Express Pharma January 16-31, 2014 by Indian Express

VOL .9 NO.6 PAGES 66

www.expresspharmaonline.com

Cover Story Bahrain beckons Indian pharma Management Plagiarism, research publications and law Packaging Special Green pack ‘age’ 16-31 JANUARY 2014, ` 40

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CONTENTS MARKET

Vol 9 No.6 JANUARY 16-31, 2014

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

GREEN PACK ‘age’

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap

CHMP RECOMMENDS EU APPROVAL OF PIRAMAL IMAGING’S NEURACEQ

STRENGTHENING AND DIVERSIFYING PRODUCT PORTFOLIO DRIVES M&A ACTIVITY

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

Biodegradable packaging is slowlymaking inroads into the Indian pharma industry.Such packaging is surelygoing to propel a drive towards making the pharma sector more environment friendly By Sachin Jagdale | P54 P50: CLINICAL UPDATE Novel osteoporosis drug could change treatment: Study

P53: RESEARCH UPDATE

MANAGEMENT

PHARMA MARKET POSTS 14 PER CENT GROWTH IN NOVEMBER 2013: IMS

PLAGIARISM, RESEARCH PUBLICATIONS AND LAW

LEVERAGING THE OTC POTENTIAL OF INDIA’S 350 MILLION ‘KIDSUMERS’

Vitamin E slows decline in Alzheimer’s patients

P59: INTERVIEW ‘Synchrotron radiation is intense, polychromatic and finely collimated’

P61: AWARD Bionova bags Rashtriya Udyog Ratan Award

PHARMA SECTOR MAY SEE MIXED OPERATING PERFORMANCE IN 3QFY14E: KOTAK INSTITUTIONAL EQUITIES

TURN TO PAGE 13 TO FIND SPECIAL DEALS

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

In search of greener pastures

FTER hanging fire for the past

At another level, as Indian companies face

few months, the Department

pricing and regulatory pressures in the domestic

of Industrial Policy and Pro-

market, many countries have been assiduously courting Indian pharma companies for invest-

motion (DIPP) has finally

ments. For instance, IDA Ireland, Ireland's agency

given some clarity on foreign

to encourage inward investment, has earmarked

direct investment (FDI) in the pharmaceutical sec-

India as a key market in its growth strategy for

tor. Quite obviously, it's the carrot and stick approach. While the carrot is in place, (100 per cent FDI in brownfield projects remains intact) the stick is also very much in the picture. Mindful of its critics and the approaching 16th general elections, the UPA Government was careful to build in some elbow room for the future, saying that it will invoke the non-compete clause in 'special circumstances' with the approval of the Foreign Investment Promotion Board (FIPB). The wording is sure to give sleepless nights to investors as they try to second guess which seg-

Wouldn't it be a tragic travesty if policies designed to protect Indian industry actually force home-grown heroes to foreign shores?

EU market. In the same vein, our cover story in this issue, (‘Bahrain beckons Indian pharma’, pages 20-24) is a primer on how Bahrain's Economic Development Board is laying out the red carpet for Indian pharma companies, vying to be the gateway to the GCC pharma market. And Indian companies are biting the bait. Wockhardt and Ranbaxy already have operations in Ireland and were recently joined by clinical services company, Synowledge while Aurobindo Pharma has a base in Bahrain. It is ironic that

ments of the industry would qualify under the

while some of our policy makers remain wary of

'special circumstances' tag. Going by past debates,

foreign investors, raising the bogey of a ‘recolonisa-

the backlash has been the fiercest when the deals

tion’, Indian companies are looking overseas like

concerned cancer care products and vaccine man-

never before. Yes, concerns about being self suffi-

ufacturing facilities. Prospective investors would be

cient in affordable medicines are valid but surely

scrutinising each word of the DIPP press release

there is a less painful middle path? Industry (and

for clues on the Government's stance.

talent) will flow and take root wherever it finds a

The UPA clearly wants to be remembered as

suitable ecosystem. Patients, at least most of them

an investor-friendly government. But is this prag-

in developing nations, unfortunately do not have

matic approach too little, too late? India is compet-

the same choice. Wouldn't it be a tragic travesty if

ing for investor attention with numerous countries

policies designed to protect Indian industry actu-

and analysts fear that once growth in the US mar-

ally force home-grown heroes to foreign shores?

ket picks up, investment will flow out of emerging markets back into the world's largest market.

2014, positioning the country as a gateway to the

EXPRESS PHARMA

January 16-31, 2014

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Pharma sector may see mixed operating performance in 3QFY14E: Kotak Institutional Equities Expects core profit growth of over 15 per cent y-o-y

KOTAK INSTITUTIONAL Equities (KIE) has posted the 3QFY14E earnings preview report for the pharmaceutical sector. According to Krishna Prasad, Pharma Sector Analyst, Kotak Institutional Equities, KIE expects mixed operating performance for the sector with US launches and currency benefit to be the key growth drivers. Sun Pharma and Dr Reddy’s will lead the sector while Lupin US generics growth is expected to remain strong. Stable growth is expected for Glenmark and remain conservative on recovery in Cipla/Cadila in 3QFY14. KIE expects core profit growth of over 15 per cent year-over-year (y-o-y) across the sector except Cipla. Sun Pharma and Dr Reddy’s will lead the pack– 45 per cent and 33 per cent y-o-y net profit growth, respectively. In both cases, US generics will be the primary growth driver along with currency. For Lupin, it is estimated 13 per cent y-o-y growth in earnings before interest, taxes, depreciation, and amortization (EBITDA) while PAT growth of 26 per cent is driven by lower tax rate. A strong margin expansion for Dr Reddy’s (360 bps y-o-y) driven by US launches more

The channel disruption witnessed in 2QFY14 has eased though the trade margin issues are still under negotiations. A gradual recovery in domestic growth rates through FY2014 is also expected than offsetting the sharp decline in PSAI. On a y-o-y basis, Sun Pharma will benefit from favourable market conditions in Doxil, price increases sustaining in Taro/Doxycycline and consolidation of URL/Dusa. For Lupin, the strong growth in US generics is partially offset by muted performance in India/Japan leading to marginal decline (40 bps) in EBITDA margin. A sharp recovery in core EBITDA margin for Ranbaxy (at nine per cent) driven by lower remediation expense is expected. A stable earnings performance for Glenmark with 19 per cent y-o-y growth in core net profit is also expected. The Indian formulations

growth will remain subdued for most players except Glenmark and Sun (at 16-17 per cent y-o-y). A weak growth for Cadila/Ranbaxy (five per cent y-o-y) while Dr Reddy’s, Cipla and Lupin are expected to grow at 10-13 per cent y-o-y. The channel disruption witnessed in 2QFY14 has eased though the trade margin issues are still under negotiations. A gradual recovery in domestic growth rates through FY2014 is also expected. KIE expect US generic launches to be the key growth driver offsetting weak growth in India. The improving US product mix and currency remain key margin drivers for Indian generics. EP News Bureau – Mumbai

Astellas to form strategic partnership with Clearpath To form a portfolio of development companies focused on vaccines targeting infectious diseases

ASTELLAS PHARMA (Astellas) and ClearPath Development Company (ClearPath) have announced a strategic partnership to form a portfolio of development companies focused on vaccines targeting infectious diseases. The partnership was established to support Astellas' goal of building a global vaccine franchise and launched its first company, RSV Corporation (RSVC), in December 2013. Astellas will fund RSVC’s development of a virosome vaccine technology, licensed from Mymetics Corporation, for respiratory syncytial virus (RSV) through completion of a phase 2b human proof-of-concept study. Based on the strategic partnership, Astellas received exclusive rights to acquire RSVC as well as further develop and commercialise the vaccine product. “This partnership highlights our commitment to build a global vaccine business and represents a highly efficient model for bringing innovative vaccines to market,” said Kenji Yasukawa, Senior Vice President and Chief Strategy Officer, Astellas. RSV is a respiratory pathogen which infects patients of all ages. The infection can be especially severe in infants and older adults with chronic pulmonary or

cardiovascular disease. Each year the virus infects 64 million people and is responsible for 160,000 deaths worldwide. Currently, there is no vaccine available for this virus. “The financial backing and commercial experience of Astellas combined with ClearPath’s development expertise and our continued programme involvement are unique factors which all work to increase the likelihood of success,” said Ronald Kempers, Chief Executive Officer, Mymetics. For its technology for RSV, Mymetics could receive upfront and post proofof-concept milestone payments up to $82 million, as well as double digits royalties and other payments. The virosome vaccine consists of membrane nanoparticles containing the native key viral surface proteins that are targets of the immune system, but lack the genetic material required to cause infection. In pre-clinical testing, it generated powerful immune responses and strong protection against RSV. Virosome-based vaccines have a proven track record of safety and efficacy for the prevention of other infections including influenza. EP News Bureau – Mumbai

EXPRESS PHARMA

January 16-31, 2014

MARKET

CHMP recommends EU approval of Piramal Imaging’s NeuraCeq NeuraCeq is a radio pharmaceutical indicated for Positron Emission Tomography (PET) imaging of neuritic beta-amyloid plaque density in the brains of adult patients

PIRAMAL IMAGING announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of NeuraCeq (florbetaben 18F). The CHMP's recommendation will now be referred to the European Commission, for approval in the European Union (EU). NeuraCeq is a radio pharmaceutical indicated for Positron Emission Tomography (PET) imaging of neuritic beta-amyloid

plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. “This recommendation marks a major milestone for Piramal Imaging in our commitment to assist in the diagnosis of Alzheimer’s disease and the development of novel tracers for PET imaging,” said Dr Ludger Dinkelborg, Director of the Board, Piramal Imaging SA.

“This is a key step towards making this innovative type of imaging more accessible to healthcare providers and patients across Europe.” “Alzheimer’s disease is a growing epidemic, with recent data suggesting more than six million people in Europe and 36 million people worldwide are living with Alzheimer’s,” said Dr Swati Piramal, Vice Chairperson, Piramal Enterprises. The CHMP’s positive opinion was based on data from the

pivotal phase III autopsy study, which showed that PET imaging with NeuraCeq detects neuritic beta-amyloid in the brains of living subjects. The visual subject-level PET reading proposed for routine clinical practice compared to histopathology for the first 31 brains demonstrated 100 per cent sensitivity and 86 per cent specificity. In a post-hoc analysis in a larger population with 74 autopsied subjects, the sensitivity of the visual assessment

was 98 per cent and specificity was 89 per cent. It is important to note, that a positive NeuraCeq scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorder. Additionally, the safety and effectiveness of Neuraceq have not been established for predicting the development of dementia or other neurologic conditions or monitoring responses to therapies. EP News Bureau – Mumbai

Venus Medicine Research Centre, Baba Farid varsity sign MoU on research

Cephalon files patent infringement suit against Glenmark

To undertake collaborative research projects, academic programmes, open new frontiers for high-end research in India in oncology, anti-infectives, pain management

This ANDA has been filed from Glenmark's Argentina lyophilized injectable facility

THE VENUS Medicine Research Centre (VMRC), the research wing of Venus Remedies in Baddi which has been accredited for good laboratory practices (GLP), has signed a Memorandum of Understanding (MoU) with Baba Farid University of Health Sciences (BFUHS), Faridkot to undertake collaborative research projects and academic programmes. Manu Chaudhary, Director, Research, VMRC, signed the MoU with BFUHS Vice-

GLENMARK PHARMACEUTICALS and Glenmark Generics, USA (Glenmark) has confirmed that Cephalon has filed a patent infringement suit on December 26, 2013 in the US District Court for the District of Delaware seeking to prevent Glenmark from commercialising its Abbreviated New Drug Application (ANDA) Bendamustine Hydrochloride product, their generic version of Treanda, prior to expiration of the Orange Book patents. A complaint against Glenmark has been filed on US

EXPRESS PHARMA

January 16-31, 2014

Chancellor Dr SS Gill in the presence of Dr Praveen Bansal, Director, Research, BFUHS, Satpal Singh, Joint Registrar, BFUHS, and Dr Renu Bansal, Associate Professor, Department of Microbiology, Guru Gobind Singh Medical College, a constituent of BFUHS. The VMRC already has research collaborations with University of Illinois, Chicago; Institute of Microbial Technology (IMTECH), Chandigarh; Department of

Microbiology, Punjab University, Chandigarh; the National Institute of Pharmaceutical Education and Research (NIPER), Mohali; Guru Jambeshwar University of Science and Technology, Hisar; Procdane Institute of Pharmaceutical Sciences, Hyderabad; Sri Ram Medical College, Chennai; Gandhi Medical College, Hyderabad; King George Medical College, Lucknow and Amity University, Noida. EP News Bureau – Mumbai

patent 8,445,524. This lawsuit was filed under the provisions of the Hatch-Waxman Act. Bendamustine is indicated for the treatment of patients with chronic lymphocytic leukaemia. This ANDA has been filed from Glenmark's Argentina lyophilized injectable facility. For the twelve-month period ending September 2013, Treanda achieved sales of $659 million according to IMS Health. EP News Bureau – Mumbai

MARKET

FDAand European Medicines Agency announce generic-drug application inspections initiative The initiative creates a process to conduct joint facility inspections for generic-drug applications submitted to both agencies FDA AND the European Medicines Agency (EMA) have announced a joint initiative to share information on inspections of bioequivalence studies submitted in support of genericdrug approvals. The initiative creates a process to conduct joint facility inspections for generic-drug applications submitted to both agencies. Objec-

tives of the initiative are to streamline the sharing of information of bioequivalence studies conducted for generic-drug applications, to share negative inspection outcomes, to conduct joint inspections internationally, and to provide training to improve inspections. “Our continued collaboration with the EMA and the EU en-

hances our ability to leverage inspection resources and helps us meet the challenges of increased globalisation in drug development,” said Janet Woodcock, Director, FDA’s Center for Drug Evaluation and Research, in a press release. “By streamlining the inspection process for generic drug applications, we will help consumers gain access

to safe and effective generic drugs.” Taking part in the initiative are the EMA and the EU member states France, Germany, Italy, the Netherlands, and the UK. This initiative will be implemented using the confidentiality arrangements established among the European Commission, the EMA, interested EU member states, and FDA. This

agreement includes an 18-month pilot phase and follows the 2009 EMA-FDA Good Clinical Practices (GCP) Initiative, designed by the agencies to ensure that clinical trials data submitted in new drug applications in the US and Europe are conducted ethically and are reliable. EP News Bureau – Mumbai

EXPRESS PHARMA

January 16-31, 2014

MARKET DEALTRACKER

Strengthening and diversifying product portfolio drives M&A activity Witnesses one deal during December 2013 M&A (including private equity) trend analysis

MERGERS AND acquisitions activity in the pharmaceutical sector was focused on strengthening and diversifying product portfolios for increasing short-term and long-term revenue growth. In line with the above trend, Germany-based Bayer agreed to acquire Algeta, a Norwegian pharma company, for approximately $2.8 billion. This acquisition will allow Bayer to strengthen its oncology business and support its efforts in providing patients with innovative treatment options. Additionally, Bayer will gain full control over Xofigo, an alpha-particle-emitting radioactive therapeutic agent for the treatment of patients with castrationresistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. In another key deal, Ireland-based Jazz Pharmaceuticals, agreed to acquire Gentium, an Italybased biopharma company, for approximately $1 billion. This transaction is expected to increase Jazzâ&#x20AC;&#x2122;s short-term and long-term revenue growth, diversify its development and commercial portfolio, and enhance its hematology/oncology business. Jazzâ&#x20AC;&#x2122;s would have access to Defitelio (defibrotide), an EMA-approved orphan drug used for the treatment of severe hepatic veno-

EXPRESS PHARMA

January 16-31, 2014

Source:

Venture financing trend analysis

Source:

Top M&A deals (Dec 2013) Rank

Date

Target

Acquirer

Deal value ($m)

12/19/13

Algeta ASA (NO)

Bayer AG (DE)

2882.17

12/24/13

Ikaria, Inc. (US)

Madison Dearborn Partners, LLC (US)

1600

12/19/13

Gentium S.p.A (IT)

Jazz Pharmaceuticals plc (IE)

1000

12/20/13

Maxxam Analytics, Inc. (CA)

Bureau Veritas S.A. (FR)

611.36

12/04/13

Rempex Pharmaceuticals, Inc. (US)

The Medicines Company US)

474

12/17/13

Aqua Pharmaceuticals, LLC (US)

Almirall, SA (ES)

402.6

12/11/13

Cangene Corporation (CA)

Emergent Biosolutions, Inc. (US)

222

12/16/13

Lotus Pharmaceutical Co., Ltd. (TW)

Alvogen, Inc. (US)

200

12/23/13

Kemira Oyj - Formic acid business (FI)

Taminco Corporation (US)

191.47

12/16/13

NuPathe, Inc. (US)

Endo Health Solutions Inc. (US)

105

Source:

Top venture financing deals (Dec 2013) Rank

Date

Target

Investors

Deal value ($m)

12/09/13

Covagen AG (CH)

Gimv nv; Ascent Biomedical Ventures; Novartis Venture Funds; Edmond de Rothschild Investment Partners; Seroba Kernel Life Sciences Limited; Ventech; MP Healthcare Venture Management, Inc.

47.13

12/04/13

Zafgen, Inc. (US)

RA Capital Management, LLC; Brookside Capital; Venrock; Alta Partners; Undisclosed Investors

12/10/13

InVitae Corp. (US)

Genomic Health, Inc.; Randy Scott; Thomas McNerney & Partners; Redmile Group, LLC; Genesys Capital; Casdin Capital, LLC

12/17/13

Crescendo Biologics, Ltd. (UK)

Imperial Innovations; Astellas Venture Management LLC; Sofinnova Partners

28.54

12/30/13

TopiVert Limited (GB)

NeoMed Management AS; Johnson & Johnson Development Corporation; SV Life Sciences; Imperial Innovations Group PLC

28.04

Source:

MARKET

occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation. Defibrotide is available in 40 countries through 10 distribution partnerships, on a named patient basis. M&A activity in the pharma sector decreased in volume terms and increased in value terms, when compared to the average of the previous six months (Jun–Nov 2013). According to Datamonitor's Medtrack database, the pharma sector recorded 31 M&A transactions in Dec 2013, against the previous six months’ average of 32.6 transactions. In value terms, the sector recorded deals worth $7.8 billion, against the previous six months’ average of $7.6 billion. The Indian pharma sector witnessed one deal during December 2013, against the previous six months’ average of 0.6 transactions, in which US-based asset management firm, Bain Capital, agreed to acquire Emcure Pharmaceuticals, an Indian pharmaceutical company.

Venture funding Companies in the pharma sector raised $271.5 million during December 2013, against the previous six months’ average of $250 million. In terms of volume, the sector recorded 14 venture funded deals, when compared to the previous six months’ average of 22.5 transactions.

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. Medtrack’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. In-

EXPRESS PHARMA

January 16-31, 2014

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.

Definitions 1.Deal value trend is based on transactions where associate values have been disclosed. 2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits.

For more information, visit us at www.medtrack.com

EVENT BRIEF JANUARY - FEBRUARY 2014 17

5th FICCI-HADSA Nutraceutical Conference

5TH FICCI-HADSA NUTRACEUTICAL CONFERENCE Date: January 17, 2014 Venue: Sci-Tech, Jogeshwari, Mumbai Summary: The objective of this conference is to enable nutraceuticals stakeholders to understand the'Business Dynamics of Nutraceuticals in India’. Discussions will be held on issues such as implications of regulations, product development, chain management, commercialisation and financial challenges. The summit aims to provide an opportunity to the Indian nutraceutical / dietary supplements industry to network and interact with various representatives of government and semi-government institutions along, with other stakeholders from private sector, financial institutions, R&D to further resolve challenges being faced by this industry. Contact details Nandini Aggrwal Asst Director - Wellness and Nutraceuticals Federation Of Indian Chambers Of Commerce and Industry 33-B, Krishnamai Sir Pochkhanwala Road Worli, Mumbai - 400030. Tel: (022) 2496 8000 Mob: 9869132887 Email: nandini.aggrwal@ficci.com

BANGALORE INDIA BIO 2014 Date: February 10- 12, 2014 Venue: The Lalit Ashok

EXPRESS PHARMA

January 16-31, 2014

Bangalore Summary: Bangalore INDIA BIO is organised by the Government of Karnataka and the Vision Group on Biotechnology - an apex advisory body consisting of members from both public and private sectors in association with MM ActivSci-Tech Communications, engaged in creating knowledge and business fora across frontier technologies and emerging sectors. The international conference will deliberate on key issues such as biosimilars; drug discovery and vaccine development through partnerships; stem cells and regenerative medicine; clinical trials; digital health fueling; pharmacogenomics, biomedical informatics and personalised medicine; investment and entrepreneurial finance for bio business; agribiotech and food security; secondary agriculture; bio energy and energy security. It will consist of multitrack conferences, international trade show, distinguished lecture and keynote talks, interlinXBioPartnering, CEO conclave, bio-excellence awards, poster session, BioQuiz and other Networking Events.

11TH EDITION OF BIOASIA Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre Summary: The 11th edition of BioAsia is dedicated to the theme – ‘Innovate. Evolve’. BioAsia’s focus on ‘Innovation in lifesciences’ will ad-

Bangalore INDIA BIO 2014

dress the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years. In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA). Contact details Paridhi Gupta Tel: 040 66446477

CPHI QUALITY BY DESIGN Date: February 24 – 26, 2014 Venue: Kuala Lumpur, Malaysia Summary: CPhI – Quality by Design will focus on the drivers, regulatory framework, risks, principles and approach for QbD, and the benefits for the pharmaceutical industry in Asia to implement QbD to compete in the global arena. This event is a

11th edition of BioAsia

CPhI Quality by Design

unique learning platform combining discussions, case studies and best practice to enhance knowledge sharing and networking; coupled with a practical training component to enhance applied and technical implementation know-how. URL: http://www.qualitybydesign-asia.com/?utm_campaign=EVENTLISTING&utm _medium=MEDIAPARTNERWEBSITE&utm_source=EXPRESSPHARMAONLINE&ut m_content=URL&utm_term=

the country and abroad, will be participating in the conference. A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact details Marcus Chan UBM Conferences ASEAN Tel: +603 2176 8712 Fax: +603 2176 8786 Email: marcus.chan@ubm.com

Contact details Dr PK Krishnan Namboori Associate Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014, Computational Chemistry Group (CCG), Computational Engineering and Networking, AMRITA Vishwa Vidyapeetham-Amrita University, Amritanagar, Coimbatore-641 112 Phone:+91 422 2685000 Extn: 5592 Email: aicadd_2014@cb.amrita.edu aicadd2014@gmail.com URL: http://www.amritaccg.in/ Conference URL: http://www.amritaccg.in/aica dd2014

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: AMRITA Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD – 2014 is an international conference organised aims to make a "industry-scientists-academics" 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

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MARKET PRE EVENT

‘Biotech for a Better Tomorrow’ key theme at Bangalore India Bio Delegations from various countries are expected, with key participation from the European Union, Scotland and the Czech Republic THE 14TH edition of Bangalore INDIA BIO (BIB), the flagship biotech event of India, is scheduled to be held from February 10 - 12, 2014 at The Lalit Ashok, Bangalore with the core theme ‘Biotech for a Better Tomorrow’. Bangalore INDIA BIO is organised by the Government of Karnataka and the Vision Group on Biotechnology, an apex advisory body consisting of members from both public

and private sectors. As per reports, delegations from various countries are expected, with key participation from the European Union, Scotland and the Czech Republic. Nobel Laureate for 2012 Sir John Bertrand Gurdon, awarded the Nobel Prize for Physiology or Medicine will deliver the distinguished lecture and the World Food Prize Laureate 2013, Em Prof Marc Van Montagu will deliver the

keynote address. Bangalore INDIA BIO 2014 will consist of multi-track conferences, international tradeshow, distinguished lecture and keynote talks, interlinxbiopartnering, ceo conclave, bio-excellence awards, poster session, bioquiz and other networking events. The event will see participation of over 110 speakers from more than 20 countries bringing together global lead-

ers, scientific minds, regulators and investors to exchange ideas and findings in biotechnology research and development, to share their experiences in advancing biotechnological development and to further research and business cooperation across borders. The international conference will deliberate on key issues such as biosimilars; drug discovery and vaccine devel-

opment through partnerships; stem cells and regenerative medicine; clinical trials; digital health fuelling; pharmacogenomics, biomedical informatics and personalised medicine; investment and entrepreneurial finance for bio business; agribiotech and food security; secondary agriculture; bio energy and energy security. EP News Bureau-Mumbai

cover )

$260 MILLION

WO RT H O F BA H R A I N â&#x20AC;&#x2122;S P H A R M A I N D UST RY IN 2012

Fast growth in the GCC offers a wealth of opportunity for Indian healthcare providers. Our markets have a combined value of $1.5 trillion, expected to reach $2 trillion by 2020, and have increasingly sophisticated mass-affluent populations on the lookout for cutting edge medical technologies and treatments Kamal bin Ahmed Minister of Transport and Chief Executive, Bahrain Economic Development Board

20 EXPRESS PHARMA January 16-31, 2014

(

THE MAIN FOCUS

BAHRAIN BECKONS

INDIAN PHARMA $1.5 TRILLION C O M B I N E D VA LU E O F GCC MARKET IN 2012

Willingness to increase private participation in the local pharmaceutical manufacturing sector and structured approach to investment has strengthened Bahrainâ&#x20AC;&#x2122;s position as an attractive investment destination BY M NEELAM KACHHAP

EXPRESS PHARMA

January 16-31, 2014

cover )

he Kingdom of Bahrain is an archipelago of 40 islands in the Middle East, located in between the Persian Gulf and the Gulf of Bahrain and close to the Kingdom of Saudi Arabia and Qatar. With a total area of 735.8 sq km, Bahrain is home to 1.3 billion people half of which are expatriates. Manama (the capital) and Muharraq are the main areas among the five main governorates in Bahrain. Over the past century, Bahrain has been at the helm of trading through oil exploration, finance and education. The Kingdom of Bahrain enjoys the reputation of being the centre for financial services in the Middle East backed by the strong regulatory framework for the industry. In fact, Bahrain’s main investment sectors are financial and banking services but its economy continues to depend on petroleum production and refining. They that account for 25 per cent of its GDP. Other major economic activities are heavy industries, retail and tourism. Bahrain launched Economic Vision 2030 with the vision to transform Bahrain from an economy based on oil wealth to an economy that is globally competitive and sustainable, which provides a higher standard of living for the people of Bahrain. The Bahraini government has targeted five industries for expansion for the purpose of achieving overall stability. These areas include business and financial services, tourism, information technology, telecommunications and healthcare.

Healthcare scenario Bahrain’s healthcare system is modern, technologically-advanced and comprehensive.

22 EXPRESS PHARMA January 16-31, 2014

Drugs are very expensive in Bahrain but a strong spending capacity and increasing health awareness coupled with the general perception of branded drugs being superior to the generics; tilts the scales in favour of branded drugs The quality of life and other healthcare indicators have raised Bahrain's status above its other Gulf neighbours and it is considered as one of the healthiest countries in the region. Bahrain has managed to control communicable diseases and reach almost 100 per cent in its immunisation coverage of basic vaccines. However, Bahrain is witnessing a continued rise in the chronic non communicable diseases such as cancer, cardiovascular diseases and diabetes. These now are the major causes of death in the country.

Pharmaceutical market in Bahrain Bahrain's pharma market has a lot of potential. The most

obvious thing about the Bahraini pharma market is that the domestic production of drugs is small and market demand is almost entirely met through imported pharma products. “The pharma sector is still an emerging industry in the GCC, and drug manufacturing is at a relatively nascent stage due to limited focus on developing indigenous production capabilities, restricted allocation of funds towards research and development, and shortage of skilled manpower,” says Sanjay Vig, Managing Director, Alpen Capital (ME), UAE. However, Bahrain is trying to attract companies looking to set up regional offices, manufacturing hubs or research and

development facilities in the country, given its strong regulatory framework and relatively stable political and economic environment. “Although size of the pharma market in Bahrain is the smallest in the GCC in absolute terms, the sector’s contribution to GDP (0.6 per cent) is largest among all the regional counterparts,” informs Vig. “The country also ranked second in the region in terms of pharma sales per capita, which was $226 in 2012. According to estimates, the pharma industry was worth $260 million in 2012, compared to $240 million in the previous year,” he adds. This may not be a remarkable thing but the fact that

the pharma sales in Bahrain are experiencing a surge may have some bearing on the companies interested in investing here. Besides, the huge demand for branded drugs and strong spending capacity points toward positive prospects for exporters who aim at entering this market. Branded drugs dominate the market, with generic drugs sales lagging behind. A huge chunk of the market is served by traditional medicines as they are still in demand in the country, and there are a number of companies making herbal pseudopharmaceuticals. Drugs are very expensive in Bahrain but a strong spending capacity and increasing health awareness coupled with the general perception of branded drugs being superior to the generics; tilts the scales in favour of branded drugs. Thus prescription drugs rule the market, however, OTC products and pseudo-pharmaceuticals like weight loss products, vitamins, and probiotics are gaining attention lately. Visibility of OTC drugs, especially branded products, available widely at pharmacies, supermarkets, and specialist stores are the main cause of growing sales. Encouraging the use of generic drugs, the government has allowed patients to claim reimbursements on prescriptions of generic products.

Market outlook Experts believe that Bahrain's pharma market will experience sustainable growth in the medium to long term. Increased domestic production, foreign investments, and consumption of generics will be the key driving force in the market's evolution. “The GCC pharma market is projected to expand at a CAGR of six per cent to eight per cent between 2010 and 2020, with the pace of industry expansion in Bahrain projected to outpace the

(

THE MAIN FOCUS

INCENTIVES AT BIIP regional growth. Increased domestic production, foreign investments, and consumption of generics are likely to support the market’s evolution,” says Vig. According to www.marketresearch.com, the per-capita spending on pharma in Bahrain is expected to almost double in the next ten years to 2021, from some $182 calculated for 2011. This growth will be driven by the expanding population, increasing consumption of medicines, government programmes targeting non-communicable diseases, significant expansion of healthcare facilities and the growing cost of medical imports.

Key challenges As elsewhere, Bahrain also has some challenges which must be overcome by Indian investors to have a successful business. Some of the key challenges while looking at Bahrain are the unavailability of information, financial risks, inadequate overall market information and price controls. Besides, the investors also get intimidated by the tough registration process in GCC countries. “Lack of focus on the development of a manufacturing sector in the GCC until a few years back, small domestic market size, difficulty in raising adequate funds, and shortage of knowledge and skilled manpower are some of the major factors that restricted flow of investments into the pharma manufacturing sector,” says Vig. These could be addressed by industry bodies like The Economic Development Board (EDB). The agency acts as a matchmakers and works closely with investors to help identify potential opportunities in Bahrain. EDB's investor relations officers assist and guide investors through the process of establishing their company in Bahrain. The licensing and operational process begins

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with finding a relevant business activity for the investor followed by retrieving the required approval from the sector-related regulators. Setting up a pharma manufacturing unit is highly capital intensive and typically involves a long payback period. The Gulf countries are highly dependent on imports of manufacturing equipment, pharma ingredients, and medicines for end use. This makes the pharma industry in the GCC vulnerable to supply-related problems and fluctuations in foreign exchange rates. Regional drug prices are significantly higher than the world average, which may prove detrimental for the overall progress and long-term growth of the industry in real terms. Further, prices vary significantly within the region.

Existing players Although Bahrain did not have a single mainstream pharma manufacturer operating in 2010, the country is gradually witnessing some development within the local manufacturing segment. Major investments are done by companies looking to set up regional offices, manufacturing hubs or research and development facilities in the country. In the later part of 2011, Bahrain Pharma (previously known as Bahrain International Medi-

cine Manufacturing Company) announced its plans to construct the nation’s first pharma factory at Bahrain. The company operates as a contract manufacturer of nutraceutical and pharma products with equipment and technology provided by the US-based Vanguard Pharmaceutical Machinery. In order to reduce its reliance on imported medicines and boost growth of the local pharma manufacturing industry, the government of Bahrain is encouraging foreign capital flow and private sector investments into the industry. SBI Pharmaceuticals, a part of the Japanese conglomerate group, SBI Holdings, was reported to be planning to open a manufacturing facility in the country. The company identified Bahrain as its research and development base in the MENA region and also set up a representative office in the country recently. Bahraini companies such as Innovest and Bahrain International Medicine Manufacturing Company are also establishing their presence in the domestic manufacturing segment. Indian pharma firm Aurobindo Pharma launched Bahrain operations in 2012.

Attractive investment destination Bahrain, the 'Gateway to the Gulf”, maintains a liberal and trusted business environment

and boasts unrivalled access to the markets of the Gulf Cooperation Council (GCC) comprising Bahrain, Kuwait, Oman, The kingdom of Saudi Arabia, Qatar and the United Arab Emirates. “Fast growth in the GCC offers a wealth of opportunity for Indian healthcare providers. Our markets have a combined value of $1.5 trillion, expected to reach $2 trillion by 2020, and have increasingly sophisticated mass-affluent populations on the lookout for cutting edge medical technologies and treatments,” says Kamal bin Ahmed, Minister of Transport and Chief Executive, Bahrain Economic Development Board.

Tax heaven Bahrain reportedly has one of the most favourable tax regimes in the world with no corporate tax, no personal tax, no capital gains tax, no withholding tax and no restriction on the repatriation of capital, profits or dividends. “Bahrain offers an attractive and supportive business environment, including competitive tax rates, transparent regulation, excellent transport connections by air, sea and road to the other countries of the GCC, and a highly-skilled local workforce, making it an ideal platform from which to access the GCC market,” says Ahmed. Bahrain also has a free

EXPRESS PHARMA

January 16-31, 2014

cover ) trade agreement (FTA) with the US that Indian manufacturers can take advantage of, particularly as India and the US do not currently have a FTA in place points out Ahmed. The Kingdom is also negotiating an FTA with India which may take shape soon. “The countries of the GCC, which include Bahrain, Saudi Arabia, Qatar, UAE, Kuwait and Oman, and India are currently negotiating a free trade agreement which it is anticipated will be completed in the near future,” informed Ahmed.

Competitive costs The overall cost of doing business in Bahrain is also comparable to the other locations in the GCC. Be it renting office space or the cost of land or the cost of electricity Bahrain is very competitive. Thus the investor has an advantage in not just taxation but in overall cost of doing business. In this regard the free trade zones established in Bahrain are instrumental in attracting foreign investments and technology required to build local capabilities for manufacturing of patented pharma products.

Bahrain International Investment Park The Bahrain International Investment Park (BIIP) is a business park catering to companies looking to establish export-oriented manufacturing and international services operations in the Middle East. “The Park is positioned as a location for high quality foreign direct investment in Bahrain, offering a tax free location with full duty free access to GCC markets. This exclusive Middle East business park, with its advanced facilities and special customs services, offers businesses an unsurpassed base with direct connectivity to the very heart of regional markets,” says Paddy Gallagher, Marketing Manager, Bahrain International Investment Park. BIIP is a high quality 247hectare business park that has

24 EXPRESS PHARMA January 16-31, 2014

been developed by the Ministry of Industry and Commerce. The Park has excellent connectivity and access to both the Bahrain International Airport and the new Shaikh Khalifa Sea Port in Hidd. The BIIP enjoys direct motorway access to Saudi Arabia, via the 25 km Saudi-Bahrain King Fahd Causeway and will enjoy the same connectivity to Qatar via the Qatar-Bahrain Friendship Bridge. “The Park extends 2.5 million sq m, and as of October 2010, 70 per cent of the space had been allocated to 77 com-

panies, of which 37 are foreign. These companies will create 8,000 jobs,” says Gallagher. “Companies operating from the Park include Kraft Foods (US), BASF (Germany), Siemens (Germany), S+A Abahsain (Saudi Arabia) and MTQ Corporation (Singapore),” he adds.

Bahrain-India trade relations Continuous growth and prosperity mark the Bahraini –Indian trade relations, wherein the non-oil imports from India have reached $395 million while its exports have

reached $835 million. Several MoUs and agreements have been signed since 2012 amongst them is a tax information exchange agreement for joint investments between the two countries. In addition to signing an MoU between the Bahrain Chamber of Commerce and Industry and the Indian Industrial Union to strengthen the trade and industrial benefits exchanged, and also the establishment of the Indian Bahraini Business Council which aims at developing the economic, trade and technologic relations

between Bahrain and India. Bahrain's allure is strong. Low costs and minimal taxes are very lucrative to the Indian pharma industry. Large saturated markets of the US, Europe and Japan have forced the pharma companies to look for other emerging markets and Bahrain fits the bill. mneelam.kachhap@ expressindia.com (The author visited Bahrain recently on the invitation of The Bahrain Economic Development Board

MANAGEMENT REPORT

Pharma market posts 14 per cent growth in November 2013: IMS MAT market growth for the industry continued to be below the 10 per cent mark, for the third successive month, in November

IMS Health view point The pharma market has remained almost static for the past five months, moving within a narrow range of `6700-6900 crores. After the dip in growth during the months of August-September following the DPCO 2013 notification and implementation, the market has seen a steady improvement in growth, as it grappled with this new policy

and gradually stabilised. While some challenges remain (particularly trade margin issues), IMS Health sees an improving trend in this segment. The non-NLEM segment which contributes to ~80 per cent of the market has grown at a healthy rate of 15 per cent for the month of November. Seasonal factor has also contributed to the strong growth in November. Therapies which are closely linked to winter related ailments, have posted strong double digit growths (respiratory +18.6 per cent, anti-infectives +10.9 per cent, and pain/analgesics+14.1 per cent). After clocking a CAGR of 15 per cent during the period 2008-12, the market has slowed progressively, and it is expected to register a single digit growth ranging between eight per cent to nine per cent

NLEM SEGMENT GROWTH April - November 2013 10

Growth%

THE PHARMACEUTICAL market was reported at ` 6763 crores for the month of November 2013, with a growth of 13.8 per cent. MAT market growth for the industry continued to be below the 10 per cent mark, for the third successive month, in November. However, the higher growth in November has pushed up the figure marginally.

0 -5

-10 -15 â&#x2013; NLEM SEGMENT GROWTH%

Apr 13

May 13

June 13

July 13

Aug 13

Sep 13

Oct 13

Nov13

-1.6

0.1

1.4

-8.7

-9

-10.7

-4

6.897

6.769

5.2

13.8

Oct 13

Nov 13

November 2013

6.744 5.956

Company Rank

RS Crore

IPM

6,763

% Growth %Contribution (SPLY) 14

100

Incremental Value Added Rs. Crore 820

5.790

5.768

2,761

287

11-30

2,319

276

31-100

1,343

247

>100

341

Source: IMS Health TSA, November 2013.

26 EXPRESS PHARMA January 16-31, 2014

6.793

6.834

6.262

13.9

13.5

11.4 8.4

TOP 10

6.883

6.370

5.9

6.8

8.9

1.8 4.9

Jan 13

Feb 13

Mar 13

Apr 13

May 13 June 13 Market (Rs.Cr)

Source: IMS Health TSA, November 2013.

Jul 13

Aug 13

Sep 13

Growth(%)

2013 MARKET GROWTH TREND in 2013. Price control measures (DPCO 2013 notification in mid 2013) and the uncertainty surrounding its implementation both in the trade as well as at the company level, combined with the overall slump in economy have contributed to a large extent to this slowdown. For the period MAT November 2013, the pharma market was reported at `77,834 crores, with a growth of 9.2 per cent, over the same period last year. For the month of Novem-

Nove’ 13 ranking Mat

ber 2013, Alkem was the fastest growing corporations among the Top 10, followed by Macleods Pharma, Sun Pharma and Mankind. Glaxosmithkline registered the highest growth decline among the Top 10 corporations, impacted primarily by the price reduction in its portfolio, falling under the NLEM notified list; Pfizer was the only other corporation among the Top 10, with a decline in growth for the month. Among the Top 10, Glaxosmithkline climbed up three

12.0 11.1 11.0

10.2

10.8 10.0

10.0

10.3

10.0

9.3

9.2

9.0

8.5

8.0 7.0 6.0 5.0 MAT MAT JAN 13 FEB 13

Corporations

Mon

10.8

10.7

MAT MAT MAT MAT MAT MAR 13 APR 13 MAY 13 JUNE 13 JUL 13

MAT MAT AUG 13 SEP 13

MAT MAT OCT 13 NOV 13

Moving annual total

Month Val Crs.

MS %

Val Gr%

Val Crs.

MS%

Val Gr%

TOTAL MARKET

6,763

100.0

13.8

77,834

100.0

9.2

ABBOTT

445

6.6

5.3

5,238

6.7

3.4

CIPLA

343

5.1

14.5

3,785

4.9

6.6

SUN

317

4.7

1.8

3,590

4.6

18.1

RANBAXY

271

4.0

8.6

3,069

3.9

2.5

ZYDUS CADILA

267

3.9

11.3

3,038

3.9

6.1

ALKEM

248

3.7

29.5

2,670

3.4

12.7

GLAXOSMITHKLINE

237

3.5

-5.8

2,919

3.8

-2.8

MANKIND

229

3.4

18.8

2,557

3.3

5.0

MACLEODS PHARMA

208

3.1

26.4

2,226

2.9

14.3

PFIZER

195

2.9

-0.9

2,435

3.1

5.5

Source: IMS Health TSA, November 2013.

NOV’13

Month

Moving annual total

Therapy supergroup Mat

Mon

Val Crs.

MS%

Val. G%

Val Crs.

MS%

Val gr%

IPM

6763

100.00%

13.8

77834

100.00%

9.2

Anti-infectives

1068

15.8%

10.9

11866

15.2%

0.2

Cardiac Drugs

766

11.3%

8.9

9198

11.8%

11.4

Gastro Intestinals

652

9.6%

13.8

8159

10.5%

9.8

Respiratory Drugs

650

9.6%

18.6

6156

7.9%

9.0

Pain / Analgesics

553

8.2%

14.1

6338

8.1%

8.7

Anti Diabetics

503

7.4%

19.5%

5666

7.3%

18.9

Vitamins / Minerals / Nutrients

494

7.3%

13.4

6005

7.7%

8.8

Dermatologicals

422

6.2%

23.6

4549

5.8%

16.4

Neuro / CNS Drugs

384

5.7%

8.0

4611

5.9%

9.5

Gynaecologicals

346

5.1%

12.7

4307

5.5%

7.1

Source: IMS Health TSA, November 2013.

EXPRESS PHARMA

January 16-31, 2014

MANAGEMENT ranks and Ranbaxy climbed one rank, in the month of November 2013, as compared to previous month; ranking of Zydus, Mankind, Macleods and Pfizer slipped by one rank for the month. Rankings of other corporations remained unchanged. A look at company growths segmented by rankings reveals that the midsized organisations as a whole (ranked 31-100) have registered the highest growth of 23 per cent; companies ranked between 11-100 and contributing ~54 per cent of the industry, have grown faster than the market. The Top 10 companies – though growing below the market growth, top contribution of incremental sales in absolute terms (`287 crores). For the month, growth of local companies outstripped that of MNCs; after posting a

decline in October for the first time in 2013, growth of MNCs have shown a marginal improvement in November. For the month of November 2013, dermatological, anti diabetics and respiratory therapies have posted the highest growths. Seasonal swing during the month of November has pushed sales of acute therapies which contribute to ~70 per cent of the market, outperforming growth of chronic therapies (which continued to grow at healthy double digit levels). As seen above, while chronic therapies have continued to post consistent healthy growths throughout 2013, it is the fluctuations in acute segment (seasonal / DPCO related) that have impacted overall market growth.

MONTHLY GROWTH TRENDS Industry vs Therapies Growth% 20 15 10 5 0 Jan 13

Feb 13

Mar 13

Apr 13

May 13

June 13

July 13

Sep 13

Aug 13

Oct 13

Nov13

-5 Acute

Chronic

IPM

2013: Industry growth trend by company type

November 2013 Therapy Value Rs crore

Contribution%

Growth %

Total Market

6763

100

13.8

Acute

4782

14.3

Chronic

1981

12.5

Jan 13

Feb 13

Mar 13

Apr 13

May 13

June 13

July 13

Aug 13

Sep 13

Oct 13

Nov13

■ Indian

12.0

9.2

7.2

15.8

7.5

10.2

15.3

5.7

2.0

7.9

17.3

■ MNC

10.1

6.7

3.4

12.3

5.4

5.5

10.1

2.8

1.3

-1.6

5.3

Source: IMS Health TSA, November 2013.

Source: IMS Health TSA, November 2013. NOV'13 Ranking

Month

Moving annual total

Brands Mat

Mon

Val Crs.

MS%

Val Gr%

Val Crs.

MS%

Val Gr%

Total Market

6,763

100.00

13.8

77,834

100.00

9.2

COREX

30.3

0.45

4.1

299.7

0.39

8.3

VOUNI

25.1

0.37

41.1

218.4

0.28

19.0

MONOCEF

22.2

0.33

24.3

244.3

0.31

6.0

REVITAL

21.9

0.32

82.5

233.2

0.30

33.8

CLAVAM

21.5

0.32

40.8

197.4

0.25

16.7

PHENSEDYL COUGH

21.1

0.31

-14.1

293.1

0.38

12.0

HUMAN MIXTRAD30 / 70

20.1

0.30

-8.6

257.4

0.33

-1.0

AUGMENTIN

20.0

0.30

-18.4

269.7

0.35

-7.4

GLYCOMET-GP

19.8

0.29

51.8

210.6

0.27

60.1

VOVERAN

18.2

0.27

-13.3

247.6

0.32

0.2

Source: IMS Health TSA, November 2013.

28 EXPRESS PHARMA January 16-31, 2014

MANAGEMENT LEGAL EAGLE

Plagiarism,research publications and law Raghvendralal Saha, Former Director, Patent Facilitating Centre, Technology Information, Forecasting and Assessment Council, Department of Science and Technology, Government of India points out that by avoiding plagiarism we would help creating stronger intellectual property and assets which would also attract global appreciation and respect PLAGIARISM IN scientific research papers has become a topic of discussion as many cases are reported from India. The core of the discussions has largely been driven by ethical considerations rather than by the relevant laws in the country. Plagiarism is stealing someone’s

intellectual property which is legally and morally untenable. In addition it can cause economic disadvantage to the original author. The issue of plagiarism needs to be handled at a much higher level of academic, legal, political and social debate for enhancing the image of Indian re-

search. A plagiarist attempts to pass off the copied work as his own. Plagiarism is a violation of the right of authorship enjoyed by the original author, sometimes also called the paternity right. The right of authorship in India is derived from the Indian Copy-

right Act. The Act provides protection to an expression or presentation of an idea and not to the idea itself; the expression may be textual, visual or audio or a combination thereof. While copyright has a life (author’s life plus 60 years in case of literary works), authorship right is not

bound by time. Section 57 of the Indian Copyright Act stipulates “Independently of the author’s

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MANAGEMENT

copyright and even after assignment either wholly or partially of the said copyright, the author of a work shall have the right to claim authorship of the work.” In other words replacing the original author’s name by some other name is a violation of authorship right of the original author. Plagiarism is also an act of copyright infringement if undertaken within the period of the copyright. In other words one can say plagiarism = infringement of copyright + infringement of authorship right. Beyond the term of copyright, plagiarism will only be infringement of authorship right.

Difference between plagiarism and copyright infringement The Oxford Dictionary defines plagiarise as “take and use (the thoughts, writings, inventions etc. of another person) as one’s own; pass off the thoughts etc. of (another person) as one’s own.” In view of this definition it is necessary to examine how plagiarism is different from infringement of copyrights at the conceptual level. Copying of an idea or a thought or data is not copyright infringement but it may be a case of plagiarism. For example, making and selling of a pirated / copied book is a copyright infringement but not a case of plagiarism. However, the infringer will also become a plagiarist if he states or implies that his (copied) work is an original work created by him thus claiming a wrong authorship. The point being made is that plagiarism therefore needs to be viewed both from legal and nonlegal angles at the same time. The non-legal angle could be linked to ethics, consideration towards the original author, honesty and appropriation of credit not due etc. A plagiarist may raise his reputation and recognition by writing an article which is plagiarised, especially in the eyes of those who have not read the original work. This may become detrimental to the reputation of the original writer whose work may sometimes be considered as plagiarised by new readers. The enhanced reputation may lead to pecuniary benefits such as get-

30 EXPRESS PHARMA January 16-31, 2014

In the Indian context, we have more reason to get concerned as most of the research papers emanate from publicly funded institutions and copying of others’ research is a more serious matter as it points towards inefficient use of public funds

ting further assignments to write. It would therefore appear that plagiarism may also get linked to economic benefits, hence is not an ethical issue alone. Plagiarism is not a new phenomenon; it existed in the past too. However, it was not easy to detect plagiarism. Digital technology has enabled finding out cases of plagiarism, easily, quickly and correctly. On the other hand internet and digital publications have helped plagiarism to grow rapidly as cut and paste of text, tables and drawings has become easy and straight forward. Therefore authorship rights can now be easily violated. Consequently, national and global concerns about plagiarism are now occupying the centre stage among the research community.

Indian context Plagiarism certainly points towards lack of originality and novelty in any writing whether scientific or otherwise. Plagiarism in scientific research papers is a serious matter because it creates doubts about the quality of research in terms of novelty. In the Indian context, we have more reason to get concerned as most of the research papers emanate from publicly

funded institutions and copying of others’ research is a more serious matter as it points towards inefficient use of public funds. Researchers’ interested majorly in increasing the count of their publications may give a go-by to originality in content and expression while submitting their papers to journals. In this backdrop it is urgently required to examine the robustness of the training being imparted to young students and researchers in terms of novelty and originality! Plagiarism is a legal and ethical matter and hence it cannot be handled by common sense. Creating awareness about unlawfulness and unethicalness of plagiarism among all types of researchers irrespective of age is the most essential step towards encouraging original research. Let us remember that a plagiarised work brings disrepute to an institution if a member of the faculty/ student engages in the act of plagiarism. As most academic and research institutions in India do not have policies for managing their intellectual property rights including copyrights, policies for restricting plagiarism have not found the right place in the scheme of things. It would be ad-

visable to have a short course on ethics and laws in research and all academic institutions. A capsule of this nature may be included in programmes conducted by Academic Staff Colleges under UGC. Every university and academic and research institution must have a policy on plagiarism which may prescribe best practices in research and dissuasive measures to restrict plagiarism. There is no dearth of software which can help in tracking plagiarism. The best and never failing step would be to exercise self-discipline and stop copying and plagiarising. Senior researchers / scientists have a major responsibility in curbing plagiarism. Any suggestion to set up a central body for checking and controlling plagiarism in Indian research should be rejected as it would prove counterproductive. The law in this regard exists which is comparable to any other law in the world. A little hand holding of researchers would pay rich dividends in nurturing science and technology in the country. By avoiding plagiarism we would help creating stronger intellectual property and assets which would also attract global appreciation and respect.

MANAGEMENT INSIGHT

Leveraging the OTC potential of India’s 350 million ‘Kidsumers’ Valued at $409 million in 2012, the children’s OCT market remains an untapped opportunity in India. Sreedevi Yallamrazu, Manager – Business Intelligence, CubeX, gives an outlook on this market segment, and analyses global trends and varrying approaches to realise its potential CHILDREN PLAY an important role in advertising and marketing campaigns, by either adding a ‘cute quotient’ to the brand or by creating an emotional appeal to the brand’s proposition. Apart from being brand ambassadors, the millennial generation seems to be maturing much faster and has assumed a greater role today as consumers, in adopting new products targeted at them. Moreover, they are influencing brand choices even for regular household products as well as durables such as cars and electronics, emerging as one of the key drivers of consumption. ‘Kidsumers’, which defines our children consumers, is thus a little kingdom by itself, comprising a sizeable proportion (close to 30 per cent) of India’s total population. Sad but true, lifestyle changes are impacting children, with long-term health implications on the country’s future generation. The emerging need gaps will soon become an inevitable necessity, considering the alarming rise in health concerns in children. Although FMCG companies have entrenched themselves in the health supplements market, consumer healthcare companies have the potential to shape the nascent children’s OTC market in India.

Children as healthcare consumers – The potential Children’s health is a major challenge and stress factor for parents. Despite the fact that erratic eating habits of children can be quite tricky for parents, packaged foods and mushrooming fast food joints, complemented with sedentary lifestyles and lack of adequate support systems in nuclear families, are creating a huge impact on children’s food habits and overall development. The worrying aspect is that almost 50 per cent of children refused to cut down their intake of colas and sweetened juices and said that they would continue to buy fast food shown in commercials, according to a study, Trends in Childhood Nutrition and Lifestyle Practices in India. Erratic habits in children can have profound effects in their growing years and in adult life as well.

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MANAGEMENT Another rampant trend among children is spending hours glued to TV, computer, phones and video games, turning them into ‘screenagers’. A study conducted by McAfee found that 70 per cent of children (aged eight to 12 years) in leading metros in India use PC or laptop and 42 per cent of them use mobile devices for Internet access.1 Furthermore, parents’ urge to raise a celebrity in the tiny tots, who also have to meet the mandatory schooling requisites, can become a stress factor for children. Nonetheless, with growing awareness about health and fitness, overall well-being of a child has become an enhanced concern among parents. With over a 100 million kidsumers residing in urban areas, the potential consumer base is quite high to be ignored.

General Health

Respiratory

Gastro Intestinal

Illness

Dermatol ogical

Aches & Pains

Lifestyle Health

Wellness

Precertive Health

Mental Health

Health concerns in children – Catching up with adults The health concerns in children can be divided into illness and wellness needs. While nutritional deficiencies and respiratory infections are frequently observed in children and childhood obesity has become a commonplace in recent times, it was only matter of time that adult health concerns like heart burn and eye strain would become predators on children too. As per media reports, approximately 10 per cent of children have been found to battle heart burn, acidity and digestive discomfort. In addition, extended use of screens has increased eye strain and fatigue among children and about half the children’s population suffers from short-sightedness, indicating that eye care in children is a growing need in India. Complain of pain in the wrists and backache too has become common among children using smartphones. Today’s children are finding it difficult to compete in sports as they lack flexibility and strength for rigorous physical activities. Behavioural issues too are taking a toll on children as a result of lack of emotional security from time-pressed working parents. According to an Associated Chambers of

32 EXPRESS PHARMA January 16-31, 2014

Commerce and Industry of India (ASSOCHAM) study conducted in 2011, prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in India has gone up from four per cent to 11 per cent in six years’ time among children aged three to 17 years.

Children’s OTC market in India – Untapped opportunities to be explored Children’s OTC market in India has been valued at $409 million in 2012 (Source: Nicholas Hall’s DB6 Global OTC Database), contributing less than one-fifth of the total sales

of the Indian OTC market. In the illness segment, OTC sales largely come from repeat purchases. Respiratory illness, being a major concern in children due to environmental as well as intrinsic health factors, presents the largest need in the children’s illness segment.

Widespread warnings on the Internet featuring safety concerns of OTC drugs on children could create a flutter among parents who might consider self-prescribing such products. Thus, this segment can be built by gaining the trust of parents and by educat-

MANAGEMENT ing them about the products. On the other hand, the potential of the wellness segment is huge due to new opportunity areas such as preventive remedies for common ailments as well as lifestyle concerns such as gastric ailments and obesity. Mental health supplements that support the treatment of ADHD would also be needed. The children’s OTC market in In-

Global trends in children’s consumer healthcare – An inspiration for innovation Global marketers have introduced innovative products addressing new delivery mechanisms, increased palatability and convenient packaging as well as innovative ways of engaging with parents and children. Since compliance is a major issue with children, popular flavours (P&G’s

CHILDREN OTC MARKET Value $409 mn: CAGR 12%

ILLNESS SEGMENT: Value $169 mn: CAGR 14%

WELLNESS SEGMENT: Value $240 mn: CAGR 10%

Source: Nicholas Hall’s DB6 Global OTC Database

As per media reports, approximately 10 per cent of children have been found to battle heart burn, acidity and digestive discomfort. Extended use of screens has increased eye strain and fatigue among children and about half the children’s population suffers from short-sightedness dia comprises largely of brands like Dabur Chyawanprash, Vicks, Dettol whose usage is skewed towards children. There are very few brands, like Calcium Sandoz in the Indian OTC market, which are exclusively positioned for children. In addition, there are deemed OTC brands like Dexorange, Liv. 52, Vi-Syneral, which can also expand the children’s OTC market by building further on their exiting equity and offering variants that cater to the specific needs of children.

Children Pepto antacid in bubble gum flavour), gummy formats (IronKids gummies) and even effervescent tablets (gastrolyte for electrolyte replenishment in diarrhoea) have been introduced as they resemble carbonated drinks, which are enjoyed by children. Children’s Zyrtec is available as a grape-flavoured chewable tablet for efficacy and convenience for young allergy sufferers. In the US, one of the leading children’s multivitamin is Flintstones (Bayer), based on the famous cartoon.

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MANAGEMENT AccuDial (AccuDial Pharma) promotes weight-based dosing as a safer and accurate way of drawing the correct dose for a child, addressing a key concern among parents. Marketers like Johnson & Johnson and Novartis focus on ‘safety’ as one of the key aspects in their brand communication (Tylenol and Triaminic respectively), assuring parents that safety concerns in children have been borne in mind while formulating the product. Calpol’s website plays a dual role of providing brand information as well as connecting emotionally with parents’ concerns on various aspects. Mumsnet, an UK-based website engages with parents by inviting them to test products, providing incentives such as vouchers in exchange.

Marketing cues - Varying approach to managing children’s health Marketers will have to take into account that parents react differently to health concerns in children, with emo-

foods, herbal supplements and tonics are administered without concerns on side-effects. Parents do tread with caution in case of allopathic supplements, being more comfortable with giving supplements based on recommendations from friends and family. Furthermore, if the products do not have a medicinal appearance, they are readily accepted by parents and children alike, malted foods drinks being a classic example. An advisory role may be needed to promote the use of vaccines, especially in older children as the relative importance to given to vaccination declines with increasing age of the child and parents are also apprehensive about new vaccines. More importantly, healthcare in children has to be child’s play too! Children are well-updated and aware of many aspects and hence engaging them with healthy habits will also be equally important. Point-of-contact programmes in schools and places of recreational activity can be an excel-

Parent education is of utmost importance, providing rational reasons on brand efficacy and emotional reasons that assure parents that children’s safety and well-being are equally prime concerns for marketers too tional and rational factors involved during illness and wellness. Due to the tender age of a child, when it comes to illness, doctors’ advice is relied upon for the right diagnosis and treatment to ensure the child is normal again soon. It has been observed that parents tend to have less faith in OTC products, as the perception is that information given about them is incomplete and hence they might harm the child. Hence parent education is of utmost importance, providing rational reasons on brand efficacy and emotional reasons that assure parents that children’s safety and well-being are equally prime concerns for marketers too. For overall wellness needs, mothers are looking for something ‘extra’ to fulfill their children’s nutritional needs. It is also one of the reasons for overweight in children which often gets misconstrued for good health and tends to get ignored. Health

34 EXPRESS PHARMA January 16-31, 2014

lent way to reach the target audience – parents as well as children. Franklin D Roosevelt’s statement, “We may not be able to prepare the future for our children, but we can at least prepare our children for the future,” reflects the sentiments of parents and marketers may just have to follow this mantra while creating innovative products for children and communicating to parents.

Reference 1 Source: http://www.indiantelevision.com/digital/y2k13/nov/ novdig69.php (CubeX is the Strategic Consulting and Business Intelligence division of Sorento Healthcare Communications with expertise in the Consumer Healthcare and Wellness domain. To know more about reports from CubeX, you can write to reports@cubex.co.in.)

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RESEARCH CLINICAL UPDATE

Novel osteoporosis drug could change treatment: Study The treatment is one-and-a-half to three times more effective than current osteoporosis drugs in rebuilding bone density at the lumbar spine

A NEW medication for osteoporosis prompts the body to rebuild bone and could potentially strengthen the skeleton against fractures, researchers report. The experimental drug, romosozumab, frees the body’s ability to stimulate bone production by blocking biochemical signals that naturally inhibit bone formation, explained Dr Michael McClung, Founding Director, Oregon Osteoporosis Centre in Portland, Ore. The treatment is one-anda-half to three times more effective than current osteoporosis drugs in rebuilding bone density at the lumbar spine, according to clinical trial results McClung and his colleagues reported in the online edition of the New England Journal of Medicine. “Most osteoporosis drugs work by stopping the progression of bone loss, but they don’t have the capability of rebuilding the skeleton,” McClung said. “This really is a new day in the consideration of how we treat osteoporosis, with the capability of truly stimulating bone production and rebuilding the skeleton, not simply keeping it from getting worse.” More research is needed, however, before romosozumab is approved to treat osteoporosis, a serious bone-thinning disease, in the US. The new drug uses an antibody to block the function of sclerostin, a protein the body produces to naturally inhibit bone growth. Without scle-

50 EXPRESS PHARMA January 16-31, 2014

rostin, overactive bone growth might clamp off nerves or end up fusing the spinal column, said Dr Robert Recker, President, National Osteoporosis Foundation and Director of the Osteoporosis Research Centre at Creighton University in Omaha, Neb. But sclerostin also prevents people with osteoporosis from building additional bone density to replace the bone that has been lost. The antibody romosozumab binds to sclerostin and prevents its signal, which allows pro-bonegrowth signals to proceed uninterrupted, the researchers explained. This phase II clinical trial involved more than 400 postmenopausal women aged 55 to 85 who had osteopenia, which is low bone mass that is not low enough to be classified as osteoporosis. They were randomly assigned to receive one of four treatments for a year: romosozumab; a placebo; or one of two current osteoporosis medications. Results showed that romosozumab increased bone mineral density in the spine by 11.3 per cent during the study period, compared with a 7.1 per cent increase with teriparatide (Forteo), a current osteoporosis treatment. The new drug also performed much better than alendronate (Fosamax), a bisphosphonate medication that increased spinal bone density by 4.1 per cent. “In terms of rebuilding bone mass, this is clearly bet-

The experimental drug, romosozumab, frees the body’s ability to stimulate bone production by blocking biochemical signals that naturally inhibit bone formation

ter than Forteo or the bisphosphonates,” said Recker, who was not involved with the study. The new drug also appears to be safe, with no major side effects reported, McClung said. Recker expects that the antibody medication will prove safe because the bone-building signals that are left uninhibited by the drug will taper off naturally as the skeleton becomes better able to withstand weight loads and stresses. “I think it's going to be self-regulating,” he said. The drug is still several years from coming to market, McClung noted. Researchers have to prove to the US Food and Drug Administration that it actually protects against bone fractures, which will require more research. But onlookers are enthusiastic regarding the potential of romosozumab. “This possibly represents the most important change in treatment of osteoporosis that we’ve seen,” Recker pointed out. “We’ve not been able to have a strongly bonebuilding product available to us. There’s no reason not to believe it will prevent fractures, but that has to be proven.” According to the National Osteoporosis Foundation, half of all Americans over age 50 are expected to have low bone density or osteoporosis by 2020. EP News Bureau - Mumbai

RESEARCH RESEARCH UPDATE

Vitamin E slows decline in Alzheimer’s patients High doses of Vitamin E delayed the decline in daily living skills, such as making meals, getting dressed and holding a conversation in mild-to-moderate Alzheimer’s disease VITAMIN E can help slow the effects of mild to moderate forms of Alzheimer’s disease, a finding doctors should consider for treating patients, researchers said. Patients given high doses of Vitamin E for about two years delayed progression of the degenerative brain disease by about 6.2 months, compared with those given a placebo, according to a study published in the Journal of the American Medical Association. Doctors may want to discuss vitamin E as an option in early-stage Alzheimer’s treatments, the researchers said. Vitamin E acts like an antioxidant, which may prevent or delay cell damage, and boost the immune system. The new study builds on findings that showed Vitamin E seemed to slow disease progression in patients with moderately severe Alzheimer’s and is the first to show it may help stall functional decline in those with milder forms, said Maurice Dysken, the lead author. “A delay in six months over two years, that’s very meaningful to some patients and caregivers,” Dysken, a professor of psychiatry at the University of Minnesota, said. Dysken, who is a former director of the Geriatric Research, Education and Clinical Center at the Minneapolis VA Health Care System, added that his study “does not address whether vitamin E will prevent Alzheimer’s disease in people who don’t have the diagnosis.” The study looked at 613 veterans who were given Vitamin E, a combination of Vitamin E and Forest Laboratories Inc’s (FRX) Namenda for moderate to severe Alzheimer’s, Namenda alone or placebo. The Vitamin E used in the study was about 20 times greater than the dosage usually found in a multivitamin. All patients in the trial were on some type of Alzheimer’s medication, such as Eisai Co’s (4523) Aricept or Johnson & Johnson (JNJ)’s Razadyne. The main outcome was how well pa-

tients could perform activities of daily living. They found that Vitamin E slowed the worsening of the disease by 19 per cent a year compared with placebo. The research also showed those who took care of patients taking Vitamin E were able to spend less time care giving compared with those taking Namenda alone. More than five million Americans have Alzheimer’s disease, a number projected to triple by 2050, according to the Alzheimer’s Association. Vitamin E is naturally found in a variety of foods including wheat germ oil, sunflower seeds, spinach and broccoli. Though some research has linked Vitamin E with an increased risk of death, cancer and stroke, no safety issues were seen in the study. Denis Evans, a professor in the Department of Internal Medicine at Rush University Medical Center in Chicago, who wrote an accompanying editorial, said the results of the study are ‘modest’ like many trials looking at Alzheimer’s and more research in preventing the disease is needed. The finding “probably represents something roughly like the ceiling of our current ability to study the disease,” he said in a telephone interview. “That raises the issue of whether we should be looking more at prevention of the disease than treatment of the disease. We should probably emphasise prevention more.” Source: Journal of the American Medical Association

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PACKAGING SPECIAL

For years now, the packaging industry is cognizant of the environmental impact of plastics and has been searching for a solution to reduce carbon footprint and increase sustainability quotient Anand Khare, GM-Innovation, ACG-Pharmapack

The entire world is now following green technology that is made available and plastics in packaging applications will be replaced to a greater extent, wherever possible and applicable Shrikant Athavale, Chief Executive Officer, Prathith Consultants

54 EXPRESS PHARMA January 16-31, 2014

GREEN PACK ‘age’ Biodegradable packaging is slowly making inroads into the Indian pharma industry. Such packaging is surely going to propel a drive towards making the pharma sector more environment friendly By Sachin Jagdale

ackaging has always remained a mode of safeguarding medicine and presenting it to the consumer in the most acceptable form. However, over the years, besides keeping patient’s health as a main priority, packaging solution providers have also started making it eco-friendly. This drive towards eco friendliness has given rise to the concept of biodegradable packaging. Biodegradable packaging does not compromise with the appeal or quality standards of packaging but it does help in safeguarding health of the consumer, as well as of the ecosystem.

Better than traditional Traditionally plastic has remained an important constituent of pharma packaging. Though it has served the purpose of safeguarding medicines very well, plastic’s non-recyclable nature has always made it a centre of criticism by industry experts and environmentalists. Medicines worth a few billion rupees are being consumed every year in India. Such a huge medicine intake also

generates large amount of packaging waste. Unfortunately, in India such wastes are not properly disposed off. This scenario has made biodegradable packaging a welcome change in the pharma packaging sector. Anand Khare, GM-Innovation, ACGPharmapack, says, “For years now, the packaging industry is cognizant of the environmental impacts of plastics and has been searching for a solution to reduce carbon footprint and increase sustainability quotient. The industry has been struggling for quite a few years now to find the right packaging solution, which is not just eco-friendly but also ensures that the contents are safe for consumption.” ACG Worldwide, through its group company, ACG Pharmapack, has made a breakthrough and successfully managed to find the missing piece of the sustainable packaging puzzle. Khare adds, “We offer unique biodegradable pharmaceutical-grade calendered PVC films, Bio-D. As compared to normal films that take thousands of years to degrade, Bio-D renders itself biodegradable at an

enhanced rate when exposed to active biological landfill environments. This is called as anaerobic biodegradation, wherein oxygen is not needed to promote the process. When buried in active biological landfills, the films attract moisture and thereby micro organism. Micro organisms feed on the polymeric chain and break them down releasing carbon dioxide and methane in the process. Methane can be further harnessed as an alternative source of energy, which is US Environmental Protection Agency (EPA) recognised landfill energy source.” Bio-D’s biodegradability has been confirmed using ASTM D5511 testing method and the test results have been validated by an USbased independent third-party laboratory. BioD films are also FDA & CONEG-compliant for direct food contact application and conform with US Federal Trade Commission’s “Green Guides.” These films have also passed the global migration and toxicity tests. Shrikant Athavale, Chief Executive Officer, Prathith Consultants, Pune, has developed a

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January 16-31, 2014

PACKAGING SPECIAL patented biodegradable water repellent coating for paper. This technology has been developed indigenously with locally available raw materials. It can be applied in the food industry as well as in the pharma industry. Athavale lists the benefits of biodegradable packaging, “The bio degradable packaging, is recyclable, reusable, repulpable and hence highly eco-friendly.” He adds, “Biodegradable technology can be coated by brush , brush roller , gravure / kiss coating / Myer Bar or can be sprayed.”

creasing. The demand for such coatings is already on a very high priority in developed countries. These coatings will be very handy and useful for applications where the packed goods, or products need to be stored under cold conditions, or freezing conditions, in cold storages.” According to Khare, products like Bio-D films provide a sustainable packaging option enhancing brand recognition and promoting company’s green initiatives. It reduces the environmental impact while protecting the product and the planet. He feels that being driven by consumer’s interest, the FMCG industry adopted green packaging, particularly biodegradable packaging films quite a while back. Considering this, even the pharma industry has shown notable interest in sustainable packaging solutions.

Quality comes at a cost? Developing new technology needs a lot of investment in terms of money and manpower. Biodegradable packaging may benefit the environment but it shouldn't make a consumer spend more on product. “Although the price point of biodegradable films is slightly higher than equivalent nonbiodegradable films, it only reflects the superior value addition that these films provide. Increasing number of pharma and consumer packaged goods companies are now environmentally conscious with corporate-driven sustainability agendas and tend to focus on the value addition rather than price per unit of packaging. Trends show that technological advances may have a favourable influence on costs in years to come,” opines Khare. The mentality of most Indian consumers is such that they might choose a less effective or slow acting product to avoid high price. So, if biodegradable packaging makes a product even a morelittle expensive, it would be a challenge for the manufacturers to convince Indian consumers to buy it. The sole purpose of biodegradable packaging is to 'degrade' in a best natural manner/process once it has served its duty. But it does not necessarily mean that its quality standards would be compromised in comparison with plastic packaging. According to experts, biodegradable

56 EXPRESS PHARMA January 16-31, 2014

Positive predictions

FMCG industry adopted green packaging, particularly biodegradable packaging films quite some time ago. Considering this, even the pharma industry has shown notable interest in sustainable packaging solutions packaging does meet all the expectations and would never alter the product's shelf life. “The shelf life of the product is certainly extended, similar to the existing packings with plastic coatings,” says Athavale. “Biodegradable films do not compromise on the intended application and usage condition, and retain the sturdiness, physical and mechanical properties exhibited by normal polymeric films,” informs Khare. He ex-

plains, “ACG’s Bio-D range of biodegradable films can be processed using the same processing parameters and can be printed on in the same manner. Besides being available in various customisable thicknesses, the biodegradable films have the same shelf life as normal films.”

A welcoming move Biodegradable packaging is a comparatively new concept. Every company wants to go green, however, for the time

being the pharma industry somehow lags its counterparts in other industrial sectors while adopting such innovative form of packaging. But though slow, there is a consistent rise in the usage of biodegradable packaging in the pharma industry. While speaking about his patented coating, Athavale says, “This is a fairly new development and the awareness amongst the packaging material manufacturers is ever in-

Athavale predicts, “The entire world is now using the available green technology and plastics in packaging applications will be replaced to a greater extent, wherever possible and applicable.” Researchers are mulling different ways to find an alternative to plastic. Biodegradable packaging will redefine the standards of packaging in the pharma industry and will also make it a key contributor to the well being of the society. Khare signs off on a positive note saying, “Packaging has evolved a lot in the past few years and will continue to do so in the coming years. Today, besides investing in developing new products and product extensions, businesses are forced to consider investing in newer, better, and eco-friendly packaging materials and technologies. Pharma packaging is on the verge of innovative rapid growth given the needs of the product, cost and patient convenience when taken into consideration to build brand identity. As awareness about environmental concerns grows so will the adoption of biodegradable packaging.” sachin.jagdale@expressindia.com

PACKAGING SPECIAL

Packed with potential Cut throat competition, impending patent expiries and increasing regulatory scrutiny are forcing pharmaceutical packaging companies to rethink their strategies. But these challenges could also mean tremendous opportunities for the right players. Usha Sharma gets two experts to share their strategies and trends to watch in the year ahead

he demands from pharmaceutical packaging companies is only set to increase as drug manufacturers continue to face a number of challenges and they are looking for solutions to protect and promote their products, increase patient compliance, and meet new regulations. Besides quantitative, qualitative adherence to customer requirements within the defined time lines of GMP, quality certification, training (continuous upgradation of skills), product re-engineering/ cost focus, concern for the environment (EHS) and good corporate governance, we at Parth Foils are focused on the following specific areas:

Support for mass serialisation Pharma companies are initiating mass serialisation to support traceability and to support this endeavour, we are in the process of installing one 'online' bar code reader on our printing machines in the 'pharma division' on a trial basis. Gradually all our printing machines will be retro fitted with this attachment.

'We shall continue to focus on developing new alternates' Debdeep Bhattacharya, Chief Executive Officer, Parth Foils

Bringing differentiated packaging solutions to market Increasingly, generic pharma manufacturers are using packaging to increase sales, boost profitability and provide greater value to customers. “ACLAR” like high moisture barrier thermo formable blister film, is serving as a key enabler in bringing differentiated packaging solutions to market. We are working with global packaging companies for a strategic partnership to promote cost effective “ACLAR” like films in India and should be able to ink the

deal by mid 2014.

specifications

Developing safer packaging alternates

Other than these initiatives, we are continuously working on:

To prevent tragic accidents and especially malicious tampering, manufacturers try to create safe packaging and governments continue to update regulations to include new tamper-evident technology. Tragic accidents involving the drug intoxication of children has led to new legislation making it difficult for drug packaging to be opened by young children, while allowing adults easy access. Such packaging is designated as child-resistant. As pioneers and leading providers of child resistant laminate in India, we shall continue to focus on developing new alternates whilst improving upon the existing

● Anti-counterfeit packaging so-

lutions including in-house and

online hologram transfer on foil and PVC ● Optimised packaging to reduce material consumption and hence cost ● Development of new 'under coat', 'over coat' and 'ink systems' to withstand high temperature sealing on the new generation express speed blister packing machines ● Development of 'universal lacquers' to facilitate sealing of the blister foil with PVC, PVDC, other thermoforming and cold forming materials ● Development of 'under coat/primer' to facilitate printing of foil on the HAPA machines ● Look at adding 'CFB Alu-Alu/ tropicalised laminates' and 'PVDC/PVC' to our product portfolio.

EXPRESS PHARMA

January 16-31, 2014

PACKAGING SPECIAL

Chakravarthi AVPS, Chief Executive Officer, Managing Director, Ecobliss India

ith more than one third of US FDA approvals from India, there is no doubt that the Indian pharmaceutical industry is emerging as a major generic player in the global market. The exports of formulations has a compounded annual growth rate (CAGR) of more than 21 per cent. Also by 2015, about $150 billion worth of drugs are set to lgo off patents. As the cost of manufacturing is relatively low in India and Indian companies too have proved capable of keeping costs low, this is the right time for exploring this opportunity. Packaging obviously plays a major role in helping Indian pharma companies catch up with innovator drugs in the US and other regulatory markets, These are the trends I foresee in the pharma packaging market in 2014: Single-dose formats have already been capturing a sizeable part of the market and this trend will increase in the future. The challenge is to keep the pack as compact as possible, and yet give users the information they need to have as clearly as possible. And they need to address patient safety and compliance simultaneously. Packaging solutions that address cool chain requirements in secondary, tertiary

58 EXPRESS PHARMA January 16-31, 2014

'It is becoming mandatory to follow scientific packaging methods' packaging will gain market as there will be a surge in the usage of temperature sensitive drugs. Combination products alias combo drug packs will see more acceptance and it's a challenge for a packaging developer to offer a solution for packing heterogeneous products while following compliance requirements. Packaging for injectables and pre-filled syringes: The market for injectable drug devices and pre-filled syringes will grow multiple times. This is because self administered therapies (suggested by physicians) will see a major surge. So the packaging must ensure dosing accuracy, be tamper evident, and ensures patient compliance. And it must

also help prevent drug spray-back and more importantly help prevent accidental injuries due to needle sticks. Blow fill seal (BFS) technology is

becoming more and more prominent as some products cannot withstand continuous exposures to high temperatures and they have issues with conventional sterilisation. BFS process paves way for bulk sterilisation, gamma radiation immediately followed by packaging. While packaging has to protect product integrity, it must also help patient safety, be child resistant and tamper evident as well. These will be in major demand as they protect people against incidental and accidental poisoning. As packaging is almost directly involved in the drug manufacturing process, it is becoming mandatory to follow scientific packaging methods

that address the product's needs, patient convenience and of course, product security and ousting factors. Needless to

say, brand identity must be addressed as well. u.sharma@expressindia.com

PACKAGING SPECIAL I N T E R V I E W

â&#x20AC;&#x2DC;Synchrotron radiation is intense, polychromatic and finely collimatedâ&#x20AC;&#x2122; Santosh Panjikar, Scientist, Australian Synchrotron, talks with Sachin Jagdale about the beams produced at his company and their applications for the pharmaceutical industry

Could you please describe the uses of different light beams in the pharma/biotech industry? Synchrotron radiation (SR) is intense, polychromatic and finely collimated. The radiation has a continuous spectrum over a broad range of frequencies - typically extending from microwave frequencies to the X-ray band. The unique properties of SR allow probing matter of widely differing nature and at very dissimilar levels of magnitude, from macroscopic assemblies to atomic structure. Pharmaceutical and biotech companies use synchrotron techniques to help develop new products at all stages of research, from drug design and formulation to pre-clinical phases. Molecular structural characterisation using X-rays forms a major proportion of the research done by pharma/biotech industry at synchrotrons, with applications ranging from macromolecular crystallography, through small molecule crystallography to high resolution powder diffraction. Macromolecular crystallography is used to study complex macromolecules and their binding to ligands with potential inhibitor effects. This is one of the most important steps in the rational drug design process. How will you describe the benefits of using light beams over the traditional methods used for the drug discovery/research and development? In order to identify new lead

compounds in the traditional way of drug discovery, large chemical libraries are experimentally screened against a biological target. Rational, structure-based drug design is proven to be more efficient than the traditional way of drug discovery since it aims to understand the molecular basis of a disease and utilises the knowledge of the three-dimensional crystal structure of the biological target in the process. Stateof-the-art structure-based drug design methods include virtual screening and de novo drug design. These serve as an efficient, alternative approach to experimentally screening of chemical libraries against a biological target. In order to determine crystal structure, high intense and collimated X-ray beam is required. X-rays produced by a synchrotron are 103 to 104 times brighter than the X-rays from a conventional X-ray source. Macromolecular crystallography is the gold standard technique for determining crystal structure of drug candidates but unfortunately, not all samples co-operate during crystallisation and some crystals that are too small to be studied using conventional X-ray sources. In addition, with samples that do diffract well, the benefits of the synchrotron are significantly higher resolution and very fast data collection. Because of the higher intensity of the X-rays generated, smaller crystals can be used for 3D structure determination, with samples of a few cubic microns routinely measured using the powerful and fully au-

tomated protein crystallography beamlines. Major applications of such beams would be in the fields such as molecular and nano medicines. In India these fields are relatively in the nascent stage. So, how do you find the scope for your business in this market? Although application of synchrotron technology for the molecule medicine field in nascent stage, however, awareness in India is increasing. On the other hand, Indian generic companies will need to compete with the multinationals by focusing on drug development and produce their ownpatented products. It is realised that intellectual property issues can only be addressed by careful screening of drugs for the absence of forms patented by other companies. Already some of the major companies in India are addressing these by using Synchrotron technology. It is likely that the demand of its use will be increasing. Do you have any tie ups with Indian universities/scientists/ scientific organisations for the research purposes? Currently, we have collabo-

ration with a scientist from the chemistry department of Indian Institute of Technology, Mumbai for scientific research in the area of bioremediation particularly proteins from the catabolic pathway from P. putida. Recently, Australia-Indian Council has approved limited funding for a few Indian scientists from a couple of institutions for access of beamtime at the macromolecular crystallography beamlines of Australian Synchrotron. Have you ever organised workshops for Indian pharma/ biotech professionals/scientist to make them understand the importance of the use of light beams in their research works? So far we have not got an opportunity to organise any workshops for Indian professionals from industry or academics and to provide insight in the importance of the use of SR in their research works except my limited number of talks this year I have hold in a few academic institutions where macromolecular crystallography method used for their research. If there is sufficient interest in Indian pharma/biotech and if funding becomes available such workshops can be organised. Who are your clients in the Indian pharma/biotech industry? We do not discuss the details of our commercial clients due to confidentiality agreement, but as India is the fastest growing market for the development of generic drugs, we have been working with some

of the major companies who send their samples to us and we provide a data collection service to them. Considering the size of the Indian pharma industry, will there be any plans of setting up your facility in India as well? India lacks a new-generation synchrotron research facility equipped with a tunable X-ray diffraction beamline, which is necessary for the elucidation of novel macromolecular crystal structures of vital importance in biology and medicine. The Indian structural biology community has grown in the recent years and a large number of excellent scientific laboratories are active in this field in the country. India is planning to build synchrotrons in the future, but such an initiative requires about ten years for completion. Currently, scientific community of the country has limited, and geographically complicated access to the European Synchrotron Research Facility in Grenoble (France) and to Elettra in Trieste (Italy) through Indian investment at their (rather old) bending magnet beamlines. The Indian pharma industry does not have easy access of beamline, often commercial beamtime is purchased according to their needs. However, similar arrangement could be made at Australian synchrotron from Indian pharma companies or academic for accessing of the micro-focus beamline and fast data collection and analysis. sachin.jagdale@expressindia.com

EXPRESS PHARMA

January 16-31, 2014

PACKAGING SPECIAL VENDOR NEWS

Sanner to display desiccant and engineering expertise at Pharmapack Europe in Paris SANNER REINFORCES its expertise and market leadership in desiccants and gives an overview of its in-house engineering at Pharmapack Europe in Paris. Following a recent strategic repositioning, the packaging specialist now focuses on the pharmaceutical, medical technology and healthcare industries. This includes the expansion of the six product categories and the expertise for customised solutions. In the effervescent packaging category, Sanner presents new design concepts for tube packaging of effervescent tablets. The company further emphasises its position as the Asian market leader in test strip packaging.

The pharma and medical packaging section highlights options for packaging development which are made possible by Sanner’s structured in-house engineering process. Sanner also presents exemplary solutions for eye care and ready-to-fill syringes at Pharmapack. The main focus of Sanner’s booth is on pharma desiccant packaging. In this segment, Sanner introduces product solutions for capsules, sachets and tablet packaging. Pharma desiccant packaging, test strip packaging and effervescent packaging all have one thing in common: Sanner's industry-leading expertise in desiccant integration. The optimum coordination of

closures and tubes or containers ensures that Sanner’s complete packaging solutions achieve an extremely high density. To maximise product shelf-life and enable usage in different climate zones, Sanner integrates the exact amount of required desiccant. This reduces weight and lowers costs and achieves positive results regarding sustainable material usage. The desiccant is either integrated into the closure or attached to the bottom of the package, thus meeting the key criteria of pharma manufacturers. Exemplary solutions demonstrate how modern and userfriendly packaging can be manufactured with fewer single

components. At the same time, the packaging can easily be introduced into the filling process prior to closing, resealing and convenient repacking. Thus Sanner packaging solutions support simple and fast processes and reduce production costs. Sanner develops customised solutions thanks to a comprehensive in-house engineering process – from the initial design draft, 3-D modelling and mold design to optimal production technology – and advanced material expertise. “From standard products to customised solutions, as a system supplier we support our customers from the initial design concept to final project

completion,” explains Holger Frank, Chief Executive Officer, Sanner. OTC products should be visually appealing, lightweight, compact and easy to use. At best, the medical packaging can be intuitively opened and reclosed. It should also have a tamper-evident seal and an integrated child-resistant function. “Packaging requirements are becoming increasingly complex. Our experienced team of packaging engineers, designers and technicians enables us to develop and manufacture the best possible solutions for our customers and their products,” says Frank. EP News Bureau-Mumbai

PRODUCT

Labtop instruments launches biofreeze LABTOP MICRO-CONTROLLER-based biofreeze provides an ideal freezing environment for advanced medical and industrial applications. Use includes preservation of plasma, related blood components, vaccines, micro-organism, and testing of materials and electronic components at desired low temperature. The system includes micro controller-based temperature controller with digital temperature display of set value and process value.

Calibration The equipment is calibrated with the help of master calibrator, which is certified for its accuracy by Electronics Regional Testing Laboratory (ERTL West) Government of India rec-

60 EXPRESS PHARMA January 16-31, 2014

ognized testing laboratory with reference to National Physical Laboratories (NPL).

Cabinet construction and refrigeration system The cabinet of Labtop freezers is insulated with high density CFC free Poly Urethane Foam. The interior of the chamber is of stainless steel (304 SS, 1.0 mm thick). The exterior is white powder coated (1.0 mm thick) mild steel and the door has a magnetic gasket with a keyed door lock. Stainless steel trays are provided for storage inside. The cooling is effected by a hermitically sealed Danfoss compressor. GMP models are in total stainless steel (Inside SS 316 and outside SS 304).

Special features ● Foamed-in place PUF insula-

tion ensures temperature stability and reduced energy consumption. ● Audiovisual alarm if the temperature deviates from the preset temperature. ● Display of set value and process value. ● Precise control of temperature by using micro controller based temperature controller. ● Refrigeration system with CFC free eco-friendly refrigeration system with time delay. ● Password protected keypad lock.

Optional accessories Mobile Alert: Via GSM technology in case system fails Data scanner: Eight Chan-

nel temperature scanner complete with sensors and printer interface and data storage facility. Software: CFR 21 Part 11 compliance windows based communication software for data management. Complete with RS-485 multi dropping to monitor multiple chambers to one software. Documentation: Labtop offers IQ, OQ and PQ validation with documentation, reports, calibration and test certificates. Contact details Byju George, Director, Labtop Instruments Labtop House, Plot No. 59, Opp. Amarson, Waliv Phata, Sativali Road, Vasai (E),

Dist – Thane - 401 208 Maharashtra Tel: +91 250 6457 376 - 99 (24 Lines) Email: byju@labtopinstruments. com Web: www.labtopinstruments. com

PHARMA LIFE AWARD

Bionova bags Rashtriya Udyog Ratan Award Receives the award for contributing towards economic development in the country

BANGALORE-BASED entrepreneur Sudhir Jain, Founder and Managing Director, Bionova, was honoured with Rashtriya Udyog Ratan Award during a seminar held in New Delhi on 'Individual Achievement for Economic & Social Development' for contributing towards economic development in the country. The award was given by Manikrao Hodlya Gavit, Minister of State for Social Justice and Empowerment. The seminar is organised every year by Economic Growth Society of India (EGSI), which is a voluntary organisation regis-

tered under the societies Act of 1860. It supports the Government to ensure success of the economic reforms initiated in July 1991. It firmly believes in government and business circle partnership. EGSI have a theme of coordinate the people all around India with honours to individual better work in their field to promote the areas like corporate, social, medical, institutions and educational. EGSI recognises men and women from various fields for their outstanding services, achievements and contributions to society. “To receive this esteemed award is truly an honour for our

company. The whole lot of credit goes to our dedicated team who worked rigidly and contributed towards this achievement. Since its inception, our goal has always been to give innovative solutions to the society,” says Sudhir Jain, Founder and Managing Director, Bionova group, on receiving the accolade. Bionova is an application research and formulation company in India. Bionova holds a recognition of being only company of it’s kind in India which is into application research and formulations of nutritional formulations for human and animal. One of it’s research formu-

lation that made a tremendous value towards the economic growth is the product which is a replacement to a chemical called DL-Methionine (DLM). DLM is used in poultry feed as an essential amino acid component for bringing in uniformity in growth of birds.

Other guests were Bhai Mahaveer, Former Governor, Madhya Pradesh, Alka Lamba, President, Go India Foundation, Dr Joginder Singh, Former CBI Director and Haroon MM – Member of Parliament. EP News Bureau - Mumbai

NEWS

Merck Serono announces Innovation Cup 2014 Innovation Cup is aimed at university students and postdocs in life science fields from all over the world MERCK SERONO, the biopharmaceutical division of Merck, has invited applications for the Merck Serono Innovation Cup 2014. This worldwide initiative is aimed at graduate students and postdocs of medicine, biotechnology, bioinformatics, biochemistry and pharmacy, who are interested in the discovery and development of new medicines. MBA graduates with a life science background and talented future scientists from all universities world-

wide can apply. Applications can be submitted till March 15, 2014 online at innovationcup.merckserono.com. The oneweek summer training camp will take place from July 13 to 18, 2014 in Darmstadt. The Merck Serono Innovation Cup offers 30 selected participants the opportunity to familiarise themselves in a one-week summer training camp with the basics of pharmaceutical industry research and development. In teams, they develop ideas for innova-

tions in oncology, immuno-oncology, autoimmune diseases, chemo and bioengineering, drug formulation as well as medical devices/electronic health and elaborate these ideas into concrete project plans with assistance from coaches. The participants learn first-hand what it means to discover and develop new drugs and what requirements must be met in order to successfully launch new drugs. At the end of the training camp, the teams present their proj-

ect plans to a jury composed of Merck executives and external experts. The team that presents the most convincing plan will win the Innovation Cup, which involves prize money of € 10,000. The training camp will take place from July 13 to 18 in Darmstadt, Germany. The Merck Serono Innovation Cup has been taking place annually since its launch in 2011. With this initiative, Merck Serono wants to promote the personal develop-

ment of postgraduates who have the potential to become the top researchers or managers of tomorrow. At the same time, the programme serves as a forum for exchanging ideas on medical innovations. Seven of the ideas developed during the summer camps of recent years are currently being further processed by Merck researchers; several of the former camp participants are involved in this work. EP News Bureau-Mumbai

EXPRESS PHARMA

January 16-31, 2014

PHARMA LIFE NAUKRI JOB SPEAK INDEX

Hiring activity in pharma sector increases by 16 per cent in Dec’13 Signals better times ahead for the sector NAUKRI JOB Speak Index for the month of December’13 has increased signalling better times ahead for the sector. A year-on-year analysis reveals that index has gone up by 16 per cent in December 2013 as compared to December 2012. Monthly comparison also shows a 16 per cent increase in December 2013 if compared to November 2013. Both set of numbers portends an improvement in hiring situation in the pharmaceutical sector.

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

outperforming its competitors in every sphere. Info Edge was the first internet Company to be listed in India. The site enjoys a traffic share consistently over 60 per cent as per the Comscore

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

ple products like Resume Database Access, listings and Response Management Tools. With 230000 jobs live at any point and over 33 million CV’s, Naukri.com serviced over 48000

corporate clients in 2012-2013. The company has over 2500 people operating through 57 offices in 36 cities in India and overseas offices in Dubai, Riyadh, Abu Dhabi and Bahrain.

JOBS FROM Naukri.com CLINICAL DATA MANAGER

Job Id: 221113004187

Company: inVentiv International Pharma Services Exp: 3-6 Location: Pune Job Id: 131013000222

CLINICAL QA

MEDICAL CODING SPECIALIST

MANAGER PACKAGING MATERIAL

Company: Theorem Clinical Research India Exp: 1-6 Location: Bengaluru/Bangalore Job Id: 080114002521

Company: Torrent Pharmaceuticals Exp: 10-15 Location: Ahmedabad Job Id: 240713000725

PERSONAL ASSISTANT

CALL CENTER EXECUTIVE

TECHNICAL SALES SPECIALIST

SENIOR EXECUTIVEDOWNSTREAM

Company: Quintiles Exp: 1-4 Location: Bengaluru/Bangalore

Company: Endosys Technologies Exp: 1-2

Company: BioGenomics Exp: 2-5 Location: Pondicherry

62 EXPRESS PHARMA January 16-31, 2014

Company: Synapse Labs Exp: 1-3 Location: Pune Job Id: 080114002384

Location: Chennai Job Id: 080114002293

Job Id: 080114002137

SAFETY OFFICER DEPUTY MANAGER MARKETING API Company: Biocon Limited Exp: 4-5 Location: Bengaluru/Bangalore Job Id: 080114002269

Company: Martin & Harris Exp: 3-8 Location: Delhi Job Id: 080114002257

Company: BDH Industries Exp: 0-2 Location: Mumbai Job Id: 080114002007

OFFICER ORDER PROCESSING Company: LGC Promochem India Exp: 0-2 Location: Bengaluru/Bangalore Job Id: 080114001954

ASSISTANT MANAGER Company: VKT Pharma Exp: 4-6 Location: Visakhapatnam Job Id: 080114001913

SALES EXECUTIVE Company: Konark Group of Companies Exp: 0-5 Location: Mumbai Job Id: 080114001832

AREA BUSINESS MANAGER Company: Microwin Labs Exp: 3-5 Location: Delhi/NCR Job Id: 080114001598

PROJECT LEAD Company: Naprod Life Science Exp: 6-11 Location: Mumbai Suburbs Job Id: 121213001849

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