Modern Pharma July 16-31

16 - 31 J u l y 2 013 I Vo l 2 I N o 2 I `10 0

www.modernpharma.in

In Conversation With 14 David Malinas

Vice President and General Manager, Global Chemicals Business, Thermo Fisher Scientific

Special Focus 15HR practices in pharma Focussing on employee

empowerment and retention

Special Focus Interface 18Aditya Narayan Misra

President - Staffing Randstad India

Insight & Outlook 21Pharma packaging

Child-resistant and senior-friendly packs: A total contradiction?

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enus Medicine Research Centre (VMRC), the R&D wing of Venus

Remedies, a research-based global pharmaceutical company has been granted a patent for Elores, an antibiotic found to be effective against carbapenemase-resistant enterococci bacteria, by the Japanese patent office. The company is expected to launch this product in Japan, the world’s second largest pharmaceutical market next to US, by the end of 2015.

Elores, which was launched in the Indian market in January this year, has received good response from the medical fraternity.“This unique antibiotic adjuvant entity creates a synergistic effect due to its activity on multi-drug resistant Extended Spectrum Beta Lactamase and Metallo Beta Lactamase (ESBL/MBL) producing gram negative bacteria. It prevents the development and the

spread of bacterial resistance from one species to another. Clinical studies on more than 1,000 patients have indicated an over 30 per cent reduction in cost of therapy as compared to conventional therapies,” said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director (Research), VMRC.

Elores was recently recognised as the best innovation of 2013 by a team of experts from Stanford Business School, US, IC2 University of Texas, Austin and Lockheed Martin Foundation in collaboration with the union department of science and technology, under the Indo-US joint science and technology innovation programme, 2013. It has also been selected among the top eight technologies to be commercialised in the US.

“Elores is a product with proven potential. The Japanese patent has given us exclusivity for the product in one of the

world’s most important and lucrative healthcare markets up to 2025. Venus has already filed the common technical document with the European Union (EU) and is on the verge of getting MA grant for the product. Since EU and Japan have an understanding on the regulatory front, the product can be made available in the Japanese market within no time after receiving the MA grant from EU,” Dr Chaudhary affirmed.

Venus has received patents for this product from 46 countries, including the US, Australia, New Zealand, Russia, South Africa, South Korea, India and all major economies, including EU constituents.

“We expect this product to generate revenue of around $ 100 million by 2018. The innovation assumes greater significance at a time when the medical community, the world over is looking for ways to deal with the growing problem of antibiotic

resistance. Drug-resistant microbes could well become a threat to human race, in the days to come as an increasing number of antibiotics are feared to be losing out in the battle. There are far fewer new antibiotics in the development pipeline, as global drug manufacturers are focussing more on drug candidates with instant blockbuster potential to treat cancer and metabolic diseases. In this complicated scenario, a drug like Elores will prove to be a boon for the society,” said Dheeraj Agrawal, Chief Financial Officer, Venus Remedies.

Regulatory agencies around the world are currently fast-tracking the approval process of antibiotic drugs. Moreover, the company is assisted by experts from IC2 Texas to get the product fast-track approval under the Generating Antibiotics Incentives Now (GAIN) Act, a legislation recently passed by the US government.

lder Pharmaceuticals recently said its UK arm, NutraHealth Ltd has acquired

West Yorkshire-based firm, Max Healthcare Ltd. This acquisition entails re-entering over-the-counter (OTC) pharmaceutical business for an undisclosed amount.

“Max Healthcare is an OTC business, which owns a range of marketing authorisations. It provides own label, branded OTC medicines and products to a broad range of customers,” Elder Pharmaceuticals said in a filing to the Bombay Stock Exchange (BSE).

This acquisition will help in extending and enhancing the company’s OTC product range, according to a statement by the company. Elder Pharma said that Max Healthcare would be a subsidiary of NutraHealth Ltd and it would be managed in parallel with its subsidiary, Brunel Healthcare Manufacturing Ltd.

Venus secures Japanese patent for Elores, an antibiotic to fight superbugs

Elder Pharma acquires UK based OTC firm

Editor’s Pick 19Special Focus: Roundtable M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

Will IT tools bridge the gap in pharma education?

The future of education in pharmacy in India is at the brink of adopting advance curriculum and next-generation system of delivering

quality education and exposure to the students. Government and educationists need to revamp the existing infrastructure by

incorporating new IT tools to create a world-class education curriculum that drives the entire machinery on the right path.

macy in India is at the brink ofThe future of education in pha

Information technology has the potential to bring positive changes and fill in the void and lapses in skill development through innovative software and improved linkages between the various pillars of advanced

education system. However, a cautious and gradual approach is needed to reap the best from it.

takeEditorial

nformation technology (IT) has revolutionised the working practices and operational procedures in almost all the corporate sectors and pharmacy is not an exception to it. Pharmacy, like any other professional stream calls for regular upgradation of knowledge

and staying abreast of the relevant recent innovations. Medical sciences are developing at a faster rate because of proliferation in research activities. In a developing country like India, where we lack enough resources to dispense medical knowhow, IT can play a pivotal role in spreading the pharmaceutical sciences through virtual space.

Also, the convergence of pharmacy sciences and information technology has led to new vistas of medications, where human intervention has been reduced to minimal and automatic/mechanised aspects of treatment that have come to fore. Networking amongst pharmacy service providers is also an area, where IT is poised to play a predominant role in the times to come.

While, prominent global pharma chains are opting for franchisees in emerging markets, IT is now advancing to become capable of diagnosing diseases in the preliminary stages of their evolution, thereby raising possibilities of taking remedial actions on a timely

basis. In view of all these aspects, it can be stated that IT is bound to play a major role in developing

the pharma skills through virtual space.

he pharma industry has always relied on information systems and data analysis as a part of the regulatory approval process. With the exponential rise in population, the scope and usage of healthcare data is changing radically. For example, the patient records held in

Electronic Medical Record (EMR) systems are a vital source for clinical trials and research. CSC is closely working with the University Hospital, Southampton,UK to extract and analyse clinical data for this purpose.

Moving beyond traditional models of data, ‘Big Data’ techniques, applied for in-depth and significantly broader gamut of available patient data are becoming an important part of the therapeutic process itself. Data analysis is being used to identify requirements, design therapies and predict medical needs. Pharma companies will move beyond creating ‘blockbuster’ medicines, applicable to large populations and begin to deliver personalised therapies.

With the volume and velocity of data involved, we believe it is impractical for all different organisations involved to maintain their own discrete data sets. We believe that the rise of global health data brokers providing access to population health data in a virtual space, offered as-a-service will eventually be the way forward. With pharma companies focussing

on the development of therapies and not the maintenance of information systems, we foresee analytics being provided as-a-service.

he Indian system of pharmacy education lacks focus on curriculum revision and improvement. The existing curriculum is old and not updated as per the current industry trends. The lack of practical orientation and training makes it difficult for the students to keep

pace with the changing trends of the industry. Practical education imparted in pharmacy colleges is limited only to a fixed number of laboratory experiments, most of which have little or no relevance to the current industry practices. IT can help bridge this gap by offering quality training modules in the pharmacy education space. There is a dire need to upgrade and modernise the curriculum, while bearing in mind the latest developments in the pharmaceutical industry.

The pharmaceutical education today needs a new outlook and fundamentals have to be consistent with the emerging technology. There is an immediate need to acquaint the students with the latest trends in industry automation like laboratory management solutions (LIMS), resource planning and business management systems (ERP), customer relationship management systems

(CRM), sales force automation solutions (SFA) etc. It is important for the pharmacy graduates to understand, update and maintain pharmacy

information systems through query, report, and use and analyse the data.The students also need to be exposed and taught about the

latest regulatory systems, validations, clinical research, quality assurance, quality control and R&D

related activities.

ndeniably for the appropriate nexus between various pillars of advanced education system, IT is what we can bank upon. With continuous upgradations in the software arena and evolving innovative technologies devised by masterminds, the evolving technology sector has tremendous

potential to fill in all lapses and lacunae with regards to skillsets of an individual.With IT in limelight now, the existing syllabus needs to be modified periodically,

to be at par with the rising demands and expectations from industry and other institutions. The academic system also lacks skilled industry representatives with acumen for various industry oriented jobs that include IT managementA need to introduce in-house practical training curriculum with some monetary benefits and soft tools exists.. Also, state pharmacy councils do not conduct recognised entrance exam or provide facility for continued pharmacy education for registration to join the profession. While on the other hand, the students-industry-regulatory interaction is also not at par to provide an insight to the pharmacy graduates. Pharma education

sector also lacks in adequate sponsorships/scholarship programmes from the industry for the meritorious students. The technical teaching modes are not in

frequent use by the teaching staff, especially in government institutes. Above all, the newly graduated students lack entrepreneurship skills that hamper

the innovation quotient, as these students are under psychological

feeling of unemployment.thsb

Dr Monica GulatiDean, Lovely Professional University

Narendra NayakDirector & Account General Manager, CSC India

Shyamal KalaniVP-Business Development, Oasis Test House Ltd

Dr Dhanlakshmi IyerDirector, Lateral-I Consulting

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Nikunj [email protected]

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Novartis AG sells 1.42 per cent stake in Indian arm for ` 25 croreSnippets

Drug firm Novartis India recently said its parent Novartis AG has offloaded 1.42 per cent stake in it through open market for a consideration of over ` 25 crore to meet market regulator, SEBI guidelines.

The company’s parent Novartis AG has sold 4,54,205 shares in the company for a total amount of ` 25.45 crore, Novartis India said in a filing to BSE. After the sale, Novartis AG will have 75 per cent stake in the Indian entity.

As per SEBI’s minimum public shareholding norms, all private sector listed

companies need to have at least 25 per cent public shareholding and promoters have been asked to lower their stake to 75 per cent or below by June, 2013.

To help companies comply with the new public shareholding norms, SEBI last year created two new routes, Offer for Sale (OFS) and Institutional P l a c e m e n t P r o g r a m m e ( I P P ) . The regulator also allowed companies to use rights and bonus issue routes to enhance public holding.

The Foreign Investment Promotion Board (FIPB) has cleared seven FDI proposals in Indian pharmaceutical companies. According to reports, FIPB deferred three cases on concerns of ownership control. “FIPB has considered all the applications and taken decisions on merit,” the Finance Ministry stated.

The FIPB is headed by Arvind Mayaram, Secretary, Department of Economic Affairs. Thirty Foreign Direct Investment (FDI) proposals were being discussed, including 10 from the pharma sector.

FIPB clears seven pharma FDI proposals

Contents

In Conversation With David Malinas

Vice President and General Manager, Global Chemicals Business, Thermo Fisher Scientific

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18.Senior Editor: Manas R BastiaPrinted at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition.*Ownership of this magazine stands transferred from Infomedia18 Ltd (Infomedia18) to Network18 Media & Investments Ltd (Network18) in pursuance of the scheme of arrangement between Network18 and Infomedia18 and their respective shareholders and creditors, as approved by the Hon’ble High Court of Delhi and the necessary approval of Ministry of Information and Broadcasting is being obtained.

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5 Editorial / Guest Editorial6 News, Views & Analysis24 Projects25 Tenders 26 Event List

27 Book Review28 Products29 Marketplace30 List of Products

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HR practices in pharmaFocussing on employee empowerment and retention 15HR challenges in pharma Cap the talent gap! 16Pharma education Is it time to redesign the current curriculum? 17

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Strategy The sales drivers: All it takes to be an MR 22Tips & Tricks Affordable and sustainable packaging solutions for pharma SMEs 23

Pharma packaging Child-resistant and senior-friendly packs: A total contradiction? 21

Interface Aditya Narayan MisraPresident - Staffing, Randstad India 18Roundtable Will IT tools bridge the gap in pharma education? 19

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Special FocusHR in pharma

Facility Visit

Insight & Outlook

5EditorialA convergent strategy

oday, the life sciences industry appears to be standing at its crossroads. The

way ahead depends a lot on how it reengages itself with fast-evolving global healthcare systems. Many megatrends such as ageing populations, a growing demand for accessible & affordable quality healthcare and a rise in the prevalence of chronic lifestyle diseases are reshaping the healthcare sector like never before.

Apart from coping with an array of challenges that include patent expiries and revitalising R&D among others, the life sciences industry would do well by addressing the rapidly changing needs of the healthcare landscape worldwide. In the new paradigm, healthcare ecosystems can focus on delivering greater value rather than mere volume and reward better outcomes at the same or lower costs. Moving forward, the interests of the life sciences industry would be served well by having a good convergence with those of healthcare providers and

payers by virtue of increasingly integrated business and delivery models.

The vision of accessible and affordable quality healthcare can be realised by redesigning the care from the patient’s perspective. It is important to note here that the new patient-centric (rather than the provider at the core) healthcare systems calls for a fresh approach from the life sciences industry.

Amid this significant transformation, the next role of life sciences organisations will be one from a traditional supplier to that of a solution provider. It will involve multiple partnerships with key stakeholders to deliver sustainable long-term value to payers and patients alike and will also drive superior returns for shareholders. This is according to a new report by KPMG’s Global Life Sciences practice. Titled, ‘More than Medicine’, the report identifies emerging opportunities for the industry to use its talents, scale and data to partner with healthcare systems to support transformative change and create new growth opportunities for the sector.

Further, this report highlights specific avenues for life sciences organisations to partner with healthcare systems. These include strategies such as improving patient outcomes and lowering healthcare costs by taking on risk-sharing agreements, optimising information technology architecture and leveraging existing data to uncover actionable insights on patients, healthcare professionals or the behaviour of payers and providers.

Finally, the report outlines three crucial strategies for the life sciences industry to consider as the next stage of co-evolution with the healthcare sector. These include understanding customers and their needs, reshaping R&D to provide reimbursable drugs & devices that deliver shareholder value and anticipating shifting power structures in the wider healthcare ecosystem. Now, it is for the industry to take the next step.

[email protected]

Excipients: The hidden challengers for times ahead

t the core of the pharmaceutical industry, is the capability to provide new drug formulations and Active Pharmaceutical

Ingredients (APIs) that cure or prevent the disease or medical conditions. The subtle role of excipients in the formulation of medicines during manufacturing and the disbursement of APIs, when consumed for the immediate effect in any treatment cycle lies hidden.

Excipient by definition is a pharmacologically inactive substance, which when formulated with API produces a dosage (medicine) that is easy for human consumption. Traditionally, excipients are polymers of various chemistries, which act in various ways like binders, fillers, disintegrating agents, coating agents, release profile managers and many more.

With advancements in the pharmaceutical formulation industry backed by superior technology and other key drivers like patient compliance, the excipient industry evolved with increasing focus on performance, higher expectations on deliverables and the need to comply with stringent regulatory norms.

The advancements in excipient technology are a result of research in the

formulation area and superior drug delivery systems being invented. With the increasing onus on excipients, came an increasing responsibility in the form of regulatory compliance. International pharmaceutical bodies started monitoring excipients more stringently for compliances. Food and Drug administration (FDA) and International Pharmaceutical Excipients Council (IPEC) laid down norms, which were required to be complied not just by the pharmaceutical companies but also by excipient producers.

From a simple pharmacopoeial compliance, the excipients were now required to fulfil Quality by Design (QbD) demands.

So how do excipient manufacturers gear up to meet the advanced industry demands? Being amongst the pioneers of the excipient technology globally, Dow Pharma and Food Solutions provides advanced technology solutions to support the industry’s growing demand. Complying with international regulatory requirements, Dow products have been used by the pharmaceutical industry for decades. Excipients solutions with METHOCEL™ (methylcellulose), ETHOCEL™ (ethyl cellulose) and POLYOX™ (water soluble resins) have provided major industry technology shifts like

drug solubilisation aids, film forming technologies , OROS technology (osmotic pump), hot melt extrusion and matrices.

The industry did not see any new or path breaking excipients being introduced in the market during the last few years. All new introductions were either extensions of the existing excipients or a combination, which is becoming increasingly popular as co-processed excipients. One of the primary reasons being the stupendous work, resource and investment that goes into an excipient discovery along with the cumbersome regulatory compliance needs that have to be met with.

This is where the important role of major excipient suppliers comes into play. Companies not only have the responsibility of bringing in new excipients backed with superior technology but also work in close co-ordination with pharmaceutical companies to understand their needs and tailor research on those lines.

From a simple immediate release dosage to an advanced technology in the area of drug solubilisation, modified release and extrusion, the role of an excipient has evolved from being a mere additive to that of a major partner in the formulation arena.

Guest Editorial

EDITORIALADVISORY BOARD

Ajit SinghChairman,

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

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

T

A

Prashant ChitgopekarDeputy General Manager,

Pharmaceuticals, Dow India

Manas R Bastia

6 News, views & analysis M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

Astex Pharmaceuticals to submit IND Application for ASTX727

In Brief

Astex Pharmaceuticals has voiced plans to submit an Investigational New Drug (IND) application to the FDA for ASTX727, a novel oral Hypomethylating Agent (HMA) in the fourth quarter of this year. The new drug candidate is intended as a fixed dose oral combination product consisting of decitabine and E7727, a novel Cytidine Deaminase Inhibitor (CDAi) licensed from Eisai Inc. ASTX727 allows for an efficient oral delivery of decitabine at low doses.

The profile of E7727 is expected to result in low inter-patient variability across doses of decitabine with little or no gastrointestinal safety issues. Later this year, preclinical data on ASTX727 will be submitted for presentation at a scientific meeting. James S J Manuso, CEO and Chairman, Astex Pharmaceuticals commented, “We are pleased to announce that ASTX727, in the late pre-clinical stage of development, becomes the third product in our epigenetic franchise that began with DACOGEN® (decitabine) for injection. This franchise includes SGI-110, expected to enter Phase-III clinical trials in 2014. The role of HMAs, in a wide range of therapeutic indications, is just beginning to be understood. ASTX727, potentially a best-in-class oral HMA, will be an important addition to our portfolio of medicines in clinical development.”

enadryl® DR, a new variant for dry cough was launched by Benadryl. Benadryl®

DR Dry Cough Active Relief contains an ingredient that exclusively targets dry cough and soothes an irritated throat, in a sugar and alcohol free mentholated base, without causing unwanted drowsiness. With this new innovation, the brand aims to help consumers decide on the right medication and attain relief, with the right solutions based on their specific cough symptoms.

At the launch of the new Benadryl® variant, Tushar Murdeshwar, Vice President – Marketing, Consumer Division, Johnson & Johnson Ltd, said, “With the launch of the new suppressant Benadryl® DR Dry Cough Active Relief, Benadryl® has further cemented its presence as an expert in the cough category. After the launch of Benadryl CR (Congestion Relief) variant last year, we have launched Benadryl® DR Dry Cough Active Relief, as we felt the need to address the lack of awareness about specialist solutions for different types of

cough. As a cough expert, it is our endeavour to constantly provide appropriate solutions to those suffering from any kind of cough.”

Dry and wet cough have different causes and symptoms. A dry or non-productive cough does not release phlegm or mucus while coughing, whereas a wet or productive cough releases phlegm while coughing. Both types of cough have equal incidence but there is a lack of awareness about the need for specific solutions for each. This calls for a clear segmentation in the cough category, as the remedy

for wet cough cannot work for dry cough and vice versa.

Wet cough requires relief from congestion by expectoration of phlegm whereas a solution for dry cough requires suppression of the cough centre in the brain and a soothing action for the irritated throat. An ideal solution should be non-drowsy and should not cause loss of productive hours, whether at home or at the workplace.

The new product, Benadryl® DR Dry Cough Active Relief, is available nationally, across leading pharmacies in pack sizes of 50 ml and 100 ml.

Benadryl launches DR Dry Cough Active Relief

US, EU slowdown to stagnate pharma export growth rate at 10%

B

harmaceutical exports from India is expected to remain in the range of 10 to 11 per cent

in the current fiscal, as a result of slowdown in some of the key markets such as North America and Europe, thereby raising an alarming concern to exporters, a senior government official said.

P V Appaji, Director General of Pharmaceuticals Export Promotion Council (Pharmexcil), under the Ministry of Commerce and Industry said, “Most of the Indian pharma exporters have secured Written Confirmation (WC) certificates from the Drug Controller General of

India (DCGI) well in time to meet the new European Union (EU) regulations on Active Pharmaceutical Ingredients (API) imports.”

“This year, there is a slowdown (in some markets). We are looking anxiously. We will have to still ascertain the position. More or less it (pharma exports growth) can be in the same range. The exact position would be clear in the next few days,” Appaji added.

The growth of Indian pharma exports during 2012-13 halved to 10.55 per cent over previous year to $ 14.6 billion. During 2011-12 the exports stood at $ 13.2 billion

registering a growth of 23.7 per cent over 2010-11.Major markets for Indian pharma exports, the US and Europe underperformed during FY’13 causing a big dent to exports.

While exports to North America grew 13.44 per cent to $ 4 billion, exports to Europe grew marginally by just 1.2 per cent to $ 2.63 billion. A year ago, exports to North America and Europe registered a growth of 33 per cent and 30 per cent, respectively. The European Medicines Agency (EMA) in its directive said, effective 2 July 2013, all active substances manufactured outside EU and imported into the EU

must be accompanied by a WC from the competent authority of the exporting country.

The concerned authority would confirm that the standards of Good Manufacturing Practice (GMP) and control of the manufacturing plant are at par with those in the EU. In case of India, DCGI is the competent authority to issue WC, Appaji said.

“DCGI is the notified competent authority for certification of goods. Pharmexcil has followed up with the DCGI in preparing guidelines and circulating it to member companies,” Appaji stated.

P

7M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3News, views & analysis

GlaxoSmithKline to introduce tablet versions for Eno brandGlaxoSmithKline Consumer Healthcare is planning to introduce liquid and tablet versions of its Eno brand. “The liquid and tablet formats represent 55 per cent of the total digestive antacid market

in India and we were not there,” said Jayant Singh, Executive Vice President, GlaxoSmithKline Consumer Healthcare.

Reports claim that the digestive antacid market in India is estimated at

` 800 crore, of which powders constitute about 45 per cent. GSK has cemented its position with Eno powder and has a 41 per cent market share, added Singh.

ovartis has inked licensing and development agreement with

Biological E Ltd (BioE), a biopharmaceutical company based in India, for two vaccines to protect against typhoid and paratyphoid fevers. The agreement advances the Novartis’ goal to deliver accessible and affordable vaccines that address unmet medical needs in endemic regions.

Within a short span of five years, the Novartis Vaccines Institute for Global Health (NVGH), part of the Novartis Institutes for BioMedical Research, has developed a typhoid vaccine with funding from the Fondazione Monte dei Paschi di Siena and Regione Toscana through the Sclavo Vaccines Association (Italy). In addition, a dual-acting vaccine with components against both typhoid and paratyphoid

fevers is being developed with on-going support from the Wellcome Trust. Both could reduce the burden of these diseases in endemic regions.

Don Ganem, VP and Global Head of Infectious Diseases, Novartis Institutes for BioMedical Research said, “NVGH uses its innovative know-how to tackle important problems in public health. BioE has a proven track record in vaccine manufacturing, and capabilities to clinically develop and deliver WHO pre-qualified affordable vaccines to the developing world. We are pleased to be working with them to address this unmet need.”

Under the licence, NVGH will transfer technology to BioE, which will have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world. The typhoid vaccine (Vi-CRM197) has

achieved proof of concept, had successful Phase 2 results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine will be transferred once Proof of Concept is completed through early, small-scale studies in humans to determine safety and immunogenicity. The Wellcome Trust continues to support the development of the dual-acting vaccine through a Strategic Award that was awarded in 2009.

Ted Bianco, Director of Technology Transfer and Acting Director of the Wellcome Trust informed, “Typhoid and paratyphoid are major causes of life-threatening diseases worldwide and with the emergence of resistance to all of the commonly used antibiotics, they are becoming increasingly difficult to treat. This licensing deal takes us a step closer to getting much-needed affordable vaccines into the communities that need them the most.”

otwithstanding high-base of the previous year, the domestic formulation industry

is expected to grow by 10-12 per cent in 2013-14, which will mostly be driven by generic opportunities in the US, according to rating agency, Indian Credit Ratings Agency (ICRA).

While growth momentum in the domestic formulation industry slowed down in 2012-13 owing to several reasons. ICRA believes that the industry would revert to its long-term growth trajectory in the medium-term as ‘structural growth drivers continue to remain impervious.’

The growth momentum has picked up over the past few months with pricing policy related matters sorted to some extent, ICRA expects the industry to return to a growth of 10 to 12 per cent in 2013-14. The impact of new Drugs Price Control Order (DPCO) though expected to be limited, could also get offset by volume expansion and efforts of industry participants to take price hike in rest of the portfolio, according to the report.

In Europe, the performance of Indian companies improved in 2012-13 in comparison to

the previous year, primarily led by new product launches which helped to offset the impact of pricing pressure.

“However, given the pace of healthcare reforms and the way competitive landscape is changing in Europe, the performance of generic companies would remain contingent on new product introductions,” the report said. As many of the European markets are gradually shifting character from being ‘branded generic’ to ‘un-branded generic’ and from being ‘physician-influenced’ to ‘payer-influenced, a relook at business plans also appears to be a common theme across companies.

Generics companies are increasingly focussing on expanding presence in relatively under-penetrated markets such as France, Spain and Italy, branded generics markets of East Europe and niche areas like complex generics, OTCs etc.

In general, domestic pharma companies generate a relatively lower share of revenues from Europe with subdued profitability as in comparison to other markets. Additionally, US generics present one of the promising growth opportunities for Indian pharmaceutical companies.

Novartis inks deal with Biological E to provide vaccines for paratyphoid A and typhoid fever

Domestic formulation industry to see 10-12% growth in 2013-14: ICRA

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rexo has received FDA approval for Zubsolv™ (buprenorphine/

naloxone) sublingual tablet CIII, which is indicated for use as a maintenance treatment for individuals suffering from opioid dependence. It should be used as part of a complete treatment plan to include counselling and psychosocial support. Zubsolv™ is a once-daily, sublingual tablet with an advanced formulation of buprenorphine and naloxone that fully dissolves within minutes. Compared to other buprenorphine/naloxone

treatments, Zubsolv™ has higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste. Zubsolv™ will be launched in September by Orexo US, Inc and its partner Publicis Touchpoint Solutions.

Opioid dependence affects nearly 5 million people across the US. Although, it is a treatable condition, only 20 per cent of Americans suffering from opioid dependence receive treatment today.

Speaking on the development Nikolaj Sørensen, President and CEO, Orexo AB said, “Orexo has developed Zubsolv™ as

a novel sublingual therapy meeting the needs of millions of patients who suffer from opioid dependence to offer them a new choice of treatment. Zubsolv™ has in previous studies showed a high acceptability compared to the leading treatment modalities in the market. We expect it to be well received by patients and prescribers, and we anticipate a peak market potential of at least $ 500 million. The approval of Zubsolv™, which is based on our advanced formulation capabilities and developed using our proprietary technology, is a great tribute to the world class pharmaceutical formulation

team at Orexo.” This is the third product from the Orexo stable being approved in the US, with the formulation expertise of the company’s R&D department in Uppsala.

Opioid dependence greatly impacts the US economy, with about $ 56 billion spent on the disease every year. In addition, the average healthcare cost per patient with opioid dependence is eight times higher in comparison to the non-dependent patients. There is also a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the US every year.

Orexo receives FDA approval for Zubsolv™

or protection of solid pharmaceutical products against humidity, light and oxygen laminates with aluminium are

used. In case of blister, a laminate with BOPA/Al/ sealing layer is used. Sealing layer mainly is PVC film. Besides PVC polyethylene and polypropylene are used.

Ansapack is producing this laminate in India, using imported raw materials. In India PVC film 60-micron is available but the price is same as imported from Europe, with comparatively poor quality. Reduction in weight of the laminate is increasing the yield and reduces cost of the laminate. Reduction of thickness of sealing layer in addition, results in higher barrier related to cross migration of oxygen, water vapour and other gasses. Formability of laminate is the same as with 60 or 100 micron PVC film; it is not reduced by reduction of thickness of sealing layer. Because of same material for sealing layer (100, 60 and 30 micron PVC) no influence for seal integrity (170 °C, 0.5 sec, angle of opening 180° è > 7 N/15 mm).

Besides barrier and for sealing to lid foil, sealing layer is responsible, together with aluminium, for stiffness / dent resistance of the formed material. Besides the 19 per cent more material related to same weight, further savings are possible because of higher yield. For Panblok 30 PVC, as for all other of Ansapack packaging materials, all used raw materials confirm to the USFDA (filed in its DMF) and regulation of European Pharmacopeia. The Panblok 30 PVC offers significant reduced cross migration, 50 per cent of water vapour and gasses through sealed seam, increased efficiency of blister machine, saving space in stock of packaging material and reduced cost of transportation.

mpax Laboratories, Inc has confirmed initiation of a challenge with regard to the patents listed in the Orange

Book in connection with TOVIAZ® (Fesoterodine Fumarate extended-release tablets, 4 mg and 8 mg). The company filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of OVIAZ® with the USFDA.

Last month, Pfizer Inc and UCB Pharma GmbH filed suit for patent infringement against Impax in the US District Court for the District of Delaware. This action formally initiated the patent challenge process under the Hatch-Waxman Act.

Once the ANDA is approved by the FDA, the generic division of Impax, Global Pharmaceuticals intends to commercialise the product. TOVIAZ® reduces spasms of the bladder muscles and is used to treat overactive bladder with symptoms of urinary frequency, urgency and incontinence. According to IMS Health, US sales of TOVIAZ®, 4 mg and 8 mg were approximately $ 159-million for the year ended May 2013.

Panblok® with low-cross migration for protecting solid pharmaceutical products

Impax Laboratories confirms challenge with regard to generic TOVIAZ® 4 mg and 8 mg

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UK issues import alert on Wockhardt’s plantDrug firm, Wockhardt recently confirmed that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has imposed an import alert on its export-oriented unit at Waluj, Maharashtra.

Commenting on the development, Habil Khorakiwala, Chairman, Wockhardt said, “We have been issued an alert by MHRA. We would be shifting the manufacturing of products from Waluj to

another facility, thereby minimising the impact of the alert.”

The Waluj facility makes injectables and solid dosages. Earlier in May, an import alert was also issued by the US health regulator on

the same manufacturing facility. USFDA has also imposed an import alert on one of the company facilities at Waluj, near Aurangabad. The company estimates that this would impact business by $ 100 million annually.


any desperate and poor people in India are unwittingly taking part in clinical trials for drugs by Indian and multinational

pharmaceutical companies that outsource the work to unregulated research organisations. Testing pharmaceuticals on humans is mandatory and expensive step for drug companies who must prove to regulatory authorities that treatments have no dangerous side-effects in order to bring them to market.

The Confederation of Indian Industry (CII) estimates that companies save up to 60 per cent by undertaking the different phases of testing a new drug in India as compared to developed countries.

The clinical research market in India grew by 12.1 per cent in 2010-11 with revenues of $ 485 million, according to a report by Frost and Sullivan, a global business research and consulting firm.

The study, released in July last year, projected the industry to reach the one-billion dollar mark by the end of 2016.

DA has accepted Roche’s Biologics License Application (BLA) for obinutuzumab (GA101) and granted priority

review for GA101 in the treatment of Chronic Lymphocytic Leukemia (CLL), one of the most common forms of blood cancer, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. This acceptance follows the GA101 FDA breakthrough therapy designation that was received in May 2013.

Hal Barron, MD, CMO and Head, Global Product Development, Roche said,“We are excited that the FDA has granted GA101 in CLL both breakthrough therapy designation and priority review. These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame.”

The FDA is evaluating data from the pivotal Phase III CLL11 trial, which found that GA101 demonstrated a statistically significant 86 percent reduction in the risk of disease worsening or death (HR=0.14, 95 per cent CI 0.09-0.21, p<0.0001) when combined with chlorambucil compared to chlorambucil alone in previously untreated people with CLL and co-existing medical conditions. In CLL11, no new safety signals were detected for GA101. The most common grade 3-4 adverse events (AEs) for GA101 were Infusion-Related Reactions (IRRs) and low cell count of certain white blood cells (neutropenia), which did not result in an increased risk of infection. The incidence and severity of IRRs decreased after the first infusion and no grade 3-4 IRRs have been reported beyond the first infusion.

Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Association (EMA) in April 2013.

assault Systèmes, a world leader in 3D design, 3D digital mock up and Product Lifecycle Management

(PLM) solutions, recently announced the launch of a new industry solution experience for pharmaceutical and biotech companies, ‘Licensed to Cure for BioPharma.’ Based on the company’s 3DExperience platform, the new solution transforms the way biotech and pharmaceutical companies manage product and process complexity by smoothing drug variation, enabling easier and faster expansion into new markets, all while managing increasing regulatory requirements.

In an environment of expiring patents, more stringent regulations and increased development costs, companies are increasingly turning to drug variations to drive growth. With one active pharmaceutical ingredient yielding as many as 1,000

finished products, a biopharmaceutical company must have a business platform that not only manages product knowledge complexity, but also simultaneously drives collaboration, innovation and compliancy.

‘Licensed to Cure for BioPharma’ boosts compliance strategies and creates a structured approach to manage product and process complexity, resulting in faster delivery of product variations to new markets. With the holistic view of all product-related information, pharmaceutical executives can analyse changes independently of their organisational origins in order to make fully informed decisions in strategic context. It results in global operational efficiency improvement, including maximising supply chain opportunities and enforcing efficient and compliant execution.

“The pharmaceutical industry is facing significant pressure to perform

and deliver new therapies that provide strong returns both financially and efficaciously. When dealing with product variants, companies are typically resistant to change given the regulatory implications and significant potential added cost. The ability to visualise a comprehensive holistic view of the full product portfolio is incredibly valuable. Systematically analysing the likely impact of proposed changes prior to investing time and money, has the potential to deliver valuable insights to management that are not available today,” said Alan Louie, PhD, Research Director, IDC Health Insights. “This approach to product management is much more than just expanded traditional information management. It is a cross-industry best practice that requires full organisational buy-in starting at the CEO and extending all the way to the lab bench.”

India’s poor ‘duped’ into clinical drug trials

FDA accepts Roche’s biologics licence application for obinutuzumab

Dassault Systèmes introduces new solution to reduce product and process complexity

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s the red tapism in India is at its bloom, India’s ` 1 lakh crore worth pharmaceutical industry is in peril with

most pharma companies shifting the research and development (R&D) operations and clinical trials to South-East Asian countries of Cambodia, Korea, Philippines, Singapore, Thailand, Vietnam and others, according to a recently conducted survey by apex industry body The Associated Chambers of Commerce and Industry of India (ASSOCHAM).

“Various South-East Asian countries are wooing India’s R&D industry by offering sops and transparent regulations. As regulatory bottlenecks and a plethora of committees have slowed permissions/approvals for trials or marketing drugs to more than 12-15 months back home in India, with such

permissions being granted by the USFDA, EU and Singapore within a month’s time,” according to a survey of Indian pharma industry conducted by ASSOCHAM.

The industry body interacted with about 250 top officials and representatives from India’s pharma industry based out of five states of Andhra Pradesh, Gujarat, Karnataka, Maharashtra and Tamil Nadu between March-June, 2013 to ascertain and seek a solution to their concerns and problems.

“The Gazette Notification (No: GSR 53 (E) dated January 30, 2013) issued by the department of Health, Ministry of Health & Family Welfare (MoHFW) has put a ‘full stop’ to the R&D in India, triggering serious concerns amid entire pharma industry,” said majority of the industry representatives interviewed by the ASSOCHAM.

“This notification is not in line with the established international standards and is likely to have a cascading effect on the future of clinical trials in India, as the flaws in the gazette could negatively impact the future growth of R&D as well as the development of low-cost high-quality medicines in the country,” ASSOCHAM spoke on behalf of India’s pharma majors in a communication addressed to the Prime Minister, Dr Manmohan Singh.

The South-East Asian countries are emerging as a preferable destination for India’s pharma companies to expand their business, as they share similar patient population and disease profile. Also, they have conducive environment for their operations such as easy market approach without any regulatory uncertainty, the ASSOCHAM survey highlights.

Indian pharma companies shifting their R&D operations overseas

ayer HealthCare has begun to enroll children in an international Phase-III trial to evaluate its investigational

compound, BAY 94-9027 for the treatment of hemophilia A, after completing the enrollment of adult individuals with hemophilia A into the PROTECT VIII trial. The PROTECT VIII Kids trial is designed to investigate whether BAY 94-9027, a recombinant human factor VIII (rFVIII), can be used prophylactically to prolong duration of protection from bleeding events for up to one week, while also being used to treat acute bleeds.

Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development said,“Children with hemophilia and their parents can find the frequent infusions associated with a prophylactic treatment regimen as a significant burden. It is this understanding that drives us at Bayer to develop new and innovative molecules like BAY 94-9027.”

BAY 94-9027 has been designed to extend the circulating half-life of rFVIII activity through site specific attachment of a Polyethylene Glycol (PEG) polymer to the light chain of the rFVIII molecule, while preserving its full biologic activity.

ith hardly any drug maker coming forth to prove safety and efficacy of ‘new drugs’ introduced in India without

proper approval, the country’s apex drug regulator, the Drug Controller General of India (DCGI) has asked all such manufacturers to apply before August 30 or face prohibition of the drug.

The deadline comes after makers of Fixed Dose Combinations (FDCs), who got approvals from state licensing

authorities without prior clearance of the drug controller, failed to apply for proving the safety and efficacy of the drugs.

In January 2013, DCGI had asked all makers of FDCs, who got manufacturing licences from states without proper approval, to prove the efficacy and safety of such drugs within a period of 18 months, failing which such FDCs would be considered prohibited for manufacturingand marketing in the country.

“So far, hardly any such manufacturer has approached the Central Drugs Standard Control Organisation (CDSCO) to prove the safety of such FDCs,” the drug controller said. In view of this, the DCGI has decided that applications for such FDCs should be submitted latest by August 30, so that they can be processed in a timely manner.

The applications will be examined by expert committees set up by the regulator and then cleared by the DCGI.

Bayer begins Phase III study on its investigational compound, BAY 94-9027 for the treatment of hemophilia A

DCGI asks drug manufacturers to get clearance before August 30

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erck has entered into an agreement with Greenpharma SAS for cosmetic active ingredient, poppy seed extract. As per the terms of the

agreement, Merck will market the active ingredient globally under its umbrella brand RonaCare® as of September 2013. Additionally, Merck is responsible for sales, logistics and application technology customer support. Poppy seed extract is a skin-firming substance with a dual mechanism of action.

Michael Weiden, Head of Functional Materials, Pigments and Cosmetics business unit explained, “We are a leading manufacturer of cosmetic ingredients and the course clearly continues to be set for growth in this area. We will continue to augment our innovative portfolio derived from in-house research and development by cooperating with external partners. Compliance with Merck quality standards is a most important precondition.”

Natural poppy seed extract displays lipolytic activity via a dual mechanism, both by inhibiting lipogenesis and by activating lipolysis. The researchers at Greenpharma have proved that the active ingredient inhibits the build-up of fat by reducing G3PDH activity (glycerol-3-phosphate dehydrogenase) in the fat cells. At the same time, it activates lipolysis by enhancing the release of free fatty acids.

As a result, poppy seed extract is particularly suited for use in anti-cellulite body care products. The skin-firming effect of the substance can also be put to use in other applications, for instance to give facial skin a smoother and more even appearance.

“This agreement does illustrate Greenpharma’s capability to conduct R&D projects from a robust scientific basis to an active ingredient ready for the market,” stated Philippe Bernard, Chief Executive Officer, Greenpharma.

ale of tuberculosis (TB) drugs could be prohibited in the open market as part of the efforts to ensure calibrated and monitored administration

of these medicines, which would then be given only on daily basis, free of cost by the government registered outlets to patients.

The Health Ministry is proposing changes in view of irregularity in administration of these drugs to patients and lack of proper monitoring that is hindering efforts to check the disease, sources said.

According to a World Health Organization (WHO) estimate, India is home to the largest number of TB patients, 2.2 million of the world’s 8.7 million. Patients are administered TB medicines either through government-run hospitals and clinics free of cost or by private practitioners.

According to the Health Ministry, about 65 per cent of the TB patients avail these drugs under the government’s DOT (Daily Observed Therapy) System while the rest, opt for treatment by private practitioners and buy

drugs from the chemists based on their prescription.

The latter result in irregularity of treatment, which may lead to relapse of the ailment, for there is lack of proper monitoring. To address this, the government is planning to prohibit sale of drugs in the open market.

Under this new initiative, patients going to private practitioners for treatment will get medicines free of cost from chemists but only after the doctor informs them through a dedicated call centre, which will be set up by the government.

The changes are being brought to ensure that all TB patients are administered the drugs on daily basis, instead of intermittently as at present. Recently, Health Minister, Ghulam Nabi Azad had expressed concern on the issue saying that the irregular regime is leading to growing resistance to anti-TB drugs.

The Health Ministry officials recently held a meeting with the WHO and other experts, who had emphasised on changing intermittent dosage system to daily regime.

Merck inks deal with Greenpharma for cosmetic active ingredient

Govt may ban sale of TB drugs in open market

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Ipca Labs steps up R&D expenditure to ` 100.74 crore harma firm, Ipca Laboratories Ltd has stepped up its R&D expenditure to ` 100.74 crore in FY’13 from ` 77.96 crore

in the previous year.The company has increased its R&D

expenditure from ̀ 77.96 crore (3.39 per cent of the turnover) in the previous year to ` 100.74 crore (3.68 per cent of the turnover) in the year 2012-13, the company said in its annual report.

The ` 2,797 crore Ipca Labs said it has always considered R&D as crucial for the sustained growth of the company. The company has R&D centres at Mumbai, Ratlam, Athal and Indore.

Ipca Labs has set up a new centre at its Mumbai facility for expanding its formulations R&D activities.

The company is also in the process of setting up a new research centre at Kandivali in Mumbai for biotech research and development activities. It is also in the process of setting up a new R&D centre at Vadodara, Gujarat.

The company has expanded its therapeutic coverage with introduction of new formulations, both in the domestic and export markets, especially in the fast growing lifestyle related segments.

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ROHA, a global leader in natural and synthetic colours for the food and beverage industry, announces a corporate reorganisation and

rebranding initiative designed to streamline service and position the company for future growth.

The company’s new organisation places six divisions under the ROHA umbrella with the corporate mission statement, ‘Innovating

for you. With you.’ These divisions include established entities such as IDACOL (Ultimate Synthetic Colors), NATRACOL (Colors

From Nature), SIMPSONS (Dyes and pigments solutions) and newest divisions ADORA (Cosmetic Colors)

and ESSENZIA (Animal Feed Solutions); and FUTURALS (Nature At Its Best).

The reorganisation enables ROHA’s global customers that manufacture products in multiple industries and/or

countries to streamline their supply chain operations by utilising a single source for a variety of

colour additive needs.

Headquartered in Andheri, Mumbai, India, ROHA’s history of growth is based on continual innovation. The

new rebranding and reorganisation initiative better represents ROHA’s corporate culture of discovery and

development. “We believe innovation is not confined to science and technology-based invention. Yes, we

continue to create new products. But we also develop and refine services, value propositions and

business models that are designed to add value to our customers’ bottom lines,” explains Mahesh

Tibrewala, Executive Director. In a step-by-step process, the company will be rolling out the new

brands and positioning across the company’s global offices, beginning at the Institute of Food

Technologists EXPO in Chicago this week.

The newest division, FUTURALS will offer products that have wide range of brilliant and

stable shades of Coloring Foodstuff & Extracts from fruits, vegetables, herbs, flowers

and algae. The entire range of Coloring Foodstuff & Extracts is sourced in a manner

that maintains the natural and essential characteristics. This Range facilitates

clean labels that consumers of the world look for.

“ROHA’s success is driven by innovation. In a span of four decades,

ROHA has given the industry various new products and processes. The

company has now taken the step to reinvent itself with new logos, a

new positioning line and new branding to better communicate our

philosophy of being committed to innovation,” says Tibrewala.

About ROHAROHA is one of the fastest-growing manufacturers of natural

and synthetic colours with offices in 15 countries. Specialising

in food & beverages, paints, cosmetics and pharmaceuticals,

the company has 11 regional application labs with sales

operations in more than 130 countries. With constant

progressive ideation, continuous improvement and cutting-

edge technologies, ROHA is a leader in providing innovative

solutions and future-ready products to a wide base of global

clients. North American headquarters are in St Louis, MO

USA. Besides Food ingredients, Roha has now invested 70

million USD in diversification in Green Energy by starting

solar plants and harnessing wind mill energy

JJT Group is a holding company of ROHA, which participates

in education, health care, and critical day food programmes

for the under privileged in India.

Global company rebranding corporate image and expands product line

Success Is Driven By InnovationWITH ROHA

14 In Conversation With M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

need to constantly challenge ourselves to do better by our customers.

As far as opportunity is concerned, a highly skilled and intelligent workforce is emerging as an innovation powerhouse that will need the best scientific tools to advance research. Thermo Fisher is well positioned to provide these tools.

How is Thermo Fisher gearing up to leverage the emerging opportunities in India? Our pharmaceutical and bio-pharmaceutical customers in India are competing globally. To meet their compliance standards, they require reliable partners - partners who can assure global quality products at competitive prices. They are looking at reliable vendors who can support them with consistent quality during their scale-up, from the R&D lab, to pilot production, to bulk manufacturing. Our strategy is to offer all this with a mix of locally manufactured and imported products, through a wide network of convenient stock points.

Elaborate on your business focus areas for India. We already have an established brand name here called Qualigens. Apart from that, we have several world-class brands such as Fisher Chemicals, Acros Organics, Fisher BioReagents and Maybridge that focus on different aspects of customers’ needs.

Our focus in India is to strengthen the relationship with our major customers and offer them the complete portfolio of products, to which our other customers across the world have access. Therefore, we continue to invest in our chemicals business in India, especially in the areas of quality assurance, inventory, and back-end infrastructure such as ERP and supply chain.

How are your new state-of-the-art toll site and quality control lab poised to add value to the user industry? We have three state-of-the-art toll manufacturing facilities based near Mumbai to cater to the Indian market. We are involved in monitoring the quality standards right from incoming raw materials to finished products and packaging.

The sites boast of 40 ft high columns for dedicated solvent distillation, filling units and a packaging facility under nitrogen environment for ensuring moisture-free packing for certain sensitive chemicals. Our world-class

Quality Assurance (QA) lab has all the latest equipment and is managed by highly qualified technical professionals operating at global standards.

Tell us about your plans for expansion of new product lines. Innovation is a core value in our organisation. Every year, Thermo Fisher invests nearly $ 400 million in R&D, which is a huge commitment to finding the best innovations that will enable our customers to do their jobs more effectively. Our global chemicals business unit is no exception. We introduce thousands of new catalog products every year that are in line with our customers’ latest research direction. Further, we have the unique capability of collaborating internally with our instrument divisions to ensure that the new products we develop, are designed for the latest applications and intended use.

What are the best practices followed by you to ensure safety of environment and people? Our global chemicals business unit rigorously follows a prioritisation framework based upon Safety Quality Delivery and Cost (SQDC). This means we view safety as our highest priority, followed by quality, then delivery and then cost. Through constant training and audits, we ensure that safety is a way of life at various stages of manufacturing and distribution. With safety as our highest priority, the senior management team reviews a safety scorecard on a monthly basis. This includes visual display of various safety parameters, including environment health safety audit and safety initiatives.

In addition, we have an internal programme called SOOS, which stands for ‘Speak out on Safety,’ which provides a very simple method for all employees in the organisation to submit ideas and concerns on a daily basis. We have very good participation in this programme and it enables us to be proactive in avoiding safety incidents.

Your message to the industry… The global chemicals business within Thermo Fisher has manufacturing, multiple stock-points, and a network of channel partners spread across the world. In India, we are uniquely positioned to support our pharmaceutical customers with extensive reach, choice and convenience that customers are looking out for.

…says David Malinas, Vice President and General Manager, Global Chemicals Business, Thermo Fisher Scientific, who was recently in India. An alumnus of the Harvard Business School, he has a proven track record of delivering substantial impact in an array of challenging roles and environments across the world. In a free-wheeling conversation, he shares his expert views and action plan on the emerging market trends in the Asia-Pacific and especially in India.

A brief take on your India visit...The Asia Pacific (APAC) market is critically important to Thermo Fisher’s growth in the region. Currently APAC contributes to approximately 17 per cent of our revenues and was a major contributor to the company’s organic growth last year. As one of the largest markets in this region, India plays an important role in our Asian strategy.

Our focus in India is to further localise our business to best serve our customers. Therefore, on each of my visits to India, I connect with the customers here, to understand their changing requirements and how we can best serve them. It is important to spend time with the local teams here to align our priorities with the local needs of customers. Finally, I personally walk through the manufacturing facilities to ensure that we are operating at a safety and efficiency level that meets our expectations.

What are the latest market trends in the chemicals and pharmaceuticals space in Asia-Pacific? Chemicals form a large part of our portfolio in Asia, and we supply to all major market sectors such as pharmaceuticals and bio-pharmaceuticals, biotechnology,

academic institutions, government-funded research organisations and other industrial applications. Our pharmaceutical customers here are growing to global scale, by following global quality standards and exporting to the US and EU. Indian

legislation in this sector is also becoming more and more stringent.

As such, our customers here expect world-class products from their chemical and reagent suppliers - right from basic research and drug discovery through to production. So, compliance with global quality standards and supply assurance are key driving factors for our chemicals business.

What are the major challenges and opportunities in Asia-Pacific and especially in India? India is an extremely price sensitive market where customers demand high quality with quick deliveries. A large presence of local manufacturers increases competition in the region. This means we

Our focus in India is to further localise our business

Manas R [email protected]

As far as opportunity is concerned, a highly skilled and intelligent

workforce is emerging as an innovation powerhouse that will

need the best scientific tools to advance research.

15M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3Special Focus

he Indian pharma growth story has been a reflection of the country’s fiscal success

in the recent past. The stage is set for the Indian pharmaceutical industry to reach a new level in the global marketplace. With continuous evolution, remodelling and reshaping of trends in the pharma industry, the Human Resource (HR) needs in the sector have undergone a sea change.

Companies are regularly reviewing and reevaluating their HR policies. New skill sets, effective leadership, better strategies, reinforcing regulatory coherence at international levels, right reward plans will sustain the health of this market going forward.

In pharma, skilled manpower is a prerequisite in sectors such as regulatory affairs, R&D, sales and marketing and intellectual property management. The industry’s ability to maximise opportunities, depends on assessing talent needs and identifying the required skillsets.

Dheeraj Aggarwal, CFO and Vice-President, HR Department, Venus Remedies Ltd elucidates, “Earlier, the role of HR professionals mainly involved recruiting talent, but today it is more about retaining it. Today, HR professionals need to have thorough knowledge about the business and human resource functions, including new innovations and problem-solving skills. The management has to team up with business leaders to ensure the company’s growth and productivity, the pharmaceutical industry being no exception.”

Some of the unique HR practices being followed by companies in the Indian pharmaceutical sector include employee empowerment, stock ownership, creativity, innovation and continuing education policy. Now, the main focus of HR departments in pharma companies is on maintaining work-life balance, managing talent and enhancing competency. Performance management tools, compensation management and diversity management are other key focus areas of these companies.

While scientific and economic creativity and willingness to experiment will create a thriving atmosphere for growth and create value addition, cultural integration between employees across borders would boost the process of wealth creation.

Tarun Chandna, Founder and Managing Director, Exper Executive Education Pvt Ltd says, “There is a need for HR heads to implement strategies that retain talented people by creating psychological environment and career track management. Organisational environment like work culture, engaged leaders, effective communication practices, challenging assignments, international exposure, flexible work-timings, quality of life, work-life balance etc, can increase employee engagement and improve productivity.”

Battling attritionWhile human resource is the key to every organisation’s prospective growth, it is

important to keep the staff motivated by empowering them as they are the building blocks of the ecosystem. Training is an important aspect of HR policy and should be implemented at every stage of an individual’s growth graph. Currently, the attrition rate in the pharma industry is pegged at 20 per cent.

Chandna reiterates, “Attrition can be reduced by providing a positive atmosphere to employees in terms of supportive culture, training programmes, a policy in place for conflict management and adequate ‘rewards and recognition’ programme. As per reports, this year the Indian pharma industry will witness projected 13.3 per cent hike in salaries. Bearing this in mind, it becomes the responsibility of an organisation to create proper slabs for salary hikes for its deserving human resources.”

Further, HR professionals need to constantly develop innovative ways to make their organisation an enjoyable place to work in. Aggarwal adds, “The HR department should work proactively in both hard and soft zones. While hard zones involve compensation and benefits, soft zones cater to the recognition and appreciation of employees’ efforts and talent on a companywide forum. Rewarding achievements, recognising employee contributions through regular appraisals, improving the quality of their work life and providing a healthy working environment can help HR departments’ battle attrition.” Further, building internationally mobile leaders that bring about variation and engage in collective action will create greater transparency and accountability.

Future opportunitiesNew attitudes among the younger workforce, changing social factors and convergence are going to be some of the game changers in the industry. Chandna states, “Alternate channels of hiring beyond the traditional science/pharma graduate must be opened. The HR department should spend time and effort in organisational development initiatives that help build a culture

of performance, where employees are taken care of and listened to. Training critical talent on a continuous basis to create change leaders and flag bearers of the culture is essential. Skill training on sales specifically designed for the pharma industry needs to be honed, while individuals should be inducted from other industries to help look at things differently.”

Further , web-based HR services will provide access to HR management reports, news, guidelines for recruitment and development, performance appraisals, benefits, personnel policies etc. Cost effectiveness and integration through web-based HR can transform perceptions of the workforce.

Thus, with traditional models being replaced by advanced technology, scientific creativity, innovative evaluation tools and novel ideas, HR managers need to quickly adapt to the new environment such that the health of the company and the industry flourishes with the changing times.

Focussing on employee empowerment and retention

HR practices in pharma

As times evolve, the role of HR has undergone a sea change. Viewed more as business and strategic partner, HR is required to churn out new ideas to render cost-effective solutions. The increasing regulatory pressures, patent challenges and R&D-specific needs, particularly with concerns stemming from declining R&D product pipeline, the companies need to regularly review and reevaluate their HR policies.

Earlier, the role of HR professionals mainly involved recruiting talent, but today it is more about retaining it. Today, HR professionals need to have a thorough knowledge about the business and human resource functions, including new innovations and problem-solving skills.

Dheeraj Aggarwal CFO and Vice-President, HR

department, Venus Remedies Ltd

T

As per reports, this year the Indian pharma industry will witness projected 13.3 per cent hike in salaries. Bearing this in mind, it becomes the responsibility of an organisation to create proper slabs for salary hikes for its deserving human resources.

Tarun Chandna Founder and MD, Exper Executive

Education Pvt Ltd

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

16 Special Focus M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

o matter, the nature of a company, a good human resource requirement shall

never cease to exist. With Indian pharmaceutical companies expanding their reach and remarking global presence, it has become increasingly important to hire the right people for the right job. However, a gap between what they expect and what they get still remains.

The common gapsToday, pharmaceutical companies are growing either due to market expansion plans or because of diversification of their facilities. Hence, the industry is breeding in an environment that requires talented workforce to battle the global competition and challenges overthrown.

Speaking about the current talent gap, Divakar Kaza, President, Human Resources, Lupin Ltd says, “While educational institutes do churn out a large number of graduates and post-graduates in science and pharmacy, very few of them are found ‘employable’ or ‘industry-ready,’ with the required life skills and technical competence.” As a result, companies are required to spend more money on training the resource effectively and thereby bridging the gaps between theoretical knowledge and practical exposure.

Generally, there are two most common skill gaps in the pharmaceutical industry - sales and technical. Shedding light on the gaps in the pharma industry, Thammaiah, Director, Kelly Scientific Resources says, “The skill gap in sales domain will continue to be communication, technical comprehension and persuasive skills that a sales person requires to promote the company’s product and services. Herein, a mix of right hire and proper training will mostly solve the problem.”

Current system loopholesCurrently, India has more than 15,000 colleges and more than 10 million students. However, the growth has mostly been in professional colleges than in conventional streams such as

‘Arts’ or ‘Commerce.’ “None of these colleges and their courses prepares the students for their professions. Although the theories, sciences and the complexities of academics are well taught and thoroughly ingrained, their applicability in their impending profession is out of focus,” emphasises Kaza.

Also, higher educational institutes and universities do not upgrade their syllabi, in tune with the industry demands. Besides this, organisations also evaluate prospective candidates on various competencies ranging from soft skills to team building. “Ensuring a well-rounded education system that will not only ensure excellence in academics, while encompassing all technological advancements, but also impart life skills and provide practical training exposure, will make the students highly employable right out of college,” adds Kaza.

Suggesting measures on how educational institutes can help filling these gaps in the learning and training system,

Thammaiah says, “The education system should provide for more practice-based learning approach rather than theory based system. They should offer internship programmes while undertaking graduate courses. Companies should also be open to accept the learning curve and provide for scalable productivity by reengineering tasks at lower level.”

The gap impactA recent survey conducted by the PricewaterhouseCoopers indicates that among most R&D executives of life sciences companies, despite significantly downsizing R&D operations, the pharmaceutical companies are unable to find employees with the right skills.

“Some skills such as licensing, regulatory sciences, molecule discovery etc, have gained importance because pharma majors are increasingly using contract research firms, outside partners and crowd sourcing to manage costs and improve prospects for drug development,” Kaza avers.

The times to come may prove increasingly difficult for the pharma industry, as the gap between demand and supply of talented people with appropriate skills continues to widen. “Traditionally the industry focussed on developing talent from within the organisation, but now due to large demand for new skill, the demand for talent has multiplied and it will need to compete with other sectors,” Thammaiah adds.

About a third of life sciences companies have revamped their approach to R&D in the past three years. Close to 72 per cent of pharmaceutical companies are looking forward to expand their R&D capacity in the next one year. However, half of them indicate that hiring has become significantly difficult than ever before, with only 28 per cent being confident about finding the top and right talent.

Prospects and probabilitiesThe increasing demand for talented workforce accompanied by phenomenal industry growth with aspirations to be an active

participant in the global market, it is a crucial necessity that the current gaps and system voids are filled. “The emerging technologies in the pharmaceutical and biotechnology sectors have significant growth potential, with new demand for new treatments and replacements for out-mode technologies and products,” says Kaza.

Envisioning the HR challenges in pharma, Thammaiah suggests, “It is necessary that we attract and retain talent, especially attracting good students to take up pharma related courses. Also, it is necessary to manage the Gen-Y workforce in the traditionally managed sector. ”

A part of industry can choose to move into higher value chain and therefore, will require attracting global top talent at mid and senior levels in technology and R&D space. The sustainability will only be put into effect when the industry can gear up its efforts to groom internal talent and make them capable of managing future roles.. Though, the ability to attract top talent will continue to be a challenge.

Skilled manpower and retaining talent is a growing need in every industry and pharma is no different. It is necessary that the industry hires skilled and trained workforce to achieve sustainable growth. However, despite the availability of talented manpower, effectively harnessing human resource potential continues to be a challenge.

While educational institutes do churn out a large number of graduates and post-graduates in science and pharmacy, very few of them are found ‘employable’ or ‘industry-ready,’ with the required life skills and technical competence.

Divakar KazaPresident - Human Resources,

Lupin Ltd

N

The education system should provide for practice-based learning rather than theory based approach. Companies should accept the learning curve and provide for scalable productivity by reengineering tasks at lower level.

Thammaiah Director,

Kelly Scientific Resources

Anubhav Sharmaanubhav.sharma @network18publishing.com

HR challenges in pharma

Cap the talent gap!

17M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3Special Focus

h e I n d i a n pharmaceutical market will grow to $ 55 billion in 2020, and

if aggressive growth strategies are implemented, it has further potential to reach $ 70-billion by 2020, according to McKinsey & Co report, ‘India Pharma 2020.’ These facts guarantee employment opportunities in the Indian pharmaceutical industry, but the issue of pharmacy students not getting satisfactory placements continue to exist. Now who holds the responsibility? The students or pharmaceutical industry as a whole, for the lack of motivation and support provided. The existing syllabus is not modified periodically, at par with the changing needs and demands of the industry and other institutions. Also, options for elective subjects in final year of degree courses are limited and refrained from core industry oriented subjects such as marketing, quality control, manufacturing, R&D, management and law procedures.

Prof Bhupinder Singh Bhoop, Dean, Faculty of Pharmaceutical Sciences, Panjab University, opines, “Pharmacy education in India has primarily been tailored as a ‘combo’ pack to train the pupils for serving the twin vocations viz, industrial pharmacy and pharmacy practice. The graduates prefer employment in the pharma industry than any other professional domain like hospital, clinical or community pharmacy, academia or drug control. The obvious advantages that allure them towards industry are lucrative packages and accelerated growth. However, the widening gap between the number of students graduating

from pharmacy institutions and those employed in pharmacy industrial houses has lately become a gnawing concern.”

The training curriculaThere is an urgent need to introduce long in-plant practical training curriculum with some monetary benefits and soft tools that play a pivotal role in realising and connecting the academia across the education arena. Also, state pharmacy councils do not conduct a recognised entrance exam or provide facility for continued pharmacy education to register and join the profession. The students-industry-regulatory interaction is not at par to provide insights to the pharmacy graduates, for they have direct role in consumer health. Pharma education sector also lacks adequate sponsorships/scholarship programmes from the industry for the meritorious students. Above all, the newly graduated students lack entrepreneurship skills. This further hampers the innovation quotient, as these students are under psychological feeling of unemployment.

“There is a dire need to segregate the existing ‘combo’ of curriculum at the level of undergraduate pharma education to cater to the individualised industry requirements as well as the pharma practice. The remarkable pace of pharma developments across the globe have resulted in a paradigm shift, in the approach of federal agencies to monitor the pharmaceutical houses, while assessing the efficacy, safety and quality of their produce. The companies are facing an uphill task to cope up with the mounting pressure of strict regulatory guidelines from federal agencies on one end and the cut-throat competition, on another. They look towards the possible ‘quality produce’ from pharma institutions to help seniors take up such formidable challenges. Today, the drug houses expect the next-generation of pharmacy graduates to be effectively literate on the vistas like preformulation and formulation development, drug regulatory affairs, Quality by

Design (QbD), stability, Current Good Manufacturing Practices (cGMP), validation, impurity profiling, toxicokinetics, biosimilars, biowaivers with and without IVIVC, intellectual property and tech-transfers, in order to steer them through potential hiccups in industrial milieu,” says Prof Bhoop.

From a futuristic perspectiveGlobally, India ranks third in terms of manufacturing pharma products by volume and 14th by value, which is expected to reach among top 10 in the world. There is a need to understand the current industry’s manpower requirement in terms of technical knowledge and skills. There are few centres of excellence where students get all the facilities and are well placed after their graduation.

On laying an effective futuristic roadmap, Prof Bhoop suggests, “Academic institutions need to gear up, by transforming the curricular contents to meet the contemporary ‘industry-oriented’ needs and demands, while disseminating the same in a befitting manner, such that the produce is much better employable by the industry. This can only be accomplished by switching from the current ‘jack-of-all and master-of-none’ pursuit to the much more pragmatic line of ‘jack-of-many and master-of-one’ approach. A stream of formal pharmacy education should be technically-oriented, while the other should emphasise on the clinical aspects of pharmacy profession like pharmacy practice, community pharmacy, clinical research, etc.”

In the next decade, pharmaceutical industries will scout for pharmacy graduates who are inclined to research. Management is not proactive in providing facilities and necessary educational environment, but by using new software and IT tools they can save on costs and improve education significantly.

“The need of the hour, therefore, is to contemplate, deliberate and detail at the collective level. There is a plausibility and modality for separating the curricula and to implement the same at

national level at the earliest. If we do not gird up our loins now, the pharmacy graduates may soon be tempted to be replaced with science graduates, who will be available to work at much lesser wages with less attrition rate. Unless we put our act together now, the future pharma generations would hold us accountable for any further debacle in their employment potential. It is high time that the gubernatorial agencies like All India Council for Technical Education (AICTE) and Pharmacy Council of India (PCI), coupled with the educators’ bodies like APTI, take initiatives to redesign bachelor of pharmacy and even master of pharmacy curricula differently for different requisites. Academicians need to be reminded that the ‘time and tide spare none.’ We have to restructure our boats to withstand the current wave of global developments, lest these may fumble and tumble in the inundated times to come,” Prof Bhoop emphasises.

Is it time to redesign the current curriculum?

Pharma education

Pharma industry, academia and market dynamics are evolving and transforming, because of the positive impact created by the developments on technological, regulatory and demand fronts across the globe. Amid the wave of change, can old curriculum designed withstand the current industry expectation and demands? Or is there an urgent need to inoculate pharma skills at the basic levels?

Academic institutions need to gear up, by transforming the curricular contents to meet the contemporary ‘industry-oriented’ needs and demands, while disseminating the same in a befitting manner, such that the produce is much better employable by the industry.

Prof Bhupinder Singh Bhoop Dean, Faculty of Pharmaceutical

Sciences, Panjab University

T


There is a plausibility and modality for separating the curricula and to implement

the same at national level at the earliest. If we do not gird up our loins now, the

pharmacy graduates may soon be tempted to be replaced with science graduates.

18 Special Focus-Interface M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

How do you visualise the demand for skilled workforce in pharma in India?We expect the hiring in pharma sector to be 12 per cent to 14 per cent higher than last year. The demand is high for candidates in the following roles

viz, regional sales managers, area sales managers, medical representatives, sales executives, QA/QC executives, maintenance engineers, analytics, data warehousing, business intelligence, formulation scientist and ERP.

Pharma sector is driven by talented pool of professionals from various disciplines to keep pace with the urgent and sensitive market. Sourcing right talent to serve industry specific needs of varying size of businesses is a responsible task for the service providers. We explore the various aspects of HR practices in pharma in a candid chat with Aditya Narayan Misra, President - Staffing, Randstad India.

Attracting, retaining and engaging talent should become the HR mantra


What are the key factors that will impact the HR perspective in the pharma market?The forces shaping the pharma industry are increased regulation, price control, increasing cost and time to develop new drug/molecule and skill shortage. It is the responsibility of the HR to take cognizance of these factors and play a critical role in:

People & Talent Management: India offers great growth potential for pharma companies and to capitalise on this opportunity, ‘people’ should be the vital factor. ‘Attracting, retaining and engaging talent’ should become the HR mantra.

HR as business partners: The HR needs to work closely with business leaders to shape their organisation and transform them to offer solutions, rather than focus on everyday transactions.

Who are the major demand drivers for SMEs and MNCs?The demand is balanced between SMEs and MNCs. With more MNCs setting up base in India and focussing on product lines, the demand for niche skills are also increasing. Also, SMEs are partnering with companies to launch new products and offer contract manufacturing services.

How has the demand scenario changed in the past decade in pharma recruiting?In the last 10 years, pharma industry has become vibrant in nature with entry of many MNCs and SMEs. This has intensified the war for talent. Companies are focussing more on R&D, process, formulation and introduction of new products to address epidemics and critical diseases. As companies move up the value chain, there is a growing demand for specialists.

Are Indian institutes at par to cater to the industry or does tier-I and tier–II categorisation exist?Indian institutes are at par with the global companies to cater to the Indian pharma market. They have been improving their focus on new products and making necessary investments in new production facilities, R&D centres etc. This will further benefit the Indian consumers in the years to come as they can get better access to effective drugs at a competitive cost.

If you could draw comparisons on Indian vs global marketplaces in pharma HR, please elaborate.Many top tier, Indian and multinational companies share common traits with regard to focus on human resources and processes, gender diversity, research and inclusive growth. We are observing that best practices are being increasingly adopted and deployed by many Indian companies as well.

19Special Focus: Roundtable M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

Will IT tools bridge the gap in pharma education?

The future of education in pharmacy in India is at the brink of adopting advance curriculum and next-generation system of delivering

quality education and exposure to the students. Government and educationists need to revamp the existing infrastructure by

incorporating new IT tools to create a world-class education curriculum that drives the entire machinery on the right path.

macy in India is at the brink of The future of education in pha

Information technology has the potential to bring positive changes and fill in the void and lapses in skill development through innovative software and improved linkages between the various pillars of advanced

education system. However, a cautious and gradual approach is needed to reap the best from it.

takeEditorial

nformation technology (IT) has revolutionised the working practices and operational procedures in almost all the corporate sectors and pharmacy is not an exception to it. Pharmacy, like any other professional stream calls for regular upgradation of knowledge

and staying abreast of the relevant recent innovations. Medical sciences are developing at a faster rate because of proliferation in research activities. In a developing country like India, where we lack enough resources to dispense medical knowhow, IT can play a pivotal role in spreading the pharmaceutical sciences through virtual space.

Also, the convergence of pharmacy sciences and information technology has led to new vistas of medications, where human intervention has been reduced to minimal and automatic/mechanised aspects of treatment that have come to fore. Networking amongst pharmacy service providers is also an area, where IT is poised to play a predominant role in the times to come.

While, prominent global pharma chains are opting for franchisees in emerging markets, IT is now advancing to become capable of diagnosing diseases in the preliminary stages of their evolution, thereby raising possibilities of taking remedial actions on a timely

basis. In view of all these aspects, it can be stated that IT is bound to play a major role in developing

the pharma skills through virtual space.

he pharma industry has always relied on information systems and data analysis as a part of the regulatory approval process. With the exponential rise in population, the scope and usage of healthcare data is changing radically. For example, the patient records held in

Electronic Medical Record (EMR) systems are a vital source for clinical trials and research. CSC is closely working with the University Hospital, Southampton,UK to extract and analyse clinical data for this purpose.

Moving beyond traditional models of data, ‘Big Data’ techniques, applied for in-depth and significantly broader gamut of available patient data are becoming an important part of the therapeutic process itself. Data analysis is being used to identify requirements, design therapies and predict medical needs. Pharma companies will move beyond creating ‘blockbuster’ medicines, applicable to large populations and begin to deliver personalised therapies.

With the volume and velocity of data involved, we believe it is impractical for all different organisations involved to maintain their own discrete data sets. We believe that the rise of global health data brokers providing access to population health data in a virtual space, offered as-a-service will eventually be the way forward. With pharma companies focussing

on the development of therapies and not the maintenance of information systems, we foresee analytics being provided as-a-service.

he Indian system of pharmacy education lacks focus on curriculum revision and improvement. The existing curriculum is old and not updated as per the current industry trends. The lack of practical orientation and training makes it difficult for the students to keep

pace with the changing trends of the industry. Practical education imparted in pharmacy colleges is limited only to a fixed number of laboratory experiments, most of which have little or no relevance to the current industry practices. IT can help bridge this gap by offering quality training modules in the pharmacy education space. There is a dire need to upgrade and modernise the curriculum, while bearing in mind the latest developments in the pharmaceutical industry.

The pharmaceutical education today needs a new outlook and fundamentals have to be consistent with the emerging technology. There is an immediate need to acquaint the students with the latest trends in industry automation like laboratory management solutions (LIMS), resource planning and business management systems (ERP), customer relationship management systems

(CRM), sales force automation solutions (SFA) etc. It is important for the pharmacy graduates to understand, update and maintain pharmacy

information systems through query, report, and use and analyse the data.The students also need to be exposed and taught about the

latest regulatory systems, validations, clinical research, quality assurance, quality control and R&D

related activities.

ndeniably for the appropriate nexus between various pillars of advanced education system, IT is what we can bank upon. With continuous upgradations in the software arena and evolving innovative technologies devised by masterminds, the evolving technology sector has tremendous

potential to fill in all lapses and lacunae with regards to skillsets of an individual.With IT in limelight now, the existing syllabus needs to be modified periodically,

to be at par with the rising demands and expectations from industry and other institutions. The academic system also lacks skilled industry representatives with acumen for various industry oriented jobs that include IT managementA need to introduce in-house practical training curriculum with some monetary benefits and soft tools exists.. Also, state pharmacy councils do not conduct recognised entrance exam or provide facility for continued pharmacy education for registration to join the profession. While on the other hand, the students-industry-regulatory interaction is also not at par to provide an insight to the pharmacy graduates. Pharma education

sector also lacks in adequate sponsorships/scholarship programmes from the industry for the meritorious students. The technical teaching modes are not in

frequent use by the teaching staff, especially in government institutes. Above all, the newly graduated students lack entrepreneurship skills that hamper

the innovation quotient, as these students are under psychological

feeling of unemployment.thsb

Dr Monica GulatiDean, Lovely Professional University

Narendra NayakDirector & Account General Manager, CSC India

Shyamal KalaniVP-Business Development, Oasis Test House Ltd

Dr Dhanlakshmi IyerDirector, Lateral-I Consulting

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20 Facility Visit M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

Integrating traditional knowledge with technology

Sami Labs Ltd

n entering the premises of the Sami’s R&D center, one can find how several advanced technologies such as High

Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS), Nuclear Magnetic Resonance (NMR) etc, are being deployed to formulate and validate claims of India’s 5,000-year old traditional medicine. “Ayurveda has long been rooted in India but was neglected in R&D. We believe in ‘do no harm’ studies. We began research and came up with formulations to convince the world that the Ayurvedic products are non-toxic,” says Dr Muhammed Majeed, Founder and Managing Director, Sami Labs Ltd.

Sami Group began its journey in 1988 with establishment of Sabinsa Corporation by Dr Majeed in New Jersey, US. The company was established with an objective of importing and marketing generic drugs into the US market. The corporation was later made as the American arm of the Sami Labs headquartered in Bengaluru. For over two decades, the group has been unlocking the mystery of herbs by extracting their goodness and offering the world a means to good health, the nature’s way.

Strong focus on researchWith photochemistry and nutraceutical products at the heart of its business, Sami Labs is among a few of the research oriented organisations in the country, which is in a constant phase of innovation and discovery of novel products. Standardised herbal extracts, specialty chemicals and phytochemicals are continuously updated in the list of products of the company. “The phytochemistry division is one of the

major contributors to the growth of this company. It has all the capability of developing a new product,” explains Dr Majeed. Identification, isolation, characterisation of the bioactives and optimisation of the extraction methods form the core activities of this department.

The strength of the R&D phytochemistry is its rich intellectual manpower. “We believe in our people, they form the company,” says Dr Majeed. The plant extracts are standardised against specific chemical markers, which are at several instances reported for the first time. This also contributes to the large list of patents that the group has acquired.

A range of supercritical extracts for several phytoactive constituents have been developed using super critical carbon dioxide. The aim is to avoid the use of organic solvents in plant extraction. The methodology of research and innovation involves different stages with emphasis on scale up and commercialisation. The stages include:

Extraction of appropriate plant material/plant part with suitable solvent or solvent mixture.

Purification and identification of unknown compounds.

Isolation of pure compounds and determination of their structure by spectroscopic methods.

Biological efficacy and safety efficacy study of the isolated pure molecule, if required.

Developing standardised extracts and formulating them in a suitable marketable form as an active ingredient.

Optimising the extraction technology, suitable for commercial scale.

All-round developmentThe biotechnology R&D is an integral part of the core R&D of Sami Labs. “The current focus of research is on probiotics, prebiotics and synbiotics products,” avers Dr Majeed. The group also has a synthetic chemistry division that encompasses a wide range of highly practical, economically driven, bulk preparation of chemicals and very elegant enantiomer specific synthesis of a complex natural product. This department has developed and commercialised a number of molecules of pharmaceutical, nutraceutical and cosmeceutical importance in the last 20 years. The characterisation of synthetic compounds is supported by state-of-the-art analytical facilities such as HPLC, GC,

Infrared spectroscopy (IR), NMR, Liquid Chromatography–Mass Spectrometry (LC-MS), Gas Chromatography–Mass Spectrometry (GC-MS) and Carbon, Hydrogen, and Nitrogen (CHN) analysers. Until now, more than 50 compounds have been scaled up in the pilot plant.

The laboratory focuses on the development of new processes for the target molecule (natural or designed) from readily available, inexpensive starting material in simple, safe and resource effective operation that proceeds quickly for quantitative yields. The process also involves development of new reaction and methodologies for efficient synthesis of bioactive molecules, discovery of practical routes to compounds of value from readily available natural products and synthetic analogs of already existing natural products for improved biological activity.

The microbiology division is an integral part of the Analytical R&D of Sami Labs. The lab has been assessed by the National Accreditation Board for Testing and Calibration Laboratories (NABL). It is also being certified with the ISO/IEC 17025: 2005 standard. The lab provides microbiological analytical support to the R&D with complete assistance for troubleshooting technical issues for quality control and quality assurance unit.

Formulation R&D department develops different dosage forms. The various dosage forms designed here include oral tablets, sustained release tablets, multiple layered tablets, dispersible tablets, effervescent tablets, stick pack powders, medicated tooth paste, topical gels, ophthalmic drops, nasal drops, medicated candies, pelletised capsules are just a few to name. The formulation R&D division is involved in the development of final products for customer use. It receives raw materials from other divisions of Sami Labs for formulation. Pre-formulation as well as formulation studies are carried out to aid the design of various dosage forms. Formulation R&D has state-of- the-art pilot scale manufacturing facility for trial and scaling up the products in a pilot batch. Once the formulation is done, it is scaled up to pilot batch followed by production. Anti-obesity, anti-hypertensive, pre-probiotics, anti-diabetics, liver supports, anti-glaucoma, joint health, prostate care, eye health,

revitalisers, rejenuvators and many such products are developed here.

Staying abreast of scientific trendsNanoscience and nanotechnology has been the focus of research institutions world over. Nanomaterials find application in pharmaceuticals, specialty chemicals, cosmetic ingredients and healthcare arena. With a view to improve the activity of nutraceutical and cosmeceutical products, Sami Labs recently established nanoscience division. “Activities of the research department here, have already selected a few key products for development,” reveals Dr Majeed. The primary function of this division is to take the active ingredients and convert them to nanomolecules (about 100 to 150 nm particle size) retaining activity and improvising efficacy with least toxicity. The company has received several awards, and as a matter of fact to be noted here, is the ‘Nutra Excellence Award’ for the best company in the field of research and development at the 8th Nutra Summit, held earlier this year.

Ayurveda has long been rooted in India but was neglected in R&D. We believe in ‘do no harm’ studies. We began research and came up with formulations to convince the world that the Ayurvedic products are non-toxic.

Dr Muhammed Majeed Founder and Managing Director,

Sami Labs Ltd

Remedies from nature play a significant role to curb and regulate changes because of the ever-increasing irregular lifestyle. Sami Labs Ltd incorporated in Bengaluru is among the country’s few indigenous companies accenting the use of Ayurvedic medicines globally. Delve deeper to understand the workings, processes, developments and innovations formulated at the R&D wing of Sami Labs.

O

Hardik Ashar pallavi.mukhopadhyay @network18publishing.com

Nuclear Magnetic Resonance (NMR) used for analysis at R&D centre

21M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3Insight & Outlook: Pharma packaging

nfortunately every year, there are 30 to 50 fatal poisoning accidents with

children in Germany related to household cleaner, poisoning plants, fertiliser, cosmetic products and pharma products. These deaths can be prevented.

The Pharmaceutical Association of Great Britain (PAGB) has been investigating accidents at home, for Home and Leisure Accident Surveillance System (HASS/LASS) database ) and has found that poisoning accidents among children during the period 1982 -1998, has been constantly decreasing by 33 per cent for all children and more than 50 per cent for children under 5 years of age. During the same period, the proportion of non-reclosable pharmaceutical packages has been increasing tremendously.

Only at the age of three, many children understand the rational reasons of the dangers involved or at least are willing to accept a ‘no’ and follow educational measures and simple safety rules. Substances with particular hazard of poisoning are household cleaning agents, pharmaceuticals, stimulants, poisonous plants, fertiliser, cosmetics and oils.

Children are familiar with blister packs containing sweets or chewing gum (Blister A). Thus, they associate blisters with something positive. The same holds true for shapes and colours of tablets (pharmaceuticals are marked by an arrow).

The history of child-resistant packages started in US with the Code of Federal Regulations Part 1700 to 1750, subchapter E: Poison Prevention Packaging Act (PPPA), 1970 regulation. This was the introduction of the concept of having packages tested by children and adults.

An American study shows that, since the introduction of child-resistant packages for prescription drugs (tablets) the mortality rate due to poisoning has been decreasing significantly. According to this analysis approximately 460 fatal accidents were prevented due to this protective measure. In other words, a reduction by 45 per cent was evident. Following US regulations, many more countries introduced standards and legislation with regards to child-resistant packages both reclosable and non-reclosable.

With the British standard BS 8404 and the European standard (for members of the CEN), it is for the very first time that tests with children and adults are requested in Europe, the CR/SF packages.

As a first country in Asia, Korea has implemented the request for Child-resistant/ Senior-friendly (CR/SF) packaging in 2007. A target range is defined which can be checked in the course of the test in a given time. The test is carried out on children and adults of a certain age group and gender. Depending on the opening performance, the package meets the target (target range) or fails.

The necessity for CR/SF packages for pharmaceuticals is reflected by the population development in Europe and US. Although, the ratio children/adults (older than 65 years) and the life expectancy varies, the trend followed in all countries is the same ie, increasing life expectancy and decreasing birth rates.

In Europe, more than 80 per cent of solid pharmaceuticals are packed in blisters, while in UK approximately 60 per cent.

CR/SF in Europe and US Regulations as to the design of CR/SF packages and the tests to be carried out vary considerably

in Europe and US. Shape and colour of pharmaceuticals are the marketing factors. The pa-tient is supposed to remember the product. Thus in US, the bottom material is transparent if in Cold Form Foil (CFF, alu-alu, Panblok) is not the material of choice. Hence, there is a risk that children mistake the drug for sweets. In Europe, mostly opaque coloured thermoform able film or Formpack® is used.

Each product that is listed and for which, there is a risk that children might poison themselves by swallowing the drug has to be packed in a CR/SF package. In US, pharmaceuticals are traditionally packed in bottles but the proportion of blisters is constantly increasing.

Irrespective of the fact whether a pharmaceutical company has (a) product(s) in CR/SF on the market, a test has to be carried out for a new or different amount of active substance (s).The criteria for the selection of test persons and test results are defined in the regulations/standards.

PPPA is applicable for the following products (without details and restrictions, original page 614 - 617 of PPA) such as aspirin, methyl salicylate, controlled drugs, iron containing drugs, dietary supplements with iron, acetaminophen, diphenhydramine prescription drugs. However, exceptions exists such asnitroglycerin, i s os orbide d in it rate , anhydrous cholestyramine, pancrelipase preparations, prednisone in tablet form, mebendazole in tablet form, colestipol in powder form, conjugated estrogen tablets, norethindrone acetate oral tablets, erythromycin ethylsuccinate granules and tablets, cyclically administrated oral contraceptives, sodium fluoride drug preparations, betamethasone tablets and all unit dose forms of

potassium supplements, methylprednisolone in tablet form.

Development and test of new solutions for CR/SFThe development of a package is influenced by the age-specific abilities and difficulties of the user. The abilities of children and adults, and also the difficulties they have to cope with, are reciprocal. This complicates the possibility to offer complex solutions. The level of difficulty involved for an adult to open the package, the chances of the package remaining open increases, or otherwise the content is filled into a package that is not CR/SF.

To check the probability for compliance of the newly developed solutions with the CR/SF test according to EN 14375, all materials have to be checked as to their puncture resistance or burst strength. The test device is fixed in a machine for check of tensile strength and the strength, at which the plug needs to puncture the lidding foil from inside is measured.

Unpacking factsThe application of CR/SF for non-reclosable packages is constantly increasing. Hence, pharmaceutical companies that sell their products to countries with respective regulations/standards have to process appropriate packages. Manufacturers of flexible packaging materials are requested to develop appropriate solutions. Ansapack has contributed to this request with the lidding foils mentioned. With Korea having implemented the CR/SF regulations, it is foreseen that other countries in Asia will follow. Nevertheless, with regards to all solutions for CR/SF, it must be self-evident that child-resistant packages are only the last measure of a whole range of protective measures and they do not assume the responsibility for parents and guardians. It is still their duty to store pharmaceuticals out of the reach of children.

A total contradiction?With the introduction of advanced packaging technologies, the pharmaceutical industry today is looking for new packaging solutions for Child-resistant and Senior-friendly (CR/SF) packs. The existing pharma packaging materials available in the market currently are close to two decades old. With increasing awareness among children in the understandable age-groups, there is a need for new technical solutions that maintain the same process ability with low production costs.

UBlisters and products with sweets and pharmaceuticals

PPPA (1970) EN 14375

Children (months) 30% 42 – 4440% 45 – 4830% 49 - 51

42 – 51; max. 200same number per age group and gender

Adults (years) 25 of 50 – 54 (since 1997)25 of 55 – 5050 of 60 - 70

25 of 50 – 5425 of 55 – 5050 of 60 – 7030 male, 70 female

Testing period children 2 x 5 minutes 2 x 5 minutes

Testing period adults 1 x 5 minutes 5 minutes preparation1 minute test

Criteria for target achievement Children

Adults

According to stipulation

> 90

< 15% more than 8 individual doses within 5 minutes without demonstration;< 20% more than 8 individual doses within 10 minutes with demonstration;> 90

Test criteria for CR/SF packages

Dr Erwin Pasbrig Director

R&D and Quality, Ansapack

[email protected]

Child-resistant and senior-friendly packs

22 Insight & Outlook: Strategy M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

edical Representatives (MRs) and first line managers are the

lowest rung in the pharmaceutical marketing team but they have the primary responsibility of regularly interacting with the physician. The role played by the MR ultimately determines the volume of sales that his employer achieves.

Until two decades ago, pharmaceutical companies recruited only male science graduates from reputed colleges and trained them in-house as well on the field to familiarise their products. The training imparted ensured that the young man was well versed with the scientific content of the drug as well as its action on the human body. A brief knowledge of the major adverse effects of the drug was also taught to him so that he could effectively tackle any queries on the subject from physicians. A sincere MR, then, knew a great deal of pharmacology to hold a discussion with the doctor, except for the clinical aspects.

MRs exodusIn the 1990s, the sudden spurt in medical transcription centres, call centres and privately run life insurance companies’ most pharmaceutical companies lost their sales representatives to these organisations due to their rewarding work environment and pay packages. Pharmaceutical companies attempted to buck this trend by recruiting pharmacy graduates but they did not hold on for long owing to the grueling nature of the field jobs.

E v e n t u a l l y d r u g manufacturers hit upon a brilliant idea to fill in their MR vacancies. Shifting their paradigm, they recruited young men (and women) – graduates in arts and commerce – who could barely differentiate an epithelial cell from a button cell! A quick training in the ABC of the brand, minus the pharmacodynamics equipped these youth to ‘push’ pharmaceutical brands in the doctors’ clinics.

Talent deficitWhile getting cheap labor solved the immediate problems of the company, the finesse of these MRs left a lot to be desired as they were ill equipped to answer minor technical queries from the physician. Although the poor performers or those who could not cope with the rigours of the job quit, the ‘persisters’ grew to become Area Managers. This led to a system where both the MR and his immediate superior are both non-science graduates and therefore senior physicians who were used to having an ‘intelligent’ conversation with the MR felt disappointed.

It is worth mentioning here that most busy general practitioners as well as consultants use the brief interlude with the MR and his boss as a break from his routine tedium. An invigorating discussion with a knowledgeable ‘rep’ temporarily eases the doctor’s stress of handling a crowd of ‘sick’ people! Conversely, having a dull MR monotonously rattling out a dozen brand names can easily put the tired physician off to sleep, thereby, wasting the time of both parties.

‘Lines’ of cautionThe ill equipped MR tends to do his job mechanically and walks out of the doctors’ cabin having completed one more call, without realising that he has hardly made any impact on the physician. A repetition of this scene for a few more occasions is a sure sign of the sales graph of this company showing a steep dip!

Many times, physicians who are not too busy may enter into a conversation and try to elicit some information about his brands. If the answers provided are authentic and accurate the MR and his company may regain some lost credibility. However, there are some standard lines mouthed by ill-trained MRs, which are ready put-offs for the doctor.I don’t know: When the physician asks the MR about the price of his brand, the

contraindications or adverse effects of a particular drug, if the response is ‘I don’t know,’ then the chances of the physician closing his mind to that particular company are very high. A sincere MR would try to revisit the physician the very next day and set things in order by responding to the query. Such an action would in fact draw further attention to the intended brands and may undo the damage created on day one.We have a campaign: Many MRs tend to ‘blackmail’ the physician into supporting his products by invoking this line! Although the idea is to get some sympathy out of the physician to support some specific brands for a short while, it may work counterproductive. A senior physician once retorted: “Is it your campaign or mine?” Another jovially enquired whether the MR can get some extra patients to help his own campaign!I am due for an incentive: MRs have for long used this famous line to entice the doctor to support his brand in order to ensure that the former gets a larger share of his annual incentive. Although this was a sensible line to use in the past, its overkill has led to physicians ignoring such pleas. In these unethical times, it also leads the physician to ask what is there in it for him!That is not my coverage area: In large cities such as Mumbai, most consultants practice at two or three places during different days and times. Once certain brands become their favourite, physicians prescribe in the same pattern in all clinics that they practice. However, some of these brands may occasionally be unavailable in specific areas. When a doctor opines about some patients from a distant area (in the same city) not locating a specific brand, the MR is expected to look into the matter in earnest. If he dryly mentions that it is beyond his area of operation, he will soon be out of his own area!

Downhill trend The main factors responsible for the field sales officers using

such unhealthy lines are:1. Recruitment of youth lacking

a scientific temper and interest in their work

2. Lack of a genuine feedback mechanism to know how the lower sales rungs work in the field.

3. Ruthlessly motivating MRs to ensure good sales ‘at all costs.’All this also comes

close on the heels of a change in perception of the pharmaceutical industry towards medical practitioners. The latter are no longer viewed by drug manufacturers as professionals who have a responsibility towards society. Senior managers should not forget that physicians are duty bound to pursue their personal goals while being committed to a duty which ensures good health of his patients. Hence, using below-par sales representatives simply as the drug company’s agent, with the sole aim of providing ‘profitable business solutions’ to doctors is an unhealthy practice.

Pharmaceutical companies have now accepted the situation where non-science graduates will, henceforth, be the norm for their field jobs. However, accepting poor commitment to work and alienating from ethical doctors will be counterproductive in the long term. A great deal of attention should be paid to improve the soft skills of these personnel so as to ensure that they are well accepted by physicians whom they face for barely three minutes. For sales staff that does not have a background in science, a major emphasis should be placed on the MRs grooming, personality, etiquette, communication skills etc.

In conclusion, every ‘I do not know’ should be followed immediately by ‘I will surely get back tomorrow with the answers!’ It needs no further emphasis to say that a failure to keep this word could be the beginning of a sinking bottom line.

All it takes to be an MRThe sales drivers

The role of a Medical Representative (MR) in the pharma supply chain is undisputable. The MR should possess a brief knowledge on the effects and side-effects of drugs supplied. However, due to the grueling nature of the on-field jobs, many pharma graduates do not choose to be an MR. Know all it takes to be an MR and get well-equipped to walk the field.

MDr Rajan T D

Pharma Consultant & Practising Dermatologist

[email protected]

23M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3Insight & Outlook: Tips & Tricks

Affordable and sustainable packaging solutions for pharma SMEs

Rajabahadur V ArcotIndependent Industry Analyst and

Automation Consultant

[email protected]

Packaging, the means for achieving safe and efficient delivery of products from producers to users, plays a critical role in ensuring pharmaceutical products’ integrity and efficacy apart from protecting them from contamination, pilferage, and such others during their distribution, storage, sale, and use. While majority of medicines come in the form of tablets or capsules, powders, pastilles, and liquids, the alternatives, such as intravenous and inhalation, are also widely used. Therefore, the industry uses various types of packaging machines, such as blister packaging machine, capsule filling machine, ampule and vial filling machine, tube filling machine, shrink wrapping

machine, palletisers etc.

The pharmaceutical industry needs reliable, convenient, and cost effective packaging solutions that preserve the stability and quality of medical products and protect them from all forms of

degeneration or damage and tampering. In order to serve the ultimate purpose, it is extremely important for the pharmaceutical packaging to conform to the prescribed standards. Drug or medicine packaging involves operations, such as filling, sealing, inspection, and labeling of a product and each of them require compliance with the packaging guidelines.

The industry has strict packaging requirements and protocols. For example, FDA’s 21 CFR Part 211 deals with current good manufacturing process (cGMP) and subpart G refers to packaging and labeling control. The World

Health Organization provides guidelines governing the inspection of manufacturing facilities to check compliance with GMP and annexure 9 of WHO Technical Report Series refers to pharmaceutical products’ packaging. India’s Directorate General of Foreign Trade (DGFT) has issued regulations to implement bar coding at the primary, secondary and tertiary levels of packaging on export consignment of pharmaceuticals and drugs for tracing and tracking purposes.

Technologies such a s h o l o g r a m s , watermarks, barcoding, and radiofrequency identification (RFID) technologies hold immense promise at affordable costs. Moving forward, India has already taken the necessary initiative

with a view to ensure product integrity apart from protecting the country’s brand image as a quality producer and supplier of generic drugs. Based on Indian government guidelines, drug companies from the country are exporting medicines with barcode markings. Another desirable consideration in pharmaceutical packing is to keep the drugs secure from children without compromising on its user-friendliness.

Domestic companies export their pharmaceutical products to countries across the globe and as such, they are constantly on the lookout to adopt the state-of-the-art packaging technologies so that they comply with the global standards. Therefore, the pharmaceutical industry is a major user of packaging machinery that in turn provides impetus for the growth of the packaging industry and sets its future direction. According to industry sources, pharmaceutical industry accounts for almost 30-35 per cent of the packaging industry revenues in India. The packaging industry is a major user of automation systems, such as sensors, programmable logic controllers, and motion control solutions.

T h e I n d i a n pharmaceutical industry has emerged as a leading low-cost producer of quality bulk drugs and formulations and exporter of generic drugs. While the industry has grown in double digits

over the last five years and the projections are that it would maintain its growth momentum over the next few years, its export earnings, which stood at little over $ 13 billion in 2011, are expected to almost double in the next couple of years. The packaging industry’s continuous technological innovations and the pharmaceutical industry’s challenging demands mutually support each other.

Their ability to integrate with enterprise solutions paves the way for the packaging machines to collaborate with the operations management for achieving efficiency along the entire value chain and end-to-end tracking. The growth of India’s pharmaceutical industry spurs the robust expansion of the entire packaging industry ecosystem, which includes suppliers of packaging machinery, control systems, packaging materials, and printing devices apart from others. Therefore, all stakeholders must establish a common platform to work together with a charter, which may include skill development,

technology forecasting, vendor development, industry academia collaboration, and such others. The future is bright but nurturing is important.

Increasing need to empower outpatients to take the right amount of the right medications is driving unit-dose packaging, such as vials, ampules, and prefill-able syringes, especially in advanced countries. Increasing environmental awareness provides the impetus for the development of sustainable packaging and pharmaceutical packaging is no exception. However, it is important that the sustainable packaging initiatives do not result in compromising on drug safety considerations. The pharmaceutical industry’s packaging needs also include cost effective, user friendly, flexible, robust, and intelligent packaging processes.

Some of the packaging considerations of the pharmaceutical industry are protection from counterfeiting, unit-dose packaging, prevention of oxygen permeation, keeping the drugs secure from children, and eco-friendly packaging. However, many of the medicine packaging requirements are niche to the industry. According to industry sources, drug counterfeiting is a major challenge that the pharmaceutical industry faces even in developed countries, such as the US and the European Union. Drug counterfeiting endangers not only the public health but also brings disrepute to the global pharmaceutical industry and it views packaging as an effective way to tackle the problem.

All stakeholders, the pharmaceutical companies, suppliers of packaging machineries, control system suppliers, and such others, must be alive to the threat from cyber hackers. The threat is real and stakeholders could only ignore them at their own peril. The harm to India’s pharmaceutical industry from cyber-attacks could be far more damaging and therefore it is necessary to be alive to such threats and be ready to thwart them. Yet another vital consideration of packaging is to ensure that it protects the pharmaceutical products for environmental and other influences, such as bacteria, moisture, and oxygen. The ability of the packaging line for quick changeover is equally important.

12 3

4

5678 9

10

he packaging technology constantly evolves to meet the ever-changing and special needs of the pharmaceutical

industry. Some of the important goals of the pharmaceutical product packaging are to ensure product identification and information, safe delivery to the patient, product preservation from contamination or environmental influence, ease of use, etc. This is also for safeguarding pharmaceutical products from drug counterfeiting and ensuring that the packaging solutions offered with the technological advancements ensure safety compliance at all times.

T

24 Projects M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

Ajanta Pharma manufacturing facilities at Savli industrial area near VadodaraProject typeNew facilityProject newsTo manufacture tablets, capsules, liquids, powder and lotions for the existing therapeutic areas. Every year, the company launches 15-20 new products in these existing segments viz, anti- malarial, cardiology, dermatology, gastroenterology, musculoskeletal, ophthalmology and respiratory segments.

Project locationVadodara, GujaratProject cost` 200 croreImplementation stagePlanning

Contact details:Ajanta Pharma Ltd98, Ajanta House, Charkop, Kandivili (West) Mumbai - 400 067, Maharashtra Tel: +91-22-6606 1000 Fax: +91-22- 6606 1200/1300 Email: info@ajantapharma.com----------------------------------------------Ajanta Pharma manufacturing facilities at SEZ DahejProject typeNew facility

Project newsTo manufacture tablets, capsules, liquids, powder and lotions for the existing therapeutic areas. Every year, the company launches 15-20 new products in these existing segments viz, anti- malarial, cardiology, dermatology, gastroenterology, musculoskeletal, ophthalmology and respiratory segments.

Project locationSEZ Dahej, GujaratProject cost` 200 croreImplementation stagePlanning

Contact details:Ajanta Pharma Ltd98, Ajanta House, Charkop, Kandivili (West) Mumbai - 400 067, Maharashtra Tel: +91-22-6606 1000 Fax: +91-22- 6606 1200/1300 Email: info@ajantapharma.com----------------------------------------------Bangladesh: Strengthening Pharmaceutical Systems Afghanistan Associate Award ProjectProject typeNew facilityProject newsThe Systems for Improved Access to Pharmaceuticals and Services (SIAPS)

programme funded by the US Agency for International Development (USAID) builds on the achievements of the its predecessor, the Strengthening Pharmaceutical Systems (SPS) programme, by working to assure the availability of quality pharmaceutical products and effective pharmaceutical services to achieve desired health outcomes. The programme promotes and uses a systems-strengthening approach that is consistent with the Global Health Initiative (GHI), which will result in an improved and sustainable health impact. SIAPS approach emphasises GHI principles, especially improving metrics, monitoring, and evaluation, empowering local governments and organisations, and increasing country ownership. At the end, the SIAPS framework and result areas reflect the dynamic relationships among five health systems building blocks with a pharmaceutical product overlay that guides technical content.

Project locationBangladeshProject costNAImplementation stagePlanning

Contact details:Management Sciences for Health784 Memorial Drive Cambridge, Massachusetts 02139, US Tel: +617-250-9500 Fax: +617-250-9090----------------------------------------------Manufacturing of fluid bed processors machinery in SataraProject typeNew facilityProject newsPam Glatt Pharma Technologies Pvt Ltd is planning to set up a new project for manufacturing plant and machinery at Satara, Maharashtra .The project involves manufacturing of fluid bed processors.

Project locationSatara, MaharashtraProject costNAImplementation stagePlanning

Contact details:Pam Glatt Pharma Technologies Pvt LtdSurvey No14 & 16, Jankar Estate, J M Compound,Mira-Bhayander Road, Thane, Maharashtra - 401104

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/lifesciences industry.

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ith the Indian pharmaceutical industry going global, effective GMP compliance is of crucial importance to ensure that the quality of drugs are maintained and safe drugs are delivered for consumption by the masses. The emergence of a booming export market in pharma has resulted in Government making the norms strict further. A mandate has been passed by the Government of India (GoI) to compulsorily include 2D barcode in pharma packaging. This most was received not welcome by the industry and experts.Since this rule came into

effect, the pharma majors and SMEs alike are demanding a valid explanation from the GoI for implying such practices. The industry fears, this decision may hamper export trade of the country. Expressing resentment, Samir R Shah, Director, Ciron Drugs & Pharmaceuticals Pvt Ltd said, “The government says that the 2D barcode will define the quality of the product. Whereas, we argue stating facts that this mandate will only burden the SMEs further. We contribute a lot to the market and we are being ignored.”

It seems difficult for pharma majors to invest into purchase of 2D barcoding machines and adopt the practices into their manufacturing and packaging processes. The 2D barcoding machines are very expensive and hence will make cost recovery difficult on the final product. Also the installation costs are so high, that companies can get swallowed or wiped out, just to bring in the machinery as a part of their system.

Apart from the above, there are various other sectoral issues. Primarily being the rising curiosity among the industry veterans and pharma majors, questioning on why does the government mandate this norm

without offering any financial support to the industry? Tushar A Korday, Director, EMIL Pharmaceutical Industries Pvt Ltd said, “Getting a machine for 2D barcode is not easy for every small enterprise. It costs a fortune and thus this will impact the sector. Many companies will shut down if this is made compulsory. Most importantly, there is no financial aid from the government which is a worrisome factor for us.”Practical implications include

that the 2D barcode cannot be read by a regular barcode reader. This requires a different machine. Plus, the material used to make cartons has to be of a very good quality such that the barcode can be imprinted properly without

any fault. Most of the products manufactured by SMEs in India are exported to Africa and other similar nations. With the 2D barcode coming into picture, these countries might stop importing products, as the prices will subsequently rise. Also with no proper 2D barcode system in place to read the barcode, the system as a whole will stand under-utilised.Shah reiterated, “We are

certainly not happy with this decision and have been trying to reach the officials but have always been met with disappointments. It is shocking that the government is simply taking decisions, without realising and properly calculating the consequences of it.” After analysing the entire

situation, it is the industry’s dictum to not favour the 2D barcode implementation as it may hamper business of the SMEs in particular. Installation of the barcode system will approximate to ` 50 lakh. However, various attempts to get government’s reaction on the industry’s non-acceptance regards the 2D barcode mandate have proved unsuccessful yet.

Anubhav Sharma

fter USFDA rounded up on Indian generic drug makers and raised alerts on Wockhardt and Dabur plants in India, the European Union (EU) has now rounded up 9 global drug manufacturers.India’s Ranbaxy along with

Denmark’s Lundbeck have been fined a total of €146-million by the EU antitrust regulators. The fine is imposed for restricting the supply of cheaper antidepressant drugs to the market.

Lundbeck was accused of paying rival generic drug companies to delay the delivery of antidepressant drug Citalopram to the market. According to an EU pharma

report in 2009, it alleged questionable deals between branded drug majors and generic rivals, which will result in consumers paying, as much as 20 per cent more.Earlier, US regulators

said that, the deals between brand name drug companies and generic rivals which lead to higher drug prices could attract legal action. Other companies to be fined are Generics UK, Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma and A L Industrier other than India’s pharmaceutical giant, Ranbaxy. These are the makers of generic drugs.

Indian Pharma in 2020 18 Regulatory challenges | Manufacturing |

Packaging | Legal battles | Clinical trials and research | Herbals and nutraceuticals

Special Focus 26Pharma supply chain Time for uplifting standards

Special Focus Interface 29Vineet Agarwal Joint Managing Director, Transport Corporation of India Ltd (TCI)

Book Review 25Top 10 books of the seasonFor an insightful read

1 - 15 J u l y 2 013 I Vo l 2 I N o 1 I `10 0

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1 st A N N I V E R S A R Y SPECIAL

Pharma companies refuse to accept 2D barcode mandate

EU fines nine drug companies including Ranbaxy € 146-million

Anniversary Attractions

Glenmark Generics gets ANDA approval for Riluzole tablets

Aurobindo receives USFDA approval for Disoproxil Fumarate

Novartis positive about Omalizumab for patients with chronic spontaneous urticaria

Snippets

A peek into 2020

Glenmark Generics Inc, the US subsidiary of Glenmark Generics Ltd has been

granted final Abbreviated New Drug Approval (ANDA) from the United

States Food and Drug Administration (USFDA) for Riluzole tablets, 50mg.

Riluzole is indicated for the treatment of amyotrophic lateral sclerosis. Based

on IMS Health sales data for the 12 month period ending March 2013, Riluzole

garnered sales of $ 64 million.

The company will commence shipping of the drug immediately.

Glenmark’s current portfolio consists of 86 products authorised for distribution

in the US market and 52 ANDA’s pending approval from the USFDA.

Additionally, the US arm of Glenmark continues to identify and explore

external development partnerships to supplement and accelerate the growth

of its existing portfolio.Aurobindo Pharma Ltd has received

the tentative approval from the US Food & Drug Administration

(USFDA) to manufacture and market, Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate tablets,

600mg/300mg/300mg.The New Drug Application

(NDA) provides for the use of Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate tablets,

600mg/300mg/300mg alone or in combination with other antiretroviral for

the treatment of HIV-1 infection in adults and adolescents, more than 16 years of

age and weighing at least 40 kg.

Novartis announced results showing Omalizumab met all primary and

secondary endpoints of a pivotal Phase-III safety registration GLACIAL

study for patients with refractory chronic spontaneous urticaria (CSU), a chronic

and debilitating form of hives with limited approved treatment options.

Omalizumab is not currently approved or indicated for CSU. Regulatory

submissions for Omalizumab in CSU are on track for later this year.Omalizumab has been found to be

effective, safe and well tolerated in refractory CSU patients, Omalizumab

eliminated or suppressed symptoms in more than half of patients who failed

multiple therapies in a span of 12 weeks.GLACIAL is the second of three

pivotal Phase III studies that investigate the efficacy and safety of Omalizumab

in CSU. The study results support the

efficacy, safety and tolerability of Omalizumab in patients with refractory

CSU. Up to 40 per cent of CSU patients fail on antihistamines, even those taking

up to four times the approved dose. Antihistamines, at the approved dose,

are currently the only licensed treatment for CSU.

“This is encouraging news for people living with CSU, whose quality

of life is greatly impacted by this serious disease and who currently have few

treatment options,” said Tim Wright, Global Head of Development, Novartis

Pharmaceuticals. “Novartis is committed to doing, all we can for these patients

by working to develop an important advance in CSU treatment, where unmet

medical need remains high.”Omalizumab is being jointly developed by Novartis and Genentech,

Inc, for CSU.

23

Indian pharma in 2020M o d e r n P h a r m a | 1 -1 5 J u l y 2 0 1 3

Patents vs generics: Who will rule?

Legal battles

ith niche markets such as biologics, biopharmaceuticals and contract research gaining

momentum, and their patents expiring in the next few years, pharma players are taking keen interest in the generics segment. Moving up the value chain would require Indian pharma companies to upgrade their profiles in the international market.USA and Europe is also dispensing a good number of generic drugs to the patients. However, there seems to be an urgent need in the west to shift focus back to research. Between 1995 and 2013, the

Intellectual Property Rights (IPR)/patent river has been flowing turbulently enough. The ‘doomsday omens and prophecies’ by pharma pundits have been proved wrongtill now. Early grant of product patents, post-2005 did result in extensive, often frivolous infringement suits, injunctions, counter claims and revocations. Other than the section 3(d) litigations, majority of suits and writ petitions were relating to patent-regulatory linkages. Despite early settlement by the Delhi High Court and the Supreme Court, the legal battle continues to be dragging on in various courts, owing to adjournments. ‘Patent is valid, but not infringed’ juare under appeal by both sides. Frivolous

litigations on incremental innovations, between Indian pharma companies are mostly driven by ‘market-share’ ego-trips are also increasing.To predict the pharma scenario in

India in 2020 with specific reference to patented molecules and dosage forms vis-à-vis generics is no tall order. Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, opines, “Generics are here to stay and will continue to be in the pink of health in 2020 too. By 2020, the early challenges to patented molecules viz, New Chemical Entity (NCE) will substantially diminish. However, licensing of patented molecules to Indian domestic companies (often more than one) will increase substantially, thereby extending the early reach of advanced ‘life saving’ and ‘quality of life’ medications to a wider cross-section of the needy community. It is predicted that the pharma patent

litigations will come down in days to come by 2020. There will be 3 types of pharma patent litigations raging in India - NGO-driven, greed-driven and ego-driven. NGO and generics driven litigations will continue to be related to lack of affordable access, non-working, government use and compulsory licenses. The greed-

igations will continue to be evergreening intentions ction 3(d), especially since

the new drug pipeline is dryingLitigations against Indiaand dosage forms are unlikely in 20

or thereafter, because issues like F27, non-working, not manufactureetc, are unlikely to come to play

in such patents.”“If the current trend is to be extrapolated, the third category of ego-driven patent litigations is expected to increase by 2020. These litigations will follow the path of ‘mother of all ego-driven pharma patent litigations’ ie, the ‘Gleevec’ patent battle. Ego-driven litigations in pharma patents are most likely to be played between Indian generic companies than between MNCs and Indian companies. MNC patent wars are mostly in the second category of greed-driven litigations. The segment-wise leadership issues, market s hare disputes, infringement of incremental innovations, disputes on confidentiality violations (due to migration of resources and IP stakeholders) are likely to be drivers for such pharma litigations in 2020,” Nair reiterates.

Generics are here to stay and will continue to be in the pink of health in 2020

too. By 2020, the early challenges to patented molecules viz, New Chemical Entity (NCE) will substantially diminish.

Dr Gopakumar G Nair CEO, Gopakumar Nair Associates

How do you visualise the outcome of

the patent vs generics war in India?The entire world market is moving towards generics. Even in US over 75 per cent prescriptions in the year 2012 were for generics. However, patents and generics are two sides of the same coin. Only when someone discovers a new molecule, patents it and when the patent expires, it becomes generic. Unfortunately in India, even valid patents have been infringed through compulsory licensing because of ambiguous criteria like ‘not worked in India’ or ‘affordability.’ This is an unhealthy trend which will certainly impact innovation and investment in research.

Will India remain the largest generics

producer by 2020?For India to become a world leader in generics by 2020, it is dependent on three factors – perception about the quality of Indian generics due to recent developments, consistent and stable government policies and global healthcare reforms. India also needs to capitalise on the immense opportunity arising in the biosimilar space. China has taken over India both in biosimilars as well as APIs. Associations are helping accelerate India’s generic exports by proactively interacting with overseas governments and negotiating export friendly policies.

Do you think the race for generics

will hamper innovation in drug

development in India?Increasing use of generics is a key strategy for developed countries to contain burgeoning healthcare costs. As long as the intellectual property of the discoverer is honoured, there is no need to worry about the impact of generics on innovation. However, this trend will certainly influence business models of research based pharmaceutical companies. More and more companies are likely to resort to a hybrid model of having both patented as well as branded generics in their portfolio, particularly because pharmaceutical research is increasingly becoming risky, expensive and lengthy.

Additionally, many blockbusters are nearing their patent expiry and research pipelines are increasingly getting constricted. How will the recent developments

impact Indian pharma industry?The recent developments will act as a deterrent for investment in innovation and research not only for MNCs but for research-based Indian companies as well. The investment will shift focus to countries wherein there exists sound ecosystem for innovation and good enforcement of Intellectual Property Right (IPR) laws in letter as well as in spirit. Countries like China, Singapore and Korea significantly attract more FDI in pharmaceuticals over India.

W

India being a progressing economy, product innovations attract very few investments from the industry players.

Increasing costs of drug development are a mammoth hindrance for countries like India. Being a leader in reverse

engineering innovator drugs, India has made a definitive mark for itself in the global healthcare market.

Pharma industry shifting focus towards generics New drug pipeline is drying out

Confidentiality violations Frivolous litigations on incremental innovations

Key takeaway points

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Dr Ajit DangiQ&A with

President and CEO, Danssen Consulting

A

W

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067, Maharashtra, India

Tel: +91 22 28666134 | Fax: +91-22-28013817 | Email: [email protected]

25M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3Tenders

Spectrophotometer

Org : National Institute of Technology Calicut (NITC)TRN : 16847632Desc : Supply of atomic absorption spectrophotometer, UV - visible spectrophotometer.BOD : 25 July, 2013Loc : KeralaBT : Domestic (NCB)

Gas Chromatography-Mass Spectrometer (GCMS)

Org : Indian Institute of Technology, BhubaneswarTRN : 16797810Desc : Procurement of Gas Chromatography-Mass Spectrometer (GCMS)BOD : 26 July, 2013Loc : Samantapuri, BhubaneswarBT : Domestic (NCB)

Focussed beam reflectance measurement

Org : IIIT BhubaneswarTRN : 16777286Desc : Supply of focussed beam reflectance measurement.BOD : 26 July, 2013Loc : Bhubaneswar, OrissaBT : Domestic (NCB)

Spectrofluorometer

Org : Directorate of Purchase and StoresTRN : 16395269Desc : Purchase of SpectrofluorometerBOD : 29 July, 2013Loc : Indore Regional Purchase Unit, Indore, Madhya PradeshBT : Domestic (NCB)

UV - VIS NIR spectrophotometer

Org : National Institute of Technology Calicut (NITC)TRN : 16846846Desc : Supply of UV - VIS NIR Spectrophotometer.BOD : 29 July, 2013Loc : Kerala BT : Domestic (NCB)

Infrared flue gas analyser

Org : PEC University of TechnologyTRN : 16943709Desc : Supply of infrared flue gas analyserBOD : 30 July, 2013Loc : ChandigarhBT : Domestic (NCB)

Scintillation detector

Org : Department of Atomic EnergyTRN : 16650302Desc : Supply and warranty of 5-inch by 4-inch nai (tl) scintillation detector with integral pmt and collar ring.BOD : 31 July, 2013Loc : Mumbai, MaharashtraBT : Domestic (NCB)

Thermal spectro radiometer

Org : National Remote Sensing Agency (NRSA)TRN : 16849297Desc : Supply and installation of Thermal Spectro Radiometer.BOD : 31 July, 2013Loc : Hyderabad, Andhra PradeshBT : Domestic (NCB)

Gas chromatograph

Org : Tata Institute of Fundamental Research (TIFR)TRN : 16939534Desc : Supply of Gas Chromatograph (GC) with Mass Spectrometer (MS). The estimated cost is ̀45 lakhBOD : 01 August, 2013Loc : Mumbai, MaharashtraBT : Domestic (NCB)

Brought to you by www.tendersinfo.com

Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067, Maharashtra, India

Tel: +91 22 28666134 | Fax: +91-22-28013817 | Email: [email protected]

26 Event List M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

National Events International EventsPHARMAbiotikaPharmabiotika 2013 is an exhibition that facilitate buyer and seller meet to network 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. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives; September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar

For details contact:Human Crayon Management Services Pvt LtdTel: +91- 120 – 6528801Email: [email protected] Website: www.pharmabiotika.com

Indian Pharma ExpoThe Indian Pharma Expo 2013 will serve as a perfect platform for pharma entrepreneurs and investors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and suppliers and distributors of pharma products under one roof to exchange ideas; September 20-21, 2013, Pragati Maidan, New Delhi

For details contact:UBM Medica India Pvt LtdTel: +91-22-66122600 / 66122673Fax: +91-22-66122626Email: [email protected]: www.ubmindia.in

Asia-ArvoSome of the primary highlights of this conference will be interactive session, papers, abstracts and programme. Masses from all over the world are welcome to be part of this conference. Topics that will be discussed in Asia Arvo include genetics of AMD, understanding AMD, reprogramming and regeneration, gene therapy, small molecule screening and drug discovery, model organisms, gene regulation during development and disease, eye development inherited eye diseases, diabetic retinopathy, common eye diseases, signaling pathways, angiogenesis, crystallins, chaperons and heat shock proteins, oxidative stress, ageing and eye disease; October 28-31, 2013, Ashok Convention Centre, New Delhi

For details contact:The Association for Research in Vision and OphthalmologyTel: +12402212900Fax: +12402210370Website: www.arvo.org

CPhI IndiaCPhI India will bring pharma professionals from all over the world to Mumbai and facilitate, initiate and close business deals. It will be a great opportunity for the industry to showcase their products and services while enhancing their brand at South Asia’s leading pharma industry event. Exhibitors will include manufacturers

of Active Pharmaceutical Ingredients, Alkaloids, Amino acids, Antibiotics, Antibodies, Antimicrobial preservatives, Antioxidants, Biocatalysts, Biotechnology, Capsules/encapsulation, Chemical synthesis/analysis, Chira intermediates and lots more; December 3-5, 2013, Bombay Exhibition Centre, Mumbai

For details contact:International UBM LiveTel: +91-22-67692415Fax: +91-22- 66122626 / 66122627Email: [email protected]: www.pmec-india.com

P-MEC IndiaWith India’s pharmaceutical machinery and equipment market growing, decision makers from all over the world are increasingly looking at India for sourcing pharmaceutical machinery and equipment. At P-MEC India, visitors will have the unique opportunity to showcase their products in front a large audience, building brand awareness and gaining new leads from over 85 countries. P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide - the ‘must attend’ event in the international pharmaceutical industry. It is a great platform for visitors to showcase high-quality pharma machinery and equipment, meet with key decision makers in pharmaceutical industry from countries, including India, China, US, UK, France, Italy, etc and network and build the brand in one of the world’s fastest growing pharmaceutical markets; December 3-5, 2013, Bombay Exhibition Centre, Mumbai

For details contact:International UBM LiveTel: +91-22-67692415Fax: +91-22- 66122626 / 66122627Email: [email protected]: www.pmec-india.com

34th International Conference on Bioscience, Biochemical and Pharmaceutical EngineeringThe main focus of this conference is to bring scientists, researchers and scholars together to exchange and share experiences and research results about bioscience, biochemical and pharmaceutical engineering, and discuss the practical challenges encountered and the solutions adopted. The conference will deal with topics such as bioscience, biochemical and pharmaceutical engineering, affective neuroscience, astrobiology; December 5-6, 2013, Sheraton, Bengaluru

For details contact:World Academy of Science Engineering and TechnologyTel: +44-782-4879405Website: www.waset.org/conferences/2013/bangalore/icbbpe/

3rd International Conference on Environmental, Biomedical and Biotechnology This conference is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society. It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore

For details contact:Asia-Pacific Chemical, Biological & Environmental Engineering SocietyTel: +86-28-86528465 (China Branch)Email: [email protected]: www.icebb.org

Fifth Annual Consumer Genetics Conference The conference will draw together a dynamic community of scientists, clinicians, technology innovators, and patients to discuss the burning issues around the analysis and delivery of genomics results directly to patients and consumers. Attendees will hear about disruptive diagnostic technologies, cognitive barriers to patients and medical professionals, ethical, regulatory, privacy issues, the issue of reimbursement, and the challenges of building relationships to realise the potential of personal genomics and individualised medicine. CGC will provide an opportunity for all stakeholders to come together at one venue, share viewpoints and engage in dialogue; September 25-27, 2013, Seaport Hotel, Boston, USA

For details contact:IlluminaTel: 781-972-1359Email: [email protected] Website: www.consumergeneticsconference.com

4th Global Drug Safety Conference and ExpositionThe 4th Global Drug Safety Conference and Exposition will be based on the theme, ‘Revitalising Drug Safety – The Decade of the Patient.’ Drug safety has become one of the most challenging public health issues of this time. It is everyone’s responsibility to take action to address the serious threat to global public health posed by the pressing issues relating to unsafe medicines and the unsafe use of medicines. The exposition will bring together government leaders, drug regulatory agencies, drug safety specialists, healthcare professionals, pharmaceutical industry, healthcare technology providers, health insurance providers, patient safety advocates, and consumer groups from

all over the globe; October 14-16, 2013, Brisbane Convention and Exhibition Centre, Brisbane

For details contact:Ozaccom+ Conference ServiceTel : +61 (0)7 3854 1611 Fax: +61 (0)7 3854 1507 Email: [email protected]: www.gds2013.org

Drug Discovery Re-Invented: Emerging Role of Biotechs, Academics and Non-ProfitsThe conference will center on new approaches to drug discovery in an industry where the landscape is changing rapidly. With large pharma reducing investment in internal early stage research, drug pipelines will increasingly be filled by alternative sources. These players include: government, academic labs, non-profits, biotech companies, and pharmaceutical “open innovation” models. The conference will also provide examples of successful strategies for advancing new drug candidates in this era of distributed discovery; October 16–19, 2013, Hilton Scottsdale Resort & Villas, Scottsdale, Arizona, USA

For details contact: Fusion ConferencesTel: +44 (0) 1638 724137Fax: +44 (0) 1638 724135Email: [email protected]: www.fusion-conferences.com

5th Pan Arab Human Genetics ConferenceThe conference will focus on topics ranging from cancer genomics and NexGen sequencing to molecular profiling and pharmacogenomics. International and regional experts will take to the platform to deliver their lectures on these topics. Researchers will be encouraged to submit their abstracts for oral or poster presentation at the conference. Also, a special feature of the conference will be a workshop on rare disorders; November 17-19, 2013, Al Bustan Rotana, Dubai-UAE

For details contact:Meeting Minds ExpertsTel: +9714-4270492Fax: +9714-4270493Email: [email protected]: www.pahgc.org

2013 International Conference on Pharmaceutical and Biological Sciences The aim of the International Conference on Pharmaceutical and Biological Sciences 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 pharmaceutical and biological Sciences; November 17-18, 2013, Cristal Hotels & Resorts, Abu Dhabi, UAE.

For details contact:Asia-Pacific Chemical, Biological & Environmental Engineering Society (APCBEES)Tel: +86-28-86528465Email: [email protected]: www.icpbs.com

For detailsNetwork18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

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.

AHMEDABADGujarat

March 07-10, 2014

LUDHIANAPunjab

December 20-23, 2013

AURANGABADMaharashtra

January 10-13, 2014

INDOREMadhya Pradesh

Jan 31 – Feb 03, 2014

KOLKATAWest Bengal

February 21-24, 2014

PUNEMaharashtra

October 18-21, 2013

CHENNAI Tamil Nadu

November 14-17, 2013

JAIPUR Rajasthan

Nov 29 - Dec 02, 2013

27M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3Book Review

Handbook of Medical Device Regulatory Affairs in Asia

FDAnews Guide to International Medical Device Regulation

egulatory affairs is a specialty soon coming into prominence, with the world becoming a global village for trade and healthcare. Pharmaceutical ‘regulatory affairs’ is a well established department

in most of the top domestic pharmaceutical companies, but medical device regulations in India are still at infancy. This handbook is promoted by the Asia regulatory professional association. It is a good overview of the regulatory landscape across the world related to the device industry. The book is divided into five parts. Part one, deals with the profession of regulatory affairs in general while laying emphasis on skill sets, quality of job, speed of the job, product launches and development. The chapter on access to affordable devices in developing countries is an interesting read. Part two, offers an overview of the biomedical market and the regulations in various countries to start with. It discusses in detail two ISO systems that are relevant in the device industry ie, ISO 13485 and ISO 14971 dealing with quality management and risk management in devices. Part three provides a brief glimpse into various organisations working towards device regulation and process harmonisation. The role of Association of Southeast Asian Nations (ASEAN) countries and technology hubs like Hong Kong and Singapore are discussed in brief. Part 4 and 5 are the real voluminous parts of the books, with part four dealing in US and EU regulations, while part five sheds light on the individual countries in the Asia Pacific region. These chapters give a good insight into the regulators way of working and thinking. The book also drives at the global harmonisation process in regulations and safety. Interspersed with flow charts, illustrations, classic case studies and anecdotes, this book is a must-have for every biomedical student, device regulators, manufacturers, importers and exporters.

he FDA is a premiere agency regulating the drugs, device and food industry in the United States. The

FDA releases news, notifications and advisories to domestic and international manufacturers on devices and also keeps up with the regulators across the globe. With international trade growing leaps and bounds, regulators across countries asserting their laws on manufacturers, it is essential to stay abreast of these developments. FDAnews is a compilation of all such notifications are introduced in the US, Europe, and countries across the world. They are catalogued into various sections for easy retrieval. This is a well sought-after annual compilation, which helps manufacturers get an insight into the regulatory landscape across the world. The guide stresses on new developments in healthcare and manufacturing, hubs in the Asia Pacific region where regulators are relatively new and evolving frequently. These hubs cater to the growing emerging economies and serve as a potential market for manufacturers. The annual edition is a must-have for every individual in trade, regulations, manufacture and policy making.

Editors: Jack Wong & Raymond K Y Tong

Price: ` 8,900/-

Price: ` 33,000/-

Publisher: Pan Stanford PublishingDistributor: 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: [email protected]

Publisher: US Food and Drug AdministrationDistributor: 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: [email protected]

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

R T

28 Products M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

Looking for a specific product?Searching and sourcing products were never so easy.

Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

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

Biosafety cabinetModel AHA -143-AA-A has power requirement of 1 1 5 V / 6 0 H z / 1 0 A , power consumption of 300 watt. It includes a control system of touch panel RS 232/485 which can be optional. The airflow is 70% recirculated/ 30% exhausted. The cabinets are EN 12469 Compliance Certified. External dimensions without footstand 660mm/26” is 1448x807 x 1519 mm/ 57* x 31.8* x 59.8* (W xD xH). Internal dimension is 1245x587 x658 mm/ 49* x 23.1* x 25.9* (WxD xH) with SUS#304 cabinet construction. Average inflow velocity is 0.51m/s (100 fpm) whereas average downflow velocity is 0.34m/s (67fpm). Light intensity is >1,000 lux and sound levels < 65dBA. It also has a 6mm tempered glass, Duplex electrical outlets with splash-proof cover*2 (UL listed) and V bar with 6 hooks/ service valves (air, gas, vacuum)/ Exhaust canopy. Net weight is approximately 310kg (683 lbs) and suggested room height is 240 cm.

Mack Auraa Nashik – MaharashtraMob: 09225528585 Fax: 02551-230877 Email: [email protected] Website: www.mackauraa.com

CheckweigherA checkweigher is an important part of a quality control program and is a means to provide benefits to the company. Anritsu Checkweighers are installed on food, industrial and pharmaceutical production lines for various quality control purposes. Often, the installation of an accurate checkweigher provides profit benefits to the user by controlling filler or scale accuracy to minimise product give away. Systems are also used to assure compliance with label weight regulations and to eliminate consumer complaints associated with missing item or low-weight packaging conditions. Line efficiencies can be tracked and ‘give away’ can be calculated providing an opportunity to streamline production and save costs within the process.

M/s Jay Instruments & Systems Pvt Ltd Mumbai – MaharashtraMob: +91-9004279992.Email: [email protected] Website: www.jayinst.com

Food emulsifierStephan Germany offers its multi-purpose high speed microcut emulsifiers MC 15, MCH 20K for continuous

process and consistent size reduction. It is easily removable and it consists of hard tipped, cutting rotors having no metal-to-metal contact – ensuring minimum product temperature rise and a long tool life. With the combination of the Stephan rotor/stator and the pre-cutting blade system operating at 3000 rpm, a size reduction of 1:100 can be achieved in one process step. For eg, vegetables in size of 35 mm can be reduced directly to 0.35 mm. The capacity available is 400 – 1000- 4500 Kg/hr. It features low power consumption, various infeed/discharge system, inline units available to suit process. It is ideal for fine pastes where protein swelling is an advantage. It is also useful for grinding fish or chicken/ skin for fat recovery, fish- head paste, sea moss, reduction for petfood, offal, feather for feed and chemical/pharma applications.

TRICON Pune – Maharashtra Tel: 020- 25652205, 25652451Mob: 09890192832Email: [email protected], [email protected]

CentrifugeLabtop large v o l u m e c e n t r i f u g e s are designed for separating blood and blood c o m p o n e n t s from whole b l o o d like platelet, plasma, RBC and Cryoprecipitate and it is ideal for blood banks and hospitals. It is used in pharmaceutical industry, research centres, vaccine manufacturing industry and universities. The heavy duty steel fabricated centrifuge is provided with stainless steel inner chamber and effectively insulated to provide sufficient cooling of the chamber. It is a CFC free refrigeration system with pre-cooling facility, maintenance free brushless induction motor with low level of vibration and noise with smooth acceleration and deceleration. Also present is an electronic motorised door lock facility to open in case of power failure. RCF, acceleration and deceleration time can be set as per user requirement. Imbalance cut off, safe door open and mechanical lid lock is provided for increased safety.

Labtop Instruments Pvt LtdThane - MaharashtraTel: 0250 – 6457376/99Email: [email protected]: www.labtopinstruments.com

Walkin stability chamberRemi Walkin stability chamber is designed to meet ICH, WHO, USFDA guidelines. It is made of modular panels with PUF Insulation. Capacity is from 3000 liters onwards and it can be made to order. It features CFC free refrigeration, forced air circulation, alarm for temperature, humidity, utility failures, facility to open the door from inside if locked accidentally, intelligent PLC controller for precise control of temperature, humidity, automatic switch over to standby refrigeration, humidity, sensor, capacitance type sensor for direct display of humidity, datalogger for multipoint recordings, GSM mobile alert, biometric door access, PC communication via Ethernet/RS-485. Condensing unit located outside lab emits hot air beyond working area. The software complies 21CFR part11 guidelines.

Remi Elektrotechnik LtdMumbai – MaharashtraTel: 022-40589888Mob: 09820627422Email: [email protected]: www.remilabworld.com

Waterproof multiparameter meterIt is a waterproof multiparameter meter of the Testr 35-series from Oakton. It is a pocket-sized meter which measures pH, conductivity, TDS, salinity, and temperature and is perfect for water, wastewater, laboratory and plant-use. These pocket-sized meters have long-life pH electrodes and stainless steel conductivity sensors for a wide range of sample compatibility. It has easy-to-replace sensor modules which can save you money, allowing you to reuse the meter body. The operating procedure is simple and changing sensors for different measurements is not required. These meters offer multiple calibration options—choose single or multipoint, automatic or manual. It can measure conductivity or TDS more accurately at varying temperatures with an adjustable temperature coefficient feature. Auto-ranging feature makes it more convenient for users with applications across broad measurement ranges. Unique sensor design provides faster ATC response and faster readings.

Cole-Parmer India Pvt LtdMumbai - MaharashtraTel: 022 - 67162209/2222Fax: 022-67162211 Email: [email protected] Website: www.coleparmer.in

Deep freezerThe temperature range of a deep freezer is 60°C with + 3°C accuracy and + 3°C uniformity. Eco-friendly PUF insulation with a thickness of 80mm and projected door prevents condensation. This facilitates product view. Inner and outer doors are sealed around their entire perimeter with a silicone sponge rubber gasket. Bullet feet with in-built screwing adjustment are specifically designed for long life under heavy load. The deep freezer is a heavy-duty refrigeration system which is maintenance free with hermetically sealed refrigeration compressors for reliable refrigeration, while minimising noise and vibration. The freezer is designed to follow the 21 CFR PART-11 Compliance. Other features include log data, event data, audit trail data, e-records, e-signatures, graphical analysis and data acquisition. Some of the optional features are GSM technology, hooter system and extra tray.

Mack Pharmatech Pvt LtdNashik – Maharashtra Tel: 02551-230877 Fax: 02551-230877Email: [email protected]: www.mackpharmatech.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 oil-free, for vastly reduced service demands compared with oil-sealed pumps. They eliminate the water waste of water-jet aspirators, and the contaminated waste-oil 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 30 Torr. Chemical resistant vacuum pumps are also supplied with 3 phase flame-proof motors.

Sri Vishnu Pumps Mfg CoThane - MaharashtraTel: 022 - 28458372Fax: 022 - 28457073Email: [email protected]: www.minivacpumps.com

29M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3Marketplace

MODERN MEDICARE is a

Modern Medicare

Scan this codeon your smart phoneto visit www.modernmedicare.co.in

For further enquiry, write to:[email protected] OR

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To source product from this magazine SMS: MM (Space) Product Name to 51818

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Advancements

New-age techniques for better drug delivery

Dermaceuticals and cosmeceuticalsTapping new market potential

Hospital audit standards Being strategically positioned does matter

Solar energy harvesting Cost-saving solutions for hospitals

Healthcare marketing Top 10 tips to maximise reach

Dr Sujit Chatterjee Chief Executive Officer, Dr L H Hiranandani Hospital

ALSO INSIDE

in Dermatology

30 Products & advertisers list M o d e r n P h a r m a | 1 6 -3 1 J u l y 2 0 1 3

Looking for a specific product?Searching and sourcing products was never so easy.

Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

Acoustic enclosure .....................................................6,27

Air sterilisation .....................................................................BC

Atlantis ..................................................................................29

Biomaterial dispensing component .......................... 10

Biosafety cabinet ................................................................28

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

Cable management system ........................................29

Centrifuge .............................................................................28

Checkweigher.......................................................................28

Chemical resistant diaphragm vacuum pump ...........28

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

Container sterilisation .......................................................BC

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

Cooling tower solution ......................................................29

D&C colour .................................................................. 12,13

Data logger series for humidity ..........................................3

Deep Freezer .................................................................... 11,28

Dispersion ..........................................................................12,13

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

Double sided rotary .............................................................. 8

Dry van pump....................................................................6,27

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

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

Fluid management component ......................................10

Food emulsifier ....................................................................28

FRP cross arm ......................................................................29

FRP epoxy pultruded profile ............................................29

FRP trefoil clamp ................................................................29

FRP/ GRP Profiles ...............................................................29

FRP/GRP handrail and fencing .......................................29

FRP/GRP ladder ..................................................................29

FRP/GRP Luminaries .........................................................29

FRP/GRP moulded grating ...............................................29

FRP/GRP pultruded grating .............................................29

FRP/GRP step tread ...........................................................29

FRP/GRP tank ......................................................................29

High speed tablet press .................................................8

Humidity chamber ............................................................... 11

HVAC and MEP ....................................................................BC

HVAC all rounder ....................................................................3

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

Light pole and utility pole ................................................29

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

Methacrylic acid copolymer ............................................BIC

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Natural food colour ................................................... 12,13

Other process equipment ..............................................8

Oven.......................................................................................... 11

Pharmaceutical excipient ......................................... BIC

Pharma Packaging .................................................................1

Photostability chamber ...................................................... 11

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

Pilot/lab scale tablet press ................................................ 8

Piping system .......................................................................29

Portale hygrometer ...............................................................3

Pressure tank .......................................................................29

Pressure vessel ....................................................................29

Professional humidity meter ..............................................3

Pump ...................................................................................6,27

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Roller compaction system ................................................. 8

Roots blower .....................................................................6,27

Rotary gear pump ............................................................... 25

Rotary jocketed pump ....................................................... 25

Rotary main oil pump ........................................................ 25

Rotary monoblock pump ................................................. 25

Rotary tablet press ............................................................... 8

Rotary tracodial pump ...................................................... 25

Rotary twin gear pump ..................................................... 25

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

Stainless steel pipe ............................................................29

Tablat coating material drugcoat............................ BIC

Tablet press machine .......................................................... 8

Tooling and spare ................................................................. 8

Tube ........................................................................................29

Turnkey solutions for biotech and pharma industry BC

U’ tube .............................................................................29

Vacuum booster pump..............................................6,27

Vacuum system ................................................................6,27

Walk in humidity chamber ........................................... 11

Walk in incubator .................................................................. 11

Walkin stability chamber .................................................28

Water soluble synthetic dye .........................................12,13

Waterproof multiparameter meter ...............................28

Waters sunfire ......................................................................29

Welded pipe .........................................................................29

X select hplc column .....................................................29

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

Product Pg No Product Pg No Product Pg No Product Pg No

Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No

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Chemical & Process World 18

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DEL Pd Pumps & Gears Pvt Ltd 25

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Everest Blower 6

T: +91-11-45457777


W: www.everestblowers.com

Everest Blowers System 27

T: +91-11-45457777


W: www.everestblowers.com

Fabtech Technologies Intl Pvt Ltd BC

T: +91-22 61592900


W: www.fabtecheng.com

GMP Technical Solutions Pvt Ltd FIC

T: +91-22 66083790


W: www.gmptech.net

Mack Pharmatech Pvt. Ltd. 11

T: +91-2551-230877


W: www.mackpharmatech.com

Nordson India Pvt Ltd 10

T: +91-80-40213524


W: www.nordson.com

P R Corporation 29

T: +91-22-24109921


W: www.indiamart.com

Roha Group 12, 13

T: +91 22 4077 3333


W: www.rohagroup.com

Salesworth Synergies Pvt Ltd (Rommelag) 9

T: +91-80-25274495


W: www.rommelag.com

Sotax India Pvt Ltd 7

T: +91-022-42950191


W: www.sotax.com

Suraj Limited 29

T: +91-79-27540720


W: www.surajgroup.com

Testo India Pvt Ltd 3

T: +91-20-65600203


W: www.testo.in

Vikram Thermo (India) Ltd BIC

T: +91-79-27543745


W: www.vikramthermo.com

RNI No: MAHENG / 2008 / 27125,

32

Modern Pharma July 16-31

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