC). In this increasingly competitive market, APAC countries face an alarming rise in cardiovascular disorders and account for half of the global burden of diseases. This situation will likely worsen during the next few years, as the region has an ageing population with an increasingly unhealthy lifestyle.

Another challenge peculiar to the region is caused by heavy subsidisation of healthcare by governments. Lower costs heighten hospitalisation rates, and, in turn, healthcare costs, severely impact the economy and the market.

“Nevertheless, the urgent requirement to decrease hospital

stay times is driving minimally invasive interventional procedures, which ensure quick recovery and lower risk of complications,” noted the analyst. “As minimally invasive interventional cardiac procedures become the solution of choice among patients and the medical fraternity, demand for interventional cardiac devices will grow.”

Acquiring added capabilities and expanding capacity through long-term strategic partnerships will be crucial for device manufacturers. Repositioning product and service offerings to enhance value for clients will help strengthen their foothold in this dynamic landscape.

EP News Bureau-Mumbai

MCD pharma market value in seven countries to increase to $6.4 bn by 2022: GlobalData The US will show the highest growth in the MCD treatment market THE MICROVASCULAR complications of diabetes (MCD) pharmaceutical market value in the seven major countries (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) is expected to increase from $3.6 billion in 2012 to $6.4 billion by 2022, at a Compound Annual Growth Rate (CAGR) of 5.8 per cent, says research and consulting firm GlobalData.

The company’s latest report states that out of the 7MM, the

US will show the highest growth in the MCD treatment market, with its total value jumping from $1.8 billion in 2012 to $3.7 billion by 2022, at a CAGR of 7.3 per cent. The US will be followed by the five European countries, with their combined market values expected to increase from $777 million in 2012 to $1.3 billion by 2022, at a CAGR of 5.4 per cent.

Valentina Gburcik, GlobalData’s Analyst covering Cardiovascular and Metabolic Dis-

orders, says, “America’s rapid MCD market growth is due to the rising overall prevalence of type II diabetes in the country, thanks to its skyrocketing obesity epidemic, which is resulting in the subsequent increase in diabetic complications.”

GlobalData anticipates that the launch of AbbVie’s atrasentan in 2018 will further boost global diabetic nephropathy treatment sales, which are expected to reach $1.8 billion by 2022. Additionally, the diabetic

retinopathy and neuropathy therapeutics market values are also expected to increase by the end of the forecast period, reaching $2.7 billion and $1.8 billion, respectively.

Gburcik continues, “The approval of Lucentis and Eylea for diabetic macular edema in 2012 and 2014, respectively, will overtake the patient share from the much cheaper off-label Avastin, which will drive the diabetic retinopathy market during the forecast period.

“On the other hand, the only driver behind the diabetic neuropathy market, besides the prevalence of the disease, will be a slow increase in opioid consumption by 2017, as the arena is being overtaken by generic drugs.”

Despite the success of the MCD pharmaceutical market, Gburcik says that the current therapies still leave a very high number of unmet needs.

EP News Bureau-Mumbai

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RESEARCH CLINICAL UPDATES

USFDAadvisory committee votes against approval of Novartis’RLX030 RLX030 is under review to improve the symptoms of AHF by reducing of the rate of worsening of heart failure THE US Food and Drug Administration (US FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approval for Novartis’ RLX030 (serelaxin) for the treatment of acute heart failure (AHF). Data presented at Advisory Committee meeting included phase II and III efficacy and safety data from the RLX030 clinical development programme, including the pivotal phase III RELAX-AHF study. In this study, RLX030 improved the symptoms of acute heart failure (AHF) through reducing the rate of worsening heart failure, a measure of symptom

deterioration that requires intensification of therapy.

“Recognising the urgent patient need, today we presented what we believe to be a persuasive picture of the evidence for RLX030 so far, compelling results from our phase II and III trials with no significant safety concerns,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals.

“The discussion provided important information that we will address with the FDA as it completes its review. In the meantime we’ll continue to drive our robust clinical trial programme and build upon the already established body of

evidence.”

RLX030 is under review to improve the symptoms of AHF through reduction of the rate of worsening of heart failure. Its proposed administration is in addition to conventional therapies, as a 48-hour infusion in the hospital during an AHF episode. The recommendation of the Advisory Committee will be considered by the FDA in its review of the Biologics License Application (BLA) for RLX030, but the FDA is not bound to follow them. The FDA makes the final decision on approvals of new treatments.

EP News Bureau-Mumbai

Puma drug better than Herceptin in HER2 breast cancers: Trial The trial also found that the experimental drug resulted in a higher rate of pCR A MID-STAGE trial of Puma Biotechnology’s experimental drug neratinib showed that it was more effective, given before surgery, than Herceptin, the Roche drug commonly used in women with a type of breast cancer fuelled by a protein called HER2. The trial involved treating 193 newly diagnosed patients prior to surgery. About 39 per cent of HER2 patients given a combination of neratinib and chemotherapy achieved a ‘pathologic complete response,’ compared with 23

48 EXPRESS PHARMA April 16-30, 2014

per cent of women treated with chemo and Herceptin. Pathologic complete response, or pCR, means there is no remaining evidence of the tumour in the breast or lymph nodes.

The trial also found that the experimental drug resulted in a higher rate of pCR, 45 per cent, than standard care, 29 per cent, in women with tumors for which genetic testing indicated a high probability that their cancer would return.

Alan Auerbach, Chief Executive Officer, Puma, said the

company is in the process of designing phase III trials of neratinib in both HER2-positive patients and in patients with a high risk of breast cancer recurrence. The drug, which was licensed by Puma from Pfizer, is also being studied in a range of other cancer indications.

In the phase II trial, due to be presented in San Diego at a meeting of the American Association for Cancer Research, patients were stratified into 10 different groups, based on hormone sensitivity and other

factors. About 25 per cent of breast cancers are HER2 positive.

The phase II trial used ‘adaptive randomisation,’ meaning patients entering the study were assigned to treatment regimens that were performing better in patients with the same cancer subtype.

Auerbach said neratinib, a pill, has a different mechanism of action than Herceptin, a bioengineered antibody given by infusion, as well as Perjeta, a newer Roche drug approved

for use in combination with Herceptin. As a result, HER2positive patients could potentially be treated with a regimen of chemotherapy, plus Herceptin, Perjeta and neratinib, he said. Breast cancer is the most common cancer among women, with about 1.4 million new cases diagnosed each year and more than 450,000 women dying of the disease annually, according to the World Health Organization.

Reuters

RESEARCH UPDATES

Childhood flu shots could result in serious clinical outcomes in adults: Study

1. Grabenstein Spn Serotype Delta Poster Adult, p1A, 3A, Grabenstein Spn Serotype Danger Poster, p1A, 2A] 2 Grabenstein Spn Serotype Delta Poster Adult p1B,2A 3 Grabenstein Spn Serotype Danger Poster p.2A 4 Grabenstein Spn Serotype Danger Poster p.4A

AMGEN SAID its experimental drug to treat a deadly form of skin cancer did not significantly improve overall survival rates in patients enrolled in a late-stage study. The drug met the study’s main goal of shrinking tumours, as it had previously reported, but did not meet the secondary goal of improving overall survival in patients with melanoma. The most common serious adverse events observed in the trial include disease progression, a bacterial skin infection and fever, the company said.

ISI Group analyst Mark Schoenebaum said the drug’s failure to significantly improve survival rates could affect its chances for approval and limit its commercial opportunity as a single therapy.

Amgen said in June that data from the pivotal study showed that the drug improved survival by 21 per cent for patients with advanced forms of melanoma compared with a standard white blood cell-boosting drug.

The company first reported in March last year that the drug, talimogene laherparepvec, met the study's main goal of inducing a durable response rate (DRR) — defined as a complete or partial tumor shrinkage lasting at least six months — in 16 per cent of patients.

Amgen is also testing the drug in combination with Bristol-Myers Squibb Co’s melanoma drug Yervoy. Skin cancer is the most common type of cancer in the US, but melanoma, which begins in skin cells that make the pigment melanin, accounts for less than two per cent of skincancer cases.

EP News Bureau-Mumbai

Reuters

Review studies show pneumococcal serotypes infecting adults are changing globally following widespread paediatric PCV vaccination programmes MSD PRESENTED two new review studies at the 9th International Symposium of Pneumococci and Pneumococcal Diseases (ISPPD). The first review, abstract 132, shows a growing difference in the proportion of serotypes included in the 23-valent pneumococcal polysaccharide vaccine (PPSV23), compared to the 13valent pneumococcal conjugate vaccine (PCV13), following widespread paediatric PCV vaccination programmes. The second review, abstract 133, shows how individual pneumococcal serotypes among adults have greater or lesser risk of causing serious clinical outcomes.1 “The findings from these reviews show how the epidemiology of IPD serotypes is changing after the introduction of PCV7 into childhood immunisation programmes in multiple countries. The differences appear to be widening further with more extensive paediatric use of PCV10 or PCV13. Also, there are certain serotypes which have repeatedly been found to be associated with elevated risk of serious outcomes in adults. Clinicians and policy makers should consider these differences in relevance to circulating serotypes to which adults are vulnerable to maximise the value provided to vaccine recipients,” said John Grabenstein, MSD scientist.

A systematic literature review was conducted to identify differences in proportions

and incidence of invasive pneumococcal disease (IPD) serotypes present in PPSV23 and PCV13 before and after widespread pediatric use of PCV7.2 One part of review included data from 16 countries including India. The Indian data came from IBIS-2 (Invasive Bacterial Infection Surveillance) study done by Kurien T et al 2013 during his career at Christian Medical College (CMC), Vellore. The India-specific data for adults =61-year-old found a difference of 24 per cent between PPSV23 and PCV13.

The investigators concluded that the paediatric vaccination has led to a widening difference in the amount of invasive pneumococcal disease that can be targeted by the two vaccines.

In the second literature review, pneumococcal serotypes associated with elevated risk in adults were identified across the world. The results showed that some serotypes are statistically more likely to cause serious diseases like pus in chest (empyema), inflammation of membranes of brain (meningitis), infection with low blood pressure (septic shock), or elevated case-fatality rates, compared to other pneumococcal serotypes.3 The investigators grouped the serotypes associated with elevated risk of serious clinical outcomes according to which vaccines are targeted against them: PPSV23 and/or PCV13.

The study concluded that: Multiple pneumococcal

Amgen skin cancer drug fails to improve survival rates

serotypes associated with increased risk for serious outcomes in adults are included in both PPSV23 and PCV13, notably serotypes 1, 3, 6B, 19F, 19A and 23F.4 Nine of 11 serotypes unique to PPSV23 were linked with elevated risk for serious disease across 14 studies reviewed.4 Serotype 6A, which is unique to PCV13, was linked in the analysis with elevated risk for serious disease in three studies only.4 Serotypes 11A and 9N (unique to PPSV23 ) were repeatedly linked with elevated case-fatality rates in adults.4 Serotypes 10A and 15B (unique to PPSV23) were repeatedly linked with elevated risk of pneumococcal meningitis in adults.4 PPSV23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

References:

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RESEARCH

NPScreen develops NPC screening test

US approves portable antidote for painkiller overdoses A move to combat the rise of deaths through the abuse of opioids, including heroin Washington US REGULATORS approved a portable device to treat painkiller overdoses that people without medical training can use in emergency situations, a move to combat the rise of deaths from the abuse of opioids, including heroin. The Food and Drug Administration said making the cellphone-sized device with the recovery drug naloxone available for wider use could help save lives as opiod drug overdoses increase. The approval means emergency responders or even family members could have an easy-to-use treatment in cases of suspected overdose of opioids, which include pain drugs like oxycodone, morphine, codeine and hydrocodone as well as heroin.

“It is really an effort to make this very usable,” FDA Commissioner Margaret Hamburg said.

More than 16,000 people die each year from prescription opioid overdose in the US, according to the FDA and the device’s maker, privately held drugmaker kaleo.

Opioid overdoses are mostly tied to those addicted to painkillers and heroin, but they can also happen accidentally in patients using the prescription medicines legitimately to treat pain. The hand-held device is called Evzio and automatically delivers a set dose of naloxone, a drug ingredient already approved to treat overdose patients that works by quickly restoring breathing.

Naloxone is now typically given through a nasal spray or a syringe that must be injected under the skin or into the muscle, and has been lim-

50 EXPRESS PHARMA April 16-30, 2014

ited mostly to medical professionals at hospitals and emergency rooms as well as a growing number of police officers and other emergency responders.

The version approved is small enough to be carried in a pocket, the FDA said. Relatives and caregivers would still need training and practice on how to use the device, and several doses may be needed to revive someone, the agency added. “Making this product available could save lives by facilitating earlier use of the drug in emergency situations,” Bob Rappaport, Head, FDA division that reviews such products.

Hamburg said that while wider use of overdose treatment was important, “The larger goal is to reduce the

need for products like these by preventing opioid addiction and abuse.”

Health experts and other advocates trying to combat the effects of drug addiction welcomed the device’s approval in a conference call with the FDA, and some even suggested doctors prescribe it along with initial opioid painkiller prescriptions. But some also worried the injector could cause some people to dismiss the risks of opioid use because an antidote would be easier to access.

FDA and other federal drug officials said Evzio was not a substitute for medical care and that it was essential that people who overdose still get quick medical attention. It was not immediately clear how much the injector would

cost or whether health insurance companies, including the government’s Medicare and Medicaid programmes, would cover it. The device will require a prescription and will be available at pharmacies this summer, the company said, adding it had not yet set a price.

Meghan Ralston of the Drug Policy Alliance advocacy group, expressed concern in a statement about costs and said people should use “whichever form of naloxone is most convenient and affordable for them.” She called on manufacturers to ensure affordability. A growing number of municipalities have stocked other naloxone treatments and have begun training firefighters, police officers and other emergency medical personnel on how to deliver the antidote.

Separately, New York Attorney General Eric Schneiderman said the state would equip every law enforcement officer in the state with naloxone to help fight a surge in heroin overdoses. The effort would be funded with $5 million recovered from drug traffickers. Schneiderman cited data from police in Quincy, Massachusetts, which began requiring officers to carry naloxone in 2010. Since that time, the police department has used the drug 221 times and reversed overdoses in 95 per cent of those cases. Last week, Massachusetts Governor Deval Patrick, in a speech declaring a public health emergency stemming from the abuse of opioids, said his state would also make naloxone more widely available.

A MARKHAM, Ontario-based company has developed a specialised test which screens for nasopharyngeal cancer. Nasopharyngeal cancer, known as NPC, is a rare but deadly disease. It is global in scope, and individuals with a Hong Kong, South East Asian, Inuit, North African, or Middle Eastern background have a higher risk for NPC. These individuals may benefit from this early screening test. In the early stages, NPC has few obvious symptoms, and the cancer often grows undetected, hidden in the nasopharynx, near the centre of the head. Usually it is diagnosed after the tumour is well developed, making treatment difficult with poor survival outcomes. When detected early and treated, the chances of full recovery are almost 90 per cent.

NPScreen has developed a genetic test that detects the cancer in its early stages, when it is still curable. The test is quick, non-invasive, and most importantly, 99 per cent accurate.

“We are excited about the launch of this innovative, unique screening process that we believe will dramatically change the course of Nasopharyngeal cancer and save thousands of lives EVERY year,” says Dr John Phillips, President, NPScreen.

The screening process is managed as a simple, non-invasive office procedure. Using a uniquely designed instrument to brush the back of the patient's throat, the specialist takes a sample of surface cells, which are then analysed for the presence of the Epstein-Barr viral genome sequence. The EpsteinBarr virus infects the epithelial cells of the nasopharynx and is closely linked to the development of NPC.

Reuters

EP News Bureau-Mumbai

RESEARCH

Fertility drugs not tied to long term breast cancer risk Extended exposure to extra estrogen could increase the risk of breast cancer New York DESPITE CONCERNS and some evidence that fertility treatments increase a woman's chances of developing breast cancer, a large, long-term study finds no added risk. Nearly 10,000 women who received drugs to stimulate ovulation were no more likely to develop breast cancer during 30 years of follow-up than those who never used the drugs, researchers report. Lead author Louise Brinton, Chief, Hormonal and Reproductive Epidemiology Branch at the National Cancer Institute

Women who were exposed to 12 or more cycles of clomiphene treatment had a 70 per cent higher risk of developing breast cancer compared to women not exposed in Bethesda, Maryland, said the findings are reassuring.

Previous studies have raised concerns over the drugs because women are exposed to higher levels of estrogen during fertility treatments. Extended exposure to extra estrogen could increase the risk of breast cancer. “The other worry is that (these drugs) cause increased ovulation and that could be linked to an increase in breast cancer risk,” Brinton said.

For the new study, the researchers analysed records for 9,892 US women

who were followed for some 30 years after having been evaluated for infertility between 1965 and 1988. About 38 per cent of the study participants were exposed to the fertility drug clomiphene and about 10 per cent were exposed to drugs known as gonadotropins. Over the three-decades of follow-up, 749 breast cancers were diagnosed among the study participants.

Overall, women who were exposed to either type of fertility drug were no more likely to develop breast cancer than those who didn't use the medicines to stimulate ovulation. The researchers did find an increased risk of breast cancer among a small subset of women who were prescribed the highest doses of clomiphene.

Current practice limits treatment with the drug to just three to six cycles.

But women who were exposed to 12 or more cycles of clomiphene treatment had a 70 per cent higher risk of developing breast cancer compared to women not exposed.

Also, women who took gonadotrophins, usually in combination with clomiphene, but were still never able to become pregnant were about twice as likely to develop breast cancer.

Some of that increased risk may be the result of whatever underlying problem caused those women's persistent infertility, the researchers speculate. For the small group of women who took clomiphene for more than a year, the reasons for the increased risk are less clear, the authors conclude in their report, published in Cancer Epidemiology, Biomarkers & Prevention.

“It’s reassuring that if women desire pregnancy and unfortunately have infertility that they can undergo treatment without modification of their overall risk for cancer later,” said Dr Kurt Barnhart, President of the Society for Reproductive Endocrinology and Infertility.

Reuters Health

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RESEARCH

Party drug Ketamine could help treat severe depression: Research Several research teams around the world have been studying the potential for ketamine use in depression London THE PARTY drug ketamine could one day be used to help some people suffering from severe depression, according to British scientists who gave infusions of the narcotic nicknamed ‘special K’ to patients. Researchers who tested the drug on 28 people with major depressive disorder found ketamine quickly helped relieve the condition for some and made a number of them completely well again for up to several weeks. "It’s dramatic and it’s exciting, and it is a novel mechanism. But it’s not about to become a routine treatment,” Rupert McShane, a consultant psychiatrist and researcher at Oxford University who led the study, said.

He said the discovery that ketamine worked, even for a

short period, had been enough to give new hope to some of the patients in the study - many of whom had in the past considered suicide.

“We’ve seen remarkable changes in people who’ve had severe depression for many years that no other treatment has touched,” McShane said.

“It’s very moving to witness.” Although many of them relapsed within a day or two, almost a third of them felt a benefit which lasted at least three weeks, he said, and 15 per cent did not relapse for more than two months.

“We now need to build up clinical experience with ketamine in a small number of carefully monitored patients,” McShane said. “By trying different infusion regimes and adding other licensed drugs, we hope to find simple ways to prolong its dramatic effect.” Ketamine is a li-

Ketamine quickly helped relieve the condition for some and made a number of them completely well again for up to several weeks censed medical drug, widely used as an anesthetic and to relieve pain. But it is also used as a recreational drug and can lead some people into drug abuse.

McShane said that the doses used were very different. On the street, users often take several grams a day and can suffer severe bladder problems and impaired brain function. The dose used in the study was no more than 80 milligrams - 80 thousandths of a gram, every week in a closely monitored hospital setting.

Several research teams around the world have been studying the potential for ketamine use in depression, since many patients with the psychiatric condition fail to respond to currently available antidepressants such as Prozac and Seroxat. The US drug giant Johnson & Johnson is developing an intranasal form of the drug, called esketamine, in midstage trials and has said its results so far have been promising. Anglo-Swedish drugmaker

AstraZeneca had also been conducting early-stage trials on a ketamine-like drug, but opted to discontinue its development after disappointing results.

In the Oxford study, 28 patients with severe and treatment-resistant depression were treated over three weeks and received either three or six ketamine infusions each lasting 40 minutes. Memory tests were carried out a few days after the final infusion and patients reported their mood symptoms daily via text or email.

The results, published in Journal of Psychopharmacology, showed that three days after the last infusion, the depression scores had halved in 29 per cent of the patients. Some patients described feeling able to think freely for the first time in years, he said.

Reuters

Oxytocin may help anorexics fight food fixation London OXYTOCIN, A brain chemical known as the ‘love hormone’, is showing promise as a potential treatment for people with the eating disorder anorexia nervosa, according to research by British and Korean scientists.

In studies of anorexic patients, researchers found oxytocin altered their tendencies to become fixated on images of fattening foods and large body shapes - suggesting it could be developed as a treatment to help them overcome unhealthy obsessions with diet.

Anorexia nervosa affects millions of people worldwide - in-

52 EXPRESS PHARMA April 16-30, 2014

cluding around one in 150 teenage girls in Britain, where it is one of the leading causes of mental health-related deaths, both due to physical complications and suicide. While it mostly affects girls and women the condition can also affect males. As well as problems with food, eating and body shape, patients with anorexia often have social difficulties, including anxiety and hypersensitivity to negative emotions.

“Patients with anorexia have a range of social difficulties which often start in their early teenage years, before the onset of the illness,” said Janet Treasure, Professor, King’s College

London’s Institute of Psychiatry.

“By using oxytocin as a potential treatment for anorexia, we are focusing on some of these underlying problems,” she said. Oxytocin is a hormone released naturally in human bonding, including during sex, childbirth and breastfeeding.

As a synthesised product, it has been tested as a treatment for various psychiatric disorders.

Some studies have shown it has benefits in lowering social anxiety in people with autism. In the first of two studies, Treasure’s team analysed 31 patients with anorexia and 33 healthy controls who were given either oxytocin or a placebo. Participants

were asked before and after taking the drug or placebo to look at images relating to weight, high and low calorie foods, and fat and thin body shapes.

As images flashed up, the researchers measured how quickly participants identified them. If they had a tendency to focus on the negative images, they would identify them more rapidly.

The results, published in the Psychoneuroendocrinology journal, showed that after taking oxytocin, anorexic patients reduced their focus on images of food and fat bodies.

In a second study, published

in Public Library of Science journal PLOS ONE, the researchers used the same participants, the same drug and placebo, but tested reactions to facial expressions such as anger, disgust or happiness. After taking a dose of oxytocin, patients with anorexia were less likely to focus on the ‘disgust’ faces.

"Our research shows that oxytocin reduces patients' unconscious tendencies to focus on food, body shape, and negative emotions," said Youl-Ri Kim, Professor at Inje University in Seoul, South Korea who worked with Treasure.

Reuters

RESEARCH

FDA approves Paladin drug to treat tropical disease

Agios leukaemia drug shows promise in tiny: Study Patients in the study received either 30 mg or 50 mg of AG-221 twice a day AN EXPERIMENTAL drug being developed by Agios Pharmaceuticals showed promising anti-cancer activity in a tiny phase I study of patients with relapsed acute myeloid leukemia (AML), according to data presented.

Of seven patients available to be evaluated following a 28-day cycle of treatment with the drug, AG-221, six had what researchers deemed objective responses to the medicine.

Three of them achieved complete remission and two achieved complete remission with incomplete platelet recovery, meaning that the leukemia had exited their bone marrow but the blood platelet count had not yet returned to normal levels. “I’m very excited about what has happened with those patients so far who have responded,” the study’s lead investigator, Dr Eytan Stein of Memorial Sloan Kettering Cancer Center in New York, said. AML, the most common type of acute leukaemia in adults, is a

cancer of the blood and bone marrow that progresses quickly if left untreated.

AG-221 targets a gene mutation that is present in 10 per cent to 15 per cent of AML patients, Stein explained.

Stein, who presented the results at the American Association for Cancer Research (AACR) meeting in San Diego, cautioned that this was very preliminary data. “If the results are confirmed (in upcoming larger trials) that would be a remarkably exciting result,” Stein said of the first-in-class drug. Patients in the study had AML that had progressed after, or failed to respond to, up to four other therapies.

They all had the specific genetic mutation in the leukaemic cells that the drug is designed to impact, called isocitrate dehydrogenase-2, or IDH2. The treatment led to substantially lower levels of a cancer metabolite in the blood called 2HG that researchers believe reprogrammes white blood cells, stripping their

ability to become infection fighters. Stein noted that in the tiny group of patients there were no observable side effects that appear related to the drug itself, “which is very different from chemotherapy."

Patients in the study received either 30 milligrams or 50 mg of AG-221 twice a day.

Another arm of the trial was studying two higher doses, but

mistakenly attacks and destroys the protective sheath surrounding nerve cells in the brain, optic nerve or spinal cord. Symptoms may include loss of balance, difficulty moving arms and legs, weakness, numbness and blindness.

US REGULATORS approved a drug, Impavido, to treat the tropical disease leishmaniasis, which is caused by a parasite transmitted to humans through fly bites.

The drug, also known as miltefosine, is already approved for sale in Europe, the Indian subcontinent and Central and South America.

Leishmaniasis occurs primarily in people who live in the tropics and subtropics. Most US patients acquire the disease while travelling overseas. Impavido, made by Canada’s Paladin Labs, is an oral medicine approved to treat the three main types of leishmaniasis: visceral, which affects internal organs; cutaneous, which affects the skin; and mucosal, which affects the nose and throat. This is the first drug approved by the FDA to treat cutaneous or mucosal leishmaniasis.

Impavido is intended for patients 12 years of age and older, the agency said. The FDA said it granted Impavido fast track designation, priority review and orphan product designation, meaning the drug demonstrated the potential to fill an unmet medical need in a serious disease, the potential to be a significant improvement in the treatment of a serious disease and is intended to treat a rare disease. The labelling for Impavido includes a boxed warning that the drug can cause fetal harm and should not be given to pregnant women. Side effects seen in clinical trials of the drug included nausea, diarrhoea, headache, dizziness, abdominal pain, itching, drowsiness and elevated levels of liver enzymes.

Reuters

Reuters

that data was not yet available.

Stein said researchers were not expecting the impact seen with the lowest doses in the first handful of patients. “We were actually kind of surprised that at the first dose level we're seeing dramatic clinical activity. That usually doesn’t happen,” he said.

Reuters

FDAdelays decision on Biogen’s multiple sclerosis drug BIOGEN IDEC said the US Food and Drug Administration extended the review process for the company’s multiple sclerosis drug by three months to evaluate the application.

Biogen, which was expecting to launch the drug, Plegridy, by mid-2014, said the

FDA did not ask for additional studies. Plegridy, is an injectable drug designed to reduce the dosing schedule of standard interferon drugs such as Biogen’s own Avonex, which are typically dosed at least once a week. Interferon is hard to tolerate as it leads to flu-like symptoms, prompting

patients to delay or discontinue treatment.

Analysts say the market for such interferon-based treatments will shrink over the next decade as newer generation products enter the fray.

Multiple sclerosis is a chronic condition that occurs when the body's immune system

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April 16-30, 2014

PACKAGING SPECIAL

With the July 1 deadline fast approaching, savvy pharmaceutical companies are on track to implement the DGFT's mandate for 2D barcoding on all primary packs to be exported. The laggards are hoping for an extension but further delay could be counterproductive

J

uly 1 this year marks the deadline for all pharmaceutical companies in India to comply with an important mandate from the Directorate General of Foreign Trade (DGFT): to include a 2D barcode all primary packs due for exports. This step is the culmination of the DGFT's efforts to safeguard consumers from counterfeit and spurious pharma products, which started with a notification in January 2011. Initially DGFT mandated serialisation at all three levels (primary, secondary and tertiary packs) simultaneously but after industry protested, the Ministry

54 EXPRESS PHARMA April 16-30, 2014

BY VIVEKA ROYCHOWDHURY

decided to implement it in stages.

These norms for primary packaging state that exporters of pharma products will have to adopt a trace & track system by incorporation of 2D (GS1 Data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding the unique product identification code (GTIN) and unique serial number of the primary pack.

Pharma exporters have complied with the mandate first at tertiary and then at secondary levels and were initially scheduled to do it at the primary level by July 2013 but asked for more time, citing complexity and cost issues.

DGFT extended the deadline by a year but while most bigger players have complied or will do so by July this year, there are moves to ask for yet another extension.

Dr PV Appaji, Director General, The Pharmaceutical Export Promotion Council of India (Pharmexcil) indicates that based on complaints from many member companies, the organisation has flagged the issue with Rajeev Kher, Secretary, Department of Commerce who took over this January. The Secretary will be reviewing implementation of the serialisation initiative so far, to determine the extent of roll out (how

many companies) as well as the effectiveness at the customs office level.

This review process could take twothree months after which the Secretary will decide if further extension of the deadline is required.

Most larger exporters are revving up to toe the line. Biocon has already implemented 2D unique identification barcode technology at manufacturing facilities meant for exports, at both secondary and tertiary levels since 2011. Sarvanan Jeyabalan, Head Packaging Development, Biocon indicates that the company is now working with Pune-based Bilcare to extend this

technology to primary level of packaging to be in compliance with the DGFT’s latest ruling.

Alok Ghosh, President Technical Operations, Lupin hails the initiative as a “welcome and progressive move” which if implemented correctly, should make the supply chain process of exported goods fool-proof. He too confirms that Lupin has implemented 2D barcodes in all secondary and tertiary packs meant for exports and will be ready to incorporate 2D barcodes on primary packing by the July 1 deadline.

Ranbaxy introduced these systems for all manufacturing sites in 2012 and all packs meant for exports are compliant to this requirement from January 2013 including at the primary level, according to a company spokesperson.

In fact, the recommendation to use track & trace technology to counter spurious drugs came from industry itself as it suffered a loss of credibility in July 2010, when consignments originating from China were branded as 'Made in India' and the Nigerian regulator NAFDAC seized the consignments and designated them substandard/ spurious.

The DGFT’s mandate gets the thumbs up from such players, with the Ranbaxy spokesperson pointing out that India is among the first countries to introduce serialised packaging with unique numbers.

Jeyabalan too hails the move as it will eliminate the threat of spurious and counterfeit drugs making into the supply chain as well as build the credibility of Indian pharma exports which are expected to cross $20 billion by 2020.

Regulatory push The increasing threat of counterfeit/ spurious drugs has forced regulators and governments across the globe to implement such systems and the move has only picked up speed over the past decade.

As Harpal Singh, Director-Business Development, ACG Inspection Systems says, “Worldwide different serialisation guidelines have been defined by national regulatory bodies.” In India, it’s the DGFT, while in the US it is the Healthcare Distribution Management Association (HDMA) which is the national trade association representing primary distributors of prescription medicines and healthcare products in the US. Similarly, in Europe, the European Federation of Pharmaceutical Industry Associations (EFPIA) chose Sweden to run a pilot serialisation project in 2009. This was the basis for the EUwide coding and serialisation system, the European Stakeholder Model (ESM) involving EFPIA, the European Association of Euro-Pharmaceutical Companies (EAEPC), Groupement In-

ternational de la Répartition Pharmaceutique (GIRP), and Pharmaceutical Group of the European Union (PGEU). The system thus brings together all stakeholders: Europe’s researchbased manufacturers, the pan-EU licensed parallel distribution companies, wholesalers and pharmacists.

The first step to develop an electronic pedigree involves the serialisation of products at different packaging levels. Singh points out that most serialisation guidelines have one common point that requires each product to be uniquely labelled in order to be easily identified or authenticated.

Following complete serialisation of products, companies need to establish a relationship (parent-child) between products at different packaging levels to create a product hierarchy also known as a pedigree. Developing and maintaining a pedigree allows greater transparency and traceability regarding the origins and movements of products throughout the pharma supply chain.

It is important to consider that packaging requirements on imports differ from country to country. Ghosh clarifies that as per DGFT rules, if importing countries have specific rules for tracking genuineness of any product, then DGFT rules will not be applicable. For example, in the US, National Drug Codes (NDC) are followed which identify the manufac-

turer along with products at the SKU level. France has a mandatory rule that all imported products should have 2D barcodes. Thus while exporting to the US and France, DGFT rules as they exist today will not be applicable.

Thus for a smaller player it could be costly to implement different systems for each destination country.

The technical complexities of the process adds to the cost as well. Ghosh admits that for smaller packs, it is really a challenge to print the barcode on the label. DGFT then redefined primary pack as saleable pack to address the space constraint problem.

Technical complexity Early attempts to implement barcoding at primary pack level faced difficulties due to the limitations of the most common system used at this level, the in line printing system. Giving more details, Avinash Mandale, Vice President, Global Business Development, Bilcare says, “The problem of using in line printing on primary packs, especially on high speed packaging lines, is that it becomes extremely difficult to not just print a barcode but also scan and upload this information into the system.”

Further, considering that the bulk of primary packs are blister packs, this system results in the formation of nearlings, which are small bubbles/dots between the aluminium and plastic film of

COMPARATIVE ANALYSIS OF SOME KEY FEATURES OF VARIOUS TECHNOLOGIES AGAINST NON-CLONABLE ID TECHNOLOGY Key Feature Requirement

SMS Technology

RFID

Serialised barcode

Non-clonable ID technology

Clone-proof

No

No

No

Yes

Anytime Anywhere Authentication & Track-n-Trace

No

No

No

Yes

Consistency & Accuracy

End-user dependent

~ 95%

~99.9%

~99.9%

Privacy

No

No

No

Yes

Affordability & Ease of Deployment

Yes

No

Yes

Yes

Implied needs

No

No

No

Yes

For smaller packs , it is really a challenge to print the bar code on label. Accordingly DGFT has redefined primary pack as saleable pack, so barcoding should be possible Alok Ghosh President Technical Operations, Lupin

We welcome the decision of the DGFT to implement 2D barcoding on primary packaging for exports, as it will eliminate the threat of spurious and counterfeit drugs making into the supply chain. It will also build the credibility of Indian pharma exports which are expected to cross $ 20 billion by 2020 Sarvanan Jeyabalan Head Packaging Development, Biocon

Source: Bilcare EXPRESS PHARMA

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PACKAGING SPECIAL COMPONENTS OF THE VERIF-I SOLUTION

Bilcare's non-ClonableID technology uses pre-printed nonclonable tags which need to be directly stuck onto the primary packs.

Each 12x12mm tag has pre-printed barcodes, with GTIN and unique serial number, as well as an authentication feature on the lower side Avinash Mandale Vice President, Global Business Development, Bilcare

For pharma companies exporting particularly to the US market, we’ve introduced a 360degree bottle and label code inspection that’s capable of capturing defects, if any, from any direction Harpal Singh Director-Business Development, ACG Inspection Systems

56 EXPRESS PHARMA April 16-30, 2014

the strips, which makes scanning difficult, says Mandale.

Bilcare's solution, called the nonClonableID technology, which is currently being installed at Biocon, uses preprinted non-clonable tags which need to be directly stuck onto the primary packs. Each 12x12mm tag has pre-printed barcodes, with GTIN and unique serial number, as well as an authentication feature on the lower side.

(See Table: Comparative analysis of some key features of various technologies against non-clonable id technology) Mandale says the primary pack tags are supplied in a roll form and can be applied on-line on blisters, strips etc. on packing lines. A specialised application system affixes these tamper-evident primary pack tags, which get scanned on-line post application on primary packs. Once the data gets uploaded in the system a parent-child relationship also gets established on-line.

Verif-i, a track and trace solution developed by ACG Inspection Systems, can be used for tertiary, secondary as well as primary packaging levels. Within primary packaging, products supported include bottles, mono cartons, labels and blisters.

T

he Verif-i solution consists of a Verif-i server, hardware such as cameras and printers for primary, secondary and tertiary packaging levels, and an external server (for example, EPCIS repository).As seen in the figure, the Verif-i solutions at different packaging levels (primary, secondary and tertiary) capture and report the appropriate (commissioning or aggregation) events.The data is reported to a plant server where is it stored until the product is shipped from the site.When the product is shipped, a transfer shipment event is triggered and data is uploaded to an EPCIS repository.The reports for each packaging level are available both at the client as well as the server systems.The server system allows the user to obtain the production report for any packaging level from any plant.

Singh mentions that for pharma companies exporting particularly to the US market, his company has introduced a 360-degree bottle and label code inspection that’s capable of capturing defects, if any, from any direction.

Giving details of the process (See flow chart: Components of the verif-i solution) , he explains, “At the primary level, the Verif-i primary solution interacts with Verif-i server that generates random serialisation numbers.

After this, the Verif-i primary solution prints the serialised data/GTIN number in a 2D datamatrix or as per regulatory guidelines for primary packaging. A GS1 compliant camera-based system is used to inspect printed or pre-printed data.”

A stitch in time …

Given that the pharma industry in India is very fragmented and has a number of

SME players, it is understandable why associations like Pharmexcil have been swamped with pleas to delay the process. Ghosh of Lupin says the overall cost (of implementing such a system) would go up and some small players may find this prohibitive but turnkey solutions are easily available and being provided by various vendors.

The Ranbaxy spokesperson too agrees that the initial investments are high and may require skilled technicians to run the equipment but the system will definitely benefit the Indian pharma industry in the long term.

Singh says that they’ve been working closely with several of the customers to ensure 100 per cent compliance but does agree that there could be several barriers while setting up track & trace systems. However, he opines that it ultimately

proves to be a value vs. cost argument. “A lapse in ensuring maximum level of tracking and traceability could leave major pharma companies at the risk of huge loss to brand value, massive lawsuits and product recalls, and, most importantly, patient safety,” he points out.

Many players have taken similar precautions to safeguard their products in the domestic market. Ghosh for instance reveals that Lupin has already implemented an SMS based system in the domestic market as an anticounterfeiting measure taken by the company. Given these examples of successful implementation, the DGFT may not delay the final stage of this process. After all, at stake is India's hard won reputation as a global source of reliable, safe and quality medicines. viveka.r@expressindia.com

PACKAGING SPECIAL

Packaging trends: The future of manufacturing Unveiling the packaging and manufacturing trends and shedding light on future opportunities will help market players anticipate the challenges and remain on the cutting edge in terms of innovation. Express Pharma presents perspectives of two experts from the The French Packaging and Processing Machinery Trade Association, the GEPPIA’s white paper, ‘Packaging Trends: The future of manufacturing"

An American’s stance on global packaging trends ach geographical zone, whether it be Asia, Europe or North America, dictates its priorities based upon consumer habits, the weight of state in the economy and how much the companies invest in innovation.

The packaging industry is no exception ; each zone pushes the industry to progress in specific directions. Often a zone is a trend setter, encouraging its neighbours to follow in its wake.

E

Innovation on the North American market Starting with the pharmaceutical area, which is a big part of packaging industry in North America, there is a strong push for unit dose packaging to replace standard high density polyethylene bottles.

Wal-Mart had made it very clear that they would like the industry to align themselves with other consumer goods and introduce blister packs containing unit doses.

Staying in pharma, serialisation is also an emerging request, meaning that every package should have a unique code. There is legislation coming out of California that will spread across the whole country. That is an opportunity for any company with an expertise in track & trace and serialisation technology.

Lastly compliance prompting technology and calendarisation are introduced in drugs, meaning that packs remind patients that they did or did not take their medication at the right time.

Generally moving out of the pharma area, stand-up pouches have not been that popular in the States. We have lagged behind Europe. But they are gaining market share as filling speeds are almost matching those of rigid containers.

The applications for standup pouches are expanding. The one-quart high density polyethylene bottle for motor oil is now displayed alongside the standup pouches in the outlets. For granular products like sugar the pouches can also replace the bag-in-box cartons.

In the controls area, information technology is impacting packaging machinery and complete lines. Real time visibility into packaging operations is becoming crucial. The main goal is asset utilisation. If manufacturers cannot see and get data from their packaging lines in real time they do not know if their assets are properly used.

These new software and data acquisition technologies are being pushed heavily.

Full-wrap shrink sleeves are increasingly popular for bottle labelling, largely because of the

Real time visibility into packaging operations is becoming crucial. The main goal is asset utilisation float in the float/sink process and don’t contaminate the PET flake when they reach the recycle stream.

The 2012 edition of the Tokyo Pack unveils Asia’s technology focuses

PAT REYNOLDS VP / Editor, Packaging World

quality of their graphics. The solution is however encountering a setback. Napcor, the National Association for PET Container Resources, stated in a March 2012 position paper that when the shrink sleeve labels reach the PET reclaimers, the label materials

sink to the bottom along with the PET flakes, contaminating them.

As a result Napcor is strongly recommending a switch to stretch sleeve labels, the ones that don’t need to be shrunk at all, because the new materials, many of them PE,

In the field of permeability control for fresh respiring produce, there are new laser technologies that operate at ultrahigh speed and accuracy on flexible films. In a separate development, Toyo Seikan introduced a laser technology that instantly eliminates the bubbles off the surface of carbonated drinks such as soda and beer.

The presence of the bubbles has always been a drag on filling speeds, so this innovation could pave the way to faster speeds.

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PACKAGING SPECIAL

Focusing design innovation on sustainability n the pharmaceutical area, packaging is very important, and it is becoming an integral part of new drug development. Traceability, new materials, formats and ergonomics are the focuses for improving packaging.

Traceability is critical for the safety and service provided to patients.

Packaging accounts for approximately 38 per cent of our production purchases. We are therefore permanently working on optimising it as we regard it as a competitive advantage that brings value-added to the product’s marketing mix.

We are therefore working closely with our franchises (urology-oncology, neurology and endocrinology) on new packaging concepts, both primary (for example, pre-filled syringes) and secondary.

For specialty care products, the ‘device’ is more and more often considered an integral part of the drug. It becomes essential in terms of quality of life for the patient: the objective is to offer ready-to-use formats, as user-friendly as possible with a maximum level of safety. The preliminary meetings between the marketing department, designers and manufacturing is therefore more and more meaningful in order to integrate very early requirements from the market and from patients in terms of efficiency and ease of use, but also of manufacturing costs.

ers systematically include questions relating to ethics, environment, safety and health. These are now essential selection criteria. Lastly, as regards preventing waste, the issue is to rationalise packaging size by making sure that it doesn’t contain an excess of air; in other words, reducing the packaging size to what is strictly necessary, obviously without impacting product quality.

I

Choosing compatible materials and adapting formats When choosing materials, we are limited by their compatibility with our products. High quality glass remains our reference material, although it is very fragile. Manufacturers have besides considerably improved glass, particularly with the development of different forms and more accurate molding.

We also use plastic (less fragile and lighter), for example on our pre-filled Somatu-

58 EXPRESS PHARMA April 16-30, 2014

Rolling out Datamatrix

ERIC DRAPÉ Executive Vice President Technical Operations, Ipsen

line Autogel syringe.

As regards conventional products (such as capsules and pills), we traditionally use PVC blisters or aluminum-based packs so as to keep moisture out.

Patient consumer habits differ noticeably between countries, depending on their living standards. This in turn impacts packaging size. Where in France a standard Smecta box contains 30 to 60 doses, we may market 10-dose packaging (and get closer to the unit dose form) in other countries in order to decrease the purchase price and adapt it to local market requirements.

Sustainable development, a major issue As regards sustainable development, we find the PSCI (Pharmaceutical Supply Chain Initiative) approach very interesting.

At Ipsen, all our calls for tender for choosing our suppli-

For specialty care products, the ‘device’ is more and more often considered an integral part of the drug. It becomes essential in terms of quality of life for the patient

Traceability is another important development focus.

Unit dose traceability, such as vials, through the new Datamatrix-type coding system has been rolled out on all our facilities in order to meet French legal requirements. The progress towards unit dose traceability (serialisation) is planned to meet the requirements of the European directive against counterfeit drugs. The globalisation of distribution methods, particularly on the Internet, involves having an efficient traceability system in order to maximise safety for patients.

This implies significant developments at the level of packaging, production lines, information systems, production methods and processes.

We must define the Group’s common standard solution that we will implement on all our packaging lines.

Tracking and tracing is currently carried out per batch with a bar code system and easy-to-copy batch numbers.

The new Datamatrix systems allows unit traceability on tertiary (crate or pallet) or secondary (case, box) packaging, and also, as some countries are requesting, at the level of primary packaging (vial, blister).

This makes it possible to customise the product that is distributed to the patient. If a doubt or a problem is brought up, it is easy to trace information on the vial or the box, which increases the level of safety but also the reliability

and accuracy of information.

These systems are also capable of coding much more data than the traditional bar code system.

Moving towards smart drugs Smartphone also opens up promising prospects with simple applications that for example allow a patient to check the dosage, the origin of the product, its purpose, its expiry date, etc., or also vocal systems that help visually impaired users. Smart packaging also connects consuming the drug to databases.

For example, if you suffer from diabetes, the IT system can make dosage recommendations depending on your blood sugar level.

If a patient is undergoing background therapy, one could easily imagine that he enters data regarding his medication in his smartphone, which would feed a database to which his doctor has access. The latter could remotely check his patient’s condition and give him recommendations.

We would get to a more personalised, interactive, reactive treatment where you would no longer need to wait for your quarterly visit to the practitioner for a review.

Constantly evolving traceability Cold chain management could also benefit from the new technology. A monitoring device integrated in each packaging is quite conceivable. Upon reading the code, for example when purchasing at the pharmacy, it would be possible to check, one vial at a time, whether the cold chain instructions have been respected.

The pharmaceutical industry has always been in the lead as far as traceability is concerned. Technological innovations make it possible to consider ever more efficient solutions and to go further in tracing a drug during its entire lifetime.

PACKAGING SPECIAL NEWS

Bosch to present new training concept at Interpack 2014 Offers customers and employees a standardised knowledge pool for the entire machine portfolio from Bosch Packaging Technology BOSCH PACKAGING Technology will presents its new concept for technical trainings at Interpack 2014. The division has begun to establish a worldwide training platform under the umbrella brand Bosch Packaging Academy, offering customers and employees a standardised knowledge pool for the entire machine portfolio from Bosch Packaging Technology.

“The centrally bundled programme makes it easy for customers to choose their suitable training product, especially for topics covering different technologies,” explains Severin Diepold, Project Manager, Bosch Packaging Services.

The Bosch Packaging Academy comprises individual centres of competence and local country academies. The sites in Crailsheim, Germany and Beringen, Switzerland are the first centres of competence to offer specific technical trainings for the product divisions pharma and confectionery and food under the academy umbrella.

Bosch further integrates sites into the comprehensive training concept, step by step, in order to make standardised trainings for the entire product portfolio available worldwide and from a single source. In the coming years, Bosch will further add local country academies for basic trainings to the Academy, amongst others in China and Egypt.

Customers will have the opportunity to choose from three different training modules: basic trainings for the safe and efficient operation and maintenance of Bosch

… moves to new location at Musashi, Japan BOSCH PACKAGING Technology has moved into a new location at Musashi, near Tokyo. Since the move in late March, over 100 associates have been developing and manufacturing inspection technology for the pharma industry on premises covering 3,240 sq mt. A total of euro 1.6 million was invested in the new site. Following relocation from Honjo to the much larger Musashi site, Bosch Packaging Technology now has considerably more space at its disposal for the

Bosch Packaging Academy

machinery, advanced trainings for increased productivity, as well as specific programmes for specialist topics such as Good Manufacturing Practice (GMP), servo technology or IT. With a combination of different training methods such as theoretical lessons, multimedia training and hands-on experience, Bosch offers its customers maximum flexibility.

In addition to training

sessions at individual academy sites, Bosch also offers trainings at customers’ premises.

Depending on the module, different trainers manage the courses: while country trainers are available as experts for basic machine knowledge in the respective local language, specialist trainers from the individual centres of competence teach in-depth content.

EP News Bureau-Mumbai

development and assembly of its machines. This investment in the Musashi site underscores the company's commitment to Japan as a major market for pharma inspection technology.

“Expansion of the Bosch global centre of competence in Japan is important for our innovative strength,” said Peter Tyroller, Member of the Bosch board of management with responsibility for the Asia-Pacific region.

In the pharma industry, demand for product safety and quality – and thus also for inspection solutions – is constantly rising. “We want to build on the experience we have amassed in Japan over many decades and offer our customers technology that is ‘Invented for life’ around the world,” said Joachim Baczewski, Head of the Inspection Technology Pharma unit and General Manager of Bosch Packaging Technology in Japan.

The Inspection Technology unit was established in 2012 following the acquisition of Eisai Machinery, a Japanese company. It comprises manual, semi-automated, and fully automated inspection machines designed to identify particles in pharma products. It also includes the cosmetic inspection of containers or tablets in order to detect defects such as scratches or discoloration.

EP News Bureau-Mumbai

EXPRESS PHARMA

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April 16-30, 2014

PACKAGING SPECIAL

DIR Technologies to present lecture at Pharmapack North America

Bryan Cox takes charge as Director of TechnologyTransfer of Pharma Tech Industries

Bob Hartwig, Managing Director, BTS International, representing DIR Technologies, will speak on first package sealing integrity inspection technology using thermal imaging

Industry veteran, who joined PTI in 2010, promoted from previous position as plant manager

BOB HARTWIG, North American Representative for DIR Technologies, a provider of premium packaging inspection and product authentication solutions for the pharma industry, will deliver an in-depth presentation discussing the company’s groundbreaking package sealing inspection technology on June 12 at Pharmapack NA, which this

year will take place at the Jacob K Javits Center in New York City. The new inspection system is the first of its kind to utilise thermal imaging, an infrared science allowing packages to be thoroughly examined without physical contact or visible illumination.

Hartwig will also participate in a panel discussion discussing the latest advances in bottling

60 EXPRESS PHARMA April 16-30, 2014

and blistering technologies, as well as the pros and cons of these packaging methods.

Thermal imaging has the potential to bring a paradigm change to in-line quality control by replacing sporadic, destructive package sampling with continuous, non-invasive process verification. Thermal imaging offers real-time testing of 100 per cent of the products

on a line, real-time process monitoring, full records (including photos) for every product, and very high throughput with no production slowdown – all in an entirely non-destructive, non-interfering fashion.

Among DIR Technologies’ first machines employing thermal imaging is the I2VS (Induction Integrity Verification System), which tests in-line the

integrity of aluminum foil sealing on induction-sealed bottles. The I2VS is the first system capable of inspecting 100 per cent of bottles undergoing induction sealing, without resulting in production slowdown and providing continuous process verification.

Until very recently, high sensitivity thermal imaging had been mostly used in defense and

aerospace application. The emergence of a new generation of lower cost/lower sensitivity uncooled detectors has led to an increased use of thermal imaging for a wide range of applications, such as security; industrial monitoring; fire-fightering, automotive (night driving), commercial aviation, NDT and even sports.

EP News Bureau – Mumbai

PHARMA TECH Industries (PTI), pharma contract manufacturer and packager of powder products, has promoted industry veteran Bryan Cox to the position of Director of Technology Transfer. In his new role, he will oversee all commercialisation activities for the transfer of technology and integration of new customers at all of the company’s manufacturing sites. Cox originally joined PTI in October 2010 as a staff engineer and, in 2012, was promoted to plant manager of the company’s primary facility in Royston, GA. Before joining PTI, Cox was a Senior Engineer at Remington Medical. Prior to that, he served two years as R&D Program Manager at Pixel Optics and, earlier, held numerous positions throughout his nine years at Johnson & Johnson.

“During his tenure with PTI, Byran has consistently demonstrated success managing a diverse roster of projects effectively,” said Tee Noland, Chairman, PTI. “As PTI continues to add new services and take on new customers, Bryan will play an instrumental role in leading the technological transfer process to ensure flawless execution during the hand off between sales and commercial production.”

Cox holds a degree in Mechanical Engineering from the University of South Carolina, and a Masters in Business Administration from Clemson University. He is a member of the Society of Professional Engineers, and

currently resides in Braselton, GA, with his family.

For PTI, Cox’s promotion comes amidst a period of growth that has seen a host of expanded and upgraded capabilities and services.

PTI recently broadened its on-site testing capabilities at its Royston, GA plant by completing a new analytical laboratory for both Rx and OTC drugs. The company also is currently expanding its production facility in Union, MO. The investment will add approximately 60,000 sq ft of manufacturing space, which will be used primarily for the production of ingestible powders and include a production room built to ISO8/100,000 clean room standards. The project is scheduled to be completed in fourth quarter 2014.

EP News Bureau – Mumbai

PACKAGING SPECIAL

Videojet Technologies to showcase its latest technology breakthroughs at Interpack 2014 Will launch the latest in print and apply labelling (LPA) innovations ADDRESSING PACKAGING, food and pharma manufacturers’ coding and marking needs for speed, simplicity and reliability, Videojet Technologies will showcase its latest technology breakthroughs at Interpack 2014, to be held in Dusseldorf, Germany from May 8-14, 2014 in Hall 6, Stand A01.

Videojet will launch the latest in print and apply labelling (LPA) innovations, intelligently designed to remove the mechanisms that frequently cause everyday operational problems such as label jams. The new LPA system was conceived to increase reliability, efficiency and productivity for outer case and bundle packaging.

The event will also see the official launch of three other brand new innovations in the

field of print applications. For high-resolution coding on non-porous packaging, Videojet has designed a breakthrough print solution that combines the high resolution and simplicity of Thermal Ink jet (TIJ) Technology with Methyl Ethyl Ketone (MEK) industrial ink performance.

In addition, Videojet will present its advanced range of CO2 laser marking systems engineered to extend marking speeds, breaking the boundaries of traditional laser printing capabilities. Also being unveiled is an intuitively-simple Code Detection System that verifies the presence of ink jet printed codes, providing an advantage over manual sampling by increasing the sheer number of products that can be inspected.

Videojet_8610_Equipment

Another breakthrough is the collaboration between Videojet and sister company Esko demonstrating how the leading packaging design software can be leveraged to more easily print variable product information,

with fewer mistakes, real time at the factory floor.

Chris Riley, VP Marketing, Videojet Technologies said, “Innovation that delivers real customer value needs to go far beyond printer design. At Video-

jet, we invest significant time and energy to gain a deep understanding of how our products are used in real-world applications, allowing us to identify potential areas for improvement. By focusing on our customers’ broader needs including constant uptime, integration ease, perfect coding and simple operation, we have delivered innovations designed to take away the pain associated with printing and coding.

Through intelligently-designed labelling, coding and marking systems, our customers can leverage their printing assets to help increase their top line profits and reduce bottom line costs through virtually zero unscheduled operational downtime and reduced coding errors.”

EP News Bureau – Mumbai

Romaco Group to organise Romaco Kilian Event on May 8 CEO of Group to discuss a new strategic approach for Romaco as a long-term partner of the pharmaceutical industry DURING INTERPACK 2014, which will be held in Dusseldorf, Germany from May 8-14, 2014, Romaco Group will host Romaco Kilian an event 'Exploiting technologies and going beyond…' at Kilian Tableting, Scarletallee 11, Cologne, Germany. The special guest during the event on May 8, 2014, will be Jutta Kleinschmidt, racing driver and winner of the Dakar Rally. Attendees will be treated to some exciting talks and presentations spanning topics such as process optimisation, teamwork and failure management – from very different perspectives.

Speakers will include Paulo Alexandre, Chief Executive Officer, Romaco Group, who will speak on 'Exploiting technologies and going beyond – a new strategic approach for Romaco as a long-term partner of the pharmaceutical industry.'

Alexandre will talk about the future trends identified by Romaco in the pharmaindustry and describe how the Romaco Group is developing new strategies to address these challenges.

Philippe Cappuyns, Global Technical Services, Janssen Supply Chain, Unit of Janssen Pharmaceutica NV, Johnson &

Johnson, will talk about “The latest trends in the pharma industry.' Cappuyns will discuss how technological innovations, a long-term sustainable vision and operational strategy and structured, disciplined project management can be applied to bring the pharma industry into line with tomorrow's world.

The keynote speaker will be Jutta Kleinschmidt, racing driver, the only woman to have won the Dakar Rally. Live presentations will be given on the complete Romaco Kilian product portfolio.

The highlight of the event will

be a presentation of almost every product in the current Romaco Kilian portfolio.

Amongst other things, the newest generation of the KTP 420X high speed tablet press, which has won the iF Award 2014 for innovative design, will make its début. The KTP 420X impresses with high uptime, strict hygienic compliance and a new and even more intuitive HMI. STYL’ONE, the singlestroke tablet press for laboratory applications, will be demonstrated for the first time with a concept study of process analytical technology (PAT).

The patented measuring sensor in the pressing tool allows tablet quality data to be gathered inline as the products are pressed.

The significantly shorter times to market when developing new tablet formulations are a great advantage for users.

The Romaco effervescent application, a solution for producing and packing effervescent tablets – from a single source, with a single contact and with worldwide service – comprising Romaco's Kilian, Siebler and Promatic brands, can also be experienced live in action.

EP News Bureau – Mumbai

EXPRESS PHARMA

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PHARMA ALLY VENDOR NEWS

COMSOLConference 2014 calls for research papers Selected papers, posters, and presentations will be featured at the 10th annual COMSOL Conference to be held in Boston from October 8-10, 2014 THE PROGRAMME Committee members of COMSOL Conference 2014, a premier event for multiphysics modeling and simulation are inviting engineers and researchers to submit abstracts to this year’s event.

Selected papers, posters, and presentations will be featured at the 10th annual COMSOL Conference. This year, the conference will be held in Boston from October 8-10, 2014.

Presenting a poster, paper, or both at the COMSOL Conference is a great opportunity for multiphysics users to achieve widespread recognition within a skilled community of engineers and researchers.

“COMSOL users who pres-

ent at the conference will have their work recognised and shared with more than 165,000 people.

Engineers and scientists will have a unique chance to present in front of colleagues who are working through similar problems,” says Jinlan Huang, Program Chair for the Boston conference.

“Attendees can really benefit from sharing new simulation techniques and innovative design strategies.”

The highlights of the conference will be applicationspecific mini-course sessions taught by COMSOL specialists covering a wide array of disciplines; keynote talks from industry leaders and prominent researchers; an exhibition

The highlights of the conference will be application-specific mini-course sessions taught

by COMSOL specialists covering a wide array of disciplines showcasing products offered by COMSOL Partners; the exciting introduction of the newest version of COMSOL Multiphysics; the chance to interact with peers and explore the simulation work of engineers.

Some of the suggested presentation topics include: AC/DC electromagnetics; acoustics and vibrations; batteries, fuel cells, and electrochemical processes; bioscience and bioengineering; chemical reaction engineering; computational fluid dynamics;

electromagnetic heating; geophysics and geomechanics; heat transfer and phase change; MEMS and Nanotechnology; microfluidics; Multiphysics; optics, photonics, and semiconductors; optimisation and inverse methods; particle tracing; piezoelectric devices; plasma physics; RF and microwave engineering; simulation methods and teaching; structural mechanics and thermal stresses and transport phenomena.

Papers and posters presented at the conference will be published on the COMSOL website where they reach a worldwide audience of engineers.

EP News Bureau-Mumbai

Infosys Public Services to set up testing centre of excellence Prime Therapeutics will streamline and optimise its quality assurance and testing services INFOSYS PUBLIC Services, a US-based subsidiary of Infosys, has been selected by Prime Therapeutics, a leading pharmacy benefit manager (PBM), will set up a testing centre of excellence (COE) and consolidate the delivery of its application testing services as part of a new three-year contract.

Prime Therapeutics will streamline and optimise its quality assurance (QA) and testing

62 EXPRESS PHARMA April 16-30, 2014

services as well as enhance its competitiveness with Infosys Public Services’ expertise and world-class delivery model.

Prime Therapeutics also expects to expand the capabilities of its QA organisation and gain efficiencies in managing a large scale QA department.

“We look forward to bringing our deep experience in the healthcare industry and pharmacy benefit management in

particular as well as globally benchmarked QA and testing service delivery to Prime Therapeutics,” said Eric Paternoster, President and Chief Executive Officer, Infosys Public Services.

As part of the contract, Infosys Public Services will consolidate and standardise Prime Therapeutics’ QA and testing services, currently provided by multiple service providers. Infosys Public Services will sup-

port Prime Therapeutics’ QA organisation as they deliver across all lines of the business and increase the agility of the QA department. Prime Therapeutics will be able to improve application and service quality, and reduce IT costs with Infosys Public Services’ range of QA and testing frameworks, techniques, tools and accelerators.

“The rapidly evolving healthcare industry demands faster re-

sponse and improved information technology quality to ensure Prime Therapeutics’ competitiveness,” said Jim Graham, Vice President Application Development, Prime Therapeutics.

“Transforming our testing and QA services will help us achieve that and better meet the needs of health plans, employers, and government programmes.”

EP News Bureau – Mumbai

Ashland opens pharma centre of excellence in Hyderabad The facility specialises in oral solid dosage form research and expands Ashland’s global reach, pharmaceutical research and footprint outside of North America ASHLAND SPECIALTY Ingredients, a commercial unit of Ashland has opened a new pharmaceutical centre of excellence in Hyderabad. This is the ninth centre of excellence that Ashland Specialty Ingredients has opened, and it joins Ashland’s global network of three dozen research and development and technical centres. The state-of-the-art facility specialises in oral solid dosage form research and

ties allow us to drive growth and deliver innovation where our customers are located.

This facility provides our customers in India and throughout the region with a centre of excellence to develop and enhance their pharmaceutical formulations.”

“Research and development dedicated to optimal yields and lower variability in oral solid dosage forms is essential to the future success of

At our new centre of excellence, we bring together our expertise in process technology and our knowledge in materials science to further support the quality, safety and efficiency of oral solid-dosage forms.”

“The Ashland Pharmaceutical Specialties research and development team takes a very customer-focused approach to our business. Roughly 70 per cent of our current R&D proj-

technical assistance for specific requests from customers.

Superior technical service forms an important part of our offering and distinguishes Ashland from our competitors.

The products we manufacture are supported by a global network of research and application scientists and technically trained salespeople.”

This centre of excellence expands Ashland’s global network of R&D and technical

Padma Shri Dr AV Rama Rao inaugurates Ashland Pharmaceutical Centre of Excellence

expands Ashland’s global reach, pharmaceutical research and footprint outside of North America.

“A key Ashland commitment is to be close to our customers,” said Luis FernandezMoreno, President, Ashland Specialty Ingredients, during the opening ceremony. “Investments in state of-the-art facili-

the pharma manufacturing industry,” said Jim Mish, Group Vice President, Consumer Specialties, Ashland Specialty Ingredients.

“Emerging manufacturing processes, such as continuous manufacturing by spray drying or hotmelt extrusion, is one component of this equation.

Excipients science is another.

ects involve working directly with our customers on a collaborative basis,” explained Tom Dürig, Senior Director, global pharmaceutical R&D, Consumer Specialties, Ashland Specialty Ingredients.

“We provide customised training on product applications to our customers. Additionally, our team can provide

support facilities dedicated to the advancement of consumer products. It’s another major investment following the opening of personal care centre of excellence in Mumbai, India, in 2012. Ashland Specialty Ingredients has nine centres of excellence around the world.

EP News Bureau-Mumbai

Intertek organises ELSeminar in Mumbai INTERTEK, A leading quality solutions provider to industries worldwide recently organised and presented a seminar ‘Manage your Extractable & Leachables Risk’ in Mumbai.

The one-day seminar focused on providing detailed information and practical guidance on the issues associated with extractables and leachables (E/L) studies.

An important part of pharmaceutical development is the assessment of substances that could potentially leach (leachables) into the drug product from packaging, components of printing ink, catalyst residues and heavy metals. E/L studies provide qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product.

The key topics of discussion were regulatory requirements and the basics of polymer stabilisation and degradation required in packaging of process, benefit of extractables and leachables testing for understanding the influence of material used in pharma process, concepts of designing and executing E&L studies of container closure system and E&L strategies for process material like tubing, filter media etc. The seminar provided insightful details regarding analytical approaches for evaluating E/L from different sources such as packaging or printing inks and also expert guidance on how to interpret analytical data in order to gain insight into risk assessment and validation of different manufacturing processes from an extractables and leachables perspective.

EP News Bureau – Mumbai

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PHARMA ALLY

Aesica led group wins grant Funding secured for project to investigate an industrial biotechnology process to enable improved sustainable manufacture of an API AESICA, A global pharmaceutical contract development and manufacturing organisation (CDMO), has led a consortium, also comprising Charnwood Technical Consulting, CatScI and Biocatalysts, which has successfully won a Technology Strategy Board grant directed at funding sustainable, high value chemical manufacturing achieved through industrial biotechnology. The winning project is focused on establishing an industrial biotechnology process aimed at improving the sustainability of the manufacture of an active pharmaceutical ingredient (API).

The grant is designed to both assist commercial entities in trialling new processes and to create demonstration scale

prototypes.

The overall project, valued at £200,000, is scheduled for completion in 2014.

The funding for the project meets the Technology Strategy Board’s objective of fostering collaboration between the chemicals sector and industrial biotechnology developers, combining biological and chemical practices. Biocatalysts will use ‘Design for Manufacture’ principles to discover, develop and manufacture novel enzymes for the production of active pharma ingredients.

CatScI will perform the proof of concept studies to assess the feasibility of a value-adding novel industrial biotechnology route to an active

pharmaceutical ingredient.

Charnwood Technical Consulting will provide expertise to help design and scale-up the process, as well as guidance on quality and regulatory issues. Aesica will manage the overall project and carry out scale-up studies to determine the feasibility of the technology at larger scale.

Utilising biocatalytic processes in the production of high value chemicals is environmentally friendly and forms part of an initiative to assist the chemicals industry in the shift away from dependency on fossil fuels towards a bio-economy based on renewable and biological compounds.

EP News Bureau – Mumbai

AK Gupta gets a doctorate degree from London University Honour was bestowed in recognition of the record created by ‘Bharat Mata Mandir-Delhi,’ a photo museum of freedom fighters of India ARVIND KUMAR Gupta, Managing Director of Pharma Synth Formulations and founder of Bharat Mata Mandir-Delhi was recently conferred with a Doctorate degree at a convocation held at Ho Chi Minh City, Vietnam by World Records University, London.

This honour was bestowed upon Gupta in recognition of the record created and registered in the India Book of Records, in the name ‘Bharat Mata Mandir-Delhi,’ a unique and one-of-its-kind photo museum of freedom fighters of

64 EXPRESS PHARMA April 16-30, 2014

India, which has more than 270 portraits of freedom fighters from 1600 to 1947 along with pictures of important events.

Bharat Mata Mandir-Delhi is a social project to promote patriotism under the aegis of Bharat Mata Foundation which is engaged in promoting activities related to value education, medical relief and environment. The foundation was started to distribute free and affordable medicines to the common citizens of India.

Gupta says, “Although the government is trying to provide af-

fordable medicines through its channels, poor in the remote areas are deprived of these benefits. Bharat Mata Foundation's medicines will try to cater to this segment of population alongwith other segments. Through this project, we will provide premium quality medicines at rates lower than the popular brands.”

Gupta is also a well known motivational guru and has got many prestigious national and international awards.

EP News Bureau-Mumbai

Waters Corporation launches software packages New software functionality addresses broad range of proteomics, metabolomics, and lipidomics applications WATERS CORPORATION has unveiled two new data analysis software packages for proteomics and metabolomics/ lipidomics analyses: Progenesis QI and Progenesis QI for Proteomics.

These new releases of the highly acclaimed software packages are an early result of Waters’ acquisition of Nonlinear Dynamics.

Progenesis QI software enables researchers to accurately quantify and identify compounds and proteins with unique methods to analyse and visualise LC-MS data.

Supporting all common LC-

matography and mass spectrometry,” said Dr Rohit Khanna, Vice President of Informatics and WW Marketing for the Waters Division. “With these latest releases, we have combined the functionality of legacy ‘omics-based data analysis software packages into a pair of stronger, broader reaching offerings. Progenesis QI maintains the heritage of previous releases and focuses our resources in delivering a suite of focused, world-leading informatics packages for ‘omics data analysis.’”

In response to customer feedback, new features of Pro-

Progenesis QI software enables researchers to accurately quantify and identify compounds and proteins with unique methods to analyse and visualise LC-MS data MS data formats and with intuitive guided workflows, Progenesis QI software allows customers to rapidly, objectively and reliably discover compounds and proteins of interest in their valuable samples.

“The development of Progenesis QI is a great example of the innovation outcome for ‘omics-focused scientists and laboratories that we at Waters envisioned when we combined Nonlinear Dynamics informatics expertise with Waters worldwide leadership in chro-

genesis QI include fragment ion support for compound identification, automation of data processing work flows, and improvements in data import routines for enhanced signal differentiation over background noise. Furthermore, new abilities to utilise Waters’ ion mobility data as well as MSE and HDMSE data independent analysis is a direct outcome of merging of Waters and Nonlinear Dynamics innovations.

EP News Bureau – Mumbai

PHARMA ALLY PRODUCTS

CLARiSUITE webserver extends the promise of ‘the right code on the right product’ VIDEOJET TECHNOLOGIES, a global leader in coding and printing solutions, has enhanced its CLARiSUITE software product line with the launch of CLARiSUITE WebServer Edition. The new CLARiSUITE WebServer Edition offers functionality to help drive sustainable improvements in overall equipment effectiveness, by helping manufacturers remove inefficiencies and the risk of operator error including data entry and job selection. Furthermore, the upgraded software helps enable manufacturers to

monitor and control a specific job, line or printer from multiple locations and is adapted to run as a service in modern IT environments with physical and virtual servers and no need for a hardware dongle.

CLARiSUITE WebServer software solution reduces the amount of time operators need to visit their production sites and lines, as they are able to observe the status of the printer, configure it and download jobs over any web browser within their networked environment.

CLARiSUITE WebServer

also allows manufacturers, in the event of a problem occurring, to respond more rapidly and minimise downtime, since operators with access to the

web server can check the status of a job, regardless of their location. In today’s global-orientated market, there is amplified reliance on manufacturers to run several production lines simultaneously with numerous products per line and codes to manage.

CLARiSUITE WebServer operates as a service independent from the main server, to meet IT infrastructure demands, so the main user administration interface is detached and runs on any machine on the network, unlike traditional applications

hosted on a single computer server. The monitoring software therefore is always active, eradicating the need for human intervention to start the program each time, increasing production line productivity and round-the-clock performance reporting.

Contact details Shuxian Li ABI 7500A Beach Road, The Plaza, #16-318 Singapore, Singapore 199591+65 62964384sli@abipr.com

Videojet Technologies’innovative CO2 laser marking systems VIDEOJET TECHNOLOGIES, a leader in coding, marking and printing solutions, has advanced its range of CO2 laser marking systems with the Videojet 3330 30 watt and the Videojet 3130 10 watt lasers. Delivering superior code quality across a range of marking speeds and suitable for a wide array of substrates, the 3330 and 3130 lasers mark simple and complex codes while providing easy integration for virtually any application. When speed is the ultimate priority, manufacturers can utilise the dot font mode in both the 3130 and 3330 to mark up to 30 per cent faster than vector fonts, enabling print speeds up to 150,000 products per hour.

Recognising that line integration is a critical element in delivering peak performance, Videojet offers over 20,000 standard configurations within its CO2 laser marking line including 21 mark window options and three laser wavelengths. With three available laser wavelengths, the Videojet CO 2 lasers can mark on a range of substrates including PET bottling, plastic labels, laminated cartons, and a host of plastic materials common in consumer packaging.

To meet the increasing demands for traceability marking, the 3330 and 3130 are ideal options for serialised coding applications in the pharmaceutical, tobacco, cosmetics, and other industries.

These laser systems deliver excellent total cost of ownership due to their inherently low maintenance requirements and limited consumables. An air cooled laser source plus optimised power settings reduce heat and provide high reliability by extending the life expectancy of the laser source up to 45,000 hours. Complementing the 3330 and 3130, Videojet offers a range of fume extraction systems and filter options that can be tailored for the given application, helping to remove smoke and particulate debris and improving uptime by keeping the laser lens clean. Specifying the right laser solution supports easy integration, speeding up the

installation and changeover process and ultimately increasing uptime. In addition to this, the detachable umbilical cable can be easily routed during set-up, helping to eliminate the need to move other machinery.

Contact details Shuxian Li ABI 7500A Beach Road, The Plaza, #16-318 Singapore, Singapore 199591 +65 62964384 sli@abipr.com

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BUCHI PrepChrom C-700 launched BUCHI HAS introduced the innovative PrepChrom C-700 chromatography system, combining flash chromatography with preparative HPLC. Bridging the gap between them, the C-700 sets a new standard for purification of synthesis mixtures or complex natural extracts. Any type of sample can now be completely purified on one single system: a first flash separation allows collecting fractions which can then be further injected on an HPLC column to isolate the target compounds at a high purity.

Efficient and cost-effective purifications can be performed on preparative HPLC columns with a diameter up to 50 mm filled with silica having a particle size down to 10 μm. The separations can be efficiently optimised using the high performance pumping system. It features a true quaternary gradient functionality and delivers accurate flow rates up to 250 mL/min at a pressure up to 100 bar (1450 psi).

The integrated UV detector (200 to 600 nm) provides diode array functionalities for a

to use system allows organic chemists to perform the complete purification process, using the interactive user interface specially designed for these applications. Using the intuitive software, it is possible to run the system either unattended or with a powerful in-run interaction for a fast optimization of the separation.

Combining high-end hardware technology together with the software designed for easy purification, the PrepChrom C-700 is the ideal solution to solve the purification bottleneck in the research of new active compounds. selective fraction collection.

For non-UV absorbing compounds, the control of the optional ELSD offers a universal detection in an easy and affordable way.

The space saving and easy

Contact details BÜCHI India Manish Thakur Tel. +91 22 66775400 thakur.m@buchi.com www.buchi.com/prepchrom

ExtaviPro 30G autoinjector byCambridge Consultants and Novartis PRODUCT DESIGN and development firm Cambridge Consultants has worked with leading pharmaceutical company Novartis and medical device manufacturer Owen

taviPro 30G is aimed at people who suffer from relapsing forms of MS – such as clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and secondaryprogressive MS (SPMS) –

Mumford – plus hundreds of MS patients – to come up with the ExtaviPro 30G auto-injector.

ExtaviPro 30G has an attractive visual design and ergonomic shape to its easyto-read adjustable needle depth control. The Ex-

who make up the majority of MS patients. The ExtaviPro 30G auto-injector has been launched in Europe, initially in Germany.

Contact details www.CambridgeConsultants.com

Fabtech Technologies,Mumbai launches fullycontained and semi automated system for OEB4 categoryproducts FABTECH TECHNOLOGIES, Mumbai has launched its first fully contained and semi automated system for OEB4 category products right from dispensing, granulation, coating, compression, primary packing designed for

66 EXPRESS PHARMA April 16-30, 2014

production of tablet and capsule for 30 kg batch size with bulk density up to 0.4.

The system provides process flexibility to handle different processes and batch sizes while utilising its proven rigid wall isolation system,

high performance split butterfly valves with IPC and closed loop materials transfer system. The engineering challenge was to fit designed system in existing foot print and integration of blister, strip, bulk packing machines with

tablet compression and capsule filling machine supplied by other vendors.

The system is designed, manufactured and is under execution. Fabtech supplied entire equipment up-to auto coater with integrated con-

tained system .The project is expected to get validated by mid May and user trial to start by May end.

For more information sales@TurnkeyFabtech.com

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We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Digestive Aids Papain Pepsin

Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules 68

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Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

Top Tank / Reactor Sampler

Flush Bottom valve

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6,/,&21(6 Peroxide Cured

Braided

Platinum Cured

Ring

Tri Clover

Septa

Washer

Cork

Gripper

Flush Bottom

Profile

Butterfly

86 )'$ UHJXODWLRQV &)5 IRU FRQWDFW ZLWK IRRG 863 FODVV 9, UHTXLUHPHQWV (XURSHDQ 3KDUPDFRSRHLD $QLPDO GHULYDWLYH IUHH

DMF No. 26710 Certified Cleanroom

205 & 206 Hill View Industrial Premises, Amrut Nagar, Ghatkopar (W), Mumbai - 400 086, India.

Tel.#:022-2500 4576 Fax #:022-2847 5722 E-mail :sales@mksilicone.com 72

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Blue Heaven

M. K. Silicone Products Pvt. Ltd.

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PLANT FOR SALE Excellent Industrial N.A. Land Area 4261.50 Sq. Mtr. (45,853 Sq.ft.) in BOISAR with RCC plant Area 1209.33 Sq. Mtr. (13012 Sq.Ft.) Ground Floor + 320.51 Sq. Mtr. (3448 Sq/ft) First floor = Total Area 1529.84 (16461 Sq.ft.)

Ideally suitable for Pharma or any other industries with High Tension connection 250 Horse Power and ample Water supply in MIDC Area, Main road Touch.

BROKERS EXCUSE Please be in touch with Mr. Vipul K Vasant @ 09321156999 Mail ID : pharmaland09@gmail.com

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PLANT FOR SALE Excellent Industrial N.A. Land Area 14,850 Sq. Mtr. (1,59,786 Sq.ft.) in PALGHAR with RCC plant Area

525.00

Sq.

Mtr.

(5649

Sq.Ft.)

with

Mezzanine Floor–338.00 Sq. Mtr. (3636 Sq.ft.) & Administrative building fully furnished Area 468.00 Sq. Mtr. (5,035 Sq. ft.) ideally suitable for Pharma or any other industries with Low Tension connection 107 Horse Power and ample Water supply, outside Nagarpalika Area, Central Excise Benefit available, Main road Touch.

BROKERS EXCUSE Please be in touch with Mr. Vipul K Vasant @ 09321156999 Mail ID : pharmaland09@gmail.com

Advertise in

Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Johnson Rajkumar 08680002244 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580

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Yes, with PEARLITOL® FLASH, a mannitol compound that allies robustness with rapid disintegration.

PEARLITOL® FLASH offers excellent chemical inertness, needs a minimum of lubricant and makes tablet formulation surprisingly simple.

What’s more, it offers the consumer a uniquely pleasing taste experience.

®

Pearlitol Flash We deliver !

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

www.roquettepharma.com For your local contact : Roquette India Pvt Ltd Email : pharmabiz.india@roquette.com - Tel : +91 22 2570 6775 Our local Distributor : Signet Chemical Corp. Pvt Ltd - Email : sales@signetchem.com

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Mortar Grinder RM 200 & Fluid Bed Dryer TG 200

If you are looking for a complete line of products for sample preparation and particle analysis, look no further than RETSCH. n Mills and grinders for all solid sample types n Widest range of sieve shakers in the market n Fast, reproducible results every time

www.retsch.com

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ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture…

Quality in our genes…

!"#$%&%'($%)# )& +"'),-%#(#$ .+)$"%#/ (/ ."+ 012 31415.(6"7 8"/$"+# -9)$7 2".$%!" ,(..%#6: ;#(9</%/ )& .+)$"%# %,.=+%$%"/ %# +"'),-%#(#$ .+".(+($%)#/ >"#" ?=(#$%&%'($%)# -< @A52B@ C9"'$+).D)+"/%/ /</$",/ E)9"'=9(+ /%F" !"$"+,%#($%)# 31CB: B9%#%'(9 -%)'D",%/$+< (#(9</%/ G".(+%# 7C#)H(.(+%#7 G=,(# 1"+=, ;9-=,%# (#(9</%/

I%)9)6%'(9 ;'$%J%$< 3 K( (#! (: BD(.$"+ LMNOP: 2<+)6"# A"/$%#6 3BD(.$"+ LONOP: I('$"+%(9 C#!)$)H%#/ 3BD(.$"+ LMNP: 1$"+%9%$< A"/$%#6 3BD(.$"+ LQOP: E"$D)! R(9%!($%)# (/ ."+ BG ;EC1 A"/$ (/ ."+ SCB4 TQO 2+"/"+J($%J" C&&%'('< A"/$ 3BD(.$"+LNOP: I%)9)6%'(9 @"('$%J%$< &)+ 2('U%#6 E($"+%(9 (/ ."+ 3BD(.$"+LMQP7LMMP:

BIOSIMILAR TESTING

SERVICES

ACCREDITATIONS

Biological Studies Pre Clinical Studies Analytical Research Formulation Research Microbiological Studies Bio-equivalence Studies Clinical Trials Dossier Preparation

USFDA registered cGMP control testing laboratory Department of Science & Technology approved R & D Centre Drugs Controller General of India (DCGI) NABL accreditation for Chemical, Biological and Medical Testing Recognized by Bureau of Indian Standards Drugs Control Administration (A.P) Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC)

4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W

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

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

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EXPRESS PHARMA Pioneer Spirit in Valve Automation Avcon's Product Offering of Aseptic Diaphragm Valves for Pharma & Biotech Application

Manual Diaphragm Valves

Pneumatic Diaphragm Valves

Multi Port Block Valves

Multi Port Block Valves

T - Block Valves

AVCON’s Bio-Pharma valve product line began in 2001 with a dedicated team of experts to Design, develop & manufacture, the products which includes line of Aseptic Diaphragm Valves for the Life Science Industry with following Technical Specifications.

USP Class VI (87) (88) Certified Diaphragms FDA 21-CFR-177.1550 (PTFE) FDA 21-CFR-177-2600 (Elastomer) Test Certificate to EN 10204 ASME BPE 2012 Testing to EN 12266-1:2003 (E)

Standards

Valve Body Material

Diaphragms:.

(US FDA & USP Class VI Certified):

End Connections:

Weldable as per BS 4825 (OD Base) and ISO 4200 (NB Base) Tri Clamp (TC) as per ASME BPE & ISO 2852 Std.

Actuation:

Manual Non Rising Handwheel (Glass Filled Poly Amide) Pneumatic Plastic Piston type (NC, NO & Double Acting) Pneumatic Plastic Diaphragm type (NC, NO & Double Acting)

Investment Casted ASTM A CF3M (St. St. 316L) Internal Surface Finish: Forged St. St. 316L Block St. St. 316L Advantages: EPDM (E) PTFE backed by EPM (T/E)

0.2 to 0.4 Ra Faster and committed Delivery, Competitive Pricing Structure, Documentation in line with Global Standard,

Manufactured by: AVCON CONTROLS PVT. LTD. Plot No.65, Road No.13, MIDC Marol, Andheri (East), Mumbai- 4000 93.

Tel : 2834 9134, 2834 9971/73, 2822 1505 Fax : 022-2821 6917/3298.

Email : avcon@avconcontrols.com Offices at : Contact No. : Chennai : 044-24463041 Coimbatore : 0422-2314527 • Hyderabad : 09391094865 • Kolkata : 033-22302471 • New Delhi : 011-26460811 • Pune 020-2712 0540

www.avconindia.com

Creative Concepts

*Ask for the literature as per model number Our Product Range: Solenoid Valves, Angle Seated & Straight Patterned Pneumatic Valves, Ball & Butterfly Valves with Pneumatic & Electric Actuators, Gas Regulation & Control Products & Gas Trains

Pharma Valves Ad1/2014

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Psychotropics India Limited

Excellent Manufacturing Facilities : Tablets, Capsules, Beta Lactams, Dry Syrups, Liquid Orals, Medicated & Cosmetic Soaps, Small Volume Parentals (Both General & Cephalosporin), External Preparations, Dusting Powders & Veterinary products (Bolus Tablets, Injections, Multivitamins)

WHO GMP Compliant Plants

Corporate Office : A-32, DLF, Sector-11, City Faridabad, State Haryana-121006, India.

Contact Person : Naresh Joshi, E-mail : naresh@psychoindia.com & Director : sid@psychoindia.com Ph. : 00-91(0)-129-2282691 Fax : 00-91-(0)-129-2296764, 0129-2226635. web site : www.psychoindia.com.

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PHARMA LIFE APPOINTMENT

Anders Malm appointed as Managing Director at Ecron Acunova Malm will assume the responsibility for operations of Europe and North America ANDERS MALM has been appointed as the Managing Director of Ecron Acunova, based in Frankfurt, Germany.

Malm assumes the responsibility for operations of Europe and North America. He joins a management team consisting of Dr Klaus Wiedey, Managing Director of EA Germany and Chief Executive Officer Europe and Klemens Schuette, Managing Director of New Business Opportunities.

Malm joined Ecron Acunova

in 2012 as Managing Director of Ecron Acunova A/S in Denmark with responsibility for the Nordic region. With his experience in managing an Oncology CRO in the US, he was made responsible for North American operation as Chief Executive Officer of Acunova Life Sciences, Princeton, NJ. With a M Sc from Cornell University and a MBA from Sweden, Anders Malm brings 25 years of business experience, with 15 years in the CRO sector on both sides of Atlantic.

Malm said, “Ecron Acunova is a CRO with rich experience and potential. With a highly trained staff in three continents Ecron Acunova has a knowledge base which is unique for a CRO of our size. The company has a global reach, while at the same time we are small enough to take care of clients on a local basis.

We will continue to serve existing clients and build close relations with biotech and smaller pharmaceutical companies for global as well as local services. It

is a pleasure and privilege for me to be part of the leadership team of Ecron Acunova.” Speaking on the appointment, DA Prasanna, Chairman, Ecron Acunova CRO (EA) said, “Malm brings extensive professional experience in clinical research services and network of customer relationship in Europe and the US. With his experience, he will grow and transform Ecron Acunova services to effectively meet the changing needs of sponsors.”

EP News Bureau-Mumbai

NEWS

C-Suite Executives in India & APAC foresee the advent of SIOs as critical success factor in 2014 Survey conducted amongst 326 C-suite executive across India & APAC region BTI CONSULTANTS, executive search division of Kelly Services, have released a report titled ‘Executive Outlook Survey 2014.’ The report reflects revenue predictions of business in 2014 which look significant alongside the arrival Socially Intelligent Organisations (SIOs) as a noticeable trend by CEOs for the success of an organisation. It also provides a glimpse into management thinking as it deals with each of these critical success factors from both an internal and an external perspective.

“Overall, global economies have proved remarkably re-

silient in emerging from the deepest downturn in a generation including seeing off a series of autonomous debt crises that could have derailed recovery. Hence, in order to improve the business scenario it is important to identify and respond to changing dynamics and promote the idea of the ‘socially intelligent organisation’—one that embraces collaboration and harnesses diversity to promote innovation and change,” said, James Agrawal, Managing Director, BTI Consultants India.

The survey captures the consideration of 326 leaders

and executives of companies with 89 per cent companies based in Asia Pacific across industries like manufacturing, ICT, consulting, health and pharmaceuticals, financial services and insurance, property, infrastructure, transport and logistics, and oil and gas.

It shows that a solid 22 per cent expect ‘significant growth’ in revenue, indicating that some firms will continue to reap the benefit of Asia’s powerhouse economic positioning.

On profits, a total of 76 per cent are expecting either no change or only marginal growth in profitability. The report addi-

tionally highlights the advent of the Socially Intelligent Organisation (SIOs) encapsulates key elements of the dynamism that is now required to manage and prosper in a rapidly evolving environment. With over 52 per cent approving the fact that they are a Socially Intelligent and 77 per cent are of the opinion that Social Intelligence Drives Profitability.

The emergence of social intelligence in a business setting brings together an array of disciplines and processes to address issues in a coherent and collaborative way. SIOs are serving to sharpen business

instincts and harness all available resources to detect, interpret and confront the challenges that are now coming faster than ever. The outlook for India seems to be positive and business leaders have demonstrated that they are confident about the situation, yet they are clear that profit improvement will not come easily and that every bit of additional returns will be hard won.

In India, business leaders are far more optimistic than their counterparts elsewhere.

EP News Bureau-Mumbai

EXPRESS PHARMA

89

April 16-30, 2014

PHARMA LIFE BOOK REVIEW

The Path: Improving the process of improvement To achieve sustainable growth amidst increasingly complex and chaotic business environment, an organisation must figure out its own path to leverage operations. Express Pharma finds that the ‘The Path’ gives great insights on the same THESE DAYS, more and more businesses seek to exploit an opportunity than fulfil a necessity. This is quite true in the case of pharma companies, where for a significant number of owners of pharma companies, ownership is all about investment. Experts have opined that the current pattern of rapid and unpredictable changes in business conditions as the ‘new normal’.

The Path: Leveraging Operations in a Complex and Chaotic World, a book authored by Shridhar Lolla, Coach - Operational Excellence, attempts to provide a business solution to one of the biggest social evils, i.e. sky-rocketing cost of medicines.

The book starts with the author meeting his school buddy on a flight when he gets to know how local pharma companies operate internally.

‘The Path’ is set in an operational war zone and it describes how teams are dealing with the ‘new normal,’ and emphasises that it is not about mastering an overwhelming number of improvement skill sets, but improving the process of improvement. It provides an outlook on how to achieve dramatic growth on an ongoing basis without taking costly trade-offs and burn-outs.

The book has been written in eight parts. Written in a subtle and lucid language, the author has provided several examples to put forth his arguments and communicate the right message. Written in a semi story-driven format, it comprises dialogues between operational players to illustrate the author’s point. Charts and graphs have been used to make it more readable where readers

90 EXPRESS PHARMA April 16-30, 2014

ABOUT THE AUTHOR Shridhar Lolla is an engineer by qualification and holds a PhD degree from IIT Delhi, Masters from IT BHU Varanasi and Bachelors Degree from MANIT, Bhopal. He is a practitioner of Business Model Innovation, Focused Execution and Operational Excellence.

Lolla worked with well known firms like ABB, Kirloskar Electric, SIFY and Tecumseh and has extensive experience engineering, product development, R&D, IT services, software development and manufacturing industries.

He runs the online hub of operational excellence at www.tine2change.co.in and resides in Bangalore.

TITLE:THE PATH: LEVERAGING OPERATIONS IN ACOMPLEX AND CHAOTIC WORLD AUTHOR: SHRIDHAR LOLLA EDITED BY: S MEERA PUBLISHER: PRODUCTIVITY& QUALITYPUBLISHING PRE PRESS BY: DSM SOFT(P) LTD,CHENNAI PAGES: 286 ISBN: 978-81-85984-58-2 PRICE: `600

will be able to identify the issues and hence effectively assist in conveying the right message.

Divided into parts, the book has several invaluable insights on steps that should be undertaken and followed to achieve operational excellence.

The first part talks about the ‘Traditional Reaction,’ where it mentions about reacting to the competitive landscape, applying traditional tactics and meeting the thought leaders. part two is on ‘Chasing the Numbers,’ part three talks about ‘Preparing for the change,’ part four on ‘Installing the New Paradigm’, part five on 'Nurturing the Right Behaviour’, ‘Reclaiming the Core’ is part six, while part seven is on Executing the Big Change’ and the last part talks about ‘Consolidating the Change.’

The book gives an in-depth analysis about how professionals can re-look at operational excellence from a very fundamental level and then build

their own way of achieving quick and dramatic growth. It recognises the growing tension between drug manufacturers with the government, regulators, social media and patients.

The book points out about the ineffective and inefficient ways of doing business as a core problem to the conflict.

One of the chapters also draws parallels with Mount Kilimanjaro. In ‘Tactics for Dealing with the Unknown’, a subchapter, the author has mentioned that it is similar to negotiating the way up to the mountain and can provide a few great lessons to any entrepreneur or manager in running a high octane business.

‘The Path’ has been co-created by 118 professionals from various industries, where insights to make their organisations more effective have been provided from their years of experience. In doing so, they have been able to provide directions to make quality medicines readily available and affordable to the world.

together. it’s how we work. it’s how we succeed.

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NEW app note with details – access it at agilent.com/chem/proteinopenaccess © Agilent Technologies, Inc. 2014

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