Modern Pharma - 16-31 January 2013 by Infomedia18

16-31 Januar y 2013 I Vol 1 I N o 14 I `100

www.modernpharma.in

In Conversation With 13

Special Focus 14

Policies & Regulations 16

Interface 19

Manish Gupta CEO, Indegene Lifesystems Pvt Ltd

Nanotech in pharma Aiming for sizeable benefits in India

Pharmaceutical trademarks: Scanning the changing trends

Pulin Shroff Managing Director, Charak Pharma

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MCC-South Africa approval opens up key African markets for Marck Biosciences 3QFY13 Preview Earnings momentum to be sustained by most large-cap generics

According to Kotak Institutional Equities earnings growth is expected to stay over 20 per cent y-o-y for large-cap generics except Ranbaxy. The strong performance will be driven by launches/market share gains in the US, stable growth in domestic formulations and a favourable currency. Cadila and Lupin will also benefit from acquisitions on a y-o-y basis. The EBITDA margin too is expected to expand y-o-y for Cadila (350 bps, weak base/currency), Cipla (150 bps, product mix/currency), Lupin (260 bps, Tricor) and Glenmark (244 bps, product mix). Dr. Reddy’s margin is expected to remain flat y-o-y.

Domestic growth to remain stable

A growth in domestic formulations is expected to be the highest for Sun Pharma (20 percent y-o-y). Cadila reported a 24 per cent growth, higher than Biochem, which is expecting an underlying growth of 18 per cent. Lupin, Glenmark and Cipla are also likely to post healthy growth (17-18 per cent y-o-y). Dr. Reddy’s is expected to grow in line with industry growth of 15 per cent and Ranbaxy’s growth may stay muted (11 per cent y-o-y).

US approvals, competition may hold the key to stock performance

For Lupin, the launch of generic Tricor has been an expected event with focus shifting to entry of further competition. The launch of more OC products and ramp up will be key factors. Dr. Reddy’s execution of US launches has gained momentum. Additional limited competition launches (in 4QFY13) and US pipeline visibility for FY2014 are likely triggers. A stable performance for the quarter and execution on the US pipeline will be the key for Cadila. The quarter will provide the base business performance for Cipla after the benefit from escitalopram over the past two quarters. Glenmark will be required to sustain its strong earnings performance given the heightened expectations.

Marck Biosciences has opened a new chapter in Africa with the award of the South African Medicines Control Council approval for six products manufactured at its Small Volume Parenterals (SVP) facility at Kheda, Gujarat. The MCC approval will also enable Marck Biosciences to achieve immediate access to key markets including Namibia, Patel Botswana, Zimbabwe, Swaziland, Lesotho, Zambia, Malawi and Madagascar. MCC approval is expected to result in waiver of inspection by the authorities of these countries and an easier registration of certified products. For

Marck Biosciences, the approval carries the opportunity of accessing some of Africa’s most stable growth economies. MCC-South Africa’s certification is also recognised by 43 participating authorities of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This may facilitate export by Marck Biosciences of certified SVP to PIC/S participating authorities as well as non-PIC/S authorities who accept GMP certificates from PIC/S participating authorities. Speaking on the MCC-South Africa

approval, Bhavesh Patel, MD, Marck Biosciences, said, “The MCC-South Africa approval for our Kheda facility will provide further impetus to our current expansion efforts in the African region and PIC/S countries. We would also augment our efforts by our own filing and licensing with new partners in SA. I see strong revenue potential in these under-served markets and we believe that we can make a quantum contribution to healthcare products in these countries.” Six products have obtained approvals from MCC-South Africa, including sterile water for injections BP 5/10 ml; ciprofloxacin eye drops 5/10 ml; timolol (0.25 and 0.5 %) eye drops 5/10 ml; lidocaine injection BP (1%) 5/10 ml and lidocaine injection BP)2%) 5/10 ml.

Abbott completes separation of research-based pharma business Abbott has completed the separation of its researchbased pharmaceuticals business, which became AbbVie, a new independent biopharma company. AbbVie is a research-based speciality biopharmaceuticals company with a broad portfolio of medicines, including leadership in immunology and virology, and a pipeline of breakthrough therapies.

Abbott is one of the largest science-based, diversified healthcare companies, with market-leading offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. “We wish our colleagues at AbbVie continued success as they become part of a new, independent company

White

that is already making a significant difference, focussing on highly specialised, market-leading therapies for some of the world’s most difficult-to-treat diseases,” said Miles D White, Chairman and CEO, Abbott.

MSF calls for rapid registration in countries with high DR-TB Médecins Sans Frontières (MSF) welcomed the approval by the US FDA of bedaquiline, the first new drug active against Tuberculosis (TB) to be registered since 1963. “The first new drug to treat TB in 50 years is an immense milestone,” said Dr Manica Balasegaram, Executive Director, MSF Access Campaign. “The fact that the drug is active against drugresistant forms of the disease makes it a potential game changer.” Today’s treatment for multidrugresistant TB (MDR-TB) is a two-year course of up to 20 different pills per day and around eight months of daily injections. Patients are subjected to excruciating side effects, ranging from permanent deafness and persistent nausea to psychosis. Globally, only 48 per cent of people who start treatment for DR-TB are cured. In MSF programmes, the cure rate is slightly better – 53 per cent – but still unacceptably low. “Ministries of health and drug regulators need to work together to make sure people with MDR-TB benefit from

this important medical advance as soon as possible. The onus is on all of us to use bedaquiline to devise new treatment regimens for drug-resistant TB that are shorter, more tolerable for patients and are more effective,” said Dr Balasegaram. “With better treatment on the way, there should be all the more incentive to scale up our efforts to treat MDR-TB today.” The scale of the DR-TB epidemic is huge, with 310,000 new cases notified in 2011. But globally, only 19 per cent of people thought to be infected are receiving treatment. “Scale-up of global DR-TB treatment has remained shockingly low, to a large degree because the current treatment regimen is so complex and costly for health programmes and difficult to tolerate for patients,” said Dr Francis Varaine, Leader - TB Working Group, MSF. “With simpler, shorter and more effective treatment regimens, we will be able to scale-up treatment and cure more people with DR-TB.”

In addition to bedaquiline, developed by Janssen, a second new drug that is active against MDRTB called delamanid, developed by Otsuka, is undergoing registration by the European Medicines Agency and is expected to be approved for use in 2013. Together, the two new drugs represent an unprecedented opportunity to improve treatment for MDR-TB, and ensuring the drugs are combined and introduced in the most effective manner is extremely urgent. Access to new drugs will depend to a large degree on the manufacturers. MSF calls on the manufacturers to make the drugs available for research in order to develop shorter, more effective regimens, to register them in high-burden countries as quickly as possible once they have been approved, and to ensure they are affordable in countries where they are needed most. MSF treated 26,600 TB patients in 36 countries in 2011 – 1,300 of whom had drug-resistant forms of the disease.

M o d e rn Pharma•16-31 Januar y 2013

CONTENTS In Conversation With

Manish Gupta CEO, Indegene Lifesystems Pvt Ltd

Special Focus

15 14

16 16

Nanotechnology Nanotech in pharma Aiming for sizeable benefits in India

Developments in nanomedicines The next gen therapy

Insight & Outlook Policies & Regulations Pharmaceutical trademarks: Scanning the changing trends Jatin Y Trivedi, Advocate and Attorney & Jitendra Raiya, Advocate, Y J Trivedi & Co

Strategy Managing constant pharmaceutical sales: Kick-starting prescriptions Dr Rajan T D, Pharma Consultant & Practising Dermatologist

Roundtable Will stringent regulations by DGFT for pharma packaging control drug counterfeiters?

Interface

Pulin Shroff MD, Charak Pharma Tips & Tricks Managing pharma/biotech vendors: Staying focussed while cutting cost

Event Preview BioAsia 2013 Pathway to a healthier tomorrow

REGULAR SECTIONS 5 Editorial / Guest Editorial

16 17 18 19

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20 25

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6 News, Views & Analysis 22 Projects 23 Tenders 24 Event List 26 Book Review 27 Products 29 Marketplace 30 List of Products & Advertisers

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Modern Pharma•16-31 Januar y 2013

Editorial

Stepping into 2013: Prospects and pitfalls

Editorial Advisory Board Ajit Singh

Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah

Chairman, IGPA & Secretary General, IPA

Daara Patel

Secretary General, IDMA

he global pharmaceutical industry can look forward to brighter days ahead in 2013, courtesy Moody’s forecast! In a recent report, the international research and ratings major has raised the pharmaceutical industry outlook to ‘stable’, which is based on expected rebound of company earning in this year, with patent expiries easing from their peak. While on one hand this report essentially reflects the rating agency’s expectations for fundamental business conditions in the pharmaceutical industry to improve over the next year or so, it also cautions about the challenges that continue to plague this industry. On a positive side, the year 2013 will hopefully carry forward some of the industry feats that were achieved in the recent months. These include approval of many new blockbuster drugs and data-based promising prospects of numerous path-breaking innovations. These may be accompanied by concrete affirmative results of several clinical trials that are underway, which will impact the techno-commercial significance of many pharmaceutical products that now occupy the shelf-space in market. All these should lead to approval of new drugs with therapies that are safer and more efficacious with the ultimate objective of bringing in a paradigm shift in healthcare delivery. The above will be played out amid a fast evolving market arena that include cost reduction on a continuous basis, M&As, restructuring of business and/or product portfolio, emerging market dynamics as well as increasing pressure on innovation led

growth vis-à-vis stringent regulatory norms. The moot question is how all these will shape the Indian pharmaceutical industry in the near- to mid-term future? In this regard, an update by ICRA Ltd – one of India’s premium credit rating organisations – offers some perspectives. The growth momentum will sustain as most of the Indian companies have a fairly well spread out product pipeline till 2014 and these will be further aided by structural demand drivers. In the light of large number of patent expiries, the growth prospects will continue to be strong for generics players in the developed markets, primarily driven by steadily expanding product portfolio and exclusivities. At the same time, the update says that competitive pressure in the domestic market is likely to sustain as MNCs become aggressive and domestic companies leverage their expanded field force, while potential regulatory interventions could hurt pricing. In the global market however, generics players will continue to face competitive environment with increasingly crowded space for filing ANDAs and Para IV challenges and aggressive product lifecycle management strategies adopted by large innovator companies. Having said that, stay tuned for the latest news and analysis unfolding in this space!

Manas R Bastia manas@network18publishing.com

Guest Editorial

Rebound effect on the pharma industry

he year 2012 was looking like a year that may be the end of the world for the pharma industry! Patent Raj no longer continued as many blockbuster brands have gone off patent and the expiration of these product patents depressed sales for their marketers. However, several of industry insiders are seeing brighter times ahead with more product approvals and envisage global rebound effect due to one remarkable fact - manifold increase in spending on medicines. Annual global spending on medicines is expected to rise from $ 956 billion in 2011 to nearly $ 1.2 trillion by 2016, representing a CAGR of 3-6 per cent. In other words, by 2016, the global growth will double and the value will not come from developed markets but from pharmerging (pharma emerging) markets, as there will be a huge increase in spending in these markets. Developed markets are expected to experience their lowest annual growth this year at less than 1 per cent or $ 3 billion. But they will also pick up and rebound to $ 18 million to $ 20 million by 2014-2016. This growth will accentuate the five major challenges industry faces in the following areas:

Access and affordability of those who consume and pay for healthcare around the world Adaptability and flexibility in changing operations of business: The mindset of focussing on developing and marketing medicines at higher prices with higher margins for smaller subsets of patients with significant diseases, needs to shift to develop solutions to take advantage of the evolving market Shift to patient centricity: Shifting from R&D and product centricity to patient centricity for its higher consumption Leadership drive: Proactive leadership initiatives to earlier reactive problem-solving steps Getting in cycle of care than solution to diseases While dealing with these challenges, it is possible that generic companies need to further differentiate themselves among companies such as Teva, working on other alternatives like biotech and biological to expand the basket of products. They can also revamp R&D with different models such as consortiums; ten pharma companies, pairing up and

putting resources as a consortium and committing to the partial resources to concentrate on getting standardisation around all processes and creating a basket of products to share. On one hand, it will reduce individual investment and collect the produce along with pooled and shared insights. Historically, this is perhaps the third era that will dominate from now for almost 20 years. First era was dominated by blockbuster products and competitive advantage through patents, second era was dominated by branding and marketing practices along with geographical expansion and further consolidation of industry as well as outsourcing to create value chain partners. The third era will now be dominated not by these inside options but will be dependent on the spending pattern of patients. Due to demographic changes especially in pharmerging markets, inclusive of developed markets, medicine spending is almost tripling and the consumption pattern will drive the growth of industry. Dr R B Smarta

Managing Director, Interlink Marketing Consultancy Pvt Ltd

Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

News, Views & Analysis

Tranzyme Pharma completes drug discovery collaboration with Bristol-Myers Squibb

Tranzyme Pharma, a biopharma company focussed on discovering, developing and commercialising novel small molecule macrocyclic compounds, has completed its chemistry-based drug discovery collaboration with Bristol-Myers Squibb. As a result of the joint research efforts, Tranzyme has transferred compounds to Bristol-Myers Squibb for further development across multiple drug targets. As part of this agreement, Tranzyme retains the option to further pursue select collaboration targets for internal development. “We have enjoyed an exceptionally close and

productive relationship with Bristol-Myers Squibb and are excited to be transitioning now the fruits of our discovery collaboration to our partner for further development,” said Helmut Thomas, Senior VP, Research and Preclinical Development, Tranzyme. “This milestone serves to further validate our technology’s broad application to a diverse range of difficult drug targets and its value in the discovery of drugs for the treatment of diseases far beyond our own internal focus on gastrointestinal and metabolic disorder.”

Elder Health Care forays into the ` 150 crore herbal energy booster market Elder Health Care Ltd (EHCL) has inked an agreement with Maruti Herbals to market its flagship brand Stay ON, the third major product in this category with a wide network of more than 700,000 stores in India and abroad. The decision is in line with EHCL’s strategy of developing its OTC portfolio spanning over skin care, pain management, hair care, men and women fairness segment, oral care, burn categories, lip care and women’s and men’s grooming range etc. Stay ON has excellent brand recall in the market, has no side effects and has high media spends to educate consumers about symptoms and deficiencies Dr Saxena and how to treat these to achieve lasting benefits. With the availability of the product across India, EHCL is expecting to double the sales to ` 15 crore by 2013-14 and to ` 50 crore by 2014-15.

Dr Anuj Saxena, MD, EHCL, said, “Our strong marketing and distribution network is encouraging us to launch brands – own or in-licensed – at a rapid pace as the distribution and supply logistics are already in place. With Stay On we are able to add another partner to our establishment which has great potential.” The herbal energy booster supplement market is pegged at ` 150 crore and is growing at the rate of 15 per cent per annum. The demand comes from men aged 25 and above across metros, tier I & II cities. Other players in this field are market leader Dabur Shilajit with a turnover of about ` 50 crore followed by Baidyanath Vita Ex/ Vita Ex Gold with a turnover of approximately ` 20 crore, Zandu Vigorex, Zydus Musli Vital and Musli Power. Ajanta Pharma’s famous brand 30+ was acquired by Dabur India Ltd some time back.

In Brief Wockhardt receives the `Best Enterprise’ award from the Europe Business Assembly

Wockhardt Ltd, was recently bestowed with the `Best Enterprise’ award by the Europe Business Assembly in Vienna, Austria for its achievements in the global pharmaceutical industry. The award was given in the field of pharmacy and is an acknowledgement of Wockhardt’s success within the industry and around the world. Dr Murtaza Khorakiwala, MD, Wockhardt, received the award at a ceremony at the Austrian Emperor’s palace in Vienna, Austria. Speaking about the award, Dr Murtaza said, “We are very happy to be recognised by the Europe Business Assembly and be awarded the Best Enterprise Award. This is indeed a testament to our success in being able to establish a truly global pharmaceutical business.” The award is also accompanied with a certificate that allows Wockhardt to use the trademark `Best Enterprise’ for marketing purposes for a period of 5 years.

Glenmark Generics rizatriptan benzoate

wins

FDA

approval

for

Glenmark Generics Inc USA, the US subsidiary of Glenmark Generics Ltd, won USFDA approval for rizatriptan benzoate tablets, the generic version of Maxalt® tablets from Merck. The agency has granted approval for 5 mg and 10 mg variants of the drug, and the company began shipping immediately after the clearance. IMS Health reported sales of US $ 333 million for the 12 month period that ended in September 2012. Glenmark’s existing portfolio includes 82 products that are approved for distribution in the US market with 46 ANDA’s are pending for clearance with the USFDA. The company would continue to focus new ANDA submissions.

Dr Reddy’s launches finasteride tablets

Dr Reddy’s Laboratories has launched finasteride tablets (1 mg), a bioequivalent generic version of Propecia® (finasteride) tablets in the US market. Dr Reddy’s ANDA for finasteride 1 mg tablets has been awarded a 180-day period of marketing exclusivity in the US. The Propecia® tablets brand has the US sales of approximately $ 136 million MAT for the most recent 12 months ending in October 2012, according to IMS Health. Dr Reddy’s finasteride tablets 1 mg is available in bottle counts of 30 and 90.

Modern Pharma•16-31 Januar y 2013

News, Views & Analysis

Suven Life Sciences wins patents for three products for CNS molecules

Suven Life Sciences has won patents for three products for CNS molecules, out of which two are from Eurasia and one is from Canada, and include New Chemical Entities (NCEs) for application in the treatment of neurodegenerative diseases. The validity of these patents would last up to 2027. Selective 5-HT compounds discovered by Suven are also part of the patents on which the claims have been granted and these HT compounds are developed as the therapeutic agents, which can be used for the treatment of

impairment cognitive that are associated with the neurodegerative disorders such as Attention Deficient Hyperactivity Disorder (ADHD), Alzheimer’s, Parkinson’s, Huntington’s diseases and Schizophrenia. After winning these patents, the list of patents in the bag of Suven from Canada and Eurasia rose up to 10 and 10, respectively, and each of these patents are the pat of exclusive Intellectual Property (IP) of Suven that were achieved following the internal discovery research efforts.

Biocon receives marketing authorisation for its novel biologic itolizumab for psoriasis Biocon, has received marketing authorisation from the Drugs Controller General of India (DCGI) for its novel biologic itolizumab, anti CD6 molecule for the treatment of chronic plaque psoriasis. Itolizumab, is a first in class therapy with a unique Mechanism of Action (MOA) and an excellent safety profile as indicated during the 52 week phase III multi-centric clinical study conducted in India. It is the second novel biologic developed by Biocon at Asia’s largest biotech hub in Bengaluru. This approval paves the way for the launch of Biocon’s AlzumabTM in India, later during 2013. AlzumabTM is a differentiated biologic drug with a superior safety profile compared to other approved biologic therapies given its very low opportunistic infection rates. A novel biologic indicated for the treatment of

Moderate-to-Severe Psoriasis, AlzumabTM will be marketed by Biocon’s Immunotherapy Division. AlzumabTM, will be manufactured and formulated as an infusion drug at Biocon’s

Dr Mazumdar-Shaw

biopharma manufacturing facility at Biocon Park, Bangalore. Dr Kiran Mazumdar-Shaw, CMD, Biocon, said, “We are excited to receive this marketing authorisation for itolizumab from DCGI that will enable Biocon to introduce this novel, first in

class biologic for the treatment of psoriasis patients in India. This is our second novel biologic that we have developed in India, BioMab EGFR, an anti-cancer monoclonal antibody, being the first. This approval paves the way for us to extend clinical development for other indications like Rheumatoid Arthritis (RA), Multiple Sclerosis (MS) and vitiligo. We also intend to file a US IND shortly to enable us to embark on a global clinical development plan. This is a defining moment for Biocon as it reaches a significant milestone in its mission of delivering affordable innovation to patients worldwide.” AlzumabTM is expected to provide a safe and effective treatment option for psoriasis, a socially debilitating disease affecting 2-3 per cent of the Indian population. The global psoriasis market size is estimated to cross $8 billion by 2016.

In Brief Watson’s generic Lysteda® receives FDA approval

Watson Pharmaceuticals, Inc has announced that its subsidiary Watson Laboratories, Inc – Florida has received approval from the US Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for tranexamic acid tablets, the generic equivalent to Ferring Pharmaceuticals’ Lysteda®. Watson intends to begin shipping the product immediately. Lysteda® is indicated for the treatment of cyclic heavy menstrual bleeding. For the 12 months ending November 30, 2012, Lysteda® had total US sales of approximately $25 million according to IMS Health data.

Par launches generic Maxalt and Maxalt-MLT

Par Pharmaceutical has begun shipping rizatriptan benzoate tablets and rizatriptan benzoate Orally Disintegrating Tablets (ODT), the generic versions of Merck’s Maxalt and Maxalt-MLT. Maxalt and Maxalt-MLT are selective 5-HT1B/1D receptor agonists indicated for the acute treatment of migraine. Maxalt is considered to presume to exert its therapeutic effects in the treatment of migraine headache by binding to the receptors located on intracranial blood vessels and sensory nerves of the trigeminal system. Both the rizatriptan benzoate tablets and the orally disintegrating tablets are available in 5 mg and 10 mg dosage.

Paratek Pharmaceuticals announces FDA grant of QIDP designation for omadacycline

Paratek Pharmaceuticals, Inc has said that the USFDA has designated the company’s lead antibiotic candidate, omadacycline, as a Qualified Infectious Disease Product (QIDP) for both intravenous (IV) and oral formulations in the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP). The QIDP designation provides Paratek access to certain incentives, including priority review associated with a New Drug Application (NDA) submission, eligibility for fast-track status for smaller population studies targeting certain resistant organisms, and a 5-year extension of exclusivity under the Hatch-Waxman Act upon FDA approval of omadacycline.

Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

News, Views & Analysis AspenBio Pharma changes company name to Venaxis, Inc

USFDA approves crofelemer for the first NCE launch by an Indian company

Venaxis, Inc, formerly AspenBio Pharma has changed its corporate name after receiving approval from its shareholders at a special meeting of shareholders. Steve Lundy, President and CEO, Venaxis, stated, “These changes represent another major step forward in our corporate rebranding process and we are pleased that our shareholders overwhelmingly supported our recent efforts to align our corporate identity with our core in vitro diagnostics business. Our goal is to become a recognisable name and we feel that the timing of these branding changes is auspicious, as we draw closer to commercialising APPY1 in Europe and initiating a pivotal clinical study for purposes of gaining regulatory clearance in the US.” Venaxis is revising and updating the company website and corporate materials, to unveil its new corporate look and investor website shortly

Glenmark Pharmaceuticals Ltd recently announced that the USFDA has provided marketing approval to its partner in US, Salix Pharmaceuticals Ltd for crofelemer 125 mg delayed-release tablets for the symptomatic relief of noninfectious diarrhoea in patients with HIV)/AIDS on AntiRetroviral Therapy (ART). “The USFDA approval of crofelemer for HIV associated diarrhoea Saldanha will pave way to launch crofelemer across our territories. This is a significant approval milestone and will enable the first NCE launch by Glenmark across emerging markets. Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience non-infectious

diarrhoea, which often can lead to reduced treatment compliance. This will also help us accelerate filing across countries and also propel our development in additional diarrhoea indications including the acute indications,” said Glenn Saldanha, CMD, Glenmark Pharmaceuticals Ltd. He added, “Crofelemer, a locally acting, minimally absorbed drug is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss seen in HIVassociated diarrhoea. It is this secretion that is believed to lead to diarrhoea with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency.”

In Brief Aurobindo acquires FDA clearance for nafcillin injections

Aurobindo Pharma Ltd has acquired US FDA clearance to market and manufacture fafcillin in 1 g and 2 g injection formulations as well as 10 g/vial pharmacy bulk package, and both are ready for launch. Nafcillin for injection is a sterile semisynthetic penicillin indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. It may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. These ANDAs have been approved out of Unit XII formulation facility in Hyderabad, India and will be marketed and sold by Aurobindo’s US subsidiary AuroMedics Pharma LLC.

Wockhardt gets USFDA anti-epilepsy tablets

nod

market

Wockhardt received final approval from the US health regulator to market generic lamotrigine tablets – used for treatment of epilepsy – in America. The company has received final approval from the US FDA for marketing lamotrigine extended-release tablets in the strengths of 25 mg, 50 mg, 100 mg, 200 mg and 300 mg. “We are continuing our rapid momentum of 2012 into the new year with this approval of Lamotrigine extended-release tablets,” Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt said on the development. This is the sixth product with drug delivery technology that has received USFDA approval in last six months, he added. The product is generic version of Lamictal XR tablets marketed in the United States by Glaxo Smithkline, it added. The tablets will be manufactured at the company’s facility at Aurangabad.

Eli Lilly reassumes sole worldwide rights for basal insulin analog Eli Lilly and Company and Boehringer Ingelheim International GmbH have announced that they will adjust the scope of their diabetes alliance with respect to LY2605541, Lilly’s investigational novel basal insulin analogue, with Lilly reassuming sole worldwide development and commercialisation rights to LY2605541. Lilly and Boehringer Ingelheim formed their diabetes alliance in January 2011, centering on four pipeline compounds representing several of the largest and most promising product classes. While Lilly and Boehringer Ingelheim will continue to jointly develop and commercialise the other assets in the alliance, Boehringer Ingelheim elected to terminate the collaboration with Lilly with respect to LY2605541 given independent strategic portfolio considerations. “There is an excellent spirit of collaboration in our alliance with Lilly, and we are committed to the continued success in our partnership to develop and commercialise the other molecules within the alliance, including TRADJENTA (linagliptin) tablets, and investigational agents empagliflozin and LY2963016, a new insulin glargine product,” said Dr Ulrich Drees, Corporate Senior Vice President, International Project Management at Boehringer Ingelheim. Lilly also announced plans for the 2013 and 2014 initiation of the remainder of the pre-planned clinical trials for LY2605541. In addition to supporting regulatory submissions, these studies will be conducted to evaluate safety, efficacy and differentiation of this novel basal insulin analogue. These studies are in addition to the five ongoing IMAGINE clinical trials. “We are encouraged by the pre-clinical, phase I and II data we have seen for our novel basal insulin analog,” said Gwen Krivi, Vice President, Diabetes Product Development, Lilly Diabetes. “We look forward to sharing the phase III data results of our novel basal insulin therapy with the medical community as early as 2014.”

Modern Pharma•16-31 Januar y 2013

News, Views & Analysis

IGI Laboratories completes filing of two ANDAs IGI Laboratories, Inc, a New Jerseypackage the products in the based generic topical pharma customer’s label. company has filed two Abbreviated Jason Grenfell-Gardner, New Drug Applications President and CEO, IGI (ANDAs), in accordance Laboratories, said, “In 2012, we with one of its customer successfully filed two ANDAs development agreements. The for our customer in accordance with our development agreement, company executed the customer and an additional three ANDAs development agreement earlier with the FDA on our behalf. We in 2012, and completed the Grenfell-Gardner also filed two 510(k) medical development of the two topical device applications for further development generic drug products and filing of the related ANDAs by year end. Upon FDA customers for products that would also be approval, the company will manufacture and manufactured at IGI.”

Valeant Pharmaceuticals announces new management appointment Valeant Pharmaceuticals International, Inc recently announced that Laizer D Kornwasser has been named to Valeant’s executive management team and will assume the role of Executive Vice President/Company Group Chairman where he will be responsible for the operations in Canada, US Neurology and various other US functions including managed care and distribution, effective February 1, 2013. Kornwasser was a Senior Executive at Medco Health prior to its acquisition by Express Scripts.

MT launches moisture analyser to enhance pharma manufacturing quality

Mettler Toledo has launched its excellence HX204 moisture analyser. This analyser, driven by a state-of-the-art halogen heating system, helps pharmaceutical manufacturers assure product quality, meet compliance requirements, save money through reduced rework and save time for enhanced productivity. Full process control during testing is crucial to safe pharmaceutical manufacturing. With Excellence HX204, this control is assured through a multifaceted adjustment process. The HX204 can be tested and adjusted at operating temperature, ensuring correct performance at specified operating conditions. Additionally, built-in LevelControl instantly warns users if the instrument is off-level. These features help to ensure that the high-performance MonoBloc weighing cell — which offers a capacity of 200g and 0.1 mg resolution — can guarantee maximum weighing accuracy for reliable, reproducible results. Ease-of-use with the Excellence HX204 also virtually guarantees enhanced lab productivity. Fully Automatic Calibration Technology (FACT) eliminates timeconsuming frequent manual testing with external weights. Personalised home screens and individual rights assignment allow quick access to necessary operations; the user sees only the information he needs and is authorised to access, practically eliminating handling errors. Real-time graphics with integrated control charts show drying curves and measure trends for fast analysis. An ability to set individual, product specific control limits also facilitates easy pass/fail determinations.

“The Board of Directors and I are pleased to add Laizer as the final complement to our senior management team,” said J Michael Pearson, Chairman and CEO, Valeant Pharmaceuticals International. “Laizer’s broad healthcare experience that ranges from running large divisions, overseeing acquisitions and strategy, to understanding the retail and mail channels, will be invaluable to us. And with our management team now complete, I believe Valeant is well positioned to capitalise on the opportunities that lie ahead.”

Questcor Pharmaceuticals to take over BioVectra Questcor Pharmaceuticals inked a definitive agreement to take over all outstanding and issued shares of BioVectra Inc, for C $ 50 million. Subsequent to the deal, Questcor will secure the production trade secrets of H P Acthar® Gel, which was co-manufactured by both companies for about ten years. Post acquisition, BioVectra will continue its independent operations in Keefe Prince Edward Island, along with current management staff, while Questcor will support its growth plans. Apart from the cash transaction, BioVectra may also receive contingency payments subjected to its performance over the next three years. Speaking on the development, Don M Bailey, President and CEO, Questcor,

said, “We are excited to join efforts with BioVectra as we look to diversify our revenue. This action puts us in a better position to meet the continuing growth in demand for Acthar, brings to our company a broader depth of technical and scientific expertise, and provides us with a platform for potential international expansion.” Ron Keefe, CEO, BioVectra, commented, “We pride ourselves on being a strategic partner, forging long-term relationships with our clients and utilising our proven technical skills to serve our clients’ business needs. Questcor has been an important long-term partner and we look forward to further building our relationship.”

Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

News, Views & Analysis

Boehringer releases safety data for Pradaxa® Boehringer Ingelheim Pharmaceuticals, Inc released updated prescription safety data for Pradaxa® (dabigatran etexilate mesylate) capsules for including a contraindication related to application in patients with mechanical prosthetic heart valve replacement. The addition of new contraindication is based on an interim analysis of the Phase II RE-ALIGNTM study data, which was conducted on patients with mechanical prosthetic heart valve replacement. The RE-ALIGNTM study did not enroll any US patients. The interim analysis showed an increased incidence of thromboembolic and bleeding events in this specific patient population treated with dabigatran etexilate compared to warfarin. Sabine Luik, Senior Vice President, Medicine & Regulatory Affairs, US Regional Medical Director, Boehringer, said, “Patient safety is our top priority and the company took appropriate action to stop the trial and inform regulatory

authorities. These findings do not affect the positive benefit-risk profile of Pradaxa® 150 mg twice daily when used as indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.” Greg Behar, President and CEO, Boehringer said, “Boehringer Ingelheim is a science-based company that is proud to bring innovative products to patients and the medical community. Our commitment to exploring innovation in areas with high unmet medical need remains unchanged.” Pradaxa® has not been evaluated in the treatment of Atrial Fibrillation (AFib) caused by heart valve problems and cannot be recommended in these patients. The use of Pradaxa® has not been evaluated in patients with bioprosthetic valves and use cannot be recommended for such patients. The efficacy and safety of Pradaxa® capsules was established in the RE-LY® trial,

one of the largest stroke prevention clinical studies ever conducted in patients with Non-Valvular Atrial Fibrillation (NVAF). Pradaxa® 150 mg twice daily is the only treatment compared to warfarin to demonstrate superior reduction in ischaemic and haemorrhagic stroke.

Bayer’s contraceptive device, Skyla receives US FDA approval Bayer HealthCare has received approval from the US FDA for its new low dose levonorgestrel-releasing intrauterine system (IUS) called Skyla in the US. The new IUS is placed in the uterus for the prevention of pregnancy for up to three years. “The approval of Skyla in the US highlights Bayer’s continued commitment to drive innovation and empower women with a variety of birth control options at different reproductive stages of their lives,” said Kemal Malik, Member Executive Committee and Head of Global Development, Bayer HealthCare. Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a hormone called levonorgestrel. The size of the Skyla T-body is 28mm x 30 mm, and its placement tube has a diameter of 3.8 mm. It slowly releases a low dose of levonorgestrel locally in the uterus and therefore only small amounts of the hormone enter the bloodstream. Compared to oral contraceptives the new IUS is a reliable contraceptive option for women that do not want to take a pill every day. It also offers rapid return to a woman’s usual level of fertility after removal.

NPS Pharmaceuticals wins FDA approval for Gattex® NPS Pharmaceuticals Inc, a leading biopharmaceutical business that develops therapies for rare disorders, won USFDA approval for Gattex® [Teduglutide (rDNA origin)] injection. The formulation will be used to cure adult patients having Short Bowel Syndrome (SBS) and dependent on parenteral support. The new drug will be be available in the market in the first quarter of 2013. Francois Nader, MD, President and CEO, NPS Pharmaceuticals, commented, “Gattex® is a groundbreaking therapy that has been evaluated in the largest clinical programme to date in short bowel syndrome. We are very excited about the opportunity to help SBS patients by offering this first-in-class therapy. The approval of Gattex® is a crowning achievement for our company and the catalyst for our transformation into a premier orphan drug business. We are prepared for a successful launch based on productive interactions with payers, methodical patient identification, and the strategic development of our fieldbased commercial infrastructure.” He added, “We have also launched NPS Advantage, our free support programme that includes, care coordinators who will work closely with patients to help them understand the clinical characteristics of Gattex® and navigate the reimbursement landscape.” Gattex® is the first major long-term treatment advance for SBS in nearly 40 years. The unique mechanism of action of Gattex® enhances gastrointestinal absorption. In phase 3 studies, significant reductions in PN/IV volume and infusion days per week were achieved from pretreatment baseline. In addition, some patients achieved independence from PN/IV support.

Modern Pharma•16-31 Januar y 2013

News, Views & Analysis

Postnova System receives GIT 2012 Innovations Award for CF2000 Series Postnova Analytics has received GIT Innovations Award 2012, under analytical instrumentation and software category, for its CF2000 Series that is used for high-resolution separation and fractionation of nanoparticles. The new range of products incorporates company’s proprietary FieldFlow Fractionation (FFF) technology and is the first centrifugal FFF system for routine use.

Dr Thorsten Klein, Founder and CEO, Postnova, said, “It is a great honour to receive this award. To be acknowledged by scientists working at the bench is particularly important for us as it shows that our innovative products are recognised as powerful practical tools for daily analysis, exactly what we designed them to be. I would like to thank the publishers at GIT Verlag for sponsoring the award, the

independent jury who placed the CF2000 on the shortlist and, most of all, everyone who took the time to vote

for us online, at Analytica, and at Achema.” The CF2000 series comprises of modular set up enabling integration of an array of different detectors such as Multi-Angle Light Scattering (MALS), Refractive Index (RI) and Dynamic Light Scattering (DLS). Irrespective of the configuration, the NovaFFF software platform offers automatic control from autosampler to detector. The CF2000 offers a broad array

of operation range and capable of separating smaller particles such as proteins and polymers from larger particles in single run with high resolution. The system is ideal for nanoparticles and can be used in the microparticle size range also, without any special sample treatment, allowing characterisation of complex biopharma, foodcosmetics, nanomaterial and environmental samples.

Roche and Precision System Science ink agreement to develop new fully automated emulsion PCR system Roche and Precision System Science Co, Ltd (PSS) inked agreement to develop and manufacture a fully automated emulsion PCR instrument for Roche’s portfolio of advanced sequencing platforms. It is intended to support Roche’s GS Junior and GS FLX+ systems as well as the sequencing platforms that Roche is currently developing.

Until now, upfront preparation of genomic samples has been a time-consuming and complicated manual process within the sequencing workflow. The new instrument will be designed to streamline the sample preparation workflow by automating the entire emulsion PCR process thereby reducing the total handson time from several hours

Goose launches online & offline 2D bar coding solution Pharma business re-engineering solutions specialist, Goose recently announced the launch of Goose ‘Tracker’, a cost-effective new generation 2D serialisation bar code for the drug industry with a choice to choose online or an offline solution to secure and protect both consumers and the pharmaceutical companies. Its multi-level authentication features allow tracking of product throughout the distribution channel including warehouse to customer retail chain. Goose ‘Tracker’ incorporates several new changes to suit GS1 global traceability guidelines. Goose ‘Tracker’ creates, manages and tracks unique serial numbers printed on the tertiary, primary and secondary packages. With the introduction of cost effective online & offline functionality options, Goose ‘Tracker’ helps pharma organisations with an alternative product serialisation technology; crucial investment option to minimise per production line serialisation costs. Leading pharma companies such as Strides Arcolab, Indoco Remedies and Macleods Pharmaceuticals, etc have already implemented and adopted Goose Tracker for track & trace solution. The company expects a rise in demand and surge in ‘Goose Tracker’ customer portfolio as pharma companies get set to implement secondary bar coding that is now compulsory for pharma exports. “Goose Tracker is a simple and easy to configure track & trace solution for achieving bar coding on drug packaging as per the recent Directorate General of Foreign Trade (DGFT) regulation,” said Deb Pattnaik, Founder & CEO, Goose. He further added, “Our online and offline solutions are highly scalable and handle the track and trace needs for all levels of packaging (up to primary) and e-pedigree easily.”

to a few minutes. Dan Zabrowski, Head Applied Science, Roche, said, “This partnership aims to address one of the key needs of sequencing customers. The automated solution will not only improve the efficiency of laboratory workflows, but also increase the reproducibility of results by eliminating manual workload. This development

programme has made great progress over the last year, and we are looking forward to working with PSS because they offer outstanding expertise and have a strong track record in developing fully automated solutions.” Hideji Tajima, President, PSS, said, “We are delighted that PSS and Roche are expanding their long-standing relationship in automated DNA extraction to

the challenging field of DNA sequencing. Preparing samples for sequencing is a complex, high-skill process that continues to hamper broader use of the technology. We believe that together PSS and Roche will be able to develop an automated instrument that helps overcome this obstacle and promote greater use of advanced sequencing systems.”

Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

News, Views & Analysis

EU approves Pfizer’s Prevenar 13 for use in older children and adolescents Pfizer Inc has said that that the European Commission has approved expanding the use of the company’s pneumococcal conjugate vaccine, Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), to older children and adolescents aged 6 to 17 years for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccinetype Streptococcus pneumoniae. Children in this age group who have not previously received Prevenar 13 may receive a single dose of the vaccine. “Prevenar 13 has been administered to millions of infants and young children around the world and helps protect against the often fatal effects of pneumococcal disease,” said Emilio Emini, Chief Scientific Officer-Vaccine Research, Pfizer. “As the global leader

in pneumococcal disease prevention, Pfizer continues to study the use of this life-saving vaccine across all ages.” The European Commission’s decision to approve this expanded indication followed submission and review of a phase 3, open-label trial of Prevenar 13 in 592 healthy children and adolescents, including those with underlying medical conditions such as asthma (17.4 per cent of the study population). The study met all endpoints, demonstrating immunogenicity and establishing a

safety profile in children and adolescents aged 6 to 17 years consistent with the safety profile established in previous trials in infants and young children. “Children and adolescents aged 6 to 17 with underlying medical conditions have an increased risk of pneumococcal disease,” said Luis Jodar, Vice President-Vaccines Global Medicines Development Group, Pfizer. “Pfizer will continue working with health authorities worldwide in an effort to provide access to Prevenar 13 to those at risk of disease.” Prevenar 13 is approved in the EU for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type S. pneumoniae in infants and children from 6 weeks to 17 years of age and invasive pneumococcal disease in adults aged 50 years and older.

Bayer announces € 30,000 Early Excellence in Science Award 2012 Bayer has announced the winners of the Bayer Early Excellence in Science Award 2012. The prizes, each worth € 10,000, have been awarded by an independent scientific committee of the Bayer Science & Education Foundation. The Bayer Foundation presents for the fourth time the Bayer Early Excellence in Science Award to talented young scientists in the early stages of their academic careers. “Research and science play a central role for the inventor company Bayer. I am delighted that these prizes give us the opportunity to support and motivate young scientists,” said Dr Wolfgang Plischke, Member of the Board of Management, Bayer AG responsible for Innovation, Technology and Sustainability, and Member of the Board of Directors of the Foundation. “Bayer’s innovation strategy has long focussed on intensive exchange with colleges and universities,” added Dr Plischke.

Mayo Clinic researchers find molecule to target in pancreatic cancer treatment Researchers at Mayo Clinic in Florida have identified a new target to improve treatment of pancreatic ductal adenocarcinoma cancer, which accounts for more than 95 percent of pancreatic cancer cases. This fast-growing, often lethal cancer is resistant to conventional chemotherapy. The researchers decoded a molecular pathway that is switched ‘on’ at all times, promoting accelerated growth of pancreatic tumours, and that discovery revealed ways to disable the pathway. They say one strategy could involve the use of the drug bortezomib, which is already approved for several human blood cancers. “Targeting this pathway to decrease the proliferation of cancer cells may represent a new strategy for pancreatic cancer therapy,” said Dr Peter Storz, Senior Investigator, a biochemist and molecular biologist, Mayo Clinic. One feature of pancreatic cancer is increased activity of the transcription factor NF-kB, which turns on expression of genes that keep the cells proliferating and protect them from death. There are two pathways, known as the classical and alternative, by which NF-kB can be activated, and the researchers looked at the alternative pathway - one in which NF-kB is activated differently, and which switches on other genes, compared to the classical signaling pathway. Both the classical and alternative pathways are active in pancreatic cancer. The research team discovered that increased activity of the alternative NF-kB pathway results from suppression of TNF receptor-associated factor 2, or TRAF2. Loss of TRAF2 promotes fast growth of pancreatic tumors and correlates with increased aggressiveness, Dr Storz said. A cocktail of drugs that includes chemotherapy, bortezomib and other inhibitors of molecules activated along the pathway may help pancreatic cancer patients, according to Dr Storz . “Of course, this hypothesis requires extensive clinical testing, but our findings offer a new direction to investigate improvements in treatment of pancreatic cancer,” he said

Modern Pharma•16-31 Januar y 2013

In Conversation With

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

What according to you is the training need in the pharma sector currently? Today, a key challenge faced by pharma companies is re-organisation. This includes all the downstream training and operational effects of exploring new service delivery models, operating structures, new sales and marketing models, optimising level of centralisation/ decentralisation within teams, driving leadership in emerging markets and concurrently meeting the needs of the emerging and developed markets. What are the oft-noticed trends in the pharma industry and how are you tapping those? The global pharmaceutical landscape is going through a significant transformation across R&D, commercial and marketing functions. A mega trend today is around multi-channel and alternate channels of stakeholder engagement. Recently, Indegene acquired leading Canada-based Aptilon’s multi-channel marketing business. This acquisition has supplemented our multichannel capabilities and solutions enabling us to provide clients with the most comprehensive solutions. According to a study by McKinsey, approximately 65 per cent of the influence on determining the choice of drugs prescribed is now exerted by new stakeholders payers (35 per cent), patients (15 per cent), pharmacies (5 per cent) and government (10 per cent). Despite the weaning influence of the physician, 84 per cent of the commercial spend by large drug companies remains focussed on the physician. Sales representatives have been the key component of sales and marketing strategies employed by pharmaceutical companies and have traditionally formed the primary link between the company and the physician. Between 1996 and 2005, total expenditure on detailing in the United States increased from $ 3.7 billion to $ 6.8 billion—an increase of more than 80 per cent. However, this growth in expenditure was not matched by revenue growth over the same period (revenue growth rates declined during the same period). Since the effectiveness of the rep-based approach is increasingly questionable, pharmaceutical companies are focussing more of their investments and efforts on

Today, a key challenge faced by pharma companies is re-organisation multi-channel marketing programmes, which promise a more effective and cost-optimised engagement with the physician.

…says Manish Gupta, CEO, Indegene. In this insightful conversation, he elaborates on the latest pharma trends and the future of the pharma industry.

Tell us about Indegene Indegene is a leading provider of R&D, commercial and marketing solutions to global pharmaceutical and healthcare organisations. We partner with clients to drive both productivity and revenues by delivering better patient outcomes, optimising cost, enhancing R&D agility and improving sales & marketing effectiveness. We apply deep scientific knowledge, flexible delivery models, proprietary technology and a clientcentric approach to drive transformational initiatives. With offices in US, UK, China, India, and Australia, Indegene can partner globally with clients; leverage a global talent pool of clinicians, technologists, creative specialists, domain experts and business process specialists; deploy global infrastructure assets; and harness global healthcare knowledge to solve client challenges. Why are companies outsourcing their work today? If one thinks about the evolution of what is commonly referred to as the BPO industry, the first phase primarily revolved around staff replacement and augmentation. This particularly involved filling short term gaps and leverage cost arbitrage. In terms of business value, this was more ad-hoc and shortterm as vendors could not scale up to support and drive more meaningful relationships. Clients’ needs also got more sophisticated and vendors playing in this space started losing out on their value proposition as services they rendered started becoming commoditised. The next phase saw a new breed of vendors that sort to help pharma by providing specialised skills to support internal teams to fill skillset gaps. Viewing this holistically, this was helpful but did force an un-natural carve-out of work and the overall service delivery model become more complex with multiple vendors doing multiple things. Over the past few years, we have seen pharma outsource sales force analytics, clinical trials, sales, marketing support, branding and medical communication and training. What has

Innovation demands medical, technology and creative teams to work together in a hybrid delivery model to produce world-class solutions. become fairly evident is that clients are looking for more specialised support that requires expertise. This is bringing into the forefront what many consulting firms are referring to as Expertise Process Outsourcing (EPO). A salient difference from EPO and the previous models described is that the vendor brings scalable and significantly high intellectual and process capabilities that can support entire functions and drive innovation both at the functional and ground level. Another driver promoting these sort of vendor relationships is a need to rationalise the number

of vendors and promote innovation, which will then lead to cost, market share and innovation benefits.

growing rapidly as clients continue to look for vested partnership and outcomebased models.

What challenges do you face as a solutions company? As a solutions company, we are constantly innovating to ensure we can build solutions that work for our clients. Innovation demands medical, technology and creative teams to work together in a hybrid delivery model to produce world-class solutions. Ensuring that people with different mind sets and different skill sets collaborate to produce a solution and then dynamically add the complexity of hybrid delivery model is challenging. Our experience in building and deploying complex solutions repeatedly has made this our competitive advantage in the market place.

Tell us about the latest technology support you are providing to pharma companies. Indegene has been providing innovative technology to global brand teams for several years now in the areas of e-detailing and teledetailing platforms, medical education, on-demand physician engagement, Continuing Medical Education (CME), sales training and clinical trial analytics. An interesting area in addition to these platforms and services for us is mobile healthcare. We have pioneered several leading iPad- and Androidbased applications for global brand teams and this is emerging to become a significant driver for the use of technology outside of the Chief Information Officer (CIO) organisation.

Which of your business verticals is most profitable and why? Our extended commercial and medical enterprise models are

Modern P h a r m a •16 -31 J a n u a r y 2 013

Special Focus

Nanotech in pharma Nikunj Sharma nikunj.kumar@network18publishing.com

Aiming for sizeable benefits in India

From super computer to superdrugs, nanomaterials continue to be at the behest of innovation and are extensively being explored for developing various delivery systems. The ability of nanoparticles to interact with biomolecules classify them as the most precise tools for targeted therapies, however, experts advise cautious and judicious application of this new-age technology.

he several beneficial attributes of nanomaterials are continuously being explored by the researchers for environmental and industrial applications. Scientists need a detailed evaluation of stability, migration, chemistry, accumulation and toxicity of these materials to emphasise on the superior performance in a specific application area with safety and efficacy. According to a market report published in World Nanomaterials, the global

Nanotechnology will enable doctors to detect the molecular changes at the earliest, prior to switching imaging and physical examinations. market is expected to reach $ 3.6 billion by 2013, exhibiting a growth of 21 per cent over 2012. Through 2025, the nanomaterials’ sector is projected to surpass $ 34 billion market in terms of sales, and offers huge growth potential in next decade or so. Most of the animal cells diameter range in between 10,000 to 20,000 nanometres and the nanoscale devices that measure below 100 nanometres are capable of penetrating the cells allowing organelles carried by them to interact with biomolecules. Nanotechnology-based

solutions may prove to be more effective in detecting the disorders at early stage. Dr Dhanlakshmi Iyer, Director, Lateral-i, informs, “While the progress of nanomaterials has been rapid in many developed countries, it has been rather a sad state of affairs in India particularly. There has been a lag phase of a decade already vis a vis the developed countries who have shown accelerated development.”

Status quo

At present, diagnosis and detection of cancer generally depend on changes in tissues and cell, which are confirmed by using an imaging device. Nanotechnology will enable doctors to detect the molecular changes at the earliest, prior to switching imaging and physical examinations. Moreover, the therapeutic innovation has its limits to provide cure and access to the vast population, so campaign to reduce the prolonged or excessive exposure to the cancer-causing substances will also be helpful in addressing the existing set of cancer diseases through novel technologies. “Government’s initiatives in the area of nanotechnology from 2001 has been substantially greater than the private industries, unlike the 2-3 times larger investments as compared to their respective governments of USA, Japan, Korea and Taiwan. Considering this existing scenario, if India is serious about making a mark in the area of nanotechnology

for better economic prospects, then the focus should be on the application areas for nanomaterials at least, because they have already missed the bus to nanomaterial synthesis and development,” avers Dr Iyer. Technology breakthroughs also highlighted various market prospects for nanoamaterials applications in almost all industries. In addition, with the extensive nanotechnology R&D performed by major players in different application areas, the adoption of nanomaterials in existing technologies is expected to be accelerated.

Indian industries at the nascent stage need to wake up and hold the reins for bettering the nanotechnology domain. When there is obvious scope to enormous economic growth and development via media nano then let us remove the speed breakers. Dr Dhanlakshmi Iyer Director, Lateral-i

Swiftly stepping ahead

Nanoscience and technology are the fast growing fields across the globe and nanomaterialsbased consumer goods are being launched at quick rates. In global context, India is trying to compete with some issues to mark a footprint in this sector. At the other end, commercialisation and application of nanomaterials faces various challenges with respect to processing and production. A recent seminar on ‘Nano-Pico Pharmaceuticals & Invivgensome’ at Amity University discussed the enhanced scale of nanotechnology to pico scale, which represents a particle size of 1000 times lesser as compared to nano particles. Pico technology offers measurement related to bio-molecular interactions to provide improved insight into living cells processes. Any technology or therapy that directly deals with the natural humanly processes has the potential to affect adversely, if used without adequate precaution and through examination of a disease condition. Exposing to nanomaterial-based treatment alternative, incorporating complex substances, may put a patient to substantial hazards. The sector needs more research activities and developments accompanied by clinical trials to utilise the best benefits of this technology. Last but not the least, researchers must be made aware of the regulatory concerns that surround the

application of nanotehcnology material research to make the efforts more productive and beneficial to human kind. “Albeit there has been research undertakings by institutes leading to patents, transfer of exclusive rights on a global scale in the nanotechnology domain pertaining to healthcare industry and processing of drinking water in India; much more is expected if India has to stand out as a global competitor. We need to gear up for commercial prospects otherwise it would be like the semiconductors story, where India was hardly in picture. Diverse players need to join hands to shape the trajectory of nanomaterials. Indian industries at the nascent stage need to wake up and hold the reins for bettering the nanotechnology domain. When there is obvious scope to enormous economic growth and development via media nano then let us remove the speed breakers,” says Dr Iyer. The increasing use of nanotechnology also pose considerable hazard to environment and health as toxic substances can harm significantly when inhaled or ingested as nanoparticles. Exposure to harmful particles at workplace can induce adverse health effects that may lead to damaging health effects, if not addressed in time. At one end, nanoparticles offer attractive novel properties, but at the other end its toxic nature can be potentially harmful.

Modern Pharma•16-31 Januar y 2013

Special Focus

Developments in nanomedicines Nikunj Sharma nikunj.kumar@network18publishing.com

he idea of nanomedicine hails from nanomedical devices, which can be developed and inserted into the body to repair cells and perform molecular level interactions. Currently, the field has made its foray into various disciplines that are being created based on the capability to develop devices and materials at the molecular level to offer significant advantages in the area of medicine.

The next gen therapy Nanomedicins are capable of mimicking the cellular interactions due to its size advantage. This novel branch of medicine offers attractive therapy alternative for critical care needs, but the potential hazard associated with exposure to nanoparticle also makes its application a risky affair for the practitioners.

Nanomedicines: The development

Leena Menghaney, Lawyer, Public Health & Intellectual Property, comments, “Nanopharmaceuticals potentially provide an opportunity to address issues such as poor solubility, low bioavailability and improving toxicity profiles of existing drugs already approved or even known compounds whose development was abandoned by companies as they could not be formulated effectively. In addition, particularly important is the potential benefit of targeted delivery, which can reduce the quantity of raw materials needed, thus reducing the cost of medicines.” The amalgamation of nanotechnology with medicine and biology introduced new research area in therapeutics know as nanomedicine. The leading projects in this field are based on rational drug delivery and targeting of pharmaceutical, diagnostic and therapeutic agents, which comprise detection of specific targets such as receptors and cells associated with particular clinical conditions and selection of adequate nanocarriers to attain the desired responses as well as reducing the side effects. Speaking on this innovative branch of medicine, Dr Dhanlakshmi Iyer, Director, Lateral-i, says, “We have ever since known the exciting and innovation-filled world of nanomedicines, but have we given a serious thought on the fiscal implications and the quantum of therapy segments in pharmaceuticals that has been explored. Nanomedicine is undoubtedly the most talked about technology domain and an area where plethora of research is ongoing both at lab and industrial levels.” Nanomedicines create well-designed nano tools to prevent, diagnose and cure several disorders. Dendritic cells, mononuclear phagocytes, cancers and endothelial cells are mainly targeted by the novel technology.

Application of nanomedicines

Till date, oncology remains the most experimented area with

nanomedicines and proved to safe and effective in various types of cancers. N K Jain, Dean (Prof), R&D, Department of Pharmaceutical Sciences, Dr. Hari Singh Gour University, SAGAR, comments, “At present, several nanoparticlebased formulations have been approved to cure a number of chronic diseases including cancer. In 1996, DaunoXome was the first nanoparticlebased formulation approved by US FDA for the treatment of Kaposi’s sarcoma in 1996. Currently, multifunctional and multiplex nanoparticles are being enthusiastically explored and are on the horizon as the

The Indian patent office needs to develop guidelines and training to avoid evergreening of existing drugs with nanotechnology and the Indian drug regulatory authority needs to develop a regulatory pathway. Leena Menghaney Lawyer, Public Health & Intellectual Property

next generation of nanoparticles for personalised and tailored cancer treatment.” Nanotechnology possess the capability to eliminate cancer completely in next ten or fifteen years, with the advanced nanotechnology-based treatments alternatives such as hyperthermia, radiation therapy and targeted chemotherapy. Menghaney shares an example of Cipla, which is developing a pharmaceutical composition comprising Efavirenz (EFV) in nano form; EFV has low bioavailability. Poor bioavailability is a common problem encountered in the development of pharmaceutical compositions, particularly for those containing an active ingredient such as EFV that is poorly soluble in water. Currently, EFV is administered in high therapeutic doses to overcome this disadvantage. However, increasing the dose leads to increase in the side effects of the drug. Cipla is developing a composition comprising EFV – a HIV medicine - in the form of particles, wherein substantially all the particles have a particle size less than or equal to 1 micrometre. In its nano form, Cipla claims the dissolution property of EFV was greatly improved by reducing the particle size of EFV to nanometer range, thus leading to better absorption and bioavailability of the drug from the gastrointestinal tract. Application of nanotechnology in cancer diagnosis and cure has increased due to the potential side effects of anticancer agents caused by cytotoxic effect on

normal cells. The non-specific interaction of chemotherapy led to the need for more targeted solutions with improved tumourkilling capability. Menghaney informs, “In the area of HIV alone, hope is being expressed for long-acting drug formulations and new drug delivery systems. For example, nanotechnologies are to be developed with several of the antiretrovirals such as efavirenz, raltegravir, rilpivirine, lopinavir and ritonavir. More investment and research in this field is required and the regulatory position needs to be clarified.” Nano oncology, the branch of medicine that deals with

Due to major progresses in science and engineering, the comparatively young field of nanotechnology has been expanding appreciably. N K Jain Dean (Prof), R&D, Department of Pharmaceutical Sciences, Dr. Hari Singh Gour University, SAGAR

cancer, is presently the most focussed area of research in nanomedicine. At present, different nanomaterial-based drug delivery systems are being used with many of them in pipeline for instance tumourtargeted drug delivery systems, which are showing encouraging results worldwide. “Even before regulatory authorities have resolved complex issues around the safe use and registration of nanopharmaceuticals, the race for patents on such products is on among pharmaceutical companies. A series of patent applications, for example, claim protection for nanoformulations of atorvastatin (cardiovascular disease), olanzapine (schizophrenia), levofloxacin (antibiotic), pantoprazole (gastroesophageal reflux disease). All of these drugs are likely to enter the public domain in the US in the next 2 to 3 years. Not only the USPTO, patent offices around the world face an onslaught of patent applications on new formulations, new compositions and new dosage regimens using nanotechnology. In this context, companies will make presumptive claims both for patent protection and for marketing and brand building,” suggests Menghaney.

Future prospects

India, with its large populace offers significant market potential to various products, and in case of therapeutics the trend is catching up with nanotechnology. “Due to major progresses in science and engineering, the comparatively young field of nanotechnology has been expanding appreciably. Despite the exciting advancements in this discipline, the field of nanomedicine has yet to be exploited to its full potential. This leaves the door open for engineered solutions to allow nanomedicine to continue progressing at its historic rate. Nanomedicine may help provide safer and more efficacious drug delivery in the not too distant future,” predicts Jain. “The Indian patent office needs to develop guidelines and training to avoid evergreening of existing drugs with nanotechnology and the Indian drug regulatory authority needs to develop a regulatory pathway so that the nanotechnology can be harnessed for safer and patient friendly longacting formulations,” avers Menghaney.

M o d e r n P h a r m a •16 -31 J a n u a r y 2 013

16 Insight & Outlook: Policies & Regulations Pharmaceutical trademarks

Scanning the changing trends

ntellectual Property Rights (IPRs) are rights given to creator(s)/innovator(s) in view to protect their interest in the created work and at the same time to motivate them to continue with such intellectual work with the same passion. These IPRs have played a significant role in building economy and business at national as well as international levels through diverse industries including pharmaceutical. In the last few years, Indian pharmaceutical industry has flourished in global market and it is ranked 4th in terms of volume and 13th in terms of value in global pharmaceutical market. Indian pharmaceutical companies such as Cipla, Ranbaxy Lab, Dr Reddy’s Labs and Sun Pharma etc, are exporting novel as well as branded generic drugs to around 220 countries after satisfying the local market demands. These Indian companies account for over 25 per cent of the total generic drug applications made to the FDA of USA. This growth is much dependent on various IPRs such as patent, trademark and trade secrets etc.

Preserving the odd one out

Among these IPRs, trademark, which is commonly referred as brand name, is one of the most important rights. A trademark for a product is a name/mark/label or graphical representation of any kind which has the capability to distinguish the product from any other same similar and/or identical goods in the market. By registering a trademark, the owner, also called proprietor, of the pharmaceutical trademark protects the goodwill of the business and receives the exclusive right to use the registered mark for its specified products. At the same time, proprietor can stop other traders from using his mark without authorisation and in case of such unauthorised use right to claim damages, compensation as well injunction against the infringer is also available to the owner/proprietor. This protection motivates traders and entrepreneurs to invest their time and money in promoting the goods under their trademark. A trademark returns the direct monetary benefits in form of profits from sales, and also indirect benefits by giving competitive advantages as the proprietor of a mark can exploit the mark in many ways including sale, transfer, assignment of trademark etc. Registration of a trademark shall deter other players in the market from imitating the brand name of someone else.

There are strict regulations when it comes to pharmaceutical products at every level including manufacturing, marketing and selling, and the same stands true when it comes to registration of trademarks. Here’s reviewing the trends in pharmaceutical trademarks

When a drug is invented patent holders gets right to manufacturer the products till 20 years, however, during this time also the patent holder does not get any right over the generic name, and the manufacturer has to adopt a different name to market its drug. Generic name is basically the active ingredient of the medicine, or the chemical name of a drug. Generic drug refers to any drug marketed under its chemical name without advertising. In India, till the Patent Amendment 2005 was in force, there were no product patent rights to medicines which led to the trend of branded generic drugs which has 99.5 per cent of the country’s generic drug share. India’s share in the global market for generic drugs is considerably higher than its share in the overall pharmaceuticals market. These generic drugs are being sold under different trademarks, which need to get registered under the Trademark Act 1999 in view to acquire statutory rights.

The legal scenario

Trademark Act 1999 governs the registration of trademark and pharmaceutical products registered under class 05. Thousands of trademarks are registered in class 205 with the trademark registry in India. However, generic name remains a public property even

though the same is used by several traders and these names cannot be registered. The Trademark Act prohibits the registration of commonly used names and descriptive names that suggest quality of a product under provisions of section 09. However, Section 13 (b) of the Trademark Act, 1999, specially prohibits while stating that words commonly used and accepted as name of any chemical element/ compound, or words declared by the WHO and notified by the Registrar of Trade Marks as International Non-Proprietary Names (INNs) or names deceptively similar to such name, shall not be registered under the Act. Since 2003, year in which the Act came into force, the INNs were not registrable; however; as the list of such INNs was not issued, this provision was dormant till now. But recently an important decision came from the Controller General of Patents, Designs and Trademarks who came up with the list of ‘INNs’. The implication of this is that all the listed 8,151 names cannot be registered as trademark under the Act as per section 13 of the Act. The decision is taken in view to provide better protection of Intellectual Property (IP) for pharmaceutical companies. Basically INNs which are generic names only, identify the pharmaceutical substances, ingredients or Molecule as discussed above. This INN is a globally recognised unique

name and same is considered as public property as the same does not qualify for the registration in view to ovoid any confusion in the market. This action will put an end to a spate of pharmaceutical trademarks litigations where the similarity of the marks becomes key issues. The cumulative list of INN as published by WHO presentably stands at some 7,000 names designated since that time, and this number is growing every year.

Consideration worthy factors

A trademark is motivated by the marketing considerations as the drugs under a trademark incur expenses for costly advertising, marketing and sales promotion. On the other hand, the drugs under generic names are much cheaper as all the expenses mentioned here are mostly absent. Roughly, a trademarked drug can be 10 times more expensive than a generic variant. In 2012, apart from the approval of the Indian Cabinet to National Pharmaceutical Pricing Policy, which brings 348 drugs under the ambit of price control, the pharmaceutical industry has also witnessed other critical decision taken by the union health ministry affecting IP rights of trademark holder. The directives of the union health ministry to the state and union territories health departments to grant or renew licenses for manufacture or sale of drugs only in generic names and not on branded or trade names,

which is the common practice currently, ensures the safety of common man’s interest. Now, regulatory authorities will issue licenses in generic names, which are mandated by the Drugs and Cosmetics (Sixth amendment) Rules (1988). The Centre also had made a direction to the doctors to prescribe generic options while prescribing medicines to the patients, which is another step to fulfill the objective of above said earlier directive. Combined implementation of these directives enables patients to purchase low priced generic drugs with the advice of the pharmacists. Till now, a few states such as Rajasthan and Orissa and Union Territories such as Daman and Diu had issued instructions to this effect. It is worth mentioning that these directives do not lessen the importance of the trademark or affect the brand promotion and marketing of branded products. The companies are still at liberty to promote goods under their brand and pharmacists are not prohibited to sell branded goods. Thus, the two decisions taken by the authorities are basically to create a balance between public policy and IPR of an owner. Jatin Y Trivedi,

Advocate and Attorney

Jitendra Raiya,

Advocate, Y J Trivedi & Co info@yjtrivedi.com

Modern Pharma•16-31 Januar y 2013

Insight & Outlook: Strategy

Managing constant pharmaceutical sales

Kick-starting prescriptions A cursory glance at the sales figures may not reveal any obvious reason for the plummeting sales. Why should the sales team, which has a good hold over the market, lose control even when the competition has not changed? Has it got anything to do with a doctor’s or MR’s presence or absence?

nce a pharmaceutical company sets up a sales promotion team comprising a Zonal/Regional Manager, Area Manager and Medical Representatives (MRs), the regular methods of drug detailing and building rapport with physicians are finalised. The team is trained to understand its mix of products and the expected focus brands of the season are identified. In most cases, companies which have the right mix of products at the right price do well if the sales team has understood physician preferences and the degree of competition involved. General practitioners and consulting specialists who find the brands genuine, start prescribing, once the brand names are committed to memory. Depending on the efficacy, its ease of availability as well as the performance of the brands in the market the sales graph rises. Some of these go on to become market leaders. Over the years, the sales graph continues to soar even if the field sales representatives become a little lax. Major national and multinational pharmaceutical companies in particular hold a good sway over their brands due to their professional approach as well as superior sales promotion techniques. What causes the sudden plummeting in sales?

Pharmaceutical factors

There are several reasons for this situation. The common factors are usually related to attrition among field sales representatives’/area managers and administrative problems with production/distribution of brands. When field staff resigns, the local chemists and distributors are left unattended. Physicians do not get regular reminders of certain brands and the brand slips away from his/hermemory. These difficulties are similar to sales issues in other consumer markets and should be tackled with better management skills and ‘human’ relations with the various strata of marketing staff. Providing better working conditions, higher incentives and providing a healthy atmosphere to the staff allowing them to thrive are the main methods of retaining talented MRs and managers and getting a better output from them. The absence of the MR

Health issues

Physicians themselves may suffer or have ailing parents battling major illnesses which force the former to stay away from clinics for extended periods of time. Family members on dialysis, chemotherapy, ICU admission, disability, etc preoccupy the physician with repeated visits to hospitals. This interrupts their thought processes even while they are in the clinic.

Maternity leave

from the field for prolonged periods creates an atmosphere of uncertainty about the availability of specific brands. This allows the physician to prescribe competitor brands, whose MRs have been making regular visits to the doctor. Similarly, if the MR is regularly visiting but the brand in question is unavailable for prolonged periods, the physician is forced to switch brands and this about turn may be irreversible even after his ‘favourite’ brand returns to the market.

Physician support

It takes time for a busy doctor to start prescribing a new brand. However, after the initial months of its launch if he finds that his patients increasingly find that drug effective and meet his requirements, the physician’s faith in the brand rises. Over some time, the brand is well entrenched in the physician’s pen and the visiting MR has very little to do but to show his face and ensure that things go on smoothly. Occasionally, when the physician is away from the clinic for long periods, he or she may lose continuity and the memory of some of the recent brands may slip away. Discontinuation in practice or breaks in the clinic occur due to various factors:

Winding up

Very senior physicians may develop sudden illnesses making them unable to continue their practice. In such a case, a locum doctor may be appointed or the practice may be handed over to a younger physician. Although the new doctor may take prescribing tips from the senior, he may not necessarily adhere to the brand preferences of the original physician. Companies that have been receiving massive support from such clinics tend to face major brunt of the loss.

For the pharmaceutical company whose brand the physician supports very well, it should be a matter of great concern when the doctor is away for a long period. For the pharmaceutical company, the new physician could be a goldmine due to the ‘running’ nature of the clinic but to get the physician to prescribe its brands is an all new ball game. Only once this hurdle is crossed successfully, can the brand regain its glory. If the sales team manages to convince the new doctor to prescribe its brands then they have the added advantage of having two supporters when the regular doctor returns to practice!

Young lady doctors who have built up a healthy practice in the late twenties and early thirties may stay away from clinics for prolonged periods when they are in the family way. While most women would like to continue to practice till almost the eighth month of pregnancy, like those attending to office work, physicians may be kept away earlier by the family to avoid the risk of catching unwanted infection from their patients. Like in the case of the elderly or ailing physician, the locum then decides on what is prescribed to his patients.

Sabbatical leave

Newly evolving surgical fields like organ transplant surgery, robotic surgery, ‘keyhole’ spine surgery etc are increasingly being performed in the West and local experts go abroad to learn these techniques or sharpen existing skills. Dermatologists and plastic surgeons from the interiors visit training centres in major cities or the US to learn laser surgery. Physicians, too, seek fellowships from universities in Europe and America to enhance their academic knowledge. Most of these courses last for periods ranging from 6 weeks 6 months. The clinic is usually run by a locum doctor during the interregnum. For the pharmaceutical company whose brand the physician supports very well, it should be a matter of great concern when the doctor is away for a long period. Some of the major factors, which create a drop in his sales figures are: Regular patients of the physician who are aware of his non-availability tend to find alternative physicians during the period if the clinic remains closed. Even if there is a replacement ‘locum’ he or she will have fewer patients to treat. The number of prescriptions will consequently plummet.

The interim doctor who runs the clinic may not have the same drug preferences as the senior doctor. Even if the same drugs are actually prescribed in large numbers by him, the brands chosen could vary. Once the regular physician returns to the clinic after a long break, it will take some time for his ‘crowd’ to return. This will continue to hit the brand sales. The physician on his return to practice may find newer brands to prescribe owing to his recent training that he has undergone. He may change the nature of his practice and may focus on a different segment of patients. A physician retuning after a maternity break or after recovering from an illnesses may lose grip on some of the brands she was prescribing earlier. Competitor brands which are now introduced by newer MRs may find favour if the latter pitches its promotion well. The physician will require a ‘cooling’ period of a few weeks before the practice picks up. His patients of too may stay away or find another physician to treat them. For the pharmaceutical manager whose eyes are on the sales graph, this can be a setback. Moreover, the physician may not develop loyalty to the earlier brands if he is now inf luenced by some competitive brands. This is a major challenge to the MR and his bosses to try to get the physician back on his track! The pharmaceutical manager has role to play in moulding the prescription of the locum doctor. Besides, he has to ensure that when the original physician returns after the six or twelve month break, the same support is provided to her favourite brands as before. When the MR encounters a doctor who has just returned from a long break, he has to redouble his efforts to get the physician to select his brands. If the doctor is a senior person with a high ‘market value,’ the representative should bring the Zonal Manager and the National Marketing Manager for sweet talking. Just like a new launch is planned very meticulously, the efforts to bring a physician returning from a holiday also requires sufficient manoeuvring so as to ensure that the company gets the same support it used to get earlier. Dr Rajan T D Pharma Consultant & Practising Dermatologist rajantd@gmail.com

M o d e r n P h a r m a •16 -31 J a n u a r y 2 013

18 Insight & Outlook: Roundtable

Will stringent regulations by DGFT for pharma packaging control drug counterfeiters? Nikunj Sharma nikunj.kumar@network18publishing.com

Brijesh Ayyappan

Regional Sales Manager, Sproxil Brand Protection Solutions Pvt Ltd

Kishore Kar

Brand India’s reputation is particularly at stake, as both counterfeit drugs originating from India and counterfeits claiming to be from India (but actually are from other countries) are surfacing in Over the course of last year, Indian markets globally and causing unnecessary casualties Director General of Foreign Trade and deaths to consumers. (DGFT) has made serialisation There is a lot of apprehension surrounding the mandatory for export drugs repeatedly. use of barcodes on product packaging. Many critics of Serialisation is an important step in ensuring the mandate have expressed that barcodes alone will not supply chain security. The industry has already be able to hinder the increase of counterfeits (fake drugs) implemented tertiary level coding, which came into in the market. The barcodes are meant to create a more effect on October 1, 2011. Secondary and primary level robust track and trace system, but if there are not enough coding requirements will come into effect on January scanners to document information on products moving down 1 and July 1, 2013, respectively. the supply chain, the system remains flawed. Finally, The manufacturers are looking for solution unreliable infrastructure characteristic of developing providers who can implement cost-effective countries such as spotty Internet and power Packaging barcoding solutions with a roadmap to comply poses another major challenge to the barcode with upcoming global requirements. Europe in pharma is emerging solution. A simple 2D barcode on primary or and US, as well as many other countries, as a security feature, and is secondary packaging will not solve the problem are coming up with regulations which completely as such a barcode can be easily Indian exporters have to comply with in proving to be an effective tool to check copied by counterfeiters. Instead, multiple the near future. Problematically, many drug counterfeiting. Regulatory agencies are levels of security must be employed. Other printer suppliers are offering quick fix security features such as tamper-evident compliant solutions without a future also upgrading norms with stringent enforcement solutions should be in place to identify roadmap that has essential security of packaging standards. However, the new regulatory attempts of stealing or compromising features. Some of the large global goods. The Track & Trace 2011 is the has pushed the boundaries for pharma packaging players are too expensive and need long first step where drugs are serialised. implementation time. This makes the solution providers to realise the cost involved and Once serialisation of all pharmaceutical scenario more complex and results in meet regulatory compliance. Will the entire products happens successfully and a more deadlines being extended repeatedly. The robust track and trace system is instituted, above regulation is intended to protect exercise make an impact? And what our Brand India can be better protected from trade, and PharmaSecure’s innovative experts think about the DGFT’s hard counterfeiting. However, a robust track and technology enables consumer protection as trace system alone cannot be the only defence stand on pharma packaging well, which is made possible when consumers against counterfeits. In order to close the loop are empowered to verify a drug when they regulatory? on the supply chain down to its end-user, a buy it. In countries such as India, where over solution must be employed at the consumer-level half the population live in rural and remote areas, as well. The track and trace system is beneficial for the access to healthcare is problematically inaccessible manufacturer throughout the distribution network, but and unaffordable. consumer verification is necessary to ensure that no products can be compromised at the retail/pharmacy level.

VP - Sales & Marketing, India & South East Asia, PharmaSecure PAS India Pvt Ltd

Didier Lacroix

Senior VP - International Sales & Marketing, Cognex According to FICCI committee report, counterfeit drugs make up to 15 to 20 per cent of the market. To help the domestic pharma industry, the DGFT has come up with different notifications that would ensure that Indian drugs do not fall in the counterfeit category. According to the DGFT notification, packaging labels of drugs and pharmaceuticals exported from India will have to add barcodes mandatorily as barcodes in packaging labels easily trace and track products across the supply chain. It has categorically specified guidelines for barcoding procedure at all the three levels of pharma packaging. This apart, the technology used for tracking and tracing by exporters should conform to the GS-1 standards at all levels of packaging. Apart from packaging guidelines, new guidelines have made it mandatory for pharma exporters to include a copy of the Certificate of Analysis (COA). To tackle this issue, the pharma industry has now taken steps, which include investing innovative packaging using authenticity markers and sponsoring programmes to increase awareness among patients and healthcare workers. Hence, tracking and tracing of individual pharma packages as well as an entire export panel using a high end barcoding mechanism is an important tool in fighting drug counterfeiting in India. These stringent measures will ensure that counterfeiting of drugs would come down in a significant manner once these steps are put in place. They also point out that packing technology should also evolve to create smaller, more cost-effective machines that can cater specifically to pharma companies’ needs.

Editorial take

Bejon Misra

Founder, Consumer Online Foundation Only technology alone cannot empower the consumer of pharmaceutical products. Along with technology, consumer education and awareness is extremely important. Technology used should be simple and easy to implement. It has to be user friendly. It has been observed that the best regulatory mechanism emerges out of effective and efficient identification of spurious medicines and its authentication done by the regulators and the consumers. The mandatory requirement by DGFT to tackle counterfeit medicines is a right step in the right direction to encourage database creation of the medicines and its source of manufacture, but one cannot expect good results till the technology used is made mandatory for all manufacturers of pharmaceutical products and not confined to only exports. The database has to be serialised and made into an effective tracing and tracking system with prompt recall process if medicines are found to be spurious of standards. It is the right of the consumer, domestic and global, to access safe and quality medicines and it is the responsibility of the pharmaceutical industry and all the players in the supply chain to ensure that along with the support from the regulator in the exporting or importing country. We can allow any organisation to undermine the India Inc. Brand globally as India is emerging as one of the most credible countries for making quality medicines most accessible and affordable. We must all work towards building a strong quality assurance movement and punish those who try to contaminate the supply chain. The punishment should be exemplary and deterrent. Any counterfeit medicinefound in the supply chain should be tackled in a stringent manner. DGFT must get the law in place to immediately enable all the manufacturers to adopt the technology for their commercial benefit and protect the consumer from unsafe and substandard medicines.

Technological enhancements pertaining to regulatory compliance are definitely the empowering tools to improve safety aspects of the drugs; however, consumer awareness is the most basic and important aspect of the entire exercise. Only a well-informed customer can make the best use of all these measures.

Modern Pharma•16-31 Januar y 2013

Insight & Outlook: Interface

The boom time for Ayurveda has truly arrived and there is no looking back now Nikunj Sharma nikunj.kumar@network18publishing.com

Ayurveda is the upcoming trend in India; how is Chark Pharma looking to cash in on the opportunity? Ayurveda is indeed the ‘upcoming trend’ in marketing terms, but at the same time, it has been a ‘trend’ since a long time, so if you want to use the word trend, it can be called a ‘time tested trend’! As for Charak Pharma ‘cashing in on the opportunity’ a similar answer is due. Charak Pharma has been the pioneer in Ayurveda in India with our first step in this domain dating back to even pre-Independence days. Charak has always believed in doing everything in the correct and best possible manner, so the question of cashing in on an opportunity is largely a semantic one. With ‘trends’ and ‘opportunities’ coming up periodically, we gear

As for regulatory scenario in India is concerned, it is getting stricter by the day. Fortunately, the regulatory authorities and the industry is working in tandem and in synergy to ensure that all regulatory compliance steps are taken at the right time in the right manner.

ourselves for the increasing demand, which we fulfill without compromising on the quality. Our systems and procedures work like a well-oiled machine and we are ready 24x7 to meet all requirements. We have now close to 1,000 people in the field convincing doctors to adopt Ayurveda for treatment of their patients demands. The global trends are encouraging and thus the acceptance is very high. How does the regulatory scenario differ when it comes to Ayurvedic products? Unlike allopathic products, which are already tested pre-clinically as well as clinically before being marketed here, Ayurvedic products enter the regulatory scenario through a different route altogether. Here, the finished product has already been ‘time tested’ over millennia and there is no need to reinvent the wheel on the efficacy front. We have, however, to prove absence of side effects/toxicity in today’s altered environment, which we do regularly in our clinical trial programmes. This is sometimes called reverse pharmacology because the drug is taken back from the bedside to the laboratory, and not in the reverse manner as allopathic drugs. As for regulatory scenario in India is concerned, it is getting stricter by the day. Fortunately, the regulatory authorities and the industry is working in tandem and in synergy to ensure that all regulatory compliance steps are taken at the right time in the right manner.

…gladly observes Pulin Shroff, MD, Charak Pharma, while providing an insight into the various aspects of this market. In the Ayurvedic market exclusively; at what position does Charak Pharma stand and what are its future plans? As mentioned earlier, Charak has been in the business of making high quality products, including the traditional Ayurvedic formulations or the modern ones where we improve upon the ingredients and their respective quantities and market them under our brand name. In addition to the above, we are doing the following on the clinical side: We have established our own brand of Ayurveda under the name Charak Paddhati, which is larger than merely giving medicines. The whole process of administering the care in our specialised clinics has been standardised to the minutest possible detail Our chain of clinics is expanding and has already been sort of ‘corporatised’ with systems and procedures to match. We hope to cover the entire country in the foreseeable future We have ambitious plans to sync everything ‘real time’ so that our clinical front is on par with the best in the industry Thus, the future can only get rosier as we go along and we are enjoying every bit of it.

How do you see the future of Ayurveda in India? And when it will be able to share significant stake in the overall medicine market of the country? In a way, the future is already here. The boom time for Ayurveda has truly arrived and there is no looking back now. With the improvement in the economy at a macro level, the healthcare sector will only grow in parallel or even more than that, and Ayurveda including Charak will be a part of that growth curve.

Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

Tips & Tricks

Managing pharma/biotech vendors

Tips for staying focussed while cutting cost

he secret while making attempts in cutting cost across pharmaceutical or biotechnology vendors, like many other cost cutting attempts, is to go cross cultural and outsourcing. Going ‘cross cultural’ often means thinking out of the box and looking at other industries for resources, often much more economically priced. The formula is to look at the cost/value matrix and quite often the major cost heads are not the ones the company derives maximum value from. A few basic but effective measures are provided.

Tips& Tricks

The fallout from the global economic downturn has created a pressure on companies to think of new ways of doing business so as to reduce costs.

2 T

Increasing interest towards ‘genericisation.’ In the past, ips patent protection ensured that multinationals faced little ricks competition for blockbuster drugs, which in turn allowed the drug manufacturers to maintain high price points and margins on each pill, ointment or liquid sold. Now, that is changing. The rise of generics, coupled with the high cost of drug development, places tremendous price pressure on products made by multinational pharmaceutical companies.

Growing payer pressure in the form of pricing and reimbursement cuts. Public and private health plans increasingly rely on third-party pharmacy benefits managers or cost-conscious reimbursement policies to favour less expensive generics over branded drugs.

Tips& Tricks

Growing interest in the developing markets of India, Russia, China and Brazil as well as other Latin American and CIS countries. The big players of pharma are now focussing on these markets as the future of pharma industry lies here. Affordability of products is a major hurdle to develop sales, especially in these regions

Tips& Tricks

Any cost cutting should involve targets that have no or very minimal impact on quality. We need to evaluate cost savings in the full context of risk versus value to the enterprise.

Tips& Tricks

When services are outsourced to external providers sometimes regulatory requirements are not met especially in emerging markets. We have to enforce GMPs and industry best practices to ensure consistency and streamline quality review cycles. It is important to proactively track and trend nonconformances to identify quality issues and drive Corrective Action Plans (CAPA) across operations.

Outsourced analytical services: Often in-house analytical services are underutilised and expensive to maintain, both in terms of resources and people. It would be prudent to outsource as much of analytical work as possible since external laboratories handle a large number of specimens and costs get divided. Several pharmaceutical analytical parameters are common to the food industry and generally food testing laboratories charge a fraction of the cost.

Tips& Tricks

Arun Kedia Managing Director, VAV Lifescinces Pvt Ltd. arun@vav.in

Tips& Tricks

Equipment vendors: Several pieces of pharmaceutical equipment other than formulation machinery are often just mixing/kneading machinery and the food or chemical industries regularly use such plants. Looking at vendors of food machinery can be a very economical option to reduce capital costs and thereby improve competitiveness.

Fully outsourced production: If production of specific products is outsourced, companies can better deal with slowdowns in demand by simply reducing procurement from a supplier rather than curtailing factory capacity utilisation and taking on the expense of idle fixed assets.

Tips& Tricks

Innovation: Pharmaceutical manufacturing operations are inefficient and costly. There is a need to find innovative methods for production to reduce costs. This is the best possible method of cost cutting in the long run. For instance, process intensification technologies provide for an efficient scale up, speed up development and drive down material costs.

Tips& Tricks

Green technology: Green technology, at its core, is about efficiency. It means smarter use of fewer resources - raw materials, energy, equipment, facilities and time - as well as less waste. This amounts to better product and better process economics. To improve the environmental profile of chemical processes, a widely used roadmap for green chemistry is encompassed in the ‘12 Principles of Green Chemistry’. These principles identify strategies for meeting goals of sustainability. Some of these approaches include: Waste reduction in chemical synthesis Using raw materials and feedstock from renewable sources Employing catalysts, not stoichiometric reagents, to minimise waste and increase process efficiency Avoiding chemical derivatives by not using blocking or protecting groups or temporary modifications if possible Maximising atom economy; replacing or reducing solvents Increasing energy efficiency of chemical reactions by running them at ambient temperature and pressure when possible Using in-process or real-time monitoring to reduce or eliminate byproduct formation; and other process safety and environmental considerations

Add flexibility to product design and packaging: Pharmaceutical companies should manage product demand volatility in low-margin drugs by implementing pack-to-order strategies. This involves manufacturing, for example, one version of a pill that could be shipped efficiently to numerous global markets, instead of multiple versions, each for a separate region.

Tips& Tricks

Modern Pharma•16-31 Januar y 2013

Technology Transfer

As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration.

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,l’-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of

sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply

Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater. Areas of application Biotechnology, engineering Forms of transfer Consultancy Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others Extract of medicinal and aromatic plants A company is interested in putting up a multi-purpose herbal extraction

plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others IV fluid manufacturing as SME An Indian company needs new and good technology to start which is a subservient of genetic manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. Areas of application Medical research Transfer terms Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, Asian and Paciﬁc Centre for Transfer of Technology (APCTT) of United Nations Economic and Social Commission for Asia and the Paciﬁc (UNESCAP), APCTT Building, C-2, Qutab Institutional Area, New Delhi – 110 016, India.Tel: +91-11-3097 3758 (Direct), +91-11-3097 3710 (Board), Fax: +91-11-2685 6274 E-mail: srinivasaraghavan@un.org, Web: www.apctt.org. For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance. Share and Solicit Technology The mission of Modern Pharma is to spread the technology culture. Here is an opportunity to be a part of this endeavour by sending your technology on offer or technology requirements. If you belong to any of these two categories, you are invited to furnish the techno-commercial details for publication. The write-up needs to be as per the format of this section with information about the particular technology offered or requested, its areas of application and forms of transfer. Contact us: Modern Pharma, Network18 Media & Investments Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4695 Fax: 022-3003 4499 Email: spedit@network18publishing.com

Mode r n P h a r m a •16 -31 J a n u a r y 2 013

Projects

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry. Bulk drug facility Project type: New facility Project news: Cadila Pharma to set up a bulk drug facility in Rajasthan. The drug company will soon begin construction of its second Indian facility outside Gujarat. The Ahmedabad-based Cadila Pharmaceuticals has acquired land in Rajasthan to set up a bulk drug facility in the region.

Fax : +91-2718-225039 Email: website@cadilapharma.co.in Website: http://www.cadilapharma.com

Project location: Rajasthan, India Project cost: NA Implementation stage: Planning

Bulk drug unit Project type: New facility Project news: CKS Pharma Labs Pvt Ltd to set up a bulk drug unit in Jaggayapet in Krishna district of Andhra Pradesh with an investment of ` 42 million. The project involves setting up of a bulk drug unit to produce pantoprazole sodium, carvedilol, lansoprazole, prasugrel hydrochloride, levocetrizine dihydrochloride, lamotrigine, lamivudine, fluconazole etc.

Contact details: Cadila Pharmaceuticals Ltd Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210 Gujarat Tel : +91-2718-225001 (15 Lines)

Project location: Krishna district, Andhra Pradesh Project cost: ` 42 million Implementation stage: Planning

Contact details: CKS Pharma Labs Pvt Ltd H. No. 6-980, Shop No.1, Opposite to NSP Canal Office, Hyderabad Road, Jagayyapet - 521175 District Krishna, Andhra Pradesh Email: dvs_ckslabs@gmail.com Manufacture of drugs Project type: New facility Project news: The Kerala government is planning to set up drug manufacturing units in public sector. Kerala, which is heavily dependent on other states for medicines, is weighing the options to set up the manufacturing plants in the public sector on the lines of the central public sector pharmaceutical manufacturing units to make drugs affordable and accessible. The state also is weighing options like going for public-private partnership model. Project location: Thiruvananthapuram, Kerala Project cost: NA Implementation stage: Planning Contact details: Kerala Department of Health & Family Welfare Secretariat Annexe Thiruvananthapuram- 1,

Kerala Tel : 0471-2327574 Fax : 0471-2332133 Email: minister-health@kerala.gov.in, secy.hlth@kerala.gov.in Manufacture of drugs Project type: New facility Project news: Israel’s Teva Pharmaceutical to sign a JV with P&G for India foray. Teva Pharmaceuticals to set up its India manufacturing facility at Sanand, Gujarat in a JV with P&G. P&G and Teva would set up Over-The-Counter (OTC) drug manufacturing facility at Sanand with an initial investment of ` 250 crore. Project location: Sanand, Gujarat Project cost: ` 250 crore Implementation stage: Planning Contact details: Procter & Gamble (P&G) India P&G plaza, Cardinal Gracias Road, Chakala, Andheri (E), Mumbai – 400099 Tel : (91-22) 2826 6000 Email: pg@corvoshandwick.co.in Website: http://www.pg.com

Information courtesy: www.tendersinfo.com 1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India • Tel: 022 28666134 • Fax: 022 28013817 • Email: parmeet.d@tendersinfo.com

invite that

rewards as well... Dear Reader, ‘Modern Pharma’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry.

1-15 Janua r y 2013 I Vol 1 I N o 13 I `100

www.mode rnpharma.i

Scan this code on your smart phone to visit www.mod ernpharma.in

The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format.

ion With 14

Special Focu

s 15

The laborat ory analyti cal market Status quo of India and developed countries

Interface 17

Paul Davies Global Busines s Manager, Malvern Instrum ents

Automation Trends 19 Software-ba sed automa Revolutionising tion pharma manufa cturing

Forest Labo ratori worldwide es and Glenmark in collaboratio a n

Court slappe ` 24,000 d fine Thiruvananth on a hospital in apuram distric Glenmark Kerala for Pharm t of running an a wholly owned aceuticals S A (GPSA pharmacy unlicensed ), advanc store in Pharmaceutic subsidiary of Glenm ement of the the hospit premise. ark inhibit ongoing mPGE The state al has entered als Ltd India (GPL), ors progra deputy drugs S-1 and controller into an agreem regulatory seized a large exclusive option mme. Forest has Forest Labora experti ent with an comme expired drugs quantity of to obtain license to the progra rcial footpri se and a strong intern ationa tories, Inc an rights mme upon the purcha from the store, while nt.” l health “Fores the comple se records care leader, on tion innova t contin ues to of phase 1 of the drug pharmacy a collaboration clinical trials. look for were found tive ways for the to expand incorrect. “This development pipelin e its broad collab oratio includ ing novel mPGE of reinforces Aurobindo n early S-1 inhibit our strateg stage collabo enteri ng into gets approv ors to treat chroni of partne abacavir tablets al for c inflammatory ring to achiev y access to novel rations to secure conditions, our goal Aurobindo e Marco produ cts,” includi of launch ng pain. Pharma Ltd Glenmark ing Presid Taglietti, Senior VP-R& said innova tive has receive final approv d ent, Forest techno logies al D and clinical candidhas identified around the manufacture from the USFDA to Research “We ates Institute. are please and market and is currently d to Glenn Saldanworld,” said this tentatively the earlier conduc collab oratio have entered into approved abacav ha, CMD, clinical studies ting preGlenmark n with Glenm USP 300 mg ir tablets one Pharm and of the other aceuticals. ark, develo pment “Forest has leadin g is ready for (ANDA 077844) and companies discov ery activit ies Saldanha an unriva launch. required to in India, lled us reputation Abaca vir which provid support the access to as a world first-in-huma es initiation a novel leadin g mg is the tablets USP 300 focussed of compa n progra mme pharm aceuti generic on a high of the agreem dosing. Under the terms ny. We cal that of ViiV interest target are proud ent, Forest associa has Healthcare equivalent the $ ted to be will make 6 million Ziagen® tablets Company’s patients and potent ial to benefi a to workin with them and look upfront Glenmark forward 300 mg t physicians.” g together. indicated and provid payment to combi and is Both parties The partne as part of e an additio $ 3 million nes Glenm will work collabo Antiretrovira (ARV) nal record to ark’s proven rship to advance combi nation l ratively of work. Forest support the next phase the progra of leadership track clinic. for the therap y mme into will make and experti rapid, innova treatment The payme the other collabo se nts in FY in Glenm of Huma Immunodefici tive 2014 to supporfuture and world- product development n ark and Forest ration between infected adultsency Virus (HIV) class t the networ will be manag by a joint and childre ed k with Forest manuf acturi ng development annual sale n. The with equal committee ’s development representatio approximately of the product both compa is n from $ nies. The produc 88 million. t has been The Baddi out of unit approved unit III IMEA award of Micro Labs receive in Hyderabad,formulations facility d (WCM for manuf excellence. India. Aurob ) model to acturing now has The evaluate the indo plant’s a total of by the Econo award was presen 169 ANDA approv als ted WCM manufacturing proced Baddi mic Times The Baddi (143 final & Sullivan. ure. The model assesse unit mainl including domes tic Frost & Sulliva and Frost excelle 2 from Auroli approv als marke t and y caters to proprietary nce adherin s manufacturing n used its LLC and fe Pharma World Class with in-hou g to high is equipp of custom 26 standa Manufacturin ed se testin from USFDA tentative approvals) g capab ility. g total assets.er satisfaction and return rds T h e p l a . nt fol on Assur ance Proce l o w s Q u a l i t y Aanjaneya dures (QAP all proces ) for Lifecare ses. second

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in India at GIR

You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,200 words, while that of a product write-up should not exceed 100 words.

In Conversat

Dr Siva Kumar Pasupathi Country Manager - Life Analysis Group, A Sciences & Chemical gilent Technologi es

Court fines hospital running for unlicensed pharmacy an in First Class Kerala

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Aanjaneya Lifecare Ltd LifeCell Interna has receive two prestig d tional has ious India’s first No 2 in India awards and ranked dual storage launched for menstr unique initiati ual blood stem service, a Pacific region and No 9 in Asiave made possibl LifeCell’s tie cell at The Global the inaugu Relations (GIR) up with Sequel banking. e with for Investor ration Lisa Ray, sample movem Logistics Summit. The stem cell center of its new advanc was co-ord Graduate & Actor, Model, Cancer ent through ed will event in Gurgaon inated by ensure Global Stem air cargo near New MZ Associ and KPMG who announ Cell Activis Delhi. LifeCe(Manesar) the sample same day relocat ates in New York. t, ced ion of storage service to ll’s dual Dr Kanna Storage Service the launch of Dual centre after the Gurgaon (Manesar) n Vishwanath, to simultaneous allows custom , said “Every processing Chairm an about the ers Vice in Chennai. ly store & MD, Mayur critical role one knows in two Lifecare Ltd, Abhay a, Aanjan eya therapy played geogra phical stem cells MD, stem cell CEO and said, “These locations, LifeCe ll, ly distan in my assess the cancer. I awards ensurin t said, “At g maximum performance am a living fight against and compl companies safety consta LifeCe ll we are proof of how of the ete protec in terms stem cells ntly implem unforeseen tion agains corporate can of their enting t events pioneering social respon LifeCell Stem save a life.” arising due natural calami services that corpo rate sibility, Cell City to offer ties. Gurgaon at the highes This service transparency govern ance (Manesar) t quality and standa . It would can hold upto offers added rds in reassurance Aanjaneya motivate 2 lakh stem to the clients storage. The stem cell in further cell sample is left to ance of endeavour new facility s and can chance when that nothing in its to provid expanded Gurga be preserving it comes e maximum value to to store up to has furtheron (Manesar) the preciou to 10 its stake lakh sample With the s stem cells. We consist strengthened holder s. s. Located launch of our commi ently look the Delhi-M the dual storage at service, the tment to continue forward to umbai corrido collected stem our our good customers the facility r, simultaneously cells will be performance and enable in furthe spans over stored at r achieving us to d 2 acre plot a centre in and outsta excelle with a floor Chennai and the existing storage activate the dual Abhaya nding results nce area of 65,000 new advanc at the brand service quality manag sq ft. The ed that provid , another milesto facility has ement , busine in Gurgaon (Mane stem cell centre an advanc ne excellence, es additio ed technology infrastructure in to the ss sar). The dual customer nal securit service will in-built with preserv satisfaction y safety corporate storage be available adequate & governance.” minimal addeded stem cells. At measures BabyCord for LifeCel a contro for temper cost, both service l’s and l, monitoring ature new custom existing stem cell bankin for umbilical cord and is manned ers can store g and LifeCel stem cells with armed fire safety. It the and at l Femme online surveil on-site security distant facilitie two independent and s.” ensuring comple lance monitoring of the preserv te safety and securit y ed stem cells.

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The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharma’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Network18 Media & Investments Ltd, ‘Modern Pharma’ is one of the leading fortnightly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80,000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

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Modern Pharma•16-31 Januar y 2013

Tenders

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Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

Event List

N AT I O N A L E V E N T S Pharma World Expo Pharma Bio World Expo is one of the foremost shows for pharma and biotech industry in India. The show aims to be one of the largest exhibition and conference for chemical and pharma industry. There will be visitors and exhibitors from pharma processing, plants & equipments, pharma packaging machinery & materials, API, bulk drugs, additives, intermediates, analytical laboratory supplies (instruments, glassware, laboratory reagents / chemicals), environment control equipment & services, etc). This event aims to be a perfect meet for the entire industry; January 15-18, 2013, Bombay Exhibition Centre, Mumbai For details contact: Chemtech Foundation Tel: +91 22 22874758 Fax: +91 22 22870502 Email: conferences@jasubhai.com Website: www.chemtech-online.com

Pharma Biotech Expo & Conferneces Pharma Biotech Expo & Conferneces is an exciting new networking platform & international exhibition for pharmaceutical machinery & equipments, biotechnology & applications industry. The event will be a preferred destination for the pharma and biotech and it will attract more than 10000 visitors & exhibitors with 100 stalls. The event will have innovative product launches, networking opportunities, joint venture partnership, one to one business meetings, locate new agents / dealers, academia, bulk buyers,

business development, contracting and contract services, drug development, equipment and supplies buyers, foreign trade missions, laboratories, logistics and distribution, contract packaging, pharma/biopharma process development, plant operations, preclinical development, quality assurance and control, supply chain, venture capitalists, etc; January 18-20, 2013, Hotel Gianz, Baddi For details contact: Paramount Exhibitors Tel: +91-172-2274801 Fax: +91-172-2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

BioAsia 2013 This year, BioAsia is geared to carry forward the momentum with its tenth edition - BioAsia 2013. One can expect the best convergence at this much-awaited and most comprehensive lifesciences dynamic global forum. This time, through the succinct, cutting-edge theme of technologies, business, etc, BioAsia 2013 will explore a bio-future waiting to be shaped by the next big industry trends primarily biologics & biosimilars; January 28-30, 2013, HICC, Hyderabad For details contact: Federation of Biotech Association (FABA) Tel: +91 (40) 66446577 Email: paridhi@bioasia.in Website: www.2013.bioasia.in

Bangalore INDIA BIO Bangalore INDIA BIO is an event which will prove to be beneficial for

AURANGABAD Maharashtra, Feb 22-25, 2013

HYDERABAD

Andhra Pradesh, May 31- June 3, 2013

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details

Network18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@network18publishing.com

the industry leaders, policy makers, opinion leaders and professional experts related to biotechnology industry. By attending this event they will get a scope to improve and enhance their knowledge. This expo will also give them an opportunity to get familiar with the latest techniques which are required for bringing some useful and modern changes in the technical institutions and companies. This event will bring forward the significance of biopharmaceuticals, bio industrial services and bio informatics and agri biotechnology; There will be a CEO Conclave that will aim at unique and niche gathering of CEO of biotechnology, lifesciences, rearch heads where they in an panel will discuss on the industry trends and the growth ahead. There will be Bio Partnering – a powerful internet platform that will enable delegates to conduct one–to–one meetings with global biotech community, February 4-6, 2013, The Lalit Ashok, Bengaluru For details contact: M M Activ Tel: +91-80-41131912

Fax: +91-80-41131914 Email: enquiry@bangaloreindiabio.in Website: www.bangaloreindiabio.in

PHARMAbiotika PharmaBiotika 2013 is an exhibition with an in built buyer and seller meet which will help one in networking with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference which is going hand in hand with the exhibition. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analyzing the exhibiting plan and help execute trade objectives, June 20-22, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar For details contact: Human Crayon Management Services Pvt Ltd Tel: +91- 120 – 6528801 Email: info@crayon4.com Website: www.pharmabiotika.com

I N T E R N AT I O N A L E V E N T S BIOSIGNALS 2013 The purpose of the international conference on Bio-inspired Systems and Signal Processing is to bring together researchers and practitioners from multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems. A diversity of signal types can be found in this area, including image, audio and other biological sources of information. The analysis and use of these signals is a multidisciplinary area including signal processing, pattern recognition and computational intelligence techniques, among others. With this vision in place the event aims to reach out to the industry professionals; February 11-14, 2013, Barcelo Sants Hotel, Barcelona, Spain For details contact: Biosignals Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: biosignals.secretariat@insticc.org Website: www.biosignals.biostec.org

Bioinformatics 2013 The purpose of the international conference on bioinformatics models, methods and algorithms is to bring together researchers and practitioners interested in the application of computational systems and information technologies to the

field of molecular biology, including for example the use of statistics and algorithms to understanding biological processes and systems, with a focus on new developments in genome bioinformatics and computational biology; February 13, 2013, Barcelona, Spain For details contact: Bioinformatics Secretariat Tel.: +351 265 100 033 Fax: +44 203 014 5436 Email: bioinformatics.secretariat@ insticc.org Website :www.bioinformatics.biostec.org

EAHP ‘Improving patient outcomes: a shared responsibility’ is the theme of the 18th Congress of European Association of Hospital Pharmacists (EAHP). This topic covers two of the major goals of the association: the commitment to the patient and the importance of collaboration with other health professionals. Hospital pharmacists are the stakeholders in optimising the medication of inpatients, but their responsibility does not end at the interface to primary care. Due to the fact that this is prone to errors, the Congress will focus on the different aspects of the interface with the scope of helping all participants to understand the origin of faults, March 13-15, 2013, Paris, France For details contact: EAHP Tel: +32-2-741-6827

Fax: +32-2-734-7910 Email: taviana.caminiti@eahp.eu Website: www.eahp.eu

International Conference on Life Science & Biological Engineering The aim objective of LS&BE 2013 is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in networking and digital society. This conference provides opportunities for the delegates to exchange new ideas and application experiences face to face, to establish business or research relations and to find global partners for future collaboration; March 15-17, 2013, Tokyo, Japan For details contact: Kwansei Gakuin University Tel: +81 798 54 7394 Fax: +81 798 54 6082 Email: craig.mark@kwansei.ac.jp Website : www.lsbe.org

International Congress of Toxicology 2013 The theme for the conference is “From Basic Science to Clinical and Environmental Outcomes”. This conference encompasses novel approaches and technologies being used to properly assess the safety, toxicity, and risk for human health. The scientific programme will consist of keynote/distinguished

lectures, symposia, workshops, round table discussions, debate and poster sessions. This meeting will provide attendees with ample opportunities to exchange the ideas and to launch collaborations; June 30-July 4, 2013, Coex, Seoul, Korea For details contact: ICT XIII Secretariat Tel: +82-2-557-8422 Fax: +82-2-566-6084 Email: ict@ict2013seoul.org Website: www.ict2013seoul.org

Pharma Trials World Korea 2013 Pharma Trials World Korea 2013 is where pharma companies, trial sponsors, regional and international CROs and clinical trial sites gather to strategise in accelerating clinical development, accessing emerging markets, enhancing clinical operations through effective offshoring and outsourcing in Korea; July 8-11,2013, Korea For details contact: Terrapinn Pte Ltd Tel: +65 6222 8550 Fax: +65 6226 3264 Email:enquiry.sg@terrapinn.com Website: www.terrapinn.com The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharma.

Modern Pharma•16-31 Januar y 2013

Event Preview

BioAsia 2013

Pathway to a healthier tomorrow

Set up with a vision to enhance, enrich and encourage innovation, BioAsia is back with its 10th edition. This edition promises offering of unmatched opportunities for sharing and enriching initiatives in technology & research, explore profitable business opportunities and show the way forward to maximise the immense potential offered by biologics.

Glimpses from the previous edition

Hardik Ashar

hardik.ashar@network18publishing.com

ioAsia 2013, Asia’s biggest technology and bio-business platform for biotechnology and life sciences, will be hosted by the Government of Andhra Pradesh with the support from Federation of Asian Biotech Associations (FABA) and Pharmaceuticals Export Promotion Council of India (Pharmexcil), Government of India, from January 28-30, 2013 at HICC, Hyderabad, India. BioAsia 2013 aims to provide an ultimate platform to anticipate the next required shift in perspective, vision and innovation in life sciences. Participants from as many as 50 countries are expected to be a part of this mega event. It aims to provide unique opportunity to get on a dynamic and future-oriented global paradigm. BioAsia is focussed in its efforts; to drive the growth of the industry by enabling an effective environment for fostering collaborations, Joint Ventures (JVs), M&As; ensure knowledge and experience sharing by global industry players to benefit all stakeholders; promote innovations and initiatives through appropriate awards and recognitions; play a

pivotal role in advocating issues to the policymakers and chartering the roadmap of biotechnology. BioAsia is a dynamic platform for companies to exhibit, launch and showcase their unique strengths, products and services. BioAsia is playing the role of a key catalyst in mobilising all elements that are required to drive the growth of the emerging industry of biotechnology as well as optimise the immense business potential of biotech. On a larger level, BioAsia is working to drive a global transformation from the treatment of illness to wellness.

Highlights of previous edition Ninth edition of BioAsia attracted 598 registered delegates from across 40 countries including sizeable delegations from Belgium, Germany, Iran, Korea, Nepal, Singapore, Sri Lanka, USA and African countries. The event witnessed various delegates/ visitors over the three days of conference and trade show. Event truly leveraged the edition’s theme of ‘Optimizing Opportunities’ in a wellcoordinated, dynamic global forum. The most happening life sciences segments - vaccines and contract research - found an added impetus through valuable inputs, discussions, interactions and perspectives by industry thought leaders and key stakeholders. Around 50 eminent speakers shared their thoughts at this

event. Problems such as rejection of Indian vaccines by WHO, infrastructure development, quality parameters etc were debated at the event with the active participation of global life sciences leaders. Various award winners included Dr Seth Berkley, CEO, GAVI Alliance and Kevin Ali, President, Emerging Markets Merck & Co, USA, received Genome Valley Excellence Award; Karun Rishi, President, USA – India Chamber of Commerce received BioAsia Special Award; Cyrus Mistry, Managing Director, Shapoorji Pallonji & Co and MedTrack received FABA Special Award.

Overview of this edition One can expect the best convergence at this much-awaited and most comprehensive life sciences dynamic global forum. This time, through the succinct, cutting-edge theme of ‘Technolgies.Business.Next’ BioAsia 2013 will explore a bio-future waiting to be shaped by the next big industry trends: biologics & biosimilars. The discussion will be focussed on biosimilars, new drug discovery, monoclonal antibodies, regenerative medicine, Intellectual Property Rights (IPR) and financial ecosystem. The event will comprise sessions, seminars, workshops, tech transfer summits, biobazaar and International Trade Show. Event will conclude with ‘Excellence Awards’.

Expert sessions would bring leaders from the life science industries to leverage and debate on leading perspectives and put forward their thoughts and ideas on emerging trends in life sciences. Panel discussion will analyse current scenarios to define the current industry challenges and the possible solutions. The CEO conclave will focus on views and perspectives on key trends in the biopharmaceutical industry that will reshape the future of the life sciences industry. International Trade Show will help companies to showcase their products, strengths, services, etc to a large and captive global audience. BioAsia 2013 will also feature a dedicated B2B portal to assist in the business development and licensing activities. Observing the prominent partnerships in the current edition, Shakthi M Nagappan, CEO, BioAsia, says, “We are delighted with the enthusiastic response from various regions and industry stalwarts. Our partners, sponsors and participants have recognised the incremental value that BioAsia has added to the industry and we are confident to carry forward the momentum with this edition, which is all set to bring excellent opportunities to network with potential business prospects across geographies and deliberate on the growth drivers of future.”

Mo d e r n P h a r m a â&#x20AC;˘16 -31 J a n u a r y 2 013

Book Review

Editor: Michael Verrall Price: ` 3,795

Publisher: Informa Healthcare Distributor:Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

Industrial Scale Natural Products Extraction

Editors: Hans â&#x20AC;&#x201C; Jorg Bart and Stephan Pilz

Natural sources have been exploited since ancient times for their medicinal value. In the modern age of pharmaceutical products, up scaling of processes to manufacture large quantities of active ingredients is of utmost value. This book explains in detail the scaling up of operations from an analytical lab to large scale extraction for naturally derived active principles. The first chapter dwells briefly on the cultivation, harvesting and extraction from plants and other natural sources. Chapters 2 and 3 deal with solubility basics and advanced solubility surfactant-based systems for active principles, respectively. Chapters 4 to 6 describe the upscaling of the process to a larger scale with use of high pressure processes, supercritical fluids, process engineering techniques and large scale extraction techniques. The book contains a chapter describing extraction of lignocellulose which serves to put the previous chapter theories into a practical perspective. The book ends with chapters dedicated to future prospects, market prospects and regulations. This book is designed for readers with fair knowledge of liquid-liquid extraction techniques and hence good for advanced readers with interests in upscaling of processes.

Price: ` 9,995

Downstream Processing of Natural Products: A Practical Handbook Naturally derived active ingredients are of great interest to both analytical chemists and pharmaceutical stakeholders. The fluid unpredictability of natural sources makes it often difficult to replicate processes based on these sources in the lab. The book puts together brilliantly a collection of chapters that serve as ready manuals for a lab to avoid various pitfalls in the processing of naturally derived active principles. The book is divided into many small chapters, each of which describes in clear detail the various aspects of downstream processing such as broth conditioning, cell disruption techniques, solvent extraction technologies, integration with biotechnology, chromatography techniques, lyophilisation, instrumentation and scale up. Chromatographic separation is discussed in detail with chapters dedicated to various techniques such as displacement, ion exchange, affinity, radial flow, HPLC, supercritical fluid extraction and liquid membranes. The chapter on lyophilisation requires special mention as it is described very comprehensively. The book is designed for an analytical chemist or pharmaceutical researcher and serves as a quality control manual to avoid the various discrepancies of naturally derived active ingredients. A must have manual for every lab. Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

Publisher: Pharmaceutical Press Distributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: thadam@vsnl.com

Modern Pharma•16-31 Januar y 2013

Products

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818

Reels for confined sanitary spaces The SSN800 series stainless steel hose reel features a narrow frame that makes it ideal for mounting in smaller spaces. With no paint to chip or potential for rust and corrosion, these reels are ideal for the food and beverage, dairy, pharmaceutical and cosmetics industries. Typical applications include washdown, chemical transfer, potable water, food ingredient transfer and even fire protection. It is constructed of fine grade 304 stainless frames, discs and drum. It handles single ID hose from 3/4 to 1 inch, accommodates pressure up to 1000 psi and sustains temperatures from 200F to 4000F (-70C to 2040C).

thus fulfill one of the major statutory requirements of European Union. A range of customised solutions as per pharma industry requirements is also offered. Pharma inspection solutions include: pharmacode readers, leaflets and cartons. These have been specially designed for online checking of pharma codes printed on tubes, cartons, leaflets, labels, etc. Pratham Technologies Pvt Ltd Pune - Maharashtra Tel: 020-24352624 Mob: 09822047399 Email: enquiry@prathamtech.com Website: www.prathamtech.com

Filtration and separation product

Hannay Reels U.S.A Tel: 518 797 3791 Fax: 518 797 3259 Email: catalogs@hannay.com. Website: www.hannay.com

Chemical resistant diaphragm vacuum pump Chemical resistant diaphragm pump are the best suited oil free vacuum option for laboratory and pilot scaled application. Typical applications for chemical resistant diaphragm pumps include evacuating chemically aggressive gases and vapours from equipments such as rotary evaporators, vacuum drying cabinets and centrifugal concentrators. Most importantly, diaphragm pumps are oilfree, for vastly reduced service demands compared with oil-sealed pumps. They eliminate the water waste of water-jet aspirators, and the contaminated wasteoil disposal of rotary vane pumps. The diaphragms are available in various options of materials like EPDM, neoprene, viton and teflon coated neoprene rubber. These vacuum pumps are available in the range of 15 lpm to 33 lpm and they generate a maximum vacuum of 30Torr. Chemical resistant vacuum pumps are also supplied with 3phase flame-proof motors. Sri Vishnu Pumps Mfg Co Thane - Maharashtra Tel: 022 - 28458372 Fax: 022 - 28457073 Email: vishnupump@rediffmail.com Website: www.minivacpumps.com

Pharma inspection machine The paper folding, shrink pack and pharma inspection machines are tested for CE marking, and

Capsule filling machine These automatic capsule filling machines also known as encapsulation equipment are compact, sturdy, covered with stainless steel panels, and hood covered with acrylic guard. The fill weight adjustment takes place within seconds. These machines are provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation with ±2 per cent. Anchor Mark Pvt Ltd Mumbai – Maharashtra Tel: 022-28682001 Email: sales@anchormark.com Website: www.anchormark.com

Sieves

Advantec’s wide range of filtration solutions are used for laboratory, research and process applications. These products are used in a wide variety of scientific capacities and applications, such as microbiological analysis, air/gas filtration, and environmental monitoring. Advantec’s range of filtration products fits comfortably within Cole-Parmer’s own product range. It offers customers an additional and valuable range of unique quality products that will enhance their processes and research. Cole-Parmer India Mumbai - Maharashtra Tel: 022-67162222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

These are silicon moulded sifter sieves, fluid bed dryer (FBD) sieves and FBE dryer sieves. The silicon moulded sifter sieves are available in various sizes from 12” to 48” diameter. These are available in rivetted and special non-rivetted design. The mesh sizes vary from 4 mesh to 500 mesh with ASTM and BSS Standards. Atlanto Enterprises Mumbai – Maharashtra Tel: 022-23096098 Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net

Shaking incubator

Walk-in humidity chamber The unit has double-walled insulated PUF modular panels, which can be easily assembled at site. Interior is made of stainless steel and exterior is either made of mild steel finished with powder coating or stainless steel. The unit has full-length inner glass door and outside metal door with magnetic gasket and lock. It is provided with perforated stainless steel trays and has forced air circulation for uniform temperature. The intelligent controlling system has PLC base and PC communication. It has long lasting stainless steel tubular heaters with SS fins.

The compact benchtop stuart SI500 and SI505 shaking incubators have a unique retractable platform providing easy access to samples, a digital display showing the independently controlled temperature and speed, and USB connectivity for long-term monitoring of the incubator temperature via a PC. Removable water reservoirs increase the humidity in the chamber of the Stuart SI505, dramatically reducing sample evaporation. The Stuart SI500 incorporates a versatile clamping system for securing flasks of most sizes, while angleadjustable stainless steel accessory tube racks with magnetic locking system providing quick coupling and de-coupling.

Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in

Bibby Scientific Ltd Staffordshire - UK Tel: +44-1785-812121 Email: info@bibby-scientific.com Website: www.bibby-scientific.com

one Before taking deliver y of any machine, time. must take trials of the product for a short cy This will help determine the product’s efficien and effectiveness.

Sharayu Sawant Director Shruti Flexipack Pvt Ltd

GPS synchronised clock G P S synchronised clock solution provides a unique and error-free timing solution for the entire facility. It features GPS satellite synchronised timing with no need of manual setting / adjustment. It is built with a wide range of LED display size from 20mm to 200mm and colours ranging from red, green and white to work in any environment. It is a complete wireless solution which helps in eliminating expensive cabling costs and significantly reducing the installation time. It is also equipped with SS-304 stainless steel housing and flame-proof enclosures available for hazardous areas. There are various choice of mounting options such as table-top, wall-mount or hanging type along with 32 timezones and automatic day-light savings adjustment facility. Essae Teraoka Limited Bengaluru – Karnataka Website: www.essae.com

Automatic labelling machine Automatic labelling machine is suitable for the application of the vignette label onto the main panel and of two self-adhesive tamper evident seals on the closure point of formed cartons. The machine is designed for carton Track & Trace by means of 2D datamatrix codes printing on line and subsequent verification with camera vision systems. It is an ergonomic balcony-design machine that offers full access to ensure cleaning and management comfort and guarantees a full view of the entire production process. The labelling machine works by steps, consequently guaranteeing high precision in label application and the finished result. Size change over is precise, easy and quick. Marchesini Group India Pvt Ltd Mumbai - Maharashtra Tel: 022 - 67082755/64 Fax: 022 - 67082761 Email: info@marchesini.com, philippe@marchesini.in Website: www.marchesini.com

Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

Products

Aerosol generator The aerosol generator (fogger machine) is used for sterilising air in the production shops of pharma, food, biotech and healthcare industry. This fogger machine takes care of 5,000 cu ft volume in single fill giving 100 per cent efficacy. The portable fogger machine is tested for droplet size of aqueous formulations in sub-microns. It generates droplet size in sub-microns and is approved by nuclear division of BARC, nuclear power stations and is patronised by leading hospitals and pharmaceutical industries. The machine comes with a 5 ltr capacity tank made out of best grade disinfectant tank & wetted parts. Gouri Engineering Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27701285 Email: gouriengg@vsnl.com

Air classifier The air classifier is a screenless machine used for grading offline powder into distinct coarse and fine grades from 60 mesh down to 40 microns. This air classifier-type separating machine is operated in closed circuit with existing equipment, such as feed from the hopper, bins pulveriser, cyclone, etc. It is manufactured in closed tolerance and well balanced to give trouble-free operation. The material is fed through the top input pipe down on a revolving distributor plate. The fluidised particles are propelled to the sides of the inner cone by whizzer blades and separated from the re-circulating air stream between inner and outer ring. Premium Vijimech Pvt Ltd Ahmedabad - Gujarat Tel: 079-40083450, Mob: 09712987467 Email: sales@vijimech.com Website: www.vijimech.com

Insulation materials T h e s e insulation materials include flexible f o a m produced from melamine resin. The three dimensional structure of the foam is made up of a microscopic, slender skeletal structure that delivers insulation properties. As a result of its unique design and inherent nature of the design, it offers properties such as high temperature resistance, low bacterial growth, 25/50 fire rating, ASTM C-1410, etc. IUS Equipments Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-56116626, Mob: 09960110373 Email: iusequip@vsnl.net Website: iusequip.com

Lyophiliser The lyophiliser is used for pharmaceuticals, biotechnology and allied industries. Lyoph i l i s a t i on is the preferred drying process,

for heat labile substances or where any physical, chemical or enzymic changes are detrimental to the products and its applications. Sublimation of frozen ice directly in the form of vapour under high vacuum is the basis of lyophilisation process. The system offers optimal flexibility in programming the recipe to suit a wide variety of products. The drying chamber is designed for full vacuum and overpressure of 2.5 bar. Machinfabrik Mumbai - Maharashtra Tel: 022-25555596 Email: machinfabrik@vsnl.com Website: machinfabrik.com

Multi-purpose trolley Multi-purpose trolley is used for ICU/hospital/ surgery. It comes with multi-purpose aluminum extruded legs, heavy-duty designed castor wheels, MDF monitor top with anti-skid rubber mat, lockable MDF, scratch-proof painted drawer box. Different box or tray are adjusted according to needs due to specially designed profile of tapped strip. Because of aluminium metallic structure, earthing is affirmative and provides safe working for electrical and electronic appliances. Envair Electrodyne Ltd Pune - Maharashtra Tel: 020-30688117 Email: envairelectro@vsnl.net Website: www.envairelectrodyne.com

Deep freezer Deep freezer has freezing temperature range upto -86° c. It has vacuum insulation panel and no doorjamming feature. Hot gas bypass tube is installed to minimise frost on the triple-silicon door lip and the equipped decompression valve balances the low air pressure built inside the freezer for an effortless door opening. It has temperature stability of ± 1° C. Available sizes are 175,340,515, 690 and 1000 litres. ± 3° C uniformity inside the whole cabinet ensures that the samples are stored inside a guaranteed temperature range. Mack Auraa Nashik- Maharashtra Mob: 9325858585, 9225508585 Fax: 2551- 230877 Email: sales@mackauraa.com Website: www.mackauraa.com

m a i n t a i n s the required temperature of water with better temperature control using automation and control. Application areas include Pharma – single fluid heating and cooling systems, food, HVAC, hospitals, hotel, textile, breweries.

The method involves the use of a unique, disposable folded capillary cell which allows measurements to be conducted on samples as small as 20 microliter.

HRS Process Systems Ltd Pune - Maharashatra Tel: 079-25890158 Tel: 020-2566 3581 /82, 9096699998 Fax: 020- 2566 3583 Email: info@hrsasia.co.in, Website: www.hrsasia.co.in

In-line homogeniser system

Laboratory spray dryer Laboratory spray dryer is used for safe, fast and efficient spray drying of aqueous and organic solutions. Spray drying is a speedy, time saving and gentle method of obtaining even the smallest quantities of substance in power form. The very short residence times and the cooling effect resulting from evaporation make it possible to process even temperature sensitive products in a gentle manner. If the use of organic solvents is involved, the thermal load is reduced to a minimum. Many other processes can also be completed in a single stage like: Modification of particle size, agglomeration of nanoparticles, drying suspensions, particle coating, immobilization of liquids and solid materials in a matrix and manufactures of microcapsules

In-line homogeniser system allows smooth changeover from laboratory to production plant. It allows the user to select from seven different mixing technologies using a variety of available mixing heads, all with programmable speed control to determine the best mixing function for the process. This laboratory machine offers a great variety of applications for many different mixing and particle size reduction processes. It eliminates the need to purchase separate mixers and operates as both a batch mixer and in-line mixer. The compact, tabletop design minimises space requirements. Cole-Parmer India Pvt Ltd Mumbai - Maharashtra Tel: 22-67162224 / 2222 Fax: 22-67162211 Email: response@coleparmer.in Website: www.coleparmer.in

Magnetic drive centrifugal pump

Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Dynamic light scattering system Zetasizer Nano ZSP dynamic light scattering system is useful for highly sensitive measurement of the zeta potential, or electrophoretic mobility of proteins. The instrument delivers unique performance specifications for both size and zeta potential measurement, employing an approach to zeta potential measurement that accords with the latest industry guidance. It uses the company’s patented Diffusion

Hot Water Systems Hot water systems provide highly efficient solution to instantaneous hot water generation using energy efficient heat exchangers such as funke brazed, gasketed plate heat exchanger or Ecoflux* corrugated tube heat exchanger. HRS hot water systems can also be installed with storage vessel for semi-instantaneous applications and in conjunction with solar based hot water systems. A Hot water system not only heats the water to a desired temperature using low pressure steam but also

Malvern Aimil Instruments Pvt Ltd Mumbai - Maharashtra Tel: 022 - 39183596 Fax: 022 - 39183562 Mob: 09867368075 Email: soloni.gosalia@malvernaimil.com Website: www.malvernaimil.com

Lutz magnetic drive centrifugal pump is available in two series range AM and TMR. The materials are in glass-filled PP or carbon-filled ETFE. Unique feature of the TMR series is that the pump can run dry for up to 15 mins without damage. The inlet/outlet for the pump is offered in threaded (BSP/NPT) or flanged (ISO/ANSI) connections. The TMR series is disassembled without disturbing the motor. Maximum flow rate that achieved is up to 30 m³/hr and heads up to 25 mWc. The strong magnetic coupling made up of rare earth materials and three versions of each model allow pumping of liquids of special gravities from 1.00 to 1.85. Shanbhag & Associates Mumbai - Maharashtra Tel: 022-28346604 Email: shanbhags@vsnl.com Website: www.shanbhags.com

Barrier Technique which protects the sample by isolating it from the electrode. Consequently the applied voltage can be switched on for longer periods to generate more reliable measurement data.

The information published in this section is as per the details furnished by the respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma

Modern Pharma•16-31 Januar y 2013

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In Convers

ation With

Dr Swati Piramal Vice Chairp erson, Piramal Enterprises Ltd

FDI throu gh FIPB investments may hamp er in

Strides, Lilly in

Special

Focus 15

Higher pharmacy studies Is the grass greener on the ‘Western’ side?

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Dr R S Gaud Dean, (SPPS PTM)

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Indian pharm Patent laws , Reacting SVKM’s 19 Why MNCs NMIMS to in pharm on all foreigthe governmen a, FABA a are shying t’s away from domestic n investments decision patenting Indian Eli Lilly policies? pharma in existin by the FIPB on firms to be cleare g Arcolab and Company Shakthi a comp ulsory basis,d expand Ltd have collaband Strides delivery included Secretary, M Nagappan, orated in emerg of Executive as part AssociationFederation of Asian ing mark cancer medic to Lilly has of the this arran ines agreement ets. As Biotech high-qualitthe right to of BioAs s (FABA), the , add will in-lic geme nt, Lilly a part of ia 2013, organ Arun Kuma products y branded gener additional route all said, “Deci isers r, Foun of high- ense a portfo CEO, Stride to the portfo the FDIs ic oncol sion der lio through qualit to ogy deligh & s Arcol lio in the y, brand gener ic the FIBP in pharma sector ab said, Group “Cancer ted to future. reduce ed injec tible “We medicines partn oral the invest may decelerate expand highest cance r and and of the unless its brand er with Lilly are ments qualit from appro medi cines with into India, ed be an unme y continue to Agila mechanism priate & to that high-quality generics platfo t need Speci the specia transp rm oncology markets deployed s and system arent lties divisi alties , around in many globa will benefit products Strides from Building the world s are on of l presen Arcolab such applicto scrutinise ce in key Lilly’s stron in Benga Ltd, based ations witho and process investmen on our recen . 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Mo d e r n P h a r m a •16 -31 J a n u a r y 2 013

30 List of Products & Advertisers Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818 eg, MPH Laboratory software and send it to 51818 Product

Pg No

Product

Pg No

Product

Pg No

Product

Pg No

Acoustic enclosure........................................... 6 , 21

Dynamic pass box ................................................FIC

Measuring and monitoring relay for 1Ph/3Ph ... 11

Seamless pipe .......................................................... 29

Activated carbon filter...........................................BC

Electro de- ionisation..........................................BC

Metal doorset ........................................................FIC

Shaking incubator .................................................. 27

Aerosol generator.................................................... 28

Encoder .................................................................... 11

Modular clean room ............................................FIC

Sieves ........................................................................ 27

Air classifier ............................................................. 28

Filtration and separation product ..................... 27

Motion control........................................................ 11

Softening unit.........................................................BC

Analytical instrument .............................................. 3

Fire resistant door.................................................FIC

Motor ....................................................................... 12

Spectrophotometer ................................................. 29

Automatic labelling machine ................................ 27

GPS synchronised clock ...................................... 27

Multiposition stirrer ............................................... 23

Bio Asia 2013......................................................... 10

Hot water system.................................................. 28

Multi-purpose trolley ............................................. 28

Blow-fill seal machine .............................................. 9

Industrial control and sensing device ............... 11

Pharma inspection machine............................... 27

Capsule filling machine ....................................... 27

In-line homogeniser system .................................. 28

Photo electric sensor .............................................. 11

Chemical resistant diaphragm vacuum pump ... 27

Insulation material ................................................. 28

Physical testing .......................................................... 7

Chromatography instrument ................................ 29

Invertor/variable frequency drive ......................... 11

Pressure sand filter ................................................BC

Clean room door ..................................................FIC

Laboratory equipment ........................................ 29

Programmable logic controller ............................. 11

Color masterbatch .................................................. 29

Laboratory glassware................................................ 3

Programmable terminal......................................... 11

Compressor ............................................................. 12

Laboratory spray dryer .......................................... 28

Proximity sensor ..................................................... 11

Content uniformity testing ..................................... 7

Laminar air flow unit...........................................FIC

Pump..............................................................6 , 12,21

Counter and power supplies ................................. 11

Large diameter welded pipe .................................. 29

Reels ....................................................................... 27

Deep freezer .......................................................... 28

Level controller ....................................................... 11

Reverse laminar air flow ......................................FIC

Demineralisation plant .........................................BC

Liquid handling product ..................................3 , 21

Reverse osmosis unit .............................................BC

Dissolution testing.................................................... 7

Lypholiser ................................................................ 28

RFID ......................................................................... 11

Dry van pump ...................................................6 , 21

Machines and plants for dry and wet preparation.......BIC

Roots blower ......................................................6 , 21

Dynamic light scattering system........................... 28

Magnetic drive centrifugal pump......................... 28

Safety light curtain............................................... 11

Stainless steel pipe .................................................. 29 Strring hot plate...................................................... 23 Switching relay ........................................................ 11 Tempurature controller....................................... 11 Timer........................................................................ 11 TPU Masterbatch ................................................... 29 Tube.......................................................................... 29 U’ Tube................................................................... 29 Ultra filteration system .........................................BC Vacuum booster pump ................................... 6 , 21 Vacuum system ................................................... 6, 21 Vision sensor ........................................................... 11 Walk-in humidity chamber ................................ 27 Water analysis instrument ..................................... 29 Welded pipe............................................................. 29

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Advertiser’s Name & Contact Details

Pg No

Alok Masterbatches Ltd

Advertiser’s Name & Contact Details

Pg No

Everest Blower Systems

Advertiser’s Name & Contact Details

Pg No

Loba Chemie Pvt Ltd

Advertiser’s Name & Contact Details

Shanbhag and Associates

T: +91-011-41612244

T: +91-11-45457777

T: +91-022 66636663

T: +91-22-28346604

E: sales@alokindustries.com

E: info@everestblowers.com

E: info@lobalife.com

E: info@shanbhags.com

W: www.alokmasterbatches.com

W: www.everestblowers.com

W: www.lobalife.com

W: www.shanbhags.com

Pg No

Sotax India Pvt Ltd Bioasia Secretariat

Everest Blowers

Netzsch Technologies India Pvt Ltd BIC

T: +91 022-42950191 E: sotaxindia@sotax.com

T: +91 -40-6644 6477

T: +91-11-45457777

T: +91-044-42965121

W: www.bioasia.in

E: info@everestblowers.com

E: anton.benjamin@netzsch.com

W: www.everestblowers.com

W: www.netzsch-grinding.com

W: www.sotax.com

Sunjay Technologies Pvt Ltd

T: +91- 22 6662 4330

Cole-Parmer India

Global Innovation Centre

T: +91-22-67162222 E: response@coleparmer.in W: coleparmer.in/3125

Essae Teoka Limited

E: info@essae.com W: www.essae.com

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Omron Automation Pvt. Ltd.

T: +91-9978904476

T: +91-22-42288400

E: support@gisindia.org.in

E: in_enquiry@ap.omron.com

W: www.innovasia.in

W: www.omron-ap.com

GMP Technical Solutions Pvt Ltd

T: +91-80-30213000

FIC

Salesworth Synergies Pvt Ltd (Rommelag) 9

T: +91 -22 66083790

T: +91-80-25274495

E: prashant@gmptech.net

E: mail@salesworthsynergies.com

W: www.gmptech.net

W: www.rommelag.com

E: info@sunjaytechnologies.com W: www.sunjaytechnologies.com

Suraj Limited

T: +91-79-27540720 E: suraj@surajgroup.com W: www.surajgroup.com

TSA Process Equipments Pvt Ltd

T: +91-022-28593808 E: base@tsapepl.com W: www.tsawatersystems.com

Our consistent advertisers

RNI No: MAHENG / 2008 / 27125, Postal Regd No: G / NMD / 122 / 2011 - 13, Posted at P.C Stg. Office, GPO, Mumbai 400 001 On 19th & 20th Of Every Month, Date Of Publication: 16th Of Every Month